Correcting the Record


American Meat Institute Statements and The Public Record
-controversy over the use of carbon monoxide in fresh meat-

Recently, officials of the American Meat Institute (AMI) have made public statements responding to the controversy surrounding the use of carbon monoxide gas to color fresh meat held in case-ready packaging, advocating this practice, and dismissing the concerns expressed by critics. Important consumer organizations1 oppose the use of carbon monoxide in fresh meat, and it has been reported that several retailers2 will not sell carbon monoxide-treated meat.

The Kalsec company has been outspoken in challenging the use of carbon monoxide in fresh meat products, and on November 15, 2005, filed a citizen petition with FDA urging FDA to take immediate action to prohibit this practice.3 Kalsec’s petition urges FDA to act promptly to address the potentially serious food safety and consumer deception risks posed by this use of carbon monoxide. Action is particularly important given the absence of mandatory product labeling to inform consumers when their meat has been treated with carbon monoxide and disclose that the red color is more persistent than the natural red color of untreated meat, and therefore, should not be relied upon as an indicator of freshness or safety.

AMI Says
The Public Record Shows
“Color is but one indicator of freshness – and possibly the weakest.”

Dr. Randall Huffman
American Meat Institute Foundation
Article in “Meatingplace,” April, 2006

The public record before FDA4 documents extensively that meat appearance – most notably, color – is the primary consideration of consumers in selecting meat and judging freshness.5

“Consumers…need to follow the use-by date on packages. Data collected by the Food Marketing Institute show that consumers pay close attention to use-by dates on meat, poultry and dairy products.”

AMI Fact Sheet

The public record of the GRAS notifications submitted to FDA includes no data regarding consumer behavior. However, a recent study suggests that even consumers who follow use-by date labeling could potentially encounter spoiled meat. Testing conducted by Consumer Reports and reported on in the July, 2006 issue indicates that some CO-treated meat could be spoiled by its use- or freeze-by date. Consumer Reports recommends that consumers “check the package and buy meat whose stamped date is a couple of weeks away.”

“The use of LOW-OX-CO packaging provides many benefits…”

Dr. Randall Huffman
American Meat Institute Foundation
Article in “Meatingplace,” April, 2006

Any alleged benefits to consumers from the use of carbon monoxide appear to be unsubstantiated.

The record shows that carbon monoxide is used for the purpose of giving fresh meat in oxygen-free and low oxygen packaging the appearance of the familiar, natural red color of fresh meat exposed to the oxygen in ordinary air. The red color produced by carbon monoxide is a chemical substance which is not present in the natural red color of fresh meat.6 It can persist in the packaged meat indefinitely, even when mishandling or the lapse of time would cause the natural red color of traditionally packaged fresh meat to deteriorate and lead to browning.

This technology has been “approved by the Food and Drug Administration.”

AMI Press release, May 17, 2006

“FDA and USDA’s Food Safety and Inspection Service have rigorously assessed this technology on three occasions over the past four years and affirmed its safety.”

Dr. Randall Huffman
American Meat Institute Foundation
Article in “Meatingplace,” April, 2006

FDA policy makes clear that, when FDA declines to object to a GRAS notification filed by a company, this never constitutes an FDA “approval” of a technology or substance added to food.7

GRAS notifications have been filed by companies advocating the use of carbon monoxide in fresh meat. To date, FDA has issued three response letters, choosing not to object based on the information that was then available to the agency from the notifications. FDA did not “approve” the uses of carbon monoxide in fresh meat specified in the GRAS notifications, in contrast to FDA determinations that are required for food additives and color additives before they can be used in food.8

The FDA response letters concerning the GRAS notifications for carbon monoxide uses in fresh meat state explicitly:

“[T]he agency has no questions at this time regarding [the company’s] conclusion that [carbon monoxide] 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 [carbon monoxide]. As always, it is the continuing responsibility of [company] to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.”9

CO has “been in use in various countries for more than a decade…..”

