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From December 19, 2001

FDA Ignores Evidence That Chemicals Created in Irradiated Food Could Be Harmful

The U.S. Food and Drug Administration (FDA) has ignored growing evidence that a new class of chemicals formed when food is irradiated could be harmful, according to a press statement on the release of a new report by Public Citizen and the Center for Food Safety entitled Hidden Harm. The groups are urging the FDA to refrain from legalizing irradiation for any additional types of food until the new chemicals are tested for safety.

The chemicals, called cyclobutanones, do not occur naturally anywhere on Earth. They recently were found to cause genetic damage in rats, and genetic and cellular damage in human and rat cells. Hidden Harm details how the FDA has ignored this unique class of chemicals, which are created in many irradiated foods that the agency has legalized for sale in this country ¾ including beef, pork, chicken, lamb, eggs, mangoes and papayas. It is expected that cyclobutanones also would be formed in many other foods the FDA is currently considering to legalize for irradiation.

The organizations also released a sworn affidavit of toxicologist William Au, who was retained by the groups to independently review the risks posed by cyclobutanones and other chemicals formed by irradiation that could cause genetic damage.
Along with a letter outlining numerous health concerns caused by food irradiation, the groups filed Hidden Harm and Au's affidavit with the FDA to oppose pending petitions to legalize irradiation for processed foods, which comprise 37 percent of the typical American's diet; molluscan shellfish, such as clams and oysters; crustacean shellfish, such as lobsters and shrimp; and meat products. A fifth petition seeks to double the maximum dose of radiation to which poultry can legally be exposed.

Though federal regulations require the FDA to determine whether food additives proposed for human consumption are likely to cause cancer, birth defects or other health problems, the agency has not done so for cyclobutanones, nor have agency officials explained why they have failed to do so. Under federal law, irradiation is considered a food additive.

Americans likely are unwittingly eating irradiated foods containing cyclobutanones. Though most irradiated food sold in stores must be labeled, there is no such requirement for restaurants, schools, hospitals, nursing homes and other institutional settings. And there is no labeling requirement for foods with irradiated ingredients, except those containing irradiated meat. Moreover, due to a lack of reporting requirements for food companies, it is unknown how much irradiated food is sold in the U.S., or where.

"Children are likely to be especially vulnerable to the risks of these untested chemicals in their food," said Peter T. Jenkins, policy analyst at the Center for Food Safety. "It is beyond me why the FDA would take a chance by exposing American children in this way. The science is against it."

Dr. Au, an environmental toxicology professor at the University of Texas Medical Branch in Galveston, is internationally recognized for his work on the toxicological mechanisms that induce human disease. For more than 20 years he has taught, published peer-reviewed research and served on expert committees. He has received numerous awards, and has published or co-published more than 100 articles.

"An emphasis should be placed on the products that are unique to the irradiation process and that are potentially mutagenic, e.g. 2-DCB [2-dodecylcyclobutanone]," Dr. Au wrote in the affidavit. "Without conclusive evidence regarding the safety of these products, the safety of irradiated food cannot be assured." Au urged the FDA to "seriously and explicitly" consider "repeated observations" of genetic damage and reproductive toxicity in feeding experiments.

Though cyclobutanones were first identified in irradiated food in 1971, it was not until 1998 that German government scientists discovered that one type of cyclobutanone, 2-DCB, caused genetic damage in rats, and genetic and cellular damage in human and rat cells. Subsequently, the scientists found that two other types of cyclobutanones ¾ 2-TCB and 2-TDCB ¾ caused genetic and cellular damage in human cells. Rat feeding studies of these two chemicals are expected to be completed soon.

Despite these findings, the FDA not only has failed to publicly acknowledge the potential risks posed by cyclobutanones, but the agency proceeded to legalize irradiation for three classes of food even after the first two German studies were made public. Last year, the FDA legalized the irradiation of eggs, juice and sprouting seeds despite the fact that several high-ranking agency officials four months earlier had attended an international conference in Beijing at which the 2-DCB toxicity findings were presented and discussed.

Ironically, cyclobutanones are so easily detectable and have been known to remain in food for such lengthy periods - more than a decade - that they are commonly used as "markers" to determine whether food has been exposed to ionizing radiation.
The groups are calling on the FDA to take several steps: refrain from legalizing irradiation for any additional foods until comprehensive, published, peer-reviewed research is conducted on cyclobutanones; conduct a comprehensive analysis of the cyclobutanone levels in foods covered by irradiation petitions already approved by or pending before the FDA; and convene public hearings to thoroughly explore the potential health effects of cyclobutanones.

For more information contact Public Citizen at 202-588-1000 or see www.publiccitizen.org.