When Local Regulatory Intervention Becomes Local Regulatory Interference How To Reverse Inappropriate Regulations When Good Intentions Fail - PowerPoint PPT Presentation

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When Local Regulatory Intervention Becomes Local Regulatory Interference How To Reverse Inappropriate Regulations When Good Intentions Fail

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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. – PowerPoint PPT presentation

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Title: When Local Regulatory Intervention Becomes Local Regulatory Interference How To Reverse Inappropriate Regulations When Good Intentions Fail


1
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.
2
When Local Regulatory InterventionBecomesLocal
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

3
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

4
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

9
Initial Participants
  • Local Municipal Fire Protection Department
  • Responsible for Code Enforcement
  • Hazardous Material Response

10
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

11
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)

12
Typical Confined Space
13
Are Biosafety Cabinets Confined Spaces?
14
Are Biosafety Cabinets Confined Spaces?
15
So Whats Really Going On?
16
Is This Thinking Outside the Box ?
17
OR
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21
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

22
Why Did Other, Local Institutions Get Involved?
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To Be Sure, There Are Concerns
28
But, are Sprinklers the Appropriate Solution?
29
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

30
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

31
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

32
Results of Late Spring Conference
  • No Relief From Initial Requirement
  • Institution Seeks Additional Assistance

33
Other Developments
  • Agency Consultant Claims Stanford Has Already
    Installed Sprinklers in several Biosafety
    Cabinets ! !

34
What ?!?!?
35
Exhaustive Search Conducted
36
Results
  • No Sprinklers found in gt600 Biosafety Cabinets at
    Stanford University or Stanford University
    Hospital
  • Consultants Response Oh

37
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)

38
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

39
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

40
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

41
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

42
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)

43
Limitations / Conditions (cont.)
  1. The amount of ethanol shall not exceed 500ml
    (stored in approved cabinets)
  2. BMBL and Cal/OSHA protocols will be maintained
  3. New BSCs will be installed in fully sprinklered
    buildings
  4. Any electrical connection inside BSC must not be
    less than Class 1 Division 2
  5. Instructions for Use of BSC sign will be posted
    on all BSCs
  6. No changes in BSCs unless reported to Agency

44


Note receptacle placement
45
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.

46
Is it just a matter of time?
47
Different Teams Same Cause
48
No Rest for the Weary or Biosafety Professionals
49
Not To Be Vigilant Invites Disaster
50
Thank You !
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