issue-1996-04-05•Federal Register final rules — 1996-04-05
Federal Register final rules — 1996-04-05
issue-1996-04-05Federal Register final rules — 1996-04-05Regulation
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. 96-8471 Animal and Plant Health Inspection Service
[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Rules and Regulations]
[Pages 15180-15184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8471]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 98
[Docket No. 94-006-2]
Importation of Embryos From Ruminants and Swine From Countries
Where Rinderpest or Foot-and-Mouth Disease Exists
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations to allow, under specified
conditions, the importation of embryos from all ruminants, including
cervids, camelids, and all species of cattle, and from swine from
countries where rinderpest or foot-and-mouth disease exists. The
regulations currently provide for importing only embryos from certain
species of cattle in countries where rinderpest or foot-and-mouth
disease exists. Research now indicates that embryos from all species of
cattle, from ruminants other than cattle, and from swine, which are
produced, collected, and handled under certain conditions in countries
where rinderpest or foot-and-mouth disease exists, can be imported with
virtually no risk of introducing communicable diseases of livestock
into the United States. This action will make additional sources of
genetic material available to domestic animal breeders.
EFFECTIVE DATE: April 5, 1996.
FOR FURTHER INFORMATION CONTACT: Dr. Roger Perkins, Staff Veterinarian,
Import Animals Program, National Center for Import and Export, VS,
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231, (301) 734-
8170.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 98 (referred to below as the
regulations) govern the importation of animal germ plasm so as to
prevent the introduction of contagious diseases of livestock or poultry
into the United States. Subpart A of part 98 applies to ruminant and
swine embryos from countries free of rinderpest and foot-and-mouth
disease (FMD), and to embryos of horses and asses. Subpart B applies to
certain cattle embryos from countries where rinderpest or FMD exists.
Subpart C applies to certain animal semen.
Subpart B currently allows for the importation of embryos from
cattle (Bos indicus and Bos taurus) from countries where rinderpest or
FMD exists only if embryos are produced, collected, and handled under
certain conditions. However, research 1 has demonstrated that the
same conditions effectively ensure that embryos from all species of
cattle, and from swine, and from ruminants other than cattle, including
camelids and cervids, can also be imported into the United States from
countries where rinderpest or FMD exists without significant risk of
introducing these diseases.
\1\ Information about pertinent research may be obtained from
the Animal and Plant Health Inspection Service, Veterinary Services,
National Center for Import-Export, 4700 River Road Unit 38,
Riverdale, Maryland 20737-1231.
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At this time, only Bos indicus and Bos taurus cattle embryos may be
imported into the United States from countries where rinderpest or FMD
exists. The available gene pool for swine and ruminants other than
cattle cannot be enlarged by using embryos from animals in countries
where rinderpest or FMD exists. Because of this, U.S. livestock
interests, except cattle-related interests, cannot fully participate in
the growing international market in germ plasm.
On June 6, 1995, we published in the Federal Register (60 FR 29781-
29784, Docket No. 94-006-1) a proposal to amend the regulations in
subpart B to allow embryos from all ruminants, including cervids and
camelids, from countries where rinderpest or FMD exists, to be imported
into the United States under the same conditions under which Bos
indicus and Bos taurus cattle embryos may be imported from those
countries into the United States. Also, we proposed to amend the
regulations in subpart B to allow embryos from swine from countries
where rinderpest or FMD exists to be imported into the United States
under conditions that are the same as those for Bos indicus and Bos
taurus cattle embryos, except with respect to the specific diseases for
which we would screen.
We solicited comments concerning our proposal for 60 days ending
August 7, 1995. We received 30 comments by that date. They were from
individuals and groups involved with veterinary medicine, from a State
Department of Agriculture, and from individuals, businesses, and
associations interested in artificial insemination (AI).
Of the 30 comments received, 2 were supportive. Of the others, 23
were identical form letters. The issues raised in these comments are
discussed below by topic.
Treatment-Based Import Conditions
Most of the comments stated that our regulations for importing
embryos should be completely revised. The commenters advocated a
treatment-based approach to preventing the importation of disease via
embryos, rather than the disease prevention/disease avoidance system we
now have, which is based on serologic testing.
We have carefully considered these comments. We are constantly
reviewing our regulations to ensure that they reflect the latest proven
technology and are as effective as possible. The proposed regulations
published in June, 1995, included the regulatory changes we believe are
technically sound and most needed and desirable at this time. However,
we intend to review all the regulations in part 98. At that time, we
will consider whether we should adopt a treatment-based approach for
any diseases. If we determine that changes are warranted, we will
publish proposed regulations for public comment in the Federal
Register.
Applying Same Requirements to Other Species
Our regulations currently apply only to embryos from Bos taurus and
Bos indicus cattle from countries where foot-and-mouth disease or
rinderpest exists. Many of the commenters questioned the scientific
basis for our proposal to allow importation of other species and
expressed the belief that it would cause ``undue risk'' or that it was
``not without risk.''
Our regulations require embryos for importation to be washed.
Washing removes some disease agents. It is correct that the washing
procedures required under our regulations have not been tested for
efficacy against all disease agents specific to swine, or against all
disease agents of all species of ruminants. However, this is not
necessary as our regulations are based on serologic testing of the
donor animals. Under proposed Sec. 98.15, we would require donor dams
to be obtained from herds which have been free of all diseases of
concern for at least 1 year before embryo collection and require donor
dams to be tested and found free of all diseases of concern. In this
way we would ensure that embryos from donor animals are free of
diseases which would pose a disease threat to U.S. livestock.
Washing Embryos With Trypsin
Many of the commenters suggested we amend the regulations to
require that
[[Page 15181]]
bovine embryos be washed with trypsin. Trypsin is an enzyme. It weakens
the attachment between infectious bovine rhinotracheitis virus (IBRV)
and embryos. Washing embryos with water alone removes other disease
agents of concern to APHIS; adding trypsin allows IBRV to be removed.
Our regulations require embryos for importation into the United
States to be washed at least 10 times (see Sec. 98.17(f)(3)). The
regulations do not require washing with trypsin--any importer may use
trypsin if he or she wishes to. We do not believe it is desirable at
this time to require all embryos to be washed with trypsin. Although
trypsin offers protection against IBRV, we do not believe the cost of
requiring it to be used for all bovine embryos is justified.
Under our current regulations, however, we may require specific
embryos to be washed with trypsin. Section 98.17, paragraph (f)(6)
states: ``The Administrator may require additional measures to be taken
in processing embryos after collection (for example, adding trypsin to
the washes) if he or she determines that such measures are necessary to
ensure the embryos freedom from infectious agents that may cause
communicable diseases.'' As stated in Sec. 98.17(f)(6), circumstances
that may result in such additional measures being required include, but
are not limited to: (1) The existence of communicable diseases of
livestock, other than the diseases specifically listed, in the country
of origin, and (2) a high prevalence or an increase in the incidence of
a communicable disease in the country of origin.
Diseases of Concern
One commenter objected to our listing vesicular stomatitis as a
``disease of concern'' in Sec. 98.15 of the proposed rule because
vesicular stomatitis is present in the United States. We agree that
vesicular stomatitis is present in the United States. Brucellosis and
tuberculosis, also listed in our proposed rule as ``diseases of
concern'' are also present in the United States. These are diseases for
which we have Federal or Federal-State cooperative control and
eradication programs. We want to prevent the importation of embryos
which could transmit vesicular stomatitis, brucellosis, or tuberculosis
to livestock in this country. Infected embryos imported into this
country would be additional sources of infection. This would make it
more difficult to control and eradicate these diseases in the United
States. For this reason, we are making no changes in the proposed
regulations based on this comment.
One commenter asked us to test imported embryos for diseases in
addition to those listed in the proposed regulations as ``diseases of
concern.'' Another commenter stated that scrapie should be included as
a ``disease of concern.'' This same commenter also stated that the
regulations should include safeguards to ensure that swine embryos
cannot transmit pseudorabies or any other virus.
The diseases listed in the regulations are those we consider the
most dangerous. We require serologic testing and other measures to
ensure that embryos that could transmit these diseases are not imported
(see Secs. 98.14 through 98.17 of the current regulations, and proposed
Secs. 98.15). With regard to pseudorabies, Sec. 98.15(a) of our
proposal lists pseudorabies as a disease of concern for swine. With
regard to scrapie, we have published proposed regulations designed to
ensure that embryos which could transmit scrapie are imported into the
United States under conditions where they do not pose a threat to the
health of livestock in the United States (see Docket No. 94-085-2,
published May 11, 1995, at 60 FR 25151-25162).
In addition to the diseases listed in the regulations, we test
embryos for other diseases if other diseases exist in the country of
origin that could pose a threat to U.S. livestock. For these reasons,
we do not believe our proposed regulations need to be amended based on
these comments.
On-Site Compliance
One commenter suggested we add specific on-site compliance
validation procedures to ensure that imported embryos have been
prepared and shipped properly. Other commenters stated that we need to
amend our regulations to provide for enforcement of import protocols.
We have carefully considered these comments and determined that
changes in the regulations are warranted. We are therefore amending
Secs. 98.16 and 98.17(b). Section 98.16 is amended to require that an
APHIS veterinarian inspect and approve embryo collection units as
meeting our requirements. Requirements for embryo collection units are
listed in Sec. 98.16. However, the regulations have not included any
mechanism for ensuring that the requirements are met. We believe this
deficiency in the regulations will be corrected by this amendment. We
are also amending Sec. 98.17(b) to require that an APHIS veterinarian
supervise all stages of embryo collection and processing. Section
98.17(b) provides that an ``official veterinarian'' must supervise
embryo collection. An ``official veterinarian'' is either an APHIS
veterinarian or a full-time salaried veterinarian of the national
government of the country of origin. We believe not only that an APHIS
veterinarian can best perform this function, but that when an APHIS
veterinarian supervises the work, we can better verify, on-site, that
requirements and procedures are met. We are further amending
Sec. 98.17, paragraphs (b) and (g), to specify that an APHIS
veterinarian must supervise, in person, certain procedures. Included
are collecting, pooling, freezing, and sending test samples to the
Foreign Animal Disease Diagnostic Laboratory, and collecting,
processing, and storing embryos. These are the crucial stages of embryo
collection and processing. We believe they require the closest possible
supervision to ensure that requirements and procedures are met.
Publish Import Protocols
Commenters stated that import protocols for individual countries
should be ``mentioned'' in the regulations and that APHIS should
consider all diseases present in the country of origin. Import
protocols for individual countries do take into account all diseases
that are present in that country. Import protocols are constantly
changed, sometimes daily, depending on the disease situation in that
country, the requirements of foreign governments, and many other
factors. Protocols exist for numerous countries. At the time an
importer applies for an import permit, he or she is given up-to-date
information on the particular import requirements that apply to the
embryos they wish to import. Our offices also provide current
information to anyone who calls or writes concerning the protocols for
a particular country. Under these circumstances, we do not believe the
regulations need to be changed based on these comments.
Emergency Preparedness and Post-Entry Surveillance
Several commenters stated that APHIS needs to be adequately
prepared to handle a foreign animal disease outbreak in the United
States.
Our regulations are designed to offer multiple levels of security.
One level consists of requirements designed to prevent the introduction
of foreign animal diseases into the United States. The regulations in
this rulemaking are in this category. Another level consists of
requirements designed to control and eradicate livestock and poultry
diseases
[[Page 15182]]
within the United States, and to regulate the interstate transportation
of animals, including poultry, and animal products to prevent the
spread of diseases and pests. These regulations are contained in the
Code of Federal Regulations, Title 9, chapter I, subchapters B and C.
In addition, APHIS maintains a staff devoted to emergency planning and
preparedness, to contain and eradicate any outbreak of animal disease
in the United States that should occur.
For these reasons, we believe APHIS is adequately prepared to
handle an outbreak of a foreign animal disease, should that occur.
Several commenters also suggested that we include a post-entry
surveillance program as part of our regulations. As explained above,
our multi-level system of regulation is designed to ensure that foreign
animal diseases are not introduced into the United States. Our controls
on importation include requirements that we be notified of the
destination of embryos. Our domestic animal identification system,
coupled with requirements concerning interstate transportation of
animals, allow us to trace animals which may be infected with disease.
These programs have worked effectively for many years. In the case of
embryos from sheep and goats that may be affected with scrapie, we have
published proposed regulations requiring that these embryos be imported
only into flocks or herds participating in the Voluntary Scrapie Flock
Certification Program (see Docket 94-085-2, published May 11, 1995, at
60 FR 25151-25162). All animals in flocks and herds participating in
this program are under our surveillance.
Additional post-entry surveillance requirements would not appear to
increase the effectiveness of most of our programs, but would add costs
for both APHIS and for the regulated industries. We are therefore not
making any changes in this document based on these comments.
Economic Analysis
One commenter questioned the value we placed on embryos imported
into the United States. In our proposed rule of June 6, 1995 (see 60 FR
29782), we stated that cattle embryos imported into the United States
``during the past several years has averaged in the hundred of
thousands of dollars.'' This data is from the Foreign Agricultural
Trade of the United States, Fiscal Year 1994 Supplement (USDA, Economic
Service).2
\2\ Page 298 of the Foreign Agricultural Trade of the United
States, Fiscal Years 1994 Supplement includes a table showing that
cattle embryos imported into the United States were valued at
$160,000 during FY 1992, $228,000 during FY 1993, and $219,000
during FY 1994.
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Therefore, based on the rationale set forth in the proposed rule
and in this document, we are adopting the provisions of the proposal as
a final rule with the changes discussed in this document.
Miscellaneous
We are amending several sections of the regulations in part 98 to
add Office of Management and Budget (OMB) control numbers for
previously approved information collection and recordkeeping
requirements. We did not propose to amend these sections in the
proposed rule of June 6, 1995. However, adding OMB control numbers to
the regulations is a minor administrative change and does not affect
the regulations substantively.
Effective Date
This is a substantive rule that relieves restrictions and, pursuant
to the provisions of 5 U.S.C. 553, may be made effective less than 30
days after publication in the Federal Register. This rule will allow
the importation of embryos from all ruminants, including cervids,
camelids, and all species of cattle, and from swine from countries
where rinderpest or foot-and-mouth disease exists. This action will
make additional sources of genetic material available to domestic
animal breeders. Therefore, the Administrator of the Animal and Plant
Health Inspection Service has determined that this rule should be
effective less than 30 days after publication in the Federal Register.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be not significant for the purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of
Management and Budget.
This rule allows the importation of certain embryos from swine and
ruminants, including camelids, cervids, and all species of cattle, from
countries where rinderpest or foot-and-mouth disease exists, under
restrictions that appear adequate to prevent the introduction or
dissemination of rinderpest, foot-and-mouth disease, and other
communicable diseases of livestock.
As part of the proposed rule document published June 6, 1995, we
invited comments concerning potential effects of the proposed rule. We
stated that we were particularly interested in determining the number
and kind of small entities that might incur benefits or costs from
implementation of the rule. Other than the comment discussed above
under the heading ``Economic Analysis,'' none of the comments we
received addressed our Initial Regulatory Flexibility Analysis, and
none provided any information of the type we requested. We have
therefore based this Final Regulatory Flexibility Analysis on the data
available to us.
The annual value of cattle embryos imported during the past several
years has averaged in the hundreds of thousands of dollars. We do not
expect this rule change to result in a significant increase in cattle
embryo imports, since demand will continue to be predominantly for the
Bos indicus and Bos taurus species. However, APHIS does foresee the
importation of embryos of other species, such as water buffalo and
certain breeds of sheep and goats from Africa.
At present, ruminants and swine from countries where rinderpest or
foot-and-mouth disease exists may only enter the United States
following quarantine at the Harry S Truman Animal Import Center
(HSTAIC). Allowing embryos of additional ruminant species and swine to
be imported will enable importers to forgo quarantine and other costs
of importing live animals. For example, we estimate that the cost to
importers of importing approximately 500 Boer goats from South Africa
would average more than $2,000 per animal for quarantine in HSTAIC.
This does not include testing, post-quarantine clean-up expenses, and
other costs associated with importing animals through HSTAIC. In
addition, importers must undergo the inconvenience and uncertainty of
lottery selection (including submitting a cashier's check of $32,000
for each application for the lottery), must bear the costs of
qualifying animals for importation through HSTAIC, and must assume the
risk that animals may not qualify for importation after quarantine.
Quarantine-related costs could easily exceed the cost of implanting an
imported embryo. Savings in transporting embryos rather than live
animals, both before and after entry into the United States, will also
be realized.
This final rule contains paperwork and recordkeeping requirements.
Under this rule, import permits and health certificates will be
required for all ruminant and swine embryos, as they are now required
for Bos indicus and Bos taurus cattle embryos. These requirements have
been approved by the Office of Management and Budget.
