Genetically Engineered Organisms and Products; Simplification of Requirements and Procedures for Genetically Engineered Organisms

This document amends the regulations pertaining to genetically engineered plants introduced under notification and to the petition process for the determination of nonregulated status. The notification amendments allow most genetically engineered plants that are considered regulated articles to be introduced under the notification procedure, provided that the introduction meets certain eligibility criteria and performance standards. The petition amendments enable the Animal and Plant Health Inspection Service to extend an existing determination of nonregulated status to certain additional regulated articles that are closely related to an organism for which a determination of nonregulated status has already been made. We have prepared 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 in support of certain actions under the regulations, and anticipate developing other such guidelines when appropriate for other actions. We are also reducing the field test reporting requirements for certain multi-year field trials conducted under permit or notification procedures. The amendments simplify procedures for the introduction of certain genetically engineered organisms, requirements for certain determinations of nonregulated status, and procedures for the reporting of field tests conducted under notification. We are also changing all references to ``Biotechnology, Biologics, and Environmental Protection'' to ``Animal and Plant Health Inspection Service'' to reflect an internal reorganization within the Agency.