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RHP Risk Management Helps Industry Navigate the Shift Toward New Approach Methodologies in Toxicology and Regulatory Risk Assessment


News provided by

RHP Risk Management

Sep 13, 2026, 14:21 ET

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As regulators expand the use of human-relevant testing approaches, companies face a more complex question: which methods are fit for purpose and capable of supporting defensible regulatory and risk-management decisions?

CHICAGO, Sept. 13, 2026 /PRNewswire-PRWeb/ -- In June 2026, the U.S. Environmental Protection Agency (EPA) announced additional actions aimed at reducing and ultimately eliminating mammalian animal testing, including expansion of the agency's list of accepted New Approach Methodologies (NAMs) and a streamlined process for evaluating new non-animal approaches. NAMs encompass a range of approaches – including in vitro systems, computational models, read-across, omics technologies, and integrated testing strategies – that can supplement or, in appropriate circumstances, replace conventional animal testing.

Increasingly, NAMs are also being used not simply as one-for-one replacements for individual animal studies, but as components of integrated evidence strategies that combine computational, mechanistic, exposure, and traditional toxicology information. RHP Risk Management, a