Since Jan. 1, 2017, the U.S. Food and Drug Administration’s new rules on the use of medicated feed have been in effect, limiting the use of antibiotics important for human health.
The rules state that those medications used both in human and animals, otherwise known as “medically important,” will be illegal to use for performance, such as for improved growth promotion and feed efficiency. The idea is to reduce use of antibiotics that are important for human and animal health to address antibiotic resistance.
In addition, veterinarians now need to provide a written order, or a veterinary feed directive, or VFDs, and the products can only be given for prevention, treatment and control of a specifically identified disease. The rule covers almost all animal antibiotics, with a few exceptions, including ionophores, dewormers, bacitracin, carbadox and bambermycins, among others.
“On Jan. 1, it [became] illegal to use antibiotics important to human health for production purposes or without veterinary oversight,” said Richard Sellers, senior vice president of public policy and education at the American Feed Industry Association. “All animal producers will need to obtain authorization from a licensed veterinarian, in the form of a VFD, to use this classification of drug for prevention, control or treatment of a specifically identified disease.”
The rule comes with requirements for animal producers, who will need to work with veterinarians to obtain VFDs where appropriate. For feed producers and distributors, there will be certain record-keeping requirements, as well as communications between those producers and distributors.
Acknowledgement letter
Before a feed distributor can legally sell VFD products to its customers, it must notify FDA of its intentions via a one-time letter known as a VFD Notice to FDA of Distribution of VFD Feeds. A second document, called an Acknowledgment of Distribution Limitations of VFD Feeds, must be sent to all of the feed distributor‘s suppliers that they are purchasing VFD feeds from.
That letter is critical, said Lori Stevermer, a marketing specialist with Hubbard Feeds, an animal feed supplier based in Mankato, MN.
“We can’t sell a VFD feed unless we get the acknowledgment of distribution letter from the dealer that says they’re not selling to a farmer without a VFD or another distributor without the acknowledgement of distribution,” Stevermer said. “That acknowledgment of distribution is a pretty important piece of paper because it helps move the VFD feed through the distribution channels.”
Keeping records
For feed distributors, the new VFD rules also come with requirements that certain records be kept, some for as long as two years.
VFD forms filled out by veterinarians must be kept on file for two years after the medicated feed has been distributed. Those records can be stored in any format in which they are received. So, if the VFD is delivered on paper, the physical copy can be kept. An electronically delivered VFD can be stored electronically.
Manufacturing records related to a VFD must be stored for one year following distribution of the VFD feed and kept in accordance with the FDA’s Current Good Manufacturing Practice recordkeeping requirements.
Stevermer said that the new rule doubles the amount of time VFD records have to be kept compared to the past, but that isn’t a significant burden on suppliers who were already likely keeping records longer than required. Hubbard is working on updating its sales system to help ensure that VFD rules are being followed, however.
The Hubbard ERP system will require that certain qualifications are met before allowing a sale. A VFD must be on file and not expired, for example. The system will also notify employees if a VFD is nearing expiration so they can reach out to producers to let them know. And once the VFD has expired, a sale won’t be possible.
“There will be a hard stop when we can’t sell that feed any longer,” Stevermer said. “It won’t physically let us work through our manufacturing process because that VFD has expired.”
Angela Mills, manager of quality control and regulatory compliance for the feed division at the Southern States Cooperative Inc. in Richmond, VA, said her company is working on policies that ensurethe company is complying properly with VFD rules, especially when it comes to the accuracy of the forms submitted by producers.
“The primary focus we are going to have is that it is filled out completely,” Mills said. “If it’s not filled out completely, it’s considered an invalid VFD.”
A company would be responsible for any inappropriate sales in that case.
“The burden is very clearly on the distributor,” Mills said.
Stevermer said Hubbard is also training employees to spot anomalies with VFDs. The name of the client needs to be filled in along with the location of the animals covered by the VFD, she said. Thenumber of head the VFD is written for is important, along with making sure the medication levels and claims are legal. And the company will not accept copies of VFDs — only original forms.
VFD forms may come in triplicate as carbon copies, or they could be sent electronically via email or fax. The key is to make sure the VFD is coming from the veterinarian or is the correct version to the best of your ability.
“That would trigger a question that maybe someone is having multiple distributors fill a VFD,” Stevermer said. “We’re going to look at those VFDs that are coming in to make sure they are being filled out correctly. We want to be sure that everything is being handled ethically.”
