Veterinary Feed Directive

The Food Animal Residue Avoidance Databank (FARAD) recently provided guidance to small ruminant producers and their veterinarians in an article titled “Extralabel drug use (ELDU) in small ruminants” in JAVMA, Vol 253, No. 8, Oct. 15, 2018, pp 1001-1009.

FARAD is a university-based national program that serves as the primary source for scientifically-based recommendations regarding safe withdrawal intervals of drugs and chemicals in food-producing animals. As such, FARAD is a key resource for protection of our nation’s food supply, including meat, milk and eggs, against accidental contamination of animal-derived foods with violative residues of drugs, pesticides or other agents that could compromise food safety.”

FARAD regularly provides guidance to the food animal producing industry and veterinarians regarding “the use of therapeutic drugs, pesticides and other agents that improve overall animal health and promote safe, efficient and humane production practices.”

The purpose of its latest digest, as stated, “was to provide US veterinarians guidance regarding ELDU in small ruminants. The lack of FDA-approved drugs for sheep and goats frequently necessitates ELDU in those species. When the FDA approves a drug for use in a particular species, it establishes a tolerance or that drug in the various tissues or products (eg, milk or eggs) of that species that might be consumed by people. When a drug not labeled for use in a small ruminant is administered in an extralabel manner, there is a zero tolerance for residues of the parent drug or its metabolites in the edible tissues or products of treated animals, and detection of the parent drug or metabolites in any product marketed for human consumption is considered a violation and subject to regulatory action. Given the lack of tolerance and pharmacokinetic and tissue depletion data for many drugs administered in an extralabel manner to small ruminants, extended meat and milk WDIs are generally required to ensure that drug residues are undetectable. Veterinarians need to be cognizant of the requirements for legal ELDU in food-animal species to safeguard the human food supply while continuing to promote the health and welfare of small ruminants.”

As a former owner of a veterinary large animal practice in which 50% of my patients were small ruminants (goats, sheep, alpaca and llama), it was imperative to be able to prescribe or administer drugs in an extralabel manner to provide humane care and prevent animal suffering.

Extralabel use means actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses.  21 CFR 530.3.

Some of these uses have included medications added to commercial feeds, that are now governed under the Veterinary Feed Directive that FDA enforces for use in major, but not minor species.

According to guidance from FDA, “many commercial medical feeds that require a VFD are not approved for use in minor species,” defined by FDA as all species other than cattle, horses, swine, chickens, turkeys, dogs, and cats.  Compliance Policy Guide Sec. 615.115 Extralabel Use of Medicated Feeds for Minor Species.  A veterinarian may consider ELDU of medicated feed in minor species if:

There are no approved treatment options available;

The health of the animals is threatened; and

Failure to treat the animals would result in suffering or death.

The veterinarian must provide a written recommendation that includes the medical rationale for ELDU of medicated feed.

Before a veterinarian can provide such professional guidance, a valid veterinarian-client-patient relationship (VCPR) must exist.  While state laws govern the practice of veterinary medicine, including such relationships, FDA has inserted itself in the equation by identifying which states do not require the elements of a VCPR that FDA considers sufficient for the purposes of enforcing its Veterinary Feed Directive and other federal laws.

These multilayered state and federal laws can be difficult for veterinarians and small ruminant producers to decipher—hence the necessity of FARAD and other agencies to provide more specific guidance.

As part of its Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings—just released—FDA announced that it plans to shift from “educating” food animal veterinarians and producers about the 2016 Veterinary Feed Directive (VFD) to “ensuring compliance with the . . . regulation to further ensure the safety of animal and human health.”  In other words, producers, veterinarians, and VFD medicated feed distributors (e.g., feed mills, retailers) should expect enhanced enforcement by FDA inspectors.

Those regulated should keep in mind that FDA inspectors will “examine VFD orders, requirements for the parties involved, and recordkeeping” during inspections.

FDA’s overall plans include three broad-based goals:

  1. Align antimicrobial drug product use with the principles of antimicrobial stewardship;

  2. Foster stewardship of antimicrobials in veterinary settings; and

  3. Enhance monitoring of antimicrobial resistance and antimicrobial drug use in animals.

While described as a One Health initiative, FDA’s plans favor the preservation of medically important antibiotics for humans over animals, particularly food animals.  Also, while acknowledging that it does not regulate either veterinary medicine or farming activities, FDA has set forth plans that appear to attempt to extend their regulatory reach, through proposed expansion of inspection and testing of animals, including food animals, companion animals, animal feed, farm-raised seafood and retail meat.

FDA also plans on bringing the 5% of antimicrobials still available over the counter under veterinary oversight, including, for example intramammary treatment to prevent or treat mastitis.  Not only will this increase costs to producers (which will be passed along to consumers), but according to the AVMA, many farmers and ranchers in rural communities do not have access to adequate veterinary care because of veterinary shortages “in more than 180 rural communities across the country.”

Certainly, the issue of antimicrobial resistance is important.  However, the emphasis by some government officials and legislators too often focuses on limiting use of antibiotics important to maintain the health of animals.  And the collection and reporting of antibiotic use and test results are used by activists to eliminate the use of animals for food completely.

