issue-1996-07-19•Federal Register final rules — 1996-07-19
Federal Register final rules — 1996-07-19
issue-1996-07-19Federal Register final rules — 1996-07-19Regulation
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. 96-18425 Standard Instrument Approach Procedures; Miscellaneous Amendments
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37677-37678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18425]
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DEPARTMENT OF TRANSPORTATION
14 CFR Part 97
[Docket No. 28627; Amdt. No. 1742]
RIN 2120-AA65
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 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 Form
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
[[Page 37678]]
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.
This amendment to part 97 is effective upon publication of each
separate SIAP as contained in the transmittal. The SIAPs contained in
this amendment are based on the criteria contained in the United States
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.
The FAA has determined through testing that current non-localizer
type, non-precision instrument approaches developed using the TERPS
criteria can be flown by aircraft equipped with Global Positioning
System (GPS) equipment. In consideration of the above, the applicable
Standard Instrument Approach Procedures (SIAPs) will be altered to
include ``or GPS'' in the title without otherwise reviewing or
modifying the procedure. (Once a stand along GPS procedure is
developed, the procedure title will be altered to remove ``or GPS''
from these non-localizer, non-precision instrument approach procedure
titles.) 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 July 12, 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, 97.27, 97.33, 97.35 [Amended]
By amending: Sec. 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec. 97.27 NDB, NDB/DME; Sec. 97.33 RNAV SIAPs; and Sec. 97.35
COPTER SIAPs, identified as follows:
* * * Effective Aug 15, 1996
St. Mary's, AK, St. Mary's, NDB/DME or GPS RWY 16, Amdt 1A CANCELLED
St. Mary's, AK, St. Mary's, NDB/DME RWY 16, Amdt 1A
St. Mary's, AK, St. Mary's, NDB or GPS RWY 34, Orig-A CANCELLED
St. Mary's, AK, St. Mary's, NDB RWY 34, Orig-A
Battle Creek, MI, W.K. Kellogg, VOR or TACAN or GPS RWY 5, Amdt. 19
CANCELLED
Battle Creek, MI, W.K. Kellogg, VOR or TACAN RWY 5, Amdt. 19
Hammonton, NJ, Hammonton Muni, VOR or GPS-B, Amdt 1 CANCELLED
Hammonton, NJ, Hammonton Muni, VOR or GPS-B, Amdt 1
Port Clinton, OH, Carl R Keller Field, NDB or GPS RWY 27, Amdt 11
CANCELLED
Port Clinton, OH, Carl R Keller Field, NDB RWY 27, Amdt 11
Wiscasset, ME, Wiscasset, NDB or GPS RWY 25, Amdt 4A CANCELLED
Wiscasset, ME, Wiscasset, NDB RWY 25, Amdt 4A
Fairmont, WV, Fairmont Municipal, VOR/DME or GPS RWY 22, Amdt 4
CANCELLED
Fairmont, WV, Fairmont Municipal, VOR/DME RWY 22, Amdt 4
Riverton, WY, Riverton Regional, VOR or GPS RWY 28, Amdt 8A
CANCELLED
Riverton, WY, Riverton Regional, VOR RWY 28, Amdt 8A
[FR Doc. 96-18425 Filed 7-18-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-18423 Establishment of Federal Colored Airway B-9; FL
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Page 37677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18423]
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DEPARTMENT OF TRANSPORTATION
14 CFR Part 71
[Airspace Docket No. 95-ASO-20]
Establishment of Federal Colored Airway B-9; FL
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule; correction.
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SUMMARY: This action corrects a final rule published in the Federal
Register on June 13, 1996 (Airspace Docket No. 95-ASO-20). In the
airspace designation of Blue 9 (B-9), effective August 15, 1996, ``Ft.
Myers, FL'' is corrected to read ``Lee County, FL.''
EFFECTIVE DATE: July 19, 1996.
FOR FURTHER INFORMATION CONTACT: Patricia P. Crawford, Airspace and
Rules Division, ATA-400, Office of Air Traffic Airspace Management,
Federal Aviation Administration, 800 Independence Avenue, SW.,
Washington, DC 20591; telephone: (202) 267-8783.
SUPPLEMENTARY INFORMATION: Federal Register Document 96-15063, Airspace
Docket No. 95-ASO-20, published on June 13, 1996 (61 FR 29937),
established B-9. However, in the June 13 publication, the description
for B-9 included an error in defining the DEEDS intersection. The
intersection should have been defined as ``Pahokee, FL, 211 deg. and
Lee County, FL, 138 deg.T (140 deg.M).'' This action corrects that
error.
Accordingly, pursuant to the authority delegated to me, the
airspace designation for B-9, published in the Federal Register on June
13, 1996 (61 FR 20037); Federal Register Document 96-15063, Column 3,
is corrected as follows:
* * * * *
B-9 [Corrected]
From INT Pahokee, FL, 211 deg. and Lee County, FL, 138 deg.
radials; Marathon, FL.
* * * * *
Issued in Washington, DC, on July 12, 1996.
Harold W. Becker,
Acting Program Director for Air Traffic Airspace Management.
[FR Doc. 96-18423 Filed 7-18-96; 8:45 am]
BILLING CODE 4910-13-P
Complete official Federal Register PDF
FR Doc. 96-18404 Removal of the ``Cheese Alternate Products'' Specifications From the National School Lunch Program
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37670-37672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18404]
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DEPARTMENT OF AGRICULTURE
Food and Consumer Service
7 CFR Parts 210 and 225
RIN 0584-AC04
Removal of the ``Cheese Alternate Products'' Specifications From
the National School Lunch Program
AGENCY: Food and Consumer Service, USDA.
ACTION: Final rule.
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SUMMARY: This final rule eliminates the specifications governing the
use of ``Cheese Alternate Products'' in the National School Lunch
Program (NSLP). The removal of these specifications should enable the
food industry more freedom to produce cheese substitute products for
use in the NSLP while maintaining program nutrition standards through
reliance on existing Food and Drug Administration rules.
EFFECTIVE DATE: July 19, 1996.
FOR FURTHER INFORMATION CONTACT:
Ms. Marion Hinners, (703) 305-2556.
SUPPLEMENTARY INFORMATION:
Executive Order 12866
This final rule has been determined to be not significant for
purposes of Executive Order 12866 and, therefore, has not been reviewed
by the Office of Management and Budget.
Regulatory Flexibility Act
This final rule has been reviewed with regard to the requirements
of the Regulatory Flexibility Act (5 U.S.C. 601 through 612). The
Administrator of the Food and Consumer Service has determined that this
final rule will not have a significant economic impact on a substantial
number of small entities. There are currently fewer than ten companies
participating in the Child Nutrition Programs (CNPs) affected by this
regulation. In addition, the removal of this regulation is expected to
reduce the regulatory burden on all companies producing a cheese
alternate type product and allow the use of a wider variety of products
than currently can be used in the CNPs.
Category of Federal Domestic Assistance
The National School Lunch Program and the Summer Food Service
Program for Children are listed in the Catalog of Federal Domestic
Assistance under No. 10.555 and 10.559, respectively, and are subject
to the provisions of Executive Order 12372 which requires
intergovernmental consultation with State and local officials. (7 CFR
part 3015, subpart V and final rule related notice at 48 FR 29112, June
24, 1983.)
Executive Order 12778
This final rule has been reviewed under Executive Order 12778,
Civil Justice Reform. This final rule is intended to have preemptive
effect with respect to any State or local laws, regulations, or
policies which conflict with its provisions or would otherwise impede
its full implementation. This final rule is not intended to have
retroactive effect unless specified in the Effective Date section of
this preamble. Prior to any judicial challenge to the provisions of
this final rule or the application of the provisions, all applicable
administrative procedures must be exhausted.
Information Collection
This final rule contains no new information collection requirements
which are subject to review by the Office of Management and Budget
under the Paperwork Reduction Act of 1980 (44 U.S.C. Chapter 35).
Background
Cheese alternates are used primarily as economical replacements for
natural or processed cheese in the National School Lunch Program
(NSLP). Cheese alternates are a class of products currently required to
be made from conventional ingredients which must meet nutritional and
physical specifications set forth in the NSLP regulations in 7 CFR part
210, Appendix A--Alternate Foods for Meals (appendix A to part 210) in
order to be used as a food component contributing to the NSLP meal
patterns.
The Department published a proposed rule to remove the ``Cheese
Alternate Products'' specifications from the NSLP in the Federal
Register on September 27, 1995 (60 FR 49807). The Department accepted
comments on the proposal until November 13, 1995. One commenter
requested an extension of the comment period. A subsequent Federal
Register publication on November 27, 1995 (60 FR 58252) reopened the
comment period until December 27, 1995.
FCS received a total of 25 comments on the proposed rule. Five
comments were from the state or federal government agencies, five were
from School Food Authorities, six were from private companies and nine
were from trade associations. Eighteen commenters were generally
supportive of FCS proposals: five of those were from private industry
and six from trade organizations. Seven commenters opposed or advocated
major changes to the proposal. Of these seven, two were trade
organizations for dairy interests and one was a private manufacturer.
Commenters who supported the proposal cited positive changes
including that the proposal would: (1) Allow use of alternate protein
sources, (2) provide more flexibility in meeting the Dietary Guidelines
for Americans, (3) reduce food costs, (4) increase the number of
products available, (5) allow for more consistency between the food-
based and nutrient-based menu planning systems used in the NSLP, (6)
increase availability of lower fat and lower saturated fat products,
(7) reduce regulatory burden, (8) eliminate costly, lengthy product
evaluations on the part of industry, (9) increase products for
vegetarians and individuals with dairy product allergies, (10) allow
for reduction in cholesterol and calories and, (11) allow for the
protein digestibility-corrected amino acid score for assessing protein
quality.
The negative comments were varied. One of the government commenters
was concerned about the nutritional impact
[[Page 37671]]
of this change, particularly the reduced zinc adsorption if more
phytate-containing foods (e.g. soy-based cheese substitutes) were used.
FCS does not anticipate that removal of the cheese alternate
specifications will cause use of cheese substitutes to increase to the
extent that the bioavailability of nutrients such as zinc will be
compromised.
A School Food Authority commented that the nutritional quality and
physical characteristics of substitute cheese would be inferior to
natural cheese and that a sodium level should be specified because
cheese substitutes generally have a higher sodium level. Food and Drug
Administration (FDA) labeling regulations (21 CFR 101.3) require
products labeled as ``substitutes'' (e.g., cheese substitutes) to be
``not nutritionally inferior'' to the product for which they substitute
(e.g., cheese). As noted in the proposed rule, FCS is adding ``cheese
substitutes'' to the Food Buying Guide for Child Nutrition Programs
(FBG), Program Aid Number 1331. Schools and FCS use the FBG to
determine what meal components are reimbursable for schools using food
based menu planning. Thus the inclusion in the FBG of cheese
substitutes should help insure that nutritional quality is maintained,
since items labeled as cheese substitutes must be ``not nutritionally
inferior'' to cheese. Moreover, section 9(f) of the National School
Lunch Act (42 U.S.C. 1758(f)) requires that school meals meet the
Dietary Guidelines for Americans (Dietary Guidelines), jointly
published by the Department of Agriculture and the Department of Health
and Human Services. The Dietary Guidelines provide for moderating salt
and sodium intake, and schools are expected to comply. As has always
been true, schools must make the final decision on what to buy based on
good menu planning practices as well as flavor, functional
characteristics, and student acceptance. Schools electing to use a
higher sodium cheese substitute can, and should, reduce the sodium
contributed to the meal from other sources.
Trade association and private industry commenters generally agreed
that FCS should eliminate the current requirement that cheese
alternates must be used in combination with at least 50 percent natural
cheese because there was no nutritional basis to keep the requirement.
One School Food Authority thought this requirement should be retained
to help maintain the nutritional integrity and physical properties of
cheese substitutes. FCS believes that nutritional quality will be
maintained by the FDA standard and that the physical properties will
not vary appreciably from current cheese substitutes, since their
marketplace acceptability is partly a function of these properties.
One private industry commenter was against the proposal because of
the possibility for abuse by manufacturers to supply inferior cheese
products. FCS believes manufacturers will have no increased opportunity
for abuse beyond their opportunity in the current approval system. As
stated above, the nutritional integrity of a cheese substitute is
maintained through compliance with FDA requirements and by inclusion of
FDA labeled cheese substitutes in the FBG. Further, FCS believes that
the functionality of cheese substitutes will also be maintained through
marketplace pressures, because their acceptability is dependent upon
their functional characteristics.
Both trade association and private industry commenters thought that
a protein quality requirement should be retained because FDA
regulations prohibits a substitute from containing a lesser amount of
protein while making no direct provisions for protein quality. Because
of this concern, FCS contacted FDA early in the regulatory process for
clarification of their regulation. In a letter to William E. Ludwig,
the Administrator of FCS, Dr. F. Edward Scarbrough, the Director of the
FDA's Office of Food Labeling, stated that: ``a substitute food must be
able to support the same nutrition claims as the reference food, and
since the protein claim for the reference food must include protein
quality, the substitute food must also account for protein quality.''
Referring to FDA regulations, he went on to say ``the (FDA) believes
that (21 CFR) 101.3(e)(4) maintains its long standing policy that
protein quality is a factor in determining if a substitute food is
nutritionally inferior to a reference food.'' Because FDA considers
protein quality when determining whether a substitute food is
``nutritionally inferior'', FCS believes that protein quality standards
will be maintained when products labeled as ``cheese substitutes'' are
used. Therefore, FCS does not need to define an independent protein
quality requirement for cheese substitutes.
Accordingly, this final rule is being published without changes
from FCS' proposed rulemaking. Upon publication this final rule removes
the section entitled ``Cheese Alternate Products'' Appendix A to part
210--Alternate Foods for Meals. The removal of the cheese alternate
products section from appendix A to part 210 eliminates FCS
specifications for use of cheese alternates as meat alternates. This
change allows the use of cheese substitutes that are consistent with
FDA regulations which allow for fat and calorie reductions. This change
adds to the choice of products available to food service managers while
reducing processors' regulatory burdens. In addition, the removal of
the cheese alternate products specifications is consistent with the
Department's ongoing efforts to promote school meals that meet the
Dietary Guidelines and is consistent with National Performance Review
goals of reducing unnecessary federal regulations. Note that the
removal of this specification also means that the cheese alternate
label statements currently required by the FCS specification will no
longer be required. FCS expects that companies that have currently
approved labels with these statements will discontinue use of these
statements as soon as it is reasonably possible but no longer than one
year from the effective date of this regulation.
List of Subjects
7 CFR Part 210
Children, Commodity School Program, Food Assistance Programs,
Grants programs-social programs, National School Lunch Program,
Nutrition, Reporting and recordkeeping requirements, Surplus
agricultural commodities.
7 CFR Part 225
Food Assistance Programs, Grant programs--Health, Infants and
Children.
For the reasons set forth in the preamble, 7 CFR parts 210 and 225
are amended as follows:
PART 210--NATIONAL SCHOOL LUNCH PROGRAM
1. The authority citation for 7 CFR part 210 continues to read as
follows:
Authority: 42 U.S.C. 1751-1760, 1779.
Sec. 210.10 [Amended]
2. In Sec. 210.10, the first sentence of paragraph (k)(3)(i) is
amended by removing the words ``cheese alternate products''.
Sec. 210.10a [Amended]
3. In Sec. 210.10a, the first sentence of paragraph (d)(2)(i) is
amended by removing the words ``cheese alternate products,''.
Appendix A to Part 210 [Amended]
4. In Appendix A to Part 210--Alternate Foods for Meals, the
section entitled ``Cheese Alternate Products'' is removed.
[[Page 37672]]
PART 225--SUMMER FOOD SERVICE PROGRAM
1. The authority citation for 7 CFR part 225 continues to read as
follows:
Authority: Secs. 9, 13 and 14, National School Lunch Act, as
amended (42 U.S.C. 1758, 1761 and 1762a).
Sec. 225.16 [Amended]
2. In Sec. 225.16, the first sentence of paragraph (f)(3) is
amended by removing the words ``cheese alternate products,''.
Dated: July 12, 1996.
William E. Ludwig,
Administrator, Food and Consumer Service.
[FR Doc. 96-18404 Filed 7-18-96; 8:45 am]
BILLING CODE 3410-30-M
Complete official Federal Register PDF
FR Doc. 96-18400 Use of Sodium Citrate Buffered With Citric Acid in Certain Cured and Uncured Processed Meat and Poultry Products
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Page 37675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18400]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 318 and 381
[Docket No. 95-001N]
RIN 0583-AB97
Use of Sodium Citrate Buffered With Citric Acid in Certain Cured
and Uncured Processed Meat and Poultry Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Affirmation of effective date for direct final rule.
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SUMMARY: On April 24, 1996, the Food Safety and Inspection Service
(FSIS) published a direct final rule ``Use of Sodium Citrate Buffered
with Citric Acid in Certain Cured and Uncured Processed Meat and
Poultry Products'' (61 FR 18047). This direct final rule notified the
public of FSIS's intention to amend the Federal meat and poultry
products inspection regulations to permit the use of a solution of
sodium citrate buffered with citric acid in cured and uncured processed
whole-muscle meat and poultry products. This use of sodium citrate
buffered with citric acid will inhibit the growth of microorganisms,
Clostridium botulinum in particular, and retain product flavor during
storage. FSIS received no adverse comments within the scope of this
rulemaking in response to the direct final rule.
EFFECTIVE DATE: June 24, 1996.
FOR FURTHER INFORMATION CONTACT: Charles R. Edwards, Director, Product
Assessment Division, Regulatory Programs, Food Safety and Inspection
Service, U.S. Department of Agriculture, Washington, DC 20250-3700,
(202) 254-2565.
Done at Washington, DC, on: July 15, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 96-18400 Filed 7-18-96; 8:45 am]
BILLING CODE 3410-DM-P
Complete official Federal Register PDF
FR Doc. 96-18354 Office of the Assistant Secretary for HousingFederal Housing Commissioner; Single Family Mortgage Insurance Premium
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37798-37801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18354]
[[Page 37797]]
_______________________________________________________________________
Part II
Department of Housing and Urban Development
_______________________________________________________________________
24 CFR Parts 203 and 221
Single Family Mortgage Insurance Premium; Final Rule
Federal Register / Vol. 61, No. 140 / Friday, July 19, 1996 / Rules
and Regulations
[[Page 37798]]
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
24 CFR Parts 203 and 221
[Docket No. FR-3899-F-02]
RIN 2502-AG55
Office of the Assistant Secretary for Housing--Federal Housing
Commissioner; Single Family Mortgage Insurance Premium
AGENCY: Office of the Assistant Secretary for Housing-Federal Housing
Commissioner, HUD.
ACTION: Final rule.
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SUMMARY: This rule makes final the proposed rule published by the
Department on January 26, 1996, which proposed many benefits to the
mortgage lenders that would reduce their servicing costs and the
confusion generated by adjustments to the annual mortgage insurance
premium (MIP) on cases not endorsed within the first six months after
amortization. The rule changes the method of payment and the
reconciliation schedule and clarifies the due date. It is expected that
the changes will result in an increase in MIP income, thereby
strengthening the FHA insurance fund. Also, costly reconciliation now
done by HUD will be cut.
Specifically, the rule provides that the FHA Commissioner can
accrue MIP from the beginning of amortization (as defined in 24 CFR
203.251) on all Section 530 (of the National Housing Act) loans and
risk-based loans, no matter what time frame exists between the
endorsement date and the beginning of amortization. It also amends the
existing regulation by requiring that mortgagees pay the monthly
installments as due on or before the 10th of the month, whether or not
collected from the mortgagor. A new system is being developed (and
expected to be operational by Summer 1997) which would produce a
monthly notice of premiums due, and the reconciliation will be made
monthly by the lender when the premium is paid. A new Single Family
Premium Collection Subsystem-Periodic (SFPCS-P) is being developed (and
expected to be operational by Summer 1997) which will produce a monthly
notice of premiums due, and the reconciliation will be made monthly by
the lender when the MIP is paid, thus eliminating the requirement for
annual reconciliation.
EFFECTIVE DATE: August 19, 1996.
FOR FURTHER INFORMATION CONTACT: John L. Stahl, Acting Director, Office
of Mortgage Insurance Accounting and Servicing, Room 2108, Department
of Housing and Urban Development, 451 7th Street, SW, Washington, DC
20410, telephone (202) 708-1046. For telephone communication, contact
Anne Baird-Bridges, Single Family Insurance Operations Division, at
(202) 708-2438. Hearing or speech-impaired individuals may call HUD's
TTY number (202) 708-4594. These are not toll-free numbers.
SUPPLEMENTARY INFORMATION:
Background
Section 320 of the Housing and Community Development Act of 1980
(Pub.L. 96-399) amended Title V of the National Housing Act (the Act)
(12 U.S.C. 1702 et seq.) to add a new section 530. Section 530
requires, with respect to insurance of mortgages under Title II of the
Act, the payment of MIPs upon receipt from the borrower, except HUD may
approve payment of such premiums within 24 months of such receipt if
the financial institution or mortgagee pays interest to the insurance
fund. On July 15, 1982, at 47 FR 30750, the Department published a
final rule that implemented section 530 by requiring mortgagees to pay
the MIP in installments due on or before the 10th day of the month
following the month in which payments are due from the mortgagors. On
June 23, 1983, at 48 FR 28794, the Department published a final rule
which set forth the requirement that the borrower pay a single premium
when the mortgage loan is closed, which represents the total premium
obligation for the insured loan. This change applied to all new
mortgages insured under the Mutual Mortgage Insurance Fund; therefore,
after the change took effect, section 530 was limited to mortgages
insured under the Special Risk and General Insurance Funds.
Section 530 loans include all FHA loans endorsed prior to September
30, 1983, and all FHA loans insured under the Special Risk and General
Insurance Funds after September 1983. Lenders are required to remit
annual MIP in 12 monthly payments totalling one-half of one percent of
the average outstanding principal obligation of the mortgage.
The risk-based premium became effective on July 1, 1991, for all
loans insured under the provisions of the Mutual Mortgage Insurance
Fund, in accordance with the Omnibus Budget Reconciliation Act of 1990
(Pub.L. 101-508) and the National Affordable Housing Act of 1990
(Pub.L. 101-625). Sections 203.284 and 203.285 of title 24 of the Code
of Federal Regulations were promulgated to implement the provisions
governing risk-based premiums (See 57 FR 15208, April 24, 1992, and 58
FR 40996, July 30, 1993). Risk-based premiums have two components: The
up-front premium and the periodic premium. Periodic premiums on risk-
based loans are collected over a set number of years, depending on the
loan-to-value ratio of the mortgage. Premium payments are paid in
twelve monthly installments totalling one-half of one percent of the
remaining insured principal balance of the mortgage, minus any amounts
included to finance up-front MIP. However, there is an exception under
Sec. 203.285 for any mortgage with a term of 15 years or less, which
requires premium payments totalling one-fourth of one percent of the
insured principal balance.
This Rule
On January 26, 1996, the Department published a proposed rule at 61
FR 2644. The public was afforded a 60-day comment period. No changes to
the January 26, 1996 proposed rule are needed as a result of the
comments. Therefore, this final rule adopts the proposed rule without
change. Below is a discussion of the changes made by this rule.
This rule changes the method of payment and the reconciliation
schedule and clarifies the due date. Specifically, the rule provides
that the FHA Commissioner can accrue MIP from the beginning of
amortization (as defined in 24 CFR 203.251) on all Section 530 and
risk-based loans, no matter what time frame exists between the
endorsement date and the beginning of amortization. It also amends the
existing regulation by requiring that mortgagees pay the monthly
installments as due on or before the 10th of the month, whether or not
collected from the mortgagor.
The rule revises Secs. 203.262, 203.264, and 203.265 to reflect the
new policy on monthly payment of MIPs. The revised provisions also
apply to risk-based premiums under Secs. 203.284 and 203.285.
Sections 203.262 and 203.264 apply to the scheduled payments.
Existing Sec. 203.264 requires that ``any portion of the periodic MIP
received by the mortgagee from the mortgagor on or after September 1,
1982, shall be paid to the Commissioner on or before the tenth of the
month following the month in which it was received,'' provided that the
full annual MIP be paid by the tenth of the month following the
anniversary date of amortization. At the initiation of
[[Page 37799]]
the Section 530 Program, mortgagees were offered two payment options:
a. The Basic Monthly Payment Method. According to this method, the
lender remits on a monthly basis, on or before the tenth of each month,
a payment equal to all Section 530 MIP amounts collected from
mortgagors during the preceding month, plus any portion of annual MIP
remaining due for the current anniversary month whether collected or
not.
b. Optional Monthly Payment Method. According to this method, the
lender remits a monthly payment equal to \1/12\th of the total of all
annual Section 530 MIPs for all mortgages in the mortgagee's servicing
portfolio for the month, plus any annual premiums remaining due,
without regard to MIP amounts collected from mortgagors.
Most lenders opt to pay the premiums as due. HUD systems are set up
to reconcile remittances of MIP, late charges, and interest based on
payment of monthly premiums by the 10th of the month; exceptions must
be manually processed. This rule eliminates the option to pay the
premiums when collected.
The two provisions to be modified for Section 530 loans also apply
to the periodic portion of risk-based loans. Mortgagees submitting
risk-based monthly premiums have been following HUD's policy on
adjustment of initial MIP depending on the date of endorsement, and
have been given the option of paying monthly premiums (1) ``as due'' or
(2) ``as collected''.
Section 530 and risk-based monthly premium payments will be due on
the first of the month after the beginning of amortization (as defined
in 24 CFR 203.251) and must be received on or before the tenth.
Reconciliation between amounts expected by HUD and amounts remitted by
the lender will be accomplished after the date of endorsement, when the
insurance information has been fed into the FHA Single Family Insurance
System. As soon as possible after endorsement, HUD will begin verifying
that the lender has paid the required monthly premiums due at that time
on each case, and will begin notifying the lender on a monthly basis of
any discrepancies existing between expected, versus remitted, amounts.
Until SFPCS-P is implemented, lenders will continue to reconcile risk-
based monthly premiums at case level using MGIC Investor Services
Corporation, and Section 530 monthly premiums at portfolio level based
on the Advance Notice of Annual Premiums for Anniversary Due Date,
which is being sent by HUD.
New Secs. 203.262 and 203.264 authorize the FHA Commissioner to
accrue annual premiums from the beginning of amortization (as defined
in 24 CFR 203.251) on all Section 530 and risk-based loans, no matter
what time frame exists between the endorsement date and the beginning
of amortization. This rule also deletes Sec. 203.263 which provides for
an adjustment on the accrual date of the initial annual MIP depending
on the date of endorsement of the loan. Section 203.268 is revised to
provide that if the insurance contract is terminated, the lender will
pay a portion of the MIP prorated from the beginning of amortization
(as defined in 24 CFR 203.251) to the month in which the loan is
terminated. The final monthly payment will be due on the first of the
month following termination.
The changes made by this rule provide many benefits to the mortgage
lenders that reduce their servicing costs and the confusion generated
by adjustments to MIP on cases not endorsed within the first six months
after amortization. The result expected is an increase in MIP income,
thereby strengthening the FHA insurance fund. The changes cut down on
the costly reconciliation now done by HUD. (The cost of reconciliation
on Section 530 and monthly risk based premiums exceeded $7.5 million in
FY 1994.)
According to research completed on FY 1993 cases, approximately 7%
of cases were not endorsed within the first six months of amortization.
Currently some lenders escrow the premiums received from the homeowners
on Section 530 and risk-based loans and remit the premiums to HUD at
the beginning of amortization rather than when the case is endorsed for
insurance. This has led to much confusion and variations in the
computation of initial premiums due, because some contingencies cannot
be foreseen at settlement; i.e., endorsement before the beginning of
amortization. The revised regulation prevents confusion for those cases
endorsed outside the six-month window by requiring lenders to follow
the same guidelines for all cases needing periodic MIP.
