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US Government's Official (Propaganda) Statement
on the Upcoming FDA Hearings on GE Foods

hearing time/place details
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Source: http://www.access.gpo.gov/su_docs/aces/aces140.html

[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]
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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 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
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 Savr<SUP>TM</SUP> 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?
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



Food and Drug Administration Hearings on Genetically Engineered
Foods--Action Alert


CHICAGO
1. Thursday, November 18, 1999, 9 a.m. to 6 p.m., Chicago, Illinois
One Prudential Plaza, Plaza Club, 40th floor,130 East Randolph St., Chicago,
IL 60601.
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 Plaza, Suite 550-South, Chicago, IL 60606, 312-353-7126,
FAX 312-886-3280, e-mail dbailey@ora.fda.gov.

WASHINGTON, DC
2. Tuesday, November 30, 1999, 10 a.m. to 7 p.m., Washington, DC
Grand Hyatt Washington, 1000 H St. NW., Washington, DC 20001.
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.

OAKLAND
3. Monday, December 13, 1999, 9 a.m. to 6 p.m., Oakland, California
Elihu Harris State Office Building, 1515 Clay St., Oakland, CA 94612.
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.

Those of you who live in any of these three areas urged to attend and make
your voices heard. If you want to speak at these hearings you should call
the appropriate contact person and register as soon as possible.

Perhaps of even more significance, the FDA is accepting written comments
regarding genetically engineered foods until January 13, 2000. We
will soon post a form letter on our web site specifically designed to
address this round of comments to the FDA .


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