Urgent! Your comments to the FDA are needed regarding Genetically Engineered Food

Action Alert: GE Food Safety - December 17, 1999

The Food and Drug Administration (FDA), the U.S. government agency responsible for food safety, has recently held a series of public meetings on its policy regarding genetically engineered (GE) food. The last of the three hearings was held December 13, 1999, in Oakland, California. Outside more than a thousand people participated in a rally demanding pre-market safety testing and labeling. The demonstration was organized by a coalition of national and local non-governmental organizations including Pesticide Action Network North America (PANNA).

FDA will also accept written comments on the policy until January 13, 1999. PANNA urges everyone to write FDA demanding that the Agency:

1. institute thorough pre-market testing and labeling of all GE foods;

2. withdraw all GE foods from the market until they are subject to thorough safety assessments; and

3. place a moratorium on all approvals of new GE food products until required safety and labeling programs are in place.

Every day, millions of infants, children and adults in the U.S. are consuming genetically engineered food without knowing it. Tests of everyday groceries by the Consumers Union show that genetically engineered foods are already on supermarket shelves--in baby formulas, tortilla chips, drink mixes, taco shells, "veggie" burgers, muffin mix--and even in fast-food.

FDA's policy for oversight of genetically engineered crops, presented in 1991, indicated that FDA would treat GE plants no differently than traditionally bred plants, except in rare circumstances. In other words, no pre-market notification nor pre-market safety testing would be required. Even though the Agency received almost 4,000 comments on the policy, most calling for safety testing and/or labeling, FDA essentially ignored the comments and has proceeded with a voluntary program that has yet to require a single safety test. While FDA urges corporations to thoroughly test GE foods, it has allowed the corporations themselves to determine whether these foods are safe.

Under the policy, FDA does not require that companies consult with the Agency before marketing GE foods. The voluntary consultation consists of discussions between FDA and the corporation concerning safety and nutritional assessments prepared by the corporation. At the end of the process, FDA prepares a brief memorandum summarizing the interaction and declaring the consultation complete. The memorandum typically indicates that the company, not FDA, has found that the GE crop does not differ significantly from non-engineered varieties.

Consultations between FDA and corporations are conducted entirely behind closed doors. The FDA gives no public notice that it is engaged in consultations, provides no information to the public and gives no opportunity for the public to participate in the process allowing GE foods on the market.

After consultations are completed, FDA announces its decisions by merely posting the information on its Web site. Even then, the company safety assessments, the basis for FDA's decisions, are available to the public only through Freedom of Information Act requests. Companies may withhold significant portions of the data from the public under claims that they are confidential business information.

ACTION -- Write FDA and tell them that current policies do not meet the public's need for information and do not adequately protect the public from potential health risks. Urge FDA:

* to institute a mandatory regulatory program, in place of its current system of voluntary consultations, to assess the safety of genetically engineered foods and to insure that no such products posing a significant health risk are put on the market. FDA should develop detailed protocols for assessing risks including allergenicity, toxicity, and nutritional changes; require long-term feeding studies using the whole engineered food; and thoroughly review company testing. All data submitted for FDA assessments should be part of an open and transparent public process that allows opportunities for citizens to comment on pending approvals.

* to require any GE product which passes FDA's safety review and is marketed to carry a label stating that "This product contains a genetically engineered material, or was produced with a genetically engineered material and contains genes from XX sources." Labels should be mandatory for all genetically engineered products, whether or not current testing techniques can detect foreign DNA. The label should be straightforward and informational and not include value-laden words like "improved with" or "enhanced by" genetic engineering.

* to require imported genetically engineered food, which currently receives no safety review, to undergo the same review as domestic foods.

* to withdraw all GE foods from the market until they are subject to thorough safety assessments; and

* to place a moratorium on all approvals of new GE food products until required safety and labeling programs are in place.

Comments may be sent directly to FDA by visiting their Web site at http://www.fda.gov/oc/biotech/ then click on "Comment on Federal Register Notice."

Or write to: Commissioner Jane Henney FDA Dockets Management Branch Attn: Docket No. 99n-4282 5630 Fishers Lane, Rm 1061 Rockville, MD 20852

Sources: "A Regulatory Patchwork--with big holes," by Michael Hansen, Consumer Policy Institute, 1999. "FDA Implements Informal Food Safety Reviews," December 1994, The Gene Exchange. "Seeds of Change," Consumer Reports, September 1999.

Contact: PANNA

To comment, send a message to: panna@panna.org