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On April 27, 2009, representatives from four international agencies, including the director of the NTP,
signed a Memorandum of Cooperation (MOC) establishing an International Cooperation on Alternative
Test Methods (ICATM). The agreement promotes enhanced international cooperation and coordination
on the scientific validation of non- and reduced-animal toxicity testing methods. If the toxicity testing
methods are shown to be reproducible based on strong scientific information, and able to accurately
identify product related health hazards, the tests are more readily accepted by regulatory agencies.
According to Dr. William Stokes, D.V.M., director of NICEATM and executive director of ICCVAM,
“This international cooperation will benefit both people and animals. The cooperation will serve an
important role in translating research
advances into more effective public health prevention tools. It will speed the adoption of new test
methods based on advances in science and technology that will provide more accurate predictions of
safety or hazard. Animal welfare will also be improved by the national and international acceptance
of alternative test methods that reduce, refine, and replace the use of animals.”
The MOC was signed by:
- Dr. Linda Birnbaum, for the NTP Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM)
- Dr. Elke Anklam, for the European Centre for the Validation of Alternative Methods (ECVAM)
- Dr. David Blakey, for the Environmental Health Science and Research Bureau within Health Canada
- Dr. Masahiro Nishijima, for the Japanese Center for the Validation of Alternative Methods (JaCVAM)
View the MOC signed April 27, 2009
[PDF]
View NIH press release announcing the signing on the NIH website
The framework for ICATM was
developed through a collaboration involving ICCVAM, ECVAM, 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 ICATM framework has been endorsed by ICCVAM and adopted by the International Cooperation on Cosmetics Regulation (ICCR).
View the ICATM framework on the FDA website
Background
The ICCVAM authorization act charges ICCVAM with facilitating appropriate international
harmonization of toxicological test protocols that encourage the reduction, refinement, or
replacement of animal test methods. This is accomplished via ICCVAM’s interactions with international
validation organizations such as ECVAM and JaCVAM. Collaborations among these groups have existed
and have steadily increased during the past ten years. However, coordination of interactions has been
on an ad hoc informal basis. The lack of consistent coordination and the different processes used by
the different validation organizations have contributed to:
- Validation studies, peer reviews, and development of formal recommendations by one organization without adequate consultation and input from others
- Test method recommendations by one organization that often cannot be considered by another organization without extensive additional review efforts
- Wide variations in transparency and outcomes of peer review processes
- Differences in recommendations on the usefulness of alternative methods for regulatory purposes
At their first meeting in September 2007, the ICCR recognized the importance of reducing, refining,
and replacing animals used in toxicity testing. The group recommended that collaboration and communication
in the design, execution, and peer review of validation studies for scientific alternatives to animal testing
be further strengthened. In response to ICCR, ICCVAM and NICEATM, ECVAM, JaCVAM, and Health Canada developed a framework to ensure a
collaborative approach to this issue, and noted that such efforts should be supported by scientific
experts from the regulatory bodies.
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.
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