Announcement of “Further Actions to Endocrine Disrupting Effects of Chemical Substances – EXTEND2022 –”

Ministry of the Environment (MOE) has announced its new program “Further Actions to Endocrine Disrupting Effects of Chemical Substances – EXTEND2022 –” for its continuous activities on endocrine disruption.
* EXTEND = Extended Tasks on Endocrine Disruption

Its text with supporting annexes (only in Japanese!) is available from MOE’s official website:
https://www.env.go.jp/chemi/risk_assessment.html
English version will be developed and uploaded later.

After five years had passed since implementation of “Further Actions to Endocrine Disrupting Effects of Chemical Substances – EXTEND2016 –”, Ministry of the Environment (MOE) initiated review on the program in 2021.  Views and advice were obtained from “Committee on Endocrine Disrupting Effects of Chemical Substances” (Chair: Prof. Taisen Iguchi, Yokohama City University) and its sub-committees.
Based on the review, MOE has developed a new program succeeding EXTEND2016, titled as “Further Actions to Endocrine Disrupting Effects of Chemical Substances – EXTEND2022 –”.

Achievements of the previous programs, including EXTEND2016, are as follows:

[Development of two-tiered framework on testing and assessment]

• The two-tiered framework on testing and assessment of endocrine disruption was developed, where assays should be conducted stepwise from concise ones (Tier 1 in vitro assays) to long-term definitive ones (Tier 2 in vivo assays).
• Under this framework, risk assessment should be conducted referring to adverse effect characterized by the Tier 2 in vivo assays.

[Development of test methods]

• Test methods have been developed for use in the framework. Medaka Extended One Generation Reproduction Test (MEOGRT) and Larval Amphibian Growth and Development Assay (LAGDA), developed under cooperation with the United States, were adopted as OECD Test Guidelines.
• Japan is leading the projects to develop screening assays using medaka and daphnids under OECD Test Guidelines Programme.

[Implementation of testing and assessment]

• Under the framework, more than two hundred chemical substances, most of which were detected in the aquatic environment, were subjected to testing and assessment of endocrine disruption.
• As the Tier 2 in vivo assay, Medaka Extended One Generation Reproduction Test (MEOGRT) was conducted for six substances including nonylphenol. Obtained data are being referred to in risk assessment of Priority Assessment Chemical Substances under Chemical Substances Control Law (CSCL) and Initial Environmental Risk Assessment of Chemicals.

[International Cooperation]

• Cooperative activities such as joint research, joint development, and information exchange have been continued in the bilateral collaborations with the United Kingdom and the United States. Their achievements have been introduced into testing and assessment under the programs.

EXTEND2022, the new program targeting FY 2030, has the same structure as the previous one, EXTEND2016:

1. Action and Effect Assessment and Test Method Development
2. Survey on Environmental Concentrations and Exposure Assessment
3. Risk Assessment and Risk Management
4. Accumulation of Knowledge
5. Promotion of International Cooperation and Information Sharing

Maintaining the existing two-tiered framework on testing and assessment as well as fundamental concepts regarding assessment of endocrine disruption, new attempts shown below will be implemented:

• Pesticides and pharmaceuticals and personal care products (PPCPs) will also be subjected to testing and assessment.
• Testing and assessment will be conducted using new test methods developed through MOE’s programs.
• New Approach Methodologies (NAMs) will be investigated to consider how they could be used for testing and assessment.
• Viewpoints on mixtures assessment will be introduced.
• Methodologies/procedures/systems on endocrine disruption will be proposed for regulatory assessment under legislative risk management.
• Dissemination of activities and achievements of this program will be promoted in English.