Conducting evaluations of evidence that are transparent, timely and can lead to health-protective actions

Abstract

Background In February 2021, over one hundred scientists and policy experts participated in a web-based Workshop to discuss the ways that divergent evaluations of evidence and scientific uncertainties are used to delay timely protection of human health and the environment from exposures to hazardous agents. The Workshop arose from a previous workshop organized by the European Environment Agency (EEA) in 2008 and which also drew on case studies from the EEA reports on ‘Late Lessons from Early Warnings’ (2001, 2013). These reports documented dozens of hazardous agents including many chemicals, for which risk reduction measures were delayed for decades after scientists and others had issued early and later warnings about the harm likely to be caused by those agents. Results Workshop participants used recent case studies including Perfluorooctanoic acid (PFOA), Extremely Low Frequency – Electrical Magnetic Fields (ELF-EMF fields), glyphosate, and Bisphenol A (BPA) to explore myriad reasons for divergent outcomes of evaluations, which has led to delayed and inadequate protection of the public’s health. Strategies to overcome these barriers must, therefore, at a minimum include approaches that 1) Make better use of existing data and information, 2) Ensure timeliness, 3) Increase transparency, consistency and minimize bias in evidence evaluations, and 4) Minimize the influence of financial conflicts of interest. Conclusion The recommendations should enhance the production of “actionable evidence,” that is, reliable evaluations of the scientific evidence to support timely actions to protect health and environments from exposures to hazardous agents. The recommendations are applicable to policy and regulatory settings at the local, state, federal and international levels.

Bisphenols and Their Interaction with GPER-1: The Invisible Enemy Behind Breast Cancer and Its Societal Impact

“…This approach acknowledges the complexity of studying BPA and the possibility that underlying mechanisms may not be fully understood Bisphenols and Their Interaction with GPER-1: The Invisible Enemy Behind Breast Cancer… DOI: http://dx.doi.org/10.5772/intechopen.112880 at present [78]. Therefore, instead of waiting for absolute scientific certainty before taking regulatory actions, advocating for acting preventively to protect the population from a public health perspective [83,84].…”

Time for CHANGE: system-level interventions for bringing forward the date of effective use of NAMs in regulatory toxicology

“…What unites both sides of the NAM use debate are that the regulatory infrastructure for "actionable evidence" created using NAMs should be effective, and that an effective system should be implemented as soon as possible. "Actionable evidence" is transparent, objective, and timely, such that it can reliably support decisions protecting health and the environment from effects of hazardous agents (Chartres et al 2022). Taking a systems-thinking approach, we aim to identify expected, unexpected, and hidden barriers for a regulatory infrastructure that uses NAM data to be effective, and interventions for breaking down the barriers.…”

“…These factors include insufficient involvement of the regulatory community, and a number of challenges related to scientific and regulatory readiness and the protective ability of NAMs as actionable evidence for human health and/or environmental risk assessment. These are examples related to the lack of central steering of this shift, uncertainty around legal constraints and the legal defensibility, the need for improvement of policies and practises, validation problems, deficits of the post-validation process, lack of funding for the development and validation of NAMs, time and costs related to the need for expertise and training, lack of familiarity with methods and uncertainty around data interpretation affecting the willingness for rethinking, lack of standardisation of the methods, economic effects, missing interaction with stakeholders, and challenges handling the uncertainty in mechanistic understanding and evidence (Archibald et al 2015;Bottini et al 2008;Bottini et al 2007;Browne et al 2024;Busquet and Hartung 2017;Čavoški et al 2024;Chartres et al 2022;ECHA 2023;Hartung et al 2013;Hoffmann et al 2022;ICCVAM 2018;Leist et al 2012;Maertens et al 2022;Maertens et al 2024;Marx-Stoelting et al 2023;Meigs et al 2018;National Academies of Sciences and Medicine 2017, 2023Pain et al 2020;USEPA 2021;von Aulock et al 2022;Vonk et al 2015).…”

Invited Perspective: Why Systematic Reviews, Scoping Reviews, and Evidence-to-Decision Frameworks Are Critical for Transparent, Consistent, Equitable, and Science-Based Decision-Making in Environmental Health

“… 2 For example, when divergent evaluations of a body of scientific evidence lead to conflicting conclusions on the harm of an exposure or the efficacy of an intervention, these empirically based methods increase transparency and comparability of the assessments, allowing end users to identify the reason for such divergence. 3 , 4 US agencies and academic scientists have developed, validated, and implemented several peer-reviewed systematic review methods, including the Navigation Guide 5 , 6 and the National Toxicology Program (NTP) Office of Health Assessment and Translation (OHAT) systematic review handbook, 7 both of which have been used and endorsed by the National Academies of Sciences, Engineering, and Medicine. 8…”

“… 2 At the same time, however, systematic review is simultaneously being corrupted as agencies, including the Texas Commission on Environmental Quality (TCEQ) and the US Environmental Protection Agency (EPA), as part of implementing the amended the Toxic Substances Control Act, are appropriating the term in regulatory decision-making without meeting many of the standards of an empirically based systematic review. 4 , 9 – 12 This could result in rulemakings that underestimate the true risk of harm posed by toxic chemical exposures, which could have devastating implications for vulnerable populations, including low-wealth communities of color. 11 …”