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LBL06001 - Risk Assessment Procedure for Lab Users Proposing New Projects

Approved by: S. Thompson SOP No. LBL06001
Signed: Effective from:
Date: Last edited:

Purpose

The purpose of this SOP is to highlight the requirements to lab users starting new projects in the London Biohackspace BioLab in terms of the risks presented by undertaking such work. In particular, risks from the use of chemicals, reagents and equipment should be considered along with the important considerations that are essentially for working with genetically modified organisms.

Scope

This SOP applies to all users of the London Biohackspace BioLab proposing a CL1 project.

Responsibilities

Ultimately, the laboratory user who initiates and undertakes the lab work (i.e. the principal investigator) is responsible for the health and safety considerations and containment requirements involved with their project. It is a requirement that they be aware of the risks involved in the project and the exposure to these risks by themselves, other lab users, the wider community and the environment. Before commencing any work the risks involved in the project must be assessed by the the principal investigator, they must seek advice from an experienced third party and the satisfactory results of this process must be signed off by the Biological Safety Officer.

The Principal investigator should begin by making a copy of the template risk asessment that is available here: - GMO Activity Risk Assessment Template. It is important to fully consider each of the section requirements before submitting the Risk assessment for evaluation by the BSO/GMSC.

Materials

List of materials and methods for project work.

Related documents

Definitions

GMM
Genetically Modified Micro-organism
GMO
Genetically Modified Organism
COSHH
Control of Substances Hazardous to Health
SOP
Standard Operating Procedure
HG
Hazard Group
CL
Containment Level
PI
Principal Investigator
PPE
Personal Protective Equipment
MSDS
Material Safety Data Sheet

Procedures

Assessing the risks in projects involving GMOs

For a project involving GMOs, the PI must provide a written risk assessment of the contained use to be undertaken.

Items for PIs to consider

  1. Consider the potential hazardous properties from your micro-organism cross referenced to national categorisation lists, e.g Approved List of Biological Agents [1].

  2. Any micro-organisms to be used within the lab must fall within the hazard group 1 (HG1) category. Biological agents are categorised into HG categories based on the following criteria:

    1. are they harmful to human health?
    2. are they a hazard to employees/workers within the organisation?
    3. transmissible to the community?
    4. whether effective treatment and/or prophylaxis (including vaccines) are available?

  3. The PI should consider how the micro-organism is being modified (in the case of GMMs), e.g are there enhancements of function, altered tropisms and/or altered routes of transmission? Consideration should be given to impacts on its hazardous properties i.e. more pathogenic, attenuated or unchanged.

  4. In handling the organism the PI should consider any risks involved, for example what PPE will be required? What risks are involved in setting up and running fermentation and growth systems, for example. Particularly, are any non-standard procedures involved?

  5. The PI should consider any special requirements in disposing of the micro-organisms, in particular, to ensure destruction of viable organisms, any GMO contaminated waste should be inactivated by autoclaving as detailed in LBL04006.

  6. The PI should consider the storage requirements for the organism, such as whether the organism will be stored frozen, in the fridge and/or at room temperature and if it requires any other special storage requirements.

  7. Important: If the micro organism is in risk group 1 and will be genetically modified then containment level one procedures must be adhered to.

    Note: If it is deemed to be in hazard group 2 or higher then this organism cannot be used in the BioLab. The PI should understand the difference between the HG groups and be able to explain why the organism falls into HG1 and not higher.

  8. The principal investigator should also assess the risks to the environment involved with the organism. Particularly, genetically modified organisms developed in the lab should not be allowed to leave the defined containment area in case of the risk of becoming introduced to the wider environment where they may have an impact on either the ecosystem or health of the community.

    1. Consider, for example, the capacity of a GM plant to survive and become established and disseminate. Including its ability to compete with or displace other plants. The PI should consider the hazards associated with inserted genetic elements, particularly if this codes for any toxic products that might affect the ecosystem or animal health.
    2. The PI should also consider the potential for transfer of genetic material between the GM plant and other organisms.
[1]http://www.hse.gov.uk/pubns/misc208.pdf

Obtaining advice on the risk assessment

It is required that the PI carrying out a contained use risk assessment should seek advice on the risk assessment from the Safety Committee (SC). The PI should contact the BSO to begin this process. The SC will review the risk assessment and work with the PI to ensure the risk assessment is adequate.

Finalising a contained use risk assessment

Once the SC is happy that the contained use risk assessment is adequate, the directors of London Biological Laboratories Ltd. will approve the commencement of work on the project. Physical and electronic copies of the written risk assessment must be filed in the appropriate places.

The BSO is responsible for keeping the written risk assessment for the required 10 year period.

Assessing the risks involved in the use of chemicals and reagents

The principal investigator should check whether a required chemical or reagent for their project is already in use in the laboratory. If not they should locate the relevant MSDS for the substance in question and should pay particular attention to the following factors:

  1. How should the substance be handled? Is particular PPE required, and is this available?
  2. How is the substance stored and can this be accommodated in the laboratory? For example, it may not be practical to store highly volatile, flammable, corrosive or controlled substances on site.
  3. How should the substance be disposed of? Primarily, can this be disposed of down the drain (diluted or undiluted?) or are special disposal measures required? If so are these available?

Assessing the risks involved in the use of instrumentation and equipment

The principal investigator should assess any risk presented by instrumentation or equipment brought into the lab for the purpose of carrying out this project.

Some examples might be: does it operate at high temperature or pressure, produce wavelengths of light that might be harmful (i.e uses lasers or UV bulbs), does it operate at high voltages (e.g electroporator), produce high frequency sounds that might be damaging to hearing (e.g sonicators) or might be heavy or awkward to operate.

The principal investigator should check the SOP documentation for information covering similar devices, and the information covering the laboratory safety induction which should cover most of the installed devices at the time of writing.

Resources

Approved List of Biological Agents:
HSE GMO Regulations index page:
The Genetically Modified Organisms (Contained Use) Regulations 2014 Guidance on Regulations:
The Genetically Modified Organisms (Contained Use) Regulations 2014: