Biotechnology Project
Center for Science in the Public Interest
 FDA Approval of Genetically Engineered Foods is Necessary to Protect Consumers

FDA should review and approve the safety of every genetically engineered ("GE") food before it is marketed. The public deserves a fair, transparent, mandatory premarket approval process, including an opportunity for meaningful public input. Only a mandatory premarket approval process will safeguard the food supply and bolster public confidence in GE foods now and as the technology matures.

Currently, FDA does not formally approve any GE crops as safe to eat. FDA has the authority to approve new food additives, but says that the GE plants developed so far do not fall within that authority. Instead, FDA adopted a voluntary process to review safety data provided by seed companies to ensure compliance with existing laws. This consultation process, which FDA states is "not a comprehensive scientific review of the data generated by the developer," culminates with FDA stating that it has "no further questions . . . at this time" regarding the food. Although no human health problems with GE crops have been detected, this developer-driven process is not the most effective way to protect human health and engender public confidence.

Recently, FDA proposed regulations that would require a mandatory notification before a GE plant intended for food or feed is marketed, in part because FDA believes that the next generation of GE crops is more likely to raise new food-safety concerns. Although that proposal improves upon the current process by mandating a transparent agency review, it does not materially change the agency’s scientific review and will not result in an official safety determination.

FDA should establish a new approval process, unrelated to the current food additive process, for GE crops. FDA should promulgate regulations that establish testing and data requirements based on advice from a National Academy of Sciences panel of scientists with a charge to determine which scientific information is needed to assess food-safety concerns, including the potential allergenicity, toxicity, and unintended effects of such crops. If new legislation is needed so that FDA can implement an approval process, Congress should pass such legislation.

FDA also should approve in an open public process the safety of transgenic food animals. FDA has stated that it will approve transgenic animals using the Food, Drug, and Cosmetic Act’s new animal drug provision (Section 512) since both the inserted gene and the protein it produces can be considered animal drugs. Although that process may satisfy human health concerns, the public will not be able to assess the adequacy of these closed-door reviews. There will be no public access to the application or supporting scientific data and no opportunity for public input. In addition, FDA has not made public any regulations or guidance documents that set forth what safety data and testing will be required for a transgenic animal. Thus, it is currently impossible to determine if the closed-door animal drug process will protect human health.

Although food safety is not the only issue in the controversy over GE foods, it is the issue that most concerns consumers. Implementing a formal approval process is something that everyone — from environmental groups to industry — should be able to support. Anything short of this will not protect human health or restore public confidence in GE foods.

[This article appeared in the June 2001 issue of "AgBiotech Buzz", a publication of the Pew Initiative on Food and Biotechnology.]


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