Daren Cornforth, Utah State Univ.
As quoted in AMI press release
March 16, 200
6

While carbon monoxide had been used in fresh meat in Norway, it has now been banned there and in the entire European Union, after the European Commission’s Scientific Committee on Food found that “the stable cherry-colour can last beyond the microbial shelf life of the meat and thus mask spoilage.”10

“Huffman brought with him to the hearing numerous examples of other food products manufactured using various types of modified atmosphere packaging to show that this type of technology has a demonstrated track record of safety and consumer benefits.”

AMI press release regarding the testimony of Dr. Randall Huffman before the Chicago City Council
March 23, 2006

Carbon monoxide gas is not toxic when consumed in small amounts, and FDA regulations allow its use in the packaging of many food products, but not in fresh meat.11 As USDA has explained, FDA regulation prohibits the use of combustion product gas in fresh meat packaging “because of concerns that the treatment of meat with combustion product gases may cause the meat to retain its fresh red color longer than meat not so treated, thereby misleading the customer and increasing the potential for masking spoilage.”12
Low-OX-CO enjoys “a longer shelf life that is sometimes twice that of other packaging formats.”

Dr. Randall Huffman
American Meat Institute Foundation
Article in “Meatingplace,” April, 2006

FDA’s letter responding to the GRAS notification filed by one company, and stating no objection, accepts that: “[Company] states that the CO is included in the modified atmosphere to help maintain the characteristic color of fresh meat. [Company] states that the CO is not intended to affect microbial growth and will not extend the shelf life of the product.”13

Similarly, the first company to submit a GRAS notification to FDA for carbon monoxide in fresh meat stated in that notification that its packaging system “is a system that is designed to permit more extended storage of meats, but . . . has no effects on retail display time or characteristics as compared with other modified atmosphere technologies currently in use.”14

Spoiled meat treated with CO “would likely appear slimy, and its odor would be offensive and unmistakable.”

Dr. Randall Huffman
American Meat Institute Foundation
Article in “Meatingplace,” April, 2006

This assertion is unsupported by the publicly available evidence in the record. As discussed in Kalsec’s citizen petition, the published scientific literature documents that odor and slime will not be reliable indicators of spoilage in low-oxygen or oxygen-free packaging systems containing carbon monoxide and carbon dioxide, because the spoilage organisms that would produce these signals are suppressed in these systems.15

Moreover, the three studies submitted by one company16 that were obtained from a FOIA request do not demonstrate that meat treated with carbon monoxide appeared slimy after the onset of spoilage, for none of the studies examined whether slime appeared. Further, none of the studies demonstrated that an odor can be detected prior to purchase, while meat is still in its packaging. Finally, the publicly available record reveals that neither of the companies17 that were the subject of FOIA requests developed any consumer research data to show that consumers would recognize and understand any odor to signal spoilage when the color of meat remained bright red.

“Kalsec’s attempt to limit or prohibit the use of low oxygen modified atmosphere packaging systems is about market share and monopoly, not food safety.”

Mark Dopp
AMI Senior Vice President of Regulatory Affairs
and General Counsel
Testimony before Chicago City Council,as reported in MeatNews, March 18, 2006

Kalsec is a vigorous proponent of case-ready modified atmosphere packaging. Kalsec filed its citizen petition with FDA out of concern that this use of carbon monoxide would undermine consumer confidence in the entire case-ready meat industry, in which Kalsec participates with one of its natural spice extracts that is identified on the meat label.

It should be noted that the proponents of this use of carbon monoxide apparently stand to benefit substantially. The record includes an industry report estimating that “U.S. retailers fail to capture at least one billion dollars of revenue annually from fresh beef sales, due to product discoloration,” and suggesting that “CO MAP could contribute to longer shelf life for T-bone steaks, sirloin steaks and ground beef patties,” because “sensory panelists found the cuts packaged in CO more acceptable” than those packaged in other systems.18

The Kalsec petition urges FDA to regulate the use of carbon monoxide in fresh meat by applying the same standards and procedures that apply to all coloring substances that are added to fresh meat and other food products. Kalsec supports consistent, fair regulatory standards that satisfy the requirements of the Federal Food, Drug, and Cosmetic Act.

“Carbon monoxide is a color stabilizer that maintains the typical red color of fresh meat.”

