Generic
Risk Assessment
Guidance
Issue: 1
Date: November 2009
Page 1 of 13
Guidance to completing the Generic Risk Assessment for work
involving Biological Materials
(taken from University of Durham)
NOTES:
i.
Current Policy –
A) The following areas of work may not be undertaken without taking advice from the
Biological Safety Officer (BSO) and completing this form before work starts.
 Work involving ‘biological materials’ or 'biological agents'. This will include the use of
experimental materials which may be contaminated with a biological agent.
 Work involving genetic modification or work with genetically modified organisms.
 Work with blood or body products.
B) “Prescribed Pathogens” must not be brought onto the premises in any quantity
without notifying the Biological Safety Officer of the intention to do so. Any such work will
require the prior approval of STFC and completion of a risk assessment form.
ii.
This document is intended to guide investigators through an initial risk assessment for a
proposed research project involving biological materials (See definition of biological
materials in Additional Notes below*). Consideration must be given to the possible risk of
harm or damage to humans, animals and the environment through the proposed work
with the biological materials.
iii.
Of particular concern are the following examples of biological materials which will require
special containment facilities or licences – human or primate blood/serum, body
secretions or tissues; human, cattle, sheep, deer brain tissues; live animals, any
materials likely to carry human pathogens; deliberate use of named human pathogens,
parasites or zoonoses; pathogens causing diseases in crop plants; diseased plant
materials; genetically modified microorganisms, plants or animals.
iv.
These are generic guidelines so not all sections or questions may be appropriate for all
types of work or experiments. Investigators may use their own risk assessment form but
should ensure that all the relevant information requested below is provided in their form
and should be made appropriate for your Department. If in any doubt please contact the
Biological Safety Officer.
v.
Where appropriate brief examples are provided for each question for illustrative purposes;
in most cases more information will be necessary.
vi.
Based on the risk assessment a Containment Level for the work will need to be assigned:
CL1, 2 or 3, (3 being the highest level, required for work on hazardous pathogens, see
below) and, as appropriate, the work will need to be carried out in a suitably equipped
laboratory facility with codes of practice for the import, handling, storage, disposal and
emergency procedures involving the specified biological materials will be required. The
staff and students involved will need to be trained in all procedures.
All projects assigned a level of CL2 or above require to be approved by the STFC
Biological Safety Committee and the risk assessment should be forwarded to the BSO for
this purpose.
vii.
Copies of the final completed risk assessment form should be retained by the investigator
and the departmental biological safety coordinator.
viii.
Depending on the nature of the proposed research a further risk assessment and approval
from the safety Committee (BGMSC) or other regulatory authorities (ACGM, DEFRA, Home
Office) may ALSO be necessary. Application for a licence may be necessary.
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Generic
Risk Assessment
Guidance
Issue: 1
Date: November 2009
Page 2 of 13
ix. Normally purified proteins (serum albumin), enzymes (nucleases), nucleic acids (E.coli
DNA), blood products (sera) or other specified extracts (tryptone) obtained from
reputable commercial suppliers should not require risk assessments, however the safety
data sheets accompanying these products should be examined for any statements
referring to hazards, pathogen screening etc.
x.
The BSO can advise on most aspects of work with biological materials and on the
completion of this form.
1. Proposer
Name:
Department:
Contact number(s):
E-mail:
Staff / Students involved in the
project:
Explanatory Notes
Provide contact details for the person
responsible for the work – the principal
investigator/grant holder/ team leader
and
list all co-investigators, technicians, postgraduate students or anyone else involved
directly in the work. Keep this list up-to-date
by adding new staff and students when they
start work.
All personnel associated with the work should
read this risk assessment and be aware of its
implications. Appropriate guidance,
supervision and training must be provided.
2. Description of the proposed work
Provide a brief description of the aims
and objectives of the work
example:
“This project is designed to investigate
responses of plants to insect pests.
Experiments will involve exposing leaves of
test plants to different types of insect pests
and measuring the amount of leaf damage
over a short time. Transgenic plants
containing anti-insect compounds will be
produced for these tests. The experiments
will be carried out in CL1 and CL2 GM labs,
and a GM glasshouse in Biological Sciences.
The work will involve genetically modified
plants and micro-organisms.”
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Say what you want to do. This section is to
provide an overview of what the research
project is about and what methods and
facilities will be used.
Try to avoid technical language / jargon so
that the description can be understood by a
non-expert.
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Risk Assessment
Guidance
Issue: 1
Date: November 2009
Page 3 of 13
3. What is the nature of the biological material?
a. Describe all the biological materials
likely to be used in the work
examples:
 microorganisms (E.coli - lab strains, yeast –
lab strains) for production of expressed
proteins. Small – medium scale cultures ~
1ml up to 10L
 sputum samples taken from human
(student) volunteers ~1ml samples from 150
subjects
 potato tuber samples of several different
varieties; several hundred samples of up to
500g tubers.
 Staphylococcus aureus MRSA strains (a
category 2 pathogen) small scale cultures
and samples used to prepare slides for
microscopy.
Describe what biological materials will be used
– will the work involve live animals (including
humans), tissues, faecal, blood, soil or water
samples, micro-organisms, viruses, plant
seeds? Provide as much information as you
have available.
How much of these materials will be handled?
Numbers of samples; volumes or weight of
samples/cultures.
Note: all experimentation with humans and
human materials, primates or primate-derived
materials will require permission from an
Ethics Committee before work can proceed.
3. (Continued)
b. Briefly describe how and where the
materials will be obtained from and
where these will be used.