MIP income is expected to increase by approximately $15 million per
year. This amount represents the reduction in premiums now taken by the
lenders for both Section 530 loans and risk-based loans, when the loans
are endorsed over six months from the beginning of amortization.
Lenders should not receive a reduction in monthly MIP due because of
late endorsement for the following reasons:
a. This is inconsistent with HUD's policy on one-time and up-front
MIP. These amounts are paid within 15 days of closing, and no reduction
is given based on the date of endorsement. On risk based loans,
Sec. 203.284 requires payment of periodic MIP for a specific number of
years, depending on the loan-to-value ratio. When the loan is endorsed
after the six-month window, the period of time for which payments are
due is being reduced.
b. Often the late endorsement results from late submission of the
closing package by the lenders to the Field Office.
The new Sec. 203.264 requires that payment of the periodic MIP be
received from the mortgagee on or before the tenth day of the month
following the month in which it was due from the mortgagor. For
example, for a case closed in August and amortized in September, the
initial premium is payable to HUD by the lender no later than October
10. Monthly reconciliation replaces annual reconciliation. Once SFPCS-P
is implemented, monthly notices will reflect a breakdown by case number
and by month of the cumulative amounts of monthly premium, late charge,
and interest due.
The rule changes the method of payment, and the reconciliation
schedule, and clarifies the due date. Payment of the periodic MIP by
the lender is to be made monthly, regardless when collected. Upon
implementation of SFPCS-P, a monthly notice from HUD will be sent and
reconciliation will be made monthly by the lender when the MIP payment
is paid, thus eliminating the requirement for annual reconciliation.
MIP shall be due, and payable to the Commissioner, no later than the
tenth day of the month.
Lenders will be informed that they are responsible for all loans in
their portfolio for which monthly payments are due, even if they do not
appear on the monthly notice. Because of servicing transfers,
endorsement delays, and terminations, monthly notices may not reflect
the current status of the lender's portfolio and may require
reconciliation.
The current Single Family Monthly Collection System used for MIP
collection is not set up to reconcile payments received under the
``Payment as Received'' option. The new SFPCS-P is not being set up to
reconcile these payments either. The system enhancements necessary to
accommodate this option would not be cost effective, and are not
necessary, because most lenders have chosen the other option anyway.
It should be noted that Sec. 203.284(f) ``Applicability of Other
Sections'' does not include Sec. 203.264 as applicable to
[[Page 37800]]
mortgages covered by Sec. 203.284, although HUD has taken the position
that this provision is properly applicable to mortgages with risk-based
premiums. This rule re-inserts a reference to Sec. 203.264 that was
inadvertently deleted when that section was published as a final rule
(See 57 FR 15209, April 24, 1992). The rule also inserts references to
Secs. 203.262 and 203.265 in lieu of the current Secs. 203.284 (d) and
(e) which are being deleted. Similar changes are made to
Sec. 203.285(c).
Public Comments
Comments were received from three commenters on the January 26,
1996 proposed rule: One housing development fund and two mortgage
corporations. One of the mortgage corporations fully supports the
proposed rule. Below is a listing of the comments presented from the
other two commenters. After each comment is the Department's response.
Comment: There are terminology conflicts between the regulations
and the HUD approved Deed of Trust, and clarification of the terms and
the changes to the HUD approved forms are requested before the rule
goes into effect.
Response: HUD Handbook 4165.1 REV-1 CHG. 3, Endorsement for
Insurance for Home Mortgage Premiums (Single Family) dated November 30,
1995 contains new model mortgage and note forms which remove
conflicting terminology. These changes became mandatory on June 1,
1996.
Comment: The reconciliation of the initial notice produced after
the SFPCS-P is completed will most likely contain thousands of
unmatched items for each lender. These will result from years of
unreconciled service transfers, terminations, incorrect case numbers,
and endorsement delays. Therefore, the commenter strongly urges the
Department to conduct a preliminary audit to quantify the extent of the
reconciliation required by both the lenders and HUD and then determine
an approach and implementation date.
Response: Since SFPCS-P is being designed to capture MIP payments
at case level, bills will contain detailed information to enable
lenders to reconcile their portfolios each billing period. Unidentified
cases will not be carried forward on SFPCS-P. HUD is working to resolve
all unidentified cases separately.
Comment: There should be some standard established and required for
the endorsement process. The commenter is concerned that the
elimination of the financial penalty could result in far more than
seven percent of the cases taking more than six months to be endorsed,
which could further complicate the ongoing reconciliation process.
Response: As long as a mortgage is submitted to HUD within 60 days
of closing as required by 24 CFR 203.255(b), HUD is committed to
proceeding within a reasonable time with its pre-endorsement review and
subsequent endorsement if the mortgage is determined to be eligible for
insurance. In nearly all cases that do not raise questions of
eligibility, the Mortgage Insurance Certificate (MIC) should be issued
long before the first half of the amortization year has expired. HUD
policy to date has not permitted Field Offices to deliberately delay
issuance of the MIC until the end of the first half of the amortization
year. HUD's Processing Center in Denver is meeting our national goal by
processing cases for endorsement in 10 days with a reject rate of six
percent or under.
Comment: The examples for timing of remittances and final payments
on terminations need clarification.
Response: To further clarify the example for the timing of
remittance as set forth in the proposed rule, the example has been
revised to read as follows: For a case closed in August with
amortization beginning in September, the initial premium is payable to
HUD by the lender no later than October 10.
For terminations, the final monthly payment would be due on the
first of the month following termination and payable to HUD no later
than the 10th of the month following termination. For example, if a
case is terminated in August, the final monthly payment would be
payable to HUD no later than September 10.
Other Matters
Environmental Review
A Finding of No Significant Impact with respect to the environment
was made in accordance with the HUD regulation at 24 CFR part 50, which
implements section 102(2) (C) of the National Environmental Policy Act
of 1969, for the January 26, 1996 proposed rule. Since this final rule
makes no changes to the proposed rule, the Finding of No Significant
Impact for the proposed rule shall serve as the finding for the final
rule. The Finding of No Significant Impact is available for public
inspection between 7:30 a.m. and 5:30 p.m. weekdays in the Office of
the Rules Docket Clerk.
Regulatory Flexibility Act
The Secretary, in accordance with the Regulatory Flexibility Act (5
U.S.C. 605(b)) has reviewed and approved this rule, and in so doing
certifies that this rule does not have a significant economic impact on
a substantial number of small entities. A review of the universe of
approved mortgagees indicates that only a small percentage of them have
assets of less than $10 million. These can be considered ``small
entities'' for purposes of this regulation. The number of ``small
entities'' affected, therefore, is not substantial. Further, HUD
records indicate smaller companies hold relatively few insured
mortgages, and they tend to concentrate their business in the
conventional mortgage market. Thus, even for those ``small entities''
affected, the impact is expected to be relatively insignificant.
Executive Order 12612, Federalism
The General Counsel, as the Designated Official under section 6(a)
of Executive order 12612, Federalism, has determined that the policies
contained in this rule will not have substantial direct effects on
states or their political subdivisions, or the relationship between the
federal government and the states, or on the distribution of power and
responsibilities among the various levels of government. As a result,
the rule is not subject to review under the order.
Executive Order 12606, The Family
The General Counsel, as the Designated Official under Executive
Order 12606, The Family, has determined that this rule does not have
potential for significant impact on family formation, maintenance, and
general well-being, and, thus, is not subject to review under the
order. No significant change in existing HUD policies or programs would
result from promulgation of this rule, as those policies and programs
relate to family concerns.
List of Subjects
24 CFR Part 203
Hawaiian Natives, Home improvement, Indians--lands, Loan programs--
housing and community development, Mortgage insurance, Reporting and
recordkeeping requirements, Solar energy.
24 CFR Part 221
Low and moderate income housing, Mortgage insurance, Reporting and
recordkeeping requirements.
[[Page 37801]]
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance number is 14.117.
Accordingly, the Department amends parts 203 and 221 of title 24 of
the Code of Federal Regulations as follows:
PART 203--SINGLE FAMILY MORTGAGE INSURANCE
1. The authority citation for part 203 continues to read as
follows:
Authority: 12 U.S.C. 1709, 1715b; 42 U.S.C. 3535(d). Subpart C
also is issued under 12 U.S.C. 1715u.
2. Section 203.262 is revised to read as follows:
Sec. 203.262 Due date of periodic MIP.
The full initial and each annual MIP shall be due and payable to
the Commissioner no later than the 10th day after the amortization
anniversary date.
Sec. 203.263 [Removed]
3. Section 203.263 is removed.
4. Section 203.264 is revised to read as follows:
Sec. 203.264 Payment of periodic MIP.
The mortgagee shall pay each MIP in twelve equal monthly
installments. Each monthly installment shall be due and payable to the
Commissioner no later than the tenth day of each month, beginning in
the month in which the mortgagor is required to make the first monthly
mortgage payment or, if later, in September.
5. In Sec. 203.265, paragraph (a) is revised to read as follows:
Sec. 203.265 Mortgagee's late charge and interest.
(a) Periodic MIP which are received by the Commissioner after the
payment dates prescribed by Secs. 203.262 and 203.264 shall include a
late charge of four percent of the amount paid.
* * * * *
6. Section 203.268 is amended by revising paragraph (a) to read as
follows:
Sec. 203.268 Pro rata payment of periodic MIP.
(a) If the insurance contract is terminated before the due date of
the initial MIP, the mortgagee shall pay a portion of the MIP prorated
from the beginning of amortization, as defined in Sec. 203.251, to the
date of termination.
* * * * *
7. Section 203.284 is amended by removing and reserving paragraphs
(d) and (e) and revising paragraph (f) to read as follows:
Sec. 203.284 Calculation of up-front and annual MIP on or after July
1, 1991.
* * * * *
(d) [Removed and reserved]
(e) [Removed and reserved]
(f) Applicability of other sections. The provisions of
Secs. 203.261, 203.262, 203.264, 203.265, 203.266, 203.267, 203.268,
203.269, 203.280, and 203.282 are applicable to mortgages subject to
premiums under this section.
* * * * *
8. Section 203.285 is amended by revising paragraph (c) to read as
follows:
Sec. 203.285 Fifteen-year mortgages: Calculation of up-front and
annual MIP on or after December 26, 1992.
* * * * *
(c) Applicability of certain provisions. The provisions of
Secs. 203.261, 203.262, 203.264, 203.265, 203.266, 203.267, 203.268,
203.269, 203.280, 203.282, 203.284(c), and 203.284(g) are applicable to
mortgages subject to premiums under this section.
* * * * *
PART 221--LOW COST AND MODERATE INCOME MORTGAGE INSURANCE
9. The authority citation for part 221 is revised to read as
follows:
Authority: 12 U.S.C. 1715b, 1715l; 42 U.S.C. 3535(d). Section
221.544(a)(3) is also issued under 12 U.S.C. 1707(a).
Sec. 221.251 [Amended]
10. Section 221.251(a) is amended by removing from the list
``203.263 Adjustment of initial MIP.''
Dated: July 10, 1996.
Nicolas P. Retsinas,
Assistant Secretary for Housing-Federal Housing Commissioner.
[FR Doc. 96-18354 Filed 7-18-96; 8:45 am]
BILLING CODE 4210-27-P
Complete official Federal Register PDF
FR Doc. 96-18352 National Flood Insurance Program; Assistance to Private Sector Property Insurers
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37687-37693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18352]
=======================================================================
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FEDERAL EMERGENCY MANAGEMENT AGENCY
44 CFR Part 62
RIN 3067-AC26
National Flood Insurance Program; Assistance to Private Sector
Property Insurers
AGENCY: Federal Insurance Administration (FIA), Federal Emergency
Management Agency (FEMA).
ACTION: Final rule.
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SUMMARY: This final rule amends National Flood Insurance Program (NFIP)
regulations establishing the Financial Assistance/Subsidy Arrangement
that may be entered into by and between the Administrator and private
sector insurers under the Write Your Own (WYO) program. The amendments:
(1) Simplify the Arrangement by streamlining the format; (2) reflect
recent policy changes regarding loss adjustment and financial operation
of the private insurers in the WYO program; and (3) delete references
to obsolete operating manuals and handbooks. The amendments also
improve the flexibility of the Arrangement and provide information to
permit WYO participants to discharge their responsibilities for
underwriting, claims adjustment, and financial control procedures
established by the Federal Insurance Administration.
EFFECTIVE DATE: October 1, 1996.
FOR FURTHER INFORMATION CONTACT: Edward T. Pasterick, Federal Emergency
Management Agency, Federal Insurance Administration, 500 C Street SW.,
Washington, DC 20472, (202) 646-3443.
SUPPLEMENTARY INFORMATION: On April 3, 1996, FEMA published in the
Federal Register, 61 FR 14709, a proposed rule to amend NFIP
regulations establishing the Financial Assistance/Subsidy Arrangement
that may be entered into by and between the Administrator and private
sector insurers under the WYO program.
FEMA received two sets of written comments on the proposed rule.
The comments were submitted by two separate Write Your Own companies.
One company expressed concerns over seven (7) issues in the
Arrangement. The first concern questioned the Arrangement's incentive
system, i.e., adjusting the percentage of retained premium relative to
the Company's performance in achieving production goals. The proposed
Arrangement provides a minimum of 30.6% of premium income to be
retained by a WYO Company for operating and administrative expenses,
including marketing expenses. When a WYO company achieves its
production or marketing goals, the amount of retained premium income
increases from the minimum of 30.6% up to a maximum of 32.6%. The
commenter felt that such a provision was punitive and amounted to a
retroactive penalty since the marketing goals are tied to the retention
of current policies as well as the production of new business.
First of all, the amount of premium income retained by a WYO
company (32.6%) includes allowances for marketing activities.
Therefore, it is not unreasonable to condition a portion of the
retained premium on the success of such marketing activities. Secondly,
the unprecedented growth in the number of flood insurance policies
during the last two years as a result of this very incentive system is
a compelling reason to continue it under the Arrangement. Thirdly, the
marketing goals are tied to retention of current policies only to the
extent that such policies leave the NFIP entirely. If they go from one
WYO company to another, the loss does not adversely affect the first
company's goals. Furthermore, policy retention is a commonly accepted
component of marketing strategies. In sum, the principle of relating
financial incentives to performance is simply a sound business practice
and has been retained in the Arrangement.
The commenter expressed a related concern that a standard
percentage is unfair to larger companies that carry more policies on
their book of business. FEMA has retained the same percentage for all
companies participating in the WYO program for the current Arrangement
believing that a consistent
[[Page 37688]]
standard is the most equitable approach for all participants since it
is applied uniformly, regardless of a company's size. However, in
calculating goal accomplishment, we will employ a formula that will
recognize not only the percentage increase in the numbers of policies
but also absolute numbers of new policies. This will be explained
further in the offer letter for the Arrangement.
The overall issues of growth goals for companies in the WYO
program, the appropriate level of the expense allowance, and the
relationship between the two, all warrant a detailed review by the FIA.
For the current Arrangement, however, the levels of retained premium
reflected in the April 3, 1996 proposed rule remain in effect.
The second concern raised by this WYO company focused on the
appropriate roles with respect to risk bearing by the Federal
Government and the insurance companies participating in the
Arrangement. (The heading in the company's submission reads
``Continuing Shift of Risk-Bearing.'') The commenter expressed concern
that if Congressional authorization or appropriation for the program is
ever withdrawn the WYO company would still be liable for its policies
in force that are allowed to run their term under the Arrangement. The
company recommended that the purpose statement be revised to emphasize
the Federal Government's continuing financial assistance role--
regardless of circumstances. The same company also recommended that
Article V.E. should reaffirm that the FIA will reimburse expenses and
ultimately be responsible for claim payment for the duration of the
Arrangement even though financial assistance under the Arrangement is
canceled for any new or renewal business. In the absence of that, the
company recommended that a WYO company be permitted to cancel all
policies in force with 45 days notice should financial assistance be
terminated for any reason.
First, the Arrangement may not obligate the Federal Government in
any way beyond Congressional authorization. Congress has built into the
Act, however, a number of safeguards for policyholders--the ultimate
beneficiaries of the National Flood Insurance Program--and private
insurance companies that participate in the NFIP. One of the major
safeguards for consumers and private insurance companies is FEMA's
borrowing authority for the National Flood Insurance Fund which
operates independently of fiscal year authorization. Furthermore, the
WYO program has operated for thirteen years and all have benefited--the
consumer, the taxpayer, and participating WYO companies that have not
had to absorb or share losses even in recent heavy loss years in spite
of their active involvement in the NFIP. While FIA cannot speak for
Congress relative to the authorization for the NFIP, FIA has recognized
the commenter's concern by revising the purpose statement of Article I
to emphasize that all flood policies issued are done so under
prescribed conditions pursuant to the Arrangement and authorization
granted by Congress for the program.
The same commenter also expressed concern over certain details in
the Arrangement for the single adjuster program for catastrophic losses
such as hurricanes when property owners suffer combined wind and flood
losses but have separate insurance carriers for these perils.
Specifically, Article II.C.3.0 of the proposed Arrangement requires
using a single adjuster when the flood coverage is provided by the WYO
company and the wind coverage is provided by another WYO company.
Article II.C.4.0 requires the use of a single adjuster when the flood
coverage is by the WYO company, the wind coverage is by another
property insurer, and the State Insurance Regulator deems it in the
interests of the policyholder that a single adjuster be used to handle
both losses.
FIA finds some merit in the commenter's concerns relative to: 1.
Article II.C.3.0, such as the potential exposure of a WYO company's
proprietary information through the use of a single adjuster.
Consequently, the Arrangement has been revised by deleting Article
II.C.3.0. Article II. C.4.0, which requires the use of a single
adjuster when the State Insurance Regulator requires one, has been
retained in the Arrangement and renumbered as Article II.C.3.0. FIA
believes strongly that at the heart of the single adjuster approach is
an overriding public benefit since claims on the same property
involving separate perils are adjusted in a coordinated manner.
Therefore, whenever a State Insurance Regulator deems it in the
interest of the public that a single adjuster be used for an event
involving wind and flood, the program will support the Regulator's
decision and require the use of a single adjuster by participating WYO
companies.
The company also expressed concern that it no longer has an
understanding with one Joint Underwriting Association and would run the
risk in Article II.C.2.0 of breach of contract or misrepresentation
since Joint Underwriting Associations are one of the wind carriers that
would require the use of a single adjuster. The commenter indicated
that Article II.C.2.0 represented only a small percentage of its
business, and Joint Underwriting Associations are in fact only one of a
number of property insurance mechanisms listed in Article II.C.2.0.
While the company may no longer act as a servicing agent for a
particular State Joint Underwriting Association, this would certainly
not preclude the use of a single adjuster when the coverage for flood
is offered by the company and the wind coverage is offered by the
underwriting association. Accordingly, Article II.C.2.0 of the
Arrangement has not been revised.
The same company also recommended that State premium tax surcharges
for flood insurance and guaranty fund assessments be excluded from
liability from a participating Company. The company believed that the
wording in the proposed Arrangement could be an impediment to
marketing. FIA agrees with this comment, and Article III.A. has been
revised to read, ``The Company shall be liable for operating,
administrative and production expenses, including any State premium
taxes, dividends, agent's commissions or any other expense of whatever
nature incurred by the Company in the performance of its obligations
under the Arrangement, but excluding surcharges on flood insurance
premium and guaranty fund assessments.''
The first commenter also objected that the percentage (3.3%) paid
to WYO companies for unallocated loss adjustment expenses is
inadequate--one that has not changed since the inception of the
program. While loss adjustment expenses, as the commenter mentioned,
will on the average be higher for catastrophic events than for smaller
events, the 3.3% contained in the Arrangement is an average percentage
for all loss adjustment scenarios, including catastrophic disasters as
well as moderate and small events where allocated loss expenses are
lower. FEMA has determined that the current 3.3% should be retained in
the current Arrangement. The matter however warrants review, and any
modification to the loss adjustment expense will be considered at the
end of the current Arrangement year.
The commenter also objected to the removal of the adjuster fee
schedule from the Arrangement and recommended that the fee schedule be
modified to reflect higher limits of coverage. FEMA agrees that
additional changes need to be made to the fee
[[Page 37689]]
schedule; however, in the interest of expedition and flexibility, FEMA
believes that any changes to the fee schedule should be made outside
the rule making process in close coordination with the participating
WYO companies. Therefore, the fee schedule has not been included in the
final Arrangement.
This commenter's final recommendation involved offering greater
flexibility in the Arrangement regarding cash management procedures and
oversight. The commenter recommended that Article VII.B. be revised to
read ``The Company shall remit all funds, including interest, not
required to meet current expenditures to the United States Treasury, in
accordance with the provisions of the WYO Accounting Procedures Manual
or procedures approved by the FIA.'' FEMA agrees with that
recommendation provided that FIA's approval of accounting procedures is
in writing. The purpose underlying the revisions in the latest
Arrangement is to streamline the document and to achieve greater
flexibility in managing the program without sacrificing essential
operational and financial controls. We have modified the Arrangement to
reflect the company's recommendation.
A second WYO company objected also to the fixed percentage of 32.6%
of retained premium only when companies achieve their marketing or
production goals and to the limitation of 30.6% when that goal is not
achieved. The company cited its extensive service and outreach programs
to its agents in an effort to achieve the growth goals for the National
Flood Insurance Program. In spite of this effort, the company indicated
that increased competition from the independent agency system has
prevented the company from achieving its goals. FEMA concludes however
that the experience of the WYO program as a whole, with these
percentages in place, has been responsible in large part for the
unprecedented growth of the program. As explained above, the percentage
rates of 30.6% (the minimum amount of premium that a company may
retain) and 32.6% (the amount of premium retained by a company when it
achieves its marketing goals) have been retained in this Arrangement
but will be reviewed by FIA for future Arrangements.
National Environmental Policy Act
This final rule is categorically excluded from the requirements of
44 CFR Part 10, Environmental Consideration. No environmental impact
assessment has been prepared.
Executive Order 12866, Regulatory Planning and Review
This final rule is not a significant regulatory action as defined
under Executive Order 12866 of September 30, 1993, Regulatory Planning
and Review, 58 FR 51735, October 4, 1993. To the extent possible, this
rule adheres to the principles of regulation as set forth in Executive
Order 12866. This rule has not been reviewed by the Office of
Management and Budget under the provisions of Executive Order 12866.
Paperwork Reduction Act
This final rule does not contain a collection of information and is
therefore not subject to the provisions of the Paperwork Reduction Act
of 1995.
Executive Order 12612, Federalism
This final rule involves no policies that have federalism
implications under Executive Order 12612, Federalism, dated October 26,
1987.
Executive Order 12778, Civil Justice Reform
This final rule meets the applicable standards of section 2(b)(2)
of Executive Order 12778.
List of Subjects in 44 CFR Part 62
Claims, Flood insurance.
Accordingly, 44 CFR part 62 is amended as follows:
PART 62--SALE OF INSURANCE AND ADJUSTMENT OF CLAIMS
1. The authority citation for Part 62 continues to read as follows:
Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 43 FR 41943, 3 CFR 1978 Comp., p. 329; E.O. 12127 of Mar. 31,
1979, 44 FR 19367, 3 CFR, 1979 Comp., p. 376.
2. Appendix A of part 62 is revised to read as follows:
Appendix A of Part 62--Federal Emergency Management Agency, Federal
Insurance Administration, Financial Assistance/Subsidy Arrangement
Purpose: To assist the company in underwriting flood insurance
using the Standard Flood Insurance Policy.
Accounting Data: Pursuant to Section 1310 of the Act, a Letter of
Credit shall be issued for payment as provided for herein from the
National Flood Insurance Fund.
Effective Date: October 1, 1996.
Issued By: Federal Emergency Management Agency, Federal Insurance
Administration, Washington, DC 20472.
Article I--Findings, Purpose, and Authority
Whereas, the Congress in its ``Finding and Declaration of Purpose''
in the National Flood Insurance Act of 1968, as amended, (``the Act'')
recognized the benefit of having the National Flood Insurance Program
(the Program) ``carried out to the maximum extent practicable by the
private insurance industry''; and
Whereas, the Federal Insurance Administration (FIA) recognizes this
Arrangement as coming under the provisions of Section 1345 of the Act;
and
Whereas, the goal of the FIA is to develop a program with the
insurance industry where, over time, some risk-bearing role for the
industry will evolve as intended by the Congress (Section 1304 of the
Act); and
Whereas, the insurer (hereinafter the ``Company'') under this
Arrangement shall charge rates established by the FIA; and
Whereas, this Arrangement will subsidize all flood policy losses by
the Company; and
Whereas, this Financial Assistance/Subsidy Arrangement has been
developed to enable any interested qualified insurer to write flood
insurance under its own name; and
Whereas, one of the primary objectives of the Program is to provide
coverage to the maximum number of structures at risk and because the
insurance industry has marketing access through its existing facilities
not directly available to the FIA, it has been concluded that coverage
will be extended to those who would not otherwise be insured under the
Program; and
Whereas, flood insurance policies issued subject to this
Arrangement shall be only that insurance written by the Company in its
own name under prescribed policy conditions and pursuant to this
Arrangement and the Act; and
Whereas, over time, the Program is designed to increase industry
participation, and, accordingly, reduce or eliminate Government as the
principal vehicle for delivering flood insurance to the public; and
Whereas, the direct beneficiaries of this Arrangement will be those
Company policyholders and applicants for flood insurance who otherwise
would not be covered against the peril of flood.
Now, therefore, the parties hereto mutually undertake the
following:
[[Page 37690]]
Article II--Undertakings of the Company
A. In order to be eligible for assistance under this Arrangement
the Company shall be responsible for:
1.0 Policy Administration, including:
1.1 Community Eligibility/Rating Criteria.
1.2 Policyholder Eligibility Determination.
1.3 Policy Issuance.
1.4 Policy Endorsements.
1.5 Policy Cancellations.
1.6 Policy Correspondence.
1.7 Payment of Agents' Commissions.
The receipt, recording, control, timely deposit and disbursement of
funds in connection with all the foregoing, and correspondence relating
to the above in accordance with the Financial Control Plan
requirements.
2.0 Claims processing in accordance with general Company standards
and the Financial Control Plan. Other technical and policy material
published by FEMA and FIA will also provide guidance to the Company.
3.0 Reports.
3.1 Monthly Financial Reporting and Statistical Transaction
Reporting shall be in accordance with the requirements of National
Flood Insurance Program Transaction Record Reporting and Processing
Plan for the Write Your Own (WYO) Program and the Financial Control
Plan for business written under the WYO Program. These data shall be
validated/edited/audited in detail and shall be compared and balanced
against Company financial reports.
3.2 Monthly financial reporting shall be prepared in accordance
with the WYO Accounting Procedures.
B. The Company shall use the following time standards of
performance as a guide:
1.0 Application Processing--15 days (Note: If the policy cannot be
mailed due to insufficient or erroneous information or insufficient
funds, a request for correction or added monies shall be mailed within
10 days);
1.1 Renewal Processing--7 days;
1.2 Endorsement Processing--15 days;
1.3 Cancellation Processing--15 days;
1.4 Claims Draft Processing--7 days from completion of file
examination;
1.5 Claims Adjustment--45 days average from receipt of Notice of
Loss (or equivalent) through completion of examination.
1.6 For the elements of work enumerated above, the elapsed time
shown is from the date of receipt through the date of mail out. Days
means working days, not calendar days.
In addition to the standards for timely performance set forth
above, all functions performed by the Company shall be in accordance
with the highest reasonably attainable quality standards generally
utilized in the insurance and data processing industries.
