Research and analysis

Annual report on GMO inspection and enforcement activities in England 2019

Updated 7 July 2023

Applies to England

Overview

This report provides a summary of the activities of the Genetic Modification Inspectorate for England (GMI) from 1 April 2018 to 31 March 2019. The work of the GMI covers three main areas:

1. Auditing of holders of consents for the deliberate release of genetically modified organisms (GMOs) to ensure that their systems are appropriate for meeting the conditions laid down in each consent, and inspection of deliberate release sites to ensure compliance with the consent conditions.
2. Auditing of producers and importers of seed of at-risk species to assist those companies in appropriately managing the risk of adventitious (accidental or technically unavoidable) GM presence (AGMP) in their seed.
3. Investigation of suspected releases or marketing of unauthorised GMOs (including plants and animals, but excluding clinical trials of genetically modified micro-organisms).

The work of the Inspectorate is carried out on behalf of two Defra policy areas (the Genetic Resources and GM Policy Team, and the Plant Varieties and Seeds Policy Team) to ensure compliance with the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (as amended) and the Environmental Protection Act 1990 (as amended).

Deliberate releases of GMOs

The GMI’s field inspection programme is designed to ensure that GMO deliberate release trials remain consistent with the limitations and conditions of their respective consents, and to make sure any potential risks to human health or the environment are kept to a minimum. To achieve this the GMI undertakes management audits of the systems consent holders have in place to manage their releases, and also conducts field inspection visits to ensure these systems are properly implemented in situ. Further information on the field inspection programme can be found at Genetic Modification Inspectorate: deliberate release inspection programme.

During the period of this report: one new deliberate release consent, covering two sites, was granted by the Secretary of State; experimental trials were sown under one further consent, on a single site; and four consents, covering seven sites, were in the post-trial management and monitoring phase of the release. A summary of the audits and inspections undertaken in connection with consents for deliberate release is given in Table 1.

Table 1. Audits and inspections of current consents and deliberate release sites

Audit or inspection type	Number of audits or inspections
Management audits of active releases (new consents and existing consents still being sown)	2
Management audits of consents under post-trial monitoring	3
Growing crop inspections	3
Post-trial monitoring inspections	7

Completed growing-season field inspection reports can be found on GOV.UK.

Seed audit programme

Currently the UK does not grow any GM crops commercially, however, there are large areas of the world where such crops are cultivated on a commercial basis, and where GM crop trials are conducted. There is therefore the potential for non-GM seed to include the accidental (adventitious) presence of GMOs, either through cross-pollination or due to seed admixture. These GMOs may not have been approved for cultivation in the UK and companies who import or produce seed of at-risk species (or those who both import and produce) must have appropriate controls in place to minimise the risk of adventitious GM presence (AGMP) in their seed.

To help companies comply with the appropriate legislation, the GMI undertakes an audit programme of companies that import or produce non-GM seed (conventional and organic seed) for cultivation in England.

Seed of crop species that are deemed at sufficient risk of AGMP to merit auditing are determined using quantitative risk assessment modelling. For 2018 to 2019 the species most at risk were identified as:

• Brassica napus (including winter and spring oilseed rape, swede)

• Brassica rapa (including turnip, turnip fodder rape, stubble turnips, pak choi)

• Glycine max (soya)

• Zea mays (maize, including sweetcorn)

The Inspectorate undertakes three types of audit of importers and producers of commercial seed and private trials:

• detailed audits, involving a thorough review of the companies AGMP-management protocols
• basic audits, involving a telephone-based assessment of the company’s practices to determine whether there has been any significant change since the last detailed audit
• targeted audits, carried out when there is considered to be a requirement for further clarification or investigation regarding AGMP risk in a company’s seed, but the company is not scheduled for a detailed audit

Detailed audits are scheduled to take place with each company every three years, with basic audits being undertaken in the intervening years. Targeted audits are undertaken on an ad hoc basis in agreement with the Defra Plant Variety and Seeds (PVS) Policy Team.

As there are currently no thresholds for unauthorised GMOs in conventional seed and there are no statutory rules on how AGMP risk in seed should be managed, participation in the GMI seed audit programme is voluntary. Seed companies are invited to participate in the audit programme as a way of ensuring they are effectively managing the risks of AGMP in their seed.

