EDTRA IG meeting, SETAC EUROPE
New Co-chair Jeff Wolf and 3R opportunities in ED by Natalie Burden
Zoom format 6th May, 9:45-10:45 UTC
As you know the SETAC EUROPE 30th Annual Meeting will take place on as "SciCon". Therefore, our EDTRA IG will meet in Zoom format on the 6th May, from 9:45 to 10:45 UTC (Central Europe Summer Time CEST=UTC+2; Irish Standard Time IST=UTC+1; Eastern Daylight Time (US) EDT=UTC-4).
Everyone is welcome to join the meeting, not just the SciCon participants. EDTRA members will receive the Zoom link on the 5th May and are encourage to share it.
We will introduce the new co-chair of the EDTRA IG, Jeff Wolf, of the Experimental Pathology Laboratories Inc., Sterling, US. And we take to opportunity to thank Heiko Schoenfuss for his excellent work as chair of the EDTRA IG for the last two years.
We will receive Natalie Burden from NC3Rs, the National Centre for the replacement, refinement and reduction of animals in research, UK, who will presents us new opportunities for 3R in the identification of endocrine disruption in aquatic vertebrates.
Fitness check on EU legislation on Endocrine disruptors
Experts, targeted stakeholder and public survey
Public survey until 9 March!
The European commission invites stakeholder organizations, experts and the public to participate in the fitness check on the EU legislation on Endocrine disruptors. The survey will be open until the 31 January 2020 on the following addresses:
For experts and stakeholders: https://ec.europa.eu/eusurvey/runner/ED_FC_StakeholdersSurvey
For the large public: https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2019-2470647/public-consultation_en
You can also check the calendar of the initiative Harmful chemicals- Endocrine disruptors on:
EU initiative: Harmful chemicals - Endocrine disruptors
Have your saying, review of EU rules
The European commission is preparing an initiative on endocrine disruptors for which the roadmap will be published soon. The legislation is planned to be adopted in 2020. Follow and contribute to this initiative on: https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2019-2470647_en
OECD series: Adverse outcome pathways
Androgen agonism and female reproductive dysfunction (AOP No. 9)
The OECD has recently added a new AOP to its OECD Series on Adverse Outcome Pathways. This AOP describes the pathway responsible for reproductive dysfunction as a consequence of androgen agonism in female fish. Find out all the details in: Adverse Outcome Pathway on Androgen receptor agonism leading to reproductive dysfunction (in repeat-spawning fish)
OECD guidance on EDC evaluation
Revised Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption (No. 150)
"This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals. The document is intended to provide... guidance on how test results might be interpreted based on the outcome of standardised assays and... provides suggestions for possible next steps in testing (if any) which might be appropriate for a regulatory authority to take, given the various data scenarios."
Read here the guidance document: guidance_for_edcs_evaluation.pdf
OECD guidance on AOP development and use
Revised Guidance Document on Developing and Assessing Adverse Outcome Pathways (No. 184)
"This guidance document provides an introduction to the development and assessment of AOPs, and the framework for consistent information gathering and organisation, including definitions for AOP-specific terminology. In this context, an AOP is a conceptual construct that portrays existing knowledge concerning the pathway of causal linkages between a molecular initiating event (MIE) and a final adverse outcome (AO) at a biological level of organisation that is relevant to a regulatory decision (Ankley et al., 2010)."
Find here the guidance document: developing_and_assessing_aop.pdf
EU Initiative: Towards a more comprehensive EU framework on endocrine disruptors
Roadmap as an example of stakeholder participation in EU initiatives
"Roadmaps aim to inform citizens and stakeholders about the Commission's work in order to allow them to provide feedback and to participate effectively in future consultation activities. Citizens and stakeholders are in particular invited to provide views on the Commission's understanding of the problem and possible solutions and to make available any relevant information that they may have."
Here you find the roadmap of EU initiative on endocrine disruption. For this particular initiative the feedback pariod has recently closed.
Developments in the EU guideline for ED identification
Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009
This document "provides guidance to applicants and assessors of competent regulatory authorities on how to identify endocrine disruptors in accordance with the ED criteria laid down in Commission Delegated Regulation (EU) No 2017/21003 and Commission Regulation (EU) No2018/6054 for biocidal products (BP) and plant protection products (PPP), respectively. The guidance document describes how to gather, evaluate and consider all relevant information for the assessment,conduct a mode of action (MoA) analysis, and apply a weight of evidence (WoE) approach, in order to establish whether the ED criteria are fulfilled."