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EUROPEAN COMMISSION DIRECTORATE-GENERAL ENVIRONMENT Directorate B – Natural Capital ENV.B.2 - Biodiversity Ref: SF3-item3-doc1 WORKING DOCUMENT RISK ANALYSIS METHODOLOGY The two major components of risk analysis are risk assessment and risk management. Risk assessment is used to assess the risk posed by an invasive alien species (IAS), while risk management provides a structured assessment of measures that can be used to reduce risk. 1. RISK ASSESSMENT The following information is required in order for a RA to comply with Article 5(1) of Regulation 1143/2014. 1 1a Legal basis Sections on risk assessment requirements for risk assessments in Regulation 1143/2014 - Article 5(1) Information on the organism Art 5(1)(a) a Taxonomy description of the - Provide the taxonomic family, order and class to species with its which the species belongs. taxonomic identity, its - Provide the scientific name and author of the history, and its natural species, as well as a list of the most common and potential range; synonym names (a list of synonyms needs to be developed to support the implementation of a trade ban). While as a general rule a risk assessment should be developed for one single species, there may be cases where it may be justified to develop one risk assessment covering more than one species (e.g. similar species, belonging to the same genus, with similar characteristics and similarly invasive). In any event, if the choice is made to include more than one species in a single risk assessment, this choice must be properly justified and the scope of the risk assessment must be clearly stated. - Describe the most common varieties, breeds or hybrids (the scope of the risk assessment should be very precisely delineated, e.g. if it includes hybrids, which hybrids it includes or if it excludes some varieties, e.g. sterile varieties). - Provide information on the existence of other species that look very similar: Other alien species with similar Confidence level (see horizontal guidance) 1 invasive characteristics, to be avoided as substitute species (in this case preparing a risk assessment for more than one species together may be considered) Other alien species without similar invasive characteristics, potential substitute species Native species, potential misidentification and mis-targeting History - Provide a brief invasion history of the species (in the EU or elsewhere if relevant). Natural and potential range - Indicate continent or part of a continent – climatic zones - habitats where the species is naturally occurring and potential changes thereof 1b Art 5(1)(e) a description of the current distribution of the species, including whether the species is already present in the Union or in neighbouring countries, and a projection of its likely future distribution; Current distribution in the Union or in neighbouring countries - List biogeographic region(s) 1 or marine subregion(s) 2 in the EU where the species is present, where it has established and where it is widely spread - List Member States and neighbouring countries where the species is present, where it has established and where it is widely spread3 Projection of its likely future distribution in the Union or in neighbouring countries - List biogeographic region(s)4 or marine subregion(s)5 in the EU where the species could establish. - List Member States and neighbouring countries where the species could establish 1c Art 5(1)(h) a description of the Known uses for the species - List and describe known uses in the EU and third 1 Use http://www.eea.europa.eu/data-and-maps/figures/biogeographical-regions-in-europe-1 2 Use http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:164:0019:0040:EN:PDF (Article 4) 3 See Annex 1 – To be developed on the basis of SF3-item3-doc2 "Description of presence, establishment and widely spread" 4 Use http://www.eea.europa.eu/data-and-maps/figures/biogeographical-regions-in-europe-1 5 Use http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:164:0019:0040:EN:PDF (Article 4) 2 known uses for the species and social and economic benefits deriving from those uses. countries if relevant Social and economic benefits deriving from those uses - Describe the environmental, social and economic relevance of each of those uses (quantitative and/or qualitative depending on what is available, regardless of the geographic area and scale. Quantifying the above at EU scale might not be possible, but qualitative data or different case studies from across the EU, or third countries if relevant, may provide useful information to inform decision making) 2 2a Probability of entry Art 5(1)(c) a description of the potential pathways of introduction and spread of the species, both intentional and unintentional, including where relevant the commodities with which the species is generally associated Intentional pathways of introduction - List6, describe and classify pathways according to their importance, where possible give details about the specific origins and end points of the pathways. Give an indication of the propagule pressure, including the likelihood of reinvasion after eradication. Unintentional pathways of introduction - List7, describe and classify pathways according to their importance, where possible give details about the specific origins and end points of the pathways. Give an indication of the propagule pressure, including the likelihood of reinvasion after eradication. Commodities with which the species is generally associated - List, describe and classify commodities according to their importance 2b Art 5(1)(d) a thorough assessment of the risk of introduction, establishment and spread in relevant biogeographical regions in current conditions and in foreseeable climate change conditions; Thorough assessment of risk of introduction in current conditions and foreseeable climate change conditions - This assessment should provide insight in the risk of introduction into the EU - It should explain how foreseeable climate change conditions will influence this risk. The risk assessment does not intend to provide a full range 6 Use the following classification of pathways: https://www.cbd.int/doc/meetings/sbstta/sbstta18/official/sbstta-18-09-add1-en.pdf 7 Use the following classification of pathways: https://www.cbd.int/doc/meetings/sbstta/sbstta18/official/sbstta-18-09-add1-en.pdf 3 of simulations on the basis of different climate scenarios, but to inform decision making: in this sense a description of likely introduction within a medium timeframe scenario, with a clear explanation of the assumptions made would be sufficient. 