dark overlay
nav button USDA Logo

FSIS

Web Content Viewer (JSR 286)

Actions
Loading...

Web Content Viewer (JSR 286)

Actions
Loading...

Web Content Viewer (JSR 286)

Actions
Loading...

Web Content Viewer (JSR 286)

Actions
Loading...

Web Content Viewer (JSR 286)

Actions
Loading...

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




 

  1. 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.

  2. 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) provide 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 conditions 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 tenets of the FMIA and PPIA, and their implementing regulations, FSIS determines the suitability (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.

  3. SCOPE
    This is a 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 a 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 of radiation used in or on a meat or poultry product.

  4. 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 or 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 the consulting agency. When appropriate, the consulting agency to this agreement will provide its evaluation on relevant parts of submissions to the other agency in writing.

  5. 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 provisions 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.

  6. 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.

  7. 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.

Signed: Signed:
By: By:
Title: Administrator, FSIS Title: Senior Associate Commissioner for Policy, Planning and Legislation, FDA
Date: Date:


 





STANDARD OPERATING PROCEDURES
For the Working Relationship between FSIS, USDA and FDA, USDHHS Regarding
The Listing or Approval of Food Ingredients and Sources of Radiation
Used in the Production of Meat and Poultry Products 

 

  1. When FDA receives a petition for the approval of a food or color additive that specifies an intended use in the production of meat or poultry products,
    1. FDA will inform the petitioner in writing that such petition will also be evaluated by FSIS.
    2. Upon commencement of review of the petition, FDA will provide FSIS with copies of relevant data and information from such petition, excluding trade secret and confidential commercial information. Only upon receipt of the petitioner’s permission will the trade secret and confidential information be shared with FSIS.
    3. FDA and FSIS will consult with one another as necessary and appropriate, regarding issues associated with the petitioned use of the substance or source of radiation in the production of meat or poultry products.
    4. FSIS will, within 60 days, provide FDA with its written comment on the petition.
    5. FDA will inform the petitioner of any concerns expressed by FSIS regarding the suitability of use of the substance or source of radiation in the production of meat or poultry products.
    6. When appropriate, FDA will include in any regulation that results from such a petition the specific use in the production of meat or poultry products that FDA determines to be safe. FDA will consider any restrictions or conditions on the use in the production of meat or poultry products that FSIS recommends in writing, provided that such restrictions or conditions are consistent with section 409 of the FFDCA.
    7. FDA will, before publication, advise FSIS of any new listing in Title 21 regarding a substance or source of radiation for use in the production of meat or poultry products, including conditions of use, use restrictions, or labeling provisions.

  2. When FDA receives a petition for approval of a food or color additive that is intended for use in or on food generally, but that does not specify whether this general use includes use in the production of meat or poultry products:
    1. FDA will contact the petitioner and clarify whether the requested use in food includes an intended use in the production of meat or poultry products.
    2. If the petitioner wishes the intended use in food to include use in the production of meat or poultry products, FDA will request that the petitioner so inform FDA in writing and provide FDA with an additional copy of the petition. FDA and FSIS will jointly review the petition for the intended use in the production of meat or poultry products.
    3. If the petitioner does not wish the intended use in food to include use in meat or poultry products, FDA will request that the petitioner so inform FDA in writing. Any regulation that FDA issues in response to the petition will explicitly exclude the use of the additive in the production of meat or poultry products.

  3. When FDA receives a GRAS notice regarding the use of a substance in the production of meat or poultry products,
    1. FDA will inform the notifier in writing that such notice will also be evaluated by FSIS to determine the suitability of the use of the substance in the production of meat or poultry products
    2. FDA will provide FSIS with copies of relevant data and information from such notices, excluding trade secret and confidential commercial information. Only upon receipt of the notifier’s written permission will the trade secret and confidential information be shared with FSIS.
    3. FDA and FSIS will consult with each other as necessary and appropriate, regarding issues associated with the notified use of a substance in meat or poultry products.
    4. FSIS will, within 60 days, provide a written response to FDA regarding such a notice.
    5. FDA will include in its written response to the notifier information regarding the notifier’s responsibilities under FMIA and PPIA. The FDA response may include concerns about the suitability of the use of the substance in the production of meat or poultry products and, when applicable, any restrictions or conditions of use in the production of meat or poultry products that FSIS recommends in writing, provided that such restrictions or conditions are consistent with Sections 409 and 201(s) of the FFDCA. FDA will send FSIS a copy of FDA’s written response to the notifier.

  4. When FSIS receives a request for an acceptability determination regarding the use of a food ingredient or source of radiation in the production of meat or poultry products and wishes to confirm the status of the intended use of the food ingredient or source of radiation under the FFDCA,
    1. FSIS will consult as necessary with FDA on the regulatory aspects under FFDCA of the suitability determination.
    2. FDA will, within 60 days, provide a written response to FSIS. When appropriate, FDA will advise FSIS that a food additive petition or color additive petition is necessary to accommodate the requested uses or recommend that the requester discuss the regulatory status with FDA.

  5. When FDA receives a request for a suitability determination regarding use of a substance in the production of meat or poultry products, FDA will inform the requester in writing that such a request must be evaluated by FSIS.

  6. When FDA receives an inquiry regarding the use of a substance in the production of meat or poultry products,
    1. FDA will consult with FSIS as appropriate.
    2. FDA’s response to the inquirer will include information regarding the inquirer’s responsibilities under the FMIA and PPIA.

  7. When FSIS receives an inquiry regarding the use of a substance in the production of meat or poultry products,
    1. FSIS will consult with FDA as appropriate.
    2. FSIS’s response to the inquirer will include information regarding the inquirer’s responsibilities under the FFDCA.


Date: ____________________
Last Modified Jun 23, 2013