The controversy over the use of carbon monoxide in meat packaging (as well as packaging for fish, such as tuna) goes back to FDA’s approval of the gas as “Generally Recognized as Safe” when used in a modified atmosphere packaging system.

When a food, additive, or ingredient is designated GRAS, the decision is theoretically based on consensus among qualified scientific experts that it poses no risk to the general population. FDA’s move is then subject to a 60-day notice and comment period, allowing stakeholders to voice their support or opposition, and then a final determination is made. Any substances designated GRAS are given a green light from the agency and are no longer subject to premarket review, the process by which FDA determines if a food or ingredient is safe.5

Although the GRAS program has been in place for years, FDA’s current use of the term was never formalized. In 1997, FDA issued a proposed rule modifying the GRAS system in several key ways.⁶ Under the proposed revision:

• Industry submits a notification to FDA that a substance is GRAS and scientific information supporting its claim
• FDA evaluates the notification and either poses no questions to the notifier or issues a decision that the supporting evidence does not stand up to the GRAS standard
• If the agency determines the substance is GRAS, it issues a “No Questions” letter to the notifying company. Crucially, the agency does not actually issue an affirmative GRAS designation, but rather accepts the petitioner’s argument that the substance is safe
• There is no notice and comment period

This last point is particularly worrisome; as the new process was never officially sanctioned, the old GRAS system is still technically law.⁷ However, according to the Congressional Research Service, “the FDA has effectively been using the GRAS notification procedure outlined in the proposed rule since 1998 without ever issuing a final rule.” This means the 1997 revision counts only as an informal guidance for industry, not a law.⁸

In today’s world, seeing is not believing –– at least not when it comes to meat. Because of an ill–thought decision by our Food and Drug Administration, the meat industry was allowed to inject the toxic gas carbon monoxide into your ground beef’s packaging. The gas kept the meat red and fresh looking long after it had already spoiled…

The current GRAS process results in a strange legal gray area for substances granted the designation. They are not approved as GRAS, although the agency treats them as such. The public has had no opportunity to comment on their safety or express its health concerns. Most importantly, there is no actual oversight of how supposedly GRAS substances are used. “In contrast to [the previous regulation], the GRAS notification procedures in the FDA’s proposed rule do not appear to impose limits on the conditions of use,” CRS explained.⁹

It was under this muddled authority that FDA first approved CO’s use in meat and fish packaging. Under the CO GRAS notifications FDA has allowed, companies take meats and fish and place them in an “impermeable film similar to a vacuum package.” Then “the air [is evacuated] from the package and replac[ed] ... with a specified mixture of gases that provides for better control of product properties.” ¹⁰

FDA has given its unofficial stamp of approval to CO four times, first in 2000, when it allowed Hawaii International Seafood, Inc., to use the gas on raw tuna. As a part of a “tasteless smoke” system, CO keeps tuna fresh–looking and red, much like it does for meat. However, while FDA did not contest Hawaii International’s GRAS notification, it did determine that CO represented a preservative and so must be labeled to avoid consumer deception.¹¹

The agency’s other decisions regarding CO have not been so transparent. The next “No Questions” letter, issued in 2002, allowed Pactiv, a meat processing company, to use CO on its products. Two more followed, for notifications filed by Precept Foods, LLC (a 51 percent owned joint venture between Hormel Foods Corporation and Cargill Meat Solutions Corporation, formerly Excel Corporation) and Tyson Foods, Inc. None of them required companies to let consumers know what was in their packaging.^12,13,14

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