3 3a Probability of establishment Art 5(1)(b) a Reproductive patterns and dynamics, including description of its availability of suitable environmental conditions in reproduction and the EU spread patterns and dynamics including an - List and describe the reproduction mechanisms assessment of whether of the species in relation to the environmental the environmental conditions in the EU. conditions necessary - Give an indication of the propagule pressure of for its reproduction each of those reproduction mechanisms in relation and spread exist; to the environmental conditions in the EU. 3b Art 5(1)(d) a thorough assessment of the risk of introduction, establishment and spread in relevant biogeographical regions in current conditions and in foreseeable climate change conditions; 4 4a Probability of spread Art 5(1)(c) a description of the potential pathways of introduction and spread of the species, both intentional and unintentional, including where relevant the commodities with which the species is generally associated Thorough assessment of risk of establishment in current conditions and foreseeable climate change conditions - This assessment should provide insight in the risk of establishment in (new areas in) the EU. - It should explain how foreseeable climate change conditions will influence this risk. The risk assessment does not intend to provide a full range of simulations on the basis of different climate scenarios, but to inform decision making: in this sense a description of likely introduction within a medium timeframe scenario, with a clear explanation of the assumptions made would be sufficient. Intentional pathways of spread - List8, describe and classify pathways according to their importance, where possible give detail about the specific origins and end points of the pathways. Give an indication of the propagule pressure, including the likelihood of reinvasion after eradication. Unintentional pathways of spread - List9, describe and classify pathways according to their importance, where possible give detail about the specific origins and end points of the pathways. Give an indication of the propagule 8 Use the following classification of pathways: https://www.cbd.int/doc/meetings/sbstta/sbstta18/official/sbstta-18-09-add1-en.pdf 9 Use the following classification of pathways: https://www.cbd.int/doc/meetings/sbstta/sbstta18/official/sbstta-18-09-add1-en.pdf 4 pressure, including the likelihood of reinvasion after eradication. Commodities with which the species is generally associated - List, describe and classify commodities according to their importance 4b 4c 5 5a Art 5(1)(b) a description of its reproduction and spread patterns and dynamics including an assessment of whether the environmental conditions necessary for its reproduction and spread exist; Spread patterns and dynamics, including availability of suitable environmental conditions in the EU Art 5(1)(d) a thorough assessment of the risk of introduction, establishment and spread in relevant biogeographical regions in current conditions and in foreseeable climate change conditions; Thorough assessment of risk of spread in current conditions and foreseeable climate change conditions Probability of impact Art 5(1)(f) a description of the adverse impact on biodiversity and related ecosystem services, including on native species, protected sites, endangered habitats, as well as on human health, safety, and the economy including an assessment of the potential future impact - List and describe the spread mechanisms of the species in relation to the environmental conditions in the EU. - Give an indication of the speed of each of those spread mechanisms in relation to the environmental conditions in the EU. - This assessment should provide insight in the risk of spread into (new areas in) the EU - It should explain how foreseeable climate change conditions will influence this risk. The risk assessment does not intend to provide a full range of simulations on the basis of different climate scenarios, but to inform decision making: in this sense a description of likely introduction within a medium timeframe scenario, with a clear explanation of the assumptions made would be sufficient. Describe and assess10 known and potential future impact on biodiversity and related ecosystem services, with reference to: - the different biogeographic regions where the species could establish - native species, including red list species and species listed in the Birds and Habitats Directives - protected sites, in particular Natura 2000 - endangered habitats, in particular habitats listed in the Habitats Directive - ecosystem services11 Describe known and potential future impact on 10 See Annex 2 – To be developed on the basis of SF3-item3-doc3 "Discussion document on the topic of scoring impacts" 11 See for example classification of ecosystem services: http://biodiversity.europa.eu/topics/ecosystemservices 5 having regard to available scientific knowledge; human health, safety, and the economy: - human health - safety - the economy Clearly differentiate between known and potential future impacts. Known impacts should be described for the EU and for third countries, if relevant. Potential future impacts should be described for the EU only. 5b Art 5(1)(g) an assessment of the potential costs of damage; Assessment of the potential costs of damage on biodiversity and ecosystem services - Describe potential costs in financial or other terms (quantitative and/or qualitative depending on what is available, regardless of the geographic area or scale. Quantifying the above at EU scale might not be possible, but qualitative data or different case studies from across the EU or third countries may provide useful information to inform decision making.) Assessment of the potential costs of damage on human health, safety, and the economy - Describe potential costs in financial or other terms (quantitative and/or qualitative depending on what is available, regardless of the geographic area or scale. Quantifying the above at EU scale might not be possible, but qualitative data or different case studies from across the EU or third countries may provide useful information to inform decision making.) 