Inspections, Compliance, Enforcement, and Criminal Investigations

SUBCHAPTER 3.1 - COOPERATIVE EFFORTS

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 3.1.1 - POLICY

The scope of consumer protection is extended by cooperative efforts of federal, state, and local agencies and international cooperation. Procedures to appropriately share responsibilities and cooperate with our consumer protection partners are essential.

Federal, state, and local cooperation shall be fostered whenever possible. The Agency issues the IOM as well as other FDA manuals to international regulators and conformity assessment bodies, and state and local inspectors. FDA fosters cooperation through correspon-dence, FDA testimony, press releases, reprints from the Federal Register, and distribution of all pertinent policy and regulations issued by FDA which have significance in other regulatory jurisdictions. The Agency may share FDA's non-public information as long as the sharing complies with the Agency's confidentiality laws and procedures.

Districts, headquarters' offices, and resident post personnel in particular, should maintain liaison with federal, state and local officials.

Follow district policy regarding contacts with appropriate federal, state, county and local officials to exchange in-formation, coordinate operations, and arrange joint inspections. If an assignment calls for joint work with state or local inspectors, make every effort to accomplish this work. See IOM 3.3.1. When you travel internationally, follow policy established in the "GUIDE TO INTERNATIONAL INSPECTIONS AND TRAVEL."

 3.1.2 - LAWS, CODES, AGENCIES

Many states have enacted the basic Uniform Food, Drug, and Cosmetic Bill, and others have adopted at least a part of the Uniform Bill. The provisions of these laws are very similar to the 1938 provisions of the Federal Food, Drug, and Cosmetic Act. A few states have enacted the Pesticide Food and Color Additives or Kefauver-Harris type amendments. See IOM 3.3.3.

Most states without the Uniform FD&C Act, have laws based on the 1906 Food and Drug Act. Most larger cities have their own ordinances and regulations. A portion of the food supply of the United States is consumed within the state in which it is produced, and is therefore, not di-rectly under the jurisdiction of the Federal Food, Drug and Cosmetic Act as amended. Thus, the various state and local agencies are solely responsible for policing this supply.

The departments of the executive branch of the federal government operate under the laws and regulations which they are specifically responsible for enforcing. Since responsibilities may overlap and be duplicated, operating agreements and liaison between agencies is essential for smooth and efficient governmental operation. Section 702(c) of the FD&C Act [21 U.S.C. 372(c)] recognizes this by providing that the records of any department in the executive branch shall be open to inspection by authorized DHHS personnel.

District management is responsible for maintaining official liaison between FDA and other federal agencies. However, for day by day operations, personal contact between various operating federal investigators, inspectors, and agents is desirable and encouraged.

 3.1.2.1 - Agreements and Memoranda of Understanding (MOU)

To provide for more efficient use of FDA and other agency manpower and resources and to prevent duplication of effort, FDA and various agencies often enter into formal or informal agreements, and/or understandings. These specify areas in which each will assume primary responsibility. Prior to disclosing FDA's information, ensure that the Agreement and MOU contain confidentiality provisions that comply with FDA's information disclosure laws and procedures (e.g., sharing with the public (FOI), federal government officials 21 CFR 20.85, state/local 21 CFR 20.88, foreign 21 CFR 20.89). Do not share information unless that sharing complies with such laws and Agency procedures even if the Agreement and MOU fail to contain proper confidentiality provisions.

Pertinent parts or paraphrasing of the Agreements and/or Memoranda of Understanding (MOU) which are of particular interest to you as operating inspectors and investigators are listed below. Copies of many of the formal Agreements and MOU are in the FDA Federal Cooperative Agreements Manual (1996 edition) and the FDA International Cooperative Agreements Manual (1996 edition). Your district and most resident posts have copies of these manuals. Refer to them as necessary. Some Agreements and MOU are listed, for your information and reference, in this Chapter of the IOM under the appropriate agencies. For FDA personnel, the Federal Cooperative Agreements Manual is located on the FDA Gold Disk or for either the Federal or International manuals, a hardcopy can be obtained by contacting the Office of Enforcement and Import Operations/Division of Compliance Systems at 301-796-8997Highlighted to denote updated text. State and local governmental agencies may contact the Office of Partnerships (OP) at 301-796-5841Highlighted to denote updated text. FDA's Office of International Programs (OIP) at 301-796-4600 will answer your questions about international Agreements and/or MOUs. If you plan to share non-public information with another federal agency, contact the Office of Policy and Risk Management (OPRM) at 301-796-1477; Highlighted to denote updated text with a state agency, contact OPHighlighted to denote updated text, or with a foreign government, contact OPRMHighlighted to denote updated text, who will consult with OIP. The public may obtain a copy of either manual for a fee by contacting the National Technical Information Services (NTIS), U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161 or by telephoning them at 800-553-6847. Partnership Agreements will be posted on the ORA Internet (See Partnership Agreements).

 3.1.3 - OTHER GOVERNMENT INSPECTION

General procedures regarding cooperation with other federal, state, and local officials are furnished below.

During establishment inspections determine the specific type of inspection service and inspecting units, such as the name of the federal, state, county, or city health agency or department. Obtain the name and title of the inspectional official, and general method of operation. IOM 5.4.9.3 discusses coverage of grade A Dairy Plants.

 3.1.3.1 - Federal

Compulsory Continuous Inspection - Do not inspect firms, or that portion of a plant, under compulsory, continuous inspection under United States Department of Agriculture's (USDA) Meat Inspection Act, Poultry Products Inspection Act, or Egg Products Inspection Act, except on specific instructions from your supervisor or assignment document.

Ingredients or manufacturing processes common to both USDA and FDA regulated products should be inspected by FDA. See IOM 3.2.1.3 for FDA/USDA Agreements in specific areas.

Provide routine FDA coverage of such firms as breweries and wineries, which may be intermittently inspected on a compulsory basis by the U.S. Treasury Department, U.S. Public Health Service, or other agencies.

Voluntary - All products inspected under the voluntary inspection service of the Agriculture Marketing Service (AMS), USDA, and the National Marine Fisheries Service (NMFS), US Department of Commerce, are subject to FDA jurisdiction and are usually given routine coverage; however, formal written Agreements or a MOU between FDA and other agencies are often executed and may govern the agreeing agencies' operations on these type of inspected plants.

 3.1.3.2 - Discussion with Federal Inspector

If you are assigned to cover a federally inspected plant which is under either compulsory or voluntary inspection, check to see if an Agreement or a MOU exists between FDA and the agency involved to determine the obligations of both agencies. When you arrive at the firm:

  1. Identify yourself to the inspector(s) and invite him/her to accompany you on the inspection but do not insist on their participation.
  2. At the conclusion of the inspection, offer to discuss your observations and provide the in-plant inspector with a copy of your Inspectional Observations (FDA 483).

 3.1.3.3 - State and Local

State and local officials usually have extensive regulatory authority over firms in their area regardless of the interstate movement or origin of the food products involved. Joint FDA-State or local inspections are occasionally conducted. These are usually arranged by district administrative or supervisory personnel. See IOM 3.3.1.

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Page Last Updated: 08/20/2014
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