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SECTION 1: GENERAL BIOSAFETY REFERENCES

This section provides a collection of general biosafety documents and resource pages covering all aspects of biosafety principles and practices.The collection categories include:

Guidance for All Biological Material Lab Operations

Guidance for Diagnostic Sample Lab Operations

Risk Assessment – Process

Risk Assessment – Agents

Special Topic – Shipping Biological Materials

Special Topic – Animal-Related Activities

Biosafety-Related Websites

 

Guidance for All Biological Material Lab Operations

Resource Link Description
World Health Organization (WHO) Laboratory Biosafety Manual, 3rd Edition The Laboratory Biosafety Manual has provided practical guidance on biosafety techniques for use in laboratories at all levels.

The manual covers risk assessment and safe use of recombinant DNA technology, and provides guidelines for certification of laboratories.

Laboratory biosecurity concepts are introduced, and the latest regulations for the transport of infectious substances.

World Health Organisation (WHO),Biorisk Management: Laboratory Biosecurity Guidance, September 2006 This document provides more detailed guidance on biosecurity within a biological laboratory and addresses its basic principles and best practices.

It aims to expand the laboratory biosecurity concepts introduced inLBM3, and to strike a balance between the long-known biosafety procedures andpractices described in LBM3 and the more recently introduced and broader biosecurityconcepts.

ComitéEuropéen de Normalisation (European Standards Organization)(CEN) Workshop Agreement (CWA) 15793:2011, Laboratory biorisk management The main activity of a CEN Workshop is the development and publication of the CEN Workshop Agreement (CWA). This CWA applies internationally. It does not have the force of regulation and conformity is voluntary.

This CWA is performance-based and sets out requirements for, and places responsibility on organizations to demonstrate that appropriate and validated risk reduction procedures have been established and implemented.The scope of this laboratory biorisk management system agreement is to set requirements necessary to control risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities.

CWA 16393:2012, Laboratory biorisk management – Guidelines for the implementation of CWA 15793:2008, This document was developed as a voluntary standard by an international consortium of biosafety and biosecurity experts through a CEN Workshop to describe the required components of an effective biorisk management system.

CWA 15793:2008 is compatible with management guidance documents, such as ISO 9000 series (Quality), ISO 14000 series (Environmental), OHSAS 18000 series (Health and Safety).

Directive 2000/54/EC-Biological Agents at Work The European Agency for Safety and Health at Work is the agency for this directive.  The directive outlines minimum requirements for the health and safety of workers exposed to biological agents at work.
Canadian Biosafety Standards and Guidelines for Facilities Handling Human and Terrestrial Animal Pathogens, Prions, and Biological Toxins This first edition of the Government of Canada’s Canadian Biosafety Standards and Guidelines (CBSG) is a harmonized national standard for the handling and storing of human and terrestrial animal pathogens and toxins in Canada.

The CBSG is the result of a joint initiative undertaken by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) to update and harmonize three existing Canadian biosafety standards and guidelines for the design, construction and operation of facilities in which pathogens or toxins are handled or stored:

1. Human pathogens and toxins: Laboratory Guidelines, 3rd Edition, 2004 (PHAC)

2. Terrestrial animal pathogens: Containment Standards for Veterinary Facilities, 1st Edition, 1996 (CFIA)

3. Prions: Containment Standards for Laboratories, Animal Facilities and Post Mortem Rooms Handling Prion Disease Agents, 1st Edition, 2005 (CFIA)

 

 

Centers for Disease Control and Prevention(CDC)/National Institutes of Health (NIH), Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition

 

 

The BMBLwas the cornerstone of biosafety practice and policy in the United States upon first publication in 1984.

BMBL remains an advisory document recommending best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective.

This edition of the BMBL includes additional sections, expanded sections on the principles and practices of biosafety and risk assessment; and revised agent summary statements and appendices.

This edition includes information on the following topics: occcupational medicine and immunization, decontamination and sterilization, laboratory biosecurity and risk assessment, Biosafety level 3 (Ag) laboratories, agent summary statements for some agricultural pathogens, and biological toxins.

Biosafety in the Laboratory: Prudent Practices for Handling and Disposal of Infectious Materials, (National Academies Press) This book is dated but has a wealth of information that is still relevant for establishing biosafety practices. This book can be downloaded free of charge using the link provided.

