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More Info on FDA Proposing Loosening Labeling Rules on Irradiated Foods

The US Food and Drug Administration (FDA) recently proposed rules that would relax some labeling restrictions on irradiated foods and invited the public to comment.

The FDA currently requires all irradiated foods to have the international radura symbol and the statement "treated by irradiation" or "treated with radiation" clearly displayed on the packaging.

However, in an Apr 4 notice published in the Federal Register, the FDA proposed that only foods that are "materially changed" by irradiation be required to carry the radura logo and the term "irradiated." The FDA defines a material change as an alteration in a food's characteristics caused by irradiation, such as extended shelf-life in bananas or changes in color, texture, or taste that exceed the normal range of variability for the food.


The proposed rule change would also allow companies to petition the FDA for permission to use alternative terms for irradiation and would permit firms to use the term "pasteurized" instead of "irradiated" if the process they use meets federal criteria for pasteurization.

Comments from the public are due by Jul 3, 2007.


The move toward loosening labeling rules for irradiated foods began nearly 5 years ago when Congress passed the 2002 farm bill. Labeling-related provisions intended to promote the acceptance of irradiated foods were included in amendments authored by Sen. Tom Harkin, D-Iowa.


The bill broadened the definition of pasteurization to include any safe process that is at least as protective as pasteurization and is reasonably certain to kill the most resistant pathogens likely to occur in the food. The legislation also directed the FDA to review its regulations on labeling of irradiated foods, receive public comments, and then revise the regulations "as appropriate."

The 2002 farm bill specified that, until the issuance of new rules, anyone could petition the FDA for permission to change the labeling of an irradiated food, provided that the change "is not false or misleading in any material respect." The FDA's Federal Register notice says that the agency has not received any petitions from companies requesting the use of alternative labeling for their irradiated products.


The FDA says in the notice that it was unclear how many products could be marketed without "irradiation" on the label if its proposal is adopted, because labeling requirements cannot be made in advance for all products. Labeling requirements will mostly likely be set case-by-case because the effects of irradiation on different foods vary. "It is more likely that this option would simply allow firms more flexibility in how they label irradiated foods," the notice states.

It also says the labeling changes could allow some consumers to make more informed decisions about their food purchases, but it acknowledges that others may regard substitute terms as misleading.


The FDA says companies are sure to consider their bottom line when deciding to make a labeling change, but the new rules could also increase the use of irradiation as a food safety tool.


"It is possible that some manufacturers not currently using irradiation as a safety tool (because of the current labeling requirement) may opt to start using irradiation in order to enhance the safety of their products," the FDA notice states.


The revised labeling rules, however, could make it more difficult for consumers who want to avoid irradiated foods, because they would need to do more research on which foods are irradiated.


Currently, few foods are irradiated. Though several major health and science organizations, such as the World Health Organization and Infectious Diseases Society of America, have endorsed food irradiation as safe, US consumers have been slow to warm to irradiated foods.

Some consumer groups, such as Public Citizen, strongly oppose food irradiation because they are suspicious about its effects and believe food producers will use it as a substitute for more traditional food safety measures.


However, recent illness outbreaks caused by contaminated produce have sparked new interest in ways to make the US food supply safer. Last October, amid a nationwide Escherichia coli O157:H7 outbreak linked to fresh spinach, the FDA, in an outbreak update on its Web site, said it had a petition under review to permit the irradiation of multi-ingredient foods, including prepackaged fresh produce, to reduce microbial contamination.


See also:

Apr 4 FDA Federal Register notice on proposed change in labeling rules

Jun 17, 2002 CIDRAP News article "New farm bill may promote food irradiation, but changes could be slow"

Oct 2006 FDA statement on E coli outbreak

CIDRAP overview on food irradiation

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