Recombinant DNA Research, Volume 4U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health, 1978 - DNA Documents relating to "NIH guidelines for research involving recombinant DNA molecules," Feb. 1975/June 1976- . |
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Administration appropriate bacteria binant DNA biohazard biological containment biological safety Califano cDNA cells certification coli Committee IBC compliance concern conducted containment levels Daniel Nathans DECEMBER 22 decisions Department Director disease DNA Advisory Committee DNA recombinants document environment eukaryotic exempt Federal agencies FEDERAL REGISTER Fredrickson genes genetic genome Guidelines for Recombinant hazards host host-vector systems human IBC's infection Institutes of Health Institutional Biosafety Committee involving recombinant DNA issues July 28 LIBASSI meeting membership ment National Institutes NIH funds NIH Guidelines ORDA organisms OSHA P4 facility pathogens physical containment plant plasmids potential prior NIH approval procedures prohibited Prokaryotic Proposed Revised Guidelines public health rDNA recom Recombinant DNA Activities Recombinant DNA Advisory recombinant DNA molecules recombinant DNA research recommended regulations regulatory responsibility scientific scientists Section September 15 shotgun experiments specific submitted tainment tion vector viral virus viruses workers
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Page 32 - Contaminated materials that are to be decontaminated at a site away from the work area...
Page 31 - ... years. Considerable information therefore already exists for the design of physical containment facilities and the selection of laboratory procedures applicable to organisms carrying recombinant DNAs. 1619] The existing programs rely upon mechanisms that, for convenience, can be divided into two categories: (1) A set of standard practices that are generally used in microbiological laboratories...
Page 35 - Personnel who enter this area shall wear a one-piece positive-pressure suit that is ventilated by a life-support system. The life-support system shall be provided with alarms and emergency backup air. Entry to this area is through an airlock fitted with airtight doors.
Page 51 - HEPA filtered mass recirculated air flow for product protection. The cabinet exhaust air is filtered through a HEPA filter. The face velocity of the inward flow of air through the full-width open front is 75 feet per minute or greater. Design and performance...
Page 48 - RAC meeting citing the major actions will be published In the FEDERAL REGISTER at least 30 days before the meeting, and the Director will also publish the proposed actions in the FEDERAL REGISTER for comment at least 30 days before the meeting.
Page 45 - Institution and those associated with it to adhere to the purpose of the Guidelines as well as to their specifics. Each Institution (and the IBC acting on its behalf is responsible for ensuring that recombinant DNA activities comply with the Guidelines. General recognition of institutional authority and responsibility properly establishes accountability for safe conduct of the research at the local level.
Page 48 - Make the initial determination of the required levels of physical and biological containment in accordance with the Guidelines; IV-B-5-c-(2).
Page 36 - IV-EWhen new host-vector systems are certified, notice of the certification will be sent by ORDA to the applicant and to all iBCs and will be published in the Recombinant DNA Technical Bulletin. Copies of a list of all currently certified host-vector systems may be obtained from ORDA at any time. The Director, NIH may at any time rescind the certification of any hostvector system.
Page 33 - The surfaces of doors, walls, floors and ceilings in the work area shall be water resistant so that they can be easily cleaned. Penetrations in these surfaces shall be sealed or capable of being sealed to facilitate decontamination.
Page 33 - Laboratory clothing that protects street clothing (eg, long-sleeve solid-front or wrap-around gowns, nobutton or slipover jackets) shall be worn in the laboratory. Front-button laboratory coats are unsuitable. Laboratory clothing shall not be worn outside the laboratory and shall be decontaminated before it is sent to the laundry.