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Agency Additional Correspondence Letter GRAS Notice No. GRN 000228

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See also Generally Recognized as Safe (GRAS) and about the GRAS Notice Inventory

CFSAN/Office of Food Additive Safety

May 31, 2011

Melvin S. Drozen
Keller and Heckman LLP
1001 G Street NW, Suite 500 West
Washington, D.C., 20001

Re: GRAS Notice No. GRN 000228

Dear Mr. Drozen:

The Food and Drug Administration (FDA) is responding to the supplement dated March 30, 2011, that you sent regarding GRN 000228 on behalf of Bemis Company, Inc. (Bemis), who initially submitted GRN 000228 in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on July 5, 2007, filed it on July 10, 2007, and designated it as GRAS Notice No. GRN 000228.

The subject of the notice is sodium nitrite. The notice informs FDA of the view of Bemis that sodium nitrite, embedded on one side of a film at a maximum level up to 113 milligrams per square meter (mg/m2), is GRAS, through scientific procedures, for use in maintaining the characteristic color of raw ground beef and raw whole muscle cuts of beef when vacuum packaged in a high-oxygen-barrier film.

In the supplement dated March 30, 2011, you informed FDA of Bemis’s determination that sodium nitrite is GRAS when used to package other types of meat such as ground pork and whole muscle cuts of pork when used as described in GRN 000228. Bemis notes that the mechanism of action of sodium nitrite on pork is the same as the mechanism of action of sodium nitrite on beef, i.e., sodium nitrite migrates from the packaging to the surface of the pork where it forms nitric oxide which reacts with myoglobin to form nitrosomyoglobin. Bemis states that pork contains less myoglobin than beef and therefore less sodium nitrite will be used to maintain the color of the pork. Bemis provides the myoglobin content of various cuts of meat. Bemis concludes that the exposure to sodium nitrite or its reaction products will be the same or less that those evaluated in GRN 000228.

FDA has examined this additional use of sodium nitrite and has concluded that this use of sodium nitrite impregnated film will not increase exposure to sodium nitrite or the reaction products that result from the interaction of sodium nitrite and myoglobin. However, to comply with Food Safety and Inspection Service (FSIS) requirements for the legal sale of this additional use of sodium nitrite, Bemis states that they will perform microbial testing on the additional meat products of interest to ensure that the treated meat is safe for consumer sale. They will submit the results of that testing to the Risk, Innovation and Management Division, Office of Policy and Program Development, FSIS, United States Department of Agriculture so that a maximum "Use by/Freeze by" date can be established. They further state that FSIS is willing to accept and review additional microbial data and revise Directive 7120.1 to reflect freeze by dates supported by additional data.

Based on the information provided by Bemis in GRN 000228, the supplement dated March 30, 2011 and other information available to FDA, the agency has no questions at this time regarding Bemis’s conclusion that sodium nitrite is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of sodium nitrite. As always, it is the continuing responsibility of Bemis to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to the supplement to GRN 000228, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying at


Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

cc: William K. Shaw Jr., Ph.D.
Risk, Innovations, and Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
U.S. Department of Agriculture
George Washington Carver Center (GWCC)
5601 Sunnyside Avenue, Mail STOP 5272
Beltsville, MD 20705-5272

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