Insects and Insecticides

Supplementary written evidence submitted by Lord de Mauley, Parliamentary Under Secretary of State, Department for Environment,
Food and Rural Affairs

At the Committee’s evidence session on 12 December I undertook to write on three points.

The soil accumulation tests for imidacloprid and the robustness of the EU pesticide regime

The Committee asked a number of questions about the assessment of imidacloprid. There are two distinct issues to consider. One is the detail of the study and its interpretation and the other is the working of the system.

Having revisited these questions, Defra has concluded that in this case the EU regime has been correctly applied and that the relevant appropriate checks and balances have been applied. The key points underlying this conclusion are:

- No upper limit for persistence is set out in the legislation. Instead, evidence of persistence triggers further testing to establish whether accumulation occurs, the level at which a plateau is reached and, most importantly, whether that plateau level will have unacceptable effects on wildlife. This part of the procedure is described at paragraphs 7 and 8 of Annex 1 to this letter.

- It was suggested during the oral evidence session on 12 December that Regulation 1107/2009 requires that any plant protection substance approved for use in the EU must have a half-life in soil of less than 120 days. The situation is actually more complicated than this. Annex II of EU Regulation 1107/2009 sets criteria for "persistence", one of which is a half-life in soil of more than 120 days. However, active substances which are deemed to be persistent are not excluded from approval unless they are also bioaccumulative and toxic (so-called PBT substances). Imidacloprid does not meet the bioaccumulative criteria and so is not a PBT substance.

- Furthermore, these criteria clearly did not exist at the time the decision on imidacloprid was made under the previous Directive 91/414/EEC. They do not apply until a substance is reviewed under Regulation 1107/2009.

- The fact that the European Food Safety Authority (EFSA) reached a different conclusion from the rapporteur Member State (Germany) is evidence that the system is working properly. Consideration by EFSA is one of a number of checks and balances that are built into the system.

- The proposal by the European Commission was made with full knowledge of the EFSA conclusion. In accordance with the legislation, this was based on a specific supported use of a product that had met all of the criteria. The Commission decision identified a number of areas where further information was required, based on the advice from EFSA, for the evaluation of other uses and products and set a deadline for Member States to complete this re-registration work or withdraw these products. This work is ongoing as explained in the annexes to this letter.

- Regulation 1107/2009 does not require that EFSA finalises the risk assessment for all supported uses in every area before the European Commission can make a risk management proposal for approval of the substance. The approach to active substance approval, set out in the legislation, is to establish that there is at least one acceptable representative use in at least one Member State. It then falls to Member States to authorise individual products containing approved active substances. Member States do this on the basis of a full safety assessment, carried out according to common EU rules, using agreed EU end points and taking account of their own national circumstances.

- When products were considered for UK authorisation for cereals, the issue of persistence and accumulation were considered carefully and the conclusion reached was that the resultant risks to soil-dwelling organisms were acceptable. This evaluation will be revisited when imidacloprid is considered for re-registration in the UK before 31st January 2014. The UK regulatory authorities have been fully aware of the discussion in relation to soil accumulation throughout the process.

Further details on these points are set out in the three Annexes to this letter, which cover respectively the EU legislative framework, the EU procedures and the specifics of the imidacloprid assessment.

Requests for substance reviews

The Committee asked whether Defra has ever requested a review of a substance approval under the provisions of Regulation 1107/2009. I can confirm that we have made no such requests of the European Commission since that Regulation applied in June 2011. There is an ongoing programme of approval reviews, outlined in Annex 1 to this letter.

National Action Plan

The National Action Plan is on schedule to be submitted to the European Commission by the end of January. This is a little behind the due date but taking the extra time will allow us to give full consideration to the points raised in the public consultation on the draft plan.

Finally, I noted the comments of one Committee member on the Today Programme on Radio 4 on 13 December. On a specific point, I hope I made it sufficiently clear during the evidence session that Defra is not seeking ‘unequivocal’ evidence and that the use of that word in our September statement was inappropriate. More generally, I hope that this letter provides a helpful account of how the complex regulatory process works and how the particular study highlighted by the Committee was handled.

Annex 1

The EU legislative framework

Basic principle: a two tier approach

1. Regulation (EC) 1107/2009 applies from June 2011. Before that date, the EU plant protection product regime was governed by Council Directive 91/414/EEC. This set out a two tier procedure whereby active substances which met the relevant safety criteria were included in Annex I to the Directive. If an active substance was included in Annex I, Member States were then permitted to authorise individual products following a set of Uniform Principles. An Annex I inclusion was therefore not in itself an authorisation and further assessments of individual products were required before they could be authorised by Member States.

Re-evaluation programme under Directive 91/414/EEC

2. Recognising that many products were already authorised by Member States prior to entry into force of the Directive, a re-evaluation programme was established. This programme first evaluated the active substance for inclusion in Annex I. Representative products and uses were assessed and, if one of these uses met the conditions for inclusion, then the substance was included in Annex I. At the point of Annex I inclusion an extensive set of common ‘end-points’ was established for Member States to use as the basis for their product authorisations. (End-points are values to be used in the risk assessment. For example, the Acceptable Daily Intake is the amount of a pesticide that can be ingested on a daily basis over a lifetime without an appreciable health risk.)

