Brief Summary
This document summarizes the key discussions and presentations from the third workshop on the Commission's roadmap for phasing out animal testing. The workshop covered various aspects, including the roadmap's structure, stakeholder involvement, research updates, and implementation strategies. Key takeaways include:
- The roadmap aims to provide a plan and schedule to accelerate the phasing out of animal testing, with recommendations applicable to all relevant EU legislation.
- Stakeholder feedback is crucial for the roadmap's development and implementation.
- The implementation phase requires coordination and steering, with proposals for a steering team, scientific network, and collaborative structures.
- A tiered approach to method development, validation, and regulatory acceptance is essential, with a focus on both short-term and long-term goals.
Opening Remarks and Housekeeping
Moner Bu welcomes attendees to the third workshop on phasing out animal testing, outlining housekeeping notes including badge visibility, locations for refreshments, and emergency exits. The workshop agenda includes opening notes, welcome speeches, inspirational talks, and sessions on actions under the roadmap, stakeholder involvement, research updates, and panel discussions. The aim is to encourage discussion and participation, with updated programs available on the event website due to recent strikes.
The Roadmap Journey and Workshop Aims
Katherine and Georg from the European Commission discuss the journey of developing the roadmap, highlighting previous workshops and stakeholder input. They outline the aims of the current workshop, which include reporting on activities, presenting elements of the roadmap, and preparing for the implementation phase. The importance of feedback is emphasized, with a call for intensive discussions to incorporate input into the roadmap's development.
ECHA's Perspective and Support
Sharon McInness, the executive director of the European Chemical Agency (ECHA), welcomes participants and emphasizes ECHA's support for the commission's roadmap to phase out animal testing for chemical safety assessments. She highlights ECHA's experience in using and developing New Approach Methodologies (NAMs) and its commitment to addressing critical gaps in their regulatory application. ECHA is also providing input for the REACH revision, advocating for the replacement of animal testing with suitable alternatives.
Commission's Welcome and Strategic Vision
Christine Shraber delivers a video message welcoming attendees and reaffirming the European Commission's commitment to phasing out animal testing. She emphasizes the importance of scientific progress in ensuring human health and environmental protection during the transition to alternative methods. The roadmap will guide the transition towards non-animal testing, taking into account progress made and remaining hurdles. New animal-free methods offer opportunities for industry innovation, increased competitiveness, and enhanced protection of citizens and the environment.
Inspirational Talk: How Do We Need to Change?
Lara Holden delivers an inspirational talk on the changes needed to transition to an animal-free chemical safety assessment. She discusses the importance of understanding internal and external influences on change, using the multi-level perspective model to describe technology transitions. The talk emphasizes the need to address societal pressures, build trust, and provide clarity on processes and expectations. Engagement, training, and communication are crucial for encouraging acceptance of change and ensuring a stable transition.
Q&A Session with Lara Holden
During the Q&A session, Lara Holden addresses questions about method qualifications, the emotional aspect of change, and industry readiness to accept NAMs. She emphasizes the importance of consensus, addressing concerns, and providing clarity on processes and expectations. The discussion highlights the need for a PR job to make the topic more accessible and engaging, as well as open discussions to address concerns and facilitate the transition.
Introducing Actions Under the Roadmap
Katherine and Georg present an overview of the roadmap's structure and main elements, including its purpose, action points, and milestones. The roadmap aims to accelerate the phasing out of animal testing and will contain recommendations applicable to all relevant EU legislation. They outline the process of developing the roadmap, involving various commission services, agencies, and stakeholder groups. The presentation also introduces ideas for organizational structures during the implementation phase.
Core Elements and Consultation Process
Katherine and Georg discuss the core elements of the roadmap, including recommendations on replacing, reducing, and refining animal testing. They present a three-basket model to organize the elements, with short-term, medium-term, and long-term actions. The consultation process is summarized, highlighting commission events, online surveys, and targeted consultations with various stakeholder groups. The EPA conference in early March is mentioned as a key stakeholder event.
Organizational Structures and Next Steps
Katherine and Georg present a proposal for organizational structures to support the implementation of the roadmap, including a steering team, scientific network, and collaborative structures. The steering team would provide directionality and oversee progress, while the scientific network would support the scientific and technical dimensions. They outline the next steps in the roadmap's development, including drafting the text, receiving reports from consultations, and finalizing the roadmap for publication in the first quarter of 2026.
Q&A Session: Roadmap Actions and Structure
During the Q&A session, Katherine and Georg address questions about the involvement of stakeholders, the role of academia, and the consideration of member state input. They emphasize the importance of having the right organizational structures to focus discussions and involve many stakeholders. The discussion also touches on the need for financial resources and the importance of collaboration and trust-building.
