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10 CFR 851 and Biosafety

10 CFR 851 and Biosafety. Division Safety Coordinator Meeting 10 CFR 851 Worker Health & Safety Program and Biosafety Overview for DSCs. Presented by Bruce King EH&S Industrial Hygiene Biosafety Program 9 February 2007. Key Points.

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10 CFR 851 and Biosafety

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  1. 10 CFR 851 and Biosafety Division Safety Coordinator Meeting 10 CFR 851 Worker Health & Safety Program and Biosafety Overview for DSCs Presented by Bruce King EH&S Industrial Hygiene Biosafety Program 9 February 2007

  2. Key Points • Structured approach to identify, assess, control, & document hazards • Biological Etiologic Agents (human pathogens) and Select Agents (bio-terrorist agents) • OSHA Regulations • OSHA Bloodborne Pathogens (BBP) Standard

  3. Etiologic & Select Agents10 CFR 851, Appendix A, Section 7 • Work at LBNL • 4 PIs at 2 primary locations • 17 bacteria • 3 Divisions: ESD, LSD, PBD • Requirements • Agent inventory • Reporting to DOE BSO • Institutional Biosafety Committee Review • Security & emergency plan review

  4. Bloodborne Pathogen (BBP) StdOSHA 29 CFR 1910.1030 & 10 CFR 851.23(a)(3) • Applies to human blood, BBPs, some fluids, tissues, and cells (PUB-3000, Table 26-2) • 5 Divisions: ALS, ESD, LSD, MSD, PBD • 20 more PIs/operations now covered by the OSHA BBP Standard • Example Requirements • Biological Use Authorization/Exposure Control Plan • Specific engineering, admin, and PPE controls • Initial and annual training • Hepatitis B medical surveillance

  5. Biological Work Review, Documentation, and Authorization PUB-3000, Biosafety, Table 26-3 Define work, evaluate hazards, implement containment, and ensure work is authorized • Biological Use Notification(3-year) • Risk Group 1, Biosafety Level 1, not rDNA • Biological Use Registration(2-year) • RG1, BL1, rDNA • Biological Use Authorization(1-year) • RG2, BL2 NIH Funding & Guidelines apply to recombinant research

  6. Biosafety Institutional Priorities(next six months) • Human pathogen work (4) • OSHA Bloodborne Pathogen work (33) & Biological Use Authorizations (+10) • Biological Use Registrations (7) • Biological Use Notifications (48) Divisions and EH&S Biosafety Program need to work together

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