Chris Zoller, Extension Educator, Agriculture and Natural Resources, Tuscarawas County and Gustavo M. Schuenemann, Professor and Dairy Extension Veterinarian, Department of Veterinary Preventive Medicine, Ohio State University Extension
At a recent Beef Quality Assurance (BQA) training session, we discussed livestock drug use, proper administration, the importance of following the label (and veterinary instructions), and the importance of keeping records of drugs administered.
A producer attending the session stood up and described to the group what happened when he had an animal test positive for a drug residue. An official from the Food and Drug Administration (FDA) came to his farm multiple times until finding him at home. He was required to write a letter explaining what steps he would take to prevent the issue from arising again. The FDA determined the first letter wasn’t adequate in addressing their concerns. He was provided with websites to consult and had to write another letter addressing the concerns. The producer now keeps detailed medication records and strongly encouraged every livestock producer to do the same!
Food Producing Animals
In livestock production, a medication may be necessary to treat diseases and restore health. Feed additives containing medications must be used only according to the label instruction. However, if precautions are not taken, problems can arise when an animal tests positive for a drug residue violation in meat, milk, and eggs. Remember, these are food producing animals and it is the responsibility of the owner to ensure that a safe product is available to consumers. Drug and chemical residues in meat, milk, and eggs are of public health concern.
The FDA regulates the use of livestock medications in the United States and establishes tolerance levels for residues in meat, milk, and eggs. Following label recommendations and maintaining accurate and proper treatment records helps ensure that violations do not occur.
Figure 1. Maintaining accurate and proper treatment records is just as important as having adequate working facilities!
The following key points are from the document Adequate Drug Treatment Records Help Ensure Food Safety, available at this FDA website: https://www.fda.gov/animal-veterinary/animal-health-literacy/adequate-drug-treatment-records-help-ensure-food-safety
Live animals sold for slaughter for human consumption are considered food.
Under the Federal Food, Drug & Cosmetic Act (FFD&C Act), the definition of “food” includes “articles used for food or drink for man or other animals.” FDA considers live animals intended for food as “food” under the FFD&C Act.
Food held under insanitary conditions is adulterated under the law.
The FFD&C Act states that a food is adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”
Giving drugs to animals without keeping adequate records can constitute “insanitary conditions.”
In cases involving illegal drug residues in dairy cows, district courts have agreed with the U.S. government that the failure of a dairy farm to keep adequate records of the administration of drugs constituted inadequate control measures. The courts found that these inadequate control measures created “insanitary conditions” and, therefore, adulterated the food under the FFD&C Act.
Drug residues in edible tissues above a level set by FDA (the “tolerance”) are illegal.
When a food-producing animal is treated with a drug, residues of the drug sometimes remain in or on edible tissues from that animal. Residues include small amounts of leftover drug, or parts of the drug that aren’t completely broken down by the animal’s body. Immediately after administering a medication to sick animals, the drug enters the blood stream and is typically metabolized by liver and then eliminated by the kidney via urine. Most sick animals experience some degree of dehydration and low intake (feed and water) due to pain, and this may extend the drug clearance from the animal. Keep your treated animals fully hydrated to avoid residues in milk or meat.
FDA, through its Center for Veterinary Medicine, makes sure the residues that may be present in or on edible tissues from treated animals pose little risk to people. As part of the approval process for any drug intended for use in food-producing animals, the agency sets the drug’s tolerance and withdrawal period. The tolerance is the level of residues allowed to be in or on the edible tissues. Residues higher than this level are called “violative” because they violate (are above) the tolerance set by FDA.
The withdrawal period is the time from when the animal was last treated with the drug to when the animal can be slaughtered for food or selling milk. The withdrawal period allows for the drug (or parts of the drug known as metabolites) in the edible tissues of the treated animal to get to levels that are at or below the tolerance.
It is illegal for dairy farmers, livestock dealers, and other animal producers to sell an animal for food that has drug residues in its edible tissues that are above the set tolerance.
What enforcement action can FDA take if I have a violation?
The producer described above did not have to pay any fines for the violation he incurred. However, having to research information, make phone calls, work with the veterinary of record, and write two letters consumed much of his time. Let’s take a look at possible enforcement action FDA may take against violators:
Warning letters – Are sent to the individuals or firms, advising them of specific noted violations. These letters request a written response as to the steps which will be taken to correct the violation.
Injunction – An order by a court that requires an individual or corporation to do or refrain from doing a specific act.
Criminal prosecution – May be recommended in appropriate cases for violation of Section 301 of the Act. Misdemeanor convictions, which do not require proof of intent to violate the Act, can result in fines and/or imprisonment up to one year. Felony convictions, which apply in the case of a second violation or intent to defraud or mislead, can result in fines and/or imprisonment up to three years.
Criminal Fines for Food Drug and Cosmetic Act Violations
Misdemeanor fines under the Act may reach $500,000 under some circumstances. The Criminal Fine Enforcement Act of 1994 (Public Law 98-596) provides for fines for violations of Federal law. Although it is not part of the Act, the Criminal Fine Enforcement Act of 1994 applies to all fines levied under the Act, as well as other statutes that contain provisions enforced by FDA.
The following fines are applicable for each offense:
- Up to $100,000 for a misdemeanor by an individual that does not result in death.
- Up to $200,000 for a misdemeanor by a corporation that does not result in death.
- Up to $250,000 for a misdemeanor by an individual that results in death or a felony.
- Up to $500,000 for a misdemeanor by a corporation that results in death or a felony.
The maximum imprisonment for a misdemeanor under the Act remains a year for each offense.
What drug treatment information do I need to maintain?
When treating food animals with any medications, the following must be recorded:
- Name of the drug used;
- Identity of the animal treated;
- Date of each administration of the drug to the animal;
- The dose;
- Route of administration. How the drug was given (for example, by mouth or by injection into muscle);
- The lawful written order of a licensed veterinarian in the context of a veterinarian-client-patient relationship (if applicable);
- Name of the person who gave the drug;
- Length of the withdrawal period; and
- Date the withdrawal period ends (milk can return to the bulk tank or treated animal can safely be sent to slaughter on or after this date).
Veterinary Client Patient Relationship (VCPR)
A VCPR is just what it says – a working relationship with a veterinarian who is familiar with your animals, production practices, and works with you to develop plans to prevent, control and treat diseases. The veterinarian is referred to as your Veterinarian of Record (VoR), and both the VoR and the client should sign a form to document this relationship. If this is you, excellent! If emergency situations are the only times you see a veterinarian, maybe it’s time to schedule a visit to establish and document the VCPR.
An ounce of prevention is worth a pound of cure! Drug and chemical residues entering the food chain (milk, meat, or eggs) are of public health concern. Review and adjust health protocols at least once per year with your veterinarian. It really is in your financial best interest to avoid residues entering the food chain to maintain your market channels. In the event you receive an FDA letter indicating a residue violation was found in milk or meat, please contact your veterinarian immediately to develop the response letter documenting the corrective actions.
Adequate Drug Records Help Ensure Food Safety, Food and Drug Administration, https://www.fda.gov/animal-veterinary/animal-health-literacy/adequate-drug-treatment-records-help-ensure-food-safety
Types of FDA Enforcement Actions, Food and Drug Administration, https://www.fda.gov/animal-veterinary/resources-you/types-fda-enforcement-actions
Veterinary Feed Directive, https://vet.osu.edu/sites/vet.osu.edu/files/documents/extension/Brochure_VFD.pdf
Veterinary-Client-Patient-Relationship (VCPR) Template, https://vet.osu.edu/extension/general-food-fiber-animal-resources