Presentation on theme: "WARNING ! This presentation is based on actual events. Specific names have been intentionally omitted to protect the innocent but mostly the guilty. Failure."— Presentation transcript:
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 Intervention Becomes 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 51 st Annual Biological Safety Conference Reno, Nevada October 21, 2008
Presentation Objectives Recognition that no matter how absurd you believe things can get, youre 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
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)
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?
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 ! !
Results No Sprinklers found in >600 Biosafety Cabinets at Stanford University or Stanford University Hospital Consultants Response: Oh…
Additional Assistance Letter from CDC Rejects Sprinkler Installation –Voids Manufacturers 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 Marshals 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 Consultants Company represented
Additional Assistance (continued) Direct communication from many colleagues in academia and private sector –WORST Idea Ive ever heard –Retrofitting costs, headaches, untenable research disruptions Behind-the-Scenes Activities –Local Fire Departments asked for input –State Fire Chiefs 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 BSC 3.Fire extinguisher (2A-10BC) within 30 feet 4.No flammable / combustible liquid or pressurized cylinders within BSCs 5.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 maintained 8.New BSCs will be installed in fully sprinklered buildings 9.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 BSCs 11.No changes in BSCs unless reported to Agency
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.