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