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ICCVAM Biennial Report 2018-2019

ICCVAM Biennial Report 2018-2019
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https://ntp.niehs.nih.gov/go/892798

Participation in the International Cooperation on Alternative Test Methods

The International Cooperation on Alternative Test Methods (ICATM) was created to foster dialog among national validation organizations. This dialog facilitates international cooperation in the critical areas of validation studies, independent peer review, and development of harmonized recommendations. ICATM includes member organizations from the European Union, United States, Japan, Canada, and South Korea. Brazil and China have been participating in ICATM since 2015 as observers.

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. The Canadian Centre for Alternatives to Animal Methods and its subsidiary, the Canadian Centre for the Validation of Alternative Methods (CaCVAM) participate as partners with Health Canada in ICATM activities.
  • 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.
  • The Brazilian Center for the Validation of Alternative Methods (BraCVAM) functions as the focal point within Brazil to identify or receive requests for test method validation. It works to implement appropriate validation studies with the National Network of Alternative Methods to the Use of Animals within the Brazilian Ministry of Science, Technology, Innovations, and Communications.

In October 2018, representatives of NICEATM and ICCVAM attended an ICATM workshop on “Validation and Establishing Scientific Confidence” and subsequent coordination meeting. Workshop participants discussed challenges to address in evolving the process of validation, including demonstrating human health relevance without animal data, and establishing more efficient validation procedures. As a first step towards addressing the identified issues, ICATM representatives agreed that they would conduct a detailed review of OECD Guidance Document 34, the current standard for validation of chemical safety test methods. The goal of this review was to identify more specific issues to be addressed in moving forward with new approaches to validation.

ICATM observed its 10th anniversary at an October 2019 workshop. ICATM representatives reflected on progress made in the last decade toward regulatory acceptance of alternatives to animal testing, and regulatory agency representatives identified challenges and opportunities to address. Specific topics discussed during the workshop and subsequent ICATM coordination meeting included:

  • Strategies to promote regulatory adoption of defined approaches to testing.
  • Challenges presented in the assessment of endocrine disruptors.
  • Approaches to building confidence in regulatory application of MPS.

Representatives from BraCVAM, CaCVAM, and KoCVAM attended the 2018 SACATM meeting. Representatives from EURL ECVAM, JaCVAM, KoCVAM, and CaCVAM attended the 2019 SACATM meeting.

ICCVAM member agency scientists serve on management teams or peer review panels for test method validation studies conducted by ICATM partners.

  • A JaCVAM-led validation study of the amino acid derivation reactivity assay for skin sensitization potential concluded in 2018. NICEATM staff served on the validation management team, and an ICCVAM member served on the peer review panel. The amino acid derivation reactivity assay was accepted by OECD in a 2019 revision to Test Guideline 442C.
  • During 2018 and 2019, an NIEHS scientist served on the management team for a validation study led by JaCVAM. The study is evaluating the multi-immunotox assay, a screening assay that identifies potentially immunotoxic chemicals by assaying the activity of T cells and dendritic cells.

The following ICCVAM workgroups had ICATM member liaison representatives during 2018 and 2019.

ICCVAM Workgroup

ICATM Organizations with Liaison Members

Acute Toxicity Workgroup

EURL ECVAM, KoCVAM

Developmental and Reproductive Toxicity Workgroup

EURL ECVAM, JaCVAM, KoCVAM

In Vitro to In Vivo Extrapolation Workgroup

EURL ECVAM, JaCVAM

Ocular and Dermal Irritation Workgroup

EURL ECVAM, Health Canada

Read Across Workgroup

EURL ECVAM, JaCVAM

Skin Sensitization Workgroup

EURL ECVAM

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