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Arizona State University BioSafety
Program Manual

Table of Contents

Preface

Introduction and Scope

Regulatory Requirements and Guidelines

Select Agents and Toxins

Responsibilities

Biohazardous Research Project Registration and Approval

Introduction

Registration and Approval Process
Additional Approvals and Requirements

Select Agents and Toxins
Human Blood and Tissue
Animal Handling

Working Safely with Biohazardous Materials

Exposure Control

Laboratory Practice and Technique
Safety Equipment (Primary Barriers)
Facility Design (Secondary Barriers)

Laboratory Biosafety Levels

Animal Biosafety Levels

Laboratory Procedures and Equipment

Guidelines for Good Laboratory Practices at BSL1
Guidelines for Good Laboratory Practices at BSL2
Guidelines for Good Laboratory Practices at BSL3
Biological Safety Cabinets (BSC)

Types of BSCs
Guidelines for Working in a BSC
Certification of a BSC

Emergency Response Procedures

Decontamination

When to Decontaminate
Autoclave Use
Chemical Disinfectant Use

Exposure to Biohazardous Agents

Intact Skin
Broken, Cut, or Damaged Skin or Puncture Wound
Eye
Ingestion or Inhalation

Biological Material Spills

Spills Inside a BSC
Small Spill of Material Outside of a BSC
Large Spill of BSL2 Material Outside of a BSC

Biohazardous Agent and Toxin Waste Handling

Incident Reporting

Transfers, Packaging, and Shipping of Biological Materials

Transfers

Packaging

Packaging with Dry Ice
Labeling

Shipping and Transportation Methods and Requirements

Registered Mail or Equivalent
Federal Express or UPS
Damaged Packages
Notice of Delivery
Importation / Exportation of Etiologic Agent
Other Permits

Security

Audits and Compliance

Record Keeping

Program Evaluation

Related Documents and Plans

Table 1: Disinfectant Activity
Table 2: Disinfectant Characteristics
Table 3: Disinfectant Applications

Appendix A: Definitions
Appendix B: Biosafety Standard Operating Procedure

Required supporting documentation for the Biosafety SOP

Appendix B-1: Floor Diagram
Appendix B-2: Health Hazard Assessment
Appendix B-3: IBC Application Documentation
Appendix B-4: Suggested Format for Lab Biosafety Binder
Appendix C: Special Considerations for Select Agents and Toxins|
Appendix D: ASU Laboratory Security Guidance for Laboratories Working with Select Agents ........

Required supporting documentation for Appendix D

Appendix D-1: Threat Analysis Procedure and Worksheet
Appendix D-2: Commissioning Checklist
Appendix D-3: Select Agent Laboratory Inspection and Policy Review Checklist
Appendix D-4: Training and Documentation Form
Appendix D-5: Bioterrorism Preparedness and Response Act, FBI Information Form
Appendix D-6: USA Patriot Act Compliance Questionnaire
Appendix D-7: Lost Door Access Card Form
Appendix D-8: Key Inventory Log Form
Appendix D-9: Visitor Log
Appendix D-10: Inventory Control Log
Appendix D-11: Internal Destruction Form
Appendix D-12: ASU Emergency Procedures Flipchart
Appendix D-13: DPS Policies and Procedures Manual
Appendix D-14: Guidance Document for Report of Theft, Loss, or Release of Select Biological Agents and Toxins
Appendix D-15: Required contents for Biosafety Select Agents Binder

 


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