National Toxicology Program

National Toxicology Program
http://ntp.niehs.nih.gov/go/icatm

International Cooperation on Alternative Test Methods

Test Method Validation and Regulatory Status Report Now Available

A January 2014 "Alternative Test Method Validation and Regulatory Acceptance Status Report" includes a comprehensive listing of test method evaluation activities undertaken by the partner organizations of the International Cooperation on Alternative Test Methods (ICATM). It also includes high-level summaries of ongoing validation studies and the status of peer reviews and harmonized recommendations. The report was prepared on behalf of ICATM by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), for the International Cooperation on Cosmetics Regulation.

About ICATM

The framework for ICATM was developed through a collaboration involving ICCVAM,  the EURL ECVAM, the Japanese Center for the Validation of Alternative Methods (JaCVAM), and Health Canada. The goals of this framework are:

  • To establish international cooperation in the critical areas of validation studies, independent peer review, and development of harmonized recommendations to ensure that alternative methods/strategies are more readily accepted worldwide
  • To establish international cooperation necessary to ensure that new alternative test methods/strategies adopted for regulatory use will provide equivalent or improved protection for people, animals, and the environment, while replacing, reducing, or refining (causing less pain and distress) animal use whenever scientifically feasible

The purpose of the framework is to promote consistent and enhanced voluntary international cooperation, collaboration, and communication among national validation organizations in order to:

  • Ensure the optimal design and conduct of validation studies that will support national and international regulatory decisions on the usefulness and limitations of alternative methods proposed for regulatory testing
  • Ensure high quality independent scientific peer reviews of alternative test methods, and consistency in transparency and stakeholder involvement
  • Enhance the likelihood of harmonized recommendations by validation organizations on the usefulness and limitations of alternative test methods for regulatory testing purposes
  • Achieve greater efficiency and effectiveness by avoiding duplication of effort and leveraging limited resources
  • Support the timely international adoption of alternative methods

The framework addresses three critical areas of cooperation: validation studies, independent peer review of the validation of test methods, and the development of formal test method recommendations on alternative testing methods.

An updated Memorandum of Cooperation (MOC) to add the Korean Center for the Validation of Alternative Methods (KoCVAM) to the ICATM agreement was signed in March 2011.

Updated ICATM MOC: signed March 8, 2011

Original ICATM MOC: signed April 27, 2009


ICATM Partner Organizations

ICCVAM

ICCVAM is an interagency committee of the U.S. government that coordinates technical reviews of alternative test methods and cross-agency activities relating to validation, acceptance, and harmonization of test methods.

European Union Reference Laboratory for Alternatives to Animal Testing

EURL ECVAM is a unit within the Institute of Health and Consumer Protection in the European Union’s Joint Research Centre. EURL ECVAM coordinates the validation of alternative test methods at the European Union level.

Japanese Center for the Validation of Alternative Methods

JaCVAM is part of the Japanese National Institute of Health Sciences, for which it coordinates the evaluation of alternative test methods.

Health Canada

Health Canada’s Environmental Health Science and Research Bureau coordinates the evaluation of alternative test methods in Canada.
Health Canada is a permanent member of the Canadian Council on Animal Care, which oversees the ethical use of animals in science in Canada.

Korean Center for the Validation of Alternative Methods

KoCVAM coordinates the evaluation of alternative test methods in South Korea. KoCVAM is part of the National Institute of Food and Drug Safety Evaluation of the South Korean Food and Drug Administration.

The NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.