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Protection goals in environmental risk assessment: a practical approach

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Abstract

Policy protection goals are set up in most countries to minimise harm to the environment, humans and animals caused by human activities. Decisions on whether to approve new agricultural products, like pesticides or genetically modified (GM) crops, take into account these policy protection goals. To support decision-making, applications for approval of commercial uses of GM crops usually comprise an environmental risk assessment (ERA). These risk assessments are analytical tools, based on science, that follow a conceptual model that includes a problem formulation step where policy protection goals are considered. However, in most countries, risk assessors face major problems in that policy protection goals set in the legislation are stated in very broad terms and are too ambiguous to be directly applicable in ERAs. This means that risk assessors often have to interpret policy protection goals without clear guidance on what effects would be considered harmful. In this paper we propose a practical approach that may help risk assessors to translate policy protection goals into unambiguous (i.e., operational) protection goals and to establish relevant assessment endpoints and risk hypotheses that can be used in ERAs. Examples are provided to show how this approach can be applied to two areas of environmental concern relevant to the ERAs of GM crops.

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References

  • Alix A, Coulson M (2012) Ecological risk assessment of pesticides: linking non-target arthropod testing with protection goals (ESCORT 3)

  • Devos Y, Aguilera J, Diveki Z, Gomes A, Liu Y, Paoletti C, du Jardin P, Herman L, Perry JN, Waigmann E (2013) EFSA’s scientific activities and achievements on the risk assessment of genetically modified organisms (GMOs) during its first decade of existence: looking back and ahead. Transgenic Res. doi:10.1007/s11248-013-9741-4

    Google Scholar 

  • Evans J, Wood G, Miller A (2006) The risk assessment–policy gap: an example from the UK contaminated land regime. Environ Int 32:1066–1071

    Article  PubMed  Google Scholar 

  • Garcia-Alonso M (2010) Current challenges in environmental risk assessment: the assessment of unintended effects of GM crops on non-target organisms. IOBC/WPRS Bull 52:57–63

    Google Scholar 

  • Garcia-Alonso M, Jacobs E, Raybould A, Nickson TE, Sowig P, Willekens H, Van der Kouwe P, Layton R, Amijee F, Fuentes A, Tencalla F (2006) A tiered system for assessing the risk of genetically modified plants to non-target organisms. Environ Biosaf Res 5:57–65

    Article  Google Scholar 

  • Gray A (2012) Problem formulation in environmental risk assessment for genetically modified crops: a practitioner’s approach. In: ICGEB (ed) Collection of biosafety reviews, vol 6

  • Herman R, Garcia-Alonso M, Layton R, Raybould A (2013) Bringing policy relevance and scientific discipline to environmental risk assessment for genetically modified crops. Trends Biotechnol 31(9):493–496

    Google Scholar 

  • Keough HL, Blahna DJ (2006) Achieving integrative, collaborative ecosystem management. Conserv Biol 20:1373–1382

    Article  PubMed  Google Scholar 

  • Macdonald P (2012) Developing workable regulatory frameworks for the environmental release of transgenic plants. In: ICGEB (ed) Collection of biosafety reviews

  • MEA (2005) Millenium ecosystem assessment, ecosystem and human well-being: synthesis. Washington DC

  • Moonen A-C, Barberi P (2008) Functional biodiversity: an agroecosystem approach. Agric Ecosyst Environ 127:7–21

    Article  Google Scholar 

  • Nienstedt KM, Brock TCM, van Wensem J, Montforts M, Hart A, Aagaard A, Alix A, Boesten J, Bopp SK, Brown C, Capri E, Forbes V, Köpp H, Liess M, Luttik R, Maltby L, Sousa JP, Streissl F, Hardy AR (2012) Development of a framework based on an ecosystem services approach for deriving specific protection goals for environmental risk assessment of pesticides. Sci Total Environ 415:31–38

    Article  PubMed  CAS  Google Scholar 

  • Raybould A (2006) Problem formulation and hypothesis testing for environmental risk assessments of genetically modified crops. Environ Biosaf Res 5:119–125

    Article  Google Scholar 

  • Raybould A, Gray A (1993) Genetically modifid crops and hybridization with wild relatives: a UK perspective. J Appl Ecol 30:199–219

