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Potential for Harmonisation:
Summary of Results from the OECD
Report
OECD Online Workshop  Approaches for
Establishing OELs
October 24, 2022
 The absence of a globally harmonised approach contributes
towards differences in derivation approaches and resulting OEL
values
 In February 2021, a survey on OEL development was sent to
WPHA and WPEA members
 Responses were received from 13 countries/regions
 Results related to harmonisation are presented today
Background
2
Available at
https://www.oecd.org/
officialdocuments
Current commonalities in OEL processes
 Similarities in overall OEL derivation processes
 Durations  8h-TWA for chronic and 15-minute STEL and Ceiling
values for acute
 Human-relevant critical effects commonly based on sensory
irritation, systemic effects, and specific target organ toxicity
 Key studies are typically epidemiology and experimental
studies published in scientific literature
 OELs are derived for threshold toxicants by dividing a POD by
uncertainty factors
 All countries use hazard notations (most commonly the
potential for toxicity from dermal absorption)
 Differences typically result from specific policy decisions
3
Current status of harmonisation
 Existing processes already involve some alignment of organisations:
 Some collaboration and coordination already exists within countries/regions
 Use of existing OELs as starting points
 Health-based values: ACGIH, SCOEL/ECHA RAC, German MAK
Commission, DECOS
 Highlights the value in making health-based OELs (and the methodology
for their derivation) publicly available
 Efficient use of resources by using existing scientific opinions as a starting
point was mentioned as a success of a program
 Lack of alignment across organisations was stated as challenge:
 Lack of control over timing of other organisations publications
 Development of OEL may be postponed if other organisations plan to
evaluate same chemical
4
 Most survey respondents were open to additional harmonisation activities
Guidance
- General OEL derivation
- Confidence/addressing
uncertainty
- Deviation from defaults
- Acceptable levels of risk
- Criteria on differences of OELs
from general population values
Information sharing
- Timing of assessments/workplans
- Sharing of new studies
- Sharing documentation for OELs
- Exchanges on research on new risk
assessment methodologies
Work sharing
- Sharing common prioritization
processes
- Division of labour for evaluating
scientific literature
- Identifying PODs
Policy alignment
- Deriving common OELs
- Least likely to occur due to
differences in approaches/policies
and needs
Interest in further harmonisation
5
Potential benefits of harmonisation
 Reduced redundancies
 Saves both time and financial resources
 Potential to increase number of existing OELs and updated older OELs
 Provision of standardised level of protection of workers
 Also can benefit employers if compliance requirements become
standardised
 Information sharing could facilitate harmonisation
 Increased transparency in OEL-deriving processes could improve
harmonisation
6
Potential barriers to harmonisation
 Lack of documentation of methodologies
 OEL documentation is not always readily available
 Different timing of assessments and priority of chemicals
 Differences in policies and approaches
 Different needs
7
Summary/conclusion
 Some degree of harmonisation and coordination is already occurring
 Survey respondents were generally interested in pursuing additional
harmonisation activities
 Types of harmonisation activities proposed ranged from developing
guidance and sharing information to work sharing and policy
alignment
 Harmonisation activities proposed could be performed despite
differences in policies, approaches, and needs
8
Acknowledgements
Ayah Abdul-Hussein
Meagan Bacciaglia
Tara Barton-Maclaren
Christine Lemieux
Sarah Vanden Hoven
Angelika Zidek
9
Tomoko Aoyagi
Patience Browne
Linda Rubene
Koki Takaki
Hannah Thabet
Members of WPHA, WPEA,
and OEL subgroup
Survey respondents
Potential for harmonisation results from the OEL report Michelle Deveau Health Canada.pdf

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Potential for harmonisation results from the OEL report Michelle Deveau Health Canada.pdf

  • 1. Potential for Harmonisation: Summary of Results from the OECD Report OECD Online Workshop Approaches for Establishing OELs October 24, 2022
  • 2. The absence of a globally harmonised approach contributes towards differences in derivation approaches and resulting OEL values In February 2021, a survey on OEL development was sent to WPHA and WPEA members Responses were received from 13 countries/regions Results related to harmonisation are presented today Background 2 Available at https://www.oecd.org/ officialdocuments
  • 3. Current commonalities in OEL processes Similarities in overall OEL derivation processes Durations 8h-TWA for chronic and 15-minute STEL and Ceiling values for acute Human-relevant critical effects commonly based on sensory irritation, systemic effects, and specific target organ toxicity Key studies are typically epidemiology and experimental studies published in scientific literature OELs are derived for threshold toxicants by dividing a POD by uncertainty factors All countries use hazard notations (most commonly the potential for toxicity from dermal absorption) Differences typically result from specific policy decisions 3
  • 4. Current status of harmonisation Existing processes already involve some alignment of organisations: Some collaboration and coordination already exists within countries/regions Use of existing OELs as starting points Health-based values: ACGIH, SCOEL/ECHA RAC, German MAK Commission, DECOS Highlights the value in making health-based OELs (and the methodology for their derivation) publicly available Efficient use of resources by using existing scientific opinions as a starting point was mentioned as a success of a program Lack of alignment across organisations was stated as challenge: Lack of control over timing of other organisations publications Development of OEL may be postponed if other organisations plan to evaluate same chemical 4
  • 5. Most survey respondents were open to additional harmonisation activities Guidance - General OEL derivation - Confidence/addressing uncertainty - Deviation from defaults - Acceptable levels of risk - Criteria on differences of OELs from general population values Information sharing - Timing of assessments/workplans - Sharing of new studies - Sharing documentation for OELs - Exchanges on research on new risk assessment methodologies Work sharing - Sharing common prioritization processes - Division of labour for evaluating scientific literature - Identifying PODs Policy alignment - Deriving common OELs - Least likely to occur due to differences in approaches/policies and needs Interest in further harmonisation 5
  • 6. Potential benefits of harmonisation Reduced redundancies Saves both time and financial resources Potential to increase number of existing OELs and updated older OELs Provision of standardised level of protection of workers Also can benefit employers if compliance requirements become standardised Information sharing could facilitate harmonisation Increased transparency in OEL-deriving processes could improve harmonisation 6
  • 7. Potential barriers to harmonisation Lack of documentation of methodologies OEL documentation is not always readily available Different timing of assessments and priority of chemicals Differences in policies and approaches Different needs 7
  • 8. Summary/conclusion Some degree of harmonisation and coordination is already occurring Survey respondents were generally interested in pursuing additional harmonisation activities Types of harmonisation activities proposed ranged from developing guidance and sharing information to work sharing and policy alignment Harmonisation activities proposed could be performed despite differences in policies, approaches, and needs 8
  • 9. Acknowledgements Ayah Abdul-Hussein Meagan Bacciaglia Tara Barton-Maclaren Christine Lemieux Sarah Vanden Hoven Angelika Zidek 9 Tomoko Aoyagi Patience Browne Linda Rubene Koki Takaki Hannah Thabet Members of WPHA, WPEA, and OEL subgroup Survey respondents