The Center for Food Safety today filed suit against the Food and Drug Administration (FDA) for the agency’s failure to adopt any pre-market safety requirements for genetically engineered (GE) foods, and for failing to require labels so consumers can know when foods contain ingredients from GE crops. The CFS lawsuit calls for a mandatory, pre-market regulatory review system for all genetically engineered foods. Currently, there are no binding FDA regulations to protect the public from the risks of the genetically engineered foods that are currently found in thousands of products on supermarket shelves.

CFS and over fifty consumer and environmental groups, including the Union of Concerned Scientists, Physicians for Social Responsibility, Natural Resources Defense Council, and others filed a detailed legal petition with FDA in March 2000, outlining the comprehensive approach that the agency should be taking to assess the health and safety issues from new GE foods.

Despite numerous attempts to engage the agency, FDA has refused to respond to this legal petition. FDA first adopted a hands-off policy on GE foods in 1992, and despite mounting evidence of health and environmental threats from GE crops, has never significantly changed its deregulatory stance. The lawsuit filed today challenges FDA’s unreasonable delay in failing to respond to the March 2000 petition.

“For too long, the FDA has let biotech companies set the table for deregulation of GE food,” said Joseph Mendelson, Legal Director for the Center for Food Safety. “Over six years ago, we challenged the agency to come up with a scientific defense for their lax approach to GE foods. Their failure to respond demonstrates the lack of science behind their GE foods policy.”

The CFS challenge to FDA calls for rigorous testing on GE foods before they are marketed. Scientists, including FDA physicians and scientists have warned that genetic engineering is different than traditional breeding techniques and may have different risks. For example, FDA and other scientists have warned that GE foods could trigger unexpected food allergies, create toxins in food, and/or hasten the spread of antibiotic-resistant disease.

Despite these scientific warnings, FDA’s policy assumes that gene altered foods are safe based solely on scant information that biotechnology companies voluntarily submit in consultations with FDA. Since these consultations are voluntary, industry determines what information they submit and in what form. Generally submissions include merely compositional comparisons to show that GE foods are “equivalent” to their natural counterparts.

But scientists say that such comparisons cannot adequately address the kinds of unexpected changes in food that the genetic engineering process can create, including changes that could create health concerns. For example, just last fall Australian scientists were surprised to find that genes from a bean engineered into pea plants created a potentially dangerous allergen in the GE peas. The tests that exposed this potential hazard have not been conducted on any of the GE foods currently marketed in the U.S., even though these GE foods contain genes from non-food organisms that have never been in the human diet and have never been adequately assessed for allergencity.

FDA also overlooked potentially dangerous allergies in its review of StarLink corn, a gene-altered crop that contaminated much of the food supply and cost American farmers hundreds of millions of dollars in lost exports and clean-up costs. In 2001, CFS was part of a coalition of organizations that discovered illegal StarLink contamination in taco shells and other products sold in supermarkets across the country. While FDA’s review failed to identify or address any potential allergenicity concerns with StarLink, scientific advisors to the Environmental Protection Agency (EPA) warned that the GE corn might trigger allergies. EPA allowed the corn to be sold only for non-food uses, but StarLink contamination of the food supply led to over 300 product recalls and crippled U.S. corn exports for months.

Numerous countries have adopted mandatory pre-market approval and labeling systems for GE foods, including Russia, China, Brazil, India, Japan, Australia, New Zealand, South Korea and all of the European Union. In international forums, FDA and other U.S. officials have endorsed at least three agreements on safety assessments and pre-market review to protect consumers around the world from the risks of GE foods. But FDA’s own guidelines for American consumers do not follow these international safety standards.

In fact, in developing its lax GE foods policies, FDA was heavily influenced by biotechnology interests. For example, a former attorney for Monsanto, the world’s leading producer of GE crops, developed FDA’s policy on GE food labeling when working as an FDA regulator in the mid-1990s. Previous legal actions by CFS unearthed numerous FDA documents showing that agency scientists warned of unintended health risks from GE foods, but were overruled by political appointees.

“While the rest of the world is rejecting these risky, untested foods, FDA’s unscientific approach is making American consumers the world’s guinea pigs in this genetic food experiment,” said Mendelson. “Americans deserve the right to know what’s in their food. FDA must stop playing politics and start developing a science-based policy to protect Americans from these risky foods.”

Today’s lawsuit was filed in district court in Washington, DC.

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