The American Feed Industry Association and the National Grain and Feed Association have 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 a citizen petition, AFIA and NGFA requested that 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 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," explained Richard Sellers, AFIA senior vice president of public policy and education.

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.

"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. With inflation, that cost is roughly $225,000 today," said Dave Fairfield, NGFA senior vice president of feed services.

AFIA and NGFA said an exemption from the Part 11 requirements also would also benefit FDA by enabling industry to provide documents to FDA for review in a more efficient and timely electronic format for facility inspections.

FDA has 180 days to respond to AFIA and NGFA's request, but given the Jan. 1 implementation of the VFD requirements, the two organizations urged the agency to make the change prior to that date.