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Transcript of WARNING ! This presentation is based on actual events. Specific names have been intentionally...
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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.
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
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
The Issue
Local Agency Requires Installation Of Automatic Sprinklers Inside
Biosafety Cabinet
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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
Initial Participants
• Local Municipal Fire Protection Department– Responsible for Code Enforcement– Hazardous Material Response
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
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)
Typical Confined Space
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Are Biosafety Cabinets Confined Spaces?
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Are Biosafety Cabinets Confined Spaces?
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So What’s Really Going On?
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Is This Thinking Outside the Box ?
OR
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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
Why Did Other, Local Institutions Get Involved?
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QuickTime™ and aTIFF (LZW) decompressor
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To Be Sure, There Are Concerns
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But, are Sprinklers the Appropriate Solution?
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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
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
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
Results of Late Spring Conference
• No Relief From Initial Requirement
• Institution Seeks Additional Assistance
Other Developments
• Agency Consultant Claims Stanford Has Already Installed Sprinklers in several Biosafety Cabinets ! !
What ?!?!?
Exhaustive Search Conducted
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Results
• No Sprinklers found in >600 Biosafety Cabinets at Stanford University or Stanford University Hospital
• Consultant’s Response: “Oh…”
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)
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
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
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
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
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)
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
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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.
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Is it just a matter of time?
Different Teams; Same Cause
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No Rest for the Weary or Biosafety Professionals
Not To Be Vigilant Invites Disaster
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Thank You !