The FDA's new veterinary feed directive (VFD) rule, which will be fully implemented in January 2017, requires that veterinarians, producers and feed distributors maintain records of all VFD medicated-feed orders for two years. Last week, the American Feed Industry Association (AFIA) and the National Grain and Feed Association (NGFA) asked the FDA to relax what the groups consider unnecessary requirements listed under Part 11, Electronic Records; Electronic Signatures requirements, listed under Title 21 in the Code of Federal Regulations.
According to a news release from AFIA and NGFA, the computer systems, and labor required to bring VFD record-keeping processes into compliance with Part 11 would be extremely costly and burdensome. The groups say that, to the best of their knowledge, none of their feed-distributor members currently have systems that are Part 11 compliant, and that most veterinarians would not have the personnel, technical or financial resources to maintain computer systems in compliance with Part 11.
Beginning in January 2017, the use of feed-grade antibiotics classified as medically important will require a VFD order from a licensed veterinarian. Most of the affected products currently are sold over the counter (OTC). This change will dramatically increase the number of VFD orders and the burden on stakeholders to maintain VFD records. AFIA and NGFA believe the current requirements will unnecessarily complicate the record-keeping component of the program.
The groups note that FDA has recently exempted other programs from Part 11 compliance, and request the agency do the same for the VFD system.
According to the feed groups, the FDA has 180 days to respond their request, but they urge the agency to make a decision sooner, to help facilitate the industry's transition toward implementing the new VFD rules at the beginning of 2017.