In a statement on February 1, National Institutes of Health (NIH) Director Monica Bertagnolli, MD, accepted the task force’s recommendations for activities to advance the development and use of non-animal methods in biomedical research. The statement emphasizes the critical role of the NIEHS office in advancing such approaches, particularly with an eye toward validation and regulatory implementation.
![NIH Director Monica M. Bertagnolli, MD](https://factor.niehs.nih.gov/sites/niehs-factor/files/2024/02/science-highlights/new-nih-director-body.jpg)
Bertagnolli’s statement endorsed the recommendations of the Task Force on Advancing the Development of New Alternative Methods for Biomedical Research, which was established by the NIH Director’s Advisory Committee to identify high-priority areas for NIH investment in New Methods and Methods (NAM), including those for studying human biology non-animal methods.
“NIH accepts these recommendations and is committed to continuing to invest in building a powerful set of tools for researchers studying human biology and disease,” Bertagnolli said. “These recommendations build on NIH’s existing investment in NAM projects.”
Bertagnolli pointed to the key role played by the Interagency Coordinating Committee for Validation of Alternative Methods (ICCVAM) in driving acceptance and use of NAM within the federal government. ICCVAM is a standing committee of NIEHS under the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM).
Working group includes ICCVAM consultants
The role of ICCVAM in driving NAM acceptance is of particular interest to two members of the working group, Dr. Antonio Baines of North Carolina Central University and VMD Szczepan Baran of VeriSIM Life, who are also members of the ICCVAM Advisory Committee.
Baines commented that the timing of the working group’s establishment reflects the need for and growing acceptance of wider use of NAM.
“There are many chemicals for which adequate toxicity data are lacking, especially chemical mixtures,” he observed. “NAM can both complement and replace animal use in providing these data.”
Baran said there are a number of areas where ICCVAM and NICEATM can support the working group’s recommendations.
“Given their extensive engagement with different stakeholders, ICCVAM and NICEATM are well-positioned to identify and articulate current challenges while highlighting the need and rationale for these innovative tools,” he noted.
Both members agreed that ICCVAM was well placed to support the Working Group’s recommendations to disseminate NAM information and encourage agencies to develop policies that prioritize the use of NAM.
Alignment with NICEATM and ICCVAM activities
![Dr. Nicole Kleinströll](https://factor.niehs.nih.gov/sites/niehs-factor/files/2024/02/science-highlights/non-animal-methods-body4.jpg)
The NIH working group was established in late 2022 and will meet throughout 2023 to solicit public input through a request for information issued in June and a public workshop in August. Speakers at the symposium included NICEATM Director Dr. Nicole Kleinstreuer, ICCVM members Dr. Elijah Petersen, National Institute of Standards and Technology, and USDA Jessie Carder.
Kleinstreuer noted how the working group’s recommendations are consistent with ongoing NICEATM activities.
“NICEATM has long been exploring how to use combinations of NAMs to improve the ability of individual NAMs to predict toxicity,” she commented, noting NICEATM’s specific efforts in the areas of skin sensitization and eye irritation. “We also play a leading role in delivering high-quality data sets and computational workflows through our integrated chemistry environment.”
Both Petersen and Carder agreed that ICCVAM’s activities in evaluating NAM for specific regulatory uses are consistent with the Working Group’s recommendations for supporting NAM infrastructure.
“This is ICCVAM’s clear current and ongoing role, and there is huge potential for collaboration and productivity in this area,” commented Petersen.
ICCVAM members also believe that their committee is in a unique position to promote collaboration and training in the appropriate use of NAM.
“We need to put more trust in NAM, and I think part of that comes from increased transparency about NAM’s intended use and purpose, and more importantly its limitations,” Card said.
(Catherine Sprankle is a communications specialist at Inotiv, the contractor supporting NICEATM.)