[Federal Register: October 25, 1999 (Volume 64, Number 205)] [Notices] [Page 57470-57472] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr25oc99-69] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 99N-4282] Biotechnology in the Year 2000 and Beyond; Public Meetings AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing three public meetings on issues within FDA's jurisdiction related to foods (both human and animal) derived from plants developed using bioengineering techniques. The purpose of these public meetings is for the agency to share its current approach and experience over the past 5 years regarding safety evaluation and labeling of food products derived from bioengineered plant varieties, to solicit views on whether FDA's policies or procedures should be modified, and to gather information to be used to assess the most appropriate means of providing information to the public about bioengineered products in the food supply. These meetings will afford consumers, industry, and academia an opportunity to provide focused comment on these issues in a manner that will assist FDA in evaluating and refining its existing policies and procedures. DATES: The meetings are scheduled as follows: 1. Thursday, November 18, 1999, 9 a.m. to 6 p.m., Chicago, IL. 2. Tuesday, November 30, 1999, 10 a.m. to 7 p.m., Washington, DC. 3. Monday, December 13, 1999, 9 a.m. to 6 p.m., Oakland, CA. Submit written comments by January 13, 2000. ADDRESSES: The meetings will be held at the following locations: 1. Chicago--One Prudential Plaza, Plaza Club, 40th floor,130 East Randolph St., Chicago, IL 60601. 2. Washington, DC-- Grand Hyatt Washington, 1000 H St. NW., Washington, DC 20001. 3. Oakland--Elihu Harris State Office Building, 1515 Clay St., Oakland, CA 94612. Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or via e-mail to www.fda.gov/ohrms/dockets. Comments are to be identified with the docket number found in brackets in the heading of this document. For Further Information Contact: For general information: Nega Beru, Center for Food Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202- 418-3090, FAX 202-418-3131, e-mail nberu@bangate.fda.gov. For information about and registration for the public meeting in Chicago, IL: Darlene Bailey, Chicago District (HFR-CE 645), Food and Drug Administration, 300 S. Riverside [[Page 57471]] Plaza, Suite 550-South, Chicago, IL 60606, 312-353-7126, FAX 312-886- 3280, e-mail dbailey@ora.fda.gov. For information about and registration for the public meeting in Washington, DC: Patricia Alexander, Office of Consumer Affairs (HFE-40), Food and Drug Administration, Rockville, MD 20857, 301-827-5006, FAX 301-827- 3052, e-mail palexand@oc.fda.gov. For information about and registration for the public meeting in Oakland, CA: Janet McDonald, San Francisco District (HFR-PA100), Food and Drug Administration, 1431 Harbor Bay Pkwy., Alameda, CA 94502-7070, 510-337- 6845, FAX 510-337-6708, e-mail jmcdonal@ora.fda.gov. Supplementary Information: I. Introduction FDA published a notice in the Federal Register of May 29, 1992 (57 FR 22984), entitled ``Statement of Policy: Foods Derived from New Plant Varieties'' (the 1992 policy) that clarified the agency's interpretation of the Federal Food, Drug, and Cosmetic Act (the act) with respect to foods derived from new plant varieties, including foods derived from plants developed through recombinant DNA techniques. The 1992 policy was issued in response to inquiries from developers and the public regarding food safety and labeling issues related to foods derived from bioengineered plants. The 1992 policy discussed how such foods would be regulated within the existing legal framework of the act and provided comprehensive guidance to developers for the safety and nutritional assessment of such foods. The agency's guidance, based on the agency's understanding of bioengineering advances in food and agriculture research then current, was intended to assist developers in meeting their legal duty under the act to ensure that relevant scientific, safety, and regulatory issues are resolved prior to commercial distribution of such foods. A basic principle of the 1992 policy is that the critical consideration in evaluating the safety of such foods should be the objective characteristics of the food product or its components rather than the fact that new development methods were used. Consistent with the 1992 policy, FDA believes that it is in the best interests of the public, the regulated industry, and the agency for developers to inform FDA about foods derived from new plant varieties developed through bioengineering prior to commercial distribution. Thus, FDA established procedures through which developers can consult with the agency, and through which these consultations can be brought to closure. FDA prepared guidance on the consultation procedures and made it available on its home page on the World Wide Web (http://www.fda.gov/cfsan under ``Biotechnology''). FDA considers a consultation to be completed when all safety and regulatory issues have been resolved. Since 1994, when FDA completed its evaluation of the first food product developed using bioengineering (the Flavr SavrTM tomato), private firms have completed consultations with FDA on food safety, nutritional, and labeling issues for foods derived from over 40 different bioengineered plants. The 1992 policy also addressed the labeling of foods derived from new plant varieties, including plants developed by genetic engineering. Under this policy and applicable law, FDA requires special labeling if the composition of a food developed through genetic engineering or any other method differs significantly from its conventional counterpart. For example, if a new food contains a protein derived from a food that commonly causes allergic reactions (and the developer cannot demonstrate that the protein