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The Food and Drug
Administration (FDA) lacks both the authority and the information
to adequately evaluate the safety of genetically engineered
(GE) foods, according to the non-profit Center for Science
in the Public Interest (CSPI). A new report from the group
says that while the few GE food crops now on the market appear
to be safe, the FDA is ill-equipped to assure the safety of
future foods that will be engineered in increasingly complex
ways.
Currently, biotechnology
companies are encouraged -- but not required -- to submit
safety-testing data to the FDA for its review. CSPI’s
examination of 14 such submissions obtained under the Freedom
of Information Act found that companies sometimes refused
FDA requests for more information. Monsanto, CIBA-Geigy (now
Syngenta), and Dow AgroSciences, for instance, each declined
to provide requested scientific data to the FDA about strains
of genetically engineered insect-resistant corn.
"The voluntary
notification process by which the FDA reviews safety data
for new crops allows biotechnology companies to safely ignore
FDA requests for more information," said Doug Gurian-Sherman,
science director of CSPI’s biotechnology project and
the report’s author. "Without a legally mandated
approval process, the FDA can only review whatever data that
a company lets it review."
The report also
found technical shortcomings in the safety data provided by
biotech companies, as well as some obvious errors that the
FDA failed to detect. Submissions from Exelixis (formerly
Agitrope) about GE delayed-ripening tomatoes and cantaloupe,
for example, contained erroneous and unsupported conclusions
that went unremarked upon by the FDA. The CSPI report also
found that one GE developer used inadequate methodology to
test for allergens, and that others failed to evaluate toxicants
and anti-nutrients. Errors like those might have been caught
by observers outside the government, says Gurian-Sherman,
had the process not been secret.
The first recommendation
in the CSPI report is to replace the voluntary notification
system with a mandatory pre-market approval system that requires
biotechnology companies to submit much more detailed testing
information and obtain FDA approval before marketing the product.
Legislation that would do exactly that was introduced last
fall by Senator Dick Durbin (D-IL), who is expected to reintroduce
the bill this year.
Even without legislation,
says CSPI, the FDA can take steps to give consumers greater
confidence that the GE foods the agency reviews are safe.
Most basically, the FDA should develop detailed safety testing
guidelines for biotech developers.
"We 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," said Gurian-Sherman.
"But the FDA isn’t giving companies enough guidance
about what tests companies should conduct, or how much data
companies should provide."
GE crops have the
potential to provide enormous benefits to both consumers and
the environment, according to CSPI’s report. But the
group warns that the technology’s life span would be
short if dangerous biotech products were to show up on supermarket
shelves.
"The public
will -- and should -- only have confidence in GE foods if
the government formally approves them as safe after a thorough
and transparent review," said Gurian-Sherman. "The
biotech industry itself should be clamoring for that kind
of a process."
On Tuesday, Gurian-Sherman
will present CSPI’s concerns at a meeting of a committee
of the National Academy of Sciences (NAS) that is reviewing
some of the food-safety aspects of GE crops. "I hope
the NAS committee will provide the FDA and industry with specific
advice on the kinds of tests that should be done," Gurian-Sherman
said.
Center
for Science in the Public Interest January 7, 2003
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