The U.S. Food and Drug Administration (FDA), through recent GRAS (Generally Regarded As Safe) notifications, established a new policy that allows carbon monoxide to be used in packaged beef and pork. The practical effect of this policy – which was illegally adopted – is to mask readily identifiable signs of aging or spoilage in fresh meats. As a result, consumers are deceived and public health is jeopardized.
By maintaining the pink or reddish color associated with meat freshness even after pathogenic bacteria may be present at harmful levels, carbon monoxide, at the very least, makes meat appear to be fresher than it is; at worst, it encourages consumers to buy and eat spoiled or toxic meat that looks fresh and safe.
Permitting Carbon Monoxide Use in Meat
In response to similar notifications from the Pactiv Corporation and Precept Foods LLC, the FDA in 20021 and 20042 allowed Generally Recognized As Safe (GRAS) determinations for the use of carbon monoxide in case-ready meats. This GRAS notification process means that the FDA conducts no independent safety investigation on its own, but relies on the notifier’s claims, research and documentation in considering the safety of a proposed substance for use in food. As a result of the FDA’s response, food processors and retailers have begun selling carbon monoxide-treated fresh meats. FDA also continues to consider and allow expanded uses of carbon monoxide in fresh meat packaging based upon its improper responses to the Pactiv and Precept GRAS notifications.3
The Allowed Use of Carbon Monoxide in Fresh Meat Deceives American Consumers
Carbon monoxide makes meat appear fresher than it actually is by reacting with the meat pigment myoglobin to create carboxymyoglobin, a bright red pigment that masks the natural aging and spoilage of meats. Meats containing carboxymyoglobin will continue to appear pink or reddish well beyond the point at which they begin to spoil. The presence of carbon monoxide also suppresses bad odors and the presence of slime, other telltale signs that meat is spoiled.
The appearance of meat, and specifically its color, is the primary factor in consumers’ decisions to buy the product. The use of carbon monoxide in meat makes it impossible for consumers to know with certainty about the meat’s freshness merely by looking at it. Because of the possible presence of carbon monoxide, a bright red color does not necessarily mean that the meat is fresh and safe.
Without labels that would inform consumers that carbon monoxide is present, and a public education campaign to inform consumers about the possible effects of carbon monoxide, purchasers of carbon monoxide-treated meats cannot know, merely by looking, that the meat they are buying is fresh or safe.
The Allowed Use of Carbon Monoxide in Fresh Meat Creates Consumer Health Risks
This consumer deception can create health risks for consumers. Meats in carbon monoxide packaging may appear and smell fresh even when they are contaminated with harmful bacteria such as Clostridium botulinum, Salmonella, Campylobacter, and E-coli 0157:H7.
Ironically, while it has allowed the use of carbon monoxide packaging, the FDA has also warned of the significant safety concern accompanying the use of reduced oxygen packaging – such as carbon monoxide packaging – stating that “the inhibition of the spoilage bacteria is significant because without these competing organisms, tell-tale signs signaling that the product is no longer fit for consumption will not occur.”4
Cooking meat cannot eliminate the health problems that could occur when toxins are present, but not readily apparent, because of carbon monoxide. Even when contaminated meats are properly cooked, some toxins can survive. And meats are not always thoroughly cooked.
Because of these safety concerns, many countries have banned the use of carbon monoxide in certain foods. The European Union prohibited the use of carbon monoxide in meat and tuna after the European Commission’s Scientific Committee on Food concluded: “[t]he stable cherry-colour can last beyond the microbial shelf life of the meat and thus mask spoilage.”5 Canada, Japan and Singapore have similarly banned the use of carbon monoxide in tuna.
The FDA’s Acceptance of the GRAS Notifications for the Use of Carbon Monoxide in Fresh Meat is Illegal
The FDA’s acceptance of the GRAS notifications for the use of carbon monoxide in fresh meat is illegal because it ignores existing Federal statutes and regulations. Precisely because of the potential for carbon monoxide to mask the appearance of spoilage and promote consumer deception, FDA regulations (Section 173.350) expressly prohibit the use of carbon monoxide in “fresh meat products.”
Regulations of the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) also prohibit the introduction of ingredients in fresh meat that function to conceal damage or inferiority, or to give the appearance the product is better or of greater value.6
Moreover, the FDA did not have legal authority to permit the use of carbon monoxide in fresh meat packaging because it is an unapproved and prohibited color additive. The properties of color additives are clearly defined by the Federal Food, Drug and Cosmetic Act (FFDCA), as are the conditions under which approval for an additive may be granted.
The FDA bypassed the required procedure for carbon monoxide to obtain a color additive designation, a necessary precondition to use any ingredient or additive that has color changing properties. The use of carbon monoxide would very likely fail to be approved as a color additive, if the established process were followed, because it creates a hazard by preventing the natural discoloration associated with spoilage.
Finally, in allowing these GRAS determinations, FDA appears to have improperly used a fast-track process to circumvent well-established policies designed to prevent food manufacturers and retailers from giving fresh meats a deceptive appearance. By allowing these fast-tracked GRAS notifications, the FDA has undermined its own commitment to improving food safety.
The FDA’s Acceptance of the GRAS Notifications for the Use of Carbon Monoxide in Fresh Meat Should be Withdrawn
The FDA should withdraw its responses to these GRAS notification and end the consumer deception encouraged by the use of carbon monoxide. At the very least, because consumers have a right to know about the presence of carbon monoxide -- and the potential health dangers its masking qualities can cause -- the agency should insist upon labels for carbon monoxide-treated meats so that consumers can be aware of the potential hazards they face in purchasing carbon monoxide-treated meat.
1Letter from Alan M. Rulis, Director, CFSAN, Office of Food Additive Safety, to Eric Greenberg, Ungaretti and Harris (Feb. 21, 2002) (“Agency Response Letter to GRAS Notice No. GRN 000083”), available at http://wwwcfsan.fda.gov/~rdb/opa-g083.html.
2Letter from Laura Tarantino, Director, CFSAN, Office of Food Additive Safety, to Gary J. Kushner and Anne M. Boekman, Hogan and Hartson (July 29, 2004) (“Agency Response Letter to GRAS Notice No. GRN 000143”), available at http://www.cfsan.fda.gov/~rdb/opa-g143.html.
3See CFSAN/Office of Food Additive Safety, Summary of All GRAS Notices, available at http://www.cfsan.fda.gov/~rdb/opa-gras.html.
4Food and Drug Administration, Food Code 546 (2005). See also, id. at 544 (“ROP [reduced oxygen packaging] which provides an environment that contains little or no oxygen…raises many microbiological concerns.”).
5Opinion of the Scientific Committee on Food on the Use of Carbon Monoxide as Component of Packaging Gases in Modified Atmosphere Packaging for Fresh Meat, SCF/CS/ADD/MSAd/04 (December 18, 2001) (Attachment 14).
6Guidance on the Procedures for Joint Food Safety and Inspection Service (FSIS) and Food and Drug Administration (FDA) Approval of Ingredients and Sources of Radiation Used in the Production of Meat and Poultry Products,” available at http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/00-022N/ApprovalofIngredients.htm.