6 Conclusion Probability of entry (conclusion of section 2) Probability of establishment (conclusion of section 3) Probability of spread (conclusion of section 4) Probability of impact (conclusion of section 5) 7 8 Bibliographic references Information on the quality assurance Author: name, title, affiliation, city, country Peer reviewer 1: name, title, affiliation, city, country Peer reviewer 2: name, title, affiliation, city, country 6 2. RISK MANAGEMENT The following information on risk management is not required in order for a risk assessment to comply with Article 5(1) of Regulation 1143/2014. Nevertheless, Article 4(4) requests Member States to provide evidence that all criteria in Article 4(3) are met. Thus, it is required that this information is compiled by the party submitting the Risk Assessment and annexed to it, to complement it and to further support decision making. In order to allow the Commission to apply those criteria with due consideration to the costs indicated in Article 4(6), Member States should also include such cost information, where available. 9 9a Risk management information12 Legal basis - Criteria for listing in Regulation 1143/2014 - Article 4(3), with due consideration to Article 4(6), not covered by the requirements for risk assessments in Article 5(1) Art 4(3)(e) it is likely that inclusion on the Union list will effectively prevent, minimise or mitigate their adverse impact Sections on risk management Confidence level Effective prevention, minimisation or mitigation measures - Provide information on existing techniques and their effectiveness, as relevant to the species considered in particular on: - measures to prevent introduction, establishment and spread into (new areas in) the EU - early detection and rapid eradication measures; - management measures where the species is widely spread (techniques for eradication, population control or containment of a population) Coverage of the entire EU will likely not be possible, but data or different case studies from across the EU or third countries may provide useful information to inform decision making. As far as possible, impacts on human health and the environment, especially non-targeted species and their habitats should also be described for the above measures. 9b Art 4(6) […] apply with due consideration to the 12 Implementation cost for Member States See Annex 3 – To be developed on the basis of SF3-item3-doc4 "Discussion document on good practices on how to report risk management information." 7 implementation cost for Member States - Provide quantitative and/or qualitative information (depending on what is available) on the costs linked to the techniques described above regardless of the geographic area or scale. Quantifying the above at EU scale will likely not be possible, but qualitative data or different case studies from across the EU or third countries may provide useful information to inform decision making 9c Cost of inaction Art 4(6) […] apply with due consideration to the cost of inaction 9d Art 4(6) […] apply with due consideration to the costeffectiveness - Summarise the cost of inaction (or benefit of action) based upon the information foreseen in Art 5(1)(f) and (g) (see section 5a and 5b) Cost-effectiveness (quantitative and/or qualitative depending on what is available) - Evaluate implementation costs (see section 9b) against the effectiveness (see section 9a) 9e 3. Art 4(6) […] apply with due consideration to the socioeconomic aspects Socio-economic aspects Summarise the socio-economic aspects, based upon - the information on the uses as foreseen under Art 5(1)(h) (see section 1c) - the assessment of the potential costs of damage on human health, safety, and the economy as foreseen under Art. 5(1)(g) (see section 5b) HORIZONTAL GUIDANCE ON THE COMPLETION OF RISK ANALYSIS Each section should be supported by primary bibliographical references. Each section should include the confidence level (high, medium or low confidence), according to a documented methodology13. The scoring of confidence level and impact classification systems used should be referenced by including a link to the underlying publication. 13 Use for example: Harmonia+: http://ias.biodiversity.be/harmoniaplus EPPO: https://www.eppo.int/QUARANTINE/Pest_Risk_Analysis/PRA_intro.htm http://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1001850, see text S1 8 The European dimension should be sufficiently covered, i.e. including the current and potential distribution in the EU (Member States, biogeographical regions and habitats), the known uses in different parts of the EU and the known and potential future impact in the EU. Authors should cover all elements under Article 5(1) of Regulation 1143/2014 and answer all questions required by the Risk Assessment methodology they use. In case there is no available information, authors should explicitly state this and not leave questions unanswered. The risk analysis should be subjected to quality assurance system, including at least: o The risk analysis should have been reviewed by at least two peer reviewers. o Each peer reviewer should have the relevant taxonomic expertise. o The author and the peer reviewers could be working in the same country, but cannot be affiliated to the same scientific institution. The peer review procedure should be briefly described. Please note that every risk analysis will be made publicly accessible online as soon as it is sent to the Commission: authors and peer reviewers may choose not to have their names publicly disclosed. 9