The Approved List of Biological Agents Advisory Committee on Dangerous Pathogens

The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Advisory Committee on Dangerous Pathogens
The Approved List of Biological Agents
Page 1 of 35
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
© Crown copyright 2011
Applications for reproduction should be made in writing to:
The Office of Public Sector Information, Information Policy Team, Kew, Richmond, Surrey TW9 4DU
or email: [email protected]
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or
transmitted in any form or by any means (electronic, mechanical, photocopying, recording or
otherwise) without the prior written permission of the copyright owner.
The categorisation of biological agents in this publication has a special legal status as it is approved
by the Health and Safety Executive. The Biological Agents and Genetically Modified Organisms
(Contained Use) Regulations 2011 and the Control of Substances Hazardous to Health Regulations
2002 (as amended) impose requirements by reference to this categorisation that are legally binding.
Thus, if the categorisation applies to your work activities, health and safety inspectors will expect you
to be complying with these requirements, and will take appropriate enforcement action, if necessary,.
This publication is prepared by the Advisory Committee on Dangerous Pathogens (ACDP) in
consultation with the Health and Safety Executive. It provides guidance that represents what is
considered to be good practice by members of the Committee. It has been agreed by the Executive
and by 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.
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The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
CONTENTS
NOTICE OF APPROVAL .............................................................................................4
INTRODUCTION..........................................................................................................5
WHAT HAS CHANGED IN THIS EDITION? ................................................................5
NOTES TO THE APPROVED LIST .............................................................................8
FURTHER INFORMATION ..........................................................................................9
THE APPROVED LIST OF BIOLOGICAL AGENTS ..................................................10
ANNEX 1: BIOLOGICAL AGENTS THAT ARE HUMAN PATHOGENS WHICH MAY
BE USED AT LESS THAN THE MINIMUM CONTAINMENT CONDITIONS
REQUIRED BY THE BIOLOGICAL AGENTS AND GENETICALLY MODIFIED
ORGANISMS (CONTAINED USE) REGULATIONS 2011 .........................................33
GUIDANCE THAT SHOULD BE CONSULTED, AS APPROPRIATE, WHEN
DECIDING ON CONTAINMENT MEASURES ...........................................................35
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The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
NOTICE OF APPROVAL
The Health and Safety Executive has on dd mm 2011 approved the publication of this document, The
Approved List of Biological Agents, for the purposes of the Biological Agents and Genetically Modified
Organisms (Contained Use) Regulations 2011 (SI 2011/xxxx) and the Control of Substances
Hazardous to Health Regulations 2002 (as amended) (SI 2002/2677).
This edition of the Approved List shall have effect from dd mm 2011. On that date the previous
edition of the list (ref to 2004 list) approved by the Health and Safety Commission on the 2 March
2004 shall cease to have effect.
Signed
NAME
Secretary to the Health and Safety Executive
dd mm 2011
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The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
INTRODUCTION
1. The categorisation of biological agents in this document is an Approved List made under Section
15 of the Health and Safety at Work etc Act 1974. The Biological Agents and Genetically Modified
Organisms (Contained Use) Regulations 2011 (CU2011) and the Control of Substances Hazardous to
Health Regulations 2002 (as amended) (COSHH), by making reference to this list, impose
requirements which are legally binding. The Notice of Approval signed by the Secretary to the Health
and Safety Executive signals its legal status.
2. The list includes biological agents deemed to be human pathogens, thereby implementing the
Community Classification of biological agents set out in European Community Directive 2000/54/EC.
It also includes certain animal pathogens, but only those that can potentially harm relevant animals
are listed and regulated by CU2011
3. Only agents in Groups 2, 3 and 4 are listed as Hazard Group 1 agents are not considered to pose
a pathogenic hazard to humans or relevant animals. See Information Box below
4. Schedule 5 Part 2 of CU2011 specifies four containment levels (1 to 4) for activities which involve
working with biological agents, and these correspond to the categorisation of biological agents into
Hazard Groups 1 to 4, i.e., Hazard Group 2 biological agents should be handled at containment level
2, etc. CU2011 sets out a risk based approach for wild type biological agents that should be used to
decide which control measures are required. European legislation does not allow human pathogens
to be allocated to a risk class below that specified by their hazard group. However, for some human
pathogens and for all animal pathogens on the list, it may not be necessary to use all the containment
measures normally required at their specified containment level because of the nature of the agent
and/or the nature of the work that is being carried out. The agents to which this applies are indicated
in the Approved List. This derogation of containment is subject to assessment and approval by HSE.
There is also specific HSE/ACDP guidance (Biosafety Guidelines) which should be consulted to
assess containment requirements
5. Genetically modified biological agents do not appear in the Approved List although the wild type
species from which many of them are derived will be listed. Guidance on aspects of work with
genetically modified micro-organisms is given in The SACGM Compendium of Guidance
http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/index.htm
6. Enquiries relating to the Approved List may be addressed to the ACDP Secretariat at HSE,
Redgrave
Court,
Merton
Road,
Bootle,
Merseyside
L20
7HS
or
via
email:
[email protected].
WHAT HAS CHANGED IN THIS EDITION?
7. This edition of the Approved List represents the fifth update of the official categorisation since it
was first published in the Categorisation of biological agents according to hazard and categories of
containment in 1995.
