Biological Safety Handbook

Biological Safety Handbook

The University of Texas Health Science Center
at San Antonio
April 2016

TABLE OF CONTENTS

1.0 Introduction ………………………………………………………………. 4

1.1 Purpose ……………………………………………………………… 5

1.2 Responsibilities ….………………………………………………….. 5

1.2.1 Institutional Biosafety Committee (IBC) …………………… 5

1.2.2 Biological Safety Officer …………………………………….. 6

1.2.3 Environmental Health and Safety Department (EH&S) … 6

1.2.4 Institution / Management …………………………………… 6

1.2.5 Principal Investigator, Faculty, Supervisors ……………….. 7

1.2.6 Employees, students, volunteers ………………………..….. 8

1.3 Reporting a Safety Concern ……………………………………….. 8

1.4 Imminently Dangerous to Life and Health ………………………… 8

1.5 Laboratory Evaluation Deficiencies ……………………………….. 8

2.0 Rules, Regulations, and Guidelines ……………………………….. 9

2.1 NIH Guidelines for Research involving Recombinant or Synthetic

Nucleic Acid Molecules …………………………………………….. 9

2.2  Health and Human Services: CDC/NIH Guidelines:

Biosafety in Microbiological and Biomedical Laboratories ……… 9

2.3 OSHA and Texas DSHS - Bloodborne Pathogens Standard ….. 9

2.4 HHS(CDC) and USDA Select Agents and Toxins ………………. 10

2.5 Shipping/transportation of Dangerous goods ……………………. 11

2.6 Import permits ………………………………………………………. 11

3.0 General Principles and Biosafety Levels ………………………… 12

3.1 Background – Risk Group Classification ………………………… 13

3.2 Definitions …………………………………………………………….. 13

Biohazard, Biosafety……………………………………………….. 13

3.3 Risk Assessment ……………………………………………………. 13

3.4 Containment …………………………………………………………. 14

Biosafety Levels 1 – 4 (BSL 1 – 4) ………………………………… 15

Animal Biosafety Level (ABSL 1- 4) ……………………………….. 16

Plant Biosafety Levels 1 –4 ………………………………………… 16

Arthropod Biosafety …………………………………………………. 16

Work with clinical specimens ………………………………………. 16

4.0 Hygiene, Housekeeping and Personal Protective Equipment 17

4.1 Lab practices and Personal Hygiene in the Laboratory …………. 17

4.2 Laboratory Housekeeping ………………………………………….. 18

4.3 Personal Protective Equipment ……………………………………. 19

5.0 General Guidelines for Handling Biological Agents ……………. 22

5.1 Introduction…………………………………………………………… 22

5.2 Training……………………………………………………………….. 22

5.3 Practices and procedures ………………………………………… 22

5.4 Laboratory requirements and security …………………………… 24

5.5 Posting and Labeling requirements ………………………………. 26

5.6 Procedures for Control of Biohazards in Clinical Laboratories … 26

Universal Precautions ……………………………………………… 27

5.7 Aerosols: Risks, production and prevention ……………………… 28

6.0 Disinfection, Sterilization, and Decontamination ………………... 30

6.1 Definitions ……………………………………………………………. 30

6.2 General Procedures ………………………………………………… 30

6.3 Choosing a Method and Selecting a Disinfectant ……………….. 30

6.4 Sterilization Methods ………………………………………………. 31

7.0 Procedures for Spills of Biohazardous Materials ………………. 32

7.1 Immediate actions for a biohazardous spill ………………………. 32

7.2 Clean up and Decontamination after a spill ……………………… 32

7.3 Procedure for spills in a corridor or common use area …………. 33

8.0 Laboratory Equipment …………………………………………… 35

8.1 Biological Safety Cabinets (BSC) ……………………………………..... 35

8.1.1 Overview and types of Biological Safety Cabinets …………. 35

8.1.2 Certification of a Biological Safety Cabinet ………………… 40

8.1.3 Decontamination of a Biological Safety Cabinet …………… 41

8.1.4 Flammable Gases in a Biological Safety Cabinet …………. 42

8.1.5 Ultraviolet Lamps in a Biological Safety Cabinet …………… 43

8.1.6 Procedures for Use of Class I and II cabinets ……………… 43

8.2 – 8.13 Other Laboratory Equipment …………………………………… 45

9.0 Medical Surveillance, Exposure control ………………………… 55

9.1 Overview of medical surveillance ………………………………………… 55

9.2 Response for Injury/Exposures and Reporting …………………………. 55

9.3 Employee Health Records ……………………………………………….. 57

9.4 Blood borne Pathogen Exposure Control Plan ………………………… 58

9.5 TB Exposure Control Plan ……………………………………………… 58

10.0 Medical Waste Management …………………………………….. 59

11.0 Transport, Packaging and Shipment Biohazardous Materials … 62

12.0 Recombinant and Synthetic Nucleic Acid Molecules (rDNA) ….. 64

13.0 Work with Viruses and Viral Vectors ……………………………… 65

14.0 Toxins of Biological Origin ………………………………………………… 74

15.0 Integrated Pest Management ……………………………………… 76

APPENDICES

Appendix A: Registration of work with recombinant and/or synthetic

nucleic acids, infectious agents and other potentially

biohazardous materials Forms ………………………………… 77

Appendix B: Risk Groups: Classification of Micro-organisms on the

Basis of Hazard as provided in the NIH Guidelines ……… 83

Appendix C: HHS/CDC Select Agents and USDA High

Consequence Livestock Pathogens ………………………….. 91

Appendix D: Laboratory Biosafety Level Criteria (BSL 1-4) …………… 95

Appendix E: Vertebrate Animal Safety Level Criteria (ABSL 1-4) …… 107

Appendix F: Lab Specific Forms: ………………………………………. 121

