Management Containment Labs - HSE

1 Advisory Committee on Dangerous PathogensManagement and operation of microbiological Containment laboratoriesHealth and Safety Executive Management and operation of microbiological Containment laboratories 2 Advisory Committee on Dangerous Pathogens (ACDP) Crown copyright 2018 First published 2018 Updated March 2019 You may reuse this information (excluding logos) free of charge in any format or medium, under the terms of the Open Government Licence. To view the licence visit , write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email Some images and illustrations may not be owned by the Crown so cannot be reproduced without permission of the copyright owner. Enquiries should be sent to This guidance is issued by the Advisory Committee on Dangerous Pathogens (ACDP).

2 Following the guidance is not compulsory, unless specifically stated, and you are free to take other action. But if you do follow the guidance you will normally be doing enough to comply with the law. Health and safety inspectors seek to secure compliance with the law and may refer to this guidance. Management and operation of microbiological Containment laboratories 3 Contents Section 1: Introduction 4 Section 2: Management arrangements for biosafety 8 Section 3: Principles of design and operation 19 Section 4: Assessing and controlling the risks 28 Section 5: Selection and application of Containment and control measures 37 Appendix 1: Containment tables 45 Appendix 2: microbiological Safety Cabinets 57 Appendix 3: Decontamination, fumigation and sealability 72 Appendix 4: microbiological waste in laboratory facilities 80 Appendix 5: Transport of infectious substances 86 Appendix 6: Dealing with accidents including spillage of biological agents 94 Appendix 7.

3 Provision and use of personal protective equipment, including respiratory protective equipment, in the laboratory 99 Appendix 8: Work with hazard group 3 parasites 101 Further reading 103 Management and operation of microbiological Containment laboratories 4 Section 1: Introduction Scope 1 This publication provides guidance on the general duties under the Health and Safety at Work etc Act 1974 (the HSW Act) and the requirements under the Control of Substances Hazardous to Health Regulations 2002 (COSHH) as they relate to those who deliberately work with biological agents that pose a risk to human health, other than genetically modified organisms (GMOs). It also describes the minimum Containment requirements that implement the minimum standards required by the European Directive (Directive 2000/54/EC) on the protection of workers from risks related to exposure to biological agents at work.

4 2 There is separate guidance covering work with GMOs and pathogens covered by the Specified Animal Pathogens Order (SAPO) which should also be considered in the context of other work related to biological agents. 3 In addition to COSHH, this guidance provides practical advice on applying the relevant parts of the Management of Health and Safety at Work Regulations 1999 (MHSWR) for deliberate work with biological agents and how to assess and control the risks associated with working with biological agents. 4 This guidance applies to contained use work in all types of laboratories where biological agents are handled including research, teaching, clinical, forensic, veterinary and environmental laboratories. It covers both deliberate work with biological agents and work with material that contains or may contain biological agents and describes in detail the minimum Containment measures required at Containment level 2 (CL2) and 3 (CL3); and should be used in conjunction with the control measures specified in Schedule 3, COSHH.

5 Further details on biosafety Management in Containment level 4 (CL4) laboratories can be found in the Principles, Design and Operation of Containment Level 4 Facilities 5 There are no legal minimum Containment requirements under COSHH for Containment level 1 laboratories. However, the practices, safety equipment and facilities are similar to those for Containment level 2, as required by an assessment of the risks, and these should be used in addition to the more general COSHH control measures. Management and operation of microbiological Containment laboratories 5 Purpose of guidance 6 This guidance is aimed at those responsible for managing, supervising, assessing and coordinating work in microbiological Containment laboratories. Safety Advisers, Biological Safety Officers and other safety professionals who provide competent advice to their employer may also find this useful.

6 It should also be considered before any changes in function, upgrading or building of facilities to be used for the type of work previously described. 7 One of the important aims of this guidance is to emphasise that it remains the dutyholders responsibility to manage the risks created from the work undertaken at their premises and should be used to make sure that any Containment and control measures are suitable and sufficient to meet the minimum requirements. Section 2: Covers the general Management for biosafety and health and safety issues, such as health and safety Management that are applicable to all relevant workplaces. Section 3: Covers the principles of design and operation of microbiological Containment laboratories. Section 4: Gives specific guidance on assessing and controlling the risk arising from deliberate work with biological agents.

7 Section 5: Explains the rationale for the selection of appropriate Containment and control measures. 8 Managing the risks that arise from deliberate work with biological agents requires that sufficient Management controls are in place. To prevent or control the potential release of a biological agent a combination of safe working practices, suitably trained staff with physical and procedural measures are required. Biological agents 9 A biological agent is defined in COSHH as: a microorganism, cell culture, or human endoparasite, whether or not genetically modified, which may cause infection, allergy, toxicity or otherwise create a hazard to human health. 10 Most biological agents are microorganisms, ie bacteria, viruses, fungi, microscopic endoparasites such as the malarial parasite, amoebae and trypanosomes and the microscopic forms of the larger endoparasites such as the ova and larval forms of helminths.

8 A microorganism is defined in COSHH as: a microbiological entity, cellular or non-cellular, which is capable of replication or of transferring genetic material. Management and operation of microbiological Containment laboratories 6 11 COSHH classifies biological agents into one of four hazard groups (HG) based on their ability to infect healthy humans using the following criteria: the likelihood that it will cause disease by infection or toxicity in humans; how likely it is that the infection would spread to the community; and the availability of any prophylaxis or treatment. 12 The four HGs are defined as follows: HG1: unlikely to cause human disease; HG2: can cause human disease and may be a hazard to employees; it is unlikely to spread to the community and there is usually effective prophylaxis or treatment available; HG3: can cause severe human disease and may be a serious hazard to employees; it may spread to the community, but there is usually effective prophylaxis or treatment available; and HG4: causes severe human disease and is a serious hazard to employees; it is likely to spread to the community and there is usually no effective prophylaxis or treatment available.

9 13 The Approved List of Biological Agents (The Approved List) is a list of biological agents and their classification (HG), approved by HSE through ACDP. COSHH implements the EU Directive 2000/54/EC on the protection of workers from the risks related to exposure to biological agents at work. The Directive requires that Member States classify biological agents that are, or may be, a hazard to human health. Annex III (community classification) to the Directive contains a list of biological agents and the Approved List is based on that. 14 The Approved List is relevant to risk assessment for work with biological agents and the application of appropriate control measures. A risk assessment under COSHH regulation 6(2)(k), of work likely to expose any employees to biological agents, should consider the approved classification of any biological agent.

10 The Approved List only includes agents in HG2-HG4. The list is not exhaustive, and unlisted agents should not automatically be categorised into HG1. The categorisation of unlisted agents should be determined by the assessment. Further guidance on this is given in Section 4. 15 Categorisation gives an indication of the inherent hazard of the agents listed, but it does not consider the route of transmission, the work undertaken using the agent (eg volume), the titre used, or procedures undertaken. It does not cover additional risks to those who have reduced or compromised immunity or are pregnant, which must be addressed in the risk assessment. Management and operation of microbiological Containment laboratories 7 Hazards other than infection 16 As indicated by the definition in COSHH, the risks of allergenicity and toxicity should be considered.