THE ROLE OF UNIVERSITY OF NEW MEXICO S INSTITUTIONAL BIOSAFETY COMMITTEE IBC

1. THE ROLE OF UNIVERSITY OF NEW MEXICO�S INSTITUTIONAL BIOSAFETY COMMITTEE(IBC) Judy Pointer University Biosafety Officer July 2003

2. IBC RESPONSIBILITIES Review and approve research involving the following hazardous agents: rDNA molecules in living cells (humans, vertebrates & RG 2-4 microbes) in vivo and in vitro Microbial pathogens of humans of Risk Group (RG) 1-4 Select Microbial Agents & Biotoxins produced by microorganisms that are listed as potential bioterrorism agents USDA restricted microbial pathogens of domestic animals and plant crops Human and non-human primate materials that could contain Bloodborne pathogens Xenotransplants to humans

3. NIH RECOMBINANT DNA GUIDELINEShttp://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm federal guidelines for safely handling recombinant DNA (rDNA) molecules affecting humans, animals & plants establishes rules & responsibilities for IBCs

4. DEFINITIONS rDNA: 1. Molecules constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell; or 2. DNA molecules that result from the replication of those described above.

5. RISK GROUPS- APPDX BCLASSIFICATION OF ORGANISMS Risk Group (RG): Appendix B of NIH Guidelines RG1: not known to cause disease (E. coli lab strains) RG2: rarely serious disease, with therapeutic intervention (Staphylococcus aureus) RG3: serious, lethal disease with therapeutic intervention (Mycobacteria tuberculosis) RG4: serious, lethal disease with no therapeutic intervention (Ebola virus)

6. RISK ASSESSMENT � Sec II Review classification of organism Review research procedures to be performed Assess available facility/physical barriers (biosafety levels) Potential for inadvertent release Other factors, such as volume, concentration, replication competency

7. PROTOCOL CATEGORY - Sec III A: NIH Director & RAC, IBC � drug resistant trait B: NIH/OBA & IBC � toxin gene of LD50 < 100 nanograms/Kg C: RAC, HRRC, IBC � HGT = human gene therapy or transfer D: IBC � RG 2-4 (host/vector systems, into whole animals, clones from RG 2-4 agents into non-pathogenic prokaryotes) E: IBC notification � if DNA < 2/3 viral genome, or purchased transgenic animals

8. EXEMPT Sec III F: Recombinant DNA that is: Not in organisms Not a risk to the environment or public health

9. UNM RESPONSIBILITIES Sec IV Ensure compliance with NIH Guidelines Establish IBC Appoint a Biosafety Officer Ensure IBC has expertise in the research that is reviewed and IBC Chair, BSO, members are trained Establish a medical surveillance program Report accidents to the NIH

10. MEMBER RESPONSIBILITIES Sec IV The review shall include: independent assessment of the containment levels required by the NIH Guidelines assessment of the facilities, procedures, practices, training, and expertise of personnel involved in rDNA research. (IV-B-2-b-(1))

11. IBC: CONFLICT OF INTEREST No member of an IBC may be involved (except to provide information requested by the IBC) in the review or approval of a project in which he/she has been or expects to be engaged or has a direct financial interest. lV-B-2-a-(4)

12. IBC ADMINISTRATIVE REQUIREMENTS Upon request, UNM shall make available to the public all IBC meeting minutes and any documents submitted to or received from funding agencies. All laboratory accidents or incidents involving rDNA molecules must be reported to NIH, OBA. Adverse events in HGT experiments must be reported to NIH / OBA if both unexpected and associated with the use of the gene transfer product. File an annual report with NIH/OBA concerning IBC member composition and qualifications

13. IBC ADMINSITRATIVE REQUIREMENTS If public comments are made on IBC actions, the institution shall forward both the public comments and the IBC�s response to: Office of Biotechnology Activities, National Institutes of Health/MSC 7010, 6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010 (301) 496-9838.

14. MICROBIAL PATHOGENS - BMBLhttp://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm CDC�S BIOSAFETY in MICROBIOLOGICAL and BIOMEDICAL LABORATORIES (BMBL) the federal reference document for biosafety when handling non-rDNA viable microorganisms affecting humans (live vaccines, wild-type microbes, lab strains used in research). the IBC reviews non - rDNA applications for compliance with this guideline

15. BMBL Types of human pathogens covered by the BMBL

16. BIOSAFETY TOPICS COVERED BY BMBL Biosafety levels Risk assessment Biological safety cabinet use Lab security & emergency response Transport and transfer of microorganisms Human & primate cell use Agent summary statements Vaccines / medical surveillance USDA restricted animal pathogens Biological toxins Pest management

17. Biosafety Levels

18. Select Agents 42 CFR 73 Possession, Use, and Transfer of Select Agents and Toxins implements provisions of Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188 Requires possessors of certain microorganisms and biotoxins to register with federal government agencies and control access to these agents (FBI, CDC & USDA) UNM has several agents that fall into this category All are handled in special BSL3 labs with strict Biosafety & Biosecurity controls Responsible Official appointed by UNM. Stiff criminal and civil penalties for non-compliance

19. Bloodborne Pathogens 29 CFR 1910 Bloodborne Pathogen Standard (BBP) provisions of OSHA (Occupational Health and Safety code) Requires users of certain viable materials (human and non-human primate) to use a set of safety precautions to guard against accidental exposure to HIV, HCV, HBV and other BBPs. Hepititis B vaccine & annual BBP training All are handled in BSL2 labs in research areas

20. Non-compliance consequesnces Forfeiture of NIH funding or suspensions Substantial criminal &/or civil penalties for individual employees or institute Denial of JACHO accreditation Denial of AAALAC accreditation Denial of research grant funding FDA suspension of Human trials

21. So how can administrators help UNM investigators comply? Be aware of which hazardous biological agents PIs in your department handle. Agent inventory requirements coming. Find out the room number(s) where they do the work. Be sure each agent has a faculty member in charge. Ask the Biosafety Office if the IBC knows about the work, IBC@salud.unm.edu or call the BSO at 2-8001. Keep records of the biosafety related training and medical surveillance required of the staff in your department. Keep copies of the IBC approved protocols for the PIs in your department. Respond to information requests from the Biosafety Office as a liaison for your department. Pay attention to shipments of new biological materials into your area (lots of shipping regulations).

22. CONCLUSION This presentation was designed to inform the audience of some key provisions of UNM�s Biosafety Program with regards to the scope of IBC responsibilities at UNM. The IBC must interact as necessary with other institutional committees and ensure that research, conducted at UNM involving hazardous biological agents, encompass biosafety measures consistent with regulatory and institutional directives.