Biosafety Cabinet Ventilation Requirements: Updating the CAL/OSHA Regulation

1. This presentation will probably involve audience discussion, which will create action items. Use PowerPoint to keep track of these action items during your presentation • In Slide Show, click on the right mouse button • Select “Meeting Minder” • Select the “Action Items” tab • Type in action items as they come up • Click OK to dismiss this box • This will automatically create an Action Item slide at the end of your presentation with your points entered. Biosafety Cabinet Ventilation Requirements: Updating the CAL/OSHA Regulation Martin Burke TSS, Inc. BSAF/BioNET Conference

2. About Technical Safety Services, Inc. • TSS is a 38 year old, national company with more NSF-accredited technicians than any anyone else • TSS derives about half of its budget from testing, certifying and maintaining Biological Safety Cabinets • We test ~14,000 BSCs/year in California BSAF/BioNET Conference

3. About Me… • I started testing fume hoods and BSCs as a work study student in 1980. • I am the 6th most senior ANSI/NSF-49 Accredited Biohazard Cabinet Field Certifier of the 316 ‘Certifiers world-wide BSAF/BioNET Conference

4. About CAL/OSHA and BSCs • Following the usual public process, and in response to industry needs, California acquired a new CAL/OSHA regulation on November 10, 1994: T8§5154.2. Ventilation Requirements for Biological Safety Cabinets BSAF/BioNET Conference

5. About T8§5154.2 • The regulation has provided instructions for the safe use of BSCs for 16 years • Prior to the regulation: • In academic settings, the need to certify BSCs was perceived as dependant on whether or not the PI received NIH funding • In other industries, even when BSCs were used to control workplace hazards, sometimes owners would not have them tested BSAF/BioNET Conference

6. So Why Change T8s5154.2? • The single most compelling reason to change the existing CAL/OSHA regulation for BSCs is that it cites an old version of the BMBL. BSAF/BioNET Conference

7. Implications of T8s5199 • The recently-enacted (and very recently described) CAL/OSHA Aerosol Transmissibe Disease regulation does not necessitate any changes in T8s5154.2. • However, since the ATD regulation discusses BSCs, it points out that it has not been updated in many years. BSAF/BioNET Conference

8. Changes in the BMBL • The NIH/CDC publication “Biosafety in Microbiological and Biomedical Laboratories’ [BMBL] cited in T8s5154.2 is the 3rd edition, and we are now on the 5th edition. • The substantive changes to the BMBL that affect T8s5154.2 are the “Type” designations for Class II BSCs BSAF/BioNET Conference

9. (Back-story on this Change in the BMBL) • The international reference standard for Class II BSCs is NSF/ANSI Standard 49 Class II Laminar Flow Biosafety Cabinetry • Basically, in 2002, the NSF-49 steering committee decided to change their nomenclature and BMBL’s editors followed. BSAF/BioNET Conference

10. BSC Classes and Types – Class I • The Class I BSC is an open-front, negative pressure, ventilated cabinet. Exhaust air is filtered by a high efficiency particulate air (HEPA) filter and discharged without internal recirculation • NO CHANGES BSAF/BioNET Conference

11. BSC Classes and Types – Class II/A1 • All Class II BSCs are open front, ventilated cabinets that provide HEPA filtered air to the exhaust and to the workspace. • Class II/A1 BSCs have positive pressure plenums, recirculate some air and may exhaust air into the laboratory • BMBL CHANGED “A” to “A1” BSAF/BioNET Conference

12. BSC Classes and Types – Class II/A2 • Class II/A2 BSCs have negative pressure plenums, recirculate some air and may exhaust air into the laboratory • BMBL CHANGED “A/B3” to “A2” BSAF/BioNET Conference

13. BSC Classes and Types – Class II/B1 • Class II/B1 BSCs have negative pressure plenums, recirculate some air and exhaust HEPA filtered air through external ducts and to space outside the laboratory. • NO CHANGES BSAF/BioNET Conference

14. BSC Classes and Types – Class II/B2 • Class II/B2 BSCs have negative pressure plenums, do not recirculate any air and exhaust HEPA filtered air through external ducts to space outside the laboratory. • NO CHANGES BSAF/BioNET Conference

15. BSC Classes and Types – Class III • Class III BSCs are negative pressure glove boxes. Supply air is HEPA filtered, and exhaust air is filtered by two HEPAs in series, and discharged to the outdoor environment without re-circulation. • NO CHANGES BSAF/BioNET Conference

16. Update language citing BMBL to 5th edition Change Class II BSC definitions: Known, Likely Changes to T8s5154.2 BSAF/BioNET Conference

17. The review and revision process is public and may include many several differing opinions about what should be included in the regulation TSS participated and played a significant role in the 1993 version of T8s5154.2 and we hope to do so again when the public hearings commence (sometime in 2010). Other Changes to T8s5154.2 ? BSAF/BioNET Conference

18. To further harmonize T8s5154.2 with safety features/concerns addressed in NSF-ANSI Standard 49, TSS hopes to discuss two issues in the review process: Thimble/Canopy Connections and Site Assessment Tests TSS’ Unofficial Agenda for Change BSAF/BioNET Conference

19. Thimble/Canopy Connections - 1 • The current text of T8s5154.2 allows for thimble connections to have a ribbon streamer attached to the edge of the thimble to indicate the direction of flow” BSAF/BioNET Conference

20. Thimble/Canopy Connections - 2 • TSS would like a discussion/clarification as to what direction the flow should be. (We think it should be into the thimble.) • System-variability (exhaust changes) at the thimble affect the BSC certification • An exhaust air flow alarm would be a better solution BSAF/BioNET Conference

21. Site Assessment Tests - 1 • Class II/B2 BSCs (total exhaust units) are among the most expensive BSCs to operate and maintain because of the extra air required and their dependence on an external fan system • Safety features that are a part of all Class II/B2 BSCs include interlocks that are designed to shut off the BSC supply fan promptly when the exhaust airflow falls more than 20% BSAF/BioNET Conference

22. Site Assessment Tests - 2 • Since 2002, testing of these interlocks are a part of the “Site Assessment Tests” section of NSF/ANSI Standard 49. • TSS would like a discussion regarding the testing and verification of these interlocks BSAF/BioNET Conference

23. End Comments • T8s5154.2 deserves to be revised and updated to restore its referential integrity. • Those updates will be done in an open format. TSS will attempt to be a part of that process. • Please participate to help make sure the final regulation is clear and useful. BSAF/BioNET Conference

24. Contact/Questions Martin Burke Manager, Engineering Services Technical Safety Services, Inc. 620 Hearst Street Berkeley, CA 94710 1.800.877.7742 mburke@techsafety.com BSAF/BioNET Conference