Regulation of biological control agents for plant protection

Transcription

1 XVIII th CEUREG Frum Octber 2014, Pznan, Pland Regulatin f bilgical cntrl agents fr plant prtectin Jeren Meeussen Eurpean Cmmissin DG SANCO ( Directrate-General) Unit Chemicals, cntaminants, pesticides

2 Cntents What are bilgical pesticides? Hw is OECD invlved in the regulatin f bipesticides? What is the state f play f different categries f bilgical pesticides? Cnclusins

3 Bilgical Pesticides Macr-rganisms (nt cvered by Reg.1107/2009) Micrbial bipesticides Semichemicals/Phermnes Btanicals/Plant extracts

4 Review f apprved pesticides Evaluatin active substances in EU Befre 1993: 1000 substances Tday: Evaluatin nging; 74 Apprved; 412 Nt apprved; 770

5 Cntents What are bilgical pesticides? Hw is OECD invlved in the regulatin f bipesticides? What is the state f play f different categries f bilgical pesticides? Cnclusins

6 A few wrds abut OECD OECD: The Organisatin fr Ecnmic C-peratin and Develpment Hw is OECD invlved in the wrk n (Bi)Pesticides?

7 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).

8 One f the fields in which OECD is actively invlved is the sustainability f agriculture.

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

10 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.

11 Cntents What are bilgical pesticides? Hw is OECD invlved in the regulatin f bipesticides? What is the state f play f different categries f bilgical pesticides? Cnclusins

12 Overview Macr- rganisms Micrbial Pesticides Semichemicals/ Phermnes Btanicals/ Plant extracts

13 Registratin requirements were reviewed fr invertebrate bicntrl agents/ibcas and published in the OECD Series n Pesticides N. 21: Guidance fr Infrmatin Requirements fr Regulatin f Invertebrates as Bilgical Cntrl Agents (IBCAs). In 2007 a survey was carried ut n hw macr-rganisms were regulated in OECD.

14 Update is cnsidered necessary. New survey abut the regulatin f macr-rganisms fr pest and disease cntrl in OECD cuntries has been circulated. Deadline: 1 December 2014.

15 Overview Macr- rganisms Micrbial Pesticides Semichemicals/ Phermnes Btanicals/ Plant extracts

16 Data requirements Registratin requirements were reviewed fr micrbial pesticides and published in the OECD Series n Pesticides N. 18: Guidance fr Registratin Requirements fr Micrbial Pesticides Data requirements fr micrbial pesticides are laid dwn in Part B f Cmmissin Regulatins (EU) N 283/2013 and N 284/2013

17 OECD Publicatins (1) > Dssier > - OECD Dssier Guidance fr Micrbials, 2003 rev. August > Mngraph > - OECD Mngraph Guidance fr Micrbials, 2003 rev. August 2006.

18 OECD Publicatins (2) 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, Safety Publicatins, Series n Pesticides N. 43, 2008

19 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.

20 Mre recent OECD Publicatins (3) 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

21 Wrkshp n the Regulatin f Bipesticides: Registratin and Cmmunicatin issues April 2008, EPA, Arlingtn, USA; OECD Envirnment, Safety Publicatins, Series n Pesticides N. 44, 2009 Prmte cmmunicatin and infrmatin exchange n Bipesticides: rganise seminars and wrkshps.

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

23 1. Reprt f Seminar n Identity and Characterisatin f micr-rganisms, 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.

24 3. Reprt f Seminar n Trichderma spp. fr the use in Plant Prtectin Prducts: similarities and differences, OECD Series n Pesticides N. 74, Reprt f Seminar n Applicatin Techniques fr Micrbial Pest Cntrl Prducts and Semichemicals: Use Scenaris and Assciated Risks, held n 31 March 2014; Publicatin in preparatin

25 Wrkshp n Micrbial Pesticides OECD/KEMI/EU Wrkshp n "Micrbial Pesticides: Assessment and Management f Risks" June 2013 in Saltsjöbaden, Sweden

26 Regulating micrbials: a challenge!

27 Why a Wrkshp Micr-rganisms fr use as pesticides are regulated in a similar way as chemical pesticides. Hwever the bilgical prperties f living micrrganisms differ frm the prperties f chemical pesticides. Therefre it was desirable t recnsider the regulatry requirements fr micrbial pesticides.

