In an effort to help prevent the inadvertent introduction of allergens or toxins into the U.S. food supply, FDA issued "Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use." The guidance details the procedure for food-safety evaluation of non-pesticidal proteins produced by new plant varieties prior to their introduction to the food supply. Under the guidance, developers would voluntarily provide FDA with information about the food safety of new proteins at an early stage of development of the new crops.
The issuance of the guidance was proposed to FDA in 2002 by the White House Office of Science and Technology Policy as part of a series of federal actions intended to update field test requirements and establish early voluntary food safety evaluations for new proteins produced by bioengineered plants.
The guidance states: "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 under field tests with commercial seeds or grain may also increase. This could result in the inadvertent, intermittent, low-level presence in the food supply of proteins that have not been evaluated through FDA's voluntary consultation process for foods derived from new plant varieties…. FDA is issuing this guidance document to address this possibility."
The complete guidance can be found at http://www.cfsan.fda.gov/~dms/bioprgu2.html.
