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Section 10: Precautions with Biological Materials

10.1 General

Biological materials present a range of hazards, which include infection, sensitisation and environmental damage. There are a number of regulations relating to the control of these hazards and these are supported by a large quantity of guidance. 

The most important legislation in relation to the use of biological material is the Control of Substances Hazardous to Health Regulations 2002 (COSHH) which provide the major framework for control of the hazards. Biological agents and other biological materials that are hazardous to health need consideration under these regulations (Safety Office Biosafety guidance describes how the biological agent's provisions of these regulations should be implemented). 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 (virus, bacteria, fungi, yeast, etc.), cell cultures and human endoparasites and have been classified into four hazard groups. These are shown below, with some possible examples which you may encounter in your work.

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.
Group 2

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.

e.g. Tissues and primary cell lines of human/primate origin. Adenovirus, clostridium, most strains of E. coli.

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.

e.g. HIV, Hepatitis B, E. coli 0157, salmonella typhi.

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. It is highly unlikely that any such agents would be permitted in the University.

Further Biosafety and Genetic Modification information is available via the Safety Office Website.

10.2 Notification Requirements

The Safety Office must be notified of any new work involving any Hazard Group 3 biological agents. Individuals working intentionally with Group 3 (or above) biological agents will have a personal record sheet completed in respect of their work activities with these agents. The record sheet should be kept locally within the School and updated as necessary with the information copied to Occupational Health. This will be kept for at least 10 years following cessation of work with the biological agents. Schools will be responsible for ensuring the long-term storage for these records.

In addition to the above, the Anti-terrorism. Crime & Security Act 2001 requires the University to notify the Home Office of its holdings of certain hazardous biological agents and toxins. A list of these agents and more details of the requirements of this legislation can be found in Safety Office Guidance. Where an individual intends to import or export any item contained on this list the prior approval and consent of the Safety Office will be required.  

10.3 Information and Sources of Guidance

There are several important documents which give very helpful guidance on the hazard associated with biological agents and how to control the risk: These are listed below:

Control of Substances Hazardous to Health Regulations 2002 and associated Approved Code of Practice for Biological Agents.
Scientific Advisory Committee for Genetic Modification - Compendium of Guidance.
Genetically Modified Organisms (Contained Use) Regulations 2003.
The management, design and operation of microbiological containment laboratories [ACDP 2001, ISBN 0717620344].
Biological agents: Managing the risks in laboratories and healthcare premises.
University information on work with Biological Agents and Genetically Modified Organisms.
Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection.

10.4 Risks Associated with work with Biological Agents

The main risk associated with 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.

10.5 Ways to control risks

Detailed information on how to control risk is contained local School Codes of Practice and in departmental/school procedural risk assessments. These should be made available to you by your supervisor, make sure you read them and apply the controls specified in them. The following is intended as a brief guide on the control measures that should be applied when working with biological materials.

      • Avoid the production of aerosols - if this is not possible then contain the process e.g. use of a microbiological safety cabinet and sealed centrifuge buckets.
      • Safe use of sharps. Avoid use of needles and scalpels and wherever possible use plastic items instead of glass. If this is not possible do not pass needles/scalpels, directly from hand to hand, do not re-sheath needles by hand, dispose of sharps at point of use directly into an approved sharps container. Sharps containers must not be overfilled or left in public/general circulation areas and should be disposed of in accordance with local procedures. Sharps injuries must be dealt with in accordance with those outlined in Section 4 of the handbook. Do not pick up broken, potentially contaminated glass by hand, use forceps or tongs.
      • Wear gloves to protect hands and make sure that all cuts are covered with waterproof dressing. If you develop skin lesions or eczema report this immediately to Occupational Health. Remove before leaving the laboratory and wash hands.
      • Wear a side fastening lab coat with knitted cuffs - remove before leaving lab to enter other 'clean areas'.
      • Avoid hand to mouth contact. No eating drinking, smoking or application of cosmetics in lab areas. Wash hands frequently and always before leaving the lab.
      • Vaccination & Immunisation. It is recommended that any potential worker be successfully immunised against hepatitis B before commencing work with human/primate samples.  Immunisation may also be appropriate for work with other organisms. ACDP guidance document [10.3.1 above] identifies these, Health surveillance and immunisation can be arranged through the Occupational Health Unit at Cripps Health Centre.
      • Training and supervision are essential requirement for safe working with micro-organisms. Training should cover the hazards of the work and the practical use of special procedures, techniques and equipment that are needed to minimise the risks. Ancillary and cleaning staff should be instructed in safety procedures in so far as the hazards of the work area could affect them. An appropriate level of supervision must be maintained.
      • Waste Treatment. All biohazard/clinical waste must be rendered safe to handle before leaving the laboratory. It should be clearly identifiable as to the type of waste and the originating location and disposed of via the appropriate route. Further information is contained in the Code of Practice for Work with Biological Agents and Genetically Modified Organisms.