28 Overall recmmendatins Take nte f valuable experiences in the assessment f chemicals. Imprve the interpretatin f the data requirements with detailed guidance fr the assessment f the bilgical aspects. Micr-rganisms are living rganisms; imprve related expsure scenaris.

29 Wrkshp issues Arund 20 different issues were discussed, including: Identificatin, incl. QA & cntaminants Secndary metablites Persistence Test methds Prcedural/regulatry issues

30 Identificatin, incl. QA & cntaminants Prepare issue papers n particular bilgical prperties (e.g. grwth temperature). Develp issue papers n individual taxnmic grups. Use marker apprach fr identificatin at strain level as well as fate quantificatin. Use "mst apprpriate justified" technlgy fr identificatin.

31 Secndary metablites OECD guidance dcument is under develpment: What level f evidence needed? Usefulness f infrmatin n related species and strains. Cnsideratin f bilgy f micr-rganisms. Des the prduct cntain metablites r are they frmed after applicatin. Ptential f effects f secndary metablites in nn-target rganisms (birds and mammals).

32 Persistence Use ppulatin dynamics t study persistence in the envirnment. Recnsider decisin-making criterin: "micrbial level has t decrease t the backgrund level within ne year". Related t natural ccurrence (backgrund level).

33 Test methds Test methds fr chemicals shuld be evaluated and adapted fr micr-rganisms. Bilgy f the micr-rganism shuld be cnsidered when designing tests (e.g. duratin f test). Develp pririty list fr develpment f new/amended test guidelines fr micrbials (based n OECD-BPSG questinnaire).

34 Prcedural/regulatry issues Encurage EFSA invlvement in develping GD. Use risk assessments frm ther areas. Prvide a list f test methds and GD hw t address each item f the data requirements. "Regulatry tlbx" n micr-rganisms?

35 Outcme f the Wrkshp Micr-rganisms are living rganisms with bilgical prperties that can die, survive r prliferate. As living rganisms micr-rganisms respnd t the envirnment in different ways. "Bilgy is the difference!" Reprt has been published in the OECD Series n Pesticides N. 76

36 Overview Macr- rganisms Micrbial Pesticides Semichemicals/ Phermnes Btanicals/ Plant extracts

37 Data requirements Registratin requirements were reviewed fr phermnes and ther semichemicals and published in the OECD Series n Pesticides N. 12: Guidance fr Registratin Requirements fr Phermnes and Other Semichemicals Used fr Arthrpd Pest Cntrl"

38 OECD Publicatins > Dssier > - OECD Dssier Guidance fr Phermnes and ther Semichemicals, 2003 > Mngraph > - OECD Mngraph Guidance fr Phermnes and ther Semichemicals, 2003.

39 SCLPs (1) Austria is Rapprteur Member State (RMS) fr phermnes. Austria prepared the Straight-Chained Lepidpteran Phermnes (SCLPs) Draft Assessment Reprt (DAR) fr the 91/414 EEC review prgram. The OECD-12 was used as guidance fr preparing the SCLP- DAR.

40 SCLPs (2) Austria was asked t prvide suggestins fr an update f the OECD-12. It shuld be clearly stated which requirements are abslutely necessary and cannt be waived (e.g. cncerning identity). In all cases references are required and must be accessible fr the evaluatrs. Mre guidance fr frmulatins ther than slid matrix dispensers (e.g. sprayable micrcapsule suspensins).

41 SCLPs (3) In the OECD N. 12 it is stated that applicatin rates f up t 375 g SCLP/ha/year are generally understd t result in expsure levels which are cmparable t natural emissins Hwever, the ratinale fr this assumptin/value is based n a 'white paper'. This value shuld be recnsidered (in line with the EFSAcnclusin n Straight Chain Lepidpteran Phermnes; January 2014). Update Guidance Dcument n the apprval f new substances falling int the grup f SCLPs (SANCO/5272/2009).

