| SECTION |
DESCRIPTION |
PAGE |
| |
|
|
| INTRODUCTION |
INTRODUCTION |
1 |
| |
|
|
| CHAPTER 1 |
INTRODUCTION TO BIOSAFETY |
2 |
| |
|
|
| CHAPTER 2 |
BIOLOGICAL SAFETY PROGRAM ADMINISTRATION |
3 |
| A |
Chancellor |
3 |
| B |
UCSF Biosafety Committee (BSC) |
3 |
| C |
Office of Environmental Health
and Safety (EH&S) |
4 |
| D |
Employee Health Service (EHS) |
5 |
| E |
Departmental Chairpersons |
5 |
| F |
Principal Investigators (PIs) |
5 |
| G |
Laboratory Personnel |
6 |
| |
|
|
| CHAPTER 3
|
CRITERIA FOR DETERMINING WHO NEED BIOSAFETY
COMMITTEE APPROVAL |
8 |
| |
|
|
| CHAPTER 4
|
THE BIOLOGICAL USE AUTHORIZATION (BUA)
APPLICATION PROCESS |
9 |
| A |
New Applications |
9 |
| B |
Renewals |
11 |
| C |
Modification of an Approved BUA |
11 |
| D |
Termination of a BUA |
11 |
| |
|
|
| CHAPTER 5 |
BIOHAZARDS AND POTENTIALLY INFECTIOUS MATERIAL |
12 |
| A |
Categories of Biohazards or Potentially Infectious
Materials |
12 |
| B |
Recombinant DNA (rDNA) |
13 |
| |
|
|
| CHAPTER 6 |
BIOLOGICAL AGENTS AND BIOHAZARD CLASSIFICATION
|
16 |
| A |
Risk Group 1 (RG1) |
16 |
| B |
Risk Group 2 (RG2) |
16 |
| C |
Risk Group 3 (RG3) |
16 |
| D |
Risk Group 4 (RG4) |
16 |
| E |
Restricted Foreign Animal Pathogens |
17 |
| |
|
|
| CHAPTER 7 |
PRINCIPLES OF BIOSAFETY |
18 |
| A |
Containment |
18 |
| B |
Laboratory Practice and Technique |
18 |
| C |
Safety Equipment (Primary Containment) |
19 |
| D |
Facility Design (Secondary Containment) |
20 |
| |
|
|
| CHAPTER 8 |
BIOSAFETY LEVELS |
21 |
| A |
Biosafety Level 1 (BSL1) |
21 |
| B |
Biosafety Level 2 (BSL2) |
21 |
| C |
Biosafety Level 3 (BSL3) |
21 |
| D |
Biosafety Level 4 (BSL4) |
22 |
| E |
Vertebrate Animal Biosafety Levels |
22 |
| |
|
|
| CHAPTER 9 |
PROTECTIVE BEHAVIOR |
23 |
| A |
Prudent Practices and Good Technique |
23 |
| B |
Personal Laboratory Housekeeping and Hygiene |
23 |
| C |
Universal Precautions |
24 |
| |
|
|
| CHAPTER 10 |
ADMINISTRATIVE CONTROLS |
25 |
| A |
Signage |
25 |
| B |
Medical Surveillance |
27 |
| C |
Training |
27 |
| D |
Audits |
28 |
| E |
Standard Operating Procedures (SOPs) |
29 |
| F |
Overall Safety Climate |
29 |
| |
|
|
| CHAPTER 11
|
ENGINEERING CONTROLS |
31 |
| A |
Biological Safety Cabinets |
31 |
| B |
Autoclaves |
32 |
| C |
Other Safety Equipment |
32 |
| |
|
|
| CHAPTER 12 |
RECOMMENDED WORK PRACTICES |
34 |
| A |
Pipettes and Pipetting Aids |
34 |
| B |
Syringes and Needles |
35 |
| C |
Safe and Effective Use of Biological Safety
Cabinets |
36 |
| D |
Biological Safety Cabinet Operational Guidelines |
36 |
| E |
Cryostats |
38 |
| F |
Centrifuge Equipment |
39 |
| G |
Personal Protective Equipment (PPE) |
40 |
| H |
Miscellaneous Aerosol-Producing Activities
|
41 |
| I |
Laundry |
43 |
| J |
Housekeeping |
43 |
| K |
Liquid Nitrogen Safety |
44 |
| L |
Biohazard Spill Clean-Up Procedures |
44 |
| M |
Decontamination |
46 |
| |
|
|
| CHAPTER 13 |
EMERGENCY RESPONSE |
49 |
| A |
Spill Response |
49 |
| B |
Decontamination |
50 |
| C |
Bloodborne Pathogen Exposures and Needlesticks |
51 |
| D |
Other Emergencies |
51 |
| |
