Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisals

Autores
Van Zwanenberg, Patrick; Millstone, Erik; Livingston Ortolani, Alice
Año de publicación
2025
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
This paper asks whether, when assessing the safety of regulated products, the standards of scrutiny and evaluation deployed by regulatory officials and scientific advisors differ for evidence indicating that a product might be harmful compared to evidence indicating an absence of harm. Four cases from the field of food chemical regulation are analysed for which safety appraisals were conducted by European and US regulatory institutions between the late 1980s and the 2010s. The cases concern selected areas of the possible toxicity of ethylene bisdithiocarbamate fungicides, a genetically modified variety of Bt maize, the artificial sweetener Aspartame, and the herbicide Glyphosate. We find that evidence that those products were unlikely to be harmful was routinely accepted by regulatory bodies as reliable, relevant, and sufficient to support judgements of safety, even when that evidence was incomplete, equivocal or the underlying studies were inadequate or flawed or both. By contrast, evidence indicating possible or actual hazards and risks was subjected to far more critical scrutiny to try to discern any possible grounds for discounting it, including reasons that were deemed not to be a problem when they characterised evidence indicative of a lack of harm, or when those reasons were entirely speculative or were contradicted by available evidence. We identify and characterise several different types of evaluative asymmetry and argue that all are antithetical to the effective protection of public and environmental health. Several also violate indispensable scientific requirements for making valid inferences and reaching well-founded conclusions; that is, they are scientifically defective. Their deployment misleads many policy decision makers and most of the public. Their effect is to conceal the scope for diminishing possible harm. We outline hypotheses as to why asymmetric patterns of scrutiny and evaluation appear to be a relatively widespread phenomena across different regulatory jurisdictions and time periods.
Fil: Van Zwanenberg, Patrick. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de San Martin. Escuela de Economia y Negocios. Centro de Investigaciones Para la Transformacion.; Argentina
Fil: Millstone, Erik. University of Sussex; Reino Unido
Fil: Livingston Ortolani, Alice. University of Sussex; Reino Unido
Materia
Asymmetries
Regulatory science
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/278459

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spelling Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisalsVan Zwanenberg, PatrickMillstone, ErikLivingston Ortolani, AliceAsymmetriesRegulatory sciencehttps://purl.org/becyt/ford/5.9https://purl.org/becyt/ford/5This paper asks whether, when assessing the safety of regulated products, the standards of scrutiny and evaluation deployed by regulatory officials and scientific advisors differ for evidence indicating that a product might be harmful compared to evidence indicating an absence of harm. Four cases from the field of food chemical regulation are analysed for which safety appraisals were conducted by European and US regulatory institutions between the late 1980s and the 2010s. The cases concern selected areas of the possible toxicity of ethylene bisdithiocarbamate fungicides, a genetically modified variety of Bt maize, the artificial sweetener Aspartame, and the herbicide Glyphosate. We find that evidence that those products were unlikely to be harmful was routinely accepted by regulatory bodies as reliable, relevant, and sufficient to support judgements of safety, even when that evidence was incomplete, equivocal or the underlying studies were inadequate or flawed or both. By contrast, evidence indicating possible or actual hazards and risks was subjected to far more critical scrutiny to try to discern any possible grounds for discounting it, including reasons that were deemed not to be a problem when they characterised evidence indicative of a lack of harm, or when those reasons were entirely speculative or were contradicted by available evidence. We identify and characterise several different types of evaluative asymmetry and argue that all are antithetical to the effective protection of public and environmental health. Several also violate indispensable scientific requirements for making valid inferences and reaching well-founded conclusions; that is, they are scientifically defective. Their deployment misleads many policy decision makers and most of the public. Their effect is to conceal the scope for diminishing possible harm. We outline hypotheses as to why asymmetric patterns of scrutiny and evaluation appear to be a relatively widespread phenomena across different regulatory jurisdictions and time periods.Fil: Van Zwanenberg, Patrick. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de San Martin. Escuela de Economia y Negocios. Centro de Investigaciones Para la Transformacion.; ArgentinaFil: Millstone, Erik. University of Sussex; Reino UnidoFil: Livingston Ortolani, Alice. University of Sussex; Reino UnidoNature2025-08info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/278459Van Zwanenberg, Patrick; Millstone, Erik; Livingston Ortolani, Alice; Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisals; Nature; Environmental Sciences Europe; 37; 1; 8-2025; 1-202190-4715CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://link.springer.com/article/10.1186/s12302-025-01176-9info:eu-repo/semantics/altIdentifier/doi/10.1186/s12302-025-01176-9info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2026-01-08T13:04:21Zoai:ri.conicet.gov.ar:11336/278459instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982026-01-08 13:04:21.635CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisals
title Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisals
spellingShingle Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisals
Van Zwanenberg, Patrick
Asymmetries
Regulatory science
title_short Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisals
title_full Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisals
title_fullStr Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisals
title_full_unstemmed Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisals
title_sort Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisals
dc.creator.none.fl_str_mv Van Zwanenberg, Patrick
Millstone, Erik
Livingston Ortolani, Alice
author Van Zwanenberg, Patrick
author_facet Van Zwanenberg, Patrick
Millstone, Erik
Livingston Ortolani, Alice
author_role author
author2 Millstone, Erik
Livingston Ortolani, Alice
author2_role author
author
dc.subject.none.fl_str_mv Asymmetries
Regulatory science
topic Asymmetries
Regulatory science
purl_subject.fl_str_mv https://purl.org/becyt/ford/5.9
https://purl.org/becyt/ford/5
dc.description.none.fl_txt_mv This paper asks whether, when assessing the safety of regulated products, the standards of scrutiny and evaluation deployed by regulatory officials and scientific advisors differ for evidence indicating that a product might be harmful compared to evidence indicating an absence of harm. Four cases from the field of food chemical regulation are analysed for which safety appraisals were conducted by European and US regulatory institutions between the late 1980s and the 2010s. The cases concern selected areas of the possible toxicity of ethylene bisdithiocarbamate fungicides, a genetically modified variety of Bt maize, the artificial sweetener Aspartame, and the herbicide Glyphosate. We find that evidence that those products were unlikely to be harmful was routinely accepted by regulatory bodies as reliable, relevant, and sufficient to support judgements of safety, even when that evidence was incomplete, equivocal or the underlying studies were inadequate or flawed or both. By contrast, evidence indicating possible or actual hazards and risks was subjected to far more critical scrutiny to try to discern any possible grounds for discounting it, including reasons that were deemed not to be a problem when they characterised evidence indicative of a lack of harm, or when those reasons were entirely speculative or were contradicted by available evidence. We identify and characterise several different types of evaluative asymmetry and argue that all are antithetical to the effective protection of public and environmental health. Several also violate indispensable scientific requirements for making valid inferences and reaching well-founded conclusions; that is, they are scientifically defective. Their deployment misleads many policy decision makers and most of the public. Their effect is to conceal the scope for diminishing possible harm. We outline hypotheses as to why asymmetric patterns of scrutiny and evaluation appear to be a relatively widespread phenomena across different regulatory jurisdictions and time periods.
Fil: Van Zwanenberg, Patrick. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad Nacional de San Martin. Escuela de Economia y Negocios. Centro de Investigaciones Para la Transformacion.; Argentina
Fil: Millstone, Erik. University of Sussex; Reino Unido
Fil: Livingston Ortolani, Alice. University of Sussex; Reino Unido
description This paper asks whether, when assessing the safety of regulated products, the standards of scrutiny and evaluation deployed by regulatory officials and scientific advisors differ for evidence indicating that a product might be harmful compared to evidence indicating an absence of harm. Four cases from the field of food chemical regulation are analysed for which safety appraisals were conducted by European and US regulatory institutions between the late 1980s and the 2010s. The cases concern selected areas of the possible toxicity of ethylene bisdithiocarbamate fungicides, a genetically modified variety of Bt maize, the artificial sweetener Aspartame, and the herbicide Glyphosate. We find that evidence that those products were unlikely to be harmful was routinely accepted by regulatory bodies as reliable, relevant, and sufficient to support judgements of safety, even when that evidence was incomplete, equivocal or the underlying studies were inadequate or flawed or both. By contrast, evidence indicating possible or actual hazards and risks was subjected to far more critical scrutiny to try to discern any possible grounds for discounting it, including reasons that were deemed not to be a problem when they characterised evidence indicative of a lack of harm, or when those reasons were entirely speculative or were contradicted by available evidence. We identify and characterise several different types of evaluative asymmetry and argue that all are antithetical to the effective protection of public and environmental health. Several also violate indispensable scientific requirements for making valid inferences and reaching well-founded conclusions; that is, they are scientifically defective. Their deployment misleads many policy decision makers and most of the public. Their effect is to conceal the scope for diminishing possible harm. We outline hypotheses as to why asymmetric patterns of scrutiny and evaluation appear to be a relatively widespread phenomena across different regulatory jurisdictions and time periods.
publishDate 2025
dc.date.none.fl_str_mv 2025-08
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/278459
Van Zwanenberg, Patrick; Millstone, Erik; Livingston Ortolani, Alice; Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisals; Nature; Environmental Sciences Europe; 37; 1; 8-2025; 1-20
2190-4715
CONICET Digital
CONICET
url http://hdl.handle.net/11336/278459
identifier_str_mv Van Zwanenberg, Patrick; Millstone, Erik; Livingston Ortolani, Alice; Asymmetric evaluations of scientific evidence indicating harm compared to evidence indicating an absence of harm in regulatory appraisals; Nature; Environmental Sciences Europe; 37; 1; 8-2025; 1-20
2190-4715
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://link.springer.com/article/10.1186/s12302-025-01176-9
info:eu-repo/semantics/altIdentifier/doi/10.1186/s12302-025-01176-9
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
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eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.format.none.fl_str_mv application/pdf
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dc.publisher.none.fl_str_mv Nature
publisher.none.fl_str_mv Nature
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