10.6 Guidance on Other Biological Hazards

10.6.1 Genetic Modification

Genetic modification includes any introduction of genetic material into organisms and micro-organisms and the subsequent use of the modified organism. These activities are regulated by the Genetically Modified Organisms (Contained Use) Regulations 2000. The release of genetically modified organisms is covered separately by the Genetically Modified Organisms (Deliberate Release) Regulations 1992.

The University’s arrangements for securing compliance with these Regulations is contained with this guidance PDF format.

The key requirements for Schools engaged in or wishing to engage in work with genetically modified organisms are:

      • Appointing a Biological Safety Officer.
      • Establishing a link with one of the University Genetic Modification Safety Committees (GMSC) for approval and monitoring of the work. The University Biological Safety Adviser will advise on the appropriate GMSC.
      • Assessment of risks to humans and the environment must be made on the appropriate GM assessment form and this must be submitted for approval by the relevant GMSC. Details and assessment form are in the above policy document.

The Safety Office must approve local arrangements for controlling work involving genetic modification. 

Some types of high risk/high category or release work require that the HSE be notified of the work in advance, and that they approve the work and the containment facilities. 

The HSE has published an extensive "Compendium of Guidance", which describes in detail the controls required and the relevant laboratory standards. This is available from the HSE website. The control measures shown in 10.5 above also work with genetically modified material. 

10.6.2 Biological Sensitising Agents

A number of biological materials are powerful sensitising agents the commonest being:

      • Urine and dander from laboratory animals – for more detail seesection 10.5 above.
      • Dust from locusts and flour.
      • Grain and hay associated with handling, milling and malting grain and baking.
      • Natural rubber latex – see Section 8.4 for information.

Other biological substances known to cause respiratory sensitisation include antibiotics, proteolytic enzymes, dusts from castor bean, green coffee bean, guar gum, soybean and tea.  

Exposure can in some individuals cause rhinitis and conjunctivitis with the symptoms of hay fever, i.e. runny or stuffy nose and watery or prickly eyes. A dry cough can occasionally occur. Continued exposure to the agent after developing these symptoms can lead to asthma - periodic attacks of wheezing, chest tightness and breathlessness resulting from constriction of the airways.  

The symptoms are substance specific and may occur after a latent period of months or years. Removal from exposure to the agent alleviates the symptoms but the sensitisation is permanent.

Ways to Minimise Exposure

The aforementioned COSHH regulations require that, as far as reasonably practicable, exposure is either prevented or kept to a minimum. The best way to achieve this level of control is to enclose the process in some way with the addition of local exhaust ventilation, such as a fume cupboard or powder booth. In animal facilities a degree of control is also afforded by having a very high standard of ventilation in areas where allergens may be present. However it is usually necessary to supplement these measures by wearing some form of respiratory protective equipment (RPE), such as a facemask, in addition to protective clothing and gloves. If the local risk assessment requires that RPE be worn to protect against exposure the individual should be consulted and involved in its choice and be face fit tested and trained in how to attain the best fir so that it provides maximum protection. It is then incumbent upon the individual to make sure that he/she wears it correctly and reports any defects. Further information on RPE can be found via the Safety Office website PDF format.