examples:
materials will be supplied from a commercial
company sent through the post in secure
packaging.
obtained from a reputable collaborating
laboratory/hospital (specify)
~50 hair samples will be collected from wild
monkeys from a colony in West Africa and
transported by the investigators to the UK.
disease-free genetically modified plant
materials will be grown from seed in specific
glasshouses in the botanic gardens
microorganisms will be cultured in a
containment laboratory in the Department /
in a collaborating University
human blood samples screened for major
blood-borne viruses (HIV and hepatitis A, B,
D)
healthy rabbits (6), checked by the Named
Veterinary Surgeon and unlikely to be
carrying any zoonoses
Where and how will you obtain the materials?
Where and when will the samples be examined
– e.g. used immediately ‘in the field’ or
brought back to a facility for storage, assay or
examination?
Will the samples be ‘screened’ to rule out the
presence of defined harmful biological agents?
c. Describe how the materials will be
treated and stored



examples:
Soil micro organisms cultured and DNA
extracted using phenol (DNA)
Ecoli clones stored on agar slopes at 4oC or
in glycerol for low-temperature storage
rabbit blood sampled directly into a formalin
fixative
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The way in which biological materials are
treated and stored may increase or decrease
the hazard. Specify any pre-treatment of the
materials - chemical extraction, culturing,
disinfection, freezing, fixation, autoclaving,
heat treatment or other processing which
could affect agents (inactivate or amplify)
Generic
Risk Assessment
Guidance
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Date: November 2009
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grouse faecal samples dried in an oven at
100oC for 24h
clarified sewage samples treated with
hypochlorite for 24h
fox carcass tissue samples cultured in
nutrient broth overnight
present.
Codes of practice (CoP) for treatment of
samples must be prepared where such
processing is used as a means of removing
pathogens / agents and evidence that this is a
validated method (ie evidence that it kills the
agent) attached to the CoP.
4. What biological agents might be present in these biological materials?
a. Name each biological agent which may
pose a risk of harm to human health,
animals or the environment
examples:
 Unscreened human blood may carry the viruses
causing hepatitis, AIDs
 Bovine brain tissue may carry infective prions
causing CJD in humans
 Deer carry ticks which may transmit Lyme
disease
 Human sputum samples may carry
M.tuberculosis (TB)
 Staphylococcus aureus (MRSA) cultures from
nasal swabs
 Agrobacterium tumefaciens is a soil-borne
pathogen of dicotyledonous plants
 animal dander or urine may cause allergies
Most biological materials unless pre-treated will
have associated biological agents which may
pose a risk to human health. List all known or
possible agents which will be used or may be
present in the biological materials. Include
viruses, prions, bacteria, fungi or parasites
(such as worms or potozoa).
Include experimentation with defined microorganisms
and
provide details
of
the
designations, genotype etc.
While plant pathogens pose no direct risk to
human / animal health they may pose an
environmental risk (crops).
See section
(section 4f). A Defra plant health licence may
be required.
If the biological material also contains a toxin or
other biologically active chemical which may
pose a risk list it here and proceed to the toxin /
chemical risk section (section 5)
4. (Continued)
b. Indicate the hazard group that the agent
has been assigned to (see guidelines).