AFIA is working with the National Grain and Feed Association to convince FDA to remove an electronic signature requirement currently associated with the VFD rules. The FDA suspended that rule under recent Food Safety and Modernization Act rules, and Sellers believes the same should happen with VFDs.
“The request was to revise the regulation to be consistent with other recent agency decisions,” Sellers said. “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 for FDA to do the same for VFDs.”
When the FDA suspended the electronic signature requirement for FSMA, Sellers said the move would be a significant financial benefit for the industry. “Applying the rule to the industry would have required firms to ‘validate’ every computer system that keeps records required by any and all FDA rules,” Sellers said then. “This is potentially the largest cost-saver for the industry in AFIA’s eyes.”
Wrinkles
Despite the fairly straightforward rules for records and the VFD forms themselves, there is still some gray area that producers will need to work through. A VFD will be written for the number of head of animals, not pounds of feed per animal, as in the past. However, the distributor or dealer is supposed to supply “an appropriate amount of feed.”
Mills said she could foresee a 4-H member with a sick calf that needs a medicated milk replacer, which would require a VFD. When the math is done, he or she might need 14 pounds of the milk replacer, which is only sold in 50-pound bags.
In another example, she said a producer may need 3,700 pounds of medicated feed to treat 150 cattle for a series of weeks or months. The producer might come in every week or so to get fresh feed. But if he or she decided to take one bulk delivery, Mills said the odd amount could cause a problem.
In the milk replacer scenario, the dealer isn’t likely to open the package and only sell that 14 pounds The appropriate amount in that case would be the entire 50 pounds The onus is on the person using the milk replacer to only use the proper amount and either obtain a new VFD to use the rest or destroy the remaining product, Mills said.
“We are not going to bust open that package because we’ll get into having to sell by the pound,”she said. “We have to trust that all parties are compliant with the law and are doing the right thing.”
Opening packages or accepting returns of unused feed also doesn’t work because those products then pose a biosecurity risk and cannot be sold.
Also, she said that delivering 4,000 pounds of medicated feed for a producer who needs 3,700 pounds might also be appropriate. The producer is responsible for using that feed properly.
Distributors should keep careful records documenting why larger amounts were sold in those types of circumstances.
“The distributor may need to explain themselves if an inspector questions why a quantity in excess of ‘an appropriate amount’ is sold,” Mills said.
Expiration dates are also a possible stumbling block. A distributor or dealer certainly cannot sell medicated feed after the expiration date on a VFD. But AFIA notes that the expiration date actually isa cutoff for the livestock producer. Once that expiration date is met, the producer is expected to stop using medicated feed or obtain a new VFD.
Outreach
Stevermer expects there to be some confusion in the coming months as producers learn more about the new rules. She said suppliers and distributors can help ease the transition by holding information sessions and reaching out to producers to give guidance and answer questions.
“In the end, from everybody I’ve talked to, we all want to do what’s best for the animal and the farmer and have everything in place. We all realize there will be some bumps and bruises as we get used to the system,” she said.
One of those bumps will be connecting some farmers to veterinarians.
“In some cases, we’re having meetings with vets in the area so we know each other. In some cases, farmers, especially in a remote area, don’t know who the veterinarians are,” Stevermer said.
Those farmers may live in an area where there isn’t a veterinarian located for a hundred miles or more. Developing a relationship with a veterinarian — which hadn’t been necessary before — will be key then in case a need for medicated feed arises.
AFIA advises that while a VFD can be filled anywhere, the veterinarian that orders the medicated feed must be licensed in the state where the animals are located. Another important aspect of the VFD is the Veterinary Client Patient Relationship (VCPR). This means the veterinarian knows the farm and the animals well enough to make an accurate diagnosis. The farmer understands their responsibility is to follow the veterinarian’s recommendation. The VCPR is part of the veterinary oversight the FDA is requiring with these changes.
Mills said she is already hearing from anxious farmers who aren’t sure how the new rules will affect them. She said that’s why it’s key to take time to work with those farmers in the weeks to come.
“I’m sure it is going to be a challenge, and the customers may not understand,” Mills said. “People are confused. There is a lot of misinformation in the field. We’re telling them that they really need to contact a vet, get familiar with a vet and start discussing this now.”
