Legislation Summary, University Requirements and Guidance
Summary of Legislation, University Requirements and Guidance
How to comply with the Genetically Modified Organisms (Contained Use) Regulations (2000) as amended in 2014
The Health and Safety Executive (HSE) has detailed guidance on the Regulations.
For practical guidance on risk assessment and containment and control measures, see the HSE’s Scientific Advisory Committee on Genetic Modification (SACGM) Compendium of Guidance. SACGM is the Health and Safety Commission's Advisory Committee on Genetic Modification under contained use. The Compendium is a substantial document containing detailed technical advice on genetic modification work. It is particularly useful for staff to consult the Compendium for guidance on risk assessment of higher risk work.
Risk Assessment and Classification
Prior to any GM activity starting, a risk assessment must be undertaken for all work involving genetic modification, and the local (eg departmental) Genetic Modification Safety Committee (GMSC) must advise and comment on the conclusions of the risk assessment.
The risks to human health and safety and the environment must be assessed and take account of the matters specified in the Regulations. The Regulations also specify the steps that must be followed in making the risk assessment. For GMMs, in addition to requiring the selection of appropriate containment and control measures, the risk assessment procedure also requires all activities involving genetically modified microorganisms to be classified into one of four classes (1-4). The assignment to a class must be made on the basis of the outcome of the risk assessment process and corresponds to the level of containment for the work.
The risk assessment and classification procedures required by the Regulations are complicated and difficult to summarise. In order to ensure that the necessary consideration is given to all relevant matters and steps, standard risk assessment forms for the various types of activities are provided. The forms include guidance sections to aid completion and in the majority of cases for low risk work it will be possible for researchers to complete the form without the need to refer to the Compendium. The University also provides a GM risk assessment training course aimed at Principle Investigators
University Policy
The University Policy differs from HSE Genetically Modified Organisms (Contained Use) Regulations 2014. Namely, the University requires:
- Department GM Safety Committee
- GM waste inactivation before disposal for all classes of GMOs
- For new Containment Level 3 laboratories: HEPA filtration installation to be considered at the design stages in order to future-proof laboratory requirements. There are containment measures in the HSE tables that will also need to be considered. It is expected that you will consult with your School Safety Officer/Safety Office at the planning and design stage.
Contained Use Notification Requirements
Under the Contained Use Regulations, all genetic modification work is controlled by requirements to notify the Health and Safety Executive and obtain appropriate consents to undertake the work. There are requirements for notification of premises and certain higher risk activities.
The Health and Safety Executive charge fees for processing notifications. The fees associated with any notification are to be met by the department concerned. The HSE provides information on the current charges. http://www.hse.gov.uk/biosafety/gmo/notifications/index.htm
Premises Notification
All premises where genetic modification activities are carried out must be notified to the Health and Safety Executive in advance of any work starting. This requires that full details be provided to the HSE for each department undertaking genetic modification work and that HSE be kept informed of any significant changes. If a department that is already registered wishes to use new or alternative premises or facilities then further notification may be required.Activity Notification
If new projects are proposed in a department that is already registered then low risk (Containment Level 1 and Class 1 GM Project) work can commence as soon as the Departmental Genetic Modification/Biological Safety Committee has approved the risk assessment. In these cases, notification to the HSE is not necessary.Higher risk activities (Containment Level 2 and Class 2 GM Project and above for GMMs or genetically modified plants or animals which are potentially more harmful to human health than their non-modified parental organism(s)) have to be notified to the HSE on an individual basis and appropriate consents obtained to carry out the work. This must be done in advance of the work starting. Any subsequent changes in the work must also be notified.
Higher risk projects must be approved by the Departmental Genetic Modification Safety Committee and then be notified to HSE. The notification periods are 30 days for containment level 2 work (class 2 GM Project) and 45 days for the others. Work must not start on any such project until the notification has been completed and consent issued where appropriate.
Individuals are advised to contact their Departmental Biological Safety Officer at an early stage to discuss notification of individual projects.
If you want to administer viable GMMs to humans as part of a clinical trial, you must speak to the Clinical Schools Safety Officer at an early stage of planning and to read the SACGM Guidance. The guidance offers advice to ensure compliance and is primarily intended to cover GMMs in the pre-marketing phase of product development.
Disclosure of Information
All information submitted to HSE as part of notification is disclosable to anyone who requests it from them. In addition, some parts of the notification are placed on the HSE public register, a copy of which is available online. In certain circumstances it is possible to claim confidentiality and exemption from public disclosure for some information. The grounds for claiming confidentiality are limited and fall into three main areas: protection of intellectual property rights, commercial confidentiality and public security. Any claim has to be fully justified against stringent criteria and is subject to agreement by HSE. Personal information is automatically treated as confidential.Researchers are advised to consider, in consultation with their head of department, whether they wish to claim confidentiality for any part of a project that is being notified to the HSE.
