Office of Research

Guidance, Regulations and Roles of Key Personel

This Biosafety Manual (BSM) provides a review of pertinent federal guidance and regulations, state regulations, information about safe work practices, safety equipment and personal protective equipment, and specific guidance for research with recombinant DNA (rDNA). Clemson’s Biological Safety Program is based on the premise that every member of the research community shares the responsibility for safety.

US Center for Disease Control’s (CDC) Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition is the key guidance document for Biosafety. Although BMBL5 only recommends practices (“We wish to emphasize that the 5th edition of the BMBL remains an advisory document recommending best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective, and is not intended as a regulatory document though we recognize that it will be used that way by some.” BMBL5 Forward), unless otherwise specifically stated herein, compliance with all BMBL5 recommendations is mandatory for all laboratory biological activities (research, teaching, public service). www.cdc.gov/biosafety/publications/bmbl5/

NIH Guidelines is also a key guidance document for this manual. Whereas BMBL5 recommends practices, NIH Guidelines specifies practices; “The purpose of the NIH Guidelines is to specify practices….” (NIH Guidelines Section I-A. Purpose). Although these NIH Guidelines closely follow the recommendations of BMBL5, in some cases the guidelines are more restrictive. In certain cases, this manual will adopt the more restrictive practices of the Guidelines, regardless of whether rDNA is involved. The advent of multi-PI labs precludes separate consideration of BMBL5 and the Guidelines. In such cases, the specific guideline will be referenced and explained. http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.pdf

South Carolina Regulation 61-105
 Infectious Waste Management governs management of infectious waste. http://www.scdhec.gov/environment/lwm/pubs/2010 Regs fin.pdf  

US Department of Transportation’s 49CFR Subchapter C Hazardous Materials Regulations governs shipment of infectious (biohazardous) materials.

http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&tpl=/ecfrbrowse/Title49/49cfrv2_02.tpl

The Institutional Biosafety Committee (IBC) reviews, approves and oversees rDNA research to ensure compliance with the 
NIH Guidelines, determines necessity of health surveillance of personnel, sets biosafety containment levels as required by the Guidelines, ensures proper training for IBC members, staff, PIs, and laboratory staff and reports any significant problems, violations or significant research-related 
accidents or illnesses to NIH within 30 days. See Appendix F.

The Infection Control Committee manages the infectious waste stream from generation until offered for transport. See Chapter 9.

 

The Biological Safety Officer (BSO) must: conduct lab inspections; develop emergency and reporting procedures; investigate lab accidents; report recombinant DNA incidents, violations of the Guidelines to the IBC; provide general biosafety training.

The Principal Investigator (PI) must: be proficient in good microbiological techniques; supervise staff to ensure safety practices are followed; instruct laboratory staff on the risk of agents used in the lab, safe work practices, emergency procedures for spills and exposures, and the reasons for vaccinations and serum collection, when applicable. The PI must ensure that: proper biosafety, biowaste, and shipping/ transport procedures are followed by staff; lab-specific SOPs are developed and followed for spills, exposure, loss of containment, and reporting research-related accidents and illnesses; biological containment is maintained; unsafe work errors are corrected.

 

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