Action Alert: Tell U.S. FDA to Test GE Food!
February 26, 2001

In the final days of the Clinton administration, the U.S. Food and Drug Administration (FDA) submitted its long awaited policy on genetically engineered foods. In total disregard of consumer concerns, the proposed policy will not require any pre-market safety testing or labeling of genetically engineered (GE) food.

Instead, the FDA requires only that biotech food producers engage in “consultations” with the agency and provide information on their products. The information, which must be submitted only three months before the product is marketed, will be posted on the Internet during the agency’s review. Some information may be kept secret, however, if companies can demonstrate to FDA that it is confidential business information or “trade secrets.” Industry studies that FDA examines in its review of new products are not submitted for scientific peer review and will not be available to the public.

FDA also proposed guidelines for a voluntary labeling system in which companies labeling their products as “GE-free” or “Non-GMO” bear the burden of certifying, testing and labeling their foods, while companies that use GE ingredients do so without any requirements to inform consumers through labeling.

Under the current U.S. regulatory framework, FDA has the authority to regulate all GE food under the Federal Food, Drug and Cosmetic Act. To date, however, FDA has not required any testing for the vast majority of GE crops. Instead, companies producing GE crops can voluntarily consult with FDA to confirm the regulatory status of their products. Companies choosing to participate in the consultation process are not required to conduct any standard set of safety tests on their products. In fact, companies that have voluntarily conducted safety studies only need to submit summaries of those studies to the FDA. Because the FDA reviews only summaries, not data, from safety studies, it does not publish conclusions on the safety of individual GE foods.

The proposed rule will make this voluntary consultation process mandatory, but no additional testing or data submission will be required. FDA continues to maintain that GE crops are “substantially equivalent” to crops bred using traditional methods, despite growing evidence to the contrary. There is mounting scientific evidence of potential health risks related to GE foods, such as allergic responses, toxicity and lower nutritional value. Under FDA’s new notification rule, GE foods will continue to reach supermarket shelves without any testing required for these health problems.

The public can comment on FDA’s proposed policy until April 3, 2001. Write to FDA Commissioner Jane Henney and tell her that you are outraged that FDA continues to ignore the safety concerns of consumers, doctors and scientists, in favor of protecting the economic interests of biotech companies. Demand that FDA change its policy to require labeling and pre-market safety testing of all genetically engineered foods.

Send your emails to fdadockets@oc.fda.gov. In the subject line write “re: dockets 00N-1396 and OOD-1598,” or send a letter referencing the same dockets to:

FDA Commissioner Jane Henney
Dockets Management Branch (HFA 305)
Food and Drug Administration
5630 Fisher’s Lane, Room 1061
Rockville, MD 20852

For an overview of GE crops and foods, see PANNA’s online presentation at:
http://www.panna.org/resources/geTutorial.html.

For a thorough analysis of the proposed rule, visit the Center for Food Safety Web site: http://www.centerforfoodsafety.org.

For the full text of the FDA proposed rules, visit: http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.

For an overview of U.S. regulation of GE crops, visit the Union of Concerned Scientists Web site: http://www.uscusa.org/food/gen.policy.html.

Source/contact: PANNA.

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