Cell cycle control of spindle morphogenesis in Saccharomyces cerevisiae
(Credit: University of Cambridge)
Departmental Arrangements
The Head of Department is responsible for all genetic modification work carried out on departmental premises irrespective of who is carrying out the work and also, although to a more limited extent, for work carried out by members of the department elsewhere. The Regulations include provisions to ensure that all genetic modification activities are regulated irrespective of where and by whom they are carried out. In addition, specific duties are placed on educational establishments and students to ensure all persons concerned (not just employers and employees) are responsible for ensuring that this type of work is carried out safely.
Notification of premises
All premises where genetic modification activities are carried out must be notified to the Health and Safety Executive in advance of any work starting. The majority of departments where this type of work is likely to be carried out in the University are already registered. If any department not currently registered wishes to start genetic modification work they must notify their premises before any GM activities begin.Departmental Biological Safety Officer (and/or the GM Safety Officer)
The Head of Department in those departments carrying out genetic modification work must appoint a Departmental Biological Safety Officer (DBSO). Persons appointed as DBSOs should have experience of working in a containment laboratory (and ideally genetic modification work) and be able to advise the Head of Department on the containment and control of biological hazards in experiments being carried out in the department. Information relating to the appointment must be included in the Departmental Statement of Safety Organisation. Departments must notify the University Safety Office of any change in the appointment of the DBSO.Departmental Genetic Modification Safety Committee
Each department where genetic modification work is carried out must set up a departmental Genetic Modification Safety Committee (GMSC). The GMSC should be constituted to represent both management and employees with its members being representatives of all persons having access to genetic modification facilities. In practice, the GMSC is incorporated into the Departmental Biological Safety Committee and is not a separate entity.The statutory purpose of the Departmental Genetic Modification Safety Committees is to advise on risk assessment and ensure that:
proper and valid assessments have been made of the risks to human health and safety and to the environment;
satisfactory decisions about the appropriate containment and control measures have been made; and
the approach to risk assessment is in accordance with the guidance provided by SACGM taking into account the parameters detailed in the Regulations.
All GM risk assessments must be approved by the local departmental GMSC/Biological Safety Committee and be reviewed annually and at any other time when there is reason to believe that the assessment is no longer valid. All new GM notifications for higher risk work made to the HSE are also subject to prior approval by the departmental GMSC.
Any problems that cannot be resolved at local level will be referred to the University Sub-committee for Biological Safety. The Biological Safety Officer should also refer matters to the University Occupational Health Service where appropriate.
Within the University the following representation is appropriate on the GMSC:
Biological Safety Officer
Deputy Biological Safety Officer
Departmental Safety Officer
Management Representative – eg Head of Department, Administrator or deputy
General Staff Representative(s) – to represent all members of the department who have access to genetic modification facilities eg technical staff, research workers, ancillary workers, students etc; appointees may include a trade union safety representative (if one is appointed in the department) from a recognised trade union.
Technical Expert – to provide additional expertise where necessary, eg on viral vectors, medical or environmental aspects (optional if the required expertise does not already exist in the department and additional technical expertise is considered beneficial)
School Safety Officer – if appropriate
Member of the Safety Office – if appropriate
- Annual Survey of Ongoing Work
The University Safety Office will ask the Departmental Biological Safety Officer to provide an up to date list of all genetic modification projects ongoing in their department on an annual basis. BSOs will commonly use the annual biosafety questionnaire from the safety office as a prompt to seek reassurance from PIs that GM RAs have been reviewed in the last 12 months.
Gal 4 drivers specific for Type Ib and Type Is motor-neurons in drosophila
(Credit: University of Cambridge)
Training and Supervision
Supervisors must ensure that all workers for whom they are responsible are competent to carry out their work safely and that they receive an appropriate level of supervision. Deputising arrangements must be made to cover times when the supervisor is not available. Procedures should be in place to ensure new workers are familiar with the local codes of practice and the correct use of laboratory equipment. On the job training is important. Each new worker should be trained by staff familiar with the laboratory techniques involved as soon as possible and before the worker starts. Familiarisation by means of individual discussion with each new entrant to the laboratory is advised. Training must specifically address safety issues and include discussion of the risk assessment for the project.
Users of microbiological safety cabinets (MSCs) should be trained and should attend the University training course.
No external personnel may enter a containment laboratory for cleaning, servicing of equipment, repairs, etc. unless the DSO, Departmental Facilities Manager or lab-specific manager has been informed and appropriate arrangements have been made, and documented for audit purposes, for them to undertake their work safely (e.g. decontamination, issuing of permit to work).
