title: Perspectives for integrating human and environmental risk assessment and synergies with socio-economic analysis.
abstract: For more than a decade, the integration of human and environmental risk assessment (RA) has become an attractive vision. At the same time, existing European regulations of chemical substances such as REACH (EC Regulation No. 1907/2006), the Plant Protection Products Regulation (EC regulation 1107/2009) and Biocide Regulation (EC Regulation 528/2012) continue to ask for sector-specific RAs, each of which have their individual information requirements regarding exposure and hazard data, and also use different methodologies for the ultimate risk quantification. In response to this difference between the vision for integration and the current scientific and regulatory practice, the present paper outlines five medium-term opportunities for integrating human and environmental RA, followed by detailed discussions of the associated major components and their state of the art. Current hazard assessment approaches are analyzed in terms of data availability and quality, and covering non-test tools, the integrated testing strategy (ITS) approach, the adverse outcome pathway (AOP) concept, methods for assessing uncertainty, and the issue of explicitly treating mixture toxicity. With respect to exposure, opportunities for integrating exposure assessment are discussed, taking into account the uncertainty, standardization and validation of exposure modeling as well as the availability of exposure data. A further focus is on ways to complement RA by a socio-economic assessment (SEA) in order to better inform about risk management options. In this way, the present analysis, developed as part of the EU FP7 project HEROIC, may contribute to paving the way for integrating, where useful and possible, human and environmental RA in a manner suitable for its coupling with SEA.
authors.affiliation: INERIS, Parc Alata, BP2, 60550 Verneuil-en-Halatte, France. alexandre.pery@ineris.fr
authors.forename: A R R
authors.initials: AR
authors.lastname: Péry
authors.forename: G
authors.initials: G
authors.lastname: Schüürmann
authors.forename: P
authors.initials: P
authors.lastname: Ciffroy
authors.forename: M
authors.initials: M
authors.lastname: Faust
authors.forename: T
authors.initials: T
authors.lastname: Backhaus
authors.forename: L
authors.initials: L
authors.lastname: Aicher
authors.forename: E
authors.initials: E
authors.lastname: Mombelli
authors.forename: C
authors.initials: C
authors.lastname: Tebby
authors.forename: M T D
authors.initials: MT
authors.lastname: Cronin
authors.forename: S
authors.initials: S
authors.lastname: Tissot
authors.forename: S
authors.initials: S
authors.lastname: Andres
authors.forename: J M
authors.initials: JM
authors.lastname: Brignon
authors.forename: L
authors.initials: L
authors.lastname: Frewer
authors.forename: S
authors.initials: S
authors.lastname: Georgiou
authors.forename: K
authors.initials: K
authors.lastname: Mattas
authors.forename: J C
authors.initials: JC
authors.lastname: Vergnaud
authors.forename: W
authors.initials: W
authors.lastname: Peijnenburg
authors.forename: E
authors.initials: E
authors.lastname: Capri
authors.forename: A
authors.initials: A
authors.lastname: Marchis
authors.forename: M F
authors.initials: MF
authors.lastname: Wilks
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D004781:Environmental Exposure / Q000009:adverse effects / Q000032:analysis; D005062:European Union; D033161:Government Regulation; D015386:Hazardous Substances / Q000633:toxicity*; D006801:Humans; D018570:Risk Assessment / Q000331:legislation & jurisprudence / Q000379:methods* / Q000639:trends; D012959:Socioeconomic Factors; D018675:Toxicity Tests / Q000191:economics / Q000379:methods / Q000592:standards
chemical_list: D015386:Hazardous Substances