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Statement of reasons for the decision on the application for emergency authorisation for the use of Cruiser SB on sugar beet crops in 2023 [1]
['The Requirements', 'Process For Emergency Authorisation', 'Fourth Test', 'Authorisation Is', 'Necessary', 'Because Of The Danger', 'Conditions To Be Attached To The Emergency Authorisation']
Date: 2023-01
Summary
In 2018 the government supported new rules which prohibit the outdoor use of three 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.
After careful consideration of all the issues, the government has decided to grant an application for emergency authorisation to allow the limited and controlled use of the product Cruiser SB, which contains the neonicotinoid thiamethoxam, for the treatment of sugar beet seed in 2023. This is in recognition of the potential danger posed to the 2023 crop from yellows virus ( YV ).
This note:
outlines the legal requirements applying to the application
explains the process followed
summarises the key evidence and the assessment made against each of the requirements (highlighting where the evidence or assessment is changed from 2022)
The decision
The Right Honourable Mark Spencer MP, Minister for Food, Farming and Fisheries, has considered an application from the National Farmers Union and British Sugar for emergency authorisation to use the product Cruiser SB on sugar beet crops in 2023 (‘the Application’). The product is a seed treatment which can protect the crop from yellows virus ( YV , a group of three damaging viruses) carried by aphids.
The Minister has considered the application in line with the relevant legal requirements for plant protection products and has decided that emergency authorisation should be granted subject to a number of strict conditions, designed to maximise the benefits and minimise the risks from use of the product.
The requirements and process for emergency authorisation
Emergency authorisation is established by Article 53 of Regulation (EC) No. 1107/2009 as retained in UK law (‘the Regulation’).
This allows the short-term emergency authorisation of plant protection product uses that are not otherwise permitted providing that, on the facts of the particular case, all of the following tests are met:
there must be a danger
there must be special circumstances which make it appropriate to derogate from the standard approach to authorisations
the danger must not be capable of being contained by any other reasonable means
an emergency authorisation must appear necessary because of that danger
an emergency authorisation may allow only limited and controlled use of the plant protection product
The emergency authorisation process provides an exemption from the standard plant protection product authorisation requirements under the Regulation. The decision-taker should still, however, take account of the overall objectives of the Regulation, including securing a high level of protection for human health, animal health and the environment while improving agricultural production.
Following the normal process for emergency authorisations, the Application was considered by the Health and Safety Executive ( HSE ), which sought advice from the UK Expert Committee on Pesticides ( ECP ) on specific scientific questions. Defra’s Chief Scientific Adviser ( CSA ) and Defra economists also provided advice.
The Minister considered the advice from the HSE , the ECP , the CSA , and Defra officials. In reaching his decision, the Minister considered whether each of the above tests for granting an emergency authorisation were met.
The Minister’s conclusions
First test: a danger
The Minister finds that this test is met.
In applying this test, the Minister considered the nature of the danger to be the threat posed by YV to sugar production at both the national and individual grower level. Sugar beet infected with YV can be reduced in size and can have a lower sugar content, and higher impurities. This leads to a lower overall yield of sugar beet and a reduced output of sugar.
YV presents a significant threat to sugar beet production in years with high levels of virus infection. The year 2020 illustrates the threat. In 2020 (a year in which no neonicotinoid seed treatments were used) 25% of the national sugar beet crop was lost, which resulted in approximately £67m of total economic loss across the industry.
However, in other years the threat from YV may not materialise to anything like the same extent. Indeed, the damage caused by YV in 2019 and 2021 (the other two recent years in which neonicotinoid seed treatments were not used) was far less than in 2020. In these years, YV did not turn out to be a significant problem at the national level although it may have been a real problem for some growers.
Another factor that varies year to year is the wider economic context, which influences the extent to which growers can cope with reduced margins on their sugar beet crop. Production costs have risen in recent times and this will tend to reduce profits.
