Agency Response Letter GRAS Notice No. GRN 000251
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CFSAN/Office of Food Additive Safety
January 25, 2012
8310 Shorecrest Drive
Fort Myers, FL 33912
Re: GRAS Notice No. GRN 000251
Dear Mr. Mercogliano:
The Food and Drug Administration (FDA) has received the notice, dated May 2, 2008, that was submitted by Arent Fox on your behalf 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 May 7, 2008, filed it on May 8, 2008, and designated it as GRN No. 000251.
The subject of the notice is carbon monoxide (CO). The notice informs FDA of the view of Vincent Mercogliano (Mercogliano) that CO is GRAS, through scientific procedures, for use as a component of a modified atmosphere packaging (MAP) system for fresh ground and muscle red meat. The level of CO in this MAP system is 0.4 percent. The other component of the MAP system is helium.
GRN 000251 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. Mercogliano states that the CO employed in the proposed MAP system is 99.99 percent minimum purity, "food grade."
Carbon monoxide was also the subject of GRN 000083 submitted by Pactiv Corporation, GRN 000143 submitted by Precept Food, LLC, and GRN 000167 submitted by Tyson Foods, Inc. The use level of CO in these MAP systems is 0.4 percent; other components of these MAP systems are carbon dioxide (30 percent) and nitrogen (70 percent). The MAP systems are used for packaging fresh cuts of muscle meat and ground meat to maintain wholesomeness, provide flexibility in distribution, and reduce shrinkage of the meat.
In Mercogliano's packaging system, meat is placed on a flat, non-porous surface, preventing the gas treatment from reaching the underside of each cut. A vacuum is then applied to remove atmospheric gases from the process chamber and the exposed surfaces of each cut of meat. An inert atmosphere of helium containing 0.4 percent carbon monoxide is then introduced into the vacuum process chamber. The meat cuts are exposed to the gas mixture for a predetermined length of time based upon the size, cut, and animal type. Following the exposure, the helium-carbon monoxide mixture is then removed from the process chamber by application of a second vacuum. The meat is then vacuum-sealed in a wrapped package using standard, non-permeable, heavy-duty plastic vacuum packaging. At a central location, the packages are labeled with a validated open date code and will be subject to no further processing or manipulation at retail. The notifier states that the open date code established for products packed in the MAP system will not exceed 21 days following the date of packaging for intact muscle cuts and for ground beef.
Mercogliano commissioned a study to substantiate the suitability of the packaging system. The study confirms that the use of CO in the MAP system will not mask spoilage and will perform in a manner comparable to similar systems. Mercogliano submitted the studies to the Food Safety and Inspection Service of the United States Department of Agriculture and has incorporated the studies by reference in GRN 000251.
Use in Products under USDA Jurisdiction
During its evaluation of GRN 000251, FDA consulted with the Risk, Innovations, and Management Division, of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA). Under the Federal Meat Inspection Act, Poultry Products Inspection Act, and the Egg Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients in meat, poultry, and egg products as well as prescribing safe conditions of use. Suitability relates to the effectiveness of the ingredient in performing the intended purpose of use and the assurance that the conditions of use will not result in an adulterated product, or one that misleads consumers.
FSIS has no further questions regarding the suitability of the use of carbon monoxide, at levels up to 0.4 percent, in an inert atmosphere of helium, for treatment of fresh red meat products prior to vacuum packaging for retail. The meat sold using this packaging system must have a "Use by" date of 21 days after, directing the consumer to either use or freeze the contents by that date. In addition, to ensure that consumers are not misled about the freshness of meat treated with carbon monoxide, the statement "color is not an accurate indicator of freshness" is used in conjunction with the "use or freeze by date." Further questions regarding regulatory guidance from FSIS about the use of carbon monoxide in MAP systems for meat products should be directed to Dr. William Shaw, Jr., Director, Risk, Innovations, and Management Division, Office of Policy and Program Development, Food Safety and Inspection Service, Mail Stop 3782, Patriots Plaza III, Cubicle 8-163A, 1400 Independence Ave. SW, Washington, DC 20250-3700.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to, among other things, add section 301(ll). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of Mercogliano's notice that CO is GRAS under the intended conditions of use, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing CO.
Accordingly, this response should not be construed to be a statement that foods that contain CO, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information that you have provided, as well as other information available to FDA, the agency has no questions at this time regarding your 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 your continuing responsibility to ensure that food ingredients that you market 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, as well as a copy of the information in your 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 www.fda.gov/grasnoticeinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition
cc: William Shaw, Jr., Ph.D.
Mail Stop 3782
Patriots Plaza III, Cubicle 8-163A
1400 Independence Ave. SW
Washington, DC 20250-3700