Center for Science in the Public Interest
August 11, 2000

Dr. Jane Henney, Commissioner
U.S. Food and Drug Administration
5600 Fisher Lane
Rockville, MD 20857

Dear Commissioner Henney:

   We write regarding the Food and Drug Administration’s (FDA) recently announced plan to strengthen its regulation of genetically modified (GM) foods. Although the FDA’s proposal to make its voluntary consultation process mandatory would be a modest improvement over the current system, we urge the agency to make more sweeping changes in its regulations.

   The FDA’s review process for GM foods has been criticized by many for being too weak and opaque, attributes that could result in health risks to consumers. We note that new and potentially more challenging GM foods based on additional GM crop and animal innovations are poised to enter the regulatory arena. To bolster public confidence in the agency’s oversight, the FDA has indicated that it plans to improve its system. Unfortunately, many critics’ concerns will not be satisfied by the FDA’s announcement on May 3 that it will require companies to notify the agency of their intent to market GM foods and to submit specific information for agency review. That is because the FDA’s proposal would not create the type of system that the public deserves: a fair, transparent, mandatory premarket approval or certification process, including an opportunity for meaningful public input.

   The FDA’s reluctance to establish such a process is inexplicable, especially considering that the two other federal agencies that share oversight of GM foods with the FDA conduct their reviews in a more open and formal manner (although we do not agree with every aspect of their processes.) Unlike the FDA, both the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) conduct mandatory premarket approvals of those GM food crops that they have determined to fall under their jurisdiction. That is, they prohibit companies from commercializing new products until they are formally approved. Both agencies solicit public comments during the review process, respond to those comments in formal decision documents, and make the details of their final decisions available to the public.

   The USDA’s Animal and Plant Health Inspection Service (APHIS) publishes a notice in the Federal Register and creates a public docket whenever it receives a petition for a determination of nonregulated status under the Federal Plant Pest Act, which is the final review step before commercialization of a GM food crop. General information about the petitions is also made available on the Internet. After completing its review of a petition, APHIS publishes a second Federal Register notice announcing its final decision. The agency also publishes a determination document, in which it explains the rationale for its decision and responds to any public comments.

   Similarly, the EPA uses the Federal Register and the Internet to notify the public and provide a 30-day public-comment period when it receives petitions for genetically modified plant-pesticides. Upon completion of its review, the EPA announces its decision in a second Federal Register notice and establishes a new comment period in which written objections and formal hearing requests may be submitted. For both registration applications and pesticide petitions, the EPA makes documents that explain the scientific basis for its decision publicly available.

   Unfortunately, the FDA’s tentative proposal as described on May 3 falls short in two important respects. First, it would not create a premarket approval or certification process; rather, the agency would continue to review submissions without making a final, published decision regarding a product’s safety for humans and the environment. Second, the proposed changes would do little to enhance the transparency of the FDA’s review because the agency apparently does not intend to place in a public docket or on the FDA’s web site any of the scientific information submitted until after completion of the consultation process. Nor, apparently, does the FDA intend to establish a formal public-comment period, respond to public comments in a published document at the end of the approval process, or include the possibility that a post-approval monitoring process may be necessary in some cases.

   To maximize confidence in the FDA’s review process and to assure both consumers and industry that the agency’s oversight of GM foods under its jurisdiction is thorough, scientifically accurate, fair, and transparent, the undersigned urge a process with the following elements:

  • The agency should require companies to: 1) apply to it; 2) wait for timely review of the application; 3) receive formal FDA approval, certification, or comparable written permission; and 4) comply with all other applicable laws, prior to marketing GM foods.
  • FDA should publish a Federal Register notice announcing the receipt of an application and the availability in a public docket of all non-confidential information submitted regarding the food. All additional information received by the agency — whether from the company or other party — should be added to the docket upon receipt. All FDA documents pertaining to the food, including the agency’s final decision and related materials, should also immediately be placed in the docket. Ideally, all of the information in the docket also would appear on the FDA’s web site; if that is impractical, the web site should at least contain a list of all GM foods, their review status, and instructions regarding how the information in the public docket may be obtained.
  • Upon completion of its review, the FDA should publish a notice in the Federal Register announcing the agency’s final decision. The notice should summarize the agency’s findings, rationale, and supporting information and should announce a final public-comment period. The notice should indicate that all relevant information may be obtained from the public docket and that, in some cases, companies would be required to undertake post approval monitoring of a product.
   Increasing the transparency of the FDA’s review process would yield obvious benefits. A sure way to engender suspicion from both consumers and the affected industry about a government regulatory program is to shield — or even to create the impression of shielding — agency actions from outside scrutiny. Though savvy groups may understand how to obtain information about the FDA’s current evaluation process by submitting a request under the Freedom of Information Act, the lack of a public docket and Internet information relevant to ongoing reviews excludes others who may wish to monitor or participate in the process. And the absence of a final agency decision regarding safety to humans and the environment, including a description of the agency’s rationale, prevents outside observers from judging the adequacy of the FDA’s review.

   By taking the steps outlined above, the FDA would both enhance the quality of its scientific review and help quell consumer concerns about the rigor and openness of the agency’s activities. We hope that the FDA, as a part of its long overdue effort to strengthen its oversight of GM foods, will propose new regulations that include all of the suggested improvements.


Michael F. Jacobson, Ph.D.
Executive Director
Center for Science in the Public Interest

Carol Tucker Foreman
Distinguished Fellow and Director
Food Policy Institute
Consumer Federation of America