Pesticides Regulation – science and policy

1. Pesticides Regulation – science and policy • Aidan Moody • 5 October 2018 TCD workshop – The future of sustainable pest management

2. Contents • Regulatory framework (Approvals, Sustainable Use, Residues, Classification) • Regulatory process for approval (evaluation, peer review, risk management) • Data requirements for approval • Hazard and risk • Decision-making criteria • Implications of regulatory approach • Examples • Forthcoming changes • Take-home message An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

3. Framework • EU legislative framework Sustainable Use (Directive 2009/128/EC) Placing on the Market (Regulation 1107/2009) Residues in Food/Feed (Regulation 396/2005) Classification and Labelling (Regulation 1272/2008) An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

4. Framework • Regulation (EC) No. 1107/2009 (placing on the market legislation) Active substance authorised at EU level Products authorised at Member State level Active substance and product approval An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

5. Framework • Regulation 1107/2009 – dual system An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

6. Framework • Directive 2009/128/EC – Sustainable Use Directive An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

7. Framework • Regulation 396/2005 – Maximum Residue Levels • Step 1: • Grow crop plots • Step 2: • Sample at intervals • MRLs are set based on: • Good Agricultural Practice (GAP) • Residue trials results • MRLs are established if: • Consumer intake is acceptable • Step 4: • Calculate MRLs • Step 3: • Analyse samples An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

8. Framework • Regulation 1272/2008 • (classification, labelling and packaging) • Harmonised classification of hazards: • carcinogenicity • mutagenicity • reproductive toxicity • respiratory sensitisation • Actors: • applicants • Member States • general public • European Chemicals Agency (ECHA) • European Commission An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

9. Process • Regulation 1107/2009 • (evaluation process) • Assessment of hazard and risk data by Rapporteur Member State (RMS) • Peer review by Member States and European Food Safety Authority (EFSA) • Peer review includes public consultation An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

10. Process • Evaluation • Data package evaluated by RMS • Risk assessment carried out • Draft Assessment Report (DAR) prepared An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

11. Process • Peer review by EFSA and Member States An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

12. Process • Risk management • Approval / non-approval proposed by Commission • Proposal voted on by Member States • Risk management measures may be specified An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

13. Data requirements • Data to classify hazard and assess risk • Human health: • user • bystander • consumer • Animal health: • non-target organisms • Environment: • soil • water • air An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

14. Data requirements • Dossier sections • Identity • Physical & Chemical properties • Analytical Methods • Toxicology • Residue Chemistry • Environmental fate and behaviour • Ecotoxicology • h. Efficacy An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

15. Data requirements An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

16. Data requirements An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

17. Hazard and risk • Hazard: • Intrinsic property that can cause a harmful effect • Risk: • Probability that hazardous potential will be expressed • Risk is a function of hazard and exposure An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

18. Hazard and risk Data evaluation Hazard identification Dose-response assessment Exposure estimation Data set Application rates Toxicity data • Risk assessment combines exposure levels and effects of exposure Environmental distribution Extrapolation Exposure levels – environmental concentrations Adverse-effect levels Risk Quotient = Effect / Exposure Risk characterisation An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

19. Decision-making criteria • Hazard-based ‘cut-off’ criteria • An active substance, safener or synergist shall only be approved if it is: • not to be classified (…) as mutagen category 1A or 1B • not to be classified (…) as carcinogen category 1A or 1B or as toxic for reproduction category 1A or 1B, unless the exposure of humans (…) under realistic proposed conditions of use, is negligible • not considered to have endocrine disrupting properties that may cause adverse effect in humans/non-target organisms, unless the exposure (…) under realistic proposed conditions of use, is negligible • not considered to be a persistent, bioaccumulative and toxic (PBT) substance • not considered to be a very persistent and very bioaccumulative substance (vPvB) An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

20. Decision-making criteria • Hazard-based ‘cut-off’ criteria Balance of science and policy Various risk-based criteria also apply CMR category 1A or 1B Endocrine disruptors POP/PBT/vPvB No approval Market removal Exposure not relevant An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

21. Implications • Some points to consider • Regulatory threshold set at a very high level – onus on applicant to demonstrate low risk • Protection of human health and environment are foremost concerns • Decisions on whether approval criteria are satisfied should be based on the scientific consensus view of all relevant information An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

22. Implications • Some points to consider What are the implications for sustainable pest management? • Decision on whether a substance should be used is informed by science but depends on wider policy considerations • No integrated approach – decisions taken on a substance by substance basis • Impacts on non-EU countries? An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

23. Examples • Reactions to regulatory opinions • Glyphosate: • Renewed for 5 years based on EFSA and ECHA opinions • EFSA and ECHA praised by industry and attacked by NGOs • Neonicotinoids: • Outdoor uses for 3 substances prohibited based on EFSA opinion • EFSA praised by NGOs and attacked by industry Stakeholders have divided views on the balance between science and policy An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

24. Changes • Proposals for enhanced transparency • Proposed revision of General Food Law (Regulation 178/2002): • Publication of studies and data early in the process • EU register of all commissioned studies • Mandate for EFSA to commission studies on difficult issues • More resources for EFSA An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

25. Take-home message Uses should be necessary and sustainable and based on robust scientific evidence demonstrating high levels of protection for human, animal and environmental health An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine

26. It’s in your hands now www.pcs.agriculture.gov.ie An RoinnTalmhaíochta, Bia agus Mara │ Department of Agriculture, Food and the Marine