Communication and Education

The 2018 ICCVAM Strategic Roadmap identified stakeholder engagement as critical to acceptance and use of new methods. To facilitate stakeholder engagement, ICCVAM and its member agencies organize public meetings and webinars. These events inform stakeholders about the availability and appropriate use of new methods and provide opportunities for stakeholders and agencies to discuss opportunities for test method development.

ICCVAM Communities of Practice Webinars

In 2015, ICCVAM initiated a series of Communities of Practice webinars to provide opportunities for detailed presentations on a current topic relevant to alternative test method development.

  • The sixth of these webinars, presented on Jan. 21, 2020, was titled Use of Animal-free Affinity Reagents. In this webinar, Alejandra Solache, Ph.D., of Abcam presented an overview of production, use, and characteristics of monoclonal and polyclonal antibodies. Rebecca Clewell, Ph.D., of 21st Century Tox Consulting summarized a recent review by a working group of the EURL ECVAM Scientific Advisory Committee of the on the scientific validity and benefits of animal-free technologies to produce affinity reagents.
  • The Jan. 26, 2021, Communities of Practice webinar focused on Non-animal Approaches for Mixtures Assessment. In this event, three ICCVAM agency scientists described approaches being used to assess human risk of toxicity from mixtures. Cynthia Rider, Ph.D., NIEHS, discussed assessing safety of botanicals. Patricia Ruiz, Ph.D., ATSDR, described computational approaches to predict toxicity of mixtures. Kristin Isaacs, Ph.D., EPA, presented a data mining approach that uses purchasing data to estimate exposure to consumer product ingredients.
ICCVAM Public Forums

Traditionally held in person, the ICCVAM public forum meetings in 2020 and 2021 were held virtually because of restrictions on public gatherings due to COVID-19. However, both meetings provided opportunities for public interaction with representatives from ICCVAM member agencies.

ICCVAM held its seventh public forum on May 21, 2020, which was viewed by about 400 individuals. Representatives of ICCVAM member agencies described work both to advance new approaches to safety testing of chemicals and medical products and to reduce the amount of testing required. Commenters at the forum commended the agencies’ progress and noted the importance of federal agencies taking leadership roles in reducing animal testing. In addition to government agencies, viewers represented pharmaceutical and chemical companies, animal welfare organizations, and test method developers.

The 2021 public forum was held on May 27 and attracted nearly 200 viewers. The program featured 13 presentations from nine of the 17 ICCVAM member agencies. Representatives described efforts to reduce animal use within their agencies and by their stakeholders, as well as research activities that advance new non-animal approaches. Stakeholders expressed particular interest in activities that advance alternatives to animal use in the context of regulatory requirements. Such activities were outlined by CPSC and two EPA offices. A request to the public for comments to be presented during the meeting produced a robust response, with nine commenters presenting during the meeting and an additional four written comments received.

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ICCVAM Advisory Committee Meetings

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. Traditionally held in person, the 2020 and 2021 public meetings of SACATM were held virtually because of restrictions on gatherings due to COVID-19.

More than 200 people viewed or participated in the Sept. 2-3, 2020, SACATM meeting, making it one of the most broadly viewed SACATM meetings ever. Committee members praised advances in use of computational methods to reduce animal use for chemical safety testing. They suggested resources and approaches that could be developed to further advance these tools and identified testing areas where they could be applied. Committee members also encouraged ICCVAM member agencies to increase efforts to advance non-animal alternatives for identifying substances that could cause cancer or other chronic toxicity outcomes, and to promote strategies for reducing animal use for vaccine testing and antibody production.

About 160 people viewed the Sept. 28-29, 2021, SACATM meeting. This event focused on detailed discussion of two topics of current interest to ICCVAM: reducing or replacing animal use for ecotoxicity testing and new approaches to validation of new testing methods. The committee urged ICCVAM member agencies to support greater communication among regulators, regulated industry, and test method developers. ICCVAM members also were encouraged to engage groups focused on environmental justice and climate change.

ICCVAM Agency-sponsored Workshops and Webinars

ICCVAM agencies convened workshops and webinars during 2020 and 2021, summarized in the table below, to foster collaboration and provide information about alternative testing methods. All meetings took place online.

Meeting Date and Location Sponsoring Agency (and partner organization) Meeting Title (with link to page if available) Meeting Summary
       
Apr 17, 2020 NIEHS NIEHS SBIR/STTR Town Hall: Development of New Approach Methodologies to Reduce Animal Use in Toxicity Testing This online town hall meeting was presented to facilitate improved communication between method developers and end-users, providing an opportunity for assay developers to hear from ICCVAM stakeholders on the desired characteristics and requirements for NAMs.
May 14, 2020 FDA Artificial Intelligence for Regulatory Science Research This presentation summarized current thinking and ongoing efforts at the FDA’s National Center for Toxicological Research in artificial intelligence, with examples from drug and food safety, natural language processing of regulatory documents, and biomarker discovery and development. The presentation also discussed guiding principles and best practices for applying artificial intelligence in regulatory science research.
Jan 22, 2020 – Nov 3, 2021 EPA (PETA Science Consortium International eV., Physicians Committee for Responsible Medicine) Webinar Series on the Use of New Approach Methodologies (NAMs) in Risk Assessment These webinars discussed computational models for acute toxicity and carcinogenicity prediction, and skin sensitization and eye irritation testing. A September 2020 event presented a proposed NAM nomination form for Toxic Substances Control Act consideration. The series will continue in 2022.
Ongoing; initiated Aug 2020 FDA Alternative Methods Webinar Series This FDA internal webinar series, organized by the FDA Alternative Methods Working Group, provides test method developers with the opportunity to introduce their new technology to FDA and give individual FDA programs the option to contact them for further information.
Feb 19, 2020 – Dec 1, 2021 FDA (Society of Toxicology) Colloquia on Emerging Toxicological Science: Challenges in Food and Ingredient Safety Since 2014, the Society of Toxicology and the FDA Center for Food Safety and Applied Nutrition have presented colloquia on high-quality, cutting-edge, future-oriented toxicological science topics. Many of the colloquia focus on alternatives to animal use. The series is continuing into 2022.
Jul 23 – Nov 12, 2020 NIEHS (PETA Science Consortium International eV., EURL ECVAM) Antibody Webinar Series Attendees learned about the applications and benefits of animal-free recombinant antibodies.
Sep 15 – 17, 2020 EPA Use of NAMs to Derive Extrapolation Factors and Evaluate Developmental Neurotoxicity for Human Health Risk Assessment This public meeting of the Federal Insecticide, Fungicide, and Rodenticide Scientific Advisory Panel considered and reviewed the use of NAMs to derive extrapolation factors and evaluate developmental neurotoxicity for human health risk assessment.
Sep 30, 2020 NIEHS, EPA (Health and Environmental Sciences Institute) Opportunities and Challenges in Using the Kinetically Derived Maximum Dose Concept to Refine Risk Assessment This symposium highlighted issues commonly raised in application of the kinetically derived maximum dose for design and interpretation of animal toxicity studies, and provided the background information needed to develop more consistent, transparent approaches to support broader application in risk assessment.
Oct 19 – 20, 2020 EPA Conference on the State of Science on Development and Use of NAMs for Chemical Safety Testing This was the second in a series of EPA conferences to highlight the state of the science on the development and use of NAMs for chemical safety testing. The next conference will be held in 2022.
May 19 – Jun 2, 2021 EPA (PETA Science Consortium International eV., Unilever, Syngenta) Inhalation Toxicity Testing These three webinars focused on using in silico and in vitro approaches for next generation risk assessment of potential respiratory toxicants.
May 26 – 27, 2021 FDA FDA Science Forum This event allowed the public to view scientific research and collaborative efforts of FDA scientists. Several topic areas focused on the application of big data and predictive toxicology to inform FDA decision-making and drive innovation.
Jun 24 – Sep 10, 2021 NIEHS Environmental Health Language Collaborative Webinars These interactive events helped set the stage, begin discussions, and draft plans for how to make progress on the Collaborative’s goals.
Sep 9, 2021 NIH Bioinformatics and Computational Biology Symposium The program for this event included a keynote presentation on “Big data for health and disease” and presentations on DNA structure, proteomic tumor analysis, data integration to study COVID-19, single-cell sequencing, and genomics.
Sep 21 – Dec 8, 2021 NIEHS (Swiss Centre for Applied Human Toxicology, Swiss State Secretariat for Economic Affairs) Current Concepts in Quantitative Risk Assessment for Skin Sensitization This webinar series provides an overview of the current state of the science in this rapidly developing field. The webinars will continue in 2022 and are intended as background for a planned workshop on quantitative risk assessment of skin sensitizing pesticides. 
Oct 25, 2021 EPA (Johns Hopkins University Center for Alternatives to Animal Testing) Challenges and Opportunities for Overcoming Dog Use in Agrochemical Evaluation and Registration At this virtual workshop, presenters reviewed the role the 90-day dog study has played in the regulation of agrochemicals in both the U.S. and Europe during the past 20 years and what approaches may be employed to substantially reduce its use.
Animal Welfare Information Center Resources

The 1985 amendments to the Animal Welfare Act established the Animal Welfare Information Center (AWIC), an information service at the USDA National Agricultural Library (NAL). 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 and minimize pain and distress to animals.

AWIC provides information to the toxicology community on the NAL website related to the development and use of alternatives to toxicity testing, as well as information and guidelines on mandatory and regulatory testing set by various agencies. These web pages highlight peer-reviewed publications and other online resources that discuss ways to replace, reduce, and refine animal use in toxicity testing. For example, AWIC provides links and selected citations (updated in 2021) on 3Rs testing methods used in ecotoxicity testing.

During 2020 and 2021, 256,208 people visited the AWIC website. These visits generated a total of 512,253 page views. AWIC also provides information on animal use alternatives through outlets such as presentations and posters, workshops, webinars, and conference exhibits. Through these outlets, AWIC presented to over 3,590 participants at 67 different outreach events in 2020 and 2021, collectively. At these outreach events, AWIC described best practices for searching and finding current literature on methods to reduce, refine, or replace animal use in testing and experimentation.

FDA Reports on Progress in Advancing Alternatives

In January 2021, FDA published “Advancing New Alternative Methodologies at FDA,” which provided updates on activities to advance development of alternatives to animal use and their application to regulatory decision-making. The report was developed by the FDA Alternative Methods Working Group to highlight the progress made by FDA scientists in laying the groundwork to integrate alternatives to animal testing into FDA regulatory programs. The report described activities within eight FDA offices and centers, as well as FDA working groups and interagency partnerships such as ICCVAM and Tox21. The report also summarized FDA engagement to advance alternatives to animal testing in international venues such as OECD and the International Cooperation on Cosmetic Regulation.

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New Agency Webpages Summarizing Alternative Methods Activities

During 2020 and 2021, several ICCVAM agencies published new webpages summarizing activities to advance alternative methods.

  • In May 2020, FDA published “Advancing Alternative Methods at FDA,” which highlights activities of its Alternative Methods Working Group. The working group was established to facilitate interactions with global regulatory bodies interested in implementing alternative methods in toxicology. Additionally, the group examines opportunities and viable ways by which emerging methods and new technologies can support regulatory review of risk, safety, and efficacy of FDA-regulated products. Resources available from the page include links to relevant reports, publications, and FDA webpages and contact information for the working group.
  • In October 2020, EPA published “Strategic Vision for Adopting New Approach Methodologies,” which describes activities, partnerships, and goals of several EPA offices to reduce animal testing. Resources available from this page include links to EPA webpages that provide more details on activities within the EPA Offices of Pesticide Programs, Pollution Prevention and Toxics, Science and Policy Coordination, and Research & Development.
    A key resource within the EPA website is the webpage, “Adopting 21st Century Science Methodologies – Metrics.” This page includes data compiled by the Hazard and Science Policy Council, the Chemistry and Acute Toxicology Science Advisory Council, and other groups about how EPA activities and policies have reduced the number of animals used in testing and saved EPA and stakeholder resources.
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