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Version 1.1 2015 BIOLOGICAL SAFETY MANUAL Version 1.1 2015 Environmental Health & Radiation Safety 3160 Chestnut Street, Suite 400 Philadelphia, PA 19104-6287 215-898-4453 [email protected] T ABLE OF C ONTENTS SECTION Page EMERGENCY CONTACTS ................................................................................ 4 INTRODUCTION ................................................................................................. 5 FREQUENTLY ASKED QUESTIONS ................................................................. 8 BIOLOGICAL RISK ASSESSMENT .................................................................. 10 BIOSAFETY LEVELS ........................................................................................ 14 ANIMAL BIOSAFETY LEVELS ......................................................................... 20 BIOSAFETY CABINETS ................................................................................... 25 COMMON LAB EQUIPMENT ........................................................................... 30 INFECTIOUS AGENTS ..................................................................................... 34 RECOMBINANT DNA ....................................................................................... 36 HUMAN SOURCE MATERIAL .......................................................................... 38 NON-HUMAN PRIMATE MATERIAL ................................................................ 41 SELECT AGENTS ............................................................................................. 44 BIOLOGICAL RESEARCH LABORATORY ...................................................... 46 DECONTAMINATION ....................................................................................... 51 INFECTIOUS WASTE MANAGEMENT ............................................................ 54 SHARPS WASTE MANAGEMENT ................................................................... 58 MIXED WASTE MANAGEMENT ....................................................................... 60 ANIMAL INFECTIOUS WASTE ........................................................................ 61 AUTOCLAVING INFECTIOUS WASTE ............................................................ 62 TRANSPORT & SHIPPING OF BIOHAZARDS ................................................ 65 APPENDIX A – BIOLOGICAL AGENTS ........................................................... 67 RISK GROUPS: Bacteria .............................................................................. 67 RISK GROUPS: Fungi .................................................................................. 72 RISK GROUPS: Viruses ............................................................................... 73 Version 1.1 2015 Page 2 T ABLE OF C ONTENTS RISK GROUPS: Parasites ............................................................................. 82 APPENDIX B – BIOSAFETY CABINET AIR FLOW .......................................... 85 APPENDIX C – SELECT AGENTS & TOXINS ................................................. 92 RESOURCES ................................................................................................... 93 Version 1.1 2015 Page 3 E MERGENCY C ONTACTS IF YOU ARE INJURED AND REQUIRE ASSISTANCE ON CAMPUS: From a CAMPUS PHONE Call: 511 From Your PERSONAL PHONE Call: 215‐573‐3333 For medical assistance DURING WORK HOURS (Mon – Fri 8AM - 4:30PM) FACULTY AND STAFF report to: HUP OCCUPATIONAL MEDICINE Ravdin Building, 2nd Floor 3400 Spruce Street 215-662-2354 STUDENTS report to: STUDENT HEALTH SERVICE 3535 Market Street, Suite 100 215-746-3535 For medical assistance AFTER WORK HOURS and HOLIDAYS: ALL report to: HUP EMERGENCY DEPARTMENT Ground Floor Silverstein Pavilion 34th & Civic Center Blvd. 215-662-3920 ENVIRONMENTAL HEALTH AND RADIATION SAFETY 215-898-4453 Version 1.1 2015 Page 4 SECTION 1.0 INTRODUCTION PURPOSE (PIs), laboratory supervisors, or laboratory managers must contact the Office of The purpose of the Biosafety Program is to Environmental Health & Radiation Safety by protect all employees, students, the public, and phone (215-898-4453) or email the environment from exposure to biological ([email protected]), if they are uncertain agents or materials being used at the University how to categorize, handle, store, treat or discard that may cause disease or be harmful to any biologically derived material. humans. This manual provides a comprehensive overview of proper work practices, regulations, and requirements for ROLES AND RESPONSIBILITIES proper containment and disposal of biological hazards. Office of the Vice Provost for Research POLICY The Vice Provost for Research has responsibility for the development and implementation of research policies and procedures across the The University of Pennsylvania