Ref. Ares(2015)5589635 - 04/12/2015
Ref. Ares(2016)1151420 - 07/03/2016
US-EU Workshop on Endocrine Disruption
6-7 October, 2015
Avenue de Beaulieu 9, 1160 Brussels, Room: BU-9 –0A
Draft Agenda
1. Welcome (DG ENV)
13:00 – 13:10
2. US and EU policy context
a. US regulatory context + distribution of responsibilities among
13:10 – 13:25
the institutions
(
, US)
b. EU regulatory context + distribution of responsibilities among
13:25 – 13:40
the institutions
(
, DG ENV)
3. US and EU screening activities
a. Overview of the US EPA Endocrine Disruptor Screening
13:40 – 14:10
Program (EDSP)
(
, EPA/OSCP)
b. Use of High Throughput Assays and Predictive Models in the
14:10 – 14:40
US EPA EDSP
(
, EPA/OSCP)
c. US EPA EDSP List 1 Tier 1 Screening Level Determinations of
14:40 – 15:10
Endocrine Activity and Additional Testing for Dose Response
and Adversity (case of conazole myclobutanil)
(
and
, EPA/OSCP)
Coffee
15:10 – 15:30
3. US and EU screening activities
a. Hazard and risk assessment as regards endocrine disruption
15:30 – 15:50
under REACH – work of EDEG
(
, ECHA)
b. Screening for potential endocrine disruptors by the European
Chemical Agency in the context of identification of substances
15:50 – 16:10
of very high concern (SVHC) under REACH
(
, ECHA)
c. Work of JRC as regards endocrine disruption
16:10 – 16:40
(
, JRC)
d. EFSA’s work on the assessment of endocrine active
16:40 – 17:10
substances
(
, EFSA)
Discussions + Wrap up of the 1st day
17:10 – 18:00
4. Hazard and risk assessment of octyl- and nonyl-phenols and their
ethoxylates
a. Hazard assessment of phenols (octyl- and nonyl-phenols and
9:00 – 9:30
their ethoxylates) as regards their endocrine disrupting
properties under REACH
(
, ECHA)
b. Discussion
9:30 – 9:45
Coffee + discussion
09:45 – 10:15
5. Hazard and risk assessment of phthalates
a. Phthalates Screening and testing in the EDSP
10:15 – 10:45
(
, EPA/OSCP)
b. Hazard assessment of phthalates as regards their endocrine
10:45 – 11:15
disrupting properties under REACH
(
, ECHA)
c. Discussion
11:15 – 11:45
6. Hazard and risk assessment of Bisphenol A
a. CLARITY-BPA Consortium Linking Academic and Regulatory
11:45 – 12:15
Insights on BPA Toxicity1,
(
, NIEHS)
b. Discussion
12:15 – 12:30
Lunch
12:30 – 14:00
7. Hazard and risk assessment of pesticides
a. US assessments of endocrine disruption potential:
14:00 – 14:30
myclobutanil, esfenvalerate, metalaxyl(-M), 2,4-D
(
, EPA/OPP via webinar)
b. Assessment of potential endocrine disrupting effects in the EU 14:30 – 15:00
Pesticides Peer Review (possible case studies: esfenvalerate,
metalaxyl(-M), 2,4-D)
(
, EFSA)
c. Discussion
15:00 – 16:00
Coffee
16:00 – 16:15
8. Assessing the Risk of Endocrine Disruption for Water Environment
a. Assessing the Risks of Endocrine Disruption from Water-Based 16:15 – 16:45
Exposures
(
or
, EPA/OSCP)
b. Prioritisation exercise to identify priority substances under
16:45 – 17:15
the Water Framework Directive with the focus on endocrine
disruption
(
, DG ENV)
9. Conclusions
17:15 – 17:30
End of the meeting
17:30
1 http://www.niehs.nih.gov/research/programs/endocrine/bpa initiatives/index.cfm
BACKGROUND
This workshop was inspired by discussions between EU Commission representatives and the US EPA
with the goal of fostering US/EU cooperation on scientific issues related to promoting chemical safety in
regard to potential for endocrine disruption. This paved the way for the idea of cooperative work on
scientific aspects related to the assessment of chemicals’ endocrine disrupting potential, and a
workshop on commonalities and differences in the European and US approaches for the screening and
assessment of potential endocrine disruption.