[[Page 15183]]
The alternatives to this final rule are to take no action, or to
allow the importation of embryos under different conditions than those
adopted in this rule. We did not consider taking no action a reasonable
alternative, because it would, in our opinion, prohibit the importation
of embryos which pose no significant risk of disease. We also did not
consider importation under conditions other than those adopted a viable
option. The only available research concerns embryos handled and
treated using the methods required by this final rule. Embryos handled
and treated using other methods have not been tested. We therefore have
no data demonstrating that other methods would be adequate to prevent
the importation of rinderpest, foot-and-mouth disease, and other
communicable diseases of livestock.
Executive Order 12778
This rule has been reviewed under Executive Order 12778, Civil
Justice Reform. This rule: (1) Preempts all State and local laws and
regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this rule have been approved by the Office of Management
and Budget under OMB control number 0579-0040 and 0579-0120.
List of Subjects in 9 CFR Part 98
Animal diseases, Imports, Reporting and recordkeeping requirements.
Accordingly, 9 CFR part 98 is amended as follows:
PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN
1. The authority citation for part 98 is revised to read as
follows:
Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 103-105,
111, 134a, 134b, 134c, 134d, 134f, 136 and 136a; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.2(d).
Subpart B--Ruminant and Swine Embryos From Countries Where
Rinderpest or Foot-and-Mouth Disease Exists
Sec. 98.5 [Amended]
2. Section 98.5 is amended by adding at the end of the section the
following:
(Approved by the Office of Management and Budget under control
number 0579-0040.)
3. The heading for subpart B is revised to read as set forth above.
4. Section 98.11 is amended by removing the definition of Cattle,
and by adding, in alphabetical order, the following definitions, to
read as follows:
Sec. 98.11 Definitions.
* * * * *
Ruminant. All animals which chew the cud, including cattle,
buffaloes, camelids, cervids (deer, elk, moose, and antelope), sheep,
goats, and giraffes.
Swine. The domestic hog and all varieties of wild hogs.
* * * * *
Secs. 98.12, 98.13, 98.14 [Amended]
5. In the following sections, the word ``Cattle'' is removed and
the words ``Ruminant and swine'' are added in its place:
a. Sec. 98.12(a);
b. Sec. 98.12(b);
c. Sec. 98.13(a); and
d. Sec. 98.14(a), the introductory text.
Sec. 98.13 [Amended]
6. Section 98.13 is amended by adding at the end of the section the
following:
(Approved by the Office of Management and Budget under control
number 0579-0040).
Sec. 98.14 [Amended]
7. Section 98.14 is amended by adding at the end of the section the
following:
(Approved by the Office of Management and Budget under control
number 0579-0040).
8. Section 98.15 is amended as follows:
a. In the introductory paragraph, by removing the word ``Cattle''
and adding the words ``Ruminant and swine'' in its place.
b. By revising paragraphs (a)(1) and (a)(2) to read as set forth
below.
c. In paragraph (a)(4), by removing the word ``cattle'' and adding
the words ``ruminants or swine'' in its place.
d. In paragraph (a)(5), by designating the first sentence as
paragraph (a)(5)(i), by designating the second sentence as paragraph
(a)(5)(ii) and revising it to read as set forth below; and by
designating the third and fourth sentences as paragraphs (a)(5)(iii)
and (a)(5)(iv), respectively.
e. In paragraph (a)(7), by designating the first sentence as
paragraph (a)(7)(i) and revising it to read as set forth below; and by
designating the second sentence as paragraph (a)(7)(ii).
f. In paragraph (a)(8), by designating the first sentence as
paragraph (a)(8)(i) and revising it to read as set forth below; and by
designating the second sentence as paragraph (a)(8)(ii).
Sec. 98.15 Health requirements.
* * * * *
(a) * * *
(1) During the year before embryo collection, no case of the
following diseases occurred in the embryo collection unit or in any
herd in which the donor dam was present:
(i) Ruminant: Bovine spongiform encephalopathy, contagious bovine
pleuropneumonia, foot-and-mouth disease, Rift Valley fever, rinderpest,
or vesicular stomatitis; or
(ii) Swine: African swine fever, foot-and-mouth disease, hog
cholera, pseudorabies, rinderpest, swine vesicular disease, or
vesicular stomatitis.
(2) During the year before embryo collection, no case of the
following diseases occurred within 5 kilometers of the embryo
collection unit or in any herd in which the donor dam was present:
(i) Ruminant: Bovine spongiform encephalopathy, contagious bovine
pleuropneumonia, foot-and-mouth disease, Rift Valley fever, rinderpest,
or vesicular stomatitis; or
(ii) Swine: African swine fever, foot-and-mouth disease, hog
cholera, pseudorabies, rinderpest, swine vesicular disease, or
vesicular stomatitis.
* * * * *
(5) (i) * * *
(ii) The donor dam was determined to be free of foot-and-mouth
disease based upon tests of the pair of serum samples. In addition, if
any of the following diseases exist in the country of origin, the donor
dam was determined to be free of these diseases based upon additional
tests of the serum samples:
(A) Ruminant: Contagious bovine pleuropneumonia, Rift Valley fever,
rinderpest, or vesicular stomatitis; or
(B) Swine: African swine fever, hog cholera, pseudorabies,
rinderpest, swine vesicular disease, or vesicular stomatitis.
* * * * *
(7) (i) Not less than 30 days nor more than 120 days after embryo
collection, the donor dam was examined by an official veterinarian and
found free of clinical evidence of the following diseases:
(A) Ruminant: Bovine spongiform encephalopathy, brucellosis,
contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley
fever, rinderpest, tuberculosis, and vesicular stomatitis; or
[[Page 15184]]
(B) Swine: African swine fever, brucellosis, foot-and-mouth
disease, hog cholera, pseudorabies, rinderpest, swine vesicular
disease, tuberculosis, and vesicular stomatitis.
* * * * *
(8) (i) Between the time the embryos were collected and all
examinations and tests required by this subpart were completed, no
animals in the embryo collection unit with the donor dam, or in the
donor dam's herd of origin, exhibited any clinical evidence of:
(A) Ruminant: Bovine spongiform encephalopathy, brucellosis,
contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley
fever, rinderpest, tuberculosis, and vesicular stomatitis; or
(B) Swine: African swine fever, brucellosis, foot-and-mouth
disease, hog cholera, pseudorabies, rinderpest, swine vesicular
disease, tuberculosis, and vesicular stomatitis.
* * * * *
9. Section 98.16 is amended as follows:
a. In the introductory paragraph, the first sentence, by removing
the word ``Cattle'' and adding the words ``Ruminant and swine'' in its
place.
b. In the introductory paragraph, by revising the second sentence
to read as set forth below.
c. In paragraph (b), the first sentence, by removing the word
``cattle'' and adding the words ``embryo donors'' in its place.
Sec. 98.16 The embryo collection unit.
* * * The embryo collection unit may be located on the premises
where the donor dam's herd of origin is kept, or at any other location,
provided that the embryo collection unit has been inspected and
approved by an APHIS veterinarian and that the following requirements
are met:
* * * * *
10. Section 98.17 is amended as follows:
a. By revising paragraph (b)(1) to read as set forth below.
b. In paragraph (g), by adding, at the end of the first and second
sentences: ``under the personal supervision of an APHIS veterinarian''.
c. By adding at the end of the section the following: ``(Approved
by the Office of Management and Budget under control number 0579-
0040)''.
Sec. 98.17 Procedures.
(a) * * *
(b) Oversight and supervision. (1) All procedures associated with
the production of embryos for importation into the United States,
including artificial insemination, natural breeding, and cleaning and
disinfection, must be performed under the oversight of an APHIS
veterinarian. Collecting test samples, and collecting, processing, and
storing embryos, must be supervised in person by an APHIS veterinarian.
* * * * *
Sec. 98.35 [Amended]
11. Section 98.35 is amended by adding at the end of the section
the following:
(Approved by the Office of Management and Budget under control
number 0579-0040)
Done in Washington, DC, this 2nd day of April 1996.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-8471 Filed 4-4-96; 8:45 am]
BILLING CODE 3410-34-P
Complete official Federal Register PDF
FR Doc. 96-8384 Airworthiness Directives; Bell Helicopter Textron, Inc., Model 214ST Helicopters
[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Rules and Regulations]
[Pages 15184-15185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8384]
=======================================================================
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 95-SW-26-AD; Amendment 39-9561; AD 96-07-12]
Airworthiness Directives; Bell Helicopter Textron, Inc., Model
214ST Helicopters
AGENCY: Federal Aviation Administration, DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This amendment adopts a new airworthiness directive (AD),
applicable to Bell Helicopter Textron, Inc. (BHTI) Model 214ST
helicopters with certain tailboom assemblies and a certain emergency
float kit installed, that requires initial and repetitive inspections
of the tailboom for cracks until modifications of the tailboom are
accomplished. This amendment is prompted by several reports of cracks
in the lower aft skin of the tailboom assembly. The actions specified
by this AD are intended to prevent cracks in the tailboom assembly,
which could result in structural failure of the tailboom and subsequent
loss of control of the helicopter.
DATES: Effective May 10, 1996.
The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of May 10, 1996.
ADDRESSES: The service information referenced in this AD may be
obtained from Bell Helicopter Textron, Inc., Attention: Customer
Support, P.O. Box 482, Fort Worth, Texas 76101. This information may be
examined at the FAA, Office of the Assistant Chief Counsel, 2601
Meacham Blvd., Room 663, Fort Worth, Texas; or at the Office of the
Federal Register, 800 North Capitol Street NW., suite 700, Washington,
DC.
FOR FURTHER INFORMATION CONTACT: Mr. Charles Harrison, Aerospace
Engineer, FAA, Rotorcraft Directorate, Rotorcraft Certification Office,
2601 Meacham Blvd., Fort Worth, Texas 76137, telephone (817) 222-5447,
fax (817) 222-5959.
SUPPLEMENTARY INFORMATION: A proposal to amend part 39 of the Federal
Aviation Regulations (14 CFR part 39) to include an airworthiness
directive (AD) that is applicable to BHTI Model 214ST helicopters,
serial numbers (S/N) 28101 through 28132, with a tailboom assembly,
part number (P/N) 214-031-003-111 or 214-031-003-277, and with an
emergency float kit, P/N 214-706-120, installed, was published in the
Federal Register on November 1, 1995 (60 FR 55495). That action
proposed to require inspections of the tailboom assembly for cracks
within 250 hours time-in-service (TIS) or at the next 180-day float
inspection, and thereafter, at each 180-day float inspection until
certain modifications of the tailboom are accomplished. The
modifications, which are to be accomplished if any crack is found in
the tailboom or on or before accumulating an additional 500 hours TIS
after the effective date of this AD, whichever occurs first, include
installing stiffeners and doublers in the tailboom, and replacing the
access door frame with a thicker access door frame.
Interested persons have been afforded an opportunity to participate
in the making of this amendment. No comments were received on the
proposal or the FAA's determination of the cost to the public. The FAA
has determined that air safety and the public interest require the
adoption of the rule as proposed.
The FAA estimates that six helicopters of U.S. registry will be
affected by this AD, that it will take approximately 20 work hours per
helicopter to accomplish the modifications, approximately 3 work hours
per helicopter to accomplish the 250 hours TIS inspection, and that the
average labor rate is $60 per work hour. Required parts will cost
approximately $1,100 per helicopter. Based on these figures, the total
cost impact of the AD on U.S. operators is estimated to be $14,880.
The regulations adopted herein will not have substantial direct
effects on the
[[Page 15185]]
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.
For the reasons discussed above, I certify that this action (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) will not have a
significant economic impact, positive or negative, on a substantial
number of small entities under the criteria of the Regulatory
Flexibility Act. A final evaluation has been prepared for this action
and it is contained in the Rules Docket. A copy of it 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, Incorporation by
reference, 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 adding a new airworthiness directive
to read as follows:
AD 96-07-12 Bell Helicopter Textron, Inc. (BHTI): Amendment 39-
9561. Docket No. 95-SW-26-AD.
Applicability: Model 214ST helicopters, serial number (S/N)
28101 through 28132, with a tailboom assembly, part number (P/N)
214-031-003-111 or 214-031-003-277 and with an emergency float kit,
P/N 214-706-120, 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 (d) 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.
Compliance: Required as indicated, unless accomplished
previously.
To prevent cracks in the tailboom assembly, structural failure
of the tailboom and subsequent loss of control of the helicopter,
accomplish the following:
(a) Within the next 250 hours time-in-service (TIS) or at the
next 180-day float inspection, whichever occurs first, and
thereafter at intervals not to exceed each 180-day float inspection,
visually inspect the tailboom assembly for cracks in accordance with
the maintenance procedures contained in Part 1 of the Accomplishment
Instructions of BHTI Alert Service Bulletin 214ST-95-72, dated July
24, 1995.
(b) Upon discovery of a crack or on or before accumulating an
additional 500 hours TIS after the effective date of this AD,
whichever occurs first, modify the tailboom assembly in accordance
with Part 2 of the Accomplishment Instructions of BHTI Alert Service
Bulletin No. 214ST-95-72, dated July 24, 1995.
(c) Modification of the tailboom assembly in accordance with
paragraph (b) constitutes terminating action for the requirements of
this AD.
(d) An alternative methods of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used when approved by the Manager, Rotorcraft Certification Office.
Operators shall submit their requests through an FAA Principal
Maintenance Inspector, who may concur or comment and then send it to
the Manager, Rotorcraft Certification Office.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Rotorcraft Certification Office.
(e) 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.
(f) The inspections and modifications shall be done in
accordance with Bell Helicopter Textron, Inc. Alert Service Bulletin
214ST-95-72, dated July 24, 1995. This incorporation by reference
was approved by the Director of the Federal Register in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from
Bell Helicopter Textron, Inc., Attention: Customer Support, P.O. Box
482, Fort Worth, Texas 76101. Copies may be inspected at the FAA,
Office of the Assistant Chief Counsel, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas; or at the Office of the Federal Register, 800
North Capitol Street, NW., suite 700, Washington, DC.
(g) This amendment becomes effective on May 10, 1996.
Issued in Fort Worth, Texas, on March 26, 1996.
Larry M. Kelly,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 96-8384 Filed 4-4-96; 8:45 am]
BILLING CODE 4910-13-M
Complete official Federal Register PDF
FR Doc. 96-8380 Office of the Secretary; Supplemental Standards of Ethical Conduct for Employees of the Department of Housing and Urban Development
[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Rules and Regulations]
[Page 15350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8380]
[[Page 15349]]
_______________________________________________________________________
Part III
Department of Housing and Urban Development
_______________________________________________________________________
24 CFR Part 0
Office of the Secretary; Supplemental Standards of Ethical Conduct for
Employees of the Department of Housing and Urban Development; Final
Rule
Federal Register / Vol. 61, No. 67 / Friday, April 5, 1996 / Rules
and Regulations
=======================================================================
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[[Page 15350]]
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
24 CFR Part 0
[Docket No. FR-3331-F-02]
RIN 2501-AB55
Office of the Secretary; Supplemental Standards of Ethical
Conduct for Employees of the Department of Housing and Urban
Development
AGENCY: Office of the Secretary, (HUD).
ACTION: Final rule.
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SUMMARY: This final rule issued by the Department of Housing and Urban
Development (Department) removes the current text of 24 CFR part 0, and
replaces it with a single section that provides a cross-reference to 5
CFR parts 2634 and 2635.
EFFECTIVE DATE: May 6, 1996.
FOR FURTHER INFORMATION CONTACT: Aaron Santa Anna, Assistant General
Counsel, Ethics Law Division, at (202) 708-3815, or Sam E. Hutchinson,
Associate General Counsel, Office of Human Resources Law, (202) 708-
0888; 451 Seventh Street SW., Washington, DC 20410. Hearing or speech-
impaired individuals may call HUD's TDD number (202) 708-3259.
(Telephone numbers are not toll-free.)
SUPPLEMENTARY INFORMATION: As proposed in a rule published on June 30,
1995 (60 FR 34420), the Department is here removing its superseded
Standards of Conduct at 24 CFR part 0 and is replacing those provisions
with a single section that provides a cross-reference to 5 CFR parts
2634 and 2635. The one comment received on the proposed rule will be
addressed in a subsequent rule.
Other Matters
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 would not have a significant economic impact
on a substantial number of small entities because it would affect only
Federal employees.
Environmental Impact
In accordance with 40 CFR 1508.4 of the regulations of the Council
on Environmental Quality and 24 CFR 50.20(k) of the HUD regulations,
the policies and procedures contained in this rule relate only to
internal administrative procedures whose content does not constitute a
development decision nor affect the physical condition of project areas
or building sites, and therefore, are categorically excluded from the
requirements of the National Environmental Policy Act.
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. Specifically,
this rule is only directed toward Federal employees and would not alter
the established roles of HUD and the States and local governments. 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 in 24 CFR Part 0
Administrative practice and procedure, Conflict of interests.
Accordingly, for the reasons set forth in the preamble, part 0 of
title 24 of the Code of Federal Regulations is revised to read as
follows:
PART 0--STANDARDS OF CONDUCT
Sec.
