issue-1996-01-30•Federal Register final rules — 1996-01-30
Federal Register final rules — 1996-01-30
issue-1996-01-30Federal Register final rules — 1996-01-30Regulation
Published Federal Register documents, not public-inspection drafts. The GPO XML/text rendition is a research aid; the linked complete official PDF retains the printed layout and all graphics. Graphics are retained in that PDF and are not independently reproduced in this text rendition. Publication does not establish that every provision remains legally in force.
FR Doc. 96-330 Availability of Information to the Public and Removal of CFR Chapters
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2898-2899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-330]
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DEPARTMENT OF AGRICULTURE
Foreign Agricultural Service
7 CFR Parts 1520, 2101, 2200, and 2507
Availability of Information to the Public and Removal of CFR
Chapters
AGENCY: Foreign Agricultural Service.
ACTION: Final rule.
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SUMMARY: This document revises regulations governing the availability
of information to the public by the Foreign Agricultural Service (FAS)
to reflect reorganizations of the Department of Agriculture since these
regulations were first published. The Foreign Economic Development
Service has been eliminated and both the Office of International
Cooperation and Development and the Office of the General Sales Manager
are part of FAS and will not have separate Freedom of Information Act
responsibilities. Therefore, this regulation also removes 7 CFR parts
2101, 2200, and 2507 and their respective CFR chapters, relating to the
availability of information by these offices. The regulation also makes
other internal management changes to the regulations.
EFFECTIVE DATE: January 30, 1996.
FOR FURTHER INFORMATION CONTACT:
Carolyn Harris, (202) 690-1851.
SUPPLEMENTARY INFORMATION: Pursuant to the reorganization of the
Department of Agriculture under Public Law 103-354, the Secretary of
Agriculture reassigned departmental functions relating to foreign
agricultural programs to the Under Secretary of Agriculture for Farm
and Foreign Agricultural Services. See 59 FR 66517, December 27, 1994.
The Under Secretary delegated certain of those functions to the
Administrator of the Foreign Agricultural Service. See 60 FR 56433,
November 8, 1995. In this document, the Foreign Agricultural Service is
amending regulations governing the availability of information to the
public to reflect the reorganization of these functions.
This rule relates to internal agency management. Therefore,
pursuant to 5 U.S.C. 553, notice of proposed rulemaking and opportunity
for comment are not required, and this rule may be made effective less
than 30 days after publication in the Federal Register. Further, since
this rule relates to internal agency management, it is exempt from the
provisions of Executive Order Nos. 12778 and 12866. This action is not
a rule as defined by the Regulatory Flexibility Act, Pub. L. 96-354,
and, thus, is exempt from the provisions of that Act.
List of Subjects in 7 CFR Parts 1520, 2101, 2200 and 2507
Freedom of information.
Accordingly, and under the authority of 5 U.S.C. 552, Title A of
the Code of Federal Regulations is amended to read as follows:
CHAPTER XV
PART 1520--[AMENDED]
1. The authority citation for part 1520 continues to read as
follows:
Authority: 5 U.S.C. 552.
2. Section 1520.3 is revised to read as follows:
Sec. 1520.3 Public inspection and copying.
5 U.S.C. 552(a)(2) requires that certain materials be made
available for public inspection and copying. Members of the public may
request access to such materials through the Information Division, FAS,
Room 5074, South Building, Department of Agriculture, 14th Street and
Independence Avenue, SW., Washington, DC 20250-1004. The office will be
open from 8:30 a.m. to 5 p.m. Monday through Friday, except legal
holidays.
3. Section 1520.4 is revised to read as follows:
Sec. 1520.4 Indexes.
5 U.S.C. 552(a)(2) required that each agency publish or otherwise
make available a current index of all materials required to be made
available for public inspection and copying. Copies of the FAS Index
may be obtained free of charge by telephoning (202) 720-7115 or writing
to the Freedom of Information Officer, Information Division, FAS, Ag
Box 1004, Department of Agriculture, 14th Street and Independence
Avenue SW., Washington, DC 20250-1004.
4. Section 1520.5 is revised to read as follows:
Sec. 1520.5 Request for records.
(a) Requests for records under 5 U.S.C. 552(a)(3) shall be made in
accordance with 7 CFR 1.3(a) and addressed to the Freedom of
Information Officer, Information Division, Foreign Agricultural
Service, Ag Box 1004, Department of Agriculture, 14th Street and
Independence Avenue, SW., Washington, DC 20250-1004.
(b) Processing of a request for information can be facilitated if
``FOIA REQUEST'' is placed in capital letters on the front of the
envelope and at the top of the letter. Additional information may be
obtained by telephoning the FAS Information Division on (202) 720-7115.
5. In section 1520.6, paragraph (a) is amended by removing
``20250'' and adding, in its place, ``20250-1001'', and paragraph (b)
is amended by adding at the end thereof a new sentence to read as
follows:
Sec. 1520.6 Appeals.
* * * * *
(b) * * * Additional information may be obtained by telephoning the
FAS Information Division on (202) 720-7115.
CHAPTERS XXI, XXII, XXV--[REMOVED]
PARTS 2101, 2200, AND 2507--[REMOVED]
6. Parts 2101, 2200 and 2507 are removed and chapters XXI, XXII,
and XXV are vacated.
[[Page 2899]]
Signed at Washington, DC on December 1, 1995.
August Schumacher, Jr.,
Administrator, Foreign Agricultural Service.
[FR Doc. 96-330 Filed 1-29-96; 8:45 am]
BILLING CODE 3410-10-M
Complete official Federal Register PDF
FR Doc. 96-1816 Standards for Grades of Slaughter Cattle and Standards for Grades of Carcass Beef
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2891-2898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1816]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
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Federal Register / Vol. 61, No. 20 / Tuesday, January 30, 1996 /
Rules and Regulations
[[Page 2891]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Parts 53 and 54
[No. LS-94-009]
Standards for Grades of Slaughter Cattle and Standards for Grades
of Carcass Beef
AGENCY: Agricultural Marketing Service (AMS), USDA.
ACTION: Final rule.
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SUMMARY: This final rule revises the official U.S. standards for grades
of carcass beef and the related standards for grades of slaughter
cattle. The changes eliminate ``B'' maturity (approximately 30-42
months of age) carcasses with small or slight marbling degrees from the
Choice and Select grades and include them in the Standard grade. This
action is being taken because carcasses with these characteristics have
been shown to be both quite variable and often unacceptable in
palatability, which contributes significantly to inconsistent
palatability of Choice and Select grade beef. The standards for grades
of slaughter cattle, which are based on the beef carcass grades, are
revised to parallel the changes in the beef carcass grade standards.
This change should serve to strengthen the competitive position of beef
products through increased quality and consistency, and thus be in the
best interests of the beef industry. Also, it should provide the
consumer with an improved product through greater consistency and
predictability in the eating quality of Choice and Select grade beef.
The changes should provide the industry with long-term benefits because
pricing systems will be improved, quality inconsistencies will be
reduced, demand for beef will be improved, and the market share beef
commands should increase. These revisions are the same as those
proposed in the January 19, 1995, Federal Register (60 FR 3982).
EFFECTIVE DATE: July 1, 1996.
FOR FURTHER INFORMATION CONTACT: Herbert C. Abraham, Chief, Livestock
and Meat Standardization Branch, Livestock and Seed Division,
Agricultural Marketing Service, U.S. Department of Agriculture, P.O.
Box 96456, Washington, D.C. 20090-6456, 202/720-4486.
SUPPLEMENTARY INFORMATION:
Executive Order 12866
The Department of Agriculture is issuing this rule in conformance
with Executive Order 12866.
Executive Order 12778
This rule has been reviewed under Executive Order 12778, Civil
Justice Reform. This action is not intended to have retroactive effect.
This rule would not preempt any State or local laws, regulations, or
policies, unless they present an irreconcilable conflict with this
rule. There are no administrative procedures which must be exhausted
prior to any judicial challenge to the provisions of this rule.
Regulatory Flexibility Act
The Administrator, Agricultural Marketing Service (AMS), has
certified that this action will not have a significant economic impact
on a substantial number of small entities, as defined in the Regulatory
Flexibility Act, P.L. 96-345 (5 U.S.C. 601). The use of the beef
carcass and slaughter cattle grade standards is voluntary, and they are
applied equally to all size entities covered by these regulations.
Further, this action does not impose any new requirements or costs, it
only modifies the grade requirements to reflect modern production
practices. All entities can make needed management changes in response
to market signals. The action is expected to benefit the industry by
improving consumer satisfaction with beef products, and there should be
a positive impact on overall industry returns.
Background
Federal beef grading is a voluntary fee for service program,
provided under the Agricultural Marketing Act of 1946, as amended (7
U.S.C. 1621 et seq.). A primary purpose of the grades is to divide the
population of cattle and beef into uniform groups (of similar quality,
yield, value, etc.), in order to facilitate marketing. Grades provide a
simple, effective means of describing a product that is easily
understood by both buyers and sellers. By identifying separate and
distinct segments of a commodity, grades enable buyers to obtain that
particular portion of the entire range of a commodity which meets their
individual needs. At the same time, grades are important in
transmitting information to cattle producers so that more informed
production decisions can be made. For example, the market preference
for a particular grade of beef can be communicated to cattle producers
so they can adjust their production accordingly.
When beef is voluntarily graded, the official grade consists of a
quality grade and/or a yield grade. The quality grades are intended to
identify differences in the palatability (eating satisfaction) of
cooked beef primarily through the combined characteristics of marbling
and maturity. The principal official USDA quality grades for young
(maturity groups A and B) cattle and carcasses are Prime, Choice,
Select, and Standard.
In developing the grades, the Department has followed the
philosophy that, to be effective, beef grades should sort the supply of
beef carcasses into homogeneous groups having a sufficiently narrow
range of grade-determining factors so that carcasses within a given
grade are essentially interchangeable. Another major objective is to
provide as uniform and consistent product as possible within a given
grade.
National Cattlemen's Association Petition
In June 1994, the National Cattlemen's Association (NCA) petitioned
USDA to modify the beef quality grade standards by removing B-maturity
carcasses with small and slight marbling scores from the Choice and
Select grades and include such carcasses in the Standard grade. This
action was recommended by a NCA Carcass Quality Task Force which worked
for approximately 1\1/2\ years to develop specific recommendations for
the beef industry to win the ``war on fat,'' while enhancing beef
quality and consistency. The task force had broad representation
[[Page 2892]]
from the cattle production and feeding sectors, as well as packers,
purveyors, and retailers. Several actions were recommended, but only
this particular recommendation related directly to the beef grade
standards.
The NCA petition stated the modern beef animal today is typically
marketed at 12 to 15 months of age when fed as calves and 18 to 24
months of age when fed as yearlings. These modern animals are the
result of progressive breeders and feeders who produce faster growing,
more efficient cattle. If these animals receive proper care and
nutrition, they should have no difficulty producing carcasses in the A-
maturity group. Carcasses of B-maturity are typically from cattle which
are 30 to 42 months of age when marketed.
Research conducted for the Department by Texas A&M University
(Smith et al., 1984, Journal of Food Quality), using trained taste
panels, indicates that nearly 50 percent of the loin steaks from B-
maturity carcasses with slight marbling, and over 30 percent of the
loin steaks from B-maturity carcasses with small marbling, are less
than satisfactory. These B-maturity carcasses significantly contribute
to the variability of palatability within the Select and Choice grades
and they do not epitomize the ``modern beef carcass.'' Permitting B-
maturity carcasses with a small and slight degree of marbling to be
graded Choice and Select when they have been proven to be considerably
more variable in palatability than A-maturity carcasses with slight and
small marbling provides no incentives for the beef industry to decrease
production and marketing of cattle which do not conform to consumer
demand for quality and consistency.
Although these cattle make up only a small percentage of the U.S.
fed beef supply, their variability in palatability can significantly
affect overall consumer satisfaction with beef. According to a national
beef quality audit conducted in 1991, B-maturity carcasses with slight
and small marbling made up about 4.8 percent of the fed-beef supply.
The beef industry processes approximately 26 million fed beef carcasses
annually. The estimated 4.8 percent of fed-beef affected by the
proposed grade change would represent approximately 1.3 million
carcasses. It is estimated that 42 percent of these carcasses would
have less than desirable palatability. This means over 500,000
carcasses with less than desirable palatability could be removed from
the Choice and Select grades, which should have a very positive effect
on consumer satisfaction with beef. The NCA believes producers can and
will respond quickly to the market signals that these ``older'' cattle
should be marketed at an age at which they can produce A-maturity
carcasses and thus produce beef that is more acceptable to consumers.
Such a shift in management could effectively eliminate most B-maturity
carcasses from the beef supply without negatively affecting overall
economic returns to the industry.
The proposed change was seen as having a positive effect on the
marketing of Select grade beef. It would not only make the palatability
more consistent, but it would also make the nutritional profile more
consistent by removing from the Select grade, B-maturity carcasses
which have higher amounts of fat due to the higher marbling level
(small in B-maturity compared to slight in A-maturity) required for
these carcasses to qualify for Select. This makes the Select grade more
uniform in both fat content and consistency of palatability and enhance
its acceptance by consumers who desire leaner beef. Since the U.S. Good
name was changed to U.S. Select in 1987 (52 FR 35679), the percentage
of Select graded beef has steadily increased, and in FY 93, 33.6
percent of graded steer and heifer beef was Select.
The NCA recommendation stated it was submitted to aid the beef
industry in producing a higher quality, more consistent beef product
under the Choice and Select grades. Eliminating B-maturity carcasses
will allow market forces to further discourage the production of cattle
which do not conform to consumers desire for tender, tasty beef
products. The modern beef animal raised using modern breeding and
feeding technology should have no trouble producing a carcass of A-
maturity. The small proposed modification to the standards will
strengthen consumer confidence in using grades to identify quality and
consistency when purchasing beef.
Proposed Standards
The Department carefully evaluated the recommendation and concurred
that the suggested changes should improve consumer satisfaction with
the Choice and Select grades and thus strengthen the competitive
position of beef in the marketplace while aiding the beef industry in
its objective of providing more palatable, consistent beef to
consumers.
Therefore, it was proposed that the beef carcass standards be
revised to eliminate B-maturity (approximately 30-42 months of age)
carcasses with small or slight marbling degrees from the Choice and
Select grades and reduce their grade to Standard.
It was also proposed that the standards for grades of slaughter
cattle, which are based on the beef carcass grade standards, be revised
to reflect the changes proposed for the beef carcass grade standards.
Grades of slaughter cattle are intended to be directly related to the
grades of the carcasses they produce.
Comments
A 90-day comment period, which closed on April 19, 1995, was
provided for submission of comments. The official number of comments
submitted prior to the close of the comment period was 403. In
addition, approximately 65 comments were received which were submitted
after the close of the comment period. These 65 comments expressed
essentially the same views as the 403 comments submitted in a timely
manner. All submitted comments are part of the public record on the
proposed change and are available for public review. The comments were
divided into several groups (sectors) representing segments of the
production and consumption chain with similar interests. The comments
were also classified as being submitted by an individual or an
organization. The distribution of comments by these categories is shown
in Table 1.
The percentage support/opposition for the proposed change by source
and classification (i.e., individual or organization) is shown in Table
2. Over 70 percent of the comments from both individuals and
organizations supported the proposed change. The proposed change was
strongly supported by the purveyor and processor, retail and
restaurant, consumer, government, and academia sectors. Of the comments
from these sectors, only two individual comments were opposed to the
proposed changes. The strongest opposition to the proposed changes was
from the cattle feeding, cattle marketing, and the packer sectors. All
comments from packers, all but one comment from the cattle marketing
sector, and a majority of cattle feeders were opposed to the proposed
changes. While the majority of cattle feeding and marketing sector
comments were opposed, if they are combined with the comments from the
cattle production sector, a large majority of comments from both
organizations (71.4%) and individuals (63.0%) representing cattle
interests (production, feeding, and marketing) supported the proposed
change.
[[Page 2893]]
Table 1--Distribution of Comments
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Source Organizations\1\ Individuals\2\ Total
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Cattle production............. 27 171 198
Cattle Feeding................ 4 96 100
Cattle Marketing.............. 3 8 11
Packer........................ 2 4 6
Purveyor and processor........ 2 17 19
Retail and Restaurant......... 1 6 7
Consumer...................... 0 34 34
Government.................... 0 5 5
Academia...................... 0 15 15
Other......................... 0 8 8
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Total................... 39 364 403
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\1\Includes comments of state, regional, and national organizations.
\2\Includes comments of individuals, comments with multiple signers, and
businesses.
Table 2.--Comments in Favor of or Opposed To Adoption of USDA Proposed Changes.\1\
----------------------------------------------------------------------------------------------------------------
Favor Oppose
Source ---------------------------------------------- Total
Number Percent Number Percent
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Cattle Production:
Individuals\2\....................................... 131 77.1 39 22.9 170
Organizations........................................ 25 92.6 2 7.4 27
Cattle Feeding:
Individuals\2\....................................... 40 42.1 55 57.9 95
Organizations........................................ 0 0 4 100.0 4
Cattle Marketing:
Individuals.......................................... 1 12.5 7 87.5 8
Organizations........................................ 0 0 3 100.0 3
Packer:
Individuals.......................................... 0 0 4 100.0 4
Organizations........................................ 0 0 2 100.0 2
Purveyor and Processor:
Individuals.......................................... 16 94.1 1 5.9 17
Organizations........................................ 2 100.0 0 0 2
Retail and Restaurant:
Individuals.......................................... 6 100.0 0 0 6
Organizations........................................ 1 100.0 0 0 1
Consumer:
Individuals\2\....................................... 32 97.0 1 3.0 33
Organizations........................................ 0 -- 0 -- 0
Government:
Individuals.......................................... 5 100.0 0 0 5
Organizations........................................ 0 -- 0 -- 0
Academia:
Individuals\2\....................................... 14 100.0 0 0 14
Organizations........................................ 0 -- 0 -- 0
Other:
Individuals.......................................... 7 100.0 0 0 7
Organizations........................................ 0 -- 0 -- 0
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Total............................................ 280 70.2 119 29.8 399
Individuals.................................... 252 70.0 108 30.0 360
Organizations.................................. 28 71.2 11 28.2 39
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\1\Includes all written comments except 4 which were nonresponsive or noncommittal regarding the proposed
changes.
\2\One comment from this source was nonresponsive or noncommittal regarding the proposed changes.
Comments in favor of the change strongly supported the removal of
B-maturity carcasses with small and slight marbling from the Choice and
Select grades. The proposed change was seen by many commenters as an
opportunity to improve the overall quality of beef from these grades by
removing a group of carcasses which only comprise a small percentage of
the fed-beef supply, but contribute significantly to beef with less
than desirable eating satisfaction for consumers. These commenters
indicated that removal of a group of carcasses of which up to
approximately 50 percent may produce an inconsistent, variable product
which provides consumers with a less than desirable eating experience
was a first step toward restoring consumer confidence and market share
which has been eroding over the last several years. These comments
expressed the view that any group of carcasses with this degree of
variability should not be allowed in the Choice and Select grades if
the industry is serious in its desire to be consumer driven.
Many supporters of the proposed change, including several from the
academic sector, stated the scientific evidence strongly supports the
proposed changes. These comments supported the conclusions of the NCA
task force which concluded the scientific evidence supported the
proposed changes. These studies indicated variability and inconsistency
of palatability of beef with small and slight marbling in B-maturity
was much greater than comparable levels of marbling in A-maturity, even
though some data did not indicate significant differences in overall
palatability. The high degree of inconsistency was cited by many
[[Page 2894]]
comments from the cattle production and feeding sectors as a situation
which must be corrected. Consumption sectors (consumer, purveyor and
processor, retail and restaurant) were also very concerned over product
which failed to meet consumer desires. Supporters of the proposed
changes postulated that few successful businesses would choose to do
nothing if they found a product line with up to 50 percent customer
dissatisfaction.
Many comments from cattle sectors and academia expressed the belief
that a large majority of B-maturity carcasses are the result of
management decisions that can be modified by the industry. Further,
these comments stated that by sending a strong market signal that these
cattle will not be included in the Choice and Select grades, management
decisions can be made that will eliminate a large number of them from
the fed-beef supply. Many supporters as well as opponents of the
proposed changes indicated many B-maturity carcasses are from older
``Mexican feeders'' or first or second-calf heifers. Supporters
strongly believed these management practices could be modified and were
against allowing these types of cattle to be included in the same
grades as properly managed, A-maturity cattle. Several cattle producers
and/or feeders indicated they had taken advantage of the system that
allowed these types of cattle to be included in the Choice and Select
grades, but feel it is now time to take a positive step with long-term
benefits in mind to improve the quality and consistency of beef.
Comments from cattle feeders, producers, and marketers which
opposed the changes often stated the belief that there would be a
significant negative economic impact. Estimates of over $100 million
annually in lost revenue were predicted by some of these commenters.
Similarly, comments from the packer sector indicated a projected
reductions of $20 million to $78 million in revenue annually. These
estimates were generally based solely on projected losses in value due
to decreasing the grade of the affected B-maturity carcasses from
Choice and Select to Standard. Some feeders and producers were
concerned that the changes would simply be used by packers as an
opportunity to further discount cattle, who would then pass the beef
through the system as ``no-roll'' product that would not be discounted
appropriately, thus providing an economic windfall for packers. These
commenters also believed the beef targeted by the change would not be
eliminated from the beef supply, but would simply be marketed in a
different manner.
Several of the comments opposed to the changes expressed the
concern that the changes ``unfairly penalized'' the approximately 50
percent of the affected B-maturity carcasses which are considered to
produce ``desirable'' product. As discussed previously, supporters of
the proposal believed any dissatisfaction level of this magnitude was
extremely detrimental to consumer acceptance of beef. Several of the
comments from cattle producers and feeders also expressed concern that
the proposed changes would unfairly penalize operations that grazed
older yearling cattle or fed ``older Mexican'' cattle or 1st or 2nd-
calf heifers. These comments suggested that these cattle would be
severely discounted in the market and would severely affect their
production and marketing.
Some comments from the packing and cattle feeding sectors
questioned the interpretation of the research considered in developing
the proposal which indicated higher variability in palatability of B-
maturity carcasses. A few of these comments indicated some studies
showed beef of B-maturity to be similar to A-maturity beef in overall
palatability. Two studies (National Consumer Retail Beef Study-1986 and
Beef Customer Satisfaction-1994) were cited by a few commenters as
showing consumers do not regard fed-beef as having palatability
problems.
Evaluation of Comments
Supporters of the changes indicated the approximately 50 percent of
B-maturity carcasses with less than desirable palatability have a
significant negative impact on consumer satisfaction with beef. Many
opponents of the changes did not disagree with the evidence of
palatability problems in up to 50 percent of B-maturity carcasses.
However, these commenters believed the remaining 50 percent of B-
maturity carcasses would be ``unfairly discounted'' under the proposal.
Even though it would be preferable to not exclude the approximately 50
percent of carcasses in B-maturity which have desirable eating
satisfaction from the Choice and Select grades, no method for
distinguishing these carcasses from those with undesirable eating
satisfaction is currently available. Although these B-maturity
carcasses with less than desirable palatability represent a relatively
small portion of the fed-beef supply, AMS recognizes that the negative
impact they can have on consumer satisfaction with Choice and Select
beef supports their exclusion from these grades. AMS also has carefully
reevaluated the supporting scientific evidence which compares the
palatability of A and B-maturity beef and concludes there is strong
evidence of greater variability of eating quality in B-maturity beef
than in A-maturity beef. While some opponents of the proposed changes
questioned some of the evidence, most of the comments (including
several from opponents of the changes) supported the evidence. The two
studies (National Consumer Retail Beef Study-1986 and Beef Customer
Satisfaction-1994) cited by some opponents as evidence that the changes
should not be made evaluated only A-maturity carcasses, B-maturity
carcasses were not included in these studies. In addition to the
scientific evidence, the very strong support for the proposed changes
from the consumption sectors (purveyor, processor, retail, restaurant,
and consumer) indicates that consumers desire a more consistent, less
variable eating experience from beef products. The need for improved
consumer satisfaction is evident, and this action should provide the
industry with an opportunity to eliminate a source of beef from the
Choice and Select grades that has been shown to be much more variable
in palatability than A-maturity beef.
Commenters who both supported and opposed the proposed changes
indicated several management practices which contribute to the
production of B-maturity carcasses. These include feeding of ``older
Mexican'' cattle and 1st and 2nd-calf heifers. While these types of
cattle are not the only source of B-maturity carcasses, they
potentially are a significant source. AMS believes these comments
support the ability of the industry to identify many sources of B-
maturity carcasses and either alter management practices to prevent
their production as fed-beef or to merchandize them according to their
value in the marketing system. Beef produced from such management
systems cannot be properly marketed with beef produced from young, fed-
cattle under 30 months of age because of the variability they introduce
into the Choice and Select grades.
A few comments from ``stocker'' operators were concerned the
changes would cause their cattle which are grazed up until about 20
months of age and leave the feedlot at about 23-24 months to be
discounted because they would produce B-maturity carcasses. There is no
evidence to indicate these cattle when properly managed and marketed
would not produce A-maturity carcasses (approximately 30 months of
age).
[[Page 2895]]
Supporters of the grade change generally indicated a belief that
the proposed changes would have a beneficial long-term impact on the
industry, but provided no monetary figures. Much of the opposition to
the proposed changes was due to potential negative economic impact.
Some opponents of the changes provided estimates of negative economic
impact on the industry from $20 million to over $100 million annually.
Because of the wide variation in the type and magnitude of the
predicted impacts expressed by commenters, AMS concluded an independent
economic study would better enable AMS to most effectively evaluate the
proposed changes. AMS contracted with Dr. Wayne Purcell, Director,
Research Institute on Livestock Pricing, Virginia Tech University, to
conduct an independent economic analysis. Dr. Purcell is widely
accepted by the industry as an authority on livestock marketing. His
analysis has been made part of the public record on the proposed
changes.
The economic impact study found if management strategies are not
changed and the same number of B-maturity carcasses continue to be
produced, a short-run negative impact on the industry of -$21 million
could be projected. These immediate costs come from the reduced prices
of B-maturity carcasses that are in the pipeline and from the price
depressing influence of an increase in ungraded and processing beef as
these carcasses are marketed. However, if management strategies are
improved to eliminate even 25 percent of these B-maturity carcasses, a
positive impact of $86 million would occur, and if 50 percent are
eliminated due to management, a positive impact of $194 million would
occur over an adjustment period of about 18 months. If credit is given
to longer term benefits coming from improved demand as some of the
quality inconsistency is eliminated, the benefits to the industry could
easily exceed $1.0 billion across the next 10 years. This study
concluded the benefits to the whole industry far outweigh short-run
adjustments. Longer term, it concluded the entire industry would
benefit because of improved pricing systems, reduction of quality
inconsistencies, improved demand for beef, and a larger market share
for beef.
AMS concludes that the industry can utilize improved management
strategies to eliminate a portion of B-maturity carcasses from the fed-
beef supply. AMS also concludes the economic impact study provides the
most reliable indication of potential economic impacts from the
changes. The projected negative impacts provided by some commentors
generally only accounted for the decrease in value of the B-maturity
carcasses which would not grade Choice or Select after the grade
change. The commentors did not account for price-related benefits,
improved consumer demand, or changes in the supply/demand price
relationship for Choice and Select beef after removal of B-maturity
carcasses. Many comments indicated producers and feeders have the
ability to identify and manage differently cattle types which
contribute significantly to production of B-maturity carcasses. What
percentage of B-maturity carcasses will be eliminated and over what
time period is difficult to predict. However, based on the comments and
other information, it is reasonable to assume that improved management
strategies will enable the industry to achieve a 25 percent reduction
in the number of B-maturity carcasses in the first or second year of
the change, if an adjustment period is provided prior to implementation
of the change. A 25 percent reduction would enable the industry to
realize the net benefits projected by the economic study of $86 million
over the eighteen months following implementation of the change by
removing an identifiable source of inconsistent quality from the Choice
and Select grades and the fed-beef supply.
In consideration of the public comments submitted in response to
the proposed rule of January 19, 1995 (60 FR 3982-3986), and all other
available information, USDA adopts the proposed rule to revise the
official U.S. standards for grades of carcass beef and the related
standards for grades of slaughter cattle by eliminating ``B'' maturity
(approximately 30-42 months of age) carcasses with small or slight
marbling degrees from the Choice and Select grades and including them
in the Standard grade. However, in order to allow the industry time to
adjust its production and marketing practices and to market beef
currently in the pipeline, implementation will be delayed until July 1,
1996.
List of Subjects
7 CFR Part 53
Cattle, Hogs, Livestock, Sheep.
7 CFR Part 54
Food grades and standards, Food labeling, Meat and meat products.
For the reasons set forth in the preamble, 7 CFR Part 53 and 7 CFR
Part 54 are amended as follows:
PART 53--LIVESTOCK (GRADING, CERTIFICATION, AND STANDARDS)
1. The authority citation for Parts 53 and 54 continues to read as
follows:
Authority: 7 U.S.C. 1621-1627.
2. In Sec. 53.203, paragraph (b) (3) is revised to read as follows:
Sec. 53.203 Application of standards for grades of slaughter cattle.
* * * * *
(b) * * *
(3) The approximate maximum age limitation for the Prime, Choice,
and Standard grades of steers, heifers, and cows is 42 months. The
maximum age limitation for the Select grade for steers, heifers, and
cows is approximately 30 months. The Commercial grade for steers,
heifers, and cows includes only cattle over approximately 42 months.
There are no age limitations for the Utility, Cutter, and Canner grades
of steers, heifers, and cows. The maximum age limitation for all grades
of bullocks is approximately 24 months.\1\
\1\Maximum maturity limits for bullock carcasses are the same as
those described in the beef carcass grade standards for steers,
heifers, and cows at about 30 months of age. However, bullocks
develop carcass indicators of maturity at younger chronological ages
than steers. Therefore, the approximate age at which bullocks
develop carcass indicators of maximum maturity is shown herein as 24
months rather than 30 months.
---------------------------------------------------------------------------
* * * * *
3. In Sec. 53.204, paragraph (c) (1) is revised to read as follows:
Sec. 53.204 Specifications for official U.S. standards for grades of
slaughter steers, heifers, and cows (quality).
* * * * *
(c) Select. (1) The Select grade is limited to steers, heifers, and
cows with a maximum age limitation of approximately 30 months.
Slaughter cattle possessing the minimum qualifications for Select have
a thin fat covering which is largely restricted to the back and loin.
The brisket, flanks, twist, and cod or udder are slightly full and the
muscling is slightly firm.
* * * * *
PART 54--MEATS, PREPARED MEATS, AND MEAT PRODUCTS (GRADING,
CERTIFICATION, AND STANDARDS)
4. Section 54.104 is revised by removing the word ``Select'' in
paragraph (n), revising the third and fifth sentences in paragraph (o)
and revising Figure 1 in paragraph (o) to read as follows:
Sec. 54.104 Application of standards for grades of carcass beef.
* * * * *
[[Page 2896]]
(o) * * * The Prime, Choice, Select, and Standard grades are
restricted to beef from young cattle; the Commercial grade is
restricted to beef from cattle too mature for Prime, Choice, and
Standard; and the Utility, Cutter, and Canner grades may include beef
from animals of all ages. * * * Except for the youngest maturity group
and the Choice grade in the second maturity group, within any specified
grade, the requirements for marbling increase progressively with
evidences of advancing maturity. * * *
BILLING CODE 3410-02-P
[[Page 2897]]
[GRAPHIC][TIFF OMITTED]TR30JA96.006
BILLING CODE 3410-02-C
[[Page 2898]]
* * * * *
5. Section 54.106 is amended by revising the third sentence in
paragraph (b) (3), revising paragraphs (c) (1) and (c) (2) and removing
paragraph (c) (3) as follows:
Sec. 54.106 Specifications for official United States standards for
grades of carcass beef (quality-steer, heifer, cow).
* * * * *
(b) * * *
(3) * * * In carcasses throughout the range of maturity included in
this group, a minimum modest amount of marbling is required (see Figure
1) and the ribeye muscle is slightly firm.
(c) Select (1) For carcasses throughout the range of maturity
permitted in the Select grade, the minimum degree of marbling required
is a minimum slight amount (see Figure 1) and the ribeye may be
moderately soft.
(2) Carcasses in the maturity group permitted range from the
youngest that are eligible for the beef class to those at the juncture
of the two youngest maturity groups, which have slightly red and
slightly soft chine bones and cartilages on the ends of the thoracic
vertebrae that have some evidence of ossification. In addition, the
sacral vertebrae are completely fused and the cartilages on the ends of
the lumbar vertebrae are nearly completely ossified. The rib bones are
slightly wide and slightly flat and the ribeye muscle is slightly light
red in color and is fine in texture.
* * * * *
Dated: January 25, 1996.
Kenneth C. Clayton,
Acting Administrator.
[FR Doc. 96-1816 Filed 1-26-96; 11:27 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 96-1748 Penalty Provisions
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2917-2918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1748]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
National Park Service
36 CFR Part 1
RIN 1024-AC06
Penalty Provisions
AGENCY: National Park Service, Interior.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The National Park Service (NPS) is amending the existing
penalty provisions for convictions of violating NPS regulations to
conform with the Criminal Fine Improvements Act of 1987 (Pub. L. 100-
185; 18 U.S.C. 3571). This Act changed the maximum fine levels for all
petty offenses, including those of a regulatory nature, to $5,000 for
individuals and $10,000 for organizations.
EFFECTIVE DATE: This rule is effective January 30, 1996.
ADDRESSES: Comments should be addressed to Dennis Burnett, National
Park Service, Ranger Activities Division, P.O. Box 37127, Washington,
DC 20013-7127.
FOR FURTHER INFORMATION CONTACT:
Dennis Burnett, Ranger Activities Division, at the above address.
Phone: 202-208-4874.
SUPPLEMENTARY INFORMATION:
Background
The current NPS penalty provisions are found in 36 CFR 1.3. Under
these provisions, four levels of penalties are delineated under
different penalty authorities. First, in Sec. 1.3(a), a person
convicted of violating applicable NPS regulations in 36 CFR Chapter 1
``shall be punished by a fine not exceeding $500 or by imprisonment not
exceeding 6 months, or both'', as authorized by 16 U.S.C. 3. Second,
Sec. 1.3(b) applies to certain military parks, battlefield sites,
national monuments, or other memorials originally under the
jurisdiction of the Secretary of the Army. In these areas the fine and
penalty are currently set, pursuant to the Act of March 2, 1933 (47
Stat. 1420), at ``not more than $100, or by imprisonment for not more
than 3 months, or by both'' for persons who ``knowingly and willfully''
violate applicable regulations. Third, at Sec. 1.3(c), persons
convicted of violating applicable regulations in park areas established
by the Act of August 21, 1935 (79 Stat. 971) ``shall be punished by a
fine of not more than $500''. Last, at Sec. 1.3(d), a person convicted
of violating 36 CFR 2.23 relating to recreation fees, pursuant to Pub.
L. No. 92-347 (86 Stat. 459) ``shall be punished by a fine of not more
than $100''.
This rule will revise the penalty language at 36 CFR 1.3 (a), (b),
(c) and (d) to reflect the revised statutory fine provisions of the
Criminal Fine Improvements Act of 1987 (18 U.S.C. 3571).
Fines: On January 1, 1985, the Criminal Fine Enforcement Act of
1984 (Pub. L. No. 98-596) became effective, in which the definition of
``petty offense'' was changed to include an offense in which the
maximum fine level was $5,000 for an individual and $10,000 for an
organization. However, this Act did not change the actual fine levels
themselves for petty offenses. This was accomplished by the Criminal
Fine Improvements Act of 1987 (Pub. L. No. 100-185). This latter Act
specifically established the maximum fine levels for petty offenses to
be $5,000 for individuals and $10,000 for organizations (18 U.S.C.
3571). Petty offenses were also defined to mean any Class B or C
misdemeanor, or an infraction, as defined in 18 U.S.C. 3559.
Additionally, Chapter 227 of Title 18, which became effective on
November 1, 1987, states:
Except as otherwise specifically provided, a defendant who has
been found guilty of an offense described in any Federal statute,
other than an Act of Congress applicable exclusively in the District
of Columbia or the Uniform Code of Military Justice, shall be
sentenced in accordance with the provisions of this chapter. (18
U.S.C. 3551(a); emphasis added).
Therefore, this rule will reflect the change in law, making the fine
levels as stated in 18 U.S.C. 3571 apply to NPS regulations.
Applicability: Section 3 of the Act of August 25, 1916 (NPS Organic
Act), as amended by Sec. 5 of the Act of June 2, 1920 (41 Stat. 732),
provides the Secretary of the Interior with the authority to ``make and
publish such rules and regulations as he may deem necessary or proper
for the use and management of the parks, monuments, and reservations
under the jurisdiction of the National Park Service, and any violation
of any of the rules and regulations authorized by this section and
sections 1, 2, and 4 of this title shall be punished by a fine of not
more than $500 or imprisonment for not exceeding six months, or both,
and be adjudged to pay all cost of the proceedings.'' (16 U.S.C. 3).
The NPS is adopting this final rule pursuant to the ``agency
procedure'' exception of the Administrative Procedures Act (5 U.S.C.
553(b)(A)) from general notice and comment rulemaking. The NPS believes
that this exception from rulemaking procedures is warranted because it
is merely conforming the penalty language found at 36 CFR 1.3 (a), (b),
(c) and (d) to reflect the revised statutory fine provisions of the
Criminal Fine Improvements Act of 1987 (18 U.S.C. 3571). The NPS finds
that notice and comment are unnecessary and contrary to the public
interest for this final rule.
The NPS has also determined, in accordance with the Administrative
Procedures Act (5 U.S.C. 553(d)(3)), that the publishing of this final
rule 30 days prior to the rule becoming effective would be
counterproductive and unnecessary for the reasons discussed above. A
30-day delay would be contrary to the public interest and the interest
of the agency. Therefore, under the ``good cause'' exception of the
Administrative Procedure Act (5 U.S.C. 553(b)(3)), it has been
determined that this rulemaking is excepted from the 30-day delay in
the effective date and shall therefore become effective on the date
published in the Federal Register.
Public Participation
It is the policy of the Department of the Interior, whenever
practicable, to
[[Page 2918]]
afford the public an opportunity to participate in the rulemaking
process. Accordingly, interested persons may submit written comments
regarding this final rule to the address noted at the beginning of this
rulemaking.
Drafting Information
The primary authors of this regulation are Tony Sisto,
Superintendent, Fort Vancouver NHS; Dennis Burnett, Washington Office
of Ranger Activities, NPS; and Michael Tiernan, Division of
Conservation and Wildlife, Office of the Solicitor, Department of the
Interior, Washington, D.C.
Paperwork Reduction Act
This rulemaking does not contain collections of information
requiring approval by the Office of Management and Budget under 44
U.S.C. 3501, et seq.
Compliance With Other Laws
This rule was not subject to Office of Management and Budget review
under Executive Order 12866. The Department of the Interior determined
that this document will not have a significant economic effect on a
substantial number of small entities under the Regulatory Flexibility
Act (5 USC 601 et seq.). The economic effects of this rulemaking are
local in nature and negligible in scope.
The NPS has determined that this proposed rulemaking will not have
a significant effect on the quality of the human environment, health
and safety because it is not expected to:
(a) increase public use to the extent of compromising the nature
and character of the area or causing physical damage to it;
(b) Introduce incompatible uses which compromise the nature and
character of the area or causing physical damage to it;
(c) Conflict with adjacent ownerships or land uses; or
(d) Cause a nuisance to adjacent owners or occupants.
Based on this determination, this regulation is categorically
excluded from the procedural requirements of the National Environmental
Policy Act (NEPA) by Departmental guidelines in 516 DM 6 (49 FR 21438).
As such, neither an Environmental Assessment (EA) nor an Environmental
Impact Statement (EIS) has been prepared.
List of Subjects in 36 CFR Part 1
National parks, Penalties, Reporting and recordkeeping
requirements.
In consideration of the foregoing, 36 CFR Chapter I is amended as
follows:
PART 1--GENERAL PROVISIONS
1. The authority citation for part 1 continues to read as follows:
Authority: 16 U.S.C. 1, 3, 460 1-6a(e), 469(k); D.C. Code 8-137,
40-721 (1981).
2. Section 1.3 is revised to read as follows:
Sec. 1.3 Penalties
(a) A person convicted of violating a provision of the regulations
contained in Parts 1 through 7, 12 and 13 of this chapter, within a
park area not covered in paragraphs (b) or (c) of this section, shall
be punished by a fine as provided by law, or by imprisonment not
exceeding 6 months, or both, and shall be adjudged to pay all costs of
the proceedings.
(b) A person who knowingly and will- fully violates any provision
of the regulations contained in parts 1 through 5, 7 and 12 of this
chapter, within any national military park, battlefield site, national
monument, or miscellaneous memorial transferred to the jurisdiction of
the Secretary of the Interior from that of the Secretary of War by
Executive Order No. 6166, June 10, 1933, and enumerated in Executive
Order No. 6228, July 28, 1933, shall be punished by a fine as provided
by law, or by imprisonment for not more than 3 months, or by both.
Note: These park areas are enumerated in a note under 5 U.S.C.
901.
(c) A person convicted of violating any provision of the
regulations contained in parts 1 through 7 of this chapter, within a
park area established pursuant to the Act of August 21, 1935, 49 Stat.
666, shall be punished by a fine as provided by law and shall be
adjudged to pay all costs of the proceedings. 16 U.S.C. 462.
(d) Notwithstanding the provisions of paragraphs (a), (b) and (c)
of this section, a person convicted of violating Sec. 2.23 of this
chapter shall be punished by a fine as provided by law. 16 U.S.C. 460.
Dated: October 20, 1995.
George T. Frampton, Jr.,
Assistant Secretary for Fish and Wildlife and Parks.
[FR Doc. 96-1748 Filed 1-29-96; 8:45 am]
BILLING CODE 4310-70-M
Complete official Federal Register PDF
FR Doc. 96-1741 Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2914-2915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1741]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride
Soluble Powder
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by Phoenix Scientific, Inc. The ANADA
provides for the use of a generic oxytetracycline hydrochloride soluble
powder administered orally in drinking water for either control or
control and treatment of certain diseases of chickens, turkeys, swine,
cattle, and sheep.
EFFECTIVE DATE: January 30, 1996.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th
St. Ter., P.O. Box 6457, St. Joseph, MO 64506-0457, filed ANADA 200-146
which provides for use of oxytetracycline hydrochloride soluble powder
in the drinking water of chickens, turkeys, swine, cattle, and sheep.
The medicated drinking water is used as follows: (1) Chickens for
control of infectious synovitis caused by Mycoplasma synoviae, chronic
respiratory disease and air sac infections caused by Mycoplasma
gallisepticum and Escherichia coli, and fowl cholera caused by
Pasteurella multocida; (2) turkeys for control of hexamitiasis caused
by Hexamita meleagridis, infectious synovitis caused by M. synoviae,
and complicating bacterial organisms associated with blue comb
(transmissible enteritis; coronaviral enteritis); (3) swine for control
and treatment of bacterial enteritis caused by E. coli and Salmonella
choleraesuis and bacterial pneumonia caused by P. multocida; (4)
breeding swine for control and treatment of leptospirosis (reducing the
incidence of abortions and shedding of leptospira) caused by Leptospira
pomona; (5) calves, beef cattle, and nonlactating dairy cattle for
control and treatment of bacterial enteritis caused by E. coli and
bacterial pneumonia (shipping fever complex) caused by P. multocida;
and (6) sheep for control and treatment of bacterial enteritis caused
by E. coli and bacterial pneumonia (shipping fever complex) caused by
P. multocida.
- ANADA 200-146 for Phoenix Scientific's oxytetracycline
hydrochloride soluble powder is approved as a generic copy of Pfizer's
Terramycin Soluble Powder which is covered by NADA 8-622. The
ANADA is approved as of December 7, 1995, and the regulations in 21 CFR
520.1660d are amended to reflect the approval. The basis for approval
is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a
summary of safety and effectiveness data and information submitted to
support approval of this application may be seen in the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
The agency has determined under 21 CFR 25.24(d)(1)(i) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
List of Subjects in 21 CFR Part 520
-Animal drugs.
[[Page 2915]]
-Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
-1. The authority citation for 21 CFR part 520 continues to read as
follows:
-Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
-2. Section 520.1660d is amended by adding new paragraphs (a)(7)
and (b)(5) to read as follows:
Sec. 520.1660d Oxytetracycline hydrochloride soluble powder.
-(a) * * *
-(7) Each 18.14 grams of powder contains 1 gram of OTC HCl (pail: 2
lb).
-(b) * * *
-(5) No. 059130 for use of OTC HCl concentration in paragraph
(a)(7) of this section in chickens, turkeys, swine, cattle, and sheep.
* * * * * -
Dated: January 3, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-1741 Filed 1-29-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-1739 Standard Instrument Approach Procedures; Miscellaneous Amendments
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2906-2908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1739]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 97
[Docket No. 28441; Amdt. No. 1705]
Standard Instrument Approach Procedures; Miscellaneous Amendments
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
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SUMMARY: This amendment establishes, amends, suspends, or revokes
Standard Instrument Approach Procedures (SIAPs) for operations at
certain airports. These regulatory actions are needed because of the
adoption of new or revised criteria, or because of changes occurring in
the National Airspace System, such as the commissioning of new
navigational facilities, addition of new obstacles, or changes in air
traffic requirements. These changes are designed to provide safe and
efficient use of the navigable airspace and to promote safe flight
operations under instrument flight rules at the affected airports.
DATES: An effective date for each SIAP is specified in the amendatory
provisions.
Incorporation by reference-approved by the Director of the Federal
Register on December 31, 1980, and reapproved as of January 1, 1982.
ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:
For Examination--
1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
2. The FAA Regional Office of the region in which the affected
airport is located; or
3. The Flight Inspection Area Office which originated the SIAP.
For Purchase--Individual SIAP copies may be obtained from:
1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
2. The FAA Regional Office of the region in which the affected
airport is located.
By Subscription--Copies of all SIAPs, mailed once every 2 weeks,
are for sale by the Superintendent of Documents, U.S. Government
Printing Office, Washington, DC 20402.
FOR FURTHER INFORMATION CONTACT:
Paul J. Best, Flight Procedures Standards Branch (AFS-420), Technical
Programs Division, Flight Standards
[[Page 2907]]
Service, Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 20591; telephone (202) 267-8277.
SUPPLEMENTARY INFORMATION: This amendment to part 97 of the Federal
Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or
revokes Standard Instrument Approach Procedures (SIAPs). The complete
regulatory description of each SIAP is contained in official FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and Sec. 97.20 of the Federal Aviation
Regulations (FAR). The applicable FAA Forms are identified as FAA Forms
8260-3, 8260-4, and 8260-5. Materials incorporated by reference are
available for examination or purchase as stated above.
The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. The provisions of this amendment state the affected CFR
(and FAR) sections, with the types and effective dates of the SIAPs.
This amendment also identifies the airport, its location, the procedure
identification and the amendment number.
The Rule
This amendment to part 97 is effective upon publication of each
separate SIAP as contained in the transmittal. Some SIAP amendments may
have been previously issued by the FAA in a National Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts. The
circumstances which created the need for some SIAP amendments may
require making them effective in less than 30 days. For the remaining
SIAPs, an effective date at least 30 days after publication is
provided.
Further, the SIAPs contained in this amendment are based on the
criteria contained in the U.S. Standard for Terminal Instrument
Approach Procedures (TERPS). In developing these SIAPs, the TERPS
criteria were applied to the conditions existing or anticipated at the
affected airports. Because of the close and immediate relationship
between these SIAPs and safety in air commerce, I find that notice and
public procedure before adopting these SIAPs are impracticable and
contrary to the public interest and, where applicable, that good cause
exists for making some SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 97
Air Traffic Control, Airports, Navigation (Air).
Issued in Washington, DC on 19 January 1996.
Thomas C. Accardi,
Director, Flight Standards Service.
Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me, part 97 of
the Federal Aviation Regulations (14 CFR part 97) is amended by
establishing, amending, suspending, or revoking Standard Instrument
Approach Procedures, effective at 0901 UTC on the dates specified, as
follows:
PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES
1. The authority citation for part 97 is revised to read as
follows:
Authority: 49 U.S.C. 106(g), 40103, 40113, 40120, 44701; and 14
CFR 11.49(b)(2).
2. Part 97 is amended to read as follows:
Secs. 97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35 [Amended]
By amending: Sec. 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec. 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec. 97.27
NDB, NDB/DME; Sec. 97.29 ILS, ILS/DME, ISMLS, MLS, MLS/DME, MLS/RNAV;
Sec. 97.31 RADAR SIAPs; Sec. 97.33 RNAV SIAPs; and Sec. 97.35 COPTER
SIAPs, identified as follows:
* * * February 1, 1996 * * *
Farmingdale, NY, Republic, NDB or GPS RWY 1, Amdt 13
Farmingdale, NY, Republic, ILS RWY 14, Amdt 6
Mesquite, TX, Phil L. Hudson Muni, LOC RWY 17, Amdt 3, CANCELLED
Mesquite, TX, Mesquite Metro, ILS RWY 17, Orig
* * * February 29, 1996 * * *
Gadsden, AL, Gadsden Muni, GPS RWY 24, Orig
Flagstaff, AZ, Flagstaff Pulliam, GPS RWY 21, Orig
Page, AZ, Page Muni, GPS RWY 15, Orig
Longmont, CO, Vance Brand, GPS RWY 29, Orig
Indianapolis, IN, Indianapolis Intl, VOR OR GPS RWY 14, Amdt 25
Indianapolis, IN, Indianapolis Intl, ILS RWY 14, Amdt 4
Indianapolis, IN, Indianapolis Intl, Radar-1, Amdt 31
Bowling Green, KY, Bowling Green-Warren County Regional, VOR OR GPS
RWY 3, Amdt 14
Bowling Green, KY, Bowling Green-Warren County Regional, VOR/DME OR
GPS RWY 21, Amdt 7
Bowling Green, KY, Bowling Green-Warren County Regional, NDB RWY 3,
Orig
Bowling Green, KY, Bowling Green-Warren County Regional, ILS RWY 3,
Orig
Farmington, MO, Farmington Regional, GPS RWY 2, Orig
Albemarle, NC, Stanly County, NDB OR GPS RWY 4, AMDT 3, CANCELLED
Albemarle, NC, Stanly County, NDB OR GPS RWY 22, Orig, CANCELLED
Albemarle, NC, Stanly County, LOC RWY 22, Orig
Albemarle, NC, Stanly County, NDB RWY 22, Orig
Winnemucca, NV, Winnemucca Muni, GPS RWY 14, Orig
Winnemucca, NV, Winnemucca Muni, GPS RWY 32, Orig
Britton, SD, Britton Muni, NDB OR GPS RWY 13, Amdt 3, CANCELLED
Britton, SD, Britton Muni, NDB OR GPS RWY 13, Orig
Renton, WA, Renton Muni, GPS RWY 15, Orig
* * * April 25, 1996 * * *
Boca Raton, FL, Boca Raton, GPS RWY 5, Orig
Harrisburg, IL, Harrisburg-Raleigh, GPS RWY 24, Orig
Clinton, IA, Clinton Muni, GPS RWY 14, Orig
Clinton, IA, Clinton Muni, GPS RWY 21, Orig
Clinton, IA, Clinton Muni, GPS RWY 32, Orig
Lafayette, LA, Lafayette Regional, GPS RWY 29, Orig
Tallulah/Vicksburg, LA, Vicksburg Tallulah Rgnl, GPS RWY 18, Orig
Greenville, MI, Greenville Muni, GPS RWY 27, Orig
Ludington, MI, Mason County, GPS RWY 25, Orig
Monett, MO, Monett Muni, GPS RWY 36, Orig
The FAA published an Amendment in Docket No. 28390, Amdt. No. 1695
to
[[Page 2908]]
Part 97 of the Federal Aviation Regulations (VOL 60 FR No. 239 Page
63905, dated Wednesday, December 13, 1995) under Section 97.25
effective February 29, 1996 which is hereby rescinded: Blacksburg, VA,
Virginia Tech, LOC RWY 12, Amdt 4.
[FR Doc. 96-1739 Filed 1-29-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-1738 Standard Instrument Approach Procedures; Miscellaneous Amendments
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2904-2906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1738]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 97
[Docket No. 28442; Amdt. No. 1706]
Standard Instrument Approach Procedures; Miscellaneous Amendments
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
[[Page 2905]]
SUMMARY: This amendment establishes, amends, suspends, or revokes
Standard Instrument Approach Procedures (SIAPs) for operations at
certain airports. These regulatory actions are needed because of
changes occurring in the National Airspace System, such as the
commissioning of new navigational facilities, addition of new
obstacles, or changes in air traffic requirements. These changes are
designed to provide safe and efficient use of the navigable airspace
and to promote safe flight operations under instrument flight rules at
the affected airports.
DATES: An effective date for each SIAP is specified in the amendatory
provisions.
Incorporation by reference-approved by the Director of the Federal
Register on December 31, 1980, and reapproved as of January 1, 1982.
ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
For Examination--
1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue SW., Washington, DC 20591;
2. The FAA Regional Office of the region in which affected airport
is located; or
3. The Flight Inspection Area Office which originated the SIAP.
For Purchase--Individual SIAP copies may be obtained from:
1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue SW., Washington, DC 20591; or
2. The FAA Regional Office of the region in which the affected
airport is located.
By Subscription--Copies of all SIAPs, mailed once every 2 weeks,
are for sale by the Superintendent of Documents, U.S. Government
Printing Office, Washington, DC 20402.
FOR FURTHER INFORMATION CONTACT:
Paul J. Best, Flight Procedures Standards Branch (AFS-420), Technical
Programs Division, Flight Standards Service, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone (202) 267-8277.
SUPPLEMENTARY INFORMATION: This amendment to part 97 of the Federal
Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or
revokes Standard Instrument Approach Procedures (SIAPs). The complete
regulatory description on each SIAP is contained in the appropriate FAA
Form 8260 and the National Flight Data Center (FDC)/Permanent (P)
Notices to Airmen (NOTAM) which are incorporated by reference in the
amendment under 5 U.S.C. 552(a), 1 CFR part 51, and Sec. 97.20 of the
Federal Aviation Regulations (FAR). Materials incorporated by reference
are available for examination or purchase as stated above.
The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction of charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. The provisions of this amendment state the affected CFR
(and FAR) sections, with the types and effective dates of the SIAPs.
This amendment also identifies the airport, its location, the procedure
identification and the amendment number.
The Rule
This amendment to part 97 of the Federal Aviation Regulations (14
CFR part 97) establishes, amends, suspends, or revokes SIAPs. For
safety and timeliness of change considerations, this amendment
incorporates only specific changes contained in the content of the
following FDC/P NOTAM for each SIAP. The SIAP information in some
previously designated FDC/Temporary (FDC/T) NOTAMs is of such duration
as to be permanent. With conversion to FCD/P NOTAMs, the respective
FDC/T NOTAMs have been cancelled.
The FDC/P NOTAMs for the SIAPs contained in this amendment are
based on the criteria contained in the U.S. Standard for Terminal
Instrument Approach Procedures (TERPS). In developing these chart
changes to SIAPs by FDC/P NOTAMs, the TERPS criteria were applied to
only these specific conditions existing at the affected airports. All
SIAP amendments in this rule have been previously issued by the FAA in
a National Flight Data Center (FDC) Notice to Airmen (NOTAM) as an
emergency action of immediate flight safety relating directly to
published aeronautical charts. The circumstances which created the need
for all these SIAP amendments requires making them effective in less
than 30 days.
Further, the SIAPs contained in this amendment are based on the
criteria contained in the TERPS. Because of the close and immediate
relationship between these SIAPs and safety in air commerce, I find
that notice and public procedure before adopting these SIAPs are
impracticable and contrary to the public interest and, where
applicable, that good cause exists for making these SIAPs effective in
less than 30 days.
Conclusion
The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal.For the same reason, the FAA certifies
that this amendment will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 97
Air Traffic Control, Airports, Navigation (Air).
Issued in Washington, DC on January 19, 1996.
Thomas C. Accardi,
Director, Flight Standards Service.
Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me, part 97 of
the Federal Aviation Regulations (14 CFR part 97) is amended by
establishing, amending, suspending, or revoking Standard Instrument
Approach Procedures, effective at 0901 UTC on the dates specified, as
follows:
PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES
1. The authority citation for part 97 is revised to read as
follows:
Authority: 49 U.S.C. 40103, 40113, 40120, 44701; 49 U.S.C.
106(g); and 14 CFR 11.49(b)(2).
2. Part 97 is amended to read as follows:
Secs. 97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35 [Amended]
By amending: Sec. 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec. 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec. 97.27
NDB, NDB/DME; Sec. 97.29 ILS, ILS/DME, ISMLS, MLS, MLS/DME, MLS/RNAV;
Sec. 97.31 RADAR SIAPs; Sec. 97.33 RNAV SIAPs; and Sec. 97.35 COPTER
SIAPs, identified as follows:
* * * Effective Upon Publication
[[Page 2906]]
----------------------------------------------------------------------------------------------------------------
FDC date State City Airport FDC No. SIAP
----------------------------------------------------------------------------------------------------------------
01/05/96... ME.............. Eastport............. Eastport Muni........ 6/0099 GPS RWY 15 ORIG...
01/02/96... KY.............. Louisville........... Louisville Intl- 6/0017 ILS RWY 17 ORIG...
Standiford Field.
01/04/96... MO.............. St Louis............. Lambert-St Louis Intl 6/0072 ILS RWY 30R, AMDT
6C...
01/04/96... TX.............. Mexia................ Mexia-Linestone 6/0073 GPS RWY 36, ORIG...
County.
01/05/96... AR.............. Springdale........... Springdale Muni...... 6/0098 VOR OR GPS RWY 18,
AMDT 14A...
01/11/96... OK.............. Lawton............... Lawton Muni.......... 6/0289 RADAR 1, AMDT 3...
01/11/96... VT............. Lyndonville.......... Caledonia County..... 6/0281 NDB RWY 2 AMDT 3...
01/16/95... CO.............. Gunnison............. Gunnison County...... 6/0400 VOR OR GPS-A, AMDT
7A...
01/16/96... AR.............. Brinkley............. Frank Federer 6/0391 NDB OR GPS-A, ORIG-
Memorial. A...
01/16/96... CO.............. Gunnison............. Gunnison County...... 6/0399 ILS RWY 6 AMDT 3...
01/16/96... TX.............. Abilene.............. Abilene Regional..... 6/0394 ILS RWY 35R, AMDT 5...
01/16/96... TX.............. Abilene.............. Abilene Regional..... 6/0395 NDB OR GPS RWY 35R,
AMDT 4...
01/17/96... AZ.............. Scottsdale........... Scottsdale........... 6/0420 VOR OR GPS-A AMDT 2...
01/17/96... AZ.............. Scottsdale........... Scottsdale........... 6/0421 VOR OR GPS-C ORIG...
12/29/95... MS.............. Jackson.............. Hawkins Field........ 5/6937 RNAV OR GPS RWY 16,
AMDT 4...
----------------------------------------------------------------------------------------------------------------
[FR Doc. 96-1738 Filed 1-29-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-1722 Clean Air Act (CAA) Final Full Approval of Operating Permits Programs; State of Kansas, and Delegation of 112(l) Authority
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2938-2939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1722]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 70
[KS001; AD-FRL-5407-8]
Clean Air Act (CAA) Final Full Approval of Operating Permits
Programs; State of Kansas, and Delegation of 112(l) Authority
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final full approval.
-----------------------------------------------------------------------
SUMMARY: The EPA is fully approving the operating permits program
submitted by the state of Kansas for the purpose of complying with
Federal requirements for an approvable state program to issue operating
permits to all major stationary sources and certain other sources. EPA
is also approving, under section 112(l), the state program for
accepting delegation of section 112 standards to enforce air toxics
regulations.
EFFECTIVE DATE: February 29, 1996.
ADDRESSES: Copies of the state's submittal and other supporting
information used in developing the final full approval are available
for inspection during normal business hours at the following location:
EPA Region VII, 726 Minnesota Avenue, Kansas City, Kansas 66101.
FOR FURTHER INFORMATION CONTACT: Wayne A. Kaiser at (913) 551-7603.
SUPPLEMENTARY INFORMATION:
I. Background and Purpose
Title V of the 1990 Clean Air Act Amendments (sections 501-507 of
the Clean Air Act (``the Act'')), and implementing regulations at 40
Code of Federal Regulations (CFR) Part 70, require that states develop
and submit operating permits programs to EPA by November 15, 1993, and
that EPA act to approve or disapprove each program within one year
after receiving the submittal. The EPA's program review occurs pursuant
to section 502 of the Act and the Part 70 regulations, which together
outline criteria for approval or disapproval.
On July 3, 1995, EPA proposed full approval of the operating
permits program for Kansas (60 FR 34493). No public comments were
received. In this notice, EPA is taking final action to promulgate full
approval of the operating permits program for the state of Kansas,
including delegation of 112(l) authority.
II. Final Action and Implications
A. Fulfillment of EPA Requested Modifications
The July 3, 1995, Federal Register notice proposing approval of the
Kansas program discussed three areas of the Kansas program which
required additional action prior to qualifying for full approval. The
state needed to: (1) modify certain regulations to ensure that they
were consistent with Part 70, (2) submit an Implementation Agreement
(I.A.) which describes certain provisions for state implementation of
the Part 70 program, and (3) submit an insignificant activities list.
The July 3, 1995, Federal Register notice and the Technical Support
Document for the notice describe in detail the changes in the program
required for full approval. The reader should refer to those documents
for a complete description of the changes required by Kansas.
The state of Kansas has satisfied the requirements for full program
approval as described in the notice proposing approval. The required
revisions were made to rules K.A.R. 28-19-7, K.A.R. 28-19-511, K.A.R.
28-19-512, and K.A.R. 28-19-518. The rule revisions were adopted by the
Secretary of the Kansas Department of Health and Environment (KDHE) on
November 14, 1995, and were effective December 8, 1995. The state also
submitted an I.A. which satisfactorily addresses the deficiencies
described in the notice which were to be addressed in the I.A. The
state also submitted an adequate insignificant activities list.
The I.A. includes a commitment that the permitting agency will not
exercise its authority under state law to grant a variance from the
duty to comply with a federally enforceable Part 70 permit, except
where such relief is granted through procedures allowed by Part 70.
Therefore, the state variance provision is not part of the Kansas Title
V program.
B. Final Action
The EPA is promulgating full approval of the operating permits
program submitted to EPA by the state of Kansas on December 12, 1994,
with supplemental submissions on April 7 and 17, 1995; November 14,
1995; and December 13, 1995. Among other things, the state of Kansas
has demonstrated its program meets the minimum elements of a state
operating permits program as specified in 40 CFR Part 70.
1. Regulations. This approval includes the following regulations
adopted by the KDHE as they relate to the Kansas Class I operating
permit program: K.A.R. 28-19-7, General provisions, definitions; K.A.R.
28-19-202, Annual emissions fee; K.A.R. 28-19-204, General provisions,
permit issuance and modification, public participation; K.A.R. 28-19-
400 through -404, General permits; K.A.R. 28-19-500 through -502,
Operating permits; and K.A.R. 28-19-510 through -518, Class I operating
permits.
2. Jurisdiction. The scope of the Part 70 program approved in this
notice applies to all Part 70 sources (as defined in the approved
program), within the state of Kansas, except any sources of air
pollution over which an Indian Tribe has jurisdiction. See 59 FR 55813,
55815-18 (November 9, 1994). The term ``Indian Tribe'' is defined under
the Act as ``any Indian Tribe, Band, Nation, or other organized group
or community, including any Alaska Native village, which is Federally
recognized as eligible for the special programs and services provided
by the United States to Indians, because of their status as Indians.''
See section 302(r) of the CAA;
[[Page 2939]]
59 FR 43956, 43962 (August 25, 1994); 58 FR 54364 (October 21, 1993).
3. CAA section 112(l). Requirements for approval, specified in 40
CFR 70.4(b), encompass section 112(l)(5) requirements for approval of a
program for delegation of section 112 standards as promulgated by EPA
as they apply to Part 70 sources. Section 112(l)(5) requires that the
state's program contain adequate authorities, adequate resources for
implementation, and an expeditious compliance schedule, which are also
requirements under Part 70. Therefore, the EPA is also approving under
section 112(l)(5) and 40 CFR 63.91 the state's program for receiving
delegation of section 112 standards for both Part 70 and non-Part 70
sources that are unchanged from Federal standards as promulgated.
4. CAA section 112(g). The EPA issued an interpretive notice on
February 14, 1995 (60 FR 8333), which outlines EPA's revised
interpretation of 112(g) applicability. The notice postpones the
effective date of 112(g) until after EPA has promulgated a rule
addressing that provision. The notice sets forth in detail the
rationale for the revised interpretation.
The section 112(g) interpretive notice explains that EPA is still
considering whether the effective date of section 112(g) should be
delayed beyond the date of promulgation of the Federal rule so as to
allow states time to adopt rules implementing the Federal rule, and
that EPA will provide for any such additional delay in the final
section 112(g) rulemaking. Unless and until EPA provides for such an
additional postponement of section 112(g), Kansas must have a Federally
enforceable mechanism for implementing section 112(g) during the period
between promulgation of the Federal section 112(g) rule and adoption of
implementing Federal regulations.
The EPA is aware that Kansas lacks a program designed specifically
to implement section 112(g). However, Kansas does have a
preconstruction review program that can serve as an adequate
implementation vehicle during the transition period, because it would
allow Kansas to select control measures that would meet Maximum
Available Control Technology, as defined in section 112, and
incorporate these measures into a Federally enforceable preconstruction
permit.
EPA is approving Kansas' preconstruction permitting program under
the authority of Title V and Part 70, solely for the purpose of
implementing section 112(g) to the extent necessary, during the
transition period between 112(g) promulgation and adoption of a state
rule implementing EPA's section 112(g) regulations. Although section
112(l) generally provides authority for approval of state air programs
to implement section 112(g), Title V and section 112(g) provide for
this limited approval because of the direct linkage between the
implementation of section 112(g) and Title V.
The scope of this approval is narrowly limited to section 112(g),
and does not confer or imply approval for purposes of any other
provision under the Act (e.g., section 110). This approval will be
without effect, if EPA decides in the final section 112(g) rule that
sources are not subject to the requirements of the rule until state
regulations are adopted. The duration of this approval is limited to 18
months following promulgation by EPA of the 112(g) rule to provide
adequate time for the state to adopt regulations consistent with the
Federal requirements.
III. Administrative Requirements
A. Docket
Copies of the state submittal and other information relied upon for
the final full approval are contained in a docket maintained at the EPA
Regional Office. The docket is an organized and complete file of all
the information submitted to, or otherwise considered by, EPA in the
development of this final full approval. The docket is available for
public inspection at the location listed under the ADDRESSES section of
this document.
B. Executive Order 12866
The Office of Management and Budget has exempted this action from
Executive Order 12866 review.
C. Regulatory Flexibility Act
The EPA's actions under section 502 of the Act do not create any
new requirements, but simply address operating permits programs
submitted to satisfy the requirements of 40 CFR Part 70. Because this
action does not impose any new requirements, it does not have a
significant impact on a substantial number of small entities.
D. Unfunded Mandates
Under sections 202, 203, and 205 of the Unfunded Mandates Reform
Act of 1995 (``Unfunded Mandates Act''), signed into law on March 22,
1995, EPA must undertake various actions in association with proposed
or final rules that include a Federal mandate that may result in
estimated costs of $100 million or more to the private sector, or to
state, local, or tribal governments in the aggregate.
Through submission of these operating permit programs, the state of
Kansas has elected to adopt the program provided for under Title V of
the CAA. These rules bind the state to perform certain actions and also
require the private sector to perform certain duties.
To the extent that the rules being proposed for approval by this
action will impose new requirements, sources are already subject to
these regulations under state law. EPA has determined that this
proposed action does not include a mandate that may result in estimated
costs of $100 million or more to state, local, or tribal governments in
the aggregate or to the private sector.
List of Subjects in 40 CFR Part 70
Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Operating permits,
Reporting record keeping requirements.
Dated: December 18, 1995.
Dennis Grams,
Regional Administrator.
Part 70, title 40 of the Code of Federal Regulations is amended as
follows:
PART 70--[AMENDED]
1. The authority citation for part 70 continues to read as follows:
Authority: 42 U.S.C. 7401--7671q.
2. Appendix A to part 70 is amended by adding the entry for Kansas
to read as follows:
Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs
* * * * *
Kansas
(a) The Kansas Department of Health and Environment program
submitted on December 12, 1994; April 7 and 17, 1995; November 14,
1995; and December 13, 1995. Full approval effective on February 29,
1996.
(b) [Reserved.]
* * * * *
[FR Doc. 96-1722 Filed 1-29-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-1709 Ocean Dumping; Final Site Designation
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2941-2946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1709]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 228
[FRL-5346-2]
Ocean Dumping; Final Site Designation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA designates an Ocean Dredged Material Disposal Site (ODMDS)
in the Atlantic Ocean offshore Miami, Florida, as an EPA-approved ocean
dumping site for the disposal of suitable dredged material. This action
is necessary to provide an acceptable ocean disposal site for
consideration as an option for dredged material disposal projects in
the greater Miami, Florida vicinity. This site designation is for an
indefinite period of time, but the site is subject to continuing
monitoring to insure that unacceptable adverse environmental impacts do
not occur.
EFFECTIVE DATE: February 29, 1996.
ADDRESSES: The supporting document for this designation is the Final
Environmental Impact Statement (EIS) for Designation of an Ocean
Dredged Material Disposal Site offshore Miami, Florida, August 1995,
which is available for public inspection at the following locations:
A. EPA/Region 4, Coastal Programs Section, 345 Courtland Street, NE.,
Atlanta, Georgia 30365
B. Department of the Army, Jacksonville District Corps of Engineers,
Planning Division, 400 West Bay Street, Jacksonville, FL 32232-0019.
FOR FURTHER INFORMATION CONTACT: Christopher J. McArthur, 404/347-1740
ext. 4289.
SUPPLEMENTARY INFORMATION:
A. Background
Section 102(c) of the Marine Protection, Research, and Sanctuaries
Act (MPRSA) of 1972, as amended, 33 U.S.C. 1401 et seq., gives the
Administrator of EPA the authority to designate sites where ocean
disposal may be permitted. On October 1, 1986, the Administrator
delegated the authority to designate ocean disposal sites to the
Regional Administrator of the Region in which the sites are located.
This designation of a site offshore Miami, Florida, which is within
Region 4, is being made pursuant to that authority.
The EPA Ocean Dumping Regulations promulgated under MPRSA (40 CFR
ch. I, subchapter H, Sec. 228.4) state that ocean dumping sites will be
designated by promulgation in this part 228. A list of ``Approved
Interim and Final Ocean Dumping Sites'' was published on January 11,
1977 (42 FR 2461 (January 11, 1977)). The list established the existing
Miami (``Miami Beach'') site as an interim site. The site is now listed
in 40 CFR 228.14(h)(6).
B. EIS Development
Section 102(2)(C) of the National Environmental Policy Act (NEPA)
of 1969, as amended, 42 U.S.C. 4321 et seq., requires that federal
agencies prepare an Environmental Impact Statement (EIS) on proposals
for legislation and other major federal actions significantly affecting
the quality of the human environment. The object of NEPA is to build
into the Agency decision making process careful consideration of all
environmental aspects of proposed actions. While NEPA does not apply to
EPA activities of this type, EPA has voluntarily committed to prepare
EISs in connection with ocean disposal site designations such as this
(see 39 FR 16186 (May 7, 1974).
EPA Region 4, in cooperation with the Jacksonville District of the
U.S. Army Corps of Engineers (COE), has prepared a Final EIS entitled,
``Final Environmental Impact Statement for Designation of An Ocean
Dredged Material Disposal Site Located Offshore Miami, Florida.'' On
September 1, 1995, the Notice of Availability (NOA) of the FEIS for
public review and comment was published in the Federal Register (60 FR
45717 (September 1, 1995)). Anyone desiring a copy of the EIS may
obtain one from the address given above. The public comment period on
the Final EIS was to have closed on October 2, 1995. However, the
closing date was extended until October 17, 1995 due to a request by
the State of Florida.
One comment letter was received in support of the Final EIS and no
letters were received critical of the Final EIS. The letter of support
endorsed the Site Management and Monitoring Plan (SMMP) and the SMMP
team.
The EIS has served as a Biological Assessment for purposes of
Section 7 of the Endangered Species Act coordination. By itself, site
designation of the Miami ODMDS will not adversely impact any threatened
or endangered species under the purview of the National Marine
Fisheries Service
[[Page 2942]]
(NMFS) and the U.S. Fish and Wildlife Service (FWS). Use of the ODMDS
is not expected to adversely impact any threatened or endangered
species. Pursuant to Section 7 of the Endangered Species Act, the
National Marine Fisheries Service (NMFS) has been asked by EPA to
concur with EPA's conclusion that this site designation will not affect
the endangered species under their jurisdictions. The National Marine
Fisheries Service determined that populations of endangered/threatened
species under their purview would not be adversely affected by the
designation and use of the proposed ODMDS. This consultation process
has been fully documented in the Final EIS.
EPA has evaluated the site designation for consistency with the
State of Florida's (the State) approved coastal management program. EPA
determined that the designation of the site is consistent to the
maximum extent practicable with the State coastal management program,
and submitted this determination to the State for review in accordance
with EPA policy. The State has concurred with this determination. In
addition, as part of the NEPA process, EPA has consulted with the State
regarding the effects of the dumping at the proposed site on the State
coastal zone. There were three main concerns raised by the State during
consultation: (1) placement of beach quality sand in the ODMDS; (2)
potential for movement of silt and clay sized particles out of the
disposal area and onto environmentally sensitive hardbottoms and coral
reefs to the west during the occurrence of Gulf Stream frontal eddies;
and (3) disposal of contaminated sediments from locations such as the
Miami River. Concerns raised by the State of Florida, regarding use of
suitable material for beach nourishment, were addressed in the Final
EIS. EPA concurs with the State of Florida regarding the use of
suitable material for beach nourishment, in circumstances where this
use is practical. To address the concern regarding movement of
material, a real-time monitoring system has been instituted by the Army
Corps of Engineers to identify the occurrence of Gulf Stream frontal
eddies. During the occurrence of such eddies, disposal at the ODMDS
will discontinue. Details of the monitoring plan and protocol has been
included in the Site Management and Monitoring Plan as part of the
Final EIS. With regard to contaminated materials, before any material
can be placed within an ODMDS, it must be evaluated and shown to be
acceptable for ocean disposal in accordance with ocean dumping
regulations (40 CFR 227.13). Certain portions of the sediments proposed
to be dredged from the Miami River have been found to be unacceptable
for ocean disposal.
In a letter dated September 13, 1990, the Florida Department of
State agreed that the designation will have no effect on any
archaeological or historic sites or properties listed, or eligible for
listing, in the National Register of Historic Places in accordance with
the National Preservation Act of 1966 (Pub. L. 89-6654), as amended.
The action discussed in the EIS is the permanent designation for
continuing use of the existing interim ocean disposal site near Miami,
Florida. The purpose of the action is to provide an environmentally
acceptable option for the ocean disposal of dredged material. The need
for the permanent designation of the Miami ODMDS is based on a
demonstrated COE need for ocean disposal of maintenance dredged
material from the Federal navigation projects in the greater Miami
area. However, every disposal activity by the COE is evaluated on a
case-by-case basis to determine the need for ocean disposal for that
particular case. The need for ocean disposal for other projects, and
the suitability of the material for ocean disposal, will be determined
on a case-by-case basis as part of the COE's process of issuing permits
for ocean disposal for private/federal actions and a public review
process for their own actions.
For the Miami ODMDS, the COE and EPA would evaluate all federal
dredged material disposal projects pursuant to the EPA criteria given
in the Ocean Dumping Regulations (40 CFR parts 220-229) and the COE
regulations (33 CFR 209.120 and 335-338). The COE also issues Marine
Protection, Research, and Sanctuaries Act (MPRSA) permits to private
applicants for the transport of dredged material intended for disposal
after compliance with regulations is determined. EPA has the right to
disapprove any ocean disposal project if, in its judgment, all
provisions of MPRSA and the associated implementing regulations have
not been met.
The EIS discusses the need for this site designation and examines
ocean disposal site alternatives to the final action. Non-ocean
disposal options have been examined in the previously published
Feasibility Report and EIS for the Miami Harbor Channel Project.
Alternatives to ocean disposal may include upland disposal within the
port area, disposal in Biscayne Bay, and beach disposal. Upland
disposal in the intensively developed Port of Miami-Biscayne Bay area
has not been found feasible. The Port of Miami itself is built
partially on fill in Biscayne Bay. Undeveloped areas within cost-
effective haul distances are environmentally valuable in their own
right.
