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 six 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
The newest 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.
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.
Read Across Workgroup
Read-across is a computational technique that uses toxicity data from data-rich chemicals to predict toxicity for an untested or data-poor chemical. In some cases, use of read-across enables identification of potential hazards without animal use.
ICCVAM established its Read Across Workgroup to build read-across capacity within member agencies, raise awareness of the state of the science, and work towards harmonization of read-across approaches. The workgroup has members from seven ICCVAM agencies.
The workgroup conducted a survey of the current applications, tools used, and needs of the seven agencies represented on the workgroup for read-across. The paper summarizing the survey (Patlewicz et al. 2019) also provided practical case studies to illustrate how the read-across approaches applied by two agencies varied on account of decision context. The workgroup is continuing to evaluate case studies of read-across use to determine how use and applications of read-across can be broadened.
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 document describing criteria and processes for validation and regulatory acceptance of toxicological test methods is currently being drafted. 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, metrics, microphysiological systems, nanomaterials, ocular and dermal irritation, and skin sensitization.