The CVM's Office of Surveillance and Compliance (OS&C), in cooperation with the FDA Field Offices, monitors marketed animal drugs, and veterinary devices to assure their safety and effectiveness. The Office also is responsible for animal food safety programs including the approval of food additives, evaluating Generally Recognized as Safe (GRAS) notifications, monitoring the safety of animal feed and administering the medicated feed program. This regulatory responsibility is carried out by scientists, investigators, and analysts around the country. Also involved in these activities are the Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and other State and Federal agencies. Federal field investigators and State inspectors conduct inspections of medicated feed manufacturers to assure that acceptable manufacturing procedures are followed. Violations can result in regulatory action.
Functions among the OS&C Divisions are varied, yet closely related. These functions are outlined as follows:
- Implementation and oversight of medicated animal feed program
- Monitoring drugs used in food and non-food animals, thus providing scientific expertise for legal cases
- Monitor adverse events for approved animal drugs, pet foods, unapproved drugs, and veterinary devices to identify safety signals and effectiveness issues of concern
- Enforce Compliance within the industry by working cooperatively amongst all OS&C Divisions
- Assure safety of animal food by approving new animal food ingredients and evaluating risks of feed contaminants
- Educational outreach to the field and industry
- Pursue regulatory actions if warranted.
One of CVM's highest priorities is assuring the safety of animal derived foods. Drugs are used in food-producing animals to treat and prevent animal diseases in order to increase animal production. Contaminants in animal food can have an adverse impact on human food safety. Even though an animal drug product is carefully tested before it is marketed, wider use of the product may reveal issues not evident during the pre-approval review. Therefore, the assessment of the safety of an animal drug is a continuing process that takes place throughout the life cycle of a drug. Post-approval surveillance is the process for monitoring drug safety.
The Office of Surveillance and Compliance has primary responsibility for four of CVM’s five core functions: compliance-related actions, post-approval monitoring, pharmacovigilance, and animal food and pet food safety. The Office of Surveillance and Compliance monitors the safety and effectiveness of approved animal drugs after they enter the market. Working with the U.S. Department of Agriculture and state agencies, OS&C monitors the occurrence of unsafe drug residues in meat, milk, and poultry products, and guides efforts to protect consumers through educational and enforcement activities related to drug residues. The Office (OS&C) coordinates enforcement actions against unapproved animal drugs that are on the market that threaten public and animal health. OS&C regulates the promotional and advertising of animal drug labels to ensure they are truthful and non-misleading.
The Office of Surveillance and Compliance conducts programs to protect animal food from contamination by toxic materials such as mycotoxins, pesticides, heavy metals, and industrial chemicals, and also to prevent the establishment and amplification of bovine spongiform encephalopathy (BSE) through animal food. It administers the Type A medicated article and feed mill licensing program and coordinates risk-based inspections of medicated feed manufacturers. It approves food additives for use in animal food, evaluates notifications that ingredients are GRAS for an intended use in animal food, and reviews genetically modified plant varieties for safety as well as coordinating the Center’s counterterrorism efforts.
The Office’s Bioresearch Monitoring Team oversees inspections of both nonclinical (laboratory) and clinical studies to provide assurance of the integrity of data submitted in support of animal drug applications. OS&C also coordinates the Center’s administrative functions involving approved animal drugs, such as injunctions, warning letters and actions to withdraw drug approvals.
The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) is responsible for the inspection of meat and poultry products in Federally-inspected establishments and has primary responsibility for the wholesomeness of these products. FSIS reports violative residues of drugs in meat and poultry to FDA for regulatory follow-up.
FDA and state agencies, under inspectional agreements with FDA, conduct follow-up inspections of producers or others involved in the production or marketing of food animals or poultry which have tissue residue violations. The goal of CVM's Tissue Residue Program is to eliminate violative drug residues in edible tissue of food animals.
The National Drug Residue Milk Monitoring Program (NDRMMP) is another effort to ensure milk safety. The NDRMMP routinely tests raw milk for drug residues. It is a cooperative effort between FDA and State milk control officials. Milk samples are assayed for eight sulfonamide and three tetracycline drugs, chloramphenicol, and the beta lactam antibiotics. Analytical methods for more compounds are added as they are developed.
Additional functions of the OS&C include:
- Monitoring approved animal drugs to assure their continued safety and effectiveness
- Monitoring marketed unapproved animal drugs and veterinary devices
- Monitoring the quantity marketed of approved animal drugs, particularly those used in food-producing animals in effort to reduce antimicrobial resistance
- Enforcing industry compliance with the FFDCA by evaluating and coordinating legal cases brought against violators by the Agency
- Reviewing product labels and providing updates as new information becomes available
- Withdrawing drugs and food additives from the market when conditions warrant removal, based on scientific fact concerning a lack of safety and/or effectiveness
- Assuring that good laboratory practices are maintained, through the monitoring of laboratory investigators who conduct studies as part of the NADA approval process. Monitoring the conduct of clinical investigators and sponsors of clinical investigations
- Monitoring and evaluating reports of adverse events reported for animal drugs, pet food, and livestock feed for animal safety and public health issues. Withdrawal of an approved animal drug may be recommended if it is determined to be unsafe or ineffective
- Collaborating with USDA/FSIS on drugs and chemicals in meat and poultry
- Developing and implementing policies that affect marketed products
- Coordinating with CORE when needed on adverse animal feed events
- Performing health hazard evaluations and assisting other FDA offices in coordinating recalls of animal and pet food products.
- Taking steps to alleviate animal drug shortages, particularly those affecting medically necessary veterinary products (MNVP).