These standards are for guidance. Although no immediate remedy for
failure to meet them is provided under this Arrangement, nevertheless,
performance under these standards and the marketing guidelines provided
for in Section G. below can be a factor considered by the Federal
Insurance Administrator (the Administrator) in requiring corrective
action by the Company, in determining the continuing participation of
the Company in the Program, or in taking other action, e.g., limiting
the Company's authority to write new business.
C. To ensure maximum responsiveness to the National Flood Insurance
Program's (NFIP) policyholders following a catastrophic event, e.g., a
hurricane, involving insured wind and flood damage to policyholders,
the Company shall agree to the adjustment of the combined flood and
wind losses utilizing one adjuster under an NFIP-approved Single
Adjuster Program in the following cases and under procedures issued by
the Administrator:
1.0 Where the flood and wind coverage is provided by the Company;
2.0 Where the flood coverage is provided by the Company and the
wind coverage is provided by a participating State Property Insurance
Plan, Windpool Association, Beach Plan, Joint Underwriting Association,
FAIR Plan, or similar property insurance mechanism; and
3.0 Where the flood coverage is provided by the Company and the
wind coverage is provided by another property insurer and the State
Insurance Regulator has determined that such property insurer shall, in
the interest of consumers, facilitate the adjustment of its wind loss
by the adjuster engaged to adjust the flood loss of the Company.
D. Policy Issuance.
1.0 The flood insurance subject to this Arrangement shall be only
that insurance written by the Company in its own name pursuant to the
Act.
2.0 The Company shall issue policies under the regulations
prescribed by the Administrator in accordance with the Act;
3.0 All such policies of insurance shall conform to the
regulations prescribed by the Administrator pursuant to the Act, and be
issued on a form approved by the Administrator;
4.0 All policies shall be issued in consideration of such premiums
and upon such terms and conditions and in such States or areas or
subdivisions thereof as may be designated by the Administrator and only
where the Company is licensed by State law to engage in the property
insurance business;
5.0 The Administrator may require the Company to discontinue
issuing policies subject to this Arrangement immediately in the event
Congressional authorization or appropriation for the National Flood
Insurance Program is withdrawn.
E. The Company shall separate Federal flood insurance funds from
all other Company accounts, at a bank or banks of its choosing for the
collection, retention and disbursement of Federal funds relating to its
obligation under this Arrangement, less the Company's expenses as set
forth in Article III, and the operation of the Letter of Credit
established pursuant to Article IV. All funds not required to meet
current expenditures shall be remitted to the United States Treasury,
in accordance with the provisions of the WYO Accounting Procedures
Manual.
F. The Company shall investigate, adjust, settle and defend all
claims or losses arising from policies issued under this Arrangement.
Payment of flood insurance claims by the Company shall be binding upon
the FIA.
G. The Company shall market flood insurance policies in a manner
consistent with the marketing guidelines established by the Federal
Insurance Administration.
Article III--Loss Costs, Expenses, Expense Reimbursement, and Premium
Refunds
A. The Company shall be liable for operating, administrative and
production expenses, including any State premium taxes, dividends,
agent's commissions or any other expense of whatever nature incurred by
the Company in the performance of its obligations under this
Arrangement but excluding surcharges on flood insurance premium and
guaranty fund assessments.
B. The Company shall be entitled to withhold, on a provisional
basis, as operating and administrative expenses, including agents' or
brokers' commissions, an amount from the Company's written premium on
the policies covered by this Arrangement in reimbursement of all of the
Company's marketing, operating and administrative
[[Page 37691]]
expenses, except for allocated and unallocated loss adjustment expenses
described in Section C. of this Article, which amount shall be 32.6% of
the Company's written premium on the policies covered by this
Arrangement. The final amount retained by the Company shall be
determined by an increase or decrease depending on the extent to which
the Company meets the marketing goals for the 1996-1997 Arrangement
year contained in marketing guidelines established pursuant to Article
II. G.
The adjustment in the amount retained by the Company shall be made
after the end of the 1996-1997 Arrangement year. Any decrease from
32.6% made as a result of a Company not meeting its marketing goals
shall be directly related to the extent to which the Company's goal was
not achieved, but shall not exceed two (2) percentage points (providing
for a minimum of 30.6%).
The increase, which shall be distributed among the Companies
exceeding their marketing goals, shall be drawn from a pool composed of
the difference between 32.6% of all WYO Companies' written premium in
Arrangement year 1996-1997 and the total amount, prior to the increase,
provided to the Companies on the basis of the extent to which they have
met their marketing goals. A distribution formula will be developed and
distributed to WYO Companies that will consider the extent to which the
Company has exceeded its goal and the size of the Company's book of
business in relation to the total number of WYO policies. The amount of
any increase shall be paid promptly to the Company after the end of the
1996-1997 Arrangement year.
The Company, with the consent of the Administrator as to terms and
costs, shall be entitled to utilize the services of a national rating
organization, licensed under state law, to assist the FIA in
undertaking and carrying out such studies and investigations on a
community or individual risk basis, and in determining more equitable
and accurate estimates of flood insurance risk premium rates as
authorized under the National Flood Insurance Act of 1968, as amended.
The Company shall be reimbursed in accordance with the provisions of
the WYO Accounting Procedures Manual for the charges or fees for such
services.
C. Loss Adjustment Expenses shall be reimbursed as follows:
1. Unallocated loss adjustment shall be an expense reimbursement of
3.3% of the incurred loss (except that it does not include ``incurred
but not reported'').
2. Allocated loss adjustment expense shall be reimbursed to the
Company pursuant to a ``Fee Schedule'' coordinated with the Company and
provided by the Administrator.
3. Special allocated loss expenses shall be reimbursed to the
Company in accordance with guidelines issued by the Administrator.
D.1. Loss payments under policies of flood insurance shall be made
by the Company from funds retained in the bank account(s) established
under Article II, Section E and, if such funds are depleted, from funds
derived by drawing against the Letter of Credit established pursuant to
Article IV.
2. Loss payments will include payments as a result of awards or
judgments for damages arising under the scope of this Arrangement,
policies of flood insurance issued pursuant to this Arrangement, and
the claims processing standards and guides set forth at Article II,
Section A, 2.0 of this Arrangement. Prompt notice of any claim for
damages as to claims processing or other matters arising outside the
scope of this section (D)(2) shall be sent to the Administrator along
with a copy of any material pertinent to the claim for damages arising
outside of the scope of the matters set forth in this section (D)(2).
Following receipt of notice of such claim, the General Counsel
(OGC), FEMA, shall review the cause and make a recommendation to FIA as
to whether the claim is grounded in actions by the Company that are
significantly outside the provisions of this section (D)(2). After
reviewing the General Counsel's recommendation, the Administrator will
make his/her decision and the Company will be notified, in writing,
within thirty (30) days of the General Counsel's recommendation, if the
decision is that any award or judgment for damages arising out of such
actions will not be recognized under Article III of this Arrangement as
a reimbursable loss cost, expense or expense reimbursement. In the
event that the Company wishes to petition for reconsideration of the
notification that it will not be reimbursed for the award or judgment
made under the above circumstances, it may do so by mailing, within
thirty days of the notice declining to recognize any such award or
judgment as reimbursable under Article III, a written petition to the
Chairman of the WYO Standards Committee established under the Financial
Control Plan. The WYO Standards Committee will, then, consider the
petition at its next regularly scheduled meeting or at a special
meeting called for that purpose by the Chairman and issue a written
recommendation to the Administrator, within thirty days of the meeting.
The Administrator's final determination will be made, in writing, to
the Company within thirty days of the recommendation made by the WYO
Standards Committee.
E. Premium refunds to applicants and policyholders required
pursuant to rules contained in the National Flood Insurance Program
(NFIP) ``Flood Insurance Manual'' shall be made by the Company from
Federal flood insurance funds referred to in Article II, Section E.
and, if such funds are depleted, from funds derived by drawing against
the Letter of Credit established pursuant to Article IV.
Article IV--Undertakings of the Government
A. Letter(s) of Credit shall be established by the Federal
Emergency Management Agency (FEMA) against which the Company may
withdraw funds daily, if needed, pursuant to prescribed procedures
implemented by FEMA. The amounts of the authorizations will be
increased as necessary to meet the obligations of the Company under
Article III, Sections C, D, and E. Request for funds shall be made only
when net premium income has been depleted. The timing and amount of
cash advances shall be as close as is administratively feasible to the
actual disbursements by the recipient organization for allowable Letter
of Credit expenses.
Request for payment on Letters of Credit shall not ordinarily be
drawn more frequently than daily nor in amounts less than $5,000, and
in no case more than $5,000,000 unless so stated on the Letter of
Credit. This Letter of Credit may be drawn by the Company for any of
the following reasons:
1. Payment of claim as described in Article III, Section D;
2. Refunds to applicants and policyholders for insurance premium
overpayment, or if the application for insurance is rejected or when
cancellation or endorsement of a policy results in a premium refund as
described in Article III, Section E; and
3. Allocated and unallocated Loss Adjustment Expenses as described
in Article III, Section C.
B. The FIA shall provide technical assistance to the Company as
follows:
1. The FIA's policy and history concerning underwriting and claims
handling.
2. A mechanism to assist in clarification of coverage and claims
questions.
3. Other assistance as needed.
[[Page 37692]]
Article V--Commencement and Termination
A. Upon signature of authorized officials for both the Company and
the FIA, this Arrangement shall be effective for the period October 1
through September 30. The FIA shall provide financial assistance only
for policy applications and endorsements accepted by the Company during
this period pursuant to the Program's effective date, underwriting and
eligibility rules.
B. By June 1, of each year, the FIA shall publish in the Federal
Register and make available to the Company the terms for the re-
subscription of this Financial Assistance/Subsidy Arrangement. In the
event the Company chooses not to re-subscribe, it shall notify the FIA
to that effect by the following July 1.
C. In the event the Company elects not to participate in the
Program in any subsequent fiscal year, or the FIA chooses not to renew
the Company's participation, the FIA, at its option, may require (1)
the continued performance of this entire Arrangement for a period not
to exceed one (1) year following the original term of this Arrangement,
or any renewal thereof, or (2) the transfer to the FIA of:
1. All data received, produced, and maintained through the life of
the Company's participation in the Program, including certain data, as
determined by FIA, in a standard format and medium; and
2. A plan for the orderly transfer to the FIA of any continuing
responsibilities in administering the policies issued by the Company
under the Program including provisions for coordination assistance; and
3. All claims and policy files, including those pertaining to
receipts and disbursements that have occurred during the life of each
policy. In the event of a transfer of the services provided, the
Company shall provide the FIA with a report showing, on a policy basis,
any amounts due from or payable to insureds, agents, brokers, and
others as of the transition date.
D. Financial assistance under this Arrangement may be cancelled by
the FIA in its entirety upon 30 days written notice to the Company by
certified mail stating one of the following reasons for such
cancellation: (1) Fraud or misrepresentation by the Company subsequent
to the inception of the contract, or (2) nonpayment to the FIA of any
amount due the FIA. Under these very specific conditions, the FIA may
require the transfer of data as shown in Section C., above. If transfer
is required, the unearned expenses retained by the Company shall be
remitted to the FIA. In such event the Government will assume all
obligations and liabilities owed to policyholders under such policies
arising before and after the date of transfer.
E. In the event the Act is amended, or repealed, or expires, or if
the FIA is otherwise without authority to continue the Program,
financial assistance under this Arrangement may be cancelled for any
new or renewal business, but the Arrangement shall continue for
policies in force that shall be allowed to run their term under the
Arrangement.
F. In the event that the Company is unable to, or otherwise fails
to, carry out its obligations under this Arrangement by reason of any
order or directive duly issued by the Department of Insurance of any
Jurisdiction to which the Company is subject, the Company agrees to
transfer, and the Government will accept, any and all WYO policies
issued by the Company and in force as of the date of such inability or
failure to perform. In such event the Government will assume all
obligations and liabilities owed to policyholders under such policies
arising before and after the date of transfer and the Company will
immediately transfer to the Government all funds in its possession with
respect to all such policies transferred and the unearned portion of
the Company expenses for operating, administrative and loss adjustment
on all such policies.
Article VI--Information and Annual Statements
The Company shall furnish to FEMA such summaries and analyses of
information including claim file information in its records as may be
necessary to carry out the purposes of the National Flood Insurance Act
of 1968, as amended, in such form as the FIA, in cooperation with the
Company, shall prescribe. The Company shall be a property/casualty
insurer domiciled in a State or territory of the United States. Upon
request, the Company shall file with the FIA a true and correct copy of
the Company's Fire and Casualty Annual Statement, and Insurance Expense
Exhibit or amendments thereof, as filed with the State Insurance
Authority of the Company's domiciliary State.
Article VII--Cash Management and Accounting
A. FEMA shall make available to the Company during the entire term
of this Arrangement and any continuation period required by FIA
pursuant to Article V, Section C., the Letter of Credit provided for in
Article IV drawn on a repository bank within the Federal Reserve System
upon which the Company may draw for reimbursement of its expenses as
set forth in Article IV that exceed net written premiums collected by
the Company from the effective date of this Arrangement or continuation
period to the date of the draw.
B. The Company shall remit all funds, including interest, not
required to meet current expenditures to the United States Treasury, in
accordance with the provisions of the WYO Accounting Procedures Manual
or procedures approved in writing by the FIA.
C. In the event the Company elects not to participate in the
Program in any subsequent fiscal year, the Company and FIA shall make a
provisional settlement of all amounts due or owing within three months
of the termination of this Arrangement. This settlement shall include
net premiums collected, funds drawn on the Letter of Credit, and
reserves for outstanding claims. The Company and FIA agree to make a
final settlement of accounts for all obligations arising from this
Arrangement within 18 months of its expiration or termination, except
for contingent liabilities that shall be listed by the Company. At the
time of final settlement, the balance, if any, due the FIA or the
Company shall be remitted by the other immediately and the operating
year under this Arrangement shall be closed.
Article VIII--Arbitration
A. If any misunderstanding or dispute arises between the Company
and the FIA with reference to any factual issue under any provisions of
this Arrangement or with respect to the FIA's non-renewal of the
Company's participation, other than as to legal liability under or
interpretation of the standard flood insurance policy, such
misunderstanding or dispute may be submitted to arbitration for a
determination that shall be binding upon approval by the FIA. The
Company and the FIA may agree on and appoint an arbitrator who shall
investigate the subject of the misunderstanding or dispute and make a
determination. If the Company and the FIA cannot agree on the
appointment of an arbitrator, then two arbitrators shall be appointed,
one to be chosen by the Company and one by the FIA.
The two arbitrators so chosen, if they are unable to reach an
agreement, shall select a third arbitrator who shall act as umpire, and
such umpire's determination shall become final only upon approval by
the FIA.
The Company and the FIA shall bear in equal shares all expenses of
the arbitration. Findings, proposed awards,
[[Page 37693]]
and determinations resulting from arbitration proceedings carried out
under this section, upon objection by FIA or the Company, shall be
inadmissible as evidence in any subsequent proceedings in any court of
competent jurisdiction.
This Article shall indefinitely succeed the term of this
Arrangement.
Article IX--Errors and Omissions
The parties shall not be liable to each other for damages caused by
ordinary negligence arising out of any transaction or other performance
under this Arrangement, nor for any inadvertent delay, error, or
omission made in connection with any transaction under this
Arrangement, provided that such delay, error, or omission is rectified
by the responsible party as soon as possible after discovery.
However, in the event that the Company has made a claim payment to
an insured without including a mortgagee (or trustee) of which the
Company had actual notice prior to making payment, and subsequently
determines that the mortgagee (or trustee) is also entitled to any part
of said claim payment, any additional payment shall not be paid by the
Company from any portion of the premium and any funds derived from any
Federal Letter of Credit deposited in the bank account described in
Article II, section E. In addition, the Company agrees to hold the
Federal Government harmless against any claim asserted against the
Federal Government by any such mortgagee (or trustee), as described in
the preceding sentence, by reason of any claim payment made to any
insured under the circumstances described above.
Article X--Officials Not to Benefit
No Member or Delegate to Congress, or Resident Commissioner, shall
be admitted to any share or part of this Arrangement, or to any benefit
that may arise therefrom; but this provision shall not be construed to
extend to this Arrangement if made with a corporation for its general
benefit.
Article XI--Offset
At the settlement of accounts the Company and the FIA shall have,
and may exercise, the right to offset any balance or balances, whether
on account of premiums, commissions, losses, loss adjustment expenses,
salvage, or otherwise due one party to the other, its successors or
assigns, hereunder or under any other Arrangements heretofore or
hereafter entered into between the Company and the FIA. This right of
offset shall not be affected or diminished because of insolvency of the
Company.
All debts or credits of the same class, whether liquidated or
unliquidated, in favor of or against either party to this Arrangement
on the date of entry, or any order of conservation, receivership, or
liquidation, shall be deemed to be mutual debts and credits and shall
be offset with the balance only to be allowed or paid. No offset shall
be allowed where a conservator, receiver, or liquidator has been
appointed and where an obligation was purchased by or transferred to a
party hereunder to be used as an offset.
Although a claim on the part of either party against the other may
be unliquidated or undetermined in amount on the date of the entry of
the order, such claim will be regarded as being in existence as of the
date of such order and any credits or claims of the same class then in
existence and held by the other party may be offset against it.
Article XII--Equal Opportunity
The Company shall not discriminate against any applicant for
insurance because of race, color, religion, sex, age, handicap, marital
status, or national origin.
Article XIII--Restriction on Other Flood Insurance
As a condition of entering into this Arrangement, the Company
agrees that in any area in which the Administrator authorizes the
purchase of flood insurance pursuant to the Program, all flood
insurance offered and sold by the Company to persons eligible to buy
pursuant to the Program for coverages available under the Program shall
be written pursuant to this Arrangement.
However, this restriction applies solely to policies providing only
flood insurance. It does not apply to policies provided by the Company
of which flood is one of the several perils covered, or where the flood
insurance coverage amount is over and above the limits of liability
available to the insured under the Program.
Article XIV--Access to Books and Records
The FIA and the Comptroller General of the United States, or their
duly authorized representatives, for the purpose of investigation,
audit, and examination shall have access to any books, documents,
papers and records of the Company that are pertinent to this
Arrangement. The Company shall keep records that fully disclose all
matters pertinent to this Arrangement, including premiums and claims
paid or payable under policies issued pursuant to this Arrangement.
Records of accounts and records relating to financial assistance
shall be retained and available for three (3) years after final
settlement of accounts, and to financial assistance, three (3) years
after final adjustment of such claims. The FIA shall have access to
policyholder and claim records at all times for purposes of the review,
defense, examination, adjustment, or investigation of any claim under a
flood insurance policy subject to this Arrangement.
Article XV--Compliance With Act and Regulations
This Arrangement and all policies of insurance issued pursuant
thereto shall be subject to the provisions of the National Flood
Insurance Act of 1968, as amended, the Flood Disaster Protection Act of
1973, as amended, the National Flood Insurance Reform Act of 1994, and
Regulations issued pursuant thereto and all Regulations affecting the
work that are issued pursuant thereto, during the term hereof.
Article XVI--Relationship Between the Parties (Federal Government
and Company) and the Insured
Inasmuch as the Federal Government is a guarantor hereunder, the
primary relationship between the Company and the Federal Government is
one of a fiduciary nature, i.e., to assure that any taxpayer funds are
accounted for and appropriately expended.
The Company is not the agent of the Federal Government. The Company
is solely responsible for its obligations to its insured under any
flood policy issued pursuant hereto.
(Catalog of Federal Domestic Assistance No. 83.100, ``Flood
Insurance'').
Dated: July 12, 1996.
Harvey G. Ryland,
Deputy Director.
[FR Doc. 96-18352 Filed 7-18-96; 8:45 am]
BILLING CODE 6718-03-P
Complete official Federal Register PDF
FR Doc. 96-18350 Implantation or Injectable Dosage Form New Animal Drugs; Gonadorelin Diacetate Tetrahydrate Injection
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Page 37682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18350]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Gonadorelin Diacetate Tetrahydrate Injection
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 Intervet, Inc. The ANADA provides for
intramuscular and intravenous use of a sterile injectable solution of
gonadorelin diacetate tetrahydrate for treating ovarian cysts in female
dairy cattle of breeding age.
EFFECTIVE DATE: July 19, 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: Intervet, Inc., 405 State St., P.O. Box 318,
Millsboro, DE 19966-0318, filed ANADA 200-134, which provides for
intramuscular and intravenous use of Fertagyl (gonadorelin
diacetate tetrahydrate injection) for treatment of ovarian cysts in
female dairy cattle of breeding age.
Approval of ANADA 200-134 is as a generic copy of Rhone Merieux's
NADA 98-379 for Cystorelin (gonadorelin diacetate
tetrahydrate injection). The ANADA is approved as of June 17, 1996, and
the regulations are amended by revising 21 CFR 522.1078(b) 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, 12420
Parklawn Dr., rm. 1-23, 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 522
Animal drugs.
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 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
-Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 522.1078 [Amended]
2. Section 522.1078 Gonadorelin diacetate tetrahydrate injection is
amended in paragraph (b) by removing ``No. 050604'' and adding in its
place ``Nos. 050604 and 057926''.
Dated: July 11, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-18350 Filed 7-18-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-18343 Removal of Form I-151, Alien Registration Receipt Card, From the Listing of Forms Recognized as Evidence of Registration for Lawful Permanent Resident Aliens
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37673-37675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18343]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Immigration and Naturalization Service
8 CFR Part 264
[INS No. 1686-95]
RIN 1115-AD87
Removal of Form I-151, Alien Registration Receipt Card, From the
Listing of Forms Recognized as Evidence of Registration for Lawful
Permanent Resident Aliens
AGENCY: Immigration and Naturalization Service, Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule amends the regulations of the Immigration and
Naturalization Service (INS) by removing Form I-151, Alien Registration
Receipt Card, from the
[[Page 37674]]
listing of forms recognized as evidence of registration as a lawful
permanent resident alien. This rule is necessary to complete the
establishment of the current Alien Registration Receipt Card, Form I-
551, as the exclusive registration card authorized for use by permanent
resident aliens.
EFFECTIVE DATE: August 19, 1996.
FOR FURTHER INFORMATION CONTACT:
Gerard Casale, Senior Adjudications Officer, Immigration and
Naturalization Service, Room 3214, 425 I Street NW., Washington, DC
20536, telephone (202) 514-5014.
SUPPLEMENTARY INFORMATION:
Background
Section 264(d) of the Immigration and Nationality Act (the Act)
provides that every immigrant alien required to register under section
262 of the Act ``shall be issued a certificate of alien registration or
an alien registration receipt card in such form and manner and at such
time as shall be prescribed under regulations issued by the Attorney
General.'' Regulations on this subject, issued under the Attorney
General's authority by the INS, are contained in 8 CFR part 264. In
particular, 8 CFR 264.1(a) lists the forms prescribed by the Service
for the registration of aliens under the Act.
On September 20, 1993, the INS published a final rule in the
Federal Register at 58 FR 48775-48780, which provided that the current
Form I-551 Alien Registration Receipt Card would be established as the
exclusive form of registration for lawful permanent resident aliens, by
terminating the validity of the old Form I-151, Alien Registration
Receipt Card. The reasons for terminating the validity of the Form I-
151 card were discussed in a previous notice of proposed rulemaking
published on May 28, 1993, at 58 FR 31000-31003. The final rulemaking
published on September 20, 1993, also addressed the public comments
which had been solicited on that subject. The INS concluded that, since
it was no longer sound public policy to recognize Alien Registration
Receipt Cards which predate the current Form I-551, the Form I-551 card
must be established as the exclusive Alien Registration Receipt Card.
The rule provided for removal of Form I-151 from 8 CFR parts 204, 211,
223, 223a, 235, 251, 252, 274a, 299, 316, and 334, effective September
20, 1994. It also amended 8 CFR part 264 to provide procedures,
effective October 20, 1993, by which bearers of the old Form I-151 card
can apply to replace it with the current Form I-551 card.
On September 14, 1994, the INS published a final rule (see 59 FR
47063) that delayed the effective date of the amendments to 8 CFR parts
204, 211, 223, 235, 251, 252, 274a, 299, 316, and 334, from September
20, 1994, until March 20, 1995. Subsequently, the INS published another
final rule on March 17, 1995 (see 60 FR 14353), which again deferred
the effective date of those changes to March 20, 1996.
It later came to the attention of the INS that the intended removal
of Form I-151 from the list of forms prescribed in 8 CFR 264.1(b) as
evidence of registration for resident aliens had been inadvertently
omitted from the previous rulemaking process. Therefore a proposed rule
published on May 24, 1995, at 60 FR 27441-27442, provided for the
removal of the Form I-151 card from that list. The effective date of
removal originally was set for March 20, 1996, the same date on which
the other remaining references to Form I-151 as a valid registration
card were terminated under the final rule published March 17, 1995.
Interested persons were invited to submit written comments on or before
July 24, 1995.
The Service received one written comment regarding the proposed
rule. Since the closing of the period for public comment, no new
factors have impacted the issues raised and discussed in the proposed
rule. The following discussion summarizes the Service's conclusions,
including issues raised by the commenter.
Removal of Form I-151 From the List of Prescribed Service Forms
The previous rule published on September 20, 1993, provided for
removal of the Form I-151 Alien Registration Receipt Card from the list
of prescribed INS forms in 8 CFR part 299. In addition, this rule
removes Form I-151 from a similar listing in 8 CFR 264.1, relating to
forms recognized as evidence of registration for lawful permanent
residence. It completes the establishment of the current Form I-551
card as the exclusive registration document for lawful permanent
residents, a declared policy objective since the first Form I-151 card
replacement program was published in the Federal Register in June 1992.
Returning Immigrants Not in Possession of Valid Form I-551 Cards
In order to effectively establish the current Form I-551 card as
the exclusive registration document for permanent resident aliens, the
previously cited final rule of September 20, 1993, provided that the
old Form I-151 card would no longer be a valid document. In particular,
8 CFR 211.1, 211.3, 211.5, and 235.9 were amended to remove references
to the Form I-151 as a valid document for admission to the United
States at Ports-of-Entry. These changes were twice published in the
Federal Register: once in the proposed rule dated May 28, 1993, and
again in the final rule dated September 20,1 993, cited above. Although
public comments regarding various provisions of the proposed rule were
received, none raised an objection regarding the amendments to 8 CFR
parts 211 and 235.
In response to the present rule, the single commenter expressed
concern that on the date when the old Form I-151 would cease to be a
valid entry document for the purposes of admission to the United States
there would be some bearers of Form I-151 card outside the United
States, unaware that the validity of the card had terminated. He
proposed that air carriers that return such aliens to the United States
be exempted from the administrative fines which section 273 of the Act
prescribes for transportation companies that bring immigrants who are
not in possession of a valid immigrant visa. The commenter's discussion
on this point is not timely. The rule which amended the documentary
requirements of 8 CFR 211.1(b) to require returning permanent resident
aliens to present a valid Form I-551 Alien Registration Receipt Card at
a Port-of-Entry became final more than 2 years ago, on September 20,
1993. As previously stated, no objections were raised during the public
comment period preceding adoption of that rule.
In meritorious cases of permanent resident aliens who arrive at a
Port-of-Entry with an expired Form I-151 card, the Act and INS
regulations allow the INS to grant discretionary relief. 8 CFR
211.1(b)(3) provides that an immigrant returning to an unrelinquished
lawful permanent residence who can satisfy the district director in
charge of the Port-of-Entry that there is good cause for his or her
failure to present a valid Form I-551 Alien Registration Receipt Card
may be granted a waiver of that requirement upon the filing of either a
Form I-193 visa waiver application or a Form I-90 card replacement
application. Moreover, section 273(e)(2) of the Act grants the INS
authority to waive a carrier's liability for transporting such an
alien, provided it has determined that the circumstances justify such a
waiver.
