Research and analysis

Consent to release genetically modified organisms: reference 22/R29/01

Updated 7 July 2022

1. Consent to release GMOs (22/R29/01)

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 The Sainsbury Laboratory 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.

(01 June 2022)

2. Genetically Modified Organisms to be released

The genetically modified organisms (GMOs) are potatoes (Solanum tuberosum L. - including but not limited to cultivars Maris Piper and Charlotte) transformed with one or a combination of the following genes:

• Rpi-vnt1.1 from Solanum venturii
• Rpi-amr3 from Solanum Americanum (both domesticated and non-domesticated)
• Rpi-amr1 from Solanum Americanum (both domesticated and non-domesticated)
• Rysto from Solanum stoloniferum
• p-Agp promoter from Solanum tuberosum
• sense and anti-sense fragments of Ppo from Solanum tuberosum
• sense and anti-sense fragments of Vlnv from Solanum tuberosum
• spacer sequence between sense and antisense fragments from Solanum tuberosum
• p-Gbss promoter from Solanum tuberosum
• NRC6 from Solanum lycopersicum
• hero from Solanum lycopersicum
• the CSR allele of ALS from Solanum lycopersicum
• NptII and p-bla promoter from Escherichia coli
• Isopentenyl transferase (ipt) gene from Agrobacterium tumefaciens
• extra Ti plasmid left border sequence from Agrobacterium tumefaciens
• dummy and end-linker sequences of synthetic origin

3. Particulars of the consent to release

(a) Maximum size of the release

1. May include either one or both of the two trial sites (specified in paragraph 3(c) of this letter of consent).
2. A total of no more than 10,000 GMOs shall be planted across all years and both of the trial sites, and such plants must be planted in accordance with the limitations and conditions of this consent.

(b) Purpose of the release

To test field performance of the novel potato plants.

(c) Locations of the release (‘trial sites’)

The release may be conducted at two locations: (i) The Sainsbury Laboratory, Dorothea de Winton field station, JIC (Ordnance Survey map grid reference TG 1509) and (ii) NIAB’s trial site, Cambridge (Ordnance Survey map grid reference TL 4362).

(d) Dates of the release period

The release (the planting of the GMO to harvest) may only take place between 2 June and 30 November in 2022, and between 1 April and 30 November in 2023, 2024, 2025 and 2026.

4. Consent granted by Jo Churchill, MP

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)

Schedule to the letter of consent to release genetically modified organisms, reference 22/R29/01

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

• “GMOs” mean the genetically modified organisms set out in paragraph 2 of the letter of consent
• “plot” means the area comprising the GMOs and any guard rows or surrounding pollen barrier
• “groundkeeper” means potato tubers and plants growing from potato tubers 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 GMOs which is subject to these limitations and conditions and “consent” in this schedule shall be construed accordingly
• “release” means planting the GMOs within the boundaries of the trial sites during the release period
• “release period” means the period specified in paragraph 3(d) 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 GMOs until the termination of the trial
• “trial sites” means areas of land to be used for the trial in each year of the trial, as more particularly described in Condition 4 and situated at the locations set out in paragraph 3(c) of the letter of consent
• “trial” means the release of the GMOs and management of that release in accordance with the limitations and conditions of this consent
• “true potato seed” means seed resulting from fertilised potato flowers
• “volunteer” means potato plants growing from true potato seed

General conditions of this consent

Condition 1

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

• subject to the express conditions below, comply with the relevant implied conditions specified in section 112 of the Environmental Protection Act 1990
• restrict human access to the trial site(s) 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 sites on request

Condition 2

The holder of the consent must apply to the Secretary of State in writing for any variation to the consent and obtain agreement for this variation prior to sowing of 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:

• the total number of 10,000 GM plants is not exceeded across both sites and all years
• an area of at least 20 metres width surrounding each of the trial sites must be free from potatoes during the period between the planting and harvest of the GMOs

Condition 5

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

• the six-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 potatoes to be planted, including the name(s) of the background cultivar(s)

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 sites

Condition 6

The consent holder must:

1. Harvest the trial, and (if seed set may have occurred) remove potato tops from the trial site, as soon as practical after research results have been obtained in order to minimise the maturation and shedding of true potato seed.
2. Remove, as far as is practically achievable, all tubers and, if seed set may have occurred, potato tops (above ground green parts) from the trial sites before the 30th November in each year of the release period and transfer them for contained use or disposal in accordance with condition 7.
3. Harvest potato tubers according to good agricultural practice to avoid groundkeepers and volunteers.
4. Ensure that all equipment used for planting and harvesting of potatoes within the trial sites is cleaned thoroughly before leaving the trial sites.
5. Ensure that all personnel leaving the trial site take appropriate steps to minimise the possibility of transfer of GMOs from the trial site via foot ware, clothing and vehicles and equipment.
6. In the two years following harvest of the GMOs from each plot, leave the plots fallow and refrain from ploughing the land. Shallow tillage should be used at least annually to stimulate germination of any true potato seed which has been shed.
7. Treat all potato groundkeepers and volunteers during the period referred to in condition 6(6) with an application of an appropriate herbicide and/or remove and transfer from the trial sites prior to flowering and in accordance with condition 7. In subsequent years all tubers must be removed from the sites prior to flowering to control groundkeepers and volunteers.
8. During the post-harvest monitoring period referred to in condition 8(2) but after the two years in which the trial site has been left fallow in accordance with condition 6(6), refrain from cultivating potatoes or any plant species in which volunteers are difficult to identify or control.

These conditions apply to all potato plants planted at the trial sites, including non-GMOs.

Material removed from the trial sites

Condition 7

The consent holder must ensure that all potato plant material removed from the trial sites under condition 6 is placed in sealed, labelled bags or containers for transfer to conditions under which the Genetically Modified Organisms (Contained Use) Regulations 2014 (SI 2014/1663), as amended, apply or to an authorised waste disposal facility for disposal by deep burial, autoclaving or incineration.

Monitoring

Condition 8

The consent holder must:

1. Inspect the trial sites during the period of cultivation of GMOs at least once per calendar month to ensure that the limitations and conditions of this consent are being met.
2. Following harvesting of potatoes on individual plots within the trial sites, inspect these plots at least once per calendar month from March to November for 4 consecutive years.
3. Maintain raw data and reports of inspections of potato groundkeepers and volunteers and provide this information to the Secretary of State on request and certainly within two weeks of receiving the request.

Reports

Condition 9

Two months after the date of harvesting potatoes in the first year of the trial the holder of the consent must 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), (the first report).

The first report 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 GMOs
• whether the trial 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, the consent holder must submit reports in the format specified in the Annex to Decision 2003/701/EC to the Secretary of State by December 31st in each of the years following submission of the first report in accordance with condition 9. These reports must include the following information:

• an assessment of the effectiveness of measures to control potato groundkeepers and volunteers, including details of the total number of potato groundkeepers/volunteers detected each month at each of the trial sites
• the re-evaluation of monitoring requirements, including whether or not the consent holder proposes to continue monitoring on individual plots for more than 4 years and the reasons for this decision
• any additional precautions considered necessary to minimise the dispersal of the GMOs outside of the trial sites

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 to the termination of the release.

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 approval as soon as practicable and in any event within forty-eight hours of the matter constituting the emergency, detailing any continued or further action that he proposes to take to restrict the dispersal of the GMOs from the trial sites

Condition 13

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

Condition 14

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

Note

The Environmental Protection Act 1990 also requires the consent holder to comply with implied general conditions for consents to release GMO 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.