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FDA Ignoring Evidence That New Chemicals Created
in Irradiated Food Could Be Harmful
Groups Urge FDA to Halt Irradiated Food Approvals
Until New Chemicals Are Tested for Safety Ý
For Immediate Release: Contact: Patty Lovera (202) 454-5132
Nov. 29, 2001
Peter Jenkins (202) 547-9359
WASHINGTON, D.C. ó 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.
Ý The chemicals are a class of cyclobutanones
that 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 groupsí 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
will be present in many other foods the FDA is currently considering
to legalize for irradiation. Ý
The organizations today also released a sworn
affidavit of renowned 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. Ý
Along with a letter outlining numerous health
concerns caused by food irradiation, the groups filed Hidden Harm
and Auís affidavit with the FDA to oppose pending petitions to legalize
irradiation for processed foods, which comprise 37 percent of the
typical Americanís 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. Ý
ìThe risk that the FDA is taking with
the health of the American people cannot be overstated,î said Wenonah
Hauter, director of Public Citizenís Critical Mass Energy and Environment
Program. ìIf government officials knowingly allow people to eat
food that contains these chemicals, they are courting a major public
health disaster.î
Ý 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.
Ý 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.
Ý ìChildren are likely to be especially vulnerable
to the risks of these untested chemicals in their food,î said Peter
T. Jenkins, policy analyst at the Center for Food Safety. ìIt is
beyond me why the FDA would take a chance by exposing American children
in this way. The science is against it.î
Ý 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.
Ý ìAn 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],î Dr. Au wrote in
the affidavit. Without conclusive evidence regarding the safety
of these products, the safety of irradiated food cannot be assured.î
Au urged the FDA to ìseriously and explicitlyî consider ìrepeated
observationsî of genetic damage and reproductive toxicity in feeding
experiments. Ý
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.
Ý 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 after several high-ranking agency officials attended
an international conference in Beijing at which the 2-DCB toxicity
findings were presented and discussed. Ý
Ironically, cyclobutanones are so easily detectable
that they are commonly used as ìmarkersî to determine whether food
has been exposed to ionizing radiation. Ý
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.
Source: http://www.centerforfoodsafety.org/inthenews/HiddenHarmRelease.htm
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