Summary: H.R.5232 — 101st Congress (1989-1990)All Information (Except Text)

There is one summary for H.R.5232. Bill summaries are authored by CRS.

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Introduced in House (07/10/1990)

Omnibus Biotechnology Act of 1990 - Title I: Biotechnology Science Coordinating Committee - Establishes the Biotechnology Science Coordinating Committee within the Office of Science and Technology Policy to take certain actions with regard to risks to human health and the environment which are or may be caused by genetically engineered organisms.

Declares that the Committee has no authority to control, affect, or delay the regulatory decisions of Federal agencies.

Title II: Biotechnology Science Research Program - Establishes the Biotechnology Science Research Program within the Office of Science and Technology Policy to: (1) coordinate the use of private and public resources to create a data base to support the review and regulation of the biotechnology sciences; (2) identify areas of research; and (3) review recommendations from the Committee and Federal agencies for purposes of developing a research agenda.

Requires the Program to: (1) function under the supervision of a Board of Governors selected by the Committee from people outside the Federal Government; and (2) be funded by both private and Federal sources, with the Federal contribution limited to one-half.

Title III: Environmental Release of Genetically Engineered Organisms - Prohibits any person from intentionally releasing a genetically engineered organism into the environment for research and development or for commercial purposes without a permit, issued under specified provisions, from the Administrator of the Environmental Protection Agency (EPA), the Secretary of Agriculture, or the Secretary of Health and Human Services.

Title IV: EPA Regulation of the Release and Use of Genetically Engineered Organisms - Amends the Toxic Substances Control Act (TSCA) to prohibit any person from intentionally releasing a genetically engineered organism into the environment for research and development or commercial purposes without a permit in one of three classes: general, research and development, and commercial.

Requires, under general permits, only notice to the Administrator of the EPA before release for research and development or commercial purposes.

Requires, for a research and development permit, submission of an application including specified information. Directs the Administrator to include in a permit such conditions and restrictions as the Administrator deems necessary to protect human health, welfare, and the environment. Prohibits the Administrator from issuing a permit if the Administrator determines that activities authorized by the permit may constitute an unreasonable risk to human health, welfare, or the environment. Places on the applicant the burden of demonstrating that the activities would not constitute an unreasonable risk. Provides for revocation and modification of a permit.

Allows a commercial use permit to be issued only to: (1) the holder of a research and development permit after submission of the data required by the permit; or (2) any person if the organism is covered by a general permit. Directs the Administrator to modify a permit if the Administrator determines that modifications are necessary to protect human health, welfare, or the environment.

Exempts organisms subject to a permit under this title from other provisions of the TSCA.

Directs the Administrator to establish a permanent Biotechnology Science Advisory Committee.

Declares that the issuance of a research and development or commercial permit shall not increase, reduce, or otherwise affect the liability of the permit recipient to other persons, under statute or common law, for any harm or damage which may result.

Adds failure or refusal to comply with the requirements of this title to the list of prohibited acts under the TSCA.

Title V: USDA Regulation of the Release and Use of Genetically Engineered Organisms - Prohibits any person from intentionally releasing a genetically engineered organism into the environment for research and development or commercial purposes without a permit in one of three classes: general, research and development, and commercial.

Requires, under general permits, only notice to the Secretary of Agriculture before release for research and development or commercial purposes.

Requires, for a research and development permit, submission of an application including specified information. Directs the Secretary to include in a permit such conditions and restrictions as the Secretary deems necessary to protect human health, welfare, and the environment. Prohibits the Secretary from issuing a permit if the Secretary determines that activities authorized by the permit may constitute an unreasonable risk to human health, welfare, or the environment. Places on the applicant the burden of demonstrating that the activities would not constitute an unreasonable risk. Provides for revocation and modification of a permit.

Allows a commercial use permit to be issued only to: (1) the holder of a research and development permit after submission of the data required by the permit; or (2) any person if the organism is covered by a general permit. Directs the Secretary to modify a permit if the Secretary determines that modifications are necessary to protect human health, welfare, or the environment.

Directs the Secretary to establish a permanent Agricultural Biotechnology Research Advisory Committee.

Declares that the issuance of a research and development or commercial permit shall not increase, reduce, or otherwise affect the liability of the permit recipient to other persons, under statute or common law, for any harm or damage which may result.

Makes failure or refusal to comply with the requirements of this title subject to the penalties in specified provisions of the TSCA.

Title VI: Application Management Board - Establishes the Application Management Board in the executive branch. Requires a person who proposes to release into the environment a genetically engineered organism of certain types, or an agency which reviews an application with such a proposal, to submit an application to the Board. Requires the Board to direct the person to submit an application under the Federal Insecticide, Fungicide, and Rodenticide Act, the Toxic Substances Control Act (TSCA), title V of this Act, the Virus, Serum, Toxin Act, or the Federal Food, Drug, and Cosmetic Act. Allows the Board, if necessary for the proper review of a permit application, to require the agency to which the application is referred to obtain the concurrence of other agencies before granting or denying a permit. Provides for failure of the Board to take action within 14 days on an application submitted to it.

Title VII: State Review - Requires any person making an application under the TSCA or title V of this Act to provide a copy of the application to the appropriate agency in the State where the proposed release is located.

Requires a State receiving a copy to protect confidential business information under guidelines equivalent to those under Federal laws and regulations. Relieves an applicant from the duty to provide a copy to a State if the State has not established enforceable guidelines.

Allows the State to submit comments, either from its own agency or reflecting comments from public hearings, to the Federal agency reviewing the application. Requires the Federal agency to respond to State comments and, if requested by the State to present its comments to the agency's science advisory committee or the official making the final determination.

Prohibits States and their subdivisions from regulating or prohibiting releases which are subject to a research and development permit under the TSCA or title V of this Act. Allows States to regulate, but not prohibit, the use within their borders of organisms approved for a general permit or a commercial permit.

Title VIII: Conforming Amendments - Amends the Hatch Act of 1887 to require each college and university receiving funds from the Secretary of Agriculture for research involving genetic engineering to establish an Institutional Biosafety Committee as prescribed in the recombinant DNA guidelines of the National Institutes of Health. Requires each Committee to notify the Department's Office of Agricultural Biotechnology of all projects which provide for the intentional release into the environment of genetically engineered organisms. Requires the Office to determine whether the Secretary of Agriculture has jurisdiction to review the release or use of the organism and, if so, to evaluate the proposed release. Requires the Office, if it determines the Secretary does not have jurisdiction, to refer the notification to the agency or agencies having jurisdiction.

Requires all research projects funded by the Department of Agriculture which involve the release of genetically engineered organisms into the environment to include risk assessment data under guidelines determined by the Agricultural Biotechnology Research Advisory Committee and the Institutional Biosafety Committee of the institution involved.

Title IX: Sunset Provision - Declares that specified provisions of this Act, and specified provisions of the TSCA as added by this Act, expire seven years after enactment unless specifically reauthorized by the Congress.