8. Changes to this edition include:
•
The term “categorisation” is used in place of the term “classification”. This is to avoid
confusion with the classification of a contained use into a risk class described in CU2011.
•
The inclusion of animal pathogens to reflect the changes brought about by the introduction of
CU2011. CU2011 regulates contained work previously done under the Specified Animal
Pathogens Order regulated by Defra, the Scottish Executive and Welsh Assembly
Government.
•
The introduction of a combined categorisation for human and animal pathogens. Agents are
listed alphabetically with navigation links included when using this document on HSE’s web
site.
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9. From time to time ACDP, in consultation with other experts, are asked to review the list, in
particular considering evidence for the addition of new agents and reviewing the evidence for the
categorisation of agents already listed.
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INFORMATION BOX: HAZARD GROUP DEFINITIONS
When categorising a biological agent it should be assigned to one of the following Groups according
to its level of risk of infection to humans and according to its level of risk to relevant animals. Where
the pathogen meets the definition in more than one group, the higher group should be assigned.
Group 1
i) is unlikely to cause human disease; and
ii) in relation to relevant animals is unlikely to produce disease or is enzootic and does not
produce notifiable animal disease;
Group 2
i)
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; or
ii)
in relation to relevant animals is exotic, novel or produces notifiable diseases; and it has
both of the following characteristics —
•
causes a low level of harm to relevant animals; and
•
has low likelihood of spread.
Group 3
i)
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;
or
ii)
in relation to relevant animals is exotic, novel or produces notifiable disease and it has
one or both of the following characteristics—
•
causes moderate or serious level of harm to relevant animals;
•
moderate likelihood of spread.
Group 4
i)
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; or
ii)
in relation to relevant animals is exotic, novel or produces notifiable disease; and it has
one or both of the following characteristics—
•
causes serious level of harm to relevant animals;
•
has a high likelihood of spread.
Relevant animals are any kind of mammal except man, any kind of four-footed beast which is not a
mammal and any species of bird likely to be affected by the biological agent.
‘Novel’ means a new strain of biological agent not previously seen.
‘Harm’ means obvious disease, subclinical infections and/or increased susceptibility to disease.
‘Spread’ means the passing of the biological agent from one susceptible animal to another and
assumes any necessary enzootic vector is present.
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10. As a result of the most recent consultation, a number of specific changes have been made to the
list as follows:
•
Suid herpesvirus 1 (Aujeszky’s disease virus) was changed from Hazard Group (HG) 2 to HG
3;
•
Mycoplasma mycoides sub species mycoides SC variant was changed from HG2 to HG 3,
with sub species mycoides LC remaining as HG2;
NOTES TO THE APPROVED LIST
11. The Approved List of Biological Agents should be read in conjunction with the Biological Agents
and Genetically Modified Organisms (Contained Use) Regulations 2011 (CU2011) and COSHH 2002
(as amended).
12. Agents appearing in the Approved List are categorised based on their ability to cause disease by
infection or toxicity to humans, or harm to animals. Only agents in Groups 2, 3 and 4 are listed.
Those not listed in these groups should not automatically be assumed to be categorised in Group 1.
13. In allocating human pathogens to a Hazard Group, no account is taken of particular effects on
those whose susceptibility to infection may be affected, for example because of pre-existing disease,
medication, compromised immunity, pregnancy or breast-feeding. Any additional risks to such
employees should be considered as part of the general risk assessment required by COSHH 2002
(as amended). In the case of new or expectant mothers, the Management of Health and Safety at
Work Regulations 1999 require assessment of infection risks.
14. If more than one species in any particular genus is known to be pathogenic to humans or relevant
animals, the most prominent of these is generally named. There may also be a wider reference (‘spp’)
indicating other species of the same genus may be hazardous. However, if a whole genus is indicated
in this way, it is implicit that species and strains that are non-pathogenic to humans or relevant
animals are excluded.
15. Where a biological agent that is a human pathogen has an approved categorisation but is
considered to present a different risk of infection from the agent listed (for example because it has lost
known virulence genes) then the agent can be recategorised in consultation with HSE in line with
CU2011. Provided there is agreement from HSE to recategorise the agent, appropriate containment
measures can be selected on the basis of the new categorisation and the assessment of the risks
from the work that is to be undertaken.
16. All viruses which have been isolated from humans, but which do not have an approved
categorisation, should be handled with caution, unless and until there is evidence that they are
unlikely to cause disease in humans.
17. Biological agents that are animal or human pathogen cannot be reclassified. Where there is
evidence that the categorisation of an animal or human pathogen is incorrect, this should be taken up
with ACDP for consideration. ACDP alone has the power to recategorise an animal pathogen.
18. The containment measures required for work with parasites (protozoa and helminths) apply only
to the stages in the life cycle of the parasite in which it is liable to be infectious for humans or relevant
animals. Derogation based on the risks associated with other stages of the life cycle may be
appropriate.
19. The Approved List also gives an indication in the ‘Notes’ column of which biological agents are
capable of causing allergic or toxic reactions in humans or where there is an effective vaccine for
humans available.
20. There is a requirement in COSHH (Schedule 3) to keep a list of employees exposed to Hazard
Group 3 or Group 4 biological agents for at least 40 years after the last exposure paragraph 4. This
requirement is extended to cover employees exposed to one Hazard Group 2 agent: Human herpes
virus type 8.
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FURTHER INFORMATION
21. HSE and ACDP publications give advice on various aspects of work with biological agents. A full
list of these publications can be accessed on the HSE web site at:
http://www.hse.gov.uk/biosafety/information.htm
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The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
THE APPROVED LIST OF BIOLOGICAL AGENTS
Quick link to biological agents listed alphabetically:
A
N
B
O
C
P
D
Q
E
R
F
S
G
T
H
U
I
V
J
W
K
X
L
Y
M
Z
BACTERIA
Combined
Hazard Group
Human
pathogen
Hazard Group
Actinobacillus actinomycetemcomitans
2
2
Actinomadura madurae
2
2
Actinomadura pelletieri
Actinomyces gerencseriae
Actinomyces israelii
Actinomyces spp
Alcaligenes spp
Bacillus anthracis
2
2
2
2
2
3
2
2
2
2
2
3
Bacillus cereus
Bacteroides fragilis
Bacteroides spp
Bartonella bacilliformis
Bartonella quintana
Bartonella spp
Bordetella bronchiseptica
Bordetella parapertussis
Bordetella pertussis
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
Bordetella spp
Borrelia burgdorferi
Borrelia duttonii
Borrelia recurrentis
Borrelia spp
Brachyspira spp (formerly Serpulina spp)
Brucella abortus
Brucella canis
2
2
2
2
2
2
3
3
2
2
2
2
2
2
3
3
Biological agent
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ACDP/97/P6/Annex 1
Combined
Hazard Group
Human
pathogen
Hazard Group
Brucella melitensis
Brucella ovis
3
3
3
-
Brucella suis
Burkholderia cepacia
Burkholderia mallei (formerly Pseudomonas
mallei)
Burkholderia pseudomallei (formerly
Pseudomonas pseudomallei)
Campylobacter fetus
Campylobacter jejuni
Campylobacter spp
Cardiobacterium hominis
Chlamydia trachomatis
Chlamydophila pneumoniae
Chlamydophila psittaci (avian strains)
Chlamydophila psittaci (non avian strains)
Clostridium botulinum
3
2
3
3
2
3
3
3
2
2
2
2
2
2
3
2
2
2
2
2
2
2
2
3
2
2
Clostridium perfringens
2
2
Clostridium tetani
2
2
Clostridium spp
Corynebacterium diphtheriae
2
2
2
2
Corynebacterium haemolyticum
Corynebacterium pseudotuberculosis
Corynebacterium pyogenes
Corynebacterium ulcerans
Corynebacterium spp
Coxiella burnetii
Edwardsiella tarda
Ehrlichia ruminantium
2
2
2
2
2
2
3
2
2
2
2
3
2
-
Biological agent
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The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined
Hazard Group
Human
pathogen
Hazard Group
Ehrlichia sennetsu (Rickettsia sennetsu)
Ehrlichia spp
Eikenella corrodens
Enterobacter aerogenes/cloacae
Elizabethkingia meningoseptica (formerly
Flavobacterium meningosepticum)
Enterobacter spp
Enterococcus spp
Erysipelothrix rhusiopathiae
Escherichia coli (with the exception of nonpathogenic strains)
Escherichia coli, verocytotoxigenic strains (eg
O157:H7 or O103)
3
2
2
2
2
3
2
2
2
2
2
2
2
2
2
2
2
2
3
3
Flavobacterium meningosepticum – see
Elizabethkingia meningoseptica
Fluoribacter bozemanae (see Legionella)
Francisella tularensis (Type A)
2
2
2
3
2
3
Francisella tularensis (Type B)
Fusobacterium necrophorum
Fusobacterium spp
Gardnerella vaginalis
Haemophilus ducreyi
Haemophilus influenzae
Haemophilus spp
Helicobacter pylori
Klebsiella oxytoca
Klebsiella pneumoniae
Klebsiella spp
Legionella pneumophila
Legionella spp
Leptospira interrogans (all serovars)
Listeria ivanovii
Listeria monocytogenes
Moraxella catarrhalis
Morganella morganii
Mycobacterium africanum
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
Mycobacterium avium/intracellulare
Mycobacterium bovis
2
3
2
3
Biological agent
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ACDP/97/P6/Annex 1
Combined
Hazard Group
Biological agent
Human
pathogen
Hazard Group
No
avai
Mycobacterium bovis (BCG strain)
Mycobacterium chelonae
Mycobacterium fortuitum
Mycobacterium kansasii
Mycobacterium leprae
2
2
2
2
3
2
2
2
2
3
Mycobacterium malmoense
Mycobacterium marinum
Mycobacterium microti
3
2
3
3
2
3
Mycobacterium paratuberculosis
Mycobacterium scrofulaceum
Mycobacterium simiae
Mycobacterium szulgai
Mycobacterium tuberculosis
2
2
2
3
3
2
2
2
3
3
Mycobacterium ulcerans
3
3
Mycobacterium xenopi
Mycoplasma agalactiae
2
2
2
-
Mycoplasma capricolum subspecies
capripneumoniae
2
-
Mycoplasma caviae
Mycoplasma hominis
Mycoplasma mycoides subspecies mycoides, LC
variant
2
2
2
2
2
-
Mycoplasma mycoides subspecies mycoides, SC
variant
3
-
Mycoplasma mycoides var capri
2
-
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Ann
Ani
