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April 26, 1999

Re: Comments on Proposal to Amend Regulations Regarding Irradiation and Labeling of Meat Food Products and Poultry Food Products (Docket No. 97-076P)

Dear Sir or Madam:

The Food Marketing Institute (FMI) is pleased to respond to the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service's (FSIS's) request for comments on the proposed rule on the irradiation of meat and poultry food products. 64 Fed. Reg. 9089 (Feb. 24, 1999). As discussed more fully below, FMI strongly supports FSIS's proposal to amend its regulations to permit and to expand the use of ionizing radiation for treating meat and poultry food products to reduce levels of foodborne pathogens and to extend the shelf-life of food products. The food industry as a whole will be strengthened by the expanded use of irradiation. In addition, FMI supports flexible labeling to advise consumers that irradiation has been used to enhance the safety of the meat and poultry they are purchasing.

FMI is a non-profit association that conducts programs in research, education, industry relations and public affairs on behalf of its 1,500 members and their subsidiaries. Our membership includes food retailers and wholesalers, as well as their customers, in the United States and around the world. FMI's domestic member companies operate approximately 21,000 retail food stores with a combined annual sales volume of $220 billion, which accounts for more than half of all grocery sales in the United States. FMI's retail membership is composed of large multi-store chains, small regional firms, and independent supermarkets. Our international membership includes 200 members from 60 countries.

Bacteria and other microorganisms are believed to cause a large and growing number of foodborne illnesses each year. Irradiation is an effective tool for reducing or eliminating foodborne bacteria and other organisms. See 64 Fed. Reg. 9089, 9090 (Feb. 24, 1999). Its use, therefore, provides a significant and substantial opportunity to improve food safety and the public health.

The use of irradiation to treat food products is safe. In May, 1992, the participants in a World Health Organization meeting concluded as follows:

1. & will not introduce changes in the composition of the food which, from a toxicological point of view, would impose an adverse effect on human health;
2. & will not introduce changes in the microflora of the food which would increase the microbiological risk to the consumer; and
3. & will not introduce nutrient losses in the composition of the food which, from a nutritional point of view, would impose an adverse effect on the nutritional status of individuals or populations.

FMI, "Food Irradiation Backgrounder" at 4 (December 1997) (copy enclosed). At least 39 countries use commercial irradiation to treat a wide variety of food products. Id. at 6.

In this country, the Food and Drug Administration (FDA) conducted a comprehensive evaluation of the safety of meat irradiation in response to a petition filed with the Agency by Isomedix to clear the use of radiation to treat fresh or frozen meat to reduce pathogens and to extend product shelf-life. 62 Fed. Reg. 64107 (Dec. 3, 1997). FDA determined that irradiation would not present a toxicological or microbiological hazard or adversely affect the nutritional adequacy of the food. 62 Fed. Reg. at 64118. Accordingly, the Agency concluded that the irradiation of meat, meat byproducts and meat food products under the conditions described in the regulation is safe. 62 Fed. Reg. at 64118.

As a result of FDA's safety determination, USDA has proposed to amend the meat regulations to permit the use of ionizing radiation to reduce levels of foodborne pathogens and to extend the shelf-life of "refrigerated or frozen uncooked meat, meat byproducts, and certain other meat food products to reduce levels of foodborne pathogens and to extend shelf life." 64 Fed. Reg. 9089 (Feb. 24, 1999). In addition, USDA proposed to revise the regulations governing the irradiation of poultry so that they will be as consistent as possible with the proposed regulations for the irradiation of meat food products. Id.

Given the well-documented safety of irradiation, and the clear public health benefits afforded by the ability of irradiation to reduce or eliminate foodborne pathogens, we urge USDA to finalize the regulation clearing the use of irradiation for meat and meat food products as quickly as possible.

Several recent outbreaks of foodborne illness have been linked to microorganisms, such as Listeria monocytogenes, that were consumed in cooked, "ready-to-eat" meat products, such as hot dogs. Given the demonstrated ability of irradiation to substantially reduce the level of pathogens in food, we submit that irradiation should be permitted to treat cooked, ready-to-eat meat products. Toward this end, USDA might conclude that the data evaluated by FDA support the safety of radiation for the treatment of cooked meats. In that case, given the public health benefits of using radiation for ready-to-eat meats, USDA should issue a final regulation that clearly permits the use of irradiation for ready-to-eat meat, perhaps in consultation with FDA. Alternatively, USDA could petition FDA to broaden the current clearance to include ready-to-eat and cooked meats explicitly.

As discussed above, FDA's final regulation specifically clears the use of ionizing radiation to treat various "refrigerated or frozen, uncooked" meat products as defined in USDA's regulations. At least in part, the final wording of the regulation reflects the specific request in the Isomedix petition that was submitted to FDA in 1994, which referenced raw or frozen meat products. 62 Fed. Reg. at 64108.

Accordingly, USDA might determine that, although FDA's regulation does not explicitly include ready-to-eat meats, the data underlying FDA's rule are sufficient to support the use of irradiation for these food products. Specifically, FDA conducted a thorough evaluation of the toxicity of irradiated meats, the effect that irradiation had on the nutritional value of the food, and the microbiological profile of irradiated meats. Although it is difficult to discern from FDA's descriptions alone whether any of the toxicity or nutritional studies were conducted on cooked foods, some studies may have been. See, e.g. , 62 Fed. Reg. at 64113 (discussing toxicity studies using radiation-sterilized chicken stew and beef stew).

