Plan Overview	Preface
Executive Summary	Introduction
CHAPTER 1 - Research, Development, Translation, and Validation Activities for Priority Test Methods to Reduce, Refine, and Replace Animals in Regulatory Testing
CHAPTER 2 - Incorporating New Science and Technology
CHAPTER 3 - Fostering Acceptance and Appropriate Use of Alternative Test Methods
CHAPTER 4 - Developing Partnerships and Strengthening Interactions with ICCVAM Stakeholders
References - Acronyms and Abbreviations - Glossary	Appendices
Acknowledgements - ICCVAM Roster - About NICEATM and ICCVAM

Executive Summary

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)¹ prepared this five-year plan in conjunction with Federal agency program offices. The plan describes how NICEATM and ICCVAM will facilitate the research, development, translation², validation, and regulatory acceptance of alternative test methods that reduce, refine, and replace the use of animals in testing, while maintaining scientific quality and the protection of human health, animal health, and the environment.

The plan addresses ICCVAM’s vision (Appendix A) to play a leading role in fostering and promoting the development, validation, and regulatory acceptance of scientifically sound alternative test methods both within the Federal government and internationally. Acceptance of such methods will reduce, refine, and replace animal use, while maintaining or improving the protection of human and animal health and the environment.

Implementing this plan involves four key challenges. The first challenge is to identify priority areas for the next five years, and to conduct and facilitate activities in these areas. The second challenge involves identifying and promoting research initiatives that are expected to support the future development of innovative alternative test methods. The third challenge is to foster the acceptance and appropriate use of alternative test methods through outreach and communication. The last challenge is to develop partnerships and to strengthen interactions with ICCVAM stakeholders in order to facilitate meaningful progress.

Identifying Priorities and Conducting and Facilitating Alternative Test Method Activities

ICCVAM priorities emphasize alternatives for those regulatory test methods that can involve significant animal pain and distress and that can use large numbers of animals. Currently, the four highest-priority testing areas are ocular toxicity, dermal toxicity, acute systemic toxicity, and biologics. Other priority testing areas include immunotoxicity, endocrine disruptors, pyrogenicity, reproductive and developmental toxicity, and chronic toxicity and carcinogenicity. Neurotoxicity testing is also an area of interest.

While these represent current priorities and interests, ICCVAM and NICEATM recognize that planning must be flexible in order to take advantage of advances in science and technology and to respond to new testing needs. Integrated testing approaches are emphasized to effectively address the inherent complexity of human and animal responses to toxicants and to maximize the impact of new testing alternatives on reduction, refinement, and replacement of animal use. NICEATM and ICCVAM will continue to facilitate research, development, translation, and validation of alternative test methods by identifying critical knowledge and data gaps for regulatory agencies, the scientific community, and other stakeholders.

Incorporating New Science and Technology

The second challenge is to identify and promote research incorporating new technologies that can be expected to support the future development of new test methods and approaches to reduce or eliminate the need for animals. While many of these approaches will require several years to develop and validate, some may be ready for use more quickly. To maximize the efficiency of this process, NICEATM and ICCVAM are working with Federal agencies and other stakeholders to link research and development activities to the standardization and validation of alternative test methods that may be used in regulatory testing.

Fostering Regulatory Acceptance and Use of Alternative Methods

The third challenge is to foster regulatory acceptance and appropriate use of alternative test methods by promoting active communication and outreach efforts with both government and non-government stakeholders. NICEATM and ICCVAM will provide high quality comprehensive test method background review documents and the results of independent scientific peer reviews to facilitate the approval of these test methods by regulatory agencies and the international community. Once an alternative test method has been accepted, ICCVAM will work to promote the use of the test method by sponsoring and participating in training workshops for interested stakeholders who may generate or review data from the test method.

Developing Partnerships

NICEATM and ICCVAM will further develop partnerships and strengthen interactions with stakeholders while considering advice from their advisory committee, the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). The overall aims of these partnerships are to make the best use of existing resources and scientific expertise, maximize the efficiency of test method validation efforts and evaluations, minimize duplication of effort, and ensure an early exchange of information concerning test method validation. This will facilitate national and international recognition, acceptance, and implementation of scientifically valid alternative test methods.

Monitoring Progress

Regular updates will be provided in the ICCVAM Biennial Progress Report, on the ICCVAM and NICEATM website, and at SACATM meetings.

Footnotes

¹ ICCVAM (The Interagency Coordinating Committee on the Validation of Alternative Methods), a permanent interagency committee administered by NIEHS under NICEATM (the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods), is composed of members designated by the heads of 15 Federal agencies. ICCVAM was established by NIEHS in 1997 and designated as a permanent committee by the ICCVAM Authorization Act of 2000.

² ICCVAM considers test method translation activities as those that are carried out to characterize if there is evidence of relevance and applicability of a test method for a specific testing purpose. If so, then the test method may be considered for further evaluation in a formal validation study.