pathoge
derog
poss
Ani
pathoge
derog
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derog
poss
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The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined
Hazard Group
Biological agent
Human
pathogen
Hazard Group
No
poss
Mycoplasma pneumoniae
Neisseria gonorrhoeae
Neisseria meningitidis
2
2
2
2
2
2
Nocardia asteroides
Nocardia brasiliensis
Nocardia farcinica
Nocardia nova
Nocardia otitidiscaviarum
Pasteurella multocida
Pasteurella spp
Peptostreptococcus anaerobius
Peptostreptococcus spp
Plesiomonas shigelloides
Porphyromonas spp
Prevotella spp
Proteus mirabilis
Proteus penneri
Proteus vulgaris
Providencia alcalifaciens
Providencia rettgeri
Providencia spp
Pseudallescheria boydii – see Scedosporium
apiospermum
Pseudomonas aeruginosa
Rhodococcus equi
Rickettsia akari
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
2
2
3
Rickettsia canada
3
3
Rickettsia conorii
Rickettsia montana
3
3
3
3
Rickettsia mooseri – see Rickettsia typhi
Rickettsia prowazekii
Rickettsia rickettsii
3
3
3
3
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The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined
Hazard Group
Human
pathogen
Hazard Group
Rickettsia sennetsu - see Ehrlichia sennetsu
Rickettsia tsutsugamushi
Rickettsia typhi (Rickettsia mooseri)
Rickettsia spp
Salmonella arizonae
Salmonella enterica serovar enteritidis
Salmonella enterica serovar typhimurium 2
Salmonella paratyphi A
3
3
3
3
2
2
2
3
3
3
3
3
2
2
2
3
Salmonella paratyphi B/java
3
3
Salmonella paratyphi C/ Choleraesuis
3
3
Salmonella typhi
3
3
Salmonella spp
2
2
Serpulina spp – see Brachyspira spp
Shigella boydii
Shigella dysenteriae (other than Type 1)
Shigella dysenteriae (Type 1)
2
2
3
2
2
3
Shigella flexneri
Shigella sonnei
Staphylococcus aureus
Streptobacillus moniliformis
Streptococcus agalactiae
Streptococcus dysgalactiae equisimilis
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus suis
Streptococcus spp
Treponema carateum
Treponema pallidum
Treponema pertenue
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
Biological agent
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Combined
Hazard Group
Human
pathogen
Hazard Group
Treponema spp
Ureaplasma parvum
Ureaplasma urealyticum
Vibrio cholerae (including El Tor)
2
2
2
2
2
2
2
2
Vibrio parahaemolyticus
Vibrio spp
Yersinia enterocolitica
Yersinia pestis
2
2
2
3
2
2
2
3
Yersinia pseudotuberculosis
Yersinia spp
2
2
2
2
Combined
Hazard Group
Human
pathogen
Hazard Group
2
2
3
2
2
2
2
3
2
2
3
3
3
3
3
3
2
3
3
2
2
2
Biological agent
No
Toxig
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FUNGI
Biological agent
Absidia corymbifera - see
Lichtheimia corymbifera
Ajellomyces dermatitidis - see Blastomyces
dermatitidis
Aspergillus fumigatus
Aspergillus spp.
Blastomyces dermatitidis (Ajellomyces dermatitidis)
Candida albicans
Candida spp.
Cladophialophora bantiana (formerly Xylohypha
bantiana, Cladosporium bantianum)
Cladophialophora devresii
Cladosporium bantianum (formerly Xylohypha
bantiana)- see Cladophialophora bantiana
Coccidioides immitis
Coccidioides posadasii
Cryptococcus neoformans var. gattii (Filobasidiella
bacillispora)
Cryptococcus neoformans var. neoformans
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Combined
Hazard Group
Human
pathogen
Hazard Group
Emmonsia cresens
Emmonsia parva
Epidermophyton floccosum
Exophiala spp.
Filobasidiella bacillispora – see Cryptococcus
neoformans var. gattii
2
2
2
2
2
2
2
2
Filobasidiella neoformans var. neoformans –
sexual state of Cryptococcus neoformans var.
neoformans
3
3
Fonsecaea compacta
Fonsecaea pedrosoi
Fusarium spp.
Geotrichum spp.
Histoplasma capsulatum var. capsulatum
(Ajellomyces capsulatus)
Histoplasma capsulatum var. duboisii
Histoplasma capsulatum var. farcinimosum
Lichtheimia corymbifera
Madurella grisea
Madurella mycetomatis
Malassezia spp.
Microsporum spp
Neotestudina rosatii
Paracoccidioides brasiliensis
Penicillium marneffei
Rhinocladiella mackenziei (formerly
Ramichloridium)
Rhizomucor pusillus
2
2
2
2
3
2
2
2
2
3
3
3
2
2
2
2
2
2
3
3
3
3
3
2
2
2
2
2
2
3
3
3
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
Biological agent
Rhizopus microspores
Saksenaea vasiformis
Scedosporium apiospermum (Pseudallescheria
boydii)
Scedosporium proliferans (inflatum)
Scopulariopsis brevicaulis
Sporothrix schenckii
Trichophyton rubrum
Trichophyton spp.
Trichosporon spp.
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Combined
Hazard Group
Biological agent
Human
pathogen
Hazard Group
No
Xylohypha bantiana – see Cladophialophora
bantiana
HELMINTHS
Combined Hazard
Group
Human pathogen
Hazard Group
Ancylostoma duodenale
Angiostrongylus cantonensis
Angiostrongylus costaricensis
Anisakis simplex
Ascaris lumbricoides
Ascaris suum
Brugia malayi
Brugia pahangi
Brugia timori
Capillaria philippinensis
Capillaria spp
Clonorchis - see Opisthorchis
Contracaecum osculatum
Dicrocoelium dendriticum
Dipetalonema - see Mansonella
Diphyllobothrium latum
Dracunculus medinensis
Echinococcus granulosus
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
Echinococcus multilocularis
3
3
D
po
Echinococcus vogeli
3
3
D
po
Enterobius vermicularis
Fasciola gigantica
Fasciola hepatica
Fasciolopsis buski
Heterophyes spp
Hymenolepis diminuta
2
2
2
2
2
2
2
2
2
2
2
2
Biological agent
Page 18 of 35
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po
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Human pathogen
Hazard Group
Hymenolepis nana
Loa loa
Mansonella ozzardi
Mansonella perstans
Mansonella streptocerca
Metagonimus spp
Necator americanus
Onchocerca volvulus
Opisthorchis felineus
Opisthorchis sinensis (Clonorchis sinensis)
Opisthorchis spp
Opisthorchis viverrini (Clonorchis viverrini)
Paragonimus westermani
Paragonimus spp
Pseudoterranova decipiens
Schistosoma haematobium
Schistosoma intercalatum
Schistosoma japonicum
Schistosoma mansoni
Schistosoma mekongi
Schistosoma spp
Strongyloides spp
Strongyloides stercoralis
Taenia saginata
Taenia solium
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
Toxocara canis
Toxocara cati
2
2
2
2
Trichinella nativa
Trichinella nelsoni
Trichinella pseudospiralis
Trichinella spiralis
Trichostrongylus orientalis
Trichostrongylus spp
2
2
2
2
2
2
2
2
2
2
2
2
Trichuris trichiura
Wuchereria bancrofti
2
2
2
2
Biological agent
PROTOZOA
Page 19 of 35
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po
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Human pathogen
Hazard Group
Acanthamoeba castellanii
Acanthamoeba spp
Babesia bigemina
2
2
2
2
2
-
Babesia bovis
2
-
Babesia caballi
2
-
Babesia divergens
Babesia microti
Babesia spp.
Balantidium coli
Blastocystis hominis
Cryptosporidium hominis
Cryptosporidium parvum
Cryptosporidium spp
Cyclospora cayetanensis
Cyclospora spp
Dientamoeba fragilis
Encephalitozoon cuniculi
Encephalitozoon hellem
Encephalitozoon intestinalis
Entamoeba histolytica
Enterocytozoon bieneusi
Giardia lamblia (Giardia intestinalis)
Isopora belli
Leishmania aethiopica
Leishmania brasiliensis
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
3
Leishmania donovani
3
3
Leishmania major
Leishmania mexicana
Leishmania peruviana
Leishmania spp
Leishmania tropica
Naegleria fowleri
2
2
2
2
2
3
2
2
2
2
2
3
Biological agent
Page 20 of 35
Anim
only
p
Anim
only
p
Anim
only
p
D
possib
D
possib
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Human pathogen
Hazard Group
Plasmodium falciparum
3
3
Plasmodium spp (human & simian)
Sarcocystis suihominis
Theileria annulata
2
2
2
2
2
-
Theileria equi
2
-
Theileria parva
2
-
Toxoplasma gondii
Trichomonas vaginalis
Trypanosoma brucei brucei
Trypanosoma brucei gambiense
Trypanosoma brucei rhodesiense
2
2
2
2
3
2
2
2
2
3
Trypanosoma congolense
2
-
Trypanosoma cruzi
Trypanosoma equiperdum
3
2
3
-
Trypanosoma evansi
2
-
Trypanosoma simiae
2
-
Trypanosoma vivax
2
-
Biological agent
PRIONS - UNCONVENTIONAL AGENTS ASSOCIATED WITH TRANSMISSIBLE
SPONGIFORM ENCEPHALOPATHIES
Page 21 of 35
D
possib
Anim
only
p
Anim
only
p
Anim
only
p
D
possib
Anim
only
p
Anim
only
p
Anim
only
p
Anim
only
p
Anim
only
p
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Human pathogen
Hazard Group
Human TSEs
Sporadic forms of human TSE:
Sporadic Creutzfeldt-Jakob disease agent
3
3
Sporadic fatal insomnia agent
3
3
Variably protease resistant prionopathy
agent
Genetic forms of human TSE:
Familial Creutzfeldt-Jakob disease agent
3
3
3
3
Gerstmann Straussler- Scheinker syndrome agent
Fatal familial insomnia agent
3
3
3
3
Acquired forms of human TSE:
