Ways to Broaden the Awareness, Consideration and Adoption of New Approach Methodologies (NAMs)*

Abstract

New approach methodologies (NAMs) refer to any technology, methodology or combination thereof used to inform on chemical hazard and risk, and support replacement, reduction or refinement of animal use. While the development and application of NAMs have recently increased, their adoption in regulatory decisions is slow, and awareness outside the community is low. The Consideration of Alternative Methods Working Group (CAMWG) within the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) focused on understanding how NAMs are considered by stakeholders and identifying ways to encourage adoption. A set of questions was developed to focus stakeholder discussions, and CAMWG members met with stakeholder representatives to collect perspectives on how alternatives to traditional animal tests are considered when developing toxicology testing and research programs. Participants represented agrochemical, industrial chemical, consumer products, and pharmaceutical companies; academic researchers in toxicology; and Institutional Animal Care and Use Committees. All stakeholders currently use or consider NAMs – some more than others. Challenges to broader NAM adoption were identified, and five common themes emerged as potential barriers: perception, regulatory acceptance, scientific and technical limitations, education, and financial considerations. Solutions to overcoming barriers were identified, such as tailored education, proactive collaboration, and improved communication. Additional recommendations were ensuring fit-for-purpose use of NAMs, developing harmonized national and global acceptance criteria, identifying funding sources, increasing awareness about NAM strengths and limitations, and a need for a central repository for NAMs information. Here, we detail these discussions about NAM use, barriers, and proposed solutions, to expand awareness, consideration, and adoption.