To be effective, Cruiser SB needs to be applied as a seed treatment before the crop is planted and before any virus threat has materialised. The variability in YV incidence year-to-year therefore poses the risk that, if authorised, the seed treatment could be used when the threat posed by YV does not materialise.
It is not possible to identify the precise magnitude of the threat before deciding whether to treat the crop. This is because Cruiser SB is a seed coating and therefore used at the time of planting, while the greatest risk to the growing sugar beet occurs later while the plant is growing. The environmental conditions for a high incidence of YV at this point of risk are not yet known at the time of planting.
There is, however, a means to predict the scale of threat. That is through the YV incidence prediction model developed and run by Rothamsted Research. This provides, on 1 March each year, a forecast of the level of YV infection that will be reached in August in the absence of any plant protection intervention. Making the prediction on 1 March allows the model to take account of preceding winter temperatures, which are important in determining the likely incidence of YV .
The applicants proposed setting a threshold of YV incidence, predicted by the model, which must be met before Cruiser SB would be used. They proposed setting the threshold at the level where growers as a whole would suffer losses without the seed treatment.
It has become clear that, since neonicotinoids stopped being used, the model has significantly overpredicted YV incidence relative to actual incidence later in the year. This is understandable, because the model assumes no crop protection whereas growers have control tools available, albeit tools that are less effective than Cruiser SB.
As more years elapse, more information about the performance of the Rothamsted model is available. Without such information, a threshold of 9% model-predicted YV was used in 2021. With greater information, this threshold was adjusted upward to a model-predicted value of 19% for use in 2022. Now we have still more data about past performance of the model, which give a clearer picture of the effectiveness of alternative pest control measures at different predicted incidence levels. Using this, Defra economists have assessed the model prediction that represents the breakeven point for the average grower.
The Minister has accepted this analysis and has decided to set the threshold at 63% of YV predicted by the model. This threshold is a condition of use and Cruiser SB will only be used if the model predicts a level of virus incidence at or above this threshold.
Second test: special circumstances
The Minister finds that this requirement is met.
The Minister considers sugar beet to be an economically important domestic crop. The sugar beet industry provides half of the UK sugar supply. British Sugar employs 1,400 skilled workers and claim a total of 9,500 jobs created by the UK beet sugar industry. The industry is a significant contributor to the UK food and drink industry, working with over 170 industrial partners. It is also a key part of the rural economy in East Anglia and Eastern England.
For over 25 years, YV was effectively controlled by a regime centred on neonicotinoid seed treatments. Subsequent experience has indicated that without these seed treatments the crop faces serious damage in some years.
The Minister also notes that UK sugar beet production has declined over a twenty year period and that crop losses this year might result in some growers turning their back on the crop.
Virus levels in aphids remain high and there is a continued build up in background aphid populations.
Problems with YV are therefore likely in future years and there is presently no adequate replacement for neonicotinoid seed treatments. The future management of YV will require an integrated approach to account for the full range of pests.
The applicants and others in the sector are taking forward the development of this integrated approach, which includes a long-term breeding programme to develop YV resistant varieties of sugar beet. There is currently only one commercial variety that provides resistance to some YV and this carries a yield penalty.
Third test: the identified danger ‘cannot be contained by any other reasonable means’
The Minister concludes that this test is met.
The alternative control measures (both chemical and non-chemical), even when used in combination, are not sufficient to address a dangerous level of virus threat. They are not, therefore, considered to be reasonable means of control.
Outcomes depend on a range of factors, many of them local. There will be variation across farms, and it is expected that for some individual farmers YV incidents will reach a level where control using foliar sprays will be significantly less effective than for Cruiser SB. The likelihood of this occurring will increase as the national incidence level rises.
The crop is most susceptible to YV for its first 12 to 16 weeks. When conditions are favourable to a danger from YV , pesticide sprays are less effective than the seed treatment, particularly in the emerging crop because much of the spray will not reach the crop seedlings. Each spray has limits on how often it can be applied and so collectively they are only able to provide up to six weeks’ protection. The sprays do not, therefore, provide effective cover for the full 12–16-week period where sugar beet is most susceptible to YV . The sprays are also slower to kill aphids, giving more time for the virus to transmit to sugar beet plants.
