Deliverable 30: Strategy for implementation of results REBECA ...

Deliverable 30:Strategy for implementation of resultsREBECARegulation of Biological Control AgentsSpecific Support ActionProject no. SSPE-CT-2005-022709Contract Start Date:Duration: 24 monthsProject Coordinator: Ralf-Udo Ehlers, Christian-Albrechts University of KielREBECA deliverable no 30, Page 1

Document ClassificationTitleStrategy for implementation of resultsDeliverable 30Reporting Period 2Contractual Date of Delivery December 2007Actual Date of Delivery December 2007AuthorsWork packageDisseminationNatureVersionKeywordsAnita FjelstedWP7PublicReport1.0 FinalImplementationDocument HistoryThe document is based on the recommendations from a questionnaire (“mainobstacles and proposals”, 2006), as well as discussions and recommendationsexpressed at the following 8 REBECA workshops:1. Innsbruck workshop on microbials April 2006;2. Brussels workshop on botanicals and semiochemicals June 2006;3. Salzau workshop in September 2006;4. Regulators and industry workshops in Salzau June 2006;5. Regulators workshop in Braunschweig, Germany April 2007;6. Cost-benefit workshop in Finland May, 2007;7. Brussels workshop on botanicals and semiochemicals June 2007;8. Final conference in Brussels September 2007.Document AbstractThis document presents a list of all the REBECA proposals apart from the proposalson invertebrate BCAs, (please refer to deliverable 22 for information regardingimplementation of proposals related to invertebrate regulation) and for each proposalit describes how it can be implemented, who will be the responsible partner forimplementing it, and a suggestions for timeframe within which the process forimplementation should be initiated and where relevant when it should be finalised.REBECA deliverable no 30, Page 2

Table of contentsIntroduction................................................................................................................. 41. General regulation of microbials, botanicals and semiochemicals.......................... 52. Microbials ............................................................................................................. 133. Botanicals ............................................................................................................. 174. Semiochemicals ................................................................................................... 19REBECA deliverable no 30, Page 3

IntroductionThe aim of the REBECA project is to propose improvements in the registrationprocess of biological control agents (microbials as well as invertebrate biocontrolagents), plant extracts and semiochemicals (here collectively called ‘BCAs’).This document contains an overview of all the REBECA proposals which have beenagreed upon within the group throughout the project period (apart from the proposalsregarding invertebrate BCA). For each proposal the possible measures to obtain animplementation of the proposals are suggested; the partners that will be responsibleand involved in the implementation process; expected timeframe for the initiation ofthe implementation.The proposals and measures for implementation are listed in the following fourtables:1. General regulation of microbials, botanicals and semiochemicals2. Microbials3. Botanicals4. SemiochemicalsThe REBECA project also includes a workpackage on invertebrate biocontrol agents.The main proposal from that workpackage is the establishment of a pan-Europeanregulatory system for invertebrate BCAs. The options for implementing such asystem are described in a separate document (refer to Deliverable No 22).REBECA deliverable no 30, Page 4

1. General regulation of microbials, botanicals and semiochemicalsAll the listed proposals in this first table have been discussed in details during several REBECA workshops. For further informationabout each specific proposal please consult the REBECA document: Proposals on how to accelerate regulation and reduction of fees(Deliverable No 27). This document contains a detailed background for all the proposals, further description of the proposals and listsof advantages and disadvantages of the proposals.Proposal Measures to obtain implementation Level ofimplementationImproved communication between regulators and applicantsInvolvedpartnersTimeframePre-submission meetingsshall be established as aroutine in all EU MemberStates.There is a need for an EU guidance document. The Commission(DG Sanco) should initiate this work by asking a small expertgroup representing a few member states (alternatively ask a singlemember state) to prepare a first draft guidance document whichwill subsequently be discussed among all member states andfinally agreed upon and taken note of by the Standing Committeeof Food Safety and Animal Health.The guidance document should describe: the purpose of presubmissionmeetings; a model describing how to carry out thesemeetings; and it should include specification for the presubmissioninformation package (see below).In case any expenses (travel expenses) will be involved in thiswork it should be covered by the Commission.EU and nationallevelTheCommission(DG Sanco),all EUmemberstates2008informa-Pre-submissiontion packageA detailed description on how to prepare a pre-submissioninformation package should be initiated by the Commission (DGSanco) and developed by the same expert group as mentionedabove. This description should be part of the above mentioned EUguidance document.A similar description exists in the US-EPA and in the PestEU and nationallevelTheCommission(DG Sanco),all EUmemberstates2008REBECA deliverable no 30, Page 5

