University of
Sheffield
Staff Occupational Health
Service
Medical Screening – Biological and Genetic Modification Agents
An occupational health assessment or health surveillance may be required for
certain hazardous work activities.
The requirement for health surveillance or
vaccination should normally be specified in the Designated Activity Checklist at the
pre-employment phase.
Legislation
Control of Substances Hazardous to Health Regulations 2002 (COSHH)
Genetically Modified Organisms (Contained Use) Regulations 2000
Advisory Committee on Dangerous Pathogens (ACDP)
Approved list of biological agents – http://www.hse.gov.uk/pubns/misc208.pdf
These arrangements describe a mechanism for the medical screening of employees
and postgraduate students where considered necessary because of the nature of
the work with which they are involved. In this way, aspects of work activities that
might interact adversely with the health status of individuals can be identified
promptly and appropriate preventive measures can be adopted.
Such an arrangement enables the University to meet its statutory obligations to its
personnel.
Definition:
Biological agents are defined in the Control of Substances Hazardous to Health
(COSHH) Regulations as:
“Any micro-organism, cell culture, or human endoparasite, including any which have
been genetically modified, which may cause any infection, allergy, toxicity or
otherwise create a hazard to human health.”
They are also commonly referred to as pathogens.
Biological materials present a range of hazards, which include infection, sensitisation
and environmental damage.
Where any work with these could lead to harmful
exposures the risks should be anticipated and controlled by a mixture of engineering
and procedural means.
Biological Agents include the general class of micro-organisms and are classified by
the Advisory Committee on Dangerous Pathogens (ACDP) into Hazard Groups 1 to 4,
reflecting the increasing severity of the hazard which they present.
Groups are defined as follows:
The Hazard
Classification of Biological Agents
Group
Unlikely to cause human disease. E.g. Tissues and cell lines of non
primate/non human origin. Human/primate cell lines that are long
1
established and have long history of safe use [e.g. HeLa cells]
Disabled/attenuated/non-pathogenic strains of some bacteria and virus.
Does not usually require health assessment or health surveillance unless
there is a specific risk or it is required by the Occupational Health Service
Group
A biological agent that can cause human disease and may be
a hazard to employees; it is unlikely to spread to the community and
2
there is usually effective prophylaxis or effective treatment available;
does not usually require health assessment or health surveillance unless
there is a specific risk (e.g. pregnant workers) or it is required by the
Occupational Health Service.
Group
Can cause severe human disease and may be a serious hazard to
employees; it may spread to the community, but there is usually
3
effective prophylaxis or treatment available. HIV, Hepatitis B, E coli 0157,
salmonella typhi.
All work with hazard group 3 biological agents or
class 3 genetically modified organisms requires health surveillance.
Group
Causes severe human disease and may be a serious hazard to
employees; it is likely to spread to the community, and there is no
4
effective prophylaxis or treatment available. E.g. Rabies, Ebola Virus.
The University does not carry out any work in this group.
The main risk associated of working with biological agents is the potential for
infection. There are three main potential routes of infection to be aware of:

Inhalation - for example breathing in a fine aerosol or vapour mist which may
contain a viable organism

Ingestion - through poor hygiene practice, mouth pipetting, [this should never
be done] or eating/drinking in a lab area

Skin penetration - This could be as a result of injury with a contaminated sharp
object, contact with mucous membrane of eyes/nose/mouth or entry via an
uncovered wound.
New and Expectant Mothers
Work with many biological hazards and particularly with pathogens may be harmful
and advice should be obtained from the Occupational Health Service as early as
possible.
Health Screening Procedure
Depending on the nature of work and the findings on screening, medical surveillance
may be ongoing. The Designated Activity Checklist should be available and a health
needs assessment made by the OHA as to the nature of the risk and category of the
biological or GM agents being utilised, those involving blood and body fluids or
animal work are dealt with in a separate chapter.
At the University of Sheffield all prospective employees working with GMO’s 1, 2, 3
and Biological agents 2-4 are requested to complete a GM / Bio health questionnaire.
An assessment will be made as to whether continued health surveillance or
monitoring is required.
Employees and other research workers already in post should be requested to
complete a new GM / Bio medical questionnaire in the following circumstances:1. Where an employee or research worker is moving to a new project
where the risk assessment varies from that of the original work for
which they received medical clearance
2. Where there is any change in the researcher’s health status. A variety
of medical conditions and medication may well affect the integrity of
the immune system or result in individuals being more susceptible to
infection. This includes:

Treatment with oral/injected steroids (this does not include inhaled
steroids for asthma)

Past or current chemotherapy or radiotherapy

Haematological disorders such as leukaemia etc

HIV or AIDS syndrome

Splenectomy

Diabetes

Cystic fibrosis

Severe skin disorders where the integrity of the skin is affected
Specific health surveillance before starting work is compulsory for all staff, students
or academic visitors working on research projects at containment levels 2 and 3
involving:

Handling of human blood, serum or unfixed human tissue (see Hepatitis B
Policy)

deliberate work with pathogens in Hazard Groups 2 and 3

class 2 or 3 GMO projects assigned to these classes on the basis of their risk to
humans

Work with animals, fish etc. (see Laboratory Animal Workers procedure)
Procedure Flow-Chart
Although most agents in Group 2 fit the epidemiological and clinical criteria reflected
in the definition, certain members of this group, including those that are infectious
by inhalation and others classified as blood-borne infections, should always be
handled in a safety cabinet or be otherwise suitably contained.
Hazard Group 2
agents are known to infect via apparently intact mucosae or through skin contact and
can present an enhanced risk. Biological agents include unfixed human tissues and
body fluids and any micro-organism, cell culture, or human endoparasite which may
cause any infection, allergy, toxicity or otherwise create a hazard to human health.
Depending on the nature of the intended work, examples of agents that are likely to
require additional containment and control measures are:
Bordetella pertussis
Borrelia burgdorferi
Borrelia duttoni
Borrelia recurrentes
Chlamydia trachomatis
Clostridium botulinum
Corynebacterium diphtheriae
Cryptococcus neoformans
Legionella pneumophila
Leptospira interrogans var. Ictohaemorrhagiae, canicola, hebdomadis
Neisseria meningitides
Sporothrix schenkii
Streptobacillus moniliformis
Treponenia pallidum and other treponemes
Vibrio cholerae (including EI Tor)
It should be noted that additional containment and control measures may be
required for other micro-organisms not listed above depending upon the nature of
the activity.
Much work involving genetic modification has no identifiable health risk. However,
some types of GM work may involve a risk of ill health resulting from work exposure
to the GM activity in which case health surveillance may be required.
Examples of GM work that may involve a risk of ill health as a result of exposure are:

Genetically modified micro-organisms derived from biological agents classified in
ACDP hazard groups 2 - 4, particularly for example, where modified viruses may
exhibit different tissue tropism, or where the agent is less susceptible to
therapeutic agents, or where immunised workers may not be fully protected;

Cloning of oncogenic or tumorigenic sequences, mutant tumour suppresser
genes or anti-sense constructs for tumour suppresser genes;

Work with modified prion protein genes;

Organisms expressing biologically active molecules such as enzymes, hormones,
toxins which may pose risks to health;

Work with a potential for exposure to cloned human genes which may lead to an
immune response and subsequent auto-immune type disease;

Work that may cause respiratory sensitisation, especially at large scale and with
the possibility that fusion proteins or inclusion bodies may enhance sensitisation.
The University policy concerning health surveillance for respiratory sensitisers
would apply under these circumstances.
Health surveillance will only be appropriate where an identifiable health effect may
be related to exposure; and there is a reasonable likelihood that the health effect
may occur under the conditions of work; and there are means for detecting
indications of the health effect. If a project risk assessment indicates that health
surveillance may need consideration in the light of the above criteria then further
advice should be obtained from Occupational Health.
Exclusions
Health screening is not required for:

Work with tissue cultures (unless used for deliberate propagation of category
2 or 3 agents)

Class 2 or 3 GMO projects classified on the basis of their risk to the
environment, when they pose no risk to humans

Work in a category 2 laboratory but without direct involvement in
work handling materials requiring this level of containment
Fitness category database
All personnel designated ‘fit’ by the SOHS will have their names, department, level
of clearance, DOB and date of fitness entered onto a database kept by the
department.
The Project Supervisor and Safety Services will have ‘read only’
access to this database. The employee will receive a copy of the fitness certificate for
their own record; a copy of this certificate will also be placed in their confidential
occupational health file.
Email address for completed forms - staff-occupational-health@sheffield.ac.uk