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

Chapter 3: Fostering Acceptance and Appropriate Use of Alternative Test Methods

NICEATM and ICCVAM will promote active communication and outreach efforts with both government and non-government stakeholders. These efforts are aimed at encouraging the use of scientific approaches to validation that will generate the information and data that Federal agencies need in order to accept scientifically valid new and revised alternative test methods¹. While NICEATM and ICCVAM promote and employ good science in determining the validation status of alternative test methods, only Federal agencies can accept these test methods and determine how they might be used in their respective programs. The extent of acceptance by Federal agencies will depend on several factors, including their legislative mandate(s) and policies that are in place to carry out these mandates. Once regulatory authorities have accepted an alternative test method, ICCVAM will work to promote its use.

NICEATM and ICCVAM will foster the use of alternative test methods by broadly communicating the outcomes of ICCVAM review activities and/or workshops via the Federal Register, at national or international scientific meetings, via peer-reviewed journal publications, and at training courses. Emphasis will also be placed on making the scientific community, including Institutional Animal Care and Use Committees (IACUCs), aware of new alternatives that are available for consideration in complying with the PHS policy and Animal Welfare Act provisions, which state that such methods be considered prior to testing in animals, where applicable. The NICEATM and ICCVAM website provides information related to new test methods and past, current, and future activities of NICEATM and ICCVAM. The website will continue to provide user-friendly access to the latest information on validation processes and the most up-to-date status of the alternative test methods previously reviewed and those currently under review. One or more lists of frequently asked questions (FAQs) will be developed to provide quick reference guides to broad issues related to the ICCVAM test method evaluation process, as well as more specific issues relevant to individual toxicity testing areas. NICEATM and ICCVAM will use a combination of e-mail and website announcements to inform the public of the availability of newly published Federal Register notices, NICEATM documents, journal articles, and upcoming events. Additionally, ICCVAM and NICEATM will encourage member agencies to create websites dedicated to their specific activities associated with alternative test methods research, development, translation, and validation. NICEATM and ICCVAM will in turn provide a link on their website to these member agency websites.

The NICEATM-ICCVAM website contains background information on NICEATM and ICCVAM, current information on ICCVAM test method evaluation activities, guidance on preparing nominations and submissions to ICCVAM, details on upcoming events, and links to other sites of interest. It currently features four searchable databases: •  NICEATM and ICCVAM publications •  Federal and international regulatory documents •  Federal Register notices relevant to NICEATM and ICCVAM activities •  Public comments on NICEATM and ICCVAM activities Please visit the website at iccvam.niehs.nih.gov.

ICCVAM will sponsor and participate in workshops that include both government and non-government stakeholders to increase the acceptance and use of new alternative test methods. ICCVAM and NICEATM will actively seek international participation in workshops as well as international scientific partnerships on validation study designs and test method evaluations, such as those described in Chapter 4. This will help ensure that studies conducted with proposed alternative test methods will facilitate international acceptance of alternative test methods. This international participation should also streamline the validation process and avoid unnecessary duplication of effort.

Partnering with Stakeholders ICCVAM co-sponsors implementation workshops to encourage interested stakeholders to use valid alternative test methods. For example, in partnership with the EPA and the International Life Sciences Institute, ICCVAM convened a training workshop on acute toxicity testing methods. The workshop provided practical information and case studies to facilitate the understanding and implementation of the UDP and other in vivo and in vitro alternative methods for acute toxicity. In addition, because calculation of dose levels to be used in the UDP test method requires complex algorithms, workshop participants were provided free software and training on its use.

NICEATM and ICCVAM will facilitate the international adoption of valid alternative test methods by providing standardized protocols that can be considered for adoption by international organizations (for example, the International Standards Organization [ISO], OECD, etc.). As appropriate, NICEATM and ICCVAM will provide comprehensive test method background review documents and the results of independent scientific peer reviews to facilitate the approval of these test methods by the international community.

Footnotes

¹ ICCVAM provides criteria for adequate validation and regulatory acceptance of test methods for its many stakeholders. These criteria and the process for achieving regulatory acceptance of scientifically valid test methods are described in the report, Validation and Regulatory Acceptance of Toxicological Test Methods: A Report of the Ad Hoc Interagency Coordinating Committee on the Validation of Alternative Methods . Validation involves determining the usefulness and limitation of a test method for a specific purpose. This includes determining the extent to which a test method will produce similar results in different laboratories around the world, and determining the extent that the test method can correctly measure or predict the biological effect of interest. ICCVAM welcomes nominations or submissions of proposed alternative or revised test methods. To aid test developers with this process, ICCVAM has published guidance on the information and data that is needed to support test method nominations and submissions in the report, ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods.

Note: Some of the links on this page, which are the same as URLs in footnotes in the PDF/hard copy version of this report, lead to pages outside the NICEATM-ICCVAM website. These links are for the convenience of the readers of this document. NICEATM and ICCVAM are not responsible for the availability or content of these external sites, nor do we endorse, warrant or guarantee the products, services or information described or offered at these other sites.