According to the April 18, 2001 Federal Register, the USDA-APHIS is withdrawing its September 28, 1999 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 or Canis lupus, or any wolf-dog cross, allowing any licensed vaccines labeled for use in dogs to be licensed and labeled for use in wolves and any wolf-dog cross.
In September of 2000, the AVMA House of Delegates supported a recommendation by the Council on Biologic and Therapeutic Agents opposing the 1999 proposed rule.
The rule was initially published when supporters of a petition submitted data showing that more than 600 wolves and wolf-dog crosses had been vaccinated with vaccines licensed for dogs, without any reported adverse reactions.
Public comment led the USDA to withdraw the proposal rule. Those who opposed the rule did so for three reasons, according to the Federal Register. Sufficient safety and efficacy data were not established by controlled studies to support adding indications for wolf and wolf-crosses to the label of vaccines licensed for dogs. Also, despite the lack of voluntary reported adverse reactions by owners of approximately 600 vaccinated wolf and wolf-dog crosses, a valid scientific inference of efficacy cannot be made about the product's safety. Finally, there is the concern that including wolf and wolf-crosses in the definition of dog sends a misleading message that wolves and wolf-dog crosses are safe as house pets, when, in actuality, such animals can be highly unpredictable and can have dangerous, instinctive wild behaviors.
After considering the above, USDA-APHIS, concluded that "many of the concerns expressed allowing canine rabies vaccines for use in wolves and wolf-dog crosses have sufficient merit to warrant withdrawal of our proposal and reevaluation of this issue."
After the proposal was withdrawn, Dr. Bonnie V. Beaver, a member of the AVMA Executive Board, said, "While veterinarians recognize that having an approved rabies vaccine for wolves and wolf hybrids is desirable, this proposal could have had a significant, negative effect on public health by eliminating the USDA's own requirement of proving rabies vaccine efficacy through direct virus challenge.
"[The proposal] would have set a serious legal precedent by allowing wolves and wolf-hybrids to be called dogs. Taxonomy classifies dogs and wolf-hybrids as subspecies of wolves, not the other way around."