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Setting up a Category-1 Biolab
- CL-1 Laboratory
- A project run at St Olaves in 2015-2016 was the setting-up of a 'Containment Level 1' laboratory at the school (which is a state-maintained school in the UK). This project is very nearly complete in August 2016. We wanted to do this at the school in order to allow our students to initiate and run their own genetic modification projects.*
On this page I will provide a brief overview to the setting up of a CL-1 laboratory/laboratories in order to perhaps make it easier for others to do the same. CL-1 laboratories need not only be set up in institutions, they can also be set up in hackspaces, personal garages etc. **Disclaimer: The information presented here should not be considered to be legal advice. Anybody setting up a CL-1 lab in the UK ought to refer to the relevant legislation themselves.**
- Relevant Documents
There are two documents to which to refer.
- [The Genetically Modified Organisms (Contained Use) Regulations 2014.](http://www.hse.gov.uk/pubns/books/l29.htm)
- [SACGM Compendium of Guidance](http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/) (Warning: This document refers to a deprecated version of the GMO regulations and therefore in some places may provide outdated information). This document provides some useful guidance on the 2014 regulations.
The GMO 2014 regulations set out the important legislation which must be followed when setting up a CL-1 laboratory.
A first reading of the GMO 2014 regulations can be quite overwhelming, but once the portions which are not relevant to your particular school and your proposed projects are ignored then the action which needs to be taken boils down to a very manageable set of steps.
The guidance which I am presenting here is relevant to schools which which to carry out Category-1 work (i.e. presenting a negligible hazard to human health and the environment) on micro-organisms (e.g. E. coli or yeast). It does not cover more unusual cases (e.g. GM work on animals or plants), but the 2014 regulations provide instruction on what to do if your work is not the sort of work with which I am dealing here.
- Things to do when you want to start Category 1 work in schools.
- A biological safety officer (BSO) needs to be appointed. This needs to be a person who works within the school. The BSO's role is outlined in the points below. This person does not necessarily need to have experience with genetic modification but such experience would be very beneficial. The BSO needs to be allocated sufficient time and resources to do their job (in the case of my school I estimated that their work required 5-6 hours per year).
- A place needs to be allocated within the school in which the risk assessments which relate to GM projects will be stored. These risk assessments need to be kept for at least ten years after the projects to which they relate have ceased therefore the risk assessments need to be clearly labelled with the date until which they need to be kept.
- Labcoats and safety spectacles need to be acquired which will be solely designated for GM projects. There need to be enough labcoats and specs such that everybody working on a GM project simultaneously has some to use.
- All the students who work on GM projects need to be trained in good microbiological practice (set out on page 66 of the 2014 regulations). A record needs to be kept of which students have received training.
- If GM projects will use laboratory equipment which poses higher risks than equipment usually used in a school laboratory (e.g. a 30,000 RPM centrifuge) such equipment needs to have rules drawn up for its use. Before students use these pieces of equipment they need to be trained in its use and records of training kept.
- Laboratories in which Category-1 work is to be carried out should contain a sink and a supply of antimicrobial soap.
- A disinfectant which is effective against the micro-organisms used in your Category-1 work needs to be included in your CL-1 lab/labs.
- Cl-1 labs need to have benches which are impervious to water; resistant to acids, alkalis, solvents, disinfectants, and decontamination agents; and are easy to clean.
- Any projects which are to be carried out need to be risk assessed using a particular risk assessment pro-forma. I used a pro-forma for Category-1 work which was kindly supplied by a teacher at another school and you might be able to source one in a similar way. If you need to create your own proforma you should follow the guidance from 'regulation 5' of the 2014 regulations.
- Notification needs to be made to the HSE needs to be made before:
* GM work begins at school for the first time or after a period of time during which it has not occurred. * A new GM project begins. * Work can begin on projects upon receipt of an acknowledgement from the HSE. This acknowledgement would typically be sent within ten days of a notification being made. Notification is best made using the facilities on the HSE's website. Since a large fee must be paid at each notification, notification that GM work is beginning and notification that your intended projects will occur should be made simultaneously. Project notifications are best phrased such that all activities which you feasibly anticipate carrying out are described within it (this avoids making further expensive notifications in future).
- Risk assessments need to be stored in the designated area and clearly marked with the date on which they can be discarded (at minimum ten years after cessation of the projects to which they relate.
- While GM experiments are being carried out in school:
- You ought to set aside enough time for practical work that the work-surfaces in use can be disinfected afterwards.
- Anybody working on GM activities needs to wear labcoats and safety spectacles when necessary.
- GMOs and any items which have come into contact with GMOs should not be kept in classrooms. When practical work finishes these items should be stored in place to which students do not have access (e.g. a prep room).
- Notification needs to be made to the HSE if a change is made to a project which significantly changes the risks associated with it.
- Notification must also be made if:
* GM work ceases at school either temporarily or permanently. (To avoid making multiple notification fees it is best for GM work to occur on a continuing basis in school). * Another teacher becomes responsible for contained use (e.g. the BSO changes). * The labs in which GM work occurs change in a way which has consequences for the risks associated with GM projects. * Any new information (e.g. a relevant published research paper) changes the perceived risks associated with a project.
- When the sorts of notifications outlined in the bullet point above are made work can continue as soon as notification as made (you don't need to wait for receipt of a notification from the HSE).
- The BSO must periodically (e.g. yearly) check labcoats, safety spectacles and any other PPE used in Category-1 work for damage.
- The BSO needs to review the measures taken in school to contain GMOs at suitable intervals (e.g. every three years).
- A review of containment measures must be made immediately if the BSO thinks any of the following things:
* The containment measures are no longer adequate. * The class (Category-1 for school projects) assigned to a project is no longer appropriate. * That in light of new knowledge current risk assessments are no longer valid.
- Waste from projects does not need to be autoclaved if the strain of microbe used:
* Does not have the potential to cause harm to human health and the environment. * Is biologically contained (e.g. possesses multiple disabling mutations or restrictive nutrient requirements that cannot be met outside the laboratory). * Do not have the capacity to establish and multiply in the environment. * Do not have the capacity to transfer genetic material to other micro-organisms (e.g. you are cloning into a non-mobilisable plasmid).