Variant Creutzfeldt-Jakob disease agent
3
3
Iatrogenic Creutzfeldt-Jakob disease agent
3
3
Kuru agent
3
3
Animal TSEs
Bovine spongiform encephalopathy (BSE)
agent
3
3
Derogat
see Ann
All strains related to or derived from BSE
(including feline spongiform encephalopathy
agent and spongiform encephalopathy
agent in exotic ungulates)
3
3
Derogat
see Ann
H-type BSE agent
3
3
L-type BSE agent
3
3
Derogat
see Ann
Derogat
see Ann
Scrapie and scrapie related agents
2
2
Atypical scrapie agent
2
2
Chronic Wasting Disease agent
3
3
Derogat
see Ann
Laboratory strains of TSEs
Any strain propagated in primates, mice
expressing human PrP gene or mice
3
3
Derogat
see Ann
Biological agent
Page 22 of 35
Deroga
see Ann
Derogat
see Ann
Derogat
see Ann
Derogat
see Ann
Derogat
see Ann
Derogat
see Ann
Derogat
see Ann
Derogat
see Ann
Derogat
see Ann
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Human pathogen
Hazard Group
3
3
Combined Hazard
Group
Human pathogen
Hazard Group
Adenoviridae
Anelloviridae
2
2
Torque Teno virus (Transfusion transmitted
virus)
Arenaviridae
2
2
Ippy virus
2
2
Lassa fever virus
4
4
Lujo virus
4
4
Lymphocytic (strains)
3
3
Lymphocytic choriomeningitis virus (other
strains)
3
3
Mobala virus
3
3
Mopeia virus
3
3
Other LCM-Lassa complex viruses
2
2
Biological agent
encoding human familial mutations in PrP
Human strains propagated in any species
Derogat
see Ann
VIRUSES
Biological agent
N
Old world arenaviruses:
Page 23 of 35
Derogat
Armstro
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Human pathogen
Hazard Group
Amapari virus
2
2
Flexal virus
3
3
Guanarito virus
4
4
Junin virus
4
4
Latino virus
2
2
Machupo virus
4
4
Parana virus
2
2
Pichinde virus
2
2
Sabia virus
4
4
Tamiami virus
2
2
Whitewater Arroyo virus
Other new world arenaviruses
Arteriviridae
2
2
2
2
Porcine Reproductive and Respiratory
Syndrome virus Genotype 2 (PRRSv2)
3
-
Equine arteritis virus
Asfarviridae
African swine fever virus
2
-
4
-
Biological agent
N
New world arenaviruses:
Page 24 of 35
Animal p
- deroga
possible
Animal p
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Biological agent
Human pathogen
Hazard Group
N
- deroga
possible
Astroviridae
Bornaviridae
2
2
Borna disease virus
Bunyaviridae
3
3
3
3
3
3
Germiston virus
Oropouche virus
Ngari virus
Hantaviruses:
Andes virus
3
3
3
3
3
3
3
3
Belgrade (Dobrava) virus
3
3
Hantaan virus (Korean haemorrhagic fever)
3
3
Seoul virus
3
3
Sin Nombre virus (formerly Muerto Canyon)
3
3
Crimean/Congo haemorrhagic fever virus
4
4
Ganjam virus
3
-
Nairobi sheep disease
3
-
Rift valley fever virus
3
3
Other bunyaviridae known to be pathogenic
(e.g. Bunyamwera, California encephalitis,
Prospect Hill, Puumala, other hantaviruses,
Hazara, Sandfly fever, Toscana)
Caliciviridae
2
2
Bunyaviruses:
Akabane virus
Bhanja virus
Nairoviruses:
Phleboviruses:
Page 25 of 35
Vaccine
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Human pathogen
Hazard Group
Norovirus (formerly Norwalk virus)
Sapo virus
2
2
2
2
Other caliciviridae
Coronaviridae
29E virus
OC43 virus
SARS virus
Other coronaviridae
Filoviridae
2
2
2
2
3
2
2
2
3
2
Ebola Cote d’Ivoire virus
Ebola Reston virus
Ebola Sudan virus
Ebola Zaire virus
Marburg virus
Flaviviridae
4
4
4
4
4
4
4
4
4
4
Absettarov virus
3
3
Central European tick-borne encephalitis
virus
Classical swine fever virus
3
3
3
-
Dengue viruses types 1-4
GB virus C (Hepatitis G virus)
3
3
3
3
Hanzalova virus
3
3
Hepatitis C virus
3
3
Hypr virus
3
3
Israel turkey meningitis virus
3
3
Japanese encephalitis virus
3
3
Kumlinge virus
3
3
Kyasanur forest disease virus
4
4
Biological agent
Page 26 of 35
N
Vaccine
Animal p
- deroga
possible
Derogat
see Ann
Vaccine
Derogat
see Ann
Vaccine
Vaccine
Vaccine
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Human pathogen
Hazard Group
Louping ill virus
3
3
Murray Valley encephalitis virus
3
3
Negishi virus
3
3
Omsk haemorrhagic fever virus
4
4
Powassan virus
3
3
Rocio virus
3
3
Russian spring summer encephalitis virus
4
4
Sal Vieja virus
3
3
San Perlita virus
3
3
Spondweni virus
3
3
St Louis encephalitis virus
3
3
Tick-borne encephalitis virus
Wesselsbron virus
3
3
3
3
West Nile fever virus
3
3
Yellow fever virus
