Environmental Risk Assessment
Environmental Risk Assessment of active substances
The European Food Safety Authority (EFSA), based in Parma, Italy, is the European agency with responsibility for the regulation of plant protection products. In June 2011 the earlier Plant Protection Products Directive (91/414/EEC) was replaced by the Plant Protection Products Regulation (EC 1107/2009) in an effort to provide greater uniformity across European member states. The main elements of this regulation are:
- Active substances, safeners, and synergists are approved at EU level, following assessment against a set of agreed criteria which cover both the intrinsic properties of active substances, safeners, and synergists (i.e. an assessment of their hazard), and the risks arising from the use of plant protection products which contain them.
- Active substances that have been shown to be without unacceptable risk to people or the environment are added to the list of approved active substances contained in Commission Implementing Regulation (EU) No 540/2011. Inclusion is for a maximum period of 15 years but is renewable, and can be subject to conditions and be reviewed at any time.
- Substances which demonstrate a less favourable toxicological profile but which still satisfy the criteria for approval may be approved as candidates for substitution.
- Existing active substances which have already undergone a review under the earlier Directive (91/414/EEC) are considered to be approved.
- Products containing approved active substances are authorised by Member States working within three “zones” which cover the different climates and landscapes from northern to southern Europe. Member States in each zone share assessments and recognise each other’s authorisations.
- Member States can only authorise the marketing and use of plant protection products after an active substance has been added to the list of approved active substances.
- Products containing active substances approved as candidates for substitution are subject to comparative assessment. Such products are withdrawn if that assessment identifies alternative products or methods of control which are significantly safer and can be used without significant drawbacks.
- The Regulation also applies to safeners and synergists in plant protection products. New safeners and synergists will need to undergo the same procedures and satisfy the same requirements as for active substances. Existing safeners and synergists will undergo a review programme to be established by the adoption of a Regulation by 14 December 2014 (Article 26).
There are also Directives or Regulations covering biocides, cosmetics, and veterinary and human medicines, which contain many similar provisions for environmental protection to the Plant Protection Products Regulation, including hazard, exposure, and risk assessments. The Biocides Regulation (EC 528/2012) replaced an earlier Directive and applied from 1st September 2013. ECHA is the European agency, based in Helsinki, Finland, responsible for the regulation of biocides (as well as all chemicals falling under the REACH regulation). The Cosmetics Regulation (EC 1223/2009), implemented in July 2013, also replaces an earlier Directive; environmental concerns associated with cosmetics ingredients are considered to be covered by the REACH regulation. Veterinary medicines are regulated by Directive 2009/9/EC and human medicines by Regulation EC 726/2004. The European Medicines Agency, based in London, England, is the European agency responsible for regulating both human and veterinary medicines.
How can AG-HERA help you?
We have extensive experience of regulatory needs when authorising active substances. Mark Crane has been a member of the UK Veterinary Products Committee and the Environmental Panel of the Advisory Committee on Pesticides. He has assisted many clients in deriving objectively defensible ecotoxicity and exposure values and in advocating these values to regulatory authorities.
We have published the following papers and book chapters on plant protection products, biocides, human and veterinary medicines, endocrine modulators, and nanoparticles since 2005:
Plant protection products and biocides
- Wheeler JR, Maynard SK, Crane M. 2014. Are acute and chronic saltwater fish studies required for plant protection and biocidal product active substance risk assessment? Environmental Toxicology and Chemistry, in review.
- Wheeler JR, Maynard SK, Crane M. 2014. A re-evaluation of fish early life stage tests for predicting reproductive and longer term toxicity. Environmental Toxicology and Chemistry, in review.
- Weltje L, Simpson P, Gross M, Crane M, Wheeler JR. 2013. Comparative acute and chronic sensitivity of fish and amphibians: a critical review of data. Environmental Toxicology and Chemistry 32: 984-994.
- Farrar D, Barry T, Hendley P, Crane M, Mineau P, Russell MH, Odenkirchen EW. 2010. Issues underlying the selection of distributions. In: Warren-Hicks W, Hart A (eds.) Application of Uncertainty Analysis to Ecological Risk of Pesticides , CRC Press, Boca Raton, FL.
- Leung KMY, Grist EPM, Morley NJ, Morritt D, Crane M. 2006. Chronic toxicity of tributyltin to development and reproduction of the European freshwater snail Lymnaea stagnalis (L.). Chemosphere 66:1358-1366.
- Crane M, Norton A, Leaman J, Chalak A, Bailey A, Yoxon M, Smith J, Fenlon. 2006. Acceptability of pesticide impacts on the environment: what do United Kingdom stakeholders and the public value? Pest Management Science 62:5-19.
- Newman MC, Crane M, Holloway G. 2006. Does pesticide risk assessment in the European Union assess long-term effects? Reviews of Environmental Contamination and Toxicology 187:1-66.
- Crane M. 2006. How should we communicate pesticide risks to non-target organisms to stakeholders and the wider public? SETAC Globe 7(4):16-17.
- Shore RF, Crocker DR, Akcakaya HR, Bennett RS, Chapman PF, Clook M, Crane M, Dewhurst IC, Edwards PJ, Fairbrother A, Ferson S, Fischer D, Hart ADM, Holmes M, Hopper MJ, Lavine M, Leopold A, Luttik R, Mineau P, Moore DRJ, Mortenson SR, Noble DJ, O’Connor RJ, Roelofs W, Sibly RM, Smith G, Spendiff M, Springer TA. Thompson HM, Topping C. 2005. Case study 1: How to calculate appropriate deterministic long-term toxicity to exposure ratios (TERs) for birds and mammals. Ecotoxicology 14:877-893.
