Classical and augmentative biological control against ... - IOBC-WPRS

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Chapter 5 Identified difficulties and conditions for field success of biocontrol. 1. Regulatory aspects Ulf Heilig 1 , Claude Alabouvette 2* and Bernard Blum 1 1 International Biocontrol Manufacturers Association, Blauenstrasse 57, CH-4054 Basel, Switzerland 2 INRA, UMR1229, Microbiologie du Sol et de l'Environnement, 17 rue Sully, F -21000 Dijon, France Objectives The objective of the work was to identify typical hurdles for the placing of biological plant protection products on the market experienced by biocontrol industry or evaluators in the recent past under the European directive 91/414/EEC. In parallel, we examined the new regulation (No 1107/2009/EC 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 and the new directive (N° 2009/128/EC of the European Parliament and of the Council of 21 October 2009) establishing a framework for Community action to achieve the sustainable use of pesticides. These two texts were examined for provisions creating new opportunities for the approval biocontrol agents, their placing on the market and use. In fine, it was the intent to establish a dialogue with EU regulators and evaluators in European institutions, i.e. in the European Commission and in the European Food Safety Agency (EFSA) and to seek solutions in common for the problems encountered. Working method An ad hoc group of representatives from the biocontrol industry and INRA called "Regulatory Review Team" was set up. Two full-day working sessions were organised in which regulatory experts identified difficulties and questions but also described positive experience and perspectives. The work of the Regulatory Review Team active under Reasearch Activity RA4.3 of the ENDURE network was then summarised and reported in a meeting of a delegation of ENDURE partners (IBMA, INRA and ACTA) with representatives of the European Commission (DG SANCO, DG Agriculture, DG Research) and the EFSA in Brussels (24 September 2009). Results A PowerPoint presentation entitled "Gaps - Problems - Opportunities for BCAs in E.U. Regulation - From Past to Future" was prepared for the ENDURE – Commission meeting, with inputs on general regulatory issues, micro-organisms, straight chain lepidopteran pheromones and botanicals. In this document, two key issues related to directive 2001/36/EC annex II B which fixed requirements for microbial active substances were highlighted. Readers may note that since 14 th June 2011 Regulation (EU) No 544/2011 implements these data requirements unchanged to reg. * Current address: AGRENE, 47 rue Constant Pierrot 21000 DIJON, c.ala@agrene.fr 42
Chapter 5 (EC) No 1109/2009. Tests suggested by evaluation experts and intended to establish the genetic stability of a strain do not reflect practical conditions, while in the case of potential microbial contaminants no European reference list is available. The incidence of many pathogens can be excluded by production methods or the geographic location of production sites. Tolerance limits for contamination levels could take into consideration thresholds used in food industry, application levels for the microbial product and naturally occurring background levels. The two issues presented here but also other examples put forward to the Regulatory Review Team lead to the statement that "not all the studies or tests that can be performed for microbials will necessarily yield relevant data". The most important experience with semiochemicals was made during the on-going reassessment of Straight Chain Lepidopteran Pheromones (SCLPs), which were supported by an IBMA Task Force. Regulators and evaluators were flexible in accepting a single common dossier for all compounds notified but although an OECD guidance document recommends data waiving for numerous SCLP requirements, the Rapporteur Member State insisted that all existing data and study reports on all compounds be submitted on the grounds that the requirements of the directive are superior to the guidance document recommendations. So far, the re-assessment procedure resulted in the inclusion with postponed peer review of SCLPs as a group, but 25 substances are also listed individually. New substances can be included in a simplified procedure provided that the applicant has access to the existing dossier. Remaining questions include what industry input will be required during the peer review by EFSA, the E.U. status of a revised OECD guidance document for semiochemicals other than SCLPs, the decision if MRLs are required for sprayable SCLP formulations, and equivalence criteria for SCLP substances. It was also noted that under the Biocidal Product Directive, rules and fees applied to SCLPs created an economic hurdle which resulted in the submission of a dossier for only one compound. Extracts from plants - as long as not purified - consist of mixtures of molecules while data requirements of directive 91/414/EEC maintained under new regulation (EC) No 1107/2009 are basically designed for defined single substances. Thus those requirements often do not fit for mixtures of several substances. It must be decided if the most “active” substance, the one with the highest content in the extract or the whole extract shall be used in studies required for different sections of a dossier i.e. for data on physical-chemical properties, metabolism, toxicology, residues, environmental fate and behaviour, and which data shall be used in risk assessment. While the whole extract can be recommended for use in toxicity studies, it is not convenient for residue, metabolism or environmental studies because in practice it is generally not possible to determine the fate of all compounds contained in an extract. Questions asked by evaluators from several Member States after the issuing of a draft assessment report for Neem extract and its lead substance Azadirachtin A illustrate the difficulties experienced by an applicant in the evaluation process for a botanical. Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market provides for a specific status for "low risk active substances" (article 22). Many biocontrol substances can be expected to qualify for this new category but one exclusion criterion, the half-life in soil, may cause problems for microbial active substances unless it is clearly limited to chemicals. A full set of data is required to gain the status of low risk active substance but products containing them exclusively and without co-formulants of concern will benefit from reduced dossier requirements and time lines for approval. Micro-organisms, plant extracts or other natural substances may also meet the criteria for "Basic substances" provided for in article 23 but the discussion in the ENDURE-Commission meeting made it clear that this category is without interest for manufacturers who intend to market their substances for plant protection. It was noted that the new regulation does not provide for generic waivers i.e. for justifications of non submission of data or exemptions from requirements for groups of substances or products. 43