42 Reprt f Seminar n Applicatin Techniques fr Micrbial Pest Cntrl Prducts and Semichemicals: Use Scenaris and Assciated Risks, held n 31 March 2014; Publicatin in preparatin. The applicatin technique and/r use pattern fr semichemicals can differ significantly frm cnventinal chemicals and hence may result in a different risk and/r risk assessment. The seminar can cntribute t a better understanding f applicatin techniques and expsure assessment in different scenaris and facilitate the registratin f semichemicals.

43 Overview Macr- rganisms Micrbial Pesticides Semichemicals/ Phermnes Btanicals/ Plant extracts

44 Btanicals/Plant Extracts OECD-seminar n Characterisatin and Analyses f Btanicals fr the use in Plant prtectin Prducts 30 March 2011; OECD Series n Pesticides N. 72, BPSG Wrkplan : Develp guidance n btanicals/plant extracts EU-expert grup n "btanicals"

45 EU-expert grup n "btanicals" (1) EU Draft Wrking Dcument n Plant Extracts SANCO/10472/2003 clearly needs t be updated. The intentin is t prepare an EU Guidance Dcument, pssibly t be 'upgraded' at a later stage t an OECDdcument. Key chapters: Identificatin, characterisatin, analyses, manufacturing prcess, histry f use and expsure. The use f 'btanicals' can be prmted as part f IPM strategies.

46 EU-expert grup n "btanicals" (2) The fllwing infrmatin has been taken int accunt: experience f ther nn-eu OECD cuntries (e.g. USA and Canada that have already sme guidance in place), infrmatin frm the EU Bicides guidance dcument, publicatins f EFSA (e.g. scientific pinins). Revised data requirements (identificatin, metablism): "Fr plant extracts, a different apprach may be taken and adequately justified".

47 Guidance Dcument n "btanicals" (1) Based n the taxnmy and/r current knwledge f the btanical surce three grups can be distinguished. Grup 1 Btanical active substances that are knwn t have n unacceptable effects n humans, animals and the envirnment and are based n materials with knwn specificatins e.g. fd grade. Nt necessary t identify each cmpnent but demnstrate that each sample is cmparable t the specificatin.

48 Guidance Dcument n "btanicals" (2) Grup 2 Btanical active substances fr which taxnmy and current knwledge indicates that the btanical active substance may cntain cmpnents f pssible cncern fr humans, animals and/r the envirnment. In this case these cmpnents shuld be identified and quantified. Grup 3 Btanical active substances that are nt based n a material with an established specificatin. Cmplete identificatin and characterisatin is needed.

49 Guidance Dcument n "btanicals"(3) Guidance Dcument has been 'nted' n 20 March 2014 and is applicable t applicatins submitted frm 1 Octber 2014 nwards (SANCO/11470/2012). Circulated t OECD-BPSG: cmments received frm CAN and CrpLife. Current dcument shuld be amended t address cmments and align with different definitins used by regulatrs in ther cuntries/regins. Explre pssibly t upgrade the EU Guidance Dcument t an OECD-dcument.

50 Cntents What are bilgical pesticides? Hw is OECD invlved in the regulatin f bipesticides? What is the state f play f different categries f bilgical pesticides? Cnclusins

51 Gene Gene New techniques RNA interference (RNAi) DNA mrna Transfers infrmatin frm gene t cnstruct a prtein Trigger Prtein Prduced DNA mrna When cells make dsrna it specifically targets an mrna X RNA brken up Prtein nt prduced

52 Cnclusins The BPSG has achieved a lt f prgress twards harmnisatin and wrk sharing thrugh the develpment f guidance and wrking dcuments, the 2008 and 2013 Wrkshps and subsequent seminars. The BPSG and EU Wrking Grup n Bipesticides will cntinue t facilitate in clse cperatin with ther stakehlders the evaluatin and assessment f bipesticides and prmte harmnisatin and wrk sharing. We have t prepare urselves fr new techniques f bicntrl.

53 Thank yu fr yur attentin Any questins?