TECHNICAL REPORT APPROVED: 11 April 2017 doi:10.2903/sp.efsa.2017.en-1213 Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs) in light of confirmatory data Abstract European Food Safety Authority (EFSA) The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA s scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the confirmatory data and their use in the risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs) are presented. The current report summarises the outcome of the consultation process organised by the rapporteur Member State Austria and presents EFSA s scientific views and conclusions on the individual comments received. European Food Safety Authority, 2017 Keywords: Straight Chain Lepidopteran Pheromones (SCLPs), peer review, confirmatory data, risk assessment, pesticide, attractant Requestor: European Commission Question number: EFSA-Q-2017-00234 Correspondence: pesticides.peerreview@efsa.europa.eu www.efsa.europa.eu/publications EFSA Supporting publication 2017:EN-1213
Outcome of the consultation on confirmatory data used in risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs) Suggested citation: EFSA (European Food Safety Authority), 2017. Technical report on the outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs) in light of confirmatory data. EFSA supporting publication 2017:EN-1213. 13 pp. doi:10.2903/sp.efsa.2017.en-1213 ISSN: 2397-8325 European Food Safety Authority, 2017 Reproduction is authorised provided the source is acknowledged. www.efsa.europa.eu/publications 2 EFSA Supporting publication 2017:EN-1213
Outcome of the consultation on confirmatory data used in risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs) Summary Straight Chain Lepidopteran Pheromones (SCLPs) was included in Annex I to Directive 91/414/EEC on 1 September 2009 by Commission Directive 2008/127/EC, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. In 2014 the approval has been amended by Commission Implementing Regulation (EU) No 918/2014, following the peer review performed by EFSA (EFSA, 2014). It was a specific provision of the approval that the applicant was required to submit to the European Commission a second batch of confirmatory data as regards exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones. EFSA finalised a technical report on the first batch of confirmatory data on 13 May 2016. In accordance with the specific provision, the applicant, IBMA SCLP Task Force, submitted an updated dossier in December 2016, which was evaluated by the designated rapporteur Member State (RMS), Austria, in the form of a revision to the draft assessment report (DAR). In compliance with guidance document SANCO 5634/2009-rev.6.1, the RMS distributed the revised DAR to Member States, the applicant and EFSA for comments on 30 January 2017. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 22 March 2017. EFSA added its scientific views on the specific points raised during the commenting phase in column 4 of the reporting table. The current report summarises the outcome of the consultation process organised by the RMS, Austria, and presents EFSA s scientific views and conclusions on the individual comments received. For the representative product Isomate-CLR that is a retrievable passive dispenser and its associated straight chain lepidopteran pheromone active substances: (E,E)-8,10-dodecadien-1-ol, 1-tetradecanol, 1-dodecanol, (Z)-9-tetradecen-1-yl acetate, (Z)-11-tetradecen-1-yl acetate sufficient information was available to finalise the human and animal health and environmental risk characterisation. However the information provided did not address the confirmatory data requirement set, as the calculations only covered one way of application (passive dispenser). For the second representative formulation Checkmate CM-F (a microencapsulated spray application), an exposure assessment comparison with natural releases from the target lepidopteran insects was not available. www.efsa.europa.eu/publications 3 EFSA Supporting publication 2017:EN-1213
Outcome of the consultation on confirmatory data used in risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs) Table of contents Abstract... 1 Summary... 3 1. Introduction... 5 1.1. Background and Terms of Reference as provided by the requestor... 5 1.2. Interpretation of the Terms of Reference... 5 2. Assessment... 6 Documentation provided to EFSA... 6 References... 6 Abbreviations... 7 Appendix A Collation of comments from Member States, applicant and EFSA on the pesticide risk assessment for the active substance Straight Chain Lepidopteran Pheromones (SCLPs) in light of confirmatory data and the conclusions drawn by EFSA on the specific points raised... 8 www.efsa.europa.eu/publications 4 EFSA Supporting publication 2017:EN-1213
