UCI BIOSAFETY MANUAL
Rev. 2009
Bacillus anthracis
University of California, Irvine
Environmental Health and Safety
4600 Health Sciences Road, Irvine, California 92697-2725
(949) 824-6200, Fax (949) 824-8539
_______________________________________
1.0
SCOPE, POLICY
AND RESPONSIBILITIES
1.1 Scope
1.1.1 General Applicability
1.1.2 Purpose
1.1.3 Definition of Biohazardous Materials
1.2 Policy
1.3 Responsibilities
1.3.1 Vice Chancellor for Research
1.3.2 Institutional Biosafety Committee (IBC)
1.3.2.1 Charge of the Committee
1.3.2.2 Committee Membership and Procedures
1.3.2.3 Functions of the IBC
1.3.3 Principal Investigator
1.3.3.1 General Responsibilities
1.3.3.2 Submissions of Proposed Work to the Institutional Biosafety Committee (IBC)
1.3.3.3 Prior to Initiating Research
1.3.3.4 During the Conduct of the Research
1.3.4 UCI Biosafety Officer
1.3.4.1 Services to the Laboratories
1.3.4.2 Training Services
1.3.4.3 Institutional Biosafety Committee Support
1.3.4.4 Services on Behalf of the Laboratories
1.3.5 Laboratory Staff
2.0
INSTITUTIONAL BIOSAFETY COMMITTEE REVIEW AND APPROVAL PROCESS
3.0
BIOSAFETY
LEVEL PRACTICES CHART
4.1 Infectious Agents and the Lab Worker
4.2 Work with Infectious Agents at UCI
4.2.1 Storage of Infectious Materials
4.2.2 List of Principal Documented Laboratory Acquired Bacterial Infection
4.3 Prions
4.3.1 The Prion Diseases
4.3.2
Modes of Infections
4.3.2.1 Infections Preceded by Overt Personal Accidents
4.3.2.2 Infections not Preceded by Personal Accidents
5.0 RECOMBINANT
DNA, GENE THERAPY & TRANSGENICS
5.1 Recombinant DNA
5.2 Human Gene Therapy
5.3 Transgenics
5.3.1 Transgenic Animals
5.3.2 Transgenic or Exotic Plants or Pests
6.0
BLOODBORNE
PATHOGENS, UNIVERSAL PRECAUTIONS, HUMAN TISSUE AND CELL CULTURE
6.1 Definitions
6.2 Bloodborne Pathogens Exposure Control Plan
6.3 Methods of Compliance
6.3.1 Universal Precautions
6.3.2 Engineering & Work Practice Controls
6.3.3 Engineered Sharps Injury Protection
6.3.4 Personal Protective Equipment (PPE)
6.3.5 Housekeeping
6.4 HIV, HBV, or HCV Research Laboratories
6.5 HBV Vaccination & Post-Exposure
6.5.1 General
6.5.2 Hepatitis B Vaccination
6.5.3 Post-Exposure Evaluation & Follow Up
6.5.4 Information to Health Care Provider
6.5.5 Health Care Provider’s Written Opinion
6.6 Hazard Communication
6.6.1 Labels and Signs
6.6.2 Information and Training
6.7 Record Keeping
6.7.1 Medical Records
6.7.2 Training Records
6.7.3 Availability of Records
6.8 Working with Human Tissue
6.8.1 Cell Culture
6.9
Universal Precautions
6.10
Bloodborne Pathogens Exposure Control Plan
7.0
USE
OF ANIMALS IN RESEARCH
7.1 Disposal of Biohazardous Animals (Campus or Medical Center)
7.2 Transgenic Animals
7.3
Animal Room Safety Information
8.0
PERSONAL
PROTECTIVE EQUIPMENT
8.1 Laboratory
8.1.1 Face Protection
8.1.2 Clothing
8.1.3 Gloves
8.1.4 Respirators
9.1 Access
9.2 Ventilation
9.3 Plumbing
9.4 Emergency Equipment
10.0 LABORATORY
EQUIPMENT
10.1 Biosafety Cabinets
10.1.1 Definition/Funtion
10.1.2 Types of Biosafety Cabinets
10.1.3 Proper Use
10.1.4 Moving/Installation
10.1.5 Decontamination
10.1.6 Certification
10.2 Chemical Fume Hoods
10.3 Centrifuges
10.4 Aerosol-Creating Equipment
10.5 Protection of Vacuum Systems Used in Tissue Culture Work
11.1 Practical Custodial Considerations
11.2 Insect/Rodent Control Plan
12.0 SIGNS
13.0 CLEAN
AREAS
14.0 LABORATORY
MOVES
14.1 General Guidelines
14.2 Moving the Biosafety Cabinet
15.0 BIOHAZARDOUS MATERIAL SPILLS
15.1 Biohazard Spill Cleanup Procedures
15.1.1 Inside the Biosafety Cabinet (BSC)
15.1.2 In the Lab, Outside the BSC
15.1.3 Inside a Centrifuge
15.1.4 Outside the Lab, In Transit
16.0 DECONTAMINATION/DISINFECTIONS
16.1 Definitions
16.2 General Procedures
16.3 Methods
16.3.1 Heat
16.3.2 Liquid Disinfection
16.3.3 Vapors & Gases
16.3.4 Radiation
17.0 BIOSAFETY LEVEL-3
LABORATORIES
17.1 General Principles
17.2 Specific Responsibilities, Practices & Procedures
17.2.1 Responsibilities
17.2.2 Information
17.2.3 Personal Protective Equipment
17.2.4 Medical Waste
17.2.5 Decontamination and Housekeeping
17.2.6 Laboratory Maintenance and Repair
17.2.7 Medical Surveillance
17.2.8 Emergencies, Potential Exposures and Spills
18.1 EH&S Laboratory Building and Safety Survey (LBSS)
18.1.1 Laboratory Identification
18.1.2 Facility/Equipment Review
18.1.3 Work Practices
18.1.4 Hazard Communication
18.1.5 Waste Handling
18.1.6 Interview
18.2 Self-Inspection
18.3 Regulatory Agency Inspection
19.0 HANDLING BIOHAZARDOUS
AND MEDICAL WASTE
19.1 Definitions
19.2 Storage & Containment
19.2.1 Storage
19.2.2 Sharps
19.2.3 Transportation
19.2.4 Secondary Containers
19.3 Disposal of Infectious/Biohazardous Waste
19.3.1 Medical Waste
19.3.2 Autoclaving
20.0 INFECTIOUS
AGENTS AND BIOHAZARDOUS MATERIAL SHIPPING
20.1 Program Description
20.2 Scope of Program
20.3 Definitions
20.4 Responsibilities
20.5 Specific Program Components
20.5.1 Requirements for Biohazardous Materials, Diagnostic Specimens, or Infectious Agents
20.5.2 UCI Requirements for Shipment of Insects
20.5.3 Import/Export Permit Information for Etiologic Agents or Insects
20.5.4 Chemical Shipments
20.6
Reporting Requirements
20.7 Information and External Sources
20.8 Competency and Training Requirements
21.0
DHHS-CDC
SELECT AGENT AND USDA HIGH CONSEQUENCE LIVESTOCK PATHOGENS
21.1 Exemptions from CDC Select Agent Rule
21.1.1 Medical use of toxins for patient treatment is exempt
21.1.2 If the aggregate amounts
21.1.3 Other exempted agents and toxins
21.2 CDC Select Agent or USDA High Consequence Livestock Pathogens Registration
21.3 Transfer of CDC Select Agents or USDA High Consequence Livestock