amendments: biosafety program responsibility: category ... · human and terrestrial animal...

Category: Health & Safety Responsibility: Director of Human Resources, Health & Safety Officer Approval: January 2016, Administration Amendments: As needed based on legislative and internal requirements.

BIOSAFETY PROGRAM

Biosafety Program

Revision Date Approved by: Responsibility Page

January 2016 Administration Biosafety Officer ii

FOREWORD This manual outlines the safe use, storage, handling, disposal, and emergency management of biohazardous materials for the Algoma University (Algoma). This information supplements and reiterates information outlined in the Canadian Biosafety Standards and Guidelines (1st edition) prepared jointly by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA), as well as the Occupational Health and Safety (OHS) regulations. If there is a discrepancy between this manual and current government policy, those policies take precedence.

DISCLAIMER The materials contained within this document were compiled from sources believed to be reliable and to represent the best knowledge on the subject. This document is meant to serve only as a starting point for good practices and is intended to provide basic guidelines for safe practices. It does not purport to represent minimal legal standards. No warranty, guarantee, or representation is made by Algoma University as the accuracy or sufficient of the information contained herein, and Algoma University assumes no responsibility in connection therewith. It cannot be assumed that all necessary warnings and precautionary measures are contained within this document and that other or additional information or measures may not be required. Users of this document should consult alternate sources of safety information prior to undertaking specific tasks.

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ACKNOWLEDGEMENTS The following individuals of Algoma University contributed to the writing, editing, and production of this Biosafety Manual: Amanda Roe, Shannon Rowell-Garvon and Brandi Bell-Tanninen. We wish to gratefully acknowledge the contributions of other universities to the compilation of this manual.

This manual was prepared for Algoma University. Any corrections, additions, or comments should be brought to the attention of the Biosafety Officer in the Dept. of Biology at 705-949-2301 ext. 4311

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Non-Emergency Phone numbers: Biosafety Officer: x4311 Health & Safety: x4373 Maintenance: x4040 Poison Control Centre: 1-800-268-9017 Union Gas: 1-877-969-0999 PUC (after hours): 705-759-6500, 705-759-6555

Emergency Numbers

Police, Fire, Ambulance 9-911

Campus Security

x4444

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ACKNOWLEDGEMENTS ................................................................................................................................................................................................ iii

ACRONYMS & ABBREVIATIONS .............................................................................................................................................................................. viii

INTRODUCTION: BIOSAFETY .................................................................................................................................................................................. - 1 -

CHAPTER 1: BIOSAFETY PROGRAM OVERVIEW ............................................................................................................................................ - 2 -

SCOPE .................................................................................................................................................................................................... - 2 -

REGULATORY GUIDELINES & POLICIES ....................................................................................................................................... - 2 - Municipal – Sault Ste. Marie ................................................................................................................................................................................................... - 2 - Provincial - Ontario .................................................................................................................................................................................................................... - 2 - Federal Legislation/Tri-council requirements .............................................................................................................................................................. - 2 -

COMPLIANCE AND ENFORCEMENT ................................................................................................................................................ - 3 - Minor Infraction .......................................................................................................................................................................................................................... - 3 - Major Infraction ........................................................................................................................................................................................................................... - 4 -

RESPONSIBILITIES AND DUTIES .................................................................................................................................................... - 4 - Responsibilities of Employer ................................................................................................................................................................................................. - 4 - Institutional Biosafety Committee (IBC) .......................................................................................................................................................................... - 4 - Responsibilities of Supervisor or Principle Investigator: ......................................................................................................................................... - 5 - Responsibilities of the Biosafety Officer (BSO) ............................................................................................................................................................. - 5 - Responsibilities of the User: .................................................................................................................................................................................................. - 6 - Responsibility of License Holder ......................................................................................................................................................................................... - 6 -

INSTITUTIONAL BIOSAFETY COMMITTEE .................................................................................................................................. - 6 - Membership ................................................................................................................................................................................................................................... - 6- Voting Rights of the Committee ............................................................................................................................................................................................ - 6 - Meetings and Minutes ............................................................................................................................................................................................................... - 6 -

BIOSECURITY ...................................................................................................................................................................................... - 7 -

CHAPTER 2: BIOSAFETY ADMINISTRATION ............................................................................................................................... - 8 -

BIOLOGICAL MATERIALS LICENSES/AU PERMITS .................................................................................................................... - 8 - License/AU Permit Application Package: ........................................................................................................................................................................ - 8 -

RISK ASSESSMENT ............................................................................................................................................................................. - 8 - 1. Overarching risk assessment (ORA) ......................................................................................................................................................................... - 8 - 2. Pathogen Risk Assessment ........................................................................................................................................................................................... - 9 - 3. Local Risk Assessments (LRA) .................................................................................................................................................................................... - 9 -

PATHOGEN SAFETY DATA SHEETS ................................................................................................................................................ - 9 -

INVENTORY CONTROL PROCEDURES ........................................................................................................................................... - 9 -

IMPORTATION & TRANSFER OF BIOLOGICAL MATERIALS .................................................................................................. - 10 - Importation Requirements ...................................................................................................................................................................................................- 10 - Material Transfer Agreements ............................................................................................................................................................................................- 10 - Transportation of Biohazardous Agents off Campus ................................................................................................................................................- 10 - Shipping on Dry Ice ..................................................................................................................................................................................................................- 10 - What if Something Goes Wrong?........................................................................................................................................................................................- 10 -

ACCESS/SECURITY CONTROLS .................................................................................................................................................... - 11 -

INSPECTIONS AND LICENSES ....................................................................................................................................................... - 12 -

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BIOSAFETY SIGNAGE ...................................................................................................................................................................... - 12 -

TRAINING REQUIREMENTS .......................................................................................................................................................... - 12 - Generic Training ........................................................................................................................................................................................................................- 13 -

LAB-SPECIFIC TRAINING ............................................................................................................................................................... - 13 -

TRAINING RECORDS ....................................................................................................................................................................... - 13 -

MEDICAL SURVEILLANCE .............................................................................................................................................................. - 13 - Health Self-Monitoring ...........................................................................................................................................................................................................- 13 - Immunizations ...........................................................................................................................................................................................................................- 14 - Allergens .......................................................................................................................................................................................................................................- 14 -

CHAPTER 3: CLASSIFICATION OF BIOLOGICAL HAZARDS ........................................................................................................................ - 16 -

TYPES OF BIOLOGICAL HAZARDS ............................................................................................................................................... - 16 - Current Species at AU .............................................................................................................................................................................................................- 16 - OTHER ...........................................................................................................................................................................................................................................- 16 -

RISK GROUPS.................................................................................................................................................................................... - 17 -

CONTAINMENT LEVELS & CONSIDERATIONS .......................................................................................................................... - 17 -

CHAPTER 4: GENERAL OPERATIONAL PRACTICES ...................................................................................................................................... - 21 -

LABORATORY DOCUMENTATION ............................................................................................................................................... - 21 -

LABORATORY COMPUTERS AND PERSONAL ELECTRONICS ................................................................................................ - 21 -

PERSONAL PROTECTIVE EQUIPMENT & GENERAL HYGIENE .............................................................................................. - 22 -

ASEPTIC TECHNIQUE FOR BENCH WORK ................................................................................................................................. - 23 -

BIOLOGICAL SAFETY CABINETS .................................................................................................................................................. - 23 -

NEEDLE SYRINGES & SHARPS ...................................................................................................................................................... - 24 -

PIPETTING ........................................................................................................................................................................................ - 25 -

BLENDERS, GRINDERS, SONICATORS & OTHER TISSUE HOMOGENIZING EQUIPMENT ............................................... - 25 -

CENTRIFUGATION ........................................................................................................................................................................... - 25 -

VACUUM PUMPS & LIQUID FILTRATION ................................................................................................................................... - 25 -

INCUBATORS .................................................................................................................................................................................... - 26 -

REFRIGERATORS & FREEZERS..................................................................................................................................................... - 26 -

LYOPHILIZERS ................................................................................................................................................................................. - 27 -

MOVEMENT OF BIOLOGICAL MATERIALS................................................................................................................................. - 27 - Between Laboratories.............................................................................................................................................................................................................- 27 - Between Floors within a Building .....................................................................................................................................................................................- 27 - Between Buildings ....................................................................................................................................................................................................................- 27 - Transportation off campus ...................................................................................................................................................................................................- 28 -

CHAPTER 5: DECONTAMINATION & WASTE MANAGEMENT ................................................................................................................... - 28 -

STERILIZATION VS. DISINFECTION ............................................................................................................................................ - 29 -

CHEMICAL DISINFECTION ............................................................................................................................................................. - 29 -

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STEAM STERILIZATION/AUTOCLAVING ................................................................................................................................... - 30 - Material preparation: ..............................................................................................................................................................................................................- 31 - When loading the autoclave:................................................................................................................................................................................................- 31 - When unloading the autoclave after completion of a cycle: ..................................................................................................................................- 31 - To ensure quality control and check autoclave functionality: ..............................................................................................................................- 31 -

STERILIZATION TIMES .................................................................................................................................................................. - 32 -

WASTE MANAGEMENT ................................................................................................................................................................... - 32 - Transport of Waste within Facility ...................................................................................................................................................................................- 32 - Laboratory Waste Pick-up ....................................................................................................................................................................................................- 32 - Mixed Hazardous Waste ........................................................................................................................................................................................................- 32 -

CHAPTER 6: EMERGENCY RESPONSE PROCEDURES ................................................................................................................................... - 33 -

FIRST AID .......................................................................................................................................................................................... - 33 -

INCIDENT REPORTING ................................................................................................................................................................... - 33 -

NEAR MISS EVENTS ......................................................................................................................................................................... - 33 -

INJURIES & POTENTIAL EXPOSURES ......................................................................................................................................... - 33 -

FIRE & EVACUATION ALARMS ..................................................................................................................................................... - 34 -

POWER FAILURES ........................................................................................................................................................................... - 35 -

BIOHAZARDOUS SPILLS ................................................................................................................................................................ - 35 - Prevention ....................................................................................................................................................................................................................................- 35 - Biological Spill Kit .....................................................................................................................................................................................................................- 35 - Responsibility for Biohazardous Spill Clean Up ..........................................................................................................................................................- 35 - Biohazardous Spill inside a Biological Safety Cabinet ..............................................................................................................................................- 36 - Clean-up of Biological Spills on Individuals ..................................................................................................................................................................- 36 - Clean up of Biological Spills Outside of a Biological Safety Cabinet ...................................................................................................................- 36 -

CHAPTER 7: LABORATORY EQUIPMENT MAINTENANCE ......................................................................................................................... - 38 -

LABORATORY SURFACES .............................................................................................................................................................. - 38 -

DIFFERENTIAL AIRFLOW PATTERNS ........................................................................................................................................ - 38 -

EMERGENCY EYEWASH AND SHOWER ...................................................................................................................................... - 38 -

FIRST AID KITS ................................................................................................................................................................................ - 38 -

SPILL KIT MAINTENANCE ............................................................................................................................................................. - 38 -

EQUIPMENT MANUALS & GENERAL MAINTENANCE .............................................................................................................. - 38 -

AUTOCLAVES .................................................................................................................................................................................... - 39 -

BIOLOGICAL SAFETY CABINETS .................................................................................................................................................. - 39 -

CENTRIFUGE ..................................................................................................................................................................................... - 40 -

APPENDICIES ............................................................................................................................................................................................................. - 41 -

Appendix A Sample Pathogen Safety Data Sheet ......................................................................................................................................... - 42 -

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ACRONYMS & ABBREVIATIONS

AU Algoma University

BSC Biological safety cabinet

BSO Biosafety Officer

CBSG Canadian Biosafety Standards and Guidelines

CFIA Canadian Food Inspection Agency

CL Containment level

DNA Deoxyribonucleic acid

GMO Genetically modified organism

HEPA High-efficiency particulate air

HPIR Human Pathogen Importation Regulation

HPTA Human Pathogens & Toxins Act

HSO JHSC

Health & Safety Officer Joint Health and Safety Committee

LRA Local risk assessment

MSDS Material Safety Data Sheets

OHSA Occupation Health & Safety Act

ORA Overarching risk assessment

PHAC Public Health Agency of Canada

PI Principle Investigator

PNT Plants with Novel Traits

PPE Personal protective equipment

PSDS Pathogen Safety Data Sheets

rDNA recombinant deoxyribonucleic acid

Reg Regulation

RG Risk group

RNA Ribonucleic acid

SOP Standard operating procedure

TDG Transportation of Dangerous Goods Act & Regulations

UV ultraviolet

WHMIS Workplace Hazardous Material Information System

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January 2016 Administration Biosafety Officer - 1 -

INTRODUCTION: BIOSAFETY Research and teaching activities may involve working with one or more types of biological hazards (biohazards). These may include pathogenic microbes (i.e. viruses, bacteria, fungi, eukaryotic parasites, etc.) that can cause disease in humans, animals, and plants, as well as eukaryotic cell lines, toxins, venoms, recombinant DNA (rDNA) constructs, and plant, animal, and insect species not indigenous to Ontario. Algoma University (AU) is committed to maintaining a safe and healthy environment for all members of the University community – staff, faculty, students, visitors, and administration. Protection of all members from injury or occupational illness is a major institutional priority. This in turn requires that all individuals who may be exposed to such materials participate and comply with the guidelines outlined herein. The guidelines presented in this document represent standardized procedures for safe handling and storage of biohazardous agents and proper maintenance of common research and safety equipment. These guidelines are a “living” document; sections will be modified or replaced as biosafety regulations evolve and the scope of research at AU changes.

