Following some questions and discussion on the presentations, FDA opened the meeting for an official comment period. Among about 40 participants in the meeting, at least half were veterinarians from private practice, government, academia and industry. Producers and producer associations also were represented and provided comments. One consumer-oriented group, the Center for Science in the Public Interest, sent a representative. The comments and discussion generally were cordial and supportive of FDA’s efforts, but stakeholders did voice concerns and requests for clarification on a number of points.
Following is a summary of concerns participants expressed during the public comment period:
Veterinary Feed Directive
- Need to clarify the length of expiration date and refill policy.
- Need to clarify rules regarding VFDs for on-farm versus commercial feed manufacturing.
- Some veterinarians believe an electronic system with standardized VFD forms would streamline the process.
- The change to basing VFD orders on the number of animals versus the volume of feed could add some complexity for veterinarians.
- Several questioned how the proposed rules would be enforced fairly and equally.
- Some comments indicated a need for training and education for veterinarians who have not filed VFD orders in the past.
General impacts of the changes
- Many concerns related to the potential increase in paperwork as more products fall under veterinary oversight.
- Several participants suggested a need for framework of specific goals for the program and a system for evaluating the costs and quantifiable benefits or impacts of the rules.
- As noted earlier, producers in some areas lack easy access to veterinary services.
- Some expressed concern that the added requirements will cause some small distributors and feed manufacturers to stop carrying affected products, resulting in loss of availability to producers.
- Veterinarian, client, patient relationship issues
- Some participants favored FDA’s intention to modify the VCPR provisions in the VFD, others believed those provisions should be more strict.
- Need more clarity on definitions of the uses of antimicrobials for prevention, control and treatment of disease.