Containment and Control Measures
As part of the risk assessment process the genetic modification work is assigned to the appropriate Containment Level needed to protect human health and safety and risk to the environment.
Work involving genetically modified microorganisms (GMMs) other than those associated with plants
Work involving genetically modified microorganisms (GMMs) is assigned to one of four levels of containment (Levels 1–4). Please note, there are no Containment Level 4 facilities at the University of Cambridge. The levels are set out in tables included in the HSE Regulations. Links to the relevant tables have been included in the individual University risk assessment templates. They cover laboratory type activities and the additional measures for work involving GMMs. These tables are to be used in the risk assessment process. Further details on interpretation of the requirements are given in the SACGM Compendium of Guidance Part 2: Risk assessment of genetically modified microorganisms (other than those associated with plants (hse.gov.uk)HSE and ACDP Containment Levels are very similar in terms of containment and control measures, but not identical. The differences are only relevant at higher containment levels where HSE Containment Levels include certain measures as mandatory requirements. The Biological Safety Officer should discuss these differences with researchers on a case by case basis where appropriate as part of the risk assessment review procedure (see Part 3 of SACGM Compendium of Guidance).
Work involving genetically modified plants and plant-associated GMMs
For genetically modified plants, the Contained Use Regulations require containment measures to be applied but do not detail specific containment measures. SACGM provides guidance on risk assessment and appropriate containment in the Compendium. Reference should be made to Part 4 of SACGM Compendium of Guidance for the risk assessment and containment requirements for work involving genetically modified plants (Sections 4.4 and 4.5). For GMMs associated with plants, see Sections 4.2 and 4.3.Work involving genetically modified animals
There is no regulatory requirement to set a formal containment level for work with GM animals, but there is a requirement for containment measures to be applied to sufficiently protect against harm to the environment and human health. Part 5 of SACGM Compendium of Guidance covers the risk assessment of activities with GM animals and the assignment and implementation of containment and control measures.Good Microbiological Practice and Good Occupational Safety and Hygiene
For activities involving genetically modified microorganisms, in addition to the standard containment levels set out in tables, control measures must include the principles of good microbiological practice (GMP) and good occupational safety and hygiene (GOSH) – see Schedule 7 in the 2014 Regulations. For activities involving genetic modification of organisms other than microorganisms, the general principles of GMP and GOSH must be applied insofar as they are appropriate.Associated Licensing
In addition to the Genetically Modified Organisms (Contained Use) requirements for GMOs, if the agent is identified as a specified Animal Pathogen or a licensable plant or plant pathogen, there are specific licensing requirements – SAPO and APHA.
Work with Genetically Modified Organisms Obtained from Outside the University
A risk assessment must be made and submitted to the departmental Genetic Modification Safety Committee for all work with GMOs even if the modification is undertaken elsewhere and the organism is supplied “ready-made” to researchers in the University (eg those obtained from commercial sources or collaborators elsewhere). It is any activity or use of the GMO that is regulated, not just the making of it. In many cases the supplier’s risk assessment could form the basis of the risk assessment for the work to be undertaken within the University. The University Safety Office can be contacted to discuss this in more detail if required.
Expression pattern of a germ cell marker fused to YFP in Arabidopsis
(Credit: University of Cambridge)
Emergency Plans
An emergency plan must be created if the risk assessment indicates that, as a result of any foreseeable accident, the health and safety of persons outside the premises may be seriously affected or if there is risk of serious damage to the environment. Such a plan is unlikely to be necessary for most small scale activities or those involving low risk organisms.
Health Surveillance
Although the Contained Use Regulations do not include a specific requirement for health surveillance for genetic modification work, health surveillance will follow the guidelines and recommendations as required by the COSHH Regulations.
All staff and students who will be involved in laboratory work with Class 3 genetically modified microorganisms (as assigned for human health), Hazard Group 3 pathogens, oncogenes, or unscreened human blood or tissue samples must complete health screening before commencing this work – see Guidance.
Notification of Accidents
There is a legal requirement to notify the Health and Safety Executive of certain accidents or incidents involving genetically modified organisms. The University Safety Office is the first point of contact in the case of any GM-related incident.
Records
Departments must maintain written records relating to genetic modification work. The Departmental Biological Safety Officer is charged with ensuring the following records are kept.
Names of all people working in the department carrying out genetic modification work together with details of the experiments with which they are involved.
A copy of the risk assessment relating to any genetic modification activity carried out by the department; and
Names of all people working in the department carrying out genetic modification work together with details of the experiments with which they are involved.
The records must be kept whilst the work is being carried out and thereafter for a minimum of 10 years following the date the work ceases as is specified in the regulations. Records must be made available to the authorities when requested.
Research into totipotency of stem cells
(Credit: University of Cambridge)