On 16 March 2021, the OECD co-organised a webinar with the Joint Research Centre (JRC) of the European Commission to discuss the recently published report on Addressing evidence needs in chemicals policy and regulation by the JRC. There are deep divisions between key stakeholders in chemical regulation regarding the best methods for obtaining data and evidence for informing policy in general and decisions on particular substances. This report summarises the key insights of a study on stakeholder perceptions of the main challenges facing chemicals regulation, and of alternative approaches to conducting toxicological studies. The report offers a proposal for overcoming mistrust between stakeholders, building on the AOP Framework to more fully support ‘transparency plus’, which supplements access to data and evidence with shared understanding. The webinar was an opportunity to hear the main findings of the report and a set of actionable recommendations, including how knowledge management systems can be designed in a user-centric fashion to address current challenges, with the Adverse Outcome Pathway (AOP) framework being a prominent example. Programme and speakers: - Introduction: Magda Sachana from the OECD Environment Directorate - Trust and Transparency Plus in chemicals regulation: Annamaria Carusi from Interchange Research - Building trust through improved tools and practice in the life cycle of mechanistic data: Antonio Franco from the EC Joint Research Centre - The role of the AOP Framework in knowledge management and trust building: Jason O’Brien from the National Wildlife Research Centre, Canada - Q&A session moderated by Magda Sachana from the OECD Environment Directorate and Clemens Wittwehr from the EC Joint Research Centre.

1. 1
Trust and Transparency Plus
in chemicals regulation
Annamaria Carusi
Interchange Research
16 March 2022

2. 2
• JRC, Feb 2022
• JRC, Feb 2022

3. 3

4. 4
Major challenges
Lack of
consensus
• There is a lack of consensus on
different methods and
approaches in toxicological
sciences, exacerbated by
difficulty of access to large
quantities of dispersed and non-
standardised data
1

5. 5
Modern safety assessment toolbox
biokinetics
QSAR docking
existing
animal data
clinical
data
human
biomonitoring
'omics
High Throughput Screening
in vitro
Organ-on-Chip

6. 6
“And we're finding out that the in vivo studies are not so gold. They're not
really the gold standard that we ought to be retreating to, because they
themselves have their own limitations”.
“Industry puts a lot of effort in these [alternative] tests to avoid expensive
animal testing. But at the same time, industry makes sure that alternative
testing is insensitive, non-validated and biased. The public will be even
more a guinea pig”.
Lack of consensus
Source: AOP Framework Study Report, 2022

7. 7
Major challenges
Mistrust • There is mistrust among
stakeholders in different sectors
(industry – government,
regulatory toxicologists – risk
assessors – risk managers)
Lack of
consensus
• There is a lack of consensus on
different methods and
approaches in toxicological
sciences, exacerbated by
difficulty of access to large
quantities of dispersed and non-
standardised data
1 2

8. 8
Regulators want more data to meet targets of their own, for their own
searches. They make exaggerated demands on data. These demands are
tailored to what the authorities want to do with all these data. Going
beyond the regulatory needs. [paraphrase]
“I think there is too much politics and too much interest in it and sometimes
that can happen of course. I think that the endocrine disruptor issue that
we just came from there, it’s a good example of it because there is not
really a scientific base for the decisions that are being made and that’s a
concern to me”.
“Opinions and decisions are under control of a few individuals per
chemical, due to a number of reasons, which cause a feeling of
intransparency and excessive political controls over clearly scientific
subjects”.
Mistrust
Source: AOP Framework Study Report, 2022

9. 9
Major challenges
Mistrust • There is mistrust among
stakeholders in different sectors
(industry – government,
regulatory toxicologists – risk
assessors – risk managers)
Lack of
consensus
Decision-
making lags
behind science
• There is a lack of consensus on
different methods and
approaches in toxicological
sciences, exacerbated by
difficulty of access to large
quantities of dispersed and non-
standardised data
• The science directly informing
policy and regulatory decision-
making often lags behind current
science
1 2
3

10. 10
“Despite the fact that science is running … we are doing risk assessment
basically like we did it 30 years ago”.
“The way we do safety assessment today is the way we’ve done it for
decades. We’re in a world of technology and science that has rapidly
progressed to the point where lots of the cars, phones, etc, are very
different than they were 50 years ago. And our science is not as advanced
as it ought to be. All of our investment in technology and science ought to
enable us to do this in a way that looks very different from the way we’ve
always done it and we’re not there.”
Decision-making lags behind the science
Source: AOP Framework Study Report, 2022

11. 11
Major challenges
Mistrust
No shared
understanding
• There is mistrust among
stakeholders in different sectors
(industry – government,
regulatory toxicologists – risk
assessors – risk managers)
• There is not a shared
understanding of how data is
constituted as evidence for
regulatory decisions, or for
current and future policy
regarding chemicals and other
potential toxins
Lack of
consensus
Decision-
making lags
behind science
• There is a lack of consensus on
different methods and
approaches in toxicological
sciences, exacerbated by
difficulty of access to large
quantities of dispersed and non-
standardised data
• The science directly informing
policy and regulatory decision-
making often lags behind current
science
1 2
3 4

12. 12
“The high-throughput assays are generally done by private companies
with proprietary systems, and even when done in a more "open" way, the
computerized fashion in which the data are collected and analyzed
prevents much transparency in assessing the data.”
“But even beyond that, I think one of the major challenges we face in the
regulatory risk assessment context is the unpredictable scientific
interpretation that is made of the data […] we never know in the regulatory
context how – I cannot even talk about scientific rigidity, but really which
scientific culture will be applied to interpret the data […]”
Absence of shared understanding
Source: AOP Framework Study Report, 2022

13. 13
Major challenges
Mistrust
No shared
understanding
• There is mistrust among
stakeholders in different sectors
(industry – government,
regulatory toxicologists – risk
assessors – risk managers)
• There is not a shared
understanding of how data is
constituted as evidence for
regulatory decisions, or for
current and future policy
regarding chemicals and other
potential toxins
Lack of
consensus
Decision-
making lags
behind science
• There is a lack of consensus on
different methods and
approaches in toxicological
sciences, exacerbated by
difficulty of access to large
quantities of dispersed and non-
standardised data
• The science directly informing
policy and regulatory decision-
making often lags behind current
science
1 2
3 4

14. 14
Information about
potential and actual
conflicts of interests
Access to relevant
data and evidence Access as understanding
TRANSPARENCY
TRANSPARENCY PLUS
TRUST

15. 15
Established
methods
New methods
and
mechanisms
Data
Science
Evidence
Policy
Established
methods New methods
and
mechanims
Data
Science Evidence
Policy
Building shared understanding
BRIDGING
• Comparability
• Connection / commonality / equivalence/
integration / complementarity of data and
methods
• Problem / question / / values / purposes

16. 16
“[…] And actually at that time we got a recommendation about start from
an AOP, something that would be a common mechanism between the
different [substance X] to build your story over there. […] It would probably
facilitate – provide a frame to be more neutral.”
“I think the AOP is the right tool because it's taking all together, using the
right data because you have the hazard, you have the mechanistic, you
have the in silico, you have the mathematical, you can really work as a
single community. I don't think it's a matter of resistance. I think it's a
matter of immaturity.”
Role of AOP Framework
Source: AOP Framework Study Report, 2022

17. 17
JRC Science for Policy Report (Feb 2022)