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January 7, 2003
Modified-Crop Makers Faulted On Safety Data
Sent to FDA
By LEILA ABBOUD THE WALL STREET JOURNAL
WASHINGTON -- Makers of genetically modified
crops have avoided answering questions and submitted erroneous data
on federal applications aimed at ensuring the safety of bioengineered
foods before they are marketed, a study by a Washington advocacy
group shows. The Center for Science in the Public Interest, which
sees benefits in biotechnology crops but wants tougher regulation
to ensure safety, said its study of 14 applications to the Food
and Drug Administration over the past seven years points out significant
holes in the safety review of new biotech crops.
A flawed review process could deal a huge blow
to efforts to market genetically modified crops. Proponents and
opponents alike see the reviews as a crucial way to build consumer
confidence -- especially amid strong resistance in Europe and other
export markets. Under current FDA rules, if genetically modified
crops are shown to be "substantially equivalent" to conventional
crops, further government review isn't needed before the crops can
be marketed. The company is responsible for doing the safety review
and showing its results to the FDA. Of the 14 submissions obtained
by the CSPI under the Freedom of Information Act, the FDA requested
more information in six cases.
In three cases, the companies provided the extra
data but the other three told the agency it wasn't needed. The FDA
has no legal authority to compel the companies to submit the data.
When Monsanto Co. applied to market two varieties of insect-resistant
corn, it included data to show that the nutritional content of both
genetically modified grains wasn't affected. But for one of the
varieties, Monsanto didn't submit nutrient data for the rest of
the corn plant, such as the stalks, which often go into animal feed.
When the FDA sought that data, it was rebuffed.
A Monsanto spokesman said the company would have addressed the FDA's
concerns if it hadn't decided against marketing the product. The
CSPI also said the FDA overlooked factual and scientific errors
in applications for genetically engineered tomatoes and cantaloupes.
The developer, Agritope Inc., which has since
been acquired by Exelixis Plant Sciences Inc., claimed the tomatoes
and cantaloupes posed little risk because humans were already naturally
exposed to the protein they were engineered to make. But the scientific
papers submitted to prove this point didn't say that. A company
spokeswoman said the FDA never mentioned the gap in the data, and
the project was dropped before marketing.
The FDA defended its review process, saying
that all biotech products on the market were safe. "In every case
where we thought more information was critical to the company's
safety assessment or our review, the companies have sent the information
and done additional studies," said Laura Tarantino, director of
the office of food-additive safety at the FDA. The agency has always
been open to changing its review process if new biotech products
demand greater scrutiny, Dr. Tarantino said. In general, an FDA
review is limited to a "voluntary consultation" in which it examines
a company's scientific information on potential allergic and toxic
reactions, and the nutrient content of the foods.
In theory, if the FDA found that a genetically
modified product wasn't "substantially equivalent" to a conventional
crop, it could require a more rigorous review as a food additive.
But that has happened only once in the 53 voluntary consultations
conducted between 1994 and 2000. The biotechnology industry has
long said it treats the FDA premarket reviews as if they were mandatory.
The Biotechnology Industry Organization, the
industry's trade association, known as BIO, also supports proposed
regulations to make the voluntary consultation mandatory. But critics
say this wouldn't change the fact that companies determine the content
and depth of safety reviews and not the FDA. "I find it highly unlikely
that companies have not provided all information requested to FDA
because every company wants the FDA letter of safety in order to
market their products," said Lisa Dry, a BIO spokeswoman. "The FDA
has all the necessary authority they need to protect the public
and make sure foods are safe." CSPI Science Director Doug Gurian-Sherman
said the review found that "biotech companies weren't always performing
the right tests to look for potentially dangerous compounds, including
allergens, and that there was a great deal of unevenness among different
developers' submissions." Since the FDA doesn't tell the companies
what to test for, analysis of some known toxins and allergens was
left out of some applications.
While most biotechnology experts agree
that the crops now on the market are safe, some are concerned that
current regulations are too weak to ensure that new products will
be safe, too. "The key question is whether the voluntary notification
system is up to the challenge of evaluating the products in the
pipeline," said Mike Taylor, former deputy commissioner for policy
at the FDA and adviser to Monsanto. New products -- rice enriched
with vitamin A or tomatoes engineered to boost cancer-fighting antioxidants
-- are engineered to produce desirable proteins and could present
novel questions about allergic and toxic reactions. _______________________________________________________________________
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