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Guidance to Define Protection Goals for Environmental Risk Assessment in 1 3 Relation to Biodiversity and Ecosystem Services

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Guidance to Define Protection Goals for Environmental Risk Assessment in 1 3 Relation to Biodiversity and Ecosystem Services EFSA Journal 20YY;volume(issue):NNNN 1 DRAFT Guidance Document 2 Guidance to define protection goals for environmental risk assessment in 1 3 relation to biodiversity and ecosystem services 4 5 Scientific Committee2, 3 6 European Food Safety Authority (EFSA), Parma, Italy 7 ABSTRACT 8 Maintaining a healthy environment and conserving biodiversity are major policy protection goals. 9 Legal frameworks therefore require the protection of human, animal and plant health, and the 10 environment. A challenge, however, is that protection goals outlined in legislation are often too 11 general and broad to be directly applicable for environmental risk assessment (ERA) performed by the 12 European Food Safety Authority (EFSA). Therefore, general and broadly formulated protection goals 13 need to be translated into specific protection goals. This Guidance presents a framework, which 14 accounts for biodiversity and ecosystem services, to make policy protection goals operational for use 15 in EFSA’s ERAs. The proposed approach follows three sequential steps: (1) the identification of 16 relevant Ecosystem Services; (2) the identification of service providing units supporting/providing 17 relevant Ecosystem Services; and (3) the specification of the degree/parameters of protection of the 18 service providing units using interrelated dimensions. This last step involves the specification of the 19 ecological entitiy and attribute to be protected, the spatial and temporal scale of protection, and the 20 magnitude of acceptable effect. Considerations are proposed against which the selected options can be 21 justified, in order to promote transparency and consistency when specifying the degree/parameters of 22 protection. The proposed approach is considered adequate to provide a framework to derive specific 23 protection goals in all different ERAs conducted by EFSA. 24 © European Food Safety Authority, 2015 25 26 27 KEY WORDS 28 Protection goals, environmental risk assessment, plant protection products, genetically modified 29 organisms, feed additives, invasive alien species. 1 On request from EFSA, Question No EFSA-Q-2013-00289, adopted on DD Month YYYY. 2 Scientific Committee members: Jan Alexander, Diane Benford, Qasim Chaudhry, John Griffin, Anthony Hardy, Michael John Jeger, Robert Luttik, Ambroise Martin, Simon More, Alicja Mortensen, Birgit Nørrung, Bernadette Ossendorp, Joe Perry, Josef Schlatter, Vittorio Silano, Kristen Sejrsen. Correspondence: [email protected] 3 Acknowledgement: The Scientific Committee wishes to thank the members and the chair* of the Working Group on Protection Goal: Theo Brock, Tony Hardy, Christer Hogstrand, Robert Luttik*, Joe Perry, Joerg Romeis and Wopke Van Der Werf for the preparatory work and EFSA staff Yann Devos, Angelo Maggiore, Sylvie Mestdagh, Agnes Rortais, Reinhilde Schoonjans, Franz Streissl, Jose Tarazona, Sara Tramontini and Maria Vittoria Vettori for the support provided to this scientific opinion. Suggested citation: EFSA ACRONYM Panel (EFSA Panel Name) [or] Scientific Committee, 20YY. Scientific Opinion on title of the opinion. EFSA Journal 20YY;volume(issue):NNNN, 75 pp. doi:10.2903/j.efsa.20YY.NNNN Available online: www.efsa.europa.eu/efsajournal © European Food Safety Authority, 20YY Framework to make protection goals operational for use in EFSA’s ERA 30 SUMMARY 31 Potential stressors assessed in any area of EFSA’s remit, such as plant protection products, genetically 32 modified organisms and feed additives are subject to a risk analysis and regulatory approval before 33 being placed on the market in the European Union. In this process, the role of the European Food 34 Safety Authority (EFSA) is to independently assess and provide scientific advice to risk managers on 35 possible risks that plant protection products, genetically modified organisms and feed additives may 36 pose to the environment. EFSA also assesses the environmental risks related to the entry and spread of 37 invasive alien species that are harmful for plant health and the effects of their management. 38 39 At EFSA’s 10th anniversary conference (EFSA, 2012), it became apparent that because of the different 40 approaches laid down in the different legislative frameworks and established practices, EFSA’s 41 environmental risk assessment (ERA) schemes have evolved independently in the different areas 42 within its remit (see EFSA, 2011), and that further harmonisation is possible on specific topics. EFSA 43 therefore mandated (under mandate M-2013-0098) the Scientific Committee to harmonise EFSA’s 44 ERA schemes with regard to: (1) defining protection goals for ERA in relation to biodiversity and 45 ecosystem services; (2) coverage of endangered species in environmental risk assessments at EFSA; 46 and (3) temporal and spatial recovery of non-target organisms for ERAs. The Scientific Committee 47 therefore prepared three separate scientific documents to address the abovementioned issues. 