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The great literary giant C.S. Lewis said, “You can’t go back and change the beginning, but you can start where you are and change the ending.” This adage embodies efforts made by the Animal-Free Safety Assessment (AFSA) Collaboration to move toxicology away from the animal-intensive risk paradigm classically used to assess chemical safety to a future paradigm based exclusively on nonanimal models. During the SOT 61st Annual Meeting and ToxExpo, in-person and virtual instructors at the AM01 Continuing Education (CE) course “Animal-Free Safety Assessment of Consumer Products and Ingredients: A Primer” introduced attendees to the Next-Generation Risk Assessment (NGRA) paradigm as it applies to cosmetics. CE course instructors from leading organizations, including International Flavors & Fragrances Inc., 21st Century Tox Consulting, Institute for In Vitro Sciences Inc., Firmenich SA, and Unilever, delivered detail-packed presentations that set the stage for the AFSA-Collaboration’s freely available online NGRA training program and webinars.

NGRA can be defined as an exposure-led, hypothesis-driven risk assessment approach that incorporates one or more new approach methods (NAMs) to ensure that chemical exposures do not cause harm to humans. Jay Ingram of Delphic HSE described the historical context of animal testing regulations around the world since the first animal testing ban was proposed in 1993 in the EU. He stressed that animal testing bans do not automatically equate to acceptance of animal-free methods, as evidenced by continued reliance on in vivo test data, particularly to predict systemic toxicity. Widespread adoption of AFSA methods requires first acknowledging uncertainties in NAMs and then becoming comfortable with the uncertainties introduced by NAMs. Many challenges remain before NGRA replaces in vivo risk assessment, such as establishing clear frameworks for in vitro to in vivo extrapolation (IVIVE), incorporating additional methods and tools that include consideration of metabolism, and increasing availability of NGRA approaches and NAMs to toxicologists in all sectors, including regulatory toxicologists.

For those unable to attend the CE course in person, you can sign up for the course through the SOT CEd-Tox Library. As evidenced by the many course attendees, there is a real momentum within SOT to embrace NGRA, making sure that the next chapter in risk assessment methods is based on practices that aren’t based on in vivo animal experimentation.

This blog was prepared by an SOT Reporter and represents the views of the author. SOT Reporters are SOT members who volunteer to write about sessions and events in which they participate during the SOT Annual Meeting and ToxExpo. SOT does not propose or endorse any position by posting this article. If you are interested in participating in the SOT Reporter program in the future, please email Giuliana Macaluso.

On-demand recordings of all Featured and Scientific Sessions delivered during the 2022 SOT Annual Meeting and ToxExpo will be available to meeting registrants in the SOT Event App and Online Planner after their conclusion, through July 31, 2022. Video recordings of the Continuing Education courses will be added to the CEd-Tox online continuing education library by May 2022.