Guidance for Industry for new plant varieties intended for food use

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its sponsor has fully consulted with the Food and Drug Administration (FDA), FDA is announcing the availability of a draft guidance document entitled “Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties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.”

This draft guidance discusses the early food safety evaluation of new proteins in new plant varieties, particularly in new bioengineered varieties that are under development for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 The draft guidance also describes procedures for communicating with FDA about this evaluation.

The issuance of draft guidance was proposed in August 2002 in a Federal Register Notice (67 FR 50578) published by the Office of Science and Technology Policy (OSTP) as part of proposed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.

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