Biocontainment Construction Commissioning

1. 2009 Biocontainment Construction Commissioning Mike Brueggerhoff CxA

2. Input …. • Have you been involved? • Are you currently involved? • Will you be involved in the future?

3. Biocontainment Biosafety • Biocontainment One entry found. Main Entry: bio·con·tain·ment Pronunciation: \bī-ō-kən-ˈtān-mənt\ Function: noun Date: 1985 : the containment of extremely pathogenic organisms (as viruses) usually by isolation in secure facilities to prevent their accidental release especially during scientific research • Biosafety • One entry found. Main Entry: bio·safe·ty • Pronunciation: \ˌbī-ō-ˈsāf-tē\ • Function: noun • Date: 1977 • : safety with respect to the effects of biological research on humans and the environment http://www.merriam-webster.com/dictionary/biocontainment

4. Containment • A fundamental objective of any biosafety program is the containment of potentially harmful biological agents. The term "containment" is used in describing safe methods, facilities and equipment for managing infectious materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents. The use of vaccines may provide an increased level of personal protection. The risk assessment of the work to be done with a specific agent will determine the appropriate combination of these elements. BMBL, 5th ed. – Section III

5. Select Agents and Toxins The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A of Public Law 107-188 (42 U.S.C. 262a), requires DHHS (Dept of Health & Human Services) to regulate the possession, use, and transfer of biological agents or toxins (i.e., select agents and toxins) that could pose a severe threat to public health and safety. The Agricultural Bioterrorism Protection Act of 2002, Subtitle B of Public Law 107-188 (7 U.S.C. 8401), requires the USDA to regulate the possession, use, and transfer of biological agents or toxins (i.e., select agents and toxins) that could pose a severe threat to animal or plant health, or animal or plant products. These Acts require the establishment of a national database of registered entities, and set criminal penalties for failing to comply with the requirements of the Acts. In accordance with these Acts, DHHS and USDA promulgated regulations requiring entities to register with the CDC or the APHIS if they possess, use, or transfer a select agent or toxin (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121). CDC and APHIS coordinate regulatory activities for those agents that would be regulated by both agencies (“overlap” select agents). BMBL, 5th ed. – Appendix F

6. Select Agent • Select Agent • :Select agents are chemically, physically, or biologically active principles capable of producing an effect that Health and Human Services considers to have the potential to pose a severe threat to human health Examples • Abrin Bacillus anthracis • Botulinum neurotoxins Brucella abortus • Botulinum neurotoxin producing species of Clostridium Brucella melitensis • Cercopithecine herpesvirus 1 (Herpes B virus) Brucella suis • Clostridium perfringens epsilon toxin Burkholderia mallei (formerly Pseudomonas mallei) • Coccidioides posadasii/Coccidioides immitis Burkholderia pseudomallei (formerly Pseudomonas • Conotoxins pseudomallei) • Coxiella burnetii Hendra virus • Crimean-Congo haemorrhagic fever virus Nipah virus • Diacetoxyscirpenol Rift Valley fever virus • Eastern Equine Encephalitis virus Venezuelan Equine Encephalitis virus • Ebola virus • Francisella tularensis

7. A to Z … High Containment BSL3 & BSL4 Articles have been and continue to be written on HC Biocontainment + Cx. These articles carry the same theme …. • Very Complex Projects • Construction Schedule Drives the project = NO • Architectural Dependencies • User Engaged = MUST • Documentation – Cx to Certification • Select Agent Certification • Compliance - Guidelines

8. Biosafety Guides and Publications

9. Affects of 9/11 and Anthrax Attack • USA Patriot Act (Signed 10/01)& Public Health Security and Bioterrorism Preparedness and Response Act of 2002 – spawned the Select Agent rule • Department of Homeland Security (DHS) – Project Bioshield, new interagency campus • NIAID develops Strategic Plan for Biodefense Research 2/2002 – • RCE/NBL/RBL • Emphasis on National Lab Network – Public Health

10. Industry Trends • Since 2001 number of BSL-3 and BSL-4 laboratories has more than tripled. • No formal checklist of certification tasks and requirements exists for the building process. • Agencies place the responsibility with the owner or end user to develop a detailed account of the building, its systems, and its methods to safely conduct research. • Select Agent rule requires institutions to notify DHS via CDC or USDA of possession of specific pathogen or toxins http://animallabnews.com/articles.asp?pid=187 http://www.gao.gov/products/GAO-08-108T