Proposal Measures to obtain implementation Level ofimplementationManagement Regulatory Agency, Canada. These documents canbe used as a basis for this work within EU.A first draft of such a pre-submission information package isdescribed in REBECA Deliverable No 27.A more detailed proposal on a pre-submission informationpackage for micro-organisms is described in the table onmicrobials below.Applicants given theopportunity of attendingpart time atexpert/evaluationmeetingsThe usefulness of such a system will first of all have to bediscussed by the EFSA, the Commission (DG Sanco) and memberstates. If it will be agreed to allow applicants attending part time atthe expert meetings (which are normally hosted by the EFSA).EFSA should establish a routine where they prior to each expertmeeting remind the Rapporteur member states responsible for theactive ingredients listed on the agenda to consider whether itwould be relevant inviting the involved applicants to participate inpart of the expert meeting.The Rapporteur member state would subsequently be responsiblefor the communication and agreement with the applicant.The applicants would of course have to cover the travel expensesfor attending such meetings them selves.InvolvedpartnersEU level EFSA, TheCommission(DG Sanco)and all EUmemberstatesTimeframe2008Improved communication between regulators of BCAsEnlargement of theOECD-BPSG and furtheractivities to take placewithin the groupThe OECD Bio-Pesticide Steering Group should be given higherpriority by OECD member states. 1) Further experts should attendthe meetings; 2) further resources from national regulatoryauthorities should be allocated to activities in relation to this group(expenses to attend meetings, expertise to develop guidanceOECD levelOECD-BPSGand theOECDmemberstates2008-…REBECA deliverable no 30, Page 6

Proposal Measures to obtain implementation Level ofimplementationdocuments and papers for discussion in the group etc.); 3) Furthermeetings/workshops should be arranged within the group.An OECD-BPSG workshop will take place in Washington DC inApril 2008. One of the main points on the draft agenda isincreased communication between regulators including presubmissionmeetings and pre-submission information package.Further and more regularexpert-/evaluationmeetings on the specificgroups of BCAsWhen active substances such as micro-organisms, botanicals orsemiochemicals will be discussed in expert meetings, thesemeetings should be arranged specifically for each of these types ofactive substances, and the meetings should be arranged as oftenas necessary. Such meetings should be attended by people withhigh level of expertise within these particular fields. This will inparticular be relevant during the evaluation of the 4 th listsubstances, where specific meetings on microbials, botanicals orsemiochemicals should be arranged.EFSA is responsible for planning such meetings and for invitingthe relevant national experts.InvolvedpartnersEU level EFSA 2008TimeframeEstablish expert groupsfor BCAsAs soon as possible, the EFSA should ask member states tonominate national experts/regulators for three expert groups, sincethe EFSA does not have expertise to deal with these specialisedfields:1. Microbials (such a group already exists and is establishedby the Commission, however the EFSA should take overthis role and establish a formal group and further expertsshould be encouraged to join the group)2. Botanicals3. SemiochemicalsEU level EFSA 2008REBECA deliverable no 30, Page 7

Proposal Measures to obtain implementation Level ofimplementationOne member state should be appointed as chair for the group.EFSA should make the necessary funding available for regularmeetings within these groups.InvolvedpartnersTimeframeLessons learned guidance documents from the 4 th stageLessons learnedguidance documents tobe used in presubmissionmeetings todeterminedatarequirements/ waiversand generic safetyprofilesMember states involved in the preparation of 4 th list DARs onmicrobials, semiochemicals and botanicals should write severallessons learned guidance documents that can be used byapplicants and regulators evaluating such types of substances inthe future.These documents should be discussed within the three expertgroups established (semiochemicals, botanicals and microbials). Ifrelevant, the documents could be further developed into OECDguidance documents. At least they should be communicated toe.g. the OECD BioPesticide Steering Group.National level, EUlevel, OECD levelCoordinationby the expertgroups/chairsof thesegroupsRapporteurmemberstates2008-2009Fees and financial supportFees for microbials andsemiochemicals to belowered substantiallyA few member states take large fees for reviewing activesubstances of low risk (e.g. microbials) since often the work has tobe carried out on a cost-recovery basis. The grower’sorganisations, consumer organisations and the industry shouldinitiate political discussions within these member states in order torequest further low risk products on the market and suggestreduced fees. In most cases a political decision to lower the feeshas to take place.National levelGrower’sorganisations,Consumerorganisation,Industry,regulators,policy people.2008- …REBECA deliverable no 30, Page 8

