Agency Response Letter GRAS Notice No. GRN 000143
CFSAN/Office of Food Additive Safety
July 29, 2004
Gary J. Kushner
Anne M. Boeckman
Hogan and Hartson
555 Thirteenth St.
Washington, D.C. 20004-1109
Re: GRAS Notice No. GRN 000143
Dear Mr. Kushner and Ms. Boeckman:
The Food and Drug Administration (FDA) has received the notice, dated January 6, 2004, that you submitted on behalf of Precept Foods, LLC (Precept) 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 January 9, 2004, filed it on January 12, 2004, and designated it as GRN No. 000143.
The subject of the notice is carbon monoxide (CO). The notice informs FDA of the view of Precept that CO is GRAS, through scientific procedures, for use as a component of a modified atmosphere packaging (MAP) system for case-ready fresh beef and pork. The level of CO in this MAP system is 0.4 percent. The other components of the MAP system are carbon dioxide (20-100 percent) and nitrogen (0-80 percent).
Carbon monoxide was also the subject of GRN 000083 submitted by Pactiv Corporation. In a submission dated August 29, 2001, Pactiv informed FDA of its view that CO is GRAS, through scientific procedures, for use as a component of a gas mixture in a MAP system. The level of CO in this MAP system is 0.4 percent; other components of this MAP system are carbon dioxide (30 percent) and nitrogen (70 percent). This packaging system is used for packaging fresh cuts of muscle meat and ground meat to maintain wholesomeness, provide flexibility in distribution, and reduce shrinkage of the meat.
As part of GRN 000143, Precept incorporates GRN 000083 by reference, and states that the detailed information establishing the GRAS status of CO in MAP systems is contained in GRN 000083.
GRN 000143 describes publicly available information pertaining to the identity and characteristic properties of CO. Carbon monoxide (Chemical Abstracts Service Registry Number 630-08-0) is a colorless, odorless, gas. The notice includes a list of properties of CO. Precept will use Pactiv's specifications; CO is a minimum purity of 98 percent and the remaining 2 percent are components found in the atmosphere (nitrogen, oxygen, carbon dioxide, argon, water, hydrogen and/or methane). Precept considers CO of this purity to be "food grade."
In Precept's packaging system, meat is placed on a tray within a chamber, the chamber is then filled with the desired atmosphere, and finally, a barrier film is affixed to the package. The packages are then labeled with a validated open date code at a central location and will be subject to no further processing or manipulation at retail. The open date code established for products packed in the MAP system will not exceed 35 days following the date of packaging for intact muscle cuts and 28 days for ground beef.
Precept states that the CO is included in the modified atmosphere to help maintain the characteristic color of fresh meat. Precept states that the CO is not intended to affect microbial growth and will not extend the shelf life of the product.
Precept estimates that the exposure to CO would be 0.054 mg CO per meal of cooked meat. Precept first assumes a scenario where the meat absorbs 30 percent of the CO in the package and 100 percent of the CO present in the meat is absorbed by the consumer. A dietary intake of 0.36 mg of CO per meal would occur when 8.8 ounces (250 g) of meat is consumed. Precept considers that this estimated intake of CO from its use in packaging meat is small compared to the amount that is presently accepted as a safe exposure limit by the Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA)(1). Precept then accounts for the fact that meat packaged with CO will be cooked prior to consumption and assumes an 85 percent reduction in CO exposure due to cooking of the meat. This 85 percent reduction decreases the maximum exposure from 0.36 mg to 0.054 mg CO per meal.
Precept makes two additional exposure estimates. First, if 100 percent of the CO in the package is absorbed, and 100 percent of the CO is consumed, an 8.8 ounce serving would expose the consumer to 1.2 mg of CO. Second, Precept states that a consumer exposed to 100% of the CO in the package would only be exposed to 2.18 mg CO, which is well below the safety limit set by the EPA and OSHA.
Precept commissioned three studies to substantiate the suitability of the MAP system. The studies confirm that the use of CO in the MAP system will not mask spoilage and will perform in a manner comparable to similar systems. Precept submitted the studies to the Food Safety Inspection Service (FSIS)) of the United States Department of Agriculture and have incorporated the studies by reference in GRN 000143.
Based on the information that you provide on behalf of Precept, as well as other information available to FDA, the agency has no questions at this time regarding Precept's conclusion that CO 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 CO. As always, it is the continuing responsibility of Precept to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
During its evaluation of GRN 000143, OFAS consulted with the Labeling and Consumer Protection Staff of FSIS regarding the use of CO in meat products. Based on the information submitted by Precept, FSIS has concluded that the MAP system as described in Precept's notice, and used under the conditions stated in Precept's notice, would be acceptable for packaging red meat cuts and ground meat. If you have any additional questions, you should direct your inquiry to Dr. Robert Post, Director, Labeling and Consumer Protection Staff, Office of Policy, Program Development and Evaluation, Food Safety and Inspection Service, 300 12th Street, SW, Room 602, Washington, DC 20250-3700. The telephone number of his office is (202) 205-0279 and the FAX number is (202)205-3625.
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).
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition
cc: Dr. Robert Post, Director
Labeling and Consumer Protection Staff
Office of Policy, Program Development and Evaluation
Food Safety and Inspection Service
300 12th Street, SW, Room 602
Washington, DC 20250-3700
(1)EPA's National Ambient Air Quality Standards is 9 ppm CO in air, resulting in the inhalation of 52 mg CO in 8 hours. The OSHA Permissible Exposure Limit is 50 ppm in air, resulting in the inhalation of 290 mg CO in 8 hours.