Botulinum in the Research Laboratory EHS Controls

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Botulinum in the Research Laboratory - EHS
Controls

• Presented by
• Lisa Wisser, CIH
• AIHCE - June 6, 2001

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Outline

• Botulinum Background
• Exposure Controls
• Engineering
• Administrative
• PPE
• Program Management

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What is Botulinum Toxin?

• Produced by Clostridium botulinum
• Toxic effect on axons of motor neurons
• Prevents release of acetylcholine, blocking
  neuromuscular transmission
• Causes cranial nerve and skeletal muscle
  paralysis

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More on Botulinum Toxin

• LD50 (mouse) 1 ng/kg

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Exposure Controls

• Laboratory design requirements
• Codes UBC, UFC
• OSHA regulations 8 CCR 5191 (CHP) and 8 CCR 5154
  (fume hoods/biosafety cabinets)
• CDC/NIH Biosafety in Microbiological and
  Biomedical Laboratories (BMBL), Guidelines for
  Work with Toxins of Biological Origin

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Engineering Controls

• Laboratory design issues for this project
• Ventilation
• Access control
• Storage

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Ventilation

• Establish pressuredifferentials
• Local exhaust ventilation
• Bench-top fume hood
• Biosafety cabinet
• Problem - not enough LEV for both

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Ventilation

• Biosafety Cabinet vs. Fume Hood

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Access Control and Storage

• Why? Bot toxin is a Select Agent
• What
• Key lock for main door
• Padlocks for refrigerator, freezer, incubator

(--)
(--)
BSC
I
F
(-)
R
FH
()
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Administrative Controls

• Laboratory Registration/Select Agent Transfer
  Program
• 42 CFR 72.6 Additional requirements for
  facilities transferring or receiving select
  agents
• From the Antiterrorism and Effective Death
  Penalty Act of 1996
• Requires registration with the CDC

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Administrative Controls

• Approval by Institutional Biosafety Committee
• Biological Use Authorization form
• Chemical Hygiene Plan
• Toxin-specific addendum
• checklist for facility requirements
• work practices
• emergency procedures (spills and exposures)
• toxin information

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Administrative Controls

• Training
• Laboratory biosafety
• Toxin-specific session
• Annual refresher with Occupational Physician
• Medical Surveillance
• Vaccine and antitoxin available

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Administrative Controls

• Inventory Control System
• Locked storage areas
• Inventory control log
• amount received
• amount removed, by whom, date
• amount remaining
• final disposition

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Administrative Controls

• Sign, Labels, etc.
• Toxins in Use - Authorized Personnel Only on
  door
• Biohazard labels
• MSDSs in lab

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Administrative Controls

• Decontamination
• Waste handling

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PPE
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Program Management

• Management by Inspection
• Locks and inventory log
• Work practices
• PPE
• Waste
• Continuous review and improvement
• e.g., emergency procedures, waste handling

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Summary

• Botulinum toxin potential hazard
• Ensure facility is adequate to control hazard
• Impose myriad of administrative controls provide
  assistance in meeting requirements
• Update the program as needed

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Useful Resources

• http//www.cdc.gov/od/ohs/default.htm (CDC OHS)
• http//www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.h
  tm (BMBL)
• http//www.cdc.gov/od/ohs/lrsat.htm (LR/SAT)
• http//www.absa.org/
• http//www.dir.ca.gov (Cal-OSHA regulations)