warning ! this presentation is based on actual events. specific names have been intentionally...
TRANSCRIPT
![Page 1: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/1.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
WARNING !
This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure to pay attention to the contents of this presentation may result in severe financial and operational penalties.
![Page 2: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/2.jpg)
When Local Regulatory InterventionBecomes
Local Regulatory Interference
How To Reverse Inappropriate Regulations When Good Intentions Fail
David Silberman
Stanford University School of Medicine, Stanford, CA
Robert Hashimoto
University of California, Berkeley, Berkeley, CA
American Biological Safety Association
51st Annual Biological Safety Conference
Reno, Nevada
October 21, 2008
![Page 3: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/3.jpg)
Presentation Objectives
• Recognition that no matter how absurd you believe things can get, you’re wrong
• Logic does not always prevail or even make headway (but you already knew that)
• When and where to ask for help• Overcoming objections to create a win-win (almost)
outcome• Accepting partial wins and moving on• Developing strategies to prevent future occurrences
![Page 4: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/4.jpg)
The Issue
Local Agency Requires Installation Of Automatic Sprinklers Inside
Biosafety Cabinet
![Page 5: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/5.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.QuickTime™ and a
TIFF (LZW) decompressorare needed to see this picture.
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 6: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/6.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 7: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/7.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 8: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/8.jpg)
Initial Participants
• Independent, Nonprofit Research Institute – conducting client sponsored research and development for:• government agencies• commercial businesses• foundations
– Brings its innovations to the marketplace by licensing its intellectual property and creating new ventures
![Page 9: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/9.jpg)
Initial Participants
• Local Municipal Fire Protection Department– Responsible for Code Enforcement– Hazardous Material Response
![Page 10: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/10.jpg)
Initial Participants
• Consultant to Fire Department– Well known, highly respected expert on
Fire Codes and Hazardous (chemical) Materials
– No professional expertise with biological organisms or biosafety practices
![Page 11: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/11.jpg)
Rationale for Requirement
• Code (local) Based – Requires automatic fire sprinkler protection
in all concealed spaces
• Influenced / encouraged by well-known consultant (primary expertise in hazardous chemicals)
![Page 12: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/12.jpg)
Typical Confined Space
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 13: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/13.jpg)
Are Biosafety Cabinets Confined Spaces?
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 14: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/14.jpg)
Are Biosafety Cabinets Confined Spaces?
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 15: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/15.jpg)
So What’s Really Going On?
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 16: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/16.jpg)
Is This Thinking Outside the Box ?
![Page 17: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/17.jpg)
OR
![Page 18: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/18.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 19: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/19.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 20: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/20.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 21: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/21.jpg)
Chronology
• Spring 2007– Local Fire Department Inspects Institution and Require
Install Automatic Sprinklers for a Biosafety Cabinet in BSL-3– Initial Discussions to Reverse Requirement Failed– Assistance From Other, Out-of-local Jurisdiction
Institutions*, Requested– Additional Meetings / Discussions Held: Requirement Stands
* Included Stanford and UC Berkeley
![Page 22: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/22.jpg)
Why Did Other, Local Institutions Get Involved?
![Page 23: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/23.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 24: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/24.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.Note Penalty Flag
![Page 25: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/25.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 26: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/26.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 27: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/27.jpg)
To Be Sure, There Are Concerns
QuickTime™ and aTIFF (Uncompressed) decompressor
are needed to see this picture.
![Page 28: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/28.jpg)
But, are Sprinklers the Appropriate Solution?
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 29: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/29.jpg)
Arguments Presented Against Installation of Sprinklers
• BSL-3 organisms cause disease in healthy humans by inhalation
• Biosafety Cabinet (BSC) is a Primary enclosure to protect the worker
• BSC prevents release of BSL-3 Organisms• Discharge of a pressurized device within the cabinet
will force the contents to be expelled into the room and contaminate occupants
![Page 30: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/30.jpg)
Potential Outcomes Explained
• An occupational exposure to occupants will occur
• Release of disease causing micro-organisms into the room and possibly beyond
• Possible exposure / contamination of emergency responders
![Page 31: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/31.jpg)
Alternatives Proposed
• Limit chemical use, including flammables and combustibles in Biosafety Cabinet
• Prohibition on Chemical Storage
• BSC SOPs will comply with CDC and OSHA requirements
• Any change will be reported to agency
![Page 32: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/32.jpg)
Results of Late Spring Conference
• No Relief From Initial Requirement
• Institution Seeks Additional Assistance
![Page 33: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/33.jpg)
Other Developments
• Agency Consultant Claims Stanford Has Already Installed Sprinklers in several Biosafety Cabinets ! !
