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Annual Report for Fiscal Year 2018

Annual Report for Fiscal Year 2018

ICCVAM International Validation Activities

NICEATM and ICCVAM participate in international test method validation activities through OECD. They also collaborate with countries and regions participating in the International Cooperation on Alternative Test Methods (ICATM), including the European Union, Japan, Korea, Canada, Brazil, and China.

Representatives from OECD and ICATM participating organizations in Canada, Brazil, and Korea attended the September 2018 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods. In a separate meeting, attendees gave updates on their organizations’ activities.

In FY 2018, ICCVAM agencies commented on draft OECD documents through the U.S. National Coordinator for the OECD Test Guidelines Programme, an ex officio ICCVAM member. Beginning in 2018, the U.S. National Coordinator will be joined at the annual meeting of the National Coordinators by one or more ICCVAM members who are subject matter experts in topics planned for discussion at the meeting. ICCVAM members and/or NICEATM staff supported the Test Guidelines Programme during FY 2018 by:

  • Serving on an expert group developing a performance-based test guideline (PBTG) for defined approaches for skin sensitization. PBTGs describe acceptable performance standards for a general class of test methods that are intended to measure the same biological effect.
  • Attending meetings of the OECD expert groups on eye irritation and skin sensitization, which produced six updated test guidelines published in 2018.

ICATM collaborations address three critical areas of cooperation: test method validation studies, independent peer review of validation studies, and development of formal recommendations on alternative testing methods. In October 2016, representatives of NICEATM and ICCVAM attended an ICATM coordination meeting and ICATM-sponsored workshop to develop criteria for evaluating non-animal approaches for skin sensitization potential. Products of this workshop included a white paper characterizing international regulatory requirements for skin sensitization testing (Daniel et al. 2018), a position paper covering workshop outcomes and ICATM recommendations (Casati et al. 2018), and a proposal to develop a PBTG for defined approaches to testing and assessment of skin sensitization, which was accepted by OECD in April 2017. NICEATM and ICCVAM representatives will attend an ICATM workshop in October 2018 on “Validation and Establishing Scientific Confidence.”

In fiscal year 2018, NICEATM staff served on the validation management team for an allergic contact dermatitis test for an international amino acid derivation reactivity assay led by the Japanese Center for the Validation of Alternative Methods. In addition, an ICCVAM member served on the peer-review panel. The study is complete.

Related Annual Report Pages:
Strategic Roadmap for New Approaches to Evaluate the Safety of Chemicals and Medical Products
ICCVAM Meetings
ICCVAM Test Method Evaluation Activities