NIEHS and NTP Director Linda Birnbaum, Ph.D., joined international
counterparts in March 2011 in signing an agreement that expanded international efforts to reduce the
number of animals required for chemical safety testing. The agreement brought a new country, the
Republic of Korea, into the International Cooperation on Alternative Test Methods (ICATM).
ICATM represents an effort to promote international cooperation that should permit
more rapid acceptance of new safety testing methods for chemicals and products. New testing methods
can better protect public health and also reduce the number of animals needed for safety testing.
The updated agreement was signed in
a ceremony March 8, 2011, during the 50th Annual Meeting of the Society of Toxicology. Dr. Birnbaum signed as
the U.S. representative on behalf of NICEATM, one of the national organizations participating in the agreement.
The agreement expands the original ICATM Memorandum of Cooperation (MOC)
agreement signed in April 2009.
View presentations on ICATM at Society of Toxicology meetings
In remarks welcoming the participants to the signing ceremony, Birmbaum highlighted the successes
that were realized during the first two years of the agreement, and looked forward to
future successes that will include input from Korean scientists. Representatives of the
participating national validation organizations also made brief statements, as did NICEATM Director
Rear Admiral William Stokes, D.V.M., and ICCVAM Chair Jodie Kulpa-Eddy, D.V.M.
In addition to Dr. Birnbaum, the MOC was signed by:
- 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)
- Dr. Seung Hee Kim, for the Korean Center for the Validation of Alternative Methods (KoCVAM)
View the updated MOC signed March 8, 2011
The ICATM framework has been endorsed by ICCVAM and adopted by the International Cooperation on Cosmetics Regulation (ICCR).
ICATM Partner Organizations
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. NICEATM administers ICCVAM and provides scientific support for its activities.
The 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.
The 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’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
The 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.
Background on ICATM
On April 27, 2009, representatives from four international agencies, including the director of the NTP,
signed a 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.
View the MOC signed April 27, 2009
View NIH press release announcing the signing on the NIH website
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 ICCVAM Authorization Act of 2000 (view PDF)
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 for over ten years. Prior to ICATM, however, coordination of interactions occurred
on an ad hoc informal basis.
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 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 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.
View the ICATM framework on the FDA website