[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

[[Page 52248]]

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.
* * * * *
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