Proposal Measures to obtain implementation Level ofimplementationFinancial support andguidance for registrationof new microbials,botanicalsandsemiochemicalsGeneric approach in risk assessmentRegulatory authorities and ‘policy people’ should take active part insuch discussions.Only a few member states have a specific policy that supports anincrease in the number of low risk products/alternative plantprotection products on their market. The grower’s organisations,organic farming organisations, consumer organisations and theindustry should initiate political discussions within member stateswith the view to: get politicians and regulators to focus on thepotential of these products; request the regulators to give higherpriority to such products and to give further guidance to applicantsof such product types; raise funds that can support the applicationprocess of such products.Apart form such activities at national level, internationalorganisations (consumer organisations, grower organisations,NGOs, organic farming organisations) should initiate similardiscussions at EU level.Regulators should take active part in such discussions. Furthermore regulators from member states where such activities havebeen initiated should regularly communicate the experience andeffect of such initiatives to their colleagues.National level andEU levelInvolvedpartnersNational andinternationalGrower’sorganisations,Consumerorganisation,Industry,regulatorsTimeframe2008- …Establishriskmanagement strategiestaking a generic approachwherever possible –evaluating certain activesubstances as a groupWhen applicants submit applications for new BCAs they should inthe dossier stress if they believe that certain part of the dossier isan issue that can be dealt with by a generic approach, (e.g. fungalmetabolites) and the dossier should contain a detailed reasoningfor this.Regulators should always be open for discussions with applicantson possibilities of evaluating certain active substances as a group,EU levelApplicantsandregulators2008 - …REBECA deliverable no 30, Page 9

Proposal Measures to obtain implementation Level ofimplementatione.g. microorganisms at a higher taxonomic level, certainsemiochemical groups, etc. A more generic approach can takeplace for active substances when adequate experience and data isavailable for such generic evaluations.InvolvedpartnersTimeframeStrict and short timelinesStrict and short timelinesfor the EU riskassessment as well as fornational registrationsshould be included in theEU regulationApplicants and regulators should be in close contact prior to thesubmission of an application (pre-submission meetings etc.) whichis likely to result in a submission of good and complete dossiers,which the regulators thus will find easy to evaluate.As mentioned above, an increased political awareness andsupport is likely to secure further resources for the regulatorswhich will help them to be able to carry out the risk assessmentwithin a short timeframe, provided the necessary data are includedin the dossier.The alternative/low risk substances should be given high priorityduring the EU evaluations. Expert meetings discussing theseproduct types should take place regularly and without delay. Asalready mentioned applicants should attend part time at suchmeetings to solve potential misunderstandings and answerquestions right away, which is likely to speed up the procedure.Member states to agree on strict and short timelines for the EUand national evaluations/authorisations.In the new regulation to replace Directive 91/414/EEC stricttimelines are included (also for national applications based onmutual recognition/zonal approach). However, this is still underdiscussion in Council.National and EUlevelApplicants,regulators,EFSA, theCommission,memberstates2008- …REBECA deliverable no 30, Page 10

