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The Washington Post January 07, 2003,
FDA Policies for Gene-Altered Foods Faulted
in Report
BY Justin Gillis, Washington Post Staff Writer
Excessive levels of harmful compounds could show
up in genetically engineered foods because the government has failed
to put strong safeguards in place to catch them, a consumer group
says in a report scheduled for release today. The Center for Science
in the Public Interest (CSPI), a Washington group known for a moderate
stance on the use of genetic engineering to alter food plants, contends
that the Food and Drug Administration, the primary federal agency
responsible for food safety, missed "obvious errors" in reviewing
some gene-altered crops.
Although crops now on the market appear to be
safe to eat, the group said the FDA's procedures are so full of
holes that continued safety cannot be ensured as companies press
to bring many more genetically engineered plants to market. "The
companies don't provide enough data to prove these foods are safe,"
said Gregory A. Jaffe, director of biotechnology issues at the center.
"And FDA's review process doesn't give you a lot of comfort that
they've looked at it closely and challenged the companies." Laura
Tarantino, deputy director of food-additive safety at the FDA, rejected
the group's contentions, saying companies have provided all the
data on their crops that the agency deemed important. She said FDA
staffers were well aware of the possibility that genetic engineering
could increase levels of harmful compounds in food. She called this
a "very hypothetical risk" and said she did not believe it had happened
with any crop now on the market.
She added, however, that the FDA was studying
whether it should make changes in the way it reviews such foods
as more move toward commercialization. The food-processing industry
also rejected the report's conclusions, saying the current regulatory
setup gives the FDA maximum "flexibility" to ensure that foods are
safe.
The center's report is designed to influence
an unfolding public debate about the way the nation regulates genetically
altered crops. At the request of the FDA and other federal agencies,
a panel of the National Academy of Sciences, meeting today in Washington,
is studying whether such crops could have unintended consequences
for human nutrition. Much of the concern centers on "anti-nutrients,"
or harmful compounds common in many food crops. Typically such compounds
are present only at minuscule levels. But when crops are genetically
altered there is at least a theoretical risk that the level of anti-nutrients
could increase, making consumption of that plant more harmful. The
FDA has failed to establish firm procedures requiring companies
to test for such harmful changes, the report said.
The center said the FDA's review process is
an outgrowth of the nation's lax approach to dealing with genetically
altered crops. Congress has never passed a law to regulate plants
or animals created through genetic engineering, and, as a result,
federal agencies have had to stretch old laws, written for other
purposes, to create a patchwork system of rules. Some gene-altered
food plants, particularly if they contain foreign genes to help
them fight bugs, fall under regulations requiring their creators
to get mandatory approval from the Environmental Protection Agency
before going to market. But others fall solely under the FDA's food-safety
jurisdiction, and that agency has adopted only voluntary procedures
for companies to follow in assuring the public their products are
safe.
The food industry likes this voluntary system.
Environmental groups, suspicious of all genetic manipulation of
plants or animals, have long decried it. CSPI is one of the few
consumer-oriented groups that supports genetic manipulation in principle
but argues that the voluntary system must be scrapped. For the report,
CSPI reviewers studied about a quarter of all the cases where gene-altered
plants have come before the FDA for review. In many instances, the
report said, the FDA requested information on the nutritional composition
of a plant that industry failed to provide. In three of 14 cases,
CSPI reviewers found "obvious errors" in FDA analyses of certain
food crops.
For instance, certain scientific papers -- cited
to prove that human exposure to a particular foreign protein in
gene-altered tomatoes and cantaloupes was safe -- don't actually
prove anything of the sort, the center said. "Had FDA conducted
thorough reviews, the errors would have been easily detected," the
report said. Tarantino of the FDA said she had not seen the CSPI
report and could not respond to the claim.
But there is routine give-and-take between the
FDA and companies about the quality of scientific evidence, she
added, and the agency will not bless crops for commercialization
until it is satisfied. CSPI called for a tighter system involving
mandatory review of new products and a detailed statistical analysis
of risks -- in essence, a version of the rigorous drug-approval
process for which the FDA is widely respected. Timothy Willard,
a spokesman for the National Food Processors Association, said the
food industry would support some changes, including making some
type of FDA review mandatory. But he noted that no company has opted
out of the current voluntary process, which has worked to date.
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