1.  Writing Lab Specific Standard Operating Procedures

2.  Lab specific SOP for work with Lentivirus Template form

3.  Biological Spill Response and Laboratory Specific Emergency

Plan – Template Form

Appendix G: Standard Operating Procedures (SOPs) and Plans …… 126

1. Biosafety Cabinet SOP

2. Transport of Biological Materials SOP

3. Biomedical Waste Management SOP

4. Lentivirus SOP

5. FACS Lentivirus SOP

6. Autoclave SOP

7. Bloodborne Pathogen Exposure Control Plan

8. TB Exposure Control Plan

1.0 INTRODUCTION

1.1 Purpose. The University of Texas Health Science Center at San Antonio is committed to the development, maintenance, and support of a comprehensive plan for the research and clinical community that has as its primary purpose the safety of all individuals who deal with, control, research, or come in contact with biological agents and toxins. The Health Science Center is committed to ensuring that all activities of a potentially biologically hazardous nature are safely conducted. All university faculty, staff and associated students will engage in prudent practices necessary to protect people and the environment from biological hazards through conformance with the federal, state, and local regulations and guidelines and Institutional policies.

The objective of the University of Texas Health Science Center at San Antonio’s Biological Safety Program is to assist all levels of management in fulfilling the Health Science Center’s commitment to provide an environment for high quality research, teaching, and learning while maintaining a safe workplace, preventing environmental contamination and complying with applicable federal, state and local requirements. It is vital that faculty, staff and students have enough information available to aid them in the safe conduct of their daily work activities related to teaching and research.

The purpose of the Biological Safety Handbook is to provide university-wide safety guidelines, policies and procedures for the use and manipulation of biohazardous and potentially biohazardous materials. This handbook provides information on how to minimize the risk to personnel from exposures to biohazards through the application of administrative, engineering, and work practice controls and by increasing awareness of the biological hazards that may be encountered in research, clinical, and teaching laboratories. The Biological Safety Handbook is not intended to be an exhaustive or fully comprehensive reference, rather a guide for Principal Investigators, staff, students and other technically qualified individuals. Each laboratory or clinic area must have specific operating procedures, contingency and emergency plans that are specific for their particular needs. Further advice concerning hazards associated with specific biological agents, recombinant or synthetic nucleic acid molecules (rDNA), and the development of new or unfamiliar activities should be obtained through consultation with the Institutional Biosafety Committee and Environmental Health and Safety's Biological Safety Division.

All faculty, staff, students, and others who work with biological agents and rDNA must be familiar with and conduct their operations in accordance with the requirements set forth in this manual and any applicable regulations and guidelines.

Signature on file __ Signature on file __

Michael A. Charlton, Ph.D. David Kolodrubetz, Ph.D.

Assistant Vice President for Risk Chair, Institutional Biosafety Committee

Management and Safety The University of Texas Health Science

The University of Texas Health Science Center at San Antonio

Center at San Antonio

Signature on file __ Signature on file __

James D. Kazen William Henrich, M.D., MACP

Executive Vice President President

Facility Planning and Operations The University of Texas Health Science

The University of Texas Health Science Center at San Antonio

Center at San Antonio

1.2 Responsibilities

1.2.1 Institutional Biosafety Committee (IBC). The Institutional Biosafety Committee (IBC) is mandated by the National Institutes of Health (NIH), Office of Science Policy (OSP) for an institution, The University of Texas Health Science Center at San Antonio, conducting or sponsoring recombinant or synthetic nucleic acid molecule research in accordance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (in successive paragraphs, this document will be referred to as the NIH Guidelines). The Committee’s responsibilities need not be restricted to recombinant or synthetic nucleic acid research and may include review of other research of a biohazardous nature.

The IBC uses the most current versions of the NIH/CDC document “Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules,” and “Biosafety in Microbiological and Biomedical Laboratories“ as well as other NIH/CDC agent specific and infection control guidance documents and best management practices as a basis for review.

