Washington, DC
November 19, 2004To
address the possibility that material from a new plant variety
intended for food use might inadvertently enter the food supply
before its sponsor has fully consulted with the
U.S. Food and Drug Administration
(FDA), FDA is announcing the availability of a draft guidance
document entitled "Guidance for Industry: Recommendations for
the Early Food Safety Evaluation of New Non-Pesticidal Proteins
Produced by New Plant Varieties Intended for Food Use."
This draft guidance discusses
the early food safety evaluation of new proteins in new plant
varieties, particularly in new bioengineered varieties that are
under development for possible use as food for humans or
animals. The draft guidance also describes procedures for
communicating with FDA about this evaluation.
The issuance of draft guidance
was proposed in August 2002 in a Federal Register Notice (67 FR
50578) published by the Office of Science and Technology Policy
(OSTP) as part of proposed Federal actions to update field test
requirements and to establish early voluntary food safety
evaluations for new proteins produced by bioengineered plants.
Rapid developments in genomics
are resulting in dramatic changes in the way new plant varieties
are developed and commercialized. Scientific advances are
expected to accelerate over the next decade, leading to the
development and commercialization of a greater number and
diversity of bioengineered crops. As the number and diversity of
field tests for bioengineered plants increase, the likelihood
that cross-pollination due to pollen drift from field tests to
commercial fields and commingling of seeds produced during field
tests with commercial seeds or grain may also increase. This
could result in low-level presence in the food supply of
material from new plant varieties that have not been evaluated
through FDA's voluntary consultation process for foods derived
from new plant varieties (referred to as a "biotechnology
consultation" in the case of bioengineered plants).
FDA believes that any potential
risk from the low level presence of such material in the food
supply would be limited to the possibility that it would contain
or consist of a new protein that might be an allergen or toxin.
Under the proposal, developers
would provide FDA with information about the food safety of the
new protein at a relatively early stage of development of the
crop. Once a developer decides to commercialize a particular
crop, the developer would still be expected to participate in
FDA's voluntary premarket consultation process. To date, all new
plant varieties developed through biotechnology that are
intended for food and feed marketed in the United States have
completed the consultation process before they entered the
market.
While FDA has not found and
does not believe that new plant varieties under development for
food and feed use generally pose any safety or regulatory
concerns, this guidance is consistent with FDA's policy of
encouraging communication early in the development process for a
new plant variety. Such communication helps to ensure that any
potential food safety issues regarding a new protein in such a
new plant variety are resolved prior to any possible inadvertent
introduction into the food supply of material from that plant
variety.
The proposed draft guidance
represents FDA's current thinking about the approach for
assessing the food safety of new proteins produced by new plant
varieties. An alternate approach may be used as long as it
satisfies the requirements of applicable statutes and
regulations.
Written comments on the draft
guidance may be submitted up to 60 days from the date it is
published in the Federal Register to Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Draft Guidance
(PDF format)
Guidance for Industry
Recommendations for the Early Food Safety Evaluation of New
Non-Pesticidal Proteins Produced by New Plant
http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0369-gdl0001.pdf
Federal Register Notice of
Availability (PDF format)
http://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0369-nad0001.pdf
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