National Toxicology Program

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

Overview

Four challenges central to implementing ICCVAM’s vision to play a leading role in fostering and promoting the development, validation and regulatory acceptance of scientifically sound alternative test methods:

• Identify priorities and conduct and facilitate alternative test method activities
  • Priorities are directed at test methods that may involve significant pain and distress, use large numbers of animals, and have the potential to provide improved prediction of adverse health or environmental effects
  • Current priority areas are ocular toxicity, dermal toxicity, acute toxicity, and biologics
  • Other priority testing areas include immunotoxicity, endocrine disruptors, pyrogenicity, reproductive and developmental toxicity, and chronic toxicity and carcinogenicity
  • Planning must be flexible to take advantage of advances in science and technology and respond to new testing needs


• Incorporate new science and technology
  • Identify and promote research expected to support the future development of alternative test methods
  • Facilitate reviews of the usefulness and limitations of defined high-throughput screening approaches
  • Follow efforts to develop assays in non-mammalian animal systems and facilitate evaluation of methods that have utility for regulatory testing
  • Promote the availability of data from toxicology databases for use in development of alternative test methods


• Foster regulatory acceptance and use of alternative methods
  • Promote active communication and outreach efforts with both government and non-government stakeholders
  • Foster the acceptance and use of alternative test methods by broadly communicating the outcomes of ICCVAM review activities and workshops
  • Facilitate the international adoption of valid alternative test methods by providing comprehensive scientific reviews and standardized protocols that can be considered by international organizations


• Develop partnerships
  • Develop partnerships and strengthen interactions with stakeholders to promote research, development, translation, and validation activities for alternative test methods
  • Foster interagency collaborations among Federal research and regulatory agencies
  • Strengthen international relationships with appropriate organizations to foster the validation and evaluation of alternative test methods