The U.S. Food and Drug Administration’s (FDA) final Veterinary Feed Directive (VFD) rule – containing a two-year recordingkeeping requirement – was a surprise to the feed industry, according to Richard Sellers, American Feed Industry Association senior vice president of legislative and regulatory affairs.
The VFD, a large piece of FDA's plan to promote judicious use of medically important antibiotics in food-producing animals, requires oversight of medicated feeds by a licensed veterinarian, with added responsibilities of the feed manufacturers/distributors.
The VFD rule will end over-the-counter (OTC) sales of medically important antimicrobial drugs intended for use in feed or water, placing their use under the supervision of a veterinarian. The final rule specifies that copies of the VFD and records of the receipt and distribution of VFD feed must be kept for a period of two years. This was a change from the proposed rule, which would have required records to be kept for one year.
Veterinarians will issue three copies of the VFD: One for their own records, one for their client, and one to the client's VFD feed distributor. The VFD includes information about the number and species of animals to receive feed containing one or more of the VFD drugs. FDA anticipates that about half of the food-animal industry will use electronic VFD generation and recordkeeping over the next three years.
"The final rule shows many improvements for the industry that will make the process more effective and timely," said Sellers, who noted AFIA was still reviewing the 100-plus page document.
"But at first glance we noticed the recordkeeping timeline is still a two-year requirement," Sellers said. "That's a concern, as we believed we had convinced FDA the two-year requirement should be reduced to one year to agree with the one-year recordkeeping requirement that appears in the Current Good Manufacturing Practices regulations (Title 21, C.F.R., Part 225)."
Meat-buying memorandum questioned
Sellers also noted the White House announcement of a new plan to buy food for federal agencies from sources that utilize responsible antibiotic-use policies is "premature given FDA's judicious-use antibiotic policy doesn't go into full effect until December 2016, when animal drug sponsors remove production claims from approved animal drugs."
"The memorandum sends the wrong message to both our trading partners and consumers," said Sellers. "It also focuses in on hormone-free products – which have not previously been part of the antibiotic discussion – and appears to imply hormone-free products are safer and should be preferred by consumers because the federal government, including our president, use them. However, FDA has made no announcements regarding any safety concerns about hormones approved for use in animals."
AFIA will evaluate the final rule and continue to work with members to implement the changes appropriately in the timeframe provided.