Proposal Measures to obtain implementation Level ofimplementationEfficacy evaluationInvolvedpartnersTimeframePotentialfutureintroduction of efficacyevaluation into the EUevaluation needs to beaccompanied by aguidance document onevaluation criteria in orderto obtain a harmonisedefficacy evaluationbetween the memberstates.Authorities should acceptmodified trial protocols,provided that theapplicant can justify themodifications (e.g. forsemiochemicals andmicrobials)EFSA should establish an efficacy expert group consisting ofefficacy experts from a number of member states and the EFSA.Through meetings and other means of communication this groupshould draft guidance documents describing requirements forefficacy data and criteria for BCAs. It should contain guidance foreach of the three groups: microbials, botanicals andsemiochemicals.The draft should subsequently be discussed among all memberstates and finally be taken note of by the Standing Committee ofFood Safety and Animal Health.However, some of the suggested changes here will need to beincluded in the negotiations of the new regulation e.g.: theproposal of giving authorisations for 5 years followed by data onefficacy.A first guidance document/position paper on efficacy for microbialshas recently been prepared by the OECD-BPSG.EU and nationallevelEFSAmemberstatesand2008-2009Long-term effects oninsect populations of e.g.semiochemicals orbaculoviruses should aswell be considered sincethe effect may not beobserved until the nextgeneration or thefollowing year.Data requirements shouldREBECA deliverable no 30, Page 11

Proposal Measures to obtain implementation Level ofimplementationbe flexible and adapted tothe special properties ofthe particular type ofactive substance.Products with minorbeneficial effects shouldbe acceptable.If the active substance isnot directly applied tocrops(e.g.semiochemicals) thereshould not be arequirement for cropdestruction after efficacytrials.To avoid unnecessaryrepetition of experimentalwork, the use of efficacydata from other areasshould be activelyencouragedFor low risk substances, itshould be possible to get5 year registrationswithout presentingefficacy data. During the 5years of market useefficacy data should begeneratedandsubsequently bepresented for furtherInvolvedpartnersTimeframeREBECA deliverable no 30, Page 12

Proposal Measures to obtain implementation Level ofimplementationregistrations after the 5years.InvolvedpartnersTimeframe2. MicrobialsFor further information about each specific proposal please consult the REBECA document: Proposals for improved regulatoryprocedures for microbial BCA (Deliverable 10).Proposal Measures to obtain implementation Level ofimplementationBaculovirusesInvolvedpartnersTimeframeAnnex I inclusion ofBaculoviruses at a highertaxonomic level than atisolate levelA REBECA proposal was discussed among all stakeholders at aREBECA meeting and afterwards in the EU Microbial ExpertGroup, where the proposal was agreed upon. This proposal hasnow been implemented. The first Baculovirus species (Spodopteraexigua NPV) was included in Annex I, and came into force on 1 stDecember 2007. A guidance document on the procedure wastaken note of by the Standing Committee of Food Safety andAnimal Health in January 2008. The proposal has thus successfullybeen implemented.EU levelREBECAstakeholders, EUmicrobial expertgroup, theCommission2007Proposal on thresholdlevels for microbialcontamination inBaculovirus productsThe above mentioned REBECA proposal contained a table withthreshold levels of microbial contaminants. This part of theproposal as well as a Canadian proposal for an OECD guidancedocument on threshold levels of microbial contaminants in allmicrobial plant protection products should be further discussedOECD and EUlevelOECD-BPSG,EU microbialexpert group2008-2009REBECA deliverable no 30, Page 13

Proposal Measures to obtain implementation Level ofimplementationwithin the OECD BioPesticide Steering Group. The output shouldbe an OECD agreed guidance document on threshold levels formicrobial contaminants in all types of microbial plant protectionproducts.InvolvedpartnersTimeframeData requirementsSimplified dossierpreparation based on apre-submissioninformation packageThe REBECA proposal with a detailed list of information/datarequired for the pre-submission information package for microbialsshould be further discussed within a specialised group such as theEU microbial expert group as well as in the OECD BPSG. Thereare two possibilities: preferably an OECD guidance documentshould be developed alternatively the EU expert group shoulddevelop a proposal for an EU guidance document which shouldsubsequently be discussed among all EU member states andfinally taken note of in the Standing Committee of Food Safety andAnimal Health.EU level orOECD levelEU microbialexpert group,OECD BPSG,EFSA, allmember states,the Commission2008- …The document should include criteria for waivers of data and adecision tree allowing applicants to submit a simplified dossier.The expenses for meetings required for the EU microbial expertgroup to discuss the information package should be covered by theEFSA.More specific datarequirements/ deletion ofsome data requirements/description of waivers fora number of dataAfter the adoption of a new EU regulation of plant protectionproducts (expected in 2008), it is anticipated that within 18 monthsfrom the date the regulation will come into force the present EUdata requirements should be revised and transferred intoone/several EU regulations.EU level EU microbialexpert group,EFSA, all EUmember states,The2008-…REBECA deliverable no 30, Page 14

