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Botulinum in the Research Laboratory - EHS Controls

Botulinum in the Research Laboratory - EHS Controls. Presented by: Lisa Wisser, CIH AIHCE - June 6, 2001. Outline. Botulinum Background Exposure Controls Engineering Administrative PPE Program Management. What is Botulinum Toxin?. Produced by Clostridium botulinum

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Botulinum in the Research Laboratory - EHS Controls

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  1. Botulinum in the Research Laboratory - EHS Controls Presented by: Lisa Wisser, CIH AIHCE - June 6, 2001 1-0199

  2. Outline • Botulinum Background • Exposure Controls • Engineering • Administrative • PPE • Program Management 1-0199

  3. 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 1-0199

  4. More on Botulinum Toxin • LD50 (mouse) = 1 ng/kg 1-0199

  5. 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 1-0199

  6. Engineering Controls • Laboratory design issues for this project • Ventilation • Access control • Storage 1-0199

  7. (--) (--) BSC (-) FH (+) Ventilation • Establish pressuredifferentials • Local exhaust ventilation • Bench-top fume hood • Biosafety cabinet • Problem - not enough LEV for both 1-0199

  8. Ventilation • Biosafety Cabinet vs. Fume Hood 1-0199

  9. 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 (+) 1-0199

  10. 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 1-0199

  11. 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 1-0199

  12. Administrative Controls • Training • Laboratory biosafety • Toxin-specific session • Annual refresher with Occupational Physician • Medical Surveillance • Vaccine and antitoxin available 1-0199

  13. Administrative Controls • Inventory Control System • Locked storage areas • Inventory control log • amount received • amount removed, by whom, date • amount remaining • final disposition 1-0199

  14. Administrative Controls • Sign, Labels, etc. • “Toxins in Use - Authorized Personnel Only” on door • Biohazard labels • MSDSs in lab 1-0199

  15. BLEACH Administrative Controls • Decontamination • Waste handling 1-0199

  16. PPE 1-0199

  17. Program Management • Management by Inspection • Locks and inventory log • Work practices • PPE • Waste • Continuous review and improvement • e.g., emergency procedures, waste handling 1-0199

  18. 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 1-0199

  19. Useful Resources • http://www.cdc.gov/od/ohs/default.htm (CDC OHS) • http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm (BMBL) • http://www.cdc.gov/od/ohs/lrsat.htm (LR/SAT) • http://www.absa.org/ • http://www.dir.ca.gov (Cal-OSHA regulations) 1-0199

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