Testing of some food products, albeit for other purposes, resulted in the conviction of the owners and operators of the Decoster Egg Farms for “introducing eggs into interstate commerce that had been adulterated with Salmonella enteritidis,” even though the government admitted that it had not identified any personnel, including the defendants who knew that the eggs were contaminated.  United States v. Decoster, 828 F.3d 626 (8th Cir. 2016) (Beam, J., dissenting).

Keep in mind that preventing Salmonella enteriditis was the basis for the adoption of enlarged cage requirements for hens in California despite evidence that such measures do not decrease the prevalence of the bacteria.  Furthermore, California and Massachusetts have imposed their regulations on producers in other states—an impermissible extraterritorial regulation in violation of dormant commerce clause, which has been challenged.  State of Missouri, et al. v. State of California, No. 22O148 (2017); State of Indiana, et al. v. Commonwealth of Mass., No. 22O149 (201

In preparation for the VFD final rule, which outlines the revised process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed and that require the supervision of a licensed veterinarian), FDA released it’s final version of its industry guidance #233 titled “Veterinary Feed Directive-Common Format Questions and Answers.”

While rejecting a suggestion that FDA require a uniform veterinary feed directive form, FDA has provided a “common VFD format [that] would help veterinarians, their clients (i.e., animal producers), and distributors (including feed mills) quickly identify relevant information on the VFD.”

In addition to providing a list of information that is required, FDA has provided a blank VFD form and several examples of completed forms, several of which are reproduced below.

Blank VFD form
Blank VFD form
Example 1 VFD form
Example 1 VFD form
Example 2 VFD form
Example 2 VFD form

Example 2 VFD form

The information that must be included pursuant to § 558.6(b)(3) on any form utilized includes:

the veterinarian’s name, address, and telephone number;

the client’s name, business or home address, and telephone number;

the premises at which the animals specified in the VFD are located;

the date of VFD issuance;

the expiration date of the VFD;

the name of the VFD drug(s);

the species and production class of animals to be fed the VFD feed;

the approximate number of animals to be fed the VFD feed by the expiration date of the

VFD;

the indication for which the VFD is issued;

the level of VFD drug in the feed and duration of use;

the withdrawal time, special instructions, and cautionary statements necessary for use of

the drug in conformance with the approval;

the number of reorders (refills) authorized, if permitted by the drug approval, conditional

approval, or index listing;

the statement: “Use of feed containing this veterinary feed directive (VFD) drug in a

manner other than as directed on the labeling (extralabel use), is not permitted.”;

an affirmation of intent for combination VFD drugs as described in § 558.6(b)(6); and

the veterinarian’s electronic or written signature.

It would be surprising if veterinarians did not use the forms suggested by FDA to insure they were providing all the information required.

Not everyone is satisfied by the increased restrictions set forth by FDA regarding antibiotics for food animals provided in feed and/or water.

A number of nonprofits filed a citizen petition under section 512(e) of the Food, Drug, and Cosmetic Act, 21 U.S.C. Section 360b(e), “to request that the Commissioner of Food and Drugs withdraw approval of the use of medically important antibiotics in livestock and poultry for disease-prevention or growth-promotion purposes.”

These nonprofits want to prohibit the use of critically important antibiotics that prevent disease in food animals.  Such use is imperative to continue to protect food animals from preventable illness.

FDA, gearing up for the implementation of the Veterinary Feed Directive (VFD), recently “issued a letter reminding retail establishments that sell medically important antimicrobials for use in feed or water for food animals that the marketing status of those products will change from over-the-counter (OTC) to prescription (Rx) or to veterinary feed directive (VFD) at the end of calendar year 2016.”

As reported in the Daily Herald, those servicing livestock producers in Utah have also been trying to spread the word:

“Local veterinarians, feed suppliers and livestock producers gathered in Lehi on Thursday to learn how the federal feed directive, which goes into effect on Jan. 1, will affect their operations.

The meeting is just one of a series of meetings being held across the state to make sure livestock producers aren’t taken by surprise when the new directive takes effect. It is expected to affect almost everyone who raises animals for human consumption — from 4-Hers to turkey farmers to bee keepers.”

The VFD sets forth “the process for authorizing use of VFD drugs and provides a framework for veterinarians to authorize the use of medically important antimicrobials in feed when needed for specific animal health purposes” as reported by Lydia Zuraw on JUNE 3, 2015 at Food Safety News.

FDA announced that the final rule is:

“an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health.”

Notably, as previously discussed here, the rule memorializes the concept that veterinarian may only prescribe antibiotics to animals “within the context of a veterinarian-client-patient relationship (VCPR), which includes sufficient knowledge of the animal, visits to the farm, and follow-up evaluation or care.”

While many states include that requirement in state veterinary medical practice acts, not all states include a definition of or specifications for the “veterinarian-client-patient relationship.”  (See table of state laws compiled by AVMA).

The VFD will require veterinarians to follow state-defined VCPR requirements as long as the state requirements include the key elements in the final VFD.

FDA requires:

“the veterinarian engage with the client (i.e., animal producer or caretaker) to assume responsibility for making clinical judgments about patient (i.e., animal) health, have sufficient knowledge of the animal by conducting examinations and/or visits to the facility where the animal is managed, and provide for any necessary follow-up evaluation or care.”

However, “where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements.”