- Roelofs W, Crocker DR, Shore RF, Moore DRJ, Smith G, Akcakaya HR, Bennett RS, Chapman PF, Clook M, Crane M, Dewhurst IC, Edwards PJ, Fairbrother A, Ferson S, Fischer D, Hart ADM, Holmes M, Hopper MJ, Lavine M, Leopold A, Luttik R, Mineau P, , Mortenson SR, Noble DJ, O’Connor RJ, Sibly RM, Spendiff M, Springer TA. Thompson HM, Topping C. 2005. Case study 2: Probabilistic modeling of long-term effects of pesticides on individual breeding success in birds and mammals. Ecotoxicology 14:895-923.
Human and veterinary medicines
- Crane M, Gross M, Maycock DS, Grant A, Fossum BH. 2011. Environmental quality standards for a deltamethrin sea louse treatment in marine finfish aquaculture based on survival time analysis and species sensitivity distributions. Aquaculture 42:68-72.
- Singer AC, Howard BM, Johnson AC, Knowles CJ, Jackman S, Accinelli C, Bernard I, Bird S, Boucard T, Boxall A, Brian J, Caracciolo AB, Cartmell E, Chubb C, Churchley J, Costigan S, Crane M, Dempsey MJ, Dorrington B, Fick J, Holmes J, Hutchinson T, Karcher F, Kelleher SL, Marsden P, Noone G, Nunn MA, Oxford J, Rachwal T, Roberts N, Roberts M, Saccà ML, Sanders M, Straub JO, Terry A, Thomas D, Toovey S, Townsend R, Voulvoulis N, Watts C, Wells U. 2008. Meeting Report: Risk Assessment of Tamiflu® use under Pandemic Conditions—Report from an Interdisciplinary Workshop. Environmental Health Perspectives 116:1563-1567.
- Crane M, Barrett K, Boxall A. 2008. Introduction. In: Crane M, Boxall ABA, Barrett K (eds.) Veterinary Medicines in the Environment. CRC Press, Boca Raton, FL pp 1-6.
- Boxall A, Crane M, Corsing C, Eirkson C, Tait A. 2008. Uses and inputs of veterinary medicines in the environment. In: Crane M, Boxall ABA, Barrett K (eds.) Veterinary Medicines in the Environment. CRC Press, Boca Raton, FL pp 7-20.
- de Knecht J, Boucard T, Brooks BW, Crane M, Eirkson C, Gerould S, Koschorreck J, Scheef G, Solomon KR, Yan Z. 2008. Environmental risk assessment and management of veterinary medicines. In: Crane M, Boxall ABA, Barrett K (eds.) Veterinary Medicines in the Environment. CRC Press, Boca Raton, FL pp 21-56.
- Crane M, Barrett K, Boxall A. 2008. Workshop conclusions and recommendations. In: Crane M, Boxall ABA, Barrett K (eds.) Veterinary Medicines in the Environment. CRC Press, Boca Raton, FL pp 181-186.
- Crane M, Watts CW, Boucard T. 2006. Chronic aquatic environmental risks from exposure to human pharmaceuticals. Science of the Total Environment 367:23-41.
- Crane M, Gross M, Matthiessen P, Ankley G T, Axford S, Bjerregaard P, Brown R, Chapman P, Dorgeloh M, Galay-Burgos M, Green J, Hazlerigg C, Janssen J, Lorenzen K, Parrott J, Rufli H, Schäfers C, Seki M, Stolzenberg H-C, van der Hoeven N, Vethaak D, Winfield IJ, Zok S, Wheeler J. 2010. Multi-criteria decision analysis of test endpoints for detecting the effects of endocrine active substances in fish full life cycle tests. Integrated Environmental Assessment and Management 6:378-379.
- Gross M, Daginnus K, Deviller G, de Wolf W, Dungey S, Galli C, Gourmelon A, Jacobs M, Matthiessen P, Micheletti C, Nestmann E, Pavan M, Paya-Perez A, Ratte H-T, Safford B, Sokull-Klüttgen B, Stock F, Stolzenberg H-C, Wheeler J, Willuhn M, Worth A, Zaldivar Comenges JM, Crane M. 2010. Thresholds of toxicological concern for endocrine active substances in the aquatic environment. Integrated Environmental Assessment and Management 6:2-11.
- Wheeler JR, Gimeno S, Crane M, Lopez-Juez E, Morritt D. 2005. Vitellogenin: A review of analytical methods to detect (anti) estrogenic activity in fish. Toxicology Mechanisms and Methods 15:293-306.
- Owen R, Crane M, Deanne K, Handy RD, Linkov I, Depledge MH. 2009. Strategic approaches for the management of environmental risk uncertainties posed by nanomaterials. In: Linkov I (ed.) Nanotechnologies: Risks and Benefits, Springer. pp 369-384.
- Handy RD, von der Kammer F, Lead JR, Hassellöv M, Owen R, Crane M. 2008. The ecotoxicology and chemistry of manufactured nanoparticles. Ecotoxicology 17:287-314.
- Crane M, Handy R, Garrod J, Owen R. 2008. Ecotoxicity test methods and environmental hazard assessment for engineered nanoparticles. Ecotoxicology 17:421-437.