The FDA recently proposed to relax its regulations governing the labeling of irradiated foods. If adopted, the new rules would require special labeling of irradiated foods only if the irradiation brings about a material change to the food.
Under FDA's current regulations, only certain foods can be irradiated and at specified maximum doses. Irradiation can be used for a variety of purposes. It can retard ripening of fresh foods, control insects and control microorganisms.
FDA's current regulations state that irradiated foods must be labeled with the Radura symbol and with the words "irradiated" or "treated by irradiation." A separate set of regulations issued by USDA impose the same labeling requirements on irradiated meat and poultry products.
When FDA first proposed, in 1984, to permit the use of ionizing radiation to treat foods, the agency did not include any special labeling requirements. FDA received more than 5,000 comments on this proposal, many of which advocated special labeling of irradiated foods. Apparently influenced by this public reaction, FDA included labeling requirements in the final rule. At the time, FDA explained its new labeling policy was necessary to prevent deception. The agency explained -- not very convincingly -- that because irradiation may not change the appearance of food, in the absence of labeling, consumers may not realize that irradiated foods have been processed.
Since 1986, the labeling requirement has proven a significant obstacle to the use of irradiation to kill microorganisms in or on food. The Radura symbol, although probably not intended to appear ominous, vaguely brings to mind the international symbol for radiation or the symbol that marks fallout shelters. It's not surprising we don't see this on grocery store shelves.
Undoubtedly, a number of foodborne illnesses and deaths can be attributed to this practical impediment to the use of irradiation to enhance food safety. The Centers for Disease Control has famously estimated that 5,000 Americans die each year from foodborne illness. More widespread use of food irradiation to kill pathogenic microorganisms on food would not eliminate food poisoning, but it would be a big step in the right direction.
In addition to the safety benefit, there is also an economic benefit associated with food irradiation. It allows fruits and vegetables to remain fresh longer so they can be transported greater distances to reach consumers.
There are, of course, some who oppose food irradiation altogether, believing it to be unsafe. Irradiation does not render food radioactive. It has been deemed safe, at specified doses, by food safety experts at FDA and internationally. Even if there were a real safety issue with irradiated food, it would be sensible to compare any theoretical risk with the occurrence of foodborne illness, which is real, immediate and quantifiable.
There are also those who argue that consumers simply have a right to know what they are eating. Regardless of what government experts believe, some consumers would like to apply their own judgment. This argument has some appeal. What's really at issue, however, is whether the government should compel food processors to label food with stigmatizing information that is unnecessary and discourages a beneficial technology. Furthermore, the right-to-know crowd can select organic foods if they are serious about avoiding irradiated foods.
This aspect of the debate is similar to the debate over the labeling of genetically modified foods. In the case of genetically modified foods, FDA has maintained that special labeling is not needed unless the genetic modification brings about a material change in the food. If and when adopted, FDA's relaxation of the labeling requirement for irradiated foods will help promote a consistent labeling policy in this respect and will be a welcome correction of a 20-year-old mistake.
Interestingly, FDA did not reopen this debate entirely on its own. The Food and Drug Administration Modernization Act of 1997 included provisions addressing the disclosure of irradiation on food labels and encouraged FDA to seek public comment on whether changes should be made to the current regulations. Public comments received at FDA undoubtedly will continue to include many submissions generated by organized campaigns against food irradiation. The agency should take these sentiments into account, but must ultimately base its decision on sound science and sound public health policy.
David Joy is a partner in the Washington, D.C., office of Keller and Heckman LLP. He specializes in food and drug law with emphasis on the domestic and international regulation of food, food additives, food labeling, antimicrobial pesticides and medical devices. He is a member of the District of Columbia Bar and holds a bachelor's degree in chemistry. For more information about Keller and Heckman, visit the firm's web site at www.khlaw.com.