Almost all inshore waters of the Biscayne Bay area are part of the
Biscayne Bay Aquatic Preserve. The waters of the southern portion of
Biscayne Bay, now included in the Aquatic Preserve, are to be
incorporated, along with some offshore waters, into the Biscayne
National Park in the near future. The Florida Department of
Environmental Regulation (DER) has afforded the waters of these areas
special protection as Outstanding Florida Waters. This effectively
removes virtually all of the Biscayne Bay area from consideration for
disposal of dredged material.
Dredged sand might be placed on beaches in the Miami Beach area.
Suitable rock might be placed in nearshore waters. These options may be
feasible where a substantial quantity of the desired type of material
is separable from silt or other undesirable material. Such usage will
be considered on a case by case basis.
The COE has been authorized to deepen Miami Harbor. For that
project, environmental and economic analyses were performed and an EIS
was prepared. The COE examined and documented the feasibility of each
of the above-described disposal options and found none to be feasible.
The following ocean disposal alternatives were evaluated in the
EIS:
1. Alternative Sites on the Continental Shelf
In the Miami nearshore area, hardgrounds supporting coral and algal
communities are concentrated on the continental shelf. Disposal
operations on the shelf could adversely impact this reef habitat.
Because the shelf is narrow, about 3.3 nmi (6 km) off Government Cut,
the transport of dredged materials for disposal beyond the shelf is
both practical and economically feasible. Therefore, alternative sites
on the continental shelf are not desirable.
2. Designated Interim Site (Candidate Site)
The preferred alternative considered in this document is the final
designation of an ODMDS. This site is an area of approximately one
square nautical mile with the following corner coordinates:
25 deg.45'30'' N, 80 deg.03'54'' W; 25 deg.45'30'' N, 80 deg.02'50'' W;
25 deg.44'30'' N, 80 deg.02'50'' W; 25 deg.44'30'' N, 80 deg.03'54'' W.
The site is centered at: 25 deg.45'00'' N and 80 deg.03'22'' W. This
site is considered suitable in
[[Page 2943]]
terms of practicality and economic feasibility. Sections 228.5 and
228.6 of EPA's Ocean Dumping Regulations and Criteria 40 CFR establish
criteria for the evaluation of ocean disposal sites.
3. Alternative Sites Beyond the Continental Shelf
The candidate site is beyond the continental shelf. The western
edge of the Gulf Stream meanders about one mile east of the candidate
site. Dumping in the Gulf Stream was considered, but the enormous task
and expense of monitoring disposal under such conditions caused
sufficient concern to eliminate that option. Therefore, additional
sites beyond the continental shelf and beyond the candidate site are
not desirable.
4. No Action
Under the ``no action'' alternative, the interim site would not
receive final designation. The Water Resources Act of 1992, title V,
section 506(a) prohibits the continued use of ocean dump sites which
have not been designated by EPA as section 102 dump sites after January
1, 1997. If EPA fails to designate the Miami ODMDS by that date, the
continued foreseeable need to have an appropriate site for disposal of
suitable sediments from dredging projects in the Miami area would place
pressure on the Corps and EPA to approve on a project-by-project basis
the use of temporary ocean dumping locations pursuant to either Clean
Water Act section 404 or MPRSA section 103.
The EIS presents the information needed to evaluate the suitability
of ocean disposal areas for final designation use and is based on one
of a series of disposal site environmental studies. The environmental
studies and final designation are being conducted in accordance with
the requirements of MPRSA, the Ocean Dumping Regulations, and other
applicable Federal environmental legislation.
This final rulemaking notice fills the same role as the Record of
Decision required under regulations promulgated by the Council on
Environmental Quality for agencies subject to NEPA.
C. Site Designation
On October 27, 1994, EPA proposed designation of this site for the
continueing disposal of dredged materials from the greater Miami,
Florida vicinity. The public comment period on this proposed action
closed on December 12, 1994. EPA received 1 letter regarding the
proposed rule. The letters comments are listed and addressed below.
1. Dredged Material Evaluation
The commentor was concerned as to whether EPA will evaluate the
contents of the dredged material for toxins and make them public.
Response. The suitability of dredged material for ocean disposal
must be verified by the COE and agreed to by EPA prior to disposal.
Verification will be valid for 3 years from the time last verified with
the option of a 2-year extension. Verification will involve: (1) A
case-specific evaluation against the exclusion criteria (40 CFR
227.13(b)), (2) A determination of the necessity for bioassay (toxicity
and bioaccumulation) testing for non-excluded material based on the
potential for contamination of the sediment since last tested, and (3)
Carrying out the testing and determining that the non-excluded, tested
material is suitable for ocean disposal.
Documentation of verification will be completed prior to use of the
site. Documentation for material suitability for dredging events
proposed for ocean disposal more than 5 years since last verified will
be a new 103 evaluation and public notice. Documentation for material
suitability for dredging events proposed for ocean disposal less than 5
years but more than 3 years since last verified will be an exchange of
letters between the COE and EPA.
Should EPA conclude that reasonable potential exists for
contamination to have occurred, acceptable testing will be completed
prior to use of the site. Testing procedures to be used will be those
delineated in the 1991 EPA/COE Dredged Material Testing Manual and 1992
Regional Implementation Manual. Only material determined to be suitable
through the verification process by the COE and EPA will be placed at
the designated ocean disposal site.
Verification documentation will be provided to the public in one of
two ways. For federal dredged material disposal projects, verification
documentation will be provided to the public by the COE through the
NEPA process, either in the form of an EIS or an Environmental
Assessment. The COE also issues MPRSA permits to private applicants for
the transport of dredged material intended for disposal. In this case
verification documentation will be made available to the public by the
COE through the Public Notice process.
2. Sources of Dredged Material
The commentor was concerned as to what regions the greater Miami,
Florida vicinity include and whether or not other sources besides the
Miami Harbor Channel Project may use the site.
Response. The primary need for designation of the Miami ODMDS was
for disposal of dredged material from the Miami Harbor Channel and the
Federal Miami Harbor Deepening Project.
However, other projects such as the maintenance dredging of that
portion of the Atlantic Intracoastal Waterway (AIWW) in the vicinity of
Miami Harbor and locally constructed channels within an economic haul
distance of the Miami ODMDS can use the site provided the material is
suitable for ocean disposal. Restrictions of use of the site to
specific projects has not been deemed necessary at this time. If in the
future, it is determined that use of the site should be restricted to a
specific project, appropriate changes will be made to the Site
Management and Monitoring Plan.
3. Period of Use
The commentor was concerned as to why a closing date of the site
had not been determined.
Response. The period of use of the Miami ODMDS has been designated
as continueing. Because the site is located in deep water, no
restrictions are presently placed on disposal volumes. Future disposal
of unrestricted volumes is dependent upon results from future
monitoring surveys. If future surveys indicate that capacity of the
site is being reached or unacceptable adverse environmental impacts are
occurring, then either the ODMDS Management and Monitoring Plan will be
modified or use of the site will be modified or discontinued.
4. Long-term Movement of Dredged Material
The commentor was concerned about movement of disposed dredged
material moving to more environmentally sensitive areas in the event of
an extreme storm event.
Response. Long-term modeling efforts were conducted to determine
whether a disposal mound is stable over long periods of time. A 24-hour
sustained storm surge simulation showed that essentially no material
would be transported as a result of the surge. A second study
investigated the potential for moving material other than uniformly
graded, non-cohesive sediments by calculating shear stress values on
the mound and in the surrounding area. Under normal environmental
conditions, shear stress values at the ODMDS are low, and little
movement is anticipated for either cohesive or non-cohesive material.
During storm events, the shear stress values increase by an order of
magnitude. However, the shear stress on the dredged material disposal
mound increases by less than 2 dynes/cm2
[[Page 2944]]
above the shear stress of the surrounding area. When subjected to
storms, material is anticipated to move from the mound for short
periods of time but large dispersion of the mound is not predicted. For
the proposed Miami ODMDS, simulations show that local velocity fields
are simply not adequate to move material in 600 feet or more of water.
Both the short-term disposal and long-term erosion simulations of
sediment transport as a function of local velocity fields indicate
little possibility of affecting reefs as a direct result of use of the
disposal site.
In addition, should the results of the monitoring surveys indicate
that continuing use of the site would lead to unacceptable impacts,
then either the ODMDS Management and Monitoring Plan will be modified
to alleviate the impacts, or the location or use of the ODMDS would be
modified.
5. Availability of Monitoring Results
The commentor asked if the monitoring results of the site will be
made public.
Response. Monitoring results will be available to the public upon
request. As discussed in the Final EIS, monitoring data will be
provided to the ODMDS Site Management and Monitoring team members for
review. Data will be provided to other interested parties requesting
such data to the extent possible.
The site is located east of Miami, Florida, the western boundary
being 3.6 nautical miles (nmi) offshore. The ODMDS occupies an area of
about 1 square nautical mile (nmi2), in the configuration of an
approximate 1 nmi by 1 nmi square. Water depths within the area range
from 130 to 240 meters (427 to 785 feet). The coordinates of the Miami
site for designation are as follows:
25 deg.45'30'' N 80 deg.03'54'' W;
25 deg.45'30'' N 80 deg.02'50'' W;
25 deg.44'30'' N 80 deg.03'54'' W; and
25 deg.44'30'' N 80 deg.02'50'' W.
Center coordinates are 25 deg.45'00'' N and 80 deg.03'22'' W.
If at any time disposal operations at the site cause unacceptable
adverse impacts, further use of the site will be restricted or
terminated.
D. Regulatory Requirements
Pursuant to the Ocean Dumping Regulations, 40 CFR Sec. 228.5, five
general criteria are used in the selection and approval for continuing
use of ocean disposal sites. Sites are selected so as to minimize
interference with other marine activities, to prevent any temporary
perturbations associated with the disposal from causing impacts outside
the disposal site, and to permit effective monitoring to detect any
adverse impacts at an early stage. Where feasible, locations off the
Continental Shelf and other sites that have been historically used are
to be chosen. The site conforms to the five general criteria.
In addition to these general criteria in Secs. 228.5, 228.6 lists
the 11 specific criteria used in evaluating a proposed disposal site to
assure that the general criteria are met. Application of these 11
criteria constitutes an environmental assessment of the impact of
disposal at the site. The characteristics of the proposed site are
reviewed below in terms of these 11 criteria (the EIS may be consulted
for additional information).
1. Geographical Position, Depth of Water, Bottom Topography, and
Distance From Coast (40 CFR 228.6(a)(1))
The boundary and center coordinates of the site are given above.
The western boundary of the site is located about 3.6 nmi offshore of
Miami, Florida. The site is an approximate 1 nmi by 1 nmi square
configuration. Water depth in the area ranges from 427 to 785 feet.
2. Location in Relation to Breeding, Spawning, Nursery, Feeding, or
Passage Areas of Living Resources in Adult or Juvenile Phases (40 CFR
228.6(a)(2))
Many of the area's species spend their adult lives in the offshore
region, but are estuary-dependent because their juvenile stages use a
low salinity estuarine nursery region. Specific migration routes are
not known in the Miami area. The site is not known to include any major
breeding or spawning area, except for sea turtles which use the entire
beach area of eastern Florida as nesting habitat. Due to the motility
of finfish, it is unlikely that disposal activities will have any
significant impact on any of the species found in the area.
3. Location in Relation to Beaches and Other Amenity Areas (40 CFR
228.6(a)(3))
The western edge of the candidate site is located 3.6 nautical
miles from the coast. Shore-related amenities include Virginia Key, the
Biscayne Bay Aquatic Preserve, Biscayne National Park, and the Bill
Baggs Cape Florida State Recreational Area. Currents in the vicinity
trend alongshore in a general north-south orientation. It is not
expected that detectable quantities of dredged material will be
transported onto beaches. Considering the distance that the disposal
site is offshore of beach areas, dredged material disposal at the site
is not expected to have an effect on the recreational uses of these
beaches. Modelling performed by the COE indicates that disposed
material will not impact these areas.
4. Types and Quantities of Wastes Proposed To Be Disposed of, and
Proposed Methods of Release, Including Methods of Packing the Waste, if
any (40 CFR 228(a)(4))
It is anticipated that the candidate site will be used primarily
for disposal of maintenance material from the Port of Miami.
Maintenance dredging has only occurred four times since 1957. Another
use of the site would be the Miami Harbor Deepening Project. Estimated
volume for this project is expected to be 6 million cubic yards. For
each future dredging project, each disposal plan must be evaluated on a
case-by-case basis to ensure that ocean disposal is the best
alternative and that the material meets the Ocean Dumping Criteria in
40 CFR part 227.
5. Feasibility of Surveillance and Monitoring (40 CFR 228.6(a)(5))
Due to the proximity of the site to shore, surveillance will not be
difficult. Survey vessels, dredges or aircraft overflights are feasible
surveillance methods. However, the depths at this site make
conventional ODMDS monitoring techniques difficult to utilize. An
interagency Site Management and Monitoring Team was established to
assist EPA in the development and implementation of a Site Monitoring
Plan (SMMP) for the Miami ODMDS. The SMMP has been developed and was
included as an appendix in the Final EIS. This SMMP establishes a
sequence of monitoring surveys to be undertaken to determine any
impacts resulting from disposal activities. The SMMP may be modified
for cause by the responsible agencies.
6. Dispersal, Horizontal Transport and Vertical Mixing Characteristics
of the Area Including Prevailing Current Direction and Velocity, if any
(40 CFR 228.6(a)(6))
Prevailing currents parallel the coast and are generally oriented
along a north-south axis. Northerly flow predominates. Mean surface
currents range from 62 to 95 cm/sec with maximum velocities of about
150 cm/sec. Current speeds are lower and current reversals more common
in near-bottom waters. Mean velocities of 3.5 cm/sec and maximum
velocities of 27 cm/sec have been reported for near-bottom waters in
the area. A pycnocline occurs in site waters throughout the
[[Page 2945]]
year at reported depths ranging from about 60 feet in the summer to 325
feet in the winter. A dredged material dispersion study conducted by
the COE for both the short- and long-term fate of material disposed at
the site indicates little possibility of disposed material affecting
near-shore reefs. Measures as discussed in the Site Management and
Monitoring Plan will be instituted during disposal operations to
minimize the possibility of material being transported to the near-
shore reefs.
7. Existence and Effects of Current and Previous Discharges and Dumping
in the Area (Including Cumulative Effects) (40 CFR 228.6(a)(7))
The ODMDS was used for the first time in April 1990. Only 225,000
cubic yards of maintenance material was disposed in the ODMDS. In
conjunction with this use of the site, the Corps of Engineers in
cooperation with the National Oceanic and Atmospheric Administration
(NOAA) monitored the physical processes and the dispersive
characteristics of the dredged material plume. Monitoring results
indicated that the material discharged, except for a low concentration
residual remaining within the water column, reached the bottom within
the designated site boundaries. During the monitoring, the resulting
plumes were observed to be transported in a north to northeast
direction. The full monitoring report has been included as part of the
Final EIS. Effects monitoring is discussed in the Site Management and
Monitoring Plan as part of the Final EIS.
No other discharges or dumping occurs in the site. The Miami-Dade
Central publicly owned treatment plant outfall discharges approximately
1.2 nmiles west of the site. The effects from this discharge are local
and predominately in a north-south direction due to prevailing currents
and should not have any effect within the site.
8. Interference With Shipping, Fishing, Recreation, Mineral Extraction,
Desalination, Fish and Shellfish Culture, Areas of Special Scientific
Importance and Other Legitimate Uses of the Ocean (40 CFR 228.6(a)(8))
While shipping is heavy at the Port of Miami, the infrequent use of
this site should not significantly disrupt either commercial shipping
or recreational boating. Commercial and recreational fishing activities
are concentrated in inshore and nearshore waters. No mineral
extraction, desalination, or mariculture activities occur in the
immediate area. Scientific resources present throughout this area are
not geographically limited to the Miami ODMDS or nearby waters.
9. The Existing Water Quality and Ecology of the Site as Determined by
Available Data or by Trend Assessment or Baseline Surveys (40 CFR
228.6(a)(9))
Water quality at the ODMDS is variable and is influenced by
discharges from inshore systems, frequent oceanic intrusions, and
periodic upwelling. The disposal site lies on the continental slope in
an area traversed by the western edge of the Florida Current. The
location of the western edge of the current determines to a large
extent whether waters at the site are predominantly coastal or oceanic.
Frequent intrusions or eddies of the Florida Current transport oceanic
waters over the continental slope in the ODMDS vicinity. Periodic
upwelling/downwelling events associated with wind stress also influence
waters in the area.
No critical habitat or unique ecological communities have been
identified at the candidate site. Buffer zone protection has been
applied to any existing fish havens, artificial reef communities,
turtle nesting areas, and onshore amenities in the general region of
the site.
10. Potentiality for the Development or Recruitment of Nuisance Species
in the Disposal Site (40 CFR 228.6(a)(10))
The disposal of dredged materials should not attract or promote the
development of nuisance species. No nuisance species have been reported
to occur at previously utilized disposal sites in the vicinity.
11. Existence at or in Close Proximity to the Site of any Significant
Natural or Cultural Features of Historical Importance (40 CFR
228.6(a)(11))
No known natural or cultural features of historical importance
occur at or in close proximity to the site. No such features were noted
in a video survey of the disposal area.
E. Site Management
Site management of the Miami ODMDS is the responsibility of EPA as
well as the COE. The COE issues permits to private applicants for ocean
disposal; however, EPA/Region 4 assumes overall responsibility for site
management.
The Site Management and Monitoring Plan (SMMP) for the Miami ODMDS
was developed as a part of the process of completing the EIS. The plan
was developed with the assistance of an interagency Site Management and
Monitoring team. The Team will also provide assistance during the
implementation of the plan. This plan provides procedures for both site
management and for the monitoring of effects of disposal activities.
This SMMP is intended to be flexible and may be modified by the
responsible agencies for cause.
F. Final Action
The EIS concludes that the site may appropriately be designated for
use. The site is compatible with the 11 specific and 5 general criteria
used for site evaluation.
The designation of the Miami site as an EPA-approved ODMDS is being
published as Final Rulemaking. Overall management of this site is the
responsibility of the Regional Administrator of EPA/Region 4.
It should be emphasized that, if an ODMDS is designated, such a
site designation does not constitute EPA's approval of actual disposal
of material at sea. Before ocean disposal of dredged material at the
site may commence, the COE must evaluate a permit application according
to EPA's Ocean Dumping Criteria. EPA has the right to disapprove the
actual disposal if it determines that environmental concerns under
MPRSA have not been met.
The Miami ODMDS is not restricted to disposal use by federal
projects; private applicants may also dispose suitable dredged material
at the ODMDS once relevant regulations have been satisfied. This site
is restricted, however, to suitable dredged material from the greater
Miami, Florida vicinity.
G. Regulatory Assessments
Under the Regulatory Flexibility Act, EPA is required to perform a
Regulatory Flexibility Analysis for all rules that may have a
significant impact on a substantial number of small entities. EPA has
determined that this action will not have a significant impact on small
entities since the designation will only have the effect of providing a
disposal option for dredged material. Consequently, this Rule does not
necessitate preparation of a Regulatory Flexibility Analysis.
Under Executive Order 12291, EPA must judge whether a regulation is
``major'' and therefore subject to the requirement of a Regulatory
Impact Analysis. This action will not result in an annual effect on the
economy of $100 million or more or cause any of the other effects which
would result in its being classified by the Executive Order as a
``major'' rule. Consequently, this Rule does not necessitate
preparation of a Regulatory Impact Analysis.
[[Page 2946]]
This Final Rule does not contain any information collection
requirements subject to Office Management and Budget review under the
Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq.
List of Subjects in 40 CFR Part 228
Water Pollution Control.
Dated: November 2, 1995.
Patrick M. Tobin,
Acting Regional Administrator.
In consideration of the foregoing, 40 CFR Chap. I, Subchapter H is
amended as set forth below.
PART 228--[AMENDED]
1. The authority citation for part 228 continues to read as
follows:
Authority: 33 U.S.C. Sections 1412 and 1418.
2. Section 228.14 is amended by removing paragraph (h)(6).
3. Section 228.15 is amended by adding paragraph (h)(19) to read as
follows:
Sec. 228.15 Dumping sites designated on a final basis
* * * * *
(h) * * *
(19) Miami, Florida; Ocean Dredged Material Disposal Site.
(i) Location:
25 deg.45'30'' N 80 deg.03'54'' W;
25 deg.45'30'' N 80 deg.02'50'' W;
25 deg.44'30'' N 80 deg.03'54'' W;
25 deg.44'30'' N 80 deg.02'50'' W.
Center coordinates are 25 deg.45'00'' N and 80 deg.03'22'' W.
(ii) Size: Approximately 1 square nautical mile.
(iii) Depth: Ranges from 130 to 240 meters.
(iv) Primary use: Dredged material.
(v) Period of use: Continuing use.
(vi) Restriction: Disposal shall be limited to suitable dredged
material from the greater Miami, Florida vicinity. Disposal shall
comply with conditions set forth in the most recent approved Site
Management and Monitoring Plan.
* * * * *
[FR Doc. 96-1709 Filed 1-29-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-1677 North American Free Trade Agreement (NAFTA)Implementation of Duty-Deferral Program Provisions
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2908-2914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1677]
=======================================================================
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DEPARTMENT OF THE TREASURY
Customs Service
19 CFR Parts 10, 113, 141, 144 and 181
[T.D. 96-14]
RIN 1515-AB87
North American Free Trade Agreement (NAFTA)--Implementation of
Duty-Deferral Program Provisions
AGENCY: Customs Service, Treasury.
ACTION: Interim regulations; solicitation of comments.
-----------------------------------------------------------------------
SUMMARY: In response to comments received on the final rule
implementing NAFTA, this document sets forth interim regulations
establishing procedural and other requirements that apply to the
collection, waiver and reduction of duties under the duty-deferral
program provisions of the North American Free Trade Agreement. The
document prescribes the documentary and other requirements that must be
followed when merchandise is withdrawn from a U.S. duty-deferral
program either for exportation to another NAFTA country or for entry
into a duty-deferral program of another NAFTA country, the procedures
that must be followed in filing a claim for a waiver or reduction of
duties collected on such merchandise, and the procedures for
finalization of duty collections and duty waiver or reduction claims.
DATES: Interim rule effective January 1, 1996; comments must be
submitted by April 1, 1996.
ADDRESSES: Written comments (preferably in triplicate) may be addressed
to the Regulations Branch, U.S. Customs Service, Franklin Court, 1301
Constitution Avenue, N.W., Washington, D.C. 20229. Comments submitted
may be inspected at the Regulations Branch, Office of Regulations and
Rulings, Franklin Court, 1099 14th Street, NW., Suite 4000, Washington,
DC.
FOR FURTHER INFORMATION CONTACT: Angela Downey, Office of Field
Operations (202-927-1082).
SUPPLEMENTARY INFORMATION:
Background
On September 6, 1995, Customs published in the Federal Register (60
FR 46334) a document which adopted, as a final rule, interim
regulations implementing the Customs-related provisions of the North
American Free Trade Agreement (NAFTA) which was adopted by the United
States with the enactment of the North American Free Trade Agreement
Implementation Act (the ``Act''), Public Law 103-182, 107 Stat. 2057.
The majority of the NAFTA implementing regulations are set forth in
Part 181 of the Customs Regulations (19 CFR Part 181) which includes,
in Subpart E, regulations implementing the NAFTA drawback (including
duty-deferral) provisions of Article 303 of the NAFTA and section 203
of the Act which apply to goods imported into the United States and
then subsequently exported from the United States to Canada on or after
January 1, 1996, or to Mexico on or after January 1, 2001.
Within Subpart E of Part 181, Sec. 181.53 specifically addresses
the provisions concerning the collection, and waiver or reduction, of
duty on goods imported into the United States pursuant to a duty-
deferral program (that is, imported into a manipulation warehouse,
manufacturing warehouse, smelting or refining warehouse or foreign
trade zone, or imported under a temporary importation bond) and
subsequently exported, or used as a material in the production of
another good that is exported, to Canada or Mexico. Paragraph (a)(1)
defines the term ``duty-deferral program'' for purposes of the section.
Paragraph (a)(2) provides that the exported good shall be treated as if
it had been entered or withdrawn for consumption and thus subject to
duty. Paragraph (a)(3) states that Customs shall waive or reduce, in
accordance with paragraphs (b) through (f), the duties paid or owed
under paragraph (a)(2) provided that evidence of exportation and
satisfactory evidence of duties paid in Canada or Mexico are submitted
within 60 calendar days of the date of exportation. Paragraphs (b)
through (f) set forth the duty assessment and waiver or reduction rules
with reference to each type of duty-deferral program, and each of these
paragraphs provides that the duty shall be waived or reduced in an
amount that does not exceed the lesser of the total amount of duty
payable under the section or the total amount of customs duties paid to
Canada or Mexico.
In the discussion of public comments submitted on the interim NAFTA
implementing regulations, the September 6, 1995, final rule document
noted that a number of commenters raised questions regarding the
procedures, including documentary requirements, that would apply for
purposes of the collection and waiver or reduction of duty under
Sec. 181.53. In responding to these comments, Customs agreed that the
regulations should specifically address such procedural issues. Customs
further stated that it would be preferable to address these issues in a
separate Federal Register document, with a view to having appropriate
regulations in place on January 1, 1996, when the Subpart E regulations
go into effect (that is, with regard to goods exported to or entered
into a duty-deferral program in Canada). The regulatory amendments set
forth in this document are intended to accomplish that purpose.
Discussion of Amendments
Section 10.31
In Sec. 10.31, which concerns temporary importations under bond,
paragraph (h) is amended by adding at the end a new sentence regarding
merchandise imported under subheading 9813.00.05, HTSUS, that is
exported to Canada or Mexico, because the entry and bond requirements
under amended Sec. 181.53 may apply to such merchandise.
Section 113.62
In Sec. 113.62, which sets forth the basic importation and entry
bond conditions, paragraphs (a) and (b) are amended by the addition of
references to the withdrawal of merchandise from a duty-deferral
program either for exportation to Canada or Mexico or for entry into a
duty-deferral program in Canada or Mexico because such transactions
will involve the filing of an entry under amended Sec. 181.53 as
discussed below. Paragraph (a) concerns the agreement to pay duties,
taxes and fees, and paragraph (b) concerns the agreement to make or
complete entry.
Section 141.0a
The definition of ``entry'' in paragraph (a) and the definition of
``entered for consumption'' in paragraph (f) have been expanded by the
addition of a sentence at the end referring to documentation required
under amended Sec. 181.53 as discussed below.
Section 141.68
A new paragraph (i) has been added to Sec. 141.68 (time of entry)
regarding merchandise covered by the entry procedures contained in
amended Sec. 181.53 as discussed below.
[[Page 2909]]
Section 144.38
In Sec. 144.38, which concerns withdrawals for consumption, a new
paragraph (b) has been added to cover withdrawals either for
exportation to Canada or Mexico or for entry into a duty-deferral
program in Canada or Mexico.
Section 181.53
Section 181.53 is retitled to reflect that the section also covers
collection (rather than only waiver or reduction) of duty, and the
section text is extensively revised in order to accommodate the
necessary documentation and other procedural requirements regarding the
collection and waiver or reduction of duty under the NAFTA duty-
deferral provisions. In addition to editorial, nonsubstantive changes
to enhance the clarity of the text, the revised text incorporates a
number of organizational and substantive changes that are outlined
below.
Paragraph (a)(1) is retitled as a definitions paragraph and a new
definition of ``date of exportation'' has been added as subparagraph
(i) thereof.
Paragraph (a)(2) still concerns the ``treatment as entered or
withdrawn for consumption'' principle but is divided into the following
subparagraphs:
1. Subparagraph (i) incorporates the provisions of former paragraph
(a)(2) and also includes two new principles stating that the
documentation required to be filed under the section shall constitute
an entry or withdrawal for consumption for purposes of the Customs
Regulations and that any assessment of duty under this section shall
include the duties and fees referred to in Secs. 181.42 (a)-(c) (that
is, antidumping and countervailing duties, premiums on quota, tariff
rate quota or tariff preference level goods, and fees under section 22
of the Agricultural Adjustment Act) and the fees provided for in
Sec. 24.23 (that is, fees for processing merchandise). Subparagraph (i)
refers to goods withdrawn for exportation to Canada or Mexico
(subparagraph (i)(A)) and goods withdrawn and entered into a duty-
deferral program in Canada or Mexico (subparagraph (i)(B)) because
Canada, Mexico and the United States (the three NAFTA Parties) agreed
that goods withdrawn from a duty-deferral program in one NAFTA country
and entered into a duty-deferral program in another NAFTA country shall
be deemed not to have been exported (see section F, article X of the
``Regulatory Standards for Implementation of the North American Free
Trade Agreement'' published in the Federal Register on September 6,
1995, at 60 FR 46464).
2. Subparagraph (ii) is new and provides for application of the
bond provisions of Sec. 142.4 to each withdrawal and exportation
transaction under Sec. 181.53.
3. Subparagraph (iii) is a new provision covering documentation
filing and duty payment procedures. Subparagraph (A) thereunder
specifies the persons who must file the documentation required under
the section. Subparagraph (B) provides for the filing of a Customs Form
7501 within 10 working days of the date of exportation or within 10
working days after being entered into a duty-deferral program in Canada
or Mexico. Subparagraph (C) concerns duty payment and requires that the
duty be deposited with Customs at any time prior to, but no later than,
60 calendar days after the date of exportation of the good or 60
calendar days after the date the good is entered into a duty-deferral
program in Canada or Mexico, and subparagraph (C) also provides for the
calculation of interest from the applicable 60th calendar day.
Paragraph (a)(3) is retitled ``waiver or reduction of duties'' and
is divided into the following subparagraphs:
1. Subparagraph (i) incorporates the provisions of former paragraph
(a)(3) but also includes two new substantive provisions. The first of
these new provisions consists of an exception clause at the beginning
of the subparagraph regarding duties and fees referred to in
Secs. 181.42 (a)-(c) and fees provided for in Sec. 24.23, because such
duties and fees may not be waived or reduced under the NAFTA drawback
(including duty-deferral) provisions. The second of these new
substantive provisions requires the filing of a ``claim'' for waiver or
reduction of duties and states that the claim shall be ``based on''
evidence of exportation to Canada or Mexico or of entry into a duty-
deferral program in Canada or Mexico and satisfactory evidence of
duties paid in Canada or Mexico. The ``based on'' provision replaces
the former requirement of submission of such evidence, is modeled on
the approach used for NAFTA preferential duty claims (see
Sec. 181.21(a) of the NAFTA regulations), and is intended to reduce the
paperwork burden and to facilitate electronic filings.
2. Subparagraph (ii) is a new provision covering the procedures for
filing claims and paying reduced duties. This subparagraph requires
that the claim be filed on Customs Form 7501 which must include
specified Canadian or Mexican import information and provides that any
reduced duties must be deposited with Customs when a claim for reduced
duties is filed.
3. Subparagraph (iii) is a new provision which provides for the
filing of a drawback claim if goods entered into a Canadian or Mexican
duty-deferral program are subsequently withdrawn from that duty-
deferral program.
Paragraph (a)(4) is a new provision setting forth procedures
regarding the liquidation of entries filed under Sec. 181.53 both if no
claim for waiver or reduction of duties is filed (subparagraph (i)) and
if a claim is filed (subparagraph (ii)). This paragraph generally
reflects existing statutory and regulatory standards regarding
liquidations, including notices of liquidation, deemed liquidations,
and the time for filing protests after liquidation. In addition, in
cases in which a claim is filed, this paragraph provides for an
automatic 3-year extension of liquidation, because Customs will require
additional time to obtain any information from Canadian or Mexican
Customs necessary to verify a claim (see Sec. 181.50(b) which provides
for a 3-year delay in liquidation of drawback claims).
Former paragraphs (b) through (f) are redesignated as subparagraphs
(1) through (5) under a new paragraph (b) titled ``assessment and
waiver or reduction of duty''. The introductory texts and/or examples
in newly designated paragraphs (b) (1)-(5), each of which still deals
with a separate type of duty-deferral program, have been modified as
follows: (1) by replacing the references to evidence of exportation and
payment of duty by references to the filing of a proper claim under
paragraph (a)(3) of the section; (2) to refer, where appropriate, to
the filing of Customs Form 7501; and (3) by revising the examples to
more accurately reflect a NAFTA duty-deferral context. In addition, the
example concerning manipulation in warehouse (former paragraph (b), now
paragraph (b)(1)) has been removed because it no longer reflects
current law as interpreted by the courts (see Tropicana Products Inc.
v. U.S., 789 F.Supp. 1154, 16 CIT 155 (1992)). Finally, an exception
regarding a good imported from Canada or Mexico for repair or
alteration has been added at the beginning of the text covering
temporary importation under bond (former paragraph (f), now paragraph
(b)(5)), in order to reflect the terms of article 307(2) of the NAFTA.
Paragraph (c) concerns recordkeeping and corresponds to former
paragraph (g) but includes a new requirement that evidence of
exportation or of entry into a Canadian or Mexican duty-deferral
[[Page 2910]]
program and payment of Canadian or Mexican duty be maintained by the
person who files a claim for waiver or reduction of duty under the
section.
Paragraph (d) corresponds to former paragraph (h) and differs from
the former text in referring to a failure to file a proper claim
(rather than to a failure to provide evidence of duties paid or owed to
Canada or Mexico) and also in referring more specifically to the
persons who are liable for the payment of full duties.
Finally, paragraph (e) corresponds to former paragraph (i) but has
been modified to refer to reliquidation of the ``entry filed under this
section pursuant to 19 U.S.C. 1508(b)(2)(B)(iii) even after liquidation
of the entry has become final'' (see Sec. 181.50(b)).
Comments
Before adopting these interim regulations as a final rule,
consideration will be given to any written comments timely submitted to
Customs. Comments submitted will be available for public inspection in
accordance with the Freedom of Information Act (5 U.S.C. 552),
Sec. 1.4, Treasury Department Regulations (31 CFR 1.4), and
Sec. 103.11(b), Customs Regulations (19 CFR 103.11(b)), on regular
business days between the hours of 9 a.m. and 4:30 p.m. at the
Regulations Branch, Office of Regulations and Rulings, U.S. Customs
Service, Franklin Court, 1099 14th Street, NW., Suite 4000, Washington,
DC.
Inapplicability of Notice and Delayed Effective Date Requirements
Pursuant to the provisions of 5 U.S.C. 553(a), public notice is
inapplicable to these interim regulations because they are within the
foreign affairs function of the United States. The United States is
obligated under Chapter Three of the NAFTA to implement the NAFTA duty-
deferral provisions with respect to exportation to Canada on January 1,
1996. Furthermore, for the same reason, it is determined that good
cause exists under the provisions of 5 U.S.C. 553(d)(3) for dispensing
with a delayed effective date.
Executive Order 12866
Because this document involves a foreign affairs function of the
United States and implements an international agreement, it is not
subject to the provisions of E.O. 12866.
Regulatory Flexibility Act
Because no notice of proposed rulemaking is required for interim
regulations, the provisions of the Regulatory Flexibility Act (5 U.S.C.
601 et seq.) do not apply.
Paperwork Reduction Act
These regulations are being issued without prior notice and public
procedure pursuant to the Administrative Procedure Act (5 U.S.C. 553).
For this reason, the collections of information contained in these
regulations have been reviewed and, pending receipt and evaluation of
public comments, approved by the Office of Management and Budget in
accordance with the requirements of the Paperwork Reduction Act (44
U.S.C. 3507) under control number 1515-0208.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless the collection of
information displays a valid control number.
The collection of information in these regulations is in
Sec. 181.53. This information is required in connection with the
withdrawal of goods from U.S. duty deferral programs for export to
Canada or Mexico and will be used by the U.S. Customs Service both to
determine the amount of duty to be collected on the exported goods and
to determine eligibility for a waiver or reduction of such duty. The
likely respondents are business organizations including importers,
exporters and manufacturers.
Estimated total annual reporting and/or recordkeeping burden:
405,070 hours.
Estimated average annual burden per respondent/recordkeeper: 227
hours.
Estimated number of respondents and/or recordkeepers: 1783.
Estimated annual frequency of responses: 1,069,800.
Comments are invited on: (a) Whether the collection of information
is necessary for the proper performance of the functions of the agency,
including whether the information shall have practical utility; (b) the
accuracy of the agency's estimate of the burden of the collection of
information; (c) ways to enhance the quality, utility, and clarity of
the information to be collected; and (d) ways to minimize the burden of
the collection of information on respondents, including through the use
of automated collection techniques or other forms of information
technology. Comments should be directed to the Office of Management and
Budget, Attention: Desk Officer for the Department of the Treasury,
Office of Information and Regulatory Affairs, Washington, DC 20503. A
copy should also be sent to the Regulations Branch, Office of
Regulations and Rulings, U.S. Customs Service, 1301 Constitution
Avenue, NW., Washington, DC 20229.
Drafting Information. The principal author of this document was
Francis W. Foote, Office of Regulations and Rulings, U.S. Customs
Service. However, personnel from other offices participated in its
development.
List of Subjects
19 CFR Part 10
Alterations, Bonds, Customs duties and inspection, Exports,
Imports, Preference programs, Repairs, Reporting and recordkeeping
requirements, Trade agreements.
19 CFR Part 113
Air carriers, Bonds, Customs duties and inspection, Exports,
Foreign commerce and trade statistics, Freight, Imports, Reporting and
recordkeeping requirements, Vessels.
19 CFR Part 141
Bonds, Customs duties and inspection, Entry of merchandise,
Invoices, Powers of attorney, Packaging, Release of merchandise,
Reporting and recordkeeping requirements.
19 CFR Part 144
Bonds, Customs duties and inspection, Reporting and recordkeeping
requirements, Warehouses.
19 CFR Part 181
Administrative practice and procedure, Canada, Customs duties and
inspection, Exports, Imports, Mexico, Reporting and recordkeeping
requirements, Trade agreements (North American Free-Trade Agreement).
Amendments to the Regulations
Accordingly, parts 10, 113, 141, 144 and 181, Customs Regulations
(19 CFR parts 10, 113, 141, 144 and 181), are amended as set forth
below.
PART 10--ARTICLES CONDITIONALLY FREE, SUBJECT TO A REDUCED RATE,
ETC.
1. The authority citation for part 10 continues to read in part as
follows:
Authority: 19 U.S.C. 66, 1202 (General Note 20, Harmonized
Tariff Schedule of the United States), 1321, 1481, 1484, 1498, 1508,
1623, 1624, 3314;
* * * * *
2. In Sec. 10.31, paragraph (h) is amended by adding a new sentence
at the end to read as follows:
Sec. 10.31 Entry; bond.
* * * * *
(h) * * * However, a TIB importer may be required to file an entry
for consumption and pay duties, or pay liquidated damages under its
bond for a failure to do so, in the case of
[[Page 2911]]
merchandise imported under subheading 9813.00.05, HTSUS, and
subsequently exported to Canada or Mexico (see Sec. 181.53 of this
chapter).
PART 113--CUSTOMS BONDS
1. The authority citation for part 113 continues to read in part as
follows:
Authority: 19 U.S.C. 66, 1623, 1624.
* * * * *
2. In Sec. 113.62, the introductory texts of paragraphs (a)(1) and
(b) are revised to read as follows:
Sec. 113.62 Basic importation and entry bond conditions.
* * * * *
(a) Agreement to Pay Duties, Taxes, and Charges.
(1) If merchandise is imported and released from Customs custody or
withdrawn from a Customs bonded warehouse into the commerce of, or for
consumption in, the United States, or under Sec. 181.53 of this chapter
is withdrawn from a duty-deferral program for exportation to Canada or
Mexico or for entry into a duty-deferral program in Canada or Mexico,
the obligors (principal and surety, jointly and severally) agree to:
* * * * *
(b) Agreement to Make or Complete Entry. If all or part of imported
merchandise is released before entry under the provisions of the
special delivery permit procedures under 19 U.S.C. 1448(b), or released
before the completion of the entry under 19 U.S.C. 1484(a), or
withdrawn from a duty-deferral program for either exportation to Canada
or Mexico or for entry into a duty-deferral program in Canada or Mexico
before the filing of the documentation provided for in
Sec. 181.53(a)(2) of this chapter, the principal agrees to file within
the time and in the manner prescribed by law and regulation,
documentation to enable Customs to:
* * * * *
PART 141--ENTRY OF MERCHANDISE
1. The authority citation for part 141 continues to read in part as
follows:
Authority: 19 U.S.C. 66, 1448, 1484, 1624.
* * * * *
Section 141.68 also issued under 19 U.S.C. 1315;
* * * * *
2. In Sec. 141.0a, paragraphs (a) and (f) are amended by adding a
sentence at the end to read as follows:
Sec. 141.0a Definitions.
* * * * *
(a) Entry. * * * ``Entry'' also means that documentation required
by Sec. 181.53 of this chapter to be filed with Customs to withdraw
merchandise from a duty-deferral program in the United States for
exportation to Canada or Mexico or for entry into a duty-deferral
program in Canada or Mexico.
* * * * *
(f) Entered for consumption. * * * ``Entered for consumption'' also
means the necessary documentation has been filed with Customs to
withdraw merchandise from a duty-deferral program in the United States
for exportation to Canada or Mexico or for entry into a duty-deferral
program in Canada or Mexico (see Sec. 181.53 of this chapter).
* * * * *
3. Section 141.68 is amended by adding a new paragraph (i) to read
as follows:
Sec. 141.68 Time of entry.
* * * * *
(i) Exportation to Canada or Mexico of goods imported into the
United States under a duty-deferral program defined in Sec. 181.53 of
this chapter. When merchandise in a U.S. duty-deferral program is
withdrawn for exportation to Canada or Mexico or for entry into a duty-
deferral program in Canada or Mexico, the date of entry is the date the
entry is required to be filed under Sec. 181.53(a)(2)(iii) of this
chapter.
PART 144--WAREHOUSE AND REWAREHOUSE ENTRIES AND WITHDRAWALS
1. The authority citation for part 144 continues to read in part as
follows:
Authority: 19 U.S.C. 66, 1484, 1557, 1559, 1624.
* * * * *
2. Section 144.38 is amended by adding a new paragraph (b) to read
as follows:
Sec. 144.38 Withdrawal for consumption.
* * * * *
(b) Withdrawal for exportation to Canada or Mexico. A withdrawal
for exportation to Canada or Mexico or for entry into a duty-deferral
program in Canada or Mexico is considered a withdrawal for consumption
pursuant to Sec. 181.53 of this chapter.
* * * * *
PART 181--NORTH AMERICAN FREE TRADE AGREEMENT
1. The authority citation for part 181 continues to read as
follows:
Authority: 19 U.S.C. 66, 1202 (General Note 20, Harmonized
Tariff Schedule of the United States), 1624, 3314.
2. Section 181.53 is revised to read as follows:
Sec. 181.53 Collection and waiver or reduction of duty under duty-
deferral programs.
(a) General.
(1) Definitions. The following definitions shall apply for purposes
of this section:
(i) Date of exportation. ``Date of exportation'' means the date of
importation into Canada or Mexico as reflected on the applicable
Canadian or Mexican entry document (see Sec. 181.47(c) (1) and (2)).
(ii) Duty-deferral program. A ``duty-deferral program'' means any
measure which postpones duty payment upon arrival of a good in the
United States until withdrawn or removed for exportation to Canada or
Mexico or for entry into a Canadian or Mexican duty-deferral program.
Such measures govern manipulation warehouses, manufacturing warehouses,
smelting and refining warehouses, foreign trade zones, and those
temporary importations under bond that are specified in paragraph
(b)(5) of this section.
(2) Treatment as entered or withdrawn for consumption.
(i) General.
(A) Where a good is imported into the United States pursuant to a
duty-deferral program and is subsequently withdrawn from the duty-
deferral program for exportation to Canada or Mexico or is used as a
material in the production of another good that is subsequently
withdrawn from the duty-deferral program for exportation to Canada or
Mexico, and provided that the good is a ``good subject to NAFTA
drawback'' within the meaning of 19 U.S.C. 3333 and is not described in
Sec. 181.45 of this part, the documentation required to be filed under
this section in connection with the exportation of the good shall, for
purposes of this chapter, constitute an entry or withdrawal for
consumption and the exported good shall be subject to duty which shall
be assessed in accordance with paragraph (b) of this section.
(B) Where a good is imported into the United States pursuant to a
duty-deferral program and is subsequently withdrawn from the duty-
deferral program and entered into a duty-deferral program in Canada or
Mexico or is used as a material in the production of another good that
is subsequently withdrawn from the duty-deferral program and entered
into a duty-
[[Page 2912]]
deferral program in Canada or Mexico, and provided that the good is a
``good subject to NAFTA drawback'' within the meaning of 19 U.S.C. 3333
and is not described in Sec. 181.45, the documentation required to be
filed under this section in connection with the withdrawal of the good
from the U.S. duty-deferral program shall, for purposes of this
chapter, constitute an entry or withdrawal for consumption and the
withdrawn good shall be subject to duty which shall be assessed in
accordance with paragraph (b) of this section.
(C) Any assessment of duty under this section shall include the
duties and fees referred to in Sec. 181.42 (a) through (c) and the fees
provided for in Sec. 24.23 of this chapter; these inclusions shall not
be subject to refund, waiver, reduction or drawback.
(ii) Bond requirements. The provisions of Sec. 142.4 of this
chapter shall apply to each withdrawal and exportation transaction
described in paragraph (a)(2)(i) of this section. However, in applying
the provisions of Sec. 142.4 of this chapter in the context of this
section, any reference to release from Customs custody in Sec. 142.4 of
this chapter shall be taken to mean exportation to Canada or Mexico.
(iii) Documentation filing and duty payment procedures.
(A) Persons required to file. In the circumstances described in
paragraph (a)(2)(i) of this section, the documentation described in
paragraph (a)(2)(iii)(B) of this section must be filed by one of the
following persons:
(1) In the case of a withdrawal of the goods from a warehouse, the
person who has the right to withdraw the goods;
(2) In the case of a temporary importation under bond (TIB)
specified in paragraph (b)(5) of this section, the TIB importer whether
or not he sells the goods for export to Canada or Mexico unless
Sec. 10.31(h) of this chapter applies; or
(3) In the case of a withdrawal from a foreign trade zone, the
person who has the right to make entry. However, if a zone operator is
not the person with the right to make entry of the good, the zone
operator shall be responsible for the payment of any duty due in the
event the zone operator permits such other person to remove the goods
from the zone and such other person fails to comply with Secs. 146.67
and 146.68 of this chapter.
(B) Documentation required to be filed and required filing date.
The person required to file shall file Customs Form 7501 no later than
10 working days after the date of exportation to Canada or Mexico or 10
working days after being entered into a duty-deferral program in Canada
or Mexico. Except where the context otherwise requires and except as
otherwise specifically provided in this paragraph, the procedures for
completing and filing Customs Form 7501 in connection with the entry of
merchandise under this chapter shall apply for purposes of this
paragraph. For purposes of completing Customs Form 7501 under this
paragraph, any reference on the form to the entry date shall be taken
to refer to the date of exportation of the good or the date the goods
are entered into a duty-deferral program in Canada or Mexico. The
Customs Form 7501 required under this paragraph may be transmitted
electronically.
(C) Duty payment. The duty estimated to be due under paragraph (b)
of this section shall be deposited with Customs 60 calendar days after
the date of exportation of the good. If a good is entered into a duty-
deferral program in Canada or Mexico, the duty estimated to be due
under paragraph (b) of this section, but without any waiver or
reduction provided for in that paragraph, shall be deposited with
Customs 60 calendar days after the date the good is entered into such
duty-deferral program. Nothing shall preclude the deposit of such
estimated duty at the time of filing the Customs Form 7501 under
paragraph (a)(2)(iii)(B) of this section or at any other time within
the 60-day period prescribed in this paragraph. However, any interest
calculation shall run from the date the duties are required to be
deposited.
(3) Waiver or reduction of duties.
(i) General. Except in the case of duties and fees referred to in
Secs. 181.42(a) through (c) and fees provided for in Sec. 24.23 of this
chapter, Customs shall waive or reduce the duties paid or owed under
paragraph (a)(2) of this section by the person who is required to file
the Customs Form 7501 (see paragraph (a)(2)(iii)(A) of this section) in
accordance with paragraph (b) of this section, provided that a claim
for waiver or reduction of the duties is filed with Customs within the
appropriate 60-day time frame. The claim shall be based on evidence of
exportation or entry into a Canadian or Mexican duty-deferral program
and satisfactory evidence of duties paid in Canada or Mexico (see
Sec. 181.47(c)).
(ii) Filing of claim and payment of reduced duties. A claim for a
waiver or reduction of duties under paragraph (a)(3)(i) of this section
shall be made on Customs Form 7501 which shall set forth, in addition
to the information required under paragraph (a)(2)(iii)(B) of this
section, a description of the good exported to Canada or Mexico and the
Canadian or Mexican import entry number, date of importation, tariff
classification number, rate of duty and amount of duty paid. If a claim
for reduction of duties is filed under this paragraph, the reduced
duties shall be deposited with Customs when the claim is filed.
(iii) Drawback on goods entered into a duty-deferral program in
Canada or Mexico. After goods in a duty-deferral program in the United
States which have been sent from the United States and entered into a
duty-deferral program in Canada or Mexico are then withdrawn from that
Canadian or Mexican duty-deferral program either for entry into Canada
or Mexico or for export to a non-NAFTA country, the person who filed
the Customs Form 7501 (see paragraph (a)(2)(iii)(A) of this section)
may file a claim for drawback if the goods are withdrawn within 5 years
from the date of the original importation of the good into the United
States. If the goods are entered for consumption in Canada or Mexico,
drawback will be calculated in accordance with Sec. 181.44 of this
part.
(4) Liquidation of entry.
(i) If no claim is filed. If no claim for a waiver or reduction of
duties is filed in accordance with paragraph (a)(3) of this section,
Customs shall determine the final duties due under paragraph (a)(2)(i)
of this section and shall post a bulletin notice of liquidation of the
entry filed under this section in accordance with Sec. 159.9 of this
chapter. Where no claim was filed in accordance with this section and
Customs fails to liquidate, or extend liquidation of, the entry filed
under this section within 1 year from the date of the entry, upon the
date of expiration of that 1-year period the entry shall be deemed
liquidated by operation of law in the amount asserted by the exporter
on the Customs Form 7501 filed under paragraph (a)(2)(iii)(A) of this
section. A protest under section 514, Tariff Act of 1930, as amended
(19 U.S.C. 1514), and part 174 of this chapter shall be filed within 90
days from the date of posting of the notice of liquidation under this
section.
(ii) If a claim is filed. If a claim for a waiver or reduction of
duties is filed in accordance with paragraph (a)(3) of this section, an
extension of liquidation of the entry filed under this section shall
take effect for a period not to exceed 3 years from the date the entry
was filed. Before the close of the extension period, Customs shall
liquidate the entry filed under this section and shall post a bulletin
notice
[[Page 2913]]
of liquidation in accordance with Sec. 159.9 of this chapter. If
Customs fails to liquidate the entry filed under this section within 4
years from the date of the entry, upon the date of expiration of that
4-year period the entry shall be deemed liquidated by operation of law
in the amount asserted by the exporter on the Customs Form 7501 filed
under paragraph (a)(3)(ii) of this section. A protest under section
514, Tariff Act of 1930, as amended (19 U.S.C. 1514), and part 174 of
this chapter shall be filed within 90 days from the date of posting of
the notice of liquidation under this section.
(b) Assessment and waiver or reduction of duty.
(1) Manipulation in warehouse. Where a good subject to NAFTA
drawback under this subpart is withdrawn from a bonded warehouse (19
U.S.C. 1562) after manipulation for exportation to Canada or Mexico or
for entry into a duty-deferral program in Canada or Mexico, duty shall
be assessed on the good in its condition and quantity, and at its
weight, at the time of such withdrawal from the warehouse and with such
additions to, or deductions from, the final appraised value as may be
necessary by reason of its change in condition. Such duty shall be paid
no later than 60 calendar days after the date of exportation or of
entry into the duty-deferral program of Canada or Mexico, except that,
upon filing of a proper claim under paragraph (a)(3) of this section,
the duty shall be waived or reduced in an amount that does not exceed
the lesser of the total amount of duty payable on the good under this
section or the total amount of customs duties paid to Canada or Mexico.
(2) Bonded manufacturing warehouse. Where a good is manufactured in
a bonded warehouse (19 U.S.C. 1311) with imported materials and is then
withdrawn for exportation to Canada or Mexico or for entry into a duty-
deferral program in Canada or Mexico, duty shall be assessed on the
materials in their condition and quantity, and at their weight, at the
time of their importation into the United States. Such duty shall be
paid no later than 60 calendar days after either the date of
exportation or of entry into a duty-deferral program of Canada or
Mexico, except that, upon filing of a proper claim under paragraph
(a)(3) of this section, the duty shall be waived or reduced in an
amount that does not exceed the lesser of the total amount of duty
payable on the materials under this section or the total amount of
customs duties paid to Canada or Mexico.
Example. Company N imports tea into the United States and makes
a Class 6 warehouse entry. Company N manufactures sweetened ice tea
mix by combining the imported tea with refined cane sugar and other
flavorings and packaging it in retail size canisters. Upon
withdrawal of the ice tea mix from the warehouse for exportation to
Canada, a Customs Form 7501 is filed showing $900 in estimated U.S.
duties on the basis of the unmanufactured tea. Upon entry into
Canada, the equivalent of US$800 is assessed on the exported ice tea
mix. Company N submits to Customs a proper claim under paragraph
(a)(3) of this section showing payment of the US$800 equivalent in
duties to Canada. Company N will only be required to pay $100 in
U.S. duties out of the $900 amount reflected on the Customs Form
7501.
(3) Bonded smelting or refining warehouse. For any qualifying
imported metal-bearing materials (19 U.S.C. 1312), duty shall be
assessed on the imported materials and the charges against the bond
canceled no later than 60 calendar days after either the date of
exportation of the treated materials to Canada or Mexico or the date of
entry of the treated materials into a duty-deferral program of Canada
or Mexico, either from the bonded smelting or refining warehouse or
from such other customs bonded warehouse after the transfer of the same
quantity of material from a bonded smelting or refining warehouse.
However, upon filing of a proper claim under paragraph (a)(3) of this
section, the duty on the imported materials shall be waived or reduced
in an amount that does not exceed the lesser of the total amount of
duty payable on the imported materials under this section or the total
amount of customs duties paid to Canada or Mexico.
Example. Company Z imports 47 million pounds of electrolytic
zinc which is entered into a bonded smelting and refining warehouse
(Class 7) for processing. Thereafter, Company Z withdraws the
merchandise for exportation to Canada and files a Customs Form 7501
showing $90,000 in estimated U.S. duty on the dutiable quantity of
metal contained in the imported metal-bearing materials. Upon entry
of the processed zinc into Canada, the equivalent of US$50,000 in
duties are assessed. Within 60 days of exportation Company Z files a
proper claim under paragraph (a)(3) of this section and Customs
liquidates the entry with duty due in the amount of $40,000.
(4) Foreign trade zone. For a good that is manufactured or
otherwise changed in condition in a foreign trade zone (19 U.S.C.
81c(a)) and then withdrawn from the zone for exportation to Canada or
Mexico or for entry into a Canadian or Mexican duty-deferral program,
the duty assessed, as calculated under paragraph (e)(1) or (e)(2) of
this section, shall be paid no later than 60 calendar days after either
the date of exportation of the good to Canada or Mexico or the date of
entry of the good into a duty-deferral program of Canada or Mexico,
except that, upon filing of a proper claim under paragraph (a)(3) of
this section, the duty shall be waived or reduced in an amount that
does not exceed the lesser of the total amount of duty payable on the
good under this section or the total amount of customs duties paid to
Canada or Mexico.
(i) Nonprivileged foreign status. In the case of a nonprivileged
foreign status good, duty is assessed on the good in its condition and
quantity, and at its weight, at the time of its exportation from the
zone to Canada or Mexico or its entry into a duty-deferral program of
Canada or Mexico.
Example. CMG imports $1,000,000 worth of auto parts from Korea
and admits them into Foreign-Trade Subzone number 00, claiming
nonprivileged foreign status. (If the auto parts had been regularly
entered they would have been dutiable at 4 percent, or $40,000.) CMG
manufactures subcompact automobiles. Automobiles are dutiable at 2.5
percent ($25,000) if entered for consumption in the United States.
CMG withdraws the automobiles from the zone and exports them to
Mexico. Upon entry of the automobiles in Mexico, CMG pays the
equivalent of US$20,000 in duty. Before the expiration of 60
calendar days from the date of exportation, CMG files a proper claim
under paragraph (a)(3) of this section and pays $5,000 in duty to
Customs representing the difference between the $25,000 which would
have been paid if the automobiles had been entered for consumption
from the zone and the US$20,000 equivalent paid to Mexico.
(ii) Privileged foreign status. In the case of a privileged foreign
status good, duty is assessed on the good in its condition and
quantity, and at its weight, at the time privileged status is granted
in the zone.
Example. O&G, Inc. admits Kuwaiti crude petroleum into its zone
and requests, one month later, privileged foreign status on the
crude before refining the crude into motor gasoline and kerosene.
Upon withdrawal of the refined goods from the zone by O&G, Inc. for
exportation to Canada, a Customs Form 7501 is filed showing $700 in
estimated duties on the imported crude petroleum (rather than on the
refined goods which would have been assessed $1,200). D&O is the
consignee in Canada and pays the Canadian customs duty assessment of
the equivalent of US$1,500 on the goods. O&G, Inc. is entitled to a
waiver of the full $700 in duties upon filing of a proper claim
under paragraph (a)(3) of this section.
(5) Temporary importation under bond. Except in the case of a good
imported from Canada or Mexico for repair or alteration, where a good,
regardless of its origin, was imported temporarily free of duty for
repair,
[[Page 2914]]
alteration or processing (subheading 9813.00.05, Harmonized Tariff
Schedule of the United States) and is subsequently exported to Canada
or Mexico, duty shall be assessed on the good on the basis of its
condition at the time of its importation into the United States. Such
duty shall be paid no later than 60 calendar days after either the date
of exportation or the date of entry into a duty-deferral program of
Canada or Mexico, except that, upon filing of a proper claim under
paragraph (a)(3) of this section, the duty shall be waived or reduced
in an amount that does not exceed the lesser of the total amount of
duty payable on the good under this section or the total amount of
customs duties paid to Canada or Mexico.
Example. Company A imports glassware under subheading
9813.00.05, HTSUS. The glassware is from France and would be
dutiable under a regular consumption entry at $6,000. Company A
alters the glassware by etching hotel logos on the glassware. Two
weeks later, Company A sells the glassware to Company B, a Mexican
company, and ships the glassware to Mexico. Company B enters the
glassware and is assessed duties in an amount equivalent to US$6,200
and claims NAFTA preferential tariff treatment. Company B provides a
copy of the Mexican landing certificate to Company A showing that
the US$6,200 equivalent in duties was assessed but not yet paid to
Mexico. If Mexico ultimately denies Company B's NAFTA claim and the
Mexican duty payment becomes final, Company A, upon submission to
Customs of a proper claim under paragraph (a)(3) of this section, is
entitled to a waiver of the full $6,000 in U.S. duty.
(c) Recordkeeping requirements. If a person intends to claim a
waiver or reduction of duty on goods under this section, that person
shall maintain records concerning the value of all involved goods or
materials at the time of their importation into the United States and
concerning the value of the goods at the time of their exportation to
Canada or Mexico or entry into a duty-deferral program of Canada or
Mexico, and if a person files a claim under this section for a waiver
or reduction of duty on goods exported to Canada or Mexico or entered
into a Canadian or Mexican duty-deferral program, that person shall
maintain evidence of exportation or entry into a Canadian or Mexican
duty-deferral program and satisfactory evidence of the amount of any
customs duties paid to Canada or Mexico on the good (see
Sec. 181.47(c)). Failure to maintain adequate records will result in
denial of the claim for waiver or reduction of duty.
(d) Failure to file proper claim. If the person identified in
paragraph (a)(2)(iii)(A) of this section fails to file a proper claim
within the 60-day period specified in this section, that person, or the
FTZ operator pursuant to paragraph (a)(2)(iii)(A)(3) of this section,
will be liable for payment of the full duties assessed under this
section and without any waiver or reduction thereof.
(e) Subsequent claims for preferential tariff treatment. If a claim
for a refund of duties is allowed by the Canadian or Mexican customs
administration under Article 502(3) of the NAFTA or under any other
circumstance after duties have been waived or reduced under this
section, Customs may reliquidate the entry filed under this section
pursuant to 19 U.S.C. 1508(b)(2)(B)(iii) even after liquidation of the
entry has become final.
George J. Weise,
Commissioner of Customs.
Approved: January 24, 1996.
John P. Simpson,
Deputy Assistant Secretary of the Treasury.
[FR Doc. 96-1677 Filed 1-29-96; 8:45 am]
BILLING CODE 4820-02-P
Complete official Federal Register PDF
FR Doc. 96-1653 Consumer Information Regulations; Vehicle Stopping Distance
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2946-2947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1653]
=======================================================================
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DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety Administration
49 CFR Part 575
[Docket No. 92-65; Notice 3]
RIN 2127-AE61
Consumer Information Regulations; Vehicle Stopping Distance
AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.
ACTION: Response to petition for reconsideration.
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SUMMARY: In response to a petition for reconsideration submitted by
Advocates for Highway and Auto Safety, this document reaffirms NHTSA's
decision to rescind the requirement that motor vehicle manufacturers
provide consumers with information about vehicle stopping distance. The
agency is taking this action because the information provided pursuant
to that requirement did not permit consumers to distinguish between
many of the new vehicles and was not used by consumers in their vehicle
purchasing decisions. Further, upgrading the requirement would be
unduly burdensome on manufacturers and could actually be
counterproductive since it might mislead consumers about the ability of
their vehicles to stop under varied circumstances.
FOR FURTHER INFORMATION CONTACT:
For non-legal issues: Ms. Henrietta Spinner, NPS-21, Office of Market
Incentives, National Highway Traffic Safety Administration, 400 Seventh
Street SW., Washington, DC 20590 (202-366-4802).
For legal issues: Mr. Marvin L. Shaw, NCC-20, Rulemaking Division,
Office of Chief Counsel, National Highway Traffic Safety
Administration, 400 Seventh Street SW., Washington, DC 20590 (202-366-
2992).
SUPPLEMENTARY INFORMATION:
I. June 1995 Final Rule
On June 26, 1995, the National Highway Traffic Safety
Administration (NHTSA) published a final rule that rescinded the
stopping distance information requirements in Sec. 575.101 of Title 49
of the Code of Federal Regulations (60 FR 32918). The agency explained
that it reached this decision after concluding that the stopping
distance requirement was not resulting in the provision of meaningful
information to consumers about the differences between vehicle models
in stopping distance and that an upgraded requirement to mandate model
specific stopping distance information would have been costly and might
not have provided significant safety benefits. The agency stated that
mandating model specific stopping distance information might not reveal
sufficiently large differences between vehicles in stopping distance to
affect vehicle purchasing decisions. Further, such information might
mislead some vehicle owners about their vehicle's braking ability under
varied circumstances. The stopping distance measurements reflect the
ability of a vehicle to stop only under optimum conditions of vehicle
loading, tire-to-road peak friction coefficient, environment, and
driver braking skills.
In considering whether to rescind Sec. 575.101, NHTSA analyzed
several alternatives to rescission, including the alternative of
requiring manufacturers to provide model-specific stopping information.
NHTSA concluded that generating such stopping distance information
would be unduly burdensome for manufacturers to obtain, based on its
assessment of the costs of such a program and the small safety
benefits, if any, that might result.
NHTSA also explained its decision not to adopt more stringent
requirements for stopping distance information because it did not
appear that consumers would use the information in making their vehicle
purchasing decisions. The agency stated that consumers typically
consider and value such attributes as reliability, styling, price,
reputation, roominess, and safety. While stopping distance relates to
safety, NHTSA believed that the upgraded information would not impact
purchasing decisions because precise stopping distance information
would not yield differences sufficiently large to make stopping
distance a factor in consumers' selections among similar vehicle
models.
NHTSA stated that it remained committed to ensuring that consumers
received appropriate safety information and noted that the agency is
working with the National Academy of Sciences (NAS) to review and
possibly expand the agency's consumer information efforts. According to
the House Appropriations Committee report addressing the NAS study:
The study should focus on the validity of current programs,
public and private, in providing accurate information to consumers
on the real-world safety of vehicles, the possibility of improving
the system in a cost effective and realistic manner, and the best
[[Page 2947]]
methods of providing useful information to consumers.
This study is expected to be completed by the statutory due date of
March 31, 1996, for the submission of a final report on the NAS
findings to the House and Senate Appropriations Committees. NHTSA
stated that it will review the NAS study for insights into whether
there is an effective means to provide consumers with information about
vehicle stopping ability. NHTSA nevertheless concluded that since
commenters agreed that the previously required information is not
meaningful or helpful to consumers, no purpose is served by retaining
section 575.101.
II. Petition for Reconsideration
On July 25, 1995, Advocates for Highway and Auto Safety (Advocates)
petitioned NHTSA to reconsider its decision to rescind the vehicle
stopping distance consumer information regulation. Advocates stated
that NHTSA's decision to rescind this regulation is ``ill-timed and
inappropriate.'' That organization requested the agency to reconsider
its decision to rescind the regulation, given the previously mentioned
NAS study of consumer information programs. It stated that the agency
should not have rescinded this regulation until after the NAS study is
completed.
III. NHTSA's Decision
After reviewing Advocates' petition, NHTSA continues to believe
that its decision to rescind the vehicle stopping distance consumer
information requirement was appropriate. The information provided
pursuant to that requirement did not permit consumers to distinguish
among many of the new vehicles and was not used by consumers in their
vehicle purchasing decisions.
The agency disagrees with the petitioner that it should have waited
to rescind the stopping distance requirements until completion of the
NAS study on consumer information. That study will not address the
rescinded requirements and thus will not yield any information or
conclusions bearing on the merits of the agency's rescission decision.
Further, the agency believes that no useful purpose would be served by
reinstating the requirement until the NAS study is completed and the
agency has a chance to analyze the findings and recommendations.
If the NAS study suggests an approach that would make the stopping
distance information meaningful and helpful to consumers at reasonable
cost, the agency would propose adopting such an approach. However,
NHTSA notes that it is unlikely that the NAS study will emphasize
vehicle stopping distance as a significant consumer information
concern. Standard Numbers 105 and 135 regulate the stopping performance
of light vehicles, thereby ensuring that these vehicles have safe
braking performance. Further, NHTSA continues to believe that, in
making their purchasing decisions, consumers will typically not be
concerned with stopping performance.
Based on the above considerations, NHTSA again concludes that the
previously required stopping distance information is not useful. The
agency therefore has decided to reaffirm its decision to rescind its
requirement for that information.
Authority: 49 U.S.C. 322, 30111, 30115, 30117, and 30166;
delegation of authority at 49 CFR 1.50.
Issued on: January 24, 1996.
Ricardo Martinez,
Administrator.
[FR Doc. 96-1653 Filed 1-29-96; 8:45 am]
BILLING CODE 4910-59-P
Complete official Federal Register PDF
FR Doc. 96-1650 Foreign Banking Organizations
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2899-2902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1650]
=======================================================================
-----------------------------------------------------------------------
FEDERAL RESERVE SYSTEM
12 CFR Part 211
[Regulation K; Docket No. R-0754]
Foreign Banking Organizations
AGENCY: Board of Governors of the Federal Reserve System.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Board is publishing amendments to Subpart B of Regulation
K (Foreign Banking Organizations). The amendments permit the
establishment of U.S. representative offices by certain foreign banks
through prior notice procedures. These prior notice procedures are
designed to permit foreign banks meeting certain requirements to
establish representative offices without the need to file a formal
application with the Board. A foreign bank that is subject to federal
regulation under the Bank Holding Company Act (BHC Act), either
directly or through the International Banking Act (IBA), and that the
Board has previously determined is subject to comprehensive supervision
or regulation on a consolidated basis by its home country supervisor,
or which previously has been approved for a representative office by
Board order, would be permitted to establish a full service
representative office by prior notice. In addition, the amendments
clarify that only those foreign banking organizations subject to the
IBA and the BHC Act may establish under general consent procedures a
representative office to engage in limited administrative functions in
connection with their existing U.S. banking operations. Lastly, the
Board has determined to review and act upon inquiries by ``special
purpose government banks'' seeking exemptions from regulation under the
Foreign Bank Supervision Enhancement Act (FBSEA) on the basis that they
do not fall within the definition of ``foreign bank'' under Regulation
K. Such inquiries would be handled on a case-by-case basis.
EFFECTIVE DATE: January 24, 1996.
FOR FURTHER INFORMATION CONTACT: Kathleen M. O'Day, Associate General
Counsel (202/452-3786), Ann E. Misback, Managing Senior Counsel (202/
452-6406), or Andres L. Navarrete, Attorney (202/452-2300), Legal
Division; William A. Ryback, Associate Director (202/452-2722), Michael
G. Martinson, Assistant Director (202/452-2798), or Betsy Cross,
Manager (202/452-2574), Division of Banking Supervision and Regulation,
Board of Governors of the Federal Reserve System. For the users of
Telecommunication Device for the Deaf (TDD) only, please contact
Dorothea Thompson (202/452-3544), Board of Governors of the Federal
Reserve System, 20th and C Streets NW., Washington, DC 20551.
SUPPLEMENTARY INFORMATION: The FBSEA required for the first time that a
foreign bank receive federal approval to establish a representative
office. Prior to the FBSEA, federal regulation provided a limited
definition of a representative office of a foreign bank and only
required a foreign bank to register a representative office established
in the United States with the Treasury Department. Federal law did not
provide for the ongoing oversight or regulation of representative
offices of foreign banks.
To fill these and other gaps in federal regulation of foreign
banks, Congress adopted a broader definition of representative office
in the FBSEA to ensure that all direct operations of a foreign bank are
subject to federal regulation and supervision. The FBSEA expanded the
definition of a representative office of a foreign bank in the IBA to
include any place of business of a foreign bank that is not a branch,
agency, or subsidiary.
[[Page 2900]]
The FBSEA also provided standards for establishing, examining, and
regulating a representative office of a foreign bank. These standards
are less rigorous than the standards governing the establishment,
examination, and supervision of a branch or agency of a foreign bank.
In evaluating an application to establish a representative office, the
FBSEA only requires the Board to take into account the standards that
are mandatory for the establishment of a branch or an agency. Thus, for
example, the Board may permit a foreign bank to establish a
representative office even though its home country supervision or
financial condition might not support the establishment of a branch
oran agency. Similarly, unlike the mandatory, annual examinations
required for a branch or agency, the Board may examine a representative
office as often as deemed appropriate.
The Board has implemented the FBSEA and the provisions governing a
representative office of a foreign bank through two rulemakings. First,
in an interim rule, the Board defined a representative office of a
foreign bank as a limited purpose office that may only engage in
representational and administrative functions on behalf of a foreign
bank. The interim rule also stated that a representative office may not
make any business decision on behalf of the foreign bank. 57 FR 12992
(April 15, 1992). In taking this approach, the Board adhered to the
traditional view that a representative office may only engage in
limited functions that facilitate the banking activities of a foreign
bank, but may not engage in the activities themselves.
Both foreign banks and some state supervisors objected to this
restrictive definition because, in some instances, it would have been
more limiting than state laws on representative offices. In response to
comments received and initial experience gained in implementing these
and other portions of the FBSEA, the Board broadened these interim
provisions in a second, final rulemaking. 58 FR 6348 (January 28,
1993). The Board determined that a representative office is permitted
to perform any activity that is neither a banking activity nor an
activity that is prohibited by state law, Board ruling, or Board order.
The Board also introduced two sub-types of representative offices that
perform activities that raise few regulatory and supervisory issues and
therefore may be established under expedited procedures. Specifically,
the Board granted its general consent to the establishment of a
representative office that solely performs limited administrative
functions for the foreign bank (a general consent office). The foreign
bank must notify the Board of the establishment of a general consent
office. The Board also provided a 45 day prior notice procedure for the
establishment of a regional administrative office that coordinates
operations in a particular geographic region.
In adopting the final rule, the Board recognized that further
experience might warrant future revision of the provisions governing a
representative office of a foreign bank. Therefore, the Board sought
additional comment on these provisions and stated that it would revisit
the regulations after gaining additional information on the matter.
The Board received public comments from the Conference of State
Bank Supervisors, a trade association, and a foreign bank. These
commenters supported the adoption of a broader definition of a
representative office and a wider range of permissible activities
provided in the final rule. Two commenters sought clarification and
expansion of the activities deemed permissible for a representative
office. The commenters also recommended measures to reduce and
streamline the application procedures for establishing a representative
office. Lastly, one commenter requested that representative offices be
permitted to send unsolicited financial instruments through inter-
office mail to a branch or bank subsidiary that is authorized to accept
deposits. The Board is of the view that this activity may constitute
deposit-taking, and is therefore inappropriate for a representative
office to conduct.
Establishment of Representative Offices by Prior Notice
The Board has concluded that the prior notice procedures may be
applied to the establishment of representative offices by foreign banks
that are subject to the BHC Act, either directly or through section
8(a) of the IBA, where the Board has made a previous determination that
the particular foreign bank is subject to comprehensive supervision on
a consolidated basis by its home country supervisor, or previously has
been approved for a representative office by Board order. This expanded
authority is intended to reduce the burden associated with the filing
of a formal representative office application by a foreign banking
organization meeting these requirements.1
\1\ Applications by foreign banks that have received
comprehensive consolidated supervision (CCS) determinations to
establish branches, agencies and commercial lending companies will
continue to be delegated to Reserve Banks. 12 CFR 265.11(d)(11).
---------------------------------------------------------------------------
The Board has taken the position that a 45-day prior notice review
period to establish such an office is sufficient where the Board has
made a formal determination that the foreign bank is subject to CCS in
the context of a previous application to establish a branch, agency,
commercial lending company, or to acquire a bank, or previously has
been approved for a representative office by Board order. The Board has
found that the goal of reducing burden for foreign banking
organizations, where possible and prudent, outweighs the limited
additional supervisory benefits of requiring a formal application for a
representative office under these circumstances.
In addition, the final rule clarifies that only foreign banks
subject to the BHC Act, either directly or through section 8(a) of the
IBA, may establish under the Board's general consent authority a
representative office to engage in limited administrative or ``back
office'' functions, and that such ``back office'' functions may only be
performed in connection with the U.S. banking activities of the foreign
bank. General consent representative offices were intended to
facilitate the establishment of limited offices by foreign banks
seeking administrative support for their existing U.S. banking
operations, and not as stand-alone operations. In that regard, the
activities must be clearly defined, performed in connection with the
U.S. banking activities of the foreign bank, and must not involve
contact or liaison with customers or potential customers beyond
incidental contact relating to administrative matters (such as
verification or correction of account information). ``Back office'' and
other administrative functions linked to banking present the fewest
supervisory and prudential concerns in the group of representative
office activities that are linked to banking. These limited activities
reflect a balancing of the Board's desire to reduce regulatory burden
with its need to continue to monitor closely the direct operations of
foreign banks.
By allowing a foreign bank meeting the criteria outlined above to
utilize the Board's prior notice procedures or general consent
authority to establish a representative office, the Board does not
intend to permit a foreign bank to
[[Page 2901]]
expand broadly its U.S. banking and nonbanking activities. The proposed
rule is designed merely to reduce the burden on those foreign banks
seeking to provide additional support for their existing U.S. banking
operations.
Special Purpose Government Banks
The FBSEA requires any foreign bank to obtain prior Board approval
to establish a branch, agency, commercial lending company, or
representative office. In issuing the final rule, the Board exempted
the central bank of a foreign country that does not engage in
commercial banking activities in the Untied States from the definition
of ``foreign bank'' and therefore from regulation under the FBSEA. The
Board has received several requests from government-owned entities that
engage in banking that is not commercial in nature for similar
exemptive treatment. A prototypical example of this type of entity is
an export-import bank of a foreign country. These so-called ``special
purpose government banks'' maintain offices in the United States that,
without this exemption, are representative offices under the FBSEA.
The Board has found that the types of institutions seeking this
exemptive relief vary considerably in their legal structure,
governmental mandate, and actual operations. Creating a regulatory
exemption akin to that provided for central banks in these
circumstances would prove unworkable and imprecise. Furthermore, each
of the requests for an exemption from regulation under the FBSEA is in
fact a request for an interpretation that the entity in question is not
a foreign bank within the meaning of the FBSEA and Regulation K.
Accordingly, the Board has determined to review and act upon each of
these interpretive requests on a case-by-case basis. Among the factors
the Board will consider are whether the foreign organization is: (i)
established and regulated pursuant to a distinct regulatory scheme that
differs from that applied to traditional commercial banks; (ii) owned
and capitalized substantially, if not exclusively, by its home
government; (iii) subject to direct government control and examination;
(iv) engaged exclusively in activities designed to serve specific
government policy goals; and (v) prohibited from accepting deposits.
