Agency Response Letter GRAS Notice No. GRN 000166
CFSAN/Office of Food Additive Safety
October 12, 2005
Mark L. Itzkoff
Olson, Frank and Weeda, P.C.
1400 Sixteenth Street, N.W.
Re: GRAS Notice No. GRN 000166
Dear Mr. Itzkoff:
The Food and Drug Administration (FDA) is responding to the notice, dated March 6, 2005, that you submitted on behalf of Freezing Machines, Inc. (FMI) 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)). FDA received the notice on March 9, 2005 and designated it as GRAS Notice No. GRN 000166.
The subject of the notice is carbon monoxide (CO). The notice informs FDA of the view of FMI that CO is GRAS, through scientific procedures, for use in meat.
In an e-mail message dated September 29, 2005, you withdrew your notice. Given your letter, we ceased to evaluate GRAS Notice 000166, effective September 29, 2005, 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, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Antonia Mattia, Ph.D. Director
Division of Biotech and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition