Todt, Oliver and Lujan, José Luis (2025) Methodological tensions in risk assessment and benefit assessment: a classification. [Preprint]

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Abstract

This article analyzes some of the methodological tensions that can be observed in the
regulation of science and technology, and that often manifest themselves as controversies.
We offer a three-way classification of such tensions. The latter can arise from: 1) external
(non-cognitive) factors that are specific to a particular regulation; 2) external (non-
cognitive) factors of wider societal importance that are not related to any particular
regulatory process; and 3) internal (non-cognitive, as well as cognitive) factors related to
the cognitive, as well as practical limitations of a particular scientific methodology in the
1
context of regulatory decision making. We analyze case studies of regulation of, among
other, pharmaceuticals, chemical products, health claims on foods, as well as genetically
modified organisms. The analysis shows that most often such methodological tensions are
driven, directly or indirectly, by different stances with respect to non-cognitive factors that
underlie the fundamental choices of methods and standards, and therefore the data that
underpin regulatory decisions. Our paper makes clear an important feature of regulatory
science: cognitive factors (like improved scientific data or accepted best practices), that in
academic science facilitate the resolution of debates, in regulatory science do not suffice for
achieving closure with respect to such tensions. Any attempt at closure has to deal primarily
with the relevant non-cognitive factors.

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Item Type:	Preprint
Creators:	Creators Email ORCID Todt, Oliver o.todt@uib.es 0000-0001-9363-0543 Lujan, José Luis jl.lujan@uib.es 0000-0002-8829-0609
Keywords:	regulatory science, risk assessment, benefit assessment, non-cognitive factors, regulatory controversy
Subjects:	General Issues > Causation General Issues > Evidence General Issues > Science and Policy General Issues > Values In Science
Depositing User:	Dr. José Luis Luján
Date Deposited:	04 Jun 2025 13:16
Last Modified:	04 Jun 2025 13:16
Item ID:	25559
DOI or Unique Handle:	https://doi.org/10.1080/13669877.2025.2512076
Subjects:	General Issues > Causation General Issues > Evidence General Issues > Science and Policy General Issues > Values In Science
Date:	2 June 2025
URI:	https://philsci-archive.pitt.edu/id/eprint/25559

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