This approach, in the Board's view, will provide the best mechanism for
determining whether the relief requested is in fact warranted.
Regulatory Review
A full review of Regulation K, as required by the IBA, is underway
and will proceed during the course of the next year. The subject of
representative offices will be revisited at that time, and will provide
additional opportunity for interested parties to express their concerns
regarding these and other relevant issues.
Regulatory Flexibility Analysis
Pursuant to section 605(b) of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.), the Board certifies that this final rule will not
have a significant economic impact on a substantial number of small
business entities that are subject to the regulation.
Pursuant to 5 U.S.C. Sec. 553(d), this amendment to Regulation K
will become effective immediately. This final grants an exemption for
certain foreign banking organizations, and, therefore, the Board waives
the 30-day general requirement for publication of a substantive rule.
Paperwork Reduction Act
In accordance with section 3506 of the Paperwork Reduction Act of
1995 (44 U.S.C. Ch. 35; 5 CFR 1320 Appendix A.1), the Board reviewed
the proposed rule under the authority delegated to the Board by the
Office of Management and Budget. No collections of information pursuant
to the Paperwork Reduction Act are contained in the final rule.
List of Subjects in 12 CFR Part 211
Exports, Federal Reserve System, Foreign banking, Holding
companies, Investments, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, the Board of Governors
amends 12 CFR Part 211 as set forth below:
PART 211--INTERNATIONAL BANKING OPERATIONS (REGULATION K)
1. The authority citation for 12 CFR part 211 continues to read as
follows:
Authority: 12 U.S.C. 221 et seq., 1818, 1841 et seq., 3101 et
seq., 3901 et seq).
2. Section 211.24 is amended by:
a. Revising paragraphs (a)(2)(i) and (a)(2)(ii); and
b. Redesignating paragraph (d)(3) as paragraph (d)(4), and adding a
new paragraph (d)(3).
The revisions and addition read as follows:
Sec. 211.24 Approval of offices of foreign banks; procedures for
applications; standards for approval; representative office activities
and standards for approval; preservation of existing authority.
(a) * * *
(2) * * *
(i) Prior notice for certain representative offices. After
providing 45 days' prior written notice to the Board, a foreign bank
that is subject to the BHC Act, either directly or through section 8(a)
of the IBA (12 U.S.C. 3106(a)), may establish:
(A) A regional administrative office; or
(B) A representative office, but only if the Board has previously
determined that the foreign bank proposing to establish a
representative office is subject to comprehensive supervision or
regulation on a consolidated basis by its home country supervisor, or
previously has been approved for a representative office by Board
order. The Board may waive the 45-day period if it finds that immediate
action is required by the circumstances presented. The notice period
shall commence at the time the notice is received by the appropriate
Reserve Bank. The Board may suspend the period or require Board
approval prior to the establishment of such an office if the
notification raises significant policy, prudential or supervisory
concerns.
(ii) General consent for representative offices. The Board grants
its general consent for a foreign bank that is subject to section 8(a)
of the IBA (12 U.S.C. 3106(a)), to establish a representative office
that solely engages in limited administrative functions (such as
separately maintaining back office support systems) that are clearly
defined, are performed in connection with the United States banking
activities of the foreign bank, and do not involve contact or liaison
with customers or potential customers beyond incidental contact with
existing customers relating to administrative matters (such as
verification or correction of account information), provided that the
foreign bank notifies the Board in writing within 30 days of the
establishment of the representative office.
* * * * *
(d) * * *
(3) Special purpose foreign government banks. A foreign government-
owned organization engaged in banking activities in its home country
that are not commercial in nature may apply to the Board for a
determination that the organization is not a foreign bank for purposes
of this section. A written request setting forth the basis for such a
determination may be submitted to the Reserve Bank of the District in
which the foreign organization's representative office is located in
the United States or to the Board in the case of a proposed
establishment of a representative office.
[[Page 2902]]
The Board will review and act upon each such request on a case-by-case
basis.
* * * * *
By order of the Board of Governors of the Federal Reserve
System, January 24, 1996.
William W. Wiles,
Secretary of the Board.
[FR Doc. 96-1650 Filed 1-29-96; 8:45 a.m.]
BILLING CODE 6210-01-P
Complete official Federal Register PDF
FR Doc. 96-1625 Standard Instrument Approach Procedures; Miscellaneous Amendments
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2903-2904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1625]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
14 CFR Part 97
[Docket No. 28426; Amdt. No. 1703]
Standard Instrument Approach Procedures; Miscellaneous Amendments
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This amendment establishes, amends, suspends, or revokes
Standard Instrument Approach Procedures (SIAPs) for operations at
certain airports. These regulatory actions are needed because of the
adoption of new or revised criteria, or because of changes occurring in
the National Airspace System, such as the commissioning of new
navigational facilities, addition of new obstacles, or changes in air
traffic requirements. These changes are designed to provide safe and
efficient use of the navigable airspace and to promote safe flight
operations under instrument flight rules at the affected airports.
DATES: An effective date for each SIAP is specified in the amendatory
provisions.
Incorporation by reference-approved by the Director of the Federal
Register on December 31, 1980, and reapproved as of January 1, 1982.
ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:
For Examination--
1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue SW., Washington, DC 20591;
2. The FAA Regional Office of the region in which the affected
airport is located; or
3. The Flight Inspection Area Office which originated the SIAP.
For Purchase--Individual SIAP copies may be obtained from:
1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue SW., Washington, DC 20591; or
2. The FAA Regional Office of the region in which the affected
airport is located.
By Subscription--Copies of all SIAPs, mailed once every 2 weeks,
are for sale
[[Page 2904]]
by the Superintendent of Documents, U.S. Government Printing Office,
Washington, DC 20402.
FOR FURTHER INFORMATION CONTACT:
Paul J. Best, Flight Procedures Standards Branch (AFS-420), Technical
Programs Division, Flight Standards Service, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone (202) 267-8277.
SUPPLEMENTARY INFORMATION: This amendment to part 97 of the Federal
Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or
revokes Standard Instrument Approach Procedures (SIAPs). The complete
regulatory description of each SIAP is contained in official FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and Sec. 97.20 of the Federal Aviation
Regulations (FAR). The applicable FAA Forms are identified as FAA Forms
8260-3, 8260-4, and 8260-5. Materials incorporated by reference are
available for examination or purchase as stated above.
The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. The provisions of this amendment state the affected CFR
(and FAR) sections, with the types and effective dates of the SIAPs.
This amendment also identifies the airport, its location, the procedure
identification and the amendment number.
The Rule
This amendment to part 97 is effective upon publication of each
separate SIAP as contained in the transmittal. Some SIAP amendments may
have been previously issued by the FAA in a National Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts. The
circumstances which created the need for some SIAP amendments may
require making them effective in less than 30 days. For the remaining
SIAPs, an effective date at least 30 days after publication is
provided.
Further, the SIAPs contained in this amendment are based on the
criteria contained in the U.S. Standard for Terminal Instrument
Approach Procedures (TERPS). In developing these SIAPs, the TERPS
criteria were applied to the conditions existing or anticipated at the
affected airports. Because of the close and immediate relationship
between these SIAPs and safety in air commerce, I find that notice and
public procedure before adopting these SIAPs are impracticable and
contrary to the public interest and, where applicable, that good cause
exists for making some SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 97
Air Traffic Control, Airports, Navigation (Air).
Issued in Washington, DC on December 29, 1995.
Thomas C. Accardi,
Director, Flight Standards Service.
Adoption of the Amendment
Accordingly, pursuant to the authority delegated to me, part 97 of
the Federal Aviation Regulations (14 CFR part 97) is amended by
establishing, amending, suspending, or revoking Standard Instrument
Approach Procedures, effective at 0901 UTC on the dates specified, as
follows:
PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES
1. The authority citation for part 97 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40103, 40113, 40120, 44701; and 14
CFR 11.49(b)(2).
2. Part 97 is amended to read as follows:
Secs. 97.23, 97.25, 97.27, 97.29, 97.31, 97.33 and 97.35 [Amended]
By amending: Sec. 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec. 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec. 97.27
NDB, NDB/DME; Sec. 97.29 ILS, ILS/DME, ISMLS, MLS, MLS/DME, MLS/RNAV;
Sec. 97.31 RADAR SIAPs; Sec. 97.33 RNAV SIAPs; and Sec. 97.35 COPTER
SIAPs, identified as follows:
* * * Effective February 29, 1996
Galliano, LA, South Lafourche, GPS RWY 18, Orig
Grand Rapids, MI, Kent County Intl, VOR OR GPS RWY 18, Amdt 6,
CANCELLED
Grand Rapids, MI, Kent County Intl, VOR-OR GPS RWY 36, Amdt 11,
CANCELLED
Grand Rapids, MI, Kent County Intl, VOR-A, Orig
Grand Rapids, MI, Kent County Intl, VOR-B, Orig
Grand Rapids, MI, Kent County Intl, NDB or GPS RWY 26L, Amdt 20
Grand Rapids, MI, Kent County Intl, ILS RWY 8R, Amdt 5
Grand Rapids, MI, Kent County Intl, ILS RWY 26L, Amdt 20
Grand Rapids, MI, Kent County Intl, RADAR-1, Amdt 10
Greenville, MI, Greenville Muni, VOR/DME OR GPS-A, Amdt 1
Hastings, MI, Hastings, VOR RWY 12, Orig
Hastings, MI, Hastings, VOR OR GPS-A, Orig, CANCELLED
Kalamazoo, MI, Kalamazoo/Battle Creek Intl, GPS RWY 5, Orig
Kalamazoo, MI, Kalamazoo/Battle Creek Intl, GPS RWY 23, Orig
Port Huron, MI, St. Clair County Intl, NDB or GPS RWY 4, Amdt 3
Port Huron, MI St. Clair County Intl, ILS RWY 4, Amdt 3
Rugby, ND, Rugby Muni, GPS RWY 30, Orig
Ashland, OH, Ashland County, VOR OR GPS-A, Amdt 7
Ashland, OH, Ashland County, NDB OR GPS RWY 18, Amdt 9
Huntingdon, TN, Carroll County, GPS RWY 19, Orig
Millington, TN, Charles W. Baker, VOR/DME RWY 18, Amdt 1
Millington, TN, Millington Muni, VOR/DME RWY 22, Amdt 1
Salt Lake City, UT, Salt Lake City Muni 2, GPS RWY 34, Orig
Burlington/Mount Vernon, Skagit Regional/Bay View, GPS RWY 10, Orig
Burlington/Mount Vernon, Skagit Regional/Bay View, GPS RWY 28, Orig
Cheyenne, WY, Cheyenne, GPS RWY 12, Orig
[FR Doc. 96-1625 Filed 1-29-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-1614 Privacy Program
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2915-2917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1614]
=======================================================================
-----------------------------------------------------------------------
[[Page 2916]]
DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 312, 317, 318, 320, 321, 323, 505, 701, and 806b
Privacy Program
AGENCY: Department of Defense.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The President signed Executive Order 12958 on April 17, 1995,
replacing Executive Order 12356 effective October 14, 1995. Therefore,
the Department of Defense is amending Privacy Act procedural and
exemption rules where they cite the old Executive Order 12356,
replacing it with Executive Order 12958.
EFFECTIVE DATE: October 14, 1995.
FOR FURTHER INFORMATION CONTACT: Ms. Jody Sinkler at (703) 607-2943 or
DSN 327-2943.
SUPPLEMENTARY INFORMATION: Executive Order 12866. The Director,
Administration and Management, Office of the Secretary of Defense has
determined that this proposed Privacy Act rule for the Department of
Defense does not constitute 'significant regulatory action'. Analysis
of the rule indicates that it does not have an annual effect on the
economy of $100 million or more; does not create a serious
inconsistency or otherwise interfere with an action taken or planned by
another agency; does not materially alter the budgetary impact of
entitlements, grants, user fees, or loan programs or the rights and
obligations of recipients thereof; does not raise novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in Executive Order 12866 (1993).
Regulatory Flexibility Act of 1980. The Director, Administration and
Management, Office of the Secretary of Defense certifies that this
Privacy Act rule for the Department of Defense does not have
significant economic impact on a substantial number of small entities
because it is concerned only with the administration of Privacy Act
systems of records within the Department of Defense.
Paperwork Reduction Act. The Director, Administration and Management,
Office of the Secretary of Defense certifies that this Privacy Act
proposed rule for the Department of Defense imposes no information
requirements beyond the Department of Defense and that the information
collected within the Department of Defense is necessary and consistent
with 5 U.S.C. 552a, known as the Privacy Act of 1974.
The President signed Executive Order 12958 on April 17, 1995,
replacing Executive Order 12356 effective October 14, 1995. Therefore,
the Office of the Inspector General is amending Privacy Act procedural
and exemption rules where they cite the old Executive Order 12356,
replacing it with Executive Order 12958.
List of Subjects in 32 CFR part 312, 317, 318, 320, 321, 323, 505,
701, and 806b
Privacy.
Accordingly, 32 CFR part 312 is amended as follows:
1.The authority citation for 32 CFR part 312, 317, 318, 320, 321,
323, 505, 701, and 806b continues to read as follows:
Authority: Pub. L. 93-579, 88 Stat 1896 (5 U.S.C.552a).
2.Section 312.12, paragraph (a), is amended by revising the first
sentence to read as follows:
Sec. 312.12Exemptions.
(a) Any record in a system of records maintained by the Office of
the Inspector General which falls within the provisions of 5 U.S.C.
552a(k)(1) may be exempt from the following subsections of 5 U.S.C.
552a: (c)(3), (d), (e)(1), (e)(4)(G) through (I) and (f) to the extent
that a record system contains any record properly classified under
Executive Order 12958 and that the record is required to be kept
classified in the interest of national defense or foreign policy.* * *
* * * * *
3.Section 317.133, paragraph (b), is amended by revising the first
sentence to read as follows:
Sec. 317.133DCAA exempt record systems.
* * * * *
(b) Classified material. The Director, DCAA has made a
determination that all systems of records maintained by the agency
shall be exempt from 5 U.S.C. 552a(d) of the Privacy Act pursuant to 5
U.S.C. 552a(k)(1) to the extent that the record system contains any
information properly classified under Executive Order 12958 and
required by the executive order to be withheld in the interest of
national defense or foreign policy.* * *
* * * * *
4.Section 318.5, paragraph (a), is amended by revising the first
sentence to read as follows:
Sec. 318.5Exemptions.
(a) Exemption for classified material. All systems of records
maintained by the Defense Nuclear Agency shall be exempt under section
(k)(1) of 5 U.S.C. 552a, to the extent that the systems contain any
information properly classified under E.O. 12958 and that is required
by that E.O. to be kept secret in the interest of national defense or
foreign policy.* * *
* * * * *
5.Section 320.11, is amended by revising the first sentence to read
as follows:
Sec. 320.11Specific exemptions.
All systems of records maintained by the Defense Mapping Agency and
its components shall be exempt from the requirements of 5 U.S.C.
552a(d) pursuant to 5 U.S.C. 552a(k)(1) to the extent that the system
contains any information properly classified under Executive Order
12958 and that is required by Executive Order to be kept secret in the
interest of national defense or foreign policy.* * *
6.Section 321.14, paragraph (b), first sentence is revised to read
as follows:
Sec. 321.14 Exemptions.
* * * * *
(b) All systems of records maintained by DIS shall be exempt from
the requirements of 5 U.S.C. 552a(d) pursuant to 5 U.S.C. 552a(k)(1) to
the extent that the system contains any information properly classified
under Executive Order 12958 and which is required by the Executive
Order to be withheld in the interest of national defense of foreign
policy.* * *
* * * * *
7.Appendix H to part 323, introductory text, first sentence is
revised to read as follows:
Appendix H to Part 323-DLA Exemption Rules
Exempt Records Systems. All systems of records maintained by the
Defense Logistics Agency will be exempt from the requirements of 5
U.S.C. 552a(d) pursuant to 5 U.S.C. 552a(k)(1) to the extent that the
system contains any information properly classified under Executive
Order 12958 and which is required by the Executive Order to be kept
secret in the interest of national defense or foreign policy.* * *
* * * * *
8.Section 505.5 is amended in paragraphs (e)k.(4), (e)m.(4),
(e)n.(4), (e)o.(4), and (e)p.(4) by revising `12356' to read `12958'
and by revising paragraph (c)(1) to read as follows:
Sec. 505.5 Exemptions.
* * * * *
(c) Specific exemptions.
[[Page 2917]]
(1) Classified information in every Army system of records. This
exemption is not limited to the systems listed in paragraph (d) of this
section. Before denying as individual access to classified information,
the Access and Amendment Refusal Authority must make sure that it was
properly classified under the standards of Executive Orders 11652,
12065, or 12958 and that it must remain so in the interest of national
defense of foreign policy. (5 U.S.C. 552a(k)(1)).
* * * * *
9.Part 701 is amended by revising `12356' to read `12958' in the
following sections:
a. Section 701.113 paragraphs (d) and (g)(1).
b. Section 701.117.
c. Section 701.118, paragraphs (a) Reasons:, (m) Reasons:, (p)
Reasons:.
d. Section 701.119, paragraph (b) Reasons:.
10.Appendix C to Part 806b, paragraph (b)(1)(i), is amended by
revising `12356' to read `12958'.
Dated: December 4, 1995.
L. M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense
[FR Doc. 96-1614 Filed 1-29-96; 8:45 am]
BILLING CODE 5000-04-F
Complete official Federal Register PDF
FR Doc. 96-1592 Approval and Promulgation of Implementation Plans; Designation of Areas for Air Quality Planning Purposes; Redesignation of the Metropolitan Washington Carbon Monoxide Area to Attainment and Approval of the Area's Maintenance Plan and Emission Inventory; Commonwealth of Virginia, District of Columbia and the State of Maryland
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2931-2938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1592]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 52 and 81
[FRL-5324-9; MD-45-3003, MD-45-3004; MD-45-3007; VA-53-5001, VA-53-
5002; VA-34-5003, VA-34-5004; DC-30-2001; DC-30-2002, DC-10-2003]
Approval and Promulgation of Implementation Plans; Designation of
Areas for Air Quality Planning Purposes; Redesignation of the
Metropolitan Washington Carbon Monoxide Area to Attainment and Approval
of the Area's Maintenance Plan and Emission Inventory; Commonwealth of
Virginia, District of Columbia and the State of Maryland
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is approving a maintenance plan and a request to
redesignate the Metropolitan Washington area; including the Counties of
Alexandria and Arlington, Virginia; Prince Georges and Montgomery
Counties in Maryland, and the District of Columbia (the ``Washington
Carbon Monoxide (CO) nonattainment area'') from nonattainment to
attainment for CO. The maintenance plan and redesignation requests were
submitted by the Commonwealth of Virginia and the State of Maryland and
the District of Columbia. Under the 1990 amendments of the Clean Air
Act (CAA) designations can be revised if sufficient data is available
to warrant such revisions. In this action, EPA is approving Virginia,
Maryland and the District of Columbia requests because it meets the
maintenance plan and redesignation requirements set forth in the CAA.
This action is being taken under section 110 of the CAA.
DATES: This action will become effective on March 15, 1996 unless, by
February 29, 1996 adverse or critical comments are received. If the
effective date is delayed, timely notice will be published in the
Federal Register.
ADDRESSES: Comments may be mailed to Marcia L. Spink, Associate
Director, Air Programs, Mailcode 3AT00, U.S. Environmental Protection
Agency, Region III, 841 Chestnut Building, Philadelphia, Pennsylvania
19107. Copies of the documents relevant to this action are available
for public inspection during normal business hours at the Air,
Radiation, and Toxics Division, U.S. Environmental Protection Agency,
Region III, 841 Chestnut Building, Philadelphia, Pennsylvania 19107;
the Air and Radiation Docket and Information Center, U.S. Environmental
Protection Agency, 401 M Street, SW, Washington, DC 20460; District of
Columbia Department of Consumer and Regulatory Affairs, 2100 Martin
Luther King Ave, S.E., Washington, DC 20020; Maryland Department of the
Environment, 2500 Broening Highway, Baltimore, Maryland 21224; Virginia
Department of Environmental Quality, 629 East Main Street, Richmond,
Virginia 23219.
FOR FURTHER INFORMATION CONTACT: Kelly A. Sheckler, (215) 597-6863.
SUPPLEMENTARY INFORMATION: On October 4, 1995 the Commonwealth of
Virginia, and on October 12, 1995 the State of Maryland and the
District of Columbia submitted formal revisions to their State
Implementation Plans (SIP). The SIP revisions consists of a request to
redesignate the Virginia, Maryland and District of Columbia portions of
the Metropolitan Washington area from nonattainment to attainment for
carbon monoxide and a maintenance plan.
[[Page 2932]]
I. Background
The Metropolitan Washington area, was a pre-1990 CO nonattainment
area and continued to be designated as nonattainment for CO by
operation of law as per section 107(d)(1)(C)(i) of the Clean Air Act
Amendments of 1990. The National Ambient Air Quality Standard (NAAQS)
for CO is 9.5 parts per million (ppm). CO nonattainment areas can be
classified as moderate or serious, based on their design values. Since
the Washington CO nonattainment area had a design value of 11.6 ppm
(based on 1988 and 1989 data), the area was classified as moderate. The
CAA established an attainment date of December 31, 1995, for all
moderate CO areas. The Metropolitan Washington area has ambient air
quality monitoring data showing attainment of the CO NAAQS from 1989
through 1993. Therefore, in an effort to comply with the CAA and to
ensure continued attainment of the NAAQS, on October 4, 1995 the
Commonwealth of Virginia submitted a CO redesignation request and a
maintenance plan for the Virginia portion of the Metropolitan
Washington area. The State of Maryland submitted on October 12, 1995 a
CO redesignation request and maintenance plan for the Maryland portion
of the Metropolitan Washington area and on October 12, 1995 the
District of Columbia submitted a CO redesignation request and
maintenance plan. Virginia, Maryland and the District of Columbia
submitted evidence that public hearings were held on September 6, 1995
in Virginia, September 15, 1995 in Maryland and September 18, 1995 in
the District of Columbia.
II. Evaluation Criteria
Section 107(d)(3)(E) of the 1990 Clean Air Act Amendments provides
five specific requirements that an area must meet in order to be
redesignated from nonattainment to attainment.
1. The area must have attained the applicable NAAQS;
2. The area must have a fully approved SIP under section 110(k) of
CAA;
3. The air quality improvement must be permanent and enforceable;
4. The area must have a fully approved maintenance plan pursuant to
section 175A of the CAA;
5. The area must meet all applicable requirements under section 110
and Part D of the CAA;
III. Review of State Submittal
On October 12, 1995, EPA determined that the information received
from the Commonwealth of Virginia, the State of Maryland and the
District of Columbia constituted a complete redesignation request under
the general completeness criteria of 40 CFR part 51, appendix V,
Secs. 2.1 and 2.2.
The Virginia, Maryland and District of Columbia redesignation
requests for the Metropolitan Washington area meets the five
requirements of section 107(d)(3)(E), noted above. The following is a
brief description of how the State has fulfilled each of these
requirements.
1. Attainment of the CO NAAQS
Virginia, Maryland and the District of Columbia have quality-
assured CO ambient air monitoring data showing that the Metropolitan
Washington area has met the CO NAAQS. The Virginia, Maryland and
District of Columbia requests are based on an analysis of quality-
assured CO air monitoring data which is relevant to the maintenance
plan and to the redesignation request. To attain the CO NAAQS, an area
must have complete quality-assured data showing no more than one
exceedance of the standard per year over at least two consecutive
years. The ambient air CO monitoring data for calendar year 1988
through calendar year 1995, relied upon by Virginia, Maryland and the
District of Columbia in their redesignation requests, shows no
violations of the CO NAAQS in the Metropolitan Washington area. Because
the area has complete quality assured data showing no more than one
exceedance of the standard per year over at least two consecutive years
(1994 and 1995), the area has met the first statutory criterion of
attainment of the CO NAAQS (40 CFR 50.8 and appendix C). Virginia,
Maryland and the District of Columbia have committed to continue
monitoring in this area in accordance with 40 CFR part 58.
2. Fully Approved SIP Under Section 110(k) of the CAA
Virginia's, Maryland's and the District of Columbia's CO SIPs are
fully approved by EPA as meeting all the requirements of Section
110(a)(2)(I) of the Act, including the requirements of Part D (relating
to nonattainment), which were due prior to the date of Virginia's,
Maryland's and the District of Columbia's redesignation requests.
Maryland's CO SIP was fully approved by EPA on September 19, 1994, at
40 CFR Sec. 52.1070(c)(71), (49 FR 36645). Virginia's CO SIP was
approved by EPA on January 25, 1984 at 40 CFR Sec. 52.2420(c)(78), (49
FR 3083). The District's CO SIP approved by EPA on October 3, 1984 at
40 CFR Sec. 52.47(c)(28), (49 FR 39059). The 1990 CAAA required that
nonattainment areas achieve specific new requirements depending on the
severity of the nonattainment classification. Requirements for the
Metropolitan Washington area include the preparation of a 1990 emission
inventory with periodic updates, adoption of an oxygenated fuels
program, the development of contingency measures, and development of
conformity procedures. Each of these requirements added by the 1990
Amendments to the CAA are discussed in greater detail below.
Consistent with the October 14, 1994 EPA guidance from Mary D.
Nichols entitled ``Part D New Source Review (Part D NSR) Requirements
for Areas Requesting Redesignation to Attainment,'' EPA is not
requiring full approval of a Part D NSR program by Virginia, Maryland
and the District of Columbia as a prerequisite to redesignation to
attainment. Under this guidance, nonattainment areas may be
redesignated to attainment notwithstanding the lack of a fully-approved
Part D NSR program, so long as the program is not relied upon for
maintenance. Because the Metropolitan Washington area is being
redesignated to attainment by this action, Virginia's, Maryland's and
the District of Columbia's Prevention of Significant Deterioration
(PSD) requirements will be applicable to new or modified sources in the
Metropolitan Washington area. All three States have been delegated PSD
authority (See Sec. 52.499 District of Columbia, 43 FR 26410, June 19,
1978, as amended 45 FR 52741, August 7, 1980; Sec. 52.1116 Maryland, 45
FR 52741, August 7, 1980, as amended 47 FR 7835, February 23, 1982;
Sec. 52.2448 Virginia 39 FR 7284, February 25, 1974.)
A. Emission Inventory
On March 1994 Maryland submitted a 1990 CO base year inventory to
EPA for review and approval. On November 1, 1993 and April 3, 1995,
Virginia submitted a 1990 CO base year emissions inventory to EPA for
review and approval. On January 13, 1994 the District of Columbia
submitted a 1990 CO base year emissions inventory to EPA for review and
approval. This inventory was used as the basis for calculations to
demonstrate maintenance. Virginia's, Maryland's and the District of
Columbia's submittal contains the detailed inventory data and summaries
by source category. Each of the State's submittals also contains
information related to how it comported with EPA's guidance, and which
model and emission factors were used (note, the MOBILE 5a model was
used), how
[[Page 2933]]
vehicle miles travelled (VMT) data was generated, and other technical
information verifying the emission inventory. A summary of the base
year and projected maintenance year inventories are shown in the
following table in this section.
Section 172(c)(3) of the CAA requires that nonattainment plan
provisions include a comprehensive, accurate, and current inventory of
actual emissions from all sources of relevant pollutants in the
nonattainment area. Maryland, Virginia and the District of Columbia
included the requisite inventory in the CO SIP. The base year for the
inventory was 1990, using a three month CO season of November 1990
through January 1991.
Stationary point sources, stationary area sources, on-road mobile
sources, and nonroad mobile sources of CO were included in the
inventory. Stationary sources with emissions of greater than 100 tons
per year were also included in the inventory.
The following list presents a summary of the CO peak season daily
emissions estimates in tons per winter day by source category:
Wintertime CO Emissions
[Tons per day]
------------------------------------------------------------------------
Point
State Mobile Area (stationary)
sources sources sources
------------------------------------------------------------------------
Virginia.............................. 288.55 9.89 .92
Maryland............................. 1161.34 71.36 4.61
District of Columbia.................. 410.30 18.08 3.32
------------------------------------------------------------------------
Available guidance for preparing emission inventories is provided
in the General Preamble (57 FR 13498, April 16, 1992).
Section 110(k) of the CAA sets out provisions governing the EPA's
review of base year emission inventory submittals in order to determine
approval or disapproval under section 187(a)(1). The EPA is granting
approval of the Virginia, Maryland and District of Columbia 1990 base
year CO emissions inventories submitted on November 11, 1994 and April
3, 1995, March 21, 1994 and January 13, 1994 respectively, based on the
EPA's technical review of the CO inventory. For further details, the
reader is referred to the Technical Support Document, which is
available for review at the addresses provided above.
B. Oxygenated Gasoline
Section 211(m) of the CAA requires that each State in which there
is located a CO nonattainment area with a design value of 9.5 ppm or
above based on data for the 2-year period of 1988 and 1989 shall submit
a SIP revision which requires the implementation of an oxygenated
gasoline program in the Consolidated Metropolitan Statistical Area
(CMSA) in which the nonattainment area is located. The Metropolitan
Washington area has a design value above 9.6 ppm based on 1988 and 1989
data and consequently was subject to the requirement to adopt an
oxygenated fuel program. Virginia, Maryland and the District of
Columbia submitted oxygenated gasoline SIP revisions for the
Metropolitan Washington CMSA to EPA on November 8, 1993, November 13,
1992 and October 22, 1993, respectively. EPA approved the SIP revisions
for Virginia and Maryland on April 15, 1994 and June 6, 1994
respectively. As noted in the Virginia, Maryland and District of
Columbia redesignation requests, the States intend to relegate the
oxygenated fuel program to contingency status upon EPA's approval of
their redesignation requests. By September 1, 1997 Virginia commits to
adopt and submit to EPA an oxygenated fuel regulation that will be
effective at the beginning of the next control period upon a monitored
violation of the CO NAAQS (two or more exceedances of the CO NAAQS in a
single calendar year). By January 1996, Maryland commits to adopt and
submit to EPA an oxygenated fuel regulation that will be effective at
the beginning of the next control period upon a monitored violation of
the CO NAAQS (two or more exceedances of the CO NAAQS in a single
calendar year). EPA took a limited approval/limited disapproval action
of the District of Columbia's oxygenated fuels SIP. The District's
regulations at 20 District of Columbia Municipal Regulations Chapter 1,
Section 199--definitions was deficient in that it lacks the following:
A definition for the terms ``carriers; a sampling procedure; and
procedures for the calculation of oxygenated content in the gasoline
sampled. With approval of the redesignation request the oxygenated
fuels program will only be relied upon as a contingency measure. For
purposes of section 175A, a state is not required to have fully adopted
contingency measures that will take effect without further action by
the State in order for the maintenance plan to be approved. However, as
stated above, the contingency plan is considered an enforceable part of
the SIP and should ensure that the contingency measures are adopted
expediently once they are triggered. The plan needs to identify the
measure to be adopted and a schedule and procedure for adoption and
implementation. For these reasons, the District can correct the
deficiency subject to the approval of the District's oxygenated fuels
SIP at 40 CFR part 52, Sec. 52.472, (published at 60 FR 5134 on January
26, 1995) when it submits the revised regulation as a contingency
measure. EPA's January 26, 1995 limited approval/limited disapproval of
the District's oxygenated fuels SIP also initiated an 18-month
sanctions clock under section 179 of the Act. By this action to move
the oxygenated fuels program into the contingency measure portion of
the maintenance plan, the sanction clock is no longer applicable. By
December 1995, the District of Columbia commits to adopt and submit to
EPA an oxygenated fuel regulation that will be effective at the
beginning of the next control period upon a monitored violation of the
CO NAAQS (two or more exceedances of the CO NAAQS in a single calendar
year), and correct the deficiencies previously identified by EPA in the
January 26, 1995 rulemaking.
In its demonstration of maintenance, described below, the States
have shown that oxygenated gasoline in the Metropolitan Washington CMSA
is not necessary for continued maintenance of the CO NAAQS.
Consequently, by this action, EPA is approving Virginia, Maryland and
the District of Columbia's use of oxygenated gasoline as a contingency
measure for the Metropolitan Washington area.
C. Conformity
Under section 176(c) of the CAA, states were required to submit
revisions to their SIPs that include criteria and procedures to ensure
that Federal actions conform to the air quality planning goals in the
applicable SIPs. The requirement to determine conformity applies to
transportation plans, programs and projects developed, funded or
approved under Title 23 U.S.C. or the Federal Transit Act
(``transportation conformity''), as well as all other Federal actions
(``general conformity''). Congress provided for the State revisions to
be submitted one year after the date of promulgation of final EPA
conformity regulations. EPA promulgated final transportation conformity
regulations on November 24, 1993 (58 FR 62188) and final general
conformity regulations on November 30, 1993 (58 FR 63214). These
conformity rules require that the States adopt both transportation and
general conformity provisions in the SIP for areas designated
nonattainment or subject to a maintenance plan approved under CAA
section 175A. Pursuant to Sec. 51.396 of the transportation conformity
rule
[[Page 2934]]
and Sec. 51.851 of the general conformity rule, the Commonwealth of
Virginia, State of Maryland and the District of Columbia were required
to submit a SIP revision containing transportation conformity criteria
and procedures consistent with those established in the Federal rule by
November 25, 1994. Similarly, Virginia, Maryland and the District of
Columbia were required to submit a SIP revision containing general
conformity criteria and procedures consistent with those established in
the Federal rule by December 1, 1994. Maryland, Virginia and the
District of Columbia submitted transportation conformity SIP revisions
to EPA on May 15, 1995; May 16, 1995; and, May 15, 1995, respectively.
Furthermore, Virginia, Maryland and the District of Columbia have all
submitted on May 15, 1995 SIP revisions for general conformity.
Although this redesignation request was submitted to EPA after the due
dates for the SIP revisions for transportation conformity [58 FR 62188]
and general conformity [58 FR 63214] rules, EPA believes it is
reasonable to interpret the conformity requirements as not being
applicable requirements for purposes of evaluating the redesignation
request under section 1079d). The rationale for this is based on a
combination of two factors. First, the requirement to submit SIP
revisions to comply with the conformity provisions of the Act continues
to apply to areas after redesignation to attainment. Therefore, the
State remains obligated to adopt the transportation and general
conformity rules even after redesignation and would risk sanctions for
failure to do so. While redesignation of an area to attainment enables
the area to avoid further compliance with most requirements of section
110 and Part D, since those requirements are linked to the
nonattainment status of an area, the conformity requirements apply to
both nonattainment and maintenance areas. Second, EPA's federal
conformity rules require the performance of conformity analyses in the
absence of state-adopted rules. Therefore, a delay in adopting State
rules does not relieve an area from the obligation to implement
conformity requirements.
Because areas are subject to the conformity requirements regardless
of whether they are redesignated to attainment and must implement
conformity under Federal rules if State rules are not yet adopted, EPA
believes it is reasonable to view these requirements as not being
applicable requirements for purposes of evaluating a redesignation
request.
Under this policy, EPA believes that the CO redesignation request
for the Washington area may be approved notwithstanding the lack of
approved state transportation and general conformity rules.
3. Improvement in Air Quality Due to Permanent and Enforceable Measures
EPA approved Virginia's, Maryland's and the District of Columbia's
CO SIPs under the 1977 CAA. Emission reductions achieved through the
implementation of control measures contained in that SIP are
enforceable. These measures were: The Federal Motor Vehicle Control
Program, the basic automobile inspection and maintenance program (I/M),
Federal Reformulated Gasoline Program, Tier I controls on new vehicles,
Low Emission Vehicles (LEV) (in Maryland and Washington, DC only),
State II Vapor Recovery, Evaporative Emissions Control Program, and On-
Board Diagnostics Controls.
As discussed above, the State initially attained the NAAQS in 1988
with monitored attainment through 1993. This indicates that the
improvements are due to the permanent and enforceable measures
contained in the 1982 CO SIP. With the exception of the LEV program and
on-board diagnostics controls, all these measures are permanent and
enforceable because they are either an existing program in the State
and part of the federally approved SIP (e.g., basic I/M, stage II vapor
recovery) or are a federally implemented program (e.g., reformulated
gasoline, FMVCP, or Tier I controls on new vehicles).
The Commonwealth of Virginia and the State of Maryland and the
District of Columbia have demonstrated that actual enforceable emission
reductions are responsible for the air quality improvement and that the
CO emissions in the base year are not artificially low due to local
economic downturn. EPA finds that the combination of certain existing
EPA-approved SIP and federal measures contribute to the permanence and
enforceability of reduction in ambient CO levels that have allowed the
area to attain the NAAQS.
4. Fully Approved Maintenance Plan Under Section 175A
Section 175A of the CAA sets forth the elements of a maintenance
plan for areas seeking redesignation from nonattainment to attainment.
The plan must demonstrate continued attainment of the applicable
NAAQS for at least ten years after the Administrator approves a
redesignation to attainment. Eight years after the redesignation, the
state must submit a revised maintenance plan which demonstrates
attainment for the ten years following the initial ten-year period. To
provide for the possibility of future NAAQS violations, the maintenance
plan must contain contingency measures, with a schedule for
implementation adequate to assure prompt correction of any air quality
problems. In this notice, EPA is approving the State of Virginia's,
Maryland's and the District of Columbia's maintenance plans for the
Metropolitan Washington area because EPA finds that Virginia's,
Maryland's, and District of Columbia's submittal meets the requirements
of section 175A.
A. Attainment Emission Inventory
As previously noted, on March 1994, November 11 and 30, 1992 and
January 7, 1993, Maryland, Virginia and the District of Columbia
respectively submitted a 1990 base year emissions inventory to EPA for
review and approval. The inventory includes emissions from area,
stationary, and mobile sources using 1990 as the base year for
calculations.
The State submittal contains the detailed inventory data and
summaries by county and source category. The comprehensive base year
emissions inventory was submitted in the National Emission Data System
format. This inventory was prepared in accordance with EPA guidance.
Although the 1990 inventory can be considered representative of
attainment conditions because the NAAQS was not violated during 1990,
Virginia, Maryland and the District of Columbia established CO
emissions for the attainment year, as well as two forecast years out to
the year 2010 (2007 and 2010) in their redesignation request. These
estimates were derived from the State's 1990 emissions inventory. The
state projected emissions for the end of the maintenance period using
appropriate growth factors, consistent with EPA guidance. To project
future emissions from mobile sources, MOBILE5a was used to assess the
benefits gained from federally mandated control measures. The control
programs assumed are listed in Section III. Stationary source emissions
were projected using the 1990 base year inventory and multiplying with
EGAS factors. The area source future emissions were projected using the
1990 base year inventory and multiplying the inventory with household,
population, and employment growth factors from the national Capital
Region Transportation Planning Board (TPB) Round 5.1 forecasting
system.
[[Page 2935]]
B. Demonstration of Maintenance-Projected Inventories
Total CO emissions were projected from 1990 base year to 2010.
These projected inventories were prepared in accordance with EPA
guidance. Virginia, Maryland and the District of Columbia will not
implement the Oxygenated Fuel program in the Metropolitan Washington
CMSA unless a violation is measured. The projections show that
calculated CO emissions, assuming no oxygenated fuels program, are not
expected to exceed the level of the base year inventory during this
time period. Therefore, it is anticipated that the Metropolitan
Washington area will maintain the CO standard without the program, and
the oxygenated fuel program would not need to be implemented following
redesignation, except as a contingency measure.
C. Verification of Continued Attainment
Continued attainment of the CO NAAQS in the Metropolitan Washington
area depends, in part, on the State's efforts toward tracking
indicators of continued attainment during the maintenance period. In
addition, comprehensive reviews will be conducted periodically of the
factors used to develop the attainment inventories and those used to
project CO emissions levels for 1995 and 2007. If any of the localities
find significant differences between actual and projected growth,
updated emission inventories will be developed to compare with the
projections.
D. Contingency Plan
The level of CO emissions in the Metropolitan Washington area will
largely determine its ability to stay in compliance with the CO NAAQS
in the future. Despite the State's best efforts to demonstrate
continued compliance with the NAAQS, the ambient air pollutant
concentrations may exceed or violate the NAAQS. Section 175(A)(d) of
the CAA requires that the contingency provisions include a requirement
that the State implement all measures contained in the SIP prior to
redesignation. Therefore, Virginia, Maryland and the District of
Columbia have provided contingency measures with a schedule for
implementation in the event of a future CO air quality problem. The
plan contains triggering mechanisms to determine when contingency
measures are needed.
The Virginia, Maryland and District of Columbia contingency plan
triggers will be a violation of the CO NAAQS. By September 1, 1997
Virginia commits to adopt and submit to EPA an oxygenated fuel
regulations that will be effective at the beginning of the next control
period upon a monitored violation of the CO NAAQS (two or more
exceedances of the CO NAAQS in a single calendar year). By January
1996, Maryland commits to adopt and submit to EPA a oxygenated fuel
regulations that will be effective at the beginning of the next control
period upon a monitored violation of the CO NAAQS (two or more
exceedances of the CO NAAQS in a single calendar year). By December
1995, the District of Columbia commits to adopt and submit to EPA a
oxygenated fuel regulations that will be effective at the beginning of
the next control period upon a monitored violation of the CO NAAQS (two
or more exceedances of the CO NAAQS in a single calendar year). EPA
finds that the contingency measure provided in the Virginia, Maryland
and the District of Columbia submittals meet the requirements of
section 175A(d) of the CAA.
E. Subsequent Maintenance Plan Revisions
In accordance with section 175A(b) of the CAA, the State has agreed
to submit a revised maintenance SIP eight years after the area is
redesignated to attainment. Such revised SIP will provide for
maintenance for an additional ten years.
5. Meeting Applicable Requirements of Section 110 and Part D
In Section III.2. above, EPA sets forth the basis for its
conclusion that Virginia, Maryland and the District of Columbia have a
fully approved SIP which meets the applicable requirements of Section
110 and Part D of the CAA.
EPA is approving this SIP revision without prior proposal because
the Agency views this as a noncontroversial amendment and anticipates
no adverse comments. However, in a separate document in this Federal
Register publication, EPA is proposing to approve the SIP revision
should adverse or critical comments be filed. This action will be
effective March 15, 1996 unless, within 30 days of publication, adverse
or critical comments are received.
If EPA receives such comments, this action will be withdrawn before
the effective date by publishing a subsequent notice that will withdraw
the final action. All public comments received will then be addressed
in a subsequent final rule based on this action serving as a proposed
rule. EPA will not institute a second comment period on this action.
Any parties interested in commenting on this action should do so at
this time. If no such comments are received, the public is advised that
this action will be effective on March 15, 1996.
Final Action
EPA is approving the Metropolitan Washington area CO maintenance
plan because it meets the requirements set forth in section 175A of the
CAA. In addition, the Agency is approving the request and redesignating
the Metropolitan Washington CO area to attainment, because the State
has demonstrated compliance with the requirements of section
107(d)(3)(E) for redesignation. EPA is also approving Virginia's,
Maryland's and the District of Columbia's 1990 base year CO emissions
inventory for the Metropolitan Washington CMSA. The EPA is publishing
this action without prior proposal because the Agency views this as a
noncontroversial amendment and anticipates no adverse comments.
However, in a separate document in this Federal Register publication,
the EPA is proposing to approve the SIP revision should adverse or
critical comments be filed. This action will be effective March 15,
1996 unless, by February 29, 1996 adverse or critical comments are
received. If the EPA receives such comments, this action will be
withdrawn before the effective date by publishing a subsequent document
that will withdraw the final action. All public comments received will
then be addressed in a subsequent final rule based on this action
serving as a proposed rule. The EPA will not institute a second comment
period on this action. Any parties interested in commenting on this
action should do so at this time. If no such comments are received, the
public is advised that this action will be effective March 15, 1996.
Nothing in this action should be construed as permitting or
allowing or establishing a precedent for any future request for
revision to any state implementation plan. Each request for revision to
the state implementation plan shall be considered separately in light
of specific technical, economic, and environmental factors and in
relation to relevant statutory and regulatory requirements.
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. 5 U.S.C. 603 and 604.
Alternatively, EPA may certify that the rule will not have a
significant impact on a substantial number of small entities. Small
entities include small businesses, small not-for-profit
[[Page 2936]]
enterprises, and government entities with jurisdiction over populations
of less than 50,000.
Under Section 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
the private sector, of $100 million or more. Under section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
EPA has determined that the approval action proposed/promulgated
does not include a Federal mandate that may result in estimated costs
of $100 million or more to either State, local, or tribal governments
in the aggregate, or to the private sector. This Federal action
approves pre-existing requirements under State or local law, and
imposes no new Federal requirements. Accordingly, no additional costs
to State, local, or tribal governments, or to the private sector,
result from this action.
Redesignation of an area to attainment under section 107(d)(3)(E)
of the CAA does not impose any new requirements on small entities.
Redesignation is an action that affects the status of a geographical
area and does not impose any regulatory requirements on sources. The
Administrator certifies that the approval of the redesignation request
will not affect a substantial number of small entities.
The CO SIP is designed to satisfy the requirements of part D of the
CAA and to provide for attainment and maintenance of the CO NAAQS. This
final redesignation should not be interpreted as authorizing the State
to delete, alter, or rescind any of the CO emission limitations and
restrictions contained in the approved CO SIP. Changes to CO SIP
regulations rendering them less stringent than those contained in the
EPA approved plan cannot be made unless a revised plan for attainment
and maintenance is submitted to and approved by EPA. Unauthorized
relaxations, deletions, and changes could result in both a finding of
non-implementation (section 179(a) of the CAA) and in a SIP deficiency
call made pursuant to sections 110(a)(2)(H) and 110(k)(2) of the CAA.
SIP approvals under section 110 and subchapter I, part D of the CAA
do not create any new requirements, but simply approve requirements
that the State is already imposing. Therefore, because the federal SIP
approval does not impose any new requirements, it does not have any
economic impact on any small entities. Redesignation of an area to
attainment under section 107(d)(3)(E) of the CAA does not impose any
new requirements on small entities.
This action has been classified as a Table 3 action for signature
by the Regional Administrator under the procedures published in the
Federal Register on January 19, 1989 (54 FR 2214-2225), as revised by a
July 10, 1995 memorandum from Mary Nichols, Assistant Administrator for
Air and Radiation. The Office of Management and Budget (OMB) has
exempted this regulatory action from E.O. 12866 review.
Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by April 1, 1996. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2).)
List of Subjects
40 CFR Part 52
Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements.
40 CFR Part 81
Air pollution control.
Dated: October 23, 1995.
Stanley Laskowski,
Acting Regional Administrator, Region III.
Chapter I, title 40 is amended as follows:
PART 52--[AMENDED]
1. The authority citation for part 52 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
Subpart J--District of Columbia
2. Section 52.470 is amended by adding paragraph (c)(36) to read as
follows:
Sec. 52.470 Identification of plan.
* * * * *
(c) * * *
(36) The carbon monoxide redesignation and maintenance plan for the
District of Columbia submitted by the District of Columbia Department
of Consumer and Regulatory Affairs on October 12, 1995, as part of the
District of Columbia SIP. The emission inventory projections are
included in the maintenance plan.
(i) Incorporation by reference.
(A) Letter of October 12, 1995 from the District of Columbia
Department of Consumer and Regulatory Affairs requesting the
redesignation and submitting the maintenance plan.
(B) Maintenance Plan for the Metropolitan Washington Carbon
Monoxide Nonattainment Area adopted on September 20, 1995.
(ii) Additional material.
(A) Remainder of October 12, 1995 State submittal.
Sec. 52.472 [Amended]
2a. Section 52.472 is amended by removing and reserving paragraph
(e).
3. Section 52.474 is added to read as follows:
Sec. 52.474 1990 Base Year Emission Inventory for Carbon Monoxide
EPA approves as a revision to the District of Columbia
Implementation Plan the 1990 base year emission inventory for the
Washington Metropolitan Statistical Area, submitted by Director,
District of Columbia Consumer and Regulatory Affairs, on January 13,
1994 and October 12, 1995. This submittal consist of the 1990 base year
stationary, area and off-road mobile and on-road mobile emission
inventories in the Washington Statistical Area for the pollutant,
carbon monoxide (CO).
Subpart V--Maryland
4. Section 52.1070 is amended by adding paragraph(c)(118) to read
as follows:
Sec. 52.1070 Identification of plan.
* * * * *
(c) * * *
(118) The carbon monoxide redesignation and maintenance plan for
the Counties of Montgomery and Prince George, Maryland submitted by the
Maryland Department of the Environment on October 12, 1995, as
[[Page 2937]]
part of the Maryland SIP. The emission inventory projections are
included in the maintenance plan.
(i) Incorporation by reference.
(A) Letter of October 12, 1995 from the Maryland Department of the
Environment requesting the redesignation and submitting the maintenance
plan.
(B) Maintenance Plan for the Maryland portion of the Metropolitan
Washington Carbon Monoxide Nonattainment Area adopted on September 20,
1995.
(ii) Additional material.
(A) Remainder of October 12, 1995 State submittal.
5. Section 52.1075 is amended by redesignating existing text as
paragraph (a) and adding paragraph (b) to read as follows:
Sec. 52.1075 1990 Base Year Emission Inventory for Carbon Monoxide
* * * * *
(b) EPA approves as a revision to the Maryland Implementation Plan
the 1990 base year emission inventory for the Washington Metropolitan
Statistical Area, submitted by Secretary, Maryland Department of the
Environment, on March 21, 1994 and October 12, 1995. This submittal
consist of the 1990 base year stationary, area and off-road mobile and
on-road mobile emission inventories in the Washington Statistical Area
for the pollutant, carbon monoxide (CO).
Subpart VV--Virginia
6. Section 52.2420 is amended by adding paragraphs (c)(107) to read
as follows:
Sec. 52.2420 Identification of plan.
* * * * *
(c) * * *
(107) The carbon monoxide redesignation and maintenance plan for
the Counties of Arlington and Alexandria, Virginia submitted by the
Virginia Department of Environmental Quality on October 4, 1995, as
part of the Virginia SIP. The emission inventory projections are
included in the maintenance plan.
(i) Incorporation by reference.
(A) Letter of October 4, 1995 from the Virginia Department of
Environmental Quality requesting the redesignation and submitting the
maintenance plan.
(B) Maintenance Plan for the Virginia portion of the Metropolitan
Washington Carbon Monoxide Nonattainment Area adopted on September 20,
1995.
(ii) Additional material.
(A) Remainder of October 4, 1995 State submittal.
7. Section 52.2425 is added to read as follows:
Sec. 52.2425 1990 Base Year Emission Inventory for Carbon Monoxide.
EPA approves as a revision to the Virginia Implementation Plan the
1990 base year emission inventory for the Washington Metropolitan
Statistical Area, submitted by Director, Virginia Department of
Environmental Quality, on November 1, 1993, April 3, 1995 and October
12, 1995. This submittal consist of the 1990 base year stationary, area
and off-road mobile and on-road mobile emission inventories in the
Washington Statistical Area for the pollutant, carbon monoxide (CO).
PART 81--[AMENDED]
8. The authority citation for part 81 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
Subpart C--Section 107 Attainment Status Designations
9. In Sec. 81.309, the table for ``District of Columbia-Carbon
Monoxide'' is amended by revising the entry for the ``Washington Area
Entire Washington Area'' to read as follows:
Sec. 81.309 District of Columbia.
* * * * *
District of Columbia-Carbon Monoxide
----------------------------------------------------------------------------------------------------------------
Designation Classification
Designated area ------------------------------------------------------------------------------
Date\1\ Type Date\1\ Type
----------------------------------------------------------------------------------------------------------------
Washington Area:
Washington Entire Area....... Attainment
----------------------------------------------------------------------------------------------------------------
\1\This date is November 15, 1990, unless otherwise noted.
* * * * *
10. In Sec. 81.321, the table for ``Maryland-Carbon Monoxide'' is
amended by revising the entry for ``Montgomery County'' and for
``Prince George's County'' to read as follows:
Sec. 81.321 Maryland.
* * * * *
Maryland-Carbon Monoxide
----------------------------------------------------------------------------------------------------------------
Designation Classification
Designated area ------------------------------------------------------------------------------
Date\1\ Type Date\1\ Type
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Washington Area:
Montgomery County (part) Attainment
Election Districts 4, 7, 13.
Prince George's County (part) Attainment
Election Districts 2, 6, 12,
16, 17, 18.
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
\1\This date is November 15, 1990, unless otherwise noted.
* * * * *
11. In Sec. 81.347, the table for ``Virginia-Carbon Monoxide'' is
amended by revising the entry for ``Alexandria'' and for ``Arlington
County'' to read as follows:
Sec. 81.347 Virginia.
* * * * *
[[Page 2938]]
Virginia-Carbon Monoxide
----------------------------------------------------------------------------------------------------------------
Designation Classification
Designated area ------------------------------------------------------------------------------
Date\1\ Type Date\1\ Type
----------------------------------------------------------------------------------------------------------------
Washington area:
Alexandria................... Attainment ......................
Arlington County............. Attainment ......................
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
\1\This date is November 15, 1990, unless otherwise noted.
* * * * *
[FR Doc. 96-1592 Filed 1-29-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-1589 Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; State of Massachusetts; Change in National Policy Regarding Applicability of Conformity Requirements to Redesignation Requests
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2918-2926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1589]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 52 and 81
[FRL-5321-4]
Approval and Promulgation of Implementation Plans and Designation
of Areas for Air Quality Planning Purposes; State of Massachusetts;
Change in National Policy Regarding Applicability of Conformity
Requirements to Redesignation Requests
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: On December 12, 1994, the Massachusetts Department of
Environmental Protection (MA DEP) submitted a request to redesignate
the Boston metropolitan area, including the communities of Boston,
Cambridge, Chelsea, Everett, Malden, Medford, Quincy, Revere, and
Somerville, from nonattainment to attainment for carbon monoxide (CO).
Under the Clean Air Act as amended in 1990 (CAA), designations can be
revised if sufficient data is available to warrant such revisions. In
this action, EPA is approving the Massachusetts request because it
meets the redesignation requirements set forth in the CAA.
In addition, EPA is approving two related State Implementation Plan
(SIP) submissions by Massachusetts DEP. On November 15, 1993,
Massachusetts DEP submitted a final 1990 base year emission inventory
for CO emissions, which includes emissions data for all sources of CO
in Massachusetts' CO nonattainment areas, as well as CO emissions for
the entire state. On October 29, 1993, Massachusetts DEP submitted an
oxygenated gasoline program for the Boston consolidated metropolitan
statistical area (CMSA). In this action, EPA is approving the CO
emissions inventory and oxygenated fuels SIP submissions.
DATES: This final rule will be effective April 1, 1996 unless critical
or adverse comments are received by February 29, 1996. If the effective
date is delayed, timely notice will be published in the Federal
Register.
ADDRESSES: Written comments should be sent to Susan Studlien, Acting
Director of the Air, Pesticides and Toxics Management Division, at the
EPA Regional Office listed below. Copies of the redesignation request
and the State of Massachusetts' submittal are available for public
review during normal business hours at the addresses listed below.
[[Page 2919]]
Air and Radiation Docket and Information Center, U.S. Environmental
Protection Agency, 401 M Street, SW., Washington, DC 20460, and;
Environmental Protection Agency, One Congress Street, Boston, MA 02203.
FOR FURTHER INFORMATION CONTACT: Wing Chau of the EPA Region I Air,
Pesticides and Toxics Management Division at (617) 565-3570.
SUPPLEMENTARY INFORMATION:
I. Background
In a March 15, 1991 letter to the EPA Region I Administrator, the
Governor of Massachusetts recommended the Boston metropolitan area,
which covers the nine surrounding cities (the ``Boston area''), be
designated as nonattainment for CO as required by section 107(d)(1)(A)
of the 1990 Clean Air Act Amendments (CAA) (Public Law 101-549, 104
Stat. 2399, codified at 42 U.S.C. 7401-7671q). The area was designated
nonattainment and classified as ``moderate'' under the provisions
outlined in sections 186 and 187 of the CAA. (See 56 FR 56694 (Nov. 6,
1991) and 57 FR 56762 (Nov. 30, 1992), codified at 40 CFR part 81,
Sec. 81.322.) Because the area had a design value of 9.8 ppm (based on
1986 data), the area was considered moderate. The CAA established an
attainment date of December 31, 1995, for all moderate CO areas. The
Boston area has ambient monitoring data showing attainment of the CO
NAAQS, since 1988. Therefore, in an effort to comply with the CAA and
to ensure continued attainment of the NAAQS, on December 12, 1994 the
State of Massachusetts submitted a CO redesignation request and a
maintenance plan for the Boston area. Massachusetts submitted evidence
that public hearings were held on September 29, 1994 in Springfield and
on September 30, 1994 in Boston.
II. Evaluation Criteria
Section 107(d)(3)(E) of the 1990 Clean Air Act Amendments provides
five specific requirements that an area must meet in order to be
redesignated from nonattainment to attainment.
1. The area must have attained the applicable NAAQS;
2. The area must have a fully approved SIP under section 110(k) of
CAA;
3. The air quality improvement must be permanent and enforceable;
4. The area must have a fully approved maintenance plan pursuant to
section 175A of the CAA;
5. The area must meet all applicable requirements under section 110
and Part D of the CAA.
III. Review of State Submittal
On January 17, 1995, EPA-New England determined that the
information received from the MA DEP constituted a complete
redesignation request under the general completeness criteria of 40 CFR
part 51, appendix V, Secs. 2.1 and 2.2.
The Massachusetts redesignation request for the Boston area meets
the five requirements of section 107(d)(3)(E), noted above. The
following is a brief description of how the State has fulfilled each of
these requirements.
1. Attainment of the CO NAAQS
Massachusetts has quality-assured CO ambient air monitoring data
showing that the Boston area has met the CO NAAQS. The Massachusetts
request is based on an analysis of quality-assured CO air monitoring
data which is relevant to the maintenance plan and to the redesignation
request. To attain the CO NAAQS, an area must have complete quality-
assured data showing no more than one exceedance of the standard per
year over at least two consecutive years. The ambient air CO monitoring
data for calendar year 1988 through calendar year 1993, relied upon by
Massachusetts in its redesignation request, shows no violations of the
CO NAAQS in the Boston area. The most recent ambient CO data shows no
exceedances in the calendar years 1994 and 1995. Because the area has
complete quality assured data showing no more than one exceedance of
the standard per year over at least two consecutive years (1991 and
1992), the area has met the first statutory criterion of attainment of
the CO NAAQS (40 CFR 50.9 and appendix C). Massachusetts has committed
to continue monitoring in this area in accordance with 40 CFR part 58.
2. Fully Approved SIP Under Section 110(k) of the CAA
Massachusetts's CO SIP is fully approved by EPA as meeting all the
requirements of Section 110(a)(2)(I) of the Act, including the
requirements of Part D (relating to nonattainment), which were due
prior to the date of Massachusetts' redesignation request.
Massachusetts' 1982 CO SIP was fully approved by EPA in 1983 as meeting
the CO SIP requirements in effect under the CAA at that time. The 1990
CAAA required that nonattainment areas achieve specific new
requirements depending on the severity of the nonattainment
classification. Requirements for the Boston area include the
preparation of a 1990 emission inventory with periodic updates,
adoption of an oxygenated fuels program, the development of contingency
measures, and development of conformity procedures. Each of these
requirements added by the 1990 Amendments to the CAA are discussed in
greater detail below.
Consistent with the October 14, 1994 EPA guidance from Mary D.
Nichols entitled ``Part D New Source Review (Part D NSR) Requirements
for Areas Requesting Redesignation to Attainment,'' EPA is not
requiring full approval of a Part D NSR program by Massachusetts as a
prerequisite to redesignation to attainment. Under this guidance,
nonattainment areas may be redesignated to attainment notwithstanding
the lack of a fully-approved Part D NSR program, so long as the program
is not relied upon for maintenance. Massachusetts has not relied on a
NSR program for CO sources to maintain attainment. Although EPA is not
treating a Part D NSR program as a prerequisite for redesignation, it
should be noted that EPA is in the process of taking final action on
the State's revised NSR regulation, which includes requirements for CO
nonattainment areas. Because the Boston area is being redesignated to
attainment by this action, Massachusetts' Prevention of Significant
Deterioration (PSD) requirements will be applicable to new or modified
sources in the Boston area.
A. Emission Inventory
Massachusetts submitted its base year inventory to EPA on November
15, 1993, which included estimates for CO at the statewide, county and
CO nonattainment city/town levels, as required under Section 187(a)(1)
of the CAA. EPA is approving the CO portion of the Massachusetts Base
Year emission inventory with this redesignation request.
Section 172(c)(3) of the CAA requires that nonattainment plan
provisions include a comprehensive, accurate, and current inventory of
actual emissions from all sources of relevant pollutants in the
nonattainment area. Massachusetts included the requisite inventory in
the CO SIP. The base year for the inventory was 1990, using a three
month CO season of November 1990 through January 1991. Stationary point
sources, stationary area sources, on-road mobile sources, and nonroad
mobile sources of CO were included in the inventory. Stationary sources
with emissions of greater than 100 tons per year were also included in
the inventory.
The following list presents a summary of the CO peak season daily
emissions estimates in tons per winter day by
[[Page 2920]]
source category: Point Sources, 32.77 tons per day; Area Sources,
711.95 tons per day; Mobile On-Road Sources, 3,387.69 tons per day;
Mobile Nonroad Sources, 109.36 tons per day; Total Sources, 4,241.77
tons per day. Available guidance for preparing emission inventories is
provided in the General Preamble (57 FR 13498, April 16, 1992).
Section 110(k) of the CAA sets out provisions governing the EPA's
review of base year emission inventory submittals in order to determine
approval or disapproval under section 187(a)(1). The EPA is granting
approval of the Massachusetts 1990 base year CO emissions inventory
submitted on November 15, 1993, based on the EPA's technical review of
the CO inventory. For further details, the reader is referred to the
Technical Support Document, which is available for review at the
addresses provided above.
B. Oxygenated Gasoline
Motor vehicles are significant contributors of CO emissions. An
important measure toward reducing these emissions is the use of
cleaner-burning oxygenated gasoline. Extra oxygen, contained within the
oxygenate in the fuel, enhances fuel combustion and helps to offset
fuel-rich operating conditions, particularly during vehicle starting,
which are more prevalent in the winter.
Section 211(m) of the CAA requires that CO nonattainment areas,
with a design value of 9.5 parts per million based on data for the 2-
year period of 1988 and 1989, submit a SIP revision for an oxygenated
fuel program for such area. The oxygenated fuel requirement must apply
to all fuel refiners or marketers who sell or dispense gasoline in the
Metropolitan Statistical area (MSA) or Consolidated Statistical Area
(CMSA) in which the nonattainment area is located. The Boston area has
a design value above 9.5 parts per million based on 1986 and 1987 data
(1988 and 1989 data was not used due to insufficient data at one of the
CO monitors) and consequently were subject to the requirement to adopt
an oxygenated fuel program. Massachusetts submitted an oxygenated fuel
SIP revision for the Boston CO nonattainment area to EPA on October 29,
1993. As noted in Massachusetts' redesignation request, the State
intends to relegate the oxygenated fuel program to contingency status
upon EPA's approval of Massachusetts' redesignation request. As part of
this action, EPA is approving Massachusetts' oxygenated fuel program
for the Boston CO area.
The oxygenated gasoline program is one in which all oxygenated
gasoline must contain a minimum oxygen content of 2.7 percent by weight
of oxygen. Under section 211(m)(4) of the CAA, EPA also issued
requirements for the labeling of gasoline pumps used to dispense
oxygenated gasoline, as well as guidelines on the establishment of an
appropriate control period. These labeling requirements and control
period guidelines may be found in 57 FR 47849, dated October 20, 1992.
Massachusetts' oxygenated gasoline regulation requires the minimum 2.7
percent oxygen content in the Boston CMSA. The regulation also contains
the necessary labeling regulations, enforcement procedures, and
oxygenate test methods. For a more detailed description of the manner
in which Massachusetts' oxygenated fuels program meets the requirements
of Section 211(m) of the CAA, the reader is referred to the Technical
Support Document, which is available for review at the addresses
provided above.
As mentioned above, Massachusetts has chosen to convert its
oxygenated fuels requirement in the Boston CMSA to a contingency
measure in its maintenance plan upon redesignation. Because
Massachusetts attained the CO standard based on data before the
oxygenated fuel program was implemented in the Boston CMSA, oxygenated
gasoline was not necessary to reach attainment. In its demonstration of
maintenance, described below, the State has shown that oxygenated
gasoline in the Boston CMSA is not necessary for continued maintenance
of the CO NAAQS. Consequently, by this action, EPA is both approving
Massachusetts' oxygenated fuels regulation and simultaneously approving
its use as a contingency measure for the Boston area.
C. Conformity
Under section 176(c) of the CAA, states were required to submit
revisions to their SIPs that include criteria and procedures to ensure
that Federal actions conform to the air quality planning goals in the
applicable SIPs. The requirement to determine conformity applies to
transportation plans, programs and projects developed, funded or
approved under Title 23 U.S.C. or the Federal Transit Act
(``transportation conformity''), as well as all other Federal actions
(``general conformity''). Congress provided for the State revisions to
be submitted one year after the date of promulgation of final EPA
conformity regulations.
EPA promulgated final transportation conformity regulations on
November 24, 1993 (58 FR 62188) and final general conformity
regulations on November 30, 1993 (58 FR 63214). These conformity rules
require that the States adopt both transportation and general
conformity provisions in the SIP for areas designated nonattainment or
subject to a maintenance plan approved under CAA section 175A. Pursuant
to Sec. 51.396 of the transportation conformity rule, the State of
Massachusetts was required to submit a SIP revision containing
transportation conformity criteria and procedures consistent with those
established in the Federal rule by November 25, 1994. Similarly,
pursuant to Sec. 51.851 of the general conformity rule, Massachusetts
was required to submit a SIP revision containing general conformity
criteria and procedures consistent with those established in the
Federal rule by December 1, 1994. Massachusetts submitted its
transportation conformity SIP revision to EPA on December 30, 1994.
This SIP was determined to be administratively and technically complete
on March 16, 1995; however, this SIP has not been fully approved by
EPA. Massachusetts has not submitted its general conformity SIP
revision.
Although this redesignation request was submitted to EPA after the
due dates for the SIP revisions for transportation conformity [58 FR
62188] and general conformity [58 FR 63214] rules , EPA believes it is
reasonable to interpret the conformity requirements as not being
applicable requirements for purposes of evaluating the redesignation
request under section 107(d). The rationale for this is based on a
combination of two factors. First, the requirement to submit SIP
revisions to comply with the conformity provisions of the Act continues
to apply to areas after redesignation to attainment. Therefore, the
State remains obligated to adopt the transportation and general
conformity rules even after redesignation and would risk sanctions for
failure to do so. While redesignation of an area to attainment enables
the area to avoid further compliance with most requirements of section
110 and part D, since those requirements are linked to the
nonattainment status of an area, the conformity requirements apply to
both nonattainment and maintenance areas. Second, EPA's federal
conformity rules require the performance of conformity analyses in the
absence of state-adopted rules. Therefore, a delay in adopting State
rules does not relieve an area from the obligation to implement
conformity requirements.
[[Page 2921]]
Because areas are subject to the conformity requirements regardless
of whether they are redesignated to attainment and must implement
conformity under Federal rules if State rules are not yet adopted, EPA
believes it is reasonable to view these requirements as not being
applicable requirements for purposes of evaluating a redesignation
request.
Therefore, with this notice, EPA is modifying its national policy
regarding the interpretation of the provisions of section 107(d)(3)(E)
concerning the applicable requirements for purposes of reviewing a
carbon monoxide redesignation request.
Under this new policy, for the reasons just discussed, EPA believes
that the CO redesignation request for the Boston area may be approved
notwithstanding the lack of submitted and approved state transportation
and general conformity rules.
3. Improvement in Air Quality Due to Permanent and Enforceable Measures
EPA approved Massachusetts' CO SIP under the 1977 CAA. Emission
reductions achieved through the implementation of control measures
contained in that SIP are enforceable. These measures were:
transportation plan reviews, a basic Inspection and Maintenance
Program, right turn on red, and the Federal Motor Vehicle Control
Program. As discussed above, the State initially attained the NAAQS in
1988 with monitored attainment through the 1994-1995 CO season. This
indicates that the improvements are due to the permanent and
enforceable measures contained in the 1982 CO SIP.
The State of Massachusetts has demonstrated that actual enforceable
emission reductions are responsible for the air quality improvement and
that the CO emissions in the base year are not artificially low due to
local economic downturn. EPA finds that the combination of certain
existing EPA-approved SIP and federal measures contribute to the
permanence and enforceability of reduction in ambient CO levels that
have allowed the area to attain the NAAQS.
4. Fully Approved Maintenance Plan Under Section 175A
Section 175A of the CAA sets forth the elements of a maintenance
plan for areas seeking redesignation from nonattainment to attainment.
The plan must demonstrate continued attainment of the applicable
NAAQS for at least ten years after the Administrator approves a
redesignation to attainment. Eight years after the redesignation, the
state must submit a revised maintenance plan which demonstrates
attainment for the ten years following the initial ten-year period. To
provide for the possibility of future NAAQS violations, the maintenance
plan must contain contingency measures, with a schedule for
implementation adequate to assure prompt correction of any air quality
problems. In this notice, EPA is approving the State of Massachusetts'
maintenance plan for the Boston area because EPA finds that
Massachusetts' submittal meets the requirements of section 175A.
A. Attainment Emission Inventory
As previously noted, on November 15, 1993, the State of
Massachusetts submitted a comprehensive inventory of CO emissions for
the Boston area. The inventory includes emissions from area,
stationary, and mobile sources using 1990 as the base year for
calculations.
The State submittal contains the detailed inventory data and
summaries by county and source category. The comprehensive base year
emissions inventory was submitted in the National Emission Data System
format. This inventory was prepared in accordance with EPA guidance.
Although the 1990 inventory can be considered representative of
attainment conditions because the NAAQS was not violated during 1990,
Massachusetts established CO emissions for the attainment year, 1993,
as well as four forecast years out to the year 2010 (1995, 2000, 2005,
and 2010) in their redesignation request. These estimates were derived
from the State's 1990 emissions inventory. The future emission
estimates are based on assumptions about economic and vehicle miles
travelled growth. These assumptions are documented in the Massachusetts
Growth Factors report dated November 1993.
1990 CO Base Year Emissions Inventory Boston Nonattainment Area (Tons per Day)
----------------------------------------------------------------------------------------------------------------
Year Area Nonroad Mobile Point Total
----------------------------------------------------------------------------------------------------------------
1990......................................... 126.76 59.04 343.41 7.62 536.83
----------------------------------------------------------------------------------------------------------------
Boston Nonattainment Area CO Emissions Inventory Summary (Tons per Day)
----------------------------------------------------------------------------------------------------------------
Year Area Nonroad Mobile Point Total
----------------------------------------------------------------------------------------------------------------
1990......................................... 126.76 59.04 343.41 7.62 536.83
1993......................................... 128.32 59.823 305.43 7.96 501.53
1995......................................... 129.35 60.344 280.10 8.19 477.98
2000......................................... 131.20 62.995 147.56 8.87 350.625
2005......................................... 134.39 64.961 125.93 9.69 334.97
2010......................................... 137.93 66.695 121.75 10.05 336.425
----------------------------------------------------------------------------------------------------------------
B. Demonstration of Maintenance-Projected Inventories
Total CO emissions were projected from 1990 base year out to 2010.
These projected inventories were prepared in accordance with EPA
guidance. Massachusetts will not implement the Oxygenated Fuel program
in the Boston CMSA unless a violation is measured. The projections show
that calculated CO emissions, assuming no oxygenated fuels program, are
not expected to exceed the level of the base year inventory during this
time period. Therefore, it is anticipated that the Boston area will
maintain the CO standard without the program, and the oxygenated fuel
program would not need to be implemented following redesignation,
except as a contingency measure.
C. Verification of Continued Attainment
Continued attainment of the CO NAAQS in the Boston area depends, in
part, on the State's efforts toward tracking indicators of continued
attainment during the maintenance period. The State has also committed
to
[[Page 2922]]
submit periodic inventories of CO emissions every three years.
D. Contingency Plan
The level of CO emissions in the Boston area will largely determine
its ability to stay in compliance with the CO NAAQS in the future.
Despite the State's best efforts to demonstrate continued compliance
with the NAAQS, the ambient air pollutant concentrations may exceed or
violate the NAAQS. Section 175A(d) of the CAA requires that the
contingency provisions include a requirement that the State implement
all measures contained in the SIP prior to redesignation. Therefore,
Massachusetts has provided contingency measures with a schedule for
implementation in the event of a future CO air quality problem. The
plan contains triggering mechanisms to determine when contingency
measures are needed.
Massachusetts has developed a contingency plan which contains a mix
of contingency measures that will address site specific CO problems and
regional CO emissions. The first set of contingency measures deals with
localized CO problems, which is either an engineering fix or traffic
flow improvement at any site which triggers the need for the
contingency measure. The second set of contingency measures deals with
regional CO emissions, which include the implementation of an
oxygenated fuels program throughout the Boston CMSA, implementation of
an enhanced inspection and maintenance program and implementation of
travel demand measures.
In order to be an adequate maintenance plan, the plan should
include at least one contingency measure that will go into effect with
a triggering event. Massachusetts is relying largely on a contingency
measure that is expected to be implemented regardless of any triggering
event, namely, enhanced Inspection and Maintenance (I/M). Massachusetts
is implementing I/M to meet other requirements of the CAA and it has
the additional benefit of reducing CO emissions. Massachusetts has two
measures that will not go into effect unless a triggering event occurs,
namely oxygenated fuels and traffic flow improvements.
E. Subsequent Maintenance Plan Revisions
In accordance with section 175A(b) of the CAA, the State has agreed
to submit a revised maintenance SIP eight years after the area is
redesignated to attainment. Such revised SIP will provide for
maintenance for an additional ten years.
5. Meeting Applicable Requirements of Section 110 and Part D
In Section III.2. above, EPA sets forth the basis for its
conclusion that Massachusetts has a fully approved SIP which meets the
applicable requirements of Section 110 and Part D of the CAA.
Final Action
EPA is approving the Boston CO maintenance plan because it meets
the requirements set forth in section 175A of the CAA. In addition, the
Agency is approving the request and redesignating the Boston CO area to
attainment, because the State has demonstrated compliance with the
requirements of section 107(d)(3)(E) for redesignation. EPA is also
approving Massachusetts' 1990 base year CO emissions inventory and the
State's oxygenated gasoline program for the Boston CMSA. The EPA is
publishing this action without prior proposal because the Agency views
this as a noncontroversial amendment and anticipates no adverse
comments. However, in a separate document in this Federal Register
publication, the EPA is proposing to approve the SIP revision should
adverse or critical comments be filed. This action will be effective
April 1, 1996 unless, by February 29, 1996 adverse or critical comments
are received. If the EPA receives such comments, this action will be
withdrawn before the effective date by publishing a subsequent document
that will withdraw the final action. All public comments received will
then be addressed in a subsequent final rule based on this action
serving as a proposed rule. The EPA will not institute a second comment
period on this action. Any parties interested in commenting on this
action should do so at this time. If no such comments are received, the
public is advised that this action will be effective April 1, 1996.
Nothing in this action should be construed as permitting or
allowing or establishing a precedent for any future request for
revision to any SIP. Each request for revision to the SIP shall be
considered separately in light of specific technical, economic, and
environmental factors and in relation to relevant statutory and
regulatory requirements.
The CO SIP is designed to satisfy the requirements of part D of the
CAA and to provide for attainment and maintenance of the CO NAAQS. This
final redesignation should not be interpreted as authorizing the State
to delete, alter, or rescind any of the CO emission limitations and
restrictions contained in the approved CO SIP. Changes to CO SIP
regulations rendering them less stringent than those contained in the
EPA approved plan cannot be made unless a revised plan for attainment
and maintenance is submitted to and approved by EPA. Unauthorized
relaxations, deletions, and changes could result in both a finding of
non-implementation (section 179(a) of the CAA) and in a SIP deficiency
call made pursuant to sections 110(a)(2)(H) and 110(k)(2) of the CAA.
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. 5 U.S.C. 603 and 604.
Alternatively, EPA may certify that the rule will not have a
significant impact on a substantial number of small entities. Small
entities include small businesses, small not-for-profit enterprises,
and government entities with jurisdiction over populations of less than
50,000. SIP approvals under section 110 and subchapter I, part D of the
CAA do not create any new requirements, but simply approve requirements
that the State is already imposing. Therefore, because the federal SIP
approval does not impose any new requirements, it does not have any
economic impact on any small entities. Redesignation of an area to
attainment under section 107(d)(3)(E) of the CAA does not impose any
new requirements on small entities.
Redesignation is an action that affects the status of a
geographical area and does not impose any regulatory requirements on
sources. Accordingly, I certify that the approval of the redesignation
request will not have an impact on any small entities.