 

 

 

 

Guidance for Diagnostic Sample Lab Operations

Resource Link Description
UK Health & Safety Executive, Safe working and the prevention of infectionin clinical laboratories and similar facilities This book provides health and safety guidance for managers, health and safety officers and employees in clinical pathology laboratories.

The guidance is relevant to the collection and handling of diagnostic specimens in patient care areas as well as the laboratory.

This book will help you to identify and assess the risks of infection and take appropriate precautions to control such risks.

CDC Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories In 2008, CDC convened a Blue Ribbon Panel of laboratory representatives from a variety of agencies, laboratory organizations, and facilities to review laboratory biosafety in diagnostic laboratories.The members of this panel recommended that biosafety guidelines be developed to address the unique operational needs of the diagnostic laboratory community and that they be science based and made available broadly.

These guidelines promote a culture of safety and include recommendations that supplement BMBL-5 by addressing the unique needs of the diagnostic laboratory. They are not requirements but recommendations that represent current science and sound judgment that can foster a safe working environment for all laboratorians.

Throughout these guidelines, quality laboratory science is reinforced by a common-sense approach to biosafety in day-to-day activities. Because many of the same diagnostic techniques are used in human and animal diagnostic laboratories, the text is presented with this in mind. All functions of the human and animal diagnostic laboratory — microbiology, chemistry, hematology, and pathology with autopsy and necropsy guidance — are addressed. A specific section for veterinary diagnostic laboratories addresses the veterinary issues not shared by other human laboratory departments.

 

 

Gudiance For Risk Assessment – Process

Resource Link Description
UK Health & Safety Executive, Infection at Work: Controlling the Risks; A guide for employers and the self-employed on identifying, assessing and controlling the risks of infection in the workplace

 

A guide for employers and the self-employed on identifying, assessing and controlling the risks of infection in the workplace.

This guidance is prepared in consultation with the Health and Safety Executive, by the Advisory Committee on Dangerous Pathogens, which was appointed by the Health and Safety Commission as part of its formal advisory structure and by Health Ministers.

This guide explains how to identify hazards, the factors related to the transmission of infections, and actions for assessing and controlling risk of infections. This is a good document for those with limited knowledge of biological risk assessment.

CDC BMBL, Section II- Biological Risk Assessment This document includes a description of Biological Risk Assessment as An Approach to Assess Risks and Select Appropriate Safeguards.

Risk assessment is the basis for the safeguards developed by the CDC, the NIH, and the microbiological and biomedical community to protect the health of laboratory workers and the public from the risks associated with the use of hazardous biological agents in laboratories. Experience shows that these established safe practices, equipment, and facility safeguards work.

 

Guidance for Risk Assessment – Agents 

Resource Link Description
Health Canada Pathogen Safety Data Sheets These documents are formatted like safety data sheets often used for hazardous chemicals. Each agent-specific document describes the hazardous properties of a human pathogen and recommendations for work involving these agents in a laboratory setting. These documents have been produced by the Public Health Agency of Canada (the Agency) as informational and exposure response resources for laboratory personnel working with these infectious substances.
Merck Veterinary Manual Global Zoonoses Table The table in this chapter lists zoonotic bacterial, viral, fungal, and parasitic diseases, grouped by category. Many proven zoonoses, including some diseases that are rare in people, organisms that are maintained primarily in people, some primate diseases, and diseases caused by fish and reptile toxins have been omitted.
ABSA/OSHA Zoonotic Agent Fact Sheet This is a table of common zoonotic pathogens of significance.  Information columns include key information such as host range, transmission, incubation period, symptoms and a microscopic image of each agent.

The OSHA/American Biological Safety Association Alliancesupports collaboration, and information-sharing to address biological hazards in the workplace and prevention of workplace hazards.

ABSA/OSHA General Microbiology Fact Sheet Like the Zoonotic Agent Fact Sheet, this document is a table of human pathogens commonly found in the research or diagnostic lab environment.  Columns include key information such as host range, transmission, incubation period, signs and symptoms and a microscopic image of each agent.
CDC Information Page on Avian Influenza

 

This page has information sections regarding flu transmission in birds and in humans. It also has a section with information relevant for lab workers regarding testing protocols and employee protection.
USFDA Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (2nd Edition) The “Bad Bug Book”contains scientific and technical information about the major foodborne pathogenic microorganisms and natural toxins that cause foodborne illnesses. This book is relevant for anyone who needs to perform a risk assessment involving lab work with any of these agents.
CDC Epidemiology and Prevention of Vaccine-Preventable Diseases The “Pink Book” provides physicians, nurses, nurse practitioners, physician assistants, pharmacists, and others with the most comprehensive information on routinely used vaccines and the diseases they prevent. This book is also relevant for anyone who needs to perform a risk assessment involving lab work with any of these agents.

