Contract Programs with States (Food)
The Office of Domestic Partnerships (ODP) manages various sole source and fixed price contract programs with states. Working collaboratively with our state partners through contracts, FDA is able to provide enhanced regulatory oversight of its regulated firms.
Contract Programs
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.
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.
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.
Current Awardees
There are 30 FDA funded Animal Food Safety contract states: AL, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, NC, ND, NE, NJ, NM, OH, PA, SC, TN, TX, UT, VA, WA, WV.
- 30 contracts with state government regulatory agencies
- 30 states are covered in these contracts
- $3.2 million in funding under this contract program
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.
Additional Information
- Animal & Veterinary Guidance for Industry
- Current and Historical BSE Inspection Contract Information
- Animal Food Safety Contract Program Fact Sheet (Version November 2023)
Under this program, inspections are performed in selected food manufacturer/processor firms to determine compliance with the Federal Food, Drug and Cosmetic (FD&C) Act, state law, or both.
During inspections, the emphasis is placed on determining significant violations to Good Manufacturing Practices (GMPs), Preventive Controls, unsanitary conditions and practices that may render the food injurious to health. This considers inspectional concerns involving the introduction or growth of pathogenic organisms, and other conditions that may cause food to become filthy, putrid, decomposed, or contaminated with foreign objects.
Current Awardees
There are 43 FDA funded Human Food Inspection contract states and 1 U.S. Territory: AK, AL, AR, AZ, CA*, CO, CT, FL, GA, IA*, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC*, TN, TX, UT, VA, VT, WA, WI, WV*, WY
- 48 contracts with state and territorial government regulatory agencies (e.g. Health, Agriculture, Consumer Protection, etc.)
- *California, Iowa, South Carolina, and West Virginia each have two agencies with contracts (Departments of Health & Agriculture) included in the total number of contracts
- Of the 48 contracts awarded, 43 states and one (1) U.S. Territory, Puerto Rico, have contracts
- Approximately $13.6 million in funding under this contract program
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.
Additional Information
The National Milk Drug Residue Database (NMDRD) system was implemented in cooperation with the National Conference on Interstate Milk Shipments. 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.
The objective of this contract is to maintain the existing database that consists of the results of testing of milk samples for drug residues by the industry, states and federal agencies. The data shall include information on the source of samples, when analyses were conducted, numbers of analyses, methods used, and results by drug and methods. The data shall be recorded, summarized, and distributed to interested parties.
Current Awardees
- GLH Inc is the awardee of this contract program
- $113,086 in funding under this contract program
Additional Information
- National Conference on Interstate Milk Shipments (NCIMS) Model Documents
- National Milk Drug Residue Contract Program Fact Sheet (Version November 2023)
SMG-8076 FDA State Contract Audit Program
Staff Manual Guide 8076 (SMG-8076) is the document governing the Food and Drug Administration (FDA) Human Food Program, Office of Domestic Partnerships (ODP) and the Office of Inspections and Investigations (OII) oversight of the audits of state contract regulatory inspections. SMG-8076 works in concert with several other FDA efforts to ensure that FDA's State partners have the capacity and capability to support the FDA's regulatory oversight and enforcement of applicable sections the Food, Drug and Cosmetic Act and regulations under contract. These goals also intersect with FDA efforts toward the overarching goals of mutual reliance and an integrated food safety system (IFSS).
SMG-8076 directly applies to contract inspections under: Human Food; Animal Food; Egg; Medical Device; and other State inspection programs. SMG-8076 established the oversight of required audits of regulatory contract work being conducted, by the state or territory, on behalf of FDA.
Staff Manual Guide 8076 (SMG-8076) and its appendices can be accessed through the links below:
- SMG-8076, FDA State Contract Audit Program, effective 11/7/2024
- Appendix A: Instructions for Evaluating Contract Inspections
- Appendix B: Human Field Inspection Audit (FORM FDA 3610H)
- Appendix B.2: Instructions for Reporting Human Food Contract Audits
- Appendix C: Animal Food Safety Inspection Audit Form (FORM FDA 3610A)
(in XLXS) - Appendix C.1: Instructions for Completing the Animal Food Safety Inspection Audit Form
- Appendix C.2: Instructions for Reporting Animal Food Contract Audits
- Appendix D: Instructions for Conducting Joint Audit Inspections, Verification Audits for State Auditors, and Joint Inspections
- Appendix H: State Implementation Agreement and Year-End Evaluation
- Appendix H.1: Completion Guide for SMG 8076 Appendix H
- Appendix I: Request for Audit Reduction Form and Instructions
- Appendix J: Corrective Action Plan for Program and Performance Factors
- HF 3610-H Summary Sheet (in XLXS)
View compiled data related to the previous year’s audits under FMD-76.