11. http://www.gao.gov/products/GAO-08-108T Full Report GAO-08-108T Page 9-10 2007

12. Operational Oversight Who’s in Charge? http://www.gao.gov/products/GAO-08-108T Full Report GAO-08-108T Page 13 2007

13. Risk Assessment • Modes of transmission determine classification of laboratory and required containment design • Select agents classified as life threatening and/or incurable also determine classification of laboratory and required containment design http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s2.htm

14. Biocontainment Facilities BSL-1 Typical undergraduate research laboratory, few restrictions, few safety features, generally unrestricted access BSL-2 Trained personnel, some additional safety features, safety cabinets are present, no ventilation requirements, access restricted during experiments http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s2.htm

15. High Containment Facilities BSL-4 Highly trained and expert personnel, extreme health risk, highly infectious diseases, extremely restricted access, all work must be performed wearing a pressurized and ventilated suit, laboratory in complete isolation from rest of building, all work documented. BSL-3 Trained and verified personnel, great risk of infection, work performed within safety cabinets or other containment equipment, double doors, greater restricted access, independent ventilation systems, impermeable workspace BSL-3Ag Agricultural facility for large animals, highly trained and expert personnel, great risk of infection amongst animals and plants, as well as humans, greater restricted access, sewage decontamination and exit showers in addition to BSL-3 requirements, impermeable workspace http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4s2.htmhttp://www.afm.ars.usda.gov/ppweb/PDF/601-2-ARS.pdf

16. BSL Configurations • BSL = working with a Select Agent in a Lab • ABSL = working with a Select Agent in an Animal in a Lab • Either can require “enhancement” based on the agent • Enhancement is site specific and determined by Risk Assessment • Pathogens affecting livestock researched in labs or with small animals would need enhanced type of BSL-3 (lab) or ABSL-3 (animals) • Pathogens affecting livestock researched in labs or with large animals would need BSL-3Ag

17. Primary and Secondary Containment Examples Envelope Barriers

18. Primary Barrier Glove Box

19. Primary Barrier PPE Body Suit

20. Secondary Barrier Air Pressure Resistant (APR) Door

21. Secondary Barrier DSCS Leak Detection EDS

22. Lab Envelope Secondary Barrier Dunk Tank HEPA Researcher Safety Alarms Windows Deep Traps Bioseal Damper

23. Construction BioCx … • Different kinds of facilities • Different kinds of systems • Unique Risks • Accountability and Oversight • Individual and Public Safety

24. High Containment is CxCentric • Focus • Communication • Documentation • Containment • Life Safety

25. Construction BioCx … Fundamentals • Focus • Big picture thinking – CM to Subs to Owner. • The User needs to be engaged – SOP’s. • CxA gives the user a functional building. • User confidence without concern of operational glitches.

26. Construction BioCx … Fundamentals • Communication • Communication is key amongst the entire team. • Project meetings must occur. • There will be Endurance issues once occupied • “Lessons Learned” is valuable

27. Construction BioCx … Fundamentals • Documentation • No Documentation – No Certification • Checklists, FPT’s, IST’s and special challenge testing • System Mapping can help everyone – put the systems together

28. Construction BioCx … Fundamentals • Containment • Pressure Decay – back boxes, envelopes, special devices • Envelope Seal – Architectural Dependencies • Pressure Control • Stable Envelope Control (Terminal Units)

29. Construction BioCx … • Sample Envelope Loop Tune

30. Construction BioCx … • Sample Envelope Loop Tune

31. Construction BioCx … • Sample Envelope Loop Tune

32. Construction BioCx … • Sample Envelope Loop Tune

33. Construction BioCx … • Sample Envelope Loop Tune

34. Construction BioCx … Fundamentals • Life Safety • Fire • Security (egress) • Breathing Air • Leak Detection

35. High Containment Commissioning Process

36. High Containment Commissioning Process

37. Construction BioCx … Fundamentals • Final IST • Fire • Security (egress) • Spore Samples • FMCS • Power

38. High Containment Commissioning Process

39. Websites: • AALAS – http://www.aalas.org/index.aspx • ARS – http://www.ars.usda.gov/main/site_main.htm?modecode=19-40-00-00 • CDC – http://www.cdc.gov/ • Office of Biotechnology Activities – http://oba.od.nih.gov/oba/about_oba.html • DHHS – http://www.hhs.gov/ • NIH – http://www.nih.gov/ • USDA APHIS – http://www.aphis.usda.gov/

40. Questions & Comments