Research and analysis

Guidance for developers notifying under qualifying higher plant notifications

Published 31 January 2025

Qualifying higher plant status

A qualifying higher plant (QHP) is a genetically modified plant with genetic changes that could have arisen naturally or through traditional breeding practices. (Read ACRE guidance for further details.)

QHPs can only be used in research and development trials, they cannot be cultivated for marketing purposes. The release of plants into the environment that does not meet the requirements set out in the Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022 under a QHP notification constitutes an unauthorised release of a GMO. These plants will need to be destroyed or authorised under the Genetically Modified Organisms (Deliberate Release) Regulations 2002 before being trialled.

If you are unsure about whether your GM plants qualify as QHPs, you must contact Defra at gm-regulation@defra.gov.uk.

Preparation, storage and handling of QHPs

Although QHPs can be used in research and development trials following a simplified notification process, for all other purposes they currently remain under the relevant GMO regulations. Therefore, their use pre- and post-trial, along with any storage will fall under The Genetically Modified Organisms (Contained Use) Regulations 2014, and persons developing QHPs must ensure they comply with these regulatory requirements.

Preventing the unintentional release of a GMO

It is important for notifiers to check that their plants only contain genetic sequences that could result from natural processes or from traditional breeding before they are used in field trials. These analyses should focus on evaluating the presence of transgenes.

Whole genome sequencing is not necessarily required but developers must systematically analyse their plants for transgenes. For example, PCR and Southern blot analysis of DNA associated with vectors or intermediaries may be sufficient to ensure that transgenes are not present.

Defra recommends referring to expert molecular diagnosticians when designing PCR primers and analysing the results obtained from PCR reactions. Notifiers should not proceed with field trials until they are confident that all transgenes have been removed.

Preventing material from a release trial being marketed

Material from field trials performed under a QHP notification can be retained for continued research use in a contained use facility (see second paragraph for regulatory details). The person having overall responsibility for the project (identified on the QHP notification) must ensure that no material is marketed or allowed to enter the food or animal feed chain.

QHP field trial best practice

Field trials performed under a QHP notification should follow due diligence to ensure that material does not enter the food and animal feed chain.

In practice, trial sites should be managed to reduce the chances of QHP material being transferred outside of the confines of the field trial or persisting at sites where commercial cultivation could take place in following seasons.

Mechanisms for dispersal include cross-pollination with sexually compatible species and machinery movement. Persistence at the site may occur in some species through seed or vegetative material.

Isolation distances and pollen barriers

Notifiers should consider how isolated the location of the field trial is and whether there will be any sexually compatible crops growing nearby which flower in the same period. This will determine the level of precautions that need to be taken to prevent cross-pollination and will vary between different plant species. Precautions could include isolation distances and/or pollen barriers.

Crop specific guidance on isolation distances can be found in:

Post-trial management

Some species can persist in the soil after a field trial is complete as volunteers or groundkeepers. The length of time that these can persist varies between plant species and will determine how long post-trial monitoring should be carried out for.

The management of the site can also affect how long reproductive material from some species can persist. For example, deep ploughing can enable oilseed rape seed to persist in the soil’s seedbank. Alternatively, shallow tilling, either post-harvest or early in the subsequent growing season(s), can maintain seed near the soil surface, where it can be encouraged to germinate and the resulting seedlings destroyed. This practice is recommended if the site is likely to be used for commercial production of the same crop in future seasons.

Any volunteers or groundkeepers should be removed and destroyed. Sexually compatible crops should not be grown on the field trial site until volunteer plants or groundkeepers have stopped appearing.

Additional measures

Standard machinery cleaning practices should be carried out to remove and collect residual plant material on any machine used during the trialling process. Measures should be taken to prevent wildlife from removing plant material from the field trial site, that are proportionate to the risk of this happening.

Emergency procedures

Emergency procedures should be in place for vandalism, trespass or other criminal acts, and also possible remedial actions if the QHP status is revised. Procedures should also be in place for extreme weather events or natural disasters that lead to the spread of plant material.

Glossary of terms

Marketing

The Environmental Protection Act 1990 (s.107, ss.11) (as amended), states that: “Genetically modified organisms of any description are “marketed” by a person when products consisting of or including such organisms are placed on the market by being made available to other persons, whether or not for consideration.”

PCR

Polymerase chain reaction. PCR is a lab technique to make many copies of a specific DNA region. It has many applications and is often used to detect the presence of trans-genes when determining if something is a GMO.

Volunteer

A plant that grows on its own, rather than being deliberately planted by a farmer or gardener. 

Groundkeeper

An undesired plant arising from self-sown seed or from tubers in a planting of a desired species or variety.

Pollen barrier

Rows of non-GM plants that trap pollen from the QHP trial.