3. It is therefore fundamental to the system that the decision taken at EU level is limited to whether a given active substance has at least one use that may meet the criteria for authorisation. Member States then make decisions on authorisation; in doing so they apply common rules to their own national circumstances. This two tier process recognises that it would be impractical for an EU process to consider the full range of products and conditions for all Member States.

Regulation 1107/2009 follows the same approach but adds hazard criteria

4. Regulation 1107/2009 replaced Directive 91/414/EEC in 2011. A number of new elements were introduced but the basic two tier approach remains and active substance decisions (now termed approvals) remain based on the expectation that products containing the active substances meet the criteria. Annex II, paragraph 2.1, of the Regulation further specifies this by requiring "Authorisation to be expected to be possible in at least one Member State, for at least one plant protection product for at least one representative use".

5. Additional criteria for active substance approval were added including so called ‘hazard triggers’. These triggers prohibit the approval of active substances on the basis of intrinsic properties, taking no account of the way in which a product might be used. One trigger is for active substances classed as PBT (Persistent, Bioaccumulative and Toxic). Annex II to the Regulation makes it clear that for a substance to be considered PBT it has to meet P, B and T criteria.

A further re-evaluation programme under Regulation 1107/2009

6. All substances included in Annex I of Directive 91/414/EEC were approved under Regulation 1107/2009 as part of the transitional measures. A similar re-evaluation programme for these active substances is underway to address the requirement for a periodic reassessment. Recital 10 of Regulation 1107/2009 makes clear that the new criteria should be applied at the time of renewal or review of their approval.

7. The legislation also specifies the data requirements for active substances and for products. With respect to soil accumulation the requirements for active substances are set out in Commission Regulation 544/2011, point Soil accumulation tests are to be carried out where the DT90 (the time taken for 90% of the applied dose to disappear) in the field is greater than one year and where repeated application is envisaged. The tests must investigate the possibility of accumulation of residues and the level at which a plateau concentration is achieved. Tests need not be conducted where reliable information can be provided by a model calculation or another appropriate assessment.

8. For products, the Uniform Principles are now set out in Commission Regulation 546/2011. Section C, point, states:

‘No authorisation shall be granted if the active substance and, where they are of significance from the toxicological, ecotoxicological or environmental point of view, metabolites and breakdown or reaction products, after use of the plant protection product under the proposed conditions of use:

- during tests in the field, persist in soil for more than 1 year (i.e. DT90 > 1 year and DT50 > 3 months), or

- during laboratory tests, form non-extractable residues in amounts exceeding 70 % of the initial dose after 100 days with a mineralisation rate of less than 5 % in 100 days,

Unless (emphasis added) it is scientifically demonstrated that under field conditions there is no accumulation in soil at such levels that unacceptable residues in succeeding crops occur and/or that unacceptable phytotoxic effects on succeeding crops occur and/or that there is an unacceptable impact on the environment, in accordance with the relevant requirements provided for in points,, and 2.5.2.’

Annex 2

The EU procedures

The basic EU evaluation procedure under both Directive 91/414/EEC and Regulation 1107/2009 is as follows:

- A dossier is provided by the company wishing to gain approval for an active substance. This dossier includes information to address all the data requirements for the active substance. It must also address the data requirements for products in respect of at least one product containing the substance and one or more representative uses. The process for considering the Dossier and ensuring its validity is described in more detail at paragraphs 10 to 14 of Defra’s original written evidence to the Committee.

- The Member State identified as the rapporteur prepares an extensive evaluation, the Draft Assessment Report, to a format dictated by EFSA.

- Since its establishment in 2001, EFSA has been responsible for giving the European Commission a conclusion on the risk assessment. EFSA’s process for this includes a peer review by experts from Member States. However, the conclusions drawn are EFSA’s own.

- On receipt of EFSA’s conclusion, the European Commission make a legislative proposal for the granting or refusal of a substance approval. They use the risk assessment carried out by EFSA to make this risk management decision and prepare a review report that explains the basis for the decision. Proposals for approval include conditions that must be applied by Member States when authorising products and set out the issues identified in the peer review to which particular attention must be paid.

- Annex I inclusion decisions under Directive 91/414 would set deadlines for Member States to re-evaluate products in accordance with the Uniform Principles and taking account of the end-points derived during the EU procedure. Regulation 1107/2009 has generic provisions for this rather than setting deadlines for each decision.

- The Commission’s legislative proposal is presented to the Standing Committee on the Food Chain and Animal Health. The Standing Committee is made up of representatives of the Member States and delivers an opinion on the proposal through qualified majority voting. Those proposals which receive a positive opinion are adopted by the Commission. Those that do not are referred through an additional procedure to reach a conclusion.

- Once an active substance is approved, Member States re-evaluate authorised products containing that active substance against the Uniform Principles and using the agreed end-points. The extent of this evaluation varies depending on how close the products and uses being considered are to those that were considered during the EU procedure. The relatively long period provided for the process reflects the extent and detail of the work that can be required to achieve this.

