Peter Collopy CHP,CIH,CSP Rensselaer Polytechnic Institute

1

Peter Collopy CHP,CIH,CSP
Rensselaer Polytechnic Institute
Biosafety in the Academic Environment
2
Acknowledgements
Program and Presentation Development Will
Fahey Any Errors all mine one can truly
shoot the messenger and be right ?
3
Topics

• Rensselaers Research Past and Present
• Regulatory Implications at BSL-2
• Facility Design and Usage
• Research Registration and Security
• Laboratory Practice and EHS Training Challenges
• Institutional Committees
• Waste Handling Procedures
• Lessons Learned in the Academic Setting

4
Rensselaers Research Past and Present
5
Focused Areas of Research

• Biocatalysis and Metabolic Engineering
• Biocomputation and Bioinformatics
• Integrative Systems Biology
• Functional Tissue Engineering and Regenerative
  Medicine

6
Facilities

• Center for Biotechnology and Interdisciplinary
  Studies
• Opened September 2004
• 218,000 square feet
• third largest academic and research structure on
  the Rensselaer campus.
• 31,250 square feet of open research laboratory
  space
• 27,350 square feet of core research laboratory
  space
• 13,000 square feet of support research laboratory
  space
• 31,775 square feet of office space
• 5,830 square feet of seminar space
• 5,200 square feet auditorium and gallery space

7
Facilities

• Future Modification to include Vivarium
• Zebrafish Facility
• Each system has a holding capacity of 10,350
  adult Zebrafish
• The systems control pH, water replenishment,
  lighting and temperature

8
Regulatory Implications at BSL-2
9
(No Transcript)
10
Regulatory Considerations Federal

• Center for Disease Control (CDC)
• Biosafety in Microbiological and Biomedical
  Laboratories (BMBL)
• Select Agent Program
• Transportation/Importation Etiologic Agents
• Occupational Safety and Health Administration
  (OSHA)
• Laboratory Safety Standard
• Bloodborne Pathogens Standard
• General Duty Clause
• National Institutes of Health (NIH)
• Recombinant DNA Guidelines
• Environmental Protection Agency (EPA)
• TSCA
• Department of Transportation (DOT)

NOTE LIST NOT INTENDED TO BE INCLUSIVE
11
Regulatory Considerations State
Local

• 6 NYCRR Subpart 360-10 Regulated Medical Waste
  Storage, Transfer and Disposal
• NYS Subpart 61-1
• 10 NYCRR Title Section 80.133
• Local POTW
• Those Local Folks

NOTE LIST NOT INTENDED TO BE INCLUSIVE
12
Facility Design and Usage

• Access control when work is in progress
• Signage relative to lab hazards
• Sinks for hand washing
• Decontamination at least daily
• Impervious materials design
• Windows fitted with fly screens

BSL-1 Requirements
13
Facility Design and Usage

• BSL-2 Basics from BMBL
• Access Control
• Work surface decontamination requirements
• Primary Barriers
• Lab worker immunizations

14
BSC Comparison
Type Face Velocity (lfpm) Air flow pattern Radionuclides, toxic chemicals Biosafety Levels Product Protection
Class I 75 In at front rear and top through HEPA filter No 2,3 No
Class II Type A 75 70 recirculated through HEPA exhaust through HEPA No 2,3 Yes
Class II Type B1 100 30 recirculated through HEPA exhaust via HEPA and hard ducted Yes (low levels volatility) 2,3 Yes
Class II Type B2 100 No recirculation total exhaust via HEPA and hard ducted Yes 2,3 Yes
Class II Type B3 100 Same as Class IIA, but under negative pressure to room and exhaust air is ducted Yes 2,3 Yes
Class III N/A Supply air inlets and exhaust through 2 HEPA filters Yes 3,4 Yes
15
The Collaboration Quandary
16
Research Registration, Risk Assessment and
Security
17
Biological Risk Assessment
The Epidemiologic Triad
The Environment
The Biological Agent
The Host
Information Source Biosafety In the
Laboratory-National Academy Press
18
Factors Influencing the risk of infection

• Host Factors (Laboratory Worker)
• Work Activity-Diagnostic, Research, Production
• Proficiency-Attitude, Safety Awareness
• Age, Sex, Pregnancy, Immune Status, Medications

19
Factors Influencing the risk of infection

• Agents Factors
• Virulence
• Infectious Dose
• Route of Exposure
• Toxigenicity
• Agents host range
• Availability of effective preventive measures
• Availability of effective treatment

20
BSL-2 Facility Requirements
Factors Influencing the risk of infection
21
Safe Lab Work PracticesBSL-2

• Mouth Pipetting, under any circumstance, is
  prohibited
• Aerosol generating activities at BSL-2 must be
  conducted in an appropriate Biological Safety
  Cabinet.

Information Source Biosafety In the
Laboratory-National Academy Press
22
Biological Registration Process

• Work Registration and Approval Process
• Biological Research Registration Form
• Risk Assessment
• Biosafety Program
• Laboratory Inspection Program

23
Laboratory Practice and EHS Training Challenges
24
The EHS Challenges of Biosafety
CDC-Biosafety in the Microbiological and
Biomedical Laboratories
Information adopted from Control of
Biohazards-Richard Gilpin, PHD, RBP,CBSP
25
The EHS Challenges of Biosafety

• Academic Institutions
• Transitional Population
• Collaborative Environment
• Chemical/Radiological/Biological Waste Management
• Inventory Management
• Security
• Biosafety Program-Registration/Review Process

26
Safe Lab Work Practices Bloodborne Pathogens

• Human Derived Materials must be used at BSL-2
• Training Requirements under OSHAs BBP Standard
• Hepatitis-B vaccine option for employees with
  Occupational Exposure
• The details of these requirements are outlined in
  Rensselaers Bloodborne Pathogen Exposure Control
  Plan.

27
Institutional Committees
28
Institutional Committees
Laser Safety
IBC
IRB
Radiation Safety
IACUC
29
Waste Handling Procedures
30
Laboratory Waste Management Biological Wastes

• Regulated Medical Waste-Liquid, Solid, Animal
  Waste
• Liquids-Closed Containers, Red Biohazard Bags
• Solids-Red Biohazard Bags
• Animal Wastes-Red Biohazard Bags

31
Laboratory Waste Management Chemical Wastes

• Request for Hazardous
• Waste Pick-Up Forms

32
Laboratory Waste Management Biological Wastes

• Biological Waste Rooms Access Keys

33
Laboratory Waste Management Glass Wastes
(Containers versus Other Glassware)
34
BioWaste Metrics
2005
2006
35
BioWaste Metrics
2005
2006
36
Lessons Learned in the Academic Setting
37
Biological Safety Cabinets

• Custom Designs

38
BSC Certification ProgramCentralize Tracking
39
BSC Installation
40
Whats Wrong Here?
41
Contamination Control
42
So Much for Card Access!

• Compromise of the Secondary Barrier

43
The Reality of Regulatory Compliance
44
Laboratory Chemical Waste Management

• Consider Compatibility and Off-Gassing

45
Resources

• Howard Hughes Medical Institute-Training
  Materials
• CDC BMBL
• NIH Recombinant DNA Guidelines
• Biological Safety Principles and Practices
  Edited by Diane Fleming and Debra Hunt
• Northeast Biological Safety Association- 2
  Conferences/year

46
Thank You For Your Attention
Questions?