{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T07:58:41Z","timestamp":1789545521821,"version":"build-2803163510"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2014,1,1]],"date-time":"2014-01-01T00:00:00Z","timestamp":1388534400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"},{"start":{"date-parts":[[2013,12,10]],"date-time":"2013-12-10T00:00:00Z","timestamp":1386633600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["setac.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2014,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Environmental hazard assessments for chemicals are carried out to define an environmentally \u201csafe\u201d level at which, theoretically, the chemical will not negatively affect any exposed biota. Despite this common goal, the methodologies in use are very diverse across different countries and jurisdictions. This becomes particularly obvious when international scientists work together on documents with global scope, e.g., in the World Health Organization (WHO) International Program on Chemical Safety. In this article, we present a study that describes the extent of such variability and analyze the reasons that lead to different outcomes in deriving a \u201csafe level\u201d (termed the predicted no effect concentration [PNEC] throughout this article). For this purpose, we chose 5 chemicals to represent well-known substances for which sufficient high-quality aquatic effects data were available: ethylene glycol, trichloroethylene, nonylphenol, hexachlorobenzene, and copper (Cu). From these data, 2 data sets for each chemical were compiled: the full data set, that contained all information from selected peer-review sources, and the base data set, a subsample of the full set simulating limited data. Scientists from the European Union (EU), United States, Canada, Japan, and Australia independently carried out hazard assessments for each of these chemicals using the same data sets. Their reasoning for key study selection, use of assessment factors, or use of probabilistic methods was comprehensively documented. The observed variation in the PNECs for all chemicals was up to 3 orders of magnitude, and this was not simply due to obvious factors such as the size of the data set or the methodology used. Rather, this was due to individual decisions of the assessors within the scope of the methodology used, especially key study selection, acute versus chronic definitions, and size of assessment factors. Awareness of these factors, together with transparency of the decision-making process, would be necessary to minimize confusion and uncertainty related to different hazard assessment outcomes, particularly in international documents. The development of a \u201cguideline on transparency in decision-making\u201d ensuring the decision-making process is science-based, understandable, and transparent, may therefore be a promising way forward. Integr Environ Assess Manag 2014;10:30\u201336. \u00a9 2013 SETAC<\/jats:p>","DOI":"10.1002\/ieam.1473","type":"journal-article","created":{"date-parts":[[2013,8,3]],"date-time":"2013-08-03T01:58:45Z","timestamp":1375495125000},"page":"30-36","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":34,"title":["Predicted no effect concentration derivation as a significant source of variability in environmental hazard assessments of chemicals in aquatic systems: An international analysis"],"prefix":"10.1093","volume":"10","author":[{"given":"Thorsten","family":"Hahn","sequence":"first","affiliation":[{"name":"Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jerry","family":"Diamond","sequence":"additional","affiliation":[{"name":"Tetra Tech, Owings Mills, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart","family":"Dobson","sequence":"additional","affiliation":[{"name":"Birchtree Consultants, Birchtree House, Jones Drove, Angle Bridge, Whittlesey, Peterborough, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Howe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet","family":"Kielhorn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gustav","family":"Koennecker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Lee-Steere","sequence":"additional","affiliation":[{"name":"Australian Environment Agency, Canberra, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inge","family":"Mangelsdorf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uwe","family":"Schneider","sequence":"additional","affiliation":[{"name":"National Standards and Guidelines Office, Environment Canada, Ottawa, Ontario, Hull, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshio","family":"Sugaya","sequence":"additional","affiliation":[{"name":"National Institute for Environmental Studies, Tsukuba Ibaraki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ken","family":"Taylor","sequence":"additional","affiliation":[{"name":"Existing Substances Division, Environment Canada, Gatineau, Quebec, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rick Van","family":"Dam","sequence":"additional","affiliation":[{"name":"Environmental Research Institute of the Supervising Scientist, Darwin, NT, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jenny L","family":"Stauber","sequence":"additional","affiliation":[{"name":"CSIRO Land and Water, Kirrawee, NSW, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2014,1,1]]},"reference":[{"key":"2025010717591154700_ieam1473-bib-0001","author":"[ANZECC\/ARMCANZ] Australian and New Zealand Environment and Conservation Council and Agriculture and Resource Management Council of Australia and New Zealand","year":"2000"},{"key":"2025010717591154700_ieam1473-bib-0002","doi-asserted-by":"crossref","first-page":"1846","DOI":"10.1002\/etc.5620200831","article-title":"Assessing acute and chronic copper risks to freshwater aquatic life using species sensitivity distributions for different taxonomic groups","volume":"20","author":"Brix","year":"2001","journal-title":"Environ Toxicol Chem"},{"key":"2025010717591154700_ieam1473-bib-0003","volume-title":"Ecological Risk Assessment in the Federal Government","author":"[CENR] Committee on Environment and Natural