[Federal Register Volume 66, Number 75 (Wednesday, April 18, 2001)]
[Proposed Rules]
[Pages 19899-19900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9624]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 101

[Docket No. 99-040-2]


Viruses, Serums, Toxins, and Analogous Products; Definitions

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule; withdrawal.

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SUMMARY: We are withdrawing a proposed rule to amend the Virus-Serum-
Toxin Act regulations by adding a definition of the term dog. The 
proposed rule would have defined the term dog to include all members of 
the species Canis familiaris, Canis lupus, or any dog-wolf cross. The 
effect of the

[[Page 19900]]

proposed rule would have been to allow canine vaccines that are 
recommended for use in dogs to be recommended for use in wolves and any 
dog-wolf cross. We are withdrawing the proposed rule due to the 
comments we received following its publication.

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 at 9 CFR part 101 contain definitions of terms used 
in the regulations concerning veterinary biologics in 9 CFR parts 101 
through 117. On September 28, 1999, we published in the Federal 
Register (64 FR 52247-52248, Docket No. 99-040-1) a proposed rule to 
amend the regulations by adding a definition of dog to include all 
members of the species Canis familiaris, Canis lupus, or any dog-wolf 
cross. The proposed action would have allowed canine vaccines that are 
recommended for use in dogs to be recommended for use in wolves and any 
dog-wolf cross.
    The question of whether rabies vaccines approved for use in dogs 
should be recommended for use in wolves and wolf-dog crosses has been 
under consideration for at least 5 years. After domestic dogs were 
reclassified as members of the species Canis lupus (gray wolf) in the 
1993 edition of the Smithsonian Institute's ``Mammal Species of the 
World, a Taxonomic and Geographic Reference,'' owners of wolves and 
wolf-dog crosses petitioned the Animal and Plant Health Inspection 
Service (APHIS) to allow the use of canine rabies vaccines in their 
animals.
    In April 1996, APHIS hosted a meeting to discuss the issue. Experts 
from the disciplines of animal taxonomy, molecular genetics, veterinary 
immunology, wildlife biology, and veterinary public health attended. 
The meeting did not result in a clear consensus among the participants 
that the immune systems of wolves and dogs are equivalent. Therefore, 
APHIS took no further action regarding the petition. However, after 
supporters of the petition submitted followup data showing that over 
600 wolves and wolf-dog crosses were vaccinated with canine vaccines 
without any reported adverse reactions, APHIS decided to publish the 
proposed rule.
    We solicited comments concerning our proposal for 60 days ending on 
November 29, 1999. We received 79 comments by that date. The comments 
were from an animal welfare organization, animal rescue organizations, 
veterinary care facilities, a veterinary biologics manufacturer, 
veterinary associations, universities, a State agency, wolf and lupine 
organizations, a wildlife foundation, and private citizens. Most of the 
commenters who expressed support for the proposed rule were owners and/
or fanciers of wolves and dog-wolf hybrids; however, several of the 
commenters who supported the proposed rule expressed concerns regarding 
ownership of wolves and dog-wolf crosses. Most of the commenters who 
were opposed to the proposed rule were concerned that the inclusion of 
wolves and dog-wolf crosses in the definition of dog would validate or 
encourage the ownership of wolves and dog-wolf crosses, and that such 
ownership could pose a risk to humans due to the unpredictable behavior 
of such animals. In addition, two of these commenters noted that the 
recommended use for a vaccine is typically supported by immunogenicity 
studies, and they cited the absence of such studies using wolves and 
dog-wolf crosses.
    Many commenters who were in support of the proposed rule were of 
the view that failure to allow canine rabies vaccines to be recommended 
for use in wolves and wolf-dog crosses would create a large pool of 
animals that are susceptible to rabies. On the other hand, commenters 
also stated that canine rabies vaccines, as well as canine vaccines 
against other diseases, are widely used off-label. However, commenters 
also pointed out the fact that States do not recognize that animals 
administered off-label vaccines are properly vaccinated.
    The commenters who opposed the proposed rule expressed three main 
areas of concern. First, they were of the view that there is 
insufficient safety and efficacy data established by controlled studies 
to recommend the use of the vaccines in wolves and wolf-dog crosses. 
Second, they did not agree that, because there was a lack of reported 
adverse reactions in approximately 600 vaccinated wolves and wolf-dog 
crosses, a valid scientific inference can be made that the products can 
safely and effectively be used in such animals. Third, these 
commenters, as well as some of those who supported the proposed rule, 
were concerned that including wolves and wolf-dog crosses in the 
definition of dog definitely sends the wrong message to the public. It 
was the opinion of the commenters that this type of change in the 
definition could have an implied meaning of domestication and 
behavioral traits normally associated with dogs. According to the 
commenters, such an implication would pose serious safety problems to 
the public. They stated that wolves and wolf-dog crosses can be highly 
unpredictable, have instinctive wild behaviors, and should not be 
promoted as ``pets.''
    After carefully considering all of the comments, including those in 
the area of veterinary medicine and animal health, we have concluded 
that many of the concerns expressed about allowing canine rabies 
vaccines to be recommended for use in wolves and wolf-dog crosses have 
sufficient merit to warrant withdrawal of our proposal and reevaluation 
of this issue.
    Therefore, we are withdrawing the September 28, 1999, proposed rule 
referenced above. The concerns and recommendations of all of the 
commenters will be considered if any new proposed regulations regarding 
the definition of dog are developed.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 12th day of April 2001.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-9624 Filed 4-17-01; 8:45 am]
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