2017 ASHS Annual Conference

US government oversight and regulation of various products of modern biotechnology began in the mid-1980s with the publication of the Coordinated Framework for Regulation of Biotechnology. This framework described in general terms how various US Agencies, primarily USDA, FDA, and EPA, would work together to ensure the safe development and use of genetically engineered (GE) organisms. Most of the early work with plants involved development of pest and herbicide resistant commodity crops as most developers identified these as the most potentially profitable products. With relatively few exceptions (e.g., papaya, plum, apple, potato) high costs associated with regulatory compliance, however, have limited the development of smaller market GE crops. After 30+ years of experience, regulation, and oversight, the US government is working to make significant revisions to some of its regulations that should facilitate the use new breeding technologies in the development of new plant varieties. These new technologies will be discussed and considered in light of both current and proposed regulatory revisions, hoping to provide guidance to developers using these technologies.