Biosafety Program



CHAPTER 1: BIOSAFETY PROGRAM OVERVIEW

SCOPE This guide has been developed as a part of AU’s overall Biosafety Program and applies to any AU owned buildings or AU sanctioned research in which:

Teaching and research activities involving potentially hazardous biological agents;

AU employees and students work with or arrange for the purchase, storage, transportation, use, and disposal of biohazardous material;

AU employees, students, and visitors work in or near an area where teaching and research activities with biohazardous materials occurs.

This manual is based upon the Public Health Agency of Canada Canadian Biosafety Standards and Guidelines (2015 edition) and reflects best practices established within the field.

REGULATORY GUIDELINES & POLICIES

Municipal – Sault Ste. Marie

Waste and Recycling Bylaw No. 2004.68

Sewer Use By-law 2009-50

Provincial - Ontario

Ministry of Labour – Occupational Health and Safety Act (OHSA) See: http://www.labour.gov.on.ca/english/hs/

o Control of Exposure to Biological or Chemical Agents (O Reg 833 1990) o Workplace Hazardous Materials Information System (O Reg 860 1900)

Ministry of the Environment – Environmental Protection Act (1990) See: http://www.e-laws.gov.on.ca/html/statutes/english/elaws_statutes_90e19_e.htm

o Waste Management (O Reg 347) o Biomedical Waste Management (Guideline C-4) o Non-Incinerations Technologies (Guideline C-17) o Biomedical Waste Requirement in Ontario (Draft Regulation)

Federal Legislation/Tri-council requirements

Human Pathogens and Toxins Act

Human Pathogens and Toxins Regulations (HPTR)

Human Pathogens and Toxin Importation Regulations (HPIR)

Health of Animals Act and associated regulations

Public Health Agency of Canada / Canadian Food Inspection Agency Canadian Biosafety Standards and Guidelines (2015) 2nd Edition

http://www.labour.gov.on.ca/english/hs/

http://www.e-laws.gov.on.ca/html/statutes/english/elaws_statutes_90e19_e.htm

Biosafety Program



Canadian Food Inspection Agency The CFIA works with Agency scientists and technical experts to establish the biocontainment levels, procedures and protocols that are needed to work safely with animal and zoonotic pathogens, chemical hazards, and plant pests of quarantine significance, and to protect laboratory staff, the Canadian public, and the environment. As of April 1, 2013, PHAC is now the single window for stakeholders who require an import license for both human and terrestrial animal pathogens. The CFIA continues to issue permits for animal pathogens that are not indigenous to Canada (pathogens causing foreign animal and emerging animal diseases), aquatic and plant pathogens as well as for animals, animal products and by-products, tissue, sera and blood that are infected with animal pathogens. See: http://www.inspection.gc.ca/animals/biohazard-containment-and-safety/eng/1300121579431/1315776600051

Additional Regulatory Forces o Disposal of biohazardous waste is regulated and monitored by the Ontario Ministry of Environment o The requirements for packaging and shipment of biomedical materials are governed by the Transportation

of Dangerous Goods (TDG) Act and Regulations, which are administered by Transport Canada. Environment Canada

Canadian Environmental Protection Act (1999) http://laws-lois.justice.gc.ca/eng/acts/C-15.31/Tri-Council Agency Memorandum of Understanding (Schedule 13 – Biosafety) See: http://www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/13-Biohazards-RisquesBiologique_eng.asp

COMPLIANCE AND ENFORCEMENT

The ability to conduct research and teach on AU campuses is a privilege extended to all research and teaching groups. In return, all faculty, staff and students are required to follow pertinent health and safety requirements in order to protect AU’s personnel, infrastructure, certification, and reputation. All members of AU groups working with biohazardous material must read and abide by the contents of these guidelines. All personnel must document their reading and understanding of these guidelines in their training and orientation records. AU shall comply with the various terms and conditions of all licenses and permits issued to the institution. This includes following all applicable Federal and Provincial statutes, and funding agencies agreements pertaining to the use, handling, storage, and disposal of biohazardous materials. Non-compliance with legislated and University requirements can result in significant penalties and fines for the University and its employees as individuals as well as severely impacting funding for research. If AU groups or personnel are found to be in noncompliance with these biosafety guidelines, a notification of noncompliance with recommended corrective actions will be issued. Minor Infraction A minor offense is an infraction that poses no immediate risk or threat to safety, health, or the environment. For example: inadequate signage, inadequate posting (i.e. license posting), or inappropriate use of biohazard warning labels.

ACTIONS FOLLOWING A MINOR OFFENCE: First Offence: A written notification will be sent by the BSO on behalf of the IBC to the License Holder, with a copy to the Department Chair, the Health & Safety Officer. Corrective action of the violation is required, with a written reply in 21 days. If the written reply is not received within 21 days, a second notice will be copied to the Dean. If there is no response within 14

http://www.inspection.gc.ca/animals/biohazard-containment-and-safety/eng/1300121579431/1315776600051

http://www.inspection.gc.ca/animals/biohazard-containment-and-safety/eng/1300121579431/1315776600051

http://laws-lois.justice.gc.ca/eng/acts/C-15.31/

http://www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/13-Biohazards-RisquesBiologique_eng.asp

http://www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/13-Biohazards-RisquesBiologique_eng.asp

Biosafety Program



days of the second notice, a meeting will be arranged by the BSO with the License Holder, the Department Chair, the IBC Chair, and the Health & Safety Officer. Second Offence: A meeting will be arranged by the BSO with the License Holder, the Department Chair, the IBC Chair and the Health & Safety Officer, to review the issues. Third Offence: The License Holder will be notified in writing by the BSO that the AU permit will be suspended until a meeting with the IBC can be held. Fourth Offence: The BSO will recommend AU permit cancellation to the IBC. Note: For the second, third and fourth occurrences, notification of the actions outlined above will be copied to the Dean, the Department Chair, the Health & Safety Officer and the IBC Chair.

Major Infraction A major offense is a violation that causes immediate risk or danger to safety and health, or could cause a release of biohazards into the environment or community. For example: eating/drinking in the laboratory, inadequate training of new staff, refusal to participate in the Inspection program, unsafe storage of biohazardous material, or unauthorized use/possession of biohazards.

ACTIONS FOLLOWING A MAJOR OFFENCE: First Offence: A written notification will be sent to the License Holder by the BSO on behalf of the IBC with a copy to the Department Chair and the Health & Safety Officer. Immediate correction of the violation is required, and a written reply to the IBC in 3 days. If the written reply is not received within 3 days, a second notice will be sent, with a copy to the Dean. If there is no response within 3 days to the second notice, a meeting will be arranged by the BSO with the License Holder, Department Chair, the IBC Chair and the Health & Safety Officer. Second Offence: The License Holder will be notified in writing by the BSO on behalf of the IBC that the AU permit will be suspended until a meeting with the Institutional Biosafety Committee can be held to discuss the offence(s). Third Offence: The BSO will recommend to the IBC that the License Holder’s AU permit will be cancelled. This recommendation will be copied to the Dean, the Department Chair, and the Health & Safety Officer.

RESPONSIBILITIES AND DUTIES

Responsibilities of Employer: Algoma University’s administration is committed to providing a safe and healthy workplace. Biosafety is an important aspect of AU’s safety commitment. AU is committed to establishing and implementing a biosafety program to protect all stakeholders. AU will appoint a Biosafety Officer to oversee the program. AU will ensure that the BSO has the following minimum qualifications:

1. Knowledge of microbiology appropriate to the risks associated with controlled activities being conducted, attained through a combination of education, training and experience;

2. Knowledge of the HPTA, the HPTR, and any applicable federal or provincial legislation; and 3. Knowledge of applicable biosafety and biosecurity policies, standards, and practices appropriate to the risks associated

with the controlled activities being conducted. Institutional Biosafety Committee (IBC)

Biosafety Program



Reviews and approves all procedures, policies, and guidelines regarding the storage, usage, transport and disposal of biohazardous materials.

Provides technical advice to users of biohazardous materials.

Reviews license and permit applications and risk assessments involving biological agents and materials.

Meets at least annually or as needed at the request of any Committee member.

Responsibilities of Supervisor or Principle Investigator: Supervisors or Principal Investigators (PIs) are responsible for implementing the Biosafety Program within the scope of their projects. They must:

Ensure that all biohazardous materials are registered and that appropriate licenses and risk assessment forms are completed prior to purchasing/obtaining the agent(s). In the case of environmental isolates and genetically modified organisms, identification of the organism should be established for isolates and a risk assessment conducted for both isolates and genetically modified organisms (GMOs).

Ensure that appropriate containment levels are established in consultation with the Biosafety Officer; ensure adherence to these levels.

Implement engineering controls to the extent feasible including containment equipment (primary barriers) and facility design (secondary barriers) appropriate for the laboratory function, hazard and risk.

Ensure strict adherence to biosafety practices and techniques.

Implement procedures for safe handling of specimens of human or primate origin.

Ensure that all individuals under their supervision are trained and knowledgeable about the hazards associated with handling biohazardous materials.

Direct laboratory activities.

Ensure appropriate training of personnel about the potential hazards of biohazardous materials and the practices and techniques required for their safe handling.

Responsibilities of the Biosafety Officer (BSO)

Verifying accuracy and completeness of license applications.

Provides a liaison between AU and the regulators.

Provides technical support, consultation, and advice on all aspects of biohazardous work.

Develops effective procedures for the implementation of current standards and guidelines.

Oversees a biosafety program that complies with the regulations for use of or exposure to biohazardous materials. o Arranging for and documenting training related to biosafety and biosecurity policies, standards and practices; o Notifying PHAC of any inadvertent possession of human pathogens and toxins or of SSBA shipments not

received as expected. o Conducting periodic internal inspections and biosafety audits and reporting findings to the license holder. o Informing the licence holder of any non-compliance by a person conducting activities under the licence that is

not resolved after that person has been made aware of it.

Develops procedures for shipping all biohazardous materials.

Provides guidance for appropriate decontamination procedures for transport and after a spill or an accident involving biohazardous materials.

Provides guidance on the proper disposal of biohazardous waste and recommends waste disposal procedures.

Ensures the university’s registration and license for the Human Pathogens and Toxins Act are up to date and accurate, and completes renewals and annual reporting as necessary.

Advises, on policy matters concerned with the protection of personnel from biohazardous agents.

Assists in the development and maintenance of the Biosafety Manual and standard operating procedures (SOPs) related to biosafety and biosecurity; and assisting with internal investigation of incidents.

Biosafety Program



Responsibilities of the User: Individuals are responsible for their own safety and the safety of others they may affect with biohazardous agents/substances. Users must:

Work with biohazardous agents/substances using the appropriate containment level, as directed by the Lab Supervisor and the Biosafety Officer.

Review containment level requirements with their Supervisor.

Work with strict adherence to biosafety practices and techniques.

Participate in health surveillance programs where appropriate.

Report unsafe conditions or any reason that duties cannot be completed safely.

Report any accidents/incidents to the Lab Supervisor and HSO. Responsibilities of the Licence Holder

If the licence holder intends to carry out scientific research, they must develop a plan that sets out how they will administratively manage and control biosafety and biosecurity risks during the term of the licence, before the licence can be issued.

Designate a BSO

Communicate licence conditions to everyone conducting activities under that licence.

Keep list of all persons authorized to access a licenced facility

INSTITUTIONAL BIOSAFETY COMMITTEE

Membership The Institutional Biosafety Committee (IBC) is composed of the Biosafety Officer, the Health & Safety Officer, a Supervisor/Principal Investigator Representative, a Faculty Representative and a user representative. Representatives of other support departments may be invited to join at the discretion of the Committee. New members are appointed by the Chair and are approved by the President (or designate). The term of committee membership is 2 years and it is renewable. The Committee members will select a Chair and a Vice-Chair. Each should have at least one year of Committee experience. The Vice-Chair shall succeed the Chair, whenever possible. Each Committee member shall appoint a substitute representative who is qualified to attend Committee meetings in their absence. Voting Rights of the Committee Each Committee member has full voting rights including substitute members. A majority vote of those present is required for an issue to be approved or passed by the Committee. At least 2/3 of the members or their substitute(s) must be present for a quorum. Meetings and Minutes The IBC shall meet at least annually and more often if needed. The meetings shall be run by the Chair or by the Vice-Chair in the absence of the Chair. The minutes of each Committee meeting shall be published and distributed to all the Committee members, the appropriate senior management, and the Co-Chairs of the Institutional Biosafety Committee. The Biosafety Officer will report on the committee status to the JHSC.