Resources","year":"1999"},{"key":"2025010717591154700_ieam1473-bib-0004","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1002\/etc.5620170112","article-title":"A critical evaluation of safety (uncertainty) factors for ecological risk assessment","volume":"17","author":"Chapman","year":"1998","journal-title":"Environ Toxicol Chem"},{"key":"2025010717591154700_ieam1473-bib-0005","doi-asserted-by":"crossref","first-page":"489","DOI":"10.1897\/03-159","article-title":"Effects of data manipulation and statistical methods on species sensitivity distributions","volume":"23","author":"Duboudin","year":"2004","journal-title":"Environ Toxicol Chem"},{"key":"2025010717591154700_ieam1473-bib-0006","author":"[EC] European Commission","year":"2003"},{"key":"2025010717591154700_ieam1473-bib-0007","volume-title":"Guidance for implementation of REACH: Guidance on information requirements and chemical safety assessment. Chapter R.10: Characterization of dose [concentration]-response for environment","author":"[ECHA] European Chemicals Agency","year":"2008"},{"key":"2025010717591154700_ieam1473-bib-0008","author":"Environment Canada","year":"1997"},{"key":"2025010717591154700_ieam1473-bib-0009","volume-title":"Supporting document for nonylphenol and ethoxylates. Priority Substances List, Canadian Environmental Protection Act","author":"Environment Canada","year":"2000"},{"key":"2025010717591154700_ieam1473-bib-0010","author":"Environment Canada","year":"2006"},{"key":"2025010717591154700_ieam1473-bib-0011","author":"[EU] European Union","year":"2002"},{"key":"2025010717591154700_ieam1473-bib-0012","author":"[EU] European Union","year":"2004"},{"key":"2025010717591154700_ieam1473-bib-0013","doi-asserted-by":"crossref","first-page":"1387","DOI":"10.1139\/f97-042","article-title":"Toxicological mechanisms of a multicomponent agricultural seed protectant in the rainbow trout (Oncorhynchus mykiss) and fathead minnow (Pimephales promelas)","volume":"54","author":"Greene","year":"1997","journal-title":"Can J Fish Aquat Sci"},{"key":"2025010717591154700_ieam1473-bib-0014","doi-asserted-by":"crossref","first-page":"175","DOI":"10.1897\/1551-3793-5.1.175","article-title":"Reducing uncertainty in environmental risk assessment (ERA): clearly defining acute and chronic toxicity tests","volume":"3","author":"Hahn","year":"2009","journal-title":"Integr Environ Assess Manag"},{"key":"2025010717591154700_ieam1473-bib-0015","author":"[IPCS] International Program of Chemical Safety","year":"2000"},{"key":"2025010717591154700_ieam1473-bib-0016","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1016\/S0045-6535(00)00087-4","article-title":"Opportunities for a probabilistic risk assessment of chemicals in the European Union","volume":"43","author":"Jager","year":"2001","journal-title":"Chemosphere"},{"key":"2025010717591154700_ieam1473-bib-0017","first-page":"162","volume-title":"Re-evaluation of the state of the science for water-quality criteria development","author":"Keating","year":"2003"},{"key":"2025010717591154700_ieam1473-bib-0018","first-page":"84","volume-title":"Chemicals in the environment: Assessing and managing risk. Issues in environmental science and technology","author":"Maltby","year":"2006"},{"key":"2025010717591154700_ieam1473-bib-0019","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1002\/ieam.5630020103","article-title":"Assessment of persistency and bioaccumulation in pesticide registration frameworks within the Organisation for Economic Cooperation and Development","volume":"2","author":"Montforts","year":"2006","journal-title":"Integr Environ Assess Manag"},{"key":"2025010717591154700_ieam1473-bib-0020","first-page":"199","author":"[NHW\/DOE] Department of the Environment and the Department of National Health and Welfare, Canada","year":"1993"},{"key":"2025010717591154700_ieam1473-bib-0021","author":"[OECD] Organisation for Economic Co-operation and Development","year":"2002"},{"key":"2025010717591154700_ieam1473-bib-0022","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1006\/eesa.1998.1745","article-title":"Critical analysis of methods for assessment of predicted no-effect concentration","volume":"43","author":"Roman","year":"1999","journal-title":"Ecotoxicol Environ Saf"},{"key":"2025010717591154700_ieam1473-bib-0023","doi-asserted-by":"crossref","first-page":"255","DOI":"10.1139\/a00-010","article-title":"Use and limitations of microbial bioassays for assessing copper bioavailability in the aquatic environment","volume":"8","author":"Stauber","year":"2000","journal-title":"Environ Rev"},{"key":"2025010717591154700_ieam1473-bib-0024","volume-title":"Guidelines for deriving numerical national water quality criteria for the protection of aquatic organisms and their uses","author":"Stephan","year":"1985"},{"key":"2025010717591154700_ieam1473-bib-0025","first-page":"15366","author":"[USEPA] US Environmental Protection Agency","year":"1995"}],"container-title":["Integrated Environmental Assessment and Management"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fieam.1473","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/academic.oup.com\/ieam\/article-pdf\/10\/1\/30\/59406749\/ieam1473.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ieam\/article-pdf\/10\/1\/30\/59406749\/ieam1473.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,1,7]],"date-time":"2025-01-07T13:37:06Z","timestamp":1736257026000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ieam\/article\/10\/1\/30\/7740945"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,1,1]]},"references-count":25,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2014,1,1]]},"published-print":{"date-parts":[[2014,1,1]]}},"URL":"https:\/\/doi.org\/10.1002\/ieam.1473","relation":{},"ISSN":["1551-3777","1551-3793"],"issn-type":[{"value":"1551-3777","type":"print"},{"value":"1551-3793","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2014,1,1]]},"published":{"date-parts":[[2014,1,1]]},"assertion":[{"value":"2012-10-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2013-07-17","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2013-12-10","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}