Joseph A. Levitt

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AFDO Millennium Conference
Joseph A. Levitt Director, Center for Food
Safety and Applied Nutrition June 19, 2000
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Topics for Discussion

• Background
• The 1992 Policy
• Consultation Process
• Public Outreach
• New Initiatives
• Additional Activities

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Background
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Regulation of Bioengineered Foods
FDA Safety and labeling of all foods and
animal feeds derived from crops EPA
Pesticides USDA/APHIS Agricultural and
environmental safety of planting and field
testing genetically engineered plants
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The 1992 Policy (57FR 22984 May 29, 1992)
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1992 Policy
Basic Principle Critical consideration in
evaluating the safety of bioengineered food
should be the objective characteristics of the
food product or its components rather than the
fact that new development methods were used.
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Labeling
A food developed through genetic engineering or
any other method that differs significantly from
its conventional counterpart must be labeled to
disclose information such as changes in
nutritional properties or the presence of new
allergens.
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• Food Advisory Committee affirmed that the 92
  policy was scientifically sound (April 6-8, 1994)
• FAC affirmed that relevant scientific issues
  concerning the FLAVR SAVRTM tomato had been
  addressed in accordance with the 92 policy
• Following review of the FLAVER SAVRTM tomato FDA
  established a consultation process to help ensure
  that foods developed using biotechnology meet
  applicable safety standards

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Voluntary Consultation Process

• Firm submits to FDA a summary of the safety and
  nutritional assessment that has been conducted on
  the bioengineered food
• FDA scientists ensure that safety concerns are
  addressed e.g., no new allergens, no increased
  levels of natural toxicants, no reduction of
  important nutrients and no presence in the food
  of an unapproved food additive

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Voluntary Consultation Process

• 40 consultations over the last five years
• Ten crops represented

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Introduced Traits
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New Bioengineered Varieties
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Public Outreach
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Public Outreach
Chicago, Il November 18, 1999 Washington,
DC November 30, 1999 Oakland, CA December 13, 1999
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Public Participation
1. FDA asked specific questions on both
scientific/safety issues as well as public
information issues, in order to focus public
comment 2. FDA heard from 35 panelists and over
250 additional speakers in 3 meetings 3. More
than 35,000 written comments submitted
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What We Heard
1. One group was concerned primarily with
anything that could possibly harm the
environment, with food safey being a secondary
concern. 2. A second group was concerned about
potential food safety problems in the future, but
did not have scientific evidence to back up their
concerns.
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What We Heard
3. A third group said they were not so concerned
about food safety, but still wanted to know what
technologies and ingredients were involved in
producing their food. 4. A fourth group was the
voice of developing countries that did not want
the technology limited or taken away.
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What We Heard
5. General support for strengthening FDAs
premarket review process 6. Views on labeling
strong and much more polarized
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What We Did Not Hear
No information was presented that indicates there
is a safety problem with bioengineered food or
feed now in the marketplace.
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NRC Report April 2000
The committee is not aware of any evidence that
foods on the market are unsafe to eat as a result
of genetic modification. NRC
Report Executive Summary April 5, 2000
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New Initiatives
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Goal
To enhance public confidence in the safety of
bioengineered foods
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FDAs scientific review continues to show that
all bioengineered foods sold here in the United
States today are as safe as their
non-bioengineered counterparts. We believe our
inititives will provide the public with continued
confidence in the safety of these foods.
Jane E. Henney, M.D. FDA Commissioner May 3, 2000
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Public Announcement May 3, 2000
1. Mandatory premarket notification and greater
transparency of the process
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Public Announcement May 3, 2000
2. FDA will augment its food and veterinary
medicine advisory committees by adding scientists
with agricultural biotechnology expertise.
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Public Announcement May 3, 2000
3. FDA will draft labeling guidance to assist
manufacturers who wish to voluntarily label their
foods being made with or without the use of
bioengineered ingredients
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Public Announcement May 3, 2000
4. Enhance research in 2001
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Additional Activities
1. Codex Committees 2. FDA Guidance on
allergenicity 3. Collaboration with EPA and
USDA 4. NAS/NRC review
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Conclusion
1. FDA has set a clear direction 2. Follow-though
is essential 3. Issue will continue to evolve
globally
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• 1. Strong science-based capacity for informed
  decision-making to improve public health

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• 2. Operational capacity to implement the
  decisions we make in a timely way

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3. Culture of accountability, cooperation, and
respect
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