[Federal Register Volume 64, Number 205 (Monday, October 25, 1999)]
[Notices]
[Pages 57470-57472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27694]


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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.

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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 [email protected].
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 [email protected].
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 [email protected].
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 [email protected].
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