Finding 1.5: Both transgenic and conventional approaches (i.e., hybridization, mutagenesis) for adding genetic variation to crops can cause changes in the plant genome that result in unintended effects on crop traits.

Finding 1.6: The transgenic process presents no new categories of risk compared to conventional methods of crop improvement, but specific traits introduced by both approaches can pose unique risks.

Finding 1.7: Screening of all crops with added genetic variation must be conducted over a number of years and locations because undesirable economic and ecological traits may only be produced under specific environmental conditions.

OVERVIEW OF CURRENT U.S. REGULATORY FRAMEWORK FOR TRANSGENIC ORGANISMS

In the early 1980s the U.S. government determined that there was a need to regulate transgenic organisms, including engineered plants, to assure health and environmental safety. However, it was decided that such regulation could be accomplished by using existing federal statutes instead of developing new ones specifically designed for transgenic organisms. The U.S. Coordinated Framework for the Regulation of Biotechnology (OSTP 1986) was developed to offer guidance for using existing federal statutes and the expertise of existing regulatory agencies in a manner that would ensure health and environmental safety while maintaining sufficient regulatory flexibility to avoid impeding the growth of the biotechnology industry. What follows is an abbreviated description of the coordinated framework, so that readers can understand the regulatory context of the USDA-APHIS regulation of transgenic organisms. The federal government, in lieu of creating a new law for transgenic organisms, asked that the USDA adapt its interpretation of the Federal Plant Pest Act (FPPA) and the Federal Plant Quarantine Act (FPQA) to ensure environmental safety while not impeding growth of the industry.

Two basic principles were intended to guide regulatory policy. First, agencies should seek to adopt consistent definitions of those transgenic organisms subject to review to the extent permitted by their respective statutory authorities. Second, agencies should use scientific reviews of comparable rigor. (Both products and research are regulated under this framework, but the review here will concentrate on “products,” which are defined as transgenic organisms that are released as commercial products into the environment).



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