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Susana Loureiro

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Review Open access Jul 2026

Developing a FAIR data policy for chemical risk assessment and exploring future topics and stakeholder interests with large language models and data sciences

The EU Partnership for the Assessment of Risk from Chemicals (PARC) develops novel methods for human health and environmental risk assessment (RA) for regulatory application. Large amounts of environmental monitoring, in vitro, in silico and other types of data are generated. To facilitate data reuse and information exchange within and between research and regulatory stakeholders, it is important to document and manage data. In 2016, the FAIR (Findable, Accessible, Interoperable and Reusable) data principles were introduced to foster reuse of data. To adopt FAIR within PARC, a PARC FAIR data policy (PFDP) was developed. To determine PFDP topics, expert panel discussions were held, followed by review of 37 stakeholder documents issued by authorities in RA and environmental, health, (open) data sciences. This resulted in a taxonomy of 57 topics (“narrower term(s)” (NT(s), together with 15 “broader terms”), forming the basis of the PFDP. These included, aside FAIR, aspects specifically relevant for RA, such as GDPR, sensitive data, transparency and data valuation. Large Language Models (LLMs) were used to contrive novel terms for PFDP revisions. Seventy-eight novel terms were discovered by LLMs, compared to 57 NTs already identified by experts. Based on a frequency analysis within stakeholder documents, of all 135 terms (57 + 78) -further categorized under eight ChatGPT-derived “FAIR categories”- and subsequent cluster analyses (PCA, K-means), differences between stakeholders were identified. Organizations concerned with environmental and human chemical RA (e.g. European Chemicals Agency, European Food Safety Authority) could be distinguished from those focused on technical FAIR data issues and those involved in publicly funded research and open science. To foster environmental and human health research data for research purposes and adoption of research data in regulatory applications, a taxonomy of terms and FAIR data policy was developed. A frequency analysis of the taxonomy (augmented with LLM-derived) terms in stakeholder documents revealed differences between stakeholders, which may help identify trends e.g. the adoption of FAIR principles within and across sciences and regulatory domains for (NG) RA. The PFDP is designed to support data driven RA improvement within PARC but can equally contribute to FAIR data in other environmental RA research and regulatory communities.

R. Stierum, Gino Kalkman, S. Bijlsma et al. · 0 citations
Open access Aug 2026

Problem formulation and conceptual framework for landscape-based environmental risk assessment of pesticides.

The use of plant protection products (PPPs) remains a major concern for biodiversity, ecosystem integrity, and human health, even under robust regulatory oversight. Current regulatory assessments are often fragmented: they typically examine single substances and single crops in isolation at local or simplified scales. As a result, they struggle to capture the cumulative and combined effects of multiple PPPs and the way exposure propagates and interacts across space and time (fields, crops, and seasons). Our previously proposed landscape-based Environmental Risk Assessment (ERA) framework offered an integrative solution. By jointly representing agricultural practices, environmental characteristics, species movement among habitats, and the combined impacts of multiple PPPs, the current framework delivers predictions that are more adapted to the field reality. These insights are valuable both for regulatory decision-making and for understanding how PPP risks contribute to the overall environmental stress. In this manuscript, we explore the needs, challenges, opportunities, and modelling tools for implementing a landscape-based ERA in both prospective (ex-ante) and retrospective (ex-post) contexts. Drawing on expert discussions and collaborative initiatives, we propose a conceptual framework with four pillars: (1) flexibility to meet diverse user and stakeholder needs, different decision contexts, and varying data availability; (2) ecological realism, the capacity to represent multiple stressors, cumulative effects, exposure pathways driven by species movement, and recovery dynamics; (3) data integration and transparency, combining monitoring and regulatory datasets for calibration, validation, uncertainty analysis, and reproducibility; and (4) regulatory uptake and interoperability, ensuring compatibility with existing ERA methodologies and producing outputs that can be interpreted and used at the landscape level across jurisdictions and tools. Beyond regulatory compliance, landscape-based ERA is a dynamic and adaptative system that provides a robust scientific basis for setting protection goals, designing targeted risk mitigation measures, shaping sustainable agricultural strategies, and communicating realistic, multi-stressor risk trade-offs to stakeholders and the public.

A. Fernandez-Agudo, Annette Aldrich, J. Axelman et al. · 0 citations