ICCVAM Biennial Report 2024-2025

In 2015, ICCVAM initiated a series of Communities of Practice webinars to provide detailed presentations on a current topic relevant to alternative test method development. ICCVAM chair Natalia Vinas, Ph.D., presented a retrospective of ten years of Communities of Practice webinars at the 2025 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). She reviewed the topics covered in all of the webinars and noted those that had set the stage for subsequent activities including collaborations and workshops.

• The January 29, 2024, Communities of Practice webinar was titled Implementing Computational Approaches for Regulatory Safety Assessments. It focused on how to establish confidence in computational approaches for regulatory applications. Michael Lowit, Ph.D., presented an overview of EPA Office of Pesticide Programs goals for applying new approach methodologies (NAMs), including computational models, to ecological risk assessments and described ongoing projects in support of those goals. Pras Pathmanathan, Ph.D., summarized recent FDA Center for Devices and Radiological Health guidance on reporting of computational modeling studies in medical device submissions. Jon Arnot, Ph.D., of Arnot Research and Consulting and the University of Toronto, described tools and approaches for bioactivity and exposure modeling and provided examples of how they can be used to support regulatory decision-making.
• The 2025 webinar was presented on July 21 and focused on Evolution of Complex In Vitro Models. Three scientists from government and academic laboratories and the private sector described how they are approaching validation of complex in vitro models such as microphysiological systems (MPS). Danilo Tagle, Ph.D., of NCATS presented an overview of their Tissue Chips for Drug Screening program. Ivan Rusyn, M.D., Ph.D., described activities of the Texas A&M University’s Tissue Chip Testing Center, which is funded through a public–private consortium. Remi Villenave, Ph.D., from Roche, summarized pharmaceutical industry perspectives on NAMs use, including perceived barriers to NAMs usage.

ICCVAM’s goals include promotion of national and international partnerships between governmental and nongovernmental groups, including academia, industry, advocacy groups, and other key stakeholders. To foster these partnerships, ICCVAM holds public forums annually to share information and facilitate direct communication of ideas and suggestions from stakeholders.

The first ICCVAM Public Forum was held in 2014. At the 2025 SACATM meeting, ICCVAM member Anna Lowit, Ph.D. (EPA principal agency representative) described how both agency participation and audience engagement with the event has grown over time. She noted how public forum meetings provide a venue for agencies to announce and discuss projects and initiatives. They also facilitate engagement with specific stakeholder groups such as nongovernmental organizations and method developers.

The 2024 ICCVAM Public Forum was held in person on May 20 and 21 at NIH in Bethesda, MD, with an option for remote viewing. About 40 people attended in person, and nearly 300 viewed the webcast. The program featured 18 presentations from seven of the 17 ICCVAM member agencies describing activities both to advance new approaches to safety testing of chemicals and medical products and to reduce the amount of testing required. Updates were also provided on ICCVAM local and international activities. Public comments ranged from general suggestions about areas of focus for ICCVAM to specific discussions on the status of replacing animals for endpoints such as inhalation toxicity or developmental neurotoxicity (DNT). Specific comments recognized ICCVAM for publication of the document “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies” and asked ICCVAM agencies to play an active role in the application of super intelligence in toxicology.

Due to uncertainty about travel and public communications, the 2025 ICCVAM Public Forum was held virtually on July 20 and 21 rather than in May as in the past. Between 150 and 180 people viewed the webinar over two days. Eight presentations provided updates on NICEATM and ICCVAM activities and activities of six ICCVAM member agencies. Five organizations submitted written comments, and six organizations presented public comments. Commenters recognized that federal agencies and stakeholders are undergoing a major transition toward NAMs that is driven by broader regulatory momentum and specifically noted new NIH policies and the 2025 FDA roadmap. However, they also noted uneven progress due to unclear guidance, inconsistent terminology, limited data sharing, and lack of standardized tracking of animal use. Organizations including advocacy groups and scientific consortia agreed on the need for better infrastructure, including training, transparent reporting, harmonized definitions, and validated methods, alongside increased international coordination. While some groups pushed for rapid replacement of animal testing where alternatives exist, others advocated a balanced approach that continues improving animal models in parallel to ensure scientific rigor and public health protection during the transition.

The Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) is a federally chartered advisory group that advises NICEATM, ICCVAM, and the Director of NIEHS about ICCVAM activities. SACATM is directed by its charter to meet at least once each fiscal year.

The September 17–18, 2024, SACATM meeting was held at NIH in Bethesda, MD. About 40 people attended in person and over 100 people viewed each day of the webcast. Advisory committee members were briefed on federal government and international activities to support validation of new methods, including new ICCVAM guidance on validation, establishment of the Method Developers Forums, updates to OECD guidance on validation, and launch of the NIH Complement-ARIE program. Advisory committee members welcomed the publication of the ICCVAM guidance and encouraged continued progress on the other activities. The other focus topic of the meeting was DNT testing, and scientists from NIEHS, FDA, EPA, and the European Food Safety Authority presented on advances in the use of NAMs for this endpoint.

The September 11–12, 2025, SACATM meeting was hosted at NIEHS in Research Triangle Park, NC, and presented virtually. The meeting attracted over 300 viewers on the first day and nearly 200 on the second day. Many of the presentations at this meeting focused on recently announced initiatives by NIH and FDA to support implementation of NAMs in research and regulatory contexts. Advisory committee members welcomed these efforts and agreed that they would support efficiency in method validation. Data standards and harmonization were both noted as key to this effort. Updates were also provided on development of online tools such as the Collection of Alternative Methods for Regulatory Application, NIH Integrated Chemical Environment, and NICEATM-developed apps for predicting skin sensitization potential. A session on “ICCVAM Public Outreach and Education” presented retrospectives of the scope and impact of the ICCVAM Public Forum meetings and ICCVAM Communities of Practice webinars, as well as a summary of NICEATM training and outreach activities during 2024 and 2025.

ICCVAM agencies convened workshops and webinars from the beginning of 2024 and continuing into 2026, summarized in the table below, to foster collaboration and provide information about alternative testing methods. 

As a follow-up to publication of the report on "Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies," ICCVAM and NICEATM envisioned a series of Method Developers Forums, each focused on a specific endpoint/toxicity. These forums would provide an opportunity for NAMs developers to present their methods and regulatory issues with relevant stakeholders.

The ICCVAM Method Developers Forum was held virtually in August 2024 and focused on NAMs for carcinogenicity testing. Ten method developers described their methods and proposed how they may be useful for regulatory and/or industry stakeholders in a webinar attended by over 200 viewers. Stakeholders representing potential government and industry users of the NAMs or the data they generate also participated in the webinar. The event was well-received with positive feedback from diverse stakeholders. Suggestions for improvement of future forums included:

• Increase engagement with industry, especially for preregulatory activities.
• Provide more time during the event for discussion between method developers and end users.
• Consider how to prioritize methods that are closer to being ready to apply to a regulatory purpose.
• Clarify evaluation criteria for proposals, which are needed to help both method developers to prepare their proposals and the steering committee come to a consensus on accepting proposals.

Planning for future iterations of the Method Developers Forum is currently underway.

In recent years, USDA’s Animal Welfare Information Center (AWIC) has been developing PubMed search strategies, known as “hedges,” for topics specific to alternatives. Hedges are complex search queries that can be used on their own or in combination with other terms to return the most current literature relevant to that query available in PubMed. The focus of AWIC’s first hedges was refinement of animal use, and these hedges tended to be focused on animal species. Since 2023, NICEATM and AWIC have been collaborating to develop hedges on topics focused on replacement of animal use. In 2023 and 2024, hedges were developed for the topics MPS, NAMs for DNT, NAMs for acute inhalation toxicity, and IVIVE. These hedges were published in spring 2024 and are available on the National Toxicology Program website. All AWIC hedges are also available on their website. Additional search hedges on the topics of NAMs for developmental and reproductive toxicology, NAMs for skin sensitization, QSAR models for chemical hazard, and reduction alternatives for the two-year rodent cancer bioassay were developed in 2025 and will be published on the National Toxicology Program and AWIC websites in 2026.

The 1985 amendments to the Animal Welfare Act established the Animal Welfare Information Center (AWIC), an information service at USDA's National Agricultural Library. AWIC’s mission is to provide information pertinent to employee training that could prevent unintended duplication of animal experimentation and on improved research methods that could reduce or replace animal use or minimize pain and distress to animals (7 USC § 2143(e)).

In 2024 and 2025, AWIC continued to strengthen its support for the toxicology community by offering information on alternative methods in ecotoxicity testing and by maintaining resources that highlight mandatory and regulatory testing guidelines across federal agencies. The 3Rs in Ecotoxicity Testing webpage features curated searches for NAMs in the PubAg and PubMed databases, as well as a bibliography that was updated in September 2025 and provides access to nearly 800 abstracts on alternative testing approaches.

AWIC’s website received substantial use during this two-year period, with 308,733 visitors generating 542,858 page views. These users accessed a variety of materials designed to facilitate the identification and application of animal use alternatives, especially within toxicology and related research disciplines.

In addition to online resources, AWIC engaged directly with the scientific and regulatory communities through presentations, posters, workshops, webinars, and conference exhibits. Across 40 outreach events in 2024 and 2025, AWIC interacted with approximately 3,191 animal researchers, veterinarians, Institutional Animal Care and Use Committee members, and others. These engagements emphasized best practices for conducting comprehensive literature searches, locating current research on alternative methods, and applying 3Rs principles within testing and experimentation, including toxicology contexts.

AWIC also continued to offer its workshops on meeting the requirements of the Animal Welfare Act. These sessions provided attendees with guidance on where to find literature and resources on the 3Rs, instruction on database literature search techniques (e.g., search syntax), and demonstrations of how to conduct literature searches to address requirements for consideration of NAMs. Four workshops were presented during 2024 and 2025, reaching a total of 927 participants. For those unable to attend live sessions, AWIC maintained access to online, on-demand training through its events webpage.

EPA created its New Approach Methods (NAMs) Work Plan to prioritize agency efforts and resources toward activities that aim to reduce the use of vertebrate animals while continuing to protect human health and the environment. The Work Plan was updated in December 2021.

To implement the Work Plan’s objective of “Engage and Communicate with Stakeholders,” EPA developed and implemented a NAMs training program. This program provides users courses and workshops with the appropriate level of oversight to enable them to use EPA NAMs tools and approaches in their own work.

In April 2024, EPA presented a comprehensive two-day NAMs Tools Training Workshop in person at their Research Triangle Park, NC, campus. It gave participants the opportunity to advance their knowledge about 10 different EPA NAMs tools through overview sessions, in-depth learning, interactions with tool and data owners, and tool-specific case studies. Materials from the workshop are available on the NAMs training program webpage.

EPA also presented several virtual training sessions during 2024 and 2025:

• June 2024: Chemical Transformation Simulator, a web-based tool for predicting transformation pathways and physicochemical properties of organic chemicals
• September 2024: Collaborative AOP Wiki
• May 2025: SeqAPASS online screening tool to extrapolate toxicity information across species
• June 2025: CompTox Chemicals Dashboard, the primary web-based application that provides access to data and algorithms from the EPA Center for Computational Toxicology and Exposure
• July 2025: httk R software package providing toxicokinetic models to estimate internal chemical concentrations from exposure and support in vitro to in vivo extrapolation (IVIVE)

Videos and other materials from these events are on the NAMs training program webpage. Other resources available on this page include links to online user guides and tool webpages.

During 2024 and 2025, DOI engaged in communications activities to raise awareness of NAMs for ecotoxicity applications within the agency and among the general public.

• DOI generates scientific information needed to support the conservation and management of the nation’s natural resources. This includes conducting ecotoxicological research and testing. In 2024, the U.S. Geological Survey, on behalf of DOI, launched a new website on “Reducing Animal Use in Ecotoxicity Testing and Biomonitoring.” This website describes Geological Survey efforts to reduce animal use and employ in vitro and in silico replacement methods.
• To raise awareness of animal testing alternatives among agency scientists, the U.S. Geological Survey presented a July 2025 webinar on “Animal Alternatives for DOI Biomonitoring and Ecotoxicological Assessments.” Presentations discussed:
  • Best practices for monitoring mercury contamination and assessing injury to wild bird populations
  • Cytotoxicity studies with fish gill cell lines: proof-of-concept for a screening approach to prioritize pesticide candidates
  • Cell culture models for screening environmentally safer tire additives
  • Development of water and sediment toxicity testing methods for a laboratory-reared mayfly

The webinar was attended by 50 agency scientists.

The NIH Office of Laboratory Animal Welfare (OLAW) ensures the humane care and use of animals in U.S. Public Health Service-supported research, testing, and training. To support this mission, OLAW provides guidance and interpretation of the Public Health Service Policy on Humane Care and Use of Laboratory Animals, monitors compliance with the policy, and supports educational programs.
The 3Rs are foundational principles in responsible animal use. In particular, the consideration of NAMs, where scientifically appropriate, is important to ensure the judicious use of animals. The choice of model used in a study, animal or otherwise, is reviewed by subject matter experts during the process of grant application or contract proposal, and OLAW does not advise on the applicability or implementation of a particular alternative model in a study. While alternative approaches cannot completely replace the use of animals at this time, NIH is committed to transparently assessing where animal use can be reduced or eliminated by transitioning to alternatives. Areas where research using animals is currently necessary represent high-priority opportunities for investment in alternatives. OLAW is committed to providing helpful information to assist investigators who wish to explore human-based approaches and other methodologies.

The resources on OLAW’s Alternatives and NAMs webpage were launched as an updated, consolidated Animal Welfare Topic page in September 2025. The updated webpage gives biomedical researchers and Institutional Animal Care and Use Committee members a place to learn about the 3Rs and NAMs, as well as resources for how to incorporate them into their work.

Resources available on OLAW’s Alternatives and NAMs webpage include:

• Recent NIH announcements relevant to NAMs acceptance and use
• Frequently asked questions about NIH and NAMs
• Links to resources and tips for investigators, Institutional Animal Care and Use Committees, students, and the public
• Background information on NAMs and OLAW, and links to relevant laws, policies, and guidance