Advisory Committee on Dangerous Pathogens Categorisation of biological agents according to hazard and categories of containment Fourth edition 1995 HSE BOOKS .................................................. © Crown copyright 1995 Applications for reproduction should be made to HMSO First published 1995 ISBN 0 7176 1038 1 This guidance is prepared in consultation with HSE, 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. The guidance represents what is considered to be good practice by members of the Committee. It has been agreed by the Commission and Health Ministers. Following the guidance is not compulsory and you are free to take other action but if you do follow it 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 as illustrating good practice. As well as guidance this publication includes an Approved List of biological agents and extracts from the law. .................................................. Page ii Advisory Committee on Dangerous Pathogens .................................................. Foreword v The Advisory Committee on Dangerous Pathogens vi Introduction 1 COSHH and the Biological Agents Directive 1 The Classification Directive 1 Managing health and safety 2 Purpose of this guidance 4 Biological Agents 5 The hazards of biological agents 6 Newly discovered agents 7 Classification/categorisation and notification 7 Sensitisation and microbial toxicity 8 lmmunisation 8 Categorisation of biological agents 9 The Approved List - background 9 Guidance List - background 9 Nomenclature 9 Synonyms 9 Use of ‘spp’ 9 Zoonotic agents 9 References and sources of advice 10 Application of derogation to certain Hazard Group 3 agents - exemption certificate 10 Categorisation of biological agents - notations used 10 Definitions of hazard groups 11 Guidance List of biological agents 12 Containment 25 Hazard, risk and containment 25 Selection of containment levels 29 Laboratory Containment Level 1 31 Laboratory Containment Level 2 33 Laboratory Containment Level 3 36 Achieving an inward flow of air 39 Laboratory Containment Level 4 41 .................................................. 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AnimalContainment 45 Definition of terms 45 AnimalContainmentLevel1 46 AnimalContainmentLevel248 AnimalContainmentLevel351 AnimalContainmentLevel455 Appendices 1 Information, instruction and training 62 2 Supplementary containment measures for agents in Group 2 64 3 Working with parasites 65 4 Work with rabies virus 66 5 The containment of invertebrates 67 6 The large-scale use of biological agents 70 7 lmmunisation 80 8 Microbiological safety cabinets 82 9 Fumigation 87 10 Respiratory protective equipment 90 11 Safe disposal of clinical waste 91 12 Consignment of infectious material by post 94 13 The hazards of cell cultures 95 14 Persistent infections in animals 98 15 Genetically modified organisms and biological agents 102 16 Blood-borne viruses 104 17 Mycobacteria 108 18 Poxviruses 110 19 Transmissible spongiform encephalopathies 113 20 Pathogens controlled by the Agriculture and Fisheries Departments 116 21 Reporting occupational injuries, disease and dangerous occurrences 129 22 Notification of first use of biological agents; consignment of agents in Part V Schedule 9 of COSHH; provision of diagnostic services concerning agents in Part V 131 23 Approved List of biological agents 134 .................................................. Page iv Advisory Committee on Dangerous Pathogens .................................................. Foreword by the Health and Safety Commission and Health Departments The first edition of the now familiar categorisation of pathogens from the ACDP appeared early in 1984 and following thorough review, a revision was published in 1990. Those publications set and helped maintain new practical standards for the safe conduct of laboratory work with infectious agents. Both editions had the status of guidance supporting the Health and Safety at Work Act and more lately the Control of Substances Hazardous to Health Regulations 1988 (COSHH). This further edition however, reflects the need to implement two European Community Directives concerned with biological agents and therefore marks a departure, in part, from guidance into law. New COSHH regulations (COSHH 1994), which came into force in January 1995, implement the first of these Directives (90/679/EEC) and include now mandatory control measures for laboratories. These are reproduced here. The second Directive (93/88/EEC) contained a European Community classification of biological agents capable of causing infection. With permissible forms of modification, the