Daily News Archive
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
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.