AMI Fact Sheet

“Carbon monoxide as used in the meat industry does not impart color and is not a color additive”

AMI Fact Sheet

Carbon monoxide binds to myoglobin to form “cherry red carboxymyoglobin,” which is “spectrally similar” to the oxymyoglobin that naturally develops on fresh meat exposed to air.19

The statutory definition of a “color additive” includes any substance that, “when added or applied to a food . . . is capable (alone or through reaction with other substance) of imparting color thereto.” 21 U.S.C. 321(t)(1). Thus, as described in detail in the Kalsec citizen petition, carbon monoxide meets the statutory definition of a color additive, and is therefore prohibited for use in meat unless and until authorized by FDA through formal rulemaking procedures.

For information verifying statements in the public record
and for further detail, contact Parag Chokshi at 202-585-2041.


1Press release regarding letter to FDA from Consumer Federation of America and Safe Tables Our Priority. “CFA and S.T.O.P. urge FDA to prohibit the use of carbon monoxide in the packaging of fresh meat …”.
http://www.consumerfed.org/pdfs/CO_&_Meat_Press_Release_1.17.06.pdf
2Press release from Consumer Federation of America noting the “refusal of many of the nation’s leading supermarket chains to sell carbon monoxide-treated meat” along with a listing of those chains. http://www.consumerfed.org/pdfs/SupermarketPressRelease040506.pdf
3The Kalsec petition explained in detail why the Federal Food Drug and Cosmetic Act forbids FDA from permitting carbon monoxide to be used in fresh meat now, and why this ban will remain in place until FDA issues regulations specifying the conditions of use of carbon monoxide in fresh meat that FDA has determined are safe and will not promote consumer deception. Since FDA has not issued the necessary regulations, Kalsec’s petition asks FDA to enforce the existing ban on carbon monoxide use in fresh meat, which is established under the Act and FDA’s own regulations.
4The Kalsec Citizen Petition and Kalsec’s February 1, 2006, Comments are available on FDA’s website, www.fda.gov. These documents can also be accessed, along with their attachments, at www.co-meat.com.
5See, e.g., the following documentation cited in the Kalsec Citizen Petition, at 19: American Meat Science Association Guidelines for Meat Color Evaluation, available at http://www.meatscience.org/Pubs/factsheets/M9110228.pdf, at 3 (“The color of muscle foods is critically appraised by consumers and often is their basis for product selection or rejection.”); National Pork Board/American Meat Science Association Facts: Modified Atmosphere Packaging (MAP): Microbial Control and Quality, available at http://www.porkscience.org/ documents/Other/Q-MAP-MICROBIAL CONTandQUAL.pdf, at 3 (“Meat color is the single greatest appearance factor that determines whether or not a meat cut will be purchased”) (citation omitted); Kohls, L.I., et al., “A Comparison of Five Different Modified Atmosphere Package Methods for Retail Display-Ready Ground Beef,” 2001 Animal Sciences Research Report, Colorado State University, available at http://ansci.colostate.edu/dp/msfs/lik011.pdf, at 1 (“Consumers view color as one of the most important attributes of fresh beef when making a decision to purchase retail product. Color, therefore, determines appeal of the product in the retail case and consumer acceptability.”); Jeremiah, L.E., et al., “Beef Color as Related to Consumer Acceptance and Palatability,” 37 Journal of Food Science 476-479 (1972), at 476 (“Consumer studies have shown that physical appearance of a retail cut in the display case is the most important factor determining retail selection of meat products. Consumers select meat cuts primarily for leanness and then for appearance and freshness, with judgments for the latter two attributes based primarily on brightness of color.”) (citations omitted); Liu, Q., et al., “Titration of Fresh Meat Color Stability and Malondialdehyde Development with Holstein Steers Fed Vitamin E-Supplemented Diets,” J. Anim. Sci. 1996, 74:117-126, at 117 (“Meat color is the main factor affecting beef product acceptability at retail points of purchase.”) (citation omitted).
6Sorheim, O., et al., “The Storage Life of Beef and Pork Packaged in an Atmosphere with Low Carbon Monoxide and High Carbon Dioxide,” 52 Meat Science 157, 162 (1999).
7See, e.g., FDA/CFSAN/Office of Food Additive Safety, Guidance for Industry: Frequently Asked Questions about GRAS, December 2004, available at http://www.cfsan.fda.gov/~dms/grasguid.html.
8Id. (contrasting FDA procedures for review of GRAS substances and approval of food or color additives); see also 21 U.S.C. 409 (statutory procedures for food additive approval) and 21 U.S.C. 721 (statutory procedures for color additive approval).
Letter 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://www.cfsan.fda.gov/~rdb/opa-g083.html;
9Letter from Laura M. Tarantino, Director, Center for Food Safety and Applied Nutrition (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; Letter from Laura M. Tarantino, Director, Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Additive Safety, to Mark L. Itzkoff, Olsson, Fran, and Weeda, P.C. (September 29, 2005) (“Agency Response Letter to GRAS Notice No. GRN 000167”), available at http://www.cfsan.fda.gov/~rdb/opa-g167.html.
10Opinion 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), at 4.
1121 C.F.R. § 173.350(a)-(c) (emphasis added):