Proposal Measures to obtain implementation Level ofimplementationrequirements:Genetic stabilityHuman infectivity andother toxicological datarequirementsExposure dataSensitisationMetabolitesPersistance in theenvironmentEco-toxicology and nontargetorganismsLow riskIt is therefore important that the EU microbial expert group soonshould start discussions on certain parts of the data requirementstaking into account the lessons learned since adoption of thepresent data requirements. A new proposal of data requirementsshould be proposed and discussed among all member states andfinally adopted as a new regulation not later than 18 months afterthe new EU regulation of plant protection products have come intoforce.Apart of a slightly revised set of data requirements, a number ofguidance documents should be developed. Partners, who shouldbe involved in preparing such guidance documents is, apart fromregulators and national experts, the industry (IBMA) and academia.The expenses for the meetings required for the EU microbial expertgroup to discuss the data requirements and the guidancedocuments should be covered by the EFSA.InvolvedpartnersCommission,Industry,AcademiaTimeframeDeveloping a risk index tocomparatively assessenvironmental risks posedby microbial andconventional pest controlagents.The tool could in the future be used to distinguish between highand low risk active substances/product types, and thereby indicatewhich active substances should be included into Annex I for e.g. 15years as opposed to 10 years (according to the Commissionproposal for a new EU regulation).It could help member states to distinguish between high and lowrisk products in case these member states would like todifferentiate the taxes on pesticides and fees for evaluation andauthorisation of products. Further more the tool could giveguidance to growers that would like to comply with rules for IPM.This will be important after the framework directive of sustainableEU/OECDlevelOECD RiskReductionSteering groupand BPSG, TheCommission, EUmember states2008 - …REBECA deliverable no 30, Page 15

Proposal Measures to obtain implementation Level ofimplementationuse of pesticides have come into force.The proposal should be discussed in the OECD Risk ReductionSteering Group and among member states and the Commissionduring the period of negotiation of a new EU regulation.A seminar attended by the OECD Risk Reduction Steering Groupand the Bio Pesticide Steering Group on “Identification of barriersand risks for low risk plant protection products & biocides” isforeseen.InvolvedpartnersTimeframeREBECA deliverable no 30, Page 16

3. BotanicalsFor further information about each specific proposal please consult the REBECA document: Improved regulatory procedures forbotanicals and semiochemicals and list of knowledge gabs (Deliverable No 16).Proposal Measures to obtain implementation Level ofimplementationData requirementsInvolvedpartnersTimeframeA new guidancedocument should cover allplant extracts.Relaxation on dataregarding identification ofplant constituents that arenot the active substance.These substances shouldbe characterized by groupanalysis.It should not be necessaryto achieve 98% closure.EFSA should as soon as possible establish an EU expert group onbotanicals. This group, consisting of RMS from the 4 th listbotanicals, other experts from member states, the Commission andthe EFSA, should during and after the EU evaluation of the 4 th listbotanicals further develop the draft document SANCO/10472 andsubsequently ask the Standing Committee of Food Safety andAnimal Health to take note of such a guidance document onbotanicals.Expenses for the meetings required for the EU Botanical expertgroup to discuss the guidance document should be covered by theEFSA.EU level EFSA andthe EUBotanicalexpert group,all memberstates2008 - …Quality assurance/manufacturing methods:The methods ofmanufacture should bedescribed in an adequatemanner, taking intoaccount measures toprevent the formation ofhazardous microbialdecay products duringmanufacture.REBECA deliverable no 30, Page 17

Proposal Measures to obtain implementation Level ofimplementationLow riskInvolvedpartnersTimeframeBotanicals of lowrisk/concern should beidentified early in theapplication/evaluationprocess and be subject toreduceddatarequirementsIn general applicants and national regulatory authorities shouldmeet early in the application process (at pre-submission meetings)and discuss this issue in order to agree on waivers. If specificissues need further discussion, these can be put forward fordiscussions in the EU Botanical expert group.EU level andnational levelApplicants,RMS,Botanicalexpert group2008 - …During the preparation ofthe dossier as well asduring evaluation andregistration the history ofsafe use in plantprotection should be takeninto account as well as theuse for other purposes(e.g. food ingredients)Regulators and applicants should discuss this issue at the presubmissionmeetings and later in the process within the Botanicalexpert group.EU level RMS andBotanicalexpert group2008 - …REBECA deliverable no 30, Page 18

