FAIR environmental and health registry (FAIREHR)- supporting the science to policy interface and life science research, development and innovation.

The environmental impact on health is an inevitable by-product of human activity. Environmental health sciences is a multidisciplinary field addressing complex issues on how people are exposed to hazardous chemicals that can potentially affect adversely the health of present and future generations. Exposure sciences and environmental epidemiology are becoming increasingly data-driven and their efficiency and effectiveness can significantly improve by implementing the FAIR (findable, accessible, interoperable, reusable) principles for scientific data management and stewardship. This will enable data integration, interoperability and (re)use while also facilitating the use of new and powerful analytical tools such as artificial intelligence and machine learning in the benefit of public health policy, and research, development and innovation (RDI). Early research planning is critical to ensuring data is FAIR at the outset. This entails a well-informed and planned strategy concerning the identification of appropriate data and metadata to be gathered, along with established procedures for their collection, documentation, and management. Furthermore, suitable approaches must be implemented to evaluate and ensure the quality of the data. Therefore, the 'Europe Regional Chapter of the International Society of Exposure Science' (ISES Europe) human biomonitoring working group (ISES Europe HBM WG) proposes the development of a FAIR Environment and health registry (FAIREHR) (hereafter FAIREHR). FAIR Environment and health registry offers preregistration of studies on exposure sciences and environmental epidemiology using HBM (as a starting point) across all areas of environmental and occupational health globally. The registry is proposed to receive a dedicated web-based interface, to be electronically searchable and to be available to all relevant data providers, users and stakeholders. Planned Human biomonitoring studies would ideally be registered before formal recruitment of study participants. The resulting FAIREHR would contain public records of metadata such as study design, data management, an audit trail of major changes to planned methods, details of when the study will be completed, and links to resulting publications and data repositories when provided by the authors. The FAIREHR would function as an integrated platform designed to cater to the needs of scientists, companies, publishers, and policymakers by providing user-friendly features. The implementation of FAIREHR is expected to yield significant benefits in terms of enabling more effective utilization of human biomonitoring (HBM) data.

Developing human biomonitoring as a 21st century toolbox within the European exposure science strategy 2020-2030.

Human biomonitoring (HBM) is a crucial approach for exposure assessment, as emphasised in the European Commission's Chemicals Strategy for Sustainability (CSS). HBM can help to improve chemical policies in five major key areas: (1) assessing internal and aggregate exposure in different target populations; 2) assessing exposure to chemicals across life stages; (3) assessing combined exposure to multiple chemicals (mixtures); (4) bridging regulatory silos on aggregate exposure; and (5) enhancing the effectiveness of risk management measures. In this strategy paper we propose a vision and a strategy for the use of HBM in chemical regulations and public health policy in Europe and beyond. We outline six strategic objectives and a roadmap to further strengthen HBM approaches and increase their implementation in the regulatory risk assessment of chemicals to enhance our understanding of exposure and health impacts, enabling timely and targeted policy interventions and risk management. These strategic objectives are: 1) further development of sampling strategies and sample preparation; 2) further development of chemical-analytical HBM methods; 3) improving harmonisation throughout the HBM research life cycle; 4) further development of quality control / quality assurance throughout the HBM research life cycle; 5) obtain sustained funding and reinforcement by legislation; and 6) extend target-specific communication with scientists, policymakers, citizens and other stakeholders. HBM approaches are essential in risk assessment to address scientific, regulatory and societal challenges. HBM requires full and strong support from the scientific and regulatory domain to reach its full potential in public and occupational health assessment and in regulatory decision-making.

Biomonitoring as an Underused Exposure Assessment Tool in Occupational Safety and Health Context-Challenges and Way Forward.

Recent advances in analytical chemistry have allowed a greater possibility of using quantitative approaches for measuring human exposure to chemicals. One of these approaches is biomonitoring (BM), which provides unequivocal evidence that both exposure and uptake of a chemical have taken place. BM has been a longstanding practice in occupational health for several reasons. BM integrates exposure from all routes. It can help identify unintentional and unexpected exposures and assess the effectiveness of existing risk-management measures. BM also provides relevant information to support policy development by delivering better evidence of workers' exposure to chemical substances, even within the framework of the present regulations. Thus, BM can allow for both the evaluation of the impact of regulation and identification of further needs for new or improved regulation. However, despite all these well-recognized advantages, BM is currently an underused exposure assessment tool. This paper provides an overview of the key aspects to be considered when using BM in the context of occupational health interventions. Additionally, this paper describes the potential of BM as an exposure assessment tool, distinguishing the role of BM in exposure assessment and health surveillance and clarifies ethical and communication aspects to guarantee that general data protection regulations are followed. In addition, actions and research needs are identified (particularly with reference to the European situation), which aim to encourage the increased use of BM as an exposure assessment tool.