Biosafety Program



BIOSECURITY Biosecurity deals with the potential of biohazardous agents to be used for malicious intent – biosecurity protects biohazards from people. Biosecurity focuses on the prevention of theft, misuse or intentional release of biohazardous agents. Steps taken to secure biohazardous agents in a laboratory will also proof the laboratory against the potential theft of chemicals, computers, expensive research equipment and personnel effects, and the possible loss of irreplaceable research data. Access to containment zones must be limited to authorized personnel only. Laboratory risk assessments must consider biosecurity including assets, potential threats, and risk mitigation. To secure their laboratory, research and teaching groups working with biohazardous agents must:

Establish procedures to ensure laboratory doors are locked when personnel are not on site.

Lock fridges and freezers containing archived biohazardous agents and those located outside the common laboratory work areas in cross-corridors or communal storage rooms.

Lock cold rooms and warm rooms located off unsecure public and semi-public hallways. Department Chairs may elect to review these and other communal use areas in their facility and develop a Department or Institute level plan to secure their holdings at the facility envelope.

Keep laboratory doors closed.

Report suspicious behavior or unauthorized persons loitering around laboratory spaces to AU Security.

Report evidence of attempted force entry to AU Security.

Report missing stocks of biohazardous agents to the PI. If stocks cannot be located, immediately file and incident report with the Biosafety Officer.

Ensure laboratory keys are returned or access is removed from swipe cards when personnel leave the group or no longer require access to the area.

Evaluate potential security issues caused by the laboratory location (i.e., laboratory is beside a high-traffic public corridor, directly next to a major building entrance, etc.) and determine if extra security features are warranted (i.e. opaque door windows or security alarms).

Biosafety Program



CHAPTER 2: BIOSAFETY ADMINISTRATION

BIOLOGICAL MATERIALS LICENSE/AU PERMIT

Research at AU involving Risk Group 1 (RG1) and/or Risk Group 2 (RG2), must be approved by the Institutional Biosafety Committee (IBC).

Risk Group 1 (RG1) A microorganism, nucleic acid, or protein that is either a) not capable of causing human or animal disease; or b) capable of causing human or animal disease, but unlikely to do so. RG1 organisms capable of causing disease are considered pathogens that pose a low risk to the health of individuals or animals, and a low risk to public health and the animal population. RG1 pathogens can be opportunistic and may pose a threat to immunocompromised individuals. Neither of the RG1 subsets is regulated by the PHAC or the CFIA due to the low risk to public health and the animal population.

Risk Group 2 (RG2) A pathogen or toxin that poses a moderate risk to the health of individuals or animals, and a low risk to public health and the animal population. These pathogens are able to cause serious disease in a human or animal but are unlikely to do so. Effective treatment and preventive measures are available and the risk of spread of diseases caused by these pathogens is low. Examples of RG2 human pathogens are included in Schedule 2 of the HPTA.

License/AU Permit Application Package:

There are two documents to be submitted in an application package; a permit and a risk assessment form. Application packages must be submitted to the BSO, with sufficient notice to allow for the review process to be completed before laboratory activities commence. Amendments to the permit and risk assessment must also be submitted to the BSO, prior to the submitted changes taking place.

RISK ASSESSMENT Risk is the probability of an undesirable event occurring and the consequences of that event. Risk assessment is the basis of all components of a Biosafety and Biosecurity program. This involves identifying potential hazards associated with activities, pathogens, and work environments, as well as developing appropriate mitigation strategies. Risk assessment also will help identify which Containment Levels (CL) should be used with an agent and the minimum safety measures and protocols needed to work with an agent safely. Risk assessments follow the same principles as those in most occupational health and safety programs:

Elimination/substitution: Is there a pathogen or process that poses less risk?

Engineering controls: selection and use of primary containment devices (i.e. biosafety cabinets - BSC).

Administrative controls: policies and standard operating procedures (SOPs) that outline how activities should be conducted.

Personal protective equipment (PPE): availability and use of PPE to reduce or minimize potential exposure.

Risk assessments are best done as a committee involving individuals with varying expertise and responsibilities such as, the lab supervisor, Health & Safety Officer, facility director, PI, microbiologist, and the Biosafety Officer (BSO). Algoma University’s Biosafety Program will include 3 types of risk assessments:

1. Overarching risk assessment (ORA)

Biosafety Program



A broad, top-down assessment of the activities being conducted within the facility and is performed during the initial development or review of a facility’s biosafety program. An ORA helps develop risk mitigation strategies, such as engineering and administrative controls, practices and procedures, and training. An ORA will include an analysis of hazards and potential routes of exposure, as well as a risk communication plan to address public concerns about the risks associated with the facility. 2. Pathogen Risk Assessment A pathogen risk assessment will be used to assess the risks posed to personnel working with the biohazard. Pathogen risk assessments are used to develop Pathogen Safety Data Sheets (PSDS) that must be readily available to personnel (see below). It is the responsibility of the users (i.e. PI / Supervisor) to conduct pathogen risk assessments on uncharacterized or modified pathogens. Pathogen risk assessment is included within the documentation for local risk assessment to assist in this characterization. Information can be obtained from primary scientific literature and in consultation with PHAC and CFIA. 3. Local Risk Assessments (LRA) These are site- and activity-specific risk assessments and help support the ORA. These are best performed by the personnel who work within the containment zone and with the pathogen. It is beneficial for the BSO to be involved with this process. A LRA involves four steps: identification of tasks and/or procedures; breakdown tasks in to steps; identify potential exposure risks in each step; determine appropriate mitigation strategies. This process will inform both the ORA, as well as the SOPs for each activity within the lab. A LRA is required for a license application under the Biosafety Program.

PATHOGEN SAFETY DATA SHEETS

Workplace Hazardous Materials Information System (WHMIS) legislation covers “controlled products”, which include infectious materials and toxins. Under this legislation, appropriate labeling and provision of Material Safety Data Sheets (MSDS) is required for all controlled products. Under the Hazardous Products Act, all chemicals are required to have MSDS, which describes the specific properties of a chemical. Similar safety sheets for biohazardous materials are called Pathogen Safety Data Sheets (PSDS). These are required for all RG2 organisms and are recommended for all biohazardous material.

PSDS provide:

Personnel a quick safety reference for biohazardous materials they are handling.

Contain information such as: pathogenicity/virulence, route of infection, mode of transmission, stability, infections dose, preventative measures, host range, distribution, and impact of release (See CBSG Chapter 4).

PHAC and CFIA has ~200 PSDS for common pathogenic microbes: For example of PSDSs see: http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/escherichia-coli-pa-eng.phP

Pathogens that lack a PSDS or have been modified will need to be characterized and a PSDS developed. As stated above it is the responsibility of the user to develop these resources. Primary literature and the PHAC are excellent sources to use when developing PSDS.

INVENTORY CONTROL PROCEDURES

In the course of research, PIs can acquire significant collections of biohazardous agents. An inventory of all archival stocks of these agents is a federal requirement and must be maintained at all times for RG2 or higher biohazards. For the purposes of this manual, an archival stock is any biohazardous agent:

Stored at -80˚C or in a liquid nitrogen Dewar.

Stored at 4˚C for more than one month.

http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/escherichia-coli-pa-eng.phP

Biosafety Program



Stored at room temperature in a non-metabolic state (i.e., spore slant, sealed lyophilized vial, etc.) for more than two weeks.

Ongoing cultures in an incubator are not considered archival stocks.

The minimum record-keeping requirements for biohazardous agents under the responsibility and ownership of the PI include:

Scientific name or equivalent designation of each biohazardous agent including strain;

Storage location;

Number of containers of each biohazardous agent;

Any restrictions imposed on the use of the biohazardous agents if provided by a commercial or third-party supplier;

If/when they are transferred to another group or destroyed;

Inventories can be kept as paper or electronic documents. Inventories must be kept up-to-date and must be made available on

request to JHSC personnel.

IMPORTATION & TRANSFER OF BIOLOGICAL MATERIALS

Importation Requirements

Human Pathogens & Terrestrial Animal Pathogens Importation of human pathogens is regulated by Human Pathogens Importing Regulation which allows the PHAC manage the risk of inadvertent transmission of communicable disease. Importation of animal pathogens is regulated by Health of Animals Act which allows the CFIA to control the use animal pathogens and pathogens associated with reportable animal diseases. Every person importing a human or terrestrial animal pathogen in RG2 or higher must obtain an importation license. PHAC and CFIA will also require appropriate CL facility certification based on the guidelines outlined in CBSG. Once the license is in hand it must be sent to the shipper of the infectious substance and attached to the outside of the shipping container.

Aquatic Animal Pathogens Facilities which handle aquatic animal pathogens are required to comply with CFIAs Containment Standards for Facilities Handling Aquatic Animal Pathogens 1st Ed. 2010. To obtain a permit, an application must be completed and submitted to CFIA’s Office of Biohazard Containment and Safety. See: http://www.inspection.gc.ca/animals/aquatic-animals/imports/pathogens/eng/1312436244596/1322885037191

Plant Pests Laboratories planning on importing plant pests should refer to the procedures and checklists described by CFIA. Import permits will only be issued to facilities which are certified and meet the appropriate physical and operational requirements described in the Containment Standards for Facilities Handling Plant Pests (2007). See: http://www.inspection.gc.ca/english/sci/bio/plaveg/placone.shtml

Material Transfer Agreements

Material transfer agreements are legal agreements used for institutions to assume responsibility for the use of material that is being transferred to the campus from another research institution or supply house.

Transportation of Biohazardous Agents off Campus

http://www.inspection.gc.ca/animals/aquatic-animals/imports/pathogens/eng/1312436244596/1322885037191

http://www.inspection.gc.ca/english/sci/bio/plaveg/placone.shtml

Biosafety Program



The Transportation of Dangerous Goods Act (TDG) is federal legislation designed to regulate the movement of dangerous goods via roads, rail, air, and ship and to protect personnel involved in the transport as well as the general public. In case of accident, emergency officials can quickly identify the hazard based on the warning symbols displayed on the package. See: http:// www.tc.gc.ca Transfer of material off campus falls under TDG regulations and it is the responsibility of the sender / recipient of the biohazardous material to ensure that all regulations are followed and that license requirements have been met. Transportation must be arranged with a TDG certified carrier. Under no circumstances is the transporter to use public transit, to transfer biological materials. All individuals who are involved in packaging and transfer of hazardous materials off campus must have valid TDG certification. This certification can be obtained by contacting the Health & Safety Officer.

Shipping on Dry Ice The shipment of biological material on dry ice carries the same TDG training requirements described above. Dry ice is considered hazardous during transportation for three reasons:

Explosion hazard - Dry ice releases a large volume of carbon dioxide gas as it sublimates. If packaged in a container that does not allow for release of the gas, it may explode, causing personal injury or property damage. Dry ice must never be packaged in a sealed container.

Suffocation hazard - A large volume of carbon dioxide gas emitted in a confined space may create an oxygen deficient atmosphere.

Contact hazard - Dry ice is a cryogenic material that causes severe frostbite upon contact with exposed skin.

What if Something Goes Wrong? The most important component in spill response is preparation. Individuals should be aware of the particular hazards associated with the material they are transporting. During transport, if materials begin leaking out of the container immediately contact the HSO via the nearest phone to activate a Spill Response for assistance in clean up. At least one person must remain at the site and prevent anyone from walking in the spill area. An incident report must be filed with the Health & Safety Officer. The incident report form can be found on the AU Health & Safety Website.

ACCESS/SECURITY CONTROLS

Access to laboratories where biohazardous agents are handled and stored is restricted to authorized personnel. Personnel who have completed the orientation and training outlined in Chapter 2 and documented with a Training Matrix may work independently and unsupervised in the laboratory. All other personnel (i.e. visitors, external contractors) may only enter the laboratory under the escort of someone who has completed this training with the exception of:

Custodial and Physical Plant staff who have completed Biosafety Orientation for non-research staff.

AU Security, Physical Plant and JHSC personnel may enter a laboratory after hours to investigate potential infrastructure or criminal issues.

Infants and children are prohibited from entering research and teaching laboratories where biohazardous agents are handled and stored.

http://www.tc.gc.ca/

Biosafety Program



INSPECTIONS AND LICENSES All work conducted by university members with biological agents on university premises or under the control of the university requires a Biosafety PHAC License and internal AU Permit. Federal research funding agencies require a License/Au Permit to be issued by an institution prior to funds being released. The application will assist the researcher or instructor in the development of appropriate containment, safety and emergency procedures. All laboratory spaces will be subject to the workplace inspection process.

BIOSAFETY SIGNAGE PHAC requires that warning signs and/or symbols be used to inform personnel and visitors of the potential of hazards in the workplace. Specifically, with regard to biohazards, the universal biohazard warning symbol, see Figure 1, must be used to "signify the actual or potential presence of a biohazard and to identify equipment, containers, rooms, materials, experimental animals or combinations thereof, which contain and/or are contaminated with, viable hazardous agents."

The universal biohazard symbol must be used to designate the presence of agents/substances that are believed to be biohazardous.

All laboratories and work areas utilizing and/or storing RG1 & RG2 biohazardous substances must have the appropriate biohazardous caution sign posted prominently. If RG2 agents are used, a biohazard sign must be located outside the laboratory door to indicate the nature of the hazard, the biohazard level, special provisions for entry and contact information for the Principal Investigator and/or other responsible person(s).

