UK: Statement on the decision to issue – with strict conditions – emergency authorisation to use a product containing a neonicotinoid to treat sugar beet seed in 2021

In 2018 the government supported new rules which prohibit the outdoor use of 3 neonicotinoids - clothianidin, imidacloprid and thiamethoxam. In taking that position, the government made it clear that it could consider emergency authorisations (in accordance with the relevant legislation) in special circumstances where authorisation for limited and controlled use appears necessary because of a danger that cannot be contained by any other reasonable means and where the risk to people, animals and the environment, and in particular to bees and other pollinators, was considered acceptably low.

After careful consideration of all the issues, the government has decided to grant an application for emergency authorisation to allow use of a product containing the neonicotinoid thiamethoxam for the treatment of sugar beet seed in 2021. This is in recognition of the potential danger posed to the 2021 crop from beet yellows virus.

This note:

- outlines the legal requirements applying to the application

- explains the assessment made against each of the requirements

The process for assessment and decision-making

The advice of the Health and Safety Executive (HSE), the UK Expert Committee on Pesticides (ECP), and Defra’s Chief Scientific Adviser on the application was put to Defra Ministers. Based on the information provided, the Secretary of State considers the application meets the requirements for an emergency authorisation and has therefore decided that authorisation should be granted, subject to a number of conditions.

The requirements for emergency authorisation

An emergency authorisation for the short-term use of a product (and placing on the market for no more than 120 days) may be granted if the following requirements are met:

- the authorisation appears necessary because of a danger which cannot be contained by any other reasonable means (the case for need)

- use of the product will be limited and controlled

- there are special circumstances

Emergency authorisations are a derogation from the normal requirements of pesticide authorisation. However, if the above requirements are met then the benefit of granting an emergency authorisation must be balanced against the potential harm from the proposed use of the product, taking into account the proposed conditions. Therefore, the potential risks to people, animals and the environment remain a key part of the evidence that needs to be considered.

The first requirement: the case for need

The case for need for the product, which is that such a measure appears necessary because of a danger which cannot be contained by any other reasonable means, is considered to be met. The neonicotinoid seed treatment provides important protection to the emerging crop against insect pests and the viruses they can transmit. This protection cannot be provided by any other reasonable means. Sugar beet yields were significantly reduced in the 2020 season due to the incidence of virus, and similar conditions in 2021 would be likely to present similar dangers.

The second requirement: limited and controlled use

The Secretary of State considered that the requirement for use of the product to be limited and controlled is met. The applicant proposed a reduced application rate for the seed treatment to deliver less of the product to the soil. In addition, the applicant proposed use of a virus forecasting model to determine whether treatment is needed, setting a threshold for the level of virus infection above which economic impacts would be incurred. If this threshold is not met the seed will not be treated. Sugar beet cultivation in England is also spatially restricted by proximity to 1 of 4 beet processing factories situated in the east of England. All UK sugar beet is grown under commercial contracting arrangements, and this is considered to provide an effective mechanism for controlling the distribution and use of the treated seed. To address the requirement to control use, the applicant proposed a stewardship scheme which includes several measures to address risks to pollinating insects, underpinned by industry commercial contracting arrangements.

The third requirement: special circumstances

The term ‘special circumstances’ is not defined in the legislation. However, it is taken to mean that in addition to requirements for the case for need and limited and controlled use being met, the applicant has also taken action to ensure that emergency authorisation is not repeated indefinitely.

The applicant outlined a plan for developing alternative, sustainable approaches to protect crops without the use of neonicotinoid seed treatments. This includes the development of resistant plant varieties, measures to improve seed germination and new practices for growers. The plan is already being delivered. The plan is considered to provide a good basis to confirm that alternative, permanent solutions to neonicotinoid seed treatments for sugar beet are being sought as a matter of priority. The plan anticipates that applications for emergency authorisations for neonicotinoid seed treatments may be needed for three years (2021 to 2023). Any future applications will be fully assessed against the regulatory framework for emergency authorisations.

Risks to people and the environment

Risks to bees

Sugar beet is a non-flowering crop and the risks to bees from the sugar beet crop itself were assessed to be acceptable. The applicant recognised that risks could be posed to bees from flowering weeds in and around the crop and proposed to address this with the use of industry-recommended herbicide programmes to minimise the number of flowering weeds in treated sugar beet crops. This was considered to be acceptable. The applicant recognised that the persistence and mobility of neonicotinoids in soils could result in residues with the potential to cause unacceptable effects to bees in following crops. Measures were proposed to mitigate the identified risks through the exclusion of flowering crops in subsequent cultivations.

The Secretary of State is satisfied there is sufficient evidence to indicate that residues of thiamethoxam and its metabolite deteriorate over time, and that with mitigation measures in place the risks are considered to be acceptably low enough that the benefits outweigh them. Conditions are attached to the emergency authorisation to ensure that no flowering crops are planted as following crops for a period of at least 22 months, with an extended period of exclusion for oilseed rape (of 32 months), to minimise the risk to bees.

Other environmental risks

Since the product was first authorised in the UK, there have been a number of updates to the available data and the rules for carrying out some aspects of the environmental risk assessment. As is normal practice where emergency authorisations give rise to areas of potential concern, risk assessments to modern standards were prepared to inform the authorisation decision. Evaluation of this application found that potential risks to birds and mammals from eating seedlings from treated seed, and risks to aquatic invertebrates were acceptable. Risks to birds from consuming treated seeds were not demonstrated to be acceptable, but the consumption of pelleted seeds is considered an unlikely route of exposure.

Decision-making

The Secretary of State carefully considered all the evidence and analysis presented and considered whether each of the requirements for granting an emergency authorisation were met. He noted that aspects of the environmental risk assessment, and particularly the risk to bees, do not fully meet the normal requirements for standard authorisation. He concluded that in relation to the requirements for emergency authorisation the case for need has been met, that the use of the product would be limited and controlled, and that the potential benefit from the use of the product outweighs the environmental risks, which are considered to be acceptable in the circumstances, subject to the conditions below. He decided that the requirements for the emergency authorisation are therefore met and it should be granted subject to conditions being attached.

Authorisation and conditions attached

The authorisation is for the use of Syngenta’s Cruiser SB on sugar beet only and covers use in 2021 in England only. Conditions are attached to the emergency authorisation to ensure that, if the threshold for virus levels is reached and it becomes necessary to treat seeds, use of the product will be limited and controlled and any potential risks to pollinators will be mitigated to an acceptable level. In particular, the application rate of the product will be below the normal commercial rate; no flowering crop is to be planted within 22 months of the sugar beet crop, and no oilseed rape crop is to be planted within 32 months. Industry-recommended herbicide programmes will be followed to limit flowering weeds in and around sugar beet crops. The applicant will be required to limit the sowing rate of treated seeds to achieve no greater than the normal commercial plant population, and to develop and implement their proposed programme to monitor soils and plants following use of the treated seed.