(a) The food additive combustion product gas may be safely used in the processing and packaging of the foods designated in paragraph (c) of this section for the purpose of removing and displacing oxygen in accordance with the following prescribed conditions.
(b) The food additive meets the following specifications: (1) Carbon monoxide content not to exceed 4.5 percent by volume. (2) The ultraviolet absorbance in isooctane solution in the range 255 millimicrons to 310 millimicrons not to exceed one-third of the standard reference absorbance when tested as described in paragraph (e) of this section.
(c) It is used or intended for use to displace or remove oxygen in the processing, storage, or packaging of beverage products and other food, except fresh meats.

12 Letter from Robert C. Post, Ph.D., Director, FSIS Labeling and Consumer Protection Staff, to Lane Highbarger, Ph.D., Office of Premarket Approval, CFSAN, FDA (February 13, 2002), at 1-2. See also Kalsec Citizen Petition, at 23-25.
13Agency Response Letter to GRAS Notice No. GRN 000143.
14Letter from Eric Greenberg, Ungaretti and Harris, to FDA Division of GRAS Notice Review, “Notification of Claim for General Recognition of Safety of Carbon Monoxide in a Modified Atmosphere System for Packaging Fresh Meat, Submitted by Pactiv Corporation” (August 29, 2001), at 3.
15See, e.g., Silliker, J.H. and Wolfe, S.K, “Microbiological Safety Considerations in Controlled-Atmosphere Storage of Meats,” 34 Food Technology 59-63 (March 1980), at 59 (describing the fact that carbon dioxide in low-oxygen atmospheres “selectively inhibits the growth of Gram-negative bacteria, such as pseudomonads and other related psychrotrophs which grow rapidly and produce off-odors and -flavors in raw meats and poultry. . . . The organoleptic changes attended by the growth of lactic acid bacteria [in low-oxygen, elevated carbon dioxide packaging atmospheres] are less noticeable than those produced by the Gram-negative bacteria which develop upon meat in air atmospheres.”); Farber, J.M., “Microbiological Aspects of Modified-Atmosphere Packaging Technology – A Review,” 54 J. Food Protection 58-70 (January 1991), at 64 (explaining that the byproducts of the metabolism of the lactobacilli produced in anaerobic carbon dioxide-containing modified atmospheres “are inoffensive compared to the typical spoilage odors produced by the pseudomonads” that thrive in oxygenated atmospheres).
16GRAS Notice No. GRN 000143.
17GRAS Notice No.s GRN 000083 and GRN 000143.
18See J. Brad Morgan, “Extending Shelf-Life of Beef Cuts Utilizing Low Level Carbon Monoxide in Modified Atmosphere Packaging Systems,” Project Summary Prepared on behalf of the Cattlemen’s Beef Board by the National Cattlemen’s Beef Association Center for Research & Knowledge Management, Funded by America’s Beef Producers (July 2003), available at http://www.beef.org/reseresearchprojectsummaries.aspx, at 4.
19Sorheim, O., et al., “The Storage Life of Beef and Pork Packaged in an Atmosphere with Low Carbon Monoxide and High Carbon Dioxide,” 52 Meat Science 157, 162 (1999).