Principal Investigators/Supervisors are responsible for ensuring that all hazard signs are current and accurate. Notify the Biosafety Officer if changes are necessary in laboratory door signage and/or equipment labeling.

Figure 1: WHMIS Biohazardous symbol.

TRAINING REQUIREMENTS Biosafety training is mandatory for all new PIs, supervisors, research staff, students, visiting scientists, and volunteers who work with biohazardous material. The BSO provides general biosafety training to all individuals handling biohazardous material. PIs are responsible for ensuring new employees have received training appropriate to the specific biological materials and/or processes in the lab. Training is to be provided prior to initiation of work and should be documented by the PI. A refresher course will be required every 3 years for all personnel. Custodial and maintenance workers are given a separate course “Biosafety Orientation for non-research staff.” Upon completion of the generic Biosafety training participants will understand:

The process of risk assessment for work with biohazardous material

The risks of working with biohazardous material

Biosafety Program



The concept of containment as it applies to biohazards within a laboratory

Procedures and equipment to help mitigate risks of working with biohazardous material

Procedures for accidental exposure or spill of biohazardous material

Proper decontamination procedures and waste disposal Generic Training

WHMIS training

Introduction to Biosafety – BSO

PHAC Biosafety e-Learning Modules: https://training-formation.phac-aspc.gc.ca o Introduction to Biosafety o General Safety Practices for Containment Labs o Operational Practices in Containment Level 2 o Personal Protective Equipment o Decontamination in the Laboratory o Chemical Disinfectants

Lab-specific Training

The PI is responsible for ensuring that all personnel in their lab receive safety training in the site-specific protocols. Only the PI or a designated alternate can evaluate whether a worker has received the appropriate information and is competent to work independently with biohazards within the lab. PIs are encouraged to use the AU Laboratory Safety Training Checklist to ensure that personnel receive the appropriate training. Note that the training needs listed on the Checklist are general and that more lab-specific training will need to be added.

Training Records

Training records must be maintained and retained. All training must be documented and records made available to the AU JHSC or external auditors when requested. The AU Laboratory Safety Training Checklist can be used to help records and track training of personnel. PIs should ensure that all relevant certificates and records are maintained in the Laboratory binder.

MEDICAL SURVEILLANCE

The medical surveillance program will be based on the overarching risk assessment. When changes are made to any laboratory program, the program will be reviewed and updated accordingly.

Health Self-Monitoring

Personnel working with biohazardous agents causing infectious disease or toxigenic effects in humans must read the PSDS associated with the biohazardous agent. Personnel must be aware of the potential exposure routes through which the biohazardous agent can gain entry into the body and self-monitor their own health for symptoms of disease associated with the biohazardous agents they are handling. If infection with a biohazardous agent under study is suspected, regardless of whether the individual can identify a known exposure event, the individual must consult with their PI. If symptoms are severe enough that the individual seeks medical attention, they must identify to the attending physician that they work in a research or teaching laboratory and what biohazardous agents they are currently working with. This will help the attending physician in their differential diagnosis. Infections and immunocompromised conditions may make individuals more susceptible to a potential infection with the biohazardous agents they are working with. Personnel should refrain from entering a laboratory where biohazardous agents

https://training-formation.phac-aspc.gc.ca/

Biosafety Program



are handled or stored if they are sick with an active infection, or are immunocompromised due to medication or other conditions. Women who become pregnant should advise their PI of the pregnancy as soon as possible. Together, the PI and worker should review the hazard assessment(s) for the applicable work activities and determine if any of the biohazardous agents, chemical hazards or other hazardous conditions in the laboratory pose an undue risk to the unborn child. If hazards are identified that do pose an elevated risk to the unborn child, the associated activity should be transferred to another member of the research group for the duration of the pregnancy. It is recommended that the pregnant worker review the results of this assessment with their physician.

Immunizations

Research groups conducting work with infectious biohazardous agents affecting humans should investigate whether a vaccine exists against the agent during their initial risk assessment of the agent. In most cases, PSDS will state if a vaccine exists against a given pathogen. If a vaccine exists, the PI should check with Algoma Public Health to see if the vaccine is available in Canada and, if available, the PI should offer it to the members of their research group who will be directly handling the biohazardous agents or any waste that may be contaminated with the biohazardous agent. If an individual in the research group declines the vaccine, the PI and the individual should co-sign a declaration stating that the vaccine was offered but was declined.

Allergens

Allergens may be encountered in research when working with biological organisms, isolated tissue specimens from these organisms, or when cleaning up waste materials from biological organisms. Although mammals, particularly rodents, dogs and cats, are most commonly known as sources for allergens, many animal, plant and mold species have the potential to generate allergic reactions in humans; even cricket waste and scales from butterfly wings can illicit human allergies. Allergy symptoms generally consist of rashes where the allergen made direct contact with skin, nasal congestion and sneezing, itchy eyes and asthma-like symptoms (i.e., coughing, wheezing and chest tightness). Personnel may be exposed and sensitized to allergens through direct skin contact, via eyes and mucous membranes or through inhalation. Personnel may also be inoculated with allergens through uncovered wounds or accidental animal bites or needle-stick injuries. If personnel suspect they are developing allergies to the biological organisms they are working with they should inform their PI/supervisor and consult with a physician. Personnel should not ignore signs of allergies; allergies tend to worsen with continued unprotected or improper exposure to the source of allergens. Personnel should also not self-medicate with off the shelf antihistamines without consulting a physician as, while the medication can alleviate symptoms, it may mask an overall worsening of symptoms.

To reduce individual exposure to animal allergens consider the following:

Pre-placement screening of personnel for allergies (pollens, molds, animal dander, etc.) before assigning specific jobs handling potential allergen sources.

Confirm appropriate ventilation rate and humidity in rooms where potential allergen sources are handled or housed.

Ensure airflow is directed away from workers and back towards the potential allergen source.

When possible, perform manipulations of potential allergen sources within ventilated hoods or biological safety cabinets; never handle potential allergen sources in a laminar flow hood.

Avoid wearing street clothes while working with potential allergen sources; change into facility dedicated laboratory scrubs.

Keep area where potential allergen sources are handled or stored clean and free of dust; regularly mop and wipe down surfaces with wet cleaning towels rather than vacuuming or sweeping (which would generate aerosols).

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When working with live animals, use absorbent pads for bedding and avoid the use of sawdust bedding which can facilitate the aerosolize of urine and fecal material from the cage.

When working with live animals, if possible, use an animal strain or sex that is known to be less allergenic than others.

Reduce skin contact with potential allergen sources by using appropriate PPE.

Use a fit-tested respirator when warranted. A surgical mask is not equivalent to a fit-tested respirator; in a hospital setting a surgical mask is meant to protect the patient from the worker and not vice versa.

Biosafety Program



CHAPTER 3: CLASSIFICATION OF BIOLOGICAL HAZARDS If an AU researchers or teaching group works with or stores any of the following biological hazards, or conducts research involving any of the following biohazardous activities they must be permitted.

Types of Biological Hazards

The following summarizes the types of biological materials that fall under the purview of the CBSG (Chapter 3).

Current Species at AU

Pathogenic Microbes Pathogenic microbes are defined as self-replicating organisms that can cause infectious disease in humans, animals, or plants. These include bacteria, viruses, fungi, prions, and eukaryotic parasites. Pathogen Safety Data Sheets (PSDS) available on the PHAC and CFIA websites describe many common microbes and assign them to biohazard risk groups (See example in Appendix A). If PSDS are not available and the risk group designation has not been determined, then it is the responsibility of the PI to develop a PSDS for the organism. Guidance can be obtained from the BSO, PHAC, and CFIA.

Eukaryotic Cell lines Human or animal cell lines are generally considered risk group 2 biohazards due to their potential to contain pathogenic viruses. Commercial suppliers should provide PSDS indicating the biohazard risk group of their product.

Biological Toxins Biological toxins are poisonous substances derived from a biological source that not capable of self-replication.

Animal tissue specimens As with human samples, it is not possible to determine an individual animal’s health status. All samples may contain potential pathogens.

Genetically modified organism (GMOs) Alteration of genetic material in a biological species via recombinant DNA technologies (rDNA) can be used to create GMOs (i.e. transgenic animals or plants with novel traits – PNTs). These manipulations may alter the pathogenicity or infectivity of an organism, or increase its vigor within the environment. As such, risk must be assessed on the modified organism.

OTHER

In the event that any of the following are used at AU, the following concerns are:

Human clinical specimens & body fluids All human clinical specimens should be assumed to contain pathogenic microbes. This includes tissue preparations used for cell cultures and human materials provided by commercial sources even if they have been screened against common human blood-borne pathogens.

Viral vectors Viral vectors are vehicles for delivering genetic material into host cells for gene expression. Many vectors are based on human viruses (i.e. adenovirus, retrovirus, herpesviruses) and risks exist for potential infection, propagation, increased pathogenicity, or oncogenesis.

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Infectious RNA Positive-sense viral RNA is capable of causing infection (i.e. polio, West Nile, dengue)

Non-indigenous plant, insect, or animal species The release of non-indigenous organisms into the environment could have serious human or animal health, environmental, or economic impacts.

Risk groups

Biological agents are classified based on the relative hazards they pose. Factors used to determine an agent’s risk group includes its pathogenicity/virulence, route of infection, mode of transmission, stability, infectious dose, preventative measures, host range, distribution, and impact of release.

Table 1: Risk classification summary for biological hazards.

CBSG RISK GROUPS Risk group

Individual risk

Community Risk

Description Examples

1 (lowest)

Low Low Unlikely to cause disease in healthy workers.

- non-infectious bacteria

- Lactobacillus spp.

2 Moderate Low

May cause disease, but no a serious hazard. Effective treatments and preventative measures available.

- influenza virus - Herpes simplex - Tetanus

3 High Low

Cause serious disease but not easily spread by casual contact. Treatment or preventative measures available.

- Hepatitis - West Nile - Anthrax - TB

4 (highest)

High High Cause very serious human disease. May or may not be treatable, but is readily transmitted.

- Ebola

All biological agents used at AU require Containment Level 1 or 2. NOTE: NO EMPLOYEE WILL PERFORM CONTAINMENT LEVEL 3 OR 4 WORK AT ALGOMA UNIVERSITY.

Containment Levels & Considerations

A containment level refers to the minimum physical containment and operational practices required for handling biological hazardous material safely in a laboratory. Classification of biological agents into risk groups does not establish the guidelines for handling these agents safely. In general, the containment level and risk group of the pathogen are the same (e.g., RG2 pathogens are handled at CL2); however, there are exceptions, and not all biological material will fall perfectly into a given risk group or containment level following a risk assessment. In some the containment level and risk group of the pathogen are the same (e.g., RG2 pathogens are handled at CL2); however, there are exceptions, and not all biological material will fall perfectly into a given risk group or containment level following a risk assessment. In some cases, there is a higher or unique level of risk associated when handling certain pathogens (e.g., non-indigenous animal pathogens or prions) or with certain types of work (e.g., in vivo work or in vitro work involving large scale volumes of pure or concentrated cultures of

Biosafety Program



pathogens). In other cases, biological material (e.g., tissues, diagnostic specimens) may harbour pathogens, toxins, prions, or modified components of a pathogen, in which case, a site-specific local risk assessment (LRA) is critical to evaluate and determine which work-specific operational practices and mitigation strategies are to be implemented to achieve the appropriate level of precaution. Risk assessment is a crucial step in establishing the appropriate containment level for any biohazardous work. A risk assessment should assess both the facility requirements, as well as the operational requirements for working with this material. It is the responsibility of the Principle Investigator (PI)/Supervisor to conduct local risk assessments to determine the appropriate containment level. The BSO and HSO may be consulted to help determine the appropriate level. Overarching risk assessments are conducted at an institutional level by a diverse range of parties (See previous)

Containment Level 1 (CL1) This is a basic laboratory that handles low risk agents (i.e. Risk Group 1 agents). CL1 does not require any special design features beyond those needed for a functional, well-designed laboratory. Work may be done on open benches. Work with Risk Group 1 pathogens is not regulated by PHAC or CFIA, and containment is achieved following basic microbiological techniques and best practices outlined below. Please refer to the General Operational Practices for an overview of basic lab skills (Chapter 4)

o Physical requirements Well-designed workspace with washable walls and countertops Laboratory is separated from public areas by a door Screens on windows Hanging space for lab coats Separation of lab wear and street clothing Availability of an autoclave is desirable

Containment Level 2 (CL2) In addition to the requirements for a CL1 lab, CL2 facilities require a number of additional physical and operational controls. The primary exposure hazards associated with organisms requiring CL2 are through ingestion, inoculation, and mucous membrane routes. Agents requiring CL2 facilities are not generally transmitted by airborne routes, but care must be taken to avoid the generation of aerosols (aerosols can settle on bench tops and become an ingestion hazard through contamination of the hands) or splashes. Work on RG2 pathogens is regulated by PHAC and CFIA and required formal registration. Physical requirements for these types of areas are outlined below and are discussed in detail in CBSG. Operational requirements are indicated in The General Operational Practices (Chapter 4)

o Physical requirements Primary containment devices (i.e. BSCs; centrifuges with sealed rotors or safety cups) PPE Hand washing sinks and emergency eye wash and shower stations Decontamination facilities (i.e. autoclave) Impervious bench tops Segregation of paper / computer work stations from areas where biohazard work is conducted Biohazard signage Controlled access to the containment zone Communication system is available between the containment zone and the external area

All biological agents used at Algoma University require Containment Level 1 or 2. No employee will perform Containment Level 3 or 4 work at Algoma University.