Unfunded Mandates
Under Sections 202, 203, and 205 of the Unfunded Mandates Reform
Act of 1995 (``Unfunded Mandates Act''), signed into law on March 25,
1995, EPA must undertake various actions in association with proposed
or final rules that include a Federal mandate that may result in
estimated costs of $100 million or more to the private sector, or to
State, local, or tribal governments in the aggregate.
Through submission of this state implementation plan or plan
revision, the State and any affected local or tribal governments have
elected to adopt the program provided for under section 175A and
section 187(a)(1) of the Clean Air Act. The rules and commitments
approved in this action may bind State, local and tribal governments to
perform certain actions and also may ultimately
[[Page 2923]]
lead to the private sector being required to certain duties. To the
extent that the imposition of any mandate upon the State, local or
tribal governments either as the owner or operator of a source or as
mandate upon the private sector, EPA's action will impose no new
requirements under State law; such sources are already subject to these
requirements under State law. Accordingly, no additional costs to
State, local, or tribal governments, or to the private sector, results
from this action. EPA has also determined that this final action does
not include a mandate that may result in estimated costs of $100
million or more to State, local, or tribal governments in the aggregate
or to the private sector.
List of Subjects
40 CFR Part 52
Environmental protection, Air pollution control, Carbon monoxide,
Hydrocarbons, Incorporation by reference, Intergovernmental relations,
Ozone.
40 CFR Part 81
Air pollution control, National parks, and Wilderness areas.
Dated: September 29, 1995.
John P. DeVillars,
Regional Administrator.
Chapter I, title 40 of the Code of Federal Regulations is amended
as follows:
PART 52--[AMENDED]
1. The authority citation for part 52 continues to read as follows:
Authority: 42.U.S.C. 7401-7671q.
Subpart W--Massachusetts
2. Section 52.1120 is amended by adding paragraph (c)(107) to read
as follows:
Sec. 52.1120 Identification of plan.
* * * * *
(c) * * *
(107) Massachusetts submitted the Oxygenated Gasoline Program on
October 29, 1993. This submittal satisfies the requirements of section
211(m) of the Clean Air Act, as amended.
(i) Incorporation by reference.
(A) Letter dated October 29, 1993 which included the oxygenated
gasoline program, amendments to the Massachusetts Air Pollution Control
Regulations, 310 CMR 7.00, with an effective date of March 1, 1994,
requesting that the submittal be approved and adopted as part of
Massachusetts' SIP.
(ii) Additional materials.
(A) The Technical Support Document for the Redesignation of the
Boston Area as Attainment for Carbon Monoxide submitted on December 12,
1994.
3. Section 52.1132 is added to read as follows:
Sec. 52.1132 Control strategy: Carbon Monoxide.
(a) Approval-On November 13, 1992, the Massachusetts Department of
Environmental Protection submitted a revision to the carbon monoxide
State Implementation Plan for the 1990 base year emission inventory.
The inventory was submitted by the State of Massachusetts to satisfy
Federal requirements under section 182(a)(1) of the Clean Air Act as
amended in 1990, as a revision to the carbon monoxide State
Implementation Plan.
(i) Approval--On December 12, 1994, the Massachusetts Department of
Environmental Protection submitted a request to redesignate the Boston
Area carbon monoxide nonattainment area to attainment for carbon
monoxide. As part of the redesignation request, the State submitted a
maintenance plan as required by 175A of the Clean Air Act, as amended
in 1990. Elements of the section 175A maintenance plan include a base
year (1993 attainment year) emission inventory for carbon monoxide, a
demonstration of maintenance of the carbon monoxide NAAQS with
projected emission inventories to the year 2010 for carbon monoxide, a
plan to verify continued attainment, a contingency plan, and an
obligation to submit a subsequent maintenance plan revision in 8 years
as required by the Clean Air Act. If the area records a violation of
the carbon monoxide NAAQS (which must be confirmed by the State),
Massachusetts will implement one or more appropriate contingency
measure(s) which are contained in the contingency plan. The menu of
contingency measures includes an enhanced motor vehicle inspection and
maintenance program and implementation of the oxygenated fuels program.
The redesignation request and maintenance plan meet the redesignation
requirements in sections 107(d)(3)(E) and 175A of the Act as amended in
1990, respectively. The redesignation meets the Federal requirements of
section 182(a)(1) of the Clean Air Act as a revision to the
Massachusetts Carbon Monoxide State Implementation Plan for the above
mentioned area.
PART 81--[AMENDED]
Subpart C--Section 107 Attainment Status Designations
1. The authority citation for part 81 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
2. In Sec. 81.322, the table for ``Massachusetts-Carbon Monoxide''
is revised to read as follows:
Sec. 81.322 Massachusetts.
* * * * *
Massachusetts-Carbon Monoxide
--------------------------------------------------------------------------------------------------------------------------------------------------------
Designation Classification
Designated area -----------------------------------------------------------------------------------------------------------------------
Date\1\ Type Date\1\ Type
--------------------------------------------------------------------------------------------------------------------------------------------------------
Boston area:
Middlesex County (part) April 1, 1996............... Attainment. ............................ ............................
Cities of: Cambridge,
Everett, Malden, Medford,
and Somerville.
Norfolk County (part) Quincy April 1, 1996............... Attainment. ............................ ............................
City.
Suffolk County (part) Cities April 1, 1996............... Attainment. ............................ ............................
of: Boston, Chelsea, and
Revere.
Lowell area:
Middlesex County (part) ............................ Nonattainment............... ............................ Not classified.
Lowell City.
Springfield area:
Hampden County (part) ............................ Nonattainment............... ............................ Not classified.
Springfield City.
Waltham area:
Middlesex County (part) ............................ Nonattainment............... ............................ Not classified.
Waltham City.
Worcester area:
Worcester County (part) City ............................ Nonattainment............... ............................ Not classified.
of Worcester.
[[Page 2924]]
AQCR 042 Hartford-New Haven- ............................ Unclassifiable/Attainment... ............................ ............................
Springfield.
Franklin County:
Hampden County (part):
Cities of: Chicopee,
Holyoke, and Westfield.
Townships of: Agawam,
Blandford, Brimfield,
Chester, East
Longmeadow, Granville,
Hampden, Holland,
Longmeadow, Ludlow,
Monson, Montgomery,
Palmer, Russell,
Southwick, Tolland,
Wales, West
Springfield, and
Wilbraham.
Hampshire County (part):
City of Northampton.
Townships of: Amherst,
Belchertown,
Chesterfield,
Cummington, Eastampton,
Goshen, Granby, Hadley,
Hatfield, Huntington,
Middlefield, Pelham,
Southampton, South
Hadley, Ware,
Westhampton,
Williamsburg, and
Worthington.
AQCR 117 Berkshire Intrastate ............................ Unclassifiable/Attainment... ............................ ............................
Berkshire County.
AQCR 118 Central Massachusetts ............................ Unclassifiable/Attainment... ............................ ............................
Intrastate.
Middlesex County (part):
Townships of: Ashby,
Shirley, and Townsend
Worcester County (part):
Cities of: Leominster,
Fitchburg, and Gardner.
Townships of:
Ashburnham, Athol,
Auburn, Barre, Berlin,
Blackstone, Boylston,
Brookfield, Charlton,
Clinton, Douglas,
Dudley, East Holden,
Hopedale, Hubbardstown,
Lancaster, Leicester,
Lunenburg, Mendon,
Millbury, Millville,
New Braintree,
Northborough,
Northbridge, North
Brookfield, Oakham,
Oxford, Paxton,
Petersham, Phillipston,
Princeton, Royalston,
Rutland, Shewsbury,
Southbridge, Spencer,
Sterling, Sutton,
Templeton, Upton,
Uxbridge, Warren,
Webster, Westborough,
West Boylston, West
Brookfield,
Westminster, and
Winchendon
AQCR 119 Metropolitan Boston ............................ Unclassifiable/Attainment... ............................ ............................
Intrastate.
[[Page 2925]]
Essex County (part):
Cities of: Beverly, ............................ ............................ ............................ ............................
Gloucester, Lynn,
Peabody, and Salem.
Townships of: Danvers,
Essex, Ipswitch,
Lynnfield, Manchester,
Marblehead, Middletown,
Nahant, Rockport,
Saugus, Swampscott,
Topsfield, and Wenham.
Middlesex County (part):
Cities of: Marlborough,
Melrose, Newton, and
Woburn. Townships of:
Acton, Arlington,
Ashland, Bedford,
Belmont, Boxborough,
Burlington, Concord,
Framingham, Holliston,
Hopkinton, Hudson,
Lexington, Lincoln,
Maynard, Natick, North
Reading, Reading,
Sherborn, Stoneham,
Stow, Sudbury,
Wakefield, Watertown,
Wayland, Wilmington,
and Winchester.
Norfolk County (part):
Townships of: Avon, ............................ ............................ ............................ ............................
Braintree, Brookline,
Canton, Cohasset,
Dedham, Dover,
Holbrook, Medfield,
Millis, Milton,
Needham, Norfolk,
Norwood, Randolph,
Sharon, Stoughton,
Walpole, Wellesley,
Westwood, and Weymouth.
Plymouth County:
City of Brockton. Townships
of: Abington, Bridgewater,
Duxbury, East Bridgewater,
Hanover, Hanson, Hingham,
and Hull..
AQCR 120 Metropolitan Providence ............................ Unclassifiable/Attainment... ............................ ............................
Interstate.
Barnstable County (part):
Townships of:
Barnstable, Bourne,
Brewster, Chatham,
Dennis, Eastham,
Falmouth, Harwich,
Mashpee, Orleans,
Provincetown, Sandwich,
Truro, Wellfleet, and
Yarmouth.
Bristol County (part)
Cities of: Attleboro, ............................ ............................ ............................ ............................
Fall River, New
Bedford, and Taunton.
Townships of: Acushnet,
Berkley, Dartmouth,
Dighton, Fairhaven,
Freetown, Mansfield,
North Attleborough,
Norton, Raynham,
Rehoboth, Seekonk,
Somerset, Swansea, and
Westport.
Dukes County (part):
Townships of: Chilmark, ............................ ............................ ............................ ............................
Edgartown, Gay Head,
Gosnold, Oak Bluffs,
Tisbury, and West
Tisbury.
Norfolk County (part):
Townships of: ............................ ............................ ............................ ............................
Bellingham, Foxborough,
Franklin, and Wrenton.
Plymouth County (part):
Townships of: Carver,
Halifax, Kingston,
Lakeville, Marion,
Mattapoisett,
Middleborough,
Plymouth, Plympton,
Rochester, and Warham.
Worcester County (part) Milford
Township.
AQCR 121 Merrimack Valley-S New ............................ Unclassifiable/Attainment... ............................ ............................
Hampshire.
[[Page 2926]]
Essex County (part):
Townships of: Andover,
Amesbury, Boxford,
Georgetown, Groveland,
Haverhill, Lawerence,
Merrimac, Methuen,
Newbury, Newburyport,
North Andover, Rowley,
Salisbury, and West
Newbury.
Middlesex County (part):
Townships of: Ayer,
Billerica, Carlisle,
Chelmsford, Dracut,
Dunstable, Groton,
Littleton,
Pepperell,Tewksbury,
Tyngsborough, and
Westford.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\This date is November 15, 1990, unless otherwise noted.
[FR Doc. 96-1589 Filed 1-29-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-1588 Air Quality Designations: Deletion of TSP Designations From New Jersey, New York, Puerto Rico and Virgin Islands
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2939-2941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1588]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 81
[Region II Docket No.147; NJ24-1-7249a, FRL-5404-8]
Air Quality Designations: Deletion of TSP Designations From New
Jersey, New York, Puerto Rico and Virgin Islands
AGENCY: Environmental Protection Agency (EPA).
[[Page 2940]]
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is removing all total suspended particulate (TSP) area
designations in New Jersey, New York, Puerto Rico and the Virgin
Islands because they are no longer relevant. EPA promulgated revised
prevention of significant deterioration (PSD) increments for
particulate matter so that the PSD increments are now measured in terms
of particulate matter with an aerodynamic diameter less than 10 microns
(PM10) instead of TSP. Section 107(d)(4)(B) of the Clean Air Act
(Act) authorizes EPA to eliminate all area TSP designations once the
PSD increments for PM10 are promulgated.
DATES: This rule is effective on April 1, 1996 unless adverse or
critical comments are received by February 29, 1996. If the effective
date is delayed, timely notice will be published in the Federal
Register.
ADDRESSES: All comments should be addressed to: William S. Baker,
Chief, Air Programs Branch, Environmental Protection Agency, Region II
Office, 290 Broadway, New York, New York 10007-1866.
Copies of the documents relevant to this action are available for
inspection during normal business hours at the following address:
Environmental Protection Agency, Region II Office, Air Programs Branch,
290 Broadway, 20th Floor, New York, New York 10007-1866.
FOR FURTHER INFORMATION CONTACT: Kirk J. Wieber, Air Programs Branch,
Environmental Protection Agency, 290 Broadway, 20th Floor, New York,
New York 10007-1866, (212) 637-4249.
SUPPLEMENTARY INFORMATION:
Background
In 1971, EPA promulgated primary and secondary National Ambient Air
Quality Standards (NAAQS) for particulate matter to be measured as TSP.
Based upon better health effects information, on July 1, 1987 (52 FR
242634), EPA replaced the TSP NAAQS for particulate matter with a
PM10 standard. On the same date, EPA promulgated final regulations
under 40 CFR part 51 for state implementation of the revised NAAQS (52
FR 24672). In the preamble to that action, EPA announced that, because
of the importance of the section 107 area designations to the
applicability of the PSD increments for TSP, it would retain the TSP
designations beyond the date on which EPA approves a state's revised
PM10 State Implementation Plan (SIP). This would protect the
applicability of the PSD increments for TSP until a PSD increment for
PM10 could be established.
The 1990 Amendments to the Act contained several pertinent
provisions relating to or affecting the TSP area designations. Under
section 107(d)(4)(B) of the amended Act, Congress established by
operation of law the first nonattainment area designations for
PM10, and mandated that areas not initially defined as
nonattainment are considered to be unclassifiable.
Moreover, section 107(d)(4)(B) provided that any designation for
particulate matter (measured in terms of TSP) that the Administrator
promulgated prior to the date of enactment of the 1990 Amendments shall
remain in effect for purposes of implementing the maximum allowable
concentrations of particulate matter (measured in terms of TSP) PSD
increments until the Administrator determines that such designation is
no longer necessary for that purpose.
On June 3, 1993 (58 FR 31622), under the authority of section
166(f) of the Act, EPA published the final rulemaking replacing the PSD
increments for TSP with equivalent PSD increments for PM10, which
became effective on June 3, 1994. As announced in the June 3, 1993
Federal Register notice, EPA intends to eliminate the TSP area
designations from states and territories where the Federal PSD program
is in effect. EPA has the legal responsibility for implementing the PSD
program in New Jersey, New York, Puerto Rico, and the Virgin Islands
pursuant to 40 CFR 52.1603, 52.1689, 52.2729, 52.2779, respectively.
However, EPA has delegated the day-to-day PSD program administration to
the states of New Jersey and New York. The delegation agreement
provides for automatic adoption of the PSD increments for PM10
once the increments became effective.
Conclusion
In accordance with the information provided above, the states
affected by today's rule do not have PSD regulations which have been
approved by the EPA under the applicable implementation plan. Instead,
the PSD regulations contained in 40 CFR 52.21 (the Federal PSD program)
govern the review and approval of permits to construct and operate
major stationary sources in these areas. Pursuant to section 166(b) of
the Act, the new PSD increments for PM10 became effective on June
3, 1994--one year after promulgation. Accordingly, EPA is today
deleting from the list of area designations in 40 CFR part 81, all of
the designations for TSP in New Jersey, New York, Puerto Rico, and the
Virgin Islands. Area designations which indicate the attainment status
of each affected area with respect to the PM10 NAAQS already exist
(56 FR 56694, November 1991), and the TSP area designations are no
longer needed.
Nothing in this rule should be construed as permitting or allowing
or establishing a precedent for any future request for revision to any
applicable implementation plan. Each request for revision to any SIP
shall be considered separately in light of specific technical,
economic, and environmental factors and in relation to relevant
statutory and regulatory requirements.
EPA is publishing this rule without prior proposal because EPA
views this as a noncontroversial amendment and anticipates no adverse
comments. However, in a separate document in this Federal Register
publication, the EPA is proposing to approve the SIP revision should
adverse or critical comments be filed. Thus, this direct final action
will be effective April 1, 1996 unless, by February 29, 1996, adverse
or critical comments are received.
If the EPA receives such comments, this rule will be withdrawn
before the effective date by publishing a subsequent notice that will
withdraw the final action. All public comments received will then be
addressed in a subsequent final rule based on this action serving as a
proposed rule. The EPA will not institute a second comment period on
this action. Any parties interested in commenting on this rule should
do so at this time. If no adverse comments are received, the public is
advised that this rule will be effective April 1, 1996. (See 47 FR
27073 and 59 FR 24059).
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. 5 U.S.C. 603 and 604.
Alternatively, EPA may certify that the rule will not have a
significant impact on a substantial number of small entities. Small
entities include small businesses, small not-for-profit enterprises,
and government entities with jurisdiction over populations of less than
50,000. The deletion of TSP tables in part 81 does not create any new
requirements.
Under section 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to state, local, or tribal governments in the
[[Page 2941]]
aggregate; or to the private sector, of $100 million or more. Under
section 205, EPA must select the most cost-effective and least
burdensome alternative that achieves the objectives of the rule and is
consistent with statutory requirements. Section 203 requires EPA to
establish a plan for informing and advising any small governments that
may be significantly or uniquely impacted by the rule.
EPA has determined that the deletion of no longer applicable TSP
tables does not include a Federal mandate that may result in estimated
costs of $100 million or more to either state, local, or tribal
governments in the aggregate, or to the private sector.
The Office of Management and Budget has exempted this action from
review under Executive Order 12866.
Under section 307(b)(l) of the Act, petitions for judicial review
of this rule must be filed in the United States Court of Appeals for
the appropriate circuit within 60 days from date of publication. Filing
a petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed and shall not postpone the effectiveness of such
rule or action. This rule may not be challenged later in proceedings to
enforce its requirements. (See 307(b)(2).)
List of Subjects in 40 CFR Part 81
Environmental protection, Air pollution control, Particulate
matter.
Dated: December 18, 1995.
Jeanne M. Fox,
Regional Administrator.
Part 81, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:
PART 81--[AMENDED]
1. The authority citation for part 81 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
Sec. 81.331 New Jersey
2. In Sec. 81.331 the table entitled ``New Jersey--TSP'' is
removed.
Sec. 81.333 New York
3. In Sec. 81.333 the table entitled ``New York--TSP'' is removed.
Sec. 81.355 Puerto Rico
4. In Sec. 81.355 the table entitled ``Puerto Rico--TSP'' is
removed.
Sec. 81.356 Virgin Islands
5. In Sec. 81.356 the table entitled ``Virgin Islands--TSP'' is
removed.
[FR Doc. 96-1588 Filed 1-29-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-1584 Food Additives Permitted for Direct Addition to Food for Human Consumption; Olestra
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 3118-3173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1584]
[[Page 3117]]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 172
Food Additives Permitted for Direct Addition to Food for Human
Consumption: Olestra; Final Rule
Federal Register / Vol. 61, No. 20 / Tuesday, January 30, 1996 /
Rules and Regulations
[[Page 3118]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. 87F-0179]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Olestra
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of sucrose esterified
with medium and long chain fatty acids (olestra) as a replacement for
fats and oils. This action is in response to a petition filed by the
Procter & Gamble Co.
DATES: The regulation is effective January 30, 1996. Submit written
objections and requests for a hearing by February 29, 1996. Submit
written comments on the labeling requirement (Sec. 172.867(c)) by April
1, 1996. The Director of the Office of the Federal Register approves
the incorporations by reference in accordance with 5 U.S.C. 552(a) and
1 CFR part 51 of certain publications at 21 CFR 172.867, effective
January 30, 1996.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Helen R. Thorsheim, Center for Food
Safety and Applied Nutrition (HFS-216), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3092.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
A. Safety Testing--Background
1. Legal Context of the Safety Evaluation
2. Dietary Context of the Safety Evaluation
B. Toxicological Studies--Overview
C. Nutritional Impact Studies--Overview
D. GI Effects--Overview
E. FDA's Decision Process
II. Identity and Use
A. Manufacturing Processes
B. Constituents
C. Specifications
D. Stability
E. Use and Intended Technical Effect
F. Estimated Daily Intake for Olestra (EDI)
III. Toxicity Data--Discussion and Evaluation
A. Absorption, Distribution, Metabolism, and Elimination.
1. Rat Studies
2. Guinea Pig Studies
3. Mini-Pig Studies
B. Genetic Toxicity Studies
C. Animal Toxicity Studies
1. Teratogenicity studies
2. Subchronic and chronic feeding studies
a. Ninety-day subchronic olestra feeding study in rats
b. Two-year carcinogenicity studies in rats
c. Two-year chronic toxicity and carcinogenicity studies in mice
d. Dog feeding studies
D. Toxicology summary
IV. Effect of Olestra on Absorption of Drugs
A. Effect of Olestra on the Absorption of Selected Lipophilic Drugs
(EC-40)
B. Effect of Olestra on the Absorption of Selected Lipophilic Drugs
(EC-41)
C. Effect of Olestra on Drug Bioavailability (EC-42)
D. Effect of Olestra on the Systemic Levels of Steroidal Hormones
in Women Taking Oral Contraceptives (EC-51)
E. Summary
V. Nutritional Studies
A. Issues Associated with Olestra
B. Effects of Olestra on Fat-Soluble Vitamins
1. Primary Human Studies
a. Eight-week DR study design
b. Eight-week VR study design
c. Results and conclusions from primary human studies
i. Vitamin A
ii. Vitamin E
iii. Vitamin D
iv. Vitamin K
v. Carotenoids
2. Other Human Studies
a. Six-week vitamin D/K study
b. Sixteen-week vitamin E study
c. Vitamin A/Fat Study
3. Pig Studies
a. Study design of the 12-, 26-, and 39-week studies
i. Twelve-week DR Study
ii. Twelve-week VR Study
iii. Twenty-six week DR/VR Study
iv. Thirty-nine week VR Study
b. Study design of the 4-week DC study
c. Results and conclusions from pig studies
i. Vitamin A
ii. Vitamin E
iii. Vitamin D
a. Petitioner conclusions
b. FDA Conclusions
iv. Vitamin K
4. Overall Conclusions Regarding Olestra's Effects on Fat-Soluble
Vitamins
a. Consumption scenarios
b. Vitamin A
c. Vitamin E
d. Vitamin D
e. Vitamin K
i. Petitioner conclusions
ii. FDA conclusions
f. Carotenoids
i. Data and information regarding carotenoids
ii. FDA's evaluation of olestra's effects on carotenoids
C. Effects of Olestra on Water-Soluble Nutrients that are Hard-to-
Absorb or Limited in Diet
1. Results and Conclusions from Human Studies
a. Vitamin B12
b. Iron
c. Folate
d. Zinc
2. Results and Conclusions from Pig Studies
a. Vitamin B12
b. Iron
c. Folate
d. Zinc-
e. Calcium
3. Overall Conclusions Regarding Olestra's Effects on Water-Soluble
Nutrients
a. Vitamin B12
b. Folate and Iron
c. Zinc
d. Calcium
VI. Effect of Olestra on the Gastrointestinal (GI) Tract
A. Introduction
B. Effect of Olestra on GI Symptoms
1. Study of GI Symptoms in 8-week Studies in Normal Subjects
a. Petitioner's evaluation of GI symptoms
b. FDA's evaluation of the GI symptoms
2. GI Symptoms in the Oil Loss Study
a. Effect of olestra stiffness on passive oil loss
b. Effect of olestra stiffness on OIT
c. Effect of olestra stiffness on GI symptoms
3. Study of Selected Fecal Parameters in Subjects Consuming Olestra
a. Study design
b. Petitioner conclusions
C. FDA Conclusions
4. Study in Patients with Inflammatory Bowel Disease
5. GI Symptoms in Young Children
C. Effect of Olestra on Intestinal Microflora Metabolism
1. Effect of Olestra on Breath Gas and Microflora-Associated
Characteristics
2. Potential for Intestinal Microflora to Metabolize Olestra
D. Effect of Olestra on Bile Acid Metabolism
E. Overall Conclusions on Effects on the GI Tract
[[Page 3119]]
VII. Labeling of Foods Containing Olestra
A. Labeling Authority
B. Labeling with Respect to GI Effects
C. Labeling with Respect to Effects on Nutrients
D. FAC Discussions Regarding Labeling
1. GI Effects
2. Fat-Soluble Vitamins and Carotenoids
E. Agency Conclusions Regarding Labeling of Foods Containing
Olestra
VIII. Response to Comments
A. Comments on Procedures
B. Substantive Comments
IX. Environmental Impact Considerations
X. FDA's Overall Conclusions
XI. Administrative Record and Inspection of Documents
XII. Objections
XIII. References
I. Introduction
Olestra, also called sucrose polyester, is the common name for a
mixture of substances formed by chemical combination of sucrose with
six, seven, or eight fatty acids. The fatty acids, bound to sucrose by
ester bonds, are of the type commonly found in edible oils and fats.
Olestra has physical properties similar to those of natural fats.
Olestra's particular physical properties depend on the specific fatty
acids used and the degree of esterification.
The Procter & Gamble Co., 6071 Center Hill Rd., Cincinnati, OH
45224-1703 (the petitioner), submitted a petition to FDA on April 15,
1987, for the use of olestra in shortenings and oils as a calorie-free
replacement for fats and oils. The petition (FAP 7A3997) was filed on
May 7, 1987. In a notice in the Federal Register of June 23, 1987 (52
FR 23606), FDA announced that the food additive petition had been filed
by Procter & Gamble, proposing the issuance of a food additive
regulation providing for the safe use of sucrose esterified with medium
and long chain fatty acids as a replacement for fats and oils. On July
6, 1990, the petitioner amended the petition to limit the intended use
of olestra to a 100 percent replacement for conventional fats in the
preparation of savory snacks (i.e., snacks that are salty or piquant
but not sweet, such as potato chips, cheese puffs and crackers). During
the course of the petition evaluation, the petitioner also amended the
proposed specifications that describe the additive.
In the Federal Register of October 17, 1995 (60 FR 53740), FDA
announced that a public meeting of the agency's Food Advisory Committee
(the FAC) and a working group of the FAC would be held on November 14
through 17, 1995. The working group was asked to discuss and comment on
whether all relevant issues associated with olestra had been addressed
(Ref. 1). The discussion covered all aspects of the safety review of
olestra, including nutrient effects and compensation, gastrointestinal
effects, and labeling (Ref. 2\1\).
\1\The transcript of the Olestra Working Group and full Food
Advisory Committee meetings are provided as reference. Throughout
the preamble to this final rue, reference is made to comments of
Committee members and presenters to the Committee; footnotes
indicate the transcript volum and page numbers of these. The
affiliation and credentials of the commenter are also described.
---------------------------------------------------------------------------
In the Federal Register of November 16, 1995 (60 FR 57586), FDA
announced that it would consider public comments on the petition,
including comments on the proceedings before the FAC, only if filed on
or before December 1, 1995. This action allowed the agency to identify
precisely which data and information to consider in making its decision
on the petition. This measure was necessary to facilitate the agency's
decision making process and to come to closure on the petition. By
letter dated December 8, 1995, FDA extended to December 21, 1995, the
time by which such comments could be submitted. This extension was in
response to a request of the Center for Science in the Public Interest
(CSPI).\2\
\2\On October 25, 1995, CSPI submitted a comment to the olestra
petition entitiled ``White Paper on Olestra'' (the White Paper).
(CSPI subsequently submitted revised versions of the White Paper on
November 2 and 3, 1995.) The November 3, 1995, White Paper was
provided to the Olestra Working Group and FAc members for
consideration at the meetins of November 14-17, 1995 (Ref.3). In
addition, the authors of the White Paper, Drs. Myra Karstadt and
Michael Jacobson, presented data from the White Paper on all of the
issues covered in the White Papers, namely, (1) consumption
estimates, (2) effect of olestra on carotenoids, (3) effect of
supplementation of olestra with vitamin K on coumadin therpay, (4)
effect of olestra on GI symptoms, and (5) animal carcinogenicity
studies.
---------------------------------------------------------------------------
A. Safety Testing-Background
1. Legal Context of the Safety Evaluation
Section 409 of the act (21 U.S.C. 348), sets forth the statutory
requirements for approval of a food additive (21 U.S.C. 321(s)). With
the enactment of the Food Additives Amendment of 1958 (the Amendment),
Congress established a premarket approval system whereby the company
seeking to market a food additive must first obtain approval from FDA.
Through this mechanism, Congress sought to shield the public from
unsafe or potentially unsafe products.
Under section 409(c)(3) of the act, 21 U.S.C. 348(c)(3), FDA is not
to approve a food additive petition ``* * * if a fair evaluation of the
data before the Secretary\3\ * * * fails to establish that the proposed
use of the food additive, under the conditions of use to be specified
in the regulation, will be safe * * *. This provision is commonly
referred to as the ``general safety clause.''
\3\This decision has been delegated to the Commissioner of Food
and Drugs, 21 CFR 5.10(a)(1).
---------------------------------------------------------------------------
By requiring that the data concerning a food additive ``establish''
safety, Congress squarely placed the burden of proving safety on the
sponsor of a food additive petition, in this case Procter & Gamble. FDA
need not prove that the additive is unsafe in order to deny approval.
The term ``safe'' is not defined in the act itself. The legislative
history of the Amendment makes clear, however, that a demonstration of
absolute harmlessness is not required to sustain the approval of a food
additive:
Safety requires proof of a reasonable certainty that no harm
will result from the proposed use of an additive. It does not-- and
cannot--require proof beyond any possible doubt that no harm will
result under any conceivable circumstance. This was emphasized
particularly by the scientific panel which testified before the
subcommittee. The scientists pointed out that it is impossible in
the present state of scientific knowledge to establish with complete
certainty the absolute harmlessness of any chemical substance.
H. Rept. No. 2284, 85th Cong., 2d sess. 4-5 (1958). Accord: S. Rept.
No. 2422, 85th Cong., 2d sess. 2 (1958). FDA regulations incorporate
the concept of safety articulated in the Amendment's legislative
history. 21 CFR 170.3(i). (``Safe'' means that ``* * * there is a
reasonable certainty in the minds of competent scientists that the
substance is not harmful under the intended conditions of use.'')
Although the concept of ``harm'' is central to the act's safety
standard, neither the statute, nor regulations implementing the food
additive provisions, define harm. Once again, however, congressional
intent is clear from the legislative history of the amendment.
Specifically, ``harm'' means the capacity to injure or otherwise damage
the health of individuals consuming the additive.+
The concept of safety used in this legislation involves the
question of whether a substance is hazardous to the health of man or
animal.
H. Rept. No. 2284, 85th Cong., 2d sess. 4 (1958). See also Letter from
Assistant Secretary of Health, Education, and Welfare Elliot L.
Richardson to Congressman Lister Hill, Chairman,
[[Page 3120]]
Senate Committee on Labor and Human Resources, dated July 29, 1958.
(``* * * in our opinion the bill is aimed at preventing the addition to
the food our people eat of any substances the ingestion of which would
expect to produce not just cancer but any disease or disability.'')
The concept of harm was discussed during the Olestra Working Group
and FAC meetings. One FAC member expressed the opinion that he would
consider an effect that is undesirable as harmful or adverse\4\.
However, the legislative history reflects that an effect is harmful if
it affects health, not if it is simply an undesirable or unexpected
effect that has no adverse health consequences.
\4\Statement of Dr. Dennis Hsieh. Dr. Hsieh is a professor of
environmental toxicology at the University of California at Davis.
Transcript of the November 14 to 17, 1995, meeting of FAC
(hereinafter Transcript), vol. 3, p. 40.
---------------------------------------------------------------------------
The statute leaves the methods and criteria for interpreting data
up to the discretion and expertise of the agency. Congress did,
however, direct FDA to consider the following three factors:
(A) The probable consumption of the additive and of any substance
formed in or on food because of the use of the additive;
(B) The cumulative effect of such additive in the diet of man or
animals, taking into account any chemically or pharmacologically
related substance or substances in such diet; and
(C) Safety factors which in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food
additives are generally recognized as appropriate for the use of animal
experimentation data. (21 U.S.C. 348(c)(5).)
In the case of olestra, the product's broad marketing potential and
expected consumption by persons of all ages, including children, are
aspects that have been considered in the safety evaluation.
Importantly, Procter & Gamble is not required to show, nor is FDA
permitted to consider, that olestra has benefits, health or otherwise,
for consumers of the additive. Again, the legislative history of the
Amendment is clear on this point.
The question of whether an additive produces such [a technical]
effect (or how much of an additive is required for such an effect)
is a factual one, and does not involve any judgement on the part of
the Secretary of whether such effect results in any added 'value' to
the consumer of such food or enhances the marketability from a
merchandising point of view.
S. Rept. No. 2422, 85th Cong., 2d sess. 7 (1958). Accord: H. Rept. No.
2284, 85th Cong., 2d sess. 6 (1958).
In summary, the general safety clause places on Procter & Gamble
the burden of proving that a fair evaluation of the data in the
administrative record establishes that there is a reasonable certainty
that olestra will not be harmful under the prescribed conditions of
use. Only if Procter & Gamble meets this burden can the food additive
be approved.
2. Dietary Context of Safety Evaluation
Olestra presents a different set of safety issues compared to most
food additives. For example, most substances can induce toxic effects
provided that the dose administered is sufficiently high. The primary
purpose of most safety testing is to determine the toxic dose and to
evaluate whether there is a sufficient margin of safety between the
highest dose that is not toxic and the expected human exposure.
Because olestra is intended to substitute for fat, a substantial
component of the diet, it is difficult, if not impossible, to feed
olestra to laboratory animals in amounts sufficiently high to allow use
of the 100-fold safety factor that is commonly used to ensure safety
(21 CFR 170.22), when evaluating animal studies. The use of a safety
factor is intended to account for the uncertainty of extrapolating from
toxicity data from animals to humans. (See 21 U.S.C. 348(c)(5)(c).) FDA
concludes that in the case of the olestra petition, the agency is
justified in not using the 100-fold safety factor for the following
reasons. First, no toxic effects from olestra consumption were observed
when olestra was fed atpara.levels up to 10 percent of the diet of
laboratory animals (as discussed in section III. of this document).
Second, olestra is not appreciably absorbed by the body and the
minuscule amount of material that is absorbed is metabolized to
substances (sucrose and fatty acids) that are further metabolized
normally in the body. Thus, no major component of olestra is available
to produce a toxic effect. Finally, a significant number of human
studies have been performed to assess the safety of olestra, which
assessment may be performed without the need for a safety factor.
The fact that olestra is not absorbed also means, however, that as
food components are absorbed from the intestine, the amounts of olestra
present in the intestine will become an increasingly larger fraction of
the total intestinal contents. Thus, the safety issues for olestra are
focused on effects in the intestine, including potential interference
with absorption of nutrients.
The petitioner completed the standard toxicological testing program
to demonstrate safety for a direct food additive, as outlined in FDA's
guidance on such testing (Ref. 4). However, to account for the possible
variations in composition, effects on composition due to heating, and
inherent difficulties in extrapolating from laboratory animals to
humans, the initial animal tests have been supplemented with a variety
of human and additional animal studies taking into account the
properties of olestra. In fact, since the original petition was
submitted inpara.1987, Procter & Gamble has submitted more than 50
additional safety studies for review. In 1992 and 1993, the pivotal
safety studies with regard to nutritional effects from the petitioned
use of olestra were submitted.
B. Toxicological Studies--Overview
The petition submitted to FDA consists of data and information from
toxicity studies in several animal species, including the rat, mouse,
dog, and rabbit. The toxicity data base includes a battery of three
mutagenicity/genotoxicity tests; subchronic feeding studies in mice,
rats, hamsters, and dogs; and reproduction/teratology testing in the
rat and rabbit. To determine whether olestra affects the structure and
function of the gastrointestinal (GI) tract, a series of absorption,
distribution, metabolism, and elimination (ADME) studies were conducted
in rats, mini-pigs, and guinea pigs.
C. Nutritional Impact Studies--Overview
The limited digestibility of olestra poses a number of nutrition
issues, including olestra's effect on fat-soluble vitamins and whether
these effects could be compensated for by the addition of an
appropriate amount of the affected vitamins. As a result, the
petitioner conducted several studies, including those listed below, in
both pigs and humans. Procter & Gamble conducted studies in swine
because they have a digestive system similar to humans and can be
evaluated for nutrient stores in the liver and bone. Five of the
studies that were carried out in swine are: (1) a 12-week dose-response
study (the 12-week DR study) of olestra on the status of
vitaminspara.A, D, E, and K, and on hard-to-absorb and limited-in-diet
nutrients; (2) a 12-week vitamin restoration study (the 12-week VR
study) to determine levels of vitamins A, D, and E needed to offset
olestra effects; (3) a 26-week dose-response and vitamin restoration
study (the 26-week DR/VR study) to extend
[[Page 3121]]
the findings of the 12-week DR and 12-week VR studies to longer times
and lower olestra intake levels; (4) a 39-week study (the 39-week VR
study) to confirm the effects of 0.25 percent olestra and added vitamin
A and E measured in the 26-week DR/VR study over a longer exposure
time; and (5) a 4-week dietary context study (the 4-week DC study) to
compare olestra's effects on vitamins A and E when olestra is consumed
either with the diet or between meals.
Procter & Gamble conducted studies of olestra in humans to
eliminate any uncertainty related to extrapolating from pigs and to
obtain subject reports on gastrointestinal effects. Those objectives
were pursued in several human studies including: Two clinical studies,
two studies in free-living subjects,\5\ and one short-term study
designed to assess olestra's effect on vitamin A and fat absorption
(the vitamin A/fat study). The two human clinical studies were an 8-
week study to determine the dose response of olestra on the status of
vitamins A, D, E, and K, and on hard-to-absorb and limited-in-diet
nutrients (the 8-week DR study) and an 8-week study to confirm the
compensation levels for vitamins A and E (the 8-week VR study). The
free-living studies were a 16-week study to assess the status of
vitamin E in subjects consuming 18 grams/day (g/d) olestra (the 16-week
vitamin E study) and a 6-week study to determine the effect of 20 g/d
olestra on vitamins D and K (the 6-week vitamin D/K study).
\5\Free-living subjects maintain their normal diets and eating
patterns except for consumption of the test article as instructed.
---------------------------------------------------------------------------
D. GI Effects--Overview
The petitioner performed several studies to evaluate olestra's
effects on the gastrointestinal (GI) tract including the following. The
two clinical studies (the 8-week DR and 8-week VR studies) were used to
evaluate adverse gastrointestinal effects as reported by the test
subjects. In addition, the effect of olestra on intestinal microflora
was measured by conducting a breath gas expiration study. Several
studies were also conducted to evaluate olestra's effects on bile acid
metabolism and absorption. In order to determine olestra's effects, if
any, in an at-risk population, studies were conducted in inflammatory
bowel disease patients. Because some drugs are lipophilic (fat-soluble)
and may partition into (i.e., be partially absorbed by) olestra,
olestra's potential to affect absorption of drugs was also
investigated. In addition, because nonabsorbable liquid oil can
separate from other fecal material in the colon and leak through the
anal sphincter, a human clinical study was performed to determine the
relationship between olestra's stiffness and passive oil loss.
E. FDA's Decision Process
In light of the novel issues raised by the review of the olestra
data, FDA's Center for Food Safety and Applied Nutrition (CFSAN)
determined that it would be valuable to obtain additional expertise in
resolving certain issues that had been raised. A Regulatory Decision
Team (RDT) composed of senior FDA managers was established for the
purpose of recommending, to the Director of CFSAN, a decision on the
olestra food additive petition. In addition, FDA retained the services
of several scientific consultants from outside the agency to facilitate
the agency's deliberations.
As is the case with all food additive petitions, the olestra data
were reviewed by staff scientists. Because of the large number of
studies and the diverse nature of the information, each of these
scientists reviewed a portion of the total body of data on the
additive, focusing on his particular area of expertise. These staff-
level reviews, including any questions or issues raised by such
reviews, were subsequently considered by the RDT, assisted by the
outside consultants. In the RDT deliberations, an overall Center
position on olestra's safety was synthesized; in the process, issues
raised by individual reviewers were resolved, were determined to be not
significant, or were incorporated into the synthesized position. During
this deliberative process, the members of the RDT weighed the various
pieces of scientific information and applied their scientific judgement
as they developed an overall Center position.
After the conclusion of the RDT deliberations and the meetings with
consultants from outside the agency, FDA convened a public meeting of
its FAC and a special Olestra Working Group of the FAC on November 14
through 17, 1995, to undertake a scientific discussion of the agency's
evaluation of the safety data in the petition. The membership of the
standing Committee was supplemented with temporary members and
consultants to the Committee, representing scientific disciplines
appropriate to the evaluation of a macro-ingredient fat substitute.
At the Olestra Working Group meeting, Procter & Gamble presented a
summary of the data it considered adequate to establish the safety of
olestra, the experts with whom the agency had consulted presented their
views on the sufficiency of the information to assess the safety of
olestra, interested members of the public presented their opinions and
evaluations of the data, and FDA presented its evaluation of the data.
The Committee was asked to assess, in light of the state of the science
relative to macro food ingredients, whether all critical safety issues
with respect to the use of olestra in savory snack foods had been
addressed.
As set out in detail below, having completed its evaluation of the
data in the petition and having considered the deliberations of the
Olestra Working Group and the FAC, including all presentations to the
Committee, and the comments received on the petition, the agency is
amending the food additive regulations to permit the use of olestra in
place of fats and oils in prepackaged ready-to-eat savory snacks.
II. Identity and Use
Olestra is the common name for the mixture of sucrose esters formed
from the addition of six, seven, or eight fatty acids to the available
eight free hydroxyl moieties of sucrose. Saturated and unsaturated
fatty acids of chain length C12 to C20 and higher can be used to
manufacture olestra. The final product is defined by specifications
which include the fatty acid composition.-
The identity of sucrose octaester as the principal component of
olestra has been verified by infrared, mass, and nuclear magnetic
(proton and 13carbon) spectrometry (Ref. 5). The generalized structure
for olestra is set forth below.
BILLING CODE 4160-01-F
[[Page 3122]]
[GRAPHIC][TIFF OMITTED]TR30JA96.000
BILLING CODE 4160-01-C
[[Page 3123]]
A. Manufacturing Processes
Olestra is prepared by the addition of medium- and long-chain fatty
acid methyl esters to sucrose in the presence of catalysts. The
postsynthesis purification steps are the same as those generally
practiced in the edible oils industry. These purification steps depend
upon physical separations and do not involve chemical bond
rearrangement or the use of solvents or catalysts.
The methyl esters used to prepare olestra can be obtained by
procedures common in the food industry such as the reaction of refined
triglyceride oils with methanol in the presence of sodium methoxide or
from esterification of their fatty acids. The resulting esters are
washed with water to remove residual methanol, dried under vacuum, and
distilled. The fats and oils can be derived from a variety of edible
sources such as, but not limited to, soybean, palm, coconut, fully
hydrogenated rapeseed, and cottonseed.
Sucrose and the methyl esters are mixed with an alkali metal soap
of a long-chain fatty acid. A small amount of transesterification
catalyst such as an alkali metal (sodium or potassium) carbonate,
bicarbonate, hydride, or alkoxide is added and the mixture heated under
vacuum to withdraw the volatile methanol byproduct. Following the
reaction, excess methyl esters and free methanol are removed by
evaporation under vacuum. Standard steam deodorization removes free
fatty acids and odors. Different lots of olestra may be mixed to
achieve desired properties or to meet product specifications.
The manufacture of olestra can be well controlled, based upon the
petitioner's analysis of representative lots (Ref. 5).
B. Constituents
The principal trace constituents of olestra are collectively
identified as the unsaponifiable fraction, ranging in concentration
from 0.08 percent to 0.3 percent. These constituents are primarily
aliphatic hydrocarbons and plant sterols that naturally arise from the
edible triglyceride sources of fatty acids used in the synthesis of
olestra. In this respect, these trace constituents of olestra do not
differ from those found in typical edible oils. Additionally, difatty
ketones (DFK's), formed during its manufacture, are found as trace
constituents in olestra as consumed.
DFK's form in olestra during the alkaline rearrangement
manufacturing process. The DFK's that are present in olestra are a
family of compounds with a common general structure consisting of two
fatty acid chains with a central keto group. They are formed from
naturally occurring vegetable oil-derived fatty acids used to make
olestra. The length and degree of unsaturation of the fatty acid chains
are determined by the source oil used to make olestra.
Quantitative analysis of olestra by gas chromatography and mass
spectrometry of 15 typical lots of olestra determined that olestra
contains 36 to 416 parts per million (ppm) DFK's. The potential DFK
range of olestra was altered to 100 to 300 ppm when the method of
manufacture was updated. Qualitative analysis of soybean oil-based
olestra showed that the DFK's ranged from 31 to 35 carbons in length,
consistent with the predominance of C16 and C18 fatty acids
in soybean oil.
Identical analytical techniques showed that similar types
(C29-C35 fatty acid chain length), but lower levels, of DFK
are found in vegetables (5 to 86 ppm), cooked meat fat (0.15 to 2.73
ppm), and food-approved emulsifiers (10 to 55 ppm). Historically, the
once-common commercial practice of rearranging fats and oils by base-
catalyzed methods produced levels of DFK that exceeded 300 ppm. These
results show that olestra is an additional dietary source of those
DFK's that are now, and have been, commonly consumed in the food supply
(Ref. 6).
C. Specifications
Olestra comprises a range of possible compositions that can be
identified by a three-dimensional matrix defined by: (1) Fatty acid
chain length; (2) the degree of fatty acid unsaturation; and (3) the
distribution of full and partial esters of olestra. The petitioner has
proposed specifications that include ranges for fatty acid chain length
and degree of unsaturation to ensure functional products for use in
savory snacks. The specified range of esterification ensures the
nonabsorbable and noncaloric nature of the product.
Traditional edible oil specifications that ensure purity and safety
also are incorporated into the olestra specifications. These values
include specifications for free fatty acid content, total methanol
residues, water, residue on ignition, peroxide value, total heavy metal
content, and lead.
D. Stability
Olestra is stable under ambient and high-temperature storage
conditions. In all cases, olestra is at least as stable as
triglycerides with similar fatty acid composition.
Polymers form in both olestra and triglycerides during cooking,
purification, or storage, when olestra or triglycerides are exposed to
heat, moisture, and air. The polymers, comprised almost entirely of
dimers and trimers, form by cross-linking at points of unsaturation on
the fatty acid chains. This mechanism of cross-linking in olestra is
the same as that which occurs in triglycerides. The amount of polymer
found in olestra is less than that found in a conventional edible oil
stored under identical, controlled conditions.
Typical bulk lots of olestra were demonstrated to be as stable as
triglycerides of similar fatty acid composition when stored at room and
elevated temperatures (120 F) for up to 1 month. These olestra batches
were found to be stable based upon the lack of significant change in
fatty acid composition, ester distribution, free fatty acid levels,
polymer levels, and oxidative stability (Ref. 7).
Heating food fats in the presence of moisture and air results in
the production of decomposition byproducts. Such byproducts are removed
regularly from commercial cookers to maintain an effective frying
system under good manufacturing practice. Use of olestra for frying
savory snacks will similarly lead to production of byproducts. The
petitioner conducted research to determine the extent of byproduct
production from olestra compared to conventional frying fats, and to
determine whether unique byproducts would be formed.
A variety of analytical techniques were employed to characterize
the profile of byproducts formed during the heating of olestra and
conventional frying fats. The gross identity of the heated products was
determined by standard methods such as fatty acid composition, carbon
number profile, and peroxide value. In addition, comprehensive analyses
of changes to the fatty acid side chains were undertaken. Fatty acids
were methylated by transesterification, isolated by silica gel column
chromatography or solid phase extraction, and analyzed by a variety of
techniques including gas chromatography (GC), GC/mass spectrometry
(MS), two-dimensional GC/MS, and high performance liquid chromatography
(HPLC). This battery of tests provided an analytical sensitivity to
detect a component present in the heated oil at a level of 17 ppm
(equivalent to 0.05 ppm in the diet of 90th percentile consumers of
olestra) (Ref. 8).
For both olestra and conventional frying fats (triglycerides), the
predominant chemical changes that occur under frying conditions are
[[Page 3124]]
oxidation reactions on the fatty acid side chains (Ref. 8). The
principal byproducts of frying are polymers (dimers and trimers) which
are joined primarily by bonds between unsaturated fatty acid
components. Both olestra and conventional fats of similar fatty acid
composition undergo a similar number of polymerization reactions under
common heating conditions. For example, the amount of polymer increased
0.003 mole/100 g for olestra and 0.004 mole/100 g for a triglyceride of
similar fatty acid composition.
Levels of olestra and triglyceride polymers absorbed into the
cooked foods under worst-case conditions are similar and show that
there is no selective concentration in food. For example, polymer
levels in food fried in either olestra or triglyceride ranged from 4 to
6 percent of total lipid weight. These values correspond to the
concentration of olestra and triglyceride polymer in the bulk heated
oil phases (Ref. 8).
Baking conditions do not degrade olestra or triglyceride as readily
as frying conditions, even though soda crackers commercially prepared
with olestra may experience temperatures ranging from 250 to 350
deg.F. This is because crackers are exposed to such temperatures for
only a few minutes (not hours), and the temperature within the body of
the cracker can be expected to be substantially lower than the oven
temperature.
This stability in baking assessment was confirmed when both olestra
and a triglyceride of similar fatty acid composition were used to
prepare soda crackers, and the crackers were baked for 6 minutes at the
more common commercial temperature of about 250 deg.F. The neat (i.e.,
prior to baking) olestra and triglyceride were analytically
characterized, and the profiles compared to those obtained from the
fats extracted after the soda crackers were baked.
Unlike during frying, neither olestra nor the triglyceride formed
any measurable polymer during the 250 F baking (Ref. 9.). Consistent
with a lack of change in polymer content, results demonstrate that
neither olestra nor the triglyceride experienced any significant change
in primary structural composition (i.e., ester distribution for
olestra; or the tri-, di-, or monoglyceride profile for the
triglyceride).
The only notable change in both olestra and the triglyceride was a
slight increase in free fatty acid content. This latter effect is
expected because free fatty acids may be present in the cracker raw
ingredients, and the alkaline chemical leavening agents used in soda
cracker production can promote ester hydrolysis. The similarity of
changes in olestra and triglycerides during soda cracker baking is
consistent with the fact that the chemical changes in both products
take place on the fatty acids, and yield the same decomposition
products.
To test stability during storage after baking, both olestra and a
triglyceride of similar fatty acid composition were used to make soda
crackers, unflavored plain crackers, and unflavored snack crackers. All
products were packed in air to reflect current market practice, aged
under controlled temperatures and time to reflect common and worst-case
storage conditions, and analyzed for parent, polymer, and decomposition
products. The results demonstrate that the stability of olestra and
triglyceride were comparable under the conditions studied (Ref. 9).
FDA concludes that use of olestra in frying media for savory snacks
results in neither more nor different byproducts of the frying process
than currently experienced with conventional oils. Also, olestra is as
stable as triglyceride in crackers during baking and in baked crackers
stored under expected and worst-case conditions.
E. Use and Intended Technical Effect
Olestra is proposed for use as a calorie-free replacement for up to
100 percent of the conventional fats and oils used in the preparation
of savory snacks such as flavored and unflavored chips and crisps,
flavored and unflavored extruded snacks, and crackers. These uses
include substitution for fat for frying as well as sources of fat in
dough conditioners, oil sprays, and flavors. Olestra will function in
savory snacks as a texturizer and as a formulation aid (21 CFR
170.3(o)) at levels not in excess of that reasonably required to
produce its intended effect.
F. Estimated Daily Intake for Olestra (EDI)
When conducting a food additive safety evaluation, FDA typically
uses estimated 90th percentile chronic intakes. The petitioner has
provided a study of probable intake for olestra, completed by the
Market Research Corporation of America (MRCA), that contains sufficient
information to estimate both chronic and acute exposures to olestra.
The MRCA methodology estimates the daily consumption of olestra
from savory snacks for individuals by combining: (1) The individual's
frequency of consumption of savory snacks; (2) the average amount eaten
per eating occasion of that savory snack; and (3) the amount of olestra
in that savory snack. Eating occasion frequencies were determined from
14-day dietary diaries that were kept by heads of household. The amount
of food eaten per eating occasion was derived from the USDA's
Nationwide Food Consumption Surveys. The amount of olestra in snacks
was determined in the petitioner's laboratories.
The MRCA survey data show that at the 90th percentile, the probable
lifetime-averaged intake of olestra is 6.4 g/p/d. FDA believes however,
that it is appropriate to consider energy needs in estimating the daily
intake of olestra. Based on the assumption that consumers of olestra
will compensate for calories ``lost'' due to consumption of olestra by
increasing their intake of food (including olestra-containing snacks),
the agency has concluded that the lifetime-averaged EDI for olestra
should be increased by 10 percent to 7.0 g/p/d (Ref. 10).
Any effects of olestra on nutrients or nutrient absorption could be
exhibited during less than chronic exposure conditions. To evaluate
sub-chronic conditions, FDA has estimated that a ``high'' acute
consumer of olestra (every day for 12 weeks) would consume 20 g/p/d,
equivalent to eating a 2-ounce (oz) bag of potato chips every day (Ref.
11). The MRCA survey information submitted by the petitioner shows that
the 99th-percentile, 14-day average intake for olestra would be 14.8 g/
p/d (corrected to 16.3 g/p/d for caloric compensation) in the 18 to 44
year old male group. The 99th-percentile single-day intake of olestra
for the group consuming the highest level of savory snacks (13 to 17
year old male group) is 40.4 g/p/d (corrected to 45 g/p/d). It is not
likely that this high single day intake would be repeated every day in
the 12-week time frame previously mentioned.
In terms of consumption patterns, the MRCA data also show that
approximately 9 percent of lunch and dinner meals include a snack food
that could potentially contain olestra. The data also show that 63
percent of snack food eating occasions occur with a meal.
Consumption estimates of olestra-containing savory snacks were
discussed at the Olestra Working Group and FAC meetings. In particular,
CSPI raised three concerns about these estimates. First, CSPI presented
several consumption scenarios to the Olestra Working Group\6\ that the
organization
[[Page 3125]]
asserted better represented expected olestra consumption. These
consumption estimates ranged from 4.2 g/p/d to 37.5 g/p/d. CSPI's
higher consumption estimates included an increase in consumption of
olestra-containing snacks over full-fat snacks; this increase was based
on the results of a telephone survey, which survey indicated that
people think they would eat 25 percent more snacks if the snacks
contained lower fat. Based on these scenarios, CSPI asserted that there
would likely be a substantial number of snack eaters consuming olestra
in quantities similar to those fed in the 8-week human studies (8, 20,
and 32 g/d).
\6\These CSPI comments were presented by Dr. Myra Karstadt,
Ph.D. Transcript, vol. 2, p. 49. This information is also discussed
in CSPI's White Paper (Ref. 3).
---------------------------------------------------------------------------
Second, CSPI asserted that consumers usually eat an entire bag of
chips at one sitting, and that bags marked ``single-serving'' typically
contain from three-quarters of an ounce to 2 ounces. Therefore, CSPI
claimed that in many cases, people would eat several ounces of chips at
one sitting, and that, in evaluating olestra's for GI effects, it is
important to consider single-sitting consumption levels.
Third, CSPI expressed concern that the MRCA survey population may
not represent the most vulnerable high-volume consumers of snack
products, such as minority teenagers resident in low socioeconomic
areas, who may both consume large quantities of savory snacks and have
poor nutritional status.
Dr. Gail Harrison, consultant to the petitioner,\7\ presented her
analysis of the MRCA survey demographics to the Olestra Working Group,
which responded to CSPI's third concern. Dr. Harrison stated that the
MRCA survey population is very representative of the U.S. population in
terms of regional census areas, census regions, and urbanization.
Further, in terms of different population groups, she said that
children of all ages are appropriately represented, while young
homemakers are slightly underrepresented. In addition, there is a
slight, though not statistically significant underrepresentation of
minority households, and the income distribution slightly
underrepresents highest-income and lowest-income households by about
three to four percent. Also, information was provided to the Olestra
Working Group by the petitioner from an analysis of USDA's 1990-1991
Continuing Survey of Food Intake that the average intake of salty
snacks (crackers, popcorn, pretzels, and corn chips) by food-stamp
recipients was about 4 g/p/d while nonrecipients consumed about 7 g/p/
d.\8\
\7\Dr. Gail Harrison, Professor, School of Public Health,
University of California-Los Angeles. Dr. Harrison presented at the
petitioner's request. Transcript, vol. 2, p. 73.
\8\Information from testimony by Mr. Thomas Breaker from the
Mathematica Policy Research Group before the Committee on
Agriculture's Subcommittee on Department Operations and Nutrition
(Transcript, vol. 2, p. 163).
---------------------------------------------------------------------------
After presentations by the petitioner, CSPI, FDA, and others, the
members of the Olestra Working Group generally agreed that all issues
with regard to the chemistry and consumption of olestra had been
adequately addressed.
FDA agrees that it is appropriate to use conservative assumptions
in the safety evaluation of olestra, the effect of which is likely to
over-estimate consumption patterns. For this reason, FDA has assumed
that 100 percent of all savory snacks will be replaced by olestra-
containing snacks. That is, once olestra is approved, some consumers
will eat only savory snacks containing olestra. FDA further believes
that it is appropriate to rely on the MRCA survey data to estimate
consumption because the survey is well designed, includes a large base
of people, and a sound methodology in that the survey relies on food-
intake diaries kept by participants rather than relying on
participants' recall of what they ate sometime in the past. In light of
the discussion before the Olestra Working Group, FDA further concludes
that the MRCA survey data are sufficiently representative of the eating
habits of the U.S. population and, in particular, that the eating
patterns of low-income individuals are captured by the MRCA data and
thus, such individuals are included in the agency's consumption
estimates. In addition, FDA finds that a scenario-driven estimate of 20
g/p/d, based on consumption of 2 oz of chips per day, which is greater
than the 99th percentile, 14-day average intake in the highest
consuming group of snack eaters (18 to 44 year old makes), is a
reasonable estimate of a ``short-term'' high consumer. FDA has not used
the largest amount reported to have been eaten in one sitting during
the MRCA survey period because that amount represents an extreme that
is unlikely to be repeated for more than a few days. FDA further
concludes that there are no scientific data to justify increasing the
estimated olestra exposure derived from the MRCA survey in order to
account for the potential consumers' increase in consumption of snacks
because the snacks are low-fat.
FDA has also evaluated the potential chronic exposure to DFK's
formed from the manufacture of olestra. Mean DFK intake from olestra-
prepared snacks is 0.4 mg/p/d (DFK level of 125 ppm). The 90th
percentile for DFK's, based on an olestra intake of 7 g/p/d, is 0.87
mg/p/d. For perspective, the mean level of DFK in foods (primarily
beef, chicken, pork, and the brassica vegetables) is 9 mg/p/d and the
90th percentile background exposure (typically approximately twice
the mean for commonly consumed foods such as meat and vegetables) would
be 18 mg/p/d (Refs. 12 and 13).
Thus, FDA has determined that the available data and information
support the use of 7 g/p/d olestra as an estimate of chronic
consumption by the 90th percentile snack eater and 20 g/p/d olestra as
an estimate of shorter term consumption.
III. Toxicity Data--Discussion and Evaluation
A. Absorption, Distribution, Metabolism, and Elimination
The petitioner conducted a series of preliminary studies to assess
the absorption of olestra in rats. In order to identify which organs
might accumulate intact olestra or metabolize olestra if absorbed, rats
were intravenously (IV) injected with olestra radiolabelled with 14C on
the sucrose portion of the molecule. The radiolabelled olestra
initially deposited in the liver and, to a lesser extent, in the
spleen. The data in these early studies show that, olestra was taken up
rapidly by the reticuloendothelial system and deposited in the liver
and spleen within 3 days following intravenous injection. There was a
minor accumulation in the fatty tissues with only a trace amount
detected in expired air. At 21 days, the concentration of olestra in
the liver dropped to about 50 percent of the 3-day level. Olestra was
excreted unchanged via the biliary and fecal routes.
These results demonstrate that the olestra that accumulated in the
liver following intravenous injection was not metabolized because
radiolabel was not accumulated in other tissues, which would have
occurred if olestra had been hydrolyzed by hepatic enzymes. The absence
of olestra's metabolization was confirmed by thin-layer chromatography,
which showed intact olestra in the bile and feces. The half-life of
olestra in the liver was about 5 days.
Examination by electron microscopy of liver tissue from rats
injected intravenously with olestra showed that, at 56 days after
dosing, lipid accumulation was greatest in the Kupffer cells. By 84
days post-dosing, the greatest accumulation was in the parenchymal
cells, indicating that both kinds of cells handle olestra following
[[Page 3126]]
iv administration. Tissue deposition studies were also conducted in
rats fed one percent olestra for 30 days. Based on the data submitted,
there was no significant radioactivity detected in the liver, spleen,
lung, thymus, or adipose tissue from animals fed olestra.
Procter & Gamble conducted a series of studies in male and female
rats to determine the fate of penta-, hexa-, hepta- and octa-ester
preparations of olestra administered by gavage. The livers were removed
and lipid extracts were analyzed for the various esters. No esters were
detected by thin layer chromatography. However, the overall sensitivity
of the method was only approximately 2 to 3 percent of the administered
dose. Therefore, any olestra in rat liver extracts containing less than
3 percent of the administered olestra ester preparations could not be
detected. Additional fat balance studies conducted in the rat
demonstrated that enzymatic hydrolysis can convert mono- through penta-
ester formulations of olestra to sucrose and fatty acids while hexa-
through octa-ester formulations are not absorbed (Ref. 14).
To assess further the potential for olestra to be absorbed from the
GI tract, the petitioner conducted a series of absorption studies in
rats, guinea pigs, and mini-pigs. These studies used uniformly-labeled
olestra with high specific activity and sensitive analytical methods to
analyze tissues, especially liver, for intact olestra and urine for
14C-sucrose, a metabolic product that would result from the
metabolism of any absorbed olestra.
1. Rat Studies
In the rat studies, in order to detect the absorption of a very
small amount of the administered dose, olestra of high chemical and
radiochemical purity and high specific activity (1 millicurie/g) was
dosed at high levels (0.1 millicurie/rat). Tissues were collected,
combusted, and analyzed for radiolabelled CO2, or the lipid
fraction was extracted and analyzed for intact olestra by HPLC. Urine,
feces, expired CO2, and the carcass were analyzed for 14C.
The urine was analyzed for 14C-sucrose to assess whether olestra
had been absorbed and metabolized (Refs. 15 through 19).
Five samples which represented the extremes, and beyond, of the
olestra specification range, as well as a typical mid-range
composition, were tested. This set of samples included the following:
(1) a sample in which the fatty acid chains were 100 percent saturated;
(2) a sample in which the fatty acid chains were highly (85 percent)
unsaturated; (3) a sample rich in short-chain length fatty acids (59
percent) and penta- and hexa-esters (84 percent); (4) a sample which
represented the unheated mid-range of the olestra specification; and
(5) a mid-range olestra sample which was subjected to conditions of
repeated thermal stress as would occur in the commercial preparation of
savory snacks. Although the short-chain length fatty acids (59 percent)
and penta- and hexaesters (84 percent) sample falls outside the olestra
specifications proposed in the petition, the sample was tested to
determine the absorption of these components that might occur in
olestra in trace amounts.
The mean recovery of unabsorbed radiolabel from the rat feces, GI
tract and contents, animal wipes and animal rinse solutions, and cage
wipes and cage rinse solutions was greater than 98.5 percent of the
administered dose regardless of the radiolabeled olestra formulation
studied (Ref. 19). This recovered amount represents olestra that is not
absorbed. The recovery of absorbed radiolabel carbon from olestra
ranged from 0.02 percent of the administered dose of the high saturated
olestra formulation to 1.5 percent of the administered dose of the
short chain length and low ester formulation. The majority of the
absorbed radioactivity was found in the expired CO2 and urine. Analysis
of liver lipids for intact olestra and urine for 14C-sucrose did not
show any radiolabelled carbon. These data demonstrate that most of the
ingested olestra remains intact and is not absorbed, but is excreted
intact in the feces. The percent absorption of these olestra
formulations are shown in Table 1 below.
TABLE 1.--PERCENT ABSORPTION OF OLESTRA FORMULATIONS IN RAT ABSORPTION STUDIES
--------------------------------------------------------------------------------------------------------------------------------------------------------
Olestra Composition Percent Absorbed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Low Chain/Low Ester.............................. 1.50
Mid-Range........................................ 0.16
Heated Mid-Range................................. 0.14
High Unsaturates................................. 0.05
High Saturates................................... 0.02
--------------------------------------------------------------------------------------------------------------------------------------------------------
The absorption measured for the sample rich in short-chain fatty
acids and penta and lower esters was 1.5 percent of the administered
dose. This higher value, compared to the other olestra formulations
tested, resulted from the hydrolysis of the penta and lower esters to
sucrose and free fatty acids in the GI tract. Sucrose molecules
released by hydrolysis of the lower esters in the GI tract were further
hydrolyzed by intracellular mucosal sucrase and passed into the portal
system as the monosaccharides glucose and fructose. These molecules
were metabolized normally and the radiolabel was excreted rapidly in
expired air and urine. The only variable that significantly affected
absorption was the lower chain length and lower degree of
esterification. Restriction of these lower chain length and lower
esters in olestra through specifications for the additive limits the
absorption to less than 0.16 percent of the administered dose. Of the
five radiolabelled olestra formulations studied in the rat, the heated
mid-range formulation with 0.14 percent recovery of absorbed radiolabel
represents the olestra formulation proposed to be marketed for human
consumption. FDA concludes that the low level (0.14 percent) of
absorbed radiolabelled carbon from penta- and lower esters contained in
the heated olestra is biologically insignificant because the only
components shown to be absorbed are metabolized to sucrose and fatty
acids which are metabolized normally (Ref. 19).
2. Guinea Pig Studies
The petitioner conducted studies in male and female poligeenan-fed
guinea pigs to assess the potential for increased absorption of olestra
across a damaged intestinal mucosa. (Poligeenan is known to cause
intestinal damage.) Male and female guinea pigs were given 3 percent
poligeenan in tap water, or tap water alone (controls), for 5 weeks
until GI lesions similar to those seen in acute and chronic human GI
diseases (such as ulcerative colitis and Crohn's disease) were induced.
The guinea pigs were then dosed with 200 microcuries of a heated
olestra and the absorption of
[[Page 3127]]
olestra was compared between animals with normal GI tracts and those
with compromised GI tracts.
The total recovery of radiolabelled olestra was greater than 97
percent of the administered dose for female guinea pigs in both the
normal and compromised groups.\9\ The majority of radiolabel, 87
percent to 95 percent, was found in feces and GI contents. Guinea pigs
in the compromised group had comparable amounts of radiolabel in the GI
tract and contents compared to the normal group. In addition, there
were no consistent differences between the normal and compromised
groups in the distribution of the absorbed radiolabel among various
tissues, blood, urine, or expired CO2. These findings show that
the absorption of intact olestra is no greater in guinea pigs with
compromised GI tracts than in guinea pigs with normal GI tracts (Refs.
20 and 21).
\9\Incomplete collection of fecal material from support screens,
sides and bottoms of cages, and fur of animals for male guinea pigs
resulted in lower radiolabel recovery (88.1 percent) and greater
variability in results than for female guinea pigs.
---------------------------------------------------------------------------
3. Mini-Pig Studies
The absorption of a typical, mid-range heated olestra was
determined in weanling mini-pigs. The weanling mini-pig was chosen
because its GI tract is physiologically and anatomically similar to
humans and, like man, the mini-pig can tolerate a high fat diet. The
design for the mini-pig study was similar to the design in the rat
absorption studies except that expired CO2 was not collected from the
mini-pigs because metabolic cages large enough to house mini-pigs were
not available at the contract laboratory. In addition, the dose of
radiolabelled olestra was increased to 0.35 millicuries per mini-pig so
that the detection limit was comparable to that in the rat studies.
For both male and female mini-pigs, 98.9 percent of the recovered
radiolabel was found unabsorbed in the feces, GI tract plus contents,
and animal rinse solutions. No radiolabelled olestra was found in the
lipid fraction that would have contained olestra, if present, in the
lipids extracted from livers of the mini-pigs (Ref. 22).
Overall, the results from these studies in rats, guinea pigs, and
mini-pigs demonstrate that while a small percentage of the olestra
formulation consisting of penta- and lower esters is absorbed and
metabolized to fatty acids and sucrose, nearly all of the ingested
olestra remains intact and is not absorbed (Refs. 19, 21, and 22).
Heating does not significantly increase olestra absorption and
absorption is no greater when the GI tract is compromised than when it
is intact.
B. Genetic Toxicity Studies
The petitioner conducted a battery of genetic toxicity studies with
the unheated mid-range olestra formulation. Olestra was not genotoxic
in any of the following test systems: An Ames Salmonella test with or
without metabolic activation, a mouse lymphoma cell mutagenicity assay
with or without activation, an unscheduled DNA synthesis test, and a
Chinese hamster ovary cell in vitro cytogenetics test with or without
activation.
Because of solubility problems with olestra in these early genetic
toxicity studies, the petitioner conducted an additional battery of in
vitro assays and in vivo cytogenetic studies on heated mid-range
olestra with Pluronic F-68, a nontoxic, nonionic surfactant to ensure
cell contact with olestra. No evidence of mutagenicity or genetic
toxicity from heated olestra was observed in the following test
systems: The Salmonella/mammalian microsome mutagenesis assay; the
L5178Y TK +/- mouse lymphoma assay; the test for chemical induction of
unscheduled DNA synthesis in rat hepatocytes; and the cytogenicity
study in Chinese hamster ovary (CHO) cells. These tests were conducted
in the presence and absence of liver enzyme (S-9) activation at
concentrations of up to 5 mg/mL. In addition, there was no evidence of
chromosomal aberrations from heated mid-range olestra observed
following examination of the bone marrow in the in vivo cytogenicity
assays (using both acute and chronic dosing protocols) conducted on
Sprague-Dawley rats (Ref. 23). Based upon the foregoing result, FDA
concludes that olestra is not genotoxic.
C. Animal Toxicity Studies
1. Teratogenicity Studies
The teratogenic potential of olestra was evaluated in studies
conducted in the rat and rabbit. These studies establish that olestra
was not teratogenic when fed during organogenesis in either species.
Olestra was also not teratogenic nor did it affect reproduction in a
multi-generation rat reproduction/teratology study.
Olestra was fed to rats (10/group) at 3.2 percent, 6.4 percent, or
12 percent of the diet beginning on the 6th day of pregnancy. Dams were
sacrificed on days 13 and 20 of pregnancy, and the fetuses examined for
abnormalities. The uterine contents of rats killed on day 13 of
pregnancy were evaluated for implantation, resorption sites, and the
number of corpora lutea. The fetuses of the dams sacrificed on day 20
were removed and corpora lutea counted; the pups were sacrificed and
evaluated for anomalies. One-third of the fetuses were cleared and
stained for study of the skeleton, and two-thirds were sectioned for
study of the soft tissues. This study provided no evidence that olestra
is teratogenic or embryotoxic (Ref. 24).
In a rabbit teratology study, heated olestra was administered via
gavage at doses representing 1 percent, 5 percent, and 10 percent of
the diet during the critical stages of gestation (days 6 to 19);
control animals were dosed with distilled water. Dams were sacrificed
on day 30 of pregnancy and the fetuses examined for abnormalities. This
study provided no evidence that olestra was teratogenic (Ref. 25).
For the multi-generation study, weanling rats were maintained on
diets containing 0 percent, 1 percent, 5 percent, or 10 percent olestra
for a 91-day growth period. The mid- and high-dose diets were
supplemented with vitamin A (2.5 times the National Research Council
(NRC) requirements\10\) and vitamin E (five times the NRC
requirements), in order to compensate for the reduced absorption of
these nutrients in the presence of olestra. At the end of 91 days,
F0 dams were mated for a reproduction (F1A) phase and then
were mated again for a teratology (F1B ) phase. After the growth
period, the F1A offspring were mated for the F2A and F2B
generations. Olestra had no effect on mating, conception, embryonic
development, fetal and postnatal viability, or postnatal growth in
either generation (Ref. 24).
\10\NRC requirements are actually recommendations set at levels
close to the amount required for good health in the subject animals.
---------------------------------------------------------------------------
2. Subchronic and Chronic Feeding Studies
Early feeding studies in rats with unheated olestra at levels of 4
percent, 8 percent, or 15 percent of the diet for 28 or 91 days
resulted in no deaths, no decrease in the absorption of triglycerides
or protein, no differences in urine or blood chemistry, hematology, or
gross or microscopic histopathology. These studies are not addressed
further.
a. Ninety-Day subchronic feeding study in rats. The petitioner
conducted two subchronic toxicity studies in rats. The first subchronic
olestra feeding study in rats showed no adverse effects but used
unheated olestra. Therefore, the petitioner, conducted a second 90-day
toxicity study in rats using olestra
[[Page 3128]]
that had been heat abused to a degree exceeding that likely to occur
during the preparation of savory snacks. Specifically, olestra that had
been heated for 7 days at 190 deg.C (representing an extreme heating
condition) was fed to 6 groups of 40 rats each (20 rats per sex) at 0
percent, 0 percent, 1 percent, 5 percent, 10 percent, and 0 percent in
rodent chow ad libitum for 90 days. Groups I and II were chow controls
while Group VI control rats were maintained on a diet that contained 10
percent previously heated triglyceride. Diets for groups II-V were
supplemented with vitamins A, D, and K (five times the NRC
requirement); vitamin E was added to these four diets at 8.0 times, 0.8
times, 4.0 times, and 8.0 times the NRC recommended levels,
respectively.
The study included twice-daily observations and weekly physical
examinations. Body weight, body weight changes, food consumption, and
olestra intake were determined weekly. Ophthalmoscopic examinations
were performed pretest and at study termination. Clinical chemistry,
hematology, and urinalysis parameters were measured at study
termination on 10 animals/sex/group.
Complete gross postmortem examinations were performed on all
animals at study termination. The brain, adrenals, ovaries, testes
(with epididymides), kidneys, and liver were removed, weighed, and
organ-to-body-weight and organ-to-brain-weight ratios were calculated.
A full complement of tissues was examined histopathologically from all
animals in Groups I, II, V, and VI surviving to study termination, and
any animals in Groups III and IV dying unscheduled deaths. Lungs,
liver, kidneys, and gross lesions were evaluated from Group III and IV
animals surviving to study termination.
Survival, physical condition, body weight, food consumption, feed
efficiency, organ weight, organ-to-body weight ratios, hematologic
parameters, and histomorphology were evaluated. Olestra fed rats
compensated for the decrease in caloric intake due to olestra having
zero calories by consuming more food than control rats. No adverse
treatment-related effects were observed. These results establish that
heated olestra is not-toxic when fed to rats at levels as high as 10
percent of their diet for a period of 90 days (Ref. 26).
b. Two-year carcinogenicity studies in rats. Two 2-year
carcinogenicity studies of olestra were conducted in rats. In the first
study, Fischer 344 rats, 70 per sex per group, were fed olestra at
levels of 0 percent, 1 percent, 5 percent, or 9 percent of the diet for
2 years with interim sacrifices at 12 and 18 months. In the second
study, Fischer 344 rats, 50 males and 73 females per group, were fed
olestra at 0 percent or 9 percent of the diet for 2 years with an
interim sacrifice at 12 months. In both studies, diets were
supplemented with five times the NRC recommended levels of vitamins A,
D, E, and K, to offset the reduced absorption of fat-soluble vitamins
in the presence of olestra. The diets in both studies also contained 2
percent fully hydrogenated palm oil to control passive oil loss (anal
leakage). The studies included twice-daily observations, and weekly
physical examinations. Body weight, body weight changes, food
consumption, and olestra intake were determined weekly for the first 12
weeks and monthly thereafter. Feed efficiency was determined during the
first 12 weeks. Ophthalmoscopic examinations were conducted pretest,
and at scheduled sacrifice. Clinical chemistry, hematology, and
urinalysis parameters were measured at 12 and 24 months. Complete gross
postmortem examinations were performed on all animals. Selected organs
were removed, weighed, and organ-to-body-weight and organ-to-brain-
weight ratios were calculated for all rats surviving to scheduled
sacrifice periods. Liver samples were taken from rats in the 9 percent
olestra groups from both studies for analysis of olestra.
Histopathological evaluations were conducted on a full complement
of tissues from animals in the control and 9 percent olestra groups
from both studies. Liver, pituitary gland, gross lesions, and tissue
masses were evaluated for all animals on study. The duodenum, jejunum,
ileum, cecum, and colon were examined for all animals sacrificed at 12,
18, and 24 months.
