January 15, 2000

 
​EXECUTIVE BOARD COVERAGE

 AVMA opposes USDA-APHIS vaccine amendment

Posted Jan. 1, 2000

 

Citing reasons of good science and the interest of public health, the AVMA Executive Board narrowly approved a recommendation opposing a government-initiated proposal that would amend the Virus-Serum-Toxin Act regulations to recognize dog vaccines as safe and effective for wolves and wolf hybrids.

The amendment, proposed by the USDA-APHIS, seeks to add the definition of "dog" to be used in the regulations to include all members of the species Canis familiaris, Canis lupus, or any dog-wolf hybrids. Licensed veterinary biologics establishments, with prior approval from APHIS, could then include wolves and wolf hybrids on their canine vaccine labels.

Wolves and hybrids pose an ethical and liability dilemma for veterinarians. Laws regarding the legality of their ownership vary among states. Because no vaccines are licensed for use in hybrids or wolves, vaccinating hybrids is illegal or the veterinarian's decision, depending on the state.

APHIS invited comments on its proposal, which appeared in the Sept 28 Federal Register (see JAVMA, Nov 1, 1999, page 1226).

At its Nov 20-21 meeting, the Executive Board considered contrasting responses to the amendment from two AVMA councils.

The board narrowly disapproved a recommendation from the Council on Public Health and Regulatory Veterinary Medicine to support the rule and approved the recommendation of the Council on Biologic and Therapeutic Agents to oppose the rule.

The Council on Public Health and Regulatory Veterinary Medicine agreed with APHIS' belief "that dogs, wolves, and any dog-wolf crosses can be safely and effectively vaccinated with canine vaccines," and suggested support for the rule.

In its recommendation, the council referred to admittedly sparse data supporting the safe and efficacious treatment of wolves and hybrids with various modified-live canine vaccines. The council further agreed with APHIS that there is evidence to indicate that canine vaccines would affect wolves and hybrids in a manner similar to dogs, because they share the same environment and have similar exposure to disease agents.

That limited research was a major sticking point for the Council on Biologic and Therapeutic Agents, however. Inferring efficacy from shared environment and exposure potential, the council explained, does not guarantee that wolves and hybrids have in fact been exposed to the diseases. No efficacy determination by use of challenge or serologic studies was provided.

If the regulations were amended, the council reasoned, APHIS would not require additional efficacy and safety studies on wolves and hybrids. There is also fear that the public could be harmed by the rule, which might inadvertently blur the line distinguishing between wolf and dog behaviors and set a precedent for owning wolves and hybrids as pets.

Debate among Executive Board members mirrored the councils' differing opinions.

Some members questioned the amount of data used to support the proposal, as well as the possible legal repercussions for the veterinarian using what could be an ineffective vaccine.

An argument in favor of the new definition was the credibility imbued by the American Animal Hospital Association's endorsement of the rule, and the fact that the USDA itself was proposing the amendment.

That the AVMA assume a neutral position on the matter by not commenting on the rule was discussed.

The AVMA's response to the proposed rule reflects the objections raised by the Council on Biologic and Therapeutic Agents.

Additional information, including the names of organizations and individuals who have commented on this rule, are available here.