48 49 Maintaining a healthy environment and conserving biodiversity are major goals of environmental 50 protection. Legal frameworks therefore require the protection of human, animal and plant health, and 51 the environment. This necessitates the characterisation of protection. A challenge, however, is that 52 protection goals outlined in legislation are often too general and vague to be directly applicable for 53 ERA. Therefore, general and broadly formulated protection goals need to be translated into concise 54 and concrete measurable endpoints, and scientifically testable hypotheses. 55 56 The overall aim of this guidance is to propose a common approach, using biodiversity and ecosystem 57 services, to operationalise environmental protection goals for ERA in a harmonised manner in the 58 different sectors of EFSA’s responsibility. 59 60 The approach follows three sequential steps: (1) the identification of relevant ecosystem services; (2) 61 the identification of service providing units supporting/providing relevant ecosystem services and (3) 62 the specification of the degree/parameters of protection of the service providing units using 63 interrelated dimensions. This last step involves the specification of the ecological entitiy and attribute 64 to be protected, the spatial and temporal scale of protection and the magnitude of acceptable effect. 65 66 Considerations are proposed against which the selected options can be justified, in order to promote 67 transparency and consistency when specifying the degree/parameters of protection. The proposed 68 approach is considered adequate for a harmonised framework to derive specific protection goals across 69 all different ERAs conducted by EFSA. 70 71 The general protection goals are defined in the legislation. The definition of specific protection goals 72 should take place in dialogue between risk assessors and risk managers since it involves normative 73 considerations, which cannot be set through natural sciences alone. This dialogue helps to define the 74 framework in which risk assessors have to operate when performing ERAs. More precisely, in the 75 context of defining specific protection goals, risk assessors may elaborate different options and 76 describe the environmental consequences for each of them. 77 78 Risk managers decide which option(s) need to be set as specific protection goal(s). Risk managers base 79 the granting of marketing authorisations on the work of the risk assessors, who do the assessment for 80 each area within the remit of EFSA under the respective legislative frameworks and according to the 81 EFSA Guidance. 82 EFSA Journal 20YY;volume(issue):NNNN 2 Framework to make protection goals operational for use in EFSA’s ERA 83 TABLE OF CONTENT 84 Abstract .................................................................................................................................................... 1 85 Key words ................................................................................................................................................ 1 86 Summary .................................................................................................................................................. 2 87 Table of Content ....................................................................................................................................... 3 88 Background and Terms of reference as provided by EFSA ..................................................................... 4 89 Interpretation of the terms of reference .................................................................................................... 4 90 Aim of the guidance ................................................................................................................................. 5 91 Data and Methodology ............................................................................................................................. 6 92 1. Introduction ..................................................................................................................................... 7 93 1.1. General protection goals and areas of environmental concern as set in the sectorial 94 legislation for EFSA areas................................................................................................................... 7 95 1.2. Specification of protection goals and problem formulation as part of the environmental risk 96 assessment ..........................................................................................................................................
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