Rats compensated for the caloric dilution of olestra by consuming
more food than was consumed by the controls. Olestra had no effect on
ophthalmology, organ weight, organ-to-body- and organ-to-brain-weight
ratios, clinical chemistry, hematology, or urinalysis parameters. There
was no evidence that intact olestra accumulated in the liver tissue of
rats fed 9 percent olestra for 2 years.
There were no treatment-related adverse effects on growth,
longevity, or general health, and there were no treatment-related
neoplastic responses or evidence of chronic toxicity in either study.
In the first study, there were four instances in which differences
between treated groups and controls required FDA pathologists to assess
whether the effect was treatment-related: male survival, incidence of
pituitary adenoma (males and females), mononuclear cell leukemia
(males), and basophilic liver foci (females). FDA pathologists also
evaluated the following differences in incidence in the second chronic
rat study: Incidence of pituitary cysts (males), mineralization of the
renal cortex and bile duct hyperplasia, and basophilic liver foci in
females. The differences observed between treated groups and controls
in both chronic studies are marginal.
Pituitary adenomas are very common spontaneous tumors in Fischer-
344 rats with a tendency for highly variable background incidences
(Ref. 27). The increased incidence of pituitary adenoma in both sexes
in the first chronic rat study represent expected variations in
spontaneous background incidences. Thus, FDA concluded that there was
no association of the pituitary adenomas with olestra treatment.
Likewise, FDA concludes that there was no association between the
incidence of leukemia in male rats and treatment with olestra for
several reasons. First, the possible association is not supported by
the results of the second study in which there was no comparable
development of leukemia. Second, the incidences in the first study,
particularly the control group, are unusually low compared to
historical data from the National Toxicology Program (NTP) data base
and compared to the results of the second study (Ref. 27). Third,
mononuclear cell leukemia in Fischer-344 rats is a common spontaneous
disease in old age with considerable tendency for background variation
(Ref. 27). Therefore, such differences in incidence are not unusual but
rather are expected from the normal variation of spontaneous tumor
incidences.
In the first rat study, there was an increase in the number of
olestra-treated female rats with basophilic liver foci at the 1 year
interim sacrifice without any clear increase in the severity of this
lesion at the end of 2 years. However, female groups including the
terminal sacrificed animals as well as the unscheduled deaths,
demonstrated no clear increase in the incidence of basophilic liver
foci with olestra treatment. The same phenomenon of early occurrence of
basophilic liver foci in olestra-fed female rats was observed in the
second study. In both studies, the basophilic foci in the control and
treated rats were similar morphologically.
In presentations to the Olestra Working Group and the FAC, and in
its White Paper, CSPI expressed concern about the significantly higher
incidence of basophilic liver foci at the end of 12 months, although
CSPI acknowledged
[[Page 3129]]
that the difference between control and treatment groups disappeared by
24 months. CSPI asserted that,
FR Doc. 96-1584 Food Additives Permitted for Direct Addition to Food for Human Consumption; Olestra
although 24 months is the majority of a
rat's lifetime, the study should have been carried out for the rats'
entire lifetime because it is possible that the foci might have
progressed to cancer. CSPI also recommended that an expert Committee
(such as NTP review) the findings.\11\
\11\Transcript, vol. 2, p. 135.
---------------------------------------------------------------------------
Based upon an examination of all of the data in both studies, FDA
pathologists concluded that these findings represented normal
biological variability in 24-month-old rats and were not related to
olestra ingestion for the following reasons. First, the findings lacked
a dose-response effect and were not observed in both male and female
rats in both chronic studies (Refs. 28 and 29). Second, the spontaneous
occurrence of basophilic liver foci is frequent and variable in aging
Fischer-344 rats (Refs. 30 and 31) and the incidence can reach 100
percent at 2 years (Refs. 32 and 33). Further, the majority of foci do
not become neoplasms. Third, the most recent studies indicate that
hepatocarcinogens induce more morphologically variable foci than those
observed spontaneously (Refs. 30, 34, and 35). Thus, the early
occurrence and morphological similarity of the basophilic liver foci in
the control and the olestra-treated female rats are not indicative of
hepatocarcinogenic potential for olestra in the rat.
Dr. John Doull, a clinical toxicologist and temporary member of the
FAC, agreed with the FDA evaluation that the basophilic liver foci
findings are not significant and that basophilic liver foci are not
predictors of carcinogenicity.\12\ Dr. Eugene McConnell,\13\ a
presenter to the Olestra Working Group, agreed with Dr. Doull, and
noted that the control groups in both chronic rat studies exhibited
abnormally low incidences of foci compared to the foci rate
historically observed in rats at these ages; he postulated that the
addition of vitamins to the feed in both chronic rat studies may have
caused this low foci occurrence rate in the control groups. The rate of
foci in the treatment groups was compared to historical control rates
and was slightly lower than historical controls.
\12\Dr. John Doull, Kansas University Medical Center Transcript
vol. 2, p. 113.
\13\Dr. Eugene McConnell, D.V.M, D.V.B.T was chief of the
Pathology Branch and Director of the Division of Toxicology Research
and Testing for the NTP. Dr. McConnell is a diplomate of the
American College of Veterinary Pathologists and the American Board
of Toxicology. Dr. McConnell consulted for the petitioner and
presented at its request. Transcript, vol. 2, p. 147.
---------------------------------------------------------------------------
Dr. McConnell also noted that the slides were reviewed by (1)
Board-certified pathologists in the contractor lab performing the study
(2) board-certified pathologists employed by the petitioner, (3) an
independent pathology laboratory,(4) a group of internationally known
pathologists, and (5) FDA pathologists. All of the reviewers came to
the same conclusion that none of the data suggests evidence of
carcinogenic activity in either species.
Therefore, in light of the discussion of the Olestra Working Group
and the presentations of CSPI and Dr. McConnell, FDA confirms its
conclusion that there was no olestra-related toxicity or
carcinogenicity in these studies.
c. Two-year chronic toxicity and carcinogenicity studies in mice.
Two 2-year mouse studies were conducted to evaluate the chronic
toxicity and carcinogenicity potential of olestra. The first mouse
study compared three levels of olestra (2.5 percent, 5.0 percent, and
10.0 percent of the daily diet) to two control groups. Olestra was
supplemented with vitamins A, D, E, and K to account for amounts which
potentially would be lost due to the high levels of olestra fed. One of
the two control groups provided basal levels of fat-soluble vitamins;
the second control group was fed supplemental vitamins A, D, E, and K.
To confirm the findings, a second mouse study was conducted with a
chow-fed control group and a 10 percent olestra group supplemented with
vitamins A, D, E, and K.
One hundred mice of each sex were placed in a total of seven groups
in the two studies. (The first mouse study had five groups and the
second mouse study had two groups.) Fifty animals/sex/group were
allocated to the carcinogenicity portions of each study, and all
survivors sacrificed at 24 months. Fifteen animals/sex/group were
allocated to the toxicity portion of each study, and all were
sacrificed at 12 months. Finally, sentinel animals (35/sex/group) were
included, and seven/sex/group were sacrificed at one, two, three, six,
and nine months for assessment of hepatic vitamin A and E status.
The studies included daily observations and weekly examinations.
Body weights and food consumption were determined weekly.
Ophthalmoscopic examinations were conducted pretest, and at scheduled
sacrifice. Clinical chemistry and hematology data, gross necropsy
observations, and organ weights were collected on animals sacrificed at
12 and 24 months in both studies. Complete gross postmortem
examinations were performed on all animals. Selected organs were
removed, weighed, and organ-to-body-weight and organ-to-brain-weight
ratios were calculated for all mice surviving to scheduled necropsy.
Histopathological evaluations were conducted on a full complement of
tissues from all control and treated animals assigned to the
carcinogenicity portion of both chronic studies.
At the end of 24 months, there were no treatment-related effects in
either study as determined by mortality, body weights, clinical
pathology, gross necropsy findings, organ weights, hematology, clinical
chemistries, or histopathology of a comprehensive collection of
tissues.
In the first study, there was an increase in the incidence of lung
carcinomas and combined lung carcinomas and adenomas in mid-dose
olestra-fed male mice but not in any other group. This association of
olestra consumption with lung tumors in male mice in the first mouse
study was not confirmed by the results of the second mouse study. Lung
adenomas and carcinomas are common lesions in Swiss CD-1 mice and tend
to have a high and variable background rate (Refs. 36 and 37). The
increased combined incidence of lung adenomas or carcinomas in male
mice in the first mouse study (Ref. 38) cannot credibly be associated
with olestra consumption, and represents expected variation in
spontaneous incidence of lung tumors in Swiss CD-1 mice (Ref. 37).
Thus, upon review, FDA pathologists concluded that this was not an
olestra-related effect because there was no other lung pathology, there
was no relation between olestra exposure and time-to-onset of the
tumors, the incidence of the tumors was typical for mice of this age
and sex based on historical data, and there was no association between
olestra exposure and lung tumors in other chronic rodent studies (Ref.
39).
At the Olestra Working Group meeting, CSPI expressed concern about
the increase in the incidence of combined lung carcinomas and adenomas
in the mid-dose male mice.\14\ Dr. Doull noted that an analysis of the
data for CSPI by Dr. Renata Kimbrough (Ref. 3) essentially agreed with
FDA's conclusions. Specifically, although the mid-dose male mice in the
first chronic study had an increased incidence in lung tumors, there
was no dose response, the increased incidence of
[[Page 3130]]
lung tumors was not repeated in the second study, and the lung tumor
incidence rate was within the range of that observed in the NTP program
in lung tumors.\15\ Dr. Doull further stated his view that this data
leads to the conclusion that olestra is not carcinogenic.\16\
\14\Transcript, vol. 2, p. 136. Discussion of this concern also
appears in the White Paper (Ref. 3)
\15\Transcript, vol. 2, p. 111.
\16\Transcript, vol. 4, p. 113.
---------------------------------------------------------------------------
Therefore, in light of the discussion before the Olestra Working
Group, FDA confirms its conclusion that the lung tumors in this study
were not an olestra-related effect.
d. Dog feeding studies. The petitioner conducted two short-term
feeding studies of olestra in beagle dogs. Olestra was fed at a level
of 4 percent of the diet for 28 days or 15 percent of the diet for 30
days. Histological examination of several tissues, including the liver,
revealed no abnormalities. The olestra-fed animals consumed more food
because of the caloric dilution of the diet by olestra, but there was
no difference in body weight gain. In a third study, olestra was fed to
dogs at 10 percent of the diet for 91 days. No adverse effects were
noted among the treated animals in terms of histopathology, hematology,
or blood chemistries.
The petitioner also conducted a 20 month chronic feeding study in
five male and five female beagle dogs. The animals were fed a chow diet
with 0 percent, 5 percent, or 10 percent olestra. Olestra diets were
supplemented by adding 1.5 times the NRC recommended dietary level of
vitamin A and 2.5 times the NRC recommended dietary level of vitamin E
to the low-dose (5 percent) diet. The high-dose (10 percent) diet
received 3.0 times the NRC recommended dietary level of vitamin A and
5.0 times the NRC recommended dietary level of vitamin E. The study
included twice-daily observations, as well as weekly physical
examinations, and determination of growth and food intake. Hematology,
clinical chemistry, serum vitamin A and E concentrations, and
ophthalmoscopic status were evaluated after 12 and 20 months of
treatment.
At the end of the study, all dogs were sacrificed and their tissues
subjected to complete gross and microscopic examination. Organ weights
and organ-to-body-weight ratios were determined for brain, adrenals,
kidney, liver, ovary, testes, and thyroid/parathyroid. A complete set
of tissues from all animals was examined by light microscopy.
No evidence of toxicity was observed, and all animals survived the
entire length of the study. Growth, as measured by body weight gain,
was not affected by olestra ingestion. Food consumption was increased
to offset the caloric dilution of the diet by olestra. No biologically
significant changes were seen in any of the hematological or
biochemical parameters measured. Histopathology revealed no olestra-
related effects (Ref. 40).
D. Toxicology Summary
In summary, the results of the toxicological tests submitted by the
petitioner support the conclusion that olestra is not toxic or
carcinogenic, not genotoxic, and not teratogenic. Heating olestra, as
would occur in the commercial preparation of savory snacks made using
olestra, does not increase the absorption of the additive or affect its
toxicity.
IV. Effect of Olestra on Absorption of Drugs
Because olestra is a fat-like material that has been shown to alter
the absorption of some lipophilic nutrients, FDA considered whether the
bioavailability of lipophilic drugs might also be affected by
consumption of olestra. To address this question, the petitioner
carried out a series of studies in both animals and humans.
The petitioner established the following criteria to use in deciding
which drugs to study:
(1)-The drugs should have wide spread use by the general population.
(2)-The absorption, metabolism and elimination of the drugs should be
similar in rats and humans.
(3)-The drugs should cover a wide range of solubilities, from water-
soluble to fat-soluble.
(4)-The drugs should include representatives of those used to prevent
life-threatening situations.
(5)-Most of the drugs should have partition coefficient data already
available.
(6)-The drugs must be commercially available in radiolabeled form.
Using these criteria, the petitioner selected the following drugs
for use in two rat studies: aspirin, diazepam, propranolol, and the
oral contraceptives ethinyl estradiol and norethindrone. Because
results of studies in rats are not definitive predictors of human
conditions (Ref. 41), the petitioner also sponsored two human clinical
trials to study the olestra/drug issue. In the first of these clinical
trials, propranolol, diazepam, norethindrone, and ethinyl estradiol
were included; in the second clinical study, the oral contraceptive Lo/
Ovral-28, containing norgestrel and ethinyl estradiol, was evaluated.
A. Effect of Olestra on the Absorption of Selected Lipophilic Drugs
(EC-40)
The primary objective of this study was to determine whether
olestra affects absorption of drugs relative to corn oil.This study was
conducted in Sprague-Dawley derived male and female rats and had three
separate experimental components. The olestra used was prepared from
safflower oil, while corn oil served as the triglyceride control.
Hydrogenated palm oil was added to both the olestra and control diets,
to mimic the earlier proposed use of olestra in combination with
convention oils.
In the first experiment, 20 male rats were fed either a control
diet with 6 percent added corn oil or a similar diet but with 6 percent
added olestra for 13 days; the test animals were then fasted, weighed,
subdivided into four groups (five rats per group), and gavaged with
slurries of either the control or olestra diets to which tritiated
diazepam or tritiated propranolol had been added. In the second and
third experiments, no initial acclimation period was used. In the
second experiment, 20 female rats were fasted, weighed, divided into
four groups (five rats per group), and gavaged with slurries of either
control or olestra diets to which tritiated ethinyl estradiol or
tritiated norethindrone had been added. In the third experiment, 10
male rats were fasted, weighed, divided into 2 groups (5 rats per
group), and gavaged with slurries of either control or olestra diets to
which C14-labeled acetylsalicylic acid (aspirin) had been added.
In all three experiments, serial blood and urine samples were taken
over a 48-hour period after dosing. Fecal samples were also collected
at 24-hour intervals. All samples collected were assayed for drug
associated radioactivity, and the results evaluated for treatment
related effects on drug absorption.
The five drugs studied in these experiments cover a range of
lipophilicity, from nonlipophilic (aspirin) to strongly lipophilic
(ethinyl estradiol and norethindrone). The petitioner concluded that
co-administration of the drugs with olestra did not affect the
absorption of any of the drugs tested when compared with corn oil.
FDA concludes that the petitioner's choice of drugs, which were
selected based on physico-chemical properties, was reasonable. Further,
the study correctly focused on rate and extent of absorption, both of
which are important factors in the overall evaluation of human drug
absorption. Although the use of total radioactivity measurements,
[[Page 3131]]
as was done in this study, is not a comprehensive evaluation taken
alone, the study design is adequate as a first exploration of olestra/
drug interactions (Ref. 41).
B. Effect of Olestra on the Absorption of Selected Lipophilic Drugs
(EC-41)
The objective of this study was to determine whether a single dose
of olestra caused an alteration of the absorption or excretion profiles
of lipophilic drugs that were orally administered prior to the olestra.
This study was conducted with Sprague-Dawley derived male rats. After a
4 day acclimation period all rats were fasted, weighed, divided into
treatment groups (four/group), and gavaged with either tritiated
diazepam, tritiated propranolol, or C14-labeled aspirin
(acetylsalicylic acid). Following each drug dosing, rats were gavaged
with one ml of either water, corn oil, or olestra. Additional rats
dosed with propranolol and aspirin received an olestra emulsion (one of
the projected final forms for initial marketing of olestra).
Serial blood and urine samples were collected over a 48-hour
period, postdosing, while fecal samples were obtained at 24-hour
intervals. Forty-eight hours after dosing all rats were sacrificed,
their gastrointestinal tracts removed and the contents collected,
selected organs excised, and carcasses frozen in liquid nitrogen and
ground. All samples were assayed for drug-associated radioactivity.
Results of the radioactivity assays were evaluated for treatment-
related effects.
The petitioner concluded that there were no differences in rate or
extent of absorption of diazepam, propranolol, or acetylsalicylic acid
when administered before olestra consumption compared with
administration prior to water consumption. Drug excretion profiles were
also not affected by olestra. Corn oil (a control substance) reduced
the rate of absorption of all drugs studied. The petitioner concludes
that these results demonstrate that olestra would not be expected to
affect the acute absorption of drugs such as diazepam, propranolol or
aspirin, and thus are consistent with EC-40. FDA concludes that, as
with EC-40, the design and conduct of this investigation are adequate
as a further exploratory study of the potential for olestra/drug
interactions (Ref. 41).
C. Effect of Olestra on Drug Bioavailability (EC-42)
The objective of this clinical trial, consisting of 3 experiments,
was to determine whether olestra consumption alters drug
bioavailability in humans when used as a substitute for absorbable
dietary fat. Subjects were assigned to test one drug in a crossover
design so that bioavailability of the drug was evaluated with single
doses of olestra, water, or a triglyceride (partially hydrogenated
soybean oil) placebo treatment. Table 2 provides basic information on
subject and treatment assignment.
TABLE 2.--SUBJECT AND TREATMENT ASSIGNMENT IN EC-42
----------------------------------------------------------------------------------------------------------------
Drug and treatment
Exp. No. Subject No. male/female Age Range (years) amount
----------------------------------------------------------------------------------------------------------------
1.................................... 5/3.................... 27 to 47............... Propranolol, 20 mg
2.................................... 4/4.................... 20 to 40............... Diazepam, 5 mg
3.................................... 0/10................... not available.......... Norethindrone, 1 mg and
Ethinyl estradiol,
0.07 mg
----------------------------------------------------------------------------------------------------------------
In each experiment, 18 g of olestra, 18 g of triglyceride, or six
ounces of water were consumed following ingestion of the respective
drug under study. Serial blood samples collected from all subjects were
processed and the resulting serums frozen for subsequent drug analyses.
The data on peak serum concentrations, times to peak, and areas under
the concentration curves (AUC) were analyzed statistically for
treatment effects.
Based on its analyses of the results from the three experiments,
the petitioner concluded that there were no statistically significant
differences in the absorption of the drugs administered with olestra,
triglyceride placebo, or water as assessed by total area under the
curve (AUC) and time to peak concentration data. The time to peak
concentration values for diazepam were slightly longer with the
triglyceride placebo than with olestra. There was wide, although not
unexpected, between-patient variability. The petitioner concluded that
a single dose of 18 g of olestra did not alter the
bioavailabilitypara.characteristics of orally administered propranolol,
diazepam, or norethindrone/ethinyl estradiol when compared to water or
a triglyceride such as partially hydrogenated soybean oil.
FDA concludes that the design of this clinical study was excellent,
and that the study may be used by itself, without any reliance on the
two studies in rats, to assess olestra's potential for affecting
absorption of lipophilic drugs. The results from EC-42 demonstrate that
olestra does not interfere with the absorption of drugs when
administered at the 18 g dose (Ref. 41).
D. Effect of Olestra on the Systemic Levels of Steroidal Hormones in
Women Taking Oral Contraceptives (EC-51)
The objective of this clinical trial was to determine the effect,
if any, of chronic olestra consumption (targeted at 20 g/d) on the
absorption and efficacy of a low-dose oral contraceptive in normal
women.
Thirty healthy, menstruating female subjects aged 20 to 38 years
were assigned to two groups. A double-blind, placebo-controlled,
crossover study design was used which covered two complete ovarian
cycles. Subjects were instructed to begin taking the oral contraceptive
Lo/Ovral-28 (0.30 mg norgestrel and 0.03 mg ethinyl estradiol), 5 days
before the onset of menstruation. One group of subjects received food
items with triglyceride placebo, while the other group received similar
food items containing a ``mid-range'' olestra formulation.
Daily intake of olestra was set at 18 g with one-third (6 g) of the
daily dose being consumed at each meal. At the conclusion of the first
28-day cycle, the treatments were crossed over (placebo to olestra,
olestra to placebo). All subjects were asked to take their oral
contraceptive only in the morning and before the morning meal. Serum
progesterone levels were determined at a baseline visit, 5 to 7 days
after menstruation and twice weekly for the remainder of the ovarian
cycles.
Serial blood samples were collected during each of the two ovarian
cycles. These samples were then processed and the serums frozen for
subsequent drug analysis. Results were evaluated for treatment effects
by comparing AUC, maximum drug concentration, and time to maximum
concentration data.
The petitioner concluded that there were no significant effects of
consuming 18 g of olestra on the absorption of either norgestrel or
ethinyl estradiol, the
[[Page 3132]]
two steroid components of Lo/Ovral-28. Serum progesterone levels in
subjects in both the olestra and triglyceride placebo groups were found
to remain in a range that would prevent ovulation, thereby providing
evidence that oral contraceptive efficacy was not affected by olestra.
The petitioner also stated that because the oral contraceptive used in
this study contains the lowest amounts of two of the most lipophilic
steroid hormones (norgestrel and ethinyl estradiol), the results from
this study should prove valid for ``all high-dose oral contraceptives
having less lipophilic constituents.'' In addition, the petitioner
believes that the data from EC-51 provide further support generally for
the conclusion from other studies in animals and humans that olestra
consumption does not alter the absorption of lipophilic drugs, and
therefore, will not affect the efficacy of orally administered drugs.
FDA believes that this study is an excellent extension from single-
dose olestra to chronic dosing, at least for the once-a-day situation.
Further, in this study, there was no evidence that olestra would affect
the efficacy of orally administered drugs (Ref. 41).
E. Summary
The petitioner has submitted two animal studies and two clinical
studies assessing olestra's potential to alter drug absorption. Procter
& Gamble believes that these studies demonstrate that olestra does not
alter the absorption nor affect the efficacy of orally administered
drugs.
Members of the Olestra Working Group were unanimous that, with
respect to drugs, all the issues had been identified and there were
sufficient data to address each issue.\17\ There was also nearly
unanimous agreement that, with respect to drug interactions, there was
no obstacle to approval and reasonable certainty of no harm from
olestra consumption.\18\
\17\Transcript, vol. 4, p. 50.
\18\Transcript, vol. 4, p. 50.
---------------------------------------------------------------------------
During the Olestra Working Group and FAC meetings and in numerous
comments to FDA, individuals have expressed concern about the effects
of olestra on coumarin drugs (e.g., Coumadin or warfarin, Dicumarol,
etc.) as well as other drugs. Dr. Ian Greaves, a specialist in
environmental and occupational medicine,\19\ expressed concern about
persons taking anticoagulants such as coumarin drugs that antagonize
Vitamin K. He asked how olestra would bind to coumarin and whether
there would be difficulty in maintaining an anticoagulant status in
people receiving coumarin who intermittently eat olestra-containing
products. He stated that his experience with managing patients on
anticoagulants is that some of them are very variable for no good
reason, and he could easily foresee a patient becoming either overly
anticoagulated or under-anticoagulated, depending on whether Vitamin K
was being bound or whether the coumarin was being bound. Also, if a
person taking coumarin happened to have an intra-cerebral bleed or
bleed from his gastrointestinal tract and was also consuming olestra,
he felt it would be difficult to know whether olestra had a role in the
bleeding. Finally, he stated he was concerned about other fat-soluble
drugs, particularly those that cross the blood-brain barrier such as
anticonvulsants, psychotropic drugs, and antidepressants. Dr. Greaves's
questions covered the concerns that were raised by other individuals.
\19\Dr. Ian Greaves is an Associate Professor and Deputy
Director, Minnesota Center for Environmental and Health Policy,
University of Minnesota School of Public Health. Dr. Greaves
presented at the request of CSPI. Transcript, vol. 2, p. 265.
---------------------------------------------------------------------------
FDA notes that the results concerning the hormonal preparations are
extremely useful because these drugs represent extremely lipophilic
substances and are substances that have a narrow therapeutic index in
which a lowering of the absorbed concentration would be a concern. In
addition, the drug, propranolol, is a compound that has very similar
physical/chemical properties to Coumadin or sodium warfarin,\20\ a drug
about which FDA has received comments concerning olestra's effects. In
response to a question by an FAC member, FDA noted that in the previous
5 years, there has been only one drug that FDA has reviewed that is
more lipophilic than the hormone drugs tested in the human drug-
interaction studies. That drug is a very specialized drug (Atovaquone),
which is an anti-pneumocystis drug used in AIDS patients.\21\
Therefore, FDA expects that the results observed in the reviewed
studies would be representative of nearly any drug on the market.
\20\Transcript, vol. p. 124.
\21\Transcript, vol. p. 124.
---------------------------------------------------------------------------
Regarding coumarin drugs specifically, FDA notes that the effects
of a variety of meals (e.g., high-protein, high-carbohydrate, and high-
fat) on absorption of sodium warfarin (Coumadin), the most commonly
prescribed form of coumarin, were studied and no effect was seen in the
total amount of sodium warfarin absorbed. Also, there was no effect on
absorption when Coumadin was consumed with high-fat or high-protein
meals. When consumed with a high-carbohydrate meal, Coumadin was more
slowly absorbed, but only for the first hour after ingestion of the
drug\22\ (Ref. 42). Therefore, FDA would not expect significant effects
on Coumadin absorption from olestra consumption.
\22\Transcript, vol. p. 119.
---------------------------------------------------------------------------
Olestra's effects on vitamin K are discussed in the Nutritional
Studies section below.
FDA concludes that the test compounds studied adequately represent
the range of physical properties of drugs marketed for human use, and
that the magnitude of olestra's effects on drug absorption were
minimal, when compared to the effects normally encountered in drug-food
interaction studies. FDA further concludes, considering the results of
all four studies, the discussions during the Olestra Working Group and
FAC meetings, comments received, and information in the literature,
that there is no evidence that consumption of olestra would
significantly influence the rate or extent of absorption of drugs
(including Coumadin drugs).
V. Nutritional Studies
A. Issues Associated with Olestra
The petitioner has hypothesized that olestra interferes with the
absorption of fat-soluble nutrients when the nutrients partition into
olestra in the GI tract. When this happens, the portion of the
nutrients that is present in the olestra phase is unavailable to the
micelle-mediated transport system and, rather than being absorbed by
the body, is excreted in the feces along with the olestra.
Neither existing olestra data nor the partitioning mechanism
suggest that water-soluble nutrients would be affected by olestra.
However, certain water-soluble nutrients such as folate and vitamin B12
(hard-to-absorb nutrients) are absorbed in multi-step processes. The
multi-step nature of the processes might allow the opportunity for
olestra to interfere with key steps in the processes, such as binding
or cleavage reactions. Calcium, zinc, and iron are limited in the U.S.
diet; thus, any effect on their absorption might increase the risk of
nutritional inadequacy. In addition, the nutrients would be present in
the diet at levels that are small, on a mass basis, relative to the
amount of olestra. Thus, if olestra has an effect on water-soluble
nutrients, these five nutrients (folate, vitamin B12, calcium,
zinc, and iron) would be the most important water-soluble nutrients
[[Page 3133]]
to monitor and the most likely to reflect adverse nutritional effects.
Therefore, folate, vitamin B12, calcium, zinc, and iron were
chosen as representative markers for olestra's effects on the
nutritional status of water-soluble nutrients.
The potential nutritional effects of olestra consumption were
studied in both humans and animals. The pig was chosen as the
appropriate animal model because it has a gastrointestinal tract
similar to that of man; it is able to ingest, tolerate, and metabolize
fat at a level comparable to that found in the human diet; and its
vitamin stores and nutritional indices are responsive to dietary
changes. Where possible, FDA has relied upon the results of human
consumption studies as the primary determinants of olestra's safety,
thereby avoiding the uncertainties raised by extrapolating from the pig
to humans. Thus, FDA is relying primarily on the human studies to
assess olestra's effects on vitamins E, D, K, and B12, and on
folate and iron. There are certain nutrients, such as vitamin A, for
which no noninvasive procedure can be used to assess status in humans.
Therefore, FDA has relied upon the results of the pig studies for
determining olestra's effects on vitamin A. In addition, there are
certain advantages to studying olestra's nutritional status in pigs.
The studies can be conducted over the major developmental and growth
periods of the pig's life, dose levels higher than those in man can be
studied, and invasive techniques can be used to measure nutrient stores
in tissues (such as bone and liver). Therefore, results from the pig
studies are valuable supportive information that expand upon the
knowledge gained in the human studies.
To apply the results of the pig studies to humans, it is necessary
to correlate the percent olestra fed in the pig diet to g/p/d olestra.
Olestra's effects on nutrients are caused by its physical presence in
the gut. If nutrients dissolve into olestra, they will be carried out
of the body with the olestra rather than being absorbed. The amount of
olestra's effect depends on the amount of olestra present in the GI
tract compared to other fats (as well as on the solubility of the
vitamins in olestra). Thus, FDA has concluded that the most appropriate
means for correlating olestra's effects in animals to humans is the
percentage by weight of olestra in the diet. For a person eating about
2,000 calories/d, 10 g of olestra would be about 2.4 percent of the
diet (Ref. 43).
B. Effects of Olestra on Fat-Soluble Vitamins-
The effect of olestra on fat-soluble vitamins was assessed in five
nutritional studies with humans and five studies with pigs, as
summarized in Table 3.
TABLE 3.--SUMMARY OF STUDIES DESIGNED TO ASSESS NUTRITIONAL EFFECTS OF OLESTRA CONSUMPTION
----------------------------------------------------------------------------------------------------------------
Human Studies Pig Studies
----------------------------------------------------------------------------------------------------------------
8-week clinical dose response (8-week DR) 26-week dose response and vitamin restoration (26-week
DR/VR)
8-week clinical vitamin restoration (8-week VR) 39-week vitamin restoration (39-week VR)
6-week vitamin D/K status in free-living subjects (6- 12-week dose response (12-week DR)
week vitamin D/K)
16-week vitamin E status in free-living subjects (16- 12-week vitamin restoration (12-week VR)
week vitamin E)
14-day vitamin A/fat absorption (14-day vitamin A/fat) 4-week dietary context (4-week DC)
----------------------------------------------------------------------------------------------------------------
In evaluating olestra's nutritional effects, FDA believes that it
is appropriate to rely primarily on the two 8-week clinical studies
because in these studies, there was complete control of nutrient
intake, they were well designed, and most nutritional parameters were
monitored. Also, these two studies were performed recently using state-
of-the-art analytical techniques and were designed taking into
consideration findings from previous studies.
FDA believes that the 16-week vitamin E study, the 6-week vitamin
D/K study, and the 14-day vitamin A/fat study are appropriately used to
support the findings in the two 8-week studies. The results of these
latter three studies do not weigh as heavily in the safety evaluation
because of their limitations: the 16-week vitamin E and 6-week vitamin
D/K studies were conducted in free-living subjects so that it was not
possible to control completely or have more than imprecise knowledge of
nutrient intake; the vitamin A/fat study investigated only olestra's
effects on preformed vitamin A absorption and provides less information
than the pig studies for assessing olestra's long-term effects on
vitamin A stores (which are derived from both preformed vitamin A and
carotenoids).
Of the studies performed in the pig, FDA believes that it is
appropriate to rely primarily on the results of the 26-week DR/VR and
39-week VR studies to assess olestra's nutritional effects because
these studies were the longest term and were designed to confirm the
results of the 12-week DR and 12-week VR studies. The 4-week DC study
was more limited in scope and duration, and was intended to demonstrate
how olestra's effects are modified by changes in dietary patterns.
1. Primary Human Studies-
The petitioner performed two 8-week human studies, in both of which
the entire diet of the subjects was controlled during the study. The
first study was the 8-week DR study which was intended to determine the
dose-response effect of olestra on the status of folate, zinc, iron,
and vitamins A, E, D, K; on the absorption of vitamin B12; and on
the bioavailability of -carotene and total carotenoids. The 8-
week VR study was intended to determine the efficacy and safety of
compensation with vitamins A, E, and D, and to confirm the conclusions
drawn in the 8-week DR study about the effects of olestra on vitamin K,
zinc, and iron status, serum 25-hydroxyvitamin D2 (25-OHD2)
concentration, carotenoid bioavailability, and vitamin B12
absorption. These two studies are of similar design and the results are
complementary.
a. Eight-week DR study design. The 8-week DR study was a parallel,
double-blind, placebo-controlled study with controlled diets fed for 8
weeks. Subjects were normal, healthy, 18 to 44 year-old males and
females. The study had four groups of 21 to 24 subjects per group (88
subjects total). Subjects were randomly assigned to treatment groups
that were balanced with respect to age, sex, body mass index (BMI),
serum -tocopherol, and total serum carotenoid concentrations.
Subjects were provided with all meals for 56 days.-
The diets were formulated to provide about 15 percent of calories
from protein, about 55 percent of calories from carbohydrate, and about
30 percent of calories from fat. The total digestible fat content was
kept the same across the four treatment groups by adding
[[Page 3134]]
triglyceride, in the form of butter, margarine, or vegetable oil, into
the diets to compensate for the amount of fat replaced by olestra in
the olestra-containing foods. Therefore, the total amount of lipid
(digestible fat plus olestra) increased with increasing olestra dose.
Olestra was added to food items (potato chips, muffins, biscuits,
and cookies) by substituting olestra for triglyceride in recipes or in
cooking oils. Because each meal contained olestra, or the corresponding
placebo (triglyceride), this study design provided maximum opportunity
for olestra to interfere with nutrient absorption.
The diets provided each subject with 80 percent to 120 percent of
the RDA of folate, zinc, and vitamins A, D, E, and K. Calcium and iron
intakes were not targeted to be within the 80 percent -120 percent RDA
range, although they were controlled and kept consistent among the
diets. Vitamin B12 levels were allowed to exceed the 80 to 120
percent RDA range in order to maintain zinc and protein consumption at
the target levels. In addition to the vitamin D in the diet, subjects
were given 20 g/day (two RDA) of vitamin D2 as a
supplement, one third of which was consumed with each meal.-
The dosages of olestra were 0 (placebo), 8, 20, and 32 g/d. Body
weights were measured every week and the subjects were questioned daily
about changes in their health, including GI symptoms. If a GI symptom
was experienced, the subject completed a detailed questionnaire that
asked about the type, severity, and duration of symptoms they
experienced. (The monitoring and reporting methods for adverse
experiences is discussed in section VI.B. of this document.) Table 4
summarizes the measurements that were made to assess the status of the
various nutrients. Most parameters were measured at baseline (week 0)
and at 2-week intervals throughout the 56-day study period.
TABLE 4.--MEASUREMENTS OF MICRONUTRIENT STATUS IN THE EIGHT WEEK DR STUDY
----------------------------------------------------------------------------------------------------------------
Nutrient Measurements
----------------------------------------------------------------------------------------------------------------
Vitamin A Serum retinol concentration\23\, serum carotenoid
concentration
Vitamin E Serum -tocopherol concentration
Vitamin D Serum concentration of 25-OHD2, 25-hydroxyvitamin D3
(25-OHD3), and 1,25-dihydroxyvitamin D (1,25-(OH)2D)
Vitamin K Serum phylloquinone concentration, urinary excretion of
-carboxy glutamic acid, plasma concentration
of des-carboxy prothrombin (PIVKA-II), plasma
prothrombin concentration, and prothrombin time, and
partial thromboplastin time
Folate Serum and red blood cell folate concentration
Vitamin B12 Schilling test, serum vitamin B12, serum vitamin B12
metabolites
Zinc Serum and urinary zinc concentrations
----------------------------------------------------------------------------------------------------------------
\23\Serum retinol concentration is the only practical measure of preformed vitamin A status that can be made in
humans who have adequate liver stores. (Other measures require invasive tissue sampling, such as measurements
of liver stores.)
b. Eight-week VR study design. The study design for the 8-week VR study
was the same as that of the 8-week DR study, except for the following
elements. The 8-week VR study had 6 groups, each containing 16 or 17
subjects (100 subjects total). The measurements of micronutrient status
in the 8-week VR study differed from those in Table 4 in that folate
and zinc were not monitored while iron status was monitored by
measuring serum ferritin and iron concentrations and total iron binding
capacity. Unlike the 8-week DR study, no vitamin D2 supplement was
consumed by the test subjects. Finally, in addition to the vitamins
provided in the diet, graded levels of vitamins A, E, and D were
provided, as described in Table 5.
TABLE 5.--VITAMIN DOSES EXPRESSED AS PER GRAM OF OLESTRA (/G) AND -PER DAY (/D) FOR THE SIX TREATMENT GROUPS IN
8-WEEK VR STUDY
----------------------------------------------------------------------------------------------------------------
Vitamin A Vitamin E Vitamin D2
-----------------------------------------------------------------------------
Treatment Group Olestra (g/d) g/ g/ g/ g/
g d mg/g mg/d g d
----------------------------------------------------------------------------------------------------------------
0 (placebo)....................... 0 0 0 0 0 0
8................................. 83 664 2.5 20 0 0
20................................ 33 660 1.5 30 0.20 4
20................................ 83 1660 2.5 50 0 0
20................................ 132 2640 3.5 70 0.80 16
32................................ 83 2656 2.5 80 0 0
----------------------------------------------------------------------------------------------------------------
c. Results and conclusions from primary human studies.--i. Vitamin
A. In the human diet, there are two sources of dietary vitamin A,
preformed vitamin A (retinyl esters) and carotenoids such as -
carotene that are converted in the body into vitamin A (provitamin A
carotenoids). Partitioning of either of these sources of vitamin A into
olestra could affect vitamin A levels in the body.
The petitioner concluded that there was no effect of olestra in
either of the two 8-week studies on the serum concentration of retinol.
This result was not unexpected because serum retinol concentrations are
relatively stable and not subject to significant change except under
conditions of prolonged and inadequate vitamin A intake. Only under
such extreme conditions would changes in liver vitamin A storage be
reflected by changes in serum retinol. Thus, the petitioner concluded,
and FDA agrees, that to establish the effect of olestra on vitamin A
status in humans, data on vitamin A liver stores collected in the pig
studies and data on the postprandial absorption of vitamin
[[Page 3135]]
A in man must be considered. Those data are discussed in sections
V.B.3.c.i. and V.B.2.c. of this document.
ii. Vitamin E. The petitioner evaluated the effect of olestra on
vitamin E status and found that there was a highly significant trend in
decreased serum levels of vitamin E with increasing olestra dose in the
8-week DR study, an effect evident by day 14 of the study. Serum
vitamin E was reduced by 6 percent, 17 percent, and 20 percent compared
to control levels when olestra was consumed at 8, 20, and 32 g/d
respectively in every meal. The maximum effect was obtained between 2
and 4 weeks.
The petitioner calculated, based on the results of the 8-week VR
study, that the effects on tissue concentrations of vitamin E were
offset by the addition of 2.07 mg of vitamin E (d--tocopheryl
acetate) per g olestra. This level is equivalent to 1.9 mg -
tocopherol equivalents/g olestra and 0.94 RDA of vitamin E per 1 oz
serving of savory snacks containing 10 g of olestra.
FDA agrees that 1.9 mg of -tocopherol equivalents/g
olestra adequately restored serum vitamin E levels in this study, as
indicated in the data adjusted for baseline serum vitamin E levels\24\
(Ref. 44). FDA finds that this study adequately controlled vitamin E
consumption, analyzed appropriately for vitamin E levels, and was of
sufficient duration to observe olestra's effect, because the effect had
reached a plateau after a few weeks into the study (Ref. 43).
Therefore, FDA agrees that compensation for olestra's effects on
vitamin E can be calculated from the results of this study, and further
agrees that 1.9 mg of -tocopherol equivalents per g of olestra
is the appropriate compensation level.
\24\In controlled diet studies such as this, the controlled diet
is often better in many respects than the free-living diet of the
subjects, thus it is not unusual that the basline vitamin E levels
were lower than controlled-diet levels. Therefore, adjustment for
baseline levels is appropriate.
---------------------------------------------------------------------------
iii. Vitamin D. In the human diet, there are two sources of vitamin
D, dietary (vitamin D2) and endogenous (vitamin D3) produced
in the body via sunlight-catalyzed dermal synthesis. The nature of the
dose-response effect of olestra on dietary vitamin D2 was
determined by measuring serum levels of 25-OHD2, which is derived
only from dietary vitamin D. Serum levels of 25-OHD3 (from
dermally synthesized vitamin D3), 1,25-(OH)2D, and 25-OHD
were also measured to assess olestra's effects on total vitamin D
status. The serum concentration of 25-OHD reflects total vitamin D
status.
The petitioner found that there was an olestra treatment effect in
the 8-week DR study on the serum concentration of 25-OHD2. At the
end of the study, the reductions in 25-OHD2 were 23 percent, 13
percent, and 27 percent for 8, 20, and 32 g olestra/d, respectively,
relative to control. The effect had levelled off within 4 weeks. There
was no effect on serum 25-OHD3 or 1,25-(OH)D. In this study, the
diet contributed 55 to 68 percent to total vitamin D status (the
remainder coming from sunlight). The amount supplied by the diet was
relatively high because of excess vitamin D2 supplied by the
dietary supplement.
Although the subjects in the 8-week VR study did not receive
supplements (the diet contributed 12 to 20 percent of total vitamin D),
the reductions in 25-OHD2 in the 8-week VR study were similar to
those observed in the 8-week DR study: 22 percent, 29 percent, and 22
percent for 8, 20, and 32 g olestra/day, respectively, relative to
control. The reductions in serum total 25-OHD were less compared to the
reductions in the 8-week DR study because a larger fraction of the
total vitamin D was endogenous. The petitioner concluded that olestra's
effect on serum vitamin D2 in the 8-week VR study could be offset
by adding 0.07 times the RDA of vitamin D2 per 1 oz serving of
savory snack containing 10 g olestra (equivalent to .07 g/g
olestra or 2.7 IU). The petitioner further concluded that olestra's
effect on vitamin D status is not nutritionally significant because the
effect is relatively small (on the order of a few percent in the 18-
week VR study) and sunlight synthesis is a more important contributor
to total vitamin D levels.
FDA agrees with the petitioner that olestra reduced serum vitamin D
in both studies. Because the effect of olestra on serum vitamin D2
levels had levelled off within the first 4 weeks of the study, FDA
considers the studies of sufficient length to assess olestra's effects
(Ref. 43). However, it is difficult to quantify olestra's effect
because of confounding factors, such as the lack of a strong
relationship between dose and reductions in 25-OHD2 in both
studies. In addition, the effect of olestra on serum total 25-OHD
levels is difficult to quantify in the 8-week VR study because total
serum 25-OHD levels were falling in the control group as well as the
treated group during the study. (For example, total serum 25-OHD levels
in the group not consuming olestra decreased 30 percent over the course
of the study.) Compensation of two of the 20 g/d olestra groups with
0.2 and 0.8 g vitamin D2/g olestra reduced the decrease
in total serum 25-OHD (which was due to both olestra and test diet
effects). At the 0.2 g/g olestra supplementation level, the
decrease in total 25-OHD was slightly less than in the group not
consuming olestra (26.8 percent vs. 30 percent respectively). With the
higher level of compensation (0.8 g/g olestra) the decrease in
25-OHD was about one-half that of the group not consuming olestra (15.6
vs. 30) (Ref. 45).
Although FDA believes that the variability of the data and the ``on
diet'' effects on vitamin D status make quantitation of the magnitude
of olestra's effects difficult, the agency concludes that the 8-week VR
study can be used to estimate olestra's effects on vitamin D because
dietary vitamin D2 consumption was not excessive and the effect of
olestra had levelled off within 4 weeks. FDA concludes that these
results show that 0.2 g vitamin D2/g olestra adequately
compensated for olestra's effects on vitamin D status in the 8-week VR
study (Ref. 45).
iv. Vitamin K. The petitioner found that in the 8-week DR study,
olestra caused a dose-response decrease in serum phylloquinone (vitamin
K1) concentration that levelled out within 2 weeks. Eight, 20, and
32 g/d olestra reduced serum phylloquinone by 36 percent, 40 percent,
and 47 percent, respectively. There was no effect of olestra on the
status of vitamin K as measured by the plasma concentration of des-
carboxylated prothrombin (PIVKA-II), urinary excretion of -
carboxyglutamic acid (urinary Gla), and plasma prothrombin
concentration, which are all measures of functional activity of vitamin
K. Prothrombin time (PT) and partial thromboplastin time (PTT), the
normal measures of clinical vitamin K status, were also not affected by
olestra intake. The 8-week VR study showed similar results. FDA agrees
with the petitioner's findings in both studies.
The petitioner concluded that the lack of any change in vitamin K
functional activity indicates that the decrease in para.serum
phylloquinone concentration does not represent a significant reduction
in vitamin K status. FDA notes that, although olestra did not
demonstrate any effect on the vitamin K-related functional parameters
(i.e., urinary excretion of -carboxy glutamic acid, plasma
concentration of des-carboxy prothrombin (PIVKA-II), plasma prothrombin
concentration, and clotting times), the length of the study was
insufficient to rule out possible effects on these vitamin K-related
functional parameters after longer term consumption of olestra. Also,
while serum levels in the studies after 56 days
[[Page 3136]]
can be considered to be only marginally reduced, when compared to true
deficiency levels, the potential remains for continued decrease with
long-term olestra consumption.
To calculate the level of vitamin K that would compensate for the
reduction of serum vitamin K levels caused by olestra consumption, the
petitioner relied upon the fact that serum vitamin K levels closely
reflect the most recent (within 24 hours) intake of vitamin K. (Vitamin
K has a half-life in serum of approximately 2 hours.) In the 8-week DR
study, a 6 day rotating menu provided different vitamin K intakes for
each day. As a result, the level of vitamin K on the days before each
biweekly blood draw varied.\25\ The serum level of vitamin K that would
result from consumption of 1 RDA (80 g) of vitamin K in the
absence of olestra was obtained from the control group measurements.
The compensation level was calculated as the amount of vitamin K needed
in the presence of olestra to maintain the serum vitamin K
concentration at the control level. This calculation yields
compensation levels of 31 g vitamin K in the 8 g/d group (4
g/g olestra), 68 g vitamin K in the 20 g/d group (3.2
g/g olestra), and 82 g vitamin K in the 32 g/d group
(2.6 g/g olestra). The petitioner averaged these three results
to yield an estimated compensation level of 3.3 g/g olestra.
\25\In the 8-week VR study a 7-day rotating menu was used to
ensure that the subjects received equivalent levels of phylloquinone
on the days prior to blood draws.
---------------------------------------------------------------------------
FDA concludes that the response of serum vitamin K to the previous
day's dietary intake is a reasonable, though imprecise, indicator of
olestra's effects on serum vitamin K levels. Thus, FDA concludes that
the petitioner's calculation provides only an estimate of appropriate
compensation levels. FDA's conclusion regarding the appropriate
compensation level for vitamin K is addressed in section V.B.4.e. of
this document.
v. Carotenoids. In the 8-week DR study, the petitioner found that
carotenoid bioavailability as measured by serum -carotene and
total carotenoid concentrations fell markedly with eight g/d olestra
consumption although higher levels of olestra consumption did not cause
a much larger decrease. At an olestra intake of 8 or 20 g/d, there was
about a 60 percent reduction in serum -carotene within the
first 4 weeks and there was essentially no further decline for the
remainder of the study. Olestra's effect on total serum carotenoids was
of a similar magnitude. These results were confirmed in the 8-week VR
study. FDA's conclusions regarding olestra's effects on carotenoids are
addressed in section V.B.4.f. of this document.
2. Other Human Studies
a. Six-week vitamin D/K study. The 6-week vitamin D/K study was a
double-blind, placebo-controlled, parallel design using 221 normal,
healthy, free-living subjects. The objective of this study was to
assess the status of vitamins D and K in subjects consuming 20 g/d
olestra. Subjects were randomly assigned to treatment groups and
balanced with respect to age, sex, and body mass index (BMI). Subjects
consumed a total of 20 g olestra or the corresponding triglyceride
placebo per day in cookies eaten at each meal. Subjects consumed self-
selected diets with an upper limit of 7 glasses of milk per day. Daily
food frequency records were used to estimate phylloquinone intake. The
diet was supplemented with 20 g (800 IU) ergocalciferol
(vitamin D2), taken in capsule form with the morning meal. The
study was conducted from February through April to lessen sunlight
effects on vitamin D status. Vitamin K status was assessed by
monitoring serum phylloquinone (vitamin K1), serum
Simplastin/Ecarin assay (S/E) (a measure of
functional prothrombin in blood), and prothrombin (PT) and partial
thromboplastin times (PTT). Vitamin D status was assessed by monitoring
serum concentrations of 25-OHD2, 25-OHD3, and 1,25-
(OH)2D. All serum parameters were measured every 2 weeks, while PT
and PTT were measured only at the beginning and end of the study.
The petitioner found that mean serum concentrations of 25-OHD2
rose in both placebo and olestra-fed groups, although serum
concentrations rose more slowly in the olestra-fed group. At week two
and beyond, the olestra group showed serum vitamin 25-OHD2 levels
that were about 19 percent below placebo, which persisted to the end of
the study. No statistically significant changes in the measurements
used to assess vitamin K status (S/E, clotting times, and serum
phylloquinone concentration) were observed in the study, except that at
week two, serum phylloquinone levels were lower in the olestra-fed
subjects. The petitioner concludes from these results that 20 g/d
olestra does not affect vitamin K status or vitamin D nutritional
status.
FDA disagrees with the petitioner's conclusions regarding olestra's
effects on vitamins D and K. First, the 19 percent decrease in serum
25-OHD2 is indicative of an olestra effect on nutritional status
and specifically, on vitamin D status. Second, the study is of limited
usefulness in assessing vitamin K status because the sensitivity of the
tests used to evaluate the impact of low serum vitamin K1 on vitamin K-
dependent clotting protein function is either poor (PT and PTT) or not
fully validated (S/E). Furthermore, the quantitative precision of the
study is diminished because the subjects were eating diets that were
not controlled. Thus, FDA disagrees with the petitioner's conclusion
that olestra does not affect vitamin D nutritional status and further
concludes that this study does not provide sufficient information for a
conclusion regarding olestra's impact on vitamin K1 nutritional
status (Ref. 46).
b. Sixteen-week vitamin E study. The 16-week vitamin E study was
also a double-blind, placebo-controlled, parallel design with 194
subjects. The purpose of the study was to assess the adequacy of 1.1 mg
of d- tocopherol acetate/g olestra in maintaining vitamin E
status in persons chronically consuming olestra and to determine the
potential effects of 18 g/d olestra on the status of vitamins K and D,
absorption of carotenoids, and concentrations of serum retinol. Test
subjects were normal, healthy, male and female free-living persons
between the ages of 18 to 65 who consumed 18 g/d olestra, with or
without 1.1 mg tocopheryl acetate/g olestra, or triglyceride placebo
for 16 weeks. The daily dose of olestra (contained in cookies and ice
cream) was to be consumed with meals; meal content was not controlled
and they were permitted to eat between meals foods of their own
choosing. Subjects were not specifically requested to evenly divide the
daily allocation of cookies and ice cream among the meals. Serum
concentrations of cholesterol, -tocopherol, -
carotene, and total carotenoids were measured biweekly. Serum 25-OHD
concentration, clotting times (PT and PTT), and serum levels of
functional prothrombin (S/E) were measured at weeks 0, 8, and 16.
The petitioner found that serum -tocopherol concentration
was reduced by 6 percent, relative to control, in the olestra group and
by 4 percent in olestra with added -tocopheryl acetate group.
Serum concentrations of -carotene and total carotenoids were
reduced by 21 to 29 percent in both olestra groups. Serum 25-OHD,
retinol concentrations, and vitamin K status were unaffected by olestra
consumption.
The petitioner concludes that 1.1 mg -tocopheryl acetate/g
olestra was not sufficient to compensate for olestra's effect in this
study and that olestra did
[[Page 3137]]
not affect vitamin D or K status. FDA agrees that compensation for
olestra's reduction of vitamin E status was not adequate and that there
was no evidence of an olestra effect on vitamin D and K status in this
study. However, the value of this study is limited because the subjects
were free-living, which limits the quantitative precision of the study
in predicting olestra's nutritional effects (Ref. 47).
c. Vitamin A/fat study. The vitamin A/fat absorption study was a
parallel, double-blind, placebo-controlled study of 70 healthy males.
The subjects consumed 0 or 10 g/d olestra in potato chips for a 30-day,
free-living adaptation period. The adaptation period was followed by a
14-day in-house period in which the subjects received 0, 8, 20, or 32
g/d olestra in potato chips and cookies. One-third of this daily dose
was eaten with each meal except on the days when vitamin A and fat
absorption was measured; on those days, the entire dose of olestra was
consumed in potato chips at breakfast along with the radiolabeled
marker. The dose response of olestra on the absorption of preformed
vitamin A was measured using radiolabeled retinyl palmitate.
The petitioner evaluated the results of the vitamin A aspects of
this study and concluded that neither 8 nor 20 g of olestra in a single
meal had any effect on the absorption of 3H-labeled retinyl palmitate
contained in the meal, and further that 32 g of olestra in the test
meal reduced vitamin A absorption from that meal by 19 percent relative
to controls. The petitioner also calculated that when high responders
(the group of subjects showing high triglyceride levels after fat
ingestion) were removed from the calculation, olestra's effect on
vitamin A absorption was reduced to 13 percent.
FDA finds no justification for removing a part of the subject
population from the calculation and thus believes that the 13 percent
reduction figure is of no value in assessing olestra's effects on
vitamin A. FDA agrees, however, that the study supports the conclusion
that olestra induced a 19 percent reduction, and considers this amount
to be the most accurate measurement of olestra's effect on preformed
vitamin A absorption in this study (Ref. 48).
The petitioner concluded that the lack of an effect at the lower
olestra doses (8 and 20 g) indicates that chronic consumption of
olestra at the 90th percentile estimated intake by the total population
(7 g/d) or the 90th percentile estimated acute intake for the heaviest
consumers of savory snacks (18 to 44 year old males, 20 g/d\26\) will
have no effect on preformed vitamin A absorption. While this
interpretation of the data appears to be reasonable, FDA notes that
this study only addresses olestra's effects on preformed vitamin A
absorption. The study cannot, by design, address the decrease in
vitamin A stores that would be caused by olestra's effects on
carotenoid absorption.
\26\A dose of 20 g is equivalent to the consumption of two 1-oz
servings of savory snacks at a single meal.
---------------------------------------------------------------------------
3. Pig Studies
The petitioner conducted five nutritional studies of varying
lengths (12, 12, 26, 39, and 4 weeks) in pigs. The objective of the 12-
week DR study was to confirm the hypothesized dose-response effect of
olestra on fat-soluble vitamins A, D, E, and K, and to determine
whether there were any effects on specific marker nutrients that are
difficult to absorb or are limited in the American diet (folate,
vitamin B12, calcium, iron, and zinc). The purpose of the 12-week
VR study was to determine whether the effects of olestra on the status
of vitamins A and E that were observed in the 12-week DR study could
adequately be compensated for by the addition of vitamins to the diet.
The 26-week DR/VR and the 39-week VR studies were undertaken after
the 12-week studies to evaluate olestra's effects on nutrient status in
the period beyond the maximum growth phase. The purpose of the 26-week
DR/VR study was three-fold: (1) To confirm the dose-response effect of
olestra observed in the 12-week DR study; (2) to evaluate the effect of
olestra on fat-soluble vitamins, folate, vitamin B12, calcium,
zinc, and iron, with longer exposure times and lower olestra levels
than had been tested in the 12-week DR study; and (3) to determine the
amounts of fat-soluble vitamins that would need to be added to the diet
to compensate for olestra's effects. The 39-week VR study was designed
to evaluate over a longer exposure period the effects of 0.25 percent
olestra and added vitamins A and E that were measured in the 26-week
DR/VR study. The 4-week DC study was designed to determine whether
olestra's effects on vitamins A and E were dependent on the timing of
olestra consumption (with meals or temporally separated from meals) or
the means by which olestra enters the diet (as chips or admixed with
feed).
a. Study design of 12-, 26-, and 39-week studies. The 12-week DR,
12-week VR, 26-week DR/VR, and 39-week VR pig studies used similar
materials and methods. The 12-week DR study is described in depth. For
the three other pig studies, only the differences from the 12-week DR
study are described.
i. Twelve-week DR study. The test animals were a domestic, cross-
bred strain of pigs, and were 5 to 7 weeks of age when received. All
treatment groups contained equal proportions of females and castrated
males. The pigs were acclimated for 14 to 16 days before being placed
on experimental diets: During the first 7 to 9 days of the acclimation
period, the animals were fed a 20 percent protein swine chow
(University of Wisconsin-Madison) ad libitum; during the last 7 days
they were fed the purified basal diet that was fed throughout the
remainder of the study.
The basal diet was a purified diet consisting of about 25 percent
casein, 24 percent starch, 24 percent sucrose, 5 percent Alphacel, 14
percent lard, and 8 percent of a vitamin/mineral premix. The diet
delivered about 30 percent of calories from fat, a level equivalent to
the target fat consumption level recommended for the U. S. population,
but lower than current actual fat consumption. The ratio of calories
from saturated:monounsaturated:polyunsaturated fats was targeted at
1:1:1.
The basal diet provided the National Research Council (NRC)
requirements of micronutrients for 5 to 10 kilogram (kg) pigs. The NRC
requirements, as a percentage of the feed, decline for many nutrients
as a function of increasing body weight. Therefore, as the pigs grew,
most nutrients were actually fed in excess of the body-weight-specific
NRC requirements.
In the basal diet, vitamin A was provided as a 3:1 ratio of retinol
equivalents from retinyl palmitate and -carotene,
respectively. This targeted ratio simulated the average dietary sources
of vitamin A for the U. S. population. Vitamin E was provided in the
form of d,l--tocopheryl acetate. Dietary vitamin D was
supplied as ergocalciferol (vitamin D2). In addition to dietary
vitamin D, pigs in this study were exposed to 2 minutes of ultraviolet
(UV) light each day. Vitamin K was provided as phylloquinone, the major
source of vitamin K in the human diet, rather than as menadione, the
form typically added to swine chow.\27\ Folate was provided as folic
acid, vitamin B12 was provided as cyanocobalamin, calcium as a
mixture of CaHPO42H2O
[[Page 3138]]
and CaCO3, iron as FeSO47H2O, and zinc as
ZnSO47H2O. The micronutrients were added directly to the diet,
separate from the olestra, during diet preparation.
\27\The swine NRC nutrient requirement table gives the vitamin K
requirement as menadione; there is no value listed for
phylloquinone. Therefore, the petitioner calculated the added amount
of phylloquinone based on the assumption that phylloquinone is
equivalent to menadione on a weight basis.
---------------------------------------------------------------------------
The 12-week DR study consisted of 7 groups of pigs, containing 12
pigs each (except the control group of 20 pigs). Olestra was added to
the diets at levels of 0 percent (control), 1.1 percent, 2.2 percent,
3.3 percent, 4.4 percent, 5.5 percent, and 7.7 percent (by weight). The
olestra was heated before incorporating into the diet by frying potato
chips.
Growth, feed intake, hematology, and clinical chemistry measures
and the status of vitamins A, B12, D, E, and K, and folate, calcium,
zinc, and iron were measured at regular intervals. Stores of vitamins
A, E, B12, calcium, phosphorus, zinc, and iron were measured in the
liver or bone at the termination of the study. The measurements used to
assess the status of the various nutrients are summarized in Table 6.
TABLE 6.--MEASUREMENTS OF NUTRIENT STATUS IN THE 12-WEEK DR PIG STUDY
----------------------------------------------------------------------------------------------------------------
Nutrient Measurements
----------------------------------------------------------------------------------------------------------------
Vitamin A Liver and serum concentration
Vitamin E Liver, serum, and adipose tissue concentration
Vitamin D Serum concentration of 25-OHD2, 25-OHD3, and 1,25-
(OH)2D
Vitamin K Prothrombin time
Folate Plasma concentration
Vitamin B12 Liver concentration
Calcium Bone, serum calcium, and bone ash concentration
Phosphorus Bone and serum concentration
Iron Liver iron concentration and serum concentrations of
hemoglobin, hematocrit, mean corpuscular volume (MCV),
mean corpuscular hemoglobin (MCH), and mean
corpuscular hemoglobin concentration (MCHC)
Zinc Liver, bone, and serum concentration
----------------------------------------------------------------------------------------------------------------
ii. Twelve-week VR study. The 12-week VR study consisted of 11
groups of pigs (one baseline, one control, and nine treatment groups),
each containing 10 pigs (5 castrated males and 5 females). Pigs were
exposed to 2 minutes of UV light each day. The amount of olestra and
total amounts of vitamins A, D, and E targeted to be in the diet for
the nine treatment groups is summarized in Table 7.
[[Page 3139]]
TABLE 7.--STUDY DESIGN FOR 12-WEEK VR PIG STUDY
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Percent Olestra Vitamin A (x NRC)\1\ Vitamin D (x NRC)1 Vitamin E (x NRC)1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
0 (control)....................... 1.00 1.00 1.00
1.1............................... 1.05 1.20 1.20
1.1............................... 1.35 1.80 1.90
1.1............................... 1.65 2.40 2.60
4.4............................... 1.65 2.40 2.60
4.4...............................
FR Doc. 96-1584 Food Additives Permitted for Direct Addition to Food for Human Consumption; Olestra
2.40 4.20 4.60
4.4............................... 3.15 6.00 6.60
7.7............................... 2.05 3.80 4.15
7.7............................... 3.45 6.60 7.30
7.7............................... 4.85 9.40 10.45
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Expressed as multiples of the NRC requirements of pigs.
[[Page 3140]]
A premix was prepared to provide additional amounts of vitamin A as
well as vitamin D for each level of olestra fed. Vitamin D was added as
vitamin D2 (ergocalciferol), while vitamin A was in the form of
retinyl palmitate. Above-basal levels of vitamin E, in the form of d-
-tocopheryl acetate, were combined with the olestra instead of
adding it directly to the diet because this procedure mimics that which
would be used to add vitamin E to olestra for savory snack use, i.e.,
the vitamin would be added directly to the frying oil.-
iii. Twenty-six week DR/VR study. The 26-week DR/VR study had 11
groups, each containing 10 pigs (5 castrated males and 5 females).
Olestra was fed at five levels (0.25, 0.5, 1.1, 3.3, and 5.5 percent).
Seven of the groups (baseline, control, 0.25, 0.5, 1.1, 3.3, and 5.5
percent olestra) did not have any additional vitamins above those
present in the basal diet. The other four groups consumed added
vitamins as described in Table 8.
TABLE 8.--VITAMIN DOSES FOR THE FOUR TREATMENT GROUPS IN THE 26-WEEK DR/
VR PIG STUDY THAT HAD VITAMIN COMPENSATION
------------------------------------------------------------------------
Vitamin E (mg d--
Percent Vitamin A (IU/kg diet) tocopherol acetate/g
olestra olestra)
------------------------------------------------------------------------
5.5 3,300 1.71
0.25 150 1.71
0.25 300 3.42
0.25 600 5.13
------------------------------------------------------------------------
Additional vitamins were added in the same manner as described for
the 12-week VR study. The pigs in the vitamin-compensated 5.5 percent
olestra group were exposed to 2 minutes of UV light each day. UV
exposure was eliminated in the remainder of the groups in order to
eliminate the possibility that the UV light might affect the magnitude
of olestra's effect on dietary vitamin D2. Instead, the diet was
modified by increasing the vitamin D level to two times the NRC
requirement to produce more readily measurable levels of vitamin
D2 in the serum.
In addition to the measurements of nutrient status listed in Table
6, serum parathyroid hormone (PTH) was monitored.
iv. Thirty-nine week VR study. The 39-week VR study consisted of
the following four groups of 10 pigs each (5 castrated males and 5
females): baseline, control, 0.25 percent olestra, and 0.25 percent
olestra with 150 IU vitamin A/kg diet (60 IU/g olestra) and 1.71 mg d-
-tocopherol acetate/g olestra. There was no UV exposure in
this study and the diet was modified by increasing the vitamin D level
to two times the NRC requirement to produce more readily measurable
levels of vitamin D2 in the serum. In addition, vitamin K level in
the basal diet was lowered to one-fifth the level that was fed in the
other three studies.
In addition to the measurements of nutrient status listed in Table
6, serum parathyroid hormone (PTH) was monitored.
b. Study design of the 4-week DC study. Young pigs, 7 to 9 weeks of
age at the start of the study were fed a casein-based diet formulated
to contain at least one times the NRC requirements of micronutrients.
Five groups of 10 pigs each were fed 0 percent or 2.2 percent olestra
for 4 weeks. A sixth group of 10 pigs provided baseline data for
vitamin A, D, and E tissue concentrations. The olestra was fed either
admixed in the diet, as chips prior to each meal, as chips prior to the
noon meal only, or as chips fed between the noon and evening meal.
The petitioner evaluated the change in status of vitamins A, D, and
E at the end of the 4-week study through serum measurements of the
concentrations of vitamin A (retinol), vitamin E (-
tocopherol), and vitamin D (25-hydroxyvitamin D2 and 25-
hydroxyvitamin D3) and liver measurements of vitamin A (total
retinol and retinyl esters) and vitamin E (-tocopherol).
c. Results and conclusions from pig studies. The results of the 4-
week DC study will be discussed in section V.B.4.a. of this document.
i. Vitamin A. Data on the dose-response effect of olestra on liver
vitamin A stores were collected in the 12-week DR study and the 26-week
DR/VR study. The petitioner observed that olestra caused a nonlinear
dose-response reduction in hepatic vitamin A stores, in which lower
amounts of olestra had a greater proportional effect on stores, in both
the 12-week DR and 26-week DR/VR studies. In the 26-week DR/VR study,
the decreases in liver vitamin A (relative to controls) were 45 percent
(0.25 percent olestra), 57 percent (0.5 percent olestra), 65 percent
(1.1 percent olestra), and 88 percent (3.3 percent and 5.5 percent
olestra). The reductions observed in the 12-week DR study were very
similar, with the highest olestra intake (7.7 percent) causing a
greater than 90 percent decrease. Serum vitamin A levels also decreased
in a dose-response manner with increasing olestra intake in both
studies.\28\
\28\Unlike adult pigs, weanling pigs do not have large stores of
vitamin A so liver stores are not able to compensate for olestra's
interference with absorption of vitamin A; thus the effect on
vitamin A status is also manifest in the serum levels.
---------------------------------------------------------------------------
In both the 12-week VR and the 26-week DR/VR studies, the addition
of varying levels of vitamin A to the diet resulted in a linear
increase in liver vitamin A stores. For the 12-week VR study, the
petitioner calculated that the effect of olestra on liver vitamin A
stores could be offset by adding 58.1 IU of vitamin A/g olestra in the
diet. FDA calculates the appropriate compensation level separately for
each level of olestra in the diet, because the required compensation
level in IU/g changed as a function of dietary olestra level, and
determined that the compensation level ranged from 130.8 IU vitamin A/g
olestra at 0.1 percent olestra to 45.8 IU vitamin A/g olestra at 7.7
percent olestra (Ref. 49).
For the 26-week DR/VR study, the petitioner calculated that 170 IU
vitamin A/g of olestra compensates for olestra's effects on vitamin A
liver status, which is equivalent to 93 g retinyl palmitate/g
olestra, or 0.34 RDA of vitamin A per 1-oz serving of snacks containing
10 g olestra. FDA agrees that this calculation is appropriate and that
when olestra is present at 0.25 percent of the pig diet, approximately
170 IU of retinol/g olestra maintains the liver vitamin A levels at
control values\29\ (Ref. 49). One hundred and seventy IU of retinol/g
olestra is equivalent to 51 retinol equivalents/g olestra.
\29\The estimates from the 12-week study are somewhat smaller
than estimates obtained from the 26-week pig study; in the 12-week
study, the required supplementation level for 0.25 percent olestra
was 128 IU/g olestra.
---------------------------------------------------------------------------
The petitioner concluded and FDA agrees that the results of the 39-
week VR
[[Page 3141]]
study confirm olestra's effect on vitamin A liver stores, although FDA
notes that the amount of vitamin A added to the diet in the 39-week
study (60 IU vitamin A/g olestra) was not sufficient to compensate for
olestra's effect on vitamin A.
ii. Vitamin E. In the 26-week DR/VR study, the decreases in liver
vitamin E (relative to controls) were 24 percent for 0.25 percent
olestra, 31 percent for 0.5 percent olestra, 53 percent for 1.1 percent
olestra, 71 percent for 3.3 percent olestra, and 75 percent for 5.5
percent olestra. In the 12-week DR study, the reductions were slightly
larger (e.g., 60 percent for 1.1 percent olestra, 69 percent for 2.2
percent olestra, 75 percent for 3.3 percent olestra, 78 percent for 4.4
percent olestra, 80 percent for 5.5 percent olestra, and 81 percent for
7.7 percent olestra). Vitamin E concentration in adipose tissue showed
a slightly smaller decrease in both studies; for example, with 5.5
percent olestra, adipose vitamin E concentration had fallen by about 73
percent in both the 12-week DR and 26-week DR/VR studies.
The results of the 12-week DR and 26-week DR/VR studies showed that
effects of olestra on vitamin E status were similar in the serum and
liver, although the percent decrease in vitamin E was slightly larger
for liver than for serum. The petitioner concluded, and FDA concurs,
that this relationship confirms that serum vitamin E concentration is a
reliable measure of vitamin E status. The concentration of vitamin E in
adipose tissue also changed in a similar fashion to the changes in
serum and liver concentrations although the magnitude and rate of
change were not as great.
The petitioner concludes that 2.09 IU of vitamin E/g olestra offset
olestra's effects in the 12-week VR study; in the 26-week DR/VR study
(where olestra was fed at a lower level), 2.79 IU of vitamin E/g
olestra (which translates to 2.06 mg d--tocopheryl acetate/g
olestra) offset olestra's effects. FDA concurs with the petitioner's
general conclusions and with the calculated level of 2.79 IU vitamin E/
g olestra from liver measurements in the 26-week VR/DR study. FDA's
calculated compensation levels for the other studies, as shown in Table
9, differ slightly because of small differences in the choices of
variables to fit the curves in the statistical analyses (Refs. 50 and
51).
[[Page 3142]]
TABLE 9.--FDA-CALCULATED COMPENSATION LEVELS OF VITAMIN E TO RESTORE LIVER AND SERUM LEVELS BASED ON 12-WEEK VR AND 26-WEEK DR/VR STUDIES
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Vitamin E compensation (IU/g olestra)
Study Olestra level (%) -------------------------------------------------------------------------------------------------------------------
Liver compensation level Serum compensation level
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
26-week DR/VR 0.25 2.79 2.98
12-week VR 1.1 2.66 2.76
12-week VR 4.4 2.27 2.34
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 3143]]
iii. Vitamin D.--a. Petitioner conclusions. The petitioner
concluded that the 12-week DR study established a dose-response effect
for olestra on dietary vitamin D at olestra levels up to 4.4 percent of
the diet, as measured by serum concentration of 25-OHD2; the serum
concentration of 25-OHD2 was about 10 percent less than control in
the 1.1 percent olestra group and about 35 percent less than control in
the 2.2 percent, 3.3 percent, and 4.4 percent groups. At higher olestra
levels, changes in the dietary contribution to total circulating 25-OHD
were confounded by changes in the contribution from vitamin D3
synthesized in the skin.
The petitioner also concluded that in the 12-week VR study, serum
concentration of 25-OHD2 increased in a dose-response manner as
the amount of vitamin D2 added to the basal diet was increased, at
all levels of olestra. However, interpretation of the serum 25-
OHD2 data at the mid- and high-olestra levels (4.4 and 7.7
percent) was confounded because the proportion of 25-OHD3 in the
serum decreased with increasing levels of olestra at these treatment
levels. The petitioner has suggested, that this decrease in serum 25-
OHD3 may have resulted from the effect of the high levels of
olestra on the reabsorption of biliary vitamin D3. Reduced
reabsorption of biliary vitamin D3 would tend to increase the
serum concentration of 25-OHD2 because of diminished vitamin
D3 competition for the liver 25- hydroxylase.
Using the serum 25-OHD2 concentrations from the groups fed 1.1
percent olestra in the 12-week VR study, the petitioner calculated that
the amount of vitamin D required to restore serum 25-OHD2 to the
control level was 13.0 IU vitamin D/g olestra, which is equivalent to
0.33 RDA/1 oz serving of chips containing 10 g olestra. The petitioner
considers that the confounding effect of vitamin D3 was absent or
minimal when olestra was fed at 1.1 percent of the diet.
The petitioner concluded that in the 26-week DR/VR study, 5.5
percent olestra (no extra vitamins) reduced plasma 25-OHD2 by 20
percent at week 26. At week 16, serum 25-OHD2 levels in the 3.3
percent and 5.5 percent olestra groups were significantly lower than
controls by 23 percent and 35 percent, respectively.
The petitioner concluded that in the 39-week VR study, olestra
decreased serum levels of 25-OHD2 by the same magnitude as in the
26-week DR/VR study, while serum 25-OHD3, total serum 25-OHD, and
serum 1,25-(OH)2D were not affected. Serum 25-OHD2 levels
were 13 to 15 percent lower than week 12 and week 26. At week 39, the
values were 6 to 11 percent lower than controls, but this difference
was not statistically significant.
b. FDA conclusions. FDA concludes that the results of the pig
studies are of limited utility for quantifying olestra's effects on
vitamin D, for several reasons. First, FDA notes that vitamin D levels
were never measured in the diet as fed in any of the pig studies. This
lack of measurement leaves open the possibility that addition or mixing
errors might have occurred, affecting the vitamin D levels in the feed.
Second, the confounding effect of UV exposure in several of the studies
makes interpretation of the results difficult.
The 26-week DR/VR study was designed to prevent UV light exposure
to any group except the 5.5 percent olestra/low vitamin group where 2
minutes of exposure were to be provided per day. However, an accidental
UV light exposure (not more than 13 hours) to this group on day 23 of
the study likely caused the very high 25-OHD3 levels and very low
25-OHD2 levels observed at week 4. In addition to the accidental
exposure of the 5.5 percent olestra/low vitamin group to UV light, it
appears that at least 10 other animals may have been exposed to UV
light in at least the 12th week of the study, as evidenced by their
elevated serum 25-OHD3 levels. Because a definitive cause for
these elevated serum 25-OHD3 values could not be determined, FDA
considers the vitamin D data from the 26-week DR/VR study to be
confounded (Ref. 52).
Although pigs in the 39-week study were not exposed to UV light,
pigs consumed only one level of olestra, therefore no dose-response
information was obtained.
FDA agrees with the petitioner that in the 12-week VR study, serum
concentration of 25-OHD2 increased in a dose-response manner as
the amount of vitamin D2 added to the basal diet was increased, at
all levels of olestra. FDA further agrees with the petitioner that the
decrease in serum 25-OHD3 observed in the mid- and high-level
groups may have resulted from olestra's effects on the reabsorption of
biliary vitamin D3. However, FDA also believes that the serum 25-
OHD2 levels may have been confounded by the daily 2-minute
exposure to UV light, which caused an increase in serum levels of 25-
OHD3 in both 12-week studies. Therefore, FDA concludes that the
results from the mid- and high-dose groups in the 12-week VR study
cannot be used to determine a quantitative compensation value for
vitamin D2 because of the apparent interaction between serum 25-
OHD3 and 25-OHD2 levels.
FDA believes that the most useful data from the pig studies comes
from a comparison of the control and 1.1 percent olestra groups in the
12-week VR study. Accordingly, FDA believes that the petitioner's
calculation based on the 12-week VR study that 13 IU vitamin D/g
olestra will compensate for olestra's effects in pigs exposed to daily
UV light may be an approximation of appropriate supplementation level
for vitamin D. However, the agency believes that it cannot rely on the
12-week VR data by themselves to establish a compensation value for
vitamin D2, because of the possible confounding effects of UV
exposure and the lack of measurements of vitamin D levels in the diets
as fed (Refs. 53 and 54).
iv. Vitamin K. There were no statistically significant effects of
olestra on prothrombin time in any of the pig studies. The petitioner
concluded, therefore, that olestra does not affect vitamin K status.
Although FDA agrees that prothrombin time was not affected by olestra
consumption, the agency does not believe that these results are
adequate to determine the potential effects of olestra on vitamin K
status, because, as discussed below, prothrombin time is not a
sufficiently sensitive analytical method and the diets of the test
animals appear to have been overfortified with vitamin K.
