LBL06001

Project 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

• • general description of the SOP purpose

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).

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.

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.

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).

6. Definitions

• • Any useful glossary stuff

e.g: SOP = Standard Operating Procedure

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 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 or
       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.

  7.1.3 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?

  7.1.4 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.

  7.1.5 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.

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

  7.1.7 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.

     7.1.7.2 Consider the potential for transfer of genetic material between the GM plant and other organisms.

8. Resources

• • This is where eternal useful documention can be linked, much like the references section in any academic paper.

...