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
.jpg)
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/278459
Ver los metadatos del registro completo
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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. |
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2025 |
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2025-08 |
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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 |
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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 |
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