SAFE AND SUITABLE INGREDIENTS USED IN THE PRODUCTION OF MEAT AND POULTRY PRODUCTS

1.    PURPOSE

This directive provides inspection program personnel with an up-to-date list of approved substances for use in the production of meat and poultry products.

2.    [RESERVED]
3.    REFERENCES

9 CFR Chapter III

4.   RESERVED
5.   BACKGROUND

A. On December 23, 1999, the Food Safety and Inspection Service (FSIS) published in the Federal Register a final rule on "Food Ingredients and Sources of Radiation Listed or Approved for Use in the Production of Meat and Poultry Products." The final rule streamlined the process for approving the use of food ingredients and sources of radiation in meat and poultry products to provide for the simultaneous review, by FSIS and the Food and Drug Administration (FDA), of petitions for new uses of food and color additives and notifications for new uses of generally recognized as safe (GRAS) substances that are submitted to FDA. Subsequent to the publication of the final rule in January, 2000, FDA and FSIS entered into a Memorandum of Understanding (MOU) that outlines the procedures that are followed by FDA and FSIS regarding the joint review of requests for the use of food ingredients and sources of radiation in meat and poultry products. Except in certain circumstances, FDA will now list in its regulations (21 CFR) food additives and sources of radiation that are safe and suitable for use in the production of meat or poultry products.

B. FDA regulations permit ingredient and food manufacturers to make their own determination that a particular use of a substance in food is GRAS by qualified experts. The substances that are determined to be GRAS through self-determinations are not listed in the FDA regulations in Title 21 of the CFR. However, on April 17, 1997, FDA published in the Federal Register a Proposed Rule that would establish a notification procedure whereby any person may notify FDA of a determination that a particular use of a substance is GRAS. Although this proposed notification procedure is not yet final, FDA is operating in accordance with the proposal. FDA has received many GRAS notifications pertaining to meat and poultry products that are included in an Inventory of GRAS Notices that FDA has established on its Website. When a GRAS notification involves a use in a meat or poultry product, FDA's response to the notifier will include any restrictions or conditions of use of the substance in the production of meat or poultry products that FSIS recommends, provided such restrictions or conditions of use are consistent with Sections 201 and 409(s) of the Federal Food, Drug, and Cosmetic Act (FFDCA). The Inventory of GRAS Notices, and FDA's responses, may be accessed on the Internet World-Wide Web at: http://vm.cfsan.fda.gov/~rdb/opa-gras.html.

C. FDA also maintains an inventory of premarket notifications for food contact substances. However, unlike the GRAS notices, a premarket notification only applies to the manufacturer or supplier identified in the notification. In the process of reviewing notifications, FDA will consult with FSIS if the intended use involves meat or poultry, per the MOU. The FDA inventory of premarket notifications may be accessed on the Internet World-Wide Web at: http://www.cfsan.fda.gov/~dms/opa-fcn.html.

D. Substances listed approved in FDA regulations for use in food generally (21 CFR, Parts 172-180) or listed as GRAS for use in food (21 CFR, Parts 182 and 184) are not automatically acceptable as safe and suitable for use in meat and poultry products. Unless the approval or listing specifically mentions meat and poultry products, FSIS' Labeling and Consumer Protection Staff would need from FDA an affirmative written statement that FDA's safety determination did, in fact, consider use in meat or poultry, or that FDA does not have any objections with regard to the safety of the use in meat or poultry products. FSIS would still need to determine the suitability of the use of the substance, and whether rulemaking is required to permit such use. Provided FDA confirms the safety of the new use of a substance, or when FDA regulations already state that the substance is safe for use in food generally, FDA will not amend its regulations to list the specific use in meat and poultry products. However, rulemaking by FSIS may be necessary where a standard of identity prohibits or limits the use of an ingredient, or the ingredient is not expected in the product, e.g., adding milk to hamburger. If FSIS determines that rulemaking is necessary, the appropriate labeling or standards of identity regulation in Title 9 of the CFR will be amended to include the substance. In the event that rulemaking is not required, FSIS would notify the requestor, in writing, concerning the acceptable use in meat and poultry products (referred to as an "acceptability determination," as described in the MOU).

E. In the December 23, 1999, final rule, FSIS acknowledged the need to provide direction to its inspection program personnel concerning the use of food ingredients and sources of radiation that have been accepted by the Agency for use in meat and poultry products, but not listed in Titles 9 or 21 of the CFR. Consequently, FSIS proposed to maintain in its directive system, a comprehensive listing of the substances that have been reviewed according to the MOU and that have been accepted as safe and suitable by FSIS.

F. The attachment below identifies the substances that have been accepted since January 2000 by FSIS as safe and suitable for use in the production of meat and poultry products that are not listed in 9 CFR 424.21(c). In order to be comprehensive, substances that have been approved in 21 CFR for use in meat and poultry as food additives; in GRAS notices and pre-market notifications, as well as in letters conveying acceptability determinations, have been included. This table is current as of November 25, 2002. The information is also available on the United States Department of Agriculture (USDA) website at www.fsis.usda.gov/OPPDE/larc/index.htm. For further policy information regarding any of the substances listed below please contact the Labeling and Consumer Protection Staff by telephone at Area Code (202) 205-0279 or by electronic mail at: FSIS.Labeling@fsis.usda.gov. FSIS issues quarterly updates to the list, as needed.

Philip S. Derfler /s/

Deputy Administrator
Office of Policy and Program
Development
 

FSIS Directive 7120.1
Attachment 1