4. SemiochemicalsFor further information about each specific proposal please consult the REBECA document: Improved regulatory procedures forbotanicals and semiochemicals and list of knowledge gabs (Deliverable No 16).Proposal Measures to obtain implementation Level ofimplementationThe process of Annex I inclusionInvolvedpartnersTimeframeCollective listing ofStraight-chainedLepidopteranPheromones (SCLP) inAnnex IAs already mentioned, the EFSA should establish an expertgroup on semiochemicals as soon as possible. When the DARfor the 4 th list group of SCLP has been finalised the EFSAshould initiate a discussion within the expert group on this issue(as well as the issues below). The group should communicatetheir conclusion to the Standing Committee of Food Safety andAnimal Health preferably as a short guidance document whichthe Standing Committee should take note of.EU level EFSA andSemiochemicalexpert group2008SCLP should beregarded as low risksubstances, as defined inthe draft for the newregulation of plantprotection products (art.22 and 46)This proposal should be discussed by the Semiochemical expertgroup after the finalisation of the EU risk assessment of the 4 thlist SCLPs (and the new regulation has come into force).EU levelSemiochemicalexpert group2008-2009Data requirements for SCLPRelaxations on the datarequired for theevaluation of “impurities”which are themselvesAll the proposals regarding data requirements for SCLP shouldbe discussed in the Semiochemical expert group (consisting ofthe RMS for the 4 th list SCLPs, the EFSA, the Commission andseveral experts from member states). Either specific dataEU level andOECD levelExpert group onsemiochemicals,comprising:RMS, The EFSA2008-…REBECA deliverable no 30, Page 19

Proposal Measures to obtain implementation Level ofimplementationSCLPrequirements for SCLP pheromones should be developed or anEU guidance document which should subsequently be takennote of by the Standing Committee.Relaxation on request for5 batch analysis forSCLP that are only rarelyproducedRelaxations on the datarequired for evaluation ofSCLPs which are used inquantities comparable tonatural emissions (up to375 g/ha per year)Data requirements for other semiochemicalsIn order to obtain harmonisation, these issues should also bediscussed within the OECD BioPesticide Steering Group.The OECD-Guidance document 12 need to be revised.Involvedpartnersand theCommission.OECD-BPSGTimeframeCase-by-case relaxationson the data required forevaluation of othersemiochemicals takinginto account the naturalemissions and the historyof exposure to thesubstance.More generic relaxationson the requested datashould be envisagedwhen 3-5 similarsubstances have beenevaluated.As soon as there will be adequate experience on suchsubstances within member states/the EFSA these substancesshould be discussed in the Semiochemical expert group and ageneric approach should be taken to the extent possible.The issue should at that stage also be discussed within theOECD-BPSG in order to obtain harmonisation.This activity is not envisaged to take place within the next coupleof years.EU level andOECD levelExpert group onsemiochemicals,comprising:RMS, the EFSAand theCommission.OECD-BPSG2010?Harmonisation with biocidesREBECA deliverable no 30, Page 20

Proposal Measures to obtain implementation Level ofimplementationInvolvedpartnersTimeframeHarmonisation in the datarequirements of plantprotection products andbiocidessincesemiochemicals mayoften be used for bothpurposes (wheresemiochemicals are usedin human or veterinarymedicine, harmonizationshould also beenvisaged).The Semiochemical expert group should discuss this issue andcome up with a proposal of harmonised data requirements anddossier format which DG Sanco should forward to DGEnvironment with the view of having a discussion between thetwo DGs and experts and thereby obtain harmonisation.EU levelExpert group onsemiochemicals,comprising:RMS, the EFSAand theCommission.DG Sanco andDG Environment2008-2009Joint dossier submittedfor registration of asemiochemical for bothpurposes should beacceptedREBECA deliverable no 30, Page 21

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