Regulatory gap means GE fods arrive on the market without FDA approval - and possibly withou

WASHINGTON -- Biotechnology companies can market genetically engineered (GE) foods without notifying the Food and Drug Administration (FDA) or obtaining its approval, thanks to regulatory gaps in a system that consumer and environmental groups today asked Health and Human Services (HHS) Secretary Tommy Thompson to fix. HHS could begin fixing that system, the groups say, by finalizing a rule stalled at the FDA for more than a year. The period for public comment on the rule ended a year ago today.

     The proposed rule would require premarket notification of bioengineered foods. And while the rule would not require government approval for GE foods, consumer groups say the rule would be a small step in the right direction.

     The signatories of today’s letter to Secretary Thompson include the Center for Science in the Public Interest (CSPI), Environmental Defense, the Consumer Federation of America, the Union of Concerned Scientists, the Institute for Environment and Agriculture, and the Whole Foods Market grocery chain. The letter also called on Secretary Thompson and the FDA to ask Congress to amend the current food-safety laws so that biotech companies are required to seek approval before putting GE foods on the market.

     “Finalizing this rule should be noncontroversial, and it would improve the current regulatory system by ensuring that FDA and the public are notified before new biotech foods are marketed,” said Gregory Jaffe, director of CSPI’s biotechnology project. “But to truly protect consumers from any unsafe genetically engineered foods, we really need new legislation. Only a mandatory pre-market approval process for biotech foods will adequately safeguard our food supply.”

     Currently, the FDA only reviews safety data on biotech crops provided by seed companies on a voluntary basis. In contrast, the FDA has a mandatory approval process for GE food animals. The Environmental Protection Agency (EPA) also has a mandatory approval process, including a food-safety component, but only for crops that have pesticides engineered into them.

     In 2001, two products, including a controversial Bt corn rootworm product from Monsanto, were voluntarily reviewed by FDA without having the benefits of the mandatory notification process.

     Also, Monsanto did not consult with the FDA before it inadvertently may have marketed a variety of GE canola. If the FDA had finalized its proposed rule, Monsanto would have been in violation of those regulations. Under current rules, though, Monsanto’s actions were completely legal.

     “The public shouldn’t have to rely entirely on the word of a big biotech company when it comes to the safety of food,” Jaffe said. “But under the current rules, companies can bypass the FDA with impunity.”

     The FDA’s food safety priority plan for 2002 states that the agency does not plan to move forward with the rule at issue until 2003. “The public should not have to wait two or more years for finalization of a non-controversial food-safety rule,” the groups wrote.