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Return to main Five-Year Plan Page
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Plan Overview |
Preface |
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Executive Summary |
Introduction |
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CHAPTER 1 - Research, Development, Translation, and Validation Activities for Priority Test Methods
to Reduce, Refine, and Replace Animals in Regulatory Testing |
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CHAPTER 2 - Incorporating New Science and Technology |
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CHAPTER 3 - Fostering Acceptance and Appropriate Use of Alternative Test Methods |
CHAPTER 4 - Developing Partnerships and Strengthening Interactions with ICCVAM Stakeholders |
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References - Acronyms and Abbreviations - Glossary |
Appendices |
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Acknowledgements - ICCVAM Roster - About NICEATM and ICCVAM
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Chapter 4: Developing Partnerships and Strengthening Interactions with ICCVAM Stakeholders
A critical aspect of this plan is the development of partnerships and the strengthening of
interactions with ICCVAM stakeholders to promote research, development, translation, and validation
activities for alternative test methods. NICEATM and ICCVAM recognize that effective interaction with
stakeholders is an essential component of successfully protecting human and animal health and the
environment while implementing the 3Rs. Progress and success in the activities outlined in this plan
depend on the collective resources, efforts, and scientific breakthroughs of many different national
and international stakeholder organizations (for example, government, industry, animal welfare). To
facilitate the advancement of alternatives for making regulatory decisions, NICEATM and ICCVAM will
identify needs and encourage activities for areas of high priority, taking into consideration the
advice of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM), a
Federally chartered advisory committee for NICEATM and ICCVAM.
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, as well as criteria for validation and
regulatory acceptance1. NICEATM and ICCVAM also recognize that they
must assume a greater leadership role by identifying needs for alternative test methods and
encouraging activities for those considered high priority. In this regard, NICEATM and ICCVAM,
along with its working groups, will be more proactive in identifying research needs and promising
methods that should be priorities for further development, translation, validation, or ICCVAM
evaluation.
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NICEATM and ICCVAM will foster interagency collaboration among Federal research and regulatory
agencies, including opportunities for test method validation activities. This also includes
promoting interagency harmonization of regulatory testing protocols, where appropriate, that
encourage reduction, refinement, or replacement of animal test methods. Similarly, the continued
involvement of representatives from multiple centers within large agencies fosters intra-agency
collaboration. Areas of mutual interest might include evaluating, where appropriate, the performance
of current test methods for protecting human and animal health, assessing the need for improved test
methods or batteries of test methods to better detect the potential adverse health effects of
substances, and identifying opportunities to use alternative test methods to match or improve
the protection of human and animal health and the environment while implementing the 3Rs.
Interagency collaboration in these areas will maximize efficiency and avoid unnecessary duplication
of efforts among the different Federal agencies.
ICCVAM will collaborate with government and non-governmental organizations, where appropriate,
to co-sponsor workshops. The objectives of these workshops will be to evaluate the state-of-the-science
related to the development and validation of alternative toxicological test methods, and to
identify high priority research, development, translation, and validation activities necessary to
advance and characterize the usefulness of such methods. The results of these workshops will be
broadly communicated to individuals and organizations that conduct such activities.
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Effective Partnerships
The use of in vitro test methods is expected to continue to increase as new science
and technologies are incorporated into in vitro test methods and such innovative
techniques enter the regulatory arena. For this reason, ICCVAM and ECVAM worked
together to promote the international application of Good Laboratory Practices (GLPs)
to in vitro systems by assisting an OECD GLP Working Group of Experts with development
of an international guidance document on this subject. With the increasing use of
non-animal testing procedures, such guidance directs the acceptable use of these
new test methods and the proper generation and documentation of data in accordance
with the requirements of GLPs. This will help ensure that in vitro data are of
acceptable quality for consideration by regulatory authorities. According to ICCVAM,
ECVAM, and OECD guidances, validation studies should ideally be conducted in
accordance with GLPs. Thus, a user-friendly, clear, and concise document devoted
to the application of GLPs to in vitro methods also should encourage the use of
GLPs for validation studies, thereby facilitating and increasing confidence in
the validation of in vitro test methods.
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ICCVAM will foster international collaboration by including experts from the international
scientific community on expert panels and workshops. This will ensure that the best international
scientific expertise is used to evaluate alternative test methods and provide an opportunity to
communicate essential aspects of the ICCVAM test method evaluation process to the international
scientific community.
Similarly, NICEATM and ICCVAM will collaborate and share experiences with ECVAM and JaCVAM
in the development of international best practices for test method evaluations. These practices
include transparency, use of an independent peer review panel, and the opportunity for stakeholder
and public comment. Such practices, once developed and adopted internationally, will reduce
duplication and streamline efforts while also facilitating the international acceptance of those
test methods found to be scientifically valid and acceptable for regulatory testing.
NICEATM and ICCVAM will strengthen international relationships with appropriate organizations
to foster the validation and evaluation of alternative test methods. For example, NICEATM and ICCVAM
will work with other national and international validation organizations (for example, ECVAM and
JaCVAM) to promote ICCVAM’s validation and acceptance criteria, which have been substantially
incorporated into OECD Guidance Document 34,
and to consider other issues related to validation as they occur. As appropriate, NICEATM and
ICCVAM will also participate in the development of performance standards for international test
guidelines. To further ensure the development of scientifically valid international test guidelines,
NICEATM and ICCVAM will seek to increase participation of its scientists in U.S. delegations to OECD
test guideline meetings, expert consultations, and workshops. Additionally, where appropriate, NICEATM
and ICCVAM will invite representatives from international organizations such as OECD and from OECD
member countries to attend and participate in relevant NICEATM and ICCVAM-sponsored workshops,
peer reviews, and other scientific activities. This provides an opportunity to promote
information exchange and scientifically sound test method evaluation processes and principles.
NICEATM and ICCVAM will also engage interested stakeholders in assessing how to efficiently
meet Federal peer review requirements, and will seek input on ways to streamline processes that will
not compromise transparency, scientific rigor, or the opportunity for stakeholder participation.
The overall aims of these partnerships are to best utilize existing resources and scientific
expertise, maximize the efficiency of evaluation/validation efforts, minimize duplication of effort,
and ensure an early exchange of information concerning test method validation. This in turn can be
expected to facilitate national and international recognition, acceptance, and implementation of
scientifically valid test methods.
Monitoring Progress
ICCVAM and NICEATM have a number of mechanisms in place for providing periodic updates to the
public. These include the ICCVAM Biennial Progress Report, the ICCVAM and NICEATM website, and
periodic meetings of SACATM. NICEATM and ICCVAM will also create a web-based database of the 185
test methods that have been reviewed or that are currently undergoing review (see Appendix F).
This database will provide transparency for interested stakeholders regarding alternative test methods.
Footnotes
1 Validation involves determining the usefulness
and limitations of a test method for a specific purpose. This includes determining the extent that a
test method will produce similar results in different laboratories around the world and that the test
method can correctly measure or predict the biological effect of interest
(see ICCVAM publication Validation and Regulatory Acceptance of Toxicological Test Methods:
A Report of the ad hoc Interagency Coordinating Committee on the Validation of Alternative Methods
(NIH 97-3981).
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.
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