Working with genetically modified organisms (GMOs) policy

This policy was approved by the Safety Managers Committee on 13 January 2021.

Policy statement

Genetically Modified Organisms (GMOs) are an essential tool for modern biomedical research and at St George’s University of London we aim to facilitate their use.

It is a legal duty under The Genetically Modified Organisms (Contained Use) Regulations 2014, to carry out a suitable and sufficient Risk Assessment (RA) for every activity involving the use of GMOs and for said RA to be reviewed by a local Genetic Modification Safety Committee (GMSC).

St George’s University of London does not allow any activity involving the use of GMOs (including their storage) on its premises until written consent, stating that the activity can commence, has been issued by the Biological Safety Officer for Genetic Modification (BSO-GM) following approval by the GMSC.

Definitions

Genetically Modified Organism: A GMO is defined according to the techniques used to create said organism. The definition is extensive and given in full detail in Part 1 of Schedule 2 of the Contained Use regulations. Briefly, a GMO is defined as an organism in which ‘the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination […] and where the genetic material is capable of continued propagation’. 

The Genetically Modified Organisms (Contained Use) Regulations 2014: Regulations concerned with the prevention of harm to human health and the environment that arises from contained use involving genetically modified micro-organisms (GMMs), Genetically Modified (GM) animals and GM plants.

Contained use: Any activity involving GMOs where barriers are used to limit contact with and protect humans and the environment. These barriers can be physical, chemical, or biological.

Containment level: COSHH specifies four containment levels for activities which involve working with biological agents. These correspond to the classification of biological agents into Hazard Groups 1 to 4 as determined in The Advisory Committee on Dangerous Pathogens’ Approved List of Biological Agents.

Activity class: Classification of a GM project into any of four classes (1 to 4) according to the maximum level of containment deemed necessary by risk assessment.

Activity number: Number that identifies a particular GM project within St George’s GMOs database.

GMSC and BSO-GM

St George’s University of London (here on referred to as St George’s) will establish a GMSC and appoint a BSO-GM in accordance with regulation 8 of the GMOs (CU) Regulations 2014.

The GMSC will be governed by its own terms of reference.

The appointment of the BSO-GM will be at the discretion of the university after nomination by the GMSC and approved by St George’s Safety Management Committee.

Registration of projects

Before any work with GMOs at St Georges can commence, the Principal Investigator (PI) must complete a risk assessment and submit it to the BSO-GM (BSO-GM@sgul.ac.uk).

The storage of GMOs is considered a GM activity and must also be risk assessed before commencing.

The BSO-GM may provide feedback on the RA and request changes or may directly submit the RA to the GMSC for revision. The GMSC may request further changes to the RA before approving the activity.

Once the activity is approved by the GMSC, the BSO-GM will:

1. Notify the PI that the activity can commence, if categorised as class 1 (see below); or
2. Start the process of notification to the Health and Safety Executive (HSE) in accordance with regulations 10 and 11 of the GMOs (CU) Regulations 2014. The BSO-GM will assign the project an activity number that will be used to identify the project internally.

After approval, the BSO-GM will enter the activity into St George’s GMOs database.

Competent Authority notification

GM activities categorised as Class 2 or Class 3 cannot commence until written acknowledgment (class 2) or consent (class 3) has been received from the HSE.

The BSO-GM will be the point of contact between the university and the HSE with regard to GM activities.

Record keeping

The GMO (CU) regulations require the keeping of a record of the GM risk assessments and any review of the risk assessments, for at least 10 years from the date the contained use stops. These records must be available to the competent authority upon request.

In order to comply with this duty, the BSO-GM will keep an up-to-date database of all GM projects including users, locations for work and storage, and any other relevant information. The BSO-GM will carry out annual audits of all active GM work within the university. All PIs must participate in these audits. The collated data will be entered into the university’s GMOs database.

Project completion and exit strategy

When projects have been completed, all GMOs covered under that activity number must be destroyed. The BSO-GM should be informed that the activity has been terminated.

PIs cannot leave St George’s, whether because of retirement or changing jobs, leaving behind live GMOs. Stored GMOs are considered active work by the regulations and the competent authorities and are subject to all the rules. PIs are encouraged to have an exit strategy and to think beforehand what is going to happen to the GMOs for which they are responsible. This exit strategy will be any of the following:

1. All GMOs are destroyed and the activity is reported as terminated to the BSO-GM.
2. The activity is transferred to another PI or a Head of Facility at St George’s.
3. The PI takes the GMOs to his or her new place of work. The BSO at the new place of work needs to be notified before the transfer.

Abbreviations

Links to relevant documents

• The Genetically Modified Organisms (Contained Use) Regulations 2014
• The Advisory Committee on Dangerous Pathogens’ Approved List of Biological Agents (PDF)
• Environmental Protection Act 1990 part VI (Genetically Modified Organisms)
• Genetically Modified Organisms (Deliberate Release) Regulations 2002