NAM Resources for Policymakers

US and international governmental agencies and working groups

• Complement Animal Research in Experimentation (Complement-ARIE) Program: NIH Common Fund program that brings together experts through a consortium of researchers participating in development, standardization, validation, and dissemination and use of NAMs in basic, translational, and clinical research
• FDA’s New Alternative Methods Program: intended to spur the adoption of alternative methods for regulatory use that can replace, reduce, and refine animal testing; help prevent products with increased toxicological risk from reaching the market; and improve the predictivity of nonclinical testing
• Validation & Qualification Network (VQN): a public-private partnership established by the Foundation for the National Institutes of Health (FNIH) in collaboration with the NIH to accelerate the deployment and regulatory implementation of NAMs.
• Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): US validation body that coordinates the activities of 18 federal regulatory and research agencies to work together to develop and evaluate new, improved, and alternative test methods and strategies to replace, reduce, or refine animal use
• International Cooperation on Alternative Test Methods (ICTAM): international partnership created to foster dialogue and facilitate international cooperation in validation studies, peer review, and development of harmonized recommendations for NAMs
• NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM): National Toxicology Program (NTP) entity that provides operational and scientific support for ICCVAM activities as well as activities with external stakeholders and international organizations; evaluates and promotes methods that replace, reduce, or refine the use of animals for chemical safety testing
• Organisation for Economic Co-operation and Development (OECD): international organization that includes 38 member countries (including the United States) tasked with setting international standards and informing policies relevant to social, economic, and environmental challenges¹
• Office of Research and Development: EPA’s scientific research arm that develops, tests, and applies NAMs to improve the agency’s approaches to the evaluation of potential impacts of chemicals on human and ecological health
• Scientific Advisory Committee on Alternative Toxicological Methods (SACATM): includes experts from academia, industry, and animal welfare organizations, who meet annually to advise the National Institute of Environmental Health Sciences director on the development, evaluation, and implementation of NAMs undertaken by NICEATM and ICCVAM
• Toxicology in the 21^st Century (Tox21) Consortium: federal research collaboration between the EPA, the FDA, the NTP, and the National Center for Advancing Translational Sciences tasked with developing high-throughput tests and NAMs that can rapidly determine whether chemicals adversely affect human health

US Laws, Regulations, and Reports

• A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States: ICCVAM resource to guide US agencies and stakeholders seeking to adopt new approaches; includes details of ongoing and planned activities for implementation of NAMs for acute systemic toxicity, eye and skin irritation, and skin sensitization; published in 2018
• Alternative Toxicity Testing Report to Congress: account of the EPA’s alternative toxicity testing activities as of 2020
• Catalyzing the Development and Use of NAMs: report by the NIH Advisory Committee to the Director that serves as a basis for the NIH and other stakeholders for considering the development and use of NAMs; published in 2023
• Code of Federal Regulations Title 9 / Chapter I / Subchapter A / Part 2 / Subpart C §2.31(d)(1)(ii): AWA regulations that require the principal investigator to investigate and report alternative methods to procedures that cause more than momentary or slight pain or distress to animals; requires the investigator to provide written assurance that activities do not unnecessarily duplicate previous experiments
• Current Alternative Methods Accepted by US Agencies: table on National Toxicology Program website
• EPA Report on Statutory and Regulatory Requirements for Vertebrate Animal Testing and Flexibility for Implementing New Approach Methods (NAMs): EPA review of existing statutes and programmatic regulations, policies, and guidance to identify vertebrate testing requirements that may allow flexibility for the agency to apply NAMs; published in 2024
• FDA Modernization Act 2.0: federal law authorizing the use of alternatives to animal testing and removing a requirement to use animal studies as part of the process to obtain a license for a biological product that is interchangeable with another biological product; signed into law in 2022
• FDA Roadmap to Reducing Animal Testing in Preclinical Safety Studies: FDA roadmap to their strategic, stepwise approach toward phasing out animal testing with scientifically-validated NAMs for preclinical safety studies; published in 2025
• ICCVAM Authorization Act of 2000: federal law to establish, wherever feasible, guidelines, recommendations, and regulations that promote the regulatory acceptance of new or revised scientifically valid toxicological tests to protect human and animal health and the environment while reducing, refining, or replacing animal tests and ensuring human safety and product effectiveness
• New Approach Methods Work Plan: EPA work plan for the prioritization of activities to reduce the use of vertebrate animal testing while continuing to protect human health and the environment; published in 2021
• NIH Revitalization Act of 1993: federal law which established the Interagency Coordinating Committee on the Use of Animals in Research and first mandated the development of alternatives to animal use in research
• OECD Test Guidelines: internationally recognized standards for nonclinical environment and health safety testing of chemicals and chemical products
• States that Ban the Sale of Cosmetics Tested on Animals: report produced by the Connecticut General Assembly, Office of Legislative Research; published in 2023²
• Testing Regulations and Guidelines: table on National Toxicology Program website
• Toxic Substances Control Act (TSCA), as amended by the Frank R Lautenberg Chemical Safety for the 21^st Century Act: federal law that directs the EPA to reduce and replace, to the extent practicable and scientifically justified, the use of vertebrate animals in the testing of chemical substances and mixtures and to promote the development and incorporation of alternative test methods that do not require new vertebrate animal testing
• TSAR – Tracking System for Alternative methods towards Regulatory acceptance: system developed by the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) to track the progress of alternative methods from submission for validation through to final adoption via inclusion into the regulatory framework
• Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies: ICCVAM Validation Workgroup report describing an approach to NAMs validation that reflects modern toxicity testing and places an emphasis on integrating results from multiple in vitro, in chemico, and in silico approaches rather than finding alternatives to single in vivo tests; published in 2024

1. The OECD contains a large number of “substantive committees,” each comprising several “working parties.” For example, the Chemicals and Biotechnology Committee oversees OECD work on chemical safety through the activities of 12 working parties, which collectively conduct research and develop guidelines on how to test chemicals for hazards to human health and the environment. One, the Working Party of the National Co-ordinators of Test Guidelines Programme, harmonizes and approves test guidelines and related documents through consensus annually, in accordance with the 3Rs principles

2. Eleven states had enacted such laws at the time of this report: California, Hawaii, Illinois, Louisiana, Maine, Maryland, Nevada, New Jersey, New York, Oregon, and Virginia. In March 2024, Washington became the 12^th state to join this list.