title: Assessment of three approaches for regulatory decision making on pesticides with endocrine disrupting properties.
abstract: Recent EU legislation has introduced endocrine disrupting properties as a hazard-based "cut-off" criterion for the approval of active substances as pesticides and biocides. Currently, no specific science-based approach for the assessment of substances with endocrine disrupting properties has been agreed upon, although this new legislation provides interim criteria based on classification and labelling. Different proposals for decision making on potential endocrine disrupting properties in human health risk assessment have been developed by the German Federal Institute for Risk Assessment (BfR) and other regulatory bodies. All these frameworks, although differing with regard to hazard characterisation, include a toxicological assessment of adversity of the effects, the evaluation of underlying modes/mechanisms of action in animals and considerations concerning the relevance of effects to humans. Three options for regulatory decision making were tested upon 39 pesticides for their applicability and to analyze their potential impact on the regulatory status of active substances that are currently approved for use in Europe: Option 1, based purely on hazard identification (adversity, mode of action, and the plausibility that both are related); Option 2, based on hazard identification and additional elements of hazard characterisation (severity and potency); Option 3, based on the interim criteria laid down in the recent EU pesticides legislation. Additionally, the data analysed in this study were used to address the questions, which parts of the endocrine system were affected, which studies were the most sensitive and whether no observed adverse effect levels were observed for substance with ED properties. The results of this exercise represent preliminary categorisations and must not be used as a basis for definitive regulatory decisions. They demonstrate that a combination of criteria for hazard identification with additional criteria of hazard characterisation allows prioritising and differentiating between substances with regard to their regulatory concern. It is proposed to integrate these elements into a decision matrix to be used within a weight of evidence approach for the toxicological categorisation of relevant endocrine disruptors and to consider all parts of the endocrine system for regulatory decision making on endocrine disruption.
authors.affiliation: Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment), Max-Dohrn-Str 8-10, 10589 Berlin, Germany. Electronic address: philip.marx-stoelting@bfr.bund.de.
authors.forename: P
authors.initials: P
authors.lastname: Marx-Stoelting
authors.affiliation: Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment), Max-Dohrn-Str 8-10, 10589 Berlin, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Niemann
authors.affiliation: Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment), Max-Dohrn-Str 8-10, 10589 Berlin, Germany.
authors.forename: V
authors.initials: V
authors.lastname: Ritz
authors.affiliation: Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment), Max-Dohrn-Str 8-10, 10589 Berlin, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Ulbrich
authors.affiliation: Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment), Max-Dohrn-Str 8-10, 10589 Berlin, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Gall
authors.affiliation: Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment), Max-Dohrn-Str 8-10, 10589 Berlin, Germany.
authors.forename: K I
authors.initials: KI
authors.lastname: Hirsch-Ernst
authors.affiliation: Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment), Max-Dohrn-Str 8-10, 10589 Berlin, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Pfeil
authors.affiliation: Bundesinstitut für Risikobewertung (Federal Institute for Risk Assessment), Max-Dohrn-Str 8-10, 10589 Berlin, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Solecki
mesh_terms: D000818:Animals; D003657:Decision Making; D052244:Endocrine Disruptors / Q000145:classification / Q000633:toxicity*; D005062:European Union; D033161:Government Regulation; D006801:Humans; D010575:Pesticides / Q000145:classification / Q000633:toxicity*; D018570:Risk Assessment / Q000145:classification / Q000331:legislation & jurisprudence / Q000379:methods
chemical_list: D052244:Endocrine Disruptors; D010575:Pesticides
keywords: Decision criteria; Endocrine Disruption; Pesticides