0.1 Cross-reference to employees ethical conduct standards and
financial disclosure regulations.
Authority: 5 U.S.C. 7301; 42 U.S.C. 3535(d).
Sec. 0.1 Cross-reference to employees ethical conduct standards and
financial disclosure regulations.
Employees of the Department of Housing and Urban Development
(Department) are subject to the executive branch-wide standards of
ethical conduct at 5 CFR part 2635 and the executive branch-wide
financial disclosure regulation at 5 CFR part 2634.
Dated: March 29, 1996.
Henry G. Cisneros,
Secretary.
[FR Doc. 96-8380 Filed 4-4-96; 8:45 am]
BILLING CODE 4210-32-P
Complete official Federal Register PDF
FR Doc. 96-8373 Federal Employees Health Benefits Program: Filing Claims; Disputed Claims Procedures and Court Actions
[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Rules and Regulations]
[Pages 15177-15180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8373]
========================================================================
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. 67 / Friday, April 5, 1996 / Rules
and Regulations
[[Page 15177]]
OFFICE OF PERSONNEL MANAGEMENT
5 CFR Part 890
RIN 3206-AH36
Federal Employees Health Benefits Program: Filing Claims;
Disputed Claims Procedures and Court Actions
AGENCY: Office of Personnel Management.
ACTION: Final rule.
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SUMMARY: The Office of Personnel Management (OPM) is issuing final
regulations revising the requirement that legal actions to recover on a
claim under the Federal Employees Health Benefits (FEHB) Program should
be brought against the health benefits carrier rather than OPM and
clarifying the procedures for filing claims for payment or service
under the FEHB Program. The purpose of these final regulations is to
prescribe that if a covered individual chooses to bring legal action
pertaining to a denial of an FEHB benefit, such legal action should be
brought against OPM, and to clarify the administrative review process
that must precede legal action in the courts.
EFFECTIVE DATE: May 6, 1996.
FOR FURTHER INFORMATION CONTACT: Margaret Sears, (202) 606-0004.
SUPPLEMENTARY INFORMATION: On March 29, 1995, OPM published interim
regulations in the Federal Register (60 FR 16037) that require
individuals who want to bring suit concerning the denial of their
health benefits claims to bring such suits against OPM instead of the
health benefits carrier, as had been the case previously. The interim
regulations also clarified the administrative review procedures that
must precede legal action in the courts, the circumstances under which
suits may be brought against OPM, and that the court's review is
limited to the record that was before OPM when it made its decision.
OPM received 11 comments on the interim regulations. Three
commenters suggested that we amend the regulations to clarify that the
regulations apply to providers to whom the covered individual has
assigned the right to pursue the claim. We have not accepted this
suggestion because the right of access to the disputed claims process
belongs to the covered individual. We have amended the interim
regulations to clarify that another person or entity, whether or not a
provider, can gain access to the disputed claims process only when
acting on behalf of the covered individual and with the covered
individual's specific written consent.
Two commenters thought that the one-year period for initiating the
disputed claims process was too long. They suggested a 90-day period
instead. The one-year period has been OPM's policy since the disputed
claims process was created in 1975. However, we believe that the period
can now be reduced to 6 months if there are sufficient safeguards to
protect the interests of individuals who, because of medical problems
or for other reasons are unable to request reconsideration within the 6
months time limit. Therefore, we are modifying the regulations to
require that covered individuals who want to ask the plan to reconsider
its denial must do so within 6 months after the denial unless the
covered individual shows that he or she was prevented by a cause beyond
his or her control from making the request within that time period. In
addition, we are adding a provision to allow OPM to reopen a decision
it made concerning a disputed claim if it receives evidence that was
unavailable at the time OPM made its decision.
Two commenters said that the amount of time carriers have to
respond to requests for reconsideration--30 days--is too short,
especially when the issue is medical necessity. They suggested that the
carriers be allowed 45 days, with the option to extend the period for
an additional 30 days, if necessary. They further suggested that the
carriers be given 45 days rather than 30 to review additional
information received from the covered individual or provider. In both
cases, the 30-day period has been in place for a number of years and
has been working well enough that we believe that extending the time
period to 45 days would unnecessarily lengthen the time required to
complete the disputed claims process. Therefore, we have not accepted
these suggestions.
Two commenters said that the time period for seeking judicial
review should be tied to the date the covered individual receives OPM's
decision rather than the date the care or service was provided. One
commenter supported the provision basing the time limit on the date the
care or service was provided and asked us not to change it. The interim
regulations provide that legal action on a disputed claim may not be
brought later than December 31 of the 3rd year after the year in which
the care or service was provided. After considering these three
comments we have decided not to modify our regulations at this time.
This timeframe reflects our brochure language over the past several
years. It is our experience that this timeframe works well; however, we
will continue to monitor all timeframes in these regulations and make
changes as warranted.
Four commenters suggested that the regulations should explicitly
state that court actions are not to be brought against a carrier or a
carrier's subcontractors. One commenter suggested that we amend the
regulations to state that the carrier is an indispensable party to the
lawsuit. After considering these five comments, we have modified the
regulations to specify that court action is not to be brought against
the carrier or the carrier's subcontractors. Since it is OPM's
decision, not the carrier's, that is being contested, it is appropriate
that OPM, rather than the carriers, be the focus of lawsuits related to
denial of benefits.
Two commenters said that the interim regulations should be set
aside because they adversely affect the covered individual's right: (1)
Of access to State courts, (2) to seek monetary compensation for
damages, (3) under State law to require insurer to prove that notice
was given concerning changes in benefits and that contract language is
clear, (4) to have the option to go to court without seeking OPM
review, (5) to present evidence that OPM did not have when it made its
determination, and (6) to seek an expedited ruling by the court when
life or health is at issue. OPM's regulations have never offered
[[Page 15178]]
such ``rights.'' The interim regulations simply clarified that these
opportunities are not available to covered individuals under the FEHB
program. The FEHB law includes a provision specifically stating that
FEHB contract provisions that relate to the extent of coverage or
benefits supersede and preempt any State law that relates to health
insurance or plans to the extent that such law is inconsistent with
FEHB contractual provisions. Therefore, we believe the interim
regulations accurately reflect the intent of the FEHB law. Further, it
has been OPM's policy, and will continue to be OPM's policy, to
expedite the dispute resolution process when there are issues of life
and health at stake. Premature involvement of the courts at such time
is unnecessary. The only real change made by the interim regulations
was which party to the FEHB contracts should be named in a suit.
Two commenters said that the interim regulations should be set
aside because they violated the Administrative Procedure Act in that
they became effective before completing a comment period. The interim
regulations were promulgated to provide immediate guidance and
information to alleviate any burden on the FEHB enrollees in cases of
possible litigation. It was OPM's view that immediate implementation of
regulations that clarify and more fully explain the proper judicial
review of an OPM decision sustaining a health benefit plan's denial of
coverage would minimize unnecessary litigation and uncertainty. Thus,
the interim regulations were intended to more clearly specify a review
procedure that sometimes appeared to be unclear and was not always
applied consistently.
One commenter inquired whether the interim regulations removed a
restriction so that there was good cause for issuing them in this form.
It was OPM's view that the interim regulations remove the restriction
requiring that enrollees sue a health benefits carrier when contesting
an OPM decision that affirmed the carrier's determination that the
benefit is not covered under the carrier's plan. Previously, enrollees
could not bring suit against OPM directly even though they ultimately
were contesting OPM's decision.
One commenter asserted that the regulations should specify that
they have no impact on an individual's rights under the Federal Sector
Equal Employment Opportunity rule set forth in 29 CFR Part 1614. That
is, individuals who believe they have been discriminated against in
regard to insurance benefits because of disability or another protected
basis are not required to pursue or exhaust the administrative remedy
provided by these regulations before pursuing their rights under 29 CFR
Part 1614. Since OPM has no authority concerning the provisions of
title 29 of the Code of Federal Regulations, it would not be
appropriate to address an individual's rights under title 29 in title
5. Instead, the circumstances under which one may access remedies
related to title 29 should be included in title 29.
One commenter felt that the interim regulations do not expressly
prescribe time limits when the carrier fails to make its decision
within 60 days after requesting, but not receiving, information from
the covered individual. We have modified the regulations to clarify
that this circumstance is included in the administrative process.
One commenter objected to the requirement that the claimants must
express their reasons in terms of the brochure provisions because
enrollees sometimes do not have brochures. Since a dispute about a
claim must be based on whether or not the claim was payable under the
FEHB contract and the brochure sets forth those contract provisions,
individuals need a brochure in order to know whether they have a
dispute. They also need a brochure to obtain information on the
procedures for disputing carriers' denials of claims. Further,
brochures are easily obtainable from the plan. We find that this
requirement is important in encouraging the individual to express his
or her reasons in a manner that will facilitate a successful result
when there is a valid dispute.
Two commenters suggested that the regulations be revised to require
that OPM's decision contain a notice of the covered individual's right
to bring suit. We are not adopting that suggestion because we are
adding that information to the brochures. The brochures will give
complete information about the disputed claims process from the initial
request to the carrier for reconsideration through the requirements for
bringing suit when OPM concurs with the carrier's reconsideration
decision to deny the claim.
We have also modified the regulations at Sec. 890.107(c) to clarify
that recovery in the FEHB Program is accomplished through a directive
from OPM to the carrier to make payment according to the court's order.
Regulatory Flexibility Act
I certify that this regulation will not have a significant economic
impact on a substantial number of small entities because the
regulations primarily affect individuals enrolled under the Federal
Employees Health Benefits Program.
List of Subjects in 5 CFR Part 890
Administrative practice and procedure, Government employees, Health
facilities, Health insurance, Health professions, Hostages, Iraq,
Kuwait, Lebanon, Reports and recordkeeping requirements, Retirement.
Office of Personnel Management.
James B. King,
Director.
Accordingly, OPM is amending 5 CFR part 890 as follows:
PART 890--FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM
1. The authority citation for part 890 continues to read as
follows:
Authority: 5 U.S.C. 8913; Sec. 890.803 also issued under 50
U.S.C. 403p, 22 U.S.C. 4069c and 4069c-1; subpart L also issued
under sec. 599C of Pub. L. 101-513, 104 Stat. 2064, as amended.
2. In Sec. 890.101 paragraph (a) is amended by adding a definition
of ``covered individual'' to read as follows:
Sec. 890.101 Definitions; time computations.
(a) * * *
Covered individual means an enrollee or a covered family member.
* * * * *
3. Section 890.105 is revised to read as follows:
Sec. 890.105 Filing claims for payment or service.
(a) General. (1) Each health benefits carrier resolves claims filed
under the plan. All health benefits claims must be submitted initially
to the carrier of the covered individual's health benefits plan. If the
carrier denies a claim (or a portion of a claim), the covered
individual may ask the carrier to reconsider its denial. If the carrier
affirms its denial or fails to respond as required by paragraph (c) of
this section, the covered individual may ask OPM to review the claim. A
covered individual must exhaust both the carrier and OPM review
processes specified in this section before seeking judicial review of
the denied claim.
(2) This section applies to covered individuals and to other
individuals or entities who are acting on the behalf of a covered
individual and who have the covered individual's specific written
consent to pursue payment of the disputed claim.
(b) Time limits for reconsidering a claim. (1) The covered
individual has 6 months from the date of the notice to the covered
individual that a claim (or
[[Page 15179]]
a portion of a claim) was denied by the carrier in which to submit a
written request for reconsideration to the carrier. The time limit for
requesting reconsideration may be extended when the covered individual
shows that he or she was prevented by circumstances beyond his or her
control from making the request within the time limit.
(2) The carrier has 30 days after the date of receipt of a timely-
filed request for reconsideration to:
(i) Affirm the denial in writing to the covered individual;
(ii) Pay the bill or provide the service; or
(iii) Request from the covered individual or provider additional
information needed to make a decision on the claim. The carrier must
simultaneously notify the covered individual of the information
requested if it requests additional information from a provider. The
carrier has 30 days after the date the information is received to
affirm the denial in writing to the covered individual or pay the bill
or provide the service. The carrier must make its decision based on the
evidence it has if the covered individual or provider does not respond
within 60 days after the date of the carrier's notice requesting
additional information. The carrier must then send written notice to
the covered individual of its decision on the claim. The covered
individual may request OPM review as provided in paragraph (b)(3) of
this section if the carrier fails to act within the time limit set
forth in this paragraph (b)(2)(iii).
(3) The covered individual may write to OPM and request that OPM
review the carrier's decision if the carrier either affirms its denial
of a claim or fails to respond to a covered individual's written
request for reconsideration within the time limit set forth in
paragraph (b)(2) of this section. The covered individual must submit
the request for OPM review within the time limit specified in paragraph
(e)(1) of this section.
(4) The carrier may extend the time limit for a covered
individual's submission of additional information to the carrier when
the covered individual shows he or she was not notified of the time
limit or was prevented by circumstances beyond his or her control from
submitting the additional information.
(c) Information required to process requests for reconsideration.
(1) The covered individual must put the request to the carrier to
reconsider a claim in writing and give the reasons, in terms of
applicable brochure provisions, that the denied claim should have been
approved.
(2) If the carrier needs additional information from the covered
individual to make a decision, it must:
(i) Specifically identify the information needed;
(ii) State the reason the information is required to make a
decision on the claim;
(iii) Specify the time limit (60 days after the date of the
carrier's request) for submitting the information; and
(iv) State the consequences of failure to respond within the time
limit specified, as set out in paragraph (b)(2) of this section.
(d) Carrier determinations. The carrier must provide written notice
to the covered individual of its determination. If the carrier affirms
the initial denial, the notice must inform the covered individual of:
(1) The specific and detailed reasons for the denial;
(2) The covered individual's right to request a review by OPM; and
(3) The requirement that requests for OPM review must be received
within 90 days after the date of the carrier's denial notice and
include a copy of the denial notice as well as documents to support the
covered individual's position.
(e) OPM review. (1) If the covered individual seeks further review
of the denied claim, the covered individual must make a request to OPM
to review the carrier's decision. Such a request to OPM must be made:
(i) Within 90 days after the date of the carrier's notice to the
covered individual that the denial was affirmed;
(ii) If the carrier fails to respond to the covered individual as
provided in paragraph (b)(2) of this section, within 120 days after the
date of the covered individual's timely request for reconsideration by
the carrier; or
(iii) Within 120 days after the date the carrier requests
additional information from the covered individual, or the date the
covered individual is notified that the carrier is requesting
additional information from a provider. OPM may extend the time limit
for a covered individual's request for OPM review when the covered
individual shows he or she was not notified of the time limit or was
prevented by circumstances beyond his or her control from submitting
the request for OPM review within the time limit.
(2) In reviewing a claim denied by the carrier, OPM may:
(i) Request that the covered individual submit additional
information;
(ii) Obtain an advisory opinion from an independent physician;
(iii) Obtain any other information as may in its judgment be
required to make a determination; or
(iv) Make its decision based solely on the information the covered
individual provided with his or her request for review.
(3) When OPM requests information from the carrier, the carrier
must release the information within 30 days after the date of OPM's
written request unless a different time limit is specified by OPM in
its request.
(4) Within 90 days after receipt of the request for review, OPM
will either:
(i) Give a written notice of its decision to the covered individual
and the carrier; or
(ii) Notify the individual of the status of the review. If OPM does
not receive requested evidence within 15 days after expiration of the
applicable time limit in paragraph (e)(3) of this section, OPM may make
its decision based solely on information available to it at that time
and give a written notice of its decision to the covered individual and
to the carrier.
(5) OPM, upon its own motion, may reopen its review if it receives
evidence that was unavailable at the time of its original decision.
4. Section 890.107 is revised to read as follows:
Sec. 890.107 Court review.
(a) A suit to compel enrollment under Sec. 890.102 must be brought
against the employing office that made the enrollment decision.
(b) A suit to review the legality of OPM's regulations under this
part must be brought against the Office of Personnel Management.
(c) Federal Employees Health Benefits (FEHB) carriers resolve FEHB
claims under authority of Federal statute (5 U.S.C. chapter 89). A
covered individual may seek judicial review of OPM's final action on
the denial of a health benefits claim. A legal action to review final
action by OPM involving such denial of health benefits must be brought
against OPM and not against the carrier or carrier's subcontractors.
The recovery in such a suit shall be limited to a court order directing
OPM to require the carrier to pay the amount of benefits in dispute.
(d) An action under paragraph (c) of this section to recover on a
claim for health benefits:
(1) May not be brought prior to exhaustion of the administrative
remedies provided in Sec. 890.105;
(2) May not be brought later than December 31 of the 3rd year after
the year in which the care or service was provided; and
(3) Will be limited to the record that was before OPM when it
rendered its
[[Page 15180]]
decision affirming the carrier's denial of benefits.
