https://ntp.niehs.nih.gov/go/iccvam-wg

ICCVAM Workgroups

ICCVAM establishes ad hoc workgroups to perform specific tasks important for the development or validation of alternatives to animal testing. The workgroups are composed of representatives from agencies that use or require data from the topic of interest. Representatives of partner organizations in the International Cooperation on Alternative Test Methods may also be invited to participate in a workgroup.

ICCVAM workgroups play a key role in carrying out ICCVAM activities, including implementing the goals of the Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States. This page lists and describes currently active ICCVAM workgroups, with links to more detailed descriptions of relevant activities.

Acute Toxicity Workgroup

Fostering the evaluation, promotion, and harmonization of alternatives to animal use for acute systemic toxicity testing has long been one of ICCVAM’s priorities. The Acute Toxicity Workgroup evaluates the usefulness of various types of data, data analyses, and testing approaches for classifying and predicting acute oral, dermal, and inhalation systemic toxicity. The workgroup has members from seven ICCVAM agencies.

Recent and ongoing activities include:

  • Publishing a scoping document (Strickland et al. 2018) that identifies U.S. agency information requirements, needs, and decision contexts for acute systemic toxicity testing.
  • Organizing a global project to develop in silico models of acute oral systemic toxicity that predict five specific endpoints needed by regulatory agencies (Mansouri et al. 2021).
  • Analyzing variability of in vivo data used as benchmarks for evaluating alternative methods (Karmaus et al. 2022).
  • Evaluating the usefulness of additivity formulas for hazard classification of formulations and mixtures (Hamm et al. 2021).
  • Assessing the usefulness of available in vitro and in silico models for acute inhalation toxicity.
  • Organizing a global project to develop in silico models of acute inhalation toxicity.
Consideration of Alternative Methods Workgroup

This ICCVAM workgroup was established in 2021 to explore opportunities for encouraging those using animal-based models to not only consider but actively pursue NAMs that could support their research goals while replacing, reducing, or refining their use of animal models. The workgroup has members from nine ICCVAM agencies. With input from appropriate stakeholders, it will develop a white paper on approaches that could potentially be used to foster the consideration and use of NAMs to replace, reduce, or refine live animal use by organizations currently using animals for testing. It will also foster communication and appropriate collaborations to encourage greater consideration of NAMs, and explore approaches to increase awareness of grants available to support development of alternatives.

Ecotoxicology Workgroup

While the focus of ICCVAM activities has largely been on human health, ICCVAM also recognizes the need to implement non-animal approaches for ecotoxicity testing. The Ecotoxicology Workgroup was established to provide expertise in identifying and evaluating in vitro and in silico methods to identify ecological and environmental hazards. The workgroup has members from seven ICCVAM agencies.

The workgroup compiled a summary of agency needs for ecotoxicity testing, emerging technologies for evaluating ecotoxicity and environmental safety, and the potential applicability of those technologies for regulatory testing (Ceger et al. 2022). The workgroup is currently evaluating ecotoxicology methods involving animal testing and what alternatives exist to replace, reduce, or refine animal use in the acute fish toxicity assay.

In Vitro to In Vivo Extrapolation Workgroup

IVIVE relates chemical concentrations that induce a response in an in vitro assay to chemical exposures that induce relevant effects in vivo. IVIVE can facilitate the use of in vitro toxicity testing data in risk assessment and regulatory decision-making.

The ICCVAM IVIVE Workgroup currently has members from eight ICCVAM agencies. It was established to catalog and evaluate currently available IVIVE approaches, to determine their suitability for specific research or regulatory purposes, and to assess whether additional tools or models are needed. A review produced by the workgroup (Chang et al. 2022) proposes operational definitions for IVIVE, presents literature examples for several common toxicity endpoints, and highlights their implications in decision-making processes across various federal agencies, as well as international organizations.

PFAS Workgroup

Per- and polyfluoroalkyl substances (PFAS) are a class of organofluorine chemicals that have been manufactured and used for decades. They have been identified as highly persistent and bioaccumulative in the environment, biota, and humans. There is no consensus definition of PFAS, and depending on how they are defined, the number of compounds considered PFAS can differ widely. While there is broad national and international interest in understanding PFAS hazards, many challenges remain to effectively and efficiently doing so due to the same properties that make them so widespread in their use and application. ICCVAM established its PFAS workgroup in 2023 to provide expertise in identifying and evaluating new approach methodologies (NAMs) to predict PFAS toxicity. The workgroup has members from eight ICCVAM agencies.

The workgroup will initially develop a summary of agency needs for assessing PFAS and how those can be met using NAMs. This summary will be used to advance the development and evaluation of defined approaches for screening, testing and assessment of relevant endpoints. Additionally, the workgroup will address the development and implementation of alternative approaches to reduce and replace animal use for PFAS testing following four key steps: (1) reviewing current PFAS definition(s); (2) identifying testing efforts among regulatory and non-regulatory agencies and related challenges; (3) identifying data gaps and opportunities in application of alternative approaches; and (4) identifying and addressing both scientific and non-scientific (including regulatory) needs and challenges.

Validation Workgroup

ICCVAM described recommended criteria and processes for validation and regulatory acceptance of toxicological test methods in a 1997 document. Advancements in technologies and tools available for toxicity testing are driving a need for new approaches to test method validation. ICCVAM established its Validation Workgroup in 2021 to update the 1997 document. The workgroup has members from ten ICCVAM agencies.

A new draft document describing criteria and processes for validation and regulatory acceptance of toxicological test methods is now available and was discussed at the September 21-22 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods. The document is being finalized to address public comments and will be published in 2024. Other charges to the group include establishing flexible robust practices to promote confidence in new methods, examine best practices for quality and quality systems development, and promote harmonization of development and validation for both U.S. and international acceptance.

ICCVAM Expert Groups

ICCVAM also establishes expert groups to facilitate communication among agencies on a specific area of interest. Expert groups can be established from workgroups that have completed their charge tasks, or by agency representatives that share interest in a topic for which no specific activity has been identified. ICCVAM currently has expert groups in the areas of developmental and reproductive toxicity, developmental immunotoxicity, FAIR data standards, metricsmicrophysiological systems, nanomaterials, ocular and dermal irritation, read-across, and skin sensitization.