Annex 3

The specific case of imidacloprid

The EU review

1. Imidacloprid was authorised in some Member States before Directive 91/414 came into force. It was therefore included in the substance re-evaluation programme.

2. The dossier was submitted by Bayer Crop Science. The representative uses supported for Annex I inclusion were as a seed treatment on sugar beet and as a foliar spray for apples and tomatoes (the latter including glasshouse use).

3. The EU rapporteur, Germany (specified in the Commission Regulation laying out the procedure for the specific phase of the re-evaluation programme), evaluated the dossier and prepared a Draft Assessment Report which was submitted to EFSA.

4. As part of an extensive data package on the fate and behaviour of imidacloprid in the environment, the rapporteur evaluated two soil accumulation studies, one from the use of imidacloprid as a foliar spray in orchards in Germany, and one as a seed treatment in barley in the UK.

5. Taking into account the submitted data, the rapporteur modelled the Predicted Environmental Concentration (PEC) for the representative uses (pages 680 to 685 of the DAR the Committee have been examining) and used these figures to complete the ecotoxicology risk assessment.

6. EFSA carried out a peer review and reported its conclusion to the European Commission (EFSA Scientific Report (2008) 148, 1-120, Conclusion on the peer review of imidacloprid, published on the EFSA website). They agreed with the rapporteur’s conclusion that soil residue levels clearly plateaued in the German study. However, they found that the reasons for the different behaviour seen in the UK study were not fully explained. Further modelling was identified as a requirement ‘so the degradation pattern from these sites (both German and UK sites) can be more accurately incorporated into future exposure assessments, should imidacloprid be included in annex 1.’ This will be part of the application required for product re-registration by Member States, which is to be completed by 31 January 2014.

7. The "soil accumulation factor" is a factor applied to the application rate to give the likely maximum soil concentration following repeated use of an active substance. EFSA proposed that a soil accumulation factor of 1.713 might be appropriate for all the uses in situations where significant amounts of treated plant material are not incorporated into soil after the crop is harvested each year. They also proposed a realistic worst case soil accumulation factor of 5.275 which would also be applicable for all uses, but might be overly conservative for uses where large amounts of treated plant material with high cellulose / lignin content (i.e. straw) are not incorporated into the soil. The first soil accumulation factor was calculated using the longest single first order field dissipation trial DT50 of 288 days. The second was calculated using the longest single first order field accumulation trial DT50 of 1,333 days. (First order means that the rate of reaction is directly proportional to the concentration).

8. EFSA noted that the incorporation of treated plant material was the one major difference between the experimental design of the UK and German studies and might be an explanation why very long DT50 of 1,333 and 1,268 days were estimated at the two UK experimental sites and a plateau in soil residues had not occurred after 6 years of experimentation. EFSA noted the additional information provided by the rapporteur after the peer review (addendum 6 to the DAR) but did not believe this was reported in sufficient detail for them to reach a conclusion. Overall EFSA concluded that the risk assessment to soil dwelling organisms could not be finalised because the assessment of soil accumulation was not finalised, as outlined above. It is routine for EFSA to identify a range of issues in their conclusions, ranging from major concerns to minor readily resolvable issues. EFSA make no judgement about the impact of these issues on the decision to be taken, which is a matter for the European Commission.

9. In line with the normal procedure, the European Commission received and examined the EFSA conclusion. They concluded in this case that at least one use (glasshouse use on tomatoes, a use for which the issue of impacts on soil dwelling organisms is not key) met the requirements of the Directive. They decided that issues relating to other uses, including that of soil accumulation, were of the order that should be dealt with when Member States considered other individual product authorisations. Accordingly, "The impact on earthworms and other soil macro-organisms" was one of a number of points identified for particular consideration by Member States. The Commission also noted that conditions of authorisation should include risk mitigation measures, where appropriate.

10. The review report also noted that some endpoints might require additional studies to be submitted to the Member States in order to ensure authorisations for use under certain conditions.

11. The deadline for Member States to conclude their re-registration of products was set at 31January 2014.

12. The Commission subsequently amended the Annex I inclusion to add additional requirements for the protection of bees.

UK assessment

13. Imidacloprid was first authorised in the UK in 1998 following a consideration by the Advisory Committee on Pesticides (ACP). This assessment pre-dates the modern approach to modelling of soil behaviour. The UK field accumulation study considered by EFSA was a specific data requirement from the ACP and was designed to provide a worst case assessment, hence the incorporation of the entire straw rather than stubble only. At the time of the ACP assessment, the accumulation experiments were continuing. However, preliminary results were available.

14. By consideration of the kinetics of degradation, the ACP concluded it could be expected that these carry-over levels would be close to a plateau after the 3 years of data considered. Assuming a DT50 of 433 days (and 1st order kinetics) residues were predicted to plateau at approximately two times the initial concentration. This level was evaluated for risk to soil dwelling organisms which were concluded to be acceptable. This assessment will be reconsidered during the re-registration of the relevant products using the latest guidelines and the end points from the EU evaluation.

16 January 2013

Prepared 23rd January 2013