warning ! this presentation is based on actual events. specific names have been intentionally...

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.

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




are needed to see this picture.QuickTime™ and a

TIFF (LZW) decompressorare needed to see this picture.





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


• Local Municipal Fire Protection Department– Responsible for Code Enforcement– Hazardous Material Response


• 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



Are Biosafety Cabinets Confined Spaces?



Are Biosafety Cabinets Confined Spaces?


are needed to see this picture.QuickTime™ and aTIFF (LZW) decompressor


So What’s Really Going On?



Is This Thinking Outside the Box ?

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?


are needed to see this picture.Note Penalty Flag

To Be Sure, There Are Concerns

QuickTime™ and aTIFF (Uncompressed) decompressor


But, are Sprinklers the Appropriate Solution?



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



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





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

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.



Is it just a matter of time?

Different Teams; Same Cause



No Rest for the Weary or Biosafety Professionals

Not To Be Vigilant Invites Disaster

QuickTime™ and aTIFF (Uncompressed) decompressor


Thank You !

warning ! this presentation is based on actual events. specific names have been intentionally...

Documents

requirement slide

agency slide

biosafety cabinet slide

additional assistance

uc berkeley slide

typical confined space

note penalty flag slide

biosafety cabinets