Agency Response Letter GRAS Notice No. GRN 000188
CFSAN/Office of Food Additive Safety
November 24, 2008
Mark L. Itzkoff
Olsson, Frank and Weeda, P.C.
1400 Sixteenth Street, N.W.
Washington, DC 20036-2220
Re: GRAS Notice No. GRN 000188
Dear Mr. Itzkoff:
The Food and Drug Administration (FDA) is responding to the notice, dated December 22, 2005, that you submitted on behalf of Tyson Foods, Inc. 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 December 23, 2005, filed it on December 28, 2005, and designated it as GRAS Notice No. GRN 000188.
The subject of the notice is carbon monoxide. The notice informs FDA of the view of Tyson Foods, Inc. that carbon monoxide is GRAS, through scientific procedures, for use in modified atmosphere packaging (MAP) for red meat products at levels of 5.5 milligrams/pound (12 milligrams/kilogram) of packaged meat.
In an e-mail message dated November 5, 2008, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective November 5, 2008, the date that we received your e-mail message.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000188, as well as a copy of the information in this notice that conforms to the information in the proposed GRAS exemption claim (21 CFR 170.36(c)(1)), is available for public review and copying via the FDA home page at http://www.fda.gov. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the "Food" topic to the "Food Ingredients and Packaging" section to the "Generally Recognized as Safe (GRAS)" page where the GRAS Inventory is listed.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: Dr. John Hicks, Jr. DVM, MPH
Risk Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
U. S. Department of Agriculture
1400 Independence Avenue, S.W., Room 3549, South Agriculture Building
Washington, DC 20250-3700