Prothrombin time is an insensitive indicator of vitamin K status.
The petitioner agrees that there are more sensitive indicators of
vitamin K status such as direct measurements of clotting factors in
blood, urinary excretion of -carboxyglutamic acid, and plasma
levels of des-carboxylated or under-carboxylated vitamin K-dependent
proteins (the PIVKA-II assay). The petitioner states however, that
these methods were not used because they had not been used previously
or validated in the pig and no body of historical data exists.
Nevertheless, FDA believes that use of an insensitive indicator limits
the conclusions that can be drawn from these pig studies regarding
vitamin K status.
FDA believes that the usefulness of the data from the 12-week and
26-week DR/VR studies is further limited because test animal diets were
oversupplemented with vitamin K. Because vitamin K is a highly
lipophilic fat-soluble vitamin, FDA considers it reasonable to assume
that it will partition into the olestra in the GI tract, in the same
manner as the other fat-soluble vitamins. Thus, oversupplementation is
significant
[[Page 3144]]
because it could mask any effect of olestra on vitamin K status.
FDA believes the pig diets were oversupplemented with vitamin K in
the 12-week and 26-week DR/VR studies for two reasons. First, the NRC
requirement for vitamin K in swine is in terms of amounts of menadione,
not phylloquinone (the form of vitamin K fed to the pigs). The NRC
requirement for menadione, 500 g/kg, is in a corn-soybean meal
base and this likely exceeds the requirements needed for a casein-based
semisynthetic diet that should not contain any substance that might
inhibit vitamin K metabolism. Second, FDA disagrees with the
petitioner's assumption that phylloquinone is necessarily of equal
potency on a weight basis as menadione. Unlike phylloquinone, menadione
is biologically inactive and must be alkylated in the liver to
menaquinone to become biologically active. Phylloquinone, following
intracardiac administration, was 10 times more active than menadione on
a weight basis at restoring the prothrombin response in rats that were
partially depleted of vitamin K (Ref. 55). Therefore, FDA cannot rule
out the possibility that phylloquinone is a more potent source of
vitamin K on a weight basis than menadione in swine following oral
administration, which would lead to further oversupplementation (Ref.
56).
4. Overall Conclusions Regarding Olestra's Effects on Fat-Soluble
Vitamins-
a. Consumption scenarios. The petitioner has asserted that in the
8-week human studies and in all of the pig studies (except the 4-week
DC study), olestra's effects on fat-soluble nutrients are exaggerated
because the additive was always consumed with meals. In addition, in
the pig studies, olestra was admixed with all the feed, rather than
being present in only select dietary ingredients (such as chips). The
petitioner hypothesizes that if olestra is eaten in a snack between
meals (instead of being eaten with a meal), there will be fewer
nutrients available with which it can interact, and that olestra's
effects on nutrients would be expected to be greatest when olestra and
the nutrients are intimately intermixed in the GI tract at the same
time.
The petitioner has provided results of consumption surveys showing
that in the United States, at the estimated 90th percentile consumption
level, savory snacks are eaten only four times per week, and one-third
of those occasions are between meals. With this consumption pattern,
olestra savory snacks will be eaten 32 times in an 8-week period (as
compared to 168 meals during that time), and 20 of those times will be
with meals. (In other words, during the 8-week period, 148 meals (or 88
percent) will be consumed without a savory snack.) These data mean
that, although a majority of snacks are eaten with meals, because of
the infrequency of snack consumption, a majority of nutrient intake
will occur in the absence of olestra savory snacks. In contrast, in
both 8-week studies, olestra was eaten 165 times in 8 weeks with every
meal, which means that essentially all of the nutrient intake occurred
with olestra consumption.
The petitioner presented the following examples of the consequences
of consumption patterns on olestra's effects on nutrients. First, the
petitioner calculated the expected effect of olestra on -
carotene in consumers eating snacks with the eating patterns reported
in the MRCA survey data.\30\ In the first scenario, the petitioner
assumed that absorption of -carotene eaten with olestra would
be decreased by 60 percent and absorption of -carotene eaten
at all other times would not be affected. In a second scenario,
presented at the Olestra Working Group and FAC meetings,\31\ the
petitioner assumed that absorption of -carotene eaten with
olestra would be decreased by 60 percent, absorption of -
carotene eaten at eating occasions either before or after the olestra
eating occasion would be decreased by 30 percent, and absorption of
-carotene eaten at all remaining times would not be affected.
Using these assumptions the petitioner calculated that an average snack
consumer would have a decrease in serum -carotene levels of
5.6 percent in the first scenario and about 6.8 percent in the second
scenario. For the heaviest consumers (top 10 percent), the first
scenario would result in a decrease in serum levels of about 10
percent, while the second scenario would result in decreases of 13 to
14 percent.
\30\ Transcript, vol. 1, p. 84 and vol. 3, p. 234.
\31\Transcript, vol. 3, p. 234.
---------------------------------------------------------------------------
The petitioner further asserts that the 4-week DC study in pigs and
16-week vitamin E study provide evidence that olestra's effects on fat-
soluble nutrients measured in the pig studies and in the 8-week human
studies exaggerate the effects expected with a normal savory snack
consumption pattern. This effect is confirmed by a comparison of the 8-
week DR study (where olestra and the vitamins were always consumed
concurrently) with results of the 16-week vitamin E study (in which
free-living subjects consumed olestra throughout the day but not
necessarily concurrently with the consumption of all vitamin E or
carotenoids). In the 8-week DR study, the effects on vitamin E status
and serum -carotene concentration measured in the 20 g/d
olestra group are about three-fold greater than those measured in the
free-living subjects in the 16-week vitamin E study consuming 18 g/d
olestra.
In the 4-week DC study in pigs, the reduction of vitamin A liver
stores in pigs fed 2.2 percent olestra was about 44 percent compared to
controls when olestra was fed admixed in the diet and about 14 percent
when olestra was fed in potato chips with all meals. Similarly, the
reduction of liver and serum vitamin E concentrations in pigs fed 2.2
percent olestra admixed in the diet was about twice as large (60
percent for liver and 52 percent for serum compared to controls) when
olestra was fed admixed as when olestra was fed in potato chips with
all meals (30 percent and 20 percent for liver and serum,
respectively). Therefore, the petitioner has concluded that the effects
of olestra that were measured in the 12-week DR, 12-week VR, 26-week
DR/VR, and 39-week VR pig studies were exaggerated by about 3-fold for
vitamin A and about 2-fold for vitamin E over what would have been
observed if the olestra were fed in chips with meals.
FDA agrees that when savory snacks containing olestra are eaten
without other foods, olestra's effects on fat-soluble vitamins will be
less than the effects measured in the 8-week human studies or in the
12-, 26-, and 39-week pig studies. However, FDA concludes that, given
the wide variety of possible dietary patterns, the most protective
approach is to ensure that compensation levels that accommodate most,
if not all of those dietary patterns. Slight overcompensation with
vitamins A, E, D, and K that might occur if an individual were to eat
all olestra-containing snacks separate from other foods would not raise
any health concerns, as discussed below. In contrast, the potential for
developing vitamin deficiencies in some of the population that
preferentially eat olestra-containing snacks with meals is of
sufficient concern to merit this approach. Further, calculating
compensation levels using the with-meal study results provides an
additional measure of safety, because based on the MRCA data, it is
probable that not all olestra consumed in savory snacks will be eaten
with meals. Therefore, FDA is not relying on the results of the
contextual studies or calculations based on eating patterns in
[[Page 3145]]
evaluating the safety of olestra with regard to nutrient effects.
b. Vitamin A. FDA and the petitioner agree that olestra's effects
on vitamin A present significant health concerns and, therefore,
compensation for olestra's interference with this vitamin's absorption
should be made. The pig studies show that olestra consumption has a
dose-response effect on vitamin A that is nonlinear, having the
greatest effect (on a per-gram-of-olestra basis) at low olestra
consumption levels. The level of vitamin A compensation was calculated
using data from the pig studies in which the effect of olestra and
olestra with added retinyl palmitate on vitamin status were determined.
Thus, the pig studies provide the most direct measure of vitamin A
status. Calculations were based on the effect at the lower olestra
doses to ensure that compensation is sufficient for all consumers.
Both the petitioner and FDA have calculated that 170 IU of vitamin
A/g olestra (51 retinol equivalents/g) compensates for olestra's
effects on vitamin A (from both preformed vitamin A and the provitamin
A carotenoids). This amount is equivalent to 0.34 times the RDA in a 1-
oz serving of savory snacks containing 10 g of olestra.
The results of the vitamin A/fat study in humans showed that only
the highest dose of olestra (32 g/d) had a measurable effect on
preformed vitamin A absorption. This direct measurement of olestra's
effect on absorption of preformed vitamin A in humans shows less of an
effect than the observed effect on vitamin A stores in the pig studies,
a difference likely due to the decreased absorption of carotenoids in
the pig studies, which are therefore less available as provitamin A
sources. Vitamin A added to olestra in the 12-week DR, 26-week DR/VR
and 39-week VR pig studies compensated for both the loss of preformed
vitamin A and carotenoids as provitamin A sources, as it would when
olestra is compensated in savory snacks. Therefore, FDA concludes that
relying on the pig data to calculate the compensation level will
account for olestra's effects on absorption of both preformed vitamin A
and carotenoids as contributors to the vitamin A body stores.
During the Olestra Working Group meeting, the members of the
Olestra Working Group unanimously agreed that FDA had appropriately
evaluated the amount of vitamin A with which olestra should be
compensated.\32\
\32\Transcript, vol. 3, pp. 220-225.
---------------------------------------------------------------------------
At the FAC meeting, Dr. Rodier, an embryologist and member of the
FAC, expressed concern about the potential toxicity, especially
teratogenicity, of the vitamin A that would be added to olestra.\33\
She pointed out that since 1986, the Teratology Society has recommended
that vitamin supplements not contain preformed vitamin A, but that they
contain carotenoids instead. FDA is aware of a recent study
investigating the teratogenicity of vitamin A intake (Ref. 57), in
which an association was found between the prevalence of defects
associated with cranial-neural-crest tissue in babies and consumption
by their mothers of preformed vitamin A supplements during pregnancy.
The researchers found an apparent threshold for the effect of about
10,000 IU of supplemental preformed vitamin A (i.e., in addition to
vitamin A consumed in the diet). Consumers eating large amounts of
olestra might obtain a small amount of bioavailable vitamin A from
olestra because the compensation level was calculated from low olestra
doses where the effect/g olestra is the highest. However, because the
teratogenic effects seen by Rothman et. al., occur with vitamin A
intakes more than 10,000 IU above that which is consumed in the daily
diet, and because most of the vitamin A in olestra will remain in the
olestra as it passes through the body, FDA concludes that there is no
reasonable scenario of olestra consumption from savory snacks that
would lead to vitamin A leaching out of the olestra at levels anywhere
near 10,000 IU. Therefore, the agency is requiring vitamin A
compensation at 170 IU/g olestra (51 retinol equivalents/g).
\33\Dr. Patricia Rodier, is a senior scientist in the Department
of Obstetrics and Gynecology, University of Rochester. Transcript,
vol. 4, p. 99.
---------------------------------------------------------------------------
c. Vitamin E. FDA and the petitioner agree that olestra's effects
on vitamin E present significant health concerns and, therefore,
compensation for this vitamin should be made. Serum data from the human
studies provide the basis for calculating the appropriate compensation
level for vitamin E, and the calculations are supported by the results
of the pig studies. The petitioner has calculated that 1.9 mg
-tocopherol equivalents (2.8 IU vitamin E) should be added per
g of olestra to compensate for olestra's effect on vitamin E levels.
This amount is equal to 0.94 times the RDA in a 1-oz serving of snack
containing 10 g of olestra. The compensation level calculated from the
pig studies for the lowest olestra consumption level (which shows the
largest effect when calculated per g of olestra) is 2.79 IU vitamin E/g
olestra, which is essentially the same as the compensation level
calculated from the 8-week human studies.
During the Olestra Working Group meeting, the members of the
Olestra Working Group unanimously agreed that FDA had appropriately
evaluated the amount of vitamin E with which olestra should be
compensated. Therefore, FDA is requiring vitamin E compensation at 2.8
IU/g olestra (1.9 mg -tocopherol equivalents/g olestra), which
will adequately compensate for olestra's effects in all realistic
consumption scenarios.
d. Vitamin D. The petitioner concluded that the effects of olestra
on vitamin D2 concentration do not warrant compensation with
vitamin D. As support, the petitioner cites the absence of changes in
serum 1,25-OH2D concentration in the pig studies as evidence that
olestra has no significant effect on overall vitamin D status despite
the decrease in dietary vitamin D2 status. Typically, the
contribution of dietary vitamin D to total vitamin D status in the
general population is from 10 to 20 percent (the rest from sunlight-
induced synthesis in the body). Therefore, the petitioner reasons that
a 23 percent decrease in dietary vitamin D status would result in only
a 2.3 to 4.6 percent reduction in overall vitamin D status in a normal
healthy human under the exaggerated conditions of olestra consumption
used in the studies. In worst-case situations, where dietary vitamin D
can contribute up to 50 percent of total vitamin D, the petitioner
calculates that the reduction in overall vitamin D status would be 11.5
percent when olestra was consumed with every meal.
FDA disagrees with the petitioner's position that the effect of
olestra on vitamin D is not sufficient to warrant compensation.
Although most individuals can produce vitamin D through exposure to
sunlight, there are some people who may not synthesize sufficient
vitamin D to compensate for potential decreases due to olestra effects,
either because they are not exposed to sufficient sunlight or because
they utilize sunlight poorly to synthesize vitamin D. Therefore, FDA
concludes that compensation for vitamin D should also be required for
olestra-containing foods.
From the 8-week human studies, the petitioner calculated that 0.07
g vitamin D2/g olestra (0.07 times the RDA per 10 g of
olestra) would be sufficient to compensate for the olestra-induced
decrease in 25-OHD2. FDA notes that in the 8-week VR study, 0.2
g vitamin D2/g olestra slightly overcompensated for
olestra's effects on vitamin D status, as measured by total 25-OHD
levels.
[[Page 3146]]
However, these values are based on only two compensation levels, and
may be confounded by the fact that serum vitamin D levels continued to
decrease over time in the study.
The petitioner has also calculated, from the 1.1 percent olestra
group of the 12-week DR pig study, that 13.0 IU vitamin D/g olestra
(0.33 times the RDA per 10 g of olestra) would compensate for olestra's
effects in that group. Although the design of that study also contains
some weaknesses, FDA believes that the results of both the pig study
and the 8-week human studies, considered together, support the need for
a compensation level and provide an approximation of an appropriate
level.
Given the importance of vitamin D, FDA concludes that it is
preferable to compensate consistent with olestra's demonstrated effects
on vitamin D, rather than risk a deficiency (Ref. 58). FDA concludes
that addition at levels of 12 IU vitamin D/g olestra (0.3 g/g
olestra) or 0.3 times the RDA per 10 g of olestra, is adequate to
compensate for any vitamin D that is lost due to diminished absorption
caused by olestra. This level of vitamin D includes the amount that was
observed to compensate for olestra's effects in the 12-week DR pig
study and is slightly higher than the 0.2 g/g that was
observed to be sufficient in the 8-week VR human study. During the
Olestra Working Group meeting, the members of the Olestra Working Group
unanimously agreed that FDA had appropriately evaluated the amount of
vitamin D with which olestra should be compensated.
This level of vitamin D compensation does not raise any toxicity
concerns, even if olestra as actually consumed has no effect on the
absorption of vitamin D, because it is generally accepted in the
medical community that one would have to ingest five times the RDA (the
RDA is 400 g of vitamin D) before toxicity effects begin to
occur (Ref. 59). Thus, slight overcompensation with vitamin D would not
cause health concerns. Assuming that the daily diet contains an RDA of
vitamin D, olestra would have to contribute four times the RDA (or
1,600 IU), which is equivalent to the amount added to about 13 oz of
potato chips, to reach levels where toxicity effects begin. However,
most of the vitamin D in olestra would not be bioavailable. Therefore,
FDA is requiring compensation with 12 IU vitamin D/g olestra (0.3
g/g olestra).
e. Vitamin K.--i. Petitioner conclusions. The petitioner concluded
that the effects of olestra on serum phylloquinone levels will not pose
a potential public health concern, and therefore, compensation of
olestra savory snacks with vitamin K is not necessary. The petitioner
based this conclusion on: (1) The absence of olestra effects on the
sensitive measures of vitamin K function under exaggerated conditions
of the studies conducted in humans; (2) the presence in the U.S. diet
of significantly more vitamin K than the single RDA fed in the studies
in which no effects on sensitive measures were observed; (3) the fact
that the dietary level of vitamin K associated with detectable effects
on sensitive functional parameters is well below the RDA; and (4) the
absence of either a dietary pattern consistent with, or clinical
evidence for, the existence of subgroups within the U.S. population at
risk of vitamin K deficiency.
The petitioner concluded that functional measures of vitamin K
status provide a reliable basis for public health decisions regarding
this vitamin, because these measures provide a direct assessment of the
ability of the vitamin K supplied to the tissues to maintain normal
vitamin K function. Because, unlike vitamins A, D, and E, there are no
significant phylloquinone stores in the body and serum concentrations
of the vitamin fluctuate significantly throughout the day, these
functional measures provide an integrated picture of the supply of
vitamin K over a time period as short as 2 to 3 days. Fasting serum
measures of phylloquinone, on the other hand, may not reflect the true
status of vitamin K because of the very short half-life of the vitamin
in the plasma (less than 2 hours). At any given time during the day,
the serum concentration of phylloquinone may suggest low or inadequate
vitamin K supply, while the tissues may be receiving more than adequate
amounts to support maximal rates of carboxylation.
The petitioner further concluded that urinary Gla excretion and
plasma des--carboxylated prothrombin (PIVKA-II) are the
markers of vitamin K function that best reflect the integrated vitamin
K status of the individual over time. If the phylloquinone supply from
the diet falls below a level adequate to support maximal synthesis of
vitamin K-dependent proteins in the body, PIVKA-II and urinary Gla will
change to reflect the inadequate supply. The half-lives of prothrombin
(Factor II) and of the vitamin K-dependent proteins which contribute
the majority of the urinary Gla excretion (60 hours or more) are
significantly longer than the half-life of phylloquinone in plasma
(about 2 hours). Therefore, the petitioner argues, these functional
measures provide a sensitive index of potential chronic effects on the
adequacy of vitamin K in the diet. Urinary Gla is particularly
important because it reflects carboxylation of vitamin K-dependent
proteins in all tissues, including bone and kidney. Although the
petitioner believes that compensation for vitamin K is unnecessary, the
petitioner has evaluated olestra's effect on vitamin K by comparing
serum vitamin K levels with vitamin K dietary intake at varying olestra
levels, and has determined that 3.3 g vitamin K/g olestra will
restore serum vitamin K levels to those of the control group. This
level is less than one-half of the 80 g RDA, when contained in
a 1-oz serving of savory snacks containing 10 g olestra. Because the 8-
week DR study was not designed to assess the olestra dose response for
vitamin K, the compensation level calculated by the petitioner is only
an estimate of an appropriate compensation level.
ii. FDA conclusions. FDA concludes that the data from the 8-week
human studies show that serum vitamin K levels were decreased by
consumption of olestra, and that the lack of effect on functional
assays could be attributable to the use of a subject population that is
not at risk for vitamin K deficiency. Similarly, as noted, the lack of
an olestra effect on prothrombin time in the pig studies may be
explained by the insensitivity of the analytical method and
oversupplementation of the test diet with vitamin K. While olestra may
not pose a health risk due to moderate reductions in serum vitamin K
levels for healthy adults consuming diets that, on average, provide
them with the minimum RDA for fat-soluble vitamins and other nutrients,
these reductions of vitamin K could be of concern for segments of the
population at risk for vitamin K deficiency or where the control of
blood clotting is more critical.
There were no studies designed to assess the dose-response nature
of olestra's effect on vitamin K. The pig studies are not useful in
this case because of the uncertainty regarding the activity of
menadione and phylloquinone in the swine diet and the likelihood that
the NRC requirements for swine are much higher than actual need. In
contrast, the 8-week DR study in humans is useful for estimating an
appropriate compensation level because the diet contained approximately
1 RDA of vitamin K and the dietary levels of vitamin K on the day
before blood draws varied for each blood draw.
FDA believes that the consequences of vitamin K depletion are
sufficiently serious and their onset so sudden as to warrant addition
of vitamin K to olestra-containing food. Also, it is well
[[Page 3147]]
recognized in the medical community that large doses of vitamin K can
be tolerated with no toxic effects.\34\ Thus, even if compensation with
vitamin K is not necessary for all olestra consumers, such compensation
poses no safety concern. FDA further believes it is appropriate to
require compensation at a level somewhat higher than that calculated
from the 8-week DR study, to provide a greater assurance of safety.
Given that the RDA is 80 g/d and vitamin K exhibits no known
toxicity, FDA recommended at the Olestra Working Group and the FAC
meetings that a level of 8 g vitamin K/g olestra, or one times
the RDA per 10 g of olestra, would provide an adequate compensation
level of vitamin K and would not cause any concern over toxicity.
\34\FDA is not aware of any toxic effects of phylloquinone. In
addition large quantities are routinely given for certain specific
situations. For example, infants usually receive a single dose of
0.5 to 1.0 mg vitamin K injected intramuscularly shortly after birth
to protect against bleeding.
---------------------------------------------------------------------------
During the Olestra Working Group meeting, the members of the
Olestra Working Group unanimously agreed that FDA had appropriately
evaluated the amount of vitamin K with which olestra should be
compensated. Although there was no disagreement among FAC members that
slight overcompensation with vitamin K would not be of concern to the
general public, a Working Group member\35\ and two presenters\36\
expressed concern about the effect that olestra consumption (whether or
not compensated with vitamin K) would have on persons for whom blood
clotting should be controlled, such as persons taking coumarin drugs.
\35\Donna Richardson, J.D., R.N., Howard University, Midlantic
Women's Health Initiative. Ms. Richardson is a member of the FAC
(Transcript, vol. 3, p. 255).
\36\Dr. Michael Jacobson, CSPI (Transcript, vol. 3, p. 179 and
vol. 4, p. 15), and Dr. Ian Greaves, Associate Professor, and Deputy
Director, Minnesota Center for Environmental and Health Policy,
University of Minnesota School of Public Health. Dr. Greaves
presented at the request of CSPI (Transcript, vol. 2, p. 267).
---------------------------------------------------------------------------
Dr. John Suttie, a researcher in the vitamin K field,\37\ responded
to these concerns. Dr. Suttie stated that monitoring of Coumadin
therapy is a well-recognized problem, and that Coumadin doses must be
titrated because of a number of adverse influences in such therapy. He
and the petitioner\38\ stated that diet is usually not one of the
primary factors of concern in anticoagulation therapy, even though
dietary vitamin K intake can vary day-to-day by three- to four-fold.
Dr. Suttie asserted that changes due to consumption of vitamin K-
compensated olestra would likely be within the normal range of dietary
variation.
\37\Dr. John Suttie is a biochemist and nutritionist at the
University of Wisconsin. Dr. Suttie consulted with the petitioner
and presented at its request. Transcript, vol. 3, p. 256.
\38\Dr. John Peters, Procter and Gamble, Transcript vol. 1, p.
147.
---------------------------------------------------------------------------
FDA concurs with Dr. Suttie's statements and concludes that olestra
should be compensated with 8 g vitamin K/g olestra. The
majority of the FAC members also agreed that olestra should be
compensated with vitamin K, and that the level selected by FDA is
appropriate. FDA notes that if, in the future, the petitioner develops
data that demonstrate that a lower level of compensation would be
adequate, a petition could be submitted requesting an appropriate
change in the required compensation level.
f. Carotenoids.--i. Data and information regarding carotenoids. The
human studies demonstrate that consumption of olestra affects serum
carotenoid levels. The petitioner concludes, and FDA concurs, that
supplementing olestra with vitamin A will compensate for olestra's
effects on the provitamin A function of carotenoids. There was no
disagreement with this conclusion during the discussions at the Olestra
Working Group and FAC meetings. The petitioner also concluded that it
is not necessary to compensate olestra with any carotenoids, as there
are no established beneficial health effects (aside from their
provitamin A role) and further, that olestra's effect on carotenoid
availability in the body is likely to be much smaller than that shown
in the 8-week studies.
At the Olestra Working Group and FAC meetings, there was a thorough
discussion of the possible beneficial health effects of carotenoids in
preventing illnesses such as macular degeneration, prostate and lung
cancer, and heart disease and whether olestra's effects on carotenoids
would increase the risk of disease. In addition, the White Paper which
was provided to the Committee, addressed the potential detrimental
health impact of olestra's effect on carotenoids (Ref. 3). Information
was also presented on whether carotenoids themselves have beneficial
health effects, or whether it is other substances in the fruits and
vegetables that provide the health benefits, and that carotenoids are
serving solely as markers for fruit and vegetable consumption.
In his presentation to the Olestra Working Group,\39\ Dr. Meir
Stampfer, a professor of nutrition, stated that the results of an
epidemiological study showed that higher levels of carotenoid intake,
particularly lutein and zeaxanthin (which concentrate in the macula),
have a marked protective effect against macular degeneration (Ref. 60).
In addition, he stated that epidemiologic data show that individuals
with high levels of lycopene intake were at a lower risk for developing
prostate cancer a reduction that was statistically significant (Ref.
61). Dr. Stampfer also stated that there are many epidemiologic studies
showing that individuals with high levels of plasma or serum
carotenoids have a lower risk of lung cancer. Written information
provided to the Committee also discussed the role of carotenoids in
preventing cataracts, cardiovascular disease, and stroke.\40\
\39\Dr. Meir Stampfer is a professor of nutrition at Harvard
University School of Public Health. Transcript, vol. 1, p. 154. CSPI
also provided FDA with a letter from Dr. Stampfer and Dr. Walter
Willett prior to the FAC meeting. Dr. Stampfer presented at the
request of CSPI.
\40\See for example Refs. 3 and 62.
---------------------------------------------------------------------------
Dr. Alvan Feinstein critiqued the epidemiological data for
carotenoids in his presentation to the FAC.\41\ Dr. Feinstein stated
that the epidemiologic evidence is not conclusive that carotenoids
reduce the incidence of cancer or any other disease. Dr. Feinstein
stated that epidemiologic case-controlled or other observational
studies are problematic because the baseline state of those studied is
not identified. In the studies of macular degeneration and of various
cancers, for example, the health or disease state of participants
before exposure is not known and differences may not be noted or
adjusted for. Also, the compared agents are ascertained in retrospect,
after they were taken; that ascertainment may be inaccurate or biased
by a knowledge of outcome events. In addition, epidemiological studies
lack reliability in terms of participants' accounts of what they ate or
did not eat in the past. Finally, in such epidemiologic studies it is
difficult to determine and adjust for the agent of interest (e.g.,
carotenoids, fruits, vegetables, or lycopenes).
\41\Transcript, vol. 1, p. 172.
---------------------------------------------------------------------------
Dr. Feinstein stated that, given these limitations with
epidemiological studies, researchers, in general, are very reluctant to
draw causal conclusions from epidemiologic data and prefer to rely,
whenever possible, on randomized trials. One reason that randomized,
experimental trials are preferable for
[[Page 3148]]
establishing cause and effect relationships is that the baseline state
is clearly specified by the admission criteria, and the randomization
produces an equal distribution for the differences in susceptibility to
disease.
Dr. Feinstein discussed the results of the randomized trials
concerning the health effects of carotenoid. He stated that to date,
there have been five randomized trials of the effects of carotenoid
consumption on disease, and that the data thus far have shown no
convincing beneficial effect. A 1994 study in Finland assessed the
effects of dietary supplements containing -carotene versus
placebo with lung and other cancers and identified a possible harmful
effect of the carotenoid supplements.\42\ Other studies assessing the
possible association between carotenoid supplement intake and
nonmelanoma skin cancer (Ref. 64), and colorectal cancer (Ref. 65) also
established no difference between the carotenoid and placebo groups in
the selected outcome or in effects in the eye or coronary disease.
Finally, a study examined the association between a combination of
supplements (no placebos) and the death certificate diagnoses of cancer
and found no statistically significant differences (Ref. 66).
\42\Dr. Greaves mentioned that blood draws at the beginning of
the Finland study showed that men in the lower quartile for serum
-carotene in the blood had significantly higher incidence
rates of lung cancer than the men with the high levels of -
carotene in blood (Ref. 63).
---------------------------------------------------------------------------
The assessment of the significance of olestra's depletion of serum
carotenoid should include consideration of the magnitude of the effect
compared to variations in carotenoid utilization. Dr. James Olson, a
professor of biochemistry,\43\ noted in his presentation to the Olestra
Working Group, that in the broader context of the diet, the effects of
olestra on carotenoid utilization when used in savory snacks will be
relatively minor, because a number of other factors influence
carotenoid utilization, including carotenoid stability,
bioavailability, and absorption. In the presence unsaturated fatty
acids such as vegetable oils, for example, carotenoid are very rapidly
destroyed. Similarly, carotenoid bioavailability can vary from almost
zero to about 50 percent, depending on the vegetable concerned, cooking
practice, and the presence and type of oils in the GI tract. (For
example, in butter fat or coconut oil, carotenoid are only about 50
percent as well absorbed as in more unsaturated oils.) Inhibitors to
carotenoid absorption also exist, including fiber, particularly acidic
pectins, and high concentrations of vitamin E. Dr. Olson subsequently
provided FDA with a published study that shows that the increase in
plasma -carotene concentration 30 hours following consumption
of a controlled meal containing 25 mg -carotene and 12 g
citrus pectin was only half as large as the increase observed in the
absence of citrus pectin (Ref. 67). Furthermore, Dr. Olson noted that
competitions occur between various carotenoid for absorption; in
particular, lutein, canthaxanthin, and -carotene mutually
inhibit each other's absorption.
\43\Dr. James Olson, Professor, Biochemistry and Biophysics
Department of Iowa State University, researcher in the filed of
carotenoid and vitamin A. Dr. Olson has consulted with the
petitioner and presented at its request. Transcript, vol. 3, p. 190.
---------------------------------------------------------------------------
Although olestra does affect carotenoid absorption, the petitioner
asserted that only the more lipophilic carotenoid would likely be
affected by olestra. The petitioner presented data regarding the
octanol:water partition coefficients (PC's), a measurement of how fat-
soluble a substance is,\44\ for the various carotenoids, and noted that
substances with a log10 PC above about 7.5 can be affected by
olestra if they are consumed simultaneously with the olestra.\45\ Three
of the four carotenoids monitored (-carotene, -
carotene, and lycopene) are the most lipophilic carotenoids with
octanol:water PC's of approximately 17.6 each and would thus be
expected to be the most affected by olestra. Indeed, the 8-week studies
and 16-week vitamin E study show that the effects of olestra on the
serum levels of these carotenoids are very similar. Lutein and
zeaxanthin, which have more hydroxyl groups, are about 1,000 times less
lipophilic (PC's of 14.82 and 14.95, respectively) than -
carotene (Ref. 68).
\44\Octanol:water partition coefficients (PC's) are generally
expressed on a log scale so that a substance with a PC of 12 is 10
times as fat soluble as a substance with a PC of 11.
\45\Transcript, vol. 2, p. 125.
---------------------------------------------------------------------------
In addition, it is possible that serum carotenoid levels are not
good indicators of carotenoid availability in the body. Dr. Olson
pointed out that the plasma carotenoids amount to approximately one
percent of the total tissue content of carotenoids. Plasma carotenoid
concentrations can vary fairly rapidly within 1 to 4 weeks whereas
tissue concentrations change much more slowly. Because protective
aspects of carotenoids would be expressed at the intracellular level,
plasma carotenoid concentrations, particularly in short-term studies,
may not be very accurate indicators of useful carotenoid levels.\46\
Similarly, Dr. Leonard Cohen,\47\ in a presentation to the Olestra
Working Group, also pointed out that serum measurements are single-
point at a certain time of the day, but that carotenoid levels have
Circadian rhythms. Therefore, one cannot tell at one point of the day
whether levels will be the same at another point of the day.
\46\Transcript, vol. 3, p. 192.
\47\Dr. Leonard Cohen, Section Head, Nutrition and
Endocrinology, American Health Foundation. Transcript, vol. 3, p.
149.
---------------------------------------------------------------------------
Finally, Dr. Olson noted that five different conferences or
reviewing groups have examined the relationship between carotenoids and
disease: A U.K. Committee on the medical aspects of food policy (1987);
the Life Science Research Offices of the Federated American Societies
of Experimental Medicine in Biology; a European Union of Scientific
Committees for Food (1992); an International Life Sciences Workshop on
Antioxidants and Health (1993); and an FDA Conference on Antioxidant
Nutrients (1993). He stated that all of these groups concluded that
there is insufficient evidence to recommend specifically consumption of
carotenoids, except to encourage the consumption of vegetables and
fruit.
After considering all the presentations and information submitted
by CSPI in their White Paper (Ref. 3), a substantial majority of the
Olestra Working Group felt that there is a reasonable certainty of no
harm from olestra's effects on serum carotenoid levels.
However, some members of the Olestra Working Group voiced concern
about olestra's effects on carotenoid serum levels. Because of this
concern, FDA subsequently consulted with scientists at the National
Institutes of Health (NIH) and requested their views on whether
olestra's effects on lipophilic carotenoids raise any significant
public health issues with respect to the possible association between
carotenoids and cancer risk\48\ and macular degeneration\49\ (Refs. 69
and 70). The agency provided these scientists with copies of letters
concerning carotenoids that the agency had received (including the
letter from Dr.'s Willett and Stampfer (Ref. 62)), submissions by the
petitioner, excerpts discussing carotenoids from the White Paper, and
relevant sections of the Transcript from the Olestra Working Group and
FAC meetings.
\48\Dr. Peter Greenwald, Director of the Division of Cancer
Prevention and Control, National Cancer Institute, NIH.
\49\Dr. Carl Kupfer, Director of the National Eye Institute,
NIH.
---------------------------------------------------------------------------
Regarding cancer risk, Dr. Peter Greenwald stated that the effects
of olestra on carotenoid utilization under
[[Page 3149]]
the conditions of use would be expected to be relatively minor, that
the provitamin role of carotenoids is the only function that has been
adequately documented, and that plasma carotenoid concentration (which
were used in the reported epidemiological studies) probably is not a
reliable indicator of tissue levels and may in fact be misleading.
Therefore, he concluded that no significant health issue was raised by
the reported effects of olestra on lipophilic carotenoids. Furthermore,
he recommended against supplementing olestra with -carotene or
other carotenoids at this time (Ref. 71).
Regarding macular degeneration, Dr. Carl Kupfer stated that
although theoretical considerations have raised the possibility that
carotenoids might play some protective role in macular degeneration,
there are currently no convincing clinical data to substantiate the
hypothesis. Furthermore, he asserted that no clear eye health benefit
has been demonstrated for carotenoids (Ref. 72).
ii. FDA's evaluation of olestra's effects on carotenoids.
On balance, having considered all the comments, data, and
information that the agency has received on this subject, FDA has
determined that the information currently available show that olestra's
effects on the absorption of the lipophilic carotenoids is reasonably
certain to be insignificant from a public health standpoint. First, FDA
has determined that the available data do not establish any
identifiable nutritional or prophylactic benefits for the carotenoids,
either individually or collectively. Specifically, controlled
randomized studies have been performed to test the potential cancer-
protective effects of carotenoid consumption and have shown no
association between carotenoid consumption and cancer.\50\ Also, there
have been no controlled studies to examine the association between
carotenoid consumption and eye disease.
\50\In fact, well-controlled studies indicate that there may be
higher incidence of lung cancer in smokers consuming high levels of
-carotene.
---------------------------------------------------------------------------
The agency believes that its conclusion regarding the absence of
harm from olestra's effect on some carotenoids, which conclusion is
based on the scientific evidence currently available, is not
inconsistent with the currently available epidemiological studies. This
is because the epidemiologic studies show an association between diets
rich in fruits and vegetables and decreased cancer risk and do not
evaluate the association between carotenoids per se and lower disease
risk. Thus, there is no direct evidence from these epidemiologic
studies that carotenoids are the substances responsible for the
protective effect. In fact, as noted by several experts, serum
carotenoid levels may simply be markers for consumption of fruits and
vegetables.
The agency's determination that olestra's effects on the absorption
of carotenoids is reasonably certain to be insignificant is bolstered
by the fact that the actual magnitude of olestra's effects on
carotenoid absorption is likely to be within the range of the normal
variation due to diet and bioavailability because the percentage of
consumed carotenoids that are actually available to the body is highly
variable and affected by a number of factors. In fact, the agency
believes that it is likely that olestra's effects on carotenoid
absorption will likely be substantially less that those observed in the
8-week studies and will be more similar to the effects observed in the
16-week vitamin E study.\51\ Finally, the association between serum
carotenoid levels and the availability of carotenoids at the cellular
level is unclear. Hence, the relationship between olestra's effects on
serum carotenoids and the body's utilization of carotenoids is also
unclear.
\51\While FDA finds that the petitioner's hypothesis that actual
reductions in carotenoid levels will be affected by consumption
patterns and will therefore be even less than those observed in the
16-week vitamin E study is plausible, the actual magnitude of the
effect is not supported with data at this time.
---------------------------------------------------------------------------
Therefore, FDA has determined, based upon the scientific evidence
that exists at this time, that there is currently no justification or
need to require compensation of olestra-containing foods with specific
carotenoids.\52\
\52\This conclusion is consistent with the recommendations of
the various conferences that have been held to examine the
relationship between carotenoids and disease and is also consistent
with FDA's decisions regarding health claims for antioxidant
vitamins and cancer (58 FR 2622, January 6, 1993.)
---------------------------------------------------------------------------
C. Effects of Olestra on Water-soluble Nutrients that are Hard-to-
Absorb or Limited in the Diet
The two 8-week clinical studies in the human and the two 12-week,
the 26-week DR/VR, and the 39-week VR studies in the pig were used to
assess olestra's potential effects on water-soluble nutrients. Iron,
folate, vitamin B12, and zinc status were measured in both the pig
and human studies. Vitamin B12 absorption was also measured in the
human studies. Calcium status was measured only in the pig studies,
because there are no non-invasive methods sufficiently sensitive to
assess calcium status in humans. The human and pig studies are
described in section V.B. of this document, and the methods used to
measure the status of calcium, zinc, iron, folate, and vitamin B12
are summarized in Table 4 (human studies) and Table 6 (pig studies).
1. Results and Conclusions from Human Studies
a. Vitamin B12. In the 8-week human DR and VR studies, there
was no change in serum measures of vitamin B12. However, 8 weeks
is insufficient to observe effects in serum, and the presence of excess
vitamin B12 in the diets likely reduced the sensitivity of the
studies to evaluate vitamin B12 status. The petitioner also found
that absorption of vitamin B12 did not change as a result of
olestra consumption in either 8-week human study, as measured by the
Schilling test. FDA notes that dietary levels of vitamin B12 were
approximately 2.2 and 1.7 times the RDA in the DR and VR studies,
respectively. However, this overfortification does not affect
interpretation of the results of the Schilling test because the level
of vitamin B12 in the diet is not a factor in the Schilling
test.\53\ FDA concludes that the results of the Schilling test shows
that olestra has no effect on vitamin B12 absorption in humans.
\53\The Schilling test is an acute test that measures the
absorption of a dose of radiolabeled vitamin B12
---------------------------------------------------------------------------
b. Iron. Measures of iron status were performed in the 8-week VR
study. The petitioner concluded that olestra had no effect on iron
status, and that sporadic, statistically significant trends with
olestra dose in one or more of the measures at one or more time points
resulted from differences in status at baseline or from a general
decrease in iron stores resulting from phlebotomy (drawing blood for
analysis). FDA agrees with the petitioner's conclusion that there were
no changes in all measures of iron stores, with the exception of serum
ferritin levels for both treatment and control groups. FDA further
concludes that the decreased serum ferritin levels were consistent with
loss due to phlebotomy (Ref. 73).
c. Folate. Folate status was monitored in the 8-week DR study in
which folate was consumed at levels between 80 and 120 percent of its
RDA. There was no olestra dose response on the indices for folate
(serum and red blood cell folate concentration). FDA considers red
blood cell folate levels to be excellent
[[Page 3150]]
indicators of folate status.\54\ Thus, the agency agrees with the
petitioner's conclusion that olestra consumption does not affect folate
status.
\54\Transcript, vol. 3, p. 117.
---------------------------------------------------------------------------
d. Zinc. Zinc status was evaluated in the 8-week DR study. There
was no olestra dose response on the indices for zinc that can be
measured noninvasively in humans (serum and urinary concentration). FDA
agrees with the petitioner's conclusion that there is no evidence that
olestra affects zinc status. However, the agency notes that serum and
urinary concentrations are not sensitive indicators of zinc status in
humans. Although these data are not particularly sensitive indicators
of zinc status, FDA finds that the data support a finding of no effect.
However, FDA does not consider the data sufficiently sensitive to
support, in and of themselves, a conclusion of no effect.
2. Results and Conclusions from Pig Studies
Data from the studies of olestra consumption in pigs generally
corroborate the findings from the human studies regarding the effect of
olestra on iron and zinc status. Although, the results of the pig
studies regarding vitamin B12, calcium, and folate, do not
indicate any effect of olestra, these studies are of limited utility in
assessing olestra's effects because of several weaknesses in study
design, as discussed below.
a. Vitamin B12. There were no statistically significant
effects of olestra on liver vitamin B12 in the 12-week VR, the 26-
week VR/DR, and the 39-week VR pig studies. In the 12-week DR study, a
statistically significant downward trend in liver vitamin B12
levels, produced by a low value in the 7.7 percent olestra group, was
observed. There were no statistically significant decreases in the 1.1
percent, 2.2 percent, 3.3 percent, 4.4 percent, or 5.5 percent olestra
groups. The low value in the 7.7 percent olestra group was not
accompanied by an elevation in mean corpuscular volume, and thus, the
petitioner concluded that this decrease did not represent a change in
vitamin B12 status. (FDA notes that the downward trend was not
found in other pig studies.)
FDA concludes that the pig studies are limited in their usefulness
in assessing olestra's effects on vitamin B12. FDA's principal
reservation is that the level of vitamin B12 was measured only in the
diet premix and not in the complete diets; such analysis of the premix
is not as reliable as analysis of the complete diet because an
accidental mixing error may have occurred or the vitamin may have been
degraded or spared from degradation by an interaction with another
ingredient during the mixing process or during storage. Accordingly,
FDA finds that, although there was no consistent effect of olestra on
vitamin B12, these pig studies are inadequate by themselves to
evaluate olestra's effect on vitamin B12.
b. Iron. A battery of tests (liver iron concentration, serum total
iron binding capacity, and serum total iron concentration) conducted in
the 12-week VR, 26-week DR/VR, and 39-week VR studies showed no adverse
effects on iron status when olestra was fed at any level (up to 7.7
percent of the diet). There were statistically significant decreases in
liver iron values in the 12-week DR study in both the 5.5 percent and
7.7 percent olestra groups. However, in these groups, mean corpuscular
hemoglobin, mean corpuscular hemoglobin concentration, and red blood
cell count were unaffected by olestra consumption. The petitioner
postulated that the trend in liver iron concentration was probably
secondary to the poor vitamin A status of the animals, and thus,
concluded that iron status was not affected by olestra.
FDA notes that there was a large variability in liver iron values
in all pig studies. FDA postulates that the variability in liver iron
levels may have been due to several factors, such as blood loss from
gastric ulcers, dewclaw lesions or abscesses, or differences in the
amount of blood present in the liver after sacrifice. FDA further notes
that the test diets were oversupplemented with iron in that the diets
contained between 1.7 to 2.4 times the NRC requirements. FDA finds that
these results make it possible to rule out gross effects on iron status
but the foregoing factors make it difficult to exclude subtle effects
in these studies (Ref. 56). Accordingly, FDA finds that the pig studies
are inadequate by themselves to evaluate olestra's effect on iron.
c. Folate. The petitioner stated that there were a few
statistically significant differences in plasma folate concentration at
week 4 in the 26-week DR/VR study, but the values in the olestra groups
were greater than the control. There were no statistically significant
changes in plasma folate in the two 12-week studies, nor in the 39-week
VR study. Therefore, the petitioner concluded that folate status in
pigs was not affected by olestra consumption.
FDA finds that a conclusion on folate status cannot be drawn from
the pig studies for several reasons. First, no measurements of folacin,
either in the premix or in the diet as fed, were made in any of the
studies. Second, folic acid was added to the diet, rather than
folylpolyglutamates, the predominant form of folate in the American
diet. Folic acid (folylmonoglutamate) is absorbed directly, while
folylpolyglutamates must be cleaved by folylpolyglutamate hydrolase in
the intestine prior to being absorbed. Therefore, folacin is not a
hard-to-absorb nutrient when it is supplied as folic acid, as in these
studies. Finally, plasma folate is not as sensitive a measure of folate
status as red blood cell folate (the method used in the human studies).
Therefore, FDA concludes that the pig studies are of limited utility in
assessing olestra's effects on folate (Ref. 56).
d. Zinc. There were no significant effects of olestra on liver,
bone, or serum zinc levels in the 12-week DR study or the 26-week DR/VR
study. The only significant differences from control values in these
three measures of zinc status in the 12-week VR and 39-week VR studies
were small (and probably spurious) increases in liver zinc in the 0.25
percent low vitamin group in the 39-week VR study and in serum zi
FR Doc. 96-1584 Food Additives Permitted for Direct Addition to Food for Human Consumption; Olestra
nc in
four olestra groups at week eight in the 12-week VR study. Accordingly,
the petitioner concluded that liver, bone, and serum zinc
concentrations were not affected by olestra in any of the pig studies.
In general, FDA concurs with this conclusion, with some
qualifications, as discussed below.
Although they did not show any significant differences, the bone
zinc measurements are less than an ideal means of assessment because
the methodology used to analyze the bone has several flaws that limit
the power and reliability of the results. (These flaws are discussed in
the calcium section below.) Because of these methodological flaws, FDA
concludes that the bone zinc measurements of the pig studies do not
provide a completely reliable assessment of zinc status.
FDA notes that liver and serum measurements of zinc, in controlled
swine studies, are acceptable measurements of zinc status that have
sensitivities comparable to properly performed bone measurements. A
potential confounding factor in the assessment of zinc status in the
pig studies is the amount of zinc in the test animal diets. FDA
estimates that zinc consumption in the 12-week VR, 26-week DR/VR, and
39-week VR studies exceeded the NRC requirements by at least 68
percent. However, a review of the literature shows that serum and liver
zinc measurements will reflect dietary zinc over a wide range of
dietary
[[Page 3151]]
concentrations in controlled swine studies. Therefore, FDA believes
that this oversupplementation would not mask any effects of olestra on
zinc status. FDA concludes, therefore, based on the results of the
liver and serum measurements in these studies, that there is no
evidence that consumption of olestra affects zinc status.
e. Calcium. Bone ash and bone calcium levels were not affected by
olestra consumption in the 12-week VR, 26-week DR/VR, or 39-week VR pig
studies. The only change was seen in the 12-week DR study where bone
ash but not bone calcium was less (60.6 2.0 vs. 61.1
1.0 percent) in the 4.4 percent olestra dose group than in
the control group (Refs. 74 and 75), a difference that was
statistically significant. The other dose groups showed no
statistically significant change in bone ash or bone calcium. The
petitioner concludes that these results demonstrate that olestra
consumption does not have an effect on calcium status.
FDA concludes that the results from the pig studies are not useful
for determining whether olestra has any subtle effects on calcium
status; the results show only that there were no gross changes in
calcium status. FDA's determination that these studies are seriously
limited in their utility to determine calcium status changes is based
on two factors: oversupplementation of calcium in the diet and flawed
methodology in measuring bone ash and bone calcium.
FDA believes that the bone ash measurements are not reliable
because the test animals' diet was oversupplemented with calcium.
Specifically, test animals received approximately 1.0 to 1.3 times the
NRC calcium requirements during the 12-week studies (with the greater
amounts during the last 7 weeks) (Refs. 76 and 53), and 1.2 to 1.7
times the NRC requirement during the 26-week DR/VR and 39-week VR
studies (Ref. 52). Based on published studies (Refs. 77 and 78), FDA
believes that bone ash will reach maximum levels when dietary calcium
is approximately 1.2 times the NRC requirement and adequate levels of
phosphorus are provided (Ref. 56). Therefore, the supplementation above
1.2 times the NRC requirement would mask any subtle effect on calcium
absorption.
In the 26-week DR/VR and 30-week studies, olestra would have to
have inhibited the absorption of approximately 30 percent of the
calcium before any adverse effects on bone ash would have been observed
(Ref. 56). Thus, the bone ash data from these studies are not a
stringent test of calcium status. Although the oversupplementation in
the 12-week studies would not mask olestra effects on calcium as much
as it would in the 26-week DR/VR and 39-week VR studies, methodological
factors in obtaining the data on bone ash, as described below, in
combination with the slight oversupplementation during the last 7
weeks, make the calcium data only useful in determining whether there
were gross effects of olestra on calcium status.
Factors that CFSAN considers contributing to the limitations of the
methodology that was used to evaluate bone ash include the following:
(1) Only half of the bone selected for analysis (the L5 lumbar
vertebra) was used, rather than using the whole bone; (2) after drying
and grinding the half bone, an aliquot of the ground bone
(approximately 1.5 g) was taken for fat extraction, rather than
extracting the entire sample; (3) an aliquot (approximately 0.5 g) of
the fat-free bone powder was ashed, rather than ashing the entire
sample; and (4) ashing was performed at 500 deg.C for 8 hours, rather
than more typical conditions of > 550 deg.C for > 12 hours (Ref. 79).
Because of these methodological flaws, FDA concludes that the bone
ash and bone calcium measurements performed in the pig studies do not
provide a reliable assessment of calcium status.
Although FDA finds that the data from the pig studies are of
limited use in determining whether olestra affects the absorption of
calcium because the test diet was overfortified with calcium and
appropriate measures of bone were not made, FDA notes that the animals
grew normally and all outward observations indicated that they had
normal skeletal growth.
3. Overall Conclusions Regarding Olestra's Effects on Water-Soluble
Nutrients
The agency received no significant comments expressing concern
about olestra's effects on water-soluble nutrients. Similarly, Dr.
Connie Weaver, FDA's consultant on water-soluble nutrients, also found
no basis for concern (Ref. 75). FDA's specific conclusions on these
nutrients follow.
a. Vitamin B12. FDA has determined that there is no need for
compensation of olestra-containing foods with vitamin B12. In
reaching this conclusion, the agency relied primarily on the 8-week
human DR and VR studies in human to evaluate the effect of olestra on
vitamin B12. Both studies showed no effect of olestra on vitamin
B12 using the Schilling test, which is a sensitive test that is
not affected by dietary vitamin B12 levels. The vitamin B12
results of the pig studies are consistent with the results of the human
studies. In the pig studies, no effect of olestra was seen in the 12-
week DR, the 26-week DR/VR, or 39-week VR studies. There was a
statistically significant decrease in liver B12 levels in the
highest olestra dose group (7.7 percent) in the earliest pig study (the
12-week VR study). Because this result was not corroborated by results
of any of the other studies, FDA concludes that, collectively, the data
establish that olestra does not affect vitamin B12 absorption.
b. Folate and iron. The results from the 8-week human studies
establish that folate and iron status were not affected by olestra
consumption. These studies were well designed, the methods used were
sufficiently sensitive to evaluate olestra's effects, and the duration
of the studies was long enough to see any such effect. Although there
were limitations in the quality of the results of the pig studies with
regard to folate and iron, in general, the results of the pig studies
support the conclusion drawn from the human studies that olestra
consumption does not adversely affect iron or folate status.
c. Zinc. Zinc status was evaluated by three acceptable methods:
serum and urinary zinc in the 8-week human studies, and serum and liver
zinc in the pig studies. None of these analyses, in any of the studies,
demonstrated an effect of olestra consumption on zinc status. The
analysis for zinc in bone has methodological limitations. Therefore,
although these results are consistent with the other zinc measurements,
FDA is not relying on the bone results.
FDA concludes that the totality of the results, in both the human
and pig, using all three methods, provides strong evidence that olestra
consumption does not affect zinc absorption. In addition, FDA is not
aware of any hypothesis that would support an effect of olestra on zinc
status.\55\ Therefore, FDA concludes that consumption of olestra does
not affect zinc status.
\55\At the Olestra Working Group meeting, Dr. Schneemna, FDA's
overarching nutritional consultant, stated that the only mechanism
she could envision of olestra to affect any water-soluble nutrient
would be a general mechanism causing lower bioavailability for a
variety of nutrient. Transcript, vol. 2, p. 97 and vol. 3, p. 130.
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d. Calcium. With respect to calcium, FDA concludes that there is no
basis for concluding that calcium absorption would be adversely
affected by olestra consumption. First, there is no plausible
hypothesis for how olestra could affect calcium absorption other than
by
[[Page 3152]]
vitamin D depletion. Unlike the fat-soluble vitamins, calcium is water
soluble and would not be expected to partition into olestra. Other
mechanisms by which olestra might affect calcium absorption are: (1) by
forming a physical barrier that would prevent calcium from reaching the
mucosal cell surface, where it is absorbed; or (2) by decreasing GI
transit time so drastically that there is little chance for calcium to
make mucosal contact. However, these mechanisms would also be expected
to affect the absorption of folate, vitamin B12, and iron, yet,
importantly, as discussed above, these nutrients are unaffected by
olestra consumption. Also, published studies (Refs. 80 and 81) indicate
that olestra does not significantly alter gastric emptying or overall
GI transit time.
Further, it is likely that the effect of variations in calcium
intake in the normal diet (especially as a result of dietary choices
concerning calcium-rich foods such as dairy products) would be much
greater than any effect from olestra consumption on calcium absorption
(Ref. 75). Also, the compensatory homeostatic mechanisms the body has
for calcium, and the fact that studies have shown that high-fat diets
do not affect absorption of vitamin B12, folate, iron, or zinc,
are additional reasons for reduced concern about the potential effect
olestra on the absorption of calcium. Finally, studies of mineral oil
(a substance much like olestra in that, like fats, it is non-polar and
is not absorbed) in the published literature support the conclusion
that any effect by olestra on calcium is likely to be vitamin D-
mediated rather than a direct effect on its absorption (Refs. 82 and
83). Compensating for olestra's effects on vitamin D will thus preclude
any effects of olestra consumption on calcium produced by vitamin D
depletion.
Thus, given the lack of effect on other water-soluble nutrients and
the lack of any probable mechanism for olestra to affect calcium, FDA
concludes that there is no basis for concern regarding olestra's
effects on calcium status.
Effect of Olestra on the Gastrointestinal (GI) Tract
A. Introduction
Because olestra is not digested or absorbed and passes unchanged
through the GI tract, it has the potential to affect GI physiology and
function. Therefore, the petitioner conducted several studies to assess
olestra's potential to affect the GI tract.
For example, the petitioner assessed the potential for olestra to
elicit GI symptoms such as cramping, bloating, loose stools, and
diarrhea-like symptoms by collecting adverse effect reports in studies
designed primarily to assess potential effects of olestra on absorption
of nutrients from the diet. The petitioner also collected data on GI
symptoms in a human study (the oil loss study) designed to set a
specification for olestra stiffness (i.e., viscosity). (The oil loss
study sought to establish the viscosity that would prevent olestra from
separating from other fecal contents in the colon and leaking past the
anal sphincter (passive oil loss)). Other studies addressed the
potential for olestra to cause GI symptoms in the young and in patients
with inflammatory bowel disease (IBD). The study in patients with IBD
also assessed the potential for olestra to adversely affect disease
activity. Finally, the petitioner conducted several studies to assess
the potential for olestra to affect the normal metabolic activity of
intestinal micro flora and the potential for olestra to affect the
absorption, synthesis, and excretion of bile acids.
B. Effect of Olestra on GI Symptoms
1. Study of GI Symptoms in 8-week Studies in Normal Subjects
Data on GI symptoms were collected in the two 8-week human clinical
studies conducted to determine olestra's potential to affect
nutritional status. The design and methodology of these studies are
described above in detail in Section IV.B.1.a.The petitioner believes
that data from the two 8-week studies are particularly useful in
understanding the potential for olestra to produce GI symptoms because
the olestra doses used were large (up to 32 g/d) and were consumed
every day, the studies were lengthy (8 weeks), and details of the GI
symptoms were recorded by the subjects for each day they reported
symptoms. Specifically, subjects were questioned daily about changes in
their health, including GI symptoms. If a GI symptom was experienced, a
subject completed a detailed questionnaire which asked about the type,
severity, and duration of symptoms experienced. To facilitate
collection of GI symptom data, the questionnaire provided a list of
common GI symptoms along with general definitions of each. This served
to remind subjects of other possible symptoms in addition to the one
that first prompted completion of the GI symptom report.
The petitioner noted two considerations relevant to the evaluation
of the GI symptom reports. First, the subjects were prompted every day
to report symptoms and were provided with a list of commonly
experienced GI symptoms; this would be expected to amplify the
reporting of GI symptoms, relative to data collected under unprompted
conditions. In addition, the collected symptom data will closely
reflect actual incidence, rather than capturing only those symptoms
that subjects judged significant enough to report. Second, the
petitioner stated that the two 8-week studies were not intended to
examine GI symptoms under real-life consumption conditions where snacks
are not consumed every day with every meal and where people may
moderate intake if they experience GI symptoms; therefore, the GI
symptom data from these studies may have exaggerated what will occur in
young, healthy adults consuming olestra snacks under real life
conditions.
a. Petitioner's evaluation of GI symptoms. Because the two 8-week
studies were run under nearly identical protocols, the petitioner
combined the GI symptom data from the two studies for analysis. GI
symptoms were reported by subjects in all groups, including placebo.
The petitioner stated that the number of people reporting GI symptoms
in the two 8-week studies increased in a dose responsive manner with
olestra dose. The number of individuals who ate eight g/d olestra\56\
for 8 weeks and reported at least one GI symptom (62 percent) was
greater than the number who ate a corresponding amount of a
triglyceride for 8 weeks and reported at least one GI symptom (45
percent). The petitioner noted that the GI symptoms reported by the
control and 8 g/d groups of subjects were essentially not different in
severity, length of episodes, or total number of symptom days (number
of days on which symptoms occurred times the number of symptoms). The
petitioner also noted that GI symptoms reported by subjects who
consumed larger amounts of olestra (20 g/d or 32 g/d) were of the same
kind and severity as those reported by subjects in the placebo and
eight g/d olestra groups; however, the total number of symptom days was
greater in the two groups consuming the higher levels of olestra.
\56\Eight g/d olestra intake approximates the lifetime average
90th-percentile intake for snack eaters.
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The petitioner concluded that none of the GI symptoms reported by
subjects eating either triglyceride or olestra at any level (8, 20, or
32 g/d) were clinically significant. According to the petitioner, the
GI symptoms spontaneously abated and recurred during the course of the
study in all
[[Page 3153]]
groups and stopped within 5 days after the study ended. The petitioner
also stated that the GI symptoms experienced by an individual eating
olestra-containing foods are self-limiting in the sense that the
symptoms either stopped in the face of continued consumption of such
foods or ceased when the individual stopped eating the olestra-
containing food or reduced the amount consumed. The number of subjects
reporting symptoms at any given time and the severity of the symptoms
remained essentially constant over time among the different treatment
groups, indicating that symptoms did not worsen with prolonged
consumption of olestra. In addition, clinical laboratory data collected
at the time subjects were reporting symptoms did not show clinically
significant effects such as hemoconcentration, electrolyte imbalance,
or increased urinary creatinine or specific gravity.
The petitioner stated that the symptoms were, on average, mild to
moderate in all groups. As an indication of the mildness of the
symptoms, the petitioner stated that few individuals reporting GI
symptoms in the two 8-week studies dropped out of the studies because
of the symptoms. (Four of a total of 115 subjects in the 20 and 32 g
olestra per day groups dropped out; out of these 4, only 1 was
attributed to GI symptoms experienced (heartburn)).
Although most of the symptoms were reported as mild on average, the
petitioner stated that at least one symptom described as severe was
reported by some subjects: 5 percent (placebo), 10 percent (8 g/d
olestra), 26 percent (20 g/d olestra), and 22 percent (32 g/d olestra).
All severe symptoms reported by the placebo and eight g/d olestra
groups were limited to 1 day. For the 20 g/d olestra group, the maximum
duration of severe symptoms was 2 days, and for the 32 g/d group, it
was 4 days. According to the petitioner, GI symptoms reported by people
eating 20 or 32 g/d olestra are similar to those reported by people
eating high amounts of common food ingredients that elicit GI symptoms.
The petitioner asserted that high fiber diets produce GI symptoms such
as stomach cramps, loose stools, diarrhea, bloating, and flatulence.
Therefore, the petitioner concluded that persons eating olestra-
containing foods, even at levels beyond the expected consumption from
snacks, are unlikely to experience GI symptoms that are different from
those they might normally experience consuming other foods or from
dietary changes.
b. FDA's evaluation of the GI symptoms. Unlike the petitioner, in
its original analysis, FDA evaluated the adverse effects reports from
the two studies separately, because there did not appear to be any
reason or need to combine the two date sets. In analyzing the two
studies, FDA, however, did combine reports of loose stools and diarrhea
(Ref. 84), for the following reason. The petitioner defined loose
stools as bowel movements that were unformed but not watery, and
diarrhea-like stools as watery stools that were difficult to control
and had little or no solid material.\57\ However, the difference was
between loose stools and diarrhea-like stools may not have always been
clear to the subjects. Further, substantial fluid and electrolyte
losses could potentially result from either form of stools. Thus, FDA
believes that it is preferable to combine these two reported effects
for analysis.
\57\Reporting of diarrhea was based on subjects' perception of
diarrhea. There was no measurement of water-content made. However,
subjects' electrolyte levels were monitored. FDA recognizes that the
effect observed may not be diarrhea in the clinical sense but is
using that term in this preamble because it is the term used in the
study report.
---------------------------------------------------------------------------
In its presentation of the GI symptom data to the Olestra Working
Group and the FAC, FDA did combine the data from the two studies;
combining the data is acceptable for the following reasons: (1) Both
studies used the same olestra dosages (placebo, 8 g/d, 20 g/d, and 32
g/d); (2) similar criteria were used in both studies for selecting and
excluding study subjects; (3) the studies were of the same duration;
and (4) the same methods were used to monitor for adverse GI
experiences. By pooling the data, the statistical power of the study
increased.\58\
\58\Transcript, vol. 2, p. 185.
---------------------------------------------------------------------------
At the Olestra Working Group and FAC meetings, there was some
discussion regarding the advisability of pooling data from the two
studies. For example, CSPI stated in their White Paper that the two
studies were analyzed separately because one of the studies had a very
high rate of GI problems in the control group that masked the
difference between the placebo and the 8 g/d groups and also because
the second study had a low level of GI problems in the control
group.\59\ Others stated that not only could the studies be combined,
but that the conclusions were the same whether or not the data were
pooled, i.e., there was increased reporting of GI effects with
increasing olestra doses.\60\
\59\Statement of Dr. Michael Jacobson, CSPI, Transcript, vol. 1,
p. 171.
\60\Statements of Dr. David Allison, Dr. Joann Lupton, and Dr.
Karl Klontz. Dr. Allison is an Associate Research Scientist at New
York Obesity Research Center, Saint Luke/Roosevelt Hospital. He was
a temporary member of the FAC. Dr. Lupton is an Associate Professor
of Human Nutrition at Texas A&M. She was FDA's consultant on GI
issues. Dr. Karl Klontz is with FDA. Transcript, vol. 3, pp. 49-54.
---------------------------------------------------------------------------
FDA's analysis of the data from the two 8-week studies showed there
was a dose-response effect for olestra with respect to two endpoints,
reported diarrhea/loose stools and fecal urgency. For example, in the
8-week DR study, the percentage of subjects who experienced loose
stools or diarrhea (at any time during the study) was 19 percent
(control group), 45 percent (8 g/d olestra group), 74 percent (20 g/d
olestra group), and 67 percent (32 g/d olestra group). In general,
whether the data from the two studies were analyzed separately or
together, the incidence of GI symptoms in the eight g/d olestra group
was not statistically different from that of the control group; the
differences in the incidences of GI symptoms between the control group
on the one hand and the 20 or 32 g/d olestra groups were statistically
significant.
Although FDA agrees that, in general, the GI symptoms started and
stopped in all groups, FDA notes that, in some olestra-fed subjects,
the GI symptoms persisted for a long period of time. For example, over
the course of the 56 days, two study subjects in the 20 g/d olestra
group reported loose stools for 38 and 40 days, respectively, and
another subject in the same group reported experiencing fecal urgency
and loose stools for 55 days. In the 32 g/d olestra group, three
subjects reported loose stools for more than 50 days. FDA agrees that
these GI symptoms cease when olestra is no longer consumed. However,
FDA believes it is important that consumers know that the GI symptoms
they are experiencing may be due to consumption of olestra. This need
for information is discussed in section VII of this document.
As noted, the petitioner contends that the nature and severity of
the GI symptoms observed among the olestra-consuming participants were
comparable to symptoms experienced by persons consuming diets moderate
or high in fiber. FDA does not agree. While high-fiber diets have been
associated with increased gas manifested as belching, flatulence, and
mild abdominal distention, diarrhea and staining of underwear
(discussed in following section) have not commonly been reported (Refs.
85 and 86).
Finally, FDA concurs with the petitioner that there was no evidence
in either study that subjects experiencing olestra-related symptoms
described as
[[Page 3154]]
``diarrhea'' also experienced significant fluid and electrolyte loss.
2. GI Symptoms in the Oil Loss Study
The petitioner conducted an oil loss study.\61\ This study had
three objectives to determine: (1) The minimum olestra stiffness that
would control passive oil loss, as measured by underwear staining, to
the level experienced by a triglyceride placebo group; (2) the
relationship between olestra stiffness\62\ and the occurrence of oil in
the toilet (OIT); and (3) whether the stiffness of olestra affected the
incidence of common GI symptoms experienced by the subjects.
\61\Passive oil loss can occur when people consume large amounts
of nonabsorbable oil that is liquid at body temperature, such as
mineral oil or liquid olestra; liquid oil separates from other fecal
material in the colon and leaks past the anal sphincter. The
petitioner observed that early formulations of olestra caused
passive oil loss, but that oil loss could be decreased by increasing
the stiffness of olestra at body temperature. Stiffer olestra has
less of a tendency to separate from the fecal matrix.
\62\The stiffness of olestra was characterized by measuring a
rheological parameter called the thixotropic area, which is
determined by measuring the shear stress on olestra as the shear
rate is first increased and then decreased. The area between the
ascending and descending shear stress versus rate curves is the
thixotropic area. Olestra that is liquid at body temperature has
thixotropic areas approaching zero. Highly saturated olestra that is
largely solid at body temperature has thixotropic areas well above
100 kiloPascals/sec (kPa/s). In practical terms, olestra with a
stiffness of 18 kPa/s had a consistency similar to a typical catsup
at room temperature; olestra with a stiffness of 50 kPa/s has a
consistency similar to mayonnaise; olestra with a stiffness of 103
kPa/s is similar to cold margarine.
---------------------------------------------------------------------------
The oil loss study was a double-blind, placebo controlled, parallel
design study with seven groups of 18 to 44 year old male and female
subjects (173 to 182 per group). Six groups consumed 34 g/d of olestra
of varying stiffness (18, 45, 50, 66, 78, or 103 Kpa/s) in potato chips
for 5 days. A placebo group consumed an equivalent amount of potato
chips prepared with triglycerides. All groups consumed the potato chips
as part of a normal diet.
At the end of the 5 days, the subjects completed a questionnaire
answering specific questions about underwear staining due to passive
oil loss and incidence of oil droplets in the toilet (OIT) following
defecation. In addition, reports of adverse GI experiences (e.g.,
diarrhea, abdominal pain, indigestion) were collected during the
consumption period as well as the 3 days following the treatment phase.
a. Effect of olestra stiffness on passive oil loss. From the
results of this study, the petitioner concluded that the incidence of
passive oil loss in subjects who consumed olestra with a stiffness less
than or equal to 45 kPa/s (i.e., those in the two lowest treatment
groups) was significantly increased relative to the incidence reported
by the subjects consuming triglycerides (the placebo group). The
incidence of passive oil loss in subjects consuming olestra of greater
that 50 kPa/s was not significantly different from the incidence
reported by subjects in the placebo group. FDA's analysis of these data
agreed with the petitioner's analysis.
At the Olestra Working Group and FAC meeting, CSPI stated that
their analysis showed that there are statistically significant
increases of passive oil loss above control with olestra at the higher
stiffness levels.\63\ However, no details on how the data were analyzed
were given. FDA had the data from the passive oil loss study analyzed
independently by Dr. Joanne Lupton, FDA's consultant on GI issues. Dr.
Lupton's analysis was consistent with FDA's analysis, i.e., there would
be an increase in passive oil loss in subjects consuming olestra having
a stiffness of under 50 kPa/s but not in subjects consuming olestra
with stiffness of 50 kPa/s or higher.\64\
\63\Transcript, vol. 4, p. 163.
\64\Statement of Dr. Joanne Lupton, Transcript, vol. 2, p. 222.
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Therefore, FDA concurs with the petitioner's conclusion that there
would not be an increased incidence of passive oil loss in subjects
consuming olestra of a stiffness greater than or equal to 50 kPa/s
(Ref. 87). FDA also notes that passive oil loss is not a hazard to
health or otherwise an adverse effect per se and that the purpose of
conducting the study was to determine the stiffness specification of
olestra above which passive oil loss would not occur.
b. Effect of olestra stiffness on OIT. The petitioner stated that
the incidence of reported OIT was significantly increased in all
olestra groups relative to the incidence in the placebo group. The
incidence of OIT in the 18 kPa/s olestra group was also significantly
greater than the incidence in any other olestra group. However, there
was no consistent trend in the incidence of OIT reported by the
subjects who consumed olestra of stiffness greater or equal to 45 kPa/
s.
FDA agrees that the incidence of OIT was significantly greater in
all olestra treatment groups (13.5 percent to 32 percent) compared to
the placebo group (4.7 percent). FDA also agrees that there was no
predictive relationship between olestra stiffness and OIT when the
stiffness was greater or equal to 45 kPa/s (Ref. 87).
c. Effect of olestra stiffness on GI symptoms. With respect to GI
symptoms, the petitioner stated that 9 percent of the subjects in the
placebo group and from 10 percent to 16 percent of the subjects in the
olestra groups reported GI symptoms including (in decreasing order of
occurrence) gas/stomach gurgle, diarrhea, abnormal (loose, soft)
stools, abdominal pain, and indigestion/heartburn. The petitioner
concluded that there was no consistent trend with olestra stiffness in
the number of GI symptoms reported. The petitioner also concluded that,
consistent with the results of other studies, the GI symptoms do not
present a safety concern because: (1) When they occur, the symptoms are
generally mild or moderate in severity; (2) they subside when olestra
consumption is stopped; and (3) they do not differ substantially from
the GI symptoms normally experienced when diets high in fiber are
consumed.
FDA agrees with the petitioner that there was no trend in reported
GI effects based on olestra stiffness. However, the percentage of
subjects who reported at least one of the eight gastrointestinal
effects assessed was significantly greater in four of the six olestra
stiffness treatment groups (18, 66, 78, 103 kPa/s) compared to the
placebo group (Ref. 87).
In addition, the percentage of subjects in the olestra groups
reporting GI symptoms in response to directed questions was 0 percent
to 19 percent greater than the percentage of subjects reporting
symptoms in the placebo group. The GI effects that were reported
significantly more often in some of the olestra groups compared to the
placebo group were urgent bowel movements, difficulty wiping, and soft
stools (Ref. 87).
An increase in the number of daily bowel movements over that
occurring in the placebo group was reported by subjects in all of the
olestra stiffness treatment groups except one (45 kPa/s). Twenty-seven
percent of subjects in the placebo group reported an increased number
of bowel movements per day compared to a range of 35 to 48 percent for
olestra recipients (Ref. 87).
FDA agrees that, when reports of loose stools and diarrhea are
analyzed separately, with only one exception, no statistically
significant increase in either loose stools or diarrhea-like stools was
reported among olestra recipients versus placebo recipients. However,
as is the case with analysis of the GI symptoms in the two 8-week
studies, FDA believes that it is appropriate to combine reports of
loose stools and diarrhea for analysis. This is because the difference
between loose stools and diarrhea-like stools may not have always been
clear to the study
[[Page 3155]]
subjects and may be simply variable manifestations of the same effect.
When reports of loose stools and diarrhea like stools are combined, the
analysis shows that during the 5 day study, 42.3 percent (447/1056) of
olestra recipients experienced loose stools or diarrhea-like stools
compared to 33.1 percent (57/172) of placebo group subjects; this
difference is statistically significant (P=0.03). (Ref. 87).
Finally, FDA notes that, in general, the results of analysis of the
GI symptoms data in the oil loss study are consistent with those
obtained in the 8-week studies. In addition, FDA agrees that, like the
GI symptoms reported in the 8-week studies, GI symptoms in the oil loss
study subside when olestra consumption is stopped. As discussed above,
however, FDA does not agree with the petitioner that the GI symptoms
experienced with olestra consumption are similar to those experienced
with high fiber consumption.
3. Study of Selected Fecal Parameters in Subjects Consuming Olestra
a. Study design. The petitioner conducted a study designed to
examine fecal composition of subjects reporting diarrhea when consuming
olestra. Normal healthy males and females (18 to 60 years of age) were
selected for the study from a population of subjects who had reported
GI symptoms while consuming olestra in previous product acceptance
studies. The study consisted of two phases. A screening phase was
conducted to identify subjects who reported GI symptoms from olestra
consumption. The second phase was a study phase during which the
identified subjects ate different amounts of olestra and GI symptoms
were recorded and fecal measurements were made.
The screening phase was a 4-week, cross-over design with two
treatment groups, 0 and 20 g/d olestra. Fifty-two adults who had
reported GI symptoms in previous olestra studies were recruited for the
study. The olestra was substituted for 20 g of triglyceride in the
three daily meals with roughly one-third of the dose provided in each
meal. The study participants were acclimated to the study procedures
during a 3-day baseline period in which they ate placebo meals. They
were then divided into two groups and ate either placebo meals or meals
providing 20 g/d olestra for 5 days. After a 7-day washout period, the
subjects again ate placebo meals (containing triglycerides) for 3 days,
and then crossed-over to olestra or placebo meals for 5 days. After the
second treatment period, the subjects were monitored for a 4-day
washout period. All meals during baseline, treatment, and washout
periods were eaten under supervision at the clinical site.
The frequency, duration, and severity of nine predefined GI
symptoms were documented daily by the subjects, starting at the
beginning of the baseline period and continuing through the final 4-day
washout period. Diarrhea was defined as ``excessive frequency of very
loose/watery stools that are extremely difficult or impossible to
control.'' Loose stools were defined as ``a bowel movement that is
easier to pass than normal, but is not watery and unformed.''
At the completion of the screening phase, those subjects who
reported an increase in the frequency, severity, or duration of GI
symptoms during the olestra period, relative to the placebo period,
were selected to take part in the study phase. Eighteen subjects met
the selection criteria.
The study phase was a crossover, placebo-controlled, single-blind
(subject) design with three treatment groups, 0, 10, and 20 g/d
olestra. Each subject received each treatment for 7 days. The treatment
periods were separated by 7-day washout periods. Subjects ate all
treatment meals under supervision at the clinical site, and ate their
habitual diets at home during the washout periods.
GI symptoms were ascertained during the treatment periods and the
first 4 days of the washout periods by GI assessment records completed
daily by the subjects. For each GI symptom episode, the subject
recorded the date, time of day, and intensity. The intensity scale for
GI symptoms was graded as follows: 0 (none); 1 (slight); 2 (mild); 3
(moderate); and 4 (severe). Total fecal collections were made for the
last 3 days of each treatment period and the daily collections were
pooled. To complete the study and have data included in the analyses, a
subject had to provide at least one fecal sample for each 3-day
collection period.
Stools were collected into plastic containers and immediately
frozen. Wet weight, volume, and density measurements were made on each
stool. Fecal samples from each subject during the 3-day collection
period were then pooled. Three-day pooled fecal samples for each
subject were analyzed for water concentration, dry weight, olestra
analysis, Na, K, Cl, total and individual bile acids, free fatty acids,
triglycerides, and total lipids.
b. Petitioner conclusions. Of the 15 subjects completing the study,
6 subjects reported diarrhea while eating 20 g/d olestra. The
petitioner concludes that this study further confirms that the diarrhea
reported by subjects consuming olestra does not present potential for
harm. This conclusion is based on the observation that there was no
significant increase in stool weight, water content, or number of bowel
movements per day for subjects reporting diarrhea while consuming
olestra at 20 g/d.
c. FDA conclusions. The number of subjects who reported diarrhea
increased with increasing dose of olestra; three subjects (20 percent)
reported diarrhea while eating 0 g/d olestra, six (40 percent) subjects
while eating 10 g/d olestra, and 11 (69 percent) while eating 20 g/d
olestra. The difference in incidence of reported diarrhea between the
20 g/d and 0 g/d consumption levels was statistically significant. In
addition, the mean number of diarrheal bowel movements per subject
reporting any diarrhea and the severity of the diarrhea both increased
with increasing olestra consumption. Although there was an increase in
the number of subjects reporting loose stools with increasing olestra
dose, this increase was not statistically significant. FDA concludes
that these results are qualitatively similar to the results of the 8-
week studies.
