FDA Proposes Early Biotech Evaluation to Protect Food Supply

Under the new guidance developers would voluntarily provide FDA with information about the food safety of new proteins at a relatively early stage of development of the new crops.

Published on: Jun 22, 2006

A new Food and Drug Administration guidance introduced Wednesday focuses on resolving any potential food safety issues through early safety evaluation of new proteins in new plant varieties - including bioengineered varieties - that are in development for possible use as food for humans or animals.

The FDA's guidance underscores the benefit of early food safety evaluations of new non-pesticidal proteins, which would be important in managing the outcome of a finding of a low-level presence in the food supply.

Under the guidance, 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," developers would voluntarily provide FDA with information about the food safety of new proteins at a relatively early stage of development of the new crops. Following a decision to commercialize a particular crop, it is recommended that each developer participate in FDA's voluntary pre-market consultation procedures.

To date, all new biotechnology-developed plant varieties intended to be used for food and feed in the United States have completed these consultation procedures before they entered the market.

Dr. Jeffrey Barach, Vice President and Director of the Center for Laboratory and Technical Services for the Food Products Association, says the guidance is a "good first step for the U.S. government in developing a comprehensive 'adventitious presence' policy for agricultural biotechnology that is science-based and deals with the biological nature of new crops being commercialized."