examples: ( taken from ACDP information)
Hepatitis is a HG2 viral pathogen – all
unscreened human blood must be handled at
CL2 or above
Proteus is a HG2 bacterial pathogen
Foot & Mouth Rhinovirus is a group 2 animal
pathogen subject to additional restrictions
(Defra)
Paracoccidiodes brasiliensis is a HG3 fungal
pathogen requiring CL3 facilities
Most Eschericia coli strains are HG1.
Haemorrhagic strains such as O157 are HG2
M.tuberculosis is a CL3 pathogen
Identified human pathogens are assigned to a
Hazard Group (HG1-4) depending on their
human pathogenicity and effective measures
of treatment against the disease - see
additional notes below. This dictates the
containment level (CL1,2 or 3) of facilities
needed to work with this pathogen or
material.
Consult the ACDP guidance on
Categorisation of Biological Agents.
The combination of the hazard group and the
likely incidence of the agent will determine the
containment level that the work should be
carried out at.
c. For each named agent provide information
(if available) on the likely presence and
prevalence in the material

examples:
Blood samples will be screened for all major
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Provide an informed estimate of the likelihood
of occurrence and incidence of each agent in
Generic
Risk Assessment
Guidance
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Issue: 1
Date: November 2009
Page 5 of 13
viral pathogens so the likelihood of the
presence of any harmful agents is low
Samples will be collected from wild birds which
may have a moderate to high risk of carrying
Campylobacteriosis (category 2 pathogen)
Sputum samples taken from unscreened
volunteers – there is some likelihood of the
presence of M.tuberculosis (TB bacterium);
incidence from medical evidence has been
estimated to be 10% of this population
Small whole blood samples taken from a wild
colony of macaque monkeys in Sumatra –
there is no reported incidence of simian herpes
B or SIV (siminian immunodeficiency virus) in
this colony or in this geographical area
the material.
This may depend on the original source of
your material and if any screening has been
carried out (1b). For further examples see
Table 1 below for estimates of the incidence of
named zoonoses in experimental animals.
Sources of information may include web sites,
literature sources or your colleagues.
Collaborators who have already carried out a
proper (written) risk assessment are
extremely valuable sources of information. All
sources of information should be quoted and
attached if they support your risk assessment.
d. Provide brief information (if available) on
mode of transmission of the named
agents, disease caused and symptoms.



examples:
hepatitis is spread through contact with blood
and blood products or contaminated hypo
needles
…is spread through inhalation of aerosol
droplets..
agent causes respiratory infection with
symptoms similar to pneumonia….
To cause harm microorganisms and other
agents must gain access to the host.
What is the route of infection by each agent.
What disease and symptoms are produced.
Is there an effective treatment for the disease
e. Provide information (if available) on the viability
of the named agents/pathogen.



examples:
Outside of living host cells the virus is short
lived and will remain viable for less than an
hour
Prions will survive normal autoclaving and heat
treatment regimes
Bacterial spores such as B.anthracis are
extremely resistant to heat, dehydration and
disinfectants
f. Environmental risk


