Novel Organism Release Act

Summary

Novel Organism Release Act - Amends the Toxic Substances Control Act to regulate the release of novel organisms. Defines "novel organism" as any living organism, including nucleic acid, or a plasmid, virus, bacterium, fungus, blue-green algae, or protist or algae, or plant or animal, the genetic material of which has been deliberately manipulated or altered by human intervention through methods including gene amplification, conjugation, transformation, transduction, transposition, cell fusion, or methods of genetic engineering. Requires the publication of an Instruction Manual for Notification of Proposed Releases of Novel Organisms to be made available to biotechnology research organizations and firms. Establishes within the Environmental Protection Agency's (EPA) Office of Pesticides and Toxic Substances a Division for Biotechnology Assistance. Calls for the establishment of a toll-free telephone information service on laws regulating biotechnology. Establishes categories of releases of novel organisms based upon factors that contribute to risk to health and the environment, requiring notification or a permit. Creates within the National Library of Medicine a Biotechnology Environmental Release Database to coordinate the accumulation of information concerning the interactions and impacts of novel organisms with the environment. Establishes a general framework for the coordination of regulatory efforts of governmental agencies for the release of novel organisms. Requires persons submitting notification of a proposed release of a novel organism to initially contact the Administrator of the Environmental Protection Agency. Requires that an Internal Environmental Biosafety Committee (IEBC) be established whenever the release of a novel organism is proposed, to review the release and recommend tentative categorization. Sets forth other IEBC duties, requires public hearings on the release, and describes authorities to withhold confidential business information regarding the release. Details procedures for petitions for review as to whether information withheld constitutes confidential business information. Makes special provision for information to health professionals, doctors, and nurses. States that research and manufacturing facilities practicing contained use of novel organisms but which demonstrate compliance with EPA Good Laboratory Practice Guidelines and compliance with Guidelines for Recombinant DNA Research and Containment of Genetically Engineered Organisms shall be exempted from the notification and permit requirements under this Act. Prohibits the release of a novel organism into the environment for any purpose except in compliance with a permit issued under this Act. Describes permit application procedures and informational requirements, including a description of the natural habitat of the organism or its parental strains and information on the relative environmental competitiveness of the microorganism. Provides for enforcement of this Act. Allows the issuance of post de facto permits for releases made in response to emergency situations, such as oil spills, toxic chemical spills, or agricultural or environmental pest infestations. Authorizes appropriations through FY 1994 to carry out this Act.

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1 official file

• Introduced in Senate

  summary · EN · 18 October 1988

  Open at official source

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