Transcript Biosafety - American Industrial Hygiene Association

Botulinum in the Research
Laboratory - EHS Controls
Presented by:
Lisa Wisser, CIH
E O
RM

AIHCE - June 6, 2001
Environmental
and Occupational
Risk Management
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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
differentials
BSC
 Establish pressure
(--)
(--)
 Local exhaust ventilation
– Bench-top fume hood
– Biosafety cabinet
– Problem - not enough LEV
for both
(-)
FH
(+)
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Ventilation
 Biosafety Cabinet vs. Fume Hood
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Access Control and Storage
– Key lock for main door
– Padlocks for
refrigerator, freezer,
incubator
BSC
 Why? Bot toxin is a “Select Agent”
 What:
(--)
(--)
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
BLEACH
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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/bm
bl4toc.htm (BMBL)
http://www.cdc.gov/od/ohs/lrsat.htm
(LR/SAT)
http://www.absa.org/
http://www.dir.ca.gov (Cal-OSHA regulations)
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