Recombinant DNA Research Act

Summary

Recombinant DNA Research Act - Amends Title IV (National Research Institutes), of the Public Health Service Act to direct the Secretary of Health, Education, and Welfare to regulate research with regard to recombinant DNA. Requires the Secretary, within 180 days after the date of enactment of this Act, to promulgate regulations to implement the license requirements of this Act. Stipulates that such regulations shall: (1) prescribe physical and biological containment requirements for recombinant DNA research projects; (2) prescribe requirements respecting laboratory safety techniques to be followed by personnel involved in recombinant DNA research projects; (3) prescribe requirements respecting the establishment and operation of institutional review committees for recombinant DNA research; and (4) prescribe requirements respecting reports to be made by persons engaged in recombinant DNA projects. Prohibits anyone from engaging in a recombinant DNA research project 180 days after enactment of this Act unless such person holds a license to engage in such research or is under the direct supervisions of a person holding such a license. Prescribes the terms and conditions that an application for such a license and the license issued by the Secretary shall contain. States that such license shall be valid for up to 24 months and may be reviewed. Directs the Secretary to publish in the Federal Register a detailed description of the research project for which the license was issued or renewed. Directs the Secretary to designate not more than ten centers for the conduct of research projects involving recombinant DNA which require the highest level of physical containment measures. Requires the Secretary to prescribe the information that an application for designation as a research center shall contain. Allows the Secretary to make grants to designated nonprofit private centers to enable such centers to meet the cost of complying with requirements for designation as a maximum containment research center. Authorizes agents designated by the Secretary to inspect any laboratory in a State in which recombinant DNA research is being conducted. Stipulates that such agents are not required to obtain a search warrant from any judicial officer prior to the inspection. Directs the inspector prior to leasing the premises to give the individual in charge of the laboratory a preliminary report indicating any violations of the licensing requirements. Requires the inspector to send a final written report to the agent in charge of the laboratory within 30 days of the completion of the inspection. Authorizes the Secretary, after reasonable notice and opportunity for a hearing, to revoke the license of a person who has violated the terms and conditions of such license or has failed or refused to permit an authorized inspection. Makes any person violating such licensing requirements liable to the United States for a civil penalty in an amount not to exceed $1,000 for each violation. Allows a person who is aggrieved by an order of the Secretary assessing a civil penalty, to file a petition for judicial review with the circuit court in which such person resides or transacts business. Prohibits, with specified exceptions, any State or political subdivision thereof from establishing or continuing any requirement with respect to recombinant DNA research projects which is different from requirements established by the Secretary. Establishes the Recombinant DNA Research Advisory Committee to make recommendations to the Secretary related to the effective administration of this Act.

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1 official file

• Introduced in House

  summary · EN · 9 March 1977

  Open at official source

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