Integrating population-level effects into the regulatory assessment of endocrine disrupting substances.
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| Title: | Integrating population-level effects into the regulatory assessment of endocrine disrupting substances. |
|---|---|
| Authors: | Hazlerigg, Charles R E1,2 (AUTHOR) charles.hazlerigg@enviresearch.com, Tagliati, Alice2 (AUTHOR), Forbes, Valery E3 (AUTHOR), Gergs, Andre4 (AUTHOR), Hallmark, Nina4 (AUTHOR), Maltby, Lorraine5 (AUTHOR), Weltje, Lennart6,7 (AUTHOR), Wheeler, James R8 (AUTHOR) |
| Source: | Integrated Environmental Assessment & Management. May2025, Vol. 21 Issue 3, p639-648. 10p. |
| Subject Terms: | *Endocrine disruptors, *Vertebrates, *Ecological models, Regulatory impact analysis, Research methodology, Scientific observation |
| Abstract: | Population modeling, field studies, and monitoring approaches have all been proposed for assessing the relevance of adverse effects of endocrine disrupting chemicals (EDCs) at the population level for nontarget (wild) vertebrates, but how these approaches should be used in the regulatory hazard assessment is unclear and not detailed in the relevant European Guidance Document. A literature review focused on identifying published approaches assessing the population relevance of adverse effects from EDCs was performed, and, subsequently, 47 primary research papers were evaluated. By extracting from these sources, a novel approach was developed with guiding principles for assessing adverse effects of EDCs at the population level considering (i) choice of focal species, scenarios (and models), (ii) the individual level apical endpoints to be considered, (iii) the magnitude of effect to be imposed, (iv) for what duration effects should be imposed, (v) whether individuals repairing the damage from exposure should be included, (vi) the population-level endpoints to be considered, and (vii) what threshold to set for defining an adverse effect at this level. Recommendations for modeling and field and monitoring studies are included. Case studies are also presented to demonstrate how the proposed approach might be implemented. Although some aspects (e.g., choice of focal species, model/experimental scenario, monitoring study assessment) require further consideration, this should not prevent the use of this approach in a regulatory EDC assessment context. As such, we propose that the approach be used immediately to implement population modeling and perform field studies within this regulatory context. We envisage that consistent application of these principles will encourage regulatory developments in this critical area to provide a much needed level of clarity in the EDC assessment for all stakeholders. Key points The majority of the literature reviewed for population relevance assessment of endocrine disrupting chemicals (EDCs) used modeling approaches and applied them to fish (rather than field or monitoring studies, applied to terrestrial vertebrates). The approaches to population relevance assessment of EDCs in the literature were diverse, highlighting the need for a consistent method for application in a regulatory context. We provide an approach to perform a population relevance assessment of EDCs that may be used in a regulatory context, identifying seven key points that need to be addressed in this process. We consider our approach against four case studies from the literature to provide an illustration of how such a population relevance assessment for EDCs may be performed. [ABSTRACT FROM AUTHOR] |
| Copyright of Integrated Environmental Assessment & Management is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | GreenFILE |
| FullText | Links: – Type: pdflink Text: Availability: 0 |
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| Header | DbId: 8gh DbLabel: GreenFILE An: 185453595 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Integrating population-level effects into the regulatory assessment of endocrine disrupting substances. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Hazlerigg%2C+Charles+R+E%22">Hazlerigg, Charles R E</searchLink><relatesTo>1,2</relatesTo> (AUTHOR)<i> charles.hazlerigg@enviresearch.com</i><br /><searchLink fieldCode="AR" term="%22Tagliati%2C+Alice%22">Tagliati, Alice</searchLink><relatesTo>2</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Forbes%2C+Valery+E%22">Forbes, Valery E</searchLink><relatesTo>3</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gergs%2C+Andre%22">Gergs, Andre</searchLink><relatesTo>4</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Hallmark%2C+Nina%22">Hallmark, Nina</searchLink><relatesTo>4</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Maltby%2C+Lorraine%22">Maltby, Lorraine</searchLink><relatesTo>5</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Weltje%2C+Lennart%22">Weltje, Lennart</searchLink><relatesTo>6,7</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Wheeler%2C+James+R%22">Wheeler, James R</searchLink><relatesTo>8</relatesTo> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Integrated+Environmental+Assessment+%26+Management%22">Integrated Environmental Assessment & Management</searchLink>. May2025, Vol. 21 Issue 3, p639-648. 