Community classification appears here as an Approved List of biological agents which is specifically invoked by the new COSHH regulations and therefore also has legal status. Although still aimed primarily at workplaces where biological agents are handled intentionally ie in diagnostic laboratories, research and industry, this new edition of the categorisation is a useful source of information for a number of other situations. For example, workers in clinical and biomedical laboratories not necessarily involved in the propagation of biological agents, will find it an essential supplement to their main source of guidance which comes from the Health Services Advisory Committee (see Bibliography).The guidance and information in the now extended list of appendixes may be helpful as these cover a number of topics not all of which are specifically addressed in any other single publication. In fact, it is appropriate for all types of laboratory where any potentially infectious material is handled to refer to both of these publications. .................................................. Page v Advisory Committee on Dangerous Pathogens .................................................. THE ADVISORY COMMITTEE ON DANGEROUS PATHOGENS The Advisory Committee on Dangerous Pathogens (ACDP) is an advisory committee of the Health and Safety Commission and also advises Health and Agriculture Ministers. The ACDP was set up in 1981 following a second outbreak (resulting in a third death) of laboratory-acquired smallpox and was the successor to the Dangerous Pathogens Advisory Group. The Committee has an independent chairman and a joint secretariat provided by the Department of Health and the Health and Safety Executive. There are eight expert members chosen from names put forward by professional bodies, four representatives of employees and four of employers (see overleaf). In addition, the committee is attended by observers from HSE, the Department of Health, the Ministry of Agriculture, Fisheries and Food, the Ministry of Defence and government departments in Scotland, Wales and Northern Ireland. The terms of reference of the ACDP were changed in 1991 and are now: To advise the Health and Safety Commission, the Health and Safety Executive and Health and Agriculture Ministers, as required, on all aspects of hazards and risks to workers and others from exposure to pathogens. Committee membership is widely representative of expertise and long experience in most aspects of microbiology and infectious diseases in both the public sector and industry. Working Groups set up to deal with specific tasks commonly include other experts co-opted for their specialist knowledge of the topic to be addressed. Advice and information on all matters relevant to the work of the Advisory Committee may be obtained from the Committee Secretariat at: Department of Health or Health and Safety Executive HEF1 HPDB1 Skipton House Rose Court 81, London Road 2, Southwark Bridge London SE1 6LW London SE1 9HS ................................................. Page vi Advisory Committee on Dangerous Pathogens .................................................. Membership of the ACDP 1991 to 19941 Chairman: Dr M J Crumpton B Sc PhD CBE FRS Imperial Cancer Research Technology London Expert members: Dr B Bannister MSc FRCP MRCS Royal Free and Coppett’s Wood Hospitals London (from November 1992) Dr C J Bostock BSc PhD Institute of Animal Health Compton Berks (until 1993) Dr G J Boulnois BSc PhD University of Leicester and then ICI (until 1993) Mr A Cremer MlBiol CBiol FIMLS MRSH University College and Middlesex Hospitals London Prof B I Duerden BSc MB BCh MRCPath MD University of Wales College of Medicine and Public Health Laboratory Cardiff Dr R J Fallon BSc MD MB BCh FRCP FRCPath formerly of Ruchill Hospital Glasgow Prof D J Jeffries BSc MB BS FRCPath St Bartholomew’s Hospital London (from 1993) Prof E R Moxon MB BChir FRCP John Radcliffe Hospital Oxford (until August 1992) Dr S Young BA MB BCh DCH Dip Bact FFCMI FRCP PHLS CDSC (until February 1992) Dr T D Wyatt BSc PhD Mater lnfirmorum Hospital Belfast 1 The membership listed here is that which was current at the time that work on the text of this publication was completed. The membership of the ACDP was reconstituted in January 1995. .................................................. Page vii Advisory Committee on Dangerous Pathogens .................................................. Employee representatives Employer representatives MS J Church BA Mr A R Clare BTech MlBiol MSF representative CBI representative Mrs R Conn SRN OHN Cert Dr E A Gould PhD RCN representative Research