Industry Derived Occupational Exposure Limits: A Survey of Professionals on the Dutch System of Exposure Guidelines.

The Netherlands' system for occupational exposure limits (OELs) encompasses two kinds of OELs: public and private. Public OELs are set by the government. Private OELs are derived by industry and cover all substances without a public OEL. In parallel, the regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) has introduced an exposure guidance value similar to the OEL, namely the Derived No-Effect Level (DNEL) for workers' inhalation exposure. This study aimed to investigate issues encountered by occupational health professionals regarding private OELs, and how they perceive the DNELs for workers in relation to private OELs. Towards this aim, we sent out a web-based questionnaire to the members of the Dutch professional organization for occupational hygienists (Nederlandse Vereniging voor Arbeidshygiëne [NVVA], n = 513) and to members of the Dutch professional organization for safety engineers (NVVK, n = 2916). Response rates were 27% (n = 139) and 7% (n = 198), respectively. More occupational hygienists (59%) than safety engineers (17%) reported to derive private OELs themselves. Our respondents reported several challenges with the derivation of private OELs. Fifty-one percent of the occupational hygienists and 20% of the safety engineers stated to see a role of REACH Registrants' worker DNELs as private OELs. However, more than half of our respondents were undecided or unfamiliar with worker DNELs. In addition, stated opinions on where worker DNELs fit in the hierarchy of private OELs varied considerably. To conclude, both these professional groups derive private OELs and stated that they need more guidance for this. Furthermore, there is a lack of clarity whether worker DNELs may qualify as private OELs, and where they would fit in the hierarchy of private OELs.

Throwing the baby out with the bath water? Occupational hygienists' views on the revised dutch system for occupational exposure limits.

In 2007, the Dutch Working Conditions Act was revised with the goal to decrease the regulatory burden, and to open up for company-specific solutions of establishing a safe and healthy work environment. One tool geared towards company-specific solutions is the compilation of the Arbocatalogs, which are company or sector-level collections of safe working methods and guidelines developed both by employers and employees. The revision also introduced a new occupational exposure limit (OEL) system in the Netherlands. This system encompasses two kinds of OELs: private and public. Private OELs are to be derived by the industry, while public OELs are issued by the Ministry of Social Affairs and Employment. With this change, the majority of the previously set Dutch OELs were removed, as the substances in question now are falling under the private realm. The motivations, expectations, and practical impacts of these revisions have been investigated through interviews with stakeholder organizations and a questionnaire study targeted at occupational hygienists. The questionnaire results show that although the Arbocatalogs seem to be relatively well received, a majority of the Dutch occupational hygienists are still relatively negative to the changes. There is a fear that private OELs will be less scientifically robust than public OELs and that the lack of robustness will have a negative impact on the field of occupational hygiene as a whole.

Discrepancy among acute guideline levels for emergency response.

Acute guidance values are tools for public health risk assessment and management during planning, preparedness and response related to sudden airborne release of hazardous chemicals. The two most frequently used values, i.e. Acute Exposure Guidance Levels (AEGL) and Emergency Response Planning Guideline (ERPG), were compared in qualitative and quantitative terms. There was no significant difference between the general level of AEGL and ERPG values, suggesting the two systems are equally precautious. However, the guidance values diverged by a factor of 3 or more for almost 40% of the substances, including many of high production volume. These deviations could be explained by differences in selection of critical effect or critical study and in a few cases differences in interpretation of the same critical study. Diverging guidance values may hamper proper risk communication and risk management. Key factors for broad international acceptance of harmonized values include transparency of the decision process, agreement on definition of toxicological tiers, and a target population including sensitive groups of the general population. In addition, development of purely health based values is encouraged. Risk management issues, such as land use and emergency response planning should be treated separately, as these rely on national legislation and considerations.