Examples
Agrobacterium is a pathogen of dicotyledonous
plants which could affect crop species
Phytophthora infestans is a potent pathogen of
potato and other Solanaceous plants / crops
Under what conditions will the agent survive,
propagate or be killed. What disinfectants are
effective against the agent. Consider the pretreatment of the material and treatment prior
to disposal.
Describe the consequences of the escape of
experimental organisms into the neighbouring
environment – consider plant pathogens,
transgenic plants, transgenic animals, animal
pathogens.
5. What other harmful substances might be present in these biological
materials?
a. Name any toxin or biologically active
substance which might be present and
may pose a hazard to human health.
Indicate routes of exposure

example
Ricin is a potent cytotoxin (ribosomeinactivating protein) extracted from caster
beans and in seed flour. Toxic effects follow
ingestion, injection or inhalation of dust
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List all known or likely harmful chemical toxins
which may be present in the biological
materials – including toxins, irritants,
corrosive chemicals, allergens, drugs or any
other biologically active substance.
Consult web sites, literature sources, Health
and Safety Office, collaborators or your
colleagues for lists of likely harmful
substances in your biological materials.
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Risk Assessment
Guidance
Issue: 1
Date: November 2009
Page 6 of 13
(protein extract or flour). Seeds also contain
potent allergens – skin and inhalation
b. Indicate the likely harmful effects of
these substances on human health.

example
Ricin is a cytotoxin which causes sickness,
fever leading to coma and death within 48h
c. For each substance provide information
(if available) on its likely concentration in
the material.

Describe the nature of the substance and its
harmful effect – what are the symptoms of
exposure; is there an effective treatment or
antidote?.
Provide any known information on the level of
harmful substances in your materials.
example
Ricin is a potent toxin with an LD50 (lethal
dose) of 0.5mg / Kg body weight
d. What level of each substance has an
effect on human health.

How does the substance enter the body?
Provide any information on the dose-response
characteristics.
example
Ricin is lethal at 1g/kg body weight. The
amount of ricin in a single seed is potentially
lethal
6. Specify risk controls for the work
a. Considering the factors detailed in the
previous sections suggest the level of
containment required for the work
(usually CL1-3).

example
“Culture of all the S.aureus strains will be
carried out in the CL2 facility…..”
b. Suggest any special precautions required
for equipment or operations (codes of
practice)

example
“Small – medium scale cultures will be
grown in a 10L fermenter in the CL2 facility.
Cells will be processed in a class 2
microbiological safety cabinet in the CL2
laboratory to contain aerosols”
c. Provide details of training of staff /
students who will be involved in the
work
example
 “All staff and students involved in this work
are trained by experienced post-doctoral
staff; they receive copies of RA and all
relevant CoP’s
d. List and attach any supporting
documentation and codes of practice