[FR Doc. 96-8373 Filed 4-4-96; 8:45 am]
BILLING CODE 6325-01-P
Complete official Federal Register PDF
FR Doc. 96-8372 Federal Employees Health Benefits Acquisition Regulation; Filing Health Benefit Claims; Addition of Contract Clause
[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Rules and Regulations]
[Pages 15196-15199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8372]
=======================================================================
-----------------------------------------------------------------------
OFFICE OF PERSONNEL MANAGEMENT
48 CFR Parts 1604 and 1652
RIN 3206-AG30
Federal Employees Health Benefits Acquisition Regulation; Filing
Health Benefit Claims; Addition of Contract Clause
AGENCY: Office of Personnel Management.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Office of Personnel Management (OPM) is issuing final
regulations to add a new contract clause in part 1652 of the Federal
Employees Health Benefits Acquisition Regulation (FEHBAR). The clause
clarifies for both FEHB carriers and covered individuals the
circumstances under which OPM may render a decision regarding a covered
individual who asks OPM to review a health benefits plan's denial of a
claim if the plan has either affirmed its denial when the covered
individual requested reconsideration, or failed to respond to the
covered individual's request for reconsideration as provided by OPM's
regulations. The clause further clarifies the circumstances under which
claimants may seek court review of benefit denials under the FEHB
Program. The purpose of these final regulations is to specify that
covered individuals who wish to bring legal action regarding a denial
of an FEHB benefit must pursue such claim against OPM. Further, the
regulations clarify the administrative review process that must precede
legal action in the courts.
EFFECTIVE DATE: May 6, 1996.
FOR FURTHER INFORMATION CONTACT: Margaret Sears, (202) 606-0004.
SUPPLEMENTARY INFORMATION: On March 29, 1995, OPM published interim
regulations in the Federal Register (60 FR 16056) that require
individuals who want to bring suit concerning the denial of their
health benefits claims to bring
[[Page 15197]]
such suits against OPM instead of the health benefits carrier, as had
been the case previously. The interim regulations also clarified the
administrative review procedures that must precede legal action in the
courts, the circumstances under which suits may be brought against OPM,
and that the court's review is limited to the record that was before
OPM when it made its decision.
OPM received 11 comments on the interim regulations. Three
commenters suggested that we amend the regulations to clarify that the
regulations apply to providers to whom the covered individual has
assigned the right to pursue the claim. We have not accepted this
suggestion because the right of access to the disputed claim process
belongs to the covered individual. We have amended the interim
regulations to clarify that another person or entity, whether or not a
provider, can gain access to the disputed claims process only when
acting on behalf of the covered individual and with the covered
individual's specific written consent.
Two commenters thought that the one-year period for initiating the
disputed claims process was too long. They suggested a 90-day period
instead. The one-year period has been OPM's policy since the disputed
claims process was created in 1975. However, we believe that the period
can now be reduced to 6 months if there are sufficient safeguards to
protect the interests of individuals who, because of medical problems
or for other reasons are unable to request reconsideration within the 6
months time limit. Therefore, we are modifying the regulations to
require that covered individuals who want to ask the plan to reconsider
its denial must do so within 6 months after the denial unless the
covered individual shows that he or she was prevented by a cause beyond
his or her control from making the request within that time period. In
addition, we are adding a provision to allow OPM to reopen a decision
it made concerning a disputed claim if it receives evidence that was
unavailable at the time OPM made its decision.
Two commenters said that the amount of time carriers have to
respond to requests for reconsideration--30 days--is too short,
especially when the issue is medical necessity. They suggested that the
carriers be allowed 45 days, with the option to extend the period for
an additional 30 days, if necessary. They further suggested that the
carriers be given 45 days rather than 30 to review additional
information received from the covered individual or provider. In both
cases, the 30-day period has been in place for a number of years and
has been working well enough that we believe that extending the time
period to 45 days would unnecessarily lengthen the time required to
complete the disputed claims process. Therefore, we have not accepted
these suggestions.
Two commenters said that the time period for seeking judicial
review should be tied to the date the covered individual receives OPM's
decision rather than the date the care or service was provided. One
commenter supported the provision basing the time limit on the date the
care or service was provided and asked us not to change it. The interim
regulations provide that legal action on a disputed claim may not be
brought later than December 31 of the 3rd year after the year in which
the care or service was provided. After considering these three
comments we have decided not to modify our regulations at this time.
This timeframe reflects our brochure language over the past several
years. It is our experience that this timeframe works well; however, we
will continue to monitor all timeframes in these regulations and make
changes as warranted.
Four commenters suggested that the regulations should explicitly
state that court actions are not to be brought against a carrier or a
carrier's subcontractors. One commenter suggested that we amend the
regulations to state that the carrier is an indispensable party to the
lawsuit. After considering these five comments, we have modified the
regulations to specify that court action is not to be brought against
the carrier or the carrier's subcontractors. Since it is OPM's
decision, not the carrier's, that is being contested, it is appropriate
that OPM, rather than the carriers, be the focus of lawsuits related to
denial of benefits.
Two commenters said that the interim regulations should be set
aside because they adversely affect the covered individual's right (1)
of access to State courts, (2) to seek monetary compensation for
damages, (3) under State law to require insurer to prove that notice
was given concerning changes in benefits and that contract language is
clear, (4) to have the option to go to court without seeking OPM
review, (5) to present evidence that OPM did not have when it made its
determination, and (6) to seek an expedited ruling by the court when
life or health is at issue. OPM's regulations have never offered such
``rights.'' The interim regulations simply clarified that these
opportunities are not available to covered individuals under the FEHB
program. The FEHB law includes a provision specifically stating that
the FEHB contract provisions that relate to the extent of coverage or
benefits supersede and preempt any State law that relates to health
insurance or plans to the extent that such law is inconsistent with
FEHB contractual provisions. Therefore, we believe the interim
regulations accurately reflect the intent of the FEHB law. Further, it
has been OPM's policy, and will continue to be OPM's policy, to
expedite the dispute resolution process when there are issues of life
and health at stake. Premature involvement of the courts at such time
is unnecessary. The only real change made by the interim regulations
was which party to the FEHB contracts should be named in a suit.
Two commenters said that the interim regulations should be set
aside because they violated the Administrative Procedure Act in that
they became effective before completing a comment period. The interim
regulations were promulgated to provide immediate guidance and
information to alleviate any burden on the FEHB enrollees in cases of
possible litigation. It was OPM's view that immediate implementation of
regulations that clarify and more fully explain the proper judicial
review of an OPM decision sustaining a health benefit plan's denial of
coverage would minimize unnecessary litigation and uncertainty. Thus,
the interim regulations were intended to more clearly specify a review
procedure that sometimes appeared to be unclear and was not always
applied consistently.
One commenter inquired whether the interim regulations removed a
restriction so that there was good cause for issuing them in this form.
It was OPM's view that the interim regulations remove the restriction
requiring that enrollees sue a health benefits carrier when contesting
an OPM decision that affirmed the carrier's determination that the
benefit is not covered under the carrier's plan. Previously, enrollees
could not bring suit against OPM directly even though they ultimately
were contesting OPM's decision.
One commenter asserted that the regulations should specify that
they have no impact on an individual's rights under the Federal Sector
Equal Employment Opportunity rule set forth in 29 CFR Part 1614. That
is, individuals who believe they have been discriminated against in
regard to insurance benefits because of disability or another protected
basis are not required to pursue or exhaust the administrative remedy
provided by these regulations before pursuing their rights under 29 CFR
Part 1614. Since OPM has no authority concerning the provisions of
title 29 of the Code of
[[Page 15198]]
Federal Regulations, it would not be appropriate to address an
individual's rights under title 29 in this contract clause. Instead,
the circumstances under which one may access remedies related to title
29 should be included in title 29.
One commenter felt that the interim regulations do not expressly
prescribe time limits when the carrier fails to make its decision
within 60 days after requesting, but not receiving, information from
the covered individual. We have modified the regulations to clarify
that this circumstance is included in the administrative process.
One commenter objected to the requirement that the claimants must
express their reasons in terms of the brochure provisions because
enrollees sometimes do not have brochures. Since a dispute about a
claim must be based on whether or not the claim was payable under the
FEHB contract and the brochure sets forth the contract provisions,
individuals need a brochure in order to know whether they have a
dispute. They also need a brochure to obtain information on the
procedures for disputing carriers' denials of claims. Further,
brochures are easily obtainable from the plan. We find that this
requirement is important in encouraging the individual to express his
or her reasons in a manner that will facilitate a successful result
when there is a valid dispute.
Two commenters suggested that the regulations be revised to require
that OPM's decision contain a notice of the covered individual's right
to bring suit. We are not adopting that suggestion because we are
adding that information to the brochures. The brochures will give
complete information about the disputed claims process from the initial
request to the carrier for reconsideration through the requirements for
bringing suit when OPM concurs with the carrier's reconsideration
decision to deny the claim.
We have also modified paragraph (g)(3) of the clause to clarify
that recovery in the FEHB Program is accomplished through a directive
from OPM to the carrier to make payment according to the court's order.
Regulatory Flexibility Act
I certify that this regulation will not have a significant economic
impact on a substantial number of small entities because the regulation
merely incorporates administrative procedures and regulatory
requirements into FEHB contracts.
List of Subjects in 48 CFR Parts 1604 and 1652
Government employees, Government procurement, Health insurance.
Office of Personnel Management.
James B. King,
Director.
Accordingly, OPM is amending 48 CFR chapter 16 as follows:
PART 1604--ADMINISTRATIVE MATTERS
1. The authority citation for parts 1604 and 1652 continue to read
as follows:
Authority: 5 U.S.C. 8913; 40 U.S.C. 486(c); 48 CFR 1.301.
2. In part 1604; subpart 1604.71 is adopted as final and
republished to read as follows:
Subpart 1604.71--Disputed Health Benefit Claims
Sec. 1604.7101 Filing Health Benefit Claims/Court Review of Disputed
Claims.
Guidelines for a Federal Employees Health Benefit (FEHB) Program
covered individual to file a claim for payment or service and for legal
actions on disputed health benefit claims are found at 5 CFR 890.105
and 890.107, respectively. The contract clause at 1652.204-72 of this
chapter, reflecting this guidance, must be inserted in all FEHB Program
contracts.
PART 1652--CONTRACT CLAUSES
3. In subpart 1652.2, section 1652.204-72 is revised and adopted as
final to read as follows:
Subpart 1652.2--Texts of FEHBP Clauses
Sec. 1652.204-72 Filing Health Benefit Claims/Court Review of Disputed
Claims.
As prescribed in 1604.7101 of this chapter, the following clause
must be inserted in all FEHB Program contracts.
Filing Health Benefit Claims/Court Review of Disputed Claims
(a) General. (1) The Carrier resolves claims filed under the
Plan. All health benefit claims must be submitted initially to the
Carrier. If the Carrier denies a claim (or a portion of a claim),
the covered individual may ask the Carrier to reconsider its denial.
If the Carrier affirms its denial or fails to respond as required by
paragraph (b) of this clause, the covered individual may ask OPM to
review the claim. A covered individual must exhaust both the Carrier
and OPM review processes specified in this clause before seeking
judicial review of the denied claim.
(2) This clause applies to covered individuals and to other
individuals or entities who are acting on the behalf of a covered
individual and who have the covered individual's specific written
consent to pursue payment of the disputed claim.
(b) Time limits for reconsidering a claim. (1) The covered
individual has 6 months from the date of the notice to the covered
individual that a claim (or a portion of a claim) was denied by the
Carrier in which to submit a written request for reconsideration to
the Carrier. The time limit for requesting reconsideration may be
extended when the covered individual shows that he or she was
prevented by circumstances beyond his or her control from making the
request within the time limit.
(2) The Carrier has 30 days after the date of receipt of a
timely-filed request for reconsideration to:
(i) Affirm the denial in writing to the covered individual;
(ii) Pay the bill or provide the service; or
(iii) Request from the covered individual or provider additional
information needed to make a decision on the claim. The Carrier must
simultaneously notify the covered individual of the information
requested if it requests additional information from a provider. The
Carrier has 30 days after the date the information is received to
affirm the denial in writing to the covered individual or pay the
bill or provide the service. The Carrier must make its decision
based on the evidence it has if the covered individual or provider
does not respond within 60 days after the date of the Carrier's
notice requesting additional information. The Carrier must then send
written notice to the covered individual of its decision on the
claim. The covered individual may request OPM review as provided in
paragraph (b)(3) of this clause if the Carrier fails to act within
the time limit set forth in this paragraph.
(3) The covered individual may write to OPM and request that OPM
review the Carrier's decision if the Carrier either affirms its
denial of a claim or fails to respond to a covered individual's
written request for reconsideration within the time limit set forth
in paragraph (b)(2) of this clause. The covered individual must
submit the request for OPM review within the time limit specified in
paragraph (e)(1) of this clause.
(4) The Carrier may extend the time limit for a covered
individual's submission of additional information to the Carrier
when the covered individual shows he or she was not notified of the
time limit or was prevented by circumstances beyond his or her
control from submitting the additional information.
(c) Information required to process requests for
reconsideration. (1) The covered individual must put the request to
the Carrier to reconsider a claim in writing and give the reasons,
in terms of applicable brochure provisions, that the denied claim
should have been approved.
(2) If the Carrier needs additional information from the covered
individual to make a decision, it must:
(i) Specifically identify the information needed;
(ii) State the reason the information is required to make a
decision on the claim;
[[Page 15199]]
(iii) Specify the time limit (60 days after the date of the
Carrier's request) for submitting the information; and
(iv) State the consequences of failure to respond within the
time limit specified, as set out in paragraph (b)(2) of this
section.
(d) Carrier determinations. The Carrier must provide written
notice to the covered individual of its determination. If the
Carrier affirms the initial denial, the notice must inform the
covered individual of:
(1) The specific and detailed reasons for the denial;
(2) The covered individual's right to request a review by OPM;
and
(3) The requirement that requests for OPM review must be
received within 90 days after the date of the Carrier's denial
notice and include a copy of the denial notice as well as documents
to support the covered individual's position.
(e) OPM review. (1) If the covered individual seeks further
review of the denied claim, the covered individual must make a
request to OPM to review the Carrier's decision. Such a request to
OPM must be made:
(i) Within 90 days after the date of the Carrier's notice to the
covered individual that the denial was affirmed; or
(ii) If the Carrier fails to respond to the covered individual
as provided in paragraph (b)(2) of this clause, within 120 days
after the date of the covered individual's timely request for
reconsideration by the Carrier; or
(iii) Within 120 days after the date the Carrier requests
additional information from the covered individual, or the date the
covered individual is notified that the Carrier is requesting
additional information from a provider. OPM may extend the time
limit for a covered individual's request for OPM review when the
covered individual shows he or she was not notified of the time
limit or was prevented by circumstances beyond his or her control
from submitting the request for OPM review within the time limit.
(2) In reviewing a claim denied by the Carrier, OPM may:
(i) Request that the covered individual submit additional
information;
(ii) Obtain an advisory opinion from an independent physician;
(iii) Obtain any other information as may in its judgment be
required to make a determination; or
(iv) Make its decision based solely on the information the
covered individual provided with his or her request for review.
(3) When OPM requests information from the Carrier, the Carrier
must release the information within 30 days after the date of OPM's
written request unless a different time limit is specified by OPM in
its request.
(4) Within 90 days after receipt of the request for review, OPM
will either:
(i) Give a written notice of its decision to the covered
individual and the Carrier; or
(ii) Notify the individual of the status of the review. If OPM
does not receive requested evidence within 15 days after expiration
of the applicable time limit in paragraph (e)(3) of this clause, OPM
may make its decision based solely on information available to it at
that time and give a written notice of its decision to the covered
individual and to the Carrier.
(f) OPM, upon its own motion, may reopen its review if it
receives evidence that was unavailable at the time of its original
decision.
(g) Court review. (1) A suit to compel enrollment under
Sec. 890.102 of Title 5, Code of Federal Regulations, must be
brought against the employing office that made the enrollment
decision.
(2) A suit to review the legality of OPM's regulations under
this part must be brought against the Office of Personnel
Management.
(3) Federal Employees Health Benefits (FEHB) carriers resolve
FEHB claims under authority of Federal statute (chapter 89, title 5,
United States Code). A covered individual may seek judicial review
of OPM's final action on the denial of a health benefits claim. A
legal action to review final action by OPM involving such denial of
health benefits must be brought against OPM and not against the
Carrier or the Carrier's subcontractors. The recovery in such a suit
shall be limited to a court order directing OPM to require the
Carrier to pay the amount of benefits in dispute.
(4) An action under paragraph (3) of this clause to recover on a
claim for health benefits:
(i) May not be brought prior to exhaustion of the administrative
remedies provided in paragraphs (a) through (f) of this clause;
(ii) May not be brought later than December 31 of the 3rd year
after the year in which the care or service was provided; and
(iii) Will be limited to the record that was before OPM when it
rendered its decision affirming the Carrier's denial of benefits.
