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Evidence Project Final Report

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NoteIn line with the Freedom of Information Act 2000, Defra aims to place the results of its completed research projects in the public domain wherever possible. The Evidence Project Final Report is designed to capture the information on the results and outputs of Defra-funded research in a format that is easily publishable through the Defra websiteAn Evidence Project Final Report must be completed for all projects.

This form is in Word format and the boxes may be expanded, as appropriate.

ACCESS TO INFORMATIONThe information collected on this form will be stored electronically and may be sent to any part of Defra, or to individual researchers or organisations outside Defra for the purposes of reviewing the project. Defra may also disclose the information to any outside organisation acting as an agent authorised by Defra to process final research reports on its behalf. Defra intends to publish this form on its website, unless there are strong reasons not to, which fully comply with exemptions under the Environmental Information Regulations or the Freedom of Information Act 2000.Defra may be required to release information, including personal data and commercial information, on request under the Environmental Information Regulations or the Freedom of Information Act 2000. However, Defra will not permit any unwarranted breach of confidentiality or act in contravention of its obligations under the Data Protection Act 1998. Defra or its appointed agents may use the name, address or other details on your form to contact you in connection with occasional customer research aimed at improving the processes through which Defra works with its contractors.

Project identification

1. Defra Project code PS2815

2. Project title

Impact Assessment for proposed Guidance Document on Aquatic Ecotoxicology Risk Assessment under EU Plant Protection Products Marketing Regulation (EC) No. 1107/2009

3. Contractororganisation(s)

WRc plcFrankland RoadBlagroveSwindonWiltshireSN5 8YF

54. Total Defra project costs £ 13913(agreed fixed price)

5. Project: start date................ 1st February 2013

end date................. 22nd April 2013

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6. It is Defra’s intention to publish this form. Please confirm your agreement to do so...................................................................................YES NO (a) When preparing Evidence Project Final Reports contractors should bear in mind that Defra intends that

they be made public. They should be written in a clear and concise manner and represent a full account of the research project which someone not closely associated with the project can follow.Defra recognises that in a small minority of cases there may be information, such as intellectual property or commercially confidential data, used in or generated by the research project, which should not be disclosed. In these cases, such information should be detailed in a separate annex (not to be published) so that the Evidence Project Final Report can be placed in the public domain. Where it is impossible to complete the Final Report without including references to any sensitive or confidential data, the information should be included and section (b) completed. NB: only in exceptional circumstances will Defra expect contractors to give a "No" answer.In all cases, reasons for withholding information must be fully in line with exemptions under the Environmental Information Regulations or the Freedom of Information Act 2000.

(b) If you have answered NO, please explain why the Final report should not be released into public domain     

Executive Summary7. The executive summary must not exceed 2 sides in total of A4 and should be understandable to the

intelligent non-scientist. It should cover the main objectives, methods and findings of the research, together with any other significant events and options for new work.

Regulation (EC) No 1107/2009 is at the centre of the European Union’s regulatory regime for plant protection products. It updated and replaced an earlier Directive (91/414/EEC) from June 2011 and provides for a two-tier authorisation process under which active substances are approved at EU level and products, containing approved active substances, are authorised by the Member States. These procedures are intended to ensure a high level of protection for both human and animal health and the The current Guidance Document on Aquatic Ecotoxicology (Ref. Sanco/3268/2001 Rev. 4 (final)) was adopted in 2001 and last amended in 2002 as a working document to assist both applicants and regulators in the implementation of Directive 91/414/EEC. Recently it was recognised that this document needed to be updated to reflect the requirement of the new regulation. Therefore, in December 2012, European Food Safety Authority’s Panel on Plant Protection Products and their Residues (PPR) launched an open consultation on the draft Guidance Document on the tiered risk assessment scheme for plant protection products for aquatic organisms in edge-of-field surface waters. The draft revised Guidance Document is intended to provide guidance to applicants and authorities in the context of the evaluation of Plant Protection Products (PPPs) and their active substances under Regulation (EC) 1107/2009.This project “Impact Assessment for Proposed Guidance Document on Aquatic Ecotoxicology Risk Assessment under EU Plant Protection Products Marketing Regulation (EC) No. 1107/2009” was seeking to understand whether the adoption of the draft revised version of the guidance and the risk assessment methodology described for uses of plant protection products could result in different regulatory outcomes to those under the current guidance. It also seeks to understand the potential reasons for any identified differences and, as far as is practicable, the potential benefits and limitations (including costs where relevant). The work programme to address the projects objective comprised six tasks:Task 1 – Identify a series of fourteen active substances for evaluation in the impact assessment.Task 2 – Collate the available data on the environmental fate and aquatic ecotoxicology of the identified substances from relevant regulatory documents.Task 3 – Determine the risk outcomes for the identified use(s) of each substance as determined using the current guidance under Council Directive 91/414/EEC and the draft revised guidance under Regulation (EC) No 1107/2009.Task 4 - Identify which differences in the approaches defined in the current guidance and the draft revised guidance result in differences in regulatory outcomes.Task 5 – As far as is practicable, quantify the benefits and limitations of the differences in risk outcomes in

