The U.S. Food and Drug Administration lacks the regulatory tools to ensure that biotech plants brought to market aren't harmful, according to a report written by the Washington, D.C.-based Center for Science in the Public Interest. The report was submitted in early January to a panel of the National Academy of Sciences that was convened by FDA to study transgenic crops and the laws that regulate them.
"Under the current system, the companies don't provide enough data to prove these foods are safe," said Gregory 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."
Under the existing laws, companies producing GM plants are encouraged, but not required, to submit safety data for review. If there are discrepancies, the FDA may request more information, but companies can decline.
In contrast, drugs regulated by the agency are approved for human consumption only after rigorous premarket safety scrutiny.
"Voluntary notification is a joke," said Craig Winters, executive director of the Seattle-based Campaign to Label Genetically Engineered Foods. "It's like the old adage of the fox watching the chicken coop. Leaving companies like Monsanto to regulate themselves is ludicrous."
CSPI reviewed 14 cases in which data regarding gene-altered plants were submitted to the FDA for safety review. In three cases, the agency found errors in the analyses, but when it requested more information, the companies—Monsanto, Syngenta and Dow AgroSciences—declined to respond.
The regulatory problem exists because when biotech products were first engineered, the FDA, under the first Bush administration, tried to shoehorn new regulations in to the old Federal Food, Drug and Cosmetic Act, said Doug Gurian-Sherman, author of CSPI's report.
"It's an overstatement to say there's no oversight," said Gurian-Sherman. He said the FDA has done its best to ensure the safety of biotech products, but there are loopholes because the law was written before GM products emerged. CSPI advocates new laws that would specifically describe the agency's review authority.
Sen. Dick Durbin, R-Ill, proposed one such bill last Congress. The Genetically Engineered Foods Act would have amended the Federal Food, Drug and Cosmetic Act to require premarket consultation and approval with respect to genetically engineered foods. CSPI hopes the bill will be reintroduced this Congress.
"We found that biotech companies weren't always performing the right tests to look for potentially dangerous compounds," said Gurian-Sherman. "But FDA isn't giving companies enough guidance."
An FDA spokeswoman said the agency hands are not tied with respect to assuring the safety of gene-altered plants. Presenting at the meeting, FDA representatives told the scientists that genetically altered animals, such as salmon or pigs engineered to grow more quickly and larger, were potentially more dangerous and would be regulated as drugs and thus have mandatory safety requirements, not voluntary.
CSPI's report is the second issued in the past six months to denounce the regulatory framework that allows voluntary submissions of safety data. The first was issued by a National Research Council panel in August 2002.
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