An INS policy memorandum HQ 70/28-P/HQ 70/11.1-P, dated March 19,
1996, provided that the implementation of the final rule terminating
the validity of the Form I-151 card was deferred to
[[Page 37675]]
April 20, 1996. The memorandum also provides transitional procedures
for the processing of returning lawful permanent residents in
possession of Form I-151 who apply for admission to the United States
at Ports-of-Entry after March 20, 1996. Pursuant to that memorandum and
until further notice, lawful permanent resident aliens who present a
Form I-151 card, have not made a prior entry since March 20, 1996, and
are found to be otherwise admissible to the United States will be
admitted and furnished with instructions for the filing of a Form I-90,
Application for Replacement Alien Registration Card, and/or
instructions regarding the documentation necessary to apply for any
subsequent readmission to the United States. The memorandum further
provides that, until further notice, the INS Port-of-Entry will not
recommend fines under section 273 of the Act against carriers that
transport lawful permanent resident aliens bearing Form I-151 cards.
Regualtory Flexibility Act
The Commissioner of the Immigration and Naturalization Service, in
accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has
reviewed this regulation and, by approving it, certifies that the rule
will not have a significant adverse economic impact on a substantial
number of small entities because of the following factors. The
provisions of this rule merely clarify the requirements of existing
regulations regarding the documentation of lawful permanent resident
aliens. Therefore, the new provisions will have no significant adverse
economic impact on the small entities.
Executive Order 12866
This rule is not considered by the Department of Justice,
Immigration and Naturalization Service, to be a ``significant
regulatory action'' under Executive Order 12866, section 3(f),
Regulatory Planning and Review, and the Office of Management and Budget
has waived its review process under section 6(a)(3)(A).
Executive Order 12612
The regulations proposed herein will not have substantial direct
effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this rule
does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
List of Subjects in 8 CFR Part 264
Aliens, Immigration, Reporting and recordkeeping requirements.
Accordingly, part 264 of chapter I of Title 8 of the Code of
Federal Regulations is amended as follows:
PART 264--REGISTRATION AND FINGERPRINTING OF ALIENS IN THE UNITED
STATES
1. The authority citation for part 264 continues to read as
follows:
Authority: 8 U.S.C. 1103, 1201, 1201a, 1301-1305.
Sec. 264.1 [Amended]
2. In Sec. 264.1, paragraph (b) is amended by removing the Form
Number and Class Reference to Form ``I-151'' from the listing of forms.
Dated: May 29, 1996.
Doris Meissner,
Commissioner, Immigration and Naturalization Service.
[FR Doc. 96-18343 Filed 7-18-96; 8:45 am]
BILLING CODE 4410-10-M
Complete official Federal Register PDF
FR Doc. 96-18337 Application Procedures, Execution and Filing of Forms: Correction of State Office Addresses for Filings and Recordings, Proper Offices for Recording of Mining Claims
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37686-37687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18337]
=======================================================================
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DEPARTMENT OF THE INTERIOR
Bureau of Land Management
43 CFR Part 1820
[WO-420-4191-02-24 1A]
RIN 1004-AC41
Application Procedures, Execution and Filing of Forms: Correction
of State Office Addresses for Filings and Recordings, Proper Offices
for Recording of Mining Claims
AGENCY: Bureau of Land Management, Interior.
ACTION: Final rule.
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SUMMARY: This administrative final rule amends the regulations
pertaining to execution and filing of forms in order to reflect the new
address of the California State Office of the Bureau of Land Management
(BLM), which moved in June 1996. All filings and other documents
relating to public lands in California must be filed at the new address
of the State Office.
EFFECTIVE DATE: July 19, 1996.
FOR FURTHER INFORMATION CONTACT: Ted Hudson, (202) 452-5042.
SUPPLEMENTARY INFORMATION: This administrative final rule reflects the
administrative action of changing the address of the California State
Office of BLM. It changes the address for the filing of documents
relating to public lands in California, but makes no other changes in
filing requirements. Therefore, this amendment is published as a final
rule with the effective date shown above.
Because this final rule is an administrative action to change the
address for one BLM State Office, BLM has determined that it has no
substantive impact on the public. It imposes no costs, and merely
updates a list of addresses included in the Code of Federal Regulations
for the convenience of the public. The Department of the Interior,
therefore, for good cause finds under 5 U.S.C. 553(b)(B) and 553(d)(3)
that notice and public procedure thereon are unnecessary and that this
rule may take effect upon publication.
[[Page 37687]]
Because this final rule is a purely administrative regulatory
action having no effects upon the public or the environment, it has
been determined that the rule is categorically excluded from review
under Section 102(2)(C) of the National Environmental Policy Act (42
U.S.C. 4332(2)(C)).
This rule was not subject to review by the Office of Management and
Budget under Executive Order 12866.
As required by Executive Order 12630, the Department of the
Interior has determined that the rule would not cause a taking of
private property. No private property rights would be affected by a
rule that merely reports address changes for BLM State Offices. The
Department therefore certifies that this proposed rule does not
represent a governmental action capable of interference with
constitutionally protected property rights.
Further, the Department has determined under the Regulatory
Flexibility Act (5 U.S.C. 601, et seq.) that it will not have a
significant economic impact on a substantial number of small entities.
Reporting address changes for BLM State Offices will not have any
economic impact whatsoever.
This rule does not contain information collection requirements that
require approval by the Office of Management and Budget under 44 U.S.C.
3501 et seq.
BLM has determined that this rule is not significant under the
Unfunded Mandates Reform Act of 1995, because it will not result in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100 million or more in any one year.
Further, this rule will not significantly or uniquely affect small
governments.
List of Subjects in 43 CFR Part 1820
Administrative practice and procedure, Application procedures,
Execution and filing of forms, Bureau offices of record.
Under the authority of section 2478 of the Revised Statutes (43
U.S.C. 1201), and 43 U.S.C. 1740, subpart 1821, part 1820, group 1800,
subchapter A, chapter II of title 43 of the Code of Federal Regulations
is amended as set forth below:
PART 1820--APPLICATION PROCEDURES
Subpart 1821--Execution and Filing of Forms
1. The authority citation for part 1820 continues to read as
follows:
Authority: R.S. 2478, 43 U.S.C. 1201; 43 U.S.C. 1740, unless
otherwise noted.
2. Section 1821.2-1(d) is amended by revising the location and
address of the Bureau of Land Management State Office in California to
read:
Sec. 1821.2-1 Office hours; place for filing.
* * * * *
(d) * * *
STATE OFFICE AND AREA OF JURISDICTION
* * * * *
California State Office, 2135 Butano Dr., Sacramento, CA 95825-
0451--California
* * * * *
Dated: July 2, 1996.
Sylvia V. Baca,
Deputy Assistant Secretary of the Interior.
[FR Doc. 96-18337 Filed 7-18-96; 8:45 am]
BILLING CODE 4310-84-P
Complete official Federal Register PDF
FR Doc. 96-18330 Safety Zone: Cuyahoga River, Cleveland, OH
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37683-37685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18330]
=======================================================================
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[[Page 37684]]
DEPARTMENT OF TRANSPORTATION
Coast Guard
33 CFR Part 165
[CGD09-95-018]
RIN 2115-AA97
Safety Zone: Cuyahoga River, Cleveland, OH
AGENCY: Coast Guard, DOT.
ACTION: Final rule.
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SUMMARY: The Coast Guard is establishing a new permanent safety zone
near the mouth of the Cuyahoga River in Cleveland, Ohio. The new safety
zone is to prevent the mooring of boats in the area from the Conrail
No. 1 railroad bridge south for six hundred feet to the end of the lot
adjacent to Fagan's Restaurant. This safety zone is required to prevent
the operators of recreational vessels patronizing the entertainment
industries in the river from rafting their boats outward into the
federally maintained navigation channel, and thus impeding the safe
passage of commercial shipping.
EFFECTIVE DATE: This rule is effective on August 19, 1996.
ADDRESSES: Unless otherwise indicated, documents referenced in this
preamble are available for inspection or copying at Coast Guard Marine
Safety Office, 1055 E. Ninth Street, Cleveland, OH.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Nathan Knapp, Project Officer and Chief of Port Operations,
Captain of the Port Cleveland, 1055 E. Ninth Street, Cleveland, Ohio,
44114, (216) 522-4405.
SUPPLEMENTARY INFORMATION:
Background and Purpose
The section of the Cuyahoga River in which this safety zone is
located is heavily used by both large commercial vessels and small
recreational vessels. Use of the river by large commercial vessels
continues to increase rising from 770 transits in 1982 to 1,264
transits in 1987, to 1,624 transits in 1994. At the same time,
businesses along the river continue to attract an increasing number of
recreational vessels. Large numbers of recreational vessels raft
together into the river near the many entertainment establishments and
restaurants, thereby creating a hazard to themselves and to the large
commercial vessels which also use this waterway, and creating an
obstruction to the use of the river as a navigable channel.
In 1987, a serious collision between a commercial vessel and a
recreational vessel highlighted the need to establish some rules for
the protection of safe navigation in this increasingly congested
waterway. After some experimentation with temporary safety zones and an
extensive process of comment and consultation with the public,
including a public hearing and a study by a local workgroup made up of
representatives of both the commercial and recreational interests in
the local area, along with representatives of the City of Cleveland and
the State of Ohio, the Coast Guard established a set of ten permanent
safety zones under the standing regulation at 33 CFR 165.903 (54 FR
9776, March 8, 1989).
Since that time, the safety zones have been effective in protecting
the safety of navigation without causing hardship to the local
businesses along the river which serve customers from recreational
vessels. However, continuing commercial development and use of the area
has led to the same problem of recreational vessels rafted out into the
channel and obstructing navigation in a location near the mouth of the
river, around Fagan's Restaurant not covered by a safety zone. The ten
foot zone prevents recreational vessels from mooring to the bulkheads.
Using the same process of informal consultation with local interests
and civil groups which contributed to the consideration of the prior
regulations, the local Coast Guard Captain of the Port in Cleveland,
Ohio, invited comments from an autonomous ad hoc working group, the
Cuyahoga River Task Force 1995, which included representatives of the
Flats Oxbow Association, a local civic group representing businesses in
the area. The consensus of the Cuyahoga River Task Force 1995 was that
congestion of recreational vessels experienced around the mouth of the
river called for the creation of an additional safety zone, under the
same terms and conditions, including provisions for conditional waivers
of the restrictions, as the other zones established for other
businesses further up the river.
In 1995, the Coast Guard published a Notice of Proposed Rulemaking
(60 FR 36375) proposing the zone recommended by the task force and
solicited comments from the general public. No comments were received.
Environment
The Coast Guard has considered the environmental impact of this
regulation and concluded that, under section 2.B.2.c of Coast Guard
Commandant Instruction M16475.1B (1994 amendments), it is categorically
excluded from further environmental documentation, and the categorical
exclusion determination is filed in the docket.
Federalism
This action has been analyzed in accordance with the principles and
criteria contained in Executive Order 12612, and it has been determined
that this regulation does not have sufficient federalism implications
to warrant the preparation of a Federalism Assessment.
Regulatory Evaluation
This regulation is considered to be nonsignificant under Executive
Order 12866 on Regulatory Planning and Review and nonsignificant under
Department of Transportation regulatory policies and procedures (44 FR
11034 of February 26, 1979). The economic impact of this regulation is
expected to be so minimal that a full regulatory evaluation is
unnecessary. Small entities that feel this regulation is causing them
to incur economic losses can partition the local Captain of the Port
for a waiver, provided they can prove adequate means of preventing the
rafting of boats at their businesses.
Small Entities
The Coast Guard certifies that this rule will not have a
significant economic impact on a substantial number of small entities.
The previous experience with the other safety zones and the local
procedures worked out by local business for the management of the
recreational vessels along their property in cooperation with the Flats
Oxbow Association and the Coast Guard, demonstrates that the
restrictions imposed for the benefit of safety can be accommodated with
minimal if any effect on the local businesses. These businesses are
primarily accessible from non-maritime avenues and rely on such avenues
for the overwhelming majority of their patronage.
Collection of Information
This regulation will impose no collection of information
requirements under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation (water), Security measures,
Vessels, Waterways.
In consideration of the foregoing the Coast Guard amends part 165
of title 33, Code of Federal Regulations as follows:
PART 165--[AMENDED]
1. The authority citation for Part 165 continues to read as
follows:
[[Page 37685]]
Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1(g),
6.04-1, 6.04-6, and 160.5; and 49 CFR 1.46.
2. In section 165.903, paragraphs (a)(1) through (a)(10) are
redesignated as paragraphs (a)(2) through (a)(11), paragraph (a),
introductory text, is revised, and a new paragraph (a)(1) is added to
read as follows:
Sec. 165.903 Safety Zone: Cuyahoga River and Old River, Cleveland,
Ohio.
(a) Location. The waters of the Cuyahoga River and the Old River
extending ten feet into the river at the following eleven locations,
including the adjacent shorelines, are safety zones, coordinates for
which are based on NAD 83.
(1) From the point where the shoreline intersects longitude
81 deg.42'24.5'' W, which is the southern side of the Conrail No. 1
railroad bridge, southeasterly along the shore for six hundred (600)
feet to the point where the shoreline intersects longitude
81 deg.42'24.5'' W, which is the end of the lot adjacent to Fagan's
Restaurant.
* * * * *
Dated: July 2, 1996.
T.M. Close,
Lieutenant Commander, U.S. Coast Guard, Alternate Captain of the Port,
Cleveland.
[FR Doc. 96-18330 Filed 7-18-96; 8:45 am]
BILLING CODE 4910-14-M
Complete official Federal Register PDF
FR Doc. 96-18305 Groundfish of the Gulf of Alaska; Pacific Ocean Perch in the Central Gulf of Alaska
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Page 37700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18305]
=======================================================================
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 679
[Docket No. 960129018-6018-01; I.D. 071596A]
Groundfish of the Gulf of Alaska; Pacific Ocean Perch in the
Central Gulf of Alaska
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Closure.
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SUMMARY: NMFS is prohibiting retention of Pacific ocean perch in the
Central Regulatory Area of the Gulf of Alaska (GOA). NMFS is requiring
that catches of Pacific ocean perch in this area be treated in the same
manner as prohibited species and discarded at sea with a minimum of
injury. This action is necessary because the Pacific ocean perch total
allowable catch (TAC) in the Central Regulatory Area of the GOA has
been reached.
EFFECTIVE DATE: 1200 hrs, Alaska local time (A.l.t.), July 15, 1996,
until 2400 hrs, A.l.t., December 31, 1996.
FOR FURTHER INFORMATION CONTACT: Mary Furuness, 907-586-7228.
SUPPLEMENTARY INFORMATION: The groundfish fishery in the GOA exclusive
economic zone is managed by NMFS according to the Fishery Management
Plan for Groundfish of the GOA (FMP) prepared by the North Pacific
Fishery Management Council under authority of the Magnuson Fishery
Conservation and Management Act. Fishing by U.S. vessels is governed by
regulations implementing the FMP at subpart H of 50 CFR part 600 and 50
CFR part 679.
The TAC for Pacific ocean perch in the Central Regulatory Area of
the GOA was established by the Final 1996 Harvest Specifications of
Groundfish (61 FR 4304, February 5, 1996), as 3,333 metric tons. (See
Sec. 679.20(c)(3)(ii).)
The Director, Alaska Region, NMFS, has determined that the TAC for
Pacific ocean perch in the Central Regulatory Area of the GOA has been
reached. (See Sec. 679.20(d)(2).) Therefore, NMFS is requiring that
further catches of Pacific ocean perch in the Central Regulatory Area
of the GOA be treated as prohibited species in accordance with
Sec. 679.21(b).
Classification
This action is taken under 50 CFR 679.20 and is exempt from review
under E.O. 12866.
Authority: 16 U.S.C. 1801 et seq.
Dated: July 15, 1996.
Richard W. Surdi,
Acting Director, Office of Fisheries Conservation and Management,
National Marine Fisheries Service.
[FR Doc. 96-18305 Filed 7-15-96; 4:54 pm]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-18294 Airworthiness Directives; Sikorsky Aircraft Model S-76B Helicopters
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37675-37677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18294]
=======================================================================
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 96-SW-16-AD; Amendment 39-9696; AD 96-15-03]
RIN 2120-AA64
Airworthiness Directives; Sikorsky Aircraft Model S-76B
Helicopters
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule; request for comments.
-----------------------------------------------------------------------
SUMMARY: This amendment supersedes an existing Airworthiness Directive
(AD), applicable to Sikorsky Aircraft Model S-76B helicopters, that
requires an inspection of the drive shaft for cracks or loose balance
weights. This amendment also supersedes a Priority Letter AD that
currently requires repetitive inspections for cracks in the driveshaft
in helicopters with certain engine drive shaft assemblies (drive
shafts) installed. This amendment is prompted by a report of a fatigue
crack found in a drive shaft that was caused by fretting of a balance
weight rivet washer. The actions specified by this AD are intended to
prevent failure of the drive shaft, loss of power to the rotor system,
and a subsequent forced landing of the helicopter.
DATES: Effective August 19, 1996.
Comments for inclusion in the Rules Docket must be received on or
before September 17, 1996.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), Office of the Assistant Chief Counsel, Attention:
Rules Docket No. 96-SW-16-AD, 2601 Meacham Blvd., Fort Worth, Texas
76137.
FOR FURTHER INFORMATION CONTACT: Mr. Terry Fahr, Aerospace Engineer,
Boston
[[Page 37676]]
Aircraft Certification Office, FAA, Engine and Propeller Directorate,
12 New England Executive Park, Burlington Massachusetts 01803,
telephone (617) 238-7155, fax (617) 238-7199.
SUPPLEMENTARY INFORMATION: On August 26, 1991, the FAA issued AD 91-19-
02, Amendment 39-8028 (56 FR 47378, September 19, 1991) to require an
initial and repetitive 25-hour interval inspections of the left and
right engine input drive shaft assemblies for loose balance weights or
cracks. On June 4, 1993, the FAA issued priority letter AD 93-11-05,
applicable to Sikorsky Aircraft Model S-76B helicopters, which requires
initial and repetitive inspections of certain engine drive shafts
assemblies for cracks only.
Both AD 91-19-02, issued August 26, 1991, and priority letter AD
93-11-05, issued June 4, 1993, require initial and repetitive
inspections of certain drive shafts assemblies for cracks. AD 91-19-02
also requires an inspection for loose drive shaft balance weights. As a
result of having two ADs that require different corrective actions,
operators may be confused about which corrective actions to perform.
Such confusion may lead an operator to inadvertently fail to comply
with the necessary safety requirements for those rotorcraft and result
in an unsafe condition. Therefore, due to the criticality of
maintaining the inspection of the drive shaft and the short compliance
time, this rule incorporates both corrective actions and must be issued
immediately to correct an unsafe condition.
Since the unsafe condition described is likely to exist or develop
on other Sikorsky Aircraft Model S-76B helicopters of the same type
design, this AD supersedes AD 91-19-02 and priority letter AD 93-11-05
and requires, within the next 6 hours time-in-service (TIS), an initial
inspection of Model S-76B helicopters with certain engine drive shafts;
balance weights or balance weight rivets (rivets); or balance weight
and rivet and washers combinations installed. If a rivet, rivet/washer
combination, or rivet/washer/balance weight combination is installed,
an initial inspection of the drive shaft is required for cracks and
loose balance weights, and thereafter, repetitive inspections every 6
hours TIS.
Since a situation exists that requires the immediate adoption of
this regulation, it is found that notice and opportunity for prior
public comment hereon are impracticable, and that good cause exists for
making this amendment effective in 30 days.
Comments Invited
Although this action is in the form of a final rule that involves
requirements affecting flight safety and, thus, was not preceded by
notice and an opportunity for public comment, comments are invited on
this rule. Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments as they may desire.
Communications should identify the Rules Docket number and be submitted
in triplicate to the address specified under the caption ADDRESSES. All
communications received on or before the closing date for comments will
be considered, and this rule may be amended in light of the comments
received. Factual information that supports the commenter's ideas and
suggestions is extremely helpful in evaluating the effectiveness of the
AD action and determining whether additional rulemaking action would be
needed.
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify the rule. All comments submitted will be
available, both before and after the closing date for comments, in the
Rules Docket for examination by interested persons. A report that
summarizes each FAA-public contact concerned with the substance of this
AD will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments
submitted in response to this rule must submit a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket No. 96-SW-16-AD.'' The postcard will be date stamped and
returned to the commenter.
The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this final
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
The FAA has determined that this regulation is an emergency
regulation that must be issued immediately to correct an unsafe
condition in aircraft, and that it is not a ``significant regulatory
action'' under Executive Order 12866. It has been determined further
that this action involves an emergency regulation under DOT Regulatory
Policies and Procedures (44 FR 11034, February 26, 1979). If it is
determined that this emergency regulation otherwise would be
significant under DOT Regulatory Policies and Procedures, a final
regulatory evaluation will be prepared and placed in the Rules Docket.
A copy of it, if filed, may be obtained from the Rules Docket at the
location provided under the caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Safety.
Adoption of the Amendment
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:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40113, 44701.
Sec. 39.13 [Amended]
2. Section 39.13 is amended by removing Amendment 39-8028 (56 FR
47378, September 19, 1991) and by adding a new airworthiness directive
(AD), Amendment 39-9696, to read as follows:
AD 96-15-03 SIKORSKY AIRCRAFT: Amendment 39-9696. Docket Number 96-
SW-16-AD. Supersedes Priority Letter AD 93-11-05, issued June 4,
1993, and AD 91-19-02, Amendment 39-8028.
Applicability: Sikorsky Aircraft S-76B helicopters, with engine
drive shaft assembly (drive shaft), part number (P/N) 76361-09202-
044, -047, -049, or -051, with either rivet, P/N CR3523P-8-XX, with
a washer or balance weight, or rivet, P/N NAS1738MW6-X, with or
without a washer, installed, certificated in any category.
Note 1: This AD applies to each helicopter 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 helicopters 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 (c) 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 helicopter from the applicability of this AD.
[[Page 37677]]
Compliance: Required as indicated, unless accomplished
previously.
To prevent failure of the drive shaft, loss of power to the
rotor system, and a subsequent forced landing of the helicopter,
accomplish the following:
(a) Within 6 hours TIS after the effective date of this AD,
visually inspect the drive shaft for cracks in the area around each
rivet, using a 10X or higher magnifying glass, and inspect the drive
shaft for loose balance weights.
(1) The inspection for loose balance weights shall be performed
by grasping the balance weights by hand and attempting to move them
in both the radial and axial directions. Any movement of the balance
weights constitutes looseness.
(2) If a crack is found on the drive shaft or any balance weight
is loose, replace the drive shaft with an airworthy drive shaft
before further flight.
(b) Thereafter, inspect for cracks and loose balance weights at
intervals not to exceed 6 hours TIS from the last inspection.
(c) 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, Boston Aircraft Certification
Office, FAA. Operators shall submit their requests through an FAA
Principal Maintenance Inspector, who may concur or comment and then
send it to the Manager, Boston Aircraft Certification Office.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Boston Aircraft Certification Office.
(d) 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 helicopter to a location where
the requirements of this AD can be accomplished.
(e) This amendment becomes effective on August 19, 1996.
Issued in Fort Worth, Texas, on July 11, 1996.
Daniel P. Salvano,
Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 96-18294 Filed 7-18-96; 8:45 am]
BILLING CODE 4910-13-P
Complete official Federal Register PDF
FR Doc. 96-18293 1996 Marketing Quota and Price Support for Flue-Cured Tobacco
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37672-37673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18293]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Farm Service Agency
7 CFR Part 723
Commodity Credit Corporation
7 CFR Part 1464
RIN 0560-AE48
1996 Marketing Quota and Price Support for Flue-Cured Tobacco
AGENCIES: Farm Service Agency and Commodity Credit Corporation, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The purpose of this final rule is to codify determinations
made by the Secretary of Agriculture (Secretary) with respect to the
1996 crop of flue-cured tobacco. In accordance with the Agricultural
Adjustment Act of 1938, as amended, (1938 Act), the Secretary
determined the 1996 marketing quota for flue-cured tobacco to be 873.6
million pounds. In accordance with the Agricultural Act of 1949, as
amended, (1949 Act), the Secretary determined the 1996 price support
level to be 160.1 cents per pound.
EFFECTIVE DATE: December 15, 1995.
FOR FURTHER INFORMATION CONTACT: Robert Tarczy, FSA, USDA, room 5726
South Building, PO. Box 2415, STOP 0514, Washington, DC 20013-2415,
telephone 202-720-5346.
SUPPLEMENTARY INFORMATION:
Executive Order 12866
This final rule has been determined to be significant for purposes
of Executive Order 12866 and, therefore, has been reviewed by OMB under
Executive Order 12866.
Federal Assistance Program
The title and number of the Federal Assistance Program, as found in
the Catalog of Federal Domestic Assistance, to which this rule applies,
are Commodity Loans and Purchases--10.051.
Executive Order 12778
This final rule has been reviewed in accordance with Executive
Order 12778, Civil Justice Reform. The provisions of this rule do not
preempt State laws, are not retroactive, and do not involve
administrative appeals.
Regulatory Flexibility Act
It has been determined that the Regulatory Flexibility Act is not
applicable to this final rule since FSA is not required by 5 U.S.C. 553
or any other provision of law to publish a notice of proposed
rulemaking with respect to the subject matter of this rule.
Paperwork Reduction Act
The amendments to 7 CFR parts 723 and 1464 set forth in this final
rule do not contain any information collection requirements that
require clearance through the Office of Management and Budget under the
provisions of the Paperwork Reduction Act of 1995.
Statutory Background
This rule is issued pursuant to the provisions of the 1938 Act and
the 1949 Act. Section 1108(c) of P.L. 99-272 provides that the
determinations made in this rule are not subject to the provisions for
public participation in rule making contained in 5 U.S.C. 553 or in any
directive of the Secretary.
On December 15, 1995, the Secretary announced the national
marketing quota and the price support level for the 1996 crop of flue-
cured tobacco. A number of related determinations were made at the same
time, which this final rule also affirms.
Marketing Quota
Section 317(a)(1)(b) of the 1938 Act provides, in part, that the
national marketing quota for a marketing year for flue-cured tobacco is
the quantity of such tobacco that is not more than 103 percent nor less
than 97 percent of the total of: (1) The amount of flue-cured tobacco
that domestic manufacturers of cigarettes estimate they intend to
purchase on U.S. auction markets or from producers, (2) the average
quantity exported annually from the U.S. during the 3 marketing years
immediately preceding the marketing year for which the determination is
being made, and (3) the quantity, if any, that the Secretary, in the
Secretary's discretion, determines necessary to adjust loan stocks to
the reserve stock level.
Section 317(a)(1)(c) further provides that, with respect to the
1995 and 1996 marketing years, any reduction in the national marketing
quota being determined shall not exceed 10 percent of the previous
year's national marketing quota. However, if actual loan stocks exceed
the prescribed reserve stock level by 50 percent the reduction limit
could be waived and the Secretary could then set the quota according to
the 3-component formula (plus or minus 3 percent). The reserve stock
level is defined in section 301(b)(14)(C) of the 1938 Act as the
greater of 100 million pounds or 15 percent of the national marketing
quota for flue-cured tobacco for the marketing year immediately
preceding the marketing year for which the level is being determined.