 

 

Special Topic – Shipping Biological Materials

Resource Link Description
WHO Guidance on regulations for the Transport of Infectious Substances 2013-2014 This publication provides information for identifying, classifying, marking, labelling, packaging, documenting and refrigerating infectious substances for transportation and ensuring their safe delivery.
IATA Packing Instruction 650 This document is from the International Air Transportation Association’s Dangerous Good Regulations (DGR). The Packing Instruction outlines all requirements for preparing a package of biological materials to be shipped as Biological Substance, Category B.

This document is a good reference for those who have completed transportation safety training and been certified for shipment of biological materials.

CDC, Biological Substances, Category B
Packing and Transportation Requirements
This CDC document outlines how to prepare a Biological Substance, Category B shipment.  This document includes pictures and stepwise instructions. It could be used as a guide for developing a site-specific SOP for personnel certified to ship biological materials.
UN Recommendations on the Transport of Dangerous Goods – Model Regulations These recommendations are addressed to governments and international organizations concerned with the regulation of the transport of dangerous goods.
WHO International Health Regulations The International Health Regulations, or IHR (2005), are intended “to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.”  196 countries have agreed to implement these regulations, and the WHO plays a coordinating role.

 

 

Special Topic – Animal-Related Activities

Resource Link Description
World Organisation for Animal Health (OiE)  Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 7th Ed. This book has a wealth of information for all dealing with veterinary diseases.
Occupational Health and Safety in the Care and Use of Research Animals (National Academies Press) This book provides information regarding all aspects of occupational hazard control related to lab animal husbandry and research. It can be downloaded free of charge at the linked provided.
Safety and Health in Agriculture (International Labour Office, Geneva) This document covers a range of safety topics and hazard control recommendations for work activities that take place in agriculture.
NIOSH Alert: Preventing Asthma in Animal Handlers This document provides background information about the development of occupational asthma in animal handlers. It includes measures animal handlers should take to protect themselves from exposure to animals and animal products.
ABSA Animal Biosafety Training Resource Page This page on the American Biological Safety Association’s website contains a number of training videos.  The videos cover both lab animal biosafety and agricultural species biosafety topics.

 

 

Biosafety-Related Websites  

Resource Link Description
Belgian Biosafety Server This website focuses on scientific aspects related to the biological safety (biosafety) of human activities carried out using pathogenic and/or genetically-modified organisms (GMOs) or microorganisms (GMM, pharmaceutical, medical, veterinary, agronomic and environmental sectors.
ABSA International’s Biosafety Links Page Official website of the American Biological Safety Association; The Association’s goals are to provide a professional association that represents the interests and needs of practitioners of biological safety, and to provide a forum for the continued and timely exchange of biosafety information.
Biosafety Page of the UKHealth & Safety Executive This page provides links to the home pages for three sites that contain information relating to microbiological safety. They cover occupationally-acquired infections, the contained use of genetically modified organisms (GMOs) and work with specified animal pathogens.
HealthcareInfection Control Practices Advisory Committee (HICPAC) A number of infection control-related guidelines can be found on this page including disinfection and sterilization, environmental fogging, hand hygiene, etc. The intended audience for this information is human healthcare, but many of the concepts and a number of the linked documents are relevant for any lab working with potentially infectious materials.
US Occupational Safety&Health Administration (OSHA) Laboratory Safety Topics Page

 

 

OSHA has promulgated rules and published guidance to make laboratories increasingly safe for personnel. Topics and links on this page include chemical safety, ergonomics, and lab equipment.

 

World Organisation for Animal Health (OiE) Scientific and Technical Reviews Page This page allows the reader to access technical reviews of zoonotic and agricultural pathogens.
International Veterinary Biosafety Workgroup

 

This web site promote best practice in microbiological biocontainment and safety in veterinary laboratories that have national responsibility for the health of large animals, and which operate at biosafety level 3 and 4.
International Federation of Biosafety Associations IFBA is dedicated to strengthening biosafety and biosecurity at the national, regional and international levels; information about upcoming events and opportunities can be found on the site.
European Biosafety Association (EBSA) European Biosafety Association (EBSA); information about upcoming events and opportunities can be found on the site.

 

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