Introducing the OECD guidance document on occupational biomonitoring: A harmonized methodology for deriving occupational biomonitoring levels (OBL)

Nancy B Hopf; Jos Bessems; Tiina Santonen; Susana Viegas; Ludwine Casteleyn; Devika Poddalgoda; Farida Lamkarkach; Thomas Göen; Maryam Zare Jeddi; Michael Koller; Christophe Rousselle; Kate Jones; Kaspar Schmid; Rex FitzGerald; Michael Bader; Koki Takaki; Patience Browne; Virpi Väänänen; Radu Corneliu Duca; Robert Pasanen-Kase

doi:10.1016/j.toxlet.2024.12.006

Introducing the OECD guidance document on occupational biomonitoring: A harmonized methodology for deriving occupational biomonitoring levels (OBL)

Toxicol Lett. 2024 Dec 15:403:132-143. doi: 10.1016/j.toxlet.2024.12.006. Online ahead of print.

Authors

Nancy B Hopf¹, Jos Bessems², Tiina Santonen³, Susana Viegas⁴, Ludwine Casteleyn⁵, Devika Poddalgoda⁶, Farida Lamkarkach⁷, Thomas Göen⁸, Maryam Zare Jeddi⁹, Michael Koller¹⁰, Christophe Rousselle¹¹, Kate Jones¹², Kaspar Schmid¹³, Rex FitzGerald¹⁴, Michael Bader¹⁵, Koki Takaki¹⁶, Patience Browne¹⁷, Virpi Väänänen¹⁸, Radu Corneliu Duca¹⁹, Robert Pasanen-Kase²⁰

Affiliations

¹ Center for Primary Care and Public Health (Unisanté), University of Lausanne, Route de la Corniche 2, 1011 Epalinges, Lausanne Switzerland. Electronic address: [email protected].
² VITO Nv, Boeretang 200, Mol 2400, Belgium. Electronic address: [email protected].
³ Finnish Institute of Occupational Health, Helsinki, Finland. Electronic address: [email protected].
⁴ ENSP/UNL, NOVA National School of Public Health, Public Health Research Centre, Comprehensive Health Research Center, CHRC, NOVA University Lisbon, Portugal. Electronic address: [email protected].
⁵ Katholieke Universiteit, Leuven, Belgium. Electronic address: [email protected].
⁶ Health Canada, Existing Substances Risk Assessment Bureau, Healthy, Environment and Consumer Safety Branch, Health Canada, Government of Canada, Canada. Electronic address: [email protected].
⁷ French Agency for Food, Environmental and Occupational Health and Safety (ANSES), Maisons Alfort 94701, France. Electronic address: [email protected].
⁸ University of Erlangen, Friedrich-Alexander University (FAU) Erlangen-Nuremberg, Schillerstrasse 25, Erlangen 91054, Germany. Electronic address: [email protected].
⁹ Shell Global Solution international, BV., Netherlands. Electronic address: [email protected].
¹⁰ SUVA, Fluhmattstrasse 1, Luzern 6002, Switzerland. Electronic address: [email protected].
¹¹ French Agency for Food, Environmental and Occupational Health and Safety (ANSES), Maisons Alfort 94701, France. Electronic address: [email protected].
¹² Health and Safety Executive, Harpur Hill, Buxton SK17 9JN, UK. Electronic address: [email protected].
¹³ State Secretariat for Economic Affairs (SECO), Section Chemicals and Occupational Health, Holzikofenweg 36, Bern 3003, Switzerland. Electronic address: [email protected].
¹⁴ Universities of Basel and Geneva, Switzerland. Electronic address: [email protected].
¹⁵ BASF SE, ESG/CB - Medical Center Z130, Carl-Bosch-Str. 38, Ludwigshafen am Rhein 67056, Germany. Electronic address: [email protected].
¹⁶ Ministry of the Environment, Japan. Electronic address: [email protected].
¹⁷ OECD, rue André Pascal 2, Paris 75775, France. Electronic address: [email protected].
¹⁸ ECHA, European Chemicals Agency, Telakkakatu 6, P.O. Box 400, Helsinki FI-00121, Finland. Electronic address: [email protected].
¹⁹ Katholieke Universiteit, Leuven, Belgium; Environmental Hygiene and Human Biological Monitoring, Department of Health Protection, Laboratoire National de Santé (LNS), 1, Rue Louis Rech, Dudelange L-3555, Luxembourg. Electronic address: [email protected].
²⁰ State Secretariat for Economic Affairs (SECO), Section Chemicals and Occupational Health, Holzikofenweg 36, Bern 3003, Switzerland. Electronic address: [email protected].

PMID: 39681241
DOI: 10.1016/j.toxlet.2024.12.006

Abstract

Derivation of occupational biomonitoring levels (OBLs) is needed to effectively utilize biomonitoring for assessing exposures to chemical substances, and consequently, implement risk reduction measures to reduce health risks among workers. OBLs are the appropriate option for chemical substances that can be absorbed through the skin. This methodology for derivation of OBLs has been developed in collaboration with scientific and regulatory experts from more than 40 institutes in 15 countries within the Organization for Economic Cooperation and Development (OECD) framework. This manuscript provides a summary of the guidance on derivation of OBLs destined for scientists, risk assessors, and regulators who are tasked with establishing OBLs for regulatory purposes and implementing occupational biomonitoring programs. The derivation methodology follows a tiered approach based on the strength of evidence and quality of the data that we have labeled level of confidence. The tiered approach serves as a practical framework in occupational health risk assessment and management. We distinguish between four OBL levels depending on the strength of scientific evidence and confidence level: health-based derivation of OBL based on robust epidemiological data showing causal exposure-health effect relationship and Provisional OBL (POBL) based on robust toxicological animal data showing dose-response relationship as well as two assessment values which are not health based: reference levels in the general population (Reference OBL or (ROBL)), and Technical achievable OBL or (TOBL). Four case studies illustrating the derivation methods for OBLs and POBLs are also provided. Using this state-of-the-art approach (OECD guidance document no. 370) will lead to a harmonized derivation of OBLs and subsequently to evidence-based risk management measures.

Keywords: Biomonitoring; Harmonized methodology; Human; OECD; Occuaptional exposure assessment; Occupational biomonitoring levels.