Section 320A of the 1938 Act provides that all domestic
manufacturers of cigarettes with more than 1 percent of U.S. cigarette
production and sales shall submit to the Secretary a statement of
purchase intentions for the 1996 crop of flue-cured tobacco by December
1, 1995. Five such manufacturers were required to submit such a
statement for the 1996 crop and the total of their intended purchases
for the 1996 crop is 475.5 million pounds. The 3-year average of
exports is 344.8 million pounds.
The national marketing quota for the 1995 crop year was 934.8
million pounds (60 FR 22458). Thus, in accordance with section
301(b)(14)(C), the reserve stock level for use in determining the 1996
marketing quota for flue-cured tobacco is 140.2 million pounds.
As of December 8, 1995, the Flue-Cured Tobacco Cooperative
Stabilization Corporation had in its inventory 59.9 million pounds of
flue-cured tobacco (excluding pre-1994 stocks committed to be purchased
by manufacturers and covered by deferred sales). Accordingly, the
adjustment to maintain loan stocks at the reserve supply level is an
increase of 80.3 million pounds.
The total of the three marketing quota components for the 1996-97
marketing year is 900.6 million pounds. In addition, the discretionary
authority to reduce the three-component total by 3 percent was used
because it was determined that the 1996/97 supply would be more than
ample. Accordingly, the national marketing quota for the marketing year
beginning July 1, 1996, for flue-cured tobacco is 873.6 million pounds.
Section 317(a)(2) of the 1938 Act provides that the national
average yield goal be set at a level that the Secretary determines will
improve or ensure the useability of the tobacco and increase the net
return per pound to the producers. Yields in crop year 1995 were down
substantially from the previous year, but this was a result of
exceptionally poor growing conditions.
[[Page 37673]]
Accordingly, the national average yield goal for the 1996-97 marketing
year will be 2,088 pounds per acre, the same as last year's level.
In accordance with section 317(a)(3) of the 1938 Act, the national
acreage allotment for the 1996 crop of flue-cured tobacco is determined
to be 418,390.80 acres, derived from dividing the national marketing
quota by the national average yield goal.
In accordance with section 317(e) of the 1938 Act, the Secretary is
authorized to establish a national reserve from the national acreage
allotment in an amount equivalent to not more than 3 percent of the
national acreage allotment for the purpose of making corrections in
farm acreage allotments, adjusting for inequities, and for establishing
allotments for new farms. The Secretary has determined that a national
reserve for the 1996 crop of flue-cured tobacco of 2,025 acres is
adequate for these purposes.
In accordance with section 317(a)(4) of the 1938 Act, the national
acreage factor for the 1996 crop of flue-cured tobacco for uniformly
adjusting the acreage allotment of each farm is determined to be 0.935,
which is the result of dividing the 1996 national allotment (418,390.80
acres) minus the national reserve (2,025 acres) by the total of
allotments established for flue-cured tobacco farms in 1995 (445,307.30
acres).
In accordance with section 317(a)(7) of the 1938 Act, the national
yield factor for the 1996 crop of flue-cured tobacco is determined to
be 0.9280, which is the result of dividing the national average yield
goal (2,088 pounds) by a weighted national average yield (2,250
pounds).
Price Support
Price support is required to be made available for each crop of a
kind of tobacco for which quotas are in effect, or for which marketing
quotas have not been disapproved by producers, at a level determined in
accordance with a formula prescribed in section 106 of the 1949 Act.
With respect to the 1996 crop of flue-cured tobacco, the level of
support is determined in accordance with sections 106 (d) and (f) of
the 1949 Act. Section 106(f)(7)(A) of the 1949 Act provides that the
level of support for the 1996 crop of flue-cured tobacco shall be:
(1) The level, in cents per pound, at which the 1995 crop of flue-
cured tobacco was supported, plus or minus, respectively,
(2) An adjustment of not less than 65 percent nor more than 100
percent of the total, as determined by the Secretary after taking into
consideration the supply of the kind of tobacco involved in relation to
demand, of:
(A) 66.7 percent of the amount by which:
(I) The average price received by producers for flue-cured tobacco
on the United States auction markets, as determined by the Secretary,
during the 5 marketing years immediately preceding the marketing year
for which the determination is being made, excluding the year in which
the average price was the highest and the year in which the average
price was the lowest in such period, is greater or less than:
(II) The average price received by producers for flue-cured tobacco
on the United States auction markets, as determined by the Secretary,
during the 5 marketing years immediately preceding the marketing year
prior to the marketing year for which the determination is being made,
excluding the year in which the average price was the highest and the
year in which the average price was the lowest in such period; and
(B) 33.3 percent of the change, expressed as a cost per pound of
tobacco, in the index of prices paid by the tobacco producers from
January 1 to December 31 of the calendar year immediately preceding the
year in which the determination is made.
The difference between the two 5-year averages (i.e., the
difference between (A) (I) and (II)) is 1.5 cents per pound. The
difference in the cost index from January 1 to December 31, 1995, is
-1.2 cents per pound. Applying these components to the price support
formula (1.5 cents per pound, two-thirds weight; -1.2 cents per pound,
one-third weight) results in a weighted total of 0.6 cent per pound. As
indicated, section 106 provides that the Secretary may, on the basis of
supply and demand conditions, limit the change in the price support
level to no less than 65 percent of that amount. In order to remain
competitive in foreign and domestic markets, the Secretary used his
discretion to limit the increase to 65 percent of the maximum allowable
increase. Accordingly, the 1996 crop of flue-cured tobacco will be
supported at 160.1 cents per pound, 0.4 cents higher than in 1995.
List of Subjects
7 CFR Part 723
Acreage allotments, Marketing quotas, Penalties, Reporting and
recordkeeping requirements, tobacco.
7 CFR Part 1464
Loan programs-agriculture, Price support programs, Reporting and
recordkeeping requirements, Tobacco, Warehouses.
Accordingly, 7 CFR parts 723 and 1464 are amended as follows:
PART 723--TOBACCO
1. The authority citation for 7 CFR part 723 continues to read as
follows:
Authority: 7 U.S.C. 1301, 1311-1314, 1314-1, 1314b, 1314b-1,
1314b-2, 1314c, 1314d, 1314e, 1314f, 1314i, 1315, 1316, 1362, 1363,
1372-75, 1421, 1445-1, and 1445-2.
2. Section 723.111 is amended by adding paragraph (d) to read as
follows:
Sec. 723.111 Flue-Cured (types 11-14) tobacco.
* * * * *
(d) The 1996 crop national marketing quota is 873.6 million pounds.
PART 1464--TOBACCO
3. The authority citation for 7 CFR part 1464 continues to read as
follows:
Authority: 7 U.S.C. 1421, 1423, 1441, 1445, and 1445-1, 15
U.S.C. 714b and 714c.
4. Section 1464.12 is amended by adding paragraph (d) to read as
follows:
Sec. 1464.12 Flue-Cured (types 11-14) tobacco.
* * * * *
(d) The 1996 crop national price support level is 160.1 cents per
pound.
Signed at Washington, DC, on July 11, 1996.
Bruce R. Weber,
Administrator, Farm Service Agency and Executive Vice President,
Commodity Credit Corporation.
[FR Doc. 96-18293 Filed 7-18-96; 8:45 am]
BILLING CODE 3410-05-P
Complete official Federal Register PDF
FR Doc. 96-18285 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls; Partial Extension of Compliance Date
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37679-37680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18285]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 210 and 211
[Docket No. 88N-0320]
Current Good Manufacturing Practice in Manufacturing, Processing,
Packing, or Holding of Drugs; Revision of Certain Labeling Controls;
Partial Extension of Compliance Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; partial extension of compliance date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a
continuation of the partial extension of the compliance date for a
provision of the final rule published in the Federal Register of August
3, 1993 (58 FR 41348). The document revised the current good
manufacturing practice (CGMP) regulations for certain labeling control
provisions. In the Federal Register of April 28, 1995 (60 FR 20897),
FDA partially extended the compliance date to August 2, 1996, for that
part of the final rule pertaining to items of cut labeling other than
immediate container labels. This document extends the compliance date
to August 1, 1997. FDA is taking this action to afford the industry
sufficient time to purchase necessary equipment or to take other steps
necessary to comply with certain provisions of the final rule, and to
provide additional time for the agency to consider any revisions to the
final rule.
DATES: Efffective July 19, 1996, the date for compliance with
Sec. 211.122(g) (21 CFR 211.122(g)) for items of labeling (other than
immediate container labels) is now extended to August 1, 1997. The date
of compliance for all other provisions of the final rule published
August 3, 1993 (58 FR 41348) remains August 3, 1994.
FOR FURTHER INFORMATION CONTACT:
Thomas C. Kuchenberg, Center for Drug Evaluation and Research (HFD-
7), Food and Drug Administration, 7500 Standish Pl., Rockville, MD
20855, 301-594-1046, or
Paul J. Motise, Center for Drug Evaluation and Research (HFD-325),
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855,
301-594-0098.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 3, 1993
(58
[[Page 37680]]
FR 41348), FDA published a final rule that amended the labeling control
provisions in the CGMP regulations. The final rule defined the term
``gang-printed labeling,'' specified conditions for the use of gang-
printed or cut labeling, exempted manufacturers that employ certain
automated inspection systems from labeling reconciliation requirements,
and made other revisions intended to reduce the frequency of drug
product mislabeling and associated drug product recalls. One of the
three special control options for cut labeling is the use of
``appropriate electronic or electromechanical equipment to conduct a
100-percent examination for correct labeling during or after completion
of finishing operations'' (Sec. 211.122(g)(2)).
In response to two citizen petitions requesting certain amendments
to Sec. 211.122(g) as it applies to cut labeling, a stay of the
effective date, and reopening of the administrative record, FDA, in the
Federal Register of August 2, 1994 (59 FR 39255), granted a partial
extension of the compliance date for certain provisions of
Sec. 211.122(g) to August 3, 1995, and a limited reopening of the
administrative record. In the Federal Register of April 28, 1995 (60 FR
20897), FDA granted a further partial extension of the compliance date
to August 2, 1996.
FDA extended the compliance date to provide industry with
additional time to comply with certain provisions of the final rule.
FDA found that additional time was needed to locate, install, and
validate scanning equipment and other necessary equipment to orient
items properly for bar code scanning because there was a shortage of
contract engineering personnel employed by some drug manufacturers to
evaluate, select, purchase, install, qualify, and validate labeling
verification systems.
FDA reopened the administrative record to receive additional
comments on the application of Sec. 211.122(g) to items of labeling
(other than the immediate container label) as defined in section 201(m)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(m)), and
whether Sec. 211.122(g) expanded the proposed scope of the provision
from immediate container labels to all drug product labeling.
FDA has held a number of meetings with representatives of the
labeling industry and others to determine control options available
through current technology and to evaluate this information in light of
comments received during the extended comment period. To assess this
information adequately, provide industry with adequate time to comply
fully with a final regulation, and provide additional time for FDA to
consider any revisions to the final rule, the agency is extending to
August 1, 1997, the compliance date for Sec. 211.122(g) as it applies
to items of labeling other than the immediate container label.
FDA's determination as to whether Sec. 211.122(g) will be retained
as currently codified or whether it will be revised will be published
in a future issue of the Federal Register. The compliance date for the
remainder of Sec. 211.122, including Sec. 211.122(g) as it applies to
immediate container labels, was August 3, 1994. The agency emphasizes
that, under 21 CFR 211.125, a waiver of labeling reconciliation is
conditioned on a 100-percent examination for correct labeling performed
in accordance with Sec. 211.122(g)(2).
Dated: July 11, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-18285 Filed 7-18-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-18234 Revocation of Certain Animal Food and Drug Regulations
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37680-37682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18234]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 500, 505, 507, 508, 510, and 570
[Docket No. 95N-310V]
Revocation of Certain Animal Food and Drug Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is revoking certain
regulations regarding animal food and animal drugs that are obsolete or
no longer necessary to achieve public health goals. These regulations
have been identified for revocation as the result of a page-by-page
review of the agency's regulations. This regulatory review is in
response to the administration's ``Reinventing Government'' initiative
which seeks to streamline Government to ease the burden on regulated
industry and consumers. These regulations are being consolidated in
order to respond to ``Reinventing Government.''
EFFECTIVE DATE: August 19, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Kristi O. Smedley, Center for
Veterinary Medicine (HFV-238), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1737.
SUPPLEMENTARY INFORMATION:
I. Background
On March 4, 1995, President Clinton announced plans for the reform
of the Federal regulatory system as part of the administration's
``Reinventing Government'' initiative. In his March 4 directive, the
President ordered all Federal agencies to conduct a page-by-page review
of all of their regulations and to ``eliminate or revise those that are
outdated or otherwise in need of reform.'' In the Federal Register of
October 13, 1995 (60 FR 53480), FDA provided its initial efforts in
implementing the President's plan. The proposed rule announced
regulations that FDA intended to eliminate based on the page-by-page
review.
The agency received no comments regarding their intention to
eliminate any of the regulations that cover animal food or animal drug
regulations. Therefore the agency is removing the following
regulations:
1. Section 500.49 Chlorofluorocarbon propellants (21 CFR 500.49).
This section prohibits the use of chlorofluorocarbons as propellants in
self-pressurized containers in animal drugs. Chlorofluorocarbons are
prohibited by the Clean Air Act Amendments of 1990 (42 U.S.C. 7671) and
can no longer be marketed for this use. This section is unnecessary
because coverage in Sec. 2.125 (21 CFR 2.125) of this prohibition is
sufficient.
2. Section 505.3 Warnings on animal drugs intended for
administration to diseased animals (21 CFR 505.3). This section states
that no warning or caution statements recommended for use in the
labeling of animal drugs intended for administration to diseased
animals shall be construed to suggest or imply that a product of
diseased animals is suitable for food use. This provision cautions
against misuse of language in Sec. 505.20 (21 CFR 505.20) which is now
being withdrawn and is, therefore, unnecessary.
3. Section 505.20 Recommended animal drug warning and caution
statements. This section provides recommended animal drug warning and
caution statements for specific drugs. The statements provided are
voluntary label statements that do not contain requirements and need
not appear in the CFR.
4. Part 507--Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers (21 CFR part 507). This part contains
the criteria that apply in determining whether the facilities, methods,
practices, and
[[Page 37681]]
controls used by the commercial processor in the manufacture,
processing, and packing of low-acid foods for animals in hermetically
sealed containers are operated or administered in a manner adequate to
protect the public health. Part 507 is identical to part 113 (21 CFR
part 113), which applies to human foods. Therefore, the agency is
removing part 507, and adding a new Sec. 500.23 to state that the
provisions in part 113 apply to animal foods.
5. Part 508--Emergency Permit Control (21 CFR part 508) covers the
requirements and issuance of emergency control permits for the
manufacturer or packer of thermally processed low-acid foods packaged
in hermetically sealed containers. Part 508 is identical to part 108
(21 CFR part 108), which applies to human foods. Therefore, the agency
is removing part 508, and adding a new Sec. 500.24 to state that the
provisions in part 108 apply to food intended for animals.
6. Section 510.120 Suspension of approval of new-drug applications
for certain diethylstilbestrol and diethylstilbestrol-containing drugs
(21 CFR 510.120). This section provides the suspension of approval of
the seven listed diethylstilbestrol (DES)-containing animal drug
products. There are no approved new animal drug applications for DES-
containing products. This regulation is obsolete and should be deleted.
7. Section 510.200 Export of new animal drug (21 CFR 510.200). This
section states that to export a new animal drug the product must comply
with regulations issued under section 512 of the act (21 U.S.C. 360b).
This provision has been superseded by changes in the act (see 21 U.S.C.
381).
8. Section 510.310 Records and reports for new animal drugs
approved before June 20, 1963 (21 CFR 510.310). This section sets out
separate requirements for recordkeeping and reporting to the agency for
drugs approved prior to June 20, 1963. These requirements are outdated
and inaccurate. The agency believes it is appropriate to apply the
current recordkeeping and reporting requirements to drugs that were
approved before 1963.
9. Section 510.413 Chloroform used as an ingredient (active or
inactive) in animal drug products (21 CFR 510.413). This section
prohibits the use of chloroform as an ingredient in animal drugs and
provides certain requirements for products that contain chloroform that
must be met by October 3, 1977. Chloroform is no longer used as an
ingredient in any animal drug formulations. Drug formulation is
reviewed by the manufacturing chemists in FDA's Center for Veterinary
Medicine (CVM), and this regulation is no longer necessary.
10. Section 570.22 Safety factors to be considered (21 CFR 570.22).
This section sets out a proposed safety factor to be used by CVM
scientists when there is not justification of a different safety
factor. The safety factors provided in the regulations are
scientifically obsolete for food additives intended for animals and are
best handled within the review process.
II. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (Pub. L. 96-354), and Pub.
L. 104-121. Executive Order 12866 directs agencies to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity).
The agency believes that this final rule is consistent with the
regulatory philosophy and principles identified in the Executive Order.
In addition, the final rule is not a significant regulatory action as
defined by the Executive Order and so is not subject to review under
the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the deletions have no compliance costs and
do not result in any new requirements, the agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities. Therefore, under the Regulatory Flexibility
Act, no further analysis is required.
Pub. L. 104-121 provides for a major rule is to be effective 60
days after date of publication in the Federal Register or 60 days after
submission of the rule to Congress for review, whichever is later. This
rule is not a major rule for purposes of Pub. L. 104-121. Therefore,
this rule is effective 30 days after date of publication.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(9) 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
21 CFR Part 500
Animal drugs, Animal feeds, Cancer, Labeling, Polychlorinated
biphenyls (PCB's).
21 CFR Part 505
Animal drugs, Labeling, Over-the-counter drugs.
21 CFR Part 507
Animal foods, Packaging and containers, Reporting and recordkeeping
requirements.
21 CFR Part 508
Animal foods.
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 570
Animal feeds, Animal foods, Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) and under authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 500, 505, 507, 508, 510, and 570 are
amended as follows:
PART 500--GENERAL
1. The authority citation for 21 CFR part 500 continues to read as
follows:
Authority: Secs. 201, 301, 402, 403, 409, 501, 502, 503, 512,
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331,
342, 343, 348, 351, 352, 353, 360b, 371).
2. Section 500.23 is added to subpart B to read as follows:
Sec. 500.23 Thermally processed low-acid foods packaged in
hermetically sealed containers.
The provisions of part 113 of this chapter shall apply to the
manufacture, processing or packing of low-acid foods in hermetically
sealed containers, and intended for use as food for animals.
3. Section 500.24 is added to subpart B to read as follows:
Sec. 500.24 Emergency permit control.
The provisions of part 108 of this chapter shall apply to the
issuance of emergency control permits for the manufacturer or packer of
thermally processed low-acid foods packaged in hermetically sealed
containers, and intended for use as food for animals.
[[Page 37682]]
Sec. 500.49 [Removed]
4. Section 500.49 Chlorofluorocarbon propellants is removed.
PART 505--[REMOVED]
5. Part 505 is removed.
PART 507--[REMOVED]
6. Part 507 is removed.
PART 508--[REMOVED]
7. Part 508 is removed.
PART 510--NEW ANIMAL DRUGS
8. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e).
Sec. 510.120 [Removed]
9. Section 510.120 Suspension of approval of new-drug applications
for certain diethylstilbestrol and diethylstilbestrol-containing drugs
is removed.
Sec. 510.200 [Removed]
10. Subpart C, consisting of Sec. 510.200, is removed and reserved.
Sec. 510.310 [Removed]
11. Section 510.310 Records and reports for new animal drugs
approved before June 20, 1963 is removed.
Sec. 510.413 [Removed]
12. Section 510.413 Chloroform used as an ingredient (active or
inactive) in animal drug products is removed.
PART 570--FOOD ADDITIVES
13. The authority citation for 21 CFR part 570 continues to read as
follows:
Authority: Secs. 201, 401, 402, 408, 409, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 346a, 348,
371).
Sec. 570.22 [Removed]
14. Section 570.22 Safety factors to be considered is removed.
Dated: July 3, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-18234 Filed 7-18-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-18233 Revocation of Certain Device Regulations
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37682-37683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18233]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 801
[Docket No. 95N-310R]
RIN 0910-AA54
Revocation of Certain Device Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to remove certain device regulations that are obsolete or no longer
necessary to achieve public health goals. These regulations have been
identified for revocation as the result of a page-by-page review of the
agency's regulations in response to the administration's ``Reinventing
Government'' initiative, which seeks to streamline Government and ease
the burden on regulated industry and consumers.
EFFECTIVE DATE: August 19, 1996.
FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-827-2974.
SUPPLEMENTARY INFORMATION:
I. Background
On March 4, 1995, President Clinton announced plans for the reform
of the Federal regulatory system as part of the administration's
``Reinventing Government'' initiative. In his March 4, 1995, directive,
entitled ``Regulatory Reinvention Initiative,''the President ordered
all Federal agencies to conduct a page-by-page review of all of their
regulations and to ``eliminate or revise
[[Page 37683]]
those that are outdated or otherwise in need of reform.'' The first
results of FDA's efforts in implementing the President's plan were
published in the Federal Register of October 13, 1995 (60 FR 53480).
That document identified the regulations that FDA was proposing to
eliminate, and the Centers within the agency responsible for those
regulations.
The agency received no comments on the proposed revocation of
regulations administered by the Center for Devices and Radiological
Health (CDRH). This final rule will finalize the proposed revocation of
the following regulations administered by CDRH:
II. Section-by-Section Analysis
1. Section 801.403 Specific medical devices; recommended warning
and caution statements (21 CFR 801.403). This regulation recommends
certain warning and caution statements for: Denture reliners, pads, and
cushions; denture repair kits; infrared generators (including heating
pads); insulin syringes; mechanical massagers and vibrators; steam or
turkish baths; and ultraviolet generators. This section does not
contain specific requirements and will therefore be removed from the
Code of Federal Regulations (CFR).
2. Section 801.408 Pessaries for intracervical and intrauterine use
(21 CFR 801.408). This section contains information that can be more
appropriately given as statements of policy and will therefore be
removed from the CFR.
3. Section 801.427 Professional and patient labeling for
intrauterine contraceptive devices (21 CFR 801.427). This regulation is
no longer necessary because these devices are no longer being marketed.
If any intrauterine contraceptive devices are approved in the future,
the labeling will be approved during the premarket approval process.
This regulation will therefore be removed from the CFR.
III. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the final
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this final rule removes unnecessary labeling
regulations, the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Therefore, under the Regulatory Flexibility Act, no further analysis is
required.
IV. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(ii) 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 801
Labeling, Medical devices, 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
801 is amended as follows:
PART 801--LABELING
1. The authority citation for 21 CFR part 801 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 507, 519, 520, 701, 704 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351,
352, 357, 360i, 360j, 371, 374).
Sec. 801.403 [Removed]
2. Section 801.403 Specific medical devices; recommended warning
and caution statements is removed.
Sec. 801.408 [Removed]
3. Section 801.408 Pessaries for intracervical and intrauterine use
is removed.
Sec. 801.427 [Removed]
4. Section 801.427 Professional and patient labeling for
intrauterine contraceptive devices is removed.
Dated: July 11, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-18233 Filed 7-18-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-18176 United States Standards for Grades of Frozen Green and Frozen Wax Beans
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37663-37670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18176]
========================================================================
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.
========================================================================
Federal Register / Vol. 61, No. 140 / Friday, July 19, 1996 / Rules
and Regulations
[[Page 37663]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 52
[FV-95-326]
United States Standards for Grades of Frozen Green and Frozen Wax
Beans
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: In response to a petition from the National Food Processors
Association (NFPA), the United States Department of Agriculture (USDA)
is revising the United States Standards for Grades of frozen green and
frozen wax beans. The revision changes the U.S. grade standards for
frozen green and frozen wax beans by providing for the ``individual
attributes'' procedure for product grading with sample sizes,
acceptable quality levels (AQL's), tolerances and acceptance numbers
(number of allowable defects), establishing AQL's and acceptance
numbers based on a specified sample size of 13 sample units, and making
minor editorial changes.
EFFECTIVE DATE: August 19, 1996.
FOR FURTHER INFORMATION CONTACT: James R. Rodeheaver, Processed
Products Branch, Fruit and Vegetable Division, Agricultural Marketing
Service, U.S. Department of Agriculture, Room 0709, South Building,
P.O. Box 96456, Washington, D.C. 20090-6456, Telephone (202) 720-4693.
SUPPLEMENTARY INFORMATION: The Department of Agriculture is issuing
this rule in conformance with Executive Order 12866.
This final rule has been reviewed under Executive Order 12778,
Civil Justice Reform. This action is not intended to have retroactive
effect. This final rule will 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.
Pursuant to the requirements set forth in the Regulatory
Flexibility Act, as amended (5 U.S.C. 601 et seq.), the Administrator,
Agricultural Marketing Service, has determined that this action will
not have a significant economic impact on a substantial number of small
entities because the changes to the standards are made to reflect
current marketing practices. In addition, under the Agricultural
Marketing Act of 1946, the use of these standards is voluntary. A small
entity may avoid incurring any additional economic impact by not
employing the standards.
Agencies periodically review existing regulations. An objective of
the regulatory review is to ensure that the grade standards are serving
their intended purpose, the language is clear, and the standards are
consistent with AMS policy and authority.
USDA received a petition from the National Food Processors
Association (NFPA), requesting that the U.S. grade standards for frozen
green beans be revised. NFPA is a trade association representing over
450 food industry companies.
NFPA's grade standards review subcommittee is responsible for
reviewing the existing U.S. grade standards for canned and frozen
fruits and vegetables to ascertain whether the standards remain current
and reflect processing and marketing practices. Based on the
subcommittee's recommendation, NFPA requested that the U.S. grade
standards for frozen green beans, which are currently based on ``full
attributes,'' where defects are grouped into four categories (minor,
major, severe, and critical) with acceptable quality levels (AQL's) for
each grouping, be revised.
Their recommendation was to convert the U.S. grade standards to
statistically-based individual attributes grade standards, similar to
the revised U.S. grade standards for canned green and wax beans (58 FR
4295, January 14, 1993) where each defect has its own AQL. Canned green
beans and frozen green beans standards would be similar in design and
format.
The proposal was based on discussion drafts provided to the
industry in December 1993, March 1994, and April 1994 through their
major trade associations, the American Frozen Food Institute (AFFI) and
NFPA. The drafts incorporated a grading system where individual
tolerances were assigned to each individual defect. The proposal
provided statistically derived acceptable quality levels (AQL's) based
on the tolerances in the current standards (except some tolerances were
changed to be similar to the tolerances in canned green beans). The
proposal also included minor editorial changes and provides a uniform
format consistent with recent revisions of other U.S. grade standards.
The format is designed to provide industry personnel and agricultural
commodity graders with simpler and more comprehensive standards.
Definitions of terms and easy-to-read tables have been incorporated to
assure a better understanding and uniform application of the standards.
USDA believes that this proposed rule would facilitate trade between
processors and buyers and improve the marketing of frozen green beans.
Proposed Rule
The proposal to revise the U.S. Standards for Grades of frozen
green and frozen wax beans was published in the Federal Register on
February 15, 1995, (60 FR 8573) with a sixty-day comment period. The
comment period closed on April 17, 1995. USDA received one comment from
the National Food Processor's Association (NFPA), one comment from
Lakeside Foods, Incorporated, Manitowoc, Wisconsin, one comment from
the American Frozen Food Institute, and one comment from Twin City
Foods, Incorporated, Stanwood, Washington.
