RDNA REGISTRATION FORM INSTRUCTIONS


Biosafety Levels

Biosafety levels define laboratory practices and containment requirements that are used with biological materials, including recombinant DNA molecules. The four biosafety levels increase in number with increased hazard and required protection of personnel, the environment and the community. For specific practices and containment criteria for research using plants or animals, please see Appendix P or Appendix Q of the NIH Guidelines.

Biosafety Level 1 (BSL-1) is suitable for work involving agents of unknown or minimal potential hazard to laboratory personnel and the environment. The laboratory is not separated from the general traffic patterns in the building. Work is generally conducted on open bench tops. Special containment equipment is not required or generally used. Laboratory personnel have specific training in the procedures conducted in the laboratory and are supervised by a scientist with general training in microbiology or a related science (see Appendix G-III-B, Footnotes and References of Appendix G). (NIH Guidelines, Appendix G-III-M)

Biosafety Level 2 is similar to Level 1 and is suitable for work involving agents of moderate potential hazard to personnel and the environment. It differs in that: (1) laboratory personnel have specific training in handling pathogenic agents and are directed by competent scientists; (2) access to the laboratory is limited when work is being conducted; and (3) certain procedures in which infectious aerosols are created are conducted in biological safety cabinets or other physical containment equipment (see Appendix G-III-B, Footnotes and References of Appendix G). (NIH Guidelines, Appendix G-III-N)

Biosafety Level 3 is applicable to clinical, diagnostic, teaching, research, or production facilities in which work is conducted with indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation route. Laboratory personnel have specific training in handling pathogenic and potentially lethal agents and are supervised by competent scientists who are experienced in working with these agents. All procedures involving the manipulation of infectious material are conducted within biological safety cabinets or other physical containment devices or by personnel wearing appropriate personal protective clothing and devices. The laboratory has special engineering and designfeatures. It is recognized, however, that many existing facilities may not have all the facility safeguards recommended for BL3 (e.g., access zone, sealed penetrations, and directional airflow, etc.). In these circumstances, acceptable safety may be achieved for routine or repetitive operations (e.g., diagnostic procedures involving the propagation of an agent for identification, typing, and susceptibility testing) in laboratories where facility features satisfy BL2 recommendations provided the recommended "Standard Microbiological Practices," "Special Practices," and "Containment Equipment" for BL3 are rigorously ollowed.
The decision to implement this modification of BL3 recommendations should be made only by the Principal Investigator. (NIH Guidelines, Appendix G-III-P)


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Category of Review

The following sections from the NIH Guidelines explain which projects are covered, and to which category they belong.

Helpful Hints

  • Make sure you answer all questions on the form.
  • Check the biosafety level to be sure you have marked the appropriate one for your project.
  • Check the NIH Guidelines to be sure you have chosen the correct category of review.
  • Be sure to include a technical summary.
  • Be sure to include a non-technical summary.
  • Leave adequate time for the committee to review and discuss your project. This usually takes 6-8 weeks.

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If you have further questions, see the Frequently Asked Questions section.


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