ICCVAM Participation on EURL ECVAM Activities
The International Cooperation on Alternative Test Methods (ICATM) facilitates cooperation, collaboration, and communication among national organizations that validate and promote the use of alternative approaches for chemical safety testing. ICCVAM has developed the following approach when working on activities of the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM).
Download graphic: ICCVAM Participation on EURL ECVAM Activities
Explanation of the Graphic
- 1. EURL ECVAM assesses a submission of an alternative test method for evaluation, its scientific and regulatory aspects, and its stakeholder relevance.
- EURL ECVAM and ICCVAM liaisons collaborate to prepare an ICCVAM briefing and present relevant materials at the next ICCVAM teleconference.
- 2. EURL ECVAM develops a Validation Project Plan, performs a validation study (if needed), and prepares a Validation Study Report.
- Determines the level of interest
- Identifies stakeholder agencies
- Nominates Validation Management Team liaisons
- ICCVAM Validation Management Team liaisons:
- Provide feedback on the draft Validation Project Plan
- Monitor study progress and update ICCVAM and the relevant ICCVAM work groups
- Provide feedback on the draft Validation Study Report
- 3. EURL ECVAM convenes a Scientific Advisory Committee (ESAC) review of the validation study conduct and Validation Study Report conclusions.
- Nominates experts for the ESAC working group
- Reviews and provides feedback on the ESAC Report and Opinion
- 4. EURL ECVAM develops a draft of the EURL ECVAM recommendations, negotiating with ICATM partners to develop harmonized recommendations.
- Assesses the relevance of EURL ECVAM draft recommendations to U.S. regulatory agencies
- Identifies additional activities needed for U.S. adoption
- Identifies and plans a response to the EURL ECVAM recommendation
- 4.2 EURL ECVAM receives public input on the draft recommendation.
- 4.3 EURL ECVAM issues a final recommendation, ESAC Report and Opinion, and a Validation Study Report.
- Publicizes a EURL ECVAM recommendation on the NICEATM website and email list
- Assesses the relevance of the recommendation to U.S. regulations
- Announces any further ICCVAM activities, such as:
- Testing additional substances to expand the domain or to compare to other test methods; additional analysis (e.g., using U.S. categorization); and/or testing at additional laboratories to assess transferability
- Workshops or collection of additional data via requests published in the Federal Register
- Issues a formal ICCVAM recommendation and transmittal to agencies; this may require a new peer review if additional data or analyses are used to develop the formal ICCVAM recommendation.