District Court’s Rulings Focused on Record-Keeping and Illegal Tissue Residues
In July 2011, a U.S. District Court in Washington state found in favor of the U.S. government in a case involving the unlawful use of animal drugs in food-producing animals. The court agreed with the government that the defendants, a dairy farm in Sumas, Wash., and its owner, violated several provisions of the Federal Food, Drug, and Cosmetic Act (FFD&C Act).
Between February 2001 and August 2010, the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA FSIS) reported 13 illegal tissue residues in 9 culled dairy cows sold for beef by the dairy farm. USDA FSIS sent the farm a residue violation letter in 2001, and at least 6 “repeat violator” letters over the next 9 years.
The USDA FSIS reports of illegal tissue residues prompted the Food and Drug Administration (FDA) to inspect the dairy farm once in 2004 and twice in 2010. The three FDA inspections found that the farm had repeatedly used drugs in ways that caused illegal tissue residues in animals sold for slaughter as food. The inspections also found that the farm had a history of incomplete record-keeping.
Each inspection resulted in FDA issuing the dairy farm a Form FDA 483, which listed the violations of the FFD&C Act observed by the FDA investigators during the inspection. The agency also issued the farm a Warning Letter, outlining the violations seen during the June 2004 inspection.
Based on the evidence from the FDA inspections, the District Court permanently enjoined the dairy farm and its owner to prevent them from continuing to violate the FFD&C Act. The court noted that the defendants showed “a prolonged resistance” to complying with FDA regulations and “have not taken measures to achieve compliance,” despite receiving several notices from two federal agencies.
The injunction prevented the dairy farm and its owner from selling any animals for food until FDA was satisfied that they had adequate record-keeping and other systems in place to prevent illegal tissue residues.
The Court’s 2011 Decision
The FFD&C Act considers live animals to be food if they are sold for slaughter with the intention of being used as food. For example, culled dairy cows are food if they are sold for beef.
Section 402(a)(4) of the FFD&C Act states that a food is adulterated if it has been “prepared, packed or held under insanitary conditions….” The purpose of this section, as noted by the District Court, is to prevent conditions that may cause food to be harmful to consumers.
The District Court agreed with the government that the dairy farm’s failure to keep adequate records of the administration of drugs to cows constituted inadequate control measures. These inadequate control measures created “insanitary” conditions and, therefore, adulterated the food under the FFD&C Act.
The District Court also found that the dairy farm and its owner adulterated drugs by using them in ways that differed from the FDA-approved labels. These “extra-label" uses made the drugs unsafe, and therefore, adulterated under the FFD&C Act. Extra-label use of a drug is allowed only in limited circumstances, such as:
- There is a written prescription by a licensed veterinarian within a valid veterinarian-client-patient relationship;
- The drug is not prohibited from extra-label use; and
- The use does not result in illegal residues in edible tissues.
The court rejected the defendants’ argument that their veterinarian “orally okayed” the extra-label uses of the animal drugs. The court found that “evidence of actual diagnoses and Defendants’ compliance with the veterinarian’s instructions regarding the extra-label use is lacking.”
The court granted the government’s request for an injunction and required the dairy farm and its owner to, among other things, set up systems to:
- Permanently identify each animal by tag number;
- Prevent the sale of animals with illegal tissue residues, including establishing written records with the following minimum information:
- Identity of the treated animal;
- Identity of the drug;
- Date the drug was given;
- Dosage and route of administration used;
- Written prescription by a licensed veterinarian within a valid veterinarian-client-patient relationship, if applicable;
- Name of the person giving the drug;
- Proper withdrawal period and the date the withdrawal period will end;
- Date the treated animal is shipped for slaughter or leaves the dairy farm’s control; and
- Name and address of the person buying or receiving the treated animal.
- Ensure animal drugs are used in ways that are consistent with the FDA-approved labels. If the farm uses a drug in an extra-label manner, it must be on the written prescription of a veterinarian and must not result in illegal tissue residues.
- Inventory and account for drugs to prevent the sale of animals with illegal tissue residues, including having written records for each drug bought or received to medicate any animal.
- Keep treated and untreated animals apart to prevent the sale of animals with illegal tissue residues.
- Ensure that each treated animal is not sold for slaughter until the withdrawal period is over.
- Identify the source of each animal bought or received by the farm.
Tissue Residues – Need to Know Information
Dairy farmers and livestock producers want healthy and profitable animals. This often means treating their animals with drugs, such as antibiotics and non-steroidal anti-inflammatory drugs. When a food-producing animal is treated with a drug, residues of the drug sometimes remain in or on edible tissues from that animal.
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. This is the level of residues legally allowed to be in or on the edible tissues.
Selling animals for food with tissue residues above the set tolerance is illegal and causes adulterated food. Illegal tissue residues are a common reason FDA writes a Warning Letter to a dairy farmer or livestock producer.
According to USDA and FDA, the top ten drugs causing illegal tissue residues in dairy cattle from 2005 to 2010, in order of frequency, were:1
aOnly cattle that are positive for antibiotics are tested for flunixin.
b May not be used in an extra-label manner in lactating dairy cattle.
c Not approved for use in cattle.
d Testing began June 2008.
e Not approved for use in dairy cattle and may not be used in an extra-label manner in lactating dairy cattle.
f Not approved for use in female dairy cattle 20 months of age or older.
Common causes of illegal tissue residues include:
- Exceeding the drug’s approved dose.
- Using a shorter withdrawal period than what’s stated on the drug’s label. If a higher-than-approved dose is given, the labeled withdrawal period may not be long enough to allow the drug in the edible tissues to deplete to levels that are at or below the tolerance.
- Using a drug in an extra-label manner without a veterinarian’s involvement. The veterinarian is responsible for establishing a “substantially extended withdrawal period” when a drug is used in an extra-label manner. (For more information about extra-label drug use in food-producing animals, please see Title 21, Code of Federal Regulations, Section 530, Subpart C.)
- Giving a drug not approved for that species.
- Giving a drug by an unapproved route of administration.
- Giving a drug by mistake.
Good Record-Keeping Helps!
Good record-keeping practices help prevent animals with illegal tissue residues from being sold for slaughter. Complete treatment records make it easier to identify:
- Which animals were treated;
- What drug they were treated with;
- How they were treated (the dose, frequency, duration, and route of administration); and
- Why they were treated.
This information allows dairy farmers and livestock producers to know when it is safe for treated animals and food products made from treated animals to enter the food supply.
FDA and Food Safety
The government’s win against the Washington state dairy farm and its owner in 2011 was a win for FDA and food safety. As highlighted by the District Court’s rulings, systems to prevent animals with illegal tissue residues from being sold for food are critical to a safe food supply. The court’s rulings also highlighted the importance of adequate treatment records.
By working together, FDA, dairy farmers, and livestock producers can help make sure potentially harmful food doesn’t reach the mouths of consumers.
1USDA FSIS/FDA Residue Violation Information Database (RVIS)
Resources for You
- Adequate Drug Treatment Records Help Ensure Food Safety
- T.A.L.K. Before You Treat
- The Ins and Outs of Extra-Label Drug Use in Animals: A Resource for Veterinarians
United States of America v. Rhody Dairy, L.L.C., and Jay L. De Jong
Case number C11-0065-RSM, Order on Summary Judgment and Request for Injunction. Filed July 14, 2011.