NFPA represents the $400 billion food processing industry on
scientific and public policy involving issues of food safety,
nutrition, and regulatory and consumer affairs. Most of their members
are in the canning industry, while many members operate both canning
and freezing facilities. NFPA's review of the proposed rule generally
agreed with the rule but pointed out four areas where the grade
standards for frozen green and frozen wax beans were not consistent
with the grade standards for canned green and canned wax beans. NFPA
urged that these differences be closely examined and that USDA
promulgate
[[Page 37664]]
grade standards that are consistent with, as much as possible, the
canned green and wax beans grade standards. The first point NFPA raised
was the definition of ``Short piece'' in whole style is 44 mm (1.75 in)
in the proposal and the same definition in the canned green and wax
beans is 32 mm (1.25 in). The second point was the AQL for Extraneous
Vegetable Material in Grade A in the proposal was 0.162 and that the
AQL in the canned green and wax beans standards for the same quality
factor and grade was 0.40. The lower the AQL, the more restrictive the
tolerance is for the defect. The third point raised was the AQL for
stems in Grade A Whole and Cut styles is 0.58 in the proposal and the
AQL in the canned green beans standards for the same factors is 1.50.
And the fourth point raised by NFPA was that the AQL for ``Mechanical
damage'' in Grade A in Whole style is 2.60 for frozen green and wax
beans and is 4.0 in the canned green beans standards. Lakeside Foods
basically cited the same four points in their comment, believing that
USDA ``misunderstands'' the industry's request that these grade
standards be similar for both canned and frozen green beans, whenever
possible. Lakeside Foods believed these differences will have an
unjustified economic impact on the frozen green and wax bean industry.
The American Frozen Food Institute, representing its 560 member
companies and accounting for over 90 percent of frozen food production
in the United States, also commented on the proposal. AFFI's Western
Technical Advisory Committee includes almost all frozen green and wax
bean processors in the United States. The comment supported the
proposed revision since most frozen green and wax bean processors'
recommendations were incorporated into the proposal. The Institute
argued however, that ``small pieces'' should be a classified defect
instead of a prerequisite as specified in the proposal citing that if a
``small piece'' continues to be included as a prerequisite, the
potential exists for one failing sample unit to down-grade an entire
lot, resulting in an inappropriate rejection of the overall quality of
the lot.
Twin City Foods, Incorporated, also commented on the proposal,
opposing the increased sample unit sizes as more time-consuming when
grading, and opposing ``small pieces and odd cuts'' in lengthwise style
only, being considered as a Prerequisite quality factor. In their
comment, Twin City Foods compared the sample unit sizes in the existing
frozen green and wax bean grade standards (250 g, 100 units, 200 units)
with the sample sizes in the proposal (500 g, 400 units). As stated in
their comment, ``One of the operational requirements of Twin City
Foods, Inc. is to have each tote bin of product be USDA Grade
Certifiable (in our plants processing under Continuous U.S.D.A.
Inspection). In order to establish a grade, the U.S.D.A. must grade a
minimum of three samples per Lot, or in this case, per tote bin. When
we are processing green beans, we fill a tote bin (1450 lbs for cut
green beans, 900 lbs. for sliced lengthwise, and 800 lbs. for whole
beans) about every 5 minutes. With the defect grading sample size twice
as large for cut and sliced lengthwise green beans, and four times
larger for whole green beans, accurate grade checks could not be
completed in time.'' Twin City Foods also opposed ``small pieces and
odd cuts'' in lengthwise style only, being categorized as a
Prerequisite quality factor in the proposal, agreed with AFFI that
``small pieces and odd cuts'' in lengthwise style only should be a
Classified quality factor, and the AQL/Tolerance for this factor should
be in terms of weight, not count.
The published proposal incorporated the positions of both canning
and freezing segments of the green and wax bean industry. With regard
to NFPA's comments, USDA agrees in principle that AQL's and tolerances
found in the frozen green and wax bean standards should be consistent
with the canned green and wax beans standards ``whenever possible.'' In
practice there will reasonably be certain differences. For each point
raised by NFPA, which note instances where the tolerances for defects
in the grade standards for canned green and wax beans and the proposed
grade standards for frozen green and wax beans differ, USDA has
received comments from AFFI which support making these specific changes
in the tolerances. AFFI, in these specific instances, is favoring
tighter tolerances for frozen green and wax beans than those for the
same defects in the canned green beans. This is consistent with the
position of the frozen food industry has taken in the past relative to
developing and revising grade standards.
Taking all the comments into account, USDA believes that effective
marketing of frozen bean and wax beans will be best served by
incorporating the provisions with respect the sample sizes set forth in
the proposed rule.
USDA agrees with AFFI's comment to make ``small pieces'' a
classified defect with an AQL to represent overall lot quality for
small pieces and has incorporated this change in the final rule. In
addition to this change, USDA makes ``small pieces and odd cuts'' in
French Style only a classified defect with an AQL to represent overall
lot quality in this rule as well.
Regarding the comment from Twin City Foods, Incorporated, they have
adopted a sampling rate that is higher than USDA minimum sampling
rates. For most of the industry, which tends to use USDA minimum
sampling rates, the increased sample unit sizes would have minimal
impact while the impact would be greater on the operations of a frozen
processor with higher sampling rates. Nonetheless, for most processors,
the proposed change would be beneficial to the industry as a whole, and
accordingly, it has been included in the final rule.
USDA found, upon additional review, that definitions for ``flavor
and odor'' were different in the current grade standards for canned and
frozen green and wax beans. USDA believes commodity graders and the
industry will apply the standards more uniformly if flavor and odor
definitions are similar for both commodities. USDA is removing ``fairly
good flavor and odor'' from the definitions of terms to make the terms
similar for both agricultural products.
Accordingly, based on all the information collected and to promote
efficient marketing of this product, USDA revises the United States
Standards for Grades of Frozen Green and Frozen Wax Beans.
List of Subjects in 7 CFR Part 52
Food grades and standards, Food labeling, Frozen foods, Fruit
juices, Fruits, Reporting and recordkeeping requirements, Vegetables.
For the reasons set forth in the preamble, 7 CFR part 52 is amended
as follows:
PART 52--[AMENDED]
1. The authority citation for Part 52 is revised to read as
follows:
Authority: 7 U.S.C. 1621-1627.
2. In part 52, Subpart--United States Standards for Grades of
Frozen Green Beans and Frozen Wax Beans is revised to read as follows:
Subpart--United States Standards for Grades of Frozen Green Beans and
Frozen Wax Beans
Sec.
52.2321 Product description.
52.2322 Styles.
52.2323 Types.
52.2324 Kinds of pack.
52.2325 Definitions of terms.
52.2326 Grades.
52.2327 Factors of quality.
52.2328 Allowances for defects.
[[Page 37665]]
52.2329 Sample size.
52.2330 Quality requirements criteria.
Subpart--United States Standards for Grades of Frozen Green Beans
and Frozen Wax Beans
Sec. 52.2321 Product description.
Frozen green beans and frozen wax beans, hereinafter called frozen
beans, means the frozen product prepared from the clean, sound,
succulent pods of the bean plant. The pods are stemmed, washed,
blanched, sorted, and properly drained. The product is frozen in
accordance with good commercial practice and maintained at temperatures
necessary for the preservation of the product.
Sec. 52.2322 Styles.
(a) Whole means frozen beans consisting of whole pods, which after
removal of either or both ends, are not less than 44 mm (1.75 in) in
length.
(b) Cut or cuts means frozen beans consisting of pods that are cut
transversely into pieces less than 70 mm (2.75 in) but not less than 19
mm (0.75 in) in length.
(c) Short cut or short cuts means frozen beans consisting of pieces
of pods of which 75 percent or more are less than 19 mm (0.75 in) in
length and not more than 1 percent are more than 32 mm (1.25 in) in
length.
(d) Mixed means a mixture of two or more of the following styles of
frozen beans: whole, cut, or short cut.
(e) Sliced lengthwise, or French style means frozen green beans
consisting of pods that are sliced lengthwise.
Sec. 52.2323 Types.
The type of frozen beans is not incorporated in the grades of
finished product, since it is not a factor of quality. The types of
frozen beans are described as round type and Romano or Italian type.
(a) Round type means frozen beans having a width not greater than
1\1/2\ times the thickness of the beans.
(b) Romano or Italian type means frozen beans having a width
greater than 1\1/2\ times the thickness of the beans.
Sec. 52.2324 Kinds of pack.
The kind of pack of frozen beans is not incorporated in the grades
of finished product, since it is not a factor of quality. The kinds of
pack of frozen beans are described as regular process, extended blanch
process, and special pack.
(a) Regular process means the frozen beans are processed in such a
manner that the brightness is not affected by the process.
(b) Extended blanch process means the frozen beans are
intentionally processed in such a manner that the brightness is
affected by the process.
(c) Special pack means the frozen bean pack intentionally contains
beans of two or more varietal characteristics (such as a mixture of
green and wax beans).
Sec. 52.2325 Definitions of terms.
(a) Acceptable Quality Level (AQL) means the maximum percent of
defective units or the maximum number of defects per hundred units of
product that, for the purpose of acceptance sampling, can be considered
satisfactory as a process average.
(b) Blemish--(1) Minor blemish means any unit which is affected by
scars, pathological injury, insect injury or other means in which the
aggregate area affected exceeds the area of a circle 3 mm (0.125 in) in
diameter or the appearance or eating quality of the unit is slightly
affected.
(2) Major blemish means any unit which is affected or damaged by
discoloration or any other means to the extent that the appearance or
eating quality of the unit is more than slightly affected.
(3) Total blemish means the total of the major and minor blemishes.
(c) Brightness means the extent that the overall appearance of the
sample unit as a mass is affected by dullness. (Applies to regular
process only).
(1) Grade A: Not affected.
(2) Grade B: Slightly affected.
(3) Grade C: Materially affected.
(4) Substandard: Seriously affected.
(d) Character--(1) Round type--Green Beans--(i) Good character
means the pods are full fleshed; after cooking, the pods are tender and
the seeds are not mealy.
(ii) Reasonably good character means the pods are reasonably
fleshy; after cooking, the pods are tender and the seeds are not mealy.
(iii) Fairly good character means the pods have not entirely lost
their fleshy structure; after cooking, the pods are fairly tender and
the seeds may be slightly mealy.
(iv) Poor character means the beans fail the requirements for
fairly good character.
(2) Round type--Wax Beans--(i) Good character means the pods are
full fleshed and may show slight breakdown of the flesh between seed
cavities; after cooking, the pods are tender and the seeds are not
mealy.
(ii) Reasonably good character means the pods are reasonably fleshy
and may show substantial breakdown of the flesh between the seed
cavities; after cooking, the pods are tender and the seeds are not
mealy.
(iii) Fairly good character means the pods may show total breakdown
of the flesh between the seed cavities with no definite seed pocket,
but still retain flesh on the inside pod wall; after cooking, the pods
are fairly tender and the seeds may be slightly mealy.
(iv) Poor character means the beans fail the requirements for
fairly good character.
(3) Romano or Italian type--(i) Good character means the pods have
a full inner membrane, typical of the variety and are tender after
cooking.
(ii) Reasonably good character means the pods have a reasonably
well developed inner membrane and are reasonably tender after cooking.
(iii) Fairly good character means the pods may lack an inner
membrane; and are fairly tender after cooking.
(iv) Poor character means the beans fail the requirements for
fairly good character.
(e) Color defective means a unit that varies markedly from the
color that is normally expected for the variety and grade.
(f) Defect means any nonconformance of a unit of product from a
specified requirement of a single quality characteristic.
(g) Extraneous vegetable material (EVM) means harmless vegetable
material (other than the bean pods) including, but not limited to,
stalk, vine material, [vine material with stem(s) attached], leaves of
the bean plant, and leaves or portions of other harmless plants.
(h) Fiber--(1) Edible fiber means fiber developed in the wall of
the bean pod that, after cooking, is noticeable upon chewing, but can
be consumed with the rest of the bean material without objection.
(2) Inedible fiber means fiber developed in the wall of the bean
pod that, after cooking, is objectionable upon chewing and tends to
separate from the rest of the bean material.
(i) Flavor and odor. Good flavor and odor means the product, after
cooking, has a characteristic green bean or wax bean flavor and odor
typical of the varietal type and is free from objectionable flavors and
odors.
(j) Mechanical damage means a unit, in all styles except French,
that is broken or split into two parts (equals 1 defect), is crushed,
or is damaged by mechanical means to such an extent that the appearance
is seriously affected; and for whole and cut styles has very ragged
edges that are greater than 8 mm (\5/16\ in).
[[Page 37666]]
(k) Short piece means a unit in cut style, that is less than 13 mm
(0.50 in) in length, and a unit in whole style that is less than 44 mm
(1.75 in) in length, measured along the longest dimension parallel to
the bean suture line.
(l) Single sample unit means the amount of product specified (500
grams for French style and 400 units for all other styles) to be used
for unofficial inspection. It may be:
(1) The entire contents of a container;
(2) A portion of the contents of a container; or
(3) A combination of the contents of two or more containers.
(m) Sloughing means the separation of the outer surface layer of
tissue from the pod.
(n) Small pieces and odd cuts, in French style only, mean pieces of
pod less than 19 mm (0.75 in) in length or pieces of pod not conforming
to the normal appearance of a sliced lengthwise bean unit.
(o) Stem means any part or portion (loose or attached) of the hard
or tough fibrous material that attaches the bean pod to the vine.
(p) Tolerance means the percentage of defective units allowed for
each quality factor for a specified sample size.
(q) Unit means a bean pod or any individual portion thereof.
Sec. 52.2326 Grades.
(a) U.S. Grade A is the quality of frozen beans that:
(1) Meets the following prerequisites in which the beans:
(i) Have similar varietal characteristics (except special packs);
(ii) Have a good flavor and odor;
(iii)Have a good overall brightness that is not affected by
dullness (regular process only); and
(iv) Are not materially affected by sloughing.
(2) Is within the limits for defects as specified in Section
52.2328, as applicable for the style.
(b) U.S. Grade B is the quality of frozen beans that:
(1) Meets the following prerequisites in which the beans:
(i) Have similar varietal characteristics (except special packs);
(ii) Have a good flavor and odor;
(iii) Have a reasonably good overall brightness (regular process
only); and
(iv) Are not materially affected by sloughing.
(2) Is within the limits for defects as specified in Section
52.2328, as applicable for the style.
(c) U.S. Grade C is the quality of frozen beans that:
(1) Meets the following prerequisites in which the beans:
(i) Have similar varietal characteristics (except special packs);
(ii) Have a good flavor and odor;
(iii) Have a fairly good overall brightness (regular process only);
and
(iv) Are not seriously affected by sloughing.
(2) Is within the limits for defects as specified in Section
52.2328, as applicable for the style.
(d) Substandard is the quality of frozen beans that fail the
requirements of U.S. Grade C.
Sec. 52.2327 Factors of quality.
The grade of frozen beans is based on requirements for the
following quality factors:
(a) Prerequisite quality factors. (1) Varietal characteristics
(except special packs);
(2) Flavor and odor;
(3) Brightness (regular process only); and
(4) Sloughing.
(b) Classified quality factors. (1) Extraneous vegetable material
(EVM);
(2) Stems;
(3) Major blemishes;
(4) Total blemishes;
(5) Mechanical damage;
(6) Short pieces (Cut, Whole Style);
(7) Small pieces and odd cuts (French Style);
(8) Color defectives;
(9) Character;
(10) Inedible fiber; and
(11) Edible fiber.
Sec. 52.2328 Allowances for defects.
Table I--Prerequisite Factors for Frozen Green Beans and Wax Beans \1\
----------------------------------------------------------------------------------------------------------------
Factors Grade A Grade B Grade C
----------------------------------------------------------------------------------------------------------------
Varietal characteristics............. Similar................ Similar................ Similar.
Flavor and odor...................... Good................... Good................... Good.
Brightness........................... Good................... Reasonably good........ Fairly good.
Sloughing............................ Not materially affected Not materially affected Not seriously affected.
----------------------------------------------------------------------------------------------------------------
\1\ Determined container-by-container.
Table II.--Acceptance Numbers for Whole, and Cut Style Frozen Green Beans and Wax Beans (Grade A)
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Sample Units x Sample Unit
Size....................... 1 x 400 1.5 x 400 3 x 400 6 x 400 13 x 400 21 x 400 29 x 400
----------------------------------------------------------------------------------------------------------------
Units of Product............ \1\ 400 \2\ 600 1200 2400 5200 8400 11600
----------------------------------------------------------------------------------------------------------------
TOL AQL \3\ Quality factors
(6)Acce
ptance
number
s
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.25... 0.162 Extraneous Vegetable Material............................ 2 2 4 7 13 19 26
0.75... 0.58 Stems.................................................... 5 6 11 20 39 60 81
1.25... 1.02 Major Blemishes.......................................... 7 10 18 33 65 101 136
3.75... 3.30 Total Blemishes (Major + Minor).......................... 19 27 50 94 193 304 415
3.00... 2.60 Mechanical Damage........................................ 16 22 40 75 154 242 330
20.00.. 19.10 Short Pieces, Whole Style................................ 89 130 251 490 1040 1664 2285
8.50... 7.90 Short Pieces, Cut Style.................................. 41 59 111 212 444 706 966
1.75... 1.48 Edible Fiber............................................. 10 14 25 45 91 142 193
0.10... 0.05 Inedible Fiber........................................... 1 1 2 3 5 7 10
5.50... 5.00 Color Defectives......................................... 27 39 73 138 286 454 620
10.75.. 10.10 Character--``B''......................................... 50 72 138 266 561 894 1225
1.25... 1.02 Character--``C''......................................... 7 10 18 33 65 101 136
0.10... 0.05 Character--``SStd''...................................... 1 1 2 3 5 7 10
\1\ For unofficial samples. \2\ For use with small container sizes only. \3\ AQL calculated from tolerance (TOL) at 5200.
[[Page 37667]]
Table IIa.--Acceptance Numbers for Whole, and Cut Style Frozen Green Beans and Wax Beans (Grade B)
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Sample Units x Sample Unit
Size....................... 1 x 400 1.5 x 400 3 x 400 6 x 400 13 x 400 21 x 400 29 x 400
----------------------------------------------------------------------------------------------------------------
Units of Product............ \1\ 400 \2\ 600 1200 2400 5200 8400 11600
----------------------------------------------------------------------------------------------------------------
TOL AQL \3\ Quality factors
(6)
Accept
ance
number
s
--------------------------------------------------------------------------------------------------------------------------------------------------------
.50.... 0.366 Extraneous Vegetable Material............................ 3 4 8 13 26 40 53
1.50... 1.25 Stems.................................................... 8 12 21 39 78 122 165
2.50... 2.17 Major Blemishes.......................................... 13 19 34 64 130 204 278
6.75... 6.20 Total Blemishes (Major + Minor).......................... 33 47 88 169 352 559 763
6.00... 5.50 Mechanical Damage........................................ 30 42 79 151 314 498 680
N/A.... N/A Short Pieces, Whole Style................................ N/A N/A N/A N/A N/A N/A N/A
12.50.. 11.80 Short Pieces, Cut Style.................................. 58 84 160 309 652 1040 1426
4.50... 4.00 Edible Fiber............................................. 22 32 59 112 232 366 500
1.50... 1.25 Inedible Fiber........................................... 8 12 21 39 78 122 165
10.75.. 10.10 Color Defectives......................................... 50 72 138 266 561 894 1225
N/A.... N/A Character-- ``B''........................................ N/A N/A N/A N/A N/A N/A N/A
10.75.. 10.10 Character-- ``C''........................................ 50 72 138 266 561 894 1225
1.25... 1.02 Character-- ``SStd''..................................... 7 10 18 33 65 101 136
\1\ For unofficial samples.
\2\ For use with small container sizes only.
\3\ AQL calculated from tolerance (TOL) at 5200.
Table IIb.--Acceptance Numbers for Whole, and Cut Style Frozen Green Beans and Wax Beans (Grade C)
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Sample Units x Sample Unit
Size....................... 1 x 400 1.5 x 400 3 x 400 6 x 400 13 x 400 21 x 400 29 x 400
----------------------------------------------------------------------------------------------------------------
Units of Product............ \1\ 400 \2\ 600 1200 2400 5200 8400 11600
----------------------------------------------------------------------------------------------------------------
TOL AQL \3\ Quality factors
(6)Acce
ptance
number
s
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.00... 0.80 Extraneous Vegetable Material............................ 6 8 15 26 52 80 108
3.00... 2.60 Stems.................................................... 16 22 40 75 154 242 330
3.75... 3.30 Major Blemishes.......................................... 19 27 50 94 193 304 415
12.75.. 12.00 Total Blemishes (Major + Minor).......................... 58 85 162 314 663 1057 1449
10.75.. 10.10 Mechanical Damage........................................ 50 72 138 266 561 894 1225
N/A.... N/A Short Pieces, Whole Style................................ N/A N/A N/A N/A N/A N/A N/A
18.25.. 17.40 Short Pieces, Cut Style.................................. 82 119 230 448 950 1519 2085
8.50... 7.90 Edible Fiber............................................. 41 59 111 212 444 706 966
3.75... 3.30 Inedible Fiber........................................... 19 27 50 94 193 304 415
17.75.. 16.90 Color Defectives......................................... 80 116 224 435 923 1476 2027
N/A.... N/A Character--``B''......................................... N/A N/A N/A N/A N/A N/A N/A
N/A.... N/A Character--``C''......................................... N/A N/A N/A N/A N/A N/A N/A
10.75.. 10.10 Character--``SStd''...................................... 50 72 138 266 561 894 1225
\1\ For unofficial samples.
\2\ For use with small container sizes only.
\3\ AQL calculated from tolerance (TOL) at 5200.
Table III.--Acceptance Numbers for Short Cut, and Mixed Cut Style Frozen Green Beans and Wax Beans (Grade A)
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Sample Units x Sample Unit
Size....................... 1 x 400 1.5 x 400 3 x 400 6 x 400 13 x 400 21 x 400 29 x 400
----------------------------------------------------------------------------------------------------------------
Units of Product............ \1\ 400 \2\ 600 1200 2400 5200 8400 11600
----------------------------------------------------------------------------------------------------------------
TOL AQL \3\ Quality factors
(6)Acce
ptance
number
s
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.25... 0.162 Extraneous Vegetable Material............................ 2 2 4 7 13 19 26
0.75... 0.58 Stems.................................................... 5 6 11 20 39 60 81
1.25... 1.02 Major Blemishes.......................................... 7 10 18 33 65 101 136
3.75... 3.30 Total Blemishes (Major + Minor).......................... 19 27 50 94 193 304 415
3.00... 2.60 Mechanical Damage........................................ 16 22 40 75 154 242 330
1.75... 1.48 Edible Fiber............................................. 10 14 25 45 91 142 193
0.10... 0.05 Inedible Fiber........................................... 1 1 2 3 5 7 10
5.50... 5.00 Color Defectives......................................... 27 39 73 138 286 454 620
10.75.. 10.10 Character--``B''......................................... 50 72 138 266 561 894 1225
1.25... 1.02 Character--``C''......................................... 7 10 18 33 65 101 136
[[Page 37668]]
0.10... 0.05 Character--``SStd''...................................... 1 1 2 3 5 7 10
\1\ For unofficial samples.
\2\ For use with small container sizes only.
\3\ AQL calculated from tolerance (TOL) at 5200.
Table IIIa--Acceptance Numbers for Short Cut, and Mixed Cut Style Frozen Green Beans and Wax Beans (Grade B)
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Sample Units x Sample Unit
Size....................... 1 x 400 1.5 x 400 3 x 400 6 x 400 13 x 400 21 x 400 29 x 400
----------------------------------------------------------------------------------------------------------------
Units of Product............ \1\ 400 \2\ 600 1200 2400 5200 8400 11600
----------------------------------------------------------------------------------------------------------------
TOL AQL \3\ Quality factors
(6)Acce
ptance
number
s
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.50... 0.366 Extraneous Vegetable Material............................ 3 4 8 13 26 40 53
1.50... 1.25 Stems.................................................... 8 12 21 39 78 122 165
2.50... 2.17 Major Blemishes.......................................... 13 19 34 64 130 204 278
6.75... 6.20 Total Blemishes (Major + Minor).......................... 33 47 88 169 352 559 763
6.00... 5.50 Mechanical Damage........................................ 30 42 79 151 314 498 680
4.50... 4.00 Edible Fiber............................................. 22 32 59 112 232 366 500
1.50... 1.25 Inedible Fiber........................................... 8 12 21 39 78 122 165
10.75.. 10.10 Color Defectives......................................... 50 72 138 266 561 894 1225
N/A.... N/A Character--``B''......................................... N/A N/A N/A N/A N/A N/A N/A
10.75.. 10.10 Character--``C''......................................... 50 72 138 266 561 894 1225
1.25... 1.02 Character--``SStd''...................................... 7 10 18 33 65 101 136
\1\ For unofficial samples.
\2\ For use with small container sizes only.
\3\ AQL calculated from tolerance (TOL) at 5200.
Table IIIb.--Acceptance Numbers for Short Cut, and Mixed Cut Style Frozen Green Beans and Wax Beans (Grade C)
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Sample Units x Sample Unit
Size....................... 1 x 400 1.5 x 400 3 x 400 6 x 400 13 x 400 21 x 400 29 x 400
----------------------------------------------------------------------------------------------------------------
Units of Product............ \1\ 400 \2\ 600 1200 2400 5200 8400 11600
----------------------------------------------------------------------------------------------------------------
TOL AQL \3\ Quality factors
(6)
Accept
ance
number
s
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.00 .. 0.80 Extraneous Vegetable Material............................ 6 8 15 26 52 80 108
3.00 .. 2.60 Stems.................................................... 16 22 40 75 154 242 330
3.75 .. 3.30 Major Blemishes.......................................... 19 27 50 94 193 304 415
8.50 .. 7.90 Total Blemishes (Major + Minor).......................... 41 59 111 212 444 706 966
10.75 . 10.10 Mechanical Damage........................................ 50 72 138 266 561 894 1225
8.50 .. 7.90 Edible Fiber............................................. 41 59 111 212 444 706 966
3.75 .. 3.30 Inedible Fiber........................................... 19 27 50 94 193 304 415
17.75 . 16.90 Color Defectives......................................... 80 116 224 435 923 1476 2027
N/A ... N/A Character--``B''......................................... N/A N/A N/A N/A N/A N/A N/A
N/A ... N/A Character--``C''......................................... N/A N/A N/A N/A N/A N/A N/A
10.725. 10.10 Character--``SStd''...................................... 50 72 138 266 561 894 1225
\1\ For unofficial samples.
\2\ For use with small container sizes only.
\3\ AQL calculated from tolerance (TOL) at 5200.
Table IV--Acceptance Numbers for French Style Frozen Green Beans and Wax Beans Grade A
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sample Units x Sample Unit Size..................... 1 x 200 x 2.
5 1.5 x 200 x
2.5 3 x 200 x 2.
5 6 x 200 x 2.
5 13 x 200 x 2
.5 21 x 200 x .
5 29 x 00 x .5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grams of Product...................................... \1\ 500 \2\ 750 1500 3000 6500 10500 14500
--------------------------------------------------------------------------------------------------------------------------------------------------------
TOL AQL \3\ Quality factors
(6)
Accept
ance
number
s
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.25... 0.153 Extraneous Vegetable Material (No. of
Pieces)................................... 1 1 2 4 7 10 14
0.75... 0.541 Stems (No. of stems)....................... 3 4 6 11 20 30 41
1.25... 0.961 Major Blemishes (Grams).................... 10 15 25 43 83 128 170
2.50... 2.05 Total Blemishes [(Grams) Major + Minor].... 18 25 45 83 163 253 343
10.0 .. 9.0 Small pieces & odd cuts (Grams)............ 63 88 165 313 648 1025 1400
[[Page 37669]]
5.50... 4.80 Color Defectives (Grams)................... 38 50 95 175 358 563 765
N/A.... N/A Character--``B'' (Grams)................... N/A N/A N/A N/A N/A N/A N/A
6.75... 6.00 Character--``C'' (Grams)................... 45 63 115 215 440 695 945
1.75... 1.40 Character--`SStd'' (Grams)................. 13 18 33 58 115 178 240
\1\ For unofficial samples.