|
|
| APPENDICES |
INTRODUCTION TO APPENDICES |
52 |
| |
|
|
| APPENDIX A |
RISK GROUPS |
53 |
| A1 |
Summary of Risk Groups and Handling Requirements |
53 |
| A2 |
Classification of Human Etiologic Agents on
the Basis of Hazard |
54 |
| |
|
|
| APPENDIX B |
BIOSAFETY LEVELS AND CONTAINMENT |
63 |
| B1 |
Summary of Requirements for Biosafety Levels
|
63 |
| B2 |
Comparison of Biological Safety Cabinets |
64 |
| |
|
|
| APPENDIX C |
ANIMAL BIOSAFETY LEVELS |
69 |
| C1 |
Summary of Requirements for Animal Biosafety
Levels |
69 |
| |
|
|
| APPENDIX D |
STERILIZATION AND DISINFECTION |
70 |
| |
|
|
| APPENDIX E |
BIOLOGICAL USE AUTHORIZATION (BUA) FORMS
|
76 |
| E1 |
Biological Use Authorization (BUA) Application
Form |
76 |
| E2 |
Principal Investigator Form |
81 |
| E3 |
Hazardous Materials Use Form - Training Experience
Verification |
82 |
| E4 |
User Authorization Modification Request |
84 |
| E5 |
Animal Involvement in the Animal Care Facility |
87 |
| E6 |
Application for Use of the Fermentation Facility |
88 |
| |
|
|
| APPENDIX F |
SPECIFIC TRAINING REQUIREMENTS |
90 |
| |
|
|
| APPENDIX G |
LABORATORY SAFETY AUDITS (INSPECTIONS) |
91 |
| G1 |
Comprehensive Laboratory Audits for Safety,
Category A (Quarterly) Checklist |
91 |
| G2 |
Comprehensive Laboratory Audits for Safety,
Category B Biological Safety Checklist |
94 |
| G3 |
Biological Safety Self-Audit Guide |
96 |
| |
|
|
| APPENDIX H |
BLOODBORNE PATHOGENS STANDARD |
100 |
| H1 |
Exposure Control Plan Summary |
102 |
| H2 |
Hepatitis B Vaccine Compliance Form |
107 |
| H3 |
Universal Precautions |
109 |
| |
|
|
| APPENDIX I |
MEDICAL SURVEILLANCE |
112 |
| |
|
|
| APPENDIX J |
MEDICAL WASTE DISPOSAL |
113 |
| J1 |
Autoclave Quality Control (QC) Program |
115 |
| J2 |
UCSF Autoclave QC Log |
118 |
| J3 |
Autoclave QC Approved/Not Approved Tags |
119 |
| J4 |
Medical Waste Policy and Procedures (Biological
Safety Update) |
120 |
| J5 |
Plastic Pipette Disposal (Biological Safety
Update) |
123 |
| |
|
|
| APPENDIX K |
TRANSPORTATION OF BIOLOGICAL MATERIALS
|
124 |
| K1 |
Transportation Within a UCSF Campus |
125 |
| K2 |
Transportation Between UCSF Campuses |
126 |
| K3 |
Domestic and International Shipment of Biological
Materials |
127 |
| K4 |
CDC’s "Interstate Shipment of Etiologic Agents"
|
134 |
| K5 |
CDC Packaging and Labeling Diagram |
140 |
| K6 |
UCSF Infectious Agent Transport Policy (Biological
Safety Update) |
141 |
| |
|
|
| APPENDIX L |
SPECIAL PROGRAMS |
143 |
| |
Coxiella
burnetii (Q fever) Management at UCSF (Appendix G of IIPP Manual) |
|
| L2 |
Prion Research/Creutzfeldt-Jacob (CJD) Disease
Guidelines |
148 |
| L3 |
Cell Culture Guidelines |
151 |
| L4 |
Human Blood or Blood Products, Unfixed Human
Tissue and Body Fluid Guidelines |
153 |
| L5 |
Tuberculosis Exposure Control Guidelines |
155 |
| L6 |
Vaccinia Guidelines |
157 |
| L7 |
Herpesvirus Simiae Guidelines |
159 |
| |
|
|
| APPENDIX M |
IMPORTATION AND EXPORTATION PERMITS FOR
BIOLOGICAL MATERIALS |
160 |
| |
|
|
| APPENDIX N |
REQUIREMENTS FOR THE USE OF CDC SELECT
AGENTS |
176 |