example
“codes of practice, papers quoting
prevalence of pathogen, risk assessment
from collaborating institute are attached”
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Consider the likelihood, incidence and the
hazard groups of all the possible agents in the
materials plus any other relevant information,
assign a suitable containment level for the
work. This in turn will decide the specifications
of the laboratory and the codes of practice
necessary to perform the work.
Containment facilities for working with
specified pathogens involving their culture is
defined by their hazard grouping – HG2
requires CL2 facilities. The detailed
specifications for containment facilities is
provided in ACDP documents “THE
MANAGEMENT, DESIGN AND OPERATION OF
MICROBIOLOGICAL CONTAINMENT
LABORATORIES” and “CATEGORISATION OF
PATHOGENS ACCORDING TO HAZARD AND
CATEGORIES OF CONTAINMENT”
Provide full justification for the assignment.
Note that for all containment categories
above CL1 (basic level), the BSO must be
notified and permission obtained before
the work can commence.
Attach to the final risk assessment any
documents, letters or references which
support the assignment of the level of
containment.
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Risk Assessment
Guidance
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Date: November 2009
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7. Does the import, production and use of the biological material require
a special licence, notification or specific permission from a legislative
body or a University committee?
Consider the legislative and advisory
bodies covering operations with the
biological materials or agents / harmful
substances which may be contained in
the materials.
example
 “Permission for these experiments to
proceed has been granted by the
Ethics Committee (03/09/04)”
 “This risk assessment has been
passed to the BGMSC for
consideration at the next meeting”
 “Notification of the intention to carry
out this research has been prepared
for submission to HSE along with this
RA when approved”
Signature:
Department:
Date:
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Because of the nature of the biological
materials it may be necessary to obtain a
licence or written permission for its import
from abroad or from another lab (specific
licensed pathogens; GM animals/plants; soil
samples). In particular consider the
possibility of pathogens or harmful
substances which might be present in the
experimental materials. Consult with the
appropriate legislative body (Web site).
Note: experimentation with humans and
human materials, primates or primate-derived
materials may
require permission from an
Ethics Committee before work can proceed.
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Risk Assessment
Guidance
Issue: 1
Date: November 2009
Page 8 of 13
Abbreviations
ACDP
CoP
DBSC
GM
Abbreviations
Advisory Committee on
Dangerous Pathogens
Code of Practice
RA
Health and Safety
Executive
Risk Assessment
Departmental Biological
Safety Coordinators
Genetic Modification
(Genetically Modified)
GMM
Genetically Modified Microorganism
GMO
Genetically Modified
Organism (GM Plant /GM
Animal)
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HSE
BSO
Biological Safety Officer
Generic
Risk Assessment
Guidance
Issue: 1
Date: November 2009
Page 9 of 13
Additional Notes:
A) Definition of Biological materials
For the purposes of this document "Biological materials" means any biologically-derived
materials or materials which, either by accident or design, contain biological agents
including bacteria, viruses, micro-organisms, genetically modified organisms / microorganisms (GMOs, GMMs), prions, or any other biological agents which might pose a
risk to health and safety or the environment. This includes 1) the intentional use of
specified micro-organisms, viruses or other biological agents, genetically modified
organisms / micro-organisms (GMO’s, GMM’s); 2) Use of materials which may
incidentally contain such agents; 3) Additionally biological materials which may contain
toxic or harmful chemicals; 4) Live animals.
B) Biological Agents: The following items are extracted sections from the COSHH
regulations relating to biological agents – numbers refer to sections:
21.
The definition of a ‘biological agent’ includes:
(a) micro-organisms such as bacteria, viruses, fungi, and the agents that cause
transmissible spongiform encephalopathies (TSEs);
(b) parasites, eg malarial parasites, amoebae and trypanosomes; and
(c) the microscopic infectious forms of larger parasites, eg the microscopic ova and
infectious larval forms of helminths;
providing they have one or more of the harmful properties specified in the definition (cause
any infection, allergy, toxicity or otherwise create a hazard to human health). Most are
infectious but some agents can be harmful in otherways, for example, via the production of
toxins or by inducing allergic responses.
22. Biological agents are classified into four hazard groups according to:
(a) their ability to cause infection;
(b) the severity of the disease that may result;
(c) the risk that infection will spread to the community; and
