International Cooperation on Alternative Test Methods
ICATM Workshop on Skin Sensitization
In October 2016, members of the International Cooperation on Alternative Test Methods (ICATM; see below) convened a workshop, “International Regulatory Applicability and Acceptance of Alternative Approaches to Skin Sensitization Assessment of Chemicals.”
Workshop participants reviewed current international regulatory requirements for skin sensitization testing, including currently available non-animal approaches for this testing, and considered what steps should be taken to support regulatory acceptance of these approaches. A review of international requirements for skin sensitization testing was developed from the workshop.
Daniel et al. 2018. International regulatory requirements for skin sensitization testing. Regul Toxicol Pharmacol 95:52-65.
A position paper developed from the workshop proposes practical ways to further promote the regulatory use and facilitate adoption of non-animal defined approaches for skin sensitization assessments.
Casati et al. 2017. Standardisation of defined approaches for skin sensitisation testing to support regulatory use and international adoption: position of the International Cooperation on Alternative Test Methods. Arch Toxicol 92:611-617.
Discussions at the workshop also formed the basis for a proposal to develop a performance-based test guideline (PBTG) for defined approaches for skin sensitization. The proposal was approved at the April 2017 meeting of the Working Group of National Coordinators of the Test Guidelines Programme of the Organisation for Economic Co-operation and Development (OECD).
Approval of the proposed PBTG allows for further development of the test guideline under the OECD annual work plan, and is a first step toward adoption of the test guideline by the OECD. PBTGs describe acceptable performance standards for a general class of test methods that are intended to measure the same biological effect. Approval of a PBTG for defined approaches will facilitate regulatory acceptance of this class of testing approaches, rather than requiring evaluation of individual testing approaches within the class. This is expected to more rapidly advance the goal of elimination of animal use for skin sensitization testing worldwide.
ICATM was originally established by 2009 agreement signed by ICCVAM, the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM), the Japanese Center for the Validation of Alternative Methods (JaCVAM), and Health Canada.
ICATM's Goals and Activities
ICATM's goals are:
- To establish international cooperation in the critical areas of validation studies, independent peer review, and development of harmonized recommendations in order to ensure worldwide acceptance of alternative methods and strategies
- 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 where scientifically feasible
ICATM works 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
- Support development of harmonized recommendations by national 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
An updated Memorandum of Cooperation (MOC) adding the Korean Center for the Validation of Alternative Methods (KoCVAM) to the ICATM agreement was signed in March 2011.
Since 2015, China and Brazil have been participating in ICATM activities as observers. Both countries actively contributed to the 2016 workshop on skin sensitization.
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.
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, part of the Japanese National Institute of Health Sciences, coordinates the evaluation of alternative test methods for Japan.
Health Canada’s Environmental Health Science and Research Bureau coordinates the evaluation of alternative test methods for 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 for South Korea. KoCVAM is part of the National Institute of Food and Drug Safety Evaluation of the South Korean Food and Drug Administration.
Status Updates from ICATM Partner Organizations
EURL ECVAM 2015 Status Report
EURL ECVAM 2014 Report to ICCR on Status of Alternative Test Method Validation
On behalf of ICATM, EURL ECVAM prepared an "Alternative Test Method Validation and Regulatory Acceptance Status Report" for the International Cooperation on Cosmetics Regulation. The report includes a comprehensive listing of test method evaluation activities undertaken by the ICATM partner organizations and high-level summaries of ongoing validation studies, validation study peer review status, and harmonized recommendations.