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terms of both aquatic ecotoxicology and agronomy.This report, in a format agreed with HSE, CRD, constitutes Task 6 of the project.In the current guidance the risk assessment procedure involves calculating Toxicity Effect Ratios (TERs) based on the available ecotoxicological effects data for the active substances and associated products and deriving Predicted Environmental Concentrations for surface waters (PECsw) using the FOCUS (the FOrum for Co-ordination of pesticide fate models and their USe) model. The TERs are then compared against relevant Annex VI trigger values to determine the extent of the risks posed to aquatic organisms. In the risk assessment the PECsw values derived from the FOCUS model are refined in a series of four assessment steps from Step 1 (where the most conservative PECsw values are derived) to Step 4 (where the most environmentally relevant are derived). The data resulting from these assessments indicated that: The risk assessments for the fourteen substances carried out using the current guidance show that

for three substances (the herbicides clomazone and metamitron and the insecticide pirimicarb) the risks posed to aquatic organisms by exposure to the substance at FOCUS Steps 1-3 were acceptable and did not require further risk refinement or a consideration of the implementation of risk mitigation measures.

For four substances (the fungicides azoxystrobin and epoxiconazole, the herbicide pyroxsulam and the insecticide dimethoate) the absence of FOCUS Step 4 PECsw values in the relevant regulatory documents meant that the risk assessments could not be finalised.

For the other seven substances (the fungicides dithianon, fenpropimorph and penthiopyrad, the herbicides carbetamide and tebuthylazine and the insecticide terbufenpyrad and zeta cypermethrin) risk mitigation measures for the use of the substance on a specified crop were evaluated at FOCUS Step 4 to address the identified risks to aquatic organisms. In the case of dithianon and fenpropimorph the identified risk mitigation measures were not sufficient to address the identified risks to all groups of aquatic organisms.

In the draft revised guidance the risk assessment procedure involves comparing Regulatory Acceptable Concentrations (RACs) based on the available ecotoxicological effects data for the active substances and associated products against PECsw derived using the FOCUS model. There are a number of tiers in the derivation of the RACs (1, 2a, 2b, 2c and 3) which involve the use of different types of data (e.g. laboratory toxicity data and semi-field mesocosm studies) and different derivation procedures (e.g. deterministic or probabilistic). The stepped risk assessment procedure described in the draft revised guidance formalises the assessment approaches which have been adopted previously when interpreting the current guidance. Therefore a degree of consistency between the outcomes using the two approaches would be expected. The data resulting from these assessments indicated that:The risk assessment at FOCUS Step 3 indicates that the risks to all aquatic organisms are acceptable for

five substances: the fungicide epoxiconazole, the herbicides clomazone and metamitron and the insecticides dimethoate and pirimicarb.

The risk assessment at FOCUS Step 3 indicates that risks to all aquatic organisms are unresolved for nine substances: the fungicides azoxystrobin, dithianon, fenpropimorph and penthiopyrad, the herbicides carbetamide, pyroxsulam and terbuthylazine and the insecticides terbufenpyrad and zeta cypermethrin. Further risk refinement and evaluation of risk mitigation measures could be carried out if additional data at higher tiers (e.g. from mesocosm studies) became available.

The comparison of the risk outcomes (e.g. in terms of the number of safe scenarios identified, the need for further data, the requirement for risk mitigation measures etc) for fourteen substance/crop combinations using the current and the draft revised guidance resulted in the following conclusions:For two substances (the fungicide epoxiconazole and the insecticide dimethoate) a different outcome

was evident in terms of the identified risks to aquatic organisms. In these cases the draft revised guidance resulted in a less prescriptive outcome (i.e. a reduction in the risk mitigation measures required for the use of the substance).

For twelve substances (the fungicides azoxystrobin, dithianon, fenpropimorph and penthiopyrad, the herbicides carbetamide, clomazone, metamitron, pyroxsulam and terbuthylazine, and the insecticides pirimicarb, tebufenpyrad and zeta cypermethrin) a similar outcome was evident in terms of the identified risks to aquatic organisms.

The differences in risk outcomes identified for two substances using the current and draft revised guidance showed no requirements for additional risk mitigation measures. In certain instances reduced risk mitigation measures were identified. The resulting benefits would be:

Continued use of current substances/products for the identified crop since this would still be considered cost-effective.

No reduction in the pool of effective pesticides for different crops potentially limiting the potential for greater resistance in pests in the longer-term.

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It is clear that changes in the availability of substances or their conditions of use can have significant impacts on crop production and the costs to industry which have to be considered against the need for effective environmental protection. Therefore, the use of risk assessment procedures that reduce uncertainty and result in outcomes that are neither under- or over-protective is a vital component of the approvals procedure at both EU and Member State level.

Project Report to Defra8. As a guide this report should be no longer than 20 sides of A4. This report is to provide Defra with details of

the outputs of the research project for internal purposes; to meet the terms of the contract; and to allow Defra to publish details of the outputs to meet Environmental Information Regulation or Freedom of Information obligations. This short report to Defra does not preclude contractors from also seeking to publish a full, formal scientific report/paper in an appropriate scientific or other journal/publication. Indeed, Defra actively encourages such publications as part of the contract terms. The report to Defra should include: the objectives as set out in the contract; the extent to which the objectives set out in the contract have been met; details of methods used and the results obtained, including statistical analysis (if appropriate); a discussion of the results and their reliability; the main implications of the findings; possible future work; and any action resulting from the research (e.g. IP, Knowledge Exchange).

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References to published material9. This section should be used to record links (hypertext links where possible) or references to other

published material generated by, or relating to this project.

     

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