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Animal Food Safety/BSE Inspection Contract Program

Animal Food Safety/BSE Inspection Contract Program

What is the Animal Food Safety/BSE Inspection Contract Program?

Firms using Category II Type medicated articles to make medicated feeds are required to register with FDA and gain licensure. 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. 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.

What is Bovine Spongiform Encephalopathy?

Bovine Spongiform Encephalopathy (BSE) belongs to the unusual group of progressively degenerative neurological diseases known as transmissible spongiform encephalopathies (TSEs). TSE diseases are characterized by long incubation periods ranging from several months for transmissible mink encephalopathy, to several years for BSE. During the incubation period there is no visible indication of the disease. In the late 1980’s and early 1990s, BSE spread within the United Kingdom and then to other countries through the practice of using rendered bovine origin proteins as an ingredient in cattle feed. Since then, feed restrictions put in place by countries that may have imported infected cattle or contaminated feed ingredients have been highly effective in reducing the number of BSE cases worldwide.

What types of inspections are conducted under the Animal Food Safety Contract?

The contract is designed to obtain state and local assistance in the inspectional coverage of licensed and non-licensed medicated feed establishments; verifying compliance with the Veterinary Feed Directive (VFD) regulations by animal food manufacturers, distributors, veterinarians, and animal producers; verifying compliance with current good manufacturing practices, hazard analysis, and risk-based preventive controls; and collecting samples for contaminant surveillance or compliance with applicable regulations.

Which states currently have a contract?

United States Map displaying 32 FDA funded Animal Food Safety contract states: AL, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, OH, OK, PA, SC, TN, TX, UT, VA, WA, WV.

United States Map displaying 32 FDA funded Animal Food Safety contract states: AL, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, OH, OK, PA, SC, TN, TX, UT, VA, WA, WV.

    • 32 contracts with state government regulatory agencies.
    • 32 states are covered in these contracts.
    • 17 of the 19 FDA-ORA field district offices are represented under this contract program.
    • Over $3.3 million in funding under this contract program.

    How does FDA ensure the quality of state contract inspections?

    Each state inspector who conducts contract inspections for FDA is audited twice in a 36-month period to ensure that the quality of the inspection work meets FDA expectations. FDA reviews the state inspector audits annually at the state program and national level to ensure the audit obligations are met and that the state programs meet the performance criteria described in FMD-76 - State Contracts - Evaluation of Inspectional Performance. FDA reports the overall audit performance rating of each state program for the contract year. See the annual state program performance data posted here

    Where can I find more information?

    For law, regulations, and guidance documents, visit: Guidance for Industry

    For current and historical BSE inspection contract information, you can visit www.usaspending.gov.

    Specific questions on this program can be directed to the appropriate Office of Partnerships' contact within the Division of Partnership Investments and Agreements. Please visit the Office of Partnerships Contacts webpage to obtain a downloaded version of the staffing roster. 

    General questions can be directed to the Office of Partnerships' general mailbox: op.feedback@fda.hhs.gov.