Helpful non-pesticide approaches include early sowing of the crop and plant hygiene, but these are insufficient to control YV when aphid populations are high in the young crop. Natural predators do not control aphids rapidly enough to prevent virus transmission and physical barriers are not economically or practically viable.
Fourth test: authorisation is ‘necessary’ because of the danger
The Minister concludes that this test is met.
The Minister has weighed the possible adverse effects of the proposed use of the product (taking into account any proposed mitigations) with the potential benefits of the use of the product in addressing the danger, recognising that there is some uncertainty in both the adverse effects and the benefits.
The Minister has considered potential risks to human health and the environment from using Cruiser SB. The risk assessments identify no concerns about human health (providing that operators use appropriate protective equipment).
In its environmental assessment, HSE noted a theoretical risk to birds using treated seed as grit but did not expect that birds would take pelleted treated seed as a source of grit.
HSE considered risks to aquatic life acceptable while noting that exposure above the Predicted No-Effect Concentration ( PNEC ) set under the Water Framework Directive would be expected in some small, edge of field water bodies. This PNEC is set to support monitoring of levels of thiamethoxam in water and exceedance of the PNEC is therefore not in itself a cause for concern
The expert evaluation discusses the potential risk to bees. The assessment carried out by HSE focuses on honeybees. It considers: the potential for acute (single exposure) and chronic lethal effects; effects that are sub-lethal but, by impairing the functioning of individual bees, carry a threat of harm to the hive; and risks to larvae. It also considers a range of routes through which bees can be exposed to thiamethoxam, taking account of the fact that thiamethoxam can remain active in the soil for a period of time and can be taken up not only by the sugar beet crop itself, but also by subsequent crops on the same field, by other plants in the field and potentially by plants in field margins.
This risk to bees in subsequent years depends on the extent to which thiamethoxam and its active metabolites remain in soil and are available to be taken up by plants. Thiamethoxam breaks down over time and so the amounts in soil will reduce year on year.
HSE concluded that a number of potential risks to bees, including acute risks to bees from all routes of exposure, were not of concern for this use of thiamethoxam with the proposed conditions of use. These conclusions drew on new evidence on chronic toxicity which enabled HSE to conclude that chronic lethal risks to bees from flowering plants in field margins are unlikely to occur. The CSA agrees with these conclusions and the Minister accepts this advice.
HSE considered the chronic lethal and sub-lethal risk arising from bees foraging on pollen and nectar from flowering crops following the treated sugar beet crop to pose a potential concern. However, the CSA advised that, taking account of the rate of breakdown of thiamethoxam in soil, exposure levels from these sources are expected to be well below those required for chronic and sub-lethal toxicity if a 32 month minimum period was observed before a flowering crop was planted in the same field as the treated sugar beet crop. The Minister accepts this advice and has set a 32 month planting restriction on a range of flowering crops as a condition of the emergency authorisation.
HSE also consider guttation fluid from succeeding crops to pose a potential concern, in terms of both chronic lethal and sub-lethal risks to adult bees and risks to larvae. They find that likely exposure is lower than the level required for either chronic toxicity or sub-lethal effects, but that the margin by which the likely exposure is lower than these levels is less than normally required for a standard authorisation. These conclusions are based on a study on maize, which shows higher concentrations of pesticide in guttation fluid than sugar beet or other crops normally planted after sugar beet (such as wheat and barley). For this reason, the CSA believes that the use of data from maize is likely to over-estimate the risk of exposure of bees to thiamethoxam.
In terms of benefits, the Minister considers that the use of Cruiser SB is expected to be effective in addressing the danger to sugar beet production described above.
As discussed above, this danger to sugar beet production is not effectively dealt with by the available alternatives.
Having considered all the risks and benefits as set out in the advice from HSE , ECP , Defra officials and Defra’s CSA , the Minister has decided that the balance of benefits and mitigated risks is in favour of allowing the limited and controlled use of Cruiser SB in 2023.