Outcome of the consultation on confirmatory data used in risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs) 1. Introduction 1.1. Background and Terms of Reference as provided by the requestor Straight Chain Lepidopteran Pheromones (SCLPs) was included in Annex I to Directive 91/414/EEC 1 on 1 September 2009 by Commission Directive 2008/127/EC 2, and has been deemed to be approved under Regulation (EC) No 1107/2009 3, in accordance with Commission Implementing Regulation (EU) No 540/2011 4, as amended by Commission Implementing Regulation (EU) No 541/2011 5. EFSA previously finalised a Conclusion on this active substance on 13 December 2013 (EFSA, 2014). Following the peer review performed by EFSA, the approval has been amended by Commission Implementing Regulation (EU) No 918/2014 6. It was a specific provision of the approval that the applicant was required to submit to the European Commission by 31 December 2016 further confirmatory information as regard: exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones In accordance with the specific provision, the applicant, IBMA SCLP Task Force, submitted an updated dossier in December 2016, which was evaluated by the designated rapporteur Member State (RMS), Austria, in the form of a revision to the draft assessment report (DAR) (Austria, 2017). In compliance with guidance document SANCO 5634/2009-rev.6.1 (European Commission, 2013), the RMS distributed the revised DAR to Member States, the applicant and EFSA for comments on 30 January 2017. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 22 March 2017. EFSA added its scientific views on the specific points raised during the commenting phase in column 4 of the reporting table. The current report summarises the outcome of the consultation process organised by the RMS, Austria, and presents EFSA s scientific views and conclusions on the individual comments received. 1.2. Interpretation of the Terms of Reference On 22 December 2014 the European Commission requested EFSA to provide scientific assistance with respect to the risk assessment of confirmatory data following approval of an active substance in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. EFSA s scientific views on the specific points raised during the commenting phase conducted with Member States, the applicant and EFSA on the risk assessment of confirmatory data for Straight Chain Lepidopteran Pheromones (SCLPs) are presented. To this end, a technical report containing the finalised reporting table is being prepared by EFSA. The deadline for providing the finalised report is 20 April 2017. On the basis of the reporting table, the European Commission may decide to further consult EFSA to conduct a full or focused peer review and to provide its conclusions on certain specific points. 1 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, 19.08.1991, p.1-32. 2 Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances. OJ L 344, 20.12.2008, p.89 111. 3 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309, 24.11.2009, p. 1-50. 4 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, 11.6.2011, p.1-186. 5 Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, 11.6.2011, p.187-188. 6 Commission Implementing Regulation (EU) No 918/2014 of 22 August 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance Straight Chain Lepidopteran Pheromones. OJ L 251, 23.8.2014, p.24 26. www.efsa.europa.eu/publications 5 EFSA Supporting publication 2017:EN-1213
Outcome of the consultation on confirmatory data used in risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs) 2. Assessment The comments received on the pesticide risk assessment for the active substance Straight Chain Lepidopteran Pheromones (SCLPs) in light of confirmatory data and the conclusions drawn by the EFSA are presented in the format of a reporting table. The comments received are summarised in column 2 of the reporting table. The RMS considerations of the comments are provided in column 3, while EFSA s scientific views and conclusions are outlined in column 4 of the table. The finalised reporting table is provided in Appendix A of this report. Documentation provided to EFSA 1. Austria, 2017. Revision of the draft assessment report on Straight Chain Lepidopteran Pheromones (SCLPs), in light of confirmatory data, February 2017. Available online: www.efsa.europa.eu. 2. Austria, 2017. Reporting table, comments on the pesticide risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs), in light of confirmatory data, March 2017. References EFSA (European Food Safety Authority), 2014. Conclusion on the peer review of the pesticide risk assessment of the active substance Straight Chain Lepidopteran Pheromones. EFSA Journal 2014;12(1):3524, 537 pp. doi:10.2903/j.efsa.2014.3524 European Commission, 2013. Guidance document on the procedures for submission and assessment of confirmatory information following approval of an active substance in accordance with Regulation (EC) No 1107/2009. SANCO 5634/2009-rev. 6.1 European Commission, 2014. Guidance document on semiochemical active substances and plant protection products. SANTE/12815/2014 rev. 5.2 www.efsa.europa.eu/publications 6 EFSA Supporting publication 2017:EN-1213
Outcome of the consultation on confirmatory data used in risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs) Abbreviations AIR IV Annex I renewal 4 th batch DAR draft assessment report GAP good agricultural practice PEC predicted environmental concentration RMS rapporteur Member State www.efsa.europa.eu/publications 7 EFSA Supporting publication 2017:EN-1213
