In the livestock and dairy industries, treating food-producing animals with drugs is sometimes necessary to keep animals healthy and productive. However, this can increase the risk of illegal drug residues in food products made from treated animals. Drug residues are small amounts of leftover drug, or parts of the drug that aren’t completely broken down by the animal’s body. Adequate records can lower the risk of illegal drug residues and help ensure food safety.
It may not be obvious how adequate records help ensure food safety, so here are several key points that connect the dots between good record-keeping and safe food.
- Live animals sold for slaughter for human consumption are 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. The agency’s interpretation has been accepted by several courts.
- 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.”
- Drugs given to food-producing animals without adequate records can create “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 created “insanitary conditions.” These insanitary conditions caused the food to be adulterated under the FFD&C Act.
- Drug residues in or on food products that are higher than the level set by FDA are illegal.
After a food-producing animal is treated with a drug, residues of the drug may be present in or on food products made from that animal for a period of time. Such food products include meat, poultry, milk, and eggs. FDA makes sure the drug residues that may be present in or on these products aren’t harmful to people. The agency does this by setting the drug’s tolerance and withdrawal period as part of the approval process for a drug for a food-producing animal.
The tolerance is the highest concentration of drug residues legally allowed to be in or on food products made from treated animals. Drug residues higher than this level are illegal.
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 the animal’s milk or eggs can be sold and safely consumed by people. The withdrawal period allows for drug residues in the animal’s body to get to levels that are at or below the tolerance. If the withdrawal period is followed, food products made from the treated animal are safe to enter the food supply.
It is illegal to send an animal to slaughter for food if the withdrawal period has not been followed because food products made from the treated animal may have drug residues above the tolerance. Similarly, it’s illegal to sell milk from treated dairy cows if the withdrawal period has not been followed.
- Adequate records help prevent illegal drug residues and ensure food safety.
Records that adequately document an animal’s treatment history are a good way to prevent illegal drug residues and ensure food safety. When dairy farmers, livestock dealers, and other animal producers keep careful records, they know which animals were treated, which drug was given, how and when it was given, and when the withdrawal period ends. This information helps them send treated animals to slaughter after the drug residues have dropped to below the tolerance. This helps prevent illegal drug residues and helps ensure the safety of the food supply.
Records – What to Document
FDA encourages all dairy farmers, livestock dealers, and other animal producers to establish and maintain a record-keeping system that keeps track of all drugs given to animals (treatment records) and of all drugs kept on the premises (inventory records).
Treatment records should include the:
- Name of the drug used;
- Identity of the animal treated;
- Date of each administration of the drug to the animal;
- Total dose given;
- How the drug was given (for example, topically or by injection into muscle);
- Name of the person who gave the drug;
- Length of the withdrawal period; and
- Date the withdrawal period ends (the treated animal can safely be sent to slaughter or its food products can safety be consumed on or after this date).
Inventory records should include the following information for each drug kept on the premises:
- Name of the drug;
- Date it was purchased or received;
- Quantity, strength, and form of the drug;
- Expiration date; and
- Name and address of the drug supplier.
Illegal Drug Residues – The Top 10
The U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA/FSIS) samples meat, poultry, and egg products for chemical contaminants, including illegal drug residues. The table below lists the top 10 drugs that caused illegal residues in food products made from treated animals, as identified by USDA/FSIS from Oct 1, 2015 to Sept 30, 2019 . Due to the diligence of dairy farmers, livestock dealers, and other animal producers, less than one half of one percent of food products sampled by USDA/FSIS contain illegal drug residues.
|In Descending Order of Frequency||Drug Name|
Extra-label use, often called “off-label use,” is using an approved drug for people or animals in a way that isn’t listed on the drug’s label. Only veterinarians can prescribe a drug for an extra-label use and they must follow certain legal requirements. One requirement is that there must be a valid veterinarian-client-patient relationship (VCPR). A valid VCPR means that:
- The veterinarian agrees to take responsibility for the health of the animal or animals and has determined the need for medication. The owner, in turns, agrees to follow the veterinarian’s instructions.
- The veterinarian has enough information about the animal or animals to diagnose a medical condition.
- The veterinarian is available for follow up in case of a side effect or treatment failure.
- The veterinarian is personally acquainted with and has recently examined the animal or animals. During the Covid-19 pandemic, FDA temporarily suspended the requirement to “recently examine the animal or animals.”
When prescribing a drug for an extra-label use in a food-producing animal, the veterinarian is responsible for establishing a substantially extended withdrawal period supported by appropriate scientific information.
Improper Extra-Label Use Often Leads to Illegal Drug Residues
Improper extra-label use is often the cause of illegal drug residues in food products made from treated animals. Improper extra-label use usually occurs when a veterinarian isn’t appropriately involved and the extended withdrawal period isn’t followed. Examples of extra-label use that may result in illegal drug residues include:
- Giving too much of the drug.
- Giving too much of the drug in one place on the animal.
- Giving a drug that’s not approved for that species or class (for example, using a drug in a goat when it’s not approved for goats, or using a drug in lactating dairy cattle when it’s not approved for that class of cattle.
- Giving a drug by an unapproved route (for example, injecting the drug into muscle when it’s approved only for injection under the skin).
- Giving a drug for an unapproved use (for example, using a drug to treat foot rot when it’s approved only to treat bovine respiratory disease).
- Sending an animal to slaughter (or its food products to market) before the drug’s withdrawal period ends.
- Using an animal feed that contains an animal drug in a way that’s contrary to the approved directions.
Consult a Veterinarian and Keep Adequate Records for any Extra-Label Use
Dairy farmers, livestock dealers, and other animal producers should always consult their veterinarian before using a drug in an extra-label way and adequately document the extra-label use in the treatment records, including the identity of the treated animal or animals and the date the substantially extended withdrawal period ends. This helps them avoid sending animals to slaughter, or the animals’ food products to market, that contain illegal drug residues.
Adequate Records are Good for Food Safety
Adequate records—both treatment records and inventory records—can go a long way toward preventing illegal drug residues in food products made from treated animals. This, in turn, helps keep the food on consumers’ tables safe.
Relevant Regulations and References
- Section 201(f) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(f)] – this section defines the term “food.”
- Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 342(a)(4)] – this section describes when a food is considered to be adulterated.
- Title 21 of the Code of Federal Regulations, Part 530 – this part describes the legal requirements for the extra-label use of a drug in animals and describes the federal requirements for a valid veterinarian-client-patient relationship (VCPR).
- CVM GFI #269 – Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak – this Guidance for Industry issued by FDA’s Center for Veterinary Medicine has information to help veterinarians continue to provide veterinary medical services during the COVID-19 pandemic.
- USDA/FSIS Residue Chemistry – this webpage contains information on the process of sampling meat, poultry, and egg products for chemical contaminants, including illegal drug residues.
- CPG Sec. 615.200 Proper Drug Use and Residue Avoidance by Non-Veterinarians – this Compliance Policy Guide has information for non-veterinarians about proper drug use in food-producing animals and ways to avoid illegal drug residues.