A summary of the audits undertaken during the period of this report is given in Table 2.

Table 2. Audits of importers and producers of commercial seed

Audit type	Number undertaken or recorded
Detailed audits	7
Basic audits	21
Targeted audits	1
Companies declining to participate or failing to respond in reasonable time	5
Companies declaring no crops of interest	13

The GMI also makes an assessment of the AGMP risk management in place for seeds of relevant crops submitted for official trials for variety listing. In most cases this involves confirming that such seeds are included in the routine audits of companies applying for inclusion in trials. On occasions, where this cannot be confirmed, or where applicants are not part of the GMI’s routine seed audit programme, the GMI undertakes reviews of applicants’ AGMP management protocols through a telephone interview and requests for supporting evidence. In cases where satisfactory evidence of appropriate management of AGMP cannot be obtained, applicants may, with the agreement of the Defra PVS Policy Team, be excluded from entering official trials for national listing of varieties until such evidence is provided.

A summary of the assessments relating to this work is given in Table 3.

Table 3. Audits of applicants submitting applications for national listing trials

Crop	Number of routine assessments	Number of assessments requiring follow-up interviews with the applicant(s)	Totals
Maize	6	2	8
Winter oilseed rape	12	2	14
Other*	2	1	3

*Combined data for trials of minor crops (just spring oilseed rape in 2018 to 19)

In 2018 to 2019 no applicants were excluded from official variety listing trials in relation to their management of AGMP.

Further information on the seed audit programme can be found at: Genetic Modification Inspectorate: seed audit programme.

Incidents and investigations

Incidents relating to consents for deliberate release of GMOs

Technical breach of consent

As part of a routine post-trial inspection of a trial site it was noted that a small number of wheat volunteers had progressed to the ear formation stage, before being killed by herbicide application. A condition of the consent required that, during the two years following harvest, the consent holder must treat all volunteers on the plot and within a 20-metre border (including non-GMO volunteers) with an application of glyphosate herbicide, or control by hand-pulling prior to inflorescence formation. The site manager stated that herbicide application had been scheduled, but had been delayed due to unfavourable conditions. Whilst it was not clear whether any of the observed volunteer wheat plants had reached the flowering stage, the fact that there were no wheat plants or wild relatives in the vicinity of the trial site (plus the fact that wheat is predominately self-pollinating) meant that there was no likelihood of pollination with non-GM plants. Also, because none of the ears had reached maturity, there was no possibility of seed having returned to the soil and therefore no increased likelihood of GM plants persisting at the site.

Following dialogue between the GMI and the consent holder, the consent holder confirmed that they had put additional management safeguards in place to minimise the likelihood of any similar occurrence in future. The GMI was content that these additional safeguards were appropriate to ensure that in future years all wheat volunteers are controlled in a timely manner and that there were no risks to human health or the environment posed by the genetically modified organism.

Incidents relating to AGMP or suspected AGMP in conventional seed for marketing or trials

GT73 detected in oilseed rape seed in France and Germany

In November 2018 the European Commission alerted the UK competent authority that they had been notified by the French authorities of the detection of trace amounts of GM oilseed rape event GT73 in several lots of an oilseed rape variety.

Following contact by the GMI, the European and UK distributor of the variety confirmed that they had not supplied any of the seed lots in question to the UK. The GMI also confirmed that none of the affected lots had appeared in audits it had undertaken on seed imported to the UK. It was concluded that there was no issue for the UK. The seed had been sown on around 8,000 hectares in France and 2,500 to 3,000 hectares in Germany and the emerging crops had to be destroyed.

Other incidents involving suspected unauthorised GMOs

Suspected GM petunias at a wholesale nursery in England

In April 2018 a member of the APHA Plant Health and Seeds Inspectorate (PHSI) reported to the GMI that they had seen petunias growing at a nursery in England with labels showing orange flowers (the plants themselves were not yet in flower). The Inspector’s concern was that the plants were genetically modified. The PHSI inspector sent the GMI a number of pictures, taken at the nursery, of trays of plants and labels showing orange flowers. One of the varieties was on the EU list of reported GM varieties.