is committed to University. providing a healthy and safe learning, teaching, research, and work environment. Accordingly, The Vice Provost chairs the Provost's Council on the goals of the University's Biological Safety Research which has representatives from the 12 Program are to: component schools of the University and advises the Vice Provost for Research on Ensure a HEALTHY and SAFE research formation and implementation of research environment. policies. PROTECT staff, students, and community The Vice Provost is also responsible for from exposure to infectious agents. administering, overseeing, and coordinating a wide variety of activities. In order to provide PREVENT environmental contamination. comprehensive services to researchers, the Office of the Vice Provost for Research unites SECURE experimental materials. and coordinates the following offices: COMPLY with Federal, State and Local Office of Research Services (ORS) works Regulations. with researchers, centers, schools, and funders on the financial and contractual aspects of sponsored projects. The Office of Environmental Health & Radiation Safety (EHRS), under the direction of the Office of Regulatory Affairs (ORA) administers University's Institutional Biosafety Committee the University's program of compliance in the (IBC) and The Office of the Vice Provost for areas of human subjects (IRB) and the care Research, developed this Biological Safety and use of animals in research (IACUC). Manual. This manual provides university-wide safety guidelines for working with biological University Laboratory Animal Resources hazards (biohazards). It also outlines general (ULAR) handles care and husbandry of policies and procedures for using and disposing laboratory animals. of infectious or other potentially infectious materials (OPIM). Penn biosafety policies Office of Environmental Health and Radiation ensure compliance with federal, state, and local Safety (EHRS) performs risk assessments, laws, regulations and guidelines. This manual is provides awareness training, resources and a guidance document that changes in response regulatory guidance to ensure safe conduct of to changes in existing regulations and inclusion research. Oversees and reviews use of of new regulations. It may not address all biological, chemical, and radiation hazards in hazards encountered by faculty, students, staff the University's research programs. and the Penn community. Center for Technology Transfer (CTT) obtains Biological safety practices and procedures in all and manages patents, copyrights, and University laboratories must comply with those trademarks derived from the University's outlined in this manual. Principal investigators Version 1.1 2015 Page 5 SECTION 1.0 INTRODUCTION academic research enterprise. and personnel contamination. In addition, the Office of the Vice Provost for The Vice Provost for Research appoints Research works closely with the Office of members of the IBC. Human Research and serves as the University of Pennsylvania's Research Integrity Officer. The Office of Environmental Health & Research Compliance and Radiation Safety (EHRS) adherence to EHRS guidelines The Office of Environmental Health and Radiation Safety (EHRS) is the operational for research at the University of arm of the Institutional Biosafety Committee Pennsylvania is mandated by the (IBC). It provides instruction and training on safe work practices, conducts routine Environmental Protection Policy inspections of work areas, investigates Statement (October 7, 2008). accidents and recommends preventive/corrective actions, reviews animal Compliance with University, research protocols involving hazardous materials, reviews renovations and new federal, state and local construction design for safety features and regulations is a condition of responds to emergencies. acceptance of research funding The Institutional Biosafety Officer (IBSO) is an EHRS Associate Director and is responsible from the NIH and various other for oversight and daily implementation of the granting agencies. Biosafety Program. The IBSO is responsible for compliance with all federal, state, and local regulations that apply to biosafety and keep University The Institutional Biosafety Committee regulations up to date. (IBC) Biosafety Officers (BSO) are EHRS staff The Institutional Biosafety Committee (IBC) members and reports to the Institutional has University-wide oversight as mandated by Biosafety Officer (IBSO). BSOs perform risk the National Institutes of Health (NIH) Office of assessments on labs as needed, help PIs Biotechnology Activities (OBA) and is charged develop SOPs, offer appropriate training to all by the Vice Provost for Research with staff and students, and perform annual formulating policy and procedures
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