|
REGULATION
BIOTECH REVIEW HAS LOOPHOLES
New report claims FDA's procedures do not ensure food crop safety
BETTE HILEMAN
FDA's review process for genetically engineered foods does not ensure they are safe, says a report from the Center for Science in the Public Interest (CSPI), a Washington, D.C.-based nonprofit education and advocacy group.
Although current crops "appear to be safe for consumers to eat," CSPI says, they are only a fraction of the crops that could be marketed in the future. FDA is ill-equipped to review the safety of future genetically engineered crops, which will be engineered in increasingly complex ways, the report says.
Doug Gurian-Sherman, science director of CSPI's biotechnology project and author of the report, conducted a detailed examination of 14 out of the 53 data summaries on biotech crops submitted to FDA.
Under current rules, companies are encouraged--but not required--to submit safety testing data to FDA. Sometimes they refuse FDA's requests for additional information. In three instances cited in the report, Dow AgroSciences, Monsanto, and Syngenta refused to supply requested data on varieties of corn. "Without a legally mandated approval process, FDA can only review whatever data a company lets it review," Gurian-Sherman says.
Gurian-Sherman also found that some data summary submissions contained obvious errors that were not identified by FDA during its review. The submissions failed to evaluate some potentially harmful compounds, and the best available tests were not always used for allergenicity testing, he writes. Also, the data summaries often lacked necessary statistical analyses.
Lisa Dry, spokeswoman for the Biotechnology Industry Organization, says: "FDA has the authority to ensure that they can collect any information they deem necessary to protect the food supply. They have done a rigorous job of reviewing biotech products for safety purposes." However, like CSPI, she wants the consultative review process for biotech foods to be mandatory.
A spokesman for FDA says: "Anytime we have wanted information that is essential to the safety review, we have been able to get it. We currently believe that we do have an adequate review system." |