Occupational exposure limits OECD next steps.pdf

The OECD workshop on approaches for establishing Occupational Exposure Limits (OELs) presented the outcomes of the OECD survey report on the OELs setting and explored the possible opportunities for harmonisation approaches for setting OELs amongst countries. In addition, the workshop introduced Japan’s new legal framework on OELs, which aims to establish approximately 500 new OELs in the next three years.

This workshop was jointly hosted by Japan and the OECD. Japan provided English-Japanese interpretation to facilitate the discussion at the workshop.

Watch the event replay at: https://www.oecd.org/en/events/2022/10/oecd-workshop-on-approaches-for-establishing-occupational-exposure-limits.html

1. [Table of Contents]
1 Introduction
1.1 Background
1.2 OEL settings in Japan
1.3 Overview of the online workshop
2 Approaches to set OEL values
2.1 Generic workflow/process
2.1.1 Definitions and Scope of Values
2.1.2 How data is evaluated to support
and develop OELs
2.1.3 Methodology for deriving OELs
2.2 Focus endpoints/methodologies
2.2.1 Carcinogenicity
2.2.2 Skin-sensitiser
2.2.3 Biomonitoring
1
Workshop report to be drafted by Japan
and the OECD
•Based on the 2-day discussion
3 Future prospective –Exploring
International Harmonisationon the
OEL settings
3.1 Current Status of Harmonisation
3.2 Harmonisationpractices around the world
3-3 Exploring more harmonized and efficient
approach in establishing OELs
3.4 Potential activities for Harmonisation
3.4.1 Guidance
3.4.2 Information sharing
3.4.3 Work sharing
3.4.4 Policy Alignment

2. •The Workshop report is expected to be published
by Q1 2023.
•Hopefully, the next follow-up activity is to be
launched by reflecting on the Workshop discussion.
•The OECD work is voluntary based.
Any follow-up project proposals from the
WPEA/WPHA delegates are welcome!
2
Timeline

3. Methods for development and derivations of occupational exposure limits
Definitions and Scope of Values
Endpoints included/excluded
•Sensory irritation
•Systemic effects
•Specific target organ toxicity
Type of OELs derived
•8h time weighted averages
•Short-term values (15 min & ceiling)
How data is evaluated to support and develop OELs
Types of data included in the data search
•Scientific literatures
•Reports made by established bodies
•Information from stakeholders
How data quality is assessed
•Use tools/guidelines
•Develop criteria
•Use data assessed by other
organisations
How critical studies are identified
•Human data
•Animal studies
•Read-across and QSARs
Points of Departure selection
•NOAEL/LOAEL
•BMD/BMDL
Points of Departure modification
•Adjust worker’s actual exposure
(exposure frequency and duration)
Use of uncertainty factors (UFs)
•Interspecies differences
•Short-term to long-term
•Individual sensitivity
•NOAEL to LOAEL
Approach for genotoxic carcinogens
•Linear extrapolation
•Statistical exposure-response models
•Setting acceptable risk levels
Methodology for deriving OELs
Notation developed
•Skin/Noise
•Sensitisation(skin and respiratory)
•CMR (carcinogenicity, mutagenicity, reproductive)