Washington, DC --- Representatives Dennis J. Kucinich (D-OH) and Jack Metcalf (R-WA) this week introduced the bipartisan Genetically Engineered Food Safety Act. The legislation, with the support of five other primary cosponsors, will overhaul the current unscientific review process of genetically engineered foods by the Food and Drug Administration (FDA). "FDA's current policy for genetically engineered food appears to do more to protect the biotechnology industry than to protect consumers," said Kucinich. "FDA's current policy strongly favors food manufacturers at the expense of consumer protection."

Several recent scientific studies indicate that some important questions remain unanswered. Many food safety experts believe that biotech companies and government regulators have failed to ask the right questions with their research. The issues of concern include allergenicity, unintended effects, toxicity, and antibiotic resistance.

Under FDA's genetically engineered food policy, the FDA only reviews summaries of company safety assessments that are voluntarily submitted. Furthermore, the FDA acknowledges that it "does not conduct a comprehensive scientific review." Under the Kucinich-Metcalf proposal, all genetically engineered foods would be required to go through FDA's current food additive process to ensure genetically engineered foods are safe for human consumption. FDA's policy appears to significantly weaken the long-standing requirement under food safety law that food manufacturers must establish scientifically the safety of new substances added to food before selling them to the public. "For traditional food additives, the word 'safe' is defined as 'reasonable certainty that no harm would result from the substance.' But for GEFs, the FDA defines safe as what the industry tells them is safe despite the potential for health concerns," said Kucinich.

Summary of "The Genetically Engineered Food Safety Act"

Purpose of the Legislation

Genetically engineered food (GEF) has become a major component of many foods in the diets of consumers in the United States. Potential health concerns have arisen as it has become clear that the Food and Drug Administration (FDA), our food safety regulatory body, takes a minimal approach to safety testing of GEFs. The potential health concerns include hidden allergens, unexpected impacts and increased toxins. Long-term safety research does not exist today, making a cautious approach the appropriate course of action.

The Food Additive Process for Strong Safety Testing

The bill will require all GEFs to go through FDA's current food additive process to ensure GEFs are safe for human consumption. The bill will also require that unique concerns of GEFS are explicitly examined in the review process. The concerns to be examined include, but are not limited to, allergenicity, unintended effects, toxicity, functional characteristics, and nutrients levels. However, the food additive process gives the FDA discretion in applying the safety factors that are generally recognized as appropriate. A Public Review Process

The bill requires FDA to conduct a public comment period of at least 30 days once the completed safety application is available to the public. The bill requires that all studies performed by the applicant must be made available including all data unfavorable to the petition. Limits on confidentiality of the information within application are also included. The FDA will maintain a publicly available registry of the GEFs for which food additives are pending or have been approved. The NEPA process is clarified to ensure a full environmental review when necessary for a GEF.

Removing Hidden Food Allergens From the Market

GEF's that contain proteins transferred from "commonly or severely allergenic" foods must undergo serum or skin tests, the best available technologies for testing known allergens. For all other foods, the best available tests for unknown allergens must be used. If testing shows that the proteins are likely to be "commonly or severely allergenic," the foods made with such proteins are prohibited. The National Institute of Health is to be consulted on the testing methods used.

Antibiotic Resistance Marker Phaseout

Antibiotic resistance markers, used to efficiently create GEFs, may lead to increased antibiotic resistance. The bill phases them out by June 2004, unless they have been removed prior to commercialization. Other alternatives for GEFs are being researched and will soon be available.

Independent Testing

The FDA is granted discretion to conduct or contract out for independent testing of any GEF undergoing a food additive review. Since all current testing is performed by the food company, the FDA has the option to conduct their own tests.

Current GEFs on the Market

Current GEFs on the market must go though this food additive process within 2 years from the date FDA issues a final rulemaking. Any GEFs on the market in 2 years without FDA approval from this food additive process must be removed from the market until they complete this food additive process.

Ensuring Adequate FDA Resources for this Task

A user fee is authorized to pay for FDA regulatory efforts including the food additive approval process, FDA's long-term research fund and any independent testing. The purpose of this funding mechanism is to ensure that FDA has the resources to ensure GEFs can move through the process in an acceptable amount of time.

FDA Research for an Efficient Regulatory Process

The FDA is authorized to fund necessary long term scientific research on issues regarding genetically engineered food that will support FDA's regulatory review. The research shall address fundamental questions and problems that arise repeatedly during the review process and shall not directly support development of new GEFs.

National Academy's Institute of Medicine

The National Academy's Institute of Medicine shall conduct a review of the all generic FDA rulemakings and report to Congress any concerns raised. For more information on the Genetically Engineered Food Safety Act, please contact the office of Representative Dennis Kucinich at (202) 225-5871.

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