Outcome of the consultation on confirmatory data used in risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs), Appendix A Collation of comments from Member States, applicant and EFSA on the pesticide risk assessment for the active substance Straight Chain Lepidopteran Pheromones (SCLPs) in light of confirmatory data and the conclusions drawn by EFSA on the specific points raised General comments on overall document and assessment No. Column 1 Reference to addendum to assessment report (1) Overall assessment/document Column 2 Comments from Member States / applicant / EFSA FR: no comment Column 3 Evaluation by rapporteur Member State Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data Noted. Mammalian toxicology No. Column 1 Reference to addendum to assessment report Column 2 Comments from Member States / applicant / EFSA (1) Vol. 3, B.6.13 SCLPs TF: The release rate of 8E,10Edodecadienol due to the use of CheckMate CM-F according to the proposed GAP is equal to 50.0 mg/ha h. The natural release rate of Cydia pomonella is 9.1 mg/h/ha, so the exposure caused by CheckMate CM-F does not significantly differ from the background derived from a severe outbreak of C. pomonella in real field conditions. According to SANTE/12815/2014, a discussion on human health for this representative use will be included in Column 3 Evaluation by rapporteur Member State We agree that the exposure caused by the application of Checkmate CM-F in comparison with natural backgroud levels of the active substance should be discussed in the course of the AIR IV evaluation of SCLPs. Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data The information briefly set out in column 2 was not available / included in the confirmatory data submission. The information included in column 2 is insufficient for any conclusion to be drawn www.efsa.europa.eu/publications 8 EFSA Supporting publication 2017:EN-1213
Outcome of the consultation on confirmatory data used in risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs), (2) B.6 Toxicology, additional text for the confirmatory data the forthcoming supplementary dossier for the AIR-IV process for SCLPs. The natural release rate of 9.1 mg/h/ha is 3-fold the value stated in SANTE/12815/2014 as the occupancy was then assumed to be of one larvae per fruit, not taking into consideration the study published by Ferro and Hardwood in 1972 (Ferro, D.N. and Harwood, R.F. 1972: Intraspecific larval competition by the Codling Moth, Laspeyresia pomonella. Environmental Entomology. 2(5): 783-789) that shown that the carrying capacity for a 4-cm-diameter apple is approximately three larvae per apple. Please note that this is a conservative approach since such a small apple has been used for laboratory studies with not further growing. EFSA: Please refer to the EFSA comments for the exposure assessment under section B.8. (3) Vol. 3, B.6.13, Exposure DE: For the spray application of the microencapsulated formulation a realistic exposure assessment for operator, worker, bystander and resident is still missing. The assessment for the passive dispenser is agreed. See response by RMS under section B.8. Noted. See column 4 entries at environmental fate and behaviour comments 2 and 3. See column 4 entry at environmental fate and behaviour comment 3 www.efsa.europa.eu/publications 9 EFSA Supporting publication 2017:EN-1213
Outcome of the consultation on confirmatory data used in risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs), Environmental fate and behaviour No. Column 1 Reference to addendum to assessment report (1) Vol. 3, Introduction - Information on the lead formulations Column 2 Comments from Member States / applicant / EFSA SCLPs TF: The release rate of 8E,10Edodecadienol due to the use of CheckMate CM-F according to the proposed GAP is equal to 50.0 mg/ha h. The natural release rate of of Cydia pomonella is 9.1 mg/h/ha, so the exposure caused by CheckMate CM-F does not significantly differ from the background derived from a severe outbreak of C. pomonella in real field conditions. According to SANTE/12815/2014, an environmental risk assessment for this representative use considering the endpoints of new ecotoxicology studies and appropriate PEC values is ongoing and will be included in the forthcoming supplementary dossier for the AIR-IV process for SCLPs. The natural release rate of 9.1 mg/h/ha is 3-fold the value stated in SANTE/12815/2014 as the occupancy was then assumed to be of one larvae per fruit, not taking into consideration the study published by Ferro and Hardwood in 1972 (Ferro, D.N. and Harwood, R.F. 1972: Intraspecific larval competition by the Codling Moth, Laspeyresia pomonella. Environmental Column 3 Evaluation by rapporteur Member State We agree that the environmental risk assessment of Checkmate CM-F should be discussed in detail in the course of the AIR IV evaluation of SCLPs. Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data The assessment briefly outlined in column 2 was not available / included in the confirmatory data submission. The information included in column 2 is insufficient for any conclusion to be drawn. www.efsa.europa.eu/publications 10 EFSA Supporting publication 2017:EN-1213
Outcome of the consultation on confirmatory data used in risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs), Entomology. 2(5): 783-789) that shown that the carrying capacity for a 4-cm-diameter apple is approximately three larvae per apple. Please note that this is a conservative approach since such a small apple has been used for laboratory studies with not further growing. (2) Information on the lead formulation / exposure calculations, pages 4-8 EFSA: We agree with the calculations comparing the release rate from the intended use of the representative product Isomate-CLR (retrievable passive dispenser) with natural releases from the target lepidopteran insects. Therefore EFSA would agree that the confirmatory data requirement has been addressed with regard to just one way of application (passive dispenser) and the straight chain lepidopteran pheromone active substances: (E,E)-8,10-dodecadien-1- ol, 1-tetradecanol, 1-dodecanol, (Z)- 9-tetradecen-1-yl acetate, (Z)-11- tetradecen-1-yl acetate contained in Isomate-CLR. This is as the SANTE/12815/2014 guidance was followed for these calculations. EFSA notes that calculations are still outstanding for the other SCLP active substances, that were the subject of the EFSA 2014 Conclusion. Noted. The RMS notes that for the preparation of the DAR it was agreed that bridging of studies within a chemical group of SCLPs (i.e. acetates, alcohols and aldehydes) was considered an acceptable approach. Outstanding calculations according to SANTE/12815/2014 for other SCLP active substances, that were subject of the EFSA conclusion, have to be provided and evaluated for the assessment of plant protection products at zonal/national level. For the representative product Isomate-CLR that is a retrievable passive dispenser and its associated straight chain lepidopteran pheromone active substances: (E,E)-8,10- dodecadien-1-ol, 1-tetradecanol, 1- dodecanol, (Z)-9-tetradecen-1-yl acetate, (Z)-11-tetradecen-1-yl acetate sufficient information was available to finalise the environmental risk characterisation. (3) Information on the lead formulation / exposure calculations, page 8 EFSA: Overall the information provided did not address the confirmatory data requirement set as the calculations only covered one way of application (passive dispenser) for another way of Noted. The applicant announced that an environmental risk assessment for the representative use of Checkmate CM-F considering the endpoints of new ecotoxicology studies and appropriate The information provided did not address the confirmatory data requirement set, as the calculations only covered one way of application (passive dispenser) for another way of www.efsa.europa.eu/publications 11 EFSA Supporting publication 2017:EN-1213
Outcome of the consultation on confirmatory data used in risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs), application, (i.e. the second representative formulation Checkmate CM-F a microencapsulated spray application), an exposure assessment comparison with natural releases from the target lepidopteran insects is not available. (4) Vol. 3, B.8 DE: Since the environmental exposure assessment for the spray application is still outstanding this type of application can not be supported. PEC values is ongoing and will be included in the forthcoming supplementary dossier for the AIR IV process for SCLPs. Furthermore, a discussion on human health for this representative use will be included in the dossier, both according to SANTE/12815/2014. Noted. application, (i.e. the second representative formulation Checkmate CM-F a microencapsulated spray application), an exposure assessment comparison with natural releases from the target lepidopteran insects was not available. See column 4 entry at environmental fate and behaviour comment 3. Ecotoxicology No. Column 1 Reference to addendum to assessment report (1) Vol. 3, Introduction - Information on the lead formulations Column 2 Comments from Member States / applicant / EFSA SCLPs TF: The original confirmatory data request was for Exposure of humans and the environment resulting from the different ways of application of SCLPs as plant protection product, in comparison with natural background levels of those pheromones. No request for risk assessment was made. The risk assessment belongs to the product authorisation evaluation at MS level. According to SANTE/12815/2014, an environmental risk assessment for this representative use considering the endpoints of new ecotoxicology studies and PEC values is ongoing and will be included in the forthcoming Column 3 Evaluation by rapporteur Member State We agree that the environmental risk assessment of Checkmate CM-F should be discussed in detail in the course of the AIR IV evaluation of SCLPs. Column 4 EFSA s scientific views on the specific points raised in the commenting phase conducted on the RMS s assessment of confirmatory data The information briefly set out in column 2 was not available / included in the confirmatory data submission. The information included in column 2 is insufficient for any conclusion to be drawn. www.efsa.europa.eu/publications 12 EFSA Supporting publication 2017:EN-1213
Outcome of the consultation on confirmatory data used in risk assessment for Straight Chain Lepidopteran Pheromones (SCLPs), (2) B.9 Ecotoxicology, additional text for the confirmatory data supplementary dossier for the AIR-IV process for SCLPs. A relevant updated environmental risk assessment for this representative use is being conducted considering, among others, the endpoints of new ecotoxicology studies (for a full list please refer to the SCLPs Renewal Application submitted by Suterra on 30th August 2016), appropriate calculated PEC values and a new literature search/review. The studies are in the process of finalisation and will be included, together with the overall risk assessment, in the forthcoming supplementary dossier for the AIR-IV process for SCLPs. EFSA: No comments. Please refer to the EFSA comments for the exposure assessment under section B.8. (3) Vol. 3, B.9 DE: Since the environmental risk assessment for the spray application is still outstanding this type of application can not be supported. See response by RMS under section B.8. Noted. See column 4 entries at environmental fate and behaviour comments 2 and 3. See column 4 entry at environmental fate and behaviour comment 3. www.efsa.europa.eu/publications 13 EFSA Supporting publication 2017:EN-1213