Additional information and help with the selection of RPE can be found at the Healthy Working Lives website.

Health Surveillance

Work with biological sensitising agents may require that the individuals exposed be subjected to health surveillance by Occupational Health (OH). University guidance PDF format summarises the health surveillance currently provided by OH. 

Should an individual experience any of the symptoms outlined above they must immediately report this to their supervisor or manager who will arrange for them to attend the OHU. 

10.6.3 Mammals and Higher Vertebrate Animals

Animals in the University are kept in areas licensed by the Home Office and to which authorised persons only have access. 

All persons working with laboratory animals, with the exception of undergraduate students involved in work of less than 6 weeks duration, will be subject to health surveillance by Occupational Health. Other staff who need to routinely enter animal houses, e.g. maintenance and cleaning, will also be subject to this. Health surveillance will comprise both pre-employment screening and periodic surveillance. Initial screening, with follow-ups at six weeks and usually six months, will be carried out by Occupational Health. Periodic screening will entail an annual check-up by Occupational Health and the completion of a confidential questionnaire which will be included into the person’s health record. Permission to work with laboratory animals will be refused or withdrawn in the event of the person’s non-compliance with this policy. Safety Office Guidance describes the health surveillance arrangements and includes at Appendix 3 a summary of the condition known as “allergy to laboratory animals”. (All new workers should be made aware of this condition).

In addition to the risk of sensitisation (see section 10.6.2), a further risk which should be considered is that of zoonoses, i.e. infections which can be transmitted from animals to humans. Examples include ringworm, orf, leptospirosis, psittacosis and brucellosis. Where possible, careful stock selection or possibly treatment could remove the risk by eradicating the organism. However, this will not always be possible, therefore good animal husbandry, personal hygiene and the use of protective clothing will be needed. The correct disposal of waste and disinfection of contaminated areas is needed. In many cases health surveillance can be provided to detect early signs and apply treatment. The Occupational Health Unit should be consulted. Further information is also contained in the HSE publication "The Occupational Zoonoses" (ISBN 0118863975).

10.6.4 Lower Vertebrate and Invertebrate Animals

There are certain hazards (e.g. venoms, allergies, etc.) associated with some lower vertebrate and invertebrate animals which must be treated as individual cases. The scales and frass produced by certain insects (e.g. locusts and crickets) is a particularly powerful respiratory sensitiser and the health surveillance requirements described in the preceding section apply. When the introduction of such animals into laboratories is expected the School Safety Officer must be notified in advance.  

10.7 Ancillary Equipment

Care must always be taken to avoid contaminating any equipment, and to ensure that the operation of the equipment does not in itself spread contamination. (This is particularly important in the case of centrifuges). The procedure for decontaminating contaminated equipment must be stipulated in the relevant protocol. 

Where equipment requires service or repair it must as far as is reasonably practicable be rendered safe by an appropriate means and a safe conditions certificate attached.

Autoclaves are designed to sterilise at high temperatures. Therefore periodic checks must be carried out to ensure that the design temperature is actually reached. Additional operational checks are also required see Section 7.15 of this handbook.

Microwave ovens PDF format are being used increasingly for microbiological purposes. Working procedures must always ensure that there is no risk of explosion.

Incubating water baths at operating temperatures of 20°C to 45°C can be a source of legionella infection, particularly if fitted with a paddle stirrer which could produce an aerosol. Advice on how to minimise this risk is contained in Safety Office Guidance PDF format.

10.8 Transport of Biological Material

Details on the safe transport of biological materials and genetically modified organisms is available on the Safety Office web site in the University Code of Practice for the Transport of Dangerous Goods PDF format. The University has engaged the services of a Dangerous Goods Safety Adviser to provide advice on the correct means of transporting biological materials and other hazardous substances. For further details contact the Safety Office.

 

Safety Office

Pharmacy Building - Lower Ground Floor
University Park
University of Nottingham
Nottingham, NG7 2RD

Telephone: +44 (0)115 951 3401
email: bb-safety-office@exmail.nottingham.ac.uk