is not an allergen), labeling would be necessary to alert sensitive consumers because they would not expect to be allergic to that food. Likewise, a new food that has a decrease in nutrients from the food's traditional counterpart would be required to contain that additional information on its label. In addition, the agency requires that the name of a new food be revised when that food is derived from a bioengineered plant that differs from its traditional counterpart such that the customary common or usual name no longer applies to the new food. FDA is not aware of information that would distinguish genetically engineered foods as a class from foods developed through other methods of plant breeding and, thus, the agency does not require that such foods be specially labeled to disclose the method of development. FDA believes that it would be useful to the public, the regulated industry, and the agency to conduct a series of public meetings to share the agency's current approach and experience over the past 5 years regarding its oversight of food products developed through bioengineering, to solicit views on whether FDA's process should be modified, and to gather information to be used to assess the most appropriate means of providing information to the public about bioengineered products in the food supply. As part of the meetings, FDA will describe its current approach to regulating foods from bioengineered plants as well as the agency's experience over the past 5 years regarding safety testing and labeling of these products. FDA also intends to invite representatives from consumer groups, industry, and academia to make presentations on scientific and safety issues and to invite representatives of these same groups to make presentations on public information and labeling. Finally, there will be opportunities for oral presentations by preregistered members of the public. II. Scope of Discussion The scope of these three public meetings will be limited to the issues discussed in this document. A brief discussion on each of the issues with specific questions on which FDA seeks comment follows. A. Scientific/Safety Issues 1. Has FDA's consultation process achieved its intended purpose? Based on experience to date, should this regulatory approach ``sunset,'' continue in its current state, be made mandatory, or otherwise be revised? 2. What newly emerging scientific information related to the safety of foods derived from bioengineered plants is there, if any? Are there specific tests which, if conducted on such foods, would provide increased assurance of safety for man or animals consuming these foods? 3. What types of food products derived from bioengineered plants are planned for the future? Will these foods raise food safety issues that would require different approaches to safety testing and agency oversight? If so, what are those approaches? B. Public Information Issues 1. Should FDA's policy requiring labeling for significant changes, including changes in nutrients or the introduction of allergens, be maintained or modified? Should FDA maintain or revise its policy that the name of the new food be changed when the common or usual name for the traditional counterpart no longer applies? Have these policies regarding the labeling of these foods served the public? 2. Should additional information be made available to the public about foods derived from bioengineered plants? If so, what information? Who should be responsible for communicating such information? [[Page 57472]] 3. How should additional information be made available to the public: e.g., on the Internet, through food information phone lines, on food labels, or by other means? III. Registration and Requests to Make Oral Presentations If you would like to attend the meetings, you must register with the appropriate contact person (addresses above) 15 days prior to the meeting you wish to attend by providing your name, title, business affiliation, address, telephone, and fax number. To expedite processing, this registration information also may be faxed to the appropriate contact person (fax number above). If you need special accommodations due to disability, please inform the contact person when you register. If, in addition to attending, you wish to make an oral presentation during the meeting, you must so inform the contact person when you register and submit: (1) A brief written statement of the general nature of the views you wish to present; (2) the names and addresses of all persons who will participate in the presentation; and (3) an indication of the approximate time that you request to make your presentation. Depending upon the number of people who register to make presentations, FDA may have to limit the time allotted for each presentation. IV. Comments Interested persons may, on or before January 13, 2000, submit written comments to the Dockets Management Branch (address above). You may also send comments to the Dockets Management Branch via e-mail to www.fda.gov/ohrms/dockets. You should annotate and organize your comments to identify the specific issues to which they refer. You must submit two copies of comments, identified with the docket number found in brackets in the heading of this document, except that you may submit one copy if you are an individual. You may review received comments in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. V. Transcripts A transcript of each meeting will be made. You may request a copy of any transcript in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page. You may also examine the transcripts of the meetings at the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday, as well as on the FDA web site, http://www.fda.gov. Dated: October 18, 1999. William K. Hubbard, Senior Associate Commissioner for Policy, Planning and Legislation. [FR Doc. 99-27694 Filed 10-20-99; 8:49 am] BILLING CODE 4160-01-F