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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 report released today by Public Citizen and the Center
for Food Safety.
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.
The groups' report, 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 -- 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 today 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.
"The
risk that the FDA is taking with the health of the American
people cannot be overstated," said
Wenonah Hauter, director of Public Citizen's Critical Mass
Energy and Environment Program. "If government officials
knowingly allow people to eat food that contains these chemicals,
they are courting a major public health disaster."
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 US, 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."
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 -- 2-TCB and 2-TDCB -- 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;
- convene public hearings to thoroughly
explore the potential health effects of cyclobutanones.
Hidden Harm can be viewed here.
Au's affidavit is available here.
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