GM (GMO, GMM, GM Plants)

Genetically Modified Organisms (GMOs)    

All work with GMOs comes under the GM regulations. The Safety Office provides a set of risk assessment templates and an online training course.

These pages include information and advice for research involving all types of genetically modified organisms (GMOs), including genetically modified microorganisms (GMMs), GM animals and GM plants.

Information includes:

  1. Summary of the Genetically Modified Organisms (Contained Use) HSE legislation.
  2. Guidance on what you must do to comply with this legislation
  3. GM Risk Assessment Templates for your research - GM Risk Assessment Proformas

Your Departmental Biological Safety Officers (BSOs) are usually your first point of call for advice and information. You are welcome to contact the Safety Office for further guidance.

        

                                                                              

                                                    Images of GM Zebra fish larvae

                                           (Credit: University of Cambridge)

Definition of "Genetic Modification"

"Genetic modification" is defined within the Genetically Modified Organisms (Contained Use) Regulations 2014 and relates to any activity involving genetically modified organisms including, but not limited to, culture, storage, transport, destruction or disposal. Under the Regulations, genetic modification "means the altering of the genetic material (DNA or RNA, referred to in the Regulations as heritable material) of an organism using a method that does not occur naturally by mating and/or recombination".

Examples of techniques constituting genetic modification include:

  1. recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules, produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector and their incorporation into a host organism in which they do not occur naturally but in which they are capable of continued propagation;
  2. techniques involving the direct introduction into an organism of heritable genetic material prepared outside the organism, including micro-injection, macro-injection and micro-encapsulation; and
  3. cell fusion (including protoplast fusion) or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.

Under the Regulations, in vitro fertilisation, natural processes including conjugation, transduction or transformation and polyploidy induction are not considered to result in genetic modification if they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms.

There are also some techniques of genetic modification to which the Regulations do not apply providing they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms as recipient or parental organisms. These techniques are mutagenesis, cell fusion of prokaryotic species which can exchange genetic material through homologous recombination, cell fusion of cells of any eukaryotic species, including production of hybridomas and plant cell fusions, and certain self-cloning where the resulting organisms is unlikely to cause disease or harm to humans.

Notes on Gene Editing

Contained Use

The Health and Safety Executive (HSE) considers gene editing technologies (eg CRISPR-Cas9) as GM techniques, and therefore they should be risk assessed, and notified where necessary, as for other GM activities. This is also consistent with the European Court of Justice (ECJ) ruling on gene editing techniques.

With the increased use of CRISPR-Cas9 for the gene modifications in a variety of organisms and an emerging trend to use it for clinical purposes, there is a duty for all scientists and research clinicians to engage in debates and critical evaluations surrounding this technology.

Some publishers and institutions have set up their own CRISPR-Cas9 discussion and communication platforms to facilitate this discourse, for example:

A new application of CRISPR-Cas9 is the genetic alteration of chromosomes leading to germline modifications using gene drive technology. Due to the profound implications for ecosystems and wild-type species of plants and animals, the Safety Office of the University must be made aware of any planned activity using this particular application of CRISPR-Cas9 so that we can assist with the risk assessment process from an early stage.

Departments are welcome to seek further advice from the University Safety Office or School (Biological Sciences or Clinical) Safety Officers.

Deliberate Release for Research Purposes

Deliberate release for research purposes - amendments to the regulations April 2022: 'Notifications to release qualifying genetically modified higher plants.'

Acre has published technical guidance on using genetic technologies (such as gene-editing) for making 'qualifying higher plants' for research trials: 'Technical guidance on using genetic technologies (such as gene-editing) for making 'qualifying higher plants' for research trials.'

Departments are welcome to seek further advice from the University Safety Office or School (Biological Sciences or Clinical) Safety Officers.