[Federal Register Volume 64, Number 187 (Tuesday, September 28, 1999)]
[Proposed Rules]
[Pages 52247-52248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25177]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 64, No. 187 / Tuesday, September 28, 1999 /
Proposed Rules
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 101
[Docket No. 99-040-1]
Viruses, Serums, Toxins, and Analogous Products; Definitions
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the Virus-Serum-Toxin Act
regulations by adding a definition of the term dog to include all
members of the species Canis familiaris, Canis lupus, or any dog-wolf
cross. APHIS believes that dogs, wolves, and any dog-wolf cross can be
safely and effectively vaccinated with canine vaccines. This action
would allow canine vaccines that are recommended for use in dogs to be
recommended for use in wolves and any dog-wolf cross.
DATES: We invite you to comment on this docket. We will consider all
comments that we receive by November 29, 1999.
ADDRESSES: Please send your comment and three copies to: Docket No. 99-
040-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03,
4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state that
your comment refers to Docket No. 99-040-1.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS rules, are available on the Internet at http://
www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Chief Staff
Officer, Operational Support Section, Center for Veterinary Biologics,
Licensing and Policy Development, APHIS, 4700 River Road Unit 148,
Riverdale, MD 20737-1231; (301) 734-8245.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 112 set forth packaging and labeling
requirements for veterinary biological products. The Animal and Plant
Health Inspection Service (APHIS) requires a product's label to
identify the animals for which the product has been demonstrated to be
effective and safe. Paragraph (b) of Sec. 113.209 requires a rabies
vaccine to be tested for immunogenicity in each species for which it
will be recommended. Therefore, rabies vaccines recommended for use in
dogs may be tested in any member of the species historically named
Canis familiaris and recommended for use in breeds of dog of the
species Canis familiaris.
In 1993, the second edition of ``Mammal Species of the World, A
Taxonomic and Geographic Reference,'' stated that domestic dogs,
formerly identified as Canis familiaris, were a member of the species
Canis lupus, which is the grey wolf. This publication is widely
accepted as the standard for mammalian taxonomy. However, there is
disagreement within the expert community.
In 1995, as a result of reclassifying dogs into the species Canis
lupus, owners of wolves and dog-wolf crosses petitioned APHIS to
recognize rabies vaccines approved for use in dogs as effective in
wolves and dog-wolf crosses. The petitioners pointed out that many
jurisdictions do not recognize the vaccination of wolves and dog-wolf
crosses against rabies. Therefore, if these animals are involved in an
incident in which rabies vaccination is an issue, they may be subject
to euthanasia.
In April 1996, after consulting with taxonomists regarding the
petition, APHIS hosted a meeting in Riverdale, MD, to review the issues
of whether dogs and wolves were members of the same species Canis lupus
and whether rabies vaccines recommended for use in dogs should be
considered effective in wolves and any dog-wolf cross. Experts from the
disciplines of animal taxonomy, molecular genetics, veterinary
immunology, wildlife biology, and veterinary public health attended the
meeting. During the meeting, there was disagreement as to whether dogs
and wolves belonged to the same species, but there was consensus that
inactivated rabies vaccines should be safe and effective in wolves and
any dog-wolf cross. It was proposed that if rabies vaccines could be
assumed to be safe and effective in wolves and dog-wolf crosses, then
modified live vaccines against other dog diseases should also be safe
and effective in wolves and dog-wolf crosses. However, the experts
could not agree to this proposal without data demonstrating the safety
of modified live canine vaccines in wolves and dog-wolf crosses.
Without a clear consensus that the immune systems of wolves and dogs
were equivalent, APHIS took no action at that time to allow canine
vaccines that were recommended for use in dogs to be recommended for
use in wolves and any dog-wolf cross.
As a follow up to the meeting, wolf and dog-wolf cross fanciers
submitted supplemental data to support the use of modified live canine
vaccines in wolves and dog-wolf crosses. The data indicated that 216
wolves and 460 dog-wolf crosses were vaccinated with various modified
live canine vaccines without any reported adverse reactions
attributable to the vaccines. Many of these animals received multiple
vaccinations over several years. These data provide only limited
statistical inference; however, the fact that wolves and dog-wolf
crosses share the same environment with dogs and have similar exposure
to disease agents with ample evidence of protection against those
diseases for which the animals were vaccinated provide strong evidence
that wolves and dog-wolf crosses respond to canine vaccines in a manner
similar to dogs. Further, the lack of reported adverse reactions after
vaccination provides strong epidemiological evidence that wolves and
dog-wolf crosses respond to canine vaccines in a manner similar to
dogs. In addition, manufacturers of canine vaccines acknowledge that
their products have
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been used extensively in wolves and dog-wolf crosses with no reported
adverse reactions.