\2\ For use with small container sizes only.
\3\ AQL calculated from tolerance (TOL) at 2600.
Table IVa.--Acceptance Numbers for French Style Frozen Green Beans and Wax Beans (Grade B)
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sample Units x Sample Unit Size..................... 1 x 200 x 2.
5 1.5 x 200 x
2.5 3 x 200 x 2.
5 6 x 200 x 2.
5 13 x 200 x 2
.5 21 x 200 x 2
.5 29 x 200 x 2
.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grams of Product...................................... \1\ 500 \2\ 750 1500 3000 6500 10500 14500
--------------------------------------------------------------------------------------------------------------------------------------------------------
TOL AQL \3\ Quality factors
(6)Acce
ptance
number
s
--------------------------------------------------------------------------------------------------------------------------------------------------------
0.50... 0.325 Extraneous Vegetable Material (No. of
Pieces)................................... 2 2 4 7 13 20 26
1.50... 1.16 Stems (No. of stems)....................... 5 6 11 20 39 60 81
2.50... 2.05 Major Blemishes (Grams).................... 18 25 45 83 163 253 343
3.75... 53.20 Total Blemishes [(Grams) Major + Minor].... 25 38 65 120 245 383 520
15.0 .. 13.9 Small pieces & odd cuts (Grams)............ 90 128 243 465 978 1553 2125
10.75.. 9.80 Color Defectives (Grams)................... 68 95 178 338 703 1113 1520
N/A.... N/A Character--``B''........................... N/A N/A N/A N/A N/A N/A N/A
20.00.. 18.80 Character--``C'' (Grams)................... 118 168 320 620 1305 2078 2848
5.50... 4.80 Character--``SStd'' (Grams)................ 38 50 95 175 358 563 765
\1\ For unofficial samples.
\2\ For use with small container sizes only.
\3\ AQL calculated from tolerance (TOL) at 2600.
Table IVb.--Acceptance Numbers for French Style Frozen Green Beans and Wax Beans (Grade C)
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sample Units x Sample Unit Size..................... 1 x 200 x 2.
5 1.5 x 200 x
2.5 3 x 200 x 2.
5 6 x 200 x 2.
5 13 x 200 x 2
.5 21 x 200 x 2
.5 29 x 200 x 2
.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grams of Product...................................... \1\ 500 \2\ 750 1500 3000 6500 10500 14500
--------------------------------------------------------------------------------------------------------------------------------------------------------
TOL AQL \3\ Quality factors
(6)Acce
ptance
number
s
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.00... 0.733 Extraneous Vegetable Material (No. of
Pieces)................................... 3 4 8 13 26 40 53
3.00... 2.50 Stems (No. of stems)....................... 8 12 21 39 78 122 165
3.75... 3.20 Major Blemishes (Grams).................... 25 38 65 120 245 383 520
10.75.. 9.80 Total Blemishes [(Grams)Major + Minor]..... 68 95 178 338 703 1113 1520
20.0... 18.8 Small pieces & odd cuts (Grams)............ 118 168 320 620 1305 2078 2848
17.75.. 16.60 Color Defectives (Grams)................... 105 150 285 550 1158 1843 2523
N/A.... N/A Character--``B'' (Grams)................... N/A N/A N/A N/A N/A N/A N/A
N/A.... N/A Character--``C'' (Grams)................... N/A N/A N/A N/A N/A N/A N/A
12.50.. 11.50 Character--``SStd'' (Grams)................ 75 108 205 390 813 1293 1768
\1\ For unofficial samples.
\2\ For use with small container sizes only.
\3\ AQL calculated from tolerance (TOL) at 2600.
[[Page 37670]]
Sec. 52.2329 Sample size.
The sample size used to determine whether the requirements of these
standards are met shall be as specified in the sampling plans and
procedures contained in Secs. 52.1 through 52.83.
Sec. 52.2330 Quality requirement criteria.
(a) Lot inspection. A lot of frozen beans is considered as meeting
the requirements for quality if:
(1) The prerequisite requirements specified in Sec. 52.2326 and
Sec. 52.2328, Table I, are met; and
(2) None of the allowances for the individual quality factors
specified in Tables II, IIa, IIb, III, IIIa, IIIb, IV, IVa, and IVb of
Sec. 52.2328, as applicable for the style, are exceeded.
(b) Single sample unit. Each unofficial sample unit submitted for
quality evaluation will be treated individually and is considered as
meeting the requirements for quality if:
(1) The prerequisites requirements specified in Sec. 52.2326 and
Sec. 52.2328, Table I, are met; and
(2) The Acceptable Quality Levels in Tables II, IIa, IIb, III,
IIIa, IIIb, IV, IVa, and IVb of Sec. 52.2328, as applicable for the
style, are not exceeded.
Dated: July 11, 1996.
Robert C. Keeney,
Director, Fruit and Vegetable Division.
[FR Doc. 96-18176 Filed 7-18-96; 8:45 am]
BILLING CODE 3410-02-P
Complete official Federal Register PDF
FR Doc. 96-18139 Miscellaneous Provisions Relating to the Tax Treatment of Partnership Items; Procedure and Administration; OMB Control Numbers; Correction
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Page 37683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18139]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 301
[T.D. 8128]
Miscellaneous Provisions Relating to the Tax Treatment of
Partnership Items; Procedure and Administration; OMB Control Numbers;
Correction
AGENCY: Internal Revenue Service, Treasury.
ACTION: Correcting amendment.
-----------------------------------------------------------------------
SUMMARY: This document contains a correction to temporary regulations
(T.D. 8128), which were published in the Federal Register on Thursday,
March 5, 1987 (52 FR 6779) relating to certain rules for the tax
treatment of partnership items.
EFFECTIVE DATE: March 5, 1987.
FOR FURTHER INFORMATION CONTACT: D. Lindsay Russell (202) 622-3050,
(not a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
The temporary regulations that are the subject of this correction
is under sections 6221 thru 6233 of the Internal Revenue Code.
Need for Correction
As published, the temporary regulations (T.D. 8128) contains an
error which may prove to be misleading and is in need of clarification.
List of Subjects in 26 CFR Part 301
Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income
taxes, Penalties, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 301 is corrected by making the following
correcting amendment:
PART 301--PROCEDURE AND ADMINISTRATION
Paragraph 1. The authority citation for part 301 continues to read
in part as follows:
Authority: 26 U.S.C. 7805 * * *
Sec. 301.6231(a)(7)-1T [Correctly redesignated from
Sec. 301.6231(a)(7)-1]
Par. 2. Section 301.6231(a)(7)-1 is redesignated as
Sec. 301.6231(a)(7)-1T.
Michael L. Slaughter,
Acting Chief, Regulations Unit, Assistant Chief Counsel (Corporate).
[FR Doc. 96-18139 Filed 7-18-96; 8:45 am]
BILLING CODE 4830-01-P
Complete official Federal Register PDF
FR Doc. 96-18135 Use of Made in'' and Assembled in'' in One Country of Origin Marking Statement
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37678-37679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18135]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Customs Service
19 CFR Part 134
Use of ``Made in'' and ``Assembled in'' in One Country of Origin
Marking Statement
AGENCY: U.S. Customs Service, Department of the Treasury.
ACTION: General marking exception.
-----------------------------------------------------------------------
SUMMARY: This document advises the public of a general country of
origin marking exception that will be granted by Customs, commencing
August 5, 1996, for three months for imported foreign articles which
reach the ultimate purchaser in the United States containing a marking
with the words ``Made in,'' ``Product of,'' or words of similar
meaning, such as ``Knit in,'' along with the use of ``Assembled in'' in
a single country of origin marking statement.
EFFECTIVE DATE: August 5, 1996, through November 5, 1996.
FOR FURTHER INFORMATION CONTACT: Monika Rice, Special Classification
and Marking Branch, Office of Regulations and Rulings (202-482-6980).
SUPPLEMENTARY INFORMATION:
Background
Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304),
provides that, unless excepted, every article of foreign origin (or its
container) imported into the U.S. shall be marked in a conspicuous
place as legibly, indelibly, and permanently as the nature of the
article (or its container) will permit, in such a manner as to indicate
to the ultimate purchaser in the U.S. the English name of the country
of origin of the article. Part 134, Customs Regulations (19 CFR Part
134), implements the country of origin marking requirements and
exceptions of 19 U.S.C. 1304.
Customs previously has determined that the use of ``Made in,''
``Product of,'' or words of similar meaning, such as ``Knit in'' (when
the country of origin was the country in which an article was knit to
shape), along with the use of the words ``Assembled in'' in a single
country of origin marking statement, was acceptable for purposes of 19
U.S.C. 1304. These prior determinations were based upon Customs
position that the words, ``Assembled in'' were not a country of origin
marking indicator, except as provided for in 19 CFR 10.22 for articles
eligible for subheading 9802.00.80, Harmonized Tariff Schedule of the
United States (HTSUS), treatment.
[[Page 37679]]
See Headquarters Ruling Letter (HRL) 087271 dated January 17, 1991,
(the expressions ``Made in China, Assembled in Hong Kong'' or ``Knit in
China, Assembled in Hong Kong'' were acceptable under 19 U.S.C. 1304
and 19 CFR 134.46 indicating that the country of origin of sweaters was
China). But see HRL 733564 dated August 10, 1990 (the marking ``Made in
Canada'' needed to be removed from hoses manufactured in Canada, after
assembly with brass fittings in Mexico, as the country of origin of the
assembled article was Mexico pursuant to 19 CFR 10.22 and the article
could be marked ``Assembled in Mexico'').
Due to the confusion generated by 19 CFR 10.22 concerning when it
is acceptable to use the words ``Assembled in,'' in country of origin
marking, this section, effective August 5, 1996, will be removed from
the Customs Regulations as part of a final document which principally
implemented Annex 311 of the North American Free Trade Agreement (T.D.
96-48, 61 FR 28932, 28955, June 6, 1996). That final rule document also
included an amendment to 19 CFR 134.43(e) to provide for the use of the
phrases, ``Assembled in (country of final assembly),'' ``Assembled in
(country of final assembly) from components of (name of country or
countries of origin of all components),'' or ``Made in, or product of,
(country of final assembly),'' as methods of marking an imported
article when the country of origin of such article is determined to be
the country in which it was finally assembled.
Accordingly, for all goods entered, or withdrawn from warehouse,
for consumption on or after August 5, 1996, the country of origin
indicator, ``Assembled in,'' may be used for the marking of imported
articles only when the country of origin of that article is determined
to be the country in which the article was finally assembled. Whether
or not the article is eligible for entry under subheading 9802.00.80,
HTSUS, will not be relevant to the use of this marking.
Furthermore, as a result of the amendment of 19 CFR 134.43(e), the
terms ``Made in'' and ``Assembled in'' are always words of similar
meaning, and it will no longer be acceptable to use ``Made in,''
``Product of,'' or words of similar meaning, along with the words
``Assembled in'' in a single country of origin marking statement on
articles of foreign origin imported into the United States.
However, the marking statute and regulations allow for exceptions
to the marking requirements under certain circumstances. One of these
exceptions concerns articles which cannot be marked prior to, or after,
importation except at an expense that would be economically
prohibitive. See 19 U.S.C. 1304(a)(3) (C) and (K), and 19 CFR 134.32
(c) and (o).
In consideration of: (1) the fact that the use of ``Made in,''
``Product of,'' or words of similar meaning, along with the use of the
words ``Assembled in'' in a single country of origin marking statement
has been acceptable until the amendment of 19 CFR 134.43(e), and many
articles or labels containing such statements may have already been
made; (2) the expectation that many individual requests will be
received for marking exceptions on the ground of economic
prohibitiveness; and (3) the importance of providing uniform Customs
treatment, Headquarters has made a general finding under these
circumstances that it would be economically prohibitive to require the
marking of imported foreign articles (either before or after
importation) in compliance with 19 CFR 134.43(e), as amended, as of the
effective date of the new regulations. This general marking exception
shall be granted for all imported foreign articles marked ``Made in,''
``Product of,'' or words of similar meaning, such as ``Knit in,'' along
with the use of the words ``Assembled in'' in a single country of
origin marking statement, for a period not to exceed three (3) months
from the effective date of 19 CFR 134.43(e), as amended, (i.e., no
later than November 5, 1996), which Customs views as a reasonable
period of time for the exhaustion of existing inventory. Please note
that, if information is obtained that the above articles or labels were
made after August 5, 1996, this general marking exception will not
apply.
Dated: July 11, 1996.
Stuart P. Seidel,
Assistant Commissioner, Office of Regulations and Rulings.
[FR Doc. 96-18135 Filed 7-18-96; 8:45 am]
BILLING CODE 4820-02-P
Complete official Federal Register PDF
FR Doc. 96-18015 Procedures for Transportation Workplace Drug and Alcohol Testing Programs; Insufficient Specimens and Other Issues
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37693-37700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18015]
=======================================================================
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DEPARTMENT OF TRANSPORTATION
Office of the Secretary
49 CFR Part 40
[Docket OST-95-321]
RIN 2105-AC22
Procedures for Transportation Workplace Drug and Alcohol Testing
Programs; Insufficient Specimens and Other Issues
AGENCY: Office of the Secretary, DOT.
[[Page 37694]]
ACTION: Final rule.
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SUMMARY: The Department of Transportation is modifying its procedures
governing situations in which employees are unable to provide
sufficient specimens for urine drug testing. The changes will allow
additional time to collect a sufficient sample. In addition, the
Department is clarifying requirements concerning relationships between
laboratories and medical review officers; providing procedures for
situations in which employees do not have contact with medical review
officers following a laboratory-confirmed positive test; and making
explicit that MROs are to report split specimen test results to
employers, regardless of who pays for the test.
DATES: This rule is effective August 19, 1996.
FOR FURTHER INFORMATION CONTACT: Mary Bernstein, Director, Office of
Drug Enforcement and Program Compliance, 400 7th Street, SW., Room
10317, 202-366-3784; or Robert Ashby, Deputy Assistant General Counsel
for Regulation and Enforcement, 400 7th Street, SW., Room 10424. 202-
366-9306.
SUPPLEMENTARY INFORMATION:
``Shy Bladder''
Background
In the February 15, 1994, revision of 49 CFR Part 40 (59 FR 7340),
the Department established new ``shy bladder'' procedures, for
situations in which employees cannot provide a sufficient urine sample.
These procedures were established in conjunction with a reduction in
the required sample volume from 60 to 45 milliliters (ml) (for split
sample collections) or 30 ml (single specimen collections). For
employees who are unable to provide this reduced sample volume, the
rule (Sec. 40.25 (f)(10)(iv)) directs the collection site person to
``instruct the individual to drink not more than 24 ounces of fluid
and, after a period of up to two hours, again attempt to provide a
complete sample.'' If the individual cannot do so, the medical review
officer (MRO) is directed to ``refer the individual for a medical
evaluation to develop pertinent information concerning whether the
individual's inability to provide a specimen is genuine or constitutes
a refusal to test.'' (This referral is not mandated in the case of pre-
employment testing where the employer does not want to hire the
individual.)
There were several reasons for this action. First, the Department
of Transportation and the Department of Health and Human Services
(DHHS) had both received information indicating that forcing large
quantities of fluids over a longer period of time could result in water
intoxication (i.e., a condition resulting from rapid, copious water
intake, that may result in dilution of the plasma and an influx of
water into the brain), which if severe can result in harm to employees'
health (e.g., lethargy, confusion, or seizures). Second, ingesting
large quantities of fluids can help to dilute specimens, giving drug-
using employees a mechanism for trying to ``beat the test.'' Third, the
Department's Drug Enforcement and Program Compliance Office consulted
with the medical community, learning that most adults, in most
circumstances, could produce 45 ml of urine following the ingestion of
24 ounces of fluid over a two-hour period. Fourth, allowing up to eight
hours for testing had resulted in employees remaining off the job for
long periods of time, with consequent costs to employers, including
some employees who appeared to intentionally and unnecessarily delay
the provision of a specimen.
Since the adoption of this provision, employers, employees and MROs
have expressed various concerns to the Department. Since, absent an
adequate medical explanation, a ``shy bladder'' constitutes a refusal
to test, and a refusal to test is equivalent to a positive test,
program participants (especially in the railroad industry, where a
refusal to test results in a nine-month suspension) have become
concerned about the operation of this provision. The principal concern
expressed has been that two hours is too short a time to allow
employees to generate sufficient urine, particularly if employees have
become somewhat dehydrated on the job (e.g., railroad unions have said
that their members are sometimes on the job for several hours without
relief, with little fluid intake). Another concern is that the
regulation does not provide sufficient guidance on the factors on which
physicians should rely in determining whether the employee's inability
to provide a sufficient specimen is medically ``genuine.''
In response to these concerns, the Department proposed changing the
procedures to provide up to four hours for an employee to drink up to
40 ounces of fluid before making the second attempt to provide a
complete specimen (60 FR 38201; July 25, 1995). The employee would be
directed to drink 8 ounces of fluid each 30 minutes during this period
until the 40 ounce maximum is reached.
We also proposed to incorporate language from the parallel
provision of the alcohol testing procedures concerning the task of the
physician who evaluates the employee, in order to make the alcohol and
drug portions of Part 40 more consistent.
Comments: The Department received substantial comment on this
issue, from employers, employee organizations, and medical and testing
service providers. Thirty-five comments, mostly from employers and
testing service organizations, opposed the proposal to lengthen the
time period for collections. Several commenters mentioned that actual
shy bladder situations were very rare, meaning that there would be few
benefits gained from increasing the time period. On the other hand, a
number of commenters, particularly in the transit industry, expressed
the concern that the proposed increase to four hours would increase
costs for employers. Already, commenters said, some employees stretch
out the time spent at the collection site to the maximum two hours, in
order to avoid returning to work. If we increased the time, time
permitted for this gold-bricking would increase, raising lost-time
costs for employers. Some collection sites were concerned about having
to remain open longer after hours to accommodate longer shy bladder
situations, increasing their overtime and other operating costs. Two
medical service providers mentioned that an individual with a normally-
functioning urinary system should be able to provide a sufficient
sample under the existing rule.
Seventeen commenters, mostly employee organizations but also
including some testing service organizations and employers, supported
the proposed extension to four hours. They said this would avoid
situations, which had happened, of people being unable to provide a
sufficient sample in two hours. A longer time frame would also reduce
costs by eliminating unnecessary medical referrals, they said. Two
testing service industry commenters suggested that three hours would be
a reasonable middle ground, while two unions supported eight hours or
no time limit at all.
Twenty-one comments, mostly from unions but including some from
other sources, supported the NPRM's proposal of having the employee
drink 40 ounces of fluid. This would better allow employees to deal
with the effects of on-the-job dehydration, they said. One commenter
favored upping the fluids to 48 ounces. Twenty-five commenters, mostly
employers and testing service organizations, suggested smaller amounts
(e.g., 24 or 32 ounces). Some of
[[Page 37695]]
these commenters said that increasing the amounts was objectionable
because doing so went along with the extended time period, which they
opposed. One commenter thought that increasing the water amount could
lead to increased numbers of dilute specimens, while two commenters
thought 32 ounces provided a better margin of safety with respect to
water intoxication. Two comments suggested that the 8 ounces every 30
minutes schedule was too restrictive and difficult to supervise. One
commenter favored allowing an additional 8 ounces (or 30 minutes) when
an employee claimed dehydration.
Nine commenters favored, and 11 opposed, retaining the existing
requirement that employee make a first, unsuccessful attempt at
providing a complete sample before the shy bladder procedure and its
time period began. Opponents of this requirement, in other words, would
start the clock without a first collection attempt, when the employee
asserted at the beginning of the collection process that he or she
could not provide a sufficient sample. Two comments suggested allowing
a first, insufficient, specimen to be combined with a second specimen
to form a sufficient specimen as part of the same collection.
There were a number of comments on the subject of the medical
evaluations that follow a collection that does not result in a
sufficient specimen. The NPRM had suggested that only a medical
explanation pertaining to a physiological reason for the inability to
provide would be adequate, as distinct from an assertion of
``situational anxiety'' or other psychological causes. Three comments
on this point approved and three disagreed with the NPRM's suggestion.
One of the comments that favored limiting the basis for a medical
explanations to physiological causes did note, however, that there were
situations in which a psychological explanation might be sufficient
(e.g., a documented pre-existing condition, diagnosed before the
collection in question, that is represented in Diagnostic and
Statistical Manual IV).
One union objected to the provision of the NPRM that limits
examining physicians to those acceptable to the employer, and two
commenters supported having the employer, rather than the MRO,
directing the employee to have a post-collection medical evaluation.
Two commenters suggested that the employer should receive, from the
examining physician, only a conclusory statement about whether there
was an adequate medical explanation, rather than a complete diagnostic
work-up. This would help protect the confidentiality of medical
information. Three commenters said the medical evaluation should be
done promptly after the collection, and two suggested that refusal to
attend or cooperate with the evaluation should be regarded as a refusal
to test.
There were a number of comments on miscellaneous shy bladder-
related subjects. Two commenters supported making the language of the
provision parallel to that in the alcohol testing procedures. Two
commenters supported, and one opposed, specifying that refusing to
drink water, or other non-cooperation, constitutes a refusal to be
tested. One comment suggested specifying that only water, and not other
drinks, could be consumed. Others suggested using blood tests when
enough urine could not be produced and allowing collectors to proceed
to other collections while an employee was waiting and drinking before
a second attempt.
DOT Response: The basic purpose of the NPRM proposal was fairness
to employees. That is, if an employee is unable to produce a sufficient
quantity of urine within the two-hour period presently provided, giving
the employee a longer time to provide a specimen might allow the
employee to produce sufficient urine to avoid the necessity for a
medical evaluation and the possibility of a refusal finding. The most
significant objection to the proposal in the comments centered on the
perception by some employers that employees already spent the maximum
time possible at collection sites, apparently with the aim of being
paid for not working. If we said that employees could take four hours
to provide a sufficient sample, we could look forward to employees
taking twice as long off the job, while employers' costs mounted. In
addition, having to keep a collection site open for a longer time
(e.g., for an employee who came to the site at 4:30 p.m. and forced the
site to stay open until 8:30) would increase collection costs.
On the surface, these concerns are plausible. The comments to this
effect were impressionistic, however, and were not accompanied by data.
There is substantial uncertainty, therefore, about how factually based
these concerns are. Recently, the Substance Abuse Program
Administrators' Association (SAPAA) shared with us information from a
survey they conducted concerning the time it took to complete a DOT
collection. The survey results concerned about 18,800 tests conducted
over a two-week period at nearly 500 collection sites affiliated with
SAPAA. The mean time reported for a DOT urine collection, from the time
the employee started filling out the paperwork (not the time the
employee first walked into the collection site) until the time the
collection was completed and the employee was told he or she could
leave the site, was about 12.4 minutes.
About 1.7% of the collections took 90 minutes or more to complete,
and slightly less than a third of these took two hours or more. About
1.2% of the total number of tests were ``shy bladder'' situations, in
which a collection could not be completed because of insufficient
volume.
The results of this survey have some limitations. They are not
based on a statistically representative sample of collection sites or a
scientifically rigorous survey design, and some responses contain
ambiguities. They represent a two-week ``snapshot'' of the experience
of the particular collection sites that responded to SAPAA's request.
However, the data are suggestive with respect to the ``stretch-out''
issue raised by commenters.
That is, it does not appear that many tests were stretched out to
near or over the two-hour time frame of the existing rule. Indeed, the
average running time of tests was far short of the two-hour time frame
of the current regulation. Suppose that the time period for shy bladder
situations were three or four hours instead of two. Is it reasonable to
infer that tests that average 12.4 minutes in length (or even if they
averaged twice that duration) would suddenly jump to close to the new
maximum? If less than two percent of tests now exceed 90 minutes in a
two-hour time period, is it reasonable to infer that a much greater
percentage of tests would approach a three or four-hour time period?
The likelihood of such dramatic changes appears low. Consequently,
while there may be a number of individual instances of employees
seeking to prolong their time at collection sites in preference to
returning to the job, the available information suggests that this is
not a pervasive problem that would lead to prohibitive cost increases
if we provided additional time for collections.
Also, given that lengthy collections and shy bladder situations
appear to arise in a very small percentage of cases, it appears that
cost increases based on keeping collection sites open longer than usual
would probably be low. Some SAPAA survey responses, as well as
anecdotal information that DOT staff have received, suggests that some
collection sites may follow a practice of simply sending an employee
home when the normal closing time approaches, even if the employee has
[[Page 37696]]
not completed the collection process. This practice is contrary to the
rules. Once begun, a collection process must be completed. We also
recommend that collection sites begin to process employees as soon as
they arrive at the collection site. Some collection sites apparently
permit employees to wait a significant period of time before beginning
the collection process. Such waiting appears to create inefficiencies
and unnecessary costs in the system.
Given that we do not have any data, beyond anecdotal expressions of
concern, showing that stretched-out collections are a pervasive
problem, and that we have some data that suggest the contrary
conclusion, the Department believes the fairness rationale for
extending the collection time period is more persuasive, at this time,
than the cost rationale for not doing so. Consequently, the final rule
will extend the time period in ``shy bladder'' situations. In order to
minimize any potential adverse effects, the time period will be three
hours, rather than four as proposed in the NPRM. Given the medical
service provider comments about the speed of urine production, this
additional time should provide a comfortable margin of safety to
employees who may need additional time to generate a sufficient
specimen.
With respect to the amount of fluids to be consumed, the Department
will retain the 40 ounce level proposed in the NPRM. This amount could
as easily be consumed within a three-hour period as within a four-hour
period. As discussed in the preamble to the NPRM, the 40 ounce level is
appropriate, in light of evidence in the medical literature concerning
water intoxication. Compared to smaller amounts, it offers an enhanced
chance of assisting employees in providing a sufficient specimen. It is
sufficiently limited that the probability of it resulting in dilute
specimens is low. The Department will not mandate the proposed schedule
for drinking fluids (i.e., 8 ounces each half hour until the 40-ounce
level is reached), out of concern that it would make the collection
process unnecessarily complicated to administer. The rule will require
simply that the fluids be administered at reasonable intervals
throughout the three-hour period. While we anticipate that collection
sites will provide water in the vast majority of instances, the
Department does not think it necessary to prohibit the administration
of other appropriate fluids.
If an employee refuses to drink the water needed to produce a
sufficient specimen, it seems clear that the employee is failing to
cooperate with the testing process in a way that can frustrate its
completion. The same can be said of an employee who is directed to
report for a medical evaluation and either declines to do so or does
not comply with the directions of the physician in the course of the
examination. In both cases, the Department believes it is appropriate
to treat the employee's behavior as a refusal to be tested, which has
the same consequences as a positive test. The final rule so provides.
The issue of what constitutes an adequate medical explanation for a
failure to provide a sufficient specimen is one that ultimately must be
decided by the examining physician on a case-by-case basis. The final
rule clarifies the determination the physician must make by providing,
first, that a finding of a physiological cause (e.g., urinary system
dysfunction) for the insufficient specimen is a ground for making a
determination of an adequate medical explanation.
The rule also provides that there are some narrow and limited
circumstances in which a psychological explanation will suffice. This
is true only in a case where there is documentation of a diagnosed pre-
existing psychological disorder (i.e., one designated in DSM IV) that
can account for the failure to provide a complete specimen. By a pre-
existing disorder, the Department means one the symptoms of which were
documented before the shy bladder incident took place. This is to avoid
basing determinations solely on information developed after the fact of
the collection in question. Assertions of ``situational anxiety'' or of
dehydration are essentially unverifiable, and the final rule directs
physicians not to determine that there is an adequate medical
explanation based on such assertions.