(End of Clause)
[FR Doc. 96-8372 Filed 4-4-96; 8:45 am]
BILLING CODE 6325-01-P
Complete official Federal Register PDF
FR Doc. 96-8362 Oral Dosage Form New Animal Drugs; Ivermectin with Pyrantel Pamoate
[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Rules and Regulations]
[Pages 15185-15186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8362]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Ivermectin with Pyrantel
Pamoate
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 a supplemental new animal drug
application (NADA) filed by Merck Research Laboratories, Division of
Merck & Co., Inc., for a chewable tablet containing ivermectin in
combination with pyrantel pamoate. The product is used to prevent
canine heartworm disease and to treat and control ascarid and hookworm
infections in dogs. The supplemental NADA provides for extending the
use in dogs to those weighing less than 5 pounds and for revising the
limitation in the regulation concerning use in dogs under 6 weeks of
age.
EFFECTIVE DATE: April 5, 1996.
FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-0614.
SUPPLEMENTARY INFORMATION: Merck Research Laboratories, Division of
Merck & Co., Inc., P.O. Box 2000, Rahway, NJ 07065, filed supplemental
NADA 140-971, which provides for extending the use of Heartgard-
30 Plus (ivermectin with pyrantel pamoate) to dogs weighing
less than 5 pounds. In addition, the limitation in the regulation,
``Not to be used in dogs under 6 weeks of age.'', is being corrected to
read ``Recommended for dogs 6 weeks of age and older.'' The product is
used to prevent canine heartworm disease by eliminating the tissue
larval stages of Dirofilaria immitis for 30 days after infection, and
for the treatment and control of adult ascarids Toxocara canis and
Toxascaris leonina, and adult hookworms Ancylostoma
[[Page 15186]]
caninum and Uncinaria stenocephala. The supplement is approved as of
February 15, 1996, and the regulations are amended in Sec. 520.1196 (21
CFR 520.1196) by revising the limitation in paragraph (c)(1)(iii) as
above to reflect the correct limitation as is stated in the approved
product labeling. The basis of approval is discussed in the freedom of
information summary.
In addition, the heading of Sec. 520.1196 is revised from
``pyrantel (as pamoate salt)'' to ``pyrantel pamoate'' in order to
conform with titles of other sections.
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.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act, this supplemental NADA qualifies for a 3-year marketing
exclusivity period beginning February 15, 1996, because new clinical or
field investigations (other than bioequivalence or residue studies)
essential to the approval were conducted or sponsored by the applicant.
The exclusivity period applies only to use in animals weighing less
than 5 pounds.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
List of Subjects in 21 CFR Part 520
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 520 is
amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
2. Section 520.1196 is amended by revising the section heading and
in paragraph (c)(1)(iii) by revising the second sentence to read as
follows:
Sec. 520.1196 Ivermectin and pyrantel pamoate chewable tablet.
* * * * *
(c) * * *
(1) * * *
(iii) * * * Recommended for dogs 6 weeks of age and older. * * *
* * * * *
Dated: March 28, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 96-8362 Filed 4-4-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-8361 Medical Devices; Temporary Suspension of Approval of a Premarket Approval Application
[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Rules and Regulations]
[Pages 15186-15190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8361]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 814
[Docket No. 93N-0047]
RIN 0910-AA09
Medical Devices; Temporary Suspension of Approval of a Premarket
Approval Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is establishing
procedures to order the temporary suspension of approval of a premarket
approval application (PMA) for a medical device. This action is being
taken under a new authority granted to the agency by the Safe Medical
Devices Act of 1990 (the SMDA). Under this new authority, if, after
providing an opportunity for an informal hearing, FDA determines there
is a reasonable probability that continued distribution of a device
would cause serious, adverse health consequences or death, the agency
shall, by order, temporarily suspend approval of a PMA, and proceed
expeditiously, but within 60 days, to permanently withdraw approval of
the PMA. The final rule also clarifies that these procedures apply to
an original PMA, as well as any PMA supplement(s), for a medical
device.
EFFECTIVE DATE: May 6, 1996.
FOR FURTHER INFORMATION CONTACT: Lisa A. Rooney, Center for Devices and
Radiological Health (HFZ-84), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4765, ext. 164.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 12, 1993 (58 FR 52729), FDA
published a proposed rule to establish procedures to order the
temporary suspension of approval of a PMA for a medical device.
Interested persons were given until December 13, 1993, to comment on
the proposed rule. The agency received four comments, one from a trade
association, and three from manufacturers.
II. Summary of the Final Rule
Section 9 of the SMDA (Pub. L. 101-629) amended section 515(e) of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(e))
by adding section 515(e)(3) of the act which provides the agency with
the authority to temporarily suspend approval of a PMA. This authority
applies to the original PMA, as well as any PMA supplement(s), for a
medical device. Section 515(e)(3) of the act and new Sec. 814.47, the
implementing regulation, provide the agency with a prompt method of
removing dangerous devices from the market pending resolution of
permanent PMA or PMA supplement withdrawal proceedings.
Under Sec. 814.47(a), FDA will issue an order temporarily
suspending approval of a PMA or a PMA supplement when FDA determines
that there is a reasonable probability that continued distribution of
the device would cause serious, adverse health consequences or death.
Pursuant to Sec. 814.47(b), when FDA makes the requisite
determination, FDA shall provide an opportunity for an informal hearing
to determine whether to issue an order temporarily suspending approval
of a PMA or a PMA supplement. Such an informal hearing is to be
initiated and conducted by FDA pursuant to part 16 (21 CFR part 16).
Generally, under Sec. 814.47(b)(2), the person provided with notice of
an opportunity for an informal hearing will have not less than 3
working days after receipt of the notice to request a hearing.
Moreover, the informal hearing ordinarily will not be held less than 2
working days after receipt of the request for the hearing, in order to
provide time for preparation. However, in those rare circumstances when
FDA believes that immediate action to remove a dangerous device from
the market is necessary to protect the public health, the agency may
waive, suspend, or modify the above-referenced timeframes in accordance
with Sec. 10.19 (21 CFR 10.19) and Sec. 16.60(h).
Under Sec. 814.47(b)(3), a PMA holder's or a PMA supplement
holder's failure to request a hearing within the timeframe specified by
FDA in the notice of opportunity for a hearing, which is generally not
less than 3 working days, is deemed a waiver of the hearing.
[[Page 15187]]
Pursuant to Sec. 814.47(c), if the PMA or PMA supplement holder
does not request a hearing or after an informal hearing, FDA shall, by
order, temporarily suspend approval of a PMA or PMA supplement if the
agency determines there is a reasonable probability that continued
distribution of the device would cause serious, adverse health
consequences or death. In accordance with Sec. 814.47(d), FDA shall
proceed expeditiously, but within 60 days, to permanently withdraw
approval of the PMA or PMA supplement.
III. Clarification of the Proposed Rule
This final rule clarifies that the procedures for ordering the
temporary suspension of approval of a PMA apply to both the original
PMA and any PMA supplement(s) for a medical device. A PMA supplement is
a supplemental application for approval of a change affecting the
safety or effectiveness of a device for which there is an approved PMA
(see Secs. 814.3(g) and 814.39). As discussed in the preamble to part
814 (21 CFR part 814) (51 FR 26342 at 26354, July 22, 1986), when an
applicant submits a PMA supplement for a change in an approved device,
the applicant has, in effect, submitted a new PMA for the ``new''
(changed) device. For this reason, FDA has concluded that the authority
provided by section 515(e)(3) of the act applies to both PMA's and PMA
supplement(s).
IV.- Changes from the Proposed Rule
Although the agency maintained the basic framework of the proposed
rule, FDA modified the proposed rule in order to be consistent and
compatible with the medical device recall authority and to address
concerns raised in the comments. Several comments raised due process
concerns that resulted in FDA clarifying proposed Sec. 814.47(b) and
modifying proposed Sec. 814.47(d).
FDA clarified that the hearing provided for in Sec. 814.47(b) will
be conducted, whenever possible, in accordance with the procedures set
out in part 16. Thus, under Sec. 814.47(b)(2), the person offered an
opportunity for an informal hearing ordinarily will have not less than
3 working days after receipt of the notice to request a hearing.
Moreover, the informal hearing ordinarily will not be held less than 2
working days after receipt of the request for the hearing. However, in
extraordinary cases, if FDA believes that immediate action to remove a
dangerous device from the market is necessary to protect the public
health, the agency may waive, suspend, or modify the above-referenced
timeframes in accordance with Sec. 10.19 and 16.60(h). -
Furthermore, FDA amended Sec. 814.47(d) to specify a timeframe
within which FDA must initiate permanent withdrawal of PMA or PMA
supplement approval after issuing an order temporarily suspending PMA
or PMA supplement approval. FDA concluded that following issuance of an
order temporarily suspending approval of a PMA or a PMA supplement, the
agency will proceed expeditiously, but within 60 days, to permanently
withdraw approval of the PMA or the PMA supplement.
V. -Relationship Between Temporary Suspension of Approval of a PMA
or PMA Supplement and Medical Device Recall Authority
The SMDA provided FDA with, among other things, the authority to
issue orders to temporarily suspend the approval of a PMA or a PMA
supplement and to recall medical devices.
Section 8 of the SMDA amended section 518 of the act (21 U.S.C.
360h) by adding a new subsection (e) entitled ``Recall Authority.''
Section 518(e)(1) of the act provides that, if FDA finds that there is
a reasonable probability that a device intended for human use would
cause serious, adverse health consequences or death, FDA shall issue an
order requiring the appropriate person to immediately cease
distribution of the device, immediately notify health professionals and
device user facilities of the order, and instruct such professionals
and facilities to cease use of the device. Section 518(e)(2) of the act
states that, after providing an opportunity for an informal hearing,
FDA may amend the cease distribution and notification order to require
a recall of the device. FDA's medical device recall authority may be
invoked for any class of device.
This recall authority may be invoked for targeted purposes, for
example, when FDA wants an individual to temporarily cease distribution
and/or recall certain lots, batches, or models of class I, class II, or
class III devices which are located either in-house or on the market
until such devices are brought into compliance; or, the recall
authority may be used more broadly to cease distribution and/or recall
all models, batches, or lots of a manufacturer's device. On the other
hand, the agency's authority to temporarily suspend approval of a PMA
or a PMA supplement is invoked only in the latter circumstance, when
FDA wants a manufacturer to cease marketing all models, batches, or
lots of a particular class III device which was approved under the
subject PMA or PMA supplement, pending permanent withdrawal of the
device's PMA or PMA supplement approval. Thus, there may be
circumstances in which FDA could invoke both authorities.
The threshold criteria for invoking the medical device recall
authority and the authority to temporarily suspend approval of a PMA or
PMA supplement are identical. Under both authorities, FDA will issue
orders only when FDA determines there is a reasonable probability that
continued distribution of a device would cause serious, adverse health
consequences or death. Furthermore, under both authorities, FDA must
provide the person subject to the order and the holder of the approved
PMA or PMA supplement for the device with an opportunity for an
informal hearing. In both situations, the informal hearing is to be
conducted by FDA pursuant to part 16.
If FDA determines that there is a reasonable probability that
continued distribution of a currently marketed class III medical device
would cause serious, adverse health consequences or death, the agency
may invoke its medical device recall authority as well as its authority
to temporarily suspend approval of the PMA or PMA supplement for the
device. If both authorities are invoked, the medical device recall
informal hearing will be combined with the temporary suspension of
approval of a PMA or PMA supplement informal hearing. This combined
informal hearing will occur after FDA makes the requisite finding,
issues a cease distribution and notification order, and issues a letter
of intent to temporarily suspend approval of a PMA or PMA supplement.
This combined informal hearing does not eliminate the PMA or PMA
supplement holder's opportunity for an informal hearing prior to FDA
permanently withdrawing approval of a PMA or PMA supplement (see
section 515(e)(1) of the act).
VI. Summary and Analysis of Comments and FDA's Response
1. -One comment noted that the proposed rule, which states that
``FDA may initiate and conduct a regulatory hearing to determine
whether to issue an order temporarily suspending approval of the PMA''
(Sec. 814.47(b)(1)), implies that FDA can use its own discretion in
determining whether or not to hold a hearing prior to temporarily
suspending PMA approval and is contrary to section 515(e)(1) and (e)(3)
of the act and to the preamble of the proposed rule itself (see 58 FR
[[Page 15188]]
52729). Thus, it was urged that the final rule unequivocally state that
FDA will provide the manufacturer with an opportunity for an informal
hearing prior to temporarily suspending PMA approval.
FDA agrees with this comment. Under final Sec. 814.47(b), FDA must
give the PMA or PMA supplement holder notice and an opportunity for a
regulatory hearing under part 16 prior to temporarily suspending PMA or
PMA supplement approval. However, whether or not a regulatory hearing
is actually conducted depends on the decision of the PMA or PMA
supplement holder. If the PMA or PMA supplement holder does not request
a regulatory hearing within the timeframe specified by FDA in the
notice of opportunity for a hearing, then FDA may temporarily suspend
approval of the PMA or PMA supplement without a hearing. On the other
hand, if the PMA or PMA supplement holder requests the regulatory
hearing within the timeframe specified by FDA in the notice of
opportunity for a hearing, then FDA must conduct the hearing before
temporarily suspending approval of the holder's PMA or PMA supplement.
2.- Under Sec. 814.47(b)(2), if FDA believes that immediate action
to remove a dangerous device from the market is necessary to protect
the public health, FDA may, pursuant to Sec. 16.60(h), waive or modify
any part 16 procedure in accordance with Sec. 10.19. A comment noted
that in this situation FDA can waive Sec. 16.24(e), which states that a
hearing may not be required to be held at a time less than 2 working
days after receipt of the request for a hearing. This comment
recommended that, at the very least, Sec. 16.60(h) should not apply to
Sec. 16.24(e). Another comment urged that the agency should not be
allowed, under Sec. 16.60(h), to waive the notice requirements of
Sec. 16.24(e), which states that a hearing may not be required to be
held at a time less than 2 working days after receipt of the request
for a hearing and Sec. 16.22(b), which gives a person at least 3 days
after receiving notice of an opportunity for a hearing to request one.
The comment urged that waiver of these sections would violate a PMA
holder's due process rights. Additionally, it was contended that
Secs. 16.22(b) and 16.24(e) cannot be waived because Secs. 10.19 and
16.60(h) do not permit FDA to waive notice requirements. The comment
requested that FDA insert language granting an informal hearing as
defined in section 201(x) of the act (21 U.S.C. 321(x)) and specifying
that notice of at least 10 calendar days is required prior to the
issuance of an order temporarily suspending approval of a PMA. This
same comment noted that, under Sec. 10.19, waiver of prehearing
requirements is only allowed ``if no participant will be prejudiced,
the ends of justice will thereby be served, and the action is in
accordance with the law.'' According to this comment, waiver of
Secs. 16.22(b) and 16.24(e) would violate section 515(e)(3) of the act,
which requires the opportunity for an informal hearing.
FDA agrees that the hearing provided for in Sec. 814.47(b)(2)
should be conducted, whenever possible, within the timeframes set out
in part 16. Thus, in accordance with Sec. 16.22(b) of this chapter,
under Sec. 814.47(b)(2), the person offered an opportunity for an
informal hearing ordinarily will have not less than 3 working days
after receipt of the notice to request a hearing. Furthermore, pursuant
to Sec. 16.24(e), the informal hearing ordinarily will not be held less
than 2 working days after receipt of the request for the hearing.
However, under Sec. 16.60(h), the Commissioner or the presiding officer
has the power to waive any part 16 provision. According to Sec. 10.19,
part 16 provisions can only be suspended, modified, or waived if no
participant will be prejudiced, the ends of justice will thereby be
served, and the action is in accordance with the law. FDA can waive,
modify, or suspend the timeframes associated with the regulatory
hearings relating to suspension of PMA or PMA supplement approvals as
long as the PMA or PMA supplement holder is given notice and an
opportunity for an informal hearing as required by section 515(e)(3) of
the act. In extraordinary cases, FDA could give the PMA holder notice,
conduct a hearing, and render a decision on the same day. This would be
consistent with Congress' intent that, for temporary suspension action,
the informal hearing, when necessary, should be analogous to a
temporary restraining order (TRO) hearing that could result in notice,
a hearing, and a judicial decision in a single day if immediate action
to remove a dangerous device from the market is absolutely necessary to
protect the public health. (See H. Rept. 808, 101st Cong., 2d sess. 31
(1990).) Expedited hearing procedures under section 513(e) of the act,
therefore, would be in accordance with the law. However, FDA believes
that most temporary suspension hearings will be conducted within the
timeframes set out in part 16.
3. Another comment stated that enacting this rule as proposed,
i.e., authorizing FDA to suspend, modify, or waive any part 16
procedures, would create a procedure whereby persons challenging recall
orders would have greater opportunities to defend themselves than
persons affected by PMA suspension orders.