Recommendations on Phasing Out Animal Testing for Human Health Assessment
Thomas from ECHA, Sophia from EFSA, Miriam from RIVM, and Ellen from leads the session on recommendations for phasing out animal testing for human health assessment. Thomas emphasizes the need for a human-centric, animal-free, and mechanistic approach to chemical safety assessment. He outlines four steps to achieve this goal: identifying critical needs, building confidence, addressing critical needs, and redesigning the regulatory system.
Specific Actions and Examples
The speakers provide examples of specific actions and recommendations, including better use of computational approaches, integration of multi-omics data, and development of performance standards. Sophia discusses the reduction potential of existing animal models, such as the 90-day dog study. Miriam presents an example of a working group on carcinogenicity, outlining the elements required for an animal-free framework. Ellen showcases the value of the developmental neurotoxicity in vitro battery.
Reduction Potential and Carcinogenicity Assessment
Sophia discusses the potential to reduce animal testing by analyzing existing animal models and identifying cases where they are redundant. She highlights ongoing projects from EFSA and EPA that aim to waive or phase out certain studies. Miriam presents an example of a working group on carcinogenicity, outlining the elements required for an animal-free framework.
Developmental Neurotoxicity and Summary
Ellen presents the value of the developmental neurotoxicity in vitro battery and outlines a six-step framework for its implementation. She discusses ongoing initiatives to implement kinetic modeling and lab-to-lab validation. The presentation concludes with a summary of the key challenges and the importance of collaboration and stakeholder involvement.
Q&A Session: Human Health Recommendations
During the Q&A session, the panel addresses questions about validation, the elimination of 90-day studies, and the involvement of stakeholders. They discuss the need for a new validation framework that is suitable for NAMs and the importance of considering the emotional aspect of change. The discussion also touches on the role of public pressure and the need to make the topic more accessible.
Stakeholder Involvement and Road Map Structure
The panel addresses questions about the involvement of stakeholders, the definition of protection levels, and the potential for a public consultation. They emphasize the importance of having a clear understanding of protection goals and the need for open discussions to address concerns. The discussion also touches on the need for a PR job to make the topic more accessible and engaging.
Organizational Structures and Regulatory Changes
The panel addresses questions about the organizational structures, the need for regulatory changes, and the emotional aspect of change. They emphasize the importance of having a clear understanding of the regulatory needs and the need for open discussions to address concerns. The discussion also touches on the role of public pressure and the need to make the topic more accessible and engaging.
Actions and Implementation
The panel addresses questions about the implementation of the road map, the involvement of national policy makers, and the emotional aspect of change. They emphasize the importance of having a clear understanding of the regulatory needs and the need for open discussions to address concerns. The discussion also touches on the role of public pressure and the need to make the topic more accessible and engaging.
Introducing Actions Under the Roadmap
The panel addresses questions about the organizational structure, the need for regulatory changes, and the emotional aspect of change. They emphasize the importance of having a clear understanding of the regulatory needs and the need for open discussions to address concerns. The discussion also touches on the role of public pressure and the need to make the topic more accessible and engaging.
Feedback from Stakeholder Involvement
Denise Mate presents the main results from stakeholder consultations and outreach activities on the roadmap. The consultations included a call for evidence, targeted online surveys, and interviews with various stakeholder groups. The feedback highlighted the need for addressing complex endpoints, speeding up validation processes, fostering collaboration, and building regulatory and non-regulatory actions.
Stakeholder Perspectives and Hurdles
Denise presents the outcome of the first targeted stakeholder survey, highlighting the benefits for industry of moving away from animal testing, such as reduced time to market and enhanced corporate image. The main hurdles identified were scientific barriers and the lack of methodologies, as well as regulatory acceptance of new methods.
Targeted Consultations and Key Findings
Denise discusses the targeted consultations, including interviews on facilitating access to information on NAMs and the needs and roles of potential expert groups. She presents the outcome of the second stakeholder survey, highlighting the broad agreement on the need for a steering team and expert groups. The survey also revealed preferences for top-down communication and the importance of publishing implementation progress.
Regulatory Needs and Organizational Structure
Denise presents the findings on regulatory needs, highlighting the support for recommendations on how to consider regulatory needs in test method development. The majority of respondents favored a central group chaired by the commission to provide input on regulatory needs. The survey also revealed support for a data sharing platform to enable the easier use of data for regulatory processes.