Based upon the above, APHIS believes that dogs, wolves, and any
dog-wolf cross can be safely and effectively vaccinated with canine
vaccines. Therefore, we are proposing to add a definition of dog to 9
CFR part 101 to include all members of the species Canis familiaris,
Canis lupus, or any dog-wolf cross. This would allow canine vaccines
recommended for use in dogs to be recommended for use in wolves and any
dog-wolf cross. Manufacturers who wish to include wolves and dog-wolf
crosses on the labels for their canine vaccines could add these animals
to the labels. APHIS believes that, even without this change, all
canine vaccines labeled for use in dogs would be accepted as being safe
and effective in wolves and any dog-wolf cross. If manufacturers wish
to include wolves and any dog-wolf cross on their labels, the labels
would first need to be approved by and filed with APHIS.
We would not require additional efficacy and safety studies to be
performed; however, manufacturers could perform additional efficacy and
safety studies, at their discretion, prior to recommending the use of
their canine vaccines in wolves and any dog-wolf cross.
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 proposed rule would amend the Virus-Serum-Toxin Act
regulations by adding a definition of the term dog to include all
members of the species Canis familiaris, Canis lupus, or any dog-wolf
cross. As a consequence, canine vaccines that are recommended for use
in dogs could also be recommended for use in wolves and any dog-wolf
cross. Manufacturers could include wolves and any dog-wolf cross on the
labels for their canine vaccines. The labels would need to be approved
by and filed with APHIS.
This proposed rule would affect all licensed veterinary biologics
establishments that produce vaccines for use in dogs. Currently, there
are approximately 150 veterinary biologics establishments. According to
the standards of the Small Business Administration, most of these
establishments would be classified as small entities, and approximately
10 percent of these establishments currently produce vaccines for use
in dogs. Because the efficacy and safety of licensed canine vaccines
have already been demonstrated in accordance with the regulations, and
because this proposed rule does not require manufacturers to replace
labels for their products for use in wolves and any dog-wolf cross, any
additional costs manufacturers would incur if this proposed rule is
adopted should be minimal.
Currently, manufacturers of veterinary biological products do not
recommend canine vaccines for use in wolves and any dog-wolf cross.
Under this proposed rule, if manufacturers recommend their canine
vaccines for use in wolves and dog-wolf crosses, additional efficacy
and safety data would not be required. Therefore, manufacturers would
not incur any additional costs as a result of the rule. This proposed
rule would not restrict manufacturers from using their discretion to
elect to perform additional efficacy and safety studies prior to
recommending the use of their canine vaccines in wolves and dog-wolf
crosses. However, if a canine vaccine is used on wolves or dog-wolf
crosses in accordance with the label recommendations, this proposed
rule would not relieve the manufacturer of responsibility for the
performance of the product (e.g., adverse reactions).
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. It is not intended to have retroactive effect.
This rule would not preempt any State or local laws, regulations, or
policies, unless they present an irreconcilable conflict with this
rule. The Act does not provide administrative procedures which must be
exhausted prior to a judicial challenge to the provisions of this rule.
Paperwork Reduction Act
This proposed rule contains no information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
Regulatory Reform
This action is part of the President's Regulatory Reform
Initiative, which, among other things, directs agencies to remove
obsolete and unnecessary regulations and to find less burdensome ways
to achieve regulatory goals.
List of Subjects in 9 CFR Part 101
Animal biologics.
Accordingly, we propose to amend 9 CFR part 101 as follows:
PART 101--DEFINITIONS
1. The authority citation for part 101 would continue to read as
follows:
Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.2(d).
2. In Sec. 101.2, a definition of ``dog'' would be added in
alphabetical order to read as follows:
Sec. 101.2 Administrative terminology.
* * * * *
Dog. All members of the species Canis familiaris, Canis lupus, or
any dog-wolf cross.
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Done in Washington, DC, this 22nd day of September 1999.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-25177 Filed 9-27-99; 8:45 am]
BILLING CODE 3410-34-U