3
3
Other flaviviruses known to be pathogenic
2
2
Hepadnaviridae
Hepatitis B virus
3
3
Hepatitis D virus (delta)
3
3
Herpesviridae
B virus - see Herpesvirus simiae
Bovine malignant catarrhal fever virus
2
-
Biological agent
Page 27 of 35
N
Vaccine
Derogat
see Ann
Vaccine
Vaccine
Derogat
see Ann
Vaccine
Vaccine
Derogat
see Ann
Vaccine
Derogat
see Ann
Animal p
- deroga
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Biological agent
Human pathogen
Hazard Group
N
possible
Cytomegalovirus
Epstein-Barr virus
Herpesvirus simiae (B virus)
Herpes simplex virus types 1 and 2
Human herpesvirus type 6 - HHV6
Human herpesvirus type 7 - HHV7
Human herpesvirus type 8 - HHV8 (Kaposi’s
sarcoma-associated herpesvirus)
Suid herpesvirus 1 (Aujeszky’s disease
virus)
2
2
4
2
2
2
2
2
2
4
2
2
2
2
3
-
Varicella-zoster virus
Orthomyxoviridae
Dhori virus
2
2
2
2
Influenza virus types A*, B and C
Influenza viruses (pathogenic avian strains)
2
4
2
-
Influenza viruses (uncharacterised avian
strains)
4
-
Thogoto virus
2
2
2
2
2
2
2
2
2
2
2
2
2
2
4
2
2
2
4
4
2
2
2
2
Papovaviridae
Polyomaviruses:
BK virus
JC virus
KI virus
Simian virus 40 (SV40)
WU virus
Papillomaviruses:
Human papillomaviruses
Paramyxoviridae
Hendra virus (formerly equine morbillivirus)
Human metapneumovirus
Measles virus
Mumps virus
Newcastle disease virus
Page 28 of 35
Animal p
- deroga
possible
Vaccine
Animal p
- deroga
possible
Animal p
- deroga
possible
Vaccine
Vaccine
Both pat
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Biological agent
Human pathogen
Hazard Group
N
unchara
Derogat
for anim
work.
Nipah virus
Parainfluenza virus (Types 1 to 4)
Peste des petits ruminants virus
4
2
4
4
2
-
Respiratory syncytial virus (human)
Rinderpest virus
2
4
2
-
2
2
2
2
2
2
2
2
2
2
2
4
2
2
-
Parvoviridae
Bocavirus genus
Goose parvovirus (Derzsky’s disease)
Parvovirus B19
Human partetravirus (Parv4/Parv5)
Picornaviridae
Acute haemorrhagic conjunctivitis virus
(AHC)
Coxsackieviruses
Echoviruses
Foot and mouth disease virus
Hepatitis A virus (human enterovirus type
72)
Parechoviruses
Polioviruses
Rhinoviruses
Swine vesicular disease virus
2
2
2
2
4
2
2
-
Teschen disease virus
4
-
Poxviridae
Capripoxvirus:
Goat pox virus
3
-
Lumpy skin disease virus
3
-
Page 29 of 35
Animal p
- deroga
possible
Animal p
- deroga
possible
Animal p
- deroga
possible
Vaccine
Vaccine
Animal p
- deroga
possible
Animal p
- deroga
possible
Animal p
- deroga
possible
Animal p
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Biological agent
Sheep pox virus
Molluscipox:
Molluscum contagiosum virus
Orthopox:
Buffalopox virus
Cowpox virus
Elephantpox virus
Monkeypox virus
Rabbitpox virus
Vaccinia virus
Variola virus (major and minor)
Whitepox virus
Parapox:
Orf virus
Pseudocowpox virus (Milker’s nodes virus)
Yatapox:
Tana virus
Yaba virus
Reoviridae
Bluetongue virus
Human pathogen
Hazard Group
3
-
2
2
2
2
2
3
2
2
4
4
2
2
2
3
2
2
4
4
2
2
2
2
2
2
2
3
2
2
2
-
Coltivirus
Epizootic haemorrhagic disease of deer
Human rotaviruses
Ibaraki virus
Orbiviruses
Reoviruses
Retroviridae
African horse sickness virus
2
3
2
3
2
2
2
2
2
2
3
-
Bovine leukosis virus
2
-
Equine infectious anaemia virus
3
-
Page 30 of 35
N
- deroga
possible
Animal p
- deroga
possible
Vaccine
Vaccine
Animal p
- deroga
possible
Vaccine
Animal p
- deroga
possible
Animal p
- deroga
possible
Animal p
- deroga
possible
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Human pathogen
Hazard Group
Human immunodeficiency viruses
3
3
Human T-cell lymphotropic viruses (HTLV)
types 1 and 2
Maedi-visna virus
Simian immunodeficiency virus
3
3
2
3
3
Xenotropic murine leukemia virus-related
virus
Rhabdoviridae
Australian bat lyssavirus
3
3
4
3
Bovine ephemeral fever virus
Duvenhage virus
3
4
3
European bat lyssaviruses 1 and 2
4
3
Lagos bat virus
4
3
Mokola virus
4
3
Piry virus
Rabies virus
3
4
3
3
Vesicular stomatitis virus
3
2
Togaviridae
Alphaviruses:
Bebaru virus
2
2
Chikungunya virus
3
3
Eastern equine encephalitis virus
Everglades virus
3
3
3
3
Getah virus
3
3
Biological agent
Page 31 of 35
N
Derogat
see Ann
Derogat
see Ann
Derogat
see Ann
Vaccine
Derogat
see Ann
Vaccine
Derogat
for anim
work.
