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Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: [Docket No. 98N-1038]; Federal Register, Vol. 64: 7834-7837; Irradiation in the Production, Processing and Handling of Food
In response to the notice published February 17, 1999, in the Federal Register, the ASM would like to comment on the advance notice of proposed rulemaking as the Food and Drug Administration (FDA) considers revising its labeling requirements for foods treated with ionizing radiation.
The American Society for Microbiology (ASM) is the premier educational, professional and scientific society dedicated to the promotion of the microbiological sciences and their applications for the common good. The Society represents more than 42,000 microbiologists, including scientists and science administrators in academic, industrial and government institutions working in a variety of areas, including applied and environmental microbiology, food science, and medical microbiology.
Food irradiation is a safe and effective processing method for enhancing the safety of food. Processing of food by irradiation should be approved for use on ingredients and finished food products where there is a clear benefit to safety. Although special labeling of irradiated foods is not scientifically based because irradiation is misclassified by rulemaking as a food additive, national uniformity of labeling should be maintained if labeling disclosure is required.
While the current radiation disclosure statement conveys information to consumers in a truthful manner, the radura logo and accompanying statement may be often perceived as a warning statement by many consumers.
Allowances should be retained for the use of "incentive labeling" statements such as "Treated by irradiation to control harmful bacteria" in order to educate the consumer about the benefits of irradiation.
Options to include other "consumer-friendly" terms for irradiation such as "cold pasteurization" or "electronic pasteurization" should be allowed by the Agency. Consumers would not be misled by the absence of radiation disclosure statements in the labeling of irradiated food since irradiation is already a proven, safe, and effective technology.
With respect to foods containing irradiated ingredients, consumers are not misled by the absence of a radiation disclosure statement since irradiation is already a proven, safe, and effective technology.
The current required labeling has seemed to discourage the widespread use of irradiation as a technology. However, other factors such as the cost of irradiation, availability of alternative technologies, and consumer perception, especially if there is no perceived benefit, also have had an impact.
A "sunset" provision in which any requirements for a radiation disclosure statement expires at a reasonable date in the future is advisable. This "sunset" provision would also include the expiration of the radura labeling requirement.
The ASM is pleased to have the opportunity to provide comments in response to the proposed rule for irradiation of meat and meat products and hopes that these comments and recommendations provide assistance.