Certainly with respect to microbiological considerations, we would expect cooked foods to present a less severe case since the original cooking process will remove any microbes that may have been present in the uncooked meat. The purpose of irradiating the cooked product would only be to remove any post-cooking surface contamination that may have occurred. Thus, if FSIS concludes that the irradiation of ready-to-eat meats poses no unique risks and, further, that the assessment conducted by FDA regarding the safety of irradiating refrigerated and frozen meat is applicable to ready-to-eat meat products, FSIS could specifically provide for the irradiation of ready-to-eat meat products in the final rule. See 64 Fed. Reg. at 9092 (comparable FSIS analysis for clearing irradiation of "hot-boned" meat despite the fact that it was not explicitly included in FDA's regulation).

Alternatively, FSIS might petition FDA to explicitly amend the food additive regulations to clear the use of ionizing radiation to treat ready-to-eat and cooked meats. The preamble to the proposed rule indicates that FSIS intends to petition FDA on a number of matters that are not specifically included in the existing regulation; we believe that clearance of radiation for use in treating ready-to-eat meats is an equally worthy goal. However, given the clear public health benefits of irradiation, and the length of time unavoidably involved in a petition process that includes two agencies, we urge USDA to issue a final regulation in this proceeding that would explicitly permit the use of irradiation for cooked meats.

Informed consumer choice is a key component to the success of food irradiation. Consumers must be provided with complete and accurate information on irradiation, and they must be able to identify new products so that they can make independent choices consistent with their personal needs and lifestyles.

FMI has long supported and assisted in the development of clear consumer information on irradiation. Indeed, last month, FMI cosponsored consumer focus groups on an irradiation brochure that was prepared by FDA. Although the final report has not yet been prepared, the FMI representative who observed the focus groups reports that the people surveyed felt that clear, balanced information on irradiation was essential to their ability to make educated choices.

The USDA proposals on labeling for irradiated meat and poultry products are an important element of informing consumers regarding their food choices. If finalized as proposed, irradiated meat and poultry products will be required to bear the radura logo along with the statement, "Treated with radiation" or "Treated by irradiation." In addition, USDA proposes to require the ingredient line on the label of a multi-ingredient product to indicate the presence of an irradiated meat or poultry product when applicable. Finally, USDA's proposal would permit the addition of optional labeling statements regarding the purpose of radiation processing, such as "Treated by irradiation to reduce pathogens."

USDA's first labeling proposal — the use of the radura logo and the basic statement regarding the use of irradiation — will provide the basic information necessary to allow consumers to identify irradiated food products and to make an informed choice regarding the food they are purchasing. Similarly, the presence of an irradiated meat or poultry product should be indicated in the ingredient statement of a multi-ingredient product. Disclosure of processing is consistent with current FSIS labeling policy and provides the information consumers want and need to make informed choices about all of the foods that they eat. See, e.g., 9 C.F.R. § 317.2(e) (requiring meat products that have been "prepared by salting, smoking, drying, cooking, chopping, or otherwise " to be identified on the label).

For example, people with compromised immune systems may be medically limited in the meat and poultry products that they may consume to those products that have been irradiated to minimize the possibility of foodborne illness; labeling advising that the meat component of a multi-ingredient product has been irradiated would provide important information that would allow a consumer in this position to consume a food that might otherwise not have been perceived as an acceptable choice.

We also agree with the Agency that labeling that explicitly connects irradiation with its benefits will be helpful to consumers. An example of a statement in this regard is, "Irradiated to kill harmful bacteria."

Last year, FMI, in conjunction with the Grocery Manufacturers of America, the National Restaurant Association and the American Meat Institute, commissioned a nationally representative survey of consumer opinions on irradiation. (A copy of the report is enclosed for your information.) In the survey, nine out of ten respondents felt that protection from disease-causing bacteria was an important reason to buy irradiated foods.

Nonetheless, despite the clear recognition of the importance of irradiation, only about half of all consumers felt comfortable with the term "irradiation." In contrast, close to 80 percent of consumers indicated that they would be likely to buy food for themselves or their children if the food was labeled, "Irradiated to kill harmful bacteria." These results may also be compared to the "Trends in the United States . Consumer Attitudes and the Supermarket 1998" survey that FMI conducted three months before the joint survey discussed above. In the "Trends" survey, only half of the respondents indicated that they would be likely to buy irradiated foods. The difference in survey results may well have occurred because consumers in the "Trends" survey did not receive an explanation of the irradiation process and because consumers in the "Trends" survey were not asked to respond to the food label, "Irradiated to kill harmful bacteria." Again, educating consumers about the process and the benefits of irradiation will be an important component in its acceptance.

Given the results of these surveys, we believe that consumers would clearly find the phrase connecting irradiation with its intended benefit (i.e., killing harmful bacteria) helpful if it appeared on the label. Approved labeling in this regard should be an acceptable alternative to the "Treated by irradiation" or "Treated with radiation" statements; the use of both would be redundant.

Finally, consistent with the idea that labeling should be informative, but flexible, USDA should allow the use of additional, alternative terms that are not included in the proposal. For example, USDA should consider "cold pasteurization" as an acceptable alternative for use on labels of irradiated meat and poultry products. The FMI survey showed that approximately 55 percent of consumers were comfortable with the term "cold pasteurization."

In sum, we urge USDA to move forward expeditiously with a final regulation permitting the use of irradiation to reduce foodborne pathogens in meat and authorizing flexible and informative consumer labeling. We appreciate the opportunity to comment on this very important food safety matter.

Sincerely,

George Green

Vice President and General Counsel

Enclosures

• FMI Backgrounder
• "Consumer Opinions" on irradiation