Genetically Engineered Organisms Face Changing Regulations

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    In late January, the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) announced its intent to make sweeping changes to the regulations that apply to genetically engineered organisms. The revisions promise to have significant, far- reaching and long-lasting implications for the agricultural, pharmaceutical and industrial chemical sectors.

    APHIS is the USDA office that regulates the introduction of genetically engineered organisms that may present a plant pest risk. The recent notice concerns genetically engineered organisms that may pose a noxious weed risk and genetically engineered biological control agents. Regulations issued by the U.S. Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) would not be affected directly.

    The notice pinpoints potential issues and alternatives that USDA intends to study to develop a mandated environmental impact statement (EIS). USDA will look at two alternatives. The first is a "take no action" option. The second would update regulations to reflect advances and trends in biotechnology. These relate to increased use of genetically engineered plants to produce pharmaceutical and industrial compounds and may create changes in the scope of the Agency's authority under the Plant Protection Act.

    The Agency is almost certain to select the latter option. The push for revised regulation is coming from many sources. Perhaps the most relevant is the National Academies' National Research Council's (NRC) January 2004 report, titled "Biological Confinement of Genetically Engineered Organisms".

    It recommends that regulators decide whether and how to confine genetically engineered organisms. An increasing barrage of criticism is also coming from environmental groups, and the Pew Initiative on Agriculture and Biotechnology has released a series of critical reports. APHIS's proposal appears to be a response to this, as well as a reflection of the need for updating of its processes and principles given the changing pace and nature of bioengineered organisms. For example, the level of concern about pharmaceutical manufacture in genetically engineered organism plants has increased as the technology becomes viable in the marketplace.

    Eleven key issues

    APHIS has identified 11 issues that may affect the quality of the environment, as follows:
  • Broaden the scope of APHIS regulation beyond genetically engineered organisms. This would include genetically engineered plants that may pose a noxious weed risk and genetically engineered organisms that may be used as biological control agents.
  • Revise the regulations to define risk-based categories for field testing, including low-risk products, products considered to pose a noxious weed risk, and pharmaceutical or industrial crops not intended for food or feed.
  • Update the regulations to provide enhanced flexibility by allowing the commercialization of certain genetically engineered organisms while continuing to regulate the organisms based on minor unresolved risks.
  • Revise the review of and permit conditions for genetically engineered plants that produce pharmaceutical and industrial compounds.
  • Add regulations for nonviable plant material (that is, a part of a plant that cannot by itself give rise to another plant).
  • Create a new mechanism to regulate the commercial production of plants intended for making of pharmaceutical and industrial compounds under confinement conditions with governmental oversight, rather than use the approval process for unconfined releases.
  • Consider the regulation of intermittent and low-level presence of genetically engineered plant material in commercial crops, food, feed or seed.
  • Provide expedited review or exemption from review of certain low-risk genetically engineered commodities intended for importation.
  • Broaden the exemption from interstate movement restrictions that now applies to genetically engineered Arabidopsis spp to include other genetically engineered plants that are believed to be equally well understood.
  • Consider relaxation of regulatory requirements in other areas based on low-risk levels.
  • Identify other environmental considerations pertinent to changing prescriptive container requirements for shipment of genetically engineered organisms to performance-based ones, and developing guidance on ways to meet such performance standards.

    APHIS will consider comments on all these issues and others until late this month. As noted, it is almost certain USDA will revise the regulatory framework that now applies to genetically engineered organisms, and sound input from the private business sector is essential.

    Lynn Bergeson is a founding shareholder of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm. The views expressed herein are solely those of the author.

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