As noted above, FDA is seeking to make as consistent and parallel
as possible the procedures for recalling a device and temporarily
suspending approval of a PMA or PMA supplement. Moreover, it is
important to point out the additional protections that exist for PMA
holders. Under section 515(e)(1) of the act, FDA must provide notice
and an opportunity for an informal hearing before issuing an order for
permanent withdrawal of PMA or PMA supplement approval. Additionally, a
PMA or PMA supplement holder may petition for review of a section
515(e)(1) order pursuant to section 515(g) of the act. Section
515(g)(1) of the act provides ``[u]pon petition for review of * * * an
order * * * withdrawing approval of an [PMA] application * * * the
Secretary shall * * * hold a hearing * * *. The panel or panels which
considered the application * * * shall designate a member to appear and
testify at any such hearing upon request of the Secretary, the
petitioner, or the officer conducting the hearing * * *. Upon
completion of such hearing and after considering the record established
in such hearing, the Secretary shall issue an order either affirming
the order subject to the hearing or reversing such order and, as
appropriate, * * * reinstating the application's approval * * *.''
Thus, a PMA or PMA supplement holder is provided with additional
opportunities for a hearing prior to permanent withdrawal of PMA or PMA
supplement approval.
4. Another comment suggested that FDA's reliance upon H. Rept. 808,
101st Cong., 2d sess. 31 for authority to give notice, conduct a
hearing, and render a judicial decision within 1 day is misplaced
because this legislative history relates to hearings, not informal
hearings.
FDA disagrees with this comment. The hearing referred to in the
legislative history clearly pertains to the informal hearing discussed
in section 515(e)(3) of the act even though Congress used the term
``hearing,'' rather than ``informal hearing'' in the legislative
history. Moreover, FDA can give notice, conduct a hearing, and render a
decision in 1 day and still satisfy the informal hearing requirements
found in section 201(x) of the act. However, as discussed in response
to comment 2 of this document, FDA anticipates that temporary
suspension hearings will almost always be conducted in accordance with
the timeframes set out in part 16.
[[Page 15189]]
5.- A comment suggested that there is no need for this rule because
FDA can simply request a PMA holder to immediately stop distributing
the product or, if a PMA holder fails to comply with this request, FDA
can issue an order under FDA's recall authority to stop distribution of
a device which threatens the public health.
FDA disagrees with this comment. Congress gave FDA two separate,
though overlapping, authorities to remove dangerous devices from the
market. FDA will use one or both of these mechanisms, depending upon
particular circumstances. As noted earlier, FDA has made the two
procedures as consistent and parallel as possible in order to minimize
confusion should both authorities be invoked.
6. -All comments noted that proposed Sec. 814.47(d) failed to
define the term ``proceed expeditiously'' and requested that the final
rule specify a timeframe within which FDA must initiate permanent
withdrawal of PMA approval after issuing an order temporarily
suspending PMA approval. The comments suggested that FDA begin the
permanent withdrawal proceedings within 10 to 30 days after issuing the
temporary suspension order and conclude the proceedings within 30 to 60
days after issuing the temporary suspension order.
FDA agrees with the goal expressed in these comments. FDA has
concluded that following the issuance of an order temporarily
suspending approval of a PMA or PMA supplement, the agency will proceed
expeditiously, but within 60 days, to hold a hearing on whether to
permanently withdraw approval of the PMA or PMA supplement. Based on
prior experience, FDA has determined that 60 days is sufficient time
for both a PMA holder and FDA to prepare for an informal hearing which
is required to be held prior to permanently withdrawing approval of a
PMA, if such a hearing is requested. Section 814.14(d) has been amended
accordingly.
7.- A comment requested that the ``serious, adverse health
consequences'' definition found in proposed Sec. 814.3 be changed. It
was suggested that the words ``long range'' be replaced with ``long
term'' because ``long term'' is a phrase that is more precise, that
conforms to the legislative history, and that is more familiar to
medical device manufacturers. (See S. Rept. 513, 101st Cong., 2d sess.
19 (1990).)
FDA agrees with this comment. The legislative history surrounding
section 515(e)(3) of the act states that the term ``serious, adverse
health consequences'' means: any significant adverse experience
attributable to a device, including those which may be either life-
threatening, or involve permanent or long-term injuries, but excluding
those nonlife-threatening injuries which are temporary and reasonably
reversible. (See S. Rept. 513, 101st Cong., 2d sess. 19 (1990).) The
definition has been changed to reflect the legislative history
definition.
FDA also has revised the definition of serious, adverse health
consequences in Sec. 814.3(l) by deleting the following sentence:
``Injuries attributable to a device that are treatable and reversible
by standard medical techniques, proximate in time to the injury, are
not included within the term's definition.'' The legislative history
makes clear that the idea captured in the second sentence of the
proposed definition was intended only to further explain the type of
injury that would trigger temporary suspension Id. FDA has made the
same revision in the medical device recall regulation.
8.- One comment said that the preamble to the proposed rule
suggested that application of section 515(e)(3) of the act turns on the
judgment of whether, if distribution of the devices continues, one or
more individual devices would be more likely than not to cause serious,
adverse health consequences or death. The comment stated that this
statement in the preamble erroneously implies that one device is enough
to allow FDA to order a temporary PMA suspension.
FDA believes this comment misunderstands FDA's intent. FDA
emphasizes that application of section 515(e)(3) of the act does not
turn on whether a particular percentage of devices would cause serious,
adverse health consequences or death, but rather on the judgment of
whether it is more likely than not that serious, adverse health
consequences or death will result if distribution of the device
continues.
9. A comment urged that the definition of ``reasonable
probability'' found in proposed Sec. 814.3 be made consistent with the
February 1988 CDRH Medical Device Reporting Questions and Answers
document, p. 22, for reportable malfunctions, which defines ``likely''
in terms of both a qualitative and quantitative evaluation of the
likelihood that a recurrence of the malfunction will cause or
contribute to a death or serious injury.
FDA disagrees with this comment. The legislative history of section
515(e)(3) of the act states that a ``reasonable probability'' is ``one
where it is more likely than not that the event will occur.'' (See S.
Rept. 513, 101st Cong., 2d sess. 19 (1990).) The same ``reasonable
probability'' definition has been incorporated in Sec. 814.3(k) for
consistency.
10.- A comment requested that the rule allow a manufacturer to
voluntarily withdraw a product before FDA issues an order temporarily
suspending approval of the PMA.
FDA agrees that a manufacturer can voluntarily withdraw a PMA or
PMA supplement before FDA issues an order temporarily suspending
approval of the application. In fact, FDA will ordinarily encourage the
manufacturer to voluntarily withdraw its application before FDA issues
a temporary suspension order. However, if FDA's attempts are
unsuccessful or if FDA chooses not to urge voluntary withdrawal
initially, FDA will follow the procedures for temporarily suspending
approval of the manufacturer's PMA or PMA supplement. Because a
voluntary withdrawal of the application renders moot the need for FDA
to suspend its approval, there is no need to include this procedure in
the final rule.
VII. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(8) 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.
VIII. 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 rule only establishes the procedures by
which FDA will implement its authority for the temporary suspension of
approval of premarket approval applications, by
[[Page 15190]]
itself it imposes no burdens on manufacturers. Thus, 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.
List of Subjects in 21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, 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
814 is amended as follows:
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
1.-The authority citation for 21 CFR part 814 continues to read as
follows:
Authority: Secs. 501, 502, 503, 510, 513-520, 701, 702, 703,
704, 705, 708, 721, 801 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375,
379, 379e, 381).
2.- Section 814.3 is amended by adding new paragraphs (k) and (l)
to read as follows:
Sec. 814.3- Definitions.
* * * * *
(k) Reasonable probability means that it is more likely than not
that an event will occur.
(l) Serious, adverse health consequences means any significant
adverse experience, including those which may be either life-
threatening or involve permanent or long term injuries, but excluding
injuries that are nonlife-threatening and that are temporary and
reasonably reversible.
3. New Sec. 814.47 is added to subpart C to read as follows:
Sec. 814.47- Temporary suspension of approval of a PMA.
(a) Scope. (1) This section describes the procedures that FDA will
follow in exercising its authority under section 515(e)(3) of the act
(21 U.S.C. 360e(e)(3)). This authority applies to the original PMA, as
well as any PMA supplement(s), for a medical device.
(2) FDA will issue an order temporarily suspending approval of a
PMA if FDA determines that there is a reasonable probability that
continued distribution of the device would cause serious, adverse
health consequences or death.
(b) Regulatory hearing. (1) If FDA believes that there is a
reasonable probability that the continued distribution of a device
subject to an approved PMA would cause serious, adverse health
consequences or death, FDA may initiate and conduct a regulatory
hearing to determine whether to issue an order temporarily suspending
approval of the PMA.
(2) Any regulatory hearing to determine whether to issue an order
temporarily suspending approval of a PMA shall be initiated and
conducted by FDA pursuant to part 16 of this chapter. If FDA believes
that immediate action to remove a dangerous device from the market is
necessary to protect the public health, the agency may, in accordance
with Sec. 16.60(h) of this chapter, waive, suspend, or modify any part
16 procedure pursuant to Sec. 10.19 of this chapter.
(3) FDA shall deem the PMA holder's failure to request a hearing
within the timeframe specified by FDA in the notice of opportunity for
hearing to be a waiver.
(c) Temporary suspension order. If the PMA holder does not request
a regulatory hearing or if, after the hearing, and after consideration
of the administrative record of the hearing, FDA determines that there
is a reasonable probability that the continued distribution of a device
under an approved PMA would cause serious, adverse health consequences
or death, the agency shall, under the authority of section 515(e)(3) of
the act, issue an order to the PMA holder temporarily suspending
approval of the PMA.
(d) Permanent withdrawal of approval of the PMA. If FDA issues an
order temporarily suspending approval of a PMA, the agency shall
proceed expeditiously, but within 60 days, to hold a hearing on whether
to permanently withdraw approval of the PMA in accordance with section
515(e)(1) of the act and the procedures set out in Sec. 814.46.
Dated: March 28, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-8361 Filed 4-4-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-8301 Veterans Education: Increase in Rates Payable Under the Montgomery GI BillActive Duty, 1994-95
[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Rules and Regulations]
[Pages 15190-15192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8301]
=======================================================================
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 21
RIN 2900-AH14
Veterans Education: Increase in Rates Payable Under the
Montgomery GI Bill--Active Duty, 1994-95
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: By statute the monthly rates of basic educational assistance
payable to veterans and servicemembers under the Montgomery GI Bill --
Active Duty must be adjusted each fiscal year. In accordance with the
statutory formula, the regulations governing rates of basic educational
assistance payable under the Montgomery GI Bill--Active Duty for fiscal
year 1995 (October 1, 1994 through September 30, 1995) are changed to
show a 1.22% increase.
EFFECTIVE DATE: April 5, 1996.
FOR FURTHER INFORMATION CONTACT: June C. Schaeffer, Assistant Director
for Policy and Program Administration, Education Service, Veterans
Benefits Administration (202) 273-7187.
SUPPLEMENTARY INFORMATION: Under the formula mandated by 38 U.S.C.
3015(g) and section 12009 of the Omnibus Budget Reconciliation Act of
1993 (Pub. L. 103-66) for fiscal year 1995, the rates of basic
educational assistance under the Montgomery GI Bill--Active Duty
payable to students pursuing a program of education full time must be
increased by one-half of the percentage that the total of the monthly
Consumer Price Index-W for July 1, 1993 through June 30, 1994 exceeds
the total of the monthly Consumer Price Index-W for July 1, 1992
through June 30, 1993. Under this formula, the changes to the
regulations governing monthly rates reflect a 1.22% increase.
It should be noted that some veterans will receive an increase in
monthly payments that will be less than 1.22%. The increase does not
apply to additional amounts payable by the Secretary of Defense to
individuals with skills or a specialty in which there is a critical
shortage of personnel (so-called ``kickers''). It does not apply to
supplemental educational assistance. It also does not apply to amounts
payable for dependents. Veterans who previously had eligibility under
the Vietnam Era GI Bill receive monthly payments that are in part based
upon basic educational assistance and in part based upon the rates
payable under the Vietnam Era GI Bill. Only that portion attributable
to basic educational assistance is increased by 1.22%.
Although 38 U.S.C. 3015(g) requires only that the full-time rates
be increased, these revisions include increases for other training
also. Monthly rates payable to veterans in apprenticeship or other on-
job training or cooperative training are set by statute at a given
percentage of the full-time rate. Hence, any rise in the full-time rate
[[Page 15191]]
automatically requires an increase in the rates for these types of
training.
38 U.S.C. 3015 (a) and (b) require that the Department of Veterans
Affairs (VA) pay part-time students at appropriately reduced rates.
Since the first student became eligible for assistance under the
Montgomery GI Bill--Active Duty in 1985, VA has paid three-quarter-time
students and one-half-time students at 75% and 50% of the full-time
rate, respectively. Students pursuing a program of education at less
than one half but more than one-quarter-time have had their payments
limited to 50% or less of the full-time rate. Similarly, students
pursuing a program of education at one-quarter-time or less have had
their payments limited to 25% or less of the full-time rate. Changes
are made consistent with the authority and formula described in this
paragraph.
Nonsubstantive changes also are made for the purpose of clarity.
The changes set forth in this final rule are applied retroactively
from the effective date of the statutory changes.
Substantive changes made by this final rule merely reflect
statutory requirements and adjustments made based on previously
established formulas. Accordingly, there is a basis for dispensing with
prior notice and comment and delayed effective date provisions of 5
U.S.C. 552 and 553.
The Secretary of Veterans Affairs hereby certifies that this final
rule will not have a significant economic impact on a substantial
number of small entities as they are defined in the Regulatory
Flexibility Act, 5 U.S.C. 601-612. This final rule directly affects
only individuals and does not directly affect small entities. Pursuant
to 5 U.S.C. 605(b), this final rule, therefore, is exempt from the
initial and final regulatory flexibility analyses requirements of
Secs. 603 and 604.
The Catalog of Federal Domestic Assistance number for the
program affected by this final rule is 64.124.
List of Subjects in 38 CFR Part 21
Administrative practice and procedure, Armed forces, Civil rights,
Claims, Colleges and universities, Conflict of interests, Defense
Department, Education, Employment, Entitlement programs-education,
Entitlement programs-veterans, Health care, Loan programs-education,
Loan programs-veterans, Manpower training programs, Reporting and
recordkeeping requirements, Schools, Travel and transportation
expenses, Veterans, Vocational education, Vocational rehabilitation.
Approved: March 28, 1996.
Jesse Brown,
Secretary of Veterans Affairs.
For the reasons set out in the preamble, 38 CFR part 21 (subpart K)
is amended as set forth below.
PART 21--VOCATIONAL REHABILITATION AND EDUCATION
Subpart K--All Volunteer Force Educational Assistance Program (New
GI Bill)
1. The authority citation for part 21, subpart K is revised to read
as follows:
Authority: 38 U.S.C. 501(a), chs. 30, 36, unless otherwise
noted.
2. In Sec. 21.7136, paragraph (b)(3) is amended by removing
``$320'' and adding, in its place, ``$323.90 for training that occurs
after September 30, 1994, and before October 1, 1995''; paragraph
(c)(3) is amended by removing ``$260'' and adding, in its place,
``$263.18 for training that occurs after September 30, 1994, and before
October 1, 1995,''; and paragraphs (b)(1), (b)(2), (c) introductory
text, (c)(1), and (c)(2) and their authority citations are revised, to
read as follows:
Sec. 21.7136 Rates of payment of basic educational assistance.
* * * * *
(b) Rates. (1) Except as provided in paragraphs (b)(2), (b)(3), and
(d) of this section, the monthly rate of basic educational assistance
payable for training that occurs after September 30, 1994, and before
October 1, 1995, to a veteran whose service is described in paragraph
(a) of this section is the rate stated in the following table.
------------------------------------------------------------------------
Monthly
Training rate
------------------------------------------------------------------------
Full time.................................................... $404.88
\3/4\ time................................................... 303.66
\1/2\ time................................................... 202.44
Less than \1/2\ but more than \1/4\ time..................... 202.44
\1/4\ time or less........................................... 101.22
------------------------------------------------------------------------
(Authority: 38 U.S.C. 3015; sec. 12009(c), Pub. L. 103-66, 107 Stat.
416)
(2) If a veteran's service is described in paragraph (a) of this
section, the monthly rate payable to the veteran for pursuit of an
apprenticeship or other on-job training that occurs after September 30,
1994, and before October 1, 1995, is the rate stated in the following
table.
------------------------------------------------------------------------
Monthly
Training period rate
------------------------------------------------------------------------
First six months of pursuit of program....................... $303.66
Second six months of pursuit of program...................... 222.68
Remaining pursuit of program................................. 141.71
------------------------------------------------------------------------
(Authority: 38 U.S.C. 3015, 3032(c); sec. 12009(c), Pub. L. 103-66,
107 Stat. 416)
* * * * *
(c) Rates for some veterans whose initial obligated period of
active duty is less than three years. If a veteran has established
eligibility under Sec. 21.7042, but the veteran's service is not
described in paragraph (a)(2) of this section, the monthly rate of
educational assistance payable to the veteran will be determined by
this paragraph.
