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. The Hazard Groups are defined as follows:

Classification of Biological Agents

Group 1 / Unlikely to cause human disease. E.g. Tissues and cell lines of non primate/non human origin. Human/primate cell lines that are long 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 2 / A biological agent that 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 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 3 / 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. HIV, Hepatitis B, E coli 0157, salmonella typhi. All work with hazard group3 biological agents or class3 genetically modified organisms requires health surveillance.
Group 4 / Causes severe human disease and may be a serious hazard to employees; it is likely to spread to the community, and there is no 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 screeningis not required for:

·  Work with tissuecultures(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 workhandling 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 -