For Federal, State, Local, Tribal, and Territorial Officials
The Division of Federal-State Relations manages various sole source and fixed price contract programs with states. These contract programs benefits states with technical training, familiarity with federal requirements and more uniform enforcement of consumer laws through cooperation and coordination with FDA. The contract programs allow FDA to enlarge coverage of the Official Establishment Inventory (OEI) and also to redirect resources to other priorities.
For more information please contact:
Food and Tissue Residue
Ms. Wendy Campbell
Feed, Egg, MQSA, Milk & Devices
Ms. Mei-Ying Li
The contract programs include Food Safety, Feed/BSE, Tissue Residue, MQSA, Milk Drug, and Medical Device. These contracts are with over 145 state regulatory agencies and acquire over 25,000 inspections and data for over 4 million samples.
- Egg Inspection Contract Program: On July 9, 2009 FDA published a final rule requiring shell egg producers to implement certain measures to prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm and from further growth during storage and transportation. The rule requires producers with 3,000 or more laying hens on a farm to implement SE prevention measures. This contract is designed to obtain state assistance for the inspectional coverage of egg producing facilities covered by FDA’s final SE egg rule, specifically to conduct inspections of egg layer farms to assess compliance with 21 CFR 118: Production, Storage and Transportation of Shell Eggs, “The New Egg Rule”.
- Food Inspection Contract Program: Under this program, inspections are performed in selected food manufacturers/processors to determine compliance with the Federal Food, Drug and Cosmetic (FD&C) Act, state law, or both; The major inspectional emphasis will be placed upon determining significant GMP, unsanitary conditions and practices which may render the food injurious to health, particularly those involving the introduction, lack of controls, and/or growth promotion of pathogenic organisms and other conditions which may have caused food to become filthy, putrid, decomposed or contaminated with foreign objects which present a reasonable possibility of causing the contamination of food.
- Feed/BSE Inspection Contract Program: The Medicated Feeds Program has been implemented with the assistance of the states under contract since 1973. For the last several years, states have accomplished surveillance inspections to determine whether firms manufacturing medicated feeds were in compliance with key good manufacturing practices (GMP) regulations. The Second Generation Medicated Feed Regulations, published by the FDA in 1986, set forth revised requirements concerning approval procedures for the manufacture of animal feeds containing new animal drugs. These regulations focus on high-risk drugs, i.e., carcinogens and drugs requiring withdrawal times at their lowest use level. Firms using Category II Type medicated articles to make medicated feeds are required to register with FDA and hold approved licenses. FDA is required to inspect these firms once every two years. On June 5, 1997, FDA published a final rule prohibiting the use of mammalian protein in ruminant feeds. This action was taken to prevent the spread of bovine spongiform encephalopathy (BSE) in the United States; thus, the phrase "BSE rule" to describe it. The rule, which is codified in 21 CFR 589.2000, provides for labeling, record keeping and clean out requirements for renderers, feed manufacturers, haulers of feed, and producers.
- Tissue Residue Inspection Contract Program - Under this program, inspections of producers/owners as identified by USDA/FSIS of a tissue residue violation are conducted. The primary objectives of the inspection will be to determine and document the cause of the violative tissue residue. The inspection will obtain information on the producer's/owner's operations, drug usage, animal husbandry practices, feed delivery systems, responsibility for the violation, and disposition of any remaining animals. Inspections will include assuring compliance with the 21CFR 589.2000, "Substance Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed", commonly known as the "BSE Rule".
- MQSA Inspection Contract Program: The Mammography Quality Standards Act (MQSA) of 1992, was signed into law on October 27, 1992. The intent of the Act is to ensure that women receive high quality mammography for early breast cancer detection by requiring the establishment of a federal certification and inspection program for mammography facilities. The Act authorizes FDA to obtain state and local assistance in enforcing the MQSA requirements including annual inspections of all certified mammography facilities.
- National Milk Drug Residue Database: The Food and Drug Administration (FDA) and the states share responsibility for assuring that the nation's milk supply is safe and not contaminated with harmful residues of drugs. This task is accomplished through a cooperative agreement between FDA and the states under the National Conference on Interstate Milk Shipments (NCIMS). The National Milk Drug Residue Database was implemented in cooperation with the National Conference on Interstate Milk shipments, and organization of state officials responsible for the Grade A fluid milk production in this country. The contract is part of an effort to improve control over drug residues in the milk supply, and to be able to demonstrate the amount and results of collective industry and government milk testing.
- Medical Device Inspection Program: Inspection of Class I and Class II medical device manufacturers to determine compliance with the QSIT/GMP regulations. Section 510 (h) of the Federal Food, Drug and Cosmetic Act states, "Every establishment in any state registered with the Secretary pursuant to this section shall be subject to inspection pursuant to Section 704 and every such establishment engaged in the manufacture, propagation, compounding or processing of a drug or drugs or of a device or devices classified in Class II or III shall be so inspected by one or more officers or employees duly designated by the secretary at least once in the two-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive two-year period thereafter."