Research and analysis

Annual report on GMO inspection and enforcement activities in England 2018

Updated 7 July 2023

Applies to England

Executive summary

The work of the Genetic Modification Inspectorate for England (GMI) covers 3 main areas:

• 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
• 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) genetically modified presence (AGMP) in their seed
• investigation of suspected releases or marketing of unauthorised GMOs (including plants and animals, but excluding clinical trials of genetically modified microorganisms)

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. More information about the field inspection programme.

During the period of this report:

• 1 new deliberate release consent was granted by the Secretary of State
• experimental trials were sown under a further 2 consents
• 3 consents were in the post-trial management and monitoring phase of the release (this includes 1 consent where there was also an active 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/inspection type	Number of audits/inspections
Management audits of active releases (new consents and existing consents still being sown)	4
Management audits of consents under post-trial monitoring	4
Growing crop inspections	3
Post-trial monitoring inspections	6

Completed growing-season field inspection reports.

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. Therefore there is 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 importing and/or producing seed of at-risk species 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 and/or produce non-GM seed (i.e. 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 2017/18 the species most at-risk were identified as:

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

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

• Glycine max (soya)

• Zea mays (maize, including sweetcorn)

The Inspectorate undertakes 3 types of audit of importers or 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 3 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 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/recorded
Detailed audits	5
Basic audits	12
Targeted audits	0
Companies declining to participate or failing to respond in reasonable time	8
Companies declaring no crops of interest	5

The GMI also makes an assessment of the AGMP risk management in place for seeds of relevant crops submitted for official variety trials. 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 Plant Variety and Seeds policy team, be excluded from entering official trials until such evidence is provided.

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

Table 3: Audits of applicants to enter official trials

Crop	Number of routine assessments	Number of assessments requiring follow-up interviews with the applicant(s)	Total
Maize	5	1	6
Winter oilseed rape	10	1	11
Other*	2	0	2

From 2017 to 2018 no applicants were excluded from official variety trials in relation to their management of AGMP.

Find out more about the seed audit programme.

Incidents and investigations

Incidents relating to consents for deliberate release of GMOs

Technical breach of consent: as part of a routine inspection by the GMI a consent holder reported that a harvester had been cleaned over a pollen barrier, rather than on the most recently harvested experimental plot as required under the conditions of the consent for release.

The GMI agreed with Defra that this a was a ‘technical breach’ - although the exact letter of the consent had not been followed there was no risk to human or animal health or the environment (as the area of the pollen barrier must monitored as part of the requirement to monitor the experimental plot and the trial site in general, in the proceeding years).

The GMI reiterated to the consent holder the importance of strictly following the consent conditions and directed them to treat the area in question as though it were part of the experimental plot with regard to further requirements of the consent relating to tillage and post-trial monitoring.

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

Suspected AGMP in winter oilseed rape seed: following an alert from another EU Member State, the GMI investigated the suspected presence of adventitious GMOs in a certified seed lot of winter oilseed rape, some of which had been sold in the UK. Following extensive testing and a thorough investigation of the provenance of the seed, the GMI was unable to confirm the presence of an unauthorised GMO or determine the likely source of such a presence if it existed.

Other incidents involving suspected unauthorised GMOs

GM Petunias: following an alert from the authorities in Finland, via the European Commission, the GMI confirmed the presence in the UK of a number of varieties of petunia that had been inadvertently produced from genetically modified stock. The GM trait, derived from maize genes, produced an orange pigment in the petunia flowers. The trait was not considered toxic, petunias are not used in food or feed and are not persistent or invasive in the UK environment, hence there was no identifiable risk to human/animal health or the environment. Nevertheless, it is illegal to market or release unauthorised GMOs and the GMI worked with Defra, the Plant Health and Seeds Inspectorate and the ornamental flower industry to ensure GM plants were withdrawn from sale. Ultimately more than 100 varieties of petunia were affected globally.

GM fish: a consignment of fish labelled ‘transgenic zebra danios’ was surrendered to APHA border inspection staff at the Manchester Airport Border Inspection Post by the importer. The GMI was satisfied there was no intention to import unauthorised GM fish and that the inclusion of such fish was due to an order substitution by the South Asian supplier. The GMI wrote a formal letter to the importer for them to pass onto their overseas supplier reminding them of the legal situation regarding the sale of GMOs in the UK. GM fish: a member of the public informed the Centre for Environment, Fisheries and Aquaculture Science (Cefas) Fish Health Inspectorate (FHI) that they had seen what they suspected were genetically modified fluorescent ornamental fish on sale in an aquarist retail outlet near Wrexham.

The FHI inspected the fish and given their appearance, including fluorescing under ultra-violet light, it was concluded that they were genetically modified and the fish were surrendered. Subsequently, the FHI also visited the wholesale supplier of the fish (based in northwest England) on behalf of the GMI, however, no suspect GM fish were found.

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.

The GMI presented an overview of its work to retail stakeholders at a ‘Multiples Day’ jointly hosted by Defra Plant Health Policy and APHA.

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
UK
YO41 1LZ

Telephone: 020 8026 2466

Email: gm-inspec@apha.gov.uk

More information about the GMI Inspectorate.