Drug Residue Avoidance in Food Producing Animals
WHAT IS A RESIDUE?
A “residue” is any compound in edible products that results from the use of a drug in an animal that produces food. This includes the drug itself, its metabolites, and other substances formed in or on the food because of the drug’s use.
NATIONAL RESIDUE PROGRAM
The National Residue Program (NRP) is a collaborative interagency program (active participation by FDA, EPA, AMS, ARS, etc.), established to protect the public from exposure to harmful levels of chemical residues in meat, poultry, and egg products produced in, or imported into, the U.S.
WHAT IS FDA’S ROLE IN THE RESIDUE PREVENTION PROCESS?
The FDA was created to assure that a product (drug or chemical compound) is safe and effective for its intended use.
FDA plays a role in ensuring that the methods, facilities and controls used for the manufacturing, processing and packaging of drug(s) are adequate to preserve their identity, strength, quality and purity.
The FDA Animal Drug Approval Process takes into consideration the following criteria when considering a product for use: Effectiveness, Target Animal Safety, Environmental Safety, Chemistry, Manufacturing and Controls, Human Food Safety and User Safety.
Animal drugs approved by FDA/CVM are evaluated for toxicology, microbial food safety and residue chemistry.
Human food safety concerns are associated with consuming edible tissues containing violative residues.
Drug Residue Key and Record Sheet
Drug Residue Frequently Asked Questions
What are the major areas of focus when preventing illegal drug residues?
The four main areas that all parties involved in raising food-producing animals should be concerned with include proper drug use, recordkeeping, withdrawal times and AMDUCA/extralabel use regulations.
What information should I learn from medicated labeling?
All parties should pay attention to drug labels for proper drug usage by following specific instructions of specific medications for administration. Drug labels also provide important information about storage of medication(s); drug labels should be read and understood before giving any medication and if a drug is issued by a licensed veterinarian under a valid veterinary-client-patient relationship, the written use and instructions from the veterinarian should be followed. Also, no drug residues above permitted levels may be present in the final food product whenever a drug is used in an extralabel manner by a veterinarian.
What measures should my control systems include?
Persons involved in raising, handling, transporting, holding and marketing food-producing animals are encouraged to establish systems to ensure that animal drugs are used properly and to prevent potentially hazardous drug residues in edible animal products. To ensure safety, control measures should include the following steps:
Identifying and tracking animals to which drugs were administered in order to preclude the sale of edible animal tissue, milk or eggs containing illegal residues (identification may be by specific animal identification, pen or lot, quarantine/segregation, or other means)
Maintaining a system of medication/treatment records that, at a minimum, identifies the animal(s) treated (individual animals, pens, lots, etc.), the date(s) of treatment, the drug(s) administered, who administered the drug(s), the amount administered, and the withdrawal time prior to slaughter (and when milk, eggs, etc. can be used, if appropriate)
Properly storing, labeling, and accounting of all drug products and medicated feeds
Obtaining and using veterinary prescription drugs only through a licensed veterinarian based on a valid veterinarian/client/patient relationship
Educating all employees and family members involved in treating, hauling and selling of the animals on proper administration techniques, observance of withdrawal times and methods to avoid marketing adulterated products for human food.
Establishing and maintaining such systems should help producers avoid marketing milk, eggs or edible animal tissue containing illegal residues and avoid regulatory action based on Sections 402(a)(2)(D), 402(a)(4), or 501(a)(5).
What if I am the person that does not administer medications to food-producing animals and an illegal residue occurs?
Persons who do not administer medications but who purchase or lease animals for milking or sale for slaughter (such as livestock dealers) should also establish and implement a record-keeping system. This system should include information on the source of the animal and whether the animal has been medicated (when, with what drug, and the withdrawal period) to preclude marketing of edible animal tissue, milk or eggs that may contain illegal residues. Such persons may also be subject to regulatory action if they market animals containing illegal residues and have failed to take reasonable precautions to prevent the sale of adulterated food.
What are the FDA’s and CVM’s regulatory action guidance?
FDA investigators should determine the extent of the misuse of drugs in food-producing animals during the course of their inspections or investigations, such as when following up on an illegal tissue residue report from United States Department of Agriculture/Food Safety and Inspection Service or other information concerning improper drug use. The occurrence of an illegal tissue residue will be regarded as prima facie evidence of improper drug use, and may be an appropriate subject for enforcement action. Of course, before recommending such action, FDA will also consider whether evidence of proper drug usage exists to demonstrate that every reasonable effort has been made to preclude residues.
CVM is prepared to recommend regulatory action when drugs are misused as described above. If the misuse involves administration contrary to labeled directions, the drug itself is adulterated under Section 501(a)(5). If an illegal residue is involved, the food is adulterated under Section 402(a)(2)(D). Further, if an illegal residue is involved and inadequate control measures are documented, the food (edible animal tissue, milk, or eggs) may also be adulterated under Section 402(a)(4). Except in egregious situations, a warning letter is ordinarily the appropriate action of choice. Compliance Program 7371.006, Illegal Drug Residues in Meat and Poultry, provides additional regulatory guidance for illegal residues.
Drug residues in milk should be handled according to Compliance Programs 7318.003, Milk Safety Program and 7371.008, National Drug Residue Milk Monitoring Program.
Who should I contact if I have additional questions?
Further questions about these issues may be directed to AskCVM@fda.hhs.gov.
Gerry VandeVorde, Compliance Investigator
Jeff Verzal, Compliance Investigator