Applicant guide to providing suitable environmental exposure assessments for plant protection products
Brexit: Transition period
The UK has now left the EU. Your health and safety responsibilities have not changed in the transition period.
The data provided by applicants must permit an assessment to be made of the fate and behaviour of the pesticide in the environment according to Regulation No. 1107/2009.
This information is subsequently used to assess the risk to non-target species (soil or aquatic organisms, plants etc.) that will be exposed to the pesticide formulation, its active substance(s), and the degradation products of the active substance(s). The information provided should be sufficient to:
- predict the distribution, fate and behaviour of the pesticide in the environment, as well as the time courses involved, ie estimate the predicted environmental concentrations (predicted environmental concentrations (PEC)) in soil, groundwater, surface water, sediment and air and assess how these concentrations compare with any recognised limits or standards;
- identify measures necessary to minimise contamination of the environment and impact on non-target species;
- permit a decision to be made as to whether the pesticide can be approved, and the uses for which it can be approved;
- classify the product as to risk;
- specify relevant risk and safety phrases, for the protection of the environment, which are to be included on labels.
It is the applicant's responsibility to ensure that all aspects of the product data requirements are addressed and that any risks are demonstrated to be acceptable in an appropriate way for the UK, as defined by Regulation No. 1107/2009.
Examples of changes that may affect the environmental exposure assessment:
- new crops/field of use, changes in non-crop situations, variations in scale of use (for instance, agriculture or horticulture, 'minor' crop or 'major' crop, arable or glasshouse);
- scale of use is not specifically included as a consideration in the 'Uniform Principles', CRD's view is that a pragmatic attitude can be adopted for some uses that are 'minor' in nature. However, applicants must exercise caution if attempting to use scale of use as a mitigating factor in respect of environmental exposure and effects. Additional issues to consider might also include geographical distribution in the UK, vulnerability of associated land to eg surface water contamination via drainflow therefore consideration on a case-by-case basis, depending on the crop/situation proposed is required.
- Higher application rates, increased numbers of treatments and method of application;
- changes to recommended timing (eg spring/summer to autumn/winter uses, reduction in application interval and application to crop at earlier growth stage);
- positive use recommendations in or near water;
- changes in formulation are usually not so important, as environmental exposure is usually more dependent on the active substance. However, changes or new products involving, for example, slow release formulation types must be considered, ie where the balance of environmental exposure characteristics are altered, eg from acute to chronic exposure or vice versa.
- any other changes which could affect environmental exposure.
Which end points should I use?
When compiling risk assessments for a product authorisation submission, you should use the end-points agreed at EU level (published in the current Review Report or EFSA conclusion for that active substance). However you will need to consider whether the end-points identified during the active substance approval process are appropriate to the products to be authorised.
Applicants may have information/data available that would support amore favourable end-point to that agreed in the EU. Where the assessment was acceptable using EU agreed end-points, there would be no need to consider the new end-point with the authorisation application.
There may be circumstances where a risk assessment conducted using EU agreed end points results in an unacceptable use. In these cases it would be appropriate for applicants to seek to amend an agreed end-point to allow consideration of the use. However Applicants must demonstrate that the use of additional data is justified by providing a standard assessment using Annex I agreed endpoints.
What guidance should I use?
Where an applicant is required to submit data to support new uses or significant changes to their product that affect the likely environmental exposure, then the data should be assessed in accordance with the latest guidance available at the time the application is made, in line with Art 36 (1) of Regulation No. 1107/2009. This includes use of the latest versions of the environmental exposure models. Where an applicant is not required to submit new data the latest guidance (and models) does not need to be applied as no new risk assessment is being undertaken. Similarly where the risk envelope approach is used the latest guidance does not need to be applied as no new risk assessment is being undertaken.
In addition to the above guidance you should refer to Summary of New Guidance for details of when more up-to-date assessment methodologies should be used.
The risk envelope approach makes use of the idea that within a group of products and uses, there will be certain uses which represent the worst-case situation in each environmental compartment.