(1) Except as provided in paragraphs (c)(2), (c)(3), and (d) of
this section, the monthly rate of basic educational assistance payable
to a veteran for training that occurs after September 30, 1994, and
before October 1, 1995, is the rate stated in the following table.
------------------------------------------------------------------------
Monthly
Training rate
------------------------------------------------------------------------
Full time.................................................... $328.97
\3/4\ time................................................... 246.73
\1/2\ time................................................... 164.49
Less than \1/2\ but more than \1/4\ time..................... 164.49
\1/4\ time or less........................................... 82.24
------------------------------------------------------------------------
(Authority: 38 U.S.C. 3015, 3032(c); sec. 12009(c), Pub. L. 103-66,
107 Stat. 416)
(2) The monthly rate of educational assistance payable to a veteran
for pursuit of an apprenticeship or other on-job training that occurs
after September 30, 1994, and before October 1, 1995, is the rate
stated in the following table.
------------------------------------------------------------------------
Monthly
Training period rate
------------------------------------------------------------------------
First six months of pursuit of program....................... $246.73
Second six months of pursuit of program...................... 180.93
Remaining pursuit of program................................. 115.14
------------------------------------------------------------------------
(Authority: 38 U.S.C. 3015, 3032(c); sec. 12009(c), Pub. L. 103-66,
107 Stat. 416)
* * * * *
3. In Sec. 21.7137, paragraph (c)(2) introductory text is amended
by removing ``rates'' and adding, in its place, ``rates for training
that occurs after September 30, 1994, and before October 1, 1995'';
paragraph (c)(2)(i) is amended by removing ``$588.00'' and adding, in
its place, ``$592.88''; paragraph (c)(2)(ii) is amended by removing
``$441.00'' and adding, in its
[[Page 15192]]
place, ``$445.16''; paragraph (c)(2)(iii) is amended by removing
``$294.00'' and adding, in its place, ``$296.44''; paragraph (c)(2)(iv)
is amended by removing ``$147.00'' and adding, in its place,
``$148.22''; and paragraphs (a)(1) and (a)(2) and their authority
citations are revised, to read as follows:
Sec. 21.7137 Rates of payment of basic educational assistance for
individuals with remaining entitlement under 38 U.S.C. ch. 34.
(a) Minimum rates. * * *
(1) Except as provided in paragraphs (a)(2), (b), and (c) of this
section, the monthly rate of basic educational assistance for training
that occurs after September 30, 1994, and before October 1, 1995, is
the rate stated in the following table.
----------------------------------------------------------------------------------------------------------------
Monthly rate
-------------------------------------------------------
Additional
Training No One Two for each
dependents dependent dependents additional
dependent
----------------------------------------------------------------------------------------------------------------
Full time............................................... $592.88 $628.88 $659.88 $16.00
\3/4\ time.............................................. 445.16 471.66 495.16 12.00
\1/2\ time.............................................. 296.44 314.44 329.94 8.50
Less than \1/2\ but more than \1/4\ time................
(3) 296.44
\1/4\ time..............................................
(3) 148.22
Cooperative............................................. 445.50 465.90 485.50 9.20
----------------------------------------------------------------------------------------------------------------
(Authority: 38 U.S.C. 3015(c), 3015(f), 3015(g); sec. 12009(c), Pub.
L. 103-66, 107 Stat. 416)
(2) For veterans pursuing an apprenticeship or other on-job
training, the monthly rate of basic educational assistance for training
that occurs after September 30, 1994, and before October 1, 1995, is
the rate stated in the following table.
----------------------------------------------------------------------------------------------------------------
Monthly rate
-------------------------------------------------------
Additional
Training period No One Two for each
dependents dependent dependents additional
dependent
----------------------------------------------------------------------------------------------------------------
1st 6 months of pursuit of program...................... $406.41 $418.79 $429.66 $5.25
2nd 6 months of pursuit of program...................... 279.06 288.41 296.11 3.85
3rd 6 months of pursuit of program...................... 165.51 171.63 176.36 2.45
Remaining pursuit of program............................ 153.61 159.38 164.63 2.45
----------------------------------------------------------------------------------------------------------------
(Authority: 38 U.S.C. 3015(d), 3015(f), 3015(g); sec. 12009(c), Pub.
L. 103-66, 107 Stat. 416)
* * * * *
[FR Doc. 96-8301 Filed 4-4-96; 8:45 am]
BILLING CODE 8320-01-P
Complete official Federal Register PDF
FR Doc. 96-8142 Pesticide Tolerances for Glyphosate
[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Rules and Regulations]
[Pages 15192-15196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8142]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP 6F3408, 4F4312, 4F4338, 4F4369, FAP 4H5701, 4H5705/R2204; FRL-5351-
1]
Pesticide Tolerances for Glyphosate
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This document establishes tolerances and feed additive
regulations for residues of the herbicide glyphosate [(N-
phosphonometyhyl)glycine]. The specific proposals are as follows:
establishment of tolerances for alfalfa hay at 200 parts per million
(ppm), alfalfa forage at 75 ppm, soybean aspirated grain fractions at
50 ppm; sunflower seed at 0.1 ppm, increased tolerances on the kidney
of cattle, goats, hog, horses, and sheep from 0.5 to 4.0 ppm; an
amended tolerance removing the metabolite aminomethylphosphonic acid
(AMPA) from the expression and increasing the established tolerance for
soybean forage from 15 to 100 ppm; amended tolerances removing the
metabolite AMPA from the expressions for the established tolerances
soybean, grain at 20 ppm, and soybean, hay at 200 ppm; deletion of the
established tolerances for soybean straw at 200 ppm; and an amended
feed additive regulation removing the metabolite AMPA from the
expression for the established tolerance soybean hulls at 100 ppm. This
rule also amends the current tolerance for citrus fruits and the feed
additive regulation for citrus pulp, dried by removing the metabolite
AMPA from the expressions and increasing the tolerance for citrus
fruits from 0.2 to 0.5 ppm and increasing the tolerance for citrus
pulp, dried from 1.0 to 1.5 ppm. Monsanto Company requested these
tolerances and feed additive regulation in petitions submitted to EPA
pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA).
EFFECTIVE DATES: These regulations become effective April 5, 1996.
ADDRESSES: Written objection and hearing requests, identified by the
document control number, [PP 6F3408, 4F4312, 4F4338, 4F4369, FAP
4H5701, 4H5705/R2204], may be submitted to: Hearing Clerk (1900),
Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington,
DC 20460. Fees accompanying objections shall be labeled ``Tolerance
Petition Fees'' and forwarded to: EPA Headquarters Accounting
Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh,
PA 15251. A copy of any objections and hearing request filed with the
Hearing Clerk should be identified by the document control number and
submitted to: Public Response and Program Resources Branch, Field
Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring a copy of objections and hearing requests to: Rm.
1132, CM#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. A copy of
objections and hearing requests filed with the Hearing
[[Page 15193]]
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected].
Copies of objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption. Copies of objections and hearing requests will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All copies of objections and hearing requests in electronic
form must be identified by the docket number [PP 6F3408, 4F4312,
4F4338, 4F4369, FAP 4H5701, 4H5705/R2204]. No Confidential Business
Information (CBI) should be submitted through e-mail. Electronic copies
of objections and hearing requests on this rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submission can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail, Robert J. Taylor, Product
Manager (PM 25), Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 241, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA, 703-305-6027; e- mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA issued notices in the Federal Register,
announcing that the Monsanto Co., 700 14th St., NW., Suite #1100,
Washington, DC 20005, had submitted petitions proposing to amend 40 CFR
part 180 pursuant to section 408 (d) of the Federal Food, Drug, and
Cosmetic (FFDCA) (21 U.S.C. 346(a), and 40 CFR part 186 under sec 409
of FFDCA (21 U.S.C. 348) by establishing regulations to permit the
combined residues of the herbicide glyphosate [N-
(phosphonomethyl)glycine] and its metabolite aminomethylphosphonic acid
(AMPA) or glyphosate in or on certain raw agricultural commodities
(RACs).
1. PP 6F3408. Published in the Federal Register of September 13,
1995 (60 FR 47578), the notice proposed establishing a regulation to
permit combined residues of glyphosate and its metabolite AMPA in or on
sunflowers at 0.1 ppm.
2. PP 4F4312. Published in the Federal Register of July 13, 1994
(59 FR 35718), the notice proposed to amend 40 CFR 180.364 by
establishing a regulation to permit residues of glyphosate and its
metabolite AMPA resulting from the application of the isopropylamine
salt of glyphosate and/or the monoammonium salt of glyphosate in or on
alfalfa, hay at 200 ppm and alfalfa forage at 75 ppm.
3. PP 4F4338. Published in the Federal Register of November 2, 1994
(59 FR 54907), the notice proposed to amend 40 CFR 180.364 by
establishing a regulation permitting residues of glyphosate and its
metabolite AMPA resulting from the application of the isopropylamine
salt of glyphosate and/or the monoammonium salt of glyphosate in or on
citrus fruits at 0.5 ppm.
4. PP 4F4369. Published in the Federal Register of February 8, 1995
(60 FR 7540), the notice proposed to amend 40 CFR 180.364 by
establishing a regulation to permit residues of glyphosate resulting
from the application of the isopropyl amine salt of glyphosate and/or
the monoammonium salt of glyphosate in or on soybean forage at 100 ppm.
5. PP 4H5692. Published in the Federal Register of July 13, 1994
(59 FR 35720), the notice proposed establishing a feed additive
regulation to permit the combined residues of glyphosate and its
metabolite aminomethylphosphonic acid (AMPA) in alfalfa meal at 400
ppm.
6. PP 4H4701. Published in the Federal Register of March 16, 1995
(60 FR 13979), the notice proposed to amend 40 CFR 186.3500 by
establishing a feed additive regulation to permit residues of
glyphosate resulting from the application of the isopropylamine salt
and/or monoammonium salt of glyphosate on the feed commodity soybeans,
aspirated grain fractions at 30 parts per million.
7. PP 4H5705. Published in the Federal Register of November 2, 1994
(59 FR 54907), the notice proposed to amend 40 CFR 185.3500 by
establishing a feed additive regulation to permit residues of
glyphosate and its metabolite aminomethylphosphonic acid in or on
citrus pulp, dried at 1.0 ppm.
There were no comments or requests for referral to an advisory
committee received in response to these notices of filing.
Subsequently, the petitioner amended several of the petitions by
submitting revised Section F`s. Amended filing notices were published
in the Federal Register of September 13, 1995 (60 FR 47578, 79)
proposing these changes.
1. PP 4F4312. Monsanto amended this petition by proposing that 40
CFR 180.364 be amended by removing the metabolite AMPA from the
expression and by establishing a regulation to permit residues of
glyphosate resulting from the application of the isopropylamine salt of
glyphosate and/or the monoammonium salt of glyphosate and/or
monoammonium salt of glyphosate for herbicidal and plant growth
regulator purposes and/or sodium sesqui salt of glyphosate for growth
regulator purposes in or on the kidney of cattle, goats, hogs, sheep,
and horses at 4.0 ppm.
2. PP 4F4338. Monsanto amended this petition by proposing to remove
the metabolite AMPA from the expression.
3. PP 4F4369. Monsanto amended this petition by proposing that 40
CFR 180.364 be amended by establishing a regulation to permit residues
of the herbicide glyphosate resulting from the application of the
isopropylamine salt of glyphosate in or on the raw agricultural
commodities (RACs) soybean grain at 20 ppm, soybean forage at 100 ppm,
soybean hay at 200 ppm, and soybean aspirated grain fractions at 50
ppm. These tolerances are to replace the existing tolerances for
soybeans, soybean forage, soybean hay, and soybean straw.
4. PP 4H5701. Monsanto amended this petition by deleting the feed
commodity soybean, aspirated grain fractions at 30 ppm from this
expression and reproposing it as a raw agricultural commodity under PP
4F4369. Monsanto also proposed that a feed additive regulation be
established permitting residues of glyphosate resulting from the
application of the isopropylamine salt of glyphosate and/or the
monoammonium salt of glyphosate in or the feed commodity soybean hulls
at 100 ppm. This entry would replace the current entry for soybean
hulls.
5. PP 4H5705. Monsanto amended this petition by proposing that 40
CFR part 186 be amended by establishing a regulation to permit residues
of glyphosate in or on the feed commodity citrus pulp, dried at 1.5
ppm.
The Agency received one comment opposing the tolerances stated in
the amended filing notices published September 13, 1995. The
commenter's opposition to the tolerances was based upon toxicological
concerns including the concept of ``NOEL'' (no observed effect level);
the use of animal testing to represent human reaction to potentially
toxic substances (pesticides); the indications of a link between
pesticide exposure and Parkinson`s Disease (PD).
The Agency has reviewed the comment and decided to proceed with
these tolerances. The Agency, made the decision that a wide variety of
toxicological studies would serve as the basis for determining if a
pesticide could be requested and used without reasonable risk. It is
true that animal models do not and can not predict every possible human
reaction to pesticides, but the general consensus is that they
[[Page 15194]]
offer the best information as to what a pesticide might do to humans.
Usually, the Agency requires and reviews long-term studies in rodents
and non-rodents to determine a dose which causes no apparent adverse
effects (NOEL). The NOEL is divided by an uncertainty factor-often at
least 100- to arrive at doses or exposures that should not cause
harmful effects on humans. In our regulation of pesticides, the Agency
does not approve uses which will cause unreasonable adverse effects to
humans or the environment.
The Agency understands that the testing of one pesticide does not
predict all the possible adverse interactions with other pesticides--or
for that matter other drugs or environmental pollutants. The Agency is
exploring ways of testing for the interactions of pesticides having
similar toxicity endpoint, but progress in that area is low.
With reference to the indications of a link between pesticide
exposure and Parkinson`s Disease, the Agency is aware that many
researchers are investigating the potential reaction of pesticide
exposures to chronic neurological diseases including Parkinson`s
Disease, and additional research is needed to study this important
area. Available studies in humans or animals have not yet established
any relationship between pesticide exposures and Parkinson`s Disease.
During the course of the review the Agency determined that the
proposed tolerance for alfalfa meal (59 FR 35720) was not necessary
since the proposed tolerance on alfalfa hay will cover any residue in
meal. This petition (4H5692) was withdrawn.
The filing notice for PP 6F3408 was amended by submitting a revised
section F deleting the metabolite AMPA from the expression, Because
this is a deletion of a metabolite not longer regulated by the Agency,
there is no potential risk to humans, therefore no additional period of
public comment is necessary.
The amended notice of filing for 4F4369 should have included the
monoammonium salt of glyphosate in the expression. The amended notice
of filing for 4H5701 should have not included reference to the salts of
glyphosate. Because these corrections are a correction of wording in
the expression, there is no potential increased risk to humans,
therefore no additional period of public comment is necessary.
The data submitted in the petitions and other relevant material
have been evaluated. The glyphosate toxicological data listed below
were considered in support of these tolerances.
1. Several acute toxicology studies placing technical-grade
glyphosate in Toxicity Category III and Toxicity Category IV.
2. A 1-year feeding study with dogs fed dosage levels of 0, 20,
100, and 500 milligrams/kilogram/day (mg/kg/day) with a no-observable-
effect level (NOEL) of 500 mg/kg/day.
3. A 2-year carcinogenicity study in mice fed dosage levels of 0,
150, 750, and 4,500 mg/kg/day with no carcinogenic effect at the
highest dose tested (HDT) of 4,500 mg/kg/day.
4. A chronic feeding/carcinogenicity study in male and female rats
fed dosage levels of 0, 3, 10, and 31 mg/kg/day (males) and 0, 3, 11,
or 34 mg/kg/day (females) with no carcinogenic effects observed under
the conditions of the study at dose levels up to and including 31 mg/
kg/day (HDT) (males) and 34 mg/kg/day (HDT) (females) and a systemic
NOEL of 31 mg/kg/day (HDT)(males) and 34 mg/kg/day (HDT) (females).
Because a maximum tolerated dose (MTD) was not reached, this study was
classified as supplemental for carcinogenicity.
5. A chronic feeding/carcinogenicity study in male and female rats
fed dosage levels of 0, 89, 362, and 940 mg/kg/day (males) and 0, 113,
457, and 1183 mg/kg/day (females) with no carcinogenic effects noted
under the conditions of the study at dose levels up to and including
940/1183 mg/kg/day (males/females) (HDT) and a systemic NOEL of 362 mg/
kg/day (males) based on an increased incidence of cataracts and lens
abnormalities, decreased urinary pH, increased liver weight and
increased liver weight/brain ratio (relative liver weight) at 940 mg/
kg/day (males) (HDT) and 457 mg/kg/day (females) based on decreased
body weight gain 1183 mg/kg/day (females) (HDT).
6. A developmental toxicity study in rats given doses of 0, 300,
1,000, and 3,500 mg/kg/day with a developmental NOEL of 1,000 mg/kg/day
based on an increase in number of litters and fetuses with unossified
sternebrae, and decrease in fetal body weight at 3,500 mg/kg/day, and a
maternal NOEL of 1,000 mg/kg/day based on decrease in body weight gain,
diarrhea, soft stools, breathing rattles, inactivity, red matter in the
region of nose, mouth, forelimbs, or dorsal head, and deaths at 3,500
mg/kg/day (HDT).
