Chapter 1 Guidance, Regulations and Roles of Key Personnel

1.1 Introduction 

 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). Arkansas State’s Biological Safety Program is based on the premise that every member of the research community shares the responsibility for safety. 

 1.2 Guidance 

 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). 

 Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition | CDC Laboratories 

 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 BMBL6, 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 BMBL6 and the Guidelines. In such cases, the specific guideline will be referenced and explained. 

 NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) 

 1.3 Regulations 

 Ark. Code Ann. § 20-7-109 and Ark. Code Ann. §§ 20-32-101 - 112 Rules and Regulations Pertaining to the Management of Medical Waste from Generators and Health Care Related Facilities governs management of biological waste. 

 Medical_Waste_Regs_2016_FINAL.pdf 

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

 eCFR :: 49 CFR Chapter I Subchapter C -- Hazardous Materials Regulations 

 1.4 Roles of Key Personnel 

 1.4.1 Institutional Biosafety Committee (IBC) 

 

 Review, approve and oversee rDNA research to ensure compliance with the NIH Guidelines. 

 Determines necessity of health surveillance of personnel 

 Set biosafety containment levels as required by the Guidelines 

 Ensure proper training for IBC members, staff, PIs, and laboratory staff and 

 Report any significant problems, violations or significant research-related accidents or illnesses to NIH within 30 days. See Appendix F. 

 Provide expert advice to the BSO in helping ensure safe research with hazardous biological materials 

 

 1.4.2 Biological Safety Officer 

 The Biological Safety Officer (BSO) should: 

 

 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 and 

 Serve on the IBC as a voting member 

 Ensure safe research with all hazardous biological materials 

 

 1.4.3 Principal Investigator 

 The Principal Investigator (PI) should: 

 

 Be proficient in good microbiological techniques 

 Supervise staff to ensure safety practices are followed 

 Develop lab-specific SOPs for spills, exposures and/or loss of containment 

 Report research-related accidents and illnesses 

 Correct unsafe work practices 

 Ensure biological containment is maintained and 

 Instruct laboratory staff on:

 

 The risk of agents used in the lab 

 Safe work practices 

 Emergency procedures for spills and exposures 

 The reasons for vaccinations and serum collection, when applicable The PI must ensure that: proper biosafety, biological waste, 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.