Protected uses: Environmental fate guidance for pesticide registration in Great Britain and Northern Ireland

When applying for pesticide registration in Great Britain and Northern Ireland for a product that will be used in a protected setting, you must consider the potential for environmental exposure to occur.

The guidance for conducting exposure assessments for protected uses in Great Britain and Northern Ireland is based on the EFSA Guidance Document on clustering and ranking of emissions of active substances of plant protection products and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments.

HSE has considered how to implement the EFSA guidance in a pragmatic and proportionate way that will not place an unnecessary burden on applicants, whilst being aligned with the EFSA recommendations and GB and NI specific guidance. In many cases it should be possible to simply refer to existing outdoor field uses using the risk envelope approach to address emissions from protected situations and no additional assessment will be required.  Note that where this guidance refers to the use of the risk envelope approach, this is to address environmental exposure only. If the risk envelope approach is used to address other specialist areas, such as ecotoxicology, further consideration of the relevance of any risk envelope may be required. This page outlines the additional factors that need to be considered when applying for a plant protection product use in a protected setting.

If you require advice on the correct situation qualifiers or on any of the exposure assessment requirements, including the suitability of refinements, or any other expert advice, contact HSE.

• Definition of situation qualifiers
• Exposure assessment: soil
• Exposure assessment: groundwater
• Exposure assessment: surface water
• Exposure assessment: air
• Restriction statements for product labels
• Further information

Definition of situation qualifiers

Situation qualifiers are terms that are used to modify a basic crop (eg. leafy vegetable) to cover specific situations where a statutory restriction is required. Situation qualifiers are important as they determine the level of exposure assessment needed for a particular situation.

You must state the relevant situation qualifiers when applying for a plant protection product use in a protected setting as an exposure assessment cannot be conducted without this information.

For assessments in Great Britain and Northern Ireland, there are two situation qualifiers that relate to the type of protection structure, and three that relate to the growing media for the target crop. The definitions presented below are taken from the Crop Definitions List.

Crop protection qualifiers

Permanent protection with full enclosure

Protected crop situations which provide full enclosure (including continuous top and side barriers down to below ground level) and which are present and maintained over a number of years. An example is a traditional glasshouse.

Protected

Any crop grown under a permanent or temporary cover. If covers are removed during the life of a crop, and not replaced later, then that crop is considered protected only while the covers are in place. It does not include structures that are not used primarily for growing crops, such as conservatories and interior landscapes. Examples include netting or plastic tunnels (polytunnels).

Growing media qualifiers

Grown in organic media

Only crops grown in organic media, such as soil or compost, either in containers or on impervious surfaces. Not to be used on crops grown in artificial media such as rockwool or hydroponic systems.

Grown in soil

Only for use on crops planted directly into the ground.

Grown in synthetic rooting media

Only on crops grown in artificial media such as rockwool or perlite. Not to be used on crops grown in soil or organic media.

Exposure assessment: soil

The soil assessment varies based on the crop protection qualifier.

Before providing a new soil exposure assessment, consider whether you can use the risk envelope approach to support your proposed use with reference to an existing authorised field use. For more information refer to Risk envelope suitability for pesticide registration in Great Britain and Northern Ireland.

Drip application and other alternative application techniques will be considered on a case-by-case basis.

Permanent protection (grown in organic media)

If there is no suitable risk envelope, you should conduct a ‘disposal of growing media’ assessment, which calculates PECsoil values based on residues within the organic media when disposed of in a field. For more information refer to Disposal and transplanting of growing media: Environmental fate consideration for pesticide registration in Great Britain and Northern Ireland and Soil assessments for pesticide registration in Great Britain and Northern Ireland.

Permanent protection (grown in synthetic rooting media)

No soil assessment is required.

Permanent protection (grown in soil)

If there is no suitable risk envelope, and the DT₉₀ of the active substance or metabolite is greater than 1 year, you must submit a full, standard soil assessment for those substances. If the DT₉₀ for all substances is less than 1 year, then a soil assessment is not required. For more information refer to Soil assessments for pesticide registration in Great Britain and Northern Ireland.

Protected crops

The soil assessment for protected crops depends on whether the crops are grown in soil or grown in containers.

• For protected crops grown in soil, you should submit a full, standard soil assessment as you would for an outdoor field use. For more information refer to Soil assessments for pesticide registration in Great Britain and Northern Ireland
• For protected crops grown in containers, you should submit a soil assessment that considers the exposure of the ground around the containers. As a worst case, assume that the entire soil (or other soft) surface is exposed to a spray application. You can refine this by assuming that pots will be arranged as close together as possible and only the area between pots is exposed. For more information refer to Ornamental crops: environmental fate considerations for pesticide registration in Great Britain and Northern Ireland

Exposure assessment: groundwater

The groundwater assessment varies based on the crop protection qualifier.

Before providing a new groundwater exposure assessment, consider whether you can use the risk envelope approach to support your proposed use with reference to an existing authorised field use. For more information refer to Risk envelope suitability for pesticide registration in Great Britain and Northern Ireland.

Drip application and other alternative application techniques will be considered on a case-by-case basis.

Permanent protection (grown in organic media)

If there is no suitable risk envelope, you should conduct a groundwater assessment based on residues remaining in growing media at the point of disposal in an open field. A ‘disposal of growing media’ assessment can be used to derive an effective field application rate for use in groundwater modelling. For more information refer to Disposal and transplanting of growing media: Environmental fate consideration for pesticide registration in Great Britain and Northern Ireland and Soil assessment for pesticide registration in Great Britain and Northern Ireland

Permanent protection (grown in synthetic rooting media)

No groundwater assessment is required.

Permanent protection (grown in soil)

If there is no suitable risk envelope, you should submit a greenhouse specific groundwater assessment conducted in line with Appendix A of the EFSA Guidance Document on clustering and ranking of emissions of active substances of plant protection products and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments. The greenhouse assessment uses the Piacenza groundwater scenario with the ‘Pistoia’ climate file, which simulates water inputs from irrigation. Modified crop parameters for ‘tomato’ must be used irrespective of the crop being assessed.

Protected crops

The groundwater assessment for protected crops depends on whether the crops are grown in soil or grown in containers.

• For protected crops grown in soil, you should submit a full, standard groundwater assessment as you would for an outdoor field use. For more information refer to Groundwater assessments for pesticide registration in Great Britain and Northern Ireland
• For protected crops grown in containers, you should submit a groundwater assessment that uses surrogate crops based on ornamental crop groups. For more information refer to Ornamental crops: environmental fate considerations for pesticide registration in Great Britain and Northern Ireland

Exposure assessment: surface water

The surface water assessment varies based on the crop protection qualifier.

Before providing a new surface water exposure assessment consider whether you can use the risk envelope approach to support your proposed use with reference to an existing authorised field use. For more information refer to Risk envelope suitability for pesticide registration in Great Britain and Northern Ireland.

If the proposed use is for a drip application, then no spray drift assessment is required but you should conduct a drainflow assessment.

Permanent protection (grown in organic media)

You should consider exposure via drainflow; however, spray drift assessments are not required.

You can risk envelope to an authorised outdoor field use if one is available with a comparable use pattern. This may be a first tier or higher tier drainflow assessment.

If there is no suitable risk envelope, you should conduct a drainflow assessment based on residues remaining in growing media at the point of disposal in an open field. You can use a ‘disposal of growing media’ assessment to derive an effective field application rate for use in a drainflow assessment. You should use this in a first tier drainflow assessment, and, where necessary, a higher tier drainflow assessment using MACRO. For more information refer to Disposal and transplanting of growing media: environmental fate consideration for pesticide registration in Great Britain and Northern Ireland and Surface water and sediment assessments for pesticide registration in Great Britain and Northern Ireland.

Permanent protection (grown in synthetic rooting media)

No surface water assessment is required.

Any dilute pesticide waste that requires disposal must be disposed of in line with advice detailed in Section 5 of the Code of Practice for Using Plant Protection Products. To ensure that users are aware of and follow this requirement, you must place the following text on the product label:

‘The use of this product in recirculating water systems in a greenhouse may result in dilute pesticide waste that requires disposal. All dilute pesticide waste must be disposed of safely and legally to protect humans, wildlife and the environment, especially groundwater and surface water. Pesticide disposal advice is detailed in the ‘Code of Practice for Using Plant Protection Products (Section 5: Disposing of Pesticide Waste)’.’

Permanent protection (grown in soil)

You should consider exposure via drainflow; however, spray drift assessments are not required.

You can risk envelope to an authorised outdoor field use if one is available with a comparable use pattern. This may be a first tier or higher tier drainflow assessment. If there is no suitable risk envelope, then you should conduct a drainflow assessment.

At tier 1, you should conduct a standard UK first tier drainflow assessment. If the risk assessment passes, there is no requirement to undertake further modelling. If tier 1 calculations fail the risk assessment, you should conduct a higher tier assessment using MACRO modelling. For more information refer to First tier drainflow calculations for pesticide registration in Great Britain and Northern Ireland and MACRO higher tier drainflow modelling for pesticide registration in Great Britain and Northern Ireland.

If both tier 1 and higher tier calculations fail the risk assessment, you should seek expert advice on how to proceed with the drainflow assessment. For advice, contact HSE.

Protected crops

The surface water assessment for protected crops depends on whether the crops are grown in soil or grown in containers.

• For protected crops grown in soil, you should submit a full, standard surface water assessment as you would for an outdoor field use. You should consider both exposure via spray drift and drainflow. In line with standard outdoor field uses, you should apply any necessary mitigation measures, for example buffer zones. For more information refer to Surface water and sediment assessments for pesticide registration in Great Britain and Northern Ireland.
• For protected crops grown in containers, you should also submit a surface water assessment considering both exposure via spray drift and drainflow. The spray drift assessment varies based upon the method of application and type of crop being grown in containers. The drainflow assessment is only necessary if the method of application includes anything other than handheld or knapsack sprayers only. If a drainflow assessment is necessary, then you should follow the standard approach of conducting a first tier drainflow assessment, and, if necessary, a higher tier drainflow assessment using MACRO that uses surrogate crops based on ornamental crop groups. For more information refer to Ornamental crops: environmental fate considerations for pesticide registration in Great Britain and Northern Ireland.

Exposure assessment: air

There is no GB/NI specific assessment for the air compartment. You can risk envelope the assessment to the active substance approval or core assessment with no further consideration required for Great Britain and Northern Ireland.

Restriction statements for product labels

There are several statements that relate to plant protection product uses in protected settings. These are known as other specific restrictions, or OSRs. You must state the relevant OSR on the product label. The table lists OSR statements related to different protected uses. The phrases can be adapted where more than one growing media is requested.

Further information

EFSA and GB/NI equivalent crop protection structures

The following table is presented for information and shows the relevant EFSA structure categories for each GB/NI definition. This may be useful if you are adapting a European assessment for an application for authorisation in Great Britain and Northern Ireland.

* EFSA guidance considered that emissions from closed buildings were not relevant for any environmental compartment. If uses in closed building situations were assessed during substance approval stage, you are advised to refer to the EFSA conclusion for further information on how to assess these as part of a product authorisation application.

** The term ‘greenhouse’ also covers use in glasshouses.

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