The Department does not believe there is any compelling reason to
require the MRO, as distinct from the employer, to refer an individual
for a medical evaluation under this portion of the rules. The employer
may delegate this function to the MRO, and in many cases it might be
efficient to do so. In other cases, however, the MRO may not be
conveniently located to the employer and/or employee, and would not
know appropriate physicians in their vicinity. However, the evaluating
physician, if someone other than the MRO, would provide the results of
the evaluation to the MRO, rather than directly to the employer. The
MRO would then provide his or her conclusion to the employer, as under
the current rule.
Allowing urine from different voids to be combined increases the
possibility of error or contamination in the collection process, and
is, in any event, inconsistent with the DHHS guidelines. The Department
also declines to change the requirement that employees attempt to
provide a specimen at the beginning of the collection process. Forty-
five ml. is not a tremendous amount of urine. Many employees who do not
subjectively feel ready to do so may well be able to provide such an
amount. In any case, the failure of the first attempt to provide a
sufficient specimen is a clear, easily understandable point to start
the clock for the three hour time period for the shy bladder procedure.
A new collection kit would be used for the second or any subsequent
attempts at collecting a complete specimen.
The rule contemplates the following sequence of events. For
example, the employee arrives at the collection site at 1:45 p.m. The
employee and collection site person begin the testing process by
filling out the initial portions of the chain of custody and control
form. The collection site person directs the employee to go to the
bathroom and provide a specimen (whether or not the employee claims to
be ``ready'' to do so). The employee returns the collection container
to the collection site person.
It is now 2 p.m. If the employee asserts that he or she has tried
and failed to produce a specimen or the specimen is short of the
required amount of urine, the employee will have until 5 p.m. (i.e.,
three hours from the time the employee returned the initial collection
container to the collection site person) to drink up to 40 ounces of
fluid and make another attempt to provide a sufficient specimen. The
Department emphasizes that collection site personnel should not attempt
to hurry the process unreasonably. There have been instances in which,
by asking an employee to ``try again'' too soon, a collection site
person has created a situation in which the employee produces two or
three ``short'' specimens instead of one complete specimen. Collection
site personnel should take care to avoid this problem.
The Department believes that commenters made good suggestions
concerning limiting information provided to employers, allowing
collectors to work on other tests while an employee was waiting and
drinking, and requiring medical examinations to take place promptly
after the collection. The final rule incorporates these comments. On
the other hand, the Department believes it is necessary to retain the
requirement that the examining physician be acceptable to the employer.
Employers have the responsibility for the safety of their
[[Page 37697]]
operations and for compliance with the Department's rules. Employees
may have an incentive to shop for a friendly evaluation. The Department
has consistently declined to permit the use of blood tests in the
context of alcohol testing, and we believe, for much the same set of
reasons, that it is inadvisable in the context of drug testing. Under
the Omnibus Employee Testing Act of 1991 and Part 40, only urine drug
testing is permitted.
Body Temperature
Currently, Sec. 40.25(e)(1)(i) refers to measurements of oral body
temperature that are made as part of the process of determining whether
the temperature of a urine specimen is consistent with the temperature
of the employee. Because the reference to ``oral'' may unnecessarily
restrict the means used to test body temperature, since other ways of
taking body temperature (e.g., tympanic temperature) exist, the NPRM
proposed to delete the word ``oral,'' with the result that taking the
individual's temperature by any medically-accepted means (including
oral) would be permitted.
Eleven comments supported the proposal and none opposed it. Four
comments suggested that the use of rectal thermometers should be
precluded or limited, because of the intrusiveness and unpleasantness
of that method. We agree with these comments, and the final rule adopts
the proposal with that modification.
MRO/Laboratory Relationships
The NPRM contained a discussion of MRO/laboratory relationship
issues, including a proposal to delete Sec. 40.33(b)(2), which could
cause confusion in relation to the more recent and definitive language
of Sec. 40.29 (n)(6), which prohibits laboratory/MRO conflicts of
interest. The NPRM also asked questions about how the Department could
best frame regulatory provisions on this general subject.
The four commenters who mentioned the proposal to delete
Sec. 40.33(b)(2) all agreed with it. The Department is adopting this
proposal. Eleven commenters favored either existing provisions
requiring laboratories and MROs to be independent of one another or of
adding more stringent requirements on this subject. Some of these
commenters mentioned other relationships that concerned them, such as
those between MROs and consortia/third-party administrators,
collectors, or employers. On the other hand, six other commenters
favored liberalizing MRO/laboratory relationship rules, permitting
laboratories to refer MROs to clients, for example.
The marketplace for drug testing services has changed considerably
since the Department issued its original rules, with mergers producing
ever-larger laboratories and a strong trend towards integration of
services manifesting itself. While these changes are understandable in
economic terms, the Department is concerned lest checks and balances
fundamental to the fairness and integrity of the Department's rules be
compromised. In a forthcoming proposal to revise and update Part 40,
the Department anticipates taking a comprehensive look at the
relationships among MROs, laboratories, employers, consortiums and
third-party administrators, collection sites, and other parties in the
testing service business to determine how best to preserve needed
checks and balances. The Department is not taking further final action
at this time, however.
Unresolved Confirmed Positive Tests
Section 40.33 establishes procedures for MROs and employers to
follow when it is difficult for the MRO to contact an employee
following a report from the laboratory of a confirmed positive drug
test. If, after making all reasonable efforts to contact the employee,
the MRO cannot do so, the MRO asks a designated management official to
contact the employee. If the designated management official cannot do
so, then the employer may place the employee on medical leave or
similar status. The confirmed positive does not become a verified
positive--the only result having consequences under the rule--in this
situation. There can be a ``non-contact positive'' only if the employee
declines an opportunity to discuss the test with the MRO or the
employer has contacted the employee and the employee fails to contact
the MRO within five days. In the latter circumstances, the MRO can
reopen the verified positive test if there is a showing that illness,
injury, or other circumstances beyond the control of the employee
prevented a timely contact.
As noted in the NPRM, the Department has become aware of a
situation these procedures do not cover. If neither the MRO nor
employer ever succeeds in contacting the employee (e.g., the applicant
never gets back in touch with the employer in a pre-employment test
case, an employee quits or never shows up again following a random
test), a confirmed laboratory positive test is left in limbo, with no
way to verify it either as a positive or negative test. This creates
problems for MROs, who have the unresolved tests on their books
indefinitely.
This situation can also create problems for subsequent employers
and the Department's program. For example, under the Federal Highway
Administration's drug testing requirements (49 CFR Part 382), the new
employer is required to seek information on previous drug test results
from other employers. In the unresolved test situation described above,
however, a previous employer will not have a drug test result that it
can report, because only a verified positive or negative test can be
reported. The employee, in this case, may be able to obtain employment
with another employer because the ``limbo'' positive was never
reported.
To avoid this difficulty, the Department proposed to add language
to Sec. 40.33. In any situation where neither the MRO nor the employer
has been able to contact the employee within 30 days from the date the
MRO receives the confirmed positive test result from the laboratory,
the MRO would be instructed to verify the laboratory result positive
and report it to the employer as such. The same provisions allowing the
employee to reopen the verification would apply as in the case where
the employer did contact the employee and the employee failed to
contact the MRO within 5 days.
Twenty-eight commenters, all of whom were employers or testing
industry companies, favored the proposal, one mentioning that they
currently have 115 unresolved tests on record that they could close out
under such a provision. Only one commenter, a union, opposed it as too
harsh on workers. Of the supporters, nine favored the proposed 30-day
time period while the remaining 19 favored shorter periods, mostly
ranging from five to 15 days. The Department will adopt the proposal,
while reducing the time period to 14 days. This reduction is made in
the interest of safety, as well as to enable employers and others to
have reasonably expeditious closure in the process. A month seems like
an unnecessarily long time to hold such a case open: an employee who is
out of touch and unavailable for that amount of time likely does not
want to be contacted. On the other hand, the five-day period proposed
by some commenters (parallel to the time an employee is given to
contact the MRO after being told to do so) may be too short, since
employees might often have legitimate reasons for being out of contact
for that length of time. In any case, the employee will have the
opportunity to re-open the matter for good cause, as the NPRM provided.
[[Page 37698]]
Seven commenters supported, and three opposed, treating confirmed
opiate positives the same as confirmed positives for other drugs for
this purpose. While the MRO verification procedure is different for
opiates, the employee has an obligation in all cases to participate in
the verification process. Employees who, without adequate
justification, are unavailable to participate in the verification
process should be treated the same, regardless of the drug for which
they tested positive. For this reason, the Department will not
differentiate among drugs in this provision.
Some commenters made procedural suggestions concerning this
provision. For example, two commenters discussed sending certified mail
letters to employees to officially start the clock with respect to the
time period. While doing so may be a reasonable step for employers to
take, the Department will not require it, lest we introduce more
procedural complexity, and opportunity for administrative error, into
the system.
Reporting of Split Sample Results
Section 40.33 goes into some detail concerning the procedures the
MRO must follow concerning reporting the split specimen test results to
the employer and employee. The section is quite specific on the
consequences of a test of the split specimen that does not reconfirm
the positive result of the primary sample. However, the section does
not explicitly specify what the MRO does in the case of a split
specimen test that does reconfirm the positive result of the test of
the primary specimen. The Department has encountered situations in
which employees who have paid for the test of the split specimen have
objected to the MRO reporting the positive result to the employer. To
clarify that the Department intends that the result of the test of a
split specimen be reported to both the employer and the employee--
regardless of who pays for the test--the NPRM proposed to add language
to this effect.
Ten commenters, all employers and testing service companies,
supported the proposal, while two unions opposed it, saying that the
employee should be able to keep the report from the employer in this
circumstance. The Department does not agree with these latter two
comments. All drug testing results pertain to the safety of the
transportation services provided by employers. The employer is
responsible for compliance with these regulations. In the Department's
view, the employer, in order to perform its functions under DOT safety
rules, must have access to all results of the drug testing process. The
Department's rules do not specify who ultimately pays for testing
services, including tests of split specimens, but the identity of the
person making payment is irrelevant to how the results are treated
under the rules. Both the employer and the employee have a need to know
the outcome of all tests that are part of the system, and the final
rule adopts the NPRM proposal.
Program participants continue to raise a number of other questions
about carrying out the split sample requirements of Part 40. In the
Part 40 revision project, the Department will consider clarifying
changes to the regulatory text itself. Meanwhile, the Department would
like to take this opportunity to repeat guidance it has provided on
certain split sample-related issues.
First, when an employee makes a timely request to the MRO for a
test of the split specimen, the MRO is required to pass on the request
to the laboratory possessing the specimen, which is required to send
the specimen to a second DHHS-certified laboratory, which is required
to test the split specimen. The employer is responsible for making sure
that all actions required under the regulations occur. Consequently,
while the Department's rules do not specify who ultimately must pay the
cost of testing the split specimen, the employer is responsible for
ensuring payment in the first instance. For this reason, if the
employee chooses not to pay ``up front'' for the test of the split
specimen, the employer must ensure, nevertheless, that the test takes
place. An employer, MRO, or laboratory cannot require, as a
prerequisite to conducting the test of a split specimen, that the
employee first produce payment. Subsequently, the employer could seek
reimbursement from the employee.
Second, the rule is silent with respect to who chooses the second
laboratory at which the split specimen is tested. The rule does not
give employees a right to choose a particular laboratory (though such a
laboratory could be designated in a labor-management agreement). All
the rule requires is that the second laboratory be certified by DHHS;
whether it is chosen by the employer, employee, MRO, or first
laboratory does not matter from the point of view of Part 40.
Third, a technical problem that sometimes occurs in testing of
split samples is that samples may occasionally fail to reconfirm
because of differences in specific methodologies or equipment among
laboratories. Each laboratory has one or more methods for clearly
identifying drug metabolites in a specimen and dealing with impurities
in the specimen that may delay or interfere with clearly identifying
the metabolites (so-called ``derivitization'' methods). The chemical
composition of urine samples differs from one specimen to another,
however, and may change with the age of the specimen. The
derivitization method used by a given laboratory may, on infrequent
occasions, not work well enough on a particular specimen to identify a
drug metabolite clearly enough to meet quality control guidelines that
tell the laboratory when they may call a test positive.
If Laboratory A has identified the primary specimen as positive,
but Laboratory B, because of the problem described above, believes that
the drug or metabolite is present in the split specimen but cannot call
it positive, is it appropriate for Laboratory B to send it to
Laboratory C for further analysis?
DOT and DHHS representatives, at a November 1995 conference with
laboratory representatives, said that, in such a situation, after
consultation with the MRO, referral to Laboratory C was appropriate.
Reconfirmation by Laboratory C would be recognized under Part 40. To
avoid the necessity for such a procedure, the Department strongly
recommends that participants take care to ensure that the laboratory
that tests the split specimen be one that uses the same methods as the
laboratory that determined that the primary specimen was positive.
Electronic Signatures
The NPRM asked for comments on the issue of the use of electronic
signatures in the drug and alcohol testing process (e.g., to sign
alcohol testing forms). In the NPRM, the Department noted that, in an
electronic signature system, an individual (e.g., the employee taking
an alcohol test) using a pen-like stylus signs an electronic pad
connected to a computer system (e.g., attaching the electronic
signature to an electronic version of the alcohol testing form). The
signature is recorded electronically by the computer system and
incorporated into a data base, without any technical need for a paper
signature or printout.
The NPRM noted a number of issues that this kind of application may
raise in the context of the Department's testing programs. For example,
Part 40 currently calls for signatures on a multiple-copy paper form,
and does not provide for the use of electronic signatures. Copies of
the form are distributed to various parties (e.g., the employer,
employee, laboratory, MRO). It is unclear how a ``paperless'' system
[[Page 37699]]
would provide equivalent service. While one could presumably use an
electronic signature device in something short of a literally paperless
system, combining electronic signatures with a system using paper forms
creates its own set of questions. For example, would there be both a
paper and an electronic signature? Would an electronic signature
somehow be transferred to the paper form? What efficiencies are gained
if one has both an electronic and paper signature?
The NPRM also mentioned issues concerning the security and
identification of electronic signatures. What kinds of technical
requirements (e.g., electronic encryption for signatures, computer
security software) and operational safeguards (e.g., access
restrictions) should surround their use? Should such controls be part
of DOT regulations? Are there industry consensus standards that have
been or could be developed to address these issues, to which DOT rules
could refer? What are the electronic equivalents of the physical
security measures and controls the Department requires for paper
records?
Six commenters to the NPRM favored the use of these technologies,
and four others thought the idea was worth exploring. Several
commenters in both categories mentioned a number of issues, such as
security, legal sufficiency of electronic signatures, confidentiality
safeguards, etc., that should be worked out. It is fair to say that the
comments did not thoroughly address the questions and concerns the
Department has on this issue.
The Department believes that electronic signature technology has
promise, and that, together with industry, we should continue to
explore and discuss its use in the DOT alcohol and drug testing
program. Meanwhile, we emphasize that pen-and-ink signatures on hard
copy forms are mandatory in the program. The use of electronic
signatures by any participant in the program (e.g., the collector,
donor, BAT, STT, MRO, certifying scientist) is not currently
authorized. Any testing services company that uses electronic
signatures is acting contrary to the express requirements of DOT
regulations, and employers who use the services of a testing services
company that uses electronic signatures are out of compliance with
these rules.
Regulatory Analyses and Notices
This is not a significant rule under Executive Order 12866 or under
the Department's Regulatory Policies and Procedures. There are not
sufficient Federalism implications to warrant the preparation of a
Federalism Assessment. The Department certifies that this rule will not
have a significant economic impact on a substantial number of small
entities. The basis of this certification is that the changes to the
shy bladder procedure, as noted above, are unlikely to significantly
increase program costs for regulated entities, and the other changes to
the rule are minor or technical and should not have any measurable cost
impacts.
List of Subjects in 49 CFR Part 40
Alcohol testing, Drug testing, Laboratories, Reporting and
recordkeeping requirements, Safety, Transportation.
Issued this 9th day of July, 1996, at Washington, DC.
Federico Pena,
Secretary of Transportation.
For the reasons set forth in the preamble, 49 CFR Part 40 is
amended as follows:
PART 40--[AMENDED]
1. The authority citation for Part 40 is revised to read as
follows:
Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, 45101-
45106.
2. Section 40.25 is amended by removing the word ``oral'' from
paragraph (e)(2)(i)(A) and paragraph (e)(2)(i)(B), and adding after the
word ``temperature,'' in paragraph (e)(2)(1)(A), the following words:
``(taken by a means other than use of a rectal thermometer)''.
3. Section 40.25(f)(10)(iv) is revised to read as follows:
Sec. 40.25 Specimen collection procedures.
* * * * *
(f) * * *
(10) * * *
(iv)(A)(1) In either collection methodology, upon receiving the
specimen from the individual, the collection site person shall
determine if the specimen has at least 30 milliliters of urine for a
single specimen collection or 45 milliliters of urine for a split
specimen collection.
(2) If the individual has not provided the required quantity of
urine, the specimen shall be discarded. The collection site person
shall direct the individual to drink up to 40 ounces of fluid,
distributed reasonably through a period of up to three hours, or until
the individual has provided a new urine specimen, whichever occurs
first. If the employee refuses to drink fluids as directed or to
provide a new urine specimen, the collection site person shall
terminate the collection and notify the employer that the employee has
refused to submit to testing.
(3) If the employee has not provided a sufficient specimen within
three hours of the first unsuccessful attempt to provide the specimen,
the collection site person shall discontinue the collection and notify
the employer.
(B) The employer shall direct any employee who does not provide a
sufficient urine specimen (see paragraph (f)(10)(iv)(A)(3) of this
section) to obtain, as soon as possible after the attempted provision
of urine, an evaluation from a licensed physician who is acceptable to
the employer concerning the employee's ability to provide an adequate
amount of urine.
(1) If the physician determines, in his or her reasonable medical
judgment, that a medical condition has, or with a high degree of
probability, could have, precluded the employee from providing an
adequate amount of urine, the employee's failure to provide an adequate
amount of urine shall not be deemed a refusal to take a test. For
purposes of this paragraph, a medical condition includes an
ascertainable physiological condition (e.g., a urinary system
dysfunction) or a documented pre-existing psychological disorder, but
does not include unsupported assertions of ``situational anxiety'' or
dehydration. The physician shall provide to the MRO a brief written
statement setting forth his or her conclusion and the basis for it,
which shall not include detailed information on the medical condition
of the employee. Upon receipt of this statement, the MRO shall report
his or her conclusions to the employer in writing.
(2) If the physician, in his or her reasonable medical judgment, is
unable to make the determination set forth in paragraph
(f)(10)(iv)(B)(1) of this section, the employee's failure to provide an
adequate amount of urine shall be regarded as a refusal to take a test.
The physician shall provide to the MRO a brief written statement
setting forth his or her conclusion and the basis for it, which shall
not include detailed information on the medical condition of the
employee. Upon receipt of this statement, the MRO shall report his or
her conclusions to the employer in writing.
* * * * *
4. Section 40.33 is amended by removing and reserving paragraph
(b)(2), by revising paragraphs (c)(5) and (c)(6), by designating the
existing text of paragraph (f) as paragraph (f)(1), and by adding
(f)(2) to read as follows:
Sec. 40.33 Reporting and review of results.
* * * * *
(c) * * *
[[Page 37700]]
(5) The MRO may verify a test as positive without having
communicated directly with the employee about the test in three
circumstances:
(i) The employee expressly declines the opportunity to discuss the
test;
(ii) Neither the MRO nor the designated employer representative,
after making all reasonable efforts, has been able to contact the
employee within 14 days of the date on which the MRO receives the
confirmed positive test result from the laboratory;
(iii) The designated employer representative has successfully made
and documented a contact with the employee and instructed the employee
to contact the MRO (see paragraphs (c)(3) and (c)(4) of this section),
and more than five days have passed since the date the employee was
successfully contacted by the designated employer representative.
(6) If a test is verified positive under the circumstances
specified in paragraph (c)(5) (ii) or (iii) of this section, the
employee may present to the MRO information documenting that serious
illness, injury, or other circumstances unavoidably prevented the
employee from being contacted by the MRO or designated employer
representative (paragraph (c)(5)(ii) of this section) or from
contacting the MRO (paragraph (c)(5)(iii) of this section) within the
times provided. The MRO, on the basis of such information, may reopen
the verification, allowing the employee to present information
concerning a legitimate explanation for the confirmed positive test. If
the MRO concludes that there is a legitimate explanation, the MRO
declares the test to be negative.
* * * * *
(f) (1) * * *
(2) If the analysis of the split specimen is reconfirmed by the
second laboratory for the presence of the drug(s) or drug
metabolites(s), the MRO shall notify the employer and employee of the
results of the test.
* * * * *
[FR Doc. 96-18015 Filed 7-18-96; 8:45 am]
BILLING CODE 4910-62-P
Complete official Federal Register PDF
FR Doc. 96-17924 Technical Amendments to Test Rules and Enforceable Testing Consent Agreements/Orders
[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)]
[Rules and Regulations]
[Pages 37685-37686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17924]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[OPPTS-40029; FRL-5378-3]
Technical Amendments to Test Rules and Enforceable Testing
Consent Agreements/Orders
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA has approved by letter certain modifications to test
standards and schedules for chemical testing programs under section 4
of the Toxic Substances Control Act (TSCA). These modifications,
requested by test sponsors, will be incorporated and codified in the
respective test regulations or enforceable testing consent agreements/
orders. Because these modifications do not significantly alter the
scope of a test or significantly change the schedule for its
completion, EPA approved these requests without seeking notice and
comment. EPA annually publishes a rule describing all of the
modifications granted by letter for the previous year.
EFFECTIVE DATE: This rule shall take effect on July 19, 1996.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Rm. E-543B, 401 M St., SW., Washington, DC
20460, (202) 554-1404, TDD (202) 554-0551. Internet Address: TSCA-
H[email protected].
SUPPLEMENTARY INFORMATION: EPA issued a rule published in the Federal
Register of September 1, 1989 (54 FR 36311), amending procedures in 40
CFR part 790 for modifying test standards and schedules for test rules
and enforceable testing consent agreements/orders under section 4 of
TSCA. The amended procedures allow EPA to approve requested
modifications which do not alter the scope of a test or significantly
change the schedule for its completion. These modifications are
approved by letter without public comment. The rule also requires
immediate placement of these letters in EPA's public files and
publication of these modifications in the Federal Register. This
document includes modifications approved from January 1, 1995 through
December 31, 1995. For a detailed description of the rationale for
these modifications, refer to the submitters' letters and EPA's
responses in the public record for this rulemaking.
I. Discussion of Modifications
Each chemical discussed in this rule is identified by a specific
CAS number and docket number. Copies of correspondence relating to
specific chemical modifications may be found in docket number (OPPTS-
40029) established for this rule. The following table lists all
chemical-specific modifications approved from January 1, 1995 through
December 31, 1995.
Modifications to Test Standards and Enforceable Testing Consent Agreements/Orders
(January 1, 1995 Through December 31, 1995)
----------------------------------------------------------------------------------------------------------------
Chemical/CAS Number CFR Cite Test Modifications Docket No
----------------------------------------------------------------------------------------------------------------
Final Rule(s).....................
Drinking Water Contaminants.....
1,1,2,2-Tetrachloroethane/CAS 799.5075 14-day oral subacute 5 40029/42111J
No. 79-34-5. testing
Enforceable Testing Consent
Agreement(s)/Order(s).
Bisphenol A diglycidyl ether / 799.5000 Reproductive toxicity 5 40029/42168A
CAS No. 1675-54-3. testing
Cyclohexane/CAS No. 110-82-7.... 799.5000 90-day subchronic 9 40029/42094E
inhalation toxicity
tests
................................ Dermal absorption 5,9
study
................................ Dermal sensitization 5
study
................................ Acute SCOB test 9
standard
n-Butyl acetate/CAS No. 123-86-4 799.5000 In vivo hydrolysis 7 40029/42138B
protocol
----------------------------------------------------------------------------------------------------------------
Modifications
1. Modify sampling schedule.
2. Change test substance (form/purity).
3. Change non-critical test procedure or condition.
4. Add satellite group for further testing.
5. Extend test or protocol deadline, delete test initiation
date.
6. Clarify and/or add specific guideline requirement.
7. Alter specific guideline requirement approved for certain
test(s).
8. Correct CAS No.
9. Amend test standard.
10. Neurotoxicity endpoint rule.
11. Revise protocol.
Note: Only modifications under numbers 5, 7, and 9 in the
above table were approved in 1995.
[[Page 37686]]
II. Public Record
EPA has established a public record for this rulemaking under
docket number OPPTS-40029. The record includes the information
considered by EPA in evaluating the requested modifications. The record
is available for inspection from 12:00 noon to 4 p.m., Monday through
Friday, excluding legal holidays, in the TSCA Nonconfidential
Information Center, U.S. EPA, Rm. NE-B607, 401 M St., SW., Washington,
DC 20460.
III. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), it has
been determined that this action is not ``significant'' pursuant to the
terms of this Executive Order because the modifications to the subject
testing actions do not impose any additional requirements on the
public. This action is therefore not subject to review by the Office of
Management and Budget (OMB).
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), I
hereby certify that this action will not have a significant economic
impact on a substantial number of small entities because the
modifications do not significantly alter the scope of a test or
significantly change the schedule for its completion and because these
modifications were made at the request of a member of the regulated
community.
C. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.
L. 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. This rule does not impose any
Federal mandates on any State, local, or tribal governments or the
private sector within the meaning of the Unfunded Mandates Reform Act
of 1995.
D. Paperwork Reduction Act
The information collection requirements associated with this rule
have been approved by OMB under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 350l et. seq. and have been assigned OMB
control number 2070-0033 (EPA ICR No. 1139). EPA has determined that
this rule does not change existing recordkeeping or reporting
requirements nor does it impose any additional recordkeeping or
reporting requirements on the public.
E. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
a report containing this rule and other required information to the
U.S. Senate, the U.S. House of Representatives and the Comptroller
General of the General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects in 40 CFR Part 799
Environmental protection, Chemicals, Chemical export, Hazardous
substances, Recordkeeping and Reporting Requirements, Testing.
Dated: June 28, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR part 799 is amended as follows:
PART 799--[AMENDED]
1. The authority citation for part 799 continues to read as
follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
2. In Sec. 799.5075 by revising paragraphs (c)(1)(ii)(A) and (d) to
read as follows:
Sec. 799.5075 Drinking Water Contaminants Subject to Testing.
* * * * *
(c) * * *
(1) * * *
(ii) * * * (A) Each subacute test shall be completed and
the final report submitted to EPA within 12 months of the date
specified in paragraph (d)(1) of this section, except for 1,1,2,2-
tetrachloroethane. The subacute testing for 1,1,2,2-tetrachloroethane
shall be completed and the final report submitted to EPA by December
15, 1995.
* * * * *
(d) Effective date. (1) This section is effective on December 27,
1993 except for paragraphs (a)(1), (a)(2), (c)(1)(i)(A), (c)(1)(ii)(A),
(c)(1)(ii)(B), (c)(2)(i)(A), and (c)(2)(ii)(A). The effective date for
paragraphs (a)(2), (c)(1)(ii)(B) and (c)(2)(ii)(A) is September 29,
1995. The effective date for paragraphs (a)(1), (c)(1)(i)(A), and
(c)(2)(i)(A) is February 27, 1996. The effective date for paragraph
(c)(1)(ii)(A) is July 19, 1996.
(2) The guidelines and other test methods cited in this section are
referenced as they exist on the effective date of the final rule.
[FR Doc. 96-17924 Filed 7-18-96; 8:45 am]
BILLING CODE 6560-50-F
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