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ICCVAM Biennial Report 2016-2017

ICCVAM Biennial Report 2016-2017
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https://ntp.niehs.nih.gov/go/843035

ICCVAM Duties and Activities

The ICCVAM Authorization Act directs ICCVAM to carry out the following duties:

  • Coordinate the technical review and evaluation of new, revised, or alternative test methods
  • Foster interagency and international harmonization of test protocols that encourage replacing, reducing, and refining animal test methods
  • Assist with and provide guidance on validation criteria and processes
  • Promote the acceptance of scientifically valid test methods
  • Promote awareness of accepted test methods
  • Submit ICCVAM test method recommendations to appropriate U.S. federal agencies
  • Consider requests from the public to review and evaluate new, revised, or alternative test methods that have evidence of scientific validity
  • Make ICCVAM’s final test recommendations available to the public
  • Prepare reports on ICCVAM progress and accomplishments under the Act and make them available to the public
The Role of ICCVAM Workgroups

ICCVAM establishes temporary ad hoc workgroups to perform specific tasks identified by the committee as being important for the development or validation of new, revised, and alternative methods. The workgroups are chaired by representatives from agencies that use or require data from the topic of interest. The chairs are responsible for developing the group’s scope and charge, which is then reviewed and approved by ICCVAM. ICCVAM member agencies and partners in the International Cooperation on Alternative Test Methods are then invited to participate in the workgroup.

ICCVAM workgroups provide a forum for agencies to share knowledge and ensure that agency priorities are considered in the course of addressing the duties listed above. It is envisioned that the workgroups will play a key role in implementing the goals of the Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States.

Alignment of ICCVAM Activities with ICCVAM Authorization Act

Since its establishment, ICCVAM and ICCVAM member agencies have contributed to the development and regulatory acceptance of a number of alternative methods that address a variety of regulatory applications. The table below notes how selected 2016-2017 ICCVAM and ICCVAM agency activities align with the ICCVAM duties as outlined in the ICCVAM Authorization Act.

ICCVAM Duty Activity
Review and evaluate new, revised, or alternative test methods

Management teams composed of NICEATM and ICCVAM agency scientists provided oversight and direction for three validation studies: the OptiSafe test method for eye irritation, the CertiChem in vitro test method to measure androgen receptor agonist and antagonist activity, and the EASA skin sensitization test method.

Facilitate appropriate interagency and international harmonization of test protocols that encourage reducing, refining, and replacing animal test methods

NICEATM scientists advised on validation studies conducted by Japan and the European Union.

NIEHS held an expert discussion to support broader adoption of zebrafish for toxicological screening through increased standardization of protocols and nomenclature.

NICEATM collaborated with the Cosmetics Europe Skin Tolerance Task Force to evaluate the defined approaches for assessment of skin sensitization hazard that have been submitted to the Organisation for Economic Co-operation and Development (OECD).

NICEATM and ICCVAM scientists participated in an ICATM-sponsored workshop, International Regulatory Applicability and Acceptance of Alternative Approaches to Skin Sensitization Assessment of Chemicals.

The U.S. National Coordinator for the OECD Test Guidelines Programme is an ex officio member of ICCVAM and provides monthly updates on OECD activities.

Facilitate and provide guidance on validation criteria and processes

EPA and NIEHS conducted an evaluation of variability in LD50 data used as reference data for alternative methods.

EPA and NIEHS compiled reference data from rodent studies for use in validating alternative methods for identifying endocrine disruptors.

Promote the acceptance of scientifically valid test methods

EPA published Process for Establishing and Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies for FIFRA Regulatory Use.

EPA is developing a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing.

FDA published a Predictive Toxicology Roadmap for integrating predictive toxicology methods into safety and risk assessments.

Promote awareness of accepted test methods

USDA published a notice of an available exemption to reduce hamster use for leptospirosis vaccine testing.

FDA published guidance and presented a webinar on pretesting evaluation and use of in vitro tests for biological evaluation of medical devices.

NLM updated its online ToxTutor course to provide more information on alternatives to animal testing.

Various ICCVAM agencies held workshops and webinars to share information and promote awareness of alternative methods.

NICEATM and ICCVAM presented on 3Rs topics and activities at scientific meetings and other venues.

Prepare reports on ICCVAM progress and accomplishments under the Act and make them available to the public

ICCVAM published ICCVAM Biennial Progress Report 2014-2015.

ICCVAM agencies provided updates at 2016 and 2017 ICCVAM public forum meetings.