Adequate Drug Treatment Records Help Ensure Food Safety
Key Points
Careful Records can be a Good Control Measure
Records - What to Document
Connection between Adequate Records and Food Safety
Relevant Regulations
Resources for You
Risk can be a part of conducting business, and many business plans include ways to reduce risk. In the livestock and dairy industries, treating animals with drugs is often necessary. The drugs can help keep animals healthy, and healthy animals often mean a more profitable business. But using drugs in food-producing animals may increase the risk of illegal residues in food made from treated animals. Keeping adequate drug treatment records can lower this risk, and as a result, help ensure food safety.
Key Points
The connection between adequate records and safe food may not be obvious, so here are several key points to illustrate how important good record-keeping can be for food safety.
- 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.”
- 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.
FDA 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 a drug for a food-producing animal, 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. The withdrawal period allows for the drug (or parts of the drug) in the edible tissues of the treated animal to get to levels that are at or below the tolerance.It is illegal for dairies, 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.
- Giving drugs to animals without keeping adequate records may lead to drug residues in edible tissues that are above the set tolerance.
If a farm’s treatment records are incomplete, the farm is more likely to send a cow to slaughter that has drug residues in its edible tissues that are above the set tolerance.
Careful Records can be a Good Control Measure
Good control measures can help keep unsafe food from reaching consumers. In the restaurant industry, one such control measure is hand-washing. Proper hand-washing practices by food workers is critical for preventing outbreaks of foodborne diseases. Just as practicing proper hand-washing can help keep food safe, so can keeping adequate drug treatment records for food-producing animals. Careful records help livestock owners and dairy producers easily know which drugs they used in their animals and when and also help them readily distinguish treated animals from untreated ones.
Records – What to Document
When treating a food-producing animal with a drug, it's helpful for livestock owners and dairy producers to keep adequate treatment records that include the:
- Name of the drug used;
- Identity of the animal treated;
- Date of each administration of the drug to the animal;
- The dose;
- 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 (the treated animal can safely be sent to slaughter on or after this date).
For any drug kept on a farm’s premises, it's helpful to document the:
- 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.
Connection between Adequate Records and Food Safety
Adequate records that fully document an animal’s treatment history and a farm’s drug use can go a long way toward preventing illegal drug residues in food made from treated animals. This, in turn, protects American consumers by making sure the food on their tables is safe.
Relevant Regulations
- 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.