Measurements of the concentration of stool water and electrolytes
(Na, K, and Cl) suggest these parameters did not differ in persons
reporting diarrhea during the 20 g/d olestra period from those of their
nondiarrheal stools during the placebo period. However, it was not
possible to analyze stool electrolyte values by individual stools or by
individual days because the stools were pooled from the 3-day
collection period, as is normally done when measuring fecal parameters.
FDA notes that there appears to be an increase weight of stools in
those subjects reporting diarrhea when eating 20 g/d olestra that is
not completely accounted for by the presence of olestra in the stools.
FDA concludes that the results of this study indicate that there is no
difference in stool composition (e.g., water and electrolyte content)
between those subjects consuming olestra who reported diarrhea and
those who did not (Ref. 88).
4. Study in Patients with Inflammatory Bowel Disease
The petitioner conducted a multi-center study in both ulcerative
colitis (UC) patients and Crohn's disease (CD) patients. The objective
of the study was to assess whether the presence of olestra in the GI
tract exacerbates conditions in which the GI epithelium is compromised.
Inflammatory bowel
[[Page 3156]]
disease (IBD) represents an extreme example of such a condition. In the
study the petitioner conducted, 45 IBD patients with at least a 2-year
history of diagnosed disease, who were in remission (21 UC and 24 CD),
were given 20 g/d of olestra in cookies and potato chips for 4 weeks.
Forty-four control subjects were given cookies and potato chips
prepared with conventional vegetable triglycerides. At the end of the
4-week consumption period, the disease status of each patient was
assessed and classified as in remission, worsened, or relapsed. Four
weeks after the end of the consumption period, the patients were
contacted by telephone and asked about the status of their disease. If
judged appropriate, they were seen by the investigator. In addition,
bowel permeability was assessed at the beginning and end of the
consumption period by measuring urinary excretion of polyethylene
glycol (PEG).
The petitioner stated that IBD patients are good surrogates in
which to determine whether olestra will have an adverse impact on a
wide range of GI diseases involving acute and chronic inflammation,
ulcerations, and possibly a compromised intestinal barrier. The
petitioner also asserted that this patient population was chosen
because UC and CD are thought to be exacerbated by a range of stimuli,
some of which may be dietary in nature. According to the petitioner,
IBD patients in remission are also good models for people who are
asymptomatic but who may have underlying predisposing conditions or
subclinical GI diseases which, when exacerbated, may become active.
FDA agrees that a study in persons with IBD is useful to assess
whether olestra may have adverse health effects on potentially
sensitive subpopulations with bowel disease. FDA believes that persons
with IBD are an appropriate target population for such a study because
the disease is prevalent, because the acute disease status of such
patients can be significantly influenced by factors that change bowel
habits, and because such patients can have increased bowel permeability
which, if further increased, could have long-range health significance.
The petitioner concluded that, in the placebo group, out of 44
subjects, 40 remained in remission, disease activity worsened for 4,
and none relapsed. For the olestra group, out of 45, 41 remained in
remission, disease activity worsened for three and one relapsed. The
petitioner concluded that the relapse was not test-related. Further,
hematologic parameters indicative of disease activity were not
different between the groups. The one relapse was not unexpected and is
consistent with the spontaneous relapse rate among IBD patients (about
30 percent per year (Ref. 89), or about 1 per month for the population
size studied). There was no increase in bowel permeability in either
the UC or CD patients. Because there was no difference between olestra
and placebo groups in the number of patients whose disease activity
worsened during the study, the petitioner concluded that consumption of
20 g/d olestra for 4 weeks did not affect disease activity of the IBD
patients.
FDA notes that for any study with a small number of subjects and
relatively low background relapse rate (e.g., 2.5 percent per month
projected in the control group), an effect of treatment (olestra)
compared with control (triglyceride) would be seen only if the effect
was large (Ref. 90). Thus, the study can be used to address the
possibility that consumption of 20 g of olestra per day will
consistently--about 30 percent of the time - exacerbate IBD. The study
gives some reassurance that consumption of olestra at 20 g/d for up to
31 days would not cause a large detrimental effect in special
populations such as UC and CD patients. This study was too small and
too brief, however, to rule out a moderate detrimental effect (e.g.,
relapse rates that are two or three times those of control) (Ref. 91).
5. GI Symptoms in Young Children
GI symptoms in the young were reported in three studies. Two of
these, a study in 5 to 8-year-old children that lasted 7 days and
another in 3 to 5-year-old children that lasted 5 days, were designed
to address the potential effects of olestra on GI symptoms. The third
study, while conducted to determine whether children (2 to 5 years of
age) adjusted their energy intake in response to variations in the
proportion of energy from dietary fats, also provided information on GI
symptoms. In this third study, children consumed olestra for five 2-day
periods over 5 weeks.
After reviewing the reports on GI symptoms from these studies, the
petitioner concluded that there were no differences in incidence of any
GI symptoms among treatment groups, and no significant health effects
from consumption of olestra by children.
Potential GI effects in the young were discussed at the meetings of
the Olestra Working Group and FAC. CSPI commented that the studies on
children were too short to provide enough meaningful data on
gastrointestinal problems.\65\ In addition, Dr. Herbert Needleman
stated that he had reviewed the petitioner's two 8-week studies and
CSPI's White Paper on olestra and that he had concluded that olestra
had not been demonstrated to safe for consumption by children.\66\
\65\Statement of Dr. Myra Karstadt, CSPI, Transcript, vol. 3, p.
9.
\66\Statement of Dr. Herbert Needleman, Professor of Psychiatry
and Pediatrics, University of Pittsburgh School of Medicine.
Transcript, vol. 3, p. 14.
---------------------------------------------------------------------------
On the other hand, Dr. William Klish\67\ stated that he had
reviewed all the relevant data on olestra and concluded stated that
olestra should in no way be considered harmful to children. Dr. Klish
added that, while children are born with an immature gastrointestinal
tract, their digestive and absorptive physiology, as well as
gastrointestinal motility, are similar to that of an adult at about 1
year of age and therefore, the adult data on olestra can be
extrapolated to children. Dr. Klish also noted that the feeding of a
nonabsorbable oil to children has been occurring without adverse
effects for at least the last 50 years in the form of mineral oil to
treat constipation, a symptom seen frequently in children. (Mineral oil
was normally given in doses of about 15 g to about 45 g/d for months or
years in the child who is chronically constipated.)
\67\Statement of Dr. William Klish, Professor of Pediatrics at
Baylor College of Medicine, Head of the Section of Gastroenterology
and Nutrition at the Texas Children's Hospital in Houston, TX.
Transcript, vol. 2, p. 260.
---------------------------------------------------------------------------
Dr. Charles Hargrove, a pediatric gastroenterologist with whom FDA
consulted regarding pediatric GI issues, stated that, in view of the
physiologic maturity of the GI tract by 9 to 12 months of age, there
should be no serious harmful effect in the toddler/preschool child if
the consumer parent has appropriate labeling information to associate
potential GI symptoms with olestra. He added that the differential
diagnosis for numerous GI upsets in the young, i.e., loose stools,
stomach cramps, would have to be expanded to include olestra despite
the apparently low incidence of the latter, and that physicians should
be made aware of olestra's potential to induce loose stools, for
example, as they should be aware that apple or grape juice can produce
loose stools in some toddlers.\68\
\68\Statement of Captain Charles Hargrove, M.D., Transcript,
vol. 2, p. 225.
---------------------------------------------------------------------------
Dr. Ronald Kleinman, a pediatric gastroenterologist and a member of
the Olestra Working Group concluded that olestra does not pose any
danger to health in the young. He added that the effect of excessive
consumption of
[[Page 3157]]
potato chips with olestra by children is analogous to ``toddlers'
diarrhea,'' one of the causes of which is excess fruit-juice
consumption. Dr. Kleinman observed that just as the number of stools
per day decreases whenpara. consumption of the fruit juice decreases,
stools will begin to firm up once consumption of olestra-containing
foods decreases. Dr. Kleinman noted that as is the case for many
constituents of foods and foods currently available, some individuals
who are intolerant to olestra or foods containing olestra include
children, and that children, like adults, can relate symptoms to foods
and will be able to stop eating such foods when they have reached a
level of intolerance for it.\69\
\69\Statement of Dr. Ronald Kleinman, Chief of the Pediatric GI
and Nutrition Unit, Massachusetts General Hospital and Associate
Professor of Pediatrics, Harvard Medical Center Dr. Kleinman was a
temporary member of the FAC. Transcript, vol. 4, p. 177 and 192.
---------------------------------------------------------------------------
FDA notes that, in general, the GI symptoms seen in the studies in
children conducted by the petitioner are consistent with those seen in
the 8-week studies in adults discussed above. Although the short
duration of the studies in children makes it difficult to compare the
GI effects to those seen in the 8-week studies in a meaningful way, FDA
has concluded that the data regarding GI effects obtained in adults can
be extrapolated to the young and that this approach is fully consistent
with the expert views provided at the Olestra Working Group and FAC
meetings. FDA also notes that despite CSPI's criticism that the studies
in children were not of adequate length, CSPI did not contradict the
basis for the agency's conclusion that extrapolation from studies in
adults is appropriate.
C. Effect of Olestra on Intestinal Microflora Metabolism
Olestra passes intact through the colon where it has the potential
to affect adversely the normal metabolic activity of the intestinal
microflora. The indigenous microflora of the colon carry out a variety
of reductive, degradative, and hydrolytic processes that are important
to the host. Therefore, it is important to know whether consumption of
olestra affects microflora populations, alters fermentation processes
or normal microflora metabolism of host-produced substrates, or acts as
a substrate for microflora.
1. Effect of Olestra on Breath Gas and Microflora-Associated
Characteristics
The petitioner used an analysis of breath hydrogen as a noninvasive
technique for studying microbial fermentation in the human colon under
``normal'' and ``high'' dietary fiber intakes (within the range
recommended as ``healthy'' fiber intake in the United States), with and
without olestra. An analysis of breath methane was also used in this
study to provide additional information on microbial fermentation
activity in methanogenic individuals.
In addition, because normal metabolic function of colonic
microflora can be assessed by measurement of several endpoints of
metabolic activity (microflora-associated characteristics\70\), the
petitioner measured microflora-associated characteristics to provide
additional information on the effect of the presence of olestra in the
colon on normal bacterial metabolism.
\70\Microflora-associated characteristics include degradation of
beta-aspartylglycine and mucin, conversion of cholesterol and
bilirubin to their respective metabolites, inactivation of trypsin,
and production of short-chain fatty acids (SCFA).
---------------------------------------------------------------------------
The breath gas study was a parallel, double-blind, placebo-
controlled study 5 weeks in length. The subjects were 97 normal healthy
males and females from 18 to 58 years of age. Subjects were randomly
assigned to four treatment groups. Following an 8-day baseline period
during which subjects consumed a placebo breakfast low in dietary
fiber, they were fed breakfast meals daily containing moderate (7 g) or
high (24 g) levels of fiber, with 24 g of either olestra or
triglyceride for 28 days. Breath gas and fecal samples were collected
at the end of the baseline period and at the end of the test period.
The breath gas samples were analyzed for hydrogen and methane. The
fecal samples were examined for viable microbial counts and direct
microscopic cell counts for fecal bacteria. (Fecal bacteria have been
demonstrated to be directly representative of the indigenous human
intestinal microflora and their metabolic activities.) In addition, the
fecal samples were analyzed for microflora-associated characteristics.
The petitioner concluded that, although there was a trend toward
lower breath hydrogen production in the olestra groups (20 percent
reduction in the olestra high fiber group compared to placebo high
fiber group) there were no statistically significant differences in
cumulative breath hydrogen production between olestra and placebo
groups. Further, the petitioner stated that olestra did not affect the
total number of direct or viable counts of the fecal microflora. The
petitioner also stated that olestra had no statistically significant
effect on cumulative breath methane production following consumption of
either the moderate or high fiber meal and that breath methane
production values for individuals in the olestra groups were similar to
individual values in the respective placebo groups.
According to the petitioner, olestra had no effect on fecal
microbial counts, and did not interfere with the normal degradation of
beta-aspartylglycine, mucin, or trypsin. The concentration and
distribution of short chain fatty acids (SCFA) was not consistently or
significantly affected by olestra, indicating the absence of an adverse
effect on microbial metabolism. Finally, the petitioner stated that
urobilinogen and coprostanol concentrations were not adversely affected
by olestra consumption. The petitioner concluded that the results of
this study demonstrate that olestra will not interfere with normal
intestinal fermentation of dietary fiber.
FDA notes that the best direct information on microbial imbalances
of concern would have been adequate direct microscopic cell counts and
viable cell counts. Although these tests were performed, the data
cannot be used due to improper handling of the samples (Ref. 92). The
study did show that the microflora-associated characteristics that are
generated by the majority of the bacterial genera found in the colon
(e.g., the proteases, peptidases) and production of SCFA were not
affected or only slightly affected by the presence of olestra in the GI
tract. However, FDA's analysis of the data further shows lowering of
hydrogen breath gas in some subjects, appearance of undergraded mucin
in some subjects, a reduction of microbial formation of coprostanol
from cholesterol, and reduced bilirubin conversion in those subjects
consuming olestra (Ref. 92). FDA notes that these variations in
microflora-associated characteristics are not different from those
observed from dietary changes, for example, from low to high fiber
diets, and that there are large variations in normal healthy subjects
with respect to microflora-related parameters (Ref. 93). In addition,
although there was some dampening of hydrogen production when olestra
was added to a high-fiber diet, this dampening was not significant.\71\
\71\Statement of Dr. Joanne Lupton, Transcript, vol. 4, p. 87.
---------------------------------------------------------------------------
2. Potential for Intestinal Microflora to Metabolize Olestra
The petitioner stated that the pivotal studies that demonstrate
that olestra is not metabolized by microflora in the GI tract are a
clinical study in humans and the rat absorption and metabolism
[[Page 3158]]
studies. The clinical study showed no production of radiolabeled
metabolic breakdown products, and no changes in either olestra fatty
acid composition or ester distribution following incubation of
radiolabeled olestra with fecal microflora from humans who consumed 7
g/d olestra for up to 31 days.
As noted, in the rat absorption studies, virtually all radiolabel
was recovered in feces and GI contents, with insignificant amounts
recovered as metabolic byproducts in CO2, urine, and tissues after
animals were fed olestra for 28 days and then dosed with radiolabeled
olestra.
The petitioner also submitted a published study (Ref. 94) that
demonstrates that olestra is not metabolized by the microflora of the
GI tract. In this study, radiolabeled (14C-fatty acids) olestra
was incubated for 72 hours in either minimal or organically enriched
anaerobic media inoculated with feces from seven healthy subjects who
had consumed 9 g/d of olestra for 3 to 4 weeks. The petitioner stated
that no significant quantities of 14CO2, 14CH4, or
14C-volatile fatty acids were detected during the incubation,
indicating that olestra was not metabolized by colonic microflora. At
the Olestra Working Group and FAC meetings, the petitioner also pointed
out that human gut microflora have never adapted to breakdown fat or
cellulose. In addition, the petitioner reasoned that because the
breakdown of fat requires beta oxidation, which requires oxygen, it is
unlikely that in the anaerobic environment of the human intestine,
microorganisms will adapt to metabolize olestra.\72\
\72\Transcript, vol. 1, p. 152. Accordingly, the petitioner
concluded that there was no evidence of degradation of the olestra
(i.e., no change in ester distribution or fatty acid composition) by
intestinal microflora.
---------------------------------------------------------------------------
FDA notes that there is a hypothetical possibility that an organism
capable of metabolizing olestra at a low level could arise among the
intestinal microflora (Ref. 95). The in vitro study on minimal medium
did suggest that olestra might be metabolized by microflora at a low
level when olestra is the only carbon source (Ref. 95). Such conditions
are unlikely to exist in the intestinal tract. Because of the
possibility that olestra might be metabolized, FDA asked Dr. Joann
Lupton, a consultant for FDA who specializes in the effect of diet on
the GI tract, to review the breath gas and in vitro studies. Dr. Lupton
did not observe any metabolism of olestra by microflora.\73\ Dr. Lupton
concluded that because no long chain fatty acids were released from the
olestra, and because the olestra was actually recovered without any
change in chain length or degree of saturation, olestra is not
metabolized by the microflora (Refs. 96 and 97). Further, given the
findings in the human and animal material balance studies (discussed in
section III.A of this document), which showed that olestra was excreted
quantitatively and was unchanged in the feces, FDA believes that the
available evidence shows that there is no metabolism of olestra by the
intestinal microflora.
\73\Statement of Dr. Joanne Lupton, Transcript, vol. 2, pp. 216-
226.
---------------------------------------------------------------------------
D. Effect of Olestra on Bile Acid Metabolism
The petitioner submitted several published and unpublished studies
in animals and humans to demonstrate that consumption of olestra will
have no meaningful effect on the absorption, synthesis or excretion of
bile acids. The studies included: (1) A 2-year rat study where olestra
was fed at 5 percent of the diet and total fecal bile acid excretion
was measured after 1, 2, and 24 months; (2) a study in rats on the
effect of olestra on the absorption of chenodeoxycholic acid, one of
the more lipophilic bile acids; (3) studies on the effect of olestra on
bile acid excretion in humans ingesting 8 to 40 g/d olestra for 30 days
or 90 g/d olestra for 37 to 55 days; (4) a study in rats on olestra s
effect on biliary acid profiles; and (5) a study examining the effect
of olestra on bile acid pool size and bile composition in African Green
Monkeys.
The petitioner stated that olestra had no effect on the rate of
recovery or the amount of chenodeoxycholic acid, that neither bile acid
synthesis nor excretion are affected by olestra, that the absorption of
bile acids is not affected by olestra, and that olestra had no effect
on biliary or fecal bile acid profiles.
FDA reviewed the studies and, although some of the studies have
limitations in experimental design or execution, has concluded that the
studies as a whole show that olestra would not be expected to produce
major changes in bile acid metabolism and absorption (Ref. 98).
E. Overall Conclusions on Effects on the GI Tract
The issues of potential concern with respect to the effect of
olestra on the GI tract are: (1) The potential for loose stools or
diarrhea to result in electrolyte and fluid loss; (2) whether the GI
effects have the potential to interfere with normal daily life of
consumers, (3) whether the GI effects seen are of special concern to
subpopulations where proper fluid control is important (e.g.,
individuals with underlying cardiovascular or GI diseases, the young
and the elderly); and (4) whether changes observed in microflora-
associated characteristics associated with olestra consumption are
meaningful to health.
These issues were discussed at the meetings of the Olestra Working
Group and the FAC. After presentation and discussion of the data
relating to the potential GI effects that olestra may cause, most
members of the Olestra Working Group and FAC, including all of the
gastroenterologists, felt that there was reasonable certainty of no
harm with respect to the potential for olestra to cause GI effects.\74\
These members felt that, while olestra may cause certain GI effects,
including loose stools, these effects are not adverse effects because
they do not threaten health. For example, effects described as
``diarrhea'' were not diarrhea in the medical sense because they were
not associated with water loss or electrolyte imbalance.
\74\Transcript, vol. 3, p. 78 and vol. 4, p. 196.
---------------------------------------------------------------------------
On the question of whether the ``diarrhea'' experienced by subjects
was diarrhea in the medical sense, the petitioner presented additional
data on fecal water content to the Olestra Working Group.\75\ (The
study from which these data were derived is described in more detail in
section VI.3. of this document). According to the petitioner, the
results of the study showed that, even in olestra-consumers
experiencing what they described as diarrhea, these subjects had no
change in the stool water content, and also, no change in electrolytes
or the pH of the stool; the only difference was that the stools of
these subjects had more lipid, which was completely accounted for by
the olestra consumed. Dr. Lawrence Johnson, a gastroenterologist member
of the Olestra Working Group, agreed with the petitioner's analysis and
stated that when one looks at stool by weight, the gross weight will
increase because olestra is not absorbed and increases the weight of
the stool. (Increased stool weight is one criterion for diarrhea.) Dr.
Johnson added that one would next determine whether fat or fluid is
responsible for stool weight increase. He noted that the amount of
fluid in the stool was about 200 cc, which is the amount that would be
in stool in normal physiologic amounts.\76\ Dr. Joanne Lupton, the FDA
consultant on GI issues, added that, in looking at the clinical data,
the larger the proportion of the stool that is olestra, the softer the
[[Page 3159]]
stool is going to be but that there is no evidence of dehydration, or
electrolyte imbalance in those subjects reporting ``diarrhea''.\77\
\75\Transcript, vol. 1, p. 112.
\76\Statement of Dr. Larry Johnson, Professor of Medicine and
Director of the Digestive Diseases Division, Uniformed Health
Service University, Transcript, vol. 4, p. 83.
\77\Statement of Dr. Joanne Lupton, Transcript, vol. 3, p. 89.
---------------------------------------------------------------------------
In addition, at the Olestra Working Group and FAC meetings, the
question of whether olestra in the feces represented steatorrhea was
raised. Drs. A. R. Colon and J. S. DiPalma\78\ stated that initial
human studies on olestra revealed steatorrhea, in addition to diarrhea,
as an apparent dose-related side effect and that there were no data
that assessed 72-hour fecal fat excretion or dose-steatorrhea
correlations. In response to a question of whether the effects seen
with olestra are steatorrhea and not diarrhea, the petitioner stated
that the effects seen with olestra are unrelated to steatorrhea, which,
according to the petitioner, is the presence of unabsorbed free fatty
acids in the lower bowel which results in an osmotic and an
inflammatory and irritative response in the bowel.\79\ The petitioner
stated that the only identified change between feces from subjects
consuming olestra and those consuming triglyceride was that the lipid
content of the stool in the olestra group was increased, an expected
result because olestra is not absorbed and is excreted in the feces.
The petitioner added that their analysis showed that there was no
additional lipid in the stool of subjects consuming olestra.\80\ Dr.
Joanne Lupton agreed that the available data do not reflect any
steatorrhea.\81\
\78\Letter from Drs. A. R. Colon and J. S. DiPalma, Georgetown
University Medical Center, read at the FAC meeting; Transcript, vol.
3, p. 19.
\79\Statement of the petitioner, Transcript, vol. 1, p. 141.
\80\Transcript, vol. p. 97.
\81\Statement of Joanne Lupton, Transcript, vol. 3, p. 24.
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FDA notes that steatorrhea (the passage of large amounts of fat in
stool) usually occurs in conjunction with pancreatic disease and
malabsorption syndrome. FDA has reviewed the data on the lipid content
in feces of subjects consuming olestra and concludes that there was no
evidence of steatorrhea in any subject in the study (Ref. 99). Most
members also felt that consumers can deal with the GI effects of
olestra in the same manner as similar effects caused by other
foodstuffs in the food supply, i.e., by limiting intake of the material
causing the effect. For this reason, most members felt that foods
containing olestra should be labeled in a manner to alert consumers to
the potential GI effects of olestra but also in a manner that will not
preclude the consumers from seeking health care for more serious
concerns. (Labeling for olestra is discussed in more detail in section
VII. of this document.)
Based upon the available data and information, FDA concludes that
consumption of olestra causes GI symptoms such as bloating, loose
stools, abdominal cramps, and diarrhea-like symptoms. There is no clear
association between the onset of these effects and time of ingestion.
In some cases, the effects occurred the few first days of consuming
olestra products; in others, such products were consumed for several
weeks before effects were seen. In addition, there were some people in
whom the effects never were reported. With some consumers, the olestra-
induced effects were seen at low olestra doses and with others, it took
a higher dose to elicit the effects. In addition, the agency notes that
few individuals reporting GI symptoms in the olestra clinical studies
dropped out of the studies because of the symptoms and that study
subjects were able to carry out their daily functions while they were
on the studies.
While olestra caused GI effects such as those mentioned above,
there is no evidence that these effects represent adverse health
consequences. The effect of olestra on stool consistency is similar to
that produced by liquid petrolatum, which softens fecal contents and
interferes with the development of firm, well-formed stools. The
``diarrhea'' experienced by the study subjects was not diarrhea in the
medical sense because it was not associated with loss of water or
electrolytes. Indeed, those subjects who experienced loose stools or
diarrhea continuouslypara.for several weeks during olestra consumption
did not show any evidence of fluid loss such as hemoconcentration or
electrolyte imbalance. This is consistent with published studies (Refs.
80 and 81) that show that olestra does not significantly alter gastric
emptying or overall GI transit time.
With respect to whether olestra's potential to cause diarrhea-like
symptoms or loose stools raises concern for special subpopulations
where proper fluid and electrolyte control is important, FDA notes
that, as discussed above, the soft stool and ``diarrhea'' appear to be
caused by disruption of the fecal matrix and are not associated with
clinical signs of fluid loss, which is the case in classical diarrhea.
Therefore, FDA has determined that there is no basis to conclude that
these subpopulations would be at special risk due to consumption of
olestra.
FDA recognizes that nutritionists generally do not recommend
reduced-calorie products for consumption by children. Nevertheless,
there is the potential that olestra-containing products may be eaten by
children. Although the studies FDA reviewed with respect to the effect
of olestra on GI symptoms in the young were not sufficiently long, FDA
notes that the GI physiology of children older than approximately 9
months is comparable to that of adults\82\ (Ref. 100). Therefore, FDA
concludes that there is no basis to conclude that the effect of olestra
on the GI tract would be any different in children than in adults, and
thus, the results of studies conducted in adults to address the effects
of olestra consumption on the GI tract can be extrapolated to the young
(Ref. 101).
\82\Statements of Drs. Charles Hargrove and Dr. William Klish,
Transcript, vol. 2, pp. 226 and 260, respectively.
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With respect to differences seen in microflora-associated
characteristics as a result of olestra consumption, FDA notes that such
variations are no different than those observed with other dietary
changes (for example, from low to high fiber diets), and that there are
large variations in normal healthy subjects with respect to microflora-
related parameters. Also, FDA believes that the available evidence
shows that there will be no significant metabolism of olestra by the
intestinal microflora. Therefore, FDA concludes that, collectively, the
data do not establish an adverse effect of olestra consumption on
microbial metabolism or function.
Notwithstanding the fact that FDA finds no safety concerns with
respect to the effect of olestra on the GI tract, FDA believes that it
is important for consumers to be aware of the GI symptoms associated
with ingestion of olestra-containing foods so that they are able to
associate olestra with the GI symptoms that it may cause. This
information would also preclude unnecessary concerns and inappropriate
medical treatment. Appropriate labeling for olestra-containing foods is
discussed in section VII. of this document.
VII. Labeling of Foods Containing Olestra
As discussed above, because olestra is not absorbed and passes
through the GI tract intact, it affects the absorption of certain fat-
soluble vitamins and nutrients, which partition into it. Olestra also
has the potential to cause certain GI effects such as abdominal
cramping and loose stools. The agency has considered whether these
effects warrant special labeling of foods containing olestra. As
discussed in detail below, FDA has determined that
[[Page 3160]]
foods containing olestra shall be labeled with the following statement:
This Product Contains Olestra. Olestra may cause abdominal
cramping and loose stools. Olestra inhibits the absorption of some
vitamins and other nutrients. Vitamins A, D, E, and K have been
added.
A. Labeling Authority
Under the act, the agency has the mandate to ensure that labeling
provides truthful and nonmisleading information to consumers. Thus, the
law provides the agency with authority to require specific label
statements when needed for reasons other than to ensure the safe use of
food.\83\ Specifically, section 409(c)(3)(B) of the act (21 U.S.C. 348
(c)(3)(B)) prohibits FDA from approving a food additive if the proposed
use would result in the misbranding of food within the meaning of the
act (21 U.S.C. 348(c)(3)(B)). Under section 403(a)(1) of the act (21
U.S.C. 343(a)(1)), a food is misbranded if its labeling is false or
misleading in any particular.
\83\Under section 409(c)(1)(A) of the act (21 U.S.C.
348(c)(1)(A)), the agency has the authority to prescribe the
conditions of safe use of a food additive, including the authority
to require label statements needed to ensure safety. Thus, in a food
additive regulation, the agency may rely on this provision for
requiring statements to appear on labels of products containing food
additives. In the case of olestra, however, FDA is not requiring the
labeling of olestra-containing foods in order to ensure the safe use
of olestra.
---------------------------------------------------------------------------
Section 201(n) of the act (21 U.S.C. 321(n)) amplifies what is
meant by ``misleading'' in section 403(a)(1) of the act. Section 201(n)
of the act states that in determining whether labeling is misleading,
the agency shall take into account not only representations made about
the product, but also the e
FR Doc. 96-1584 Food Additives Permitted for Direct Addition to Food for Human Consumption; Olestra
xtent to which the labeling fails to reveal
facts material in light of such representations made or suggested in
the labeling or material with respect to consequences which may result
from use of the article to which the labeling relates under the
conditions of use prescribed in the labeling or under such conditions
of use as are customary or usual (see 21 CFR 1.21). Thus the omission
of certain material facts from the label or labeling of a food causes
the product to be misbranded within the meaning of 21 U.S.C. 343(a)(1)
and 321(n). In general, the agency believes the concept of ``material
fact'' is one that must be applied on a case-by-case basis. The agency
has required special labeling in cases where information is necessary
to ensure that consumers are aware of special health risks associated
with consumption of a particular product. For example, although protein
products intended for use in weight reduction are not inherently
unsafe, FDA requires a warning statement for such products that states,
in part, that very low calorie protein diets may cause serious illness
or death. Another example of required information is the use of the
term ``milk derivative'' following the ingredient declaration of sodium
caseinate when used in a product labeled ``non dairy'' (21 CFR
101.4(d)).
FDA believes that such a labeling statement is appropriately
established as part of the rulemaking for a food additive approval
under section 409 of the act. As noted, under section 409(c)(3)(B) of
the act a food additive regulation cannot issue if the available data
show that ``the proposed use of the additive would *** result in ***
misbranding of food within the meaning of the Act.'' Thus, the status
of foods containing a particular additive, in terms of misbranding
under the act, is always an issue to be considered and determined by
the agency for each food additive petition. (In most cases, the
proposed use of the additive presents no issue regarding misbranding of
foods that contain the additive.) Accordingly, the notice of filing of
a food additive petition published under 21 U.S.C. 348(b)(5)
necessarily includes notice that proper labeling under the act of foods
containing such additive is a question before the agency. In the case
of olestra, the notice of filing published in the Federal Register of
June 23, 1987 (52 FR 23606), was a public announcement that the olestra
food additive petition had been filed, and that all issues regarding
the approval of the proposed use, including the proper labeling of
foods containing olestra, would be considered by FDA.\84\
\84\FDA's regulation regarding the failure to reveal material
facts, (21 CFR 1.21), states that ``affirmative disclosure of
material facts *** may be required, among other appropriate
regulatory procedures, by *** regulations in this chapter
promulgated pursuant to section 701(a) of the act; or direct court
enforcement action (emphasis added).'' Thus, establishing a
requirement for a label statement for olestra-containing foods as
part of a section 409 proceeding is consistent with 21 CFR 1.21.
---------------------------------------------------------------------------
As discussed below, FDA has determined that all foods containing
olestra should bear a label disclosing olestra's GI effects and its
effects on nutrients, and disclosing that certain vitamins have been
added back. The agency believes that these labeling statements can be
imposed as final requirements as part of the food additive petition
process of section 409 of the act, and that it is important that once
approved, products containing olestra be properly labelled so as not to
be misbranded. Thus, FDA is imposing an immediately effective labeling
requirement. However, the agency acknowledges the importance of the
opportunity for interested members of the public to express their views
on the labeling for olestra. In addition, the petitioner, Procter &
Gamble, intends conduct focus group testing of the required olestra
label (Ref. 103). Accordingly, the labeling requirement for foods
containing olestra, while immediately effective, is an interim
requirement only. The agency requests comments on this label from
interested persons, on such issues as the need for such labeling, the
adequacy of its content, the agency's word choice, and the
configuration of the label. Three copies of such comments shall be
submitted to the Dockets Management Branch (address above) April 1,
1996. FDA will then evaluate and respond to any comments received, as
well as any studies or other information from focus group testing
conducted by the petitioner. As noted below, under section 409(f)(1) of
the act, interested persons have the opportunity to file objections to
the final rule; such objections shall be filed within 30 days of the
final rule, and shall conform to certain requirements in terms of
format and content, which are articulated below. Commenters on the
labeling for olestra who intend their comments to be treated and
function as objections under section 409(f)(1) of the act shall conform
to the time restrictions, format, and content requirements for
objections. Any labeling comments received more than 30 days from the
date of this final rule and any comments not otherwise conforming to
the requirements for objections shall be considered by FDA as simply a
comment and not an objection under 409(f)(1) of the act and addressed
by the agency accordingly.-
In these circumstances, FDA has concluded that it is appropriate
for the agency to establish labeling requirements for olestra-
containing foods that are effective concurrent with the promulgation of
a final rule regulating the additive.
B. Labeling with Respect to GI Effects
As discussed in section VI. of this document, consumption of
olestra may cause GI symptoms such as abdominal cramping and loose
stools. However, there is no evidence that these effects represent
adverse health consequences. As noted, the effect of olestra on stool
consistency is similar to that produced by mineral oil, which softens
fecal contents and interferes with the development of firm, well-formed
stools. Further, the ``diarrhea'' experienced by the study subjects was
not diarrhea in the usual medical sense because it was not associated
with loss
[[Page 3161]]
of water or electrolytes. Nonetheless, while the agency has concluded
that based upon the evaluation of the available evidence there are no
safety concerns with respect to the effect of olestra on the GI tract,
the agency believes that consumers should be provided with information
to enable them to associate olestra with the GI symptoms that it may
cause. The agency believes that providing this information to consumers
would preclude unnecessary concerns about the origin of GI effects,
were they to be observed, and may also prevent unnecessary or
inappropriate medical treatment of those symptoms. Accordingly, FDA has
determined that the relationship between GI symptoms and consumption of
foods containing olestra is a fact that is material in light of the
consequences of consuming olestra in savory snacks. In such
circumstances, this relationship must be disclosed to consumers
consistent with sections 201(n) and 403(a)(1) of the act.
C. Labeling with Respect to Effects on Nutrients
As discussed in section V. of this document, olestra interferes
with the absorption of the fat-soluble vitamins A, E, D, and K and
therefore, these vitamins will be required to be added to olestra-
containing foods to compensate for that amount of the vitamins that is
not absorbed due to olestra's effects. As required under section
403(i)(2) of the act, these vitamins will be declared in the ingredient
listing.
The added vitamins, however, may not be considered in determining
nutrient content of the food for the nutritional label or for any
nutrient claims, express or implied. This is because the added vitamins
will simply compensate for the amounts lost due to decreased absorption
of the vitamins from other foods but will not contribute significant
amounts of these vitamins to the diet. In other words, the purpose of
adding the four fat-soluble vitamins is to ensure that no significant
change in vitamin availability (neither decrease nor increase) occurs.
Olestra also decreases absorption of some lipophilic carotenoids,
which can lead to lower serum levels of those nutrients. As noted, the
agency has concluded that supplementing olestra with vitamin A will
compensate for olestra's effects on the provitamin A function of
carotenoids. Except for the provitamin A function (which is taken care
of by addition of vitamin A), other specific health benefits for
carotenoids have not been established.
As noted, labeling may be considered misleading not only if it
fails to reveal facts that are material in light of consequences which
may result from use of a food, but also if it fails to reveal facts
that are material in light of representations made. As discussed above,
FDA concludes that no consequences will result from inhibition of
lipophilic nutrients by olestra because vitamins A, D, E and K will be
added back to compensate. However, the mandatory listing of these
vitamins on the ingredient statement could confuse consumers by
implying that the food would provide significant amounts of these
vitamins. Therefore, FDA is requiring a statement indicating that
olestra inhibits the absorption of vitamins and other nutrients to set
the context for why they are added. FDA is including the term other
nutrients because any nutrient that is as lipophilic as these vitamins
would also be affected, although there is currently no basis for adding
them back. Thus, in light of the disclosure in the ingredient statement
that vitamins A, D, E, and K have been added, FDA has determined that
the label statement explaining such compensation must be made.
FDA is not requiring a specific statement on carotenoids in this
labeling statement because doing so could falsely imply that their
decreased absorption is known to be of significance. As stated
previously, the current evidence does not show that inhibition of
carotenoid absorption would result in any significant health
consequences. This decision is consistent with FDA's policy for
nutrient content claims, as required by 21 CFR 101.54. In that
regulation, claims that a food is a ``good source'' of, ``high'' in, or
contains ``more'' of a nutrient can be made only if the difference is
significant with respect to a recommended daily intake (RDI) or daily
reference value (DRV) for a nutrient, as established by regulation, so
that consumers are not confused by implications that are of no
nutritional significance. Such claims may not be made for substances
for which a RDI or DRV has not been established. FDA believes that its
policy concerning when a company may state that a food provides more of
a nutrient should guide FDA in when it requires a company to disclose
that a food would decrease availability of a nutrient. Therefore, FDA
concludes that the label of foods containing olestra should not state
that olestra inhibits the availability of carotenoids because to do so
may imply that the inhibition of carotenoid absorption is of
nutritional significance.
D. FAC Discussions Regarding Labeling
1. GI Effects
Both the Olestra Working Group and the FAC discussed the importance
of labeling that would disclose the association between olestra and the
additive's potential GI effects. The FAC members agreed with the agency
that it is important that consumers be able to associate the GI effects
that olestra may cause with the additive. Committee members, however,
recommended some amendments to a tentative label statement discussed at
the FAC meeting (``Foods containing olestra may cause intestinal
discomfort or a laxative effect'').
First, members of the Committee suggested\85\ that the label read
``Olestra may cause***'' instead of ``Foods containing olestra may
cause***'' to make clear that the GI effects experienced are caused by
the additive, olestra. The agency agrees that the suggested change
results in a clearer and more succinct label, and thus is following
this suggestion.
\85\Transcript, vol. 3, p. 91.
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Second, some Committee members felt that significant increases in
the frequency of GI effects were seen only at the higher olestra doses
(20 and 32 g olestra/day) in the 8-week studies (see discussion in
section VI.B.1 of this document) and therefore, that the label
statement should be amended to state that it is excess consumption of
olestra that may cause the GI symptoms.\86\ Others felt that a test of
trends might show a dose-response effect, i.e., that the more olestra
one consumes the more one experiences symptoms; in addition,
significant differences might be observed at eight g/d olestra if the
power of the study was increased sufficiently.\87\
\86\Transcript, vol. 3, p. 93.
\87\Transcript, vol. 3, p. 52.
---------------------------------------------------------------------------
The agency agrees that there is a clear dose response effect with
respect to olestra's ability to elicit GI effects. The agency also
agrees that the lack of statistical difference between the placebo
group and the eight g/d group in the two 8-week studies might be due
only to the lack of power of the studies. In addition, the agency notes
that consumption of 20 g/day olestra (equivalent to two 1-oz bags of
potato chips, for example), for which there was a clearly significant
difference from the placebo group with respect to GI effects, may not
be considered excessive consumption by many consumers. As noted above,
a scenario-driven estimate of 20 g/p/d, based on consumption of 2 oz of
chips per day is a reasonable
[[Page 3162]]
estimate of a ``short-term'' high consumer. Therefore, the agency does
not agree that the label statement should be amended to indicate that
only excessive consumption could lead to GI symptoms.
Third, some Committee members expressed concern that the presence
of a label statement could lead some consumers to disregard GI symptoms
caused by factors other than olestra consumption and that erroneous
attribution to olestra might unnecessarily cause them to delay
consulting their healthcare provider.\88\ Therefore, several Committee
members recommended that a second sentence be added to the proposed
label to advise consumers that they should consult their healthcare
provider should symptoms persist after consumption of olestra-
containing foods ceases.
\88\Transcript, vol. 3, p. 90.
---------------------------------------------------------------------------
Data submitted in the petition show that GI symptoms caused by
olestra do not persist more than 2 days after consumption of olestra
ceases. Thus, the agency agrees that persistent GI symptoms are
unlikely to be related to consumption of olestra. Nevertheless, the
agency believes that it should not require a label to bear information
about medical advice unrelated to the food in the package.
Finally, some Committee members questioned whether it is
appropriate to refer to the stool softening effect of olestra as a
``laxative effect.''-As discussed above, the effect of olestra on stool
consistency is similar to that produced by mineral oil, an over the
counter laxative that works by lubricating the intestinal tract,
softening the fecal contents, and facilitating the passage of feces.
However, unlike mineral oil, olestra would be consumed for a purpose
other than its potential laxative effect. In this case, FDA believes
that requiring use of the term laxative may imply the therapeutic use
of a laxative.
Therefore, instead of the term ``laxative effect,'' the agency
believes it is more appropriate to use ``may cause loose stools'' on
the label to indicate clearly to consumers, olestra's potential to
affect stool consistency.
2. Fat-Soluble Vitamins and Carotenoids
Some Committee members felt that consumers, upon seeing vitamins A,
E, D, and K in the ingredient listing of olestra-containing foods,
could be confused into thinking that the product is fortified with
these vitamins. Therefore, they suggested that the ingredient list
ought to contain a parenthetical note explaining that the vitamins were
added to restore what would be lost due to olestra's interference with
vitamin absorption.\89\ Other Committee members recommended that the
agency handle this issue consistent with similar prior cases.\90\
\89\Transcript, vol. 3, p. 218, 259, 261.
\90\Transcript, vol. 3, p. 263.
---------------------------------------------------------------------------
With respect to olestra's potential to decrease the bioavailability
of carotenoids, most members of the Committee agreed with the agency
that, given the current state of knowledge, the observed degree of
reduction in carotenoid bioavailability does not raise concern. Given
this conclusion, most Committee members further agreed that the effect
of olestra on the bioavailability of carotenoids is not a fact material
in light of consequences that may result from consumption of foods
containing olestra and therefore, does not warrant disclosure on the
labels of such foods.\91\ Others felt that it was necessary to inform
consumers that consumption of olestra may lower serum carotenoid
levels.\92\
\91\Transcript, vol. 3, p. 271.
\92\Transcript, vol. 3, p. 258.
---------------------------------------------------------------------------
The agency notes that there are no prior cases on which to base how
labeling with respect to the vitamins that are added to olestra-
containing foods might be handled. The agency has not previously
approved an additive which interferes with the absorption of vitamins
to a degree that necessitates requiring that foods containing the
additive be compensated with such vitamins to mitigate the effect of
olestra.
As stated above, the agency believes that consumers who see the
added vitamins listed on the ingredient listing could be misled and
believe that the food is fortified with the vitamins unless they are
given information explaining why the vitamins are added to the olestra-
containing food. Therefore, the agency believes that the fact that the
olestra inhibits vitamin absorption and that vitamins have been added
back are material facts that should be disclosed to consumers.
E. Agency Conclusions Regarding Labeling of Foods Containing Olestra
Based on the entire record before the agency, FDA has concluded
that foods containing olestra should bear the following label
statement:
This Product Contains Olestra. Olestra may cause abdominal
cramping and loose stools. Olestra inhibits the absorption of some
vitamins and other nutrients. Vitamins A, D, E and K have been
added.
In the absence of such labeling, the agency would consider olestra-
containing foods to be misbranded (21 U.S.C. 343(a) and 321(n)). FDA
believes that this information will be used by consumers both in their
decisions on purchases and to help them adjust their consumption to
minimize side effects. To ensure that the required labeling statement
will be readily recognized and easy to read, FDA is requiring a
standardized format that specifies among other things, type style and
type size. FDA's recent experience with graphic requirements for the
new Nutrition Facts label, as well as focus group discussions of the
new Nutrition Facts label requirements, show that messages put in a
boxed area help consumers distinguish the message from other
information as well as draw attention to it (see 60 FR 67176 at 67181,
December 28, 1995). Therefore, FDA is requiring that the message on the
label of olestra-containing foods be surrounded by a box. Additionally,
FDA is also specifying the minimum type size to ensure proper
prominence. FDA welcomes any comments on the adequacy of this label
requirement, including the format, as it reassesses this interim rule.
The agency would not object to any additional truthful
nonmisleading information that a manufacturer may wish to include in
the label statement, including, for example, a telephone number that
consumers can call to obtain additional information regarding GI
effects caused by olestra or olestra's effect on the absorption of fat-
soluble nutrients.
VIII. Response to Comments
FDA received approximately 2,300 comments on the olestra petition.
Comments were received from health care professionals, scientists,
nutritionists, members of academia, consumer organizations, and
professional associations as well as individual consumers. These
comments, together with the Olestra Working Group and the FAC
deliberations on the issues raised by the comments, have been taken
into account in FDA's final decision on the olestra petition.
Most of the comments opposing olestra's approval (about 2,000
comments) were from individual consumers who identified themselves as
members of CSPI and simply stated that fat substitutes must be
absolutely safe and urged the agency to reject the ``petition to
approve the unsafe fat substitute olestra.'' These comments did not
provide any factual information or any rationale to support the opinion
expressed. Because these comments raise no factual issue, they will not
be discussed further.
[[Page 3163]]
Most of the remaining comments opposing olestra's approval (the
majority of which were form letters with some of the writers declaring
affiliation with CSPI) expressed similar views on one or more of the
following issues that were discussed extensively at the meetings of the
Olestra Working Group and the FAC: (1) The potential for olestra to
cause GI effects (including the nature of the GI effects); (2) the
potential for olestra to deplete fat soluble vitamins, carotenoids, and
other phytochemicals, and para.whether such depletion increases the
risk for certain cancers and other diseases such as coronary heart
disease, stroke, macular degeneration, and other eye diseases; (3)
whether adding vitamins to olestra-containing foods to compensate for
depletion is efficacious or raises vitamin toxicity issues; (4) whether
olestra, with or without supplemented vitamin K, interferes with
coumadin therapy; (5) whether labeling with respect to GI issues and
nutrient issues should be required for foods containing olestra
(including the nature of the information that should be included in the
label statement); (6) adequacy of the length of the studies to assess
long term effects of olestra consumption and whether adequate studies
have been conducted in special populations; (7) whether liver lesions
seen in two rat studies and lung tumors in one mouse study are
meaningful to human health; (8) whether vitamin A-supplemented olestra
raises teratogenic concerns; and (9) whether the petitioner's estimates
of olestra intake from savory snacks are credible.
Because the agency's analysis of these comments has already been
incorporated at the appropriate places throughout this document, that
analysis will not be repeated here. Comments raising issues that have
not been previously discussed in this document and the agency's
responses are given below.
The agency also received many comments supporting the approval of
olestra. These comments were from individual consumers as well as
scientists, clinicians, and nutritionists. Several of the comments
cited problems with obesity in the population and the need for a fat
replacer such as olestra and that the health benefits from lower fat
intake far outweigh the perceived adverse side effects. These comments
stated that under the intended conditions of use, olestra is safe and
that it provides those who wish to use products made with olestra with
an option for low fat, low saturated fat salty snacks. One comment
signed by nine scientists and clinicians countered point-by-point
arguments made in the CSPI White Paper; the comment added that their
in-depth review of the olestra research program shows that olestra is
safe for use as a fat replacer. Other comments stated that the Olestra
Working Group and FAC meetings were conducted in an open and fair
manner, that the meetings permitted a thorough exchange of scientific
information, that all issues were adequately addressed, and that the
commenters concurred with the majority of the FAC members who concluded
that olestra was safe for its intended use.
A. Comments on Procedures
CSPI made several comments about the agency's process for review of
the olestra petition. None of these procedural comments raise issues
regarding the olestra safety data. Nevertheless, because the agency
greatly values public participation and has provided a substantial
opportunity for such participation regarding FDA's review of the
olestra petition, FDA is addressing these procedural comments in this
preamble. Importantly, however, none of these comments, even if
correct, undermines the agency's safety determination here.
1. One comment from CSPI stated that the period allotted for
comments following the Olestra Working Group and FAC meetings of
November 14 through 17, 1995, was unjustifiably brief. The comment
added that the comment period was too brief a time for review of
transcripts and other data to prepare a thoughtful and complete
postmeeting comment. The comment suggested that an additional 50 days
be provided for comment.
The point raised by this comment is moot because FDA granted CSPI
additional time (Ref. 105) to prepare its comments. The agency notes
that CSPI did submit extensive comments prepared after the Olestra
Working Group and FAC meetings on December 1, 1995, the date for
submission of comments announced in the Federal Register of November
16, 1995 (60 FR 57586), the deadline to which CSPI objected. The agency
granted CSPI additional time because the agency accepted CSPI's
representation that it needed additional time to obtain and review a
new study presented by the petitioner at the Olestra Working Group and
FAC meeting, and to prepare comments on the study. The data were
delivered to CSPI on December 8, 1995, with the letter extending the
time for submission of comments (Ref. 105). FDA notes that CSPI
submitted additional comments on December 21, 1995, but that these
additional comments did not mention the new study.
2. One comment from CSPI asserted that FAC members could not reach
well-reasoned positions because they did not receive copies of CSPI's
White Paper until noon on Friday, November 17, 1995.
The agency believes that both Working Group and FAC members had
sufficient access to CSPI's White Paper and the organization's views
and thus, FDA does not agree with this comment. FDA distributed copies
of a revised draft that the agency had received from CSPI the week
preceding the November meetings to each Olestra Working Group member,
guest, or consultant prior to convening of the Olestra Working Group
meeting. Nine FAC members served on the Olestra Working Group and
received copies of the CSPI White Paper. Also, several other FAC
members attended part or all of the Olestra Working Group meeting and
therefore, heard CSPI's presentations and responses to questions during
the Working Group meeting. Thus, the assertion that no Committee member
had access to or time to consider CSPI's views prior to noon on Friday,
November 17, 1995, is incorrect.\93\
\93\In addition, CSPI itself selectively sent a draft of the
White Paper document to 11 of the standing 18 FAC members who
participated in the Friday, November 17, 1995, meeting. (This direct
distribution was squarely contrary to the applicable regulations, 21
CFR 14.35(d).) Of the other seven, two were also members of the
Working Group and received copies of the revised draft on the first
day of that meeting. Three of the seven attended the Working Group
meeting (and therefore heard CSPI's oral presentations). Only 2 of
the 18 FAC members potentially were unaware of CSPI's written or
oral views until the public hearing on the morning of Friday,
November 17, 1995.
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Finally, it is important to consider the roles of the FAC and the
Olestra Working Group. The Olestra Working Group was composed of FAC
members with expertise directly relevant to the safety issues for
olestra and of additional temporary members with needed expertise not
available from standing FAC members. FDA fully expected that this
specialized subgroup would conduct the focused consideration of the
olestra petition; under the FAC charter, however, subgroup views can
only be passed on to FDA through the full FAC. Thus, the purpose of the
FAC meeting was to apprise FAC members of the Working Group discussion,
and for the FAC to consider whether to pass the Working Group views on
to FDA, to pass the views on with additional commentary, or to return
the matter to the Working Group for further discussion.
3. One comment from CSPI challenged the way in which
[[Page 3164]]
consultants and special, temporary members were appointed to the
Olestra Working Group and FAC. CSPI contended that FDA failed to
consider experts on vitamin K and carotenoids that CSPI had suggested
for the Olestra Working Group, and that FDA did not appoint any other
experts in those subject areas to either the Working Group or the FAC.
CSPI alleged that therefore, the FAC was ill-prepared to discuss these
matters.
The agency carefully considered CSPI's suggested experts on
carotenoids and vitamin K. However, several of these experts had
already provided written views on the issues to CSPI (apparently in
response to a solicitation by CSPI). Statements by some of these
experts were included as part of CSPI's mailing to selected FAC
members, and statements by some or all of these experts were included
in materials distributed during the Olestra Working Group and FAC
meetings. Because the individuals appear to have had previously
established views regarding olestra, FDA concluded that they could not
appropriately be included in the Olestra Working Group. Furthermore,
there is no reason to believe that the nutrition (10 members or
consultants) and toxicology (3 members) experts participating at the
Committee meeting were not able to comprehend or interpret the
information and views on carotenoids and vitamin K presented orally or
in writing by experts on behalf of either CSPI or the petitioner.
4. Another comment from CSPI argued that Dr. Fergus Clydesdale was
an inappropriate choice as chair of the Olestra Working Group,
asserting that Dr. Clydesdale had a pro-industry stance.
First, it is significant to note that CSPI does not allege that Dr.
Clydesdale conducted the Olestra Working Group meeting unfairly or did
not allow for an open and orderly exchange of views. Second, FDA notes
that all advisory committee members undergo an evaluation for conflicts
of interest with respect to specific issues to be presented to a
committee. Dr. Clydesdale was subjected to that review, and his
participation was ultimately determined to be consistent with the
applicable conflict of interest laws and regulations.
5. A comment from CSPI asserted that FDA's interpretation of
conflict of interest is too restrictive in that it only applies to
interests in the petitioner or its competitors. CSPI would disqualify
any member who holds strong views, pro or con, regarding the food
industry or food additives.
FDA believes that the agency's policies, procedures, and practices
comport with the applicable conflicts of interest laws and regulations
and thus, disagrees with CSPI's comment on this point.
6. CSPI also claimed that the amount of time Olestra critics were
allotted at the Olestra Working Group and Committee meetings was
insufficient in contrast to the ``ample amounts'' of time given to the
petitioner and to FDA staff.
FDA disagrees with this comment for several reasons. -First, the
agency believes that the appropriate question is whether there was
ample opportunity for public participation, not whether a particular
participant had enough time. Second, CSPI was provided with substantial
opportunities to present its views to both the Olestra Working Group
and Committee, much more than customarily provided to any single group
or individual during advisory committee public hearings and much more
than that provided to any other group or individual during the public
hearing portions of the meetings.
FDA notes that at a typical advisory committee meeting concerning a
product approval application or petition, FDA presents its analysis of
the data, and the applicant/petitioner is permitted to ``defend'' its
application or petition. Although there is always a public hearing
portion to the meeting, the bulk of the meeting is devoted to Committee
discussion, including questioning by committee members of FDA, the
applicant/petitioner, or other presenters.
FDA policy is to provide a minimum of 1 hour of public hearing time
at each advisory committee hearing. Because of the substantial interest
in olestra, and because FDA desired comments focussed on specific
issues, considerably more public hearing time that the minimum was
allotted. (A total of nearly 6 hours of public hearing time occurred
during the Olestra Working Group and FAC meetings.) A significant
portion of that time was allotted to CSPI or other participants who
presented views consistent with those of CSPI. In addition to time
specifically allotted to it, CSPI was permitted to respond to questions
posed by the Working Group and the FAC. Finally, CSPI participated in
an unscheduled public hearing session along with the petitioner near
the close of the FAC meeting.
7. One comment urged that the FAC should be reconstituted because
of a perceived strong pro-industry orientation of its members and Dr.
Clydesdale (chair of the Working Group), and the ``lack of consumer
health activists.'' The comment added that advisory committees should
include ``a preponderance of public-health advocates'' in order to
provide the best advice to the agency.
FDA disagrees with this comment. FDA appoints Committee members
based on their scientific, medical, or other technical expertise,
members are screened before each meeting with respect to conflict of
interest in the particular matters to be brought before them, and
members are expected to provide an unbiased evaluation of the
information presented to them. Furthermore, consumer representatives
were members of both the Working Group and the FAC, members who were
nominated by a consumer consortium for consideration by FDA. Finally,
the FACA requires that advisory committees be fairly balanced. The
agency believes that both the Working Group and the FAC meet this
standard. Thus, FDA does not agree with this comment.
8. One comment from CSPI stated that the Committee could not
formulate well-reasoned positions because CFSAN staff failed to provide
Committee members with a study published in the American Journal of
Clinical Nutrition 2 months earlier demonstrating that 3 g of olestra
caused remarkable declines in serum carotenoid levels, and a second
study published in the New England Journal of Medicine in early
November that found a strong correlation between low lycopene levels in
blood and optic neuropathy. In addition, the comment stated that CFSAN
staff failed to mention that olestra caused premature liver foci in
rats and a statistically significant increase in lung tumors in male
mice and further failed to provide any evidence that carotenoids may
reduce the risk of cancer, cardiovascular diseases, and age-related
macular degeneration.
The agency disagrees with this comment in its entirety. First, with
regard to the first published study, the agency notes that the effect
of olestra on serum carotenoids was discussed at length at the Olestra
Working Group and FAC meeting. Not only were the results of the study
cited by the comment presented by CSPI, a study conducted by the
petitioner showing olestra effects on serum carotenoids that were much
greater than those shown in the cited study were presented by FDA.
With regard to the second published study, FDA notes that CSPI and
other presenters submitted and presented detailed information regarding
the potential relationship between carotenoids and disease, and after
consideration of this information, most Olestra Working Group and FAC
members determined that there is a reasonable certainty of no harm with
[[Page 3165]]
respect to olestra's effects on serum carotenoids.
Finally, with regard to liver foci and lung tumors, FDA presented
data on olestra's effect on liver foci in rats and in on lung tumors in
male mice. In addition, this topic was thoroughly discussed at the
Olestra Working Group and FAC meetings.
B. Substantive Comments
9. One comment questioned whether an acceptable daily intake (ADI)
based on a ``no observed-effect level'' has been established for
olestra. One comment asserted that even applying even a minimal safety
factor of 10 to the 8 g/d consumption level tested by the petitioner,
and at which carotenoids were depleted by up to 60 percent within 2
weeks after the start of olestra consumption, would preclude the
approval of olestra for use in snack foods, because the estimated daily
intake (EDI) would greatly exceed the 0.8 g/d ADI.
The agency acknowledges that it has not established a numerical
value for an ADI for olestra. First, as noted earlier, safety factors
are applied to toxic effects observed in animal studies; the purpose of
the safety factor is to allow for any discrepancy when extrapolating
from animals to humans. Because olestra is intended for use as a
macroingredient, it is not possible to feed it to test animals at
sufficiently high amounts to elicit toxic effects and thereby establish
an ADI using the traditional 100-fold safety factor. The agency notes,
however, that no toxic effects were observed when test animals were fed
olestra at up to 10 percent of the diet. Furthermore, as discussed at
length in this preamble, the clinical data establishing the safety of
olestra for its intended use are nutrition studies conducted in humans
to which the traditional 100-fold safety factor is not applied.
With respect to olestra's effect to decrease serum carotenoid
levels, the agency has concluded, as discussed in detail above, that
based upon the available data, this effect does not represent an
adverse health effect and therefore, cannot appropriately be used for
establishing an ADI for olestra.
10. A comment stated that the NCI and other public health leaders
have been encouraging Americans to eat at least five servings a day of
fruits and vegetables. The comment added that this advice is grounded,
in part, on the presence of carotenoids in fruits and vegetables and
the belief of senior scientists at the NCI and elsewhere on
chemoprotective activities of carotenoids and similar nutrients. The
comment asserted that if FDA were to approve olestra, it would be
undercutting NCI's scientific judgement and stand in favor of
protecting public health. Another comment stated, specifically with
respect to the carotenoids and their potential importance, that the
issue receive an impartial review by the National Research Council or a
specially convened advisory group of researchers in the carotenoid
field.
FDA agrees with the comments that the issue with respect to the
potential importance of carotenoids deserves special attention. This is
why FDA convened a working group for olestra and the full FAC to
examine the issue along with others. The Olestra Working Group and the
full FAC were supplemented with appropriate experts in the field of
nutrition; in addition, noted experts in the carotenoid field as well
as epidemiology experts who could speak to the epidemiological data on
carotenoids and incidence of diseases such as cancer and macular
degeneration made presentations to the Olestra Working Group and FAC.
Finally, because of significant discussion of this issue and because
the agency received additional comments since the Olestra Working Group
and FAC meetings on the potential chemoprotective function of
carotenoids, FDA consulted with Dr. Greenwald at NCI and Dr. Kupfer at
the NEI regarding whether olestra's effects on carotenoids raise any
significant health issues (Refs. 69 and 70). FDA provided letters
concerning carotenoids that the agency had received and excerpts
discussing carotenoids from: (1) Submissions from the petitioner, (2)
the White Paper, (3) FDA's briefing document for the Olestra Working
Group, and (4) the transcript of the Olestra Working Group and FAC
meetings to Dr.'s Greenwald and Kupfer.
After reviewing the data, Dr. Greenwald concluded that there is no
significant public health issue raised by the effects of olestra on
lipophilic carotenoids and that supplementing olestra with beta
carotene or other carotenoids was not warranted (Ref. 71). Dr. Kupfer
from NEI concluded that although theoretical considerations have raised
the possibility that carotenoids might play some protective role in
macular degeneration, there are currently no convincing clinical data
to support the hypothesis, and there are no demonstrated eye health
benefits for carotenoids (Ref. 72). Given the NIH conclusions, FDA does
not agree that FDA would be undercutting NCI's scientific judgement if
it were to approve olestra. Further, FDA notes that by approving
olestra, FDA is not contradicting or undercutting the NCI advice to eat
fruits and vegetables.
11. One comment stated that 30-300 mg/day of beta-carotene was used
to prevent or lessen the photosensitivity characteristic of the disease
erythropoietic protoporphyria (EPP). The comment added that if a
significant amount of the beta-carotene taken by the EPP patients, who
also eat foods containing olestra, is not absorbed, the patients will
suffer from photosensitivity and will have to curtail markedly the
activities the beta-carotene ingestion would permit. The comment added
that it was not enough to theorize that supplementation of olestra with
carotenoids will cure the problem and suggested the design of two
studies on the effect of olestra on the absorption of beta-carotene,
which should be conducted and evaluated before approval of olestra is
considered.
The comment raises the issue of food-drug interactions; in this
instance, beta-carotene is being used as a drug, i.e., to treat
patients with EPP. Food-drug interactions are generally handled through
labeling for the drug product or through advice of the physician
prescribing the drug. The agency fully intends to apprise physicians
regarding the effect of olestra on the absorption of beta-carotene and
other lipophilic carotenoids so that physicians will in turn be able to
advise EPP patients appropriately. Further, because the agency believes
that this potential drug-food interaction problem can be adequately
addressed through education of physicians and their patients, the
agency does not agree that the suggested studies on the effect of
olestra on the absorption of supplemented beta-carotene are necessary.
12. One comment cited an association between retinitis pigmentosa
and steatorrhea and asserted that olestra causes steatorrhea and that
chronic consumption of olestra may result in retinitis pigmentosa. The
comment also stated that the studies show that vitamin supplementation
results in reversal of the condition.
The agency does not agree that olestra causes steatorrhea; the
basis for that conclusion is discussed above. However, the agency
acknowledges that loss of fat soluble vitamins due to the presence of
olestra in the GI tract has the potential for harm. For this reason,
the agency is requiring, as a condition of safe use, that olestra be
supplemented with vitamins A, D, E and K in such a way that the
bioavailability of these vitamins from the diet remains unchanged.
Thus, any potential consequence of decreased absorption of
[[Page 3166]]
fat-soluble vitamins will be offset by the vitamin compensation
required by the final rule.
13. Some comments stated that approval of the petition will result
in unnecessary medical care associated with olestra's GI effects.
Another comment questioned whether FDA has evaluated the potential
impact of olestra on the health care delivery system, specifically, on
the cost of office visits and diagnostic procedures by primary care
physicians and gastroenterologists who evaluate GI disturbances that
may occur from the use of the additive. The comment added that it
seemed ill advised for FDA to approve the introduction of a product
which may increase expenditures for healthcare.
The agency does not agree that approval of the petition will result
in unnecessary medical care associated with olestra's GI effects and
therefore, does not agree that use of the additive will lead to
increased costs associated with medical care for these effects. This is
because the agency has determined that foods containing olestra shall
be labeled so that consumers will be able to associate olestra with the
GI symptoms that it may cause. The agency believes that this will
significantly reduce or eliminate any unnecessary or inappropriate
medical treatment. Therefore, the agency does not believe that it is
necessary to evaluate the potential impact of olestra on the cost to
the health care delivery system.
14. One comment stated that while a general reduction in fat
intake, especially saturated fat, is desirable, it seems unlikely that
substituting olestra for part of the fat in a few products will have,
or can be shown to have substantial benefit and added that benefits
should be substantial to warrant the use of materials like olestra.
Other comments stated that when GI disturbances are considered in
conjunction with depletion of fat-soluble vitamins that are critical to
the maintenance of health and depletion of other fat-soluble materials
whose importance is not yet fully understood, the potential benefits
that could result form the use of olestra are outweighed by the risk to
the public health.
The agency notes that, unlike approval of drugs, the law applicable
to the approval of food additives does not permit consideration of, or
require a showing of, benefits. As stated above, before a food additive
can be approved, it has to be established that there is a reasonable
certainty that the additive will not be harmful under the prescribed
conditions of use. Further, as discussed in detail above, the agency
does not agree that the GI symptoms that may occur due to consumption
of foods containing olestra represent risk to the public health.
Similarly, as discussed above, because the agency is requiringpara.that
olestra be supplemented with the affected vitamins, the agency does not
agree that olestra's potential to decrease the absorption of fat-
soluble vitamins and other nutrients with purported uses represent risk
to the public health.
Finally, the agency notes that the petitioner is not required to
show that olestra has health or other benefits for consumers of the
additive. Likewise, FDA is not permitted to consider such benefits in
its evaluation of the safety of olestra for its intended use.
15. Several comments stated that once approved for use in savory
snacks, olestra will be used in everything and urged the agency to
prevent its use in other products such as fat-free cakes and fast-food
fries.
The agency notes that the final rule that is being promulgated
restricts the use of olestra for only in prepackaged ready-to-eat
savory (i.e., salty or piquant but not sweet) snacks. Use of olestra in
any other foods, including fat-free cakes and fast-food fries, is not
permitted. Any additional use will require an evaluation of that use
through a food additive petition in accordance with 21 CFR 171.1.
16. Two comments expressed concern that olestra may cause allergic
reactions in many people and, therefore, should not be approved.
These comments did not provide any data to substantiate the
assertion that olestra would be an allergen. FDA does not agree with
these comments. FDA notes that, in general, food allergens are known to
be protein or glycoprotein in nature. Olestra, composed of six, seven,
or eight fatty acids esterified to sucrose, is neither a protein nor a
glycoprotein and does not contain these substances even as minor
constituents. Therefore, the agency believes that olestra is unlikely
to cause any allergic reactions and finds that these comments are
without merit.
17. One comment stated that unless olestra can be converted into an
acceptable energy source for livestock/poultry and pet rations or
properly removed from the environment, a major disposal problem would
result. The comment added that since olestra has no energy value,
neither the spent frying olestra nor the waste savory snacks will be
recycled. The comment asserted that this issue needs to be addressed
prior to approval of olestra.
The agency agrees that the question of whether disposal of olestra
or olestra-containing products raises environmental concerns needs to
be addressed before olestra can be approved. In fact, the National
Environmental Policy Act (NEPA) mandates that FDA review the
environmental consequences of its actions. In accordance with NEPA, FDA
required the submission of, and reviewed, an environmental assessment
(EA) for olestra prepared by the petitioner. Among other things, the EA
addresses whether disposal of olestra or olestra-containing products
has the potential to cause adverse environmental effects. As discussed
below, the agency has consulted with the U.S. Environmental Protection
Agency (EPA), has reviewed the petitioner's EA, and has concluded that
approval of olestra will not have any para.significant adverse
environmental impacts from its manufacture, use, or disposal.
IX. Environmental Impact Considerations
The petitioner submitted an environmental assessment (EA) with its
food additive petition for the use of olestra as a replacement for fats
and oils in food. In May 1987, shortly after the food additive petition
was filed, FDA was contacted by EPA regarding olestra. EPA was
interested in whether the use of olestra would have an adverse effect
on water quality and wastewater treatment processes. FDA agreed to
consult with EPA regarding olestra and give EPA an opportunity to
comment on the petitioner's environmental submission after FDA had
completed its evaluation. In July 1990, the petitioner submitted a
request to limit the intended use of olestra to substitution for
conventional fat in the preparation of savory snacks. At that time, the
petitioner submitted a revised EA for the limited use of olestra in
savory snacks.
The expected route of environmental introduction for olestra is
through wastewater treatment systems and, subsequently, to aquatic and
terrestrial environments. The petitioner performed studies on primary
and secondary wastewater treatment processes which demonstrated that
olestra does not have an adverse effect on the effective functioning of
wastewater treatment plants. The petitioner provided studies on the
fate and effects of olestra in aquatic and terrestrial systems which
establish that, at the expected concentrations, olestra would not have
an adverse effect upon organisms exposed in the water column, in
sediments, or in soil following land application of sewage sludge.
After analysis of the information provided,
[[Page 3167]]
FDA tentatively concluded that approval of this petition would not
cause significant environmental effects.
Before reaching a final conclusion on the environmental effects of
olestra, however, FDA requested that EPA review the information
provided by the petitioner on the potential effect of olestra on
wastewater treatment systems; exposed aquatic organisms, such as fish
and sediment dwelling animals; soil physical and chemical properties
subsequent to sewage sludge applications; and possible effects
resulting from an accidental spill or treatment plant malfunction. EPA
concluded that these issues had been satisfactorily addressed by the
petitioner in the EA for the olestra food additive petition, and did
not raise any environmental objection to the use of olestra in savory
snacks. In light of the consultations with EPA, and based upon its own
review, FDA has concluded that adverse environmental effects are not
expected to result from the manufacture of olestra or from production
or consumption of savory snacks containing olestra.
Accordingly, the agency has concluded that the action will not have
a significant impact on the human environment and that an environmental
impact statement is not required. The agency's finding of no
significant impact and the evidence supporting that finding, contained
in an environmental assessment, may be seen in the Dockets Management
Branch (address above) between 9 a.m. and 4 p.m., Monday through
Friday.
X. FDA's Overall Conclusions
The question before FDA regarding olestra is whether the additive
is safe for its intended use as a fat substitute in savory snacks. (21
U.S.C. 409(c)(3)(a).) To determine that olestra is safe, the agency
must conclude, based upon a fair evaluation of the evidence of record,
that there is a reasonable certainty that olestra is not harmful under
the intended conditions of use. (21 CFR 170.3(i).) This determination
of reasonable certainty of no harm necessarily involves the application
of scientific judgement. Under the act, the agency has a duty to deny
approval to an additive that has not been shown to be safe within the
meaning of the act; the agency has a parallel duty to permit the
marketing of those additives where the available scientific record
establishes safety.
It is not uncommon for an agency safety decision regarding a
regulated product, including a food additive, to be very difficult. The
decision regarding the food additive olestra is one such decision. The
difficulty presented by the olestra food additive petition results from
a relatively unique intersection of a number of factors, including the
following.
First, the volume of available safety evidence for olestra is
enormous, all of which FDA was obligated to review, evaluate, and
synthesize. Second, as a macro-ingredient, olestra is intended to
replace a sizeable portion of the diet, and thus, will likely be
consumed in relatively large amounts; this alone sets olestra apart
from almost all food additives previously reviewed by FDA. Third,
olestra presents a number of questions regarding nutritional effects,
most of which have not been presented previously to FDA. Fourth, much
of the pivotal scientific safety evidence for olestra comes from
studies in humans; human studies, even well conducted ones like those
for olestra, are necessarily limited in terms of the number of subjects
that can reasonably be tested in a clinical trial conducted prior to
marketing, the length of the trial, and the endpoints measured.
Finally, under the act, once approved, olestra may be consumed by the
entire U.S. population of 250 million people. This potentially
widespread consumption for olestra does not, of course, set it apart
from other foods and food additives. It does, however, distinguish this
decision from those that FDA makes regarding drug and medical device
products.
It is important to emphasize that the coalescing of the foregoing
factors does not preclude an agency decision at this time; it does,
however, make the determination challenging. Similarly, it is worth
noting that because of the challenge presented by olestra, the agency
used an expanded approach to its evaluation of the petition, and
established and utilized the internal Regulatory Decision Team, sought
out and utilized the expertise of five subject-specific experts, and
held a lengthy public meeting of the agency's Food Advisory Committee
and a subgroup of that Committee (the Olestra Working Group) to foster
an open and public discussion of the safety issues presented by
olestra.
Consistent with the act and its applicable standards, FDA has
conducted an evaluation and synthesis of the evidence of record
concerning olestra, including the proceedings of the FAC and comments
submitted to the agency. In this process, FDA has applied its best
scientific judgement, aided by the scientific judgement of the experts
and public participants who contributed to the evaluation process. As
the foregoing discussion makes clear, and as the proceedings of the FAC
illustrate, olestra presents a number of important scientific
questions. For some questions, there is arguably evidence, including
support from recognized experts, on both sides of the question,
ultimately requiring FDA to evaluate and weigh the data currently
available and apply its scientific judgement. The agency has, as a
result of this process, determined that there is a reasonable certainty
that no harm will result from the use of olestra in savory snacks.
Based upon a fair evaluation of the evidence of record, FDA
concludes that olestra is not toxic, carcinogenic, genotoxic, or
teratogenic. Olestra is essentially not absorbed or metabolized.
Heating olestra, as would occur in the commercial preparation of snacks
made using olestra, does not increase the absorption of the additive.
FDA further concludes that the studies conducted show that olestra has
an effect on the absorption of vitamins A, E, D, and K. FDA also
concludes that it is possible to supplement foods containing olestra
with all four vitamins in such a way as to compensate for the amounts
that are not absorbed from the diet due to the action of olestra. FDA
concludes that the amounts that should be provided are those listed
below:
TABLE 10.--COMPENSATION LEVELS FOR VITAMINS A, D, E, AND K
------------------------------------------------------------------------
Vitamin Compensation level
------------------------------------------------------------------------
Vitamin A................................ 51 retinol equivalents/g
olestra as retinyl palmitate
or retinyl acetate)(170 IU/g
olestra or 0.34 X RDA/10 g
olestra
Vitamin E................................ 1.9 mg -tocopherol
equivalents/g olestra (0.94
X RDA/10 g olestra)
Vitamin D................................ 12 IU vitamin D/g olestra
(0.3 X RDA per 10 g olestra)
Vitamin K................................ 8 g vitamin K11/g
olestra (1.0 X RDA per 10 g
olestra)
------------------------------------------------------------------------
[[Page 3168]]
As discussed previously, in order to avoid confusion about the
purpose of the added vitamins in olestra-containing foods, FDA is
requiring a label statement to indicate that olestra affects the
absorption of some nutrients and that in order to compensate for
olestra's effects on vitamins A, D, E, and K, these vitamins have been
added.
As discussed above, at present, carotenoids have no identifiable
health benefit role (except for the provitamin A role of beta
carotene.) Further, randomized studies have failed to show an
association between selective carotenoid repletion and cancer. Although
epidemiological studies show an association between diets rich in
fruits and vegetables (including those that contain carotenoids) and
decreased cancer risk, there is no direct evidence that carotenoids
themselves are responsible for or contribute in a significant way to
that protective benefit. In addition, the level of effects on
carotenoids from olestra may well be within the normal variation due to
diet and bioavailability. In light of the current state of the
scientific evidence, FDA believes that there is a reasonable certainty
of no harm from olestra's effects on carotenoid absorption.
Accordingly, the agency concludes that there is currently no
justification or need to require compensation of olestra-containing
foods with specific carotenoids.
Regarding water soluble nutrients, given the totality of the study
results, FDA concludes that there is a reasonable certainty that
olestra will not cause any harmful effects on vitamin B12,
calcium, iron, zinc, or folate or other water soluble nutrients.
Collectively, the clinical data on the water-soluble vitamins that are
hard to absorb (folate and vitamin B12) show that olestra does not
affect the absorption of these nutrients. Similarly, the data on two of
the nutrients that are limited in the diet (iron and zinc) show that
olestra does not interfere with their absorption.
Although the data on the third nutrient that is limited in the
diet, calcium, are not sufficiently rigorous to detect possible subtle
changes, the lack of any plausible argument for expecting an effect,
the lack of any olestra effect on folate, iron, or zinc, the fact that
supplementation with vitamin D will preclude any vitamin D-mediated
calcium depletion, and the insignificance of any subtle effect compared
to variations in the human diet, lead FDA to conclude that there is a
reasonable certainty that olestra will not have any harmful effect on
calcium absorption.
With respect to the potential effect of olestra on the GI tract,
FDA concludes that the effects seen do not represent significant
adverse health consequences and therefore, do not preclude approval of
the petition. However, while FDA believes that there are no direct
safety concerns with respect to olestra's potential effect on the GI
tract, FDA concludes that the GI symptoms associated with ingestion of
olestra-containing foods are material fact information within the
meaning of 201(n) of the act. Disclosing this information on food
labels will enable consumers to associate olestra with any GI effects
that it may cause. Consequently, FDA is requiring that such information
be disclosed on the label of foods containing olestra to preclude
consumers from being misled about consequences which may result from
the consumption of the olestra-containing foods. Therefore, in the
final rule, FDA concludes that foods containing olestra should bear an
appropriate label statement.