Biosafety Program



Other Considerations:

Laboratory Animals All research involving animals must be done in accordance with Algoma University Animal Care Committee (AUACC). By definition, all work involving animals is considered biohazardous. Animals can harbor infectious organisms that can be transmitted to humans. Laboratory facilities must provide containment for laboratory animals exposed to or harbouring infectious agents that is appropriate to the risk level of the infectious agents involved. Requirements for the maintenance of animals may differ in scale and degree, but the basic principles for microbiological safety will be similar to those outlined above and should include the following precautions:

Infected animals and insects should be segregated from uninfected animals wherever possible, and it is preferable to separate any handling area from the holding area.

Animals or insects in use in an experiment must be maintained at a level of containment that is at least equivalent to the containment level for the biological agent with which it has been infected or treated.

Provision must be made to ensure that inoculated animals or insects cannot escape.

Dead animals or insects and the refuse from the animal room and cages (e.g. bedding, feces and food) must be placed in a leak-proof container and autoclaved or incinerated.

All cages must be properly labeled, and procedures in the holding area must minimize the dispersal of dander and dust from the animals and cage refuse.

Gloves and safety glasses should be worn by animal care providers while feeding and watering animals or cleaning cages.

Gloves, boots, floors, walls and cage racks should be disinfected frequently. All aspects of the proposed use of animals in research must satisfy all the standards and regulations of the Canadian Council on Animal Care (CCAC), and the Animals for Research Act. All work involving animals must receive prior approval from AUACC.

The appropriate species must be selected for animal experiments.

The investigator and/or person(s) responsible for an animal experiment must ensure that all those having contact with the animals and waste materials are aware of and familiar with any special precautions and procedures that may be required. Where possible and warranted, personnel should be protected by immunization with appropriate vaccines.

All incidents, including animal bites and scratches or cuts from cages or other equipment must be documented and reported by the employee to the Lab Supervisor. The Lab Supervisor must send the report to the Animal Care Coordinator to be forwarded to the HSO.

Plant Pathogens The Containment Standards for Facilities Handling Plant Pests, published by the CFIA, describes the minimum acceptable physical and operational requirements for facilities that work with plant pests other than weeds, soil, genetically modified plants and arthropod biological control agents. Any persons who grow, raise, culture or produce anything that is a pest or is infected or infested with a pest must adhere to these containment standards. They provide guidance on the operation of plant pest containment facilities such as laboratories, greenhouses and screen houses. Compliance with these standards and with documents such as import licenses will help to ensure that economically and environmentally significant plant pests do not inadvertently escape into the environment and become established in Canada.

Plants with Novel Traits (PNTs) & Genetically Modified Organisms (GMOs) PNTs/GMOs must be housed in a facility that prevents the release of the plant and its pollen or seeds into the environment. Regulation and monitoring of facilities handling PNTs is handled by CFIA. Laboratories and greenhouses to be used with PNTs must go through CFIA’s Safety Assessment Process for Plants with Novel Traits prior to

http://www.inspection.gc.ca/plants/plants-with-novel-traits/general-public/assessment-process/eng/1338189630096/1338189929476

Biosafety Program



initiation of research or the acquisition of the agents to ensure the infrastructure can properly contain these organisms. Base requirements for working PNTs are similar to Plant Pathogens.

Aquatic Animal Pathogens The Containment Standards for Facilities Handling Aquatic Animal Pathogens, published by the CFIA, applies to facilities importing aquatic animal pathogens, aquatic animal product(s) and by-product(s) or other substances that may carry an aquatic animal pathogen or part thereof. The standards provide general guidance on the design and operating requirements for any aquatic animal containment facility. All persons wishing to import aquatic animal pathogens and related infectious materials for in vitro or in vivo work must comply with these standards along with any import requirements established by the Canadian Food Inspection Agency (CFIA) and, where applicable, by the Public Health Agency of Canada.

Species non-indigenous to Ontario Facilities housing live animal, plant and insect species not indigenous to Ontario must be designed to ensure that the non-native organism cannot escape and potentially establish itself in the province. Base requirements are as detailed in Section 4.3 for CL-2 facilities. In addition, PIs wishing to work with live species not indigenous to Ontario must declare their research plans to the IBC prior to bringing the species into the province and obtain the appropriate importation and certification for PHAC and/or CFIA.

Biosafety Program



CHAPTER 4: GENERAL OPERATIONAL PRACTICES

Laboratory Documentation A number of documents and records are required to be kept within the containment zone and be available for inspection. These are:

AU Biosafety Manual

AU Laboratory Safety Manual

PHAC Letter of Compliance (CL2 only)

Internal AU Biosafety Permit

Training & retraining records (retain for minimum of 1 year for workers; 2 years for visitors)

Training needs assessment

Equipment maintenance, repair, testing, certification (retain for 5 years minimum)

Verification of decontamination equipment and processes (retain for 5 years minimum)

Incident reports (retain 10 years minimum)

Standard Operating Procedures; Emergency Procedures; Contact Information

Local Risk Assessments

Pathogen Safety Data Sheets (CL1 recommended; CL2 required)

From an AU Administration perspective:

Inspections and corrective actions (retain 5 years minimum)

Building and equipment maintenance, repair, testing, certification (retain 5 years minimum)

Incident reports (retain minimum 10 years)

Overarching Risk Assessment

Pathogen Safety Data Sheets (CL1 recommended; CL2 required)

Laboratory Computers and Personal Electronics Computer keyboards are difficult to decontaminate. Computer work stations should be kept well away from work areas where biohazardous materials are handled or stored. Personnel should remove disposable gloves before typing at a computer. If an individual’s work activities prevent them from repeatedly donning and doffing gloves to work at a computer, the research group should invest in a liquid-resistant medical keyboard and regularly wipe down the keyboard with a suitable decontaminant throughout the work day. Individuals bringing personal smart phones and tablets into a laboratory environment must be aware that these items can carry biohazardous agents out of the laboratory and to their home. If these items are to be used in the laboratory, their screens must be covered with an adhesive screen protector and must be wiped down with an appropriate decontaminant before being taken out of the laboratory at the end of the day. If these items are employed in the laboratory, their use by other members of the individual’s household, especially by children, is strongly discouraged. The use of personal devices is not permitted in CL2 teaching laboratories.

Biosafety Program



Personal Protective Equipment & General Hygiene Personal Protective Equipment (PPE) refers to a variety of barrier protections that used alone or in combination will protect an individual’s skin, clothes, mucous membranes and airways from contact with hazardous materials at the work place. In the case of PPE against biohazardous agents, many also in turn protect research material, such as cell and microbial cultures, from contaminants on the individual’s clothes or body. When entering a research or teaching laboratory for the purpose of performing a task other than working at a computer work station or transiting the laboratory to reach a non-research space, the following minimal PPE must be worn and properly fastened:

A properly fitting, fully fastened laboratory coat;

Disposable gloves appropriate against the types of biological and chemical hazards;

Shoes that fully cover the foot (i.e. no slip-ons) and do not have a high heel;

Clothing that does not expose any skin below the waist;

Additional PPE may be required as determined by the research group’s LRAs (i.e. safety goggles).

Other considerations:

All requirements of the Laboratory Safety Manual must be met

Open wounds, cuts, scratches and grazes must be covered with waterproof dressings. If a wound cannot be sufficiently covered with dressing, the individual may not enter the laboratory.

Gloves must never be worn when opening doors, answering a phone, or typing on a keyboard.

Hands must be washed after gloves have been removed, before leaving the laboratory, and at any time after handling materials known or suspected of being contaminated.

Additional full-face protection must be used during activities where a potential splash hazard exists, for instance when retrieving specimens from a liquid nitrogen Dewar.

A fit-tested respirator must be used during an activity with the potential to aerosolize a biohazardous agent and cannot be conducted in a biological safety cabinet (BSC) or other appropriate aerosol containment device. Fit records must be maintained.

Surgical masks are not equivalent to fit-tested respirators to protect against biohazardous agents. Place designated waste containers for gloves and other disposable PPE in a convenient location. A coat stand should not be used with laboratory coats and gowns. Street jackets and coats must be stored separately from laboratory coats and gowns, such as in an individual’s locker or office space. Always wash hands with soap and water at a designated hand-wash sink as the final step after the removal of PPE and before leaving the laboratory. Never wear PPE outside of the of the laboratory or research support areas. The wearing of laboratory PPE, regardless of whether it is “clean” or not, is prohibited in any AU public areas. An exception to this guideline is allowed when personnel transport research material between areas on a building floor (for instance, moving material down the hall to the autoclave). In this case PPE may be worn but one hand should be kept “un-gloved” to allow for the opening of doors. The ungloved hand should not come into contact with the research material. Under no circumstances should personnel consume food or drink, or store food, dinnerware, drink containers or utensils in rooms where biohazardous agents are handled or stored. Gum, candy and lozenges are considered food items in this circumstance.

Biosafety Program



Aseptic Technique for Bench Work Working at the bench is one of the most common activities conducted in a research or teaching laboratory. The use of aseptic technique is essential for ensuring both the safety of personnel and contamination-free success of research. Aseptic technique refers to procedures and techniques designed to avoid and prevent cross-contamination of the worker, the work environment and the specimens/material being handled. Aseptic technique can be summarized with three rules:

1. Maintain a clean, organized work area o Keep laboratory benches clear of clutter o Avoid reading and writing at the bench o Decontaminate bench surfaces before and after experiments

2. Keep sample/media containers closed o Open and keep containers at a 45˚ angle while pipetting to minimize aerosol formation o Decontaminate edges of containers prior to transferring liquids

3. Minimize movements o Assemble all solutions, samples and equipment before commencing work o Avoid rapid movement, or waving of tools or pipettes in the air o Establish work flow that moves work materials from “clean” to “dirty” areas

Biological Safety Cabinets

Experiments involving pathogenic microbes, tissue culture, and human clinical samples require the use of an aerosol containment device. As well, work with invasive plants not native to Ontario may also require aerosol containment. The most commonly used piece of equipment for this is a Biological Safety Cabinet (BSC). The purpose of the BSC is both to protect the investigator from potential infection, and to protect the experimental materials from contamination. There is currently one BSC in use at AU (Class II – A2). Class II-A BSC - These remove aerosolized biohazardous agents from the air in the cabinet via a highly-efficient particulate air (HEPA) filter and recirculate the filtered air back into the laboratory, therefore they do not require hard-ducting. However, because they return the filtered air back into the laboratory, they are inappropriate for combined projects involving biohazardous agents with chemicals, anesthetics or radioactive isotopes that are volatile in nature.

Preparing for work in the BSC:

1. Turn off UV lights if in use and ensure that the sash is in the appropriate position. 2. Turn on fluorescent light and cabinet blower. 3. Check the air intake and exhaust grilles for obstructions. 4. If the cabinet is equipped with an alarm, test the alarm and switch it to the "on" position. 5. Confirm inward airflow by holding a tissue at the middle of the edge of the viewing panel and ensuring that it is

drawn in. 6. Disinfect the interior surfaces with a suitable, noncorrosive disinfectant (e.g., 70% alcohol). 7. Assemble all materials required for the procedure and load them into the cabinet; do not obstruct the air grilles;

the working surface may be lined with absorbent paper with plastic backing; segregate "clean" items from "contaminated" items.

8. Wait 5 minutes to purge airborne contaminants from the work area.

Working in the BSC: 1. Put on protective lab-coat and gloves as appropriate.

Biosafety Program



2. Perform operations as far to the rear of the work area as possible. 3. Avoid movement of materials or excessive movement of hands and arms through the front access opening during

use; when you do enter or exit the cabinet, do so from straight on; allow the cabinet to stabilize before resuming work.

4. Keep discarded, contaminated material to the rear of the cabinet; do not discard materials in containers outside of the cabinet.

5. Do not work with open flames inside the cabinet. a. If there is a spill during use, surface decontaminate all objects in the cabinet; disinfect the working area of

the cabinet while it is still in operation (do not turn the cabinet off). 6. Ensure small items such as KimWipes don’t get sucked into the vents, as they can disrupt motor operations.

Clean-Up of BSC:

1. Allow the cabinet to run for 5 minutes with no activity. 2. Close or cover open containers before removing them from the cabinet. 3. Surface disinfect by spraying objects with 70% alcohol in contact with contaminated material before removal from

the cabinet. 4. Remove contaminated gloves and dispose of them as appropriate; wash hands. 5. Put on clean gloves, and ensure that all contaminated materials are placed into biohazard bags within the cabinet. 6. Using a suitable non-corrosive disinfectant (e.g., 70% ethanol), disinfect interior surfaces of cabinet; periodically

remove the work surface and disinfect the area beneath it (including the catch pan) and wipe the surface of the UV light with disinfectant.

7. Turn off the fluorescent light and cabinet blower. 8. Turn on the UV light if appropriate (do not turn on when people are working close by).

