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May 18, 1999

Response to Request for Comments and Advance Notice of Proposed Rulemaking on Labeling of Irradiated Food Products (Docket No. 98N-1038)

Dear Sir or Madam,

The Food Marketing Institute (FMI) is pleased to respond to the Food and Drug Administration's (FDA's) advance notice of proposed rulemaking and request for comments to aid the Agency's consideration of potential revisions to the labeling requirements for irradiated foods. 64 Fed. Reg. 7834 (Feb. 17, 1999). As discussed more fully below, FMI supports the use of informative labeling to advise consumers that certain foods have been irradiated. If FDA decides to amend the current rule, we recommend that the Agency clarify the rule to expressly permit the use of labeling that connects the irradiation process with its benefits, e.g., "Irradiated to kill harmful bacteria."

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.

Currently, FDA's regulations require that the label and labeling of retail packages or displays of food treated with ionizing radiation include both the radura logo (the international symbol that indicates radiation treatment) and a disclosure statement. 21 C.F.R. Section 179.26(c). The two possible disclosure statements specifically set forth in the regulation are "Treated with radiation" or "Treated by irradiation." The ANPRM solicits comments on two general issues: (1) whether the wording of the current radiation disclosure statement should be revised and (2) whether the labeling requirements should expire at a specified date in the future. In conjunction with these general questions, FDA raised a number of specific questions concerning consumer perceptions of irradiated food and the appropriate labeling for irradiated food products.

A. Recent surveys suggest significant consumer education will be a prerequisite to consumer acceptance of irradiated food products.

FMI has long supported and assisted in the development of clear consumer information on irradiation. Indeed, FMI cosponsored consumer focus groups on an irradiation brochure that was prepared by FDA. See FDA, "Focus Groups on the Evaluation of the Food Irradiation Brochure" (March 1999) (hereinafter Focus Group Report). The study concluded that consumer awareness of the food irradiation process is low.

The majority of participants were "uncomfortable and unwilling to knowingly purchase and/or consume foods that had been irradiated;" however, some participants at the end of the study expressed willingness to try irradiated foods in the future if they had more information. Focus Group Report at 37. Moreover, although most of the focus group participants had heard the term "food irradiation," few knew the meaning of the phrase or were aware of the use, application or benefits of the process. Focus Group Report at 2.

Significantly, the focus group participants were very interested in the use of irradiation to prevent food-related illnessess and to promote better health for their families. See, e.g., Focus Group Report at 7, 11 ("If it [irradiation] protects something that you're eating . . . you want to know about it.").

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 comment on the food label, "Irradiated to kill harmful bacteria."

The foregoing surveys indicate that substantial consumer education will be an integral part of consumer acceptance of irradiated food products. Although a brochure of the type evaluated by the focus groups will certainly be helpful, the focus groups themselves recommended that a more comprehensive educational effort be undertaken that includes the national and local media, as well as classroom education for children.

Labeling of irradiated food products, the focus of the ANPRM at hand, will be an important component of this effort. Indeed, as FDA recognized in 1986, "labeling itself is a valuable source of consumer education." 51 Fed. Reg. 13376, 13389 (April 18, 1986). Therefore, if the Agency decides to propose changes to the current irradiation labeling rules, FMI recommends that FDA amend Section 179.26(c) to state explicitly that labeling that connects the process of irradiation with its benefits and applications is permitted.

In this regard, the preamble to the irradiation regulation promulgated in 1986 states that, "FDA encourages optional statements to be included on the retail label that expand upon the kind of treatment used or the purpose of the treatment." 51 Fed. Reg. at 13389. The Agency stated that this "additional explanatory language may be used whenever the additional language is applicable and not misleading." Id. Examples given in the preamble include, "Treated with irradiation to control insect infestation" and "Treated with radiation to inhibit spoiling." Id. In addition to the educational benefit of these statements, the Agency recognized that they would discourage consumers from viewing the required labeling as a warning statement. Id. The preamble to the instant ANPRM reiterates that statements such as "Treated by irradiation to control pathogens" may be included, provided, of course, that the specific statement truthfully describes the primary purpose of the ionizing treatment. 64 Fed. Reg. at 7835.

Accordingly, in light of the clear educational benefit of the descriptive labeling discussed above, as well as the Agency's apparent intent that this labeling be used, we recommend that, if FDA decides to issue a proposed rule as a result of the comments received in response to the ANPRM, the Agency propose to amend Section 179.26(c) to explicitly permit the labeling discussed above. Specifically, the regulation should clearly state that statements such as "Treated by irradiation to extend shelf-life" or "Treated by irradiation to control foodborne pathogens" are acceptable, especially in those instances in which irradiation has been cleared by FDA specifically for this purpose. See, e.g., 21 C.F.R. Section 179.26(b)8. (ionizing radiation cleared "for control of foodborne pathogens in, and extension of the shelf-life of" described meat products).

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We appreciate the opportunity to comment on labeling for irradiated food products and we look forward to our continued collaboration in this regard.

Cordially yours,

Tim Hammonds
President and Chief Executive Officer