Funding and Stakeholder Engagement
Denise presents the findings on funding for validation activities, noting that a majority of respondents were not ready to contribute to the funding. The European Commission was seen as taking a leading role in the coordination of these activities. The presentation also highlights the key outcomes from the animal-free chemical safety conference, including recommendations on structured safe spaces and a scientific vision for next-generation risk assessment.
Q&A Session: Stakeholder Involvement
During the Q&A session, Denise addresses questions about the role of European 3R centers, the validation process, and the involvement of member states. The discussion highlights the need for a scientific discussion on which methods are adequate and the importance of engaging with member states and academia. The session also touches on the emotional aspect of change and the need for a PR job to make the topic more accessible.
Learnings from Bilateral Discussions and Transitional Initiatives
Elizabeth Bergrren shares learnings from bilateral discussions and the potential impact of transitional initiatives. The bilateral discussions involved a wide range of stakeholders and provided insights into their preparations for the transition to animal-free safety assessment. The summary includes insights into the regulatory science ecosystem, the lack of trust between stakeholders, and the importance of industrial associations.
Key Insights and Challenges
Elizabeth discusses key insights from the bilateral discussions, including the need for better confidence in non-animal methods and the importance of engaging with citizens. She highlights the need for an overarching governance and collaboration model and emphasizes the importance of the international level. The presentation also touches on the role of transitional initiatives and the need to streamline ongoing activities.
Q&A Session: Stakeholder Feedback and Implementation
During the Q&A session, Elizabeth addresses questions about the involvement of stakeholders, the emotional aspect of change, and the need for a public consultation. She emphasizes the importance of having a clear understanding of the regulatory needs and the need for open discussions to address concerns. The discussion also touches on the role of public pressure and the need to make the topic more accessible and engaging.
Commission Actions on Research
Christian descent presents updates on commission actions on research, highlighting the funding of over 400 projects with a cumulative budget of 1.5 billion euro. He discusses the increasing involvement of regulators in research projects and the shift towards microphysiological systems. The presentation also introduces the European research area action on NAMs, which aims to coordinate and streamline actions on NAMs.
ERA Structure and Future Opportunities
Christian outlines the structure of the ERA, which is organized along four working groups: development of NAMs, validation and implementation, education and training, and awareness. He discusses the next steps for the ERA, including member state commitment and the potential for a large partnership after Horizon 20 Europe. The presentation also highlights other possible future RTD opportunities for NAMs.
Workshop on Future Priority Research Areas
Christian discusses a workshop on future priority research areas, highlighting the key challenges and recommendations that came out of the discussions. The recommendations include balancing low-hanging fruit with long-term innovation, prioritizing areas with high animal usage, and developing harmonized regulatory training. The workshop also emphasized the need for cross-sector synergies and the importance of including NAMs in the OECD test guidelines.
Q&A Session: Research and Funding
During the Q&A session, Christian addresses questions about the redirection of funding, the emotional aspect of change, and the need for a public consultation. He emphasizes the importance of having a clear understanding of the regulatory needs and the need for open discussions to address concerns. The discussion also touches on the role of public pressure and the need to make the topic more accessible and engaging.
Implementation Phase: Organizational Structure, Test Method Development, and Validation
Morris Sweden chairs the session on the implementation phase, focusing on organizational structure, test method development, validation, safe spaces, and sandboxing. Marco Fabi discusses the concepts of safe spaces and regulatory sandboxes, highlighting their importance for facilitating informal feedback and promoting collaboration. He presents a mapping of existing activities that align with these concepts.
Organizational Structures and Tasks
Georg outlines the organizational structures for the implementation phase, including the roadmap steering team, regulatory science network, agency collaborative structures, and inter-agency working group. He discusses the tasks of each group, emphasizing the importance of coordination, communication, and the exchange of scientific and regulatory knowledge.
Test Method Development and Validation
Katherine discusses the three-level approach to bringing regulatory needs into test method development, emphasizing the importance of identifying regulatory needs and prioritizing methods for development and validation. She highlights the need for a validation and qualification framework that can standardize the evaluation of NAM methods.
Accelerating Validation and Funding
Katherine discusses strategies for accelerating validation, including better alignment with member states, exploring context-of-use qualification, and increasing support for EU network labs. She also highlights the need for more funding and explores options for public-private partnerships. The presentation concludes with examples of validation and qualification processes from OECD and EMA.
Q&A Session: Implementation and Validation
During the Q&A session, the panel addresses questions about validation, the involvement of stakeholders, and the need for a public consultation. They emphasize the importance of having a clear understanding of the regulatory needs and the need for open discussions to address concerns. The discussion also touches on the role of public pressure and the need to make the topic more accessible and engaging.
