Research and analysis

Consent to release genetically modified organisms: reference 21/R54/01

Updated 20 April 2022

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This publication is available at https://www.gov.uk/government/publications/genetically-modified-organisms-cambridge-university-crop-science-centre-21r5401/consent-to-release-genetically-modified-organisms-reference-21r5401

In accordance with section 111 of the Environmental Protection Act 1990, the Secretary of State for Environment, Food and Rural Affairs hereby grants consent to Cambridge University Crop Science Centre to perform the release of the genetically modified organisms described in paragraph 2, in accordance with the particulars set out in paragraph 3, and subject to the limitations and conditions set out in the schedule to the letter of consent.

Genetically modified organism (GMO) to be released

The genetically modified organisms (GMOs) are Barley Hordeum vulgare plants, based on the cultivar Golden Promise. They have been both gene edited and genetically modified with respect to symbiosis pathways involved in the perception of arbuscular mycorrhizal fungi (AMF).

The lines planned for release are as detailed in the consent application (reference 21/R54/01 form part A1) but briefly will include lines that have been independently gene-edited in one of the 6 genes involved in perception of AMF. The release will also involve further lines that have been genetically modified via the introduction of T-DNA containing one of the afore-mentioned 6 genes.

The area sown with the genetically modified (GM) barley must not exceed 2,500 square metres each year. It may take the form of one or more plots within the trial site.

Purpose of the release

To investigate the impacts of arbuscular mycorrhizal fungi inoculation on biomass and yield of genetically modified barley lines that have been modified with respect to symbiosis pathways, in the field.

Locations of the release (trial sites)

The release must be conducted at the following experimental farm sites:

  • Park Farm (National Grid Reference TL 42 61)
  • Barkers Top (Duxford) (National Grid Reference TL 46 43)
  • Noon Folly (National Grid Reference TL 38 64)

These sites are operated by the National Institute of Agricultural Botany (NIAB) Cambridge regional trials centre, Cambridgeshire.

Dates of the release period

The release (the planting of the GMO) may only take place between 18 March 2022 and 31 December 2026.

Before granting this consent, I have:

  • taken advice from the Advisory Committee on Releases to the Environment and Natural England
  • agreed the terms, limitations and conditions of this consent with the Food Standards Agency and, insofar as they relate to the protection of human health and safety, with the Health and Safety Executive.

Signed, Jo Churchill, Parliamentary Under Secretary of State (Minister for Agri-Innovation and Climate Adaptation)

References in the letter of consent and in this schedule to:

  • “GMO” means the genetically modified organism set out in paragraph 2 of the letter of consent
  • “plot” means the area comprising the GMOs and the surrounding pollen barrier
  • “volunteer” means plants growing from seed remaining in the soil after harvest
  • “holder of the consent” means the party named in paragraph 1 of the letter of consent or such other or additional party who has been approved by the Secretary of State
  • “letter of consent” means the letter granting consent to release the GMO which is subject to these limitations and conditions and “consent” in this schedule shall be construed accordingly
  • “release” means planting the GMO within the boundaries of the trial site during the release period
  • “release period” means the period specified in paragraph 3(c) of the letter of consent
  • “termination of the trial” means the completion of the trial period as more particularly described in condition 11
  • “trial period” means the period from the first release of the GMO until the termination of the trial
  • “trial site” means the area of land to be used for the trial as more particularly described in paragraph 3 of the letter of consent and condition 4, and situated at the location set out in paragraph 3(b) of the letter of consent
  • “trial” means the release of the GMO and management of that release in accordance with the limitations and conditions of this consent

Condition 1

The holder of the consent must, during the trial period:

  • restrict human access to the trial site to named personnel who are familiar with the limitations and conditions of the consent, or those escorted by named personnel
  • allow the GM Inspectorate access to the trial site on request

Condition 2

The holder of the consent must:

  • apply to the Secretary of State in writing for any variation to the consent
  • obtain agreement for this variation before sowing the GMOs in any year during the release period

Condition 3

Where the holder of the consent enters into any agreement with a person or persons who will perform the whole or any part of the trial on the holder’s behalf, then:

  • such an agreement must be in writing and it must be in keeping with the limitations and conditions of this consent as may be varied by the Secretary of State from time to time in accordance with article 111(10) of the Environmental Protection Act 1990 and regulation 22 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002
  • the release of the GMOs must not take place until that agreement or variation of that agreement has received the written approval of the Secretary of State

Size and description of the trial sites

Condition 4

The consent holder must ensure that:

  • in each year of the trial the plot or plots are as described in paragraph 3 of the letter of consent
  • a barley pollen barrier of at least 3 metres width surrounding the GMOs at a distance of up to 1 metre from the GMOs, is sown on the same day as the GMOs, at the same sowing density as the GMOs, with the variety Golden Promise within the perimeter of the plot
  • during the release period, cereals (other than those cultivated as part of this consent) are not grown in an area of at least 20 metres width surrounding the perimeter of the plot on which the GMOs are planted and that if this area is cropped, it is cropped with a non-cereal crop

Condition 5

At least one week before the GMOs are sown, the consent holder must provide to the Secretary of State:

  • the 6-figure grid reference(s) of the plot(s) within the trial site
  • a plan showing the location of the trial site
  • details of the GM barley to be planted

Any deviation from the plan referred to in sub-paragraph (2) must be notified to the Secretary of State in writing as soon as practicable and in any event before planting of the GMO takes place.