In summary, FDA concludes that all safety issues have been
addressed adequately and that based upon the currently available
evidence, the use of olestra in savory snacks will be safe when used in
accordance with the final rule.
FDA's determination will permit the use of olestra in savory
snacks. In order for olestra to be lawfully used in other foods (e.g.,
cakes and pies), a new food additive petition would need to be filed
and approved. In conjunction with that review, the agency would then
conduct a separate and independent safety evaluation of the additional
proposed uses.
Procter and Gamble has notified FDA that the company will be
conducting additional studies of olestra exposure (both amounts
consumed and patterns of consumption) and the effects of olestra
consumption (Ref. 103).
FDA believes that Procter and Gamble's plans to continue to study
the consumption and effects of olestra are both prudent and
responsible. It is likewise prudent and responsible for FDA to evaluate
the results of such studies as it monitors the on-going marketing and
distribution of olestra. Only with data from the broader marketing of
olestra can the agency, be in the position to evaluate in the future
whether there continues to be reasonable certainty of no harm from the
use of olestra in savory snacks. Therefore, as a condition of approval,
Procter and Gamble is to conduct the studies that it has identified in
its letter to FDA (Ref. 103), consistent with the timetables identified
in that letter. Furthermore, consistent with the terms of that letter,
Procter and Gamble is to provide the Food and Drug Administration with
access to all data, information, and reports of those studies as such
information becomes available.
It is the agency's responsibility as a public health agency to
review and evaluate the data generated by Procter and Gamble's studies,
as well as any new data that bear on the safety of olestra (such as
data and information on the health significance of carontenoids)\94\ to
determine whether there continues to be a basis for a reasonable
certainty that the use of olestra in savory snacks is not harmful.
Thus, consistent with the agency's continuing obligation to oversee the
safety of the food supply, FDA will, within 30 months of this approval,
review and evaluate any new data and information bearing on the safety
of olestra and present such information to the agency's Food Advisory
Committee (or a working group of the FAC). To the extent that
additional data and information bearing on olestra's safety are
submitted to and reviewed by the agency, FDA will, in its discretion,
hold any additional meetings of the FAC that may be necessary to
consider such information.
\94\The record of this proceeding, particularly the meeting of
the Olestra Working Group and the FAC, demonstrates that the
question of the role of carotenoids in disease prevention or health
maintenance is an issue of intense interest and the focus of
continuing scientific study and evaluation. It is thus likely that
there will be additional scientific data and information that bears
on the question of the role of carotenoids in the future.
---------------------------------------------------------------------------
This future meeting of the FAC (and any subsequent FAC meetings)
will be open public meetings with an opportunity for participation by
FDA, Procter and Gamble, and interested members of the public, and will
provide an opportunity for public discussion and deliberation of the
newly developed data regarding olestra.
As an indication of the agency's view of the importance of this
review, evaluation, and public discussion by the FAC of future data on
olestra, as well as an indication of the depth of the agency's
commitment to do so, the final rule established by this decision
includes a statement concerning FDA's commitment in this regard. FDA
has used the word ``will'' in Sec. 172.867(f) with respect to the
agency's commitment to conduct such review and evaluation. The agency
has thus legally bound itself to institute this review and evaluation.
(See CNI v. Young, 818 F.2d 943 (D.C. Cir. 1987).)
The decision embodied in this document necessarily articulates
certain
[[Page 3169]]
baseline parameters concerning the safety data for olestra,
particularly parameters with respect to the finding of a reasonable
certainty of no harm. These parameters include the exposure to olestra
(both amount of consumption and patterns of consumption), and the
nature, severity, incidence, and prevalence of any effects of olestra
consumption, including any effects on fat-soluble nutrients and any
gastrointestinal effects. If, as a result of the agency's review and
evaluation and its consultation with the FAC, FDA determines that the
results reflected in the new data and information are not consistent
with the parameters that form the basis of this decision, or the agency
otherwise concludes that the available safety evidence for olestra
shows that there is no longer reasonable certainty of no harm from the
use of this substance, FDA will institute appropriate regulatory
proceedings.
It is important to recognize that to institute a proceeding to
limit or revoke the approval of olestra, FDA would not be required to
show that olestra is unsafe. Rather, the agency would only need to show
that based upon new evidence, FDA is no longer able to conclude that
the approved use of olestra is safe, i.e., that there is no longer a
reasonable certainty of no harm from the use of the additive. Further,
in any proceeding to withdrawal or limit the approval of olestra,
Procter and Gamble would have the burden to establish the safety of the
additive. 21 CFR 12.87(c).
Imposing a condition of approval such as this is not without
precedent in the area of food additive approvals. At the time that FDA
reinstated the approval of the artificial sweetener, aspartame, the
Commissioner of Food and Drugs required that the petitioner for
aspartame (G.D. Searle & Co.) develop data and other information on the
actual use levels of the additive so that the estimated use levels of
aspartame that formed the basis of the agency's safety decision could
be compared with levels of actual use. (46 FR 38283, 38303; July 24,
1981).
This condition of approval is not, and should not be interpreted
as, an indication that FDA has somehow not determined that there is a
reasonable certainty that no harm will result from the use of olestra
in savory snacks. As discussed in great detail above, the agency has
determined, based upon a fair evaluation of the evidence in the record
at this time, that such certainty exists. Having so concluded, however,
the agency cannot responsibly ignore its continuing obligation to
monitor the safety of the food supply and hence, has imposed the
condition of approval set forth above.
As noted, olestra presents several new challenges. It is a is a
macro-ingredient that it not metabolized, one of the first of its type
to be subject to FDA review. In addition, olestra's effects on nutrient
absorption are not routinely presented by food additives reviewed by
FDA. The safety decision for olestra is in large part based on the data
from human studies. These studies are more than sufficient to provide a
basis to conclude that olestra is safe. The agency recognizes, however,
that olestra has the potential to be consumed by the bulk of the U.S.
population of 250 million. In these circumstances, FDA believes that it
is not only consistent with the agency's mandate under the act to
protect the public health to condition the approval of olestra on the
conduct of future studies, see United States v. Bacto-Unidisk, 394 U.S.
784 (1969), but it is also the most responsible course for the agency
to take in these circumstances.
The Procter and Gamble Co. has made a commitment to the agency that
it will conduct the studies outlined in the letter to FDA (Ref. 103),
and FDA doubts neither the company's independent interest in conducting
these studies nor the good faith of its commitment to the agency to do
so. Nevertheless, FDA believes that it is important to articulate here
the agency's view of the consequences of a failure of the company to
adhere to its commitment. That is, if Procter and Gamble does not
conduct the identified studies and does not conduct them according to
the articulated timetable, FDA will consider the approval set forth in
this document to be void ab initio and will institute appropriate
proceedings, judicial or otherwise, consistent with that view.
XI. Administrative Record and Inspection of Documents
The administrative record for this final rule consists of the food
additive petition (FAP 7A3997), all documents filed in that petition,
and any items cited in this preamble.
In accordance with Secs. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
CFSAN (address above) by appointment with the information contact
person listed above. As provided in Sec. 171.1(h), the agency will
delete from the documents any materials that are not available for
public disclosure before making the documents available for inspection.
XII. Objections
Any person who will be adversely affected by this regulation may at
any time on or before February 29, 1996 file with the Dockets
Management Branch (address above) written objections thereto. Each
objection shall be separately numbered, and each numbered objection
shall specify with particularity the provisions of the regulation to
which objection is made and the grounds for the objection. Each
numbered objection on which a hearing is requested shall specifically
so state. Failure to request a hearing for any particular objection
shall constitute a waiver of the right to a hearing on that objection.
Each numbered objection for which a hearing is requested shall include
a detailed description and analysis of the specific factual information
intended to be presented in support of the objection in the event that
a hearing is held. Failure to include such a description and analysis
for any particular objection shall constitute a waiver of the right to
a hearing on the objection. Three copies of all documents shall be
submitted and shall be identified with the docket number found in
brackets in the heading of this document. Any objections received in
response to para.the regulation may be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
FDA will publish notice of the objections that the agency has
received or lack thereof in the Federal Register.
XIII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m. Monday through Friday.
1. Charge to Olestra Working Group, Draft, Nov. 13, 1995.
2. Transcript of meeting of the Olestra Working Group (vols. 1-
3) and Food Advisory Committee (vol. 4),
FR Doc. 96-1584 Food Additives Permitted for Direct Addition to Food for Human Consumption; Olestra
Alexandria, VA, November 14
through 17, 1995.
3. Myra Karstadt, Ph.D. and Michael F. Jacobson, Ph.D., ``White
Paper on Olestra,'' Center for Science in the Public Interest,
November 3, 1995.
4. ``Toxicological Principles for the Safety Assessment of
Direct Food Additives and Color Additives Used in Food,'' Draft,
(Redbook II), U.S. Food and Drug Administration, 1993.
5. Memorandum from M. DiNovi, FDA to J. Gordon, FDA, June 28,
1989.
6. Memorandum from M. DiNovi, FDA to J. Gordon, FDA, April 17,
1989.
7. Memorandum from M. DiNovi, FDA to J. Gordon, FDA, July 14,
1989.
8. Memorandum from M. DiNovi, FDA to J. Gordon, FDA, January 17,
1991.
[[Page 3170]]
9. Memorandum from M. DiNovi, FDA to F. O. Fields, FDA, June 6,
1994.
10. Memorandum from M. DiNovi, FDA to J. Gordon, FDA, October 3,
1990.
11. Memorandum from M. DiNovi, FDA to F. O. Fields, FDA,
February 5, 1993.
12. Memorandum from M. DiNovi, FDA to H. Thorsheim, FDA, March
13, 1995.
13. Memorandum from M. DiNovi, FDA to H. Thorsheim FDA, May 4,
1995.
14. Mattson, F. H. and Volpenhein, R.A., ``Hydrolysis of Fully
Esterified Alcohols Containing from One to Eight Hydroxyl Groups by
the Lipolytic Enzymes of Rat Pancreatic Juice,'' Journal of Lipid
Research, 13:325-328, 1972.
15. Memorandum from L. S. Pellicore, FDA, to F. O. Fields, FDA,
July 6, 1993.
16. Memorandum from L. S. Pellicore, FDA, to F. O. Fields, FDA,
August 1, 1993.
17. Memorandum from L. S. Pellicore, FDA, to F.O. Fields, FDA,
August 2, 1993.
18. Memorandum from L. S. Pellicore, FDA, to F. O. Fields, FDA,
August 4, 1993.
19. Memorandum from L. S. Pellicore, FDA, to F. O. Fields, FDA,
August 5, 1993.
20. Memorandum from L. S. Pellicore, FDA, to F. O. Fields, FDA,
January 25, 1995.
21. Memorandum from L. S. Pellicore, FDA, to F. O. Fields, FDA,
July 28, 1995.
22. Memorandum from L. S. Pellicore, FDA, to F. O. Fields, FDA,
July 28, 1995.
23. Memorandum from E. J. Matthews, FDA to F. O. Fields, FDA,
December 16, 1993.
24. Memorandum from T. F. X. Collins, FDA, to F. O. Fields, FDA,
October 23, 1993.
25. Memorandum from J. J. Welsh, FDA, to L. S. Pellicore, FDA,
March 1, 1994.
26. Memorandum from M. J. Bleiberg, FDA, to F. O. Fields, FDA,
February 8, 1993.
27. Goodman, D. G., J. M. Ward, R. A. Squire, K. C. Chu, and M.
S. Linhart, ``Neoplastic and Nonneoplastic Lesions in Aging F344
Rats,'' Toxicology and Applied Pharmacology, 48:237-248, 1979.
28. Memorandum from F. S. D. Lin, FDA, to R. Lorentzen, FDA,
February 4, 1988.
29. Memorandum from R. W. Moch, FDA, to F. O. Fields, FDA, April
5, 1993.
30. Harada, T., R. P. Maronpot, R. W. Morris, K. A. Stitzel, and
G. A. Boorman, ``Morphological and Stereological Characterization of
Hepatic Foci of Cellular Alteration in Control Fischer 344 Rats,''
Toxicology and Pathology 17(4):579-593, 1989.
31. Harada, T., R. R. Maronpot, R.W. Morris, and G. A. Boorman,
``Observations on Altered Hepatocellular Foci in National Toxicology
Program 2-Year Carcinogenicity Studies in Rats,'' Toxicology and
Pathology, 17(4):690-708, 1989.
32. Maronpot, R. R., T. Harada, A. S. K. Murthy, and G. A.
Boorman, ``Documenting Foci of Hepatocellular Alteration in 2-Year
Carcinogenicity Studies: Current Practices of the National
Toxicology Program,'' Toxicology and Pathology, 17(4):675-684, 1989.
33. Mahon, D. C., ``Altered Hepatic Foci in Rat Liver as Weight
of the Evidence of Carcinogenicity: The Canadian Perspective,''
Toxicology and Pathology, 17(4):709-715, 1989.
34. Squire, R. A., ``Evaluation and Grading of Rat Liver Foci in
Carcinogenicity Tests,'' Toxicology and Pathology, 17(4):685-
689,1989.
35. Moch, R. W. and T. P. O'Neill, ``Hepatocellular Foci-A
Regulator's Gordian,'' Toxicology and Pathology, 17(4):724-728,
1989.
36. Lang, P. L., ``Spontaneous Neoplastic Lesions in the Crl:CD-
1(1CR)BR Mouse,'' Charles River Breeding Laboratories, Wilmington,
MA, February 1, 1987.
37. Maita, K., M. Hirano, T. Harada, K. Mitsumori, A. Yoshida,
K. Takahashi, N. Nakashima, T. Kitazawa, A. Enomoto, K. Inui, and Y.
Shirasu, ``Mortality, Major Cause of Morbidity and Spontaneous
Tumors in CD-1 Mice,'' Toxicology and Pathology, 16(3):340-349,
1988.
38. Memorandum from M. J. Bleiberg, FDA, to F. O . Fields, FDA,
November 1994.
39. Memorandum from M. A. Bryant, FDA to N. Beru, August 17,
1995.
40. Memorandum from M. J. Bleiberg, FDA, to J. Gordon, FDA,
August 8, 1990
41. Memorandum from J. M. Collins, FDA to F. O. Fields, FDA,
April 12, 1994.
42. Musa, M. M. and L. L. Lyman, ``Absorption and Disposition of
Warfarin: Effects of Food and Liquids,'' Current Therapeutic
Research, 20:630-633, 1976.
43. Memorandum of Meeting, May 3, 1995.
44. Memorandum from J. Judd, USDA to G. N. Biddle, FDA, August
7, 1995.
45. Memorandum of Telephone Conversation between J. Judd, USDA,
and H. Thorsheim, FDA, September 17 and 18, 1995.
46. Memorandum from M. S. Calvo, FDA to J. Gordon, FDA, August
8, 1989.
47. Memorandum from M. Jenkins, FDA to G. Biddle, FDA, August
14, 1995.
48. Memorandum from R. Chanderbhan, FDA, to K. N. Biddle, FDA,
July 11, 1995.
49. Memorandum from C. Barton, FDA to H. Thorsheim, FDA, May 23,
1995.
50. Memorandum from C. Barton, FDA to H. Thorsheim, FDA, May 18,
1995.
51. Memorandum from C. Barton, FDA to H. Thorsheim, FDA, May 19,
1995.
52. Memorandum from R. Lovell, FDA to H. Thorsheim, FDA, March
21, 1995.
53. Memorandum from Randall Lovell, FDA to F. O. Fields, FDA,
March 22, 1994.
54. Memorandum from Randall Lovell, FDA to F. O. Fields, FDA,
January 27, 1995.
55. Matschiner, J. T. and W. V. Taggart, ``Bioassay of Vitamin K
by Intracardial Injection in Deficient Adult Male Rats,'' Journal of
Nutrition, 94:57-59, 1968.
56. Memorandum from R. Lovell, FDA to H. Thorsheim, FDA,
September 13, 1995.
57. Rothman, K. J., L. L. Moore, M. R. Singer, U.S.D.T. Nguyen,
S. Mannino, and A. Milunsky, ``Teratogenicity of High Vitamin A
Intake,'' New England Journal Medicine, 333:1369-1373, 1995.
58. Memorandum of Conference, August 1, 1995.
59. Recommended Dietary Allowances, National Research Council,
National Academy of Sciences Press; pp. 96 and 97.
60. Seddon M. J., et. al., ``Dietary Carotenoids, Vitamins A, C,
and E, and Advanced Age-Related Macular Degeneration,'' Journal of
the American Medical Association, 272:1413-1420, 1994.
61. Giovannucci E., et. al., ``Intake of Carotenoids and Retinol
in Relation to Risk of Prostate Cancer,'' Journal of the National
Cancer Institute 87:1767-1776, 1995.
62. Letter from W. Willett and M. Stampfer, Harvard School of
Public Health to D. Kessler, FDA, November 1, 1995.
63. The Alpha-tocopherol Beta-carotene Cancer Prevention Study
Group, ``The Effect of Vitamin E and Beta Carotene on the Incidence
of Lung Cancer and Other Cancers in Male Smokers,'' New England
Journal of Medicine, 330:1029-1035, 1994.
64. Greenberg, E. R., et.al., ``A Clinical Trial of Beta
Carotene to Prevent Basal-Cell and Squamous-Cell Cancers of the
Skin,'' New England Journal of Medicine, 323:789-795, 1990.
65. Greenberg, E. R., et.al., ``A Clinical Trial of Antioxidant
Vitamins to Prevent Coloractal Adenoma,'' New England Journal of
Medicine, 331:141-147, 1994.
66. Blot, W. J. et.al., ``Nutrition Intervention Trials in
Linxian, China: Supplementation with Specific Vitamin/Mineral
Combinations, Cancer Incidence, and Disease Specific Mortality in
the General Population,'' Journal of the National Cancer Institute,
85:16-30, 1993.
67. Rock, C. L. and M. E. Swendseid, ``Plasma -Carotene Response
in Humans after Meals Supplemented with Dietary Pectin,'' American
Journal Clinical Nutrition, 55:96-99, 1992.
68. Letter from J. Peters, Procter & Gamble to H. Thorsheim,
FDA, January 16, 1996.
69. Letter from J. E. Vanderveen, FDA to P. Greenwald, NCI,
November 30, 1995.
70. Letter from J. E. Vanderveen, FDA to C. Kupfer, NEI,
December 4, 1995.
71. Letter from P. Greenwald, NCI, to J. Vanderveen, FDA,
December 5, 1995.
72. Letter from C. Kupfer, NEI to J. Vanderveen, FDA, January
17, 1995.
73. Letter from S. R. Lynch, VAMC to J. Vanderveen, FDA, June
19, 1995.
74. Memorandum from C. Barton, FDA to O. Fields, FDA, September
20, 1993.
75. Memorandum of Meeting, May 31, 1995.
76. Memorandum from M. S. Calvo, FDA and W.V. Rumpler, USDA to
F. O. Fields, October 13, 1993.
77. Maxson, P. F. and D. C. Mahan, ``Dietary Calcium and
Phosphorus Levels for Growing Swine from 18 to 56 Kilograms Body
Weight,'' Journal of Animal Science, 56:1124-1134, 1983.
78. Cromwell, G. L., V. W. Hays, C. W. Scherer, and J. R.
Overfield, ``Effects of Dietary Calcium and Phosphorus on
Performance and Carcass, Metacarpal and Turbinate Characteristics of
Swine,'' Journal of Animal Science, 34:746-751, 1972.
79. Memorandum from L. Lutwak, FDA to K. Biddle, FDA, January 6,
1995.
80. Cortot, A., S. F. Phillips, and J. Malagelada, ``Parallel
Gastric Emptying of Nonhydrolyzable Fat and Water after a Solid-
Liquid Meal in Humans,'' Gastroenterology, 82:877-881, 1982.
81. Aggarwal, A. M., M. Camilleri, S. F. Phillips, T. G.
Schlagheck, M. L. Brown, and G. M. Thomforde, ``Olestra, a
Nondigestible, Nonabsorbable Fat/Effects on Gastrointestinal and
Colonic Transit,'' Digestive Diseases and Sciences, 38:1009-1014,
1993.
82. Smith, M. C. and H. Spector, ``Calcium and Phosphorus
Metabolism in Rats and
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Dogs as Influenced by the Ingestion of Mineral Oil,'' Journal of
Nutrition, 20:19-30, 1940.
83. Smith, M. C. and H. Spector, ``Further Evidence of the Mode
of Action of Vitamin D,'' Journal of Nutrition, 20:197-202, 1940.
84. Memorandum from K. Klontz, FDA to F. O. Fields, FDA, January
11, 1995.
85. Anderson, J. W., L. Story, B. Sieling, W. J. L. Chen, M. S.
Petro, J. Story, ``Hypocholesterolemic Effects of Oat-Bran or Bean
Intake for Hypercholesterolemic Men,'' American Journal of Clinical
Nutrition, 40:1146-1155, 1984.
86. Stasse-Wolthuis, M., et.al., ``The Effect of a Natural High-
Fiber Diet on Serum Lipids, Fecal Lipids, and Colonic Function,''
American Journal of Clinical Nutrition, 32:1881-1888, 1979.
87. Memorandum from K. Klontz, FDA to F. O. Fields, FDA, August
9, 1994.
88. Memorandum from K. Klontz, FDA to H. Thorsheim, FDA,
December 26, 1995.
89. Jalan, K. N., et. al., ``An Experience of Ulcerative
Colitis. III. Long Term Outcome,'' Gastroenterology, 59:598-609,
1970.
90. Memorandum of Conference, October 4, 1994.
91. Memorandum from S. Fredd, FDA to F. O. Fields, FDA, January
3, 1995.
92. Memorandum from R. Pertel, FDA to N. Beru, FDA, September 6,
1995.
93. Memorandum of Meeting, May 26, 1995.
94. Nuck, B. A., T. G. Schlagheck, and R. W. Federle,
``Inability of the Human Fecal Microflora to Metabolize the
Nonabsorbable Fat Substitute, Olestra,'' Indian Journal of Pathology
and Microbiology, 13:328-334, 1994.
95. Memorandum from R. Pertal, FDA to N. Beru, FDA, September 6,
1995.
96. Letter from J. Lupton, Texas A&M to L. Pellicore, FDA,
December 15, 1995.
97. Memorandum of telephone conversation between L. Pellicore,
FDA, and J. Lupton, Texas A&M, January 17, 1995.
98. Memorandum from R. Chanderbhan, FDA, to G. N. Biddle, FDA,
August 24, 1995.
99. Memorandum for the Record, January 18, 1996.
100. Memorandum of Meeting, June 16, 1995.
101. Memorandum of Conference, June 26, 1995.
102. Swinyard, E. A. (1990) Gastrointestinal Drugs In:
Remington's Pharmaceutical Sciences, 18th Edition. A. R. Gennaro
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103. Letter from Procter & Gamble, to FDA, January 24, 1996.
104. Letter from W. Schultz, FDA to M. Jacobson, CSPI, December
8, 1995.
List of Subjects in 21 CFR 172
Food additives, Incorporation by reference, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
172 is amended as follows:
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION
1. The authority citation for 21 CFR part 172 continues to read as
follows:
Authority: Secs. 201, 401, 402, 409, 701, 721 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371,
379e).
2. New Sec. 172.867 is added to subpart I to read as follows:
Sec. 172.867 Olestra.
Olestra, as identified in this section, may be safely used in
accordance with the following conditions:
(a) Olestra is a mixture of octa-, hepta-, and hexa-esters of
sucrose with fatty acids derived from edible fats and oils or fatty
acid sources that are generally recognized as safe or approved for use
as food ingredients. The chain lengths of the fatty acids are no less
than 12 carbon atoms.
(b) Olestra meets the following specifications:
(1) The total content of octa-, hepta-, and hexa-esters is not less
than 97 percent as determined by a method entitled ``Determination of
Olestra by Size Exclusion Chromatography,'' dated December 19, 1995,
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies are available from the Office of Premarket
Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food
and Drug Administration, 200 C St. SW., Washington, DC, or may be
examined at the Center for Food Safety and Applied Nutrition's Library,
200 C St. SW., rm. 3321, Washington, DC, or at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC.
(2) The content of octa-ester is not less than 70 percent as
determined by a method entitled ``Measurement of the Relative Ester
Distribution of Olestra Test Material'' dated December 19, 1995, which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from the Office of Premarket
Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food
and Drug Administration, 200 C St. SW., Washington, DC, or may be
examined at the Center for Food Safety and Applied Nutrition's Library,
200 C St. SW., rm. 3321, Washington, DC, or at the Office of the
Federal Register, 800 North Capitol Street, NW., suite 700, Washington,
DC.
(3) The content of hexa-ester is not more than 1 percent as
determined by the method listed in paragraph (b)(2) of this section.
(4) The content of penta-ester is not more than 0.5 percent as
determined by the method listed in paragraph (b)(2) of this section.
(5) The unsaturated fatty acid content is not less than 25 percent
(thus not more than 75 percent saturated fatty acid) and not more than
83 percent as determined by a method entitled ``Measurement of the
Fatty Acid Composition of Olestra Test Material,'' dated December 19,
1995, which is incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the Office of
Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-
200), Food and Drug Administration, 200 C St. SW., Washington, DC, or
may be examined at the Center for Food Safety and Applied Nutrition's
Library, 200 C St. SW., rm. 3321, Washington, DC, or at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC.
(6) The content of C12 and C14 fatty acids is each not more than 1
percent, and total C20 and longer fatty acids is not more than 20
percent. C16 and C18 fatty acids make up the remainder with total
content not less than 78 percent as determined by the method listed in
paragraph (b)(5) of this section.
(7) The free fatty acid content is not more than 0.5 percent as
determined by a method entitled ``Free Fatty Acids'' published in the
Official Methods and Recommended Practices of the American Oil
Chemists' Society, 3d Ed. (1985) vol. 1, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
are available from the American Oil Chemists Society, 1608 Broadmoor
Dr., Champaign, IL 61821, or may be examined at the Center for Food
Safety and Applied Nutrition's Library, 200 C St. SW., rm. 3321,
Washington, DC, or at the Office of the Federal Register, 800 North
Capitol Street, NW., suite 700, Washington, DC.
(8) The residue on ignition (sulfated ash) is not more than 0.5
percent.
(9) Total methanol content is not more than 300 parts per million
as determined by the ``Total Available Methanol Method,'' dated
December 19, 1995, which is incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the
Office of Premarket Approval, Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug Administration, 200 C St. SW.,
Washington, DC or may be examined at the Center for Food Safety and
Applied Nutrition's Library, 200 C St. SW., rm. 3321, Washington, DC,
or at the Office of the Federal Register, 800 North
[[Page 3172]]
Capitol Street, NW., suite 700, Washington, DC.
(10) The total heavy metal content (as Pb) is not more than 10
parts per million.
(11) Lead is not more than 0.1 part per million, as determined by a
method entitled ``Atomic Absorption Spectrophotometric Graphite Furnace
Method,'' Food Chemicals Codex, 3d Ed. 3d Supp. p. 168 (1992), which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the National Research Council Press,
2101 Constitution Ave. NW., Washington, DC, or may be examined at the
Center for Food Safety and Applied Nutrition's Library, 200 C St. SW.,
rm. 3321, Washington, DC, or at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC.
(12) Water is not more than 0.1 percent, as determined by a method
entitled ``Moisture,'' Official Methods and Recommended Practices of
the American Oil Chemists' Society, 4th Ed. (1989), vol. 1, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the American Oil Chemists Society,
1608 Broadmoor Dr., Champaign, IL 61821, or may be examined at the
Center for Food Safety and Applied Nutrition's Library, 200 C St. SW.,
rm. 3321, Washington, DC, or at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC.
(13) Peroxide value is not more than 10 meq/kg as determined by a
method entitled ``Peroxide Value,'' Official Methods and Recommended
Practices of the American Oil Chemists' Society, 4th Ed. (1989) vol. 1,
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies are available from the American Oil Chemists
Society, 1608 Broadmoor Dr., Champaign, IL 61821, or may be examined at
the Center for Food Safety and Applied Nutrition's Library, 200 C St.
SW., rm. 3321, Washington, DC, or at the Office of the Federal
Register, 800 North Capitol Street, NW., suite 700, Washington, DC.
(14) The stiffness is not less than 50 kiloPascals/second, as
determined by a method entitled ``Method for Measurement of the
Stiffness of Olestra,'' dated December 19, 1995, which is incorporated
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies are available from the Office of Premarket Approval, Center for
Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 200 C St. SW., Washington, DC, or may be examined at
the Center for Food Safety and Applied Nutrition's Library, 200 C St.
SW., rm. 3321, Washington, DC, or at the Office of the Federal
Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(c) Olestra may be used in place of fats and oils in prepackaged
ready-to-eat savory (i.e., salty or piquant but not sweet) snacks. In
such foods, the additive may be used in place of fats and oils for
frying or baking, in dough conditioners, in sprays, in filling
ingredients, or in flavors.
(d) To compensate for any interference with absorption of fat
soluble vitamins, the following vitamins shall be added to foods
containing olestra: 1.9 milligrams alpha-tocopherol equivalents per
gram olestra; 51 retinol equivalents per gram olestra (as retinyl
lacetate or retinyl palmitate); 12 IU vitamin D per gram olestra; and 8
g vitamin K1 per gram olestra.
(e)(1) The label of a food containing olestra shall bear the
following statement in the manner prescribed in paragraph (e)(2) of
this section:
This Product Contains Olestra. Olestra may cause abdominal
cramping and loose stools. Olestra inhibits the absorption of some
vitamins and other other nutrients. Vitamins A, D, E, and K have
been added.
(2) The statement required by paragraph (e)(1) of this section
shall:
(i) Appear either on the principal display panel or on the
information panel of the label;
(ii) Be enclosed by a 0.5 point box rule with 2.5 points of space
around the statement.
(iii) Utilize at least one point leading;
(iv) Have type that is kearned so the letters do not touch;
(v) Be all black or one color type, printed on a white or other
neutral contrasting background whenever possible;
(vi) Utilize a single easy-to-read type style such as Helvetica
Regular and upper and lower case letters; and
(vii) Be in type size no smaller than 8 point.
(3) The sentence ``This Product Contains Olestra.'' shall be
highlighted by bold or extra bold type, such as Helvetica Black. The
label shall appear as follows:
BILLING CODE 4160-01-F
[[Page 3173]]
[GRAPHIC][TIFF OMITTED]TR30JA96.001
BILLING CODE 4160-01-C
(4) Vitamins A, D, E, and K present in foods as a result of the
requirement in paragraph (d) of this section shall be declared in the
listing of ingredients. Such vitamins shall not be considered in
determining nutrient content for the nutritional label or for any
nutrient claims, express or implied.-
(5) Olestra shall not be considered as a source of fat or calories
for purposes of Secs. 101.9 and 101.13 of this chapter.
(f) Consistent with its obligation to monitor the safety of all
additives in the food supply, including olestra, the Food and Drug
Administration will review and evaluate all data and information
bearing on the safety of olestra received by the agency after the
effective date of this regulation, and will present such data,
information, and evaluation to the agency's Food Advisory Committee
within 30 months of the effective date of this regulation. The purpose
of such presentation will be to receive advice from the Committee on
whether there continues to be reasonable certainty that use of olestra
in compliance with this regulation is not harmful. The agency will hold
such additional Food Advisory Committee meetings on olestra as the
agency determines, in its discretion, to be necessary. Based upon the
results of this entire process, the FDA will initiate any appropriate
regulatory proceedings.
Dated: January 24, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 96-1584 Filed 1-25-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-1577 Agency Name Change
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Page 2899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1577]
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DEPARTMENT OF AGRICULTURE
Rural Housing Service
Rural Business-Cooperative Service
Rural Utilities Service
Farm Service Agency
7 CFR Chapter XVIII
Agency Name Change
AGENCIES: Rural Housing Service, Rural Business-Cooperative Service,
Rural Utilities Service, and Farm Service Agency.
ACTION: Final rule.
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SUMMARY: This document amends the regulations to change the names of
the Rural Housing and Community Development Service to the Rural
Housing Service and the Rural Business and Cooperative Development
Service to the Rural Business-Cooperative Service as a result of the
Department of Agriculture reorganization.
EFFECTIVE DATE: January 30, 1996.
FOR FURTHER INFORMATION CONTACT: Richard A. Gartman, Regulations and
Paperwork Management Division, Rural Economic and Community
Development, room 6348-S, Washington, DC 20250, telephone 202-720-9745.
SUPPLEMENTARY INFORMATION:
Background
The Secretary of Agriculture announced that the agency previously
referred to as the Rural Housing and Community Development Service
(RHCDS) is to be named the Rural Housing Service (RHS), and the agency
previously referred to as the Rural Business and Cooperative
Development Service (RBCDS) is to be named the Rural Business-
Cooperative Service (RBS). On December 26, 1995, USDA published in the
Federal Register (60 FR 66713) a final rule that contained
redelegations of authority for the Department of Agriculture and
changed the names of RHCDS to RHS and RBCDS to RBS. This rule includes
amendments to 7 CFR chapter XVIII that are necessary to bring agency
regulations into alignment with the departmental reorganization.
This action is not subject to the provisions of Executive Order
12866 since it involves only internal agency management. This action is
not published for comment under the Administrative Procedure Act since
it involves only internal agency management and publication for comment
is unnecessary.
Accordingly, 7 CFR Chapter XVIII is amended as follows:
1. The heading of 7 CFR chapter XVIII is revised to read as
follows:
CHAPTER XVIII--RURAL HOUSING SERVICE, RURAL BUSINESS-COOPERATIVE
SERVICE, RURAL UTILITIES SERVICE, AND FARM SERVICE AGENCY, DEPARTMENT
OF AGRICULTURE
2. In 7 CFR chapter XVIII, all references to ``Rural Housing and
Community Development Service'' are revised to read ``Rural Housing
Service'', all references to ``Rural Business and Cooperative
Development Service'' are revised to read ``Rural Business-Cooperative
Service'', all references to ``RHCDS'' are revised to read ``RHS'' and
all references to ``RBCDS'' are revised to read ``RBS''.
Dated: January 23, 1996.
Arthur C. Campbell,
Acting Under Secretary, Rural Economic and Community Development.
[FR Doc. 96-1577 Filed 1-29-96; 8:45 am]
BILLING CODE 3410-07-U
Complete official Federal Register PDF
FR Doc. 96-1569 Airworthiness Directives; McDonnell Douglas Model DC-10-10 Airplanes
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2902-2903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1569]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 94-NM-178-AD; Amendment 39-9498; AD 95-13-11 R1]
Airworthiness Directives; McDonnell Douglas Model DC-10-10
Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: This amendment clarifies information in an existing
airworthiness directive (AD), applicable to certain McDonnell Douglas
Model DC-10-10 airplanes, that currently requires repetitive
inspections to detect cracking of the upper caps in the front spar of
the left and right wing, and repair, if necessary. The actions
specified in that AD are intended to prevent progression of fatigue
cracking, which could cause reduced structural integrity of the wing
front spar and damage to adjacent structures. This amendment clarifies
the requirements of the current AD by revising the area of inspection.
This amendment is prompted by communications received from affected
operators that the current requirements of the AD are unclear.
DATES: Effective August 7, 1995.
The incorporation by reference of certain publications listed in
the regulations was approved previously by the Director of the Federal
Register as of August 7, 1995 (60 FR 35326, July 7, 1995).
ADDRESSES: The service information referenced in this AD may be
obtained from McDonnell Douglas Corporation, 3855 Lakewood Boulevard,
Long Beach, California 90846, Attention: Technical Publications
Business Administration, Department C1-L51 (2-60). This information may
be examined at the Federal Aviation Administration (FAA), Transport
Airplane Directorate, Rules Docket, 1601 Lind Avenue, SW., Renton,
Washington; or at the FAA, Los Angeles Aircraft Certification Office,
Transport Airplane Directorate, 3960 Paramount Boulevard, Lakewood,
California; or at the Office of the Federal Register, 800 North Capitol
Street NW., suite 700, Washington, DC.
FOR FURTHER INFORMATION CONTACT: John Cecil, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Transport Airplane Directorate, Los
Angeles Aircraft Certification Office, 3960 Paramount Boulevard,
Lakewood, California 90712; telephone (310) 627-5322; fax (310) 627-
5210.
SUPPLEMENTARY INFORMATION: On June 22, 1995, the FAA issued AD 95-13-
11, amendment 39-9291 (60 FR 35326, July 7, 1995), which is applicable
to certain McDonnell Douglas Model DC-10-10 airplanes. That AD requires
repetitive eddy current test high frequency (ETHF) surface inspections
to detect fatigue cracking, and repair of the upper cap in the front
spar of the wing if any cracking is found. That AD also requires
additional repetitive inspections after any repair of the upper cap.
Additionally, that AD stipulates that, if the preventive modification
is installed on an airplane on which no cracks are found during the
initial inspection, the repetitive inspections may be terminated. That
action was prompted by reports of fatigue cracking in the upper cap of
the front spar of the wing in the forward flange area. The actions
required by that AD are intended to prevent progression of fatigue
cracking, which could cause reduced structural integrity of the wing
front spar and damage to adjacent structures.
Since the issuance of that AD, the FAA has received communications
from affected operators that the area defined for the ETHF surface
inspection is unclear. Specifically, these operators have indicated
that the referenced McDonnell Douglas DC-10 Service Bulletin 57-129,
dated August 12, 1994, recommends inspection of the upper cap of the
front spar of the left and right wing ``between'' stations Xos 667.678
and Xos 789.645 in certain paragraphs but describes the inspection
``at'' stations Xos 667.678 and Xos 789.645 in the accomplishment
instructions. AD 95-13-11 requires inspection ``between'' stations Xos
667.678 and Xos 789.645.
These operators have therefore, requested that the FAA clarify the
AD to indicate exactly what area is required to be inspected.
In considering this request, and upon further review of the wording
of the current AD, the FAA concurs that some clarification is
necessary.
It was the FAA's intent that the requirements of AD 95-13-11 be
parallel to those actions recommended by the manufacturer in the
accomplishment instructions of its referenced service bulletin. The
intended requirements of the AD were that affected operators would
conduct the ETHF inspections to detect fatigue cracks at the areas
where cracking had been reported, namely at stations Xos 667.678 and
Xos 789.645. However, as AD 95-13-11 is currently worded, operators may
incorrectly conduct ETHF inspections ``between'' these stations, rather
than ``at'' those stations. Such misunderstanding could result in
operators unnecessarily conducting ETHF inspections at other stations,
which would be of no significant safety value and would entail
incurring needless additional costs in labor and downtime.
Operators should note that the economic information supplied in the
preamble of AD 95-13-11 remains unchanged since that information was
based on the workhours required to perform the ETHF inspection at
stations Xos 667.678 and Xos 789.645, in accordance with data supplied
in McDonnell Douglas Service Bulletin 57-129, dated August 12, 1994.
Since it is obvious that the required ETHF inspection area is not
totally clear in the way that AD 95-13-11 is currently worded, the FAA
has determined that the wording of paragraph (a) of the AD must be
revised to clarify the intent of the required actions. This action
revises that paragraph to specify that the inspection area is at
stations Xos 667.678 and Xos 789.645.
Action is taken herein to clarify these requirements of AD 95-13-11
and to correctly add the AD as an amendment to section 39.13 of the
Federal Aviation Regulations (14 CFR 39.13).
The final rule is being reprinted in its entirety for the
convenience of affected operators. The effective date remains August 7,
1995.
Since this action only clarifies a current requirement, it has no
adverse economic impact and imposes no additional burden on any person.
Therefore, notice and public procedures hereon are unnecessary.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.
Adoption of the Correction
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:
[[Page 2903]]
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 USC 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by removing amendment 39-9291 (60 FR
35326, July 7, 1995), and by adding a new airworthiness directive (AD),
amendment 39-9498, to read as follows:
95-13-11 R1 McDonnell Douglas: Amendment 39-9498. Docket 94-NM-178-
AD. Revises AD 95-13-11, Amendment 39-9291.
Applicability: Model DC-10-10 airplanes, as listed in McDonnell
Douglas DC-10 Service Bulletin 57-129, dated August 12, 1994;
certificated in any category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must use the authority
provided in paragraph (e) of this AD to request approval from the
FAA. This approval may address either no action, if the current
configuration eliminates the unsafe condition; or different actions
necessary to address the unsafe condition described in this AD. Such
a request should include an assessment of the effect of the changed
configuration on the unsafe condition addressed by this AD. In no
case does the presence of any modification, alteration, or repair
remove any airplane from the applicability of this AD.
Compliance: Required as indicated, unless accomplished
previously.
To prevent reduced structural integrity of the wing front spar
and damage to adjacent structures due to fatigue cracking in the
upper cap of the front spar of the wing, accomplish the following:
(a) Prior to the accumulation of 10,000 total landings, or
within 1,800 landings after the effective date of this AD, whichever
occurs later, perform an initial eddy current test high frequency
(ETHF) surface inspection to detect cracks in the upper cap of the
front spar of the left and right wing at stations Xos 667.678 and
Xos 789.645, in accordance with McDonnell Douglas DC-10 Service
Bulletin 57-129, dated August 12, 1994. Repeat this inspection
thereafter at the intervals specified in paragraph (b) or (c) of
this AD, as applicable.
(b) For airplanes on which no crack is found: Repeat the
inspection required by paragraph (a) of this AD thereafter at
intervals not to exceed 10,000 landings, or accomplish the crack
preventative modification in accordance with McDonnell Douglas DC-10
Service Bulletin 57-129, dated August 12, 1994. Accomplishment of
that preventative modification constitutes terminating action for
the requirements of this paragraph.
(c) For airplanes on which any crack is found that is identified
as ``Condition II'' in McDonnell Douglas DC-10 Service Bulletin 57-
129, dated August 12, 1994: Accomplish paragraphs (c)(1) and (c)(2)
of this AD in accordance with that service bulletin.
(1) Prior to further flight, perform the permanent repair for
cracks in accordance with the service bulletin; and
(2) Within 12,500 landings after the installation of the
permanent repair specified in paragraph (c)(1) of this AD, perform
an ETHF surface inspection for cracks, in accordance with the
service bulletin. Repeat this inspection thereafter at intervals not
to exceed 7,000 landings.
(d) For airplanes on which any crack is found that is identified
as ``Condition III'' in McDonnell Douglas DC-10 Service Bulletin 57-
129, dated August 12, 1994: Prior to further flight, repair the
cracking in accordance with a method approved by the Manager, Los
Angeles Aircraft Certification Office (ACO), FAA, Transport Airplane
Directorate.
(e) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Los Angeles ACO. Operators shall
submit their requests through an appropriate FAA Principal
Maintenance Inspector, who may add comments and then send it to the
Manager, Los Angeles ACO.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Los Angeles ACO.
(f) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
(g) The inspections, modification, and permanent repair shall be
done in accordance with McDonnell Douglas DC-10 Service Bulletin 57-
129, dated August 12, 1994. This incorporation by reference was
approved previously by the Director of the Federal Register, in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 as of August 7,
1995 (60 FR 35326, July 7, 1995). Copies may be obtained from
McDonnell Douglas Corporation, 3855 Lakewood Boulevard, Long Beach,
California 90846, Attention: Technical Publications Business
Administration, Department C1-L51 (2-60). Copies may be inspected at
the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW.,
Renton, Washington; or at the FAA, Transport Airplane Directorate,
Los Angeles Aircraft Certification Office, 3960 Paramount Boulevard,
Lakewood, California; or at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC.
(g) This amendment is effective on August 7, 1995.
Issued in Renton, Washington, on January 22, 1996.
Darrell M. Pederson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-1569 Filed 1-29-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-1531 Repeal of Certain Tort and Property Damage Claims Regulations
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Page 2915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1531]
=======================================================================
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DEPARTMENT OF STATE
22 CFR Part 31
[Public Notice 2298]
Repeal of Certain Tort and Property Damage Claims Regulations
AGENCY: Office of the Legal Adviser, Department of State.
ACTION: Direct final rule.
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SUMMARY: The Department of State will repeal 22 CFR part 31, which
contains regulations implementing the Federal Tort Claims Act (FTCA)
with respect to the Department (subparts A and B), the State
Department's independent authority to pay tort claims arising in
foreign countries (subpart C), and certain claims against the
International Boundary and Water Commission, United States and Mexico
(IBWC) (subpart D).
DATES: This rule is effective May 13, 1996, unless significant adverse
comments are received on or before March 8, 1996.
If significant adverse comments are received, the State Department
will publish a document in the Federal Register before May 13, 1996
withdrawing this rule.
ADDRESSES: Interested persons are invited to submit comments to the
Office of International Claims and Investment Disputes, Office of the
Legal Adviser, Suite 203, South Building, 2430 E Street NW.,
Washington, DC 20037-2800.
FOR FURTHER INFORMATION CONTACT:
Stephen D. McCreary, Attorney-Adviser, Office of International Claims
and Investment Disputes, Office of the Legal Adviser, Suite 203, South
Building, 2430 E Street NW., Washington, DC 20037-2800; telephone (202)
776-8440.
SUPPLEMENTARY INFORMATION: The State Department regulations
implementing the Federal Tort Claims Act are a combination of
substantive provisions largely drawn from the Department of Justice
FTCA regulations in 28 CFR part 14, which apply to tort claims against
all government agencies, and procedural provisions drawn from the State
Department's internal Foreign Affairs Manual. The State Department FTCA
regulations in subparts A and B of part 31 add little additional
information, and are thus duplicative and unnecessary. Section 2672 of
the FTCA (28 U.S.C. 2672) provides that claims are to be considered in
accordance with regulations issued by the Attorney General. Section
14.11 of the Justice Department regulations authorize agencies to issue
supplementary FTCA regulations, but do not require that they do so. The
State Department has concluded that it need not maintain supplementary
FTCA regulations.
Claims against the Department of State should continue to be
submitted directly to the office, bureau, division, or Foreign Service
establishment out of whose activities the claim arises, if known; or if
not known, to the Assistant Legal Adviser for International Claims and
Investment Disputes, L/CID, Department of State, Washington, DC 20520.
Subpart C of part 31 concerns the Department's independent
authority to pay tort claims arising overseas, and has no counterpart
in the Justice Department's FTCA regulations. However, subpart C is a
single paragraph which provides little information beyond that already
available in the statute (22 U.S.C. 2669(f)). Thus, the Department has
concluded that subpart C may be deleted.
The regulations in subpart D of part 31 regarding claims against
the International Boundary and Water Commission, United States and
Mexico, have not been used in many years, and in any case essential
repeat the provisions of the underlying statute. Repeal of these
regulations has been coordinated with the Legal Adviser's Office of the
IBWC, United States Section. The State Department and the IBWC, United
States Section, have concluded that it is appropriate to delete subpart
D.
Implemention of this rule as a direct final rule, with provision
for postpromulgation comments, is based on the ``good cause'' exception
to the Administrative Procedures Act found at 5 U.S.C. 553(b)(B).
Repeal of these regulations is expected to be noncontroversial, and
therefore unlikely to engender public comment. Thus, provision for
prepromulgation notice and comment is considered unnecessary. Written
comments are invited from the public on or before March 8, 1996. Unless
the State Department receives on or before that date significant
comments adverse to repeal of these regulations, and publishes a notice
in the Federal Register before May 13, 1996, withdrawing this rule,
this rule becomes effective on May 13, 1996.
Repeal of these regulations by this rule is not expected to have a
significant impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. This rule does not impose a
Federal regulatory mandate on state, local, or tribal government
entities under the Unfunded Mandates Act (P.L. 104-4) because it
repeals regulations which themselves created no such mandate. This rule
has been reviewed as required by Executive Order 12778 and is in
compliance therewith. This rule is exempt from review under Executive
Order 12866, but has been reviewed to ensure consistency with its
overall policies and purposes. This rule does not contain a new or
amended information requirement subject to the Paperwork Reduction Act
of 1980.
List of Subjects in 22 CFR Part 31
Claims.
PART 31--[REMOVED]
Accordingly, under the authority of 22 U.S.C. 2651a(4), 22 CFR part
31 is removed.
Dated: December 8, 1995.
Jamison Selby Borek,
Deputy Legal Adviser.
[FR Doc. 96-1531 Filed 1-29-96; 8:45 am]
BILLING CODE 4710-08-M
Complete official Federal Register PDF
FR Doc. 96-1104 Approval and Promulgation of Implementation Plans; Designation of Areas for Air Quality Planning Purposes; Redesignation of the Philadelphia County Carbon Monoxide Area to Attainment and Approval of the Area's Maintenance Plan and the Philadelphia County 1990 Base Year Carbon Monoxide Emission Inventory; Commonwealth of Pennsylvania
[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Rules and Regulations]
[Pages 2926-2931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1104]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 52 and 81
[SIPTRAX No. PA075-4001; PA075-4002; PA024-4005; FRL-5329-1]
Approval and Promulgation of Implementation Plans; Designation of
Areas for Air Quality Planning Purposes; Redesignation of the
Philadelphia County Carbon Monoxide Area to Attainment and Approval of
the Area's Maintenance Plan and the Philadelphia County 1990 Base Year
Carbon Monoxide Emission Inventory; Commonwealth of Pennsylvania
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: EPA is approving a maintenance plan and a request to
redesignate part of Philadelphia County from nonattainment to
attainment for carbon monoxide (CO) and is also approving the 1990 base
year CO emissions inventory for Philadelphia County. The maintenance
plan, redesignation request and 1990 base year CO emissions inventory
were submitted by the Commonwealth of Pennsylvania. Under the 1990
amendments of the Clean Air Act (CAA) designations can be revised if
sufficient data is available to warrant such revisions. In this action,
EPA is approving the Pennsylvania request because it meets the
maintenance plan and redesignation requirements set forth in the CAA.
This action is being taken under section 110 of the CAA.
EFFECTIVE DATE: This action will become effective on March 15, 1996
unless, within 30 days of publication, adverse or critical comments are
received. If the effective date is delayed, timely notice will be
published in the Federal Register.
ADDRESSES: Comments may be mailed to Marcia L. Spink, Associate
Director, Air Programs, Mailcode 3AT00, U.S. Environmental Protection
Agency, Region III, 841 Chestnut Building, Philadelphia, Pennsylvania
19107. Copies of the documents relevant to this action are available
for public inspection during normal business hours at the Air,
Radiation, and Toxics Division, U.S. Environmental Protection Agency,
Region III, 841 Chestnut Building, Philadelphia, Pennsylvania 19107;
Pennsylvania Department of Environmental Protection, Bureau of Air
Quality, P.O. Box 8468, 400 Market Street, Harrisburg, Pennsylvania
17105 and Philadelphia Department of Public Health, Air Management
Services, 321 University Avenue, Philadelphia, Pennsylvania 19104.
FOR FURTHER INFORMATION CONTACT: Kelly L. Bunker, (215) 597-4554.
SUPPLEMENTARY INFORMATION: On September 8, 1995 the Commonwealth of
Pennsylvania submitted a request for parallel processing of a
redesignation request and maintenance plan for the Philadelphia portion
of the Philadelphia-Camden County CO nonattainment area and
supplemented the request on October 30, 1995, in order to formalize the
submittal as an official revision to its State Implementation Plan
(SIP). The SIP revision consists of a maintenance plan and a request to
redesignate part of Philadelphia County from nonattainment to
attainment for carbon monoxide and the 1990 base year CO emissions
inventory for Philadelphia County.
I. Background
Part of Philadelphia County in Pennsylvania, specifically the high
traffic areas within the Central Business District and certain other
high traffic density areas of the City of Philadelphia, was a pre-1990
CO nonattainment area and continued to be designated as nonattainment
for CO by operation of law as per section 107 (d)(1)(C)(i) of the Clean
Air Act Amendments of 1990. The National Ambient Air Quality Standard
(NAAQS) for CO is 9.5 parts per million (ppm). Philadelphia County is
part of the Philadelphia-Camden County CO nonattainment area. CO
nonattainment areas can be classified as moderate or serious, based on
their design values. Since the Philadelphia CO nonattainment area had a
design value of 11.6 ppm (based on 1988 and 1989 data), the area was
classified as moderate. The CAA established an attainment date of
December 31, 1995, for all moderate CO areas. Philadelphia County has
ambient air quality monitoring data showing attainment of the CO NAAQS
from 1990 through 1994. No exceedances or violations of the CO NAAQS
have been monitored in Philadelphia County to date during calendar year
1995. Therefore, in an effort to comply with the CAA and to ensure
continued attainment of the NAAQS, on September 8, 1995 and October 30,
1995 the Commonwealth of Pennsylvania submitted a CO redesignation
request and a maintenance plan for Philadelphia County. Pennsylvania
submitted evidence that a public hearing was held on October 16, 1995
in Philadelphia.
II. Evaluation Criteria
Section 107(d)(3)(E) of the 1990 Clean Air Act Amendments provides
five specific requirements that an area must meet in order to be
redesignated from nonattainment to attainment.
1. The area must have attained the applicable NAAQS;
2. The area must have a fully approved SIP under section 110(k) of
CAA;
[[Page 2927]]
3. The air quality improvement must be permanent and enforceable;
4. The area must have a fully approved maintenance plan pursuant to
section 175A of the CAA;
5. The area must meet all applicable requirements under section 110
and Part D of the CAA;
III. Review of State Submittal
On October 31, 1995, EPA determined that the information received
from the Commonwealth of Pennsylvania constituted a complete
redesignation request under the general completeness criteria of 40 CFR
part 51, appendix V, Secs. 2.1 and 2.2.
The Pennsylvania redesignation request for part of Philadelphia
County meets the five requirements of section 107(d)(3)(E), noted
above. The following is a brief description of how the Commonwealth has
fulfilled each of these requirements.
1. Attainment of the CO NAAQS
Pennsylvania has quality-assured CO ambient air monitoring data
showing that Philadelphia County has met the CO NAAQS. The Pennsylvania
request is based on an analysis of quality-assured CO air monitoring
data which is relevant to the maintenance plan and to the redesignation
request. To attain the CO NAAQS, an area must have complete quality-
assured data showing no more than one exceedance of the standard per
year over at least two consecutive years. The ambient air CO monitoring
data for calendar year 1990 through calendar year 1994, relied upon by
Pennsylvania in its redesignation request, shows no violations of the
CO NAAQS in Philadelphia County. The most recent ambient CO data shows
one exceedance in the calendar years 1993 and 1994. In addition, the
most recent ambient CO data for calendar year 1995 shows no exceedances
of the NAAQS to date in Philadelphia County. Because the area has
complete quality assured data showing no more than one exceedance of
the standard per year over at least two consecutive years (1993 and
1994), the area has met the first statutory criterion of attainment of
the CO NAAQS (40 CFR 50.8 and appendix C). Pennsylvania has committed
to continue monitoring in this area in accordance with 40 CFR part 58.
Furthermore, air quality data for the New Jersey portion of the
Philadelphia-Camden County CO nonattainment area shows that the
remainder of the nonattainment area has met the CO NAAQS since 1990.
Therefore, air quality in the entire area has been meeting the CO
standards since 1990.
2. Fully Approved SIP Under Section 110(k) of the CAA
Pennsylvania's CO SIP is fully approved by EPA as meeting all the
requirements of Section 110(a)(2)(I) of the Act, including the
requirements of Part D (relating to nonattainment), which were due
prior to the date of Pennsylvania's redesignation request. All portions
of Pennsylvania's CO SIP, except for the motor vehicle inspection and
maintenance (I/M) portion, were fully approved by EPA on February 26,
1985, at 40 CFR Sec. 52.2020(c)(63), (50 FR 7772). The I/M portion of
the CO SIP was approved by EPA on April 8, 1987 at 40 CFR
Sec. 52.2020(c)(66), (52 FR 11259). The 1990 CAA required that
nonattainment areas achieve specific new requirements depending on the
severity of the nonattainment classification. Requirements for the
Philadelphia area include the preparation of a 1990 emission inventory
with periodic updates, adoption of an oxygenated fuels program, the
development of contingency measures, and development of conformity
procedures. Each of these requirements added by the 1990 Amendments to
the CAA are discussed in greater detail below.
Consistent with the October 14, 1994 EPA guidance from Mary D.
Nichols entitled ``Part D New Source Review (Part D NSR) Requirements
for Areas Requesting Redesignation to Attainment,'' EPA is not
requiring full approval of a Part D NSR program by Pennsylvania as a
prerequisite to redesignation to attainment. Under this guidance,
nonattainment areas may be redesignated to attainment notwithstanding
the lack of a fully-approved Part D NSR program, so long as the program
is not relied upon for maintenance. Pennsylvania has not relied on a
NSR program for CO sources to maintain attainment. Although EPA is not
treating a Part D NSR program as a prerequisite for redesignation, it
should be noted that EPA is in the process of taking final action on
the State's revised NSR regulation, which includes requirements for CO
nonattainment areas. Because part of Philadelphia County is being
redesignated to attainment by this action, Pennsylvania's Prevention of
Significant Deterioration (PSD) requirements will be applicable to new
or modified sources in Philadelphia County. Pennsylvania has been
delegated PSD authority (see CFR Sec. 52.2058 Pennsylvania and 49 FR
33128, August 21, 1984).
A. Emission Inventory
Pennsylvania submitted its 1990 base year emissions inventory as
part of the maintenance plan which was submitted on September 8, 1995
and October 30, 1995. The inventory estimated CO emissions for
Philadelphia County, as required under Section 187(a)(1) of the CAA.
This inventory was used as the basis for calculations to
demonstrate maintenance. Pennsylvania's submittal contains the detailed
inventory data and summaries by source category. The inventory was
prepared in accordance with EPA guidance. A summary of the base year
and projected maintenance year inventories are shown in the following
table in this section.
Section 172(c)(3) of the CAA requires that nonattainment plan
provisions include a comprehensive, accurate, and current inventory of
actual emissions from all sources of relevant pollutants in the
nonattainment area. Pennsylvania included the requisite inventory in
the redesignation request and maintenance plan SIP revision. The base
year for the inventory was 1990, using a three month CO season of
December 1990 through February 1991. Stationary sources, area sources,
on-road mobile sources, and non-road mobile sources of CO were included
in the inventory. The following table, Table 1, presents a summary of
the base year (1990), attainment year (1992) and projected year (2007)
CO peak season daily emissions estimates in tons per winter day (tpd)
by source category:
Table 1.--CO Peak Season Daily Emissions
------------------------------------------------------------------------
1992 2007
1990 Base Attainment Projected
year year year
emissions emissions emissions
(tons per (tons per (tons per
day) day) day)
------------------------------------------------------------------------
On-road Mobile........................ 608.99 561.25 334.33
Non-road Mobile....................... 9.62 9.69 10.11
Area.................................. 13.77 13.80 13.98
Stationary............................ 20.98 22.07 31.11
---------------------------------
Total............................. 653.36 606.81 389.53
------------------------------------------------------------------------
Available guidance for preparing emission inventories is provided
in the General Preamble (57 FR 13498, April 16, 1992).
Section 110(k) of the CAA sets out provisions governing the EPA's
review of base year emission inventory submittals in order to determine
approval or disapproval under section 187(a)(1). The EPA is granting
approval
[[Page 2928]]
of the Philadelphia County 1990 base year CO emissions inventories as
found in the Pennsylvania CO Redesignation Request, based on the EPA's
technical review of the CO inventory. For further details on the
emission inventory, the reader is referred to the Technical Support
Document, which is available for review at the addresses provided
above.
B. Oxygenated Gasoline
Section 211(m) of the CAA requires that each State in which there
is located a CO nonattainment area with a design value of 9.5 ppm or
above based on data for the 2-year period of 1988 and 1989 shall submit
a SIP revision which requires the implementation of an oxygenated
gasoline program in the Consolidated Metropolitan Statistical Area
(CMSA) in which the nonattainment area is located. The Philadelphia-
Camden County CO nonattainment area has a design value above 11.6 ppm
based on 1988 and 1989 data and consequently was subject to the
requirement to adopt an oxygenated fuel program. Pennsylvania submitted
an oxygenated gasoline SIP revision for the Pennsylvania portion of the
Philadelphia CMSA to EPA on November 12, 1992. EPA approved the SIP
revision on July 21, 1994 at 40 CFR Sec. 52.2020(c)(88), (59 FR 37162).
As noted in the Pennsylvania redesignation request, the State intends
to relegate the oxygenated fuel program to contingency status upon
EPA's approval of Pennsylvania's redesignation request. On August 19,
1995 Pennsylvania modified their oxygenated gasoline regulations to
allow for the discontinuance of the program if EPA approves a
redesignation request and maintenance plan which does not require the
implementation of an oxygenated gasoline program. The modified
Pennsylvania oxygenated gasoline regulation also states that if an area
is redesignated to attainment and then violates the CO standard that
the program must be reinstated at the beginning of the next oxygenated
gasoline control period. In its demonstration of maintenance, described
below, the Commonwealth has shown that oxygenated gasoline in the
Pennsylvania portion of the Philadelphia CMSA is not necessary for
continued maintenance of the CO NAAQS. Consequently, by this action,
EPA is approving Pennsylvania's use of oxygenated gasoline as a
contingency measure for the Philadelphia area.1
\1\Cecil County, Maryland is part of the Philadelphia CMSA and
had implemented the oxygenated gasoline program. This action will
also serve to remove the oxygenated fuel requirement from Cecil
County, Maryland.
---------------------------------------------------------------------------
C. Conformity
Under section 176(c) of the CAA, states were required to submit
revisions to their SIPs that include criteria and procedures to ensure
that Federal actions conform to the air quality planning goals in the
applicable SIPs. The requirement to determine conformity applies to
transportation plans, programs and projects developed, funded or
approved under Title 23 U.S.C. or the Federal Transit Act
(``transportation conformity''), as well as all other Federal actions
(``general conformity''). Congress provided for the State revisions to
be submitted one year after the date of promulgation of final EPA
conformity regulations. EPA promulgated final transportation conformity
regulations on November 24, 1993 (58 FR 62188) and final general
conformity regulations on November 30, 1993 (58 FR 63214). These
conformity rules require that the States adopt both transportation and
general conformity provisions in the SIP for areas designated
nonattainment or subject to a maintenance plan approved under CAA
section 175A. Pursuant to Sec. 51.396 of the transportation conformity
rule and Sec. 51.851 of the general conformity rule, the Commonwealth
of Pennsylvania was required to submit a SIP revision containing
transportation conformity criteria and procedures consistent with those
established in the Federal rule by November 25, 1994. Similarly,
Pennsylvania was required to submit a SIP revision containing general
conformity criteria and procedures consistent with those established in
the Federal rule by December 1, 1994. Pennsylvania submitted its
transportation conformity SIP revision to EPA on November 21, 1994.
This SIP was determined to be administratively and technically complete
on February 21, 1995. Pennsylvania has not submitted its general
conformity SIP revision.
Although this redesignation request was submitted to EPA after the
due dates for the SIP revisions for transportation conformity and
general conformity rules, EPA believes it is reasonable to interpret
the conformity requirements as not being applicable requirements for
purposes of evaluating the redesignation request under section 107(d).
The rationale for this is based on a combination of two factors. First,
the requirement to submit SIP revisions to comply with the conformity
provisions of the Act continues to apply to areas after redesignation
to attainment. Therefore, the State remains obligated to adopt the
transportation and general conformity rules even after redesignation
and would risk sanctions for failure to do so. While redesignation of
an area to attainment enables the area to avoid further compliance with
most requirements of section 110 and part D, since those requirements
are linked to the nonattainment status of an area, the conformity
requirements apply to both nonattainment and maintenance areas. Second,
EPA's federal conformity rules require the performance of conformity
analyses in the absence of state-adopted rules. Therefore, a delay in
adopting State rules does not relieve an area from the obligation to
implement conformity requirements.
Because areas are subject to the conformity requirements regardless
of whether they are redesignated to attainment and must implement
conformity under Federal rules if State rules are not yet adopted, EPA
believes it is reasonable to view these requirements as not being
applicable requirements for purposes of evaluating a redesignation
request.
For the reasons just discussed, EPA believes that the CO
redesignation request for Philadelphia County may be approved
notwithstanding the lack of a general conformity submittal and an
approved state transportation conformity rule.
3. Improvement in Air Quality Due to Permanent and Enforceable Measures
EPA approved Pennsylvania's CO SIP under the 1977 CAA. Emission
reductions achieved through the implementation of control measures
contained in that SIP are enforceable. Pennsylvania cites the Federal
Motor Vehicle Control Program (FMVCP) and the basic Inspection and
Maintenance Program as the major sources of reduction that led to
attainment of the CO standard. As discussed above, the State initially
attained the NAAQS in 1990 with monitored attainment through 1994. This
indicates that the improvements are due to the permanent and
enforceable measures contained in the 1982 CO SIP.
The Commonwealth of Pennsylvania has demonstrated that actual
enforceable emission reductions are responsible for the air quality
improvement and that the CO emissions in the base year are not
artificially low due to local economic downturn. EPA finds that the
combination of certain existing EPA-approved SIP and federal measures
contribute to the permanence and enforceability of reduction in ambient
CO levels that have allowed the area to attain the NAAQS.
[[Page 2929]]
4. Fully Approved Maintenance Plan Under Section 175A
Section 175A of the CAA sets forth the elements of a maintenance
plan for areas seeking redesignation from nonattainment to attainment.
The plan must demonstrate continued attainment of the applicable
NAAQS for at least ten years after the Administrator approves a
redesignation to attainment. Eight years after the redesignation, the
state must submit a revised maintenance plan which demonstrates
attainment for the ten years following the initial ten-year period. To
provide for the possibility of future NAAQS violations, the maintenance
plan must contain contingency measures, with a schedule for
implementation adequate to assure prompt correction of any air quality
problems. In this notice, EPA is approving the Commonwealth of
Pennsylvania's maintenance plan for the Philadelphia area because EPA
finds that Pennsylvania's submittal meets the requirements of section
175A.
A. Attainment Emission Inventory
As previously noted, Pennsylvania submitted its 1990 base year
emissions inventory for Philadelphia County as part of the maintenance
plan which was submitted on September 8, 1995 and October 30, 1995. The
inventory includes emissions from stationary, area, and mobile sources
using 1990 as the base year for calculations.
The State submittal contains the detailed inventory data and
summaries by source category. The comprehensive base year emissions
inventory was submitted in the National Emission Data System format.
This inventory was prepared in accordance with EPA guidance.
The 1992 emission inventory was selected as representative of
Philadelphia County emissions during the period showing attainment.
Pennsylvania established the 1992 inventory as the attainment inventory
and forecasted future emissions out to the year 2007 in its maintenance
plan. The future emission estimates were all calculated by applying
appropriate growth factors to the 1990 base year inventory, consistent
with EPA guidance.
B. Demonstration of Maintenance-Projected Inventories
Total CO emissions were projected from 1990 base year out to 2007.
These projected inventories were prepared in accordance with EPA
guidance. Pennsylvania will not implement the oxygenated gasoline
program in the Pennsylvania portion of the Philadelphia CMSA unless a
violation of the standard triggers the implementation of the program.
The projections show that calculated CO emissions, assuming no
oxygenated fuels program, are not expected to exceed the level of the
base year inventory during this time period. Therefore, it is
anticipated that the Philadelphia area will maintain the CO standard
without the program, and the oxygenated gasoline program would not need
to be implemented following redesignation, except as a contingency
measure.
C. Verification of Continued Attainment
Continued attainment of the CO NAAQS in Philadelphia County
depends, in part, on the Commonwealth's efforts toward tracking
indicators of continued attainment during the maintenance period. The
Commonwealth commits to revise the emission inventory every three years
beginning in 1993, until at least 2007. If future emission levels
exceed those in the 1992 attainment inventory, the Commonwealth commits
to investigate the reasons and take appropriate action.
D. Contingency Plan
The level of CO emissions in Philadelphia County will largely
determine its ability to stay in compliance with the CO NAAQS in the
future. Despite the Commonwealth's best efforts to demonstrate
continued compliance with the NAAQS, the ambient air pollutant
concentrations may exceed or violate the NAAQS. Section 175(A)(d) of
the CAA requires that the contingency provisions include a requirement
that the State implement all measures contained in the SIP prior to
redesignation. Therefore, Pennsylvania has provided contingency
measures with a schedule for implementation in the event of a future CO
air quality problem. The plan contains triggering mechanism (a
violation of the CO standard) to determine when contingency measures
are needed.
On August 19, 1995 Pennsylvania modified their oxygenated gasoline
regulations to allow for the discontinuance of the program if EPA
approves a redesignation request and maintenance plan which does not
require the implementation of an oxygenated gasoline program. The
modified Pennsylvania oxygenated gasoline regulation states that if an
area is redesignated to attainment and then violates the CO standard
that the program must be reinstated at the beginning of the next
oxygenated gasoline control period.
E. Subsequent Maintenance Plan Revisions
In accordance with section 175A(b) of the CAA, the Commonwealth has
agreed to submit a revised maintenance SIP eight years after the area
is redesignated to attainment. Such a revised SIP will provide for
maintenance for an additional ten years.
5. Meeting Applicable Requirements of Section 110 and Part D
In Section III.2. above, EPA sets forth the basis for its
conclusion that Pennsylvania has a fully approved SIP which meets the
applicable requirements of Section 110 and Part D of the CAA.
EPA is approving this SIP revision without prior proposal because
the Agency views this as a noncontroversial amendment and anticipates
no adverse comments. However, in a separate document in this Federal
Register publication, EPA is proposing to approve the SIP revision
should adverse or critical comments be filed. This action will be
effective March 15, 1996 unless, within 30 days of publication, adverse
or critical comments are received.
If EPA receives such comments, this action will be withdrawn before
the effective date by publishing a subsequent notice that will withdraw
the final action. All public comments received will then be addressed
in a subsequent final rule based on this action serving as a proposed
rule. EPA will not institute a second comment period on this action.
Any parties interested in commenting on this action should do so at
this time. If no such comments are received, the public is advised that
this action will be effective on March 15, 1996.
Final Action
EPA is approving the Philadelphia County CO maintenance plan
because it meets the requirements set forth in section 175A of the CAA.
In addition, the Agency is approving the request and redesignating the
Philadelphia County CO area to attainment, because the Commonwealth has
demonstrated compliance with the requirements of section 107(d)(3)(E)
for redesignation. EPA is also approving Pennsylvania's 1990 base year
CO emissions inventory for Philadelphia County, as found in the
Commonwealth's redesignation request and maintenance plan. The EPA is
publishing this action without prior proposal because the Agency views
this as a noncontroversial amendment and anticipates no adverse
comments. However, in a separate document in this
[[Page 2930]]
Federal Register publication, the EPA is proposing to approve the SIP
revision should adverse or critical comments be filed. This action will
be effective March 15, 1996 unless, by February 29, 1996 adverse or
critical comments are received. If the EPA receives such comments, this
action will be withdrawn before the effective date by publishing a
subsequent document that will withdraw the final action. All public
comments received will then be addressed in a subsequent final rule
based on this action serving as a proposed rule. The EPA will not
institute a second comment period on this action. Any parties
interested in commenting on this action should do so at this time. If
no such comments are received, the public is advised that this action
will be effective March 15, 1996.
Nothing in this action should be construed as permitting or
allowing or establishing a precedent for any future request for
revision to any state implementation plan. Each request for revision to
the state implementation plan shall be considered separately in light
of specific technical, economic, and environmental factors and in
relation to relevant statutory and regulatory requirements.
Under the Regulatory Flexibility Act, 5 U.S.C. 600 et seq., EPA
must prepare a regulatory flexibility analysis assessing the impact of
any proposed or final rule on small entities. 5 U.S.C. 603 and 604.
Alternatively, EPA may certify that the rule will not have a
significant impact on a substantial number of small entities. Small
entities include small businesses, small not-for-profit enterprises,
and government entities with jurisdiction over populations of less than
50,000.
Under Section 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
the private sector, of $100 million or more. Under section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
EPA has determined that the approval action proposed/promulgated
does not include a Federal mandate that may result in estimated costs
of $100 million or more to either State, local, or tribal governments
in the aggregate, or to the private sector. This Federal action
approves pre-existing requirements under State or local law, and
imposes no new Federal requirements. Accordingly, no additional costs
to State, local, or tribal governments, or to the private sector,
result from this action.
The CO SIP is designed to satisfy the requirements of part D of the
CAA and to provide for attainment and maintenance of the CO NAAQS. This
final redesignation should not be interpreted as authorizing the State
to delete, alter, or rescind any of the CO emission limitations and
restrictions contained in the approved CO SIP. Changes to CO SIP
regulations rendering them less stringent than those contained in the
EPA approved plan cannot be made unless a revised plan for attainment
and maintenance is submitted to and approved by EPA. Unauthorized
relaxations, deletions, and changes could result in both a finding of
non-implementation (section 179(a) of the CAA) and in a SIP deficiency
call made pursuant to sections 110(a)(2)(H) and 110(k)(2) of the CAA.
SIP approvals under section 110 and subchapter I, part D of the CAA
do not create any new requirements, but simply approve requirements
that the State is already imposing. Therefore, because the federal SIP
approval does not impose any new requirements, it does not have any
economic impact on any small entities. Redesignation of an area to
attainment under section 107(d)(3)(E) of the CAA does not impose any
new requirements on small entities. Redesignation is an action that
affects the status of a geographical area and does not impose any
regulatory requirements on sources. Accordingly, I certify that the
approval of the redesignation of an area to attainment under section
107(d)(3)(E) of the CAA will not affect a substantial number of small
entities.
This action has been classified as a Table 3 action for signature
by the Regional Administrator under the procedures published in the
Federal Register on January 19, 1989 (54 FR 2214-2225), as revised by a
July 10, 1995 memorandum from Mary Nichols, Assistant Administrator for
Air and Radiation. The Office of Management and Budget (OMB) has
exempted this regulatory action from E.O. 12866 review.
Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by April 1, 1996. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action on the Philadelphia CO redesignation
request, maintenance plan and the 1990 base year CO emission inventory
may not be challenged later in proceedings to enforce its requirements.
(See section 307(b)(2).)
List of Subjects
40 CFR Part 52
Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements.
40 CFR Part 81
Air pollution control.
Dated: October 31, 1995.
Stanley Laskowski,
Acting Regional Administrator, Region III.
For the reasons set forth in the preamble 40 CFR part 52, subpart
NN of chapter I, title 40 is amended as follows:
PART 52--[AMENDED]
1. The authority citation for Part 52 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
Subpart NN--Pennsylvania
2. Section 52.2020 is amended by adding paragraph (c)(105) to read
as follows:
Sec. 52.2020 Identification of plan.
* * * * *
(c) * * *
(105) The carbon monoxide redesignation and maintenance plan for
part of Philadelphia County submitted by the Pennsylvania Department of
Environmental Protection on September 8, 1995 and October 30, 1995, as
part of the Pennsylvania SIP. The 1990 base year CO emission inventory
and projections are included in the maintenance plan.
(i) Incorporation by reference.
(A) Letters of September 8, 1995 and October 30, 1995 from the
Pennsylvania Department of Environmental Protection requesting the
redesignation and submitting the maintenance plan.
(B) Maintenance Plan for the Philadelphia Carbon Monoxide
Nonattainment Area adopted on October 16, 1995.
(ii) Additional Material.
[[Page 2931]]
(A) Remainder of September 8, 1995 and October 30, 1995 State
submittal.
3. Section 52.2036 is added to read as follows:
Sec. 52.2036 1990 Base Year Carbon Monoxide Emission Inventory for
Philadelphia County.
EPA approves as a revision to the Pennsylvania State Implementation
Plan the 1990 base year carbon monoxide emission inventory for
Philadelphia County, submitted by the Secretary, Pennsylvania
Department of Environmental Protection, on September 8, 1995 and
October 30, 1995. This submittal consists of the 1990 base year
stationary, area, non-road mobile and on-road mobile emission
inventories in Philadelphia County for the pollutant carbon monoxide
(CO).
PART 81--[AMENDED]
Subpart C--Section 107 Attainment Status Designations
1. The authority citation for part 81 continues to read as follows:
Authority: 42 U.S.C. 7401-7671q.
2. In Sec. 81.339, the table for ``Pennsylvania-Carbon Monoxide''
is amended by revising the entry for the Philadelphia-Camden County
area to read as follows:
Sec. 81.339 Pennsylvania.
* * * * *
Pennsylvania--Carbon Monoxide
----------------------------------------------------------------------------------------------------------------
Designation Classification
Designated Area ------------------------------------------------------------------------------
Date\1\ Type Date\1\ Type
----------------------------------------------------------------------------------------------------------------
.................. Nonattainment...... ........... Not Classified.
* * * * * *
*
Philadelphia-Camden County Area
Philadelphia County (part)
City of Philadelphia-high March 15, 1996.... Attainment......... ........... .......................
traffic areas within the
Central Business
District and certain
other high traffic
density areas.
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
\1\This date is November 15, 1990, unless otherwise noted.
[FR Doc. 96-1104 Filed 1-29-96; 8:45 am]
BILLING CODE 6560-50-P
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