Additional BSC considerations:

The use of an open flame within a BSC is prohibited. Flames disrupt the airflow and may potentially cause the release of biohazardous agents from the cabinet or contaminate research within the cabinet. It may also damage the HEPA filter. If deemed absolutely necessary, touch plate micro burners that provide flame on demand may be used.

UV light has been proven to be an ineffective method of decontamination, so they may be used to supplement, but not replace, chemical decontamination of the work surfaces and equipment.

Laminar flow hoods are NOT aerosol containment devices. They only protect the product, but offer no protection to the user or the environment.

Chemical fume hoods will protect the user from the product, but do not protect the product or the environment from contamination. Chemical fume hoods lack HEPA filters on the exhaust ventilation, allowing release of aerosols into the environment.

Needle Syringes & Sharps Sharps include needle/syringe assemblies, razor blades, scalpels, and other objects with a jagged or sharp edge that could puncture a plastic bag or potentially cause injury to someone handling them. Alternatives for sharps should be used when available. While working with sharps minimize risk with the following precautions:

Use sharps with engineered injury protections. For example, a syringe that shields the needle with a plastic cover when it is not in use.

Keep needles pointed away from yourself and others.

If needles or scalpels are required with animals, anesthetize or restrain the animal prior to initiating the procedure.

Never attempt to clip, recap or reuse a needle.

Discard intact needle and syringe assemblies into an appropriate sharps disposal container (do not attempt to disassemble).

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Laboratories may use plastic containers as sharps containers provided that the plastic is strong enough to not be penetrated by the sharps. Remove the original label and re-label as a sharps container. Dedicated sharps disposal containers are also available from common laboratory supply companies. Note: Used bleach containers are not puncture resistant and therefore are not to be used as sharps containers.

Once sharps containers are 75% full, seal, decontaminate, and dispose of appropriately in accordance with AU hazardous waste procedure.

Report any needle stick injury to PI as soon as possible and submit and Incident Report to HSO.

Pipetting

The main hazard involved with pipetting is the production of aerosols. Use the following safety measures while pipetting to minimize the risk of exposure to hazardous materials:

Never pipet by mouth.

Use a mechanical device such as a Pipet Aid™ or equivalent, equipped with a 0.2 μL filter.

Use micro-pipettes for the delivery or transfer of small volumes of liquid.

Where contamination is of particular concern, use aerosol-resistant, filtered pipet tips.

Avoid mixing infectious substances (may generate aerosols). o Submerge contaminated pipets in disinfectant after use with biohazards.

Blenders, Grinders, Sonicators & Other Tissue Homogenizing Equipment

The use of blenders, grinders, homogenizers and sonicators with open containers of biohazardous agent will aerosolize the agent. When working with tissue homogenizing equipment and biohazardous agents, adhere to the following:

Conduct all homogenization with biohazardous agents in a BSC.

After sonication or blending a sealed preparation, allow aerosols to settle for at least five minutes before opening container.

Wear appropriate hearing protection when using the sonicators.

Wear double gloves when handling equipment.

Centrifugation

The two major hazards involved with centrifuging are the production of aerosols and mechanical failure. In order to ensure the safe operation of the centrifuge and to minimize contamination, the following guidelines must be observed:

Check all rotors, tubes and buckets for cracks or breaks prior to use.

Ensure the centrifuge speed (relative centrifugal force; rcf) does not exceed the maximum speed allowable for the rotor and/or tubes.

Wipe up any condensed water present in the centrifuge chamber prior to use.

Allow sufficient time for temperature-controlled centrifuges to stabilize at the desired temperature before use.

Use sealed safety centrifuge buckets and rotors when working with ANY biohazardous agents.

Fill and balance all tubes and rotors in a BSC. After centrifugation is complete, unload the rotor in a BSC. When opening the tubes, the top of the tube should be pointed away from the user.

Only fill tubes to no more than 75% capacity to prevent spills.

After centrifugation is completed, unload tubes from rotor or safety cups within a BSC.

In the event of a leak, soak the rotor assembly in disinfectant and clean before using again.

Examine the interior of the centrifuge for cracks, breaks, and spills after every use.

Vacuum pumps & Liquid Filtration

Biosafety Program



Vacuum systems are often used in laboratories for a wide variety of applications and experiments. Most laboratories on campus are equipped with house vacuum lines on laboratory benches. As well, many fume hoods and BSCs contain vacuum lines. When working with vacuum systems and liquid filtration adhere to the following:

All vacuum lines must contain a 0.2 micron in-line filter between the collection flask and vacuum connection valve, to prevent both contamination of experimental samples and the vacuum line.

Filtration of fluids containing infectious materials must be done inside a BSC.

A vacuum flask partially filled with a suitable decontaminant (i.e., a reservoir trap) should be installed between the flask storing the drawn off liquid and the vacuum source.

Vacuum flasks should be taped on the outside to reduce shattering of glass in the event of a vessel implosion. Tubing connections should be secured with quick disconnects, and the vacuum must be ON and operational before any fluid is filtered. To turn the system OFF, first break the vacuum by disconnecting the tubing at the sample flask, then turn the vacuum pump off. This will prevent a potential back-flow of fluid into the sample flask.

During filtration, filter pores may become clogged causing the flow rate to slow or stop completely. Visually monitor the flow rate to determine if a filter requires replacement. Filtration of several smaller volumes rather than one large volume is recommended.

If filtering volatile solutions, a cold trap should be placed in-line between the filtration apparatus and vacuum source.

Venting of rotary pumps must be to an air exhaust system; not directly into the laboratory.

Belt driven vacuum pumps must have protective guards, to prevent accidental entanglement.

Incubators

Incubators holding biohazardous agents must be labeled with a Biohazard Sign. Incubators and are often shared laboratory spaces, and all users should be aware of any biohazardous agents being utilized in the space by other groups. To ensure the optimal use of incubators and warm rooms and to minimize contamination, the following guidelines must be observed:

All cultures must be well labeled with the name of the microbe (including strain, if applicable), date started and name(s) of the person running the experiment.

Incubators should be disinfected regularly (at least quarterly).

If equipped with an alarm, incubators must have contact information posted on the equipment and on file with Physical Plant to ensure that appropriate action can be taken if equipment tails outside of regular working hours.

Refrigerators & Freezers

Archival stocks of biohazardous agents held in fridges and freezers must be logged into the PI’s inventory. Note that refrigerators should be kept clean and organized, and not used for long-term storage of cultures. Refrigerators, cold rooms and freezers are often shared laboratory spaces, and all users should be aware of any biohazardous agents being utilized in the space by other groups. In order to ensure the optimal use of refrigerators, cold rooms and freezers and to minimize contamination, the following guidelines must be observed:

Never store food or drink in a laboratory refrigerator or freezer

Adequately seal containers.

Minimize clutter.

Defrost and clean freezers regularly in order to minimize accumulation of ice and hazardous vapour inside the unit.

Post contact names and phones numbers on -80°C freezers and file contact information with the Physical Plant to ensure that action can be taken if a unit fails outside of regular working hours.

Biosafety Program



Lyophilizers Lyophilizers are used to remove liquid by a process commonly referred to as freeze-drying. Because the removal of liquid is complete, the chance of generating aerosol contamination can be quite high if appropriate procedures are not followed.

Ensure equipment is clean and sanitized prior to use.

Ensure appropriate filters are attached to vacuum and exhaust lines.

Do not remove samples till cycle is complete. Do not attempt to break vacuum.

Periodically inspect the equipment.

Where possible cap all material before removal from the unit.

Movement of Biological Materials

The transfer of biological material requires special precautions. There are two main considerations when transporting biological material:

Ensuring the safety of personnel, the public and the environment in the event of a spill of the material, and,

Public perception of the safety of the materials being transported.

Biological material may be moved within a building or between buildings on campus provided the guidelines listed below are followed. Any movement of biohazardous agents off-campus, falls under TDG regulations and is outlined in Chapter 2 previously. In all cases, personnel transferring biological materials are to proceed directly from the pick-up location to the delivery location and are not to deviate from the task to conduct other errands. Personnel transporting biological material are not to stop along the way to use washroom facilities, or to purchase or consume food or drink.

Between Laboratories

When transporting biological material between rooms on the same floor, use a cart with the material contained on a tray or in a bin. Wear PPE but keep one hand ungloved to open doors.

Between Floors within a Building

o Ensure primary containers are in good condition and caps are tightly closed. Damaged containers must not be transported.

o Review the PSDSs for materials being transported to ensure that there are no physical hazards or temperature restrictions associated with the materials.

o Label primary containers to describe the contents accurately. o If transporting more than one item, use a cart. o Place bottles of liquid biohazards in a secondary container large enough to contain the volume of liquid being

transported. Include absorbent material on the cart or in a secondary container. o Wear appropriate PPE but keep one hand ungloved to open doors and push elevator buttons. o Do not use stairs when transporting hazardous materials.

Between Buildings

o When transporting biological material between AU buildings transport on foot only. Wearing appropriate laboratory PPE, place the primary container of biological material in a zip-lock bag along with enough absorbent material to contain the sample if a leak from the primary container occurs. Once the bag is sealed, surface-decontaminate it with an appropriate decontaminant. Label the bag with the researcher’s name, date and sample contents.

Biosafety Program



o If the material to be transported contains a biohazardous or chemical agent, label the zip-lock bag with the appropriate WHMIS symbols. Note: once the material has been successfully delivered, cross out or deface the WHMIS symbols prior to disposing of the bag.

o Place the zip-lock package in a cooler or equivalent safety container with a water-tight lid that could withstand a fall from waist height. Label the outside of the cooler with the name of the researcher, their laboratory address and phone number. The outside of the cooler should be free of biohazard symbols.

o Do not wear lab coats and gloves during transport. o Once at the destination, standard laboratory PPE must be put on before opening the cooler to empty the contents.

Transportation off campus

See Chapter 2 for details on off campus transportation, importation, and material transfer agreements. Transportation is not permitted unless in accordance with TDG. All transportation requires prior notification of the HSO.

CHAPTER 5: DECONTAMINATION & WASTE MANAGEMENT

Biosafety Program



All work surfaces and equipment used with biological material (whether or not it is considered a biohazardous agent) must be kept clean and regularly wiped down with an appropriate chemical decontaminant during and at the end of work activities. This helps to prevent odors and cross-contamination of research and protect individuals’ health. If a surface is visibly soiled with organic material, decontaminant should be applied twice, once to remove the organic material and a second time to decontaminate the surface. Research and teaching groups working with biological materials may use a commercial bench coat to cover their work surfaces but should replace the coat as soon as it becomes visibly soiled or at the completion of the day’s work. Bench coat used with biological materials must be autoclaved prior to disposal or disposed of via incineration. All waste containing biohazardous agents and all culture material must be inactivated via one of the decontamination methods described below. Under no circumstances are personnel to dispose of untreated waste potentially contaminated with biohazardous agents into the regular building waste stream. In addition, personnel are prohibited from pouring untreated, active cultures of any microbe or eukaryotic cell line down a sink or sewer drain.

Sterilization vs. Disinfection

Often terms such as sterilization, disinfection and decontamination are used interchangeably within a research environment. Technically these terms have distinct meaning which should be understood. Decontamination is a broad term that refers to the removal of biohazardous material rendering waste or surfaces non-hazardous. There are two paths for achieving decontamination: sterilization and disinfection. The path chosen will depend on the nature of the biological hazard, the material to be decontaminated, and the research requirements. Sterilization is the killing or removal of all biological hazards, including highly resistant entities such as bacterial spores. Disinfection significantly reduces the number of pathogenic microorganisms by removing or killing them, but does not remove all infectious agents (i.e. bacterial spores). The level of disinfection and the agent used is determined through a risk assessment.

Chemical Disinfection Chemical disinfectants are primarily used to sterilize equipment, work surfaces, or for spill clean-up. Selection of an appropriate chemical disinfectant is based on individual risk assessments for the specific biohazard. Table 2 provides a summary of the common classes of disinfectants used in research environments.

Table 2: Characteristics of some common chemicals for disinfection of work surfaces.

Biosafety Program



Disinfectant

Active Ingredient

Concentrationa (%)

Minimum Contact

Time (min)

Effective Againstb

Tiss

ue

spec

ime

ns

Veg

etat

ive

bac

teri

a

Enve

lop

ed

viru

ses

Myc

ob

acte

ria

&

fun

gi

Fun

gal s

po

res

No

n-e

nve

lop

ed

viru

ses

Bac

teri

al s

po

res

Alcohols (e.g. ethanol, isopropanol)

70-85 10-30 + + + ± NA ± NA

Chlorines (e.g. bleach PreseptTM)

5-10 5-30 + + + + + + +

Phenolics (e.g. DettolTM, LysolTM)

0.2-3 10-30 + + + ± NA NA NA

Peroxides (e.g. hydrogen peroxide)

3-30 1-60 + + + + + + +

Iodophor Compounds (e.g. WescodyneTM)

0.47 10-30 + + + ± ± ± NA

Quaternary Ammonium Compounds

(e.g. RoccalTM) 0.1-2 10-30 + + ± + NA NA NA

a See manufacturer’s guidelines for dilution of commercially available disinfectants b + means the decontaminant is effective against the indicate biological material, ± means the decontaminant is effective against some but not all members of the indicated type of biological material, and NA indicates the decontaminant should not be used against that class of microbe.

