Drivers of and Obstacles to the Adoption of Toxicogenomics for Chemical Risk Assessment: Insights from Social Science Perspectives.

BACKGROUND: Some 20 y ago, scientific and regulatory communities identified the potential of omics sciences (genomics, transcriptomics, proteomics, metabolomics) to improve chemical risk assessment through development of toxicogenomics. Recognizing that regulators adopt new scientific methods cautiously given accountability to diverse stakeholders, the scope and pace of adoption of toxicogenomics tools and data have nonetheless not met the ambitious, early expectations of omics proponents. OBJECTIVE: Our objective was, therefore, to inventory, investigate, and derive insights into drivers of and obstacles to adoption of toxicogenomics in chemical risk assessment. By invoking established social science frameworks conceptualizing innovation adoption, we also aimed to develop recommendations for proponents of toxicogenomics and other new approach methodologies (NAMs). METHODS: We report findings from an analysis of 56 scientific and regulatory publications from 1998 through 2017 that address the adoption of toxicogenomics for chemical risk assessment. From this purposeful sample of toxicogenomics discourse, we identified major categories of drivers of and obstacles to adoption of toxicogenomics tools and data sets. We then mapped these categories onto social science frameworks for conceptualizing innovation adoption to generate actionable insights for proponents of toxicogenomics. DISCUSSION: We identify the most salient drivers and obstacles. From 1998 through 2017, adoption of toxicogenomics was understood to be helped by drivers such as those we labeled Superior scientific understanding, New applications, and Reduced cost & increased efficiency but hindered by obstacles such as those we labeled Insufficient validation, Complexity of interpretation, and Lack of standardization. Leveraging social science frameworks, we find that arguments for adoption that draw on the most salient drivers, which emphasize superior and novel functionality of omics as rationales, overlook potential adopters' key concerns: simplicity of use and compatibility with existing practices. We also identify two perspectives-innovation-centric and adopter-centric-on omics adoption and explain how overreliance on the former may be undermining efforts to promote toxicogenomics. https://doi.org/10.1289/EHP6500.

Factors Affecting the Perception of New Approach Methodologies (NAMs) in the Ecotoxicology Community.

Given current legislative mandates to assess the safety of thousands of chemicals and the slow pace at which conventional testing proceeds, there is a need to accelerate chemical risk assessment. Governments and businesses are increasingly interested in new approach methodologies (NAMs) that promise to reduce costs and delays. We explore 5 sociological factors within the ecotoxicology community that can influence the perception of NAMs: 1) professional profile (educational cohort, employer), 2) internal science communication within professional forums, 3) concern for "error cost," 4) collaboration across stakeholders, and 5) fundamental beliefs regarding toxicology. We conducted an online survey (n = 171; 2018) asking participants about their experiences and perspectives at events of the Society of Environmental Toxicology and Chemistry (SETAC) to assess 1) how NAMs are discussed compared to conventional testing and 2) how respondents perceive their viability. We developed ordered logistic regression (OLR) models to understand the influence of exploratory variables (cohort, core views on toxicology, frequency of collaboration) on respondents' evaluation of the viability of different NAMs. Our results showed that 1) NAMs were more likely than conventional methods to be challenged in forum discussions, which may be fueled by concerns for error costs in regulatory decision making; 2) perceptions of the viability of NAMs tended to follow a "pattern of familiarity," whereby respondents that were more knowledgeable about a test method tended to find it more viable; 3) respondents who agreed with the Paracelsus maxim had a greater likelihood of finding conventional testing viable; and 4) the more a respondent reported collaborating with industry on alternative testing strategies, the more likely she or he was to report that NAMs were less viable. These results suggest that there are professional and organizational barriers to greater acceptance of NAMs that can be addressed through a social learning process within the professional community. Integr Environ Assess Manag 2020;16:269-281. © 2020 SETAC.

The problem of epistemic jurisdiction in global governance: The case of sustainability standards for biofuels.

While there is ample scholarly work on regulatory science within the state, or single-sited global institutions, there is less on its operation within complex modes of global governance that are decentered, overlapping, multi-sectorial and multi-leveled. Using a co-productionist framework, this study identifies 'epistemic jurisdiction' - the power to produce or warrant technical knowledge for a given political community, topical arena or geographical territory - as a central problem for regulatory science in complex governance. We explore these dynamics in the arena of global sustainability standards for biofuels. We select three institutional fora as sites of inquiry: the European Union's Renewable Energy Directive, the Roundtable on Sustainable Biomaterials, and the International Organization for Standardization. These cases allow us to analyze how the co-production of sustainability science responds to problems of epistemic jurisdiction in the global regulatory order. First, different problems of epistemic jurisdiction beset different standard-setting bodies, and these problems shape both the content of regulatory science and the procedures designed to make it authoritative. Second, in order to produce global regulatory science, technical bodies must manage an array of conflicting imperatives - including scientific virtue, due process and the need to recruit adoptees to perpetuate the standard. At different levels of governance, standard drafters struggle to balance loyalties to country, to company or constituency and to the larger project of internationalization. Confronted with these sometimes conflicting pressures, actors across the standards system quite self-consciously maneuver to build or retain authority for their forum through a combination of scientific adjustment and political negotiation. Third, the evidentiary demands of regulatory science in global administrative spaces are deeply affected by 1) a market for standards, in which firms and states can choose the cheapest sustainability certification, and 2) the international trade regime, in which the long shadow of WTO law exerts a powerful disciplining function.