ARLINGTON, VIRGINIA, U.S. — The American Feed Industry Association (AFIA) and the National Grain and Feed Association (NGFA) on Aug. 25 urged the U.S. Food and Drug Administration to remove the unnecessary regulatory burden that records required as part of the agency's revised Veterinary Feed Directive (VFD) program be maintained in accordance with the agency's onerous Part 11, Electronic Records; Electronic Signatures requirements.

FDA's VFD program serves as a major component of the agency's overall strategy to promote the judicious use of medically important antimicrobials in feed for food-producing animals. The VFD program requires the use of these drugs be under veterinary supervision so that they are used only when necessary for assuring animal health. The program also requires numerous records to be established and maintained by veterinarians, feed distributors and animal producers.

In June 2015, the FDA amended the regulation on VFD animal drugs to reduce regulatory burdens and improve the efficiency of the VFD process. Initially, the FDA said it would not require compliance with Part 11 regarding electronic records, but in its final decision the agency changed its mind, AFIA said.

In a citizen petition, AFIA and NGFA requested that the FDA revise Part 11 in a manner consistent with other recent agency decisions, in which the agency has determined that records do not need to be Part 11-compliant.

"With FDA's recent decision to exempt from Part 11 compliance on all documents related to the Food Safety Modernization Act (FSMA) for current good manufacturing practices, hazard analysis and preventive controls for animal and human food, it only makes common sense FDA do the same for VFDs," said Richard Sellers, AFIA senior vice-president of public policy and education.

AFIA and NGFA said the number of VFD-related documents will be small compared to the documents related to the new FSMA requirements. Because those records are already exempt from Part 11, it makes sense for the same exemption to be granted to VFD, the groups said in their petition.

The majority of feed mills that receive VFDs do not have the resources needed to implement and maintain computer systems in compliance with Part 11. Most veterinarians that issue VFDs are in small or solo practices that do not have the personnel, technical or financial resources to maintain computer systems in compliance with Part 11.

AFIA and NGFA said to the best of their knowledge, none of their members in the business of manufacturing and distributing medicated feed have a computer system that is fully Part 11 compliant. The costs associated with developing and maintaining a Part 11-compliant computer system would be extremely burdensome, the groups said in their petition.

"In 1997, the cost of developing a computerized electronic records and signature system in full compliance with Part 11 was about $150,000 per facility,” said Dave Fairfield, NGFA senior vice-president of feed services. “With inflation, that cost is roughly $225,000 today."

AFIA and NGFA said an exemption from the Part 11 requirements also would benefit the FDA. The industry would be able to provide FDA investigators with electronic access to records, rather than printing them out in hard copy for review, AFIA and NGFA said, making inspections faster and more efficient.

The FDA has 180 days to respond to AFIA and NGFA's request, but the groups are urging FDA to make a decision sooner. The FDA has said it intends to have the great majority of antimicrobial drugs limited to therapeutic uses under the VFD process by the end of the year.

Starting in 2017, there will be a significant increase in the number of VFDs issued by licensed veterinarians. To prevent disruptions in the use of these drugs, the AFIA and NGFA said it is important that the FDA eliminate the requirement to comply with Part 11 for all VFD-related records before Jan. 1, 2017.