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Risk assessments for new work in the lab, HSE/CL1 requirements.
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(Risk assessments for new work in the lab, HSE/CL1 requirements.)
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'''1. Purpose'''
'''1. Purpose'''


**  general description of the SOP 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'''
'''2. Scope'''


**  the extent of the SOP in terms of to what equipment and procedures it applies, also when and where (which will always be at all times in the LBL lab).
This SOP applies to all users of the Biohackspace Laboratory and all projects undertaken within it.


'''3. Responsibilities'''
'''3. Responsibilities'''


**  for who is the procedure relevant, typically the operator and anyone present while it's carried out, it's also worth mentioning the risks here and that the operator is responsible for their health and safety and that of anyone else present during the procedure.
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'''
'''4. Materials'''


**  Are there any extra materials required, in the case of operating an instrument, peice of equipment or in a molecular biology procedure this might be consumables, reagents, chemicals or other instrumentation, e.g pipets. Any special PPE can be mentioned here.
i) Risk assessment checklist.<br>
ii) List of materials and methods for project work.<br>


'''5. Related documents'''
'''5. Related documents'''


**  Are other SOPs (or other documents within our framework) related to this procedure. If so then listing them here can be useful, for example the media prep SOP might be relevant when carrying out the transformation procedures and it saves time to link it here rather than describe the preparation of media in every procedure where it is used (bit like an include/import/use lol).
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'''
'''6. Definitions'''
 
GMM
**  Any useful glossary stuff
GMO
e.g:
COSHH
SOP = Standard Operating Procedure
SOP
HG
CL
PI
PPE


'''7. Procedures'''
'''7. Procedures'''
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  7.1 Items for principal investigator to consider in assessing the risks in projects involving GMM.
  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. Consider the potential hazardous properties from your microorganism cross referenced to national categorisation lists,
   7.1.1.1 Any microorganisms to be used within the lab must fall within the Hazard Group 1 category. Biological agents are categorised into HG categories based on the following criteria:
            e.g Approved list of biological agents.
         i) are they harmful to human health,
   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  
        ii) are they a hazard to employees/workers within the organisation
          into HG categories based on the following criteria:
        iii) transmissible to the community or
          
        iv) whether effective treatment and/or prophylaxis (including vaccines) are available?
              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 enhancements of function? altered tropisms? altered routes of transmission? (consider impacts on its hazardous properties i.e more pathogenic, attenuated or unchanged.
   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 involved in setting up and running fermentation and growth systems. Particularly are any non-standard procedures involved?
   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.
   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 organsism will be stored frozen, in the fridge or at room temperature and if it requires any special storage requirements.
   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.
   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 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 the capacity of a GM plant to survive, become established and deseminate. Including its ability to compete with or displace other plants.6c. Consider hazards associated with inserted genetic elements. Particularly if this codes for any toxic products that might affect the ecosystem or animal health.
       7.1.7.1 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 Consider the potential for transfer of genetic material between the GM plant and other organisms.
       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'''
'''8. Resources'''


** This is where eternal useful documention can be linked, much like the references section in any academic paper.
HSE docs on risk (in general and GMM stuff)




Samb1
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