01-9624. Viruses, Serums, Toxins, and Analogous Products; Definitions

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule; withdrawal.

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 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; [phone].

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.