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      Managing value‐laden judgements in regulatory science and risk assessment

      1

      EFSA Journal

      John Wiley and Sons Inc.

      science, values, research ethics, risk assessment, transparency, engagement, open science

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          Abstract

          This paper argues that value‐laden judgements play an important role in regulatory science and risk assessment. These judgements include choices about what topics to study; what questions to ask about those topics; how best to design studies to answer those questions; how to collect, analyse, and interpret data; and how to frame and communicate findings. Rather than defending a ‘value‐free ideal’ for responding to these judgements, the paper calls for a ‘value‐management ideal’ based on three principles: (1) value‐laden judgements should be handled as transparently as possible; (2) these judgements should be made in ways that reflect social and ethical priorities; and (3) they should be made in a manner that is informed by engagement among interested and affected parties. Based on these principles, the paper suggests several strategies for moving forward to handle value‐laden judgements in regulatory science and risk assessment in a responsible manner. First, decision makers should become more comfortable with scientific disagreement, finding ways to respect different positions on value‐laden judgements and formulate policies despite inconclusive evidence. Second, those engaged in regulatory science should explore creative ways to clarify important judgements and communicate how they are being handled. Third, institutional processes for setting standards and guidelines for regulatory science and risk assessment should be scrutinised to ensure that they provide fair opportunities for all interested and affected parties to participate in and inform those processes.

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          Most cited references 29

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          SCIENTIFIC STANDARDS. Promoting an open research culture.

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            Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data: The Case of Bisphenol A

            Background In their safety evaluations of bisphenol A (BPA), the U.S. Food and Drug Administration (FDA) and a counterpart in Europe, the European Food Safety Authority (EFSA), have given special prominence to two industry-funded studies that adhered to standards defined by Good Laboratory Practices (GLP). These same agencies have given much less weight in risk assessments to a large number of independently replicated non-GLP studies conducted with government funding by the leading experts in various fields of science from around the world. Objectives We reviewed differences between industry-funded GLP studies of BPA conducted by commercial laboratories for regulatory purposes and non-GLP studies conducted in academic and government laboratories to identify hazards and molecular mechanisms mediating adverse effects. We examined the methods and results in the GLP studies that were pivotal in the draft decision of the U.S. FDA declaring BPA safe in relation to findings from studies that were competitive for U.S. National Institutes of Health (NIH) funding, peer-reviewed for publication in leading journals, subject to independent replication, but rejected by the U.S. FDA for regulatory purposes. Discussion Although the U.S. FDA and EFSA have deemed two industry-funded GLP studies of BPA to be superior to hundreds of studies funded by the U.S. NIH and NIH counterparts in other countries, the GLP studies on which the agencies based their decisions have serious conceptual and methodologic flaws. In addition, the U.S. FDA and EFSA have mistakenly assumed that GLP yields valid and reliable scientific findings (i.e., “good science”). Their rationale for favoring GLP studies over hundreds of publically funded studies ignores the central factor in determining the reliability and validity of scientific findings, namely, independent replication, and use of the most appropriate and sensitive state-of-the-art assays, neither of which is an expectation of industry-funded GLP research. Conclusions Public health decisions should be based on studies using appropriate protocols with appropriate controls and the most sensitive assays, not GLP. Relevant NIH-funded research using state-of-the-art techniques should play a prominent role in safety evaluations of chemicals.
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              Inductive Risk and Values in Science

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                Author and article information

                Journal
                EFSA J
                EFSA J
                10.1002/(ISSN)1831-4732
                EFS2
                EFSA Journal
                John Wiley and Sons Inc. (Hoboken )
                1831-4732
                08 July 2019
                July 2019
                : 17
                : Suppl 1 , Proceedings of the Third EFSA Scientific Conference: Science, Food and Society Guest Editors: Devos Y, Elliott KC and Hardy A ( doiID: 10.1002/efs2.2019.17.issue-S1 )
                Affiliations
                [ 1 ] Lyman Briggs College Department of Fisheries and Wildlife, and Department of Philosophy Michigan State University East Lansing MI 48825 USA
                Author notes
                Correspondence: kce@ 123456msu.edu
                Article
                EFS2E170709
                10.2903/j.efsa.2019.e170709
                7015493
                © 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.

                Page count
                Figures: 0, Tables: 0, Pages: 11, Words: 6419
                Product
                Categories
                Conference Article
                Fit for Purpose Risk Assessment
                Custom metadata
                2.0
                July 2019
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:21.01.2020

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