Appendix A: ICCVAM - Mission, Vision and Strategic Priorities Appendix B: Federal Agencies and Programs with Authority to Require or Use Toxicological Testing Information Appendix C: Process For Development of the NICEATM-ICCVAM Five-Year Plan Appendix D: U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training Appendix E: The ICCVAM Authorization Act of 2000 Appendix F: Test Methods Reviewed or Under Consideration by ICCVAM

Appendix A: ICCVAM - Mission, Vision and Strategic Priorities

Background

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) held a strategic planning meeting on January 7-8, 2004 at the National Institutes of Health in Bethesda, MD. The purpose of this meeting was to set the strategic direction of ICCVAM for the next three years. This document provides a concise overview of that direction.

ICCVAM’s Mission and Vision

Mission¹: ICCVAM’s mission is to facilitate development, validation and regulatory acceptance of new and revised regulatory test methods that reduce², refine³, and replace⁴ the use of animals in testing while maintaining and promoting scientific quality and the protection of human health, animal health, and the environment.

Vision: ICCVAM will:

• Be recognized as a leading authority on test method development and validation both within the federal government and internationally
• Play a leading role in
  • Promoting high quality science as the basis of national and international regulatory policy
  • Setting and harmonizing international standards for scientific validation of test methods
  • Promoting and facilitating the development of priority alternative test methods
  • Identifying key alternative test methods and strategies and facilitating their validation and acceptance
  • Fostering humane and ethical approaches to testing that replace, reduce, and refine the use of animals
  • Promoting awareness and adoption of scientifically validated test methods by regulatory agencies both nationally and internationally
• Develop the internal and collaborative capacity to:
  • Ensure the scientific quality and integrity of its work
  • Implement reliable processes and operating procedures that are credible, effective and efficient
  • Build national and international partnerships with governmental and non-governmental groups, including academia, industry, advocacy groups, and other key stakeholders
  • Secure the necessary human and financial resources to effectively carry out its mission

Central Challenge

From 2004 through 2006, the central challenge that the ICCVAM faces is to strengthen ICCVAM’s impact nationally and internationally.

Strategic Priorities

The following strategic priorities have been established in order to meet the central challenge:

• Set priorities for evaluating test methods and carry out the reviews
• Facilitate collaborative scientific validation internationally
• Stimulate development of priority test methods and strategies
• Foster appropriate use of validated test methods
• Strengthen ICCVAM capability and sustainability
• Strengthen interaction with ICCVAM stakeholders

The table below depicts a Strategic Map; rationale for each strategic priority, its supporting objectives, and the accountabilities for implementation are detailed in the pages that follow.

STRATEGIC PRIORITY 1: Set priorities for evaluating test methods and carry out reviews

Rationale: ICCVAM’s ability to fulfill its legislative mandate requires that it function with both effectiveness and efficiency. This priority sets specific objectives to ensure ICCVAM’s effectiveness, including implementation of the priority setting process that has already been developed and periodic evaluation of the priorities of its stakeholders. In addition, this priority includes objectives to ensure that ICCVAM continues to carry out quality reviews while improving its timeliness and efficiency in doing so.

Objectives:

• Implement ICCVAM’s priority setting process
• Periodically evaluate stakeholder priorities
• Develop review documents and performance standards
• Conduct appropriate review activities
• Develop and forward recommendations to federal agencies
• Periodically re-evaluate applicability of recommended test methods

Accountability:

• ICCVAM
• NICEATM

STRATEGIC PRIORITY 2: Facilitate collaborative scientific validation internationally

Rationale: ICCVAM’s effectiveness in validating alternative test methods that replace, reduce and refine the use of animals in testing requires it to engage in a wide range of international collaborations. These collaborations provide the basis for ICCVAM to ensure sound science serves as the foundation for validating alternative methods, to promote broad use of validated alternative methods, and to encourage the harmonization of scientific approaches to validation and review.

Objectives:

• Foster a network of international collaborators
• Build consensus on validation and collaboration processes
• Develop ICCVAM infrastructure to promote and track collaborative efforts

Accountability:

• ICCVAM
• NICEATM

STRATEGIC PRIORITY 3: Stimulate development of priority test methods and strategies

Rationale: Test methods must be developed and validated in order for them to be evaluated by ICCVAM. This priority outlines key objectives that ICCVAM needs to carry out in order to stimulate the development of test methods and testing strategies by others. It identifies actions ICCVAM will take to establish priorities for test method development, stimulate method development in prioritized areas, and facilitate the nomination of promising test methods.

Objectives:

• Establish ICCVAM priorities for test method development
• Conduct technical meetings on state of the science in priority areas
• Formulate research recommendations and stimulate research
• Evaluate research progress and results in prioritized areas
• Facilitate nomination of promising test methods for validation studies

Accountability:

• ICCVAM
• NICEATM

STRATEGIC PRIORITY 4: Foster appropriate use of validated test methods

Rationale: Achieving ICCVAM’s goal of replacing, reducing, and refining the use of animals in testing requires that validated test methods achieve widespread appropriate use. This priority and its supporting objectives outline key actions that ICCVAM will take to promote the awareness of those validated methods, educate key stakeholders on their appropriate use, and provide support for their effective implementation.

Objectives:

• Promote awareness of validated methods
• Provide education on utility, advantages, and disadvantages
• Support implementation of new methods using workshops and training

Accountability:

• ICCVAM
• NICEATM

STRATEGIC PRIORITY 5: Strengthen ICCVAM capability and sustainability

Rationale: This priority recognizes that ICCVAM’s ability to carry out its legislative mandate requires both strong core capability and sustainable resource support. ICCVAM’s success in implementing this strategic plan is dependent on the human and financial resources available to support the plan. As a result, this priority and its supporting objectives set forth efforts to obtain dedicated funding, explore the possibility of expanding resources and capabilities, and ensure the effective succession of ICCVAM agency representatives. In addition, this priority also includes ongoing efforts to ensure that ICCVAM develops effective organizational processes and operating procedures.

Objectives:

• Document organizational procedures and partnerships
• Public accomplishments and explore other outreach opportunities
• Attract/obtain dedicated funding
• Develop and implement ICCVAM representative succession plan
• Explore possibility of expanding resources and capabilities
• Seek Ex-Officio status with OECD and other international organizations

Accountability:

• ICCVAM
• NICEATM

STRATEGIC PRIORITY 6: Strengthen interaction with ICCVAM stakeholders

Rationale: This cross-cutting strategic priority recognizes that effective interaction with stakeholders is an essential component of implementing each of ICCVAM’s strategic priorities. Strengthening interaction with stakeholders will help ICCVAM:

• Improve its effectiveness and efficiency in setting priorities for evaluating test methods and carrying out reviews
• Develop international collaborations that promote sound science in validating alternative methods and encourage broad use of validated alternative methods
• Stimulate others to develop test methods and strategies in prioritized areas
• Promote the awareness of validated methods among key stakeholders and provide implementation support for their appropriate use
• Build strong base capability and secure sustainable resource support

Accountability:

• ICCVAM
• NICEATM

Footnotes

¹ All of ICCVAM’s activities are grounded in the U.S. Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

² Reduction alternative: New or modified test method/s that reduce/s the number of animals required for a test method, while remaining consistent with sound scientific practices necessary to obtain valid results.

³ Refinement alternative: New or modified test method/s that refine/s procedures to lessen or eliminate pain or distress in animals or enhances animal well-being.

⁴ Replacement alternative: New or modified test method/s that replace/s animals with non-animal systems or replace/s an animal species with a phylogenetically lower species.