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MOU number: 225-00-2000

Memorandum of Understanding

Between
The Food Safety and Inspection Service
United States Department of Agriculture

and

The Food and Drug Administration
United States Department of Health and Human Services

Regarding the Listing or Approval of Food Ingredients and Sources of Radiation Used in the Production of Meat and Poultry Products

I. PURPOSE

This agreement establishes the working relationship to be followed by FSIS and FDA in responding to requests for the sanctioning of the use of food ingredients and sources of radiation subject to regulation by the FDA and intended for use in the production of meat and meat food products (hereinafter known collectively as meat products) and poultry products regulated by FSIS.

II. BACKGROUND

The Federal Food, Drug, and Cosmetic Act (FFDCA) provides FDA with the authority to determine the safety, wholesomeness, and accurate labeling of food. The Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) provides FSIS with the authority to regulate establishments that process meat and poultry, and determine the safety, wholesomeness, and accurate labeling of such meat and poultry products.

Section 409 of the FFDCA (21 U.S.C. 348) requires premarket approval of food additives that are not food contact substances. Under section 409, any person may submit to FDA a food additive petition that includes data and information that the petitioner believes establish that use of the substance is safe under its intended conditions of use, (i.e., that there is reasonable certainty that the substance is not harmful under the intended conditions of use (21 CFR 170.3(i)). If, based on the data and information in the petition, FDA finds that the food additive is safe under the conditions of its intended use, FDA promulgates a regulation specifying the conditions under which the additive may be safely used.

Likewise, section 721 of the FFDCA (21 U.S.C. 379e) requires premarket review and listing of color additives. Under section 721, any person may submit to FDA a color additive petition that includes data and information that the petitioner believes establish that the intended use of the substance is safe, and that the color additive is suitable for its intended use. If, based on the data and information in the petition, FDA finds that the color additive is suitable and safe under the conditions of its intended use, FDA promulgates a regulation specifying the condition under which the color additive may be safely used.

In enacting Section 409, Congress recognized that many substances intentionally added to foods would not require a formal premarket review by FDA to ensure their safety, either because their safety had been established by a long history of safe use in food or by virtue of the nature of the substance, its customary or projected conditions of use, and the information generally available to scientists about the substance. Congress thus adopted a two-step definition of "food additive" (21 U.S.C. 321(s)). The first step broadly includes any substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of food. The second step, however, excludes from the definition of food additive substances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety, as having been adequately shown to be safe under the conditions of their intended use. It is on the basis of this generally recognized as safe (GRAS) provision in the food additive definition that many food ingredients are marketed without formal FDA review and approval. However, there is no corresponding GRAS provision for color additives.

The FMIA and the PPIA grant FSIS the authority to regulate the use of GRAS substances, FDA-listed food and color additives, and sources of radiation to ensure that their use does not adulterate meat or poultry products. Under the tenet of the FMIA and PPIA, and their implementing regulations, FSIS determines the suitable (i.e., status) of the use of food ingredients and sources of radiation used in the production of meat and poultry products, in accordance with various FSIS regulations and policies.

III. SCOPE

This collaborative FSIS-FDA agreement regarding food ingredients and sources of radiation intended for use in the production of meat and poultry products. This agreement between FSIS and FDA covers the following circumstances: (1) when a party requests Federal approval of a food ingredient or source of radiation that specifies use in or on a meat or poultry product; (2) when a party requests Federal approval of a food ingredient or source of radiation that is intended for use in or on food generally, but does not specify whether it is intended for use in or on meat and poultry product; (3) when a party requests a suitability determination regarding the use of a food ingredient or source of radiation in or on a meat or poultry product; and (4) when a party inquires about the use of a food ingredient or source radiation used in or on a meat or poultry product.

IV. COLLABORATIVE FSIS-FDA AGREEMENT REGARDING FOOD INGREDIENTS AND SOURCES OF RADIATION INTENDED FOR USE IN THE PRODUCTION OF MEAT AND POULTRY PRODUCTS

FSIS and FDA agree to cooperate and collaborate on the review of submissions each agency receives regarding the use of food ingredients and sources of radiation used in the production of meat and poultry products. The agencies further agree that the details of that cooperative relationship are to be elaborated on in a set of mutually agreeable standard operating procedures. The standard operating procedures will provide consistency in the processing of the relevant submissions regardless of which agency is the receiving agency or which agency is the consulting agency. When appropriate, the consulting agency to this agreement will provide its evaluation on relevant parts of submission to the other agency in writing.

V. IMPLEMENTATION OF THE AGREEMENT

FSIS and FDA jointly agree:

1. That the officials of the two agencies responsible for implementing the agreement are:

At FSIS: Director, Labeling and Additives Policy Division (or other FSIS designee).

At FDA: Director, Office of Premarket Approval, Center for Food Safety and Applied Nutrition

2. That written notice will be provided to the Director of the Center for Food Safety and Applied Nutrition, FDA, and to the Administrator of the Food Safety and Inspection Service, USDA, of any rulemaking initiative not in keeping with the provision of this MOU or about which there is an interagency disagreement, prior to public announcement of the rulemaking.

3. That the Administrator of FSIS and Director of CFSAN shall resolve any problems and make decisions by consensus in areas of disagreement.

VI. OTHER AGREEMENTS

The provisions of this MOU are not intended to add to or detract from any of the authorities provided to either FDA or FSIS by the FFDCA, FMIA, or PPIA, or the regulations promulgated by each agency under such authorities. Each agency reserves the authority to review, independently of the other, matters of concern to their respective authorities.

VII. DURATION OF MOU

This agreement becomes effective upon acceptance by both agencies and will continue indefinitely. It may be modified by mutual written consent or terminated by either agency with a 30-day written notice to the other agency.

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