(d) the availability of vaccines and effective treatment.
23. The four groups of biological agents and their accompanying descriptions are set out in
paragraph 2(2) of Schedule 3 to these Regulations. Biological agents in Groups 2 to 4 are
listed in a classification list approved by HSC (referred to as the Approved list of biological
agent^). The Approved List may be viewed on the Internet at
http://www.hse.gov.uk/press/2004/e04078.htm (The document itself is at
http://www.hse.gov.uk/pubns/misc208.pdf). The List is not exhaustive and a biological
agent that does not appear on it does not automatically fall into Group 1. Even where a
non-infectious biological agent does fall into Group 1, substantial control measures may still
be needed for it, depending on its other harmful properties.
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Generic
Risk Assessment
Guidance
Issue: 1
Date: November 2009
Page 10 of 13
C) Hazard groupings based on the likelihood of significant disease resulting
from infection by the pathogen
Hazard Group 1:
Hazard Group 2:
Hazard Group 3:
Hazard Group 4:
A biological agent unlikely to cause human disease.
A biological agent that can cause human disease and and may be a
hazard to employees; it is unlikely to spread to the community and
there is usually effective prophylaxis or effective treatment available.
A biological agent that can cause severe human disease and presents a
serious hazard to employees; it may present a risk of spreading to the
community, but there is usually effective prophylaxis or treatment
available.
A biological agent that 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. This category
is highly specialised and restricted to research hospitals or infectious
disease research institutes
D) Examples of human pathogens potentially carried and spread by natural populations of
animal species (Zoonoses). The table is not all-inclusive and consideration should always be
given to any special factors which may affect your risk assessment. The table should be used for
initial guidance only since ACDP advice may be updated at any time. For accurate info please
refer to current ACDP Guidance at HSE website.
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Generic
Risk Assessment
Guidance
Issue: 1
Date: November 2009
Page 11 of 13
ZOONOSIS
PREVALENCE IN
HOST
HAZARD GROUP OF
CAUSATIVE AGENT
Salmonellosis
Low-moderate
2+*+
Leptospirosis
Low
2
Lymphocytic choriomeningitis
(LCM)
Low
3
Campylobacteriosis
Moderate
2
Hantavirus disease (pulmonary
and renal syndrome
Moderate
2/3
Rat bite fever
(STREPTOBACILLUS)
Moderate
2
Leptospirosis
Low-moderate
2
Hantavirus disease
Low
2/3
Campylobacteriosis
Moderate
2
Salmonellosis
Moderate
2+*+
Lymphocytic choriomeningitis
(LCM)
Low
3
Salmonellosis
Moderate
2+*+
Pasteurellosis
Moderate
2
GUINEA PIGS
Salmonellosis
Moderate
2+*+
FERRETS
Salmonellosis
Low-moderate
2+*+
Tuberculosis
Low
2/3
Salmonellosis
Moderate
2+*+
Toxoplasmosis
Moderate-high
2
Cat scratch fever (BARTONELLA
HENSELAE)
Low
2
Cowpox infection
Low
2
Tuberculosis
Low
3
Chlamydiosis
Low
2
HOST SPECIES
MICE/RATS
MONILIFORMIS AND SPIRILLUM
MINUS)
VOLES/SHREWS
HAMSTERS
RABBITS
CATS
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Risk Assessment
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DOGS
SHEEP/GOATS
PIGS
CATTLE
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Campylobacteriosis
Moderate-high
2
Leptospirosis
Low
2
Salmonellosis
Low
2+*+
Toxocariasis
Moderate
2
Pasteurellosis
Moderate
2
Cryptosporidiosis
Moderate
2
Q fever
Moderate
3
Orf virus infection
Moderate
2
Salmonellosis
Low-moderate
2+*+
Louping ill
Low
3
Toxoplasmosis
Moderate
2
Ovine chlamydiosis (enzootic
abortion)
Moderate
2
Erysipelas
Low
2
E. COLI 0157 infection
Low-moderate
2
STREPTOCOCCUS SUIS infection
Moderate
2
Salmonellosis
Moderate
2+*+
Campylobacteriosis
Moderate
2
Erysipelas
Moderate
2
Cryptosporidiosis
Moderate
2
Leptospirosis
Moderate-high
2
Q fever
Moderate
3
Ringworm (eg TRICHOPHYTON
spp)
Moderate
2
Salmonellosis
Moderate
2+*+
Tuberculosis
Low
3
Generic
Risk Assessment
Guidance
BIRDS
NON-HUMAN
PRIMATES
REPTILES (eg
lizards) (eg
terrapins) Aquatic
vertebrates
Invertebrates(eg
ticks)
Aquatic
invertebrates(eg
shellfish)
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Date: November 2009
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E. COLI O157 infection
Moderate
2
Campylobacteriosis
Moderate-high
2
Chlamydiosis
Moderate
3
Salmonellosis
Low
2+*+
Newcastle disease
Low
2
MYCOBACTERIUM AVIUM
infection
Moderate
3
Marburg virus
Rare
4
Ebola virus
Rare
4
HERPESVIRUS SIMIAE (Simian
herpes B virus)
Moderate-high
3
Tuberculosis
Low
3
Salmonellosis
Moderate
2+*+
Shigellosis
Moderate
2/3
Campylobacteriosis
Moderate
2
Helminth infection
Low
2
Other herpes viral infections
Moderate
2
Salmonellosis
Moderate-high
2+*+
Mycobacterial infection
Low
2/3
Ehrlichiosis
Low
3
Lyme disease
Moderate
2
Louping ill
Moderate
3
Various viral gastrointestinal
diseases - organisms which filter
feed concentrate viruses, eg
Norwalk
Moderate
2
hepatitis A
+*+ SALMONELLA TYPHI AND S. PARATYPHI are in Hazard Group 3
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