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ICCVAM Biennial Report 2016-2017

Biennial Progress Report 2016-2017 Interagency Coordinating Committee on the Validation of Alternative Methods
https://ntp.niehs.nih.gov/go/843093

International Cooperation on Alternative Test Methods

The International Cooperation on Alternative Test Methods (ICATM) was established in 2009 to promote consistent and enhanced voluntary international cooperation, collaboration, and communication among national validation organizations. The goals of ICATM are to:

  • Ensure optimal design and conduct of validation studies
  • Ensure high-quality independent scientific peer reviews of alternative test methods
  • Ensure consistent and transparent stakeholder involvement
  • Achieve greater efficiency and effectiveness by internationally leveraging limited resources and avoiding duplication of effort
  • Support the timely international adoption of alternative test methods

This cooperation enables scientifically valid alternative methods or strategies to be more readily accepted worldwide for regulatory use.

ICATM includes member organizations from the European Union, United States, Japan, Canada, and South Korea (see sidebar). Brazil and China have been participating in ICATM since 2015 as observers.

ICATM meetings provide an opportunity for participant organizations to discuss activities in identified areas of cooperation. These interactions allow ICATM partners to develop good communications and working relationships in support of collaborative test method development. ICCVAM representatives participated in an ICATM coordination meeting in 2016.

ICATM Skin Sensitization Workshop

In October 2016, ICATM convened a workshop on 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 poster presented at the 2017 Society of Toxicology Meeting (Kleinstreuer et al.) summarized the workshop and its outcomes. A position paper developed from the workshop proposed practical ways to further promote the regulatory use and facilitate adoption of non-animal defined approaches for skin sensitization assessments. Another product of the workshop was a paper summarizing international regulatory requirements for skin sensitization testing, which will be published in 2018. Discussions at the workshop also formed the basis for a proposal to develop a performance-based test guideline 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) for inclusion in the OECD workplan.

Collaborations with International Validation Organizations

Representatives from JaCVAM, KoCVAM, and Health Canada attended the 2016 meeting of SACATM as nonvoting liaisons; representatives from KoCVAM and CaCVAM attended the 2017 SACATM meeting.

A NICEATM scientist participated on a EURL ECVAM Scientific Advisory Committee working group on eye irritation methods in May 2016.

The following ICCVAM workgroups had ICATM member liaison representatives during 2016 and 2017.

ICCVAM Workgroup

ICATM Organizations with Liaison Members

Acute Toxicity

EURL ECVAM, KoCVAM

Developmental and Reproductive Toxicity

EURL ECVAM, JaCVAM, KoCVAM

IVIVE

EURL ECVAM, JaCVAM

Ocular and Dermal Irritation

EURL ECVAM, Health Canada

Read-across

EURL ECVAM, JaCVAM

Reference Chemical

EURL ECVAM, Health Canada, JaCVAM, KoCVAM

Skin Sensitization

EURL ECVAM

NICEATM or ICCVAM scientists served on the management teams or peer review panels for the following JaCVAM-coordinated validation studies during 2016 and 2017.

  • IL-8 in vitro test for assessing skin sensitization potential: study is complete; NICEATM staff served on the validation management team and an ICCVAM member served on the peer review panel.
  • Vitrigel-EIT assay for eye irritation testing: study is complete; NICEATM staff served on the validation management team and an ICCVAM member served on the peer review panel.
  • Hand1-luc in vitro test for assessing reproductive toxicity potential: study is complete; NICEATM staff served on the validation management team and an ICCVAM member served on the peer review panel.
  • SIRC-CVS assay for eye irritation testing: study is complete; an ICCVAM member served on the peer review panel.
  • Amino acid derivation reactivity assay for assessing skin sensitization potential: study is complete; a peer review is scheduled for spring 2018; NICEATM staff served on the validation management team and an ICCVAM member will serve on the peer review panel.
  • Vitrigel-SST assay for assessing skin sensitization potential: study is on hold; NICEATM staff are serving on the validation management team.
Drs. Casey and Kim

NICEATM Director Warren Casey, Ph.D., and Tae Sung Kim, Ph.D. of KoCVAM at the 2017 SACATM meeting

ICATM Participant 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.
  • EURL ECVAM (European Union Reference Laboratory for Alternatives to Animal Testing) 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 in the European Union.
  • JaCVAM (Japanese Center for the Validation of Alternative Methods) coordinates the evaluation of alternative test methods for the Japanese National Institute of Health Sciences, its parent organization.
  • Health Canada’s Environmental Health Science and Research Bureau coordinates the evaluation of alternative test methods in Canada. Responsibility for Canada’s participation in ICATM is transitioning to the Canadian Centre for the Validation of Alternative Methods (CaCVAM), which was established in 2017.
  • KoCVAM (Korean Center for the Validation of Alternative Methods) is part of the National Institute of Food and Drug Safety Evaluation of the South Korean Food and Drug Administration.
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