Genetic Modification. University Health and Safety Policy. Version 1: September 2015 Author: Health & Safety Services 1

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1 Genetic Modification University Health and Safety Policy Author: Health & Safety Services 1

2 Genetic Modification Procedure to support University Health and Safety Policy CONTENT Section Page 1 Introduction 3 2 Legal Framework 3 3 Lines of Responsibility 4 4 Procedure 5 5 Further Support and Advice 5 6 Procedure Version and History 5 Appendices Appendix 1 Appendix 2 Biological Agents Health Assessment Form GM Activity Proposal Author: Health & Safety Services 2

3 1. INTRODUCTION This procedure describes the arrangements by which Heriot-Watt University will ensure that appropriate measures are taken to protect employees, other persons and the environment from risks caused by the genetic modification of micro-organisms (GMMs). Only GM Class 1 and Class 2 contained use activities are permitted at Heriot-Watt University. Class 3 and Class 4 contained use activities are prohibited as is the use, storage or other possession of related materials and organisms. 2. LEGAL FRAMEWORK The Health and Safety at Work etc. Act 1974 The Act requires us to show that we have taken reasonably practicable steps to protect the health and safety of anyone affected by our work-related activities. We can do this by assessing our work activities, evaluating the risks and implementing suitable control measures. The Management of Health and Safety at Work Regulations 1999 These Regulations require the University to prepare suitable and sufficient risk assessments to control any foreseeable risks presented by our work activities. The Genetically Modified Organisms (Contained Use) Regulations 2014 The Regulations require that a risk assessment be carried out for all work involving genetic modification. The Regulations require that institutions set up a Genetic Modification Committee and appoint a competent person to advise on relevant risk assessment processes. This role will be fulfilled by the Biological Safety Officer (BSO). Control of Substances Hazardous to Health Regulations 2002 (COSHH). These Regulations impose a requirement to carry out an assessment of the risks associated with work activities involving both chemical and biological substances and to implement appropriate control measures. The Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations These regulations govern the deliberate release or marketing of GMOs and are designed to minimise the damage to the environment which may arise due to the release of the GMO. As the regulations are enacted via devolved government (i.e. via Environmental Protection legislation), there are separate regulations for Scotland and for England / Wales. Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations These require that the records of environmental risk assessments for GMOs, should be kept for 10 years. Plant Health (Scotland) Order This Order deals with the control of Import and Exports of plants and plant materials in Scotland. Author: Health & Safety Services 3

4 3 LINES OF RESPONSIBILITY Health & Safety Services has overall responsibility for the development and implementation of this procedure, and review in consultation with the University Health and Safety Committee and Genetic Modification Committee. Health & Safety Services shall: provide support, advice and training as required appoint Biological Safety Officer monitor the quality of assessments and arrangements via a sampling process in order to ensure that they meet good practice standards liaise with the University Occupational Health Service Biological Safety Officer shall: assess, approve and review all genetic modification (GM) activity proposals and risk assessments notify the HSE of work with genetically modified organisms and work with specified pathogens carry out regular inspections and annual auditing of GM processes investigate all relevant incidents and where applicable report to required enforcing authority have membership of the Genetic Modification Committee maintain all GM activity proposal and risk assessment records within Shield HSMS maintain a database of the Biological Agents Health Assessment Forms Academic Staff Supervising Research or other Projects are responsible for: ensuring that activities taking place in their area of responsibility are subjected to this procedure ensuring that all activity proposals and risk assessments are assessed, approved and reviewed by the Biological Safety Officer ensuring that all activity proposals and risk assessments are reviewed and re-submitted to the Biological Safety Officer if process changes or annually, whichever comes first ensuring that activities and materials relating to GMMs brought in from external sources including other Universities are subject to this procedure ensuring that all staff or students that engage with GM processes complete the Biological Agents Health Assessment Form, see appendix 1 ensuring that a safe environment is maintained for staff, students and visitors ensuring appropriate communication of information, instruction, training and supervision of anyone involved with GM processes ensuring that appropriate personal protective equipment is provided and used ensuring that suitable storage and waste disposal regime is in place providing equipment and procedures to deal with accidents and emergencies Heads of School are responsible for: ensuring that suitable resources are provided for GM activities Genetic Modification Committee are responsible for: supporting the University Health and Safety Committee as a specialist Genetic Modification Committee ensuring compliance with the requirements of legislation relating to genetic modification activities monitoring the management of health and safety within this area of specialism supporting the process of approving GM activity proposals and risk assessments relating to Class 2 genetic modification activities receiving reports and making recommendations for all relevant activities on behalf of the University Health and Safety Committee reporting to the Chair of University Health and Safety Committee on issues affecting the Genetic Modification Committee consulting on and considering consistent standards of working, including safe operational Author: Health & Safety Services 4

5 procedures and related guidelines considering the impact on changes to legislation and best practice relative to Genetic Modification liaising with Health & Safety Services in matters relating to Genetic Modification ensuring that their activities comply with the requirements of the Research Ethics Policy and Procedures University Occupational Health Physician shall: provide advice to the Genetic Modification Committee process the Biological Agents Health Assessment Form, where required conduct health assessments and screening, where required All Staff and Students are responsible for: complying with this procedure and local arrangements making themselves fully conversant with the GM activity proposal and risk assessments applicable to the activities which they are involved in ensure appropriate personal protective equipment is worn on all occasions reporting any concerns to their Line Manager, Supervisor or Tutor ensuring that all hazards and accidents involving genetically modified organisms are notified to the Biological Safety Officer and recorded on Shield HSMS 4. PROCEDURE Approval Process Prior to conducting any GM processes, an activity proposal and risk assessment must be completed using the following forms: Genetic Modification Procedure - Appendix 2, GM Activity Proposal Form. Risk Assessment Procedure - Appendix 1, Risk Assessment Form. This paperwork must be submitted electronically to the Biological Safety Officer at least 2 months prior to commencing of works in order for the appropriate notification and approval arrangements to be completed. Class 1 activities must be approved by the Biological Safety Officer. Class 2 activities must be authorised by the Genetic Modification Committee. The activity must not commence until you have received written approval from the Biological Safety Officer. On approval and permission to carry out the GM process a copy of the signed activity proposal form and risk assessment must be provided to all parties involved (staff and students). Note: Activity must cease immediately if instructed by Health & Safety Services. 5. FURTHER SUPPORT AND ADVICE Health & Safety Services on healthandsafety@hw.ac.uk 6. POLICY VERSION AND HISTORY Version No Date of Approval Approving Authority Brief Description of Amendment Health & Safety Services 1 st version of new procedure Author: Health & Safety Services 5