
Staff Reporter The Wall Street Journal January 7, 2003
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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Last Updated on 1/7/03 Email: information@biotech-info.net |
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