The committee membership as mandated by NIH/OSP consists of at least five (5) primary members and appropriate ex-officio members including a Chair, Biological Safety Officer (if applicable), plant expert (if applicable), animal expert (if applicable), human gene therapy expertise or ad hoc consultant (if applicable) and two community members. Appropriate alternate members may be assigned. For more information on the term of membership and their terms, consult the Handbook of Operating Procedures (HOP), 1.7.1. http://uthscsa.edu/hop2000/1.7.1.pdf

The Institutional Biosafety Committee is charged to …

·  advise the President, Executive Vice President for Facilities Planning and Operations, and the Director of Environmental Health and Safety in matters pertaining to hazards of a biological nature;

·  review and approve research projects involving recombinant or synthetic nucleic acid molecules (rDNA) conducted at or sponsored by the institution

·  review and approved other projects of a biohazardous nature including assessment of the containment levels, facilities, procedures, practices, training and expertise of personnel;

·  assess the risks involved in such projects and the measures proposed for their containment

·  advise on the safe receipt, use, storage, and disposal of potentially hazardous biological agents;

·  assess the risks involved in such projects and the measures proposed for their containment;

·  review plans for areas designated to be constructed or remodeled for biohazardous work;

·  establish criteria and monitor adherence to these criteria for the use of rDNA and biohazardous agents and facilities designed for use with such agents;

·  ensure that all aspects of Appendix M (Transfer of Recombinant or Synthetic Nucleic Acid Molecules into human research participants) of the NIH Guidelines have been met;

·  serve as the Institutional Review Entity in accordance with Section 7.1 of the U.S. Government Policy for Dual Use Research of Concern including toxins; and serve as an avenue of appeal in cases of dispute and exception.

See Appendix A for Institutional Biosafety Committee procedures and registration for work with biohazardous materials and recombinant or synthetic nucleic acid molecules.

1.2.2 Biological Safety Officer (BSO). An individual appointed by an institution to oversee management of biosafety risks. The NIH Guidelines require that a BSO be appointed when the institution is engaged in large-scale research or production activities involving viable organisms containing recombinant or synthetic nucleic acid molecules, or in research requiring containment at BL-3 or BL-4. For purposes of NIH funding, the Biological Safety Officer will be the Director of the Environmental Health and Safety department, or qualified staff member(s) so appointed by the Director. The duties of the BSO are described in section IV-B-3 of the NIH Guidelines and include but not limited to:

·  being a member of the Institutional Biosafety Committee

·  conducting periodic inspections to ensure that laboratory standards are rigorously followed;

·  reporting to the Institutional Biosafety Committee and the institution any significant problems, violations of the NIH Guidelines, and any significant research-related accidents or illnesses of which the Biological Safety Officer becomes aware unless the Biological Safety Officer determines that a report has already been filed by the Principal Investigator;

·  developing emergency plans for handling accidental spills and personnel contamination and investigating laboratory accidents involving recombinant or synthetic nucleic acid molecule research;

·  providing advice on laboratory security;

·  providing technical advice to Principal Investigators and the Institutional Biosafety Committee on research safety procedures

1.2.3 Environmental Health and Safety Department (EH&S), Biological Safety Division. The Environmental Health and Safety Office, Biological Safety Division will …

·  establish general polices and standards for the use of biological materials at the Health Science Center with the advice and guidance of the Institutional Biosafety Committee (IBC) and the Infection Policy and Education Committee.

·  provide consultation and technical information for handling biological agents.

·  review proposals and protocols for the use of hazardous biological agents and recombinant and/or synthetic nucleic acid molecules and submit these to the Institutional Biosafety Committee with recommendations.

·  oversee the biological safety cabinet certification program.

·  present training in biosafety and bloodborne pathogens and other safety seminars

upon request

·  provide consultation on the purchases of biological safety cabinets and other specialized safety related equipment

·  provide assistance or advice in the decontamination or disinfection of facilities and equipment

·  assist in the development of safety plans and training programs

·  perform injury/accident investigations related to a potential biological exposure

·  perform initial laboratory evaluations to review compliance with this handbook and applicable federal, state and local regulations. Annual laboratory safety evaluations may be delegated to other personnel.

·  follow up on spills or releases of biohazardous agents, assist in containment, decontamination and disinfection within the scope of their response training on UTHSC property.

1.2.4 Institution/Management. The institution is responsible for:

·  ensuring that recombinant and synthetic nucleic acid research is conducted in conformance with the NIH Guidelines.

·  establishing and implementing policies that provide for safe conduct of research

·  ensuring compliance with applicable federal, state and local regulations, which are binding on all personnel and students within all divisions and departments at the UTHSC working in research laboratories and clinical areas involving biohazardous materials.

1.2.5 Principal Investigators/Faculty/and Supervisors. The Principal Investigator (PI) is the individual who submits the application to employ biological agents and/or rDNA in his or her work or is the responsible faculty supervisor over student labs. This individual has the primary responsibility for adherence to all UTHSC policies, guidelines and federal, state and local regulations. The PI is also fully responsible for the safe use of such agents by himself/herself and those under his or her direction.

Principal Investigators/Faculty/and Supervisors will…