    Google Scholar 

  • Raybould A, Tuttle A, Shore S, Stone T (2010) Environmental risk assessments for transgenic crops producing output trait enzymes. Transgenic Res 10:595–609

    Google Scholar 

  • Raybould A, Vlachos D (2011) Non-target organism effects tests on Vip3A and their application to the ecological risk assesment for cultivation of MIR162 maize. Transgenic Res 20:599–611

    Article  PubMed  CAS  Google Scholar 

  • Raybould A, Kilby P, Graser G (2013) Characterising microbial protein test substances and establishing their equivalnce with plant produced proteins for use in risk assessments for transgenic crops. Transgenic Res 22:445–460

    Article  PubMed  CAS  PubMed Central  Google Scholar 

  • Romeis J, Bartsch D, Bigler F, Candolfi M, Gielkens M, Hartley S, Hellmich RL, Huesing J, Jepson P, Layton R, Quemada H, Raybould A, Rose RI, Schiemann J, Sears MK, Shelton AM, Sweet J, Vaituzis S, Wolt J (2006) Moving through the tiered and methodological framework for non-target arthropod risk assessment of transgenic insecticidal crops. International symposium on the biosafety of genetically modified organisms pp 62–67

  • Romeis J, Bartsch D, Bigler F, Candolfi M, Gielkens M, Hartley S, Hellmich RL, Huesing J, Jepson P, Layton R, Quemada H, Raybould A, Rose RI, Schiemann J, Sears MK, Shelton AM, Sweet J, Vaituzis S, Wolt J (2008) Assessment of risk of insect-resistant transgenic crops to nontarget arthropods. Nat Biotechnol 26(2):203–207

    Article  PubMed  CAS  Google Scholar 

  • Romeis J, Lawo NC, Raybould A (2009) Making effective use of existing data for case-by-case risk assessments of genetically engineered crops. J Appl Entomol 133:571–583

    Article  Google Scholar 

  • Romeis J, Hellmich RL, Candolfi M, Carstens K, De Schrijver A, Gatehouse A, Herman R, Huesing J, McLean M, Raybould A, Shelton AM, Waggoner A (2011) Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants. Transgenic Res 20:1–22

    Article  PubMed  CAS  PubMed Central  Google Scholar 

  • Romeis J, Raybould A, Bigler F, Candolfi M, Hellmich RL, Huesing J, Shelton AM (2013) Deriving criteria to select arthropod species for laboratory tests to assess the ecological risks from cultivating arthropod-resistant genetically engineered crops. Chemosphere 90:901–909

    Article  PubMed  CAS  Google Scholar 

  • Sanvido O, Romeis J, Gathmann A, Gielkens M, Raybould A, Bigler F (2012) Evaluating environmental risks of genetically modified crops: ecological harm criteria for regulatory decision-making. Environ Sci Policy 15:82–91

    Article  Google Scholar 

  • Stewart CN, Halfhill MD, Warwick SI (2003). Transgene introgression from genetically modified crops to their wild relatives. Nat Rev 4(October): 806–817

    Google Scholar 

  • Tscharntke T, Clough Y, Wanger TC, Jackson L, Motzke I, Perfecto I, Vandermeer J, Whitbread A (2012) Global food security, biodiversity conservation and the future of agricultural intensification. Biol Conserv 151:53–59

    Article  Google Scholar 

  • USEPA (2003) Generic ecological assessment endpoints (GEAEs) for ecological risk assessment risk assessment forum U.S. Environmental Protection Agency Washington, DC

  • Wolt JD, Keese P, Raybould A, Fitzpatrick JW, Burachik M, Gray A, Olin SS, Schiemann J, Sears M, Wu F (2010) Problem formulation in the environmental risk assessment for genetically modified plants. Transgenic Res 19(3):425–436

    Article  PubMed  CAS  PubMed Central  Google Scholar 

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Correspondence to Monica Garcia-Alonso.

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Garcia-Alonso, M., Raybould, A. Protection goals in environmental risk assessment: a practical approach. Transgenic Res 23, 945–956 (2014). https://doi.org/10.1007/s11248-013-9760-1

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