In taking his decision, the Minister has taken into consideration that there is a degree of uncertainty as to the benefits of using Cruiser SB to address the identified danger (given the uncertainty as to the virus incidence at this stage) and a degree of uncertainty in relation to the risks to bees (as outlined above).
In order to address this, the emergency authorisation incorporates a number of conditions and safeguards.
The threshold discussed above will ensure that Cruiser is only used if the YV threat is predicted to constitute a danger to sugar beet production. Risks to bees will be reduced by proposed measures. Limitations on the amount of seed treatment applied and on the sowing density of the crop and a ban on further use of thiamethoxam seed treatments on the same field within 46 months will limit the quantity of thiamethoxam in the environment. A ban on planting flowering crops within 32 months of the treated sugar beet and a requirement for the control of weeds in the crop will reduce risks from pollen and nectar from flowering weeds and from flowering crops following treated sugar beet in the same field.
Fifth test: ‘limited’ and ‘controlled’ use
The Minister concludes that this test is met.
In terms of limited use, there is a degree of limitation from the fact that Cruiser SB will only be used on sugar beet, which is only grown in a region dictated by proximity to the four processing factories in West Norfolk, East Norfolk, West Suffolk and East Nottinghamshire.
Further limitations will be applied as conditions of the emergency authorisation. These are listed in full below and include a reduced application rate of the product, a maximum drilling rate and the imposition of the threshold discussed above.
In terms of controlled use, the application proposes a stewardship scheme underpinned by industry commercial contracting arrangements. Additionally, the Minister may remove or withdraw the emergency authorisation at any time if the conditions are not met/followed.
The stewardship scheme includes several measures, each of which will be set as conditions of the authorisation, to address risks to pollinating insects.
The Minister has concluded that the proposed conditions set out in full below are sufficient, in combination, to ensure that use of the product will be limited and controlled.
Overall conclusion on the five tests
The Minister finds that the five tests are met and that there are clear and substantial benefits to crop production from the use of Cruiser SB in a year with high pest pressures. Taking into account the mitigations and strict controls listed below, the potential risks of authorisation (including potential risks to bees) are outweighed by the benefits of use in these circumstances.
The Minister has therefore decided to grant the emergency authorisation, with the above strict conditions.
Conditions to be attached to the emergency authorisation
The Minister has directed that the following key conditions should be attached to the emergency authorisation (in addition to standard requirements that HSE would apply to the product):
use is only permitted if the predicted virus incidence level is 63% or above, as determined on 1 March 2022 by the Rothamsted YV forecast model
forecast model Only a specific list of crops, none of which flower before harvest, are permitted to be planted in the same field as treated sugar beet within 32 months
no further use of thiamethoxam seed treatments on the same field within 46 months
application rate of Cruiser SB reduced from 100 ml/100,000 seeds to 75 ml/100,000 seeds (this reduces the application rate of thiamethoxam from 60g/100,000 seeds to 45g/100,000 seeds)
observance of industry-recommended herbicide programmes for weeds growing in treated fields
a maximum drilling rate for treated seed of 115,000 seeds/ha
treated seed must be entirely incorporated in the soil and fully incorporated at the end of rows
treated seed should not be left on the soil surface. Spillages should be buried or removed
compliance with a stewardship scheme including a number of requirements for monitoring levels of neonicotinoids in the environment.
the authorisation can be withdrawn or amended at any time if the conditions are not adhered to
The Minister has decided that it is appropriate to grant the authorisation for a 120-day period to cover the period from treatment of seed until the end of the season for seed drilling.
[END]
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[1] Url:
https://www.gov.uk/government/publications/neonicotinoid-product-as-seed-treatment-for-sugar-beet-emergency-authorisation-application/statement-of-reasons-for-the-decision-on-the-application-for-emergency-authorisation-for-the-use-of-cruiser-sb-on-sugar-beet-crops-in-2023
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