10p. – Name: Subject Label: Subject Terms Group: Su Data: *<searchLink fieldCode="DE" term="%22Endocrine+disruptors%22">Endocrine disruptors</searchLink><br />*<searchLink fieldCode="DE" term="%22Vertebrates%22">Vertebrates</searchLink><br />*<searchLink fieldCode="DE" term="%22Ecological+models%22">Ecological models</searchLink><br /><searchLink fieldCode="DE" term="%22Regulatory+impact+analysis%22">Regulatory impact analysis</searchLink><br /><searchLink fieldCode="DE" term="%22Research+methodology%22">Research methodology</searchLink><br /><searchLink fieldCode="DE" term="%22Scientific+observation%22">Scientific observation</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Population modeling, field studies, and monitoring approaches have all been proposed for assessing the relevance of adverse effects of endocrine disrupting chemicals (EDCs) at the population level for nontarget (wild) vertebrates, but how these approaches should be used in the regulatory hazard assessment is unclear and not detailed in the relevant European Guidance Document. A literature review focused on identifying published approaches assessing the population relevance of adverse effects from EDCs was performed, and, subsequently, 47 primary research papers were evaluated. By extracting from these sources, a novel approach was developed with guiding principles for assessing adverse effects of EDCs at the population level considering (i) choice of focal species, scenarios (and models), (ii) the individual level apical endpoints to be considered, (iii) the magnitude of effect to be imposed, (iv) for what duration effects should be imposed, (v) whether individuals repairing the damage from exposure should be included, (vi) the population-level endpoints to be considered, and (vii) what threshold to set for defining an adverse effect at this level. Recommendations for modeling and field and monitoring studies are included. Case studies are also presented to demonstrate how the proposed approach might be implemented. Although some aspects (e.g., choice of focal species, model/experimental scenario, monitoring study assessment) require further consideration, this should not prevent the use of this approach in a regulatory EDC assessment context. As such, we propose that the approach be used immediately to implement population modeling and perform field studies within this regulatory context. We envisage that consistent application of these principles will encourage regulatory developments in this critical area to provide a much needed level of clarity in the EDC assessment for all stakeholders. Key points The majority of the literature reviewed for population relevance assessment of endocrine disrupting chemicals (EDCs) used modeling approaches and applied them to fish (rather than field or monitoring studies, applied to terrestrial vertebrates). The approaches to population relevance assessment of EDCs in the literature were diverse, highlighting the need for a consistent method for application in a regulatory context. We provide an approach to perform a population relevance assessment of EDCs that may be used in a regulatory context, identifying seven key points that need to be addressed in this process. We consider our approach against four case studies from the literature to provide an illustration of how such a population relevance assessment for EDCs may be performed. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Integrated Environmental Assessment & Management is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1093/inteam/vjae039 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 10 StartPage: 639 Subjects: – SubjectFull: Endocrine disruptors Type: general – SubjectFull: Vertebrates Type: general – SubjectFull: Ecological models Type: general – SubjectFull: Regulatory impact analysis Type: general – SubjectFull: Research methodology Type: general – SubjectFull: Scientific observation Type: general Titles: – TitleFull: Integrating population-level effects into the regulatory assessment of endocrine disrupting substances. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Hazlerigg, Charles R E – PersonEntity: Name: NameFull: Tagliati, Alice – PersonEntity: Name: NameFull: Forbes, Valery E – PersonEntity: Name: NameFull: Gergs, Andre – PersonEntity: Name: NameFull: Hallmark, Nina – PersonEntity: Name: NameFull: Maltby, Lorraine – PersonEntity: Name: NameFull: Weltje, Lennart – PersonEntity: Name: NameFull: Wheeler, James R IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 05 Text: May2025 Type: published Y: 2025 Identifiers: – Type: issn-print Value: 15513777 Numbering: – Type: volume Value: 21 – Type: issue Value: 3 Titles: – TitleFull: Integrated Environmental Assessment & Management Type: main |
| ResultId | 1 |
