College of Medical, Veterinary and Life Sciences Institute of Molecular, Cell and Systems Biology General Safety Regulations and Information The following information and instructions supplement the Safety Policy for the Institute, and are key elements to ensure that the Safety Policy is implemented effectively GM Definition: The introduction of new combinations of heritable material by the insertion of nucleic acid molecules, produced by whatever means outside the cell, into any virus, bacterial plasmid or other vector system so as to allow their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation. Legal requirement Experiments in which Genetic Manipulation is involved are subject to legislation enforced by the Health and Safety Executive and SEERAD/DEFRA and guidance endorsed by the Scientific Advisory Committee on Genetic Modification (SACGM). It is therefore a legal requirement to carry out a risk assessment before you commence for the first time any GMO operation. For activities that are containment Class 2/notifiable or above, the Health and Safety Executive (HSE) Request (CU2) form must also be completed. If you are in doubt, check with your GM Biological Safety Officer, Dr Joel Milner, in the first instance. Who to contact The GM-37 Safety Committee has the remit for overseeing all proposals in the School of Life Sciences, WCMP and Chemistry, and the GM Safety Officer and committee chair is Dr Joel Milner, Bower Building. Info here for other committees? Procedure for GM project approval Speak to your local GM safety advisor to ascertain if your work is covered by an existing risk assessment. If there is an existing risk assessment, you may need to submit only an amendment form to cover your own specific project. If there is no existing risk assessment, select the most appropriate general risk assessment form to your proposal – see below for the full list of existing pro-forma assessments which will be available on the Institute’s safety website (alison will put forms on the website as soon as it is ready, and will supply the necessary text) or by emailing Alison Neill, Clerk to GM-37 committee. Complete the form and send it to Alison Neill who will pass it through the committee and return it to you, either with consent or amendments. Note: all GM work must be approved by the relevant GM Biological Safety Officer or committee before any work begins. Note that classes 2 and above or notifiable proposals require the additional approval of HSE with a fee currently at £940 per application. The committee may be able to include a new proposal under an existing class 2 HSE project, check with the GM-BSO, Dr Joel Milner. If your proposal involves the use of listed biological agents, or produces a toxin that is listed in Schedule 5 Anti-terrorism, Crime and Security Act 2001 (link to http://www.hse.gov.uk/pubns/misc208.pdf ) it will be class 2 or above, and a copy of the GM risk assessment should be sent to the Institute’s safety committee chair, Prof Marshall Stark. If your work will involve the use of animals please contact the unit manager of the unit where the work is to take place for further advice. A copy of the risk assessment should be sent to the appropriate unit manager. If your work is part of a project for which you already hold an assessment, please quote the original Risk Assessment reference number when submitting an amendment. When project approved You will be asked by the Committee to review your GM risk assessments at regular intervals, however, changes in personnel, organism, substance or location should be notified Alison Neill, clerk to GM-37 committee prior to work commencing. Current Risk Assessment forms available Note that some proposals may involve more than one Risk Assessment, for example, animal work may be involved in a lentiviral project, in which case, both forms should be completed. E.coli sub-cloning and expression of recombinant DNA in (standard class 1), E.coli (class 2, non-standard), sub-cloning and expression of recombinant DNA in Plasmodium berghei, Genetic modification of Agrobacterium Cell lines GM Rodent Risk Assessment with Annex for Rodent Containment Bacteria other than Lentiviral Constructs, for use as vectors Parasitic protozoa, genetic manipulation of Plant (Arabidopsis) risk assessment Plant (general) risk assessment Plant (Nicotiana species) risk If there is not a Risk Assessment in the above lists that seems relevant, please submit details in free text in the first instance If you know that the proposal is category 2 containment or above, please also complete the HSE Class 2 application form Amendments to Existing Proposals It is important to keep records of ongoing projects up-to-date. If you make any changes to an existing proposal, please complete and send to Alison Neill an Update & amendment form