Vaccine
Derogat
see Ann
Vaccine
Derogat
see Ann
Vaccine
Derogat
see Ann
Vaccine
Derogat
see Ann
Derogat
for use a
Derogat
see Ann
Derogat
see Ann
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Combined Hazard
Group
Human pathogen
Hazard Group
Mayaro virus
3
3
Middleburg virus
3
3
Mucambo virus
3
3
Ndumu virus
3
3
O’nyong-nyong virus
2
2
Ross river virus
2
2
Sagiyama virus
3
3
Semliki forest virus
2
2
Sindbis virus
2
2
Tonate virus
3
3
Venezuelan equine encephalitis virus
3
3
Western equine encephalitis virus
3
3
Other known alphaviruses
2
2
2
2
2
2
2
2
2
2
3
3
Biological agent
N
Derogat
see Ann
Includes
viruses K
Fever, O
Pogosta
Derogat
see Ann
Vaccine
Rubivirus:
Rubella virus
Toroviridae
Berne virus
Breda virus
Porcine torovirus
No assigned family
Hepevirus:
Hepatitis E virus
Page 32 of 35
Vaccine
Derogat
see Ann
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
ANNEX 1: DEROGATION: BIOLOGICAL AGENTS THAT ARE HUMAN
PATHOGENS WHICH MAY BE USED AT LESS THAN THE MINIMUM
CONTAINMENT CONDITIONS REQUIRED BY THE BIOLOGICAL AGENTS AND
GENETICALLY MODIFIED ORGANISMS (CONTAINED USE) REGULATIONS
2011
22. The Biological Agents and Genetically Modified Organisms (Contained Use) Regulations
2011 set out the containment requirements for work with human and certain animal
pathogens. However, it allows for a risk-based approach to remove those control measures
that are not required provided that this is justified by the risk assessment and derogation is
sought.
23. For most human pathogens, EU Directives require that all the minimum requirements for that
containment level must be maintained. For the Hazard Group 3 human pathogens listed
below, this risk-based approach allows for some containment measures to be dispensed with
(derogation). For example, where a pathogen is not infectious via inhalation there may be no
need for a safety cabinet. Furthermore, for work with organisms that are resistant to
fumigation (e.g. TSEs) there may be no need for the contained area to be sealable to allow
for fumigation.
24. This risk based approach to allow derogation from some containment measures applies to all
animal pathogens on the approved list unless they are also human pathogens, i.e., they are
zoonotic, and are not on the EU Directive list shown below. The following decision tree
summarises the process.
25. Derogation from containment measures is not an automatic right and any decision to change
the containment conditions must only be taken after carrying out a local risk assessment and
with approval from HSE.
Page 33 of 35
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
EU List of human pathogens to which derogation can be applied
Bacteria
1 Escherichia coli, vero-cytotoxigenic strains (eg O157:H7 or O103)
2 Mycobacterium microti
3 Mycobacterium ulcerans
4 Rickettsia akari
5 Rickettsia canada
6 Rickettsia montana
7 Salmonella typhi
8 Salmonella paratyphi
9 Shigella dysenteriae (Type 1)
Unconventional agents associated with TSEs
24 The agent of bovine spongiform encephalopathy (BSE) and other related animal TSEs
25 The agent of Creutzfeldt-Jakob disease
26 The agent of variant Creutzfeldt-Jakob disease
27 The agent of fatal familial insomnia
28 The agent of Gerstmann-Sträussler-Scheinker syndrome
29 The agent of Kuru
Viruses
10 Chikungunya virus
11 Everglades virus
12 Hepatitis B virus
13 Hepatitis C virus
14 Hepatitis D virus
15 Hepatitis E virus
16 Hepatitis G virus
17 Human immunodeficiency viruses
18 Human T-cell lymphotropic viruses
19 Hepatitis viruses not yet identified
20 Louping ill virus
21 Mucambo virus
22 Rabies virus
23 Simian immunodeficiency virus
30 Tonate virus
31 Wesselsbron virus
Page 34 of 35
The Approved List of Biological Agents 2010: Draft 30 June 2010
ACDP/97/P6/Annex 1
Parasites
32 Echinococcus granulosus
33 Echinococcus multilocularis
34 Echinococcus vogeli
35 Leishmania braziliensis
36 Leishmania donovani
37 Plasmodium falciparum
38 Taenia solium
39 Trypanosoma brucei rhodesiense
GUIDANCE THAT SHOULD BE CONSULTED, AS APPROPRIATE, WHEN
DECIDING ON CONTAINMENT MEASURES
A Guide to the Biological Agents and Genetically Modified Organisms (Contained Use) Regulations
2011 (HSE)
The Biological Agents and Genetically Modified Organisms (Contained Use) Regulations 2011:
BioSafety Guidelines (ACDP)
Other sector specific guidance is available on HSE web site at:
http://www.hse.gov.uk/biosafety/information.htm
Page 35 of 35