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Introduction

The main legislation that applies to the use of genetically modified organisms (GMOs) in the workplace is the .

The GMO (CU) Regulations describe the human health, safety and environmental protection we must consider when using genetically modified microorganisms, plants and animals (GMOs). The main requirement of the GMO (CU) Regulations is to assess the risks of all activities involving GMOs and to make sure that any necessary controls are put in place. The GMO (CU) Regulations provide a framework for this and place clear legal obligations on the people who work with GMOs. Key technical guidance for use of GMOs is provided by the , which describes best practice in this field.

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• require risk assessments to be carried out for activities involving genetically modified microorganisms and activities involving organisms other than microorganisms. All activities must be assessed for risk to humans and those involving Genetically Modified Microorganisms (GMMs) must also be assessed for risk to the environment;
• introduce a based on the risk of the activity independent of the purpose of the activity. The classification is based on the four levels of containment for microbial laboratories;
• require notification of all premises to HSE before they are used for genetic modification activities for the first time;
• require notification of individual activities of Class 2 (low risk) to Class 4 (high risk) to be notified to the Competent Authority (which the HSE administers). Consents are issued for all Class 3 (medium risk) and Class 4 (high risk) activities. Class 1 (no or negligible risk) activities are non-notifiable, although they are open to examination by HSE's specialist inspectors who enforce the Regulations. Activities involving GM animals and plants which are more hazardous to humans than the parental non-modified organism also require notification to the Competent Authority;
• require fees payable for the notification of premises for first time use of class 2, 3 and 4 activities notifications, and notified activities involving GM animals and plants;
• require the maintenance of a public register of GM premises and certain activities.

Actions

• GM specific risk assessment forms and guidance notes have been produced for assessment of work involving genetically modified organisms and plant tissue. These assessments must be provided to the Biological and Genetically Modified Materials Safety Committee (BGMS) for review before commencement of the work.
• Draft risk assessment forms should be sent to the Secretary of the BGMS, who will distribute the assessment to committee members for comment as necessary.
• Members of the BGMS will review the risk assessment and make comments if necessary.
• Work can only commence once the assessment has been approved by the Head of Department/Deputy Director of Research.
• A copy of the final agreed assessment must be sent to the Secretary of the BGMS for the committee records and the provision of information to the University Health, Safety, Sustainability and Wellbeing Board.
• All risk assessments must be reviewed at least annually, or sooner if there is an accident or significant change to the work, with notification provided to the BGMS Secretary.

Note: There is a five year cap on risk assessment reviews. Therefore, all project leads must submit a completely new proposal to the BGMS Committee before the project continues beyond the 5 year mark.

• Any work with GM material must be carried out in a laboratory with the relevant containment measures (1 – 4) in place.
• If any proposed work requires a licence, such as importing plant material, a relevant licence must be held or a licence obtained before commencing the work.
• The BGMS will meet twice per annum as a minimum.

Responsibilities

Heads of Department/Deputy Directors of Research are responsible for:

• Providing adequate resources for individuals carrying out GM projects to comply with relevant regulations, codes of practice and guidance.
• Ensuring that all GM work is carried out in appropriate laboratories under the correct conditions and with appropriate licences.
• Ensuring that adequate and correct disposal procedures are in place for waste GM material

GM Project Leaders are responsible for:

• Ensuring that a risk assessment is prepared and a draft copy provided to the BGMS for comment as necessary.
• Ensuring that all members of their project team and students are aware of the risks associated with the project and that work is carried out in accordance with the control measures/local rules stated in the assessment.
• Notifying the Biological and Genetically Modified Materials Safety Committee of any accidents or significant changes that might affect the risk of harm to humans or environment.
• Reviewing and where necessary revising project risk assessments on at least an annual basis, or sooner if there is an accident or a significant change in the work.

The University Biological Safety Adviser is responsible for:

• Advising the Vice-Chancellor and the University Secretary on matters of biological safety, including genetic modification. The University Biological Safety Adviser gives an annual report to the University Health, Safety, Sustainability and Wellbeing Board.

See Responsibilities of the University Biological Safety Adviser for full details.

Last review - March 2023