----- forwarded message -----
Date: Fri, 10 Jan 2003 06:49:36 -0700
From: Teresa Binstock <[EMAIL PROTECTED]>
Subject: FDA's biotech food reviews blasted
Biotech food reviews blasted
By MIKE TONER, The Atlanta Journal-Constitution
http://www.accessatlanta.com/ajc/news/science/0103/08fdafood.html
The U.S. Food and Drug Administration lacks the regulatory tools it needs to
assure the safety of genetically modified foods, a public policy group reported
Tuesday.
The Center for Science in the Public Interest warned that a looming "hole in the
biotech safety net" poses risks for both consumers and biotech companies as
genetic manipulation of crops expands to include "nutriceutical" foods that are
enriched with nutritional supplements and a host of disease-fighting proteins.
The center said today's genetically modified foods -- mostly corn and soy
products -- appear to be safe. But within a few years, biotech companies are
expected to launch a host of new foods like a tomato engineered to be rich in
lycopene, a potential cancer-fighting compound, and a faster-growing genetically
engineered salmon.
"The FDA is ill-equipped to assure the safety of future foods that will be
engineered in increasingly complex ways," the center's Doug Gurian-Sherman told
a committee of the National Academy of Sciences.
Under existing FDA regulations, biotechnology companies are encouraged, but not
required, to submit safety-related test data to the agency for review. The FDA
can request more data from the companies but cannot require it. Any research, as
well as consultations between the government and the company, remain secret.
Using the Freedom of Information Act, the nonprofit, Washington-based group
obtained information on 14 such cases and found that in six cases, the FDA
decided that it didn't have enough information and requested more. In three
cases, all involving strains of genetically engineered insect-resistant corn,
the parent companies -- Monsanto, Syngenta and Dow AgroSciences -- declined to
provide it. The FDA approved the products anyway.
"Without a legally mandated approval process, the FDA can only review whatever
data a company will let it review," Gurian-Sherman said.
In contrast, drugs regulated by the agency undergo rigorous pre-market scrutiny
and are approved only after the FDA is assured that it has adequate safety data.
Because the FDA reviews of biotech foods are conducted behind closed doors,
independent experts have no opportunity to review the reviewers. The center's
analysis of the data found "erroneous and unsupported conclusions" in safety
data for several foods, including delayed ripening tomatoes and cantaloupe.
The loopholes reflect the patchwork system the government has used since 1992 to
regulate genetically modified plants and animals. Responsibility for biotech
products -- now shared by the FDA, the Environmental Protection Agency and the
U.S. Agriculture Department -- has created a muddled regulatory landscape.
Under its pesticide regulations, for instance, EPA can prohibit the use of
potentially harmful genetic traits simply because their safety is unproved --
guilty, in effect, until proved innocent. The contamination of corn products
with what was merely a suspected allergen from Starlink corn a few years ago was
enough to trigger a nationwide recall of tacos, tortillas and corn chips.
Under food regulations, however, the burden of proof in any pre-market approval
lies with the FDA. And that, the critics say, is something the agency can't do
as long as research on the trait is incomplete and the FDA can't demand better
data.
In a world where the line between food and drugs is blurring rapidly,
Gurian-Sherman says the FDA's ability to protect the food supply is further
clouded by the fact that the agency hasn't told biotech companies what kinds of
studies it expects them to provide, as it has for drug makers for decades.
"Genetically engineered crops have the potential to provide enormous benefits to
both consumers and the environment," he said, "but the technology's life span
will be short if dangerous biotech products start showing up on supermarket
shelves."