Management of the site

Condition 6

The consent holder must:

  • ensure that suitable measures are in place to keep birds out of the plots during and after sowing and at the first signs of emergence of barley ears
  • control other cereals or grasses before flowering within the plot on which the GMOs are planted and surrounding area of at least 20 metres width referred to in condition 4(3) (“the 20 m border”), either by hand pulling or application of a glyphosate herbicide between 1 May and 30 September in each year of the trial
  • as far as is practicable, harvest non-GM barley grain after harvesting GM barley grain on each plot, and clean the combine on the plot from which the material is harvested after each plot is harvested but before the next plot is harvested
  • clean all machinery (including wheels and tyres) used on the trial site thoroughly and over plastic sheeting on the trial site before leaving the trial site
  • ensure that all personnel entering the trial site take appropriate steps to minimise transfer of GMOs via clothing and vehicles from the trial site
  • ensure that all material (including straw) dislodged during cleaning is removed from the trial site on the same day and ensure that it is transferred for contained use or stored securely whilst awaiting disposal in accordance with condition 7
  • when GM and non-GM grain is harvested on a plot, on the same day remove this material from the trial site or store securely on-farm, and in the autumn of the same year, lightly till that plot to a depth of approximately 5 cm (the area should be left fallow over the following winter and lightly tilled to a depth of approximately 5cm in the spring)
  • when GM and non-GM grain is harvested on a plot, following the harvest, inspect that plot and the 20 metres border for volunteers at least once per calendar week until the end of November of the relevant year and then once per calendar month from 1 March until 31 August in the following 2 years (record the number of volunteers detected in each calendar month (approximately if necessary) before they are controlled in accordance with condition 6(9)(b))
  • for the 2 years following harvest of the GM and non-GM grain from a plot within the trial site, leave the plot fallow and treat all volunteers on the plot and the 20 metre border, including volunteers from non-GMOs, with an application of glyphosate herbicide or by hand-pulling before inflorescence forms
  • not cultivate cereal crops intended to enter the food or feed chain on the trial site until monitoring of the plots for volunteers has ended

Material removed from the trial site

Condition 7

The consent holder must ensure that all harvested grain and material collected during cleaning of machinery removed from the trial site under condition 6 is either:

  • placed in sealed, labelled bags or containers for transfer, to conditions under the Genetically Modified (Contained Use) Regulations 2014 (SI 2014/1663), as amended
  • sent to an authorised waste disposal facility for disposal by deep burial or incineration

General monitoring requirements

Condition 8

The consent holder must:

  • inspect the entire trial site and the 20 metre border during the period of cultivation of GMOs at least once a week, and if it is observed that the limitations and conditions of this consent have not been met, inform the GM Inspectorate and the Secretary of State immediately
  • maintain raw data and reports of inspections and provide this information to the Secretary of State on request

Reports

Condition 9

The holder of the consent must, within 2 months of harvesting or terminating the GMOs on a plot within the trial site, submit a report to the Secretary of State in the format outlined in the Annex to Commission Decision 2003/701/EC (O.J. L254, 08/10/2003, p.21).

Such report or reports must also include the following information:

  • an assessment of any risks or actual or potential adverse effects to human health or the environment from the GMO
  • whether the release on that particular plot progressed as planned and if it did not:
    • what occurred
    • any additional measures that were taken
    • any additional measures that will be taken
    • why these measures were taken

Condition 10

Subject to condition 11, each year the consent holder must submit a report in the format specified in the Annex to Decision 2003/701/EC to the Secretary of State within 2 calendar months of the post-trial monitoring being concluded. This report must include the following information:

  • an assessment of the effectiveness of measures to control volunteers, including details of the number of volunteers detected each month in the trial site and the 20 metre borders
  • the re-evaluation of monitoring requirements, including whether the consent holder proposes to continue monitoring and the reasons for this decision
  • any additional precautions considered necessary to minimise the dispersal of the GMO outside of the trial site

Condition 11

The consent holder must continue to submit the reports referred to in condition 10 until the Secretary of State has agreed in writing that the trial site (and, where appropriate, the 20m borders) have been controlled in accordance with conditions 6(9)(b) and 6(10), and that the trial is therefore terminated.

Emergency action

Condition 12

In the event of an emergency, the consent holder must:

  • take immediate and appropriate preventative and remedial action
  • notify the Secretary of State of the emergency as soon as practicable and in any event within 36 hours of the matter constituting the emergency, detailing the nature of the emergency and any action that has been taken
  • submit a plan to the Secretary of State for their approval as soon as practicable and in any event within 48 hours of the matter constituting the emergency, detailing any continued or further action that they propose to take to restrict the dispersal of the GMO from the trial site

Condition 13

For the purposes of condition 12, an emergency includes vandalism or any other unauthorised interference with the trial site.

Condition 14

None of the provisions of condition 12 shall prevent the Secretary of State from taking such action as they reasonably believe is necessary to prevent, reduce or remedy any risk of harm to human health or of damage to the environment.

The Environmental Protection Act 1990 also requires the consent holder to comply with implied general conditions for consents to release GMOs as set out in section 112(5) and section 112(7) of that Act. These implied conditions have effect subject to the conditions imposed above.

If you would like a copy of the official document please email gm-regulation@defra.gov.uk

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