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.
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 considered 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 with tissue residues above the set tolerance.
- Giving drugs to animals without keeping adequate records may lead to violative drug residues in edible tissues.
If a farm’s treatment records are incomplete, the farm is more likely to send a cow to slaughter with violative drug residues in its edible tissue.
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. Frequent and effective hand-washing by restaurant employees reduces the spread of foodborne illnesses. Just as good hand-washing techniques can help keep food safe, so can 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 can be 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;
- Dosage used;
- Route of administration;
- 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 may be 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.
FDA News Release. Wisconsin livestock dealer enters into consent decree involving drug residues in cows. July 10, 2012.
United States District Court for the Eastern District of Wisconsin. United States of America v. Dan Nolan Livestock, L.L.C., and Daniel W. Nolan. Civil Action No. 12-C-643, Consent Decree of Permanent Injunction. Filed July 9, 2012.
Department of Justice, Office of Public Affairs. US Settles Complaint Against Wisconsin Livestock Company for Improper Medication Practices. June 26, 2012.
Department of Justice, Office of Public Affairs. Court Enters Consent Decree Resolving Food, Drug & Cosmetic Act Allegations Against Idaho Dairy. December 15, 2011.
United States District Court for the District of Idaho. United States of America v. G & H Dairy, L.L.C., and Jesus M. Hurtado, Gilbert M. Hurtado, and John J. Gomez. Case No. 1:11-cv-00568-CWD, Consent Judgment. Filed December 14, 2011.
FDA Press Release. FDA seeks court order against Michigan dairy. August 31, 2010. Updated November 2011.
Department of Justice. Michigan Dairy Farm Enjoined From Unlawful Drug Use. November 7, 2011.
United States District Court for the Western District of Michigan Southern Division. United States of America v. Scenic View Dairy, L.L.C., and Michael D. Geerlings, Mark A. Lucas, and Michael J. Van Dam. Case No. 1:10-CV-865, Opinion. Filed September 1, 2011.
United States District Court for the Western District of Michigan Southern Division. United States of America v. Scenic View Dairy, L.L.C., and Michael D. Geerlings. Case No. 1:10-CV-865, Memorandum Regarding Injunctive Order. Filed October 21, 2011.
United States District Court Western District of Washington at Seattle. United States of America v. Rhody Dairy, L.L.C., and Jay L. De Jong. Case No. C11-0065-RSM, Order on Summary Judgment and Request for Injunction. Filed July 14, 2011.
FDA. CPG Sec. 615.200 Proper Drug Use and Residue Avoidance by Non-Veterinarians. Issued July 9, 1993.
- 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.