The GMI contacted the breeder who replied that they quite often have one variety name on the front of a label and another on the reverse and that they would look into this case. The breeder subsequently confirmed that they had supplied a non-GM variety to the nursery, but with labels that detailed a known (withdrawn) GM variety on the reverse, and provided evidence that the labels did indeed have different variety names on each side. They also provided assurance that, following the worldwide incident with GM petunias in 2017 and 2018, all of the GM lines had been removed from their stocks and they were certain this was a labelling issue and not a GM issue.

The GMI and the Defra competent authority accepted the breeder’s explanation and no further action was necessary.

The GMI provided PHSI senior staff with an update on GM petunias reiterating that not all orange petunias are genetically modified and stating the action that has been taken by the industry to remove GM lines from breeders’ stocks. The update also noted that the GMI was still interested in hearing of cases where a PHSI inspector suspected that GM petunias were being marketed. The update was cascaded across the PHSI.

GM ornamental fish

On 21 August 2018 the Cefas Fish health Inspectorate (FHI) notified the GMI that an aquarists’ shop in West Yorkshire had contacted them to say they had received a shipment including fish they thought might be genetically modified. The shipment came from a European supplier. The shop in question provided the FHI with pictures of the fish and on the strength of this evidence the FHI decided they were probably genetically modified. The FHI reminded the shop keeper that marketing unauthorised GM fish is illegal and advised them to remove the suspect fish from sale pending further investigation.

The GMI visited the premises on 24 August 2018 with a member of Fera Science Limited’s scientific staff to assess the fish using the newly developed dark box and ultraviolet (UV) light apparatus (described in the next section, ‘Other activities in support of Defra policy on regulation of GMOs’). The GMI were able to clearly show the shop’s owner the fluorescence of the suspect fish compared with no fluorescence in wild type conspecifics. On the strength of this evidence, the shop owner agreed that the fish were genetically modified (without recourse to genetic testing) and the fish in question were permanently removed from sale.

As the fish were imported from the Czech Republic, the GMI intends to discuss the matter with the GM Policy Team with a view to reminding the Czech supplier and breeder of their legal obligations regarding GM fish.

Other activities in support of Defra policy on regulation of GMOs

The GMI presented a paper at the annual meeting of the European Enforcement Project on Contained Use and Deliberate Release of Genetically Modified Organisms.

During 2018, as part of routine updates to AGMP risk assessments on behalf of the PVS Policy Team, the GMI undertook two fact-finding exercises on imports of sugar beet and creeping bentgrass seed. Such assessments are carried out on an ad hoc basis to underpin outputs from the GMI’s quantitative risk assessment (QRA) models for AGMP in seed. The exercises involved guiding key importers of the two crops through questionnaires similar to those used for detailed audits of the most at-risk species, as outlined above. For both species it was agreed with the PVS team that trade had not altered significantly since the last assessment, that the risks of AGMP were consistent with the outputs of the GMI’s QRA models, and that no further action was necessary.

In collaboration with Fera Science Limited, the GMI developed a rapid assessment tool for determining the status of suspected GM fluorescent fish. The apparatus is designed to standardise visual assessment of suspect fish and provide a more objective basis for determining GM status than would be possible under current protocols. It consists of: a ‘dark box’ to exclude extraneous light; a single-wavelength 6w UV light source (l = 365nm, optimised to excite known fluorescent proteins used in GM fish); and a UV graduated scale, which provides comparators to determine the intensity of fluorescence in test samples. Unlike genetic testing, the test can be carried out at border inspection points on live samples (in their shipping bags). Should fish be shown to fluoresce the importer or retailer would have the option to voluntarily remove them from sale, surrender them, or ask for confirmatory genetic testing.

Contacting the GMI

The GMI is located at the York Biotech Campus:

Genetic Modification Inspectorate
Animal & Plant Health Agency (APHA)
Room 11G03
Sand Hutton
York
YO41 1LZ
UK

Email: [email protected]

Further information on the GM Inspectorate and its activities can be found at: Guidance and reports on GM inspections.