The agenda for the workshop addresses the major scientific activities going on in the US and EU on
endocrine disruption, with presentations and discussions on screening, priority setting and assessment
of endocrine disrupting substances. This 2 day workshop will involve participants from each side, with
case studies presented by EU (DG ENV, SANTE, GROW, JRC, ECHA, EFSA) and US (EPA, NIEHS, FDA, CPSC)
participants. These case studies will be examined and discussed in order to identify similarities in
approaches and possibilities for further cooperation in sharing the scientific basis for the assessment.
Whereas the work in US until now has been focused on pesticides, the identification of EDs in Europe
has until now covered mainly industrial chemicals. Taking into consideration available time, experience
and resources, pesticides (azole fungicides), phthalates, phenols (nonylphenol/octylphenol) and BPA
have all been discussed potential candidate case-studies. The workshop should focus on both
commonalities and differences while doing a lot of exploration. Coming out of the workshop, groups
could work in subsequent months to prepare workshop summary reports on designated topics. For each
case study it should be analysed whether we look at the same data, identified the same endocrine
activity and adverse effects, and whether the interpretation of data, dose-response, hazard, exposure
and risk is similar. Key findings will be identified in the meeting, forming the basis for the workshop
summary reports. Additional questions could be whether the different methodologies for screening and
priority setting achieve the same, what are the similarities and differences, and why do they exist. It was
agreed that the work should be integrated and attempt to cover both human health and environment
which is extremely relevant due to the conservation of the hormonal system across vertebrate species.
WORKSHOP TOPICS
1. Screening activities and methods to identify potential endocrine disruptors
Description of EU and US approaches and methodologies for screening for endocrine disruption and
sharing of data. Comparison and analysis of similarities and differences and possible explanation of
differences, if any.
2. Priority setting activities and methodologies to select among the potential endocrine disruptors those
to investigate further or first
Description of EU and US priority setting methodologies to select, among the potential endocrine
disruptors, those to investigate further or first. Sharing of work. Comparison and analysis of similarities
and differences and possible explanation of differences, if any.
3. Identification of intrinsic hazard of endocrine disruption
Description of EU and US approaches and methodologies to identify inherent endocrine disruptive
properties of chemical substances. Comparison and analysis of similarities and differences and possible
explanation of differences, if any.
4. Risk assessment
Description of EU and US approaches for risk assessment of endocrine disruptors. Comparison and
analysis of similarities and differences and explanation of differences.
PARTICIPANTS
The workshop would be attended by up to 30 participants – 10-15 from each side. US side will be
represented by US EPA, FDA, CPSC, and NIH. EU will be represented by the relevant Commission
Services and EU Agencies.
U.S. Participants:
US EPA –
,
(OSCP),
(OPP, by webinar
)
FDA-
NIH-
(NIEHS)
USDA
CPSC
EU Participants
DG ENV –
,
, (
)
DG SANTE –
,
, (
),
DG GROW –
,
,
, (
)
SG –
,
DG RTD –
DG JRC –
, (
)
EFSA –
,
,
,
ECHA –
,
ORGANISATION OF THE WORKSHOP
Both EU and US would present their activities, approaches and methodologies for screening, priority
setting, hazard and risk assessment as regards endocrine disruptors. Commonalities and differences
could be then identified and discussed for each of the topics. Specific examples and case-studies are
encouraged. Concluding discussions will focus on possible collaborative work, building from the case-
studies or other projects, that will help elucidate similarities, differences and conclusions.