	Introduction

The use of carbon monoxide (CO) in the packaging of meat and fish has generated considerable debate. The presence of CO results in the meat turning a bright red color that lasts longer than the color in untreated meat. Additionally, fish treated with CO (for example, as part of a gas mixture called "tasteless smoke") gain a fresher appearance and a red tint. The meat industry, consumer groups, scientists, and policy makers disagree as to whether the use of CO in meat and fish packaging should be regulated by the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA), through labeling or otherwise, and whether CO should be a substance Generally Recognized As Safe (GRAS) under current and proposed FDA rules. This section will focus on the FDA's regulation of food additives and GRAS substances, which the agency is responsible for under the Federal Food, Drug, and Cosmetic Act (FFDCA) and parts of Title 21, Code of Federal Regulations. In 2000, the roles of FDA and FSIS in this joint review process of substances used in meat and poultry products were laid out in a Memorandum of Understanding (MOU). GRAS Notices Regarding Intended Uses of Carbon Monoxide

Under the process outlined in the FDA's 1997 proposed rule, manufacturers have submitted GRAS notifications to the FDA that state their view that carbon monoxide is a GRAS substance. Proposed Legislation in the 110th Congress

Two bills have been introduced in the House of Representatives regarding the use of carbon monoxide in meat and poultry products: H.R. Additionally, the discussion draft of the Food and Drug Administration Globalization Act of 2008, issued by Representatives Dingell, Pallone, and Stupak, similarly addresses the issue. Other bills also address GRAS substances: H.R. 2633 , H.R. 3290 , H.R. 3580 , H.R. 6635 , and S. 1342 . 3115 , H.R. 3610 , and the discussion draft propose to amend FFDCA Â§ 201. Under the proposals, if carbon monoxide is used to treat meat, poultry or seafood that is intended for human consumption and if the conditions of that use would affect the color of the products, carbon monoxide must be treated as a color additive under FFDCA, unless the product's label includes a statement that is "prominently and conspicuously" placed to notify the consumer of the use of carbon monoxide and to warn the consumer of proper factors to judge the safety of the product. The bills and the discussion draft would allow the Secretary of Health and Human Services (HHS) to establish alternative labeling requirements five years after the effective date of the labeling requirement, if the Secretary finds that the labeling requirement is no longer necessary to prevent consumer deception. The discussion draft contains an additional provision related to GRAS determinations that would require the Secretary to publish, in the Federal Register , notice of receipt of a request for a substance to be determined by the Secretary to be GRAS. The Secretary would then have 90 days after publication of the notice to determine whether the substance is GRAS; the Secretary's determination would also be published in the Federal Register .
The use of carbon monoxide (CO) in the packaging of meat and fish has generated considerable debate. The presence of CO results in the meat turning a bright red color that lasts longer than the color in untreated meat. Additionally, fish treated with CO gain a fresher appearance and a red tint. The meat industry, consumer groups, scientists, and policy makers disagree as to whether the use of CO in meat and fish packaging should be regulated by the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA), through labeling or otherwise, and whether CO should be a substance Generally Recognized As Safe (GRAS) under current and proposed FDA rules.
Two bills have been introduced in the 110 th Congress regarding the use of carbon monoxide in meat, poultry products, and seafood: H.R. 3115 and H.R. 3610 . The discussion draft of the Food and Drug Administration Globalization Act of 2008, issued by Representatives Dingell, Pallone, and Stupak, similarly addresses the issue. The bills and the discussion draft propose to amend section 201 of the Federal Food, Drug, and Cosmetic Act (FFDCA). Under the proposals, if CO is used to treat meat, poultry, or seafood that is intended for human consumption, and if the conditions of that use would affect the color of the products, CO must be treated as a color additive under FFDCA, unless the product's label includes a statement that is prominently and conspicuously placed to notify the consumer of the use of CO and to warn the consumer of proper factors to judge the safety of the product. The bills and the discussion draft would allow the Secretary of Health and Human Services (HHS) to establish alternative labeling requirements five years after the effective date of the labeling requirement, if the Secretary finds that the labeling requirement is no longer necessary to prevent consumer deception. The discussion draft contains an additional provision related to GRAS determinations that would require the Secretary to publish, in the Federal Register , notice of receipt of a request for a substance to be determined by the Secretary to be GRAS. The Secretary would then have 90 days after publication of the notice to determine whether the substance is GRAS; the Secretary's determination would also be published in the lain Federal Register . Other bills also address GRAS substances: H.R. 2633 , H.R. 3290 , H.R. 3580 , H.R. 6635 , and S. 1342 .
This report provides an overview of the FDA's regulation of GRAS substances, which are exempt from the premarket approval process for food additives. The report next discusses the FDA's 1997 proposed rule, which would create a notification procedure for GRAS substances through which manufacturers can notify the FDA of their "determination that a particular use of a substance is GRAS." The FDA has been using this GRAS notification procedure since the publication of the proposed rule on an "interim policy" basis. The roles of the USDA and FDA are also discussed, including the 2000 Memorandum of Understanding regarding review of substances used in the production of meat and poultry products. Finally, the report examines GRAS notices regarding intended uses of carbon monoxide.