OECD Harmonisation. Activities of the BPSG

Transcription

1 Item 14a OECD Harmnisatin Activities f the BPSG Jeren Meeussen, DG SANCO 7 th ABIM Meeting, Lucerne, Switzerland 22 nd -24 th Octber 2012

2 OECD A few wrds abut OECD OECD Wrk n (Bi)Pesticides

3 OECD OECD: The Organisatin fr Ecnmic C-peratin and Develpment

4 OECD Started after Wrld War II; Transfrmed in 1961 int the Organisatin fr Ecnmic C-peratin and Develpment with trans-atlantic and then glbal reach; Tday the OECD has 34 member cuntries; Mre than 70 develping and transitin ecnmies are engaged in wrking relatinships with the OECD (Brazil, China and India).

5 What is OECD? A frum in which gvernments wrk tgether t: C-rdinate and harmnise plicies; Discuss issues f mutual cncern; Wrk tgether t respnd t internatinal prblems. A prvider f cmparative statistics and ecnmic and scial data with mre than 250 publicatins per year.

6 Hw d pesticides fit in all this? One f the fields in which OECD is actively invlved is the sustainability f agriculture.

7 OECD Wrking Grup n Pesticides The OECD wrk n agricultural pesticides aims t help member cuntries: imprve the efficiency f pesticide cntrl; share the wrk f pesticide registratin and re-registratin; minimise nn-tariff trade barriers; reduce risks t human health and the envirnment.

8 OECD Wrking Grup n Pesticides Wrking Grup n Pesticides: Registratin Steering Grup (RSG) Risk Reductin Steering Grup (RRSG) BiPesticides Steering Grup (BPSG)

9 OECD - BPSG The BiPesticides Steering Grup (BPSG) was established by the WGP in 1999 t help member cuntries: - t harmnise the methds and appraches used t assess bilgical pesticides and - t imprve the efficiency f cntrl prcedures.

10 OECD - BPSG Bilgical Pesticides: Macr-rganisms Micrbial bipesticides Semichemicals Plant extracts/btanicals

11 OECD - BPSG The first tasks f the BPSG cnsisted f: (i) reviewing regulatry data requirements fr three categries f bipesticides; and (ii) develping frmats fr dssiers and mngraphs fr micrbials, and phermnes and ther semi-chemicals.

12 OECD Publicatins (1) Registratin requirements: - fr phermnes (Series n Pesticides, N. 12, 2001); - fr micrbial pesticides (Series n Pesticides, N. 18, 2003); - fr invertebrate bicntrl agents/ibcas (Series n Pesticides, N. 21, 2004).

13 OECD Publicatins (2) Dssier - OECD Dssier Guidance fr Micrbials, 2003 rev. August OECD Dssier Guidance fr Phermnes and ther Semichemicals, 2003 Mngraph - OECD Mngraph Guidance fr Micrbials, 2003 rev. August OECD Mngraph Guidance fr Phermnes and ther Semichemicals, 2003.

14 OECD - BPSG The BPSG then decided t cncentrate its effrts n science issues that remain as barriers t harmnisatin and wrksharing.

15 OECD Publicatins (3) Wrking Dcument n the Evaluatin f Micrbials fr Pest Cntrl This dcument is essentially a set f examples/case studies aimed at helping the regulatry authrities t deal with these issues in the assessment f (micrbial) bipesticides. OECD Envirnment, Health and Safety Publicatins, Series n Pesticides N. 43, 2008

16 Wrking Dcument - Chapters 1. Taxnmic identificatin f micr rganisms in MPCP; 2. Genetic txicity assessment f micrbial pesticides; 3. Expsure (peratrs, bystanders, cnsumers) 4. Micrbial metablite residues in fd; 5. Efficacy evaluatin f micrbials.

17 Wrkshp n the Regulatin f Bipesticides Wrkshp n the Regulatin f Bipesticides: Registratin and Cmmunicatin issues April 2008, EPA, Arlingtn, USA; OECD Envirnment, Health and Safety Publicatins, Series n Pesticides N. 44, 2009 The bjectives f the wrkshp were met: - T cllect input t reslve science issues; - T imprve cmmunicatin and infrmatin exchange.

18 BPSG Wrkplan Reslve science issues assciated with registering bipesticides: - micrbial cntaminants limits; - envirnmental safety evaluatin; - strage stability; - etc. Prmte cmmunicatin and infrmatin exchange n Bipesticides : - rganise seminars.

19 OECD Publicatins (4) Mst recent publicatins: Issue Paper n Micrbial Cntaminant Limits fr Micrbial Pest Cntrl Prducts (OECD Series n Pesticides N. 65, 2011) SANCO/12116/2012 rev. 0, September 2012 Guidance t the Envirnmental Safety Evaluatin f Micrbial Bicntrl Agents (OECD Series n Pesticides N. 67, 2012) SANCO/12117/2012 rev. 0, September 2012

20 OECD Seminars (1) 1. Reprt f Seminar n Identity and Characterisatin f micrrganisms, OECD Series n Pesticides N. 53, Reprt f Seminar n The fate in the envirnment f micrbial cntrl agents and their effect n nn-target rganisms, OECD Series n Pesticides N. 64, 2011.

21 OECD Seminars (2) 3. Reprt f Seminar n Characterisatin and Analyses f Btanicals fr the use in Plant Prtectin Prducts, held n 30 March 2011; Publicatin in preparatin 4. Reprt f Seminar n Trichderma spp. fr the use in Plant Prtectin Prducts: similarities and differences, held n 11 June 2012; Publicatin in preparatin

22 Seminar Structure Presentatins n: gvernment, research and stakehlder experience and perspectives, fllwed by discussin after each set f presentatins.

23 BPSG Wrkplan (1) Develp guidance n btanicals/plant extracts; Develp guidance n Trichderma; Develp guidance n 'equivalence check' fr different surces f micr-rganisms; Prepare checklist fr pre-submissin meetings; Cntinue develpment f "issue papers" n: - strage stability; - phermnes.

24 BPSG Wrkplan (2) Review the regulatry status f invertebrates used fr pest cntrl; Crdinate implementatin f harmnised study templates fr bipesticides; Make an inventry f available test methds and develp a guidance regarding the use f existing OECD Test Guidelines fr micrbials.

25 BPSG Wrkplan (3) Wrkshp n micrbilgical plant prtectin prducts: jint OECD-EU wrkshp (June 2013) Pssible tpics fr seminars: - applicatin techniques fr micrbials (especially in relatin t expsure and releases int the envirnment); - secndary metablites fr bi-pesticides (particularly with respect t envirnmental area); - Straight-Chained Lepidpteran Phermns (SCLPs): frmulatins/dispensers/expsures.

26 Cnclusin The BPSG has achieved a lt f prgress twards harmnisatin and wrk sharing thrugh the develpment f guidance and wrking dcuments, the 2008 Wrkshp and subsequent seminars. The BPSG will cntinue t facilitate the evaluatin and assessment f bipesticides and prmte harmnisatin and wrk sharing fr the next perid frm

27 Thank yu fr yur attentin Any questins?