![Page 34: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/34.jpg)
What ?!?!?
![Page 35: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/35.jpg)
Exhaustive Search Conducted
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
![Page 36: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/36.jpg)
Results
• No Sprinklers found in >600 Biosafety Cabinets at Stanford University or Stanford University Hospital
• Consultant’s Response: “Oh…”
![Page 37: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/37.jpg)
Additional Assistance• Letter from CDC Rejects Sprinkler Installation
– Voids Manufacturer’s Warranty and NSF Certification
– Impedes Exhaust– Laminar Flow not ensured– Relocation of BSC virtually impossible– Effective and safe handling compromised– Serious containment breach / contamination– Contaminated water– Decontamination issues with sprinkler head– Additional points (3 page rebuttal or requirement)
![Page 38: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/38.jpg)
Additional Assistance (continued)
• Major Safety Service / Certification Vendor Unequivocally Does Not Recommend Practice– Supports CDC– Offers list of governmental, academic, biotech and
Big Pharma labs that do not use sprinklers in BSCs
• Stanford Fire Marshal’s Office Offers Support– Discusses with other fire marshals– Language written amending CA Fire Code,
specifically citing exemptions for Biosafety Cabinets
![Page 39: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/39.jpg)
Additional Assistance (continued)• ABSA
– Discusses use of natural gas in BSCs– UL listing– Annual Certifications– NSF and Warranty Implications– Flow / Containment Disruptions
• BSAF / BIONET– Topic part of September 2007 Joint Symposium– Agency Consultant’s Company represented
![Page 40: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/40.jpg)
Additional Assistance (continued)
• Direct communication from many colleagues in academia and private sector– “WORST Idea I’ve ever heard”– Retrofitting costs, headaches, untenable research
disruptions
• “Behind-the-Scenes” Activities– Local Fire Departments asked for input– State Fire Chief’s Association involved– Informal discussions among fire protection professionals
![Page 41: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/41.jpg)
Next Steps
• September 2007– Institution submits another request for variance
from local fire protection agency:• Permission to install BSCs without internal automatic fire
sprinkler protection
– Fire protection agency responds• Approves request subject to 11 specified limitations and
restrictions to all new and existing BSCs
![Page 42: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/42.jpg)
Limitations / Conditions
1. Physically remove natural gas source and other compressed gas piping and valves from inside BSCs
2. No open flames inside BSC3. Fire extinguisher (2A-10BC) within 30 feet4. No flammable / combustible liquid or
pressurized cylinders within BSCs5. All equipment / agents to be removed from
BSC prior to decontamination (with ethanol)
![Page 43: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/43.jpg)
Limitations / Conditions (cont.)6. The amount of ethanol shall not exceed 500ml
(stored in approved cabinets)7. BMBL and Cal/OSHA protocols will be
maintained8. New BSCs will be installed in fully sprinklered
buildings9. Any electrical connection inside BSC must not be
less than Class 1 Division 2*10. “Instructions for Use of BSC” sign will be posted
on all BSCs11. No changes in BSCs unless reported to Agency
![Page 44: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/44.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
Qu
ickTim
e™
an
d a
TIF
F (L
ZW
) decom
pre
ssor
are
need
ed
to se
e th
is pic
ture
.
* *
Note receptacle placement
![Page 45: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/45.jpg)
Consequences
• Any violation of limitations / conditions or Fire Code regarding use of a BSC, or any fire that occurs with the origin determined to be at the BSC shall constitute a violation of the variance.
• A violation of the variance shall require all new and existing BSCs to have internal fire sprinkler protection installed within 90 days of the violation.
![Page 46: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/46.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
Is it just a matter of time?
![Page 47: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/47.jpg)
Different Teams; Same Cause
![Page 48: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/48.jpg)
QuickTime™ and aTIFF (LZW) decompressor
are needed to see this picture.
No Rest for the Weary or Biosafety Professionals
![Page 49: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/49.jpg)
Not To Be Vigilant Invites Disaster
QuickTime™ and aTIFF (Uncompressed) decompressor
are needed to see this picture.
![Page 50: WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure](https://reader036.vdocuments.net/reader036/viewer/2022062417/55189b45550346a61f8b462e/html5/thumbnails/50.jpg)
Thank You !