USDA Amends Regulations for Genetically Engineered Plants, July 1997

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The U.S. Department of Agriculture is amending its regulations pertaining to genetically engineered plants introduced under USDA's notification and petition regulatory processes.

The amendment will simplify procedures for the introduction of certain genetically engineered organisms, expedite review for certain determinations of nonregulated status, and adjust procedures for the reporting of field tests conducted under notification to the biology of the test organisms. Developing and commercializing new genetically engineered plant varieties most often involves field testing under APHIS oversight (permits), followed by submission of a petition for determination of nonregulated status by the agency. APHIS grants nonregulated status to a new plant variety when it determines that the new variety has no potential to pose a plant pest risk and is as safe to grow as any other variety of the same plant.

The amended regulations will allow a broader application of existing simplified procedures for requests for movement or field testing of genetically engineered plants. They will also streamline the determination of nonregulated status for plant varieties that closely resemble other varieties that have already been through the determination process. This will enable APHIS, when appropriate, to extend the existing determination of nonregulated status for new products that do not raise new risk issues.

For plants that are being evaluated in field tests, reporting requirements have been made more consistent. For example, for trees and other long lived plants, field data reports will only need to be provided upon the conclusion of the trial. However, applicants must apply to APHIS for yearly renewal to ensure appropriate measures are taken when plants become reproductively mature. APHIS will also use appropriate guidelines to provide additional information to developers of regulated articles and other interested persons regarding procedures, methods, scientific principles, and other factors that could be considered for various aspects of its regulations. The first quidelines will provide information to help applicants on requests for extension of a determination of nonregulated status.

USDA has the responsibility to ensure that, in releasing any bioengineered plant, no plant pest risk is presented. APHIS reviewers focus on the biology, propagation, and cultivation of the plant. APHIS reviewers also consider the source of the engineered genes, the vector used to transfer them, and the stability of the insertion. For further information on the regulatory changes, contact John Payne, director, biotechnology and scientific services, 4700 River Road, Unit 98, Riverdale, MD 20737-1237; 301-734-7602. For technical information, contact Michael Schechtman, biotechnology and scientific services, plant protection and quarantine, Unit 146, Riverdale, MD 20737. (301)-734-7601.