LBL06001

Risk Assessment Procedure for Lab Users Proposing New Projects

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

1. Purpose

The purpose of this SOP is to highlight the requirements to lab users starting new projects in the Biohackspace Laboratory 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.

2. Scope

This SOP applies to all users of the Biohackspace Laboratory and all projects undertaken within it.

3. Responsibilities

Ultimately the laboratory user who initiates and undertakes the lab work (aka 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.

4. Materials

i) Risk assessment checklist.
ii) List of materials and methods for project work.

5. Related documents

See also general lab induction LBL02001 based on initial lab risk assessment and other SOPs describing the best practice in terms of materials and methods to be used.

6. Definitions

GMM
GMO
COSHH
SOP
HG
CL
PI
PPE

7. Procedures

7.1 Items for principal investigator to consider in assessing the risks in projects involving GMM.

  7.1.1. Consider the potential hazardous properties from your microorganism cross referenced to national categorisation lists,
            e.g Approved list of biological agents.
  7.1.1.1 Any microorganisms 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:
       
             i) are they harmful to human health?
             ii) are they a hazard to employees/workers within the organisation?
             iii) transmissible to the community? 
             iv) whether effective treatment and/or prophylaxis (including vaccines) are available?

  7.1.2 The PI should condsider how the microorganism 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.

  7.1.3 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?

  7.1.4 The PI should consider any special requirements in disposing of the microorganisms, in particular, cultures should be destroyed in the
        kill bin and any GM material should be autoclaved as well before disposal to ensure destruction.

  7.1.5 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.

  7.1.6 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 London biohackspace laboratory. 
                   The PI should understand the difference between the HG groups and be able to explain why the organism falls into HG1 and 
                   not higher.

  7.1.7 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 definied 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.

     7.1.7.1 Consider, for example, the capacity of a GM plant to survive and become established and deseminate. 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.

     7.1.7.2 The PI should also consider the potential for transfer of genetic material between the GM plant and other organisms.

8. Resources

HSE docs on risk (in general and GMM stuff)

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