The most common chemical disinfectants recommended for use in AU research and training laboratories are:

70% Ethanol – Used with a minimum contact time of 2 minutes to clean surfaces and equipment used with human clinical specimens, animal specimens, eukaryotic cell lines and non-hydrophilic viruses. Higher concentrations of ethanol will not effectively disinfect as water is needed to assist with cell penetration.

2% VirkonTM – Used with a minimum contact time of 3 minutes to clean surfaces and equipment used with human clinical specimens, animal specimens, eukaryotic cell lines, viruses and non-spore forming bacteria.

10% bleach – Is effective against human clinical specimens, animal specimens, eukaryotic cell lines, viruses, bacteria and rDNA technologies. Used at a minimum contact time of 5 minutes it can be used to clean surfaces and equipment. 10% bleach is also used for the remediation of all spills of biological material although the minimum contact time is increased to 30 minutes (CBSG, Table 16-2 Characteristics of chemical decontaminants). Metal surfaces treated with 10% bleach should be rinsed with water (or 70% ethanol if wanting to maintain sterility) in order to prevent corrosion of the metal.

Personnel mixing chemical decontaminants must read the MSDS and wear PPE appropriate for the specific disinfectant.

Steam Sterilization/Autoclaving

Autoclaves and steam sterilizers provide an effective means of sterilizing and decontaminating materials that are biohazardous, or have been exposed to biohazardous agents. Autoclaves are also routinely used to sterilize laboratory supplies, solutions and media. Autoclaving is the method of choice for the inactivation and disposal of microbial and eukaryotic cell cultures regardless of their risk group designation.

Autoclaves operate under high pressure (up to 40 psi) and temperatures (121º - 134ºC) posing significant risk of injury such as:

Biosafety Program



Contact burns from the chamber, doors, racks or autoclaved materials,

Steam burns from autoclaved liquids or residual steam escaping from the chamber,

Fluid scalds from autoclaved material or residual condensate splashing onto exposed skin, and,

Bodily injury from a sealed containers or vessels exploding due to internal pressure during an autoclave cycle.

In order to ensure that autoclaves function properly and to minimize the risk of injury to personnel, the following guidelines are required:

All personnel must receive training before operating any autoclave unit in accordance with the SOP.

Before initiating autoclave runs, conduct a daily check according to the manufacturer’s operating instructions. If a problem is found or suspected, contact the PI responsible and post “out of service” signage on the autoclave door.

Material preparation: o Use clear autoclave bags with no WHMIS symbols or label bags to indicate non-hazardous. o Place materials to be autoclaved (such as loosely closed autoclave bags, covered containers of liquid wastes,

secured sharps containers, etc.) in a bin large enough to contain a total spill of the contents. o Do not crowd or overstuff items into autoclave bags or bins. o When autoclaving liquids:

Only autoclavable glassware or plastics should be used to autoclave liquids. Ensure containers of liquids are no more than 2/3 full, in order to prevent liquids from boiling over. Loosen lids or covers on containers of liquid prior to autoclaving to prevent containers from bursting.

o Open all autoclave bags prior to autoclaving to allow steam to reach the contents of the bags. o Affix a piece of autoclave tape to each item or bag in the autoclave.

When loading the autoclave:

o Wear appropriate PPE, including heat-insulating gloves. o Do not overload the autoclave. o Ensure that a proper seal occurs when you close the door. o Upon initiation of cycle, wait until the sterilization time has begun before leaving the autoclave.

When unloading the autoclave after completion of a cycle:

o Wear appropriate PPE, including heat-insulating gloves. o Ensure that the pressure of the chamber is “0” before opening the door. o Open the autoclave door gradually to release residual steam and allow pressure within liquids and containers

to normalize. o Let sterilized material stand for at least 10 minutes before opening the door fully and unloading the autoclave

rack. o Allow the contents to cool to room temperature before removing from the autoclave rack and processing.

To ensure quality control and check autoclave functionality:

o Use autoclave tape with markings that change colour when the tape has been exposed to autoclave sterilization temperatures.

o Biological indicators must be used monthly to ensure the autoclave is effectively sterilizing the materials being autoclaved. For more information on autoclave quality control testing SOP.

Biosafety Program



Sterilization Times Effective sterilization depends upon the cycle, length of time, volume of material, and type of material. Table 3 lists some basic autoclave parameters and when they should be used. It is up to each PI to ensure that loads are effectively sterilized and rendered non-hazardous. Biological indicators can be used to test for effective sterilization.

Table 3: Common autoclave cycle parameters.

Cycle Sterilization Times at

121ºC (min) Comments

Liquids 15-30

Sterilization time is dependent on use and the type of media/liquids being autoclaved. Refer to laboratory specific SOPs.

Gravity/Dry Materials 15-30 followed by 15-30

dry (exhaust) cycle

This cycle is used for autoclaving lab supplies such as pipette tips, tubes and empty glassware. Refer to lab-specific SOPs for time requirements.

Biological Waste 45 Appropriate for most biological materials including microbial and eukaryotic cell cultures.

Biological Waste containing microbial spores

120 A longer sterilization time is required to ensure complete sterilization of all spores.

Waste Management

Transport of Waste within Facility Personnel removing biological waste from a research or teaching laboratory for treatment in an autoclave room must place the primary containers of waste in a leak-proof, sealable plastic or metal secondary container of sufficient size to contain waste material if the primary container leaks. The waste packaged in this way must be transported to the autoclave room on a cart and never hand-carried.

Laboratory Waste Pick-up

Custodial staff are only authorized to collect waste that has been decontaminated. It is the responsibility of the waste generator to ensure that decontaminated waste is clearly labeled as non-hazardous, with any biohazard symbols removed or obscured.

Mixed Hazardous Waste

When biohazardous agents are used with chemical hazards, the resultant waste must be treated as follows: o Biohazardous & flammable, combustible, volatile, or corrosive chemical waste: Notify HSO who will arrange

disposal. o Biohazardous & other chemical waste: may be autoclaved and then disposed of following disposal methods for

chemical involved. o Chemical waste: see Laboratory Safety Manual

Biosafety Program



CHAPTER 6: EMERGENCY RESPONSE PROCEDURES

First Aid At AU a list of first aid locations as well as personnel trained in CPR/AED are listed here: http://algomau.ca/about/administration/humanresources/healthandsafety

All research personnel should be familiar with the location of the following:

First aid kits

List of first aid attendants

Location of nearest medical facilities

Incident Reporting

Incidents which involve personal injury and/or damage to University property must be reported to the HSO at ext. 4373 or [email protected] within 48 hours of the incident occurring. It is important to note that if an incident involves multiple negative outcomes (i.e., a personal injury and property damage) only one Incident & Investigation Report should be completed. The following types of incidents must be reported:

Personal Injury - Physical harm or potential exposure to hazardous materials, such as harmful chemicals or pathogenic microbes. This category includes needle sticks, exposure to human blood or body fluids and animal bites.

Health & Safety Violation - Any work-or research-related activity, or work area configuration that compromises existing federal, provincial or institutional health and safety policy, regulations or guidelines. This category includes, but is not limited to, unsecured gas cylinders, improper disposal of hazardous waste materials, blockage of emergency exits, and improper storage of chemical reagents.

Hazardous Spill or Environmental Release - Uncontrolled release of any radioactive, chemical or biological material.

Property Damage - Damage to any AU property resulting in a loss exceeding $500.00.

Stolen or Lost Property - The loss of AU property, the private property of University personnel while on University business, or the private property of personnel visiting the AU.

Near Miss Events

A near miss event is defined as “an event where no actual harm was done but where there was the potential for serious injury, hazardous spill, or property damage”. Near miss events offer the opportunity to refine practices and protocols which may prevent an actual event occurring in the future. Near miss events may also point to degrading equipment and infrastructure which have the potential to fail in the future. When a near-miss event occurs, individuals should discuss the event with their supervisor, and together complete an Incident & Investigation Report and submit it to HSO.

Injuries & Potential Exposures

All injuries and potential exposures to biohazardous agents must be reported. When reporting injuries and potential exposures, the report should note the biohazardous agent involved, and the quantity or concentration of biohazardous agent, if known. Table 4 provides basic guidelines to follow for an initial response to injuries and potential exposures in the laboratory.

http://algomau.ca/about/administration/humanresources/healthandsafety

mailto:[email protected]

Biosafety Program



Table 4: Initial response for injuries and potential exposure events occurring in the laboratory. Type Recommended Immediate Actions

Needle sticks

Remove PPE covering affected area

Wash affected area with soap and water, flush for at least 5 min. Squeeze wound to promote bleeding

If there was potential exposure to human blood or clinical specimens, seek immediate medical attention.

Cuts & Puncture Wounds


Wash affected area with soap and water, flush for at least 5 min.

Apply appropriate skin disinfectant and bandage with water proof dressing

Seek medical attention as necessary

Animal bites


Wash affected area with soap and water, flush for at least 5 min.

Apply appropriate skin disinfectant and bandage with water proof dressing


In Incident report, indicate if the animal was naïve or had been inoculated with a biohazardous agent or chemical hazard

Eye splash Rinse eyes at eyewash station for at least 15 min. (CCOHS recommendation;

Standard for Emergency Eyewash and Shower Equipment ANSI Z358.1-2009)


Splash onto body

Remove PPE and affected clothing

Wash affected area well with soap and water and flush with water for at least 15 minutes (CCOHS recommendation; Standard for Emergency Eyewash and Shower Equipment ANSI Z358.1-2009)

Use emergency shower as necessary

If splash made contact with broken skin, wound should be treated as per cuts & puncture wounds above

Ingestion

Seek immediate medical attention (Poison Control: 1-800-332-1414)

Note quantity of material ingested, report quantity to attending physician and in Incident Report

Self-monitor health for symptoms

Inhalation Seek immediate medical attention

Self-monitor health for symptoms

Fire & Evacuation Alarms

All fire and evacuation alarms are to be treated seriously. When the Fire Alarm goes in a building, immediately secure all biohazardous agents. Shut off all equipment, remove PPE and exit the laboratory as soon as possible, shutting off the lights and closing doors. AU has an Emergency System in place with designated Fire Warden to assist in the event of a fire alarm. Always be aware of the nearest exit point from the laboratory and building, and muster point. In the event of a fire within the laboratory, individuals should immediately notify those in close vicinity, and ensure that the laboratory is evacuated. The fire alarm in the corridor should then be activated. Attempts to fight the fire should not be made unless the individual has received fire extinguisher training, and only after any personnel in immediate danger have left the area.

Biosafety Program



Power Failures In the event of a power failure, seal and secure all biohazardous agents in use. Research groups are not to continue work with biohazardous agents when power is not available for BSCs and laboratory ventilation. If group has a BSC with emergency power, it is requested the group not conduct non-essential research in the cabinet while regular power is off as emergency power may be needed elsewhere in the building. Avoid opening freezers, cold rooms and incubators if possible.

Biohazardous Spills Spills of biohazardous substances may constitute a significant and ongoing health hazard if not handled in an appropriate manner. As part of the laboratory safety regimen, each laboratory should have a spill cleanup plan detailing specific disinfectants and procedures for that area. Clean-up of any spill requires the use of appropriate personal protective equipment. Even if the material involved was not a biohazardous agent, improper remediation can result in biological material being left behind to rot and cause foul odors in the laboratory, or to cross-contaminant other experiments and disrupt or ruin research. Since the capacity of most commonly used laboratory culture containers is small, it is anticipated that most spills within the laboratory will be limited in size and therefore minor in nature. Although the specific response will depend on the type and nature of the incident, decontamination and clean-up procedures incorporating the steps outlined below are recommended. If a spill is large or of a nature that cannot be handled by laboratory personnel, call 4373 from any campus phone to speak with the Health & Safety Officer. Effective disinfectants must be available in the laboratory at all times and for immediate use.

Prevention

Prevention of spills should be the first priority and general precautions should be in place. An emergency spill response protocol specific for the microorganisms in use should be posted in a visible location with the laboratory. Prevention of spills, include but are not limited to the following:

o Use plastics rather than breakable glassware whenever possible. o Transport materials on carts that have lipped shelves, using secondary containers if possible. o Do not rush through procedures or when moving goods and materials. o Be aware of how heavy or awkward some items may be to carry by hand and use carts or extra help.

Biological Spill Kit

All biological laboratory spaces must have ready access to a biological spill kit. Each spill kit will located in a visible, marked and accessible location within the laboratory or immediately outside the laboratory. Each spill kit will be assembled in a single container and contain at a minimum:

An appropriate chemical decontaminate for the agent being used.

Spill clean-up procedures, list of emergency contact numbers, and an incident report form

Materials to absorb liquids after decontamination, i.e. paper towels, absorbent lab pads.

Appropriate personal protective equipment to wear during the clean-up procedure. Gloves, long-sleeved lab coat, and eye/facial protection will be adequate in most cases.

A mechanical means of handling broken glass, i.e. tongs, forceps, autoclavable dust pans or any other method that prevents direct contact with the broken glass.

Biohazard bags, garbage bags, sharps containers and/or other containers to place the material in for further treatment or disposal.

Responsibility for Biohazardous Spill Clean Up

Biosafety Program



o Responsibility for spill cleanup is shared between several people, depending on the degree of hazard. The person who causes the spill is always responsible for either the cleanup or ensuring that someone with the necessary equipment and expertise has been informed of the spill.

o Before attempting to clean up any spill, ensure that you have appropriate PPE such as lab coats and gloves before retrieving the spill kit from its storage.

o All spills must be cleaned up as soon as possible and must be reported by the individual to the PI or lab supervisor. o Complete all sections of the incident report form and deliver to the PI or supervisor to deliver to the Health & Safety

Officer. o Anyone working with biological materials must receive training in spill clean-up appropriate for materials routinely

used. o Always label contents of all containers and waste buckets.

Biohazardous Spill inside a Biological Safety Cabinet

Spills confined to the interior of a biological safety cabinet should present little hazard provided: a) clean-up is initiated at once, and b) the cabinet ventilation system continues to operate to prevent the escape of contaminants.

1. Leave the BSC fan on and immediately secure all other biological materials in the vicinity of the spill. 2. Cover the spill with paper towels and gently flood the surface with disinfectant (e.g. sodium hypochlorite) starting

at the outside and working into the centre of the spill. 3. Wipe walls, work surfaces and equipment with a solution of appropriate disinfectant. 4. Allow to stand for the required contact time for the particular hazard (usually 20-30 min) 5. Remove excess decontaminant solution with paper towel. 6. Dispose of materials soaked in disinfectant in garbage bags using tongs to pick up and move the paper towels. 7. Use forceps to pick up broken or sharp material and place in an approved sharps container. 8. Ensure that the disposal container and your arm movements are located inside the BSC, as much as possible. 9. If bleach solution was used on stainless steel, rinse all surfaces well with water. You may re-wipe with 70% alcohol. 10. If the spill contacted the front grille of the cabinet, then the work surface must be lifted and its underside and

catch pan underneath must be treated with 10% bleach for the appropriate time as described above. 11. Let the BSC run for at least 10 minutes following clean-up. 12. Used disinfectant, gloves, clothes, paper towels and contaminated lab coats should be placed in a biohazard bag

and autoclaved 13. Inform the PI / Lab Supervisor and Biosafety Officer of the spill and file an Incident report. 14. Restock the spill kit.

Note: that this procedure will not disinfect the cabinet filters, blower etc. The interior of the cabinet should be completely cleaned with formaldehyde (if necessary) by a qualified and trained individual.

Clean-up of Biological Spills on Individuals

1. Must be remediated before clean-up of other affected surfaces. 2. Remove affected clothing and place in an autoclave bag. Make arrangements to have the clothing autoclaved prior

to returning the clothing to the affected individual. 3. If spilled material contacted an individual’s skin hair eyes, mouth or nose, the individual should be treated as per

guidelines in Table 4. 4. Inform the PI / Lab Supervisor and Biosafety Officer of the spill and file an Incident report. Note: Individuals working with biohazardous material are recommended to have a clean change of clothing in case of spills.

Clean up of Biological Spills Outside of a Biological Safety Cabinet Biohazardous spills outside of a BSC could represent significant health risks due to difficulty in containment. For the purposes of incident reporting, unintended releases outside of a BSC should be classified as a minor or major spill. A minor

Biosafety Program



spill would include the release of a RG1 organism or the release of a small volume (<100mL) and a low concentration of a RG2 organism without splashing or aerosolization. A major spill would involve: A) Release of an RG2 organism with splashing or aerosolization, B) A large volume of an RG2 organism (>100mL), or C) A spill that requires assistance.

a. For a major spill where aerosols may have been generated evacuate area for 30 min.

i. Ensure all doors are closed, and entry is prevented via personal supervision or clearly posted signs on all doors.

b. Tend to personal or co-worker injuries or potential injuries. i. Follow protocol above if spills occurred on personnel.

ii. Follow guidelines in Table 4 for injury and post exposure response. c. Retrieve Biohazard Spill kit and don appropriate PPE for clean-up.

i. Minimum: double gloves, lab coat, close-toed shoes, goggles, and covered legs. ii. Consider respiration or face shields if warranted.

d. Attend the spill. i. Pick up broken glass with forceps and save for decontamination in sharps container.

ii. Gently cover spill with paper towels or absorbent, include the full extent of the splash area. iii. Gently pour disinfectant on the absorbent starting outside and working inwards. iv. If the spill area is large, consider soaking absorbent material in disinfectant and then placing over spill. v. Let stand 30 min to allow adequate contact time.

e. Clean-up decontaminated spill i. Collect all disinfected material and place in leak-proof bag or container (i.e. 5 gallon pail). Chemically

disinfected material does not need to be autoclaved, but should be disposed of as chemical waste. ii. Any material that was not chemically disinfected must be autoclaved prior to disposal.

iii. Reapply disinfectant to spill area following initial clean-up. Wait for required time and clean-up again. iv. Disinfect the surface of any items or equipment that may have been exposed. v. Carefully remove all PPE. Prepare for autoclaving, surface disinfection or disposal.

vi. Thoroughly wash hands. f. Report incident to supervisor and ensure an incident report is filed. Written records of all incidents must be

maintained. g. Restock spill kit.

Biosafety Program



CHAPTER 7: LABORATORY EQUIPMENT MAINTENANCE

Laboratory Surfaces Unless their access to a laboratory is restricted, building custodial staff only pick-up non-hazardous waste and clean floors. All other surface cleaning is the responsibility of the laboratory. If they wish for the custodial staff to clean the surfaces, the custodial staff must be trained by the PI or educated about the hazards in the laboratory and the required disinfection method. Research groups must keep their laboratory clean and tidy. Groups should refrain from storing surplus consumables and equipment on top of cabinetry as surplus could fall on and injure personnel. In the teaching labs, students are to clean their bench space before and after each lab.

Differential Airflow Patterns

Heating, ventilation and air conditioning (HVAC) systems clean and filter indoor air and help to regulate temperature, humidity, and odours. HVAC systems can be designed to maintain a laboratory under negative differential air pressure so that clean air flows into the containment zone thereby reducing the spread of contamination by establishing a physical containment barrier of air. Inward directional airflow can only be maintained when laboratory doors are closed. All doors are required to be kept closed in any area storing or working with biohazardous materials. For questions and concerns about your HVAC system please contact Physical Plant at ext. 4040.

Emergency Eyewash and Shower In accordance with the OHSA, all laboratories that work with hazardous materials (including biohazardous agents) must have an eyewash station and/or an emergency shower either within the laboratory, or located in close proximity to the laboratory. Eyewashes and emergency showers must be easily accessible and kept free of obstructing equipment and supplies. Laboratory personnel must know where to find safety showers and eyewashes, and how to use them. Laboratory personnel are required to maintain plumbed eyewashes by flushing eyewash stations for three minutes, once a week. Document this weekly flushing using an Eyewash Testing Record. Non-plumbed eyewash bottles should be changed in accordance with the expiry dates listed on the bottles. Emergency showers are flushed monthly by Physical Plant staff and recorded on the Shower Testing Record.

First Aid Kits

First aid kits at AU are supplied and maintained by St. John’s Ambulance. If the First Aid kit requires maintenance contact the HSO or enter a Physical Plant Ticket.

Spill Kit Maintenance All research groups and teaching labs must maintain spill kits appropriate to the hazards used in the laboratory. Chemical and biological spill kits should be stored in the laboratory and be easily accessible. See Chapter 6 for more detail.

Equipment Manuals & General Maintenance

Biosafety Program



All equipment manuals should be easily accessible to all personnel and stored nearby the equipment. Review of the equipment manuals should be part of the Laboratory-Specific Orientation and Training provided to all personnel working within the laboratory. All equipment should be maintained as per the manufacturer’s preventative maintenance schedule provided.

Autoclaves All recommended maintenance within the manufacturer’s manual should be performed. In addition to this recommended maintenance, users should ensure that:

The area around the unit is kept tidy and free of clutter.

Service panels for the unit remain accessible and are not obstructed with other equipment.

Leaking water and pressure lines are reported immediately to Physical Plant.

Water leaking from the unit is promptly cleaned up.

The drain filter inside the unit’s chamber is inspected for debris on a weekly basis.

The autoclave is not used unless it is in good repair.

Users do not attempt to make repairs.

Report possible malfunctions to the BSO.

Repairs are performed by Physical Plant ext. 4040.

Documented quality control of autoclaves and heat sterilizers is federally mandated and must occur monthly. Test records must be kept on file and available upon request. Quality control verifies that autoclaves and sterilizers are functioning properly. If an autoclave fails to properly sterilize media, subsequent experiments may be compromised by contamination and waste containing biohazardous agents that is improperly autoclaved can present serious hazards to personnel as well as the environment. For these reasons, personnel operating autoclaves and sterilizers at the AU must use the following quality control measures.

1. Autoclave Tape

Autoclave tape contains markings that change color when the tape has been exposed to normal autoclave sterilization temperatures for a few minutes. Tape indicators should be used on all material placed in the autoclave or sterilizer to show that the material has been processed. Note: autoclave tape indicates that an autoclave has reached the proper temperature but does NOT prove that organisms have been killed.

2. Biological Indicators

Use biological indicators at least monthly to ensure that autoclaves and sterilizers are effectively sterilizing materials. Different types of loads will require verification to ensure that sterilization has been achieved. There are several commercially available validation tests generally containing Bacillus stearothermophilus spores, either on strips or in vials. Biological Indicators are available from several laboratory supply distributors (i.e., Innovatek Medical Inc., etc.). Consult with personnel responsible for the autoclave or sterilizer to find out how to assist with biological indicator testing and where test results are stored. Follow manufacturer’s instructions when using indicators. See Autoclave SOP for instructions on how to properly validate an autoclave (or sterilizer).

Biological Safety Cabinets

A BSC works by providing and uninterrupted curtain of inward flowing air at the front of its workspace. This air curtain is critical the cabinet performance, therefore a BSC should be situated in an area where there will be no interference with this air barrier. Cabinets must be:

Located away from high traffic areas, doors and air supply ducts.

Biosafety Program



No directly facing another cabinet or chemical fume hood.

Have a minimum unobstructed clearance of 40 cm above the exhaust outlet on top of the cabinet.

Have a minimum of 30 cm clearance on each side of the cabinet to allow for maintenance access.

Federal regulations require BSCs to be tested annually. Testing is done in accordance with NSF standards or to manufacturer's specifications. To ensure that they are operating properly and not exposing laboratory personnel or the environment to biohazardous agents or allowing particulate in to contaminant research. The BSO will contact laboratories to schedule testing. To prepare for testing, groups must:

Empty the cabinet of all equipment and supplies.

Decontaminate the interior surfaces of the cabinet.

Lift up cabinet work surface, and clean and decontaminate the underside and catch pan underneath.

If a BSC is found to be malfunctioning, it must be shut down immediately. Then proceed as follows: 1. Decontaminate and remove all equipment and biohazardous agents from the cabinet. 2. Inform PI/Supervisor. 3. Place an out of service signed on the front sash of the BSC. 4. Contact the service provider and/or manufacturer for further instruction.

Centrifuge

Regular maintenance is recommended to ensure centrifuges are performing to manufacturer’s specifications for an extended lifetime. In addition to performing maintenance according to manufacturer’s specification:

Keep record of repairs and service calls.

For refrigerated centrifuges: Remove accumulated liquid from the rotor chamber after each use with a dry cloth.

Biosafety Program



APPENDICIES

Biosafety Program



APPENDIX A SAMPLE PATHOGEN SAFETY DATA SHEET



Pathogen Safety Data Sheet

Well characterized pathogens may have PSDS developed by PHAC or CFIA that are available to regulated and interested parties. However, it is the responsibility of the users to conduct pathogen risk assessments on uncharacterized pathogens or pathogens that may have been modified. Assistance may be available from the aforementioned agencies. A Pathogen risk assessment informs this PSDS.

SECTION I – INFECTIOUS AGENT Name:

Synonym or cross reference:

Characteristics:

SECTION II – HEALTH HAZARD

Pathogenicity:

Epidemiology:

Host Range:

Infectious dose and route:

Mode of Transmission:

Incubation period:

Communicability:

SECTION III – DISSEMINATION

Reservoir:




Zoonosis:

Vectors:

SECTION IV – VIABILITY

Drug Susceptibility:

Drug Resistance:

Susceptibility to disinfectants:

Physical Inactivation:

Survival outside host:

SECTION V – MEDICAL

Surveillance:

First Aid/Treatment:

Immunization:

Prophylaxis:

SECTION VI – LABORATORY HAZARDS

Laboratory-acquired Infections:

Sources/Specimens:




Primary Hazards:

Special Hazards:

SECTION VII – RECOMMENDED PRECAUTIONS

Containment requirements:

Protective Clothing

Other Precautions:

SECTION VIII – HANDLING INFORMATION

Spills:

Disposal:

Storage:

SECTION IX – MISCELLANEOUS INFORMATION

Date prepared:

Prepared by:

Relevant sources:

amendments: biosafety program responsibility: category ... · human and terrestrial animal...

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