7. A developmental toxicity study in rabbits given doses of 0, 75,
175, and 350 mg/kg/day with a developmental NOEL of 350 mg/kg/day
(HDT); a maternal NOEL of 175 mg/kg/day based on increased incidence of
soft stool, diarrhea, nasal discharge, and deaths at 350 mg/kg/day
(HDT).
8. A multigeneration reproduction study with rats fed dosage levels
of 0, 3, 10, and 30 mg/kg/day with a developmental NOEL of 10 mg/kg/day
based on increased incidence of focal tubular dilation of the kidney
(both unilateral and bilateral combined) of male F3b pups.
9. A two generation reproduction study with rats fed dosage levels
of 0, 100, 500, and 1,500 mg/kg/day with a developmental NOEL of 500
mg/kg/day based on decreased pup body weight and body weight gain on
lactation days 14 and 21 at 1,500 mg/kg/day (HDT), a systemic NOEL of
500 mg/kg/day based on soft stools in Fo and F1 males and females at
1500 mg/kg/day (HDT) and a reproductive NOEL of 1500 mg/kg/day (HDT).
10. Mutagenicity data included chromosomal aberration in vitro (no
aberrations in Chinese hamster ovary cells were caused with and without
S9 activation); DNA repair in rat hepatocyte; in vivo bone marrow
cytogenic test in rats; rec-assay with B. subtilis; reverse mutation
test with S. typhimurium; Ames test with S. typhimurium; and dominant-
lethal mutagenicity test in mice (all negative).
The reference dose (RfD) based on a developmental study with
rabbits (NOEL of 175 mg/kg/ bwt/day) and using a hundred-fold safety
factor is calculated to be 2.0 mg/kg body weight/day. The theoretical
maximum residue contribution (TMRC) for published tolerances and food
and feed additive regulations is 0.020733 mg/kg bwt/day or 1.0 percent
of the RfD for the overall U.S. population. The current actions on
citrus fruits, citrus dried pulp, alfalfa, kidney of cattle, goats,
hog, horses, and sheep, sunflower, and soybean forage will contribute
0.000726 mg/kg/bwt/day to the TMRC. These tolerances and the food
additive regulation will utilize a total of 1.0 percent of the RfD for
the overall U.S. population.
For both U.S. subgroup populations, nonnursing infants and children
1 to 6 years of age, the current action and previously established
tolerances and the food additive regulation utilize, a total of 2.5
percent of the RfD, assuming that residue levels are at the established
tolerance levels and that 100 percent of the crop is treated.
There are no desirable data lacking for this pesticide. There are
currently no actions pending against the continued registration of this
pesticide. No detectable residues of N-nitrosoglyphosate, a contaminant
of glyphosate, are expected to be present in the commodities for which
tolerances
[[Page 15195]]
are established. The carcinogenic potential of glyphosate was first
considered by a panel, then called the Toxicology Branch AD Hoc
Committee, in 1985. The Committee, in a consensus review dated March 4,
1985, classified glyphosate as a Group C carcinogen based on an
increased incidence of renal tumors in male mice. The Committee also
concluded that dose levels tested in the 26-month rat study were not
adequate for assessment of glyphosate's carcinogenic potential in this
species. These findings, along with additional information, including a
reexamination of the kidney slides from the long-term mouse study, were
referred to the FIFRA Scientific Advisory Panel (SAP). In its report
dated February 24, 1986, SAP classified glyphosate as a Group D
Carcinogen (inadequate animal evidence of carcinogenic potential). SAP
concluded that, after adjusting for the greater survival in the high-
dose mice compared to concurrent controls, that no statistically
significant pairwise differences existed, although the trend was
significant.
The SAP determined that the carcinogenic potential of glyphosate
could not be determined from existing data and proposed that the rat
and/or mouse studies be repeated in order to classify these equivocal
findings. On reexamination of all information, the Agency classified
glyphosate as a Group D Carcinogen and requested that the rat study be
repeated and that a decision on the need for a repeat mouse study would
be made upon completion of review of the rat study.
Upon receipt and review of the second rat chronic feeding/
carcinogenicity study, all toxicological findings for glyphosate were
referred to the Health Effects Division Carcinogenicity Peer Review
Committee on June 26, 1991, for discussion and evaluation of the weight
of evidence on glyphosate with particular emphasis on its carcinogenic
potential. The Peer Review Committee classified glyphosate as a Group E
(evidence of noncarcinogenicity for humans), based upon lack of
convincing carcinogenicity evidence in adequate studies in two animal
species. This classification is based on the following findings: (1)
None of the types of tumors observed in the studies (pancreatic islet
cell adenomas in male rat, thyroid c-cell adenomas and/or carcinomas in
male and female rats, hepatocellular adenomas and carcinomas in male
rats, and renal tubular neoplasms in male mice) were determined to be
compound related; (2) glyphosate was tested up to the limit dose on the
rat and up to levels higher than the limit dose in mice; and (3) there
is no evidence of genotoxicity for glyphosate. Accordingly, EPA
concludes that glyphosate has not been ``found to induce cancer when
ingested by man or animal.'' 21 U.S.C. 348(c)(3).
The nature of the residue in plants is adequately understood,
adequate methodology (HPLC) with flurometric detection is available for
enforcement purposes, and the methodology has been published in the
Pesticide Analytical Manual (PAM), Vol. II. Any secondary residues
occurring in liver of cattle, goats, horses, hogs, and sheep and liver
and kidney of poultry will be covered by existing tolerances. Any
secondary residues occurring in kidney of cattle, goats, hogs, horses,
and sheep will be covered by the 4.0 ppm tolerances being established
concurrently.
The pesticide is considered useful for the purpose for which the
regulation is sought and is capable of achieving the intended physical
or technical effect.
Based on the information cited above, the Agency has determined
that the establishment of tolerances by amending 40 CFR part 180 will
protect the public health, and the establishment of feed additive
regulations by amending 40 CFR part 186 will be safe. Therefore, EPA is
establishing the tolerances and feed additive regulations as set forth
below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections with the Hearing Clerk, at the address given above.
40 CFR 178.20. A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections. 40
CFR 178.25. Each objection must be accompanied by the fee prescribed by
40 CFR 180.33(i). If a hearing is requested, the objections must
include a statement of the factual issue(s) on which the hearing is
requested, the requestor`s contentions on each such issue, and a
summary of any evidence relied upon by the objector. 40 CFR 178.27. A
request for a hearing will be granted if the Administrator determines
that the material submitted shows the following: There is a genuine and
substantial issue of fact; there is a reasonable possibly that
available evidence identified by the requestor would, if established,
resolve one or more issues in favor of the requestor, taking into
account uncontested claims or facts to the contrary; and resolution of
the factual issue(s) in the manner sought by the requestor would be
adequate to justify the action requested. 40 CFR 178.32.
A record has been established for this rulemaking under docket
number [PP 6F3408, 4F4312, 4F4338, 4F4369, FAP 4H5701, 4H5705/R2204]
(including objections and hearing requests submitted electronically as
described below). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA.
Written objections and hearing requests, identified by the document
control number [PP 6F3804, 4F4312, 4F4338, 4F4369, FAP 4h5701, 4H5705/
R2204] may be submitted to the Hearing Clerk (1900), Environmental
Protection Agency, Rm 3708, 401 M St SW., Washington, DC 20460. A copy
of electronic objections and hearing requests filed with the Hearing
Clerk can be sent directly to EPA at:
opp-D[email protected]
A copy of electronic objections and hearing requests filed with the
Hearing Clerk must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any objections and hearing requests received
electronically into printed, paper form as they are received and will
place the paper copies in the official rulemaking record which will
also include all objections and hearing requests submitted directly in
writing. The official rulemaking record is the paper record maintained
at the address in ``ADDRESSES'' at the beginning of this document.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action `` as an action
that is likely to result in a rule (1) having an annual effect on the
economy of $100 million or more, or adversely and materially affecting
a
[[Page 15196]]
sector of the economy, productivity, competition,jobs, the environment,
public health or safety, or State, local, or tribal governments or
communities (also referred to as ``economically significant''); (2)
creating serious inconsistency or otherwise interfering with an action
taken or planned by another agency; (3) materially altering the
budgetary impacts of entitlement, grants, user fees, or loan programs
or the rights and obligation of recipients thereof; or (4) raising
novel legal or policy issues arising out of legal mandates, the
President`s priorities, or the principles set forth in this Executive
Order.
Pursuant to the terms of the Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review. Pursuant to the requirements of the Regulatory Flexibility
Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the
Administrator has determined that regulations establishing new
tolerances or raising tolerance levels or establishing exemptions from
tolerance requirements do not have a significant impact on a
substantial number of small entities. A certification statement to this
effect was published in the Federal Register of May 4, 1981 (46 FR
24950).
List of Subjects
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests.
40 CFR Part 186
Environmental protection, Animal feeds, Feed additives.
Dated: March 22, 1996.
Stephen L. Johnson,
Director, Registration Division. Office of Pesticide Programs.
Therefore, chapter I of title 40 of the Code of Federal Regulations
is amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. In Sec. 180.364, the table in paragraph (a) is amended by
removing the entries for citrus, fruits at 0.2 ppm; soybean, straw at
200 ppm; soybeans at 20 ppm; soybeans, forage at 15 ppm; and soybeans,
hay at 15 ppm; by revising the entries in the table to paragraph (b)
for cattle, kidney; goats, kidney; hogs, kidney; horses, kidney; and
sheep, kidney; and in paragraph (d) by adding alphabetically the raw
agricultural commodities alfalfa, forage; alfalfa, hay; citrus fruits;
soybeans; soybeans, grain; soybeans, forage; soybeans, hay; soybeans,
aspirated grain fractions; and sunflower seed, to read as follows:
Sec. 180.364 Glyphosate; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cattle, kidney............................................... 4.0
* * * * *
Goats, kidney................................................ 4.0
Hogs, kidney................................................. 4.0
* * * * *
Horses, kidney............................................... 4.0
* * * * *
Sheep, kidney................................................ 4.0
* * * * *
------------------------------------------------------------------------
* * * * *
(d) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Alfalfa, forage.............................................. 75.0
Alfalfa, hay................................................. 200.0
* * * * *
Citrus, fruits............................................... 0.5
Soybeans..................................................... 20.0
Soybeans, grain.............................................. 20.0
Soybeans, aspirated grain fractions.......................... 50.0
Soybeans, forage............................................. 100.0
Soybeans, hay................................................ 200.0
Sunflower seed............................................... 0.1
* * * * *
------------------------------------------------------------------------
2. In part 186:
PART 186--[AMENDED]
a. The authority citation for part 186 continues to read as
follows;
Authority: 21 U.S.C. 348.
b. In Sec. 186.3500 by removing from the table in paragraph (a) the
entries for citrus pulp, dried and soybean, hulls, and by adding new
paragraph (b), to read as follows:
Sec. 186.3500 Glyphosate.
* * * * *
(b) A feed additive regulation is established permitting residues
of glyphosate (N-(phosphonomethyl)glycine) in or on the following feed
commodities.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Citrus pulp, dried........................................... 1.5
Soybean, hulls............................................... 100.0
------------------------------------------------------------------------
[FR Doc. 96-8142 Filed 4-4-96; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 96-7994 Summer Flounder Fishery; Adjustments to 1996 State Quotas
[Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
[Rules and Regulations]
[Pages 15199-15200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 625
[Docket No. 951116270-5308-02; I.D. 031296B]
Summer Flounder Fishery; Adjustments to 1996 State Quotas
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Commercial quota adjustment.
-----------------------------------------------------------------------
SUMMARY: NMFS announces adjustments to the commercial quota for the
1996 summer flounder fishery. This action complies with regulations
implementing the Fishery Management Plan for the Summer Flounder
Fishery (FMP), which require that annual quota overages landed in any
state be deducted from that state's quota for the following year. The
public is advised that a quota adjustment has been made and is informed
of the revised state quotas. The Director, Northeast Region, NMFS
(Regional Director), has also determined that there is no Federal
summer flounder quota available for those coastal states that did not
receive a portion of the annual commercial summer flounder quota.
Vessels issued a Federal moratorium permit for the summer flounder
fishery may not land summer flounder in these states.
EFFECTIVE DATE: April 4, 1996, through December 31, 1996.
FOR FURTHER INFORMATION CONTACT: David Gouveia, 508-281-9280.
SUPPLEMENTARY INFORMATION: Regulations implementing Amendment 2 to the
FMP are found at 50 CFR part 625 (December 4, 1992, 57 FR 57358). The
regulations require annual specification of a commercial quota that is
apportioned among the Atlantic coastal states from North Carolina
through Maine. The process to set the annual commercial quota and the
percent allocated to each state is described in Sec. 625.20. Amendment
7 to the FMP (November 24, 1995, 60 FR 57955) revised the fishing
mortality rate reduction schedule for summer flounder, and the revised
schedule was the basis for establishing the 1996 quota. The commercial
summer flounder quota for the 1996 calendar year, adopted to ensure
achievement of the appropriate fishing mortality rate of 0.41 for 1996,
is set to equal 11,111,298 lb (5.0 million kg) (January 4, 1996, 61 FR
291). The notification of a commercial quota transfer from the State of
North Carolina to the Commonwealth of Virginia was published on March
13, 1996 (61 FR 10286). This quota transfer is reflected in Table 1.
Section 625.20(d)(2) provides that all landings for sale in a state
shall be applied against that state's annual commercial quota. Any
landings in excess of the state's quota will be deducted from that
state's annual quota for the following year. Based on dealer reports
and other available information, NMFS has determined that the States of
Massachusetts, Rhode Island, New York, Delaware, and Virginia have
exceeded their 1995 quotas. The remaining States of Maine, New
Hampshire, Connecticut, New Jersey, Maryland, and North Carolina did
not exceed their 1995 quotas. A complete summary of quota adjustments
for 1996 is in Table 1.
[[Page 15200]]
Table 1.--Adjusted 1996 Commercial Quota for the Summer Flounder Fishery
----------------------------------------------------------------------------------------------------------------
1995 1995 Initial Adjusted 1996 quota
1995 Quota Landings Overage 1996 quota -------------------------
(lb) (lb) (lb) (lb) (lb) (kg)
----------------------------------------------------------------------------------------------------------------
ME................................ 6,987 5,318 ........... 5,284 5,284 2,397
NH................................ 67 ........... ........... 51 51 23
MA................................ 1,122,246 1,127,995 5,749 757,841 752,092 341,143
RI................................ 2,243,224 2,365,465 122,241 1,742,583 1,620,342 734,975
CT................................ 331,574 306,404 ........... 250,791 250,791 113,757
NY................................ 1,243,374 1,248,078 4,704 849,680 844,976 383,275
NJ................................ 2,306,198 2,298,303 ........... 1,858,363 1,858,363 842,939
DE................................ 2,614 3,072 458 1,977 1,519 689
MD................................ 199,551 136,167 ........... 226,570 226,570 102,770
VA................................ 3,182,177 3,355,838 173,661 2,374,342 2,200,681 998,212
NC................................ 3,974,018 3,967,291 ........... 3,043,816 3,043,816 1,380,652
----------------------------------------------------------------------------------------------------------------
This notification also announces the Regional Director's
determination that no quota is available for those coastal states that
did not receive a distribution from the annual commercial summer
flounder quota. The Regional Director's determination triggers the
summer flounder moratorium permit condition that owners of federally
permitted vessels agree not to land summer flounder in any state that
did not receive any part of the annual commercial summer flounder
quota. The purpose of this condition is to aid in maintaining the
integrity of the overall quota, which is set to achieve a specific
mortality reduction goal, as state quotas are filled.
Historically, measurable landings of summer flounder have occurred
only in those coastal states from North Carolina northward to Maine.
These are the states that have received distributions from the annual
commercial summer flounder quota. Recent reports, however, indicate
that harvesters intend to land summer flounder in other states, such as
South Carolina, in response to the closures of Virginia and North
Carolina to landings of summer flounder. States other than those
specified in Table 1 do not have any available summer flounder quota,
because they did not receive a share of the annual commercial quota.
Therefore, vessels with a Federal summer flounder moratorium permit may
not land summer flounder in these states.
This notification serves to trigger the permit condition that
prevents vessels that are issued a Federal summer flounder moratorium
permit from landing summer flounder in any state that has no commercial
summer flounder quota.
Classification
This action is required by 50 CFR part 625 and is exempt from
review under E.O. 12866.
Authority: 16 U.S.C. 1801 et seq.
Dated: March 27, 1996.
Richard W. Surdi,
Acting Director, Office of Fisheries Conservation and Management,
National Marine Fisheries Service.
[FR Doc. 96-7994 Filed 4-4-96; 8:45 am]
BILLING CODE 3510-22-W
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