www.czu.cz ; www.raupp.info

To 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 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announcing the availability of a draft guidance document entitled "Guidance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." November 2004.



This draft guidance discusses the early food safety evaluation of new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The draft guidance also describes procedures for communicating with FDA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The issuance of draft guidance was proposed in August 2002 in a Federal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]

[www.fda.gov]

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