Page 1 and 2: IOBC OILB WPRS SROP In te rn atio n
Page 3 and 4: Preface One of the Research Activit
Page 5 and 6: LORITO Matteo UNINA, Dip. Arboricol
Page 7 and 8: List of Tables (continued) Table 17
Page 9 and 10: Contents Chapter 1 Potential of bio
Page 11 and 12: Chapter 1 Potential of biological c
Page 13 and 14: Chapter 1 To allow for the analysis
Page 15 and 16: Chapter 1 Table 4: Microbial specie
Page 17 and 18: Chapter 1 Table 4 (continued) T. lo
Page 19 and 20: Chapter 1 Table 4 (continued) Cupri
Page 21 and 22: Chapter 1 other was aiming at ident
Page 23 and 24: Chapter 2 Table 5: References extra
Page 25 and 26: Chapter 2 Table 6: Biocontrol agent
Page 27 and 28: Table 7 (continued) Chapter 2 Hemip
Page 29 and 30: Chapter 2 Bacillus thuringiensis: 2
Page 31 and 32: Chapter 3 - financial; since the de
Page 33 and 34: Chapter 3 Pathogens and Nematodes a
Page 35 and 36: Chapter 3 [Remark: Estimating the s
Page 37 and 38: Chapter 3 100% 80% 60% P = Phytopha
Page 39 and 40: Chapter 3 0,25 4 0,20 % dedicated t
Page 41 and 42: Chapter 3 Table 9: Recent introduct
Page 43 and 44: Chapter 3 Table 9: Recent introduct
Page 45 and 46: Chapter 4 The survey was limited to
Page 47 and 48: Chapter 4 Table 11 (continued) Othe
Page 49 and 50: Chapter 4 SCLPs are included in ann
Page 51: Chapter 4 laminarin is available on
Page 55 and 56: Chapter 6 Identified difficulties a
Page 57 and 58: Chapter 6 Table 12: Evidence for, a
Page 59 and 60: Table 13: Trichoderma-based prepara
Page 61 and 62: Chapter 6 Many preparations have be
Page 63 and 64: Chapter 6 Persistence, physiologica
Page 65 and 66: Chapter 6 Harman, G. E. (2006) Over
Page 67 and 68: Chapter 6 Sharon, E., Bar-Eyal, M.,
Page 69 and 70: Chapter 7 purification, formulation
Page 71 and 72: Chapter 7 Business profitability Co
Page 73 and 74: Chapter 8 A survey was carried out
Page 75 and 76: Chapter 8 80 70 60 %of supply %of a
Page 77 and 78: Chapter 8 efficacy and the price of
Page 79 and 80: Conclusions and perspectives reduct
Page 81 and 82: Appendices For Chapter 1 Appendix 1
Page 83 and 84: Appendix 1 B O Milsana + Brevibacil
Page 85 and 86: Appendix 1 Strawberry (target patho
Page 87 and 88: Appendix 1 Fruits - postharvest (ap
Page 89 and 90: Appendix 1 Legumes (Fabaceae) (targ
Page 91 and 92: Appendix 1 Miscellaneous crops (tar
Page 93 and 94: Appendix 1 Lecanicillium muscarium
Page 95 and 96: Appendix 1 Bedini, S., Bagnoli, G.,
Page 97 and 98: Appendix 1 Dik, A., and Wubben, J.
Page 99 and 100: Appendix 1 Gerlagh, M., Amsing, J.
Page 101 and 102: Appendix 1 Jing, W., Tu, K., Shao,
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Appendix 1 Li, G. Q., Huang, H. C.,
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Appendix 1 Morandi, M. A. B., Maffi
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Appendix 1 Rabea, E. I., Badawy, M.
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Appendix 1 Sutton, J. C., Liu, W.,
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Appendix 1 Zahavi, T., Cohen, L., W
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Appendix 2 Powdery mildew on grapes
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Appendix 2 Powdery mildew on cucurb
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Appendix 2 Askary, H. (1998). Patho
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Appendix 2 Malathrakis, N. E. (2002
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Appendix 3. Inventory of biocontrol
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Appendix 3 References on biocontrol
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Appendix 4. Inventory of biocontrol
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Appendix 4 Grapes (target pathogen
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Appendix 4 References on biocontrol
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Appendix 4 Robak, J., and Ostrowska
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Appendix 5 Cherry (target pathogens
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Appendix 5 Successful inhibition in
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Appendix 5 Smilanick, J. L., Denis-
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Appendix 6 showed protein content o
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Appendix 6 El-Khallal, S. M. (2007)
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Appendix 6 Liu, Q., J. C. Yu, et al
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Appendix 6 of tomato wilt pathogen
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Appendix 6 incognita, respectively.
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Appendix 7. Number of references re
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Appendix 8. Collection of data on a
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Appendix 8 Camporese & Duso, 1996 T
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Appendix 8 8.5 Fungi [5 species] Re
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Appendix 8 Berner & Schnetter, 2002
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Appendix 8 Morandi-Filho et al., 20
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Appendix 8 Marshall D.B. & Lester P
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Appendix 9 9.2. Details on the use
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Appendix 9 References 1. Abd-Rabou
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Appendix 9 50. Gariepy TD, Kuhlmann
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Appendix 9 97. Langewald J, Neuensc
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Appendix 9 146. Roltsch WJ, Meyerdi
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Appendix 10. Substances included in
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Appendix 10 Chemical Dimoxystrobin
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Appendix 10 Chemical Prosulfocarb '
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Appendix 10 Natural other Abamectin
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Appendix 11. Invertebrate beneficia
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Appendix 11 11.2. Invertebrate bioc
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Appendix 11 Coccinella septempuncta
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Appendix 11 Trichogramma brassicae
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Appendix 11 Diglyphus isaea Digline
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