Animal & Veterinary

Records Can Help Ensure Food Safety

By Melanie McLean, DVM, Center for Veterinary Medicine, FDA

Key Points
Records As A Control Measure
Records - What to Document
Connection Between Records and Food Safety

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 can mean a profitable business. But using drugs in food-producing animals can increase the risk of residues in food made from treated animals. Selling animals for food with residues above the tolerance set by FDA is illegal. Keeping adequate drug treatment records can mitigate the risk of selling animals with illegal drug residues for food. Adequate records can help ensure food safety.

The connection between keeping records and safe food may not be obvious. However, four recent cases illustrate how adequate record-keeping can be important in maintaining a safe food supply. The four cases, three in 2011 and one this year, involved illegal drug residues in dairy cows. The defendants included three dairies and a livestock dealer who all sell culled dairy cows for beef as part of their business. The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service found illegal drug residues in the edible tissues of culled cows sold by each defendant.

In two cases, one involving a dairy in Washington state and the second involving a Michigan dairy, the district courts granted the government’s requests for injunctions. Among other things, the injunctions prohibit the dairies from selling animals for food until they satisfy certain terms set by the courts, including establishing record-keeping systems.

The U.S. government settled the other two cases, one against a dairy in Idaho and the latest against a Wisconsin livestock dealer. Both ended in what’s legally called a consent decree, where the defendants agreed (consented) to an injunction but didn’t admit or deny the allegations in the government’s complaint against them. Under the terms of the consent decrees, the defendants are prohibited from selling animals for food until they meet certain requirements, including establishing record-keeping systems.

Key Points

Several key points from the four cases illustrate how important record-keeping can be in helping to keep the food supply safe.

  • 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 regards 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.”1

  • Giving drugs to animals without keeping adequate records can constitute “insanitary conditions.”

    In the cases against the Michigan and Washington dairies, the courts noted that to prove that a food is adulterated, the government doesn’t need to show the food is actually dangerous to human health. The government must show that there’s a “reasonable possibility” of injury from food produced at facility because of the conditions there.

    In the Michigan case, the court stated that administering drugs to animals without adequate control measures, including the failure to maintain adequate drug treatment records, creates a reasonable possibility that edible tissues from those animals may be injurious to human health. Both the courts in the Michigan and Washington cases agreed with the government that the dairies’ failure 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, a farm is more likely to send a cow to slaughter with violative drug residues in its edible tissue.

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Records As A 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 greatly reduces the spread of foodborne illnesses.2 Just as good hand-washing techniques can help protect consumers, keeping adequate drug treatment records for food-producing animals can help keep food safe. By keeping careful records, livestock owners and dairy producers can know which drugs they used in their animals and when. Records can also help readily distinguish treated animals from untreated ones.

Inadequate drug treatment records, on the other hand, can increase the chance that unsafe food will get to consumers. “When farms fail to maintain appropriate controls concerning the medication of food-producing animals, they jeopardize the public health,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division.3

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Records – What to Document

The defendants in all four cases must keep certain records on animals to which they administer drugs. These records include the following:

  • Name of the drug used;
  • Identity of the animal treated;
  • Date of each administration of each medication to the animal;
  • Dosage of each drug used;
  • The route of administration of each drug;
  • The lawful written order of a licensed veterinarian in the context of a veterinarian-client-patient relationship for each drug used (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).

The defendants must also keep a drug accountability and inventory system, which must include a written record for each drug the defendants purchase or receive for use. The record must include the following:

  • 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.

The defendants must also track each date the drug is administered, the amount given, and route of administration.

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Connection Between Records and Food Safety

“It’s important to the health and safety of the American people that our farms adequately monitor and record how they [are] using medications with their food-producing livestock, because failure to do so puts people at risk,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice.”

Adequate records that document an animal’s treatment history and a farm’s, or another business’, drug use can go a long way toward preventing illegal drug residues. This, in turn, protects American consumers by making sure the food on their tables is safe.

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1 Federal Food, Drug, and Cosmetic Act, Section 402(a)(4) [21 U.S.C. 342(a)(4)]

2 Prevention is Key to Avoiding Foodborne Illness Outbreaks

3 US Settles Complaint Against Wisconsin Livestock Company for Improper Medication Practices

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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.disclaimer icon Civil Action No. 12-C-643. 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 8, 2011.

FDA, Center for Veterinary Medicine. A Win for FDA’s Food Safety Mission. November 8, 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.disclaimer icon Case No. 1:10-CV-865. Filed September 1, 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.disclaimer icon Civil Action No. 2:11-cv-65, Complaint. Filed January 13, 2011.

Steel A, McLean M, Greenlees K, et al. T.A.L.K. Before You Treat.

FDA. CPG Sec. 615.200 Proper Drug Use and Residue Avoidance by Non-Veterinarians. Issued July 9, 1993.

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