The proposed GAP of a product can be compared against the use patterns of existing authorised products, or the representative use of the most recent Community level assessment.
If the evaluation of an authorised product is considered to provide a more worst-case environmental exposure, then it can be said that the new product is within the 'risk envelope'. In other words, the previous evaluation is considered sufficient to demonstrate that the proposed uses for the new submission are without unacceptable risk.
To compare products, the critical use pattern(s) of each should be identified.
Risk envelopes are assessed for each compartment (PECsoil, PECgw, PECsw, PECair) independently. Therefore you may find one product provides a risk envelope for PECsoil, and a different product provides a risk envelope for PECgw.
Guidance on the selection and suitability of risk envelopes can be found at Risk envelope suitability
Authorisation of Products with Multiple Crops/Uses
In producing submissions for the authorisation of individual products with multiple crops/uses, applicants are encouraged to limit the environmental exposure assessments to a worst case example in each environmental compartment in order that the 'risk envelope' can be clearly established. Applicants should note:
- The onus is on the applicant to demonstrate that the representative scenario or scenarios selected are 'worst case' and cover all other proposed uses on the actual product label ( eg groundwater exposure is unlikely to be addressed simply based on the highest application rate if use on many crops are sought). Justification can be via the comparison of appropriate PECs or other suitable methods
- Worst case assessments for different environmental compartments may vary and a combination of worst case assessments may be required to fully cover the different environmental compartments.
- Even for the same environmental compartment, the worst case use pattern appropriate for the acute risk assessment may be different to that required for the chronic assessment.
- Where the applicant's portfolio contains more than one plant protection product containing a particular active substance the applicant is encouraged to submit authorisation applications for a number of products in groups. This will assist us with the consideration of worst case usage patterns relating to that active substance.
- If worst case GAPs or risk envelopes are used for products containing multiple active substances, that when combined the suggested exposure may prove unacceptable, the applicants must generate exposure calculations which reflect the actual label rates and timings.
Some UK Considerations
Applicants must satisfy themselves that the approach taken encompasses the UK geoclimatic situation and agricultural practices. Some areas to consider are detailed below:
- when the product is applied in accordance with the proposed UK GAP, the stage of crop and in particular canopy development must be comparable to any assessment already carried out at Community level / or in the submission being made. This is required to ensure that the PECs presented are pertinent to the UK situation.
- for many arable crops in the UK, in addition to spray drift, a major route of exposure for aquatic life is via drainage. To ensure that the surface water predicted environmental concentrations (PECsw) used in aquatic risk assessments are pertinent to the UK situation, the drainage route of entry to surface water, in accordance with the uses requested and appropriate to the UK soil hydrological situation, must be considered and addressed.
- the groundwater exposure assessment must be relevant to the geoclimatic conditions in the UK. When applicants are submitting first tier null Forum for the Co-ordination of Pesticide Fate Models and their Use (FOCUS) groundwater modelling with standard scenarios, the scenarios considered pertinent to UK conditions are:
Châteaudun; Hamburg; Kremsmünster; and Okehampton.
Noting that for some compounds (those more strongly adsorbed) a MACRO simulation for the Châteaudun scenario may be required.
- If the Community level assessment identified that risk management or mitigation is required to protect the environment,the measures being proposed must be compatible with UK regulatory requirements and agricultural practice (eg no spray zones to mitigate the risk to aquatic life from spray drift). Applicants are encouraged to discuss the potential applicability of any risk mitigation measures that they wish to propose with CRD's Environment Branch before an application is made.
Extrapolation of data
For authorisation of new products, uses and changes to existing uses, the extrapolation of supporting data and risk assessments for authorised products containing that active substance should be considered. This may be addressed by comparison of the following critical aspects of the proposed use with that authorised.
- Maximum individual dose, maximum number of applications and the maximum total dose of active substance;
- Application interval and the season/timing of application (including earliest and latest recommended time of application and changes in crop interception expected over the season of use);
- Any changes in the extent of use (potential total area treated); See comment above related to scale of use
- Any major change in soil type or geographic distribution associated with the use;
- Changes in the recommended methods of application and whether these would result in a less targeted dosing of the active substance eg recommendations for the use of air assisted broadcast sprayer/aerial application, move from seed treatment to spray, foliar spray to bare ground spray, or soil incorporated granules.
- Changes in formulation which result in a change to the exposure characteristics, as detailed above.
Any comparison between products and their uses should critically assess whether the change in the product and/or pattern of use will result in increased levels of environmental exposure to both target and non-target environmental compartments. There are two possible outcomes from this initial critical assessment:
- there will not be increased levels of environmental exposure, in which case extrapolation to existing data will be possible and you will not need to submit additional information.
- increased levels of environmental exposure may occur, in which case you will need to submit a further assessment/reasoned case, often with additional supporting experimental data. This further assessment must enable the higher environmental exposure in the different environmental compartments to be determined
Further advice on providing suitable exposure calculations in the range of Environmental Compartments considered may be found by following the links below.
For acute assessment, the highest initial PECsoil (for persistent compounds, the peak plateau concentration);
For chronic assessment, (the requirement for which is triggered by the DT90 field value), in the first instance, the highest initial PECsoil (for persistent compounds, the peak plateau concentration) should be used. If this does not result in an acceptable risk assessment, then depending on the ecotoxicity profile for the compound, an appropriate time weighted average value may be used. Applicants are directed to Soil.
PECgw according to EU Forum for the Co-ordination of Pesticide Fate Models and their Use (FOCUS) guidance.
Applicants should check that the groundwater exposure assessment is relevant to the geoclimatic conditions in the UK. Applicants should submit first tier FOCUS groundwater modelling with standard scenarios, the scenarios considered pertinent to UK conditions being: Châteaudun, Hamburg, Kremsmünster and Okehampton (see Groundwater).
Assessment of Groundwater Exposure from Use on Hard Surfaces
Where recommendations are made for use on hard surfaces, CRD guidance on assessment of groundwater exposure from such uses should be followed. Current guidance on calculating the PECgw for the UK from hard surface use is included at HardSPEC.
Surface Water and Sediment
For community level assessments and zonal assessments Applicants are directed to EU PECsw for additional information.
For UK specific assessments, 'following zonal' requests and 'Mutual Recognition' requests, Applicants are directed to UK PECsw for additional information.
Assessment of Surface Water Exposure from Use on Hard Surfaces
Where recommendations are made for use on hard surfaces, CRD guidance on assessment of surface water exposure from such uses should be followed. Current guidance on calculating the PECsw for the UK from hard surface use is included at HardSPEC.
Guidance is presently under development see Air.
Cases where environmental fate and behaviour data may not be required
There are patterns of product use where exposure to the external environment is limited following treatment, (eg permanent glasshouses, livestock sheds). Where products are used in this way, you may make a case for the non submission of environmental fate and behaviour data providing the recommended use specified on the label ensures containment.
However, potential secondary exposure to the environment should be addressed. Examples of where this may be necessary include:
- Emissions from use in permanent glasshouses (currently assumed to be 0.2% at community level, but updated guidance in the SANCO guidance document on assessing emissions from protected crops will be implemented from 1st December 2015)
- possible effluent from produce washing plants where pesticide applications have been made post-harvest in store (for example on ornamental bulbs, stored potatoes or other food commodities);
- runoff from hardstandings in glasshouses or nurseries;
- possible residues in animal waste which would then be spread on agricultural land as a fertiliser/soil conditioner;
- residues in spent compost from glass or mushroom houses.
Any queries can be discussed with HSE's Chemicals Regulation Division (CRD).
- Pesticides A-Z
- Reporting Incidents
- Contacting CRD
- Regulatory Updates Index
- Information Updates Index
- Codes of Practice
- Pesticide/Plant Protection Product Databases
- Application forms
- Handling pesticide investigation and concerns