Letter About Updated Internet Site Regarding Completed Consultations Between FDA and Developers of Foods Derived Through Biotechnology

March 14, 2001

Dear Colleague, FDA Foods Community:

I am pleased to announce that the FDA's Center for Food Safety and Applied Nutrition (CFSAN) has, on March 14, 2001, updated its Internet site regarding completed consultations between FDA and developers of foods derived through biotechnology (also known as bioengineered foods) to include additional information about each completed consultation. The revised "List of Completed Consultations on Bioengineered Foods" is available at http://www.cfsan.fda.gov/~lrd/biotechm.html.

Developers of foods derived through biotechnology have actively consulted with FDA since the agency issued its 1992 “Statement of Policy: Foods Derived from New Plant Varieties.” In 1996, FDA outlined procedures for these consultations and made a list of consultations completed under these procedures available on its Internet site. That list of completed consultations identified the developer of the bioengineered food, and provided information about the intended effect of the modification to the bioengineered food and about the gene that was introduced into the bioengineered food (including its source).

As you probably know, FDA recently proposed to require that developers of foods derived through biotechnology notify FDA about these foods at least 120 days before the food would be marketed (66 FR 4706; January 18, 2001). In that proposed rule, FDA announced its intention to increase the transparency of the process by which FDA evaluates foods derived through biotechnology. For example, under the proposed rule, FDA would announce the receipt of each notice about a bioengineered food at the beginning, rather than at the end, of the evaluation process. In addition, the developer of the bioengineered food would provide FDA with an electronic copy of the premarket notice and, consistent with the Electronic Freedom of Information Act (EFOIA), FDA would place that electronic copy in an electronic reading room on its Internet site. These provisions, if adopted by the agency after reviewing comments to the proposed rule, would not take effect until FDA issues a final rule based on the proposed rule. The comment period for the proposed rule remains open until April 3, 2001.

In the proposed rule, FDA also described its intention to list more information about each bioengineered food that FDA evaluates. For completed consultations, FDA can make this information available now. Therefore, for each completed consultation about a bioengineered food, the revised Internet site:

• Continues to identify the developer of the bioengineered food, and to provide information about the intended effect of the modification to the bioengineered food and about the gene (or gene fragment or gene product) that was introduced into the bioengineered food, including its source;
• Provides a file number that the public can use to identify a submission about a bioengineered food in order to obtain information about that submission through the Freedom of Information Act;
• Identifies each bioengineered food that contains an introduced pesticidal substance and, thus, is also subject to regulation by the U.S. Environmental Protection Agency (EPA);
• Provides the developer’s distinctive designation for the bioengineered food to aid the public in finding information about the regulatory status of the food, or its source plant, at EPA and the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture;
• Includes a link to FDA’s final memorandum regarding the bioengineered food; and
• Includes a link to the letter that FDA sends to the developer regarding the bioengineered food.

The revised Internet site regarding foods derived through biotechnology is part of CFSAN’s ongoing commitment to improve public access to information through electronic dissemination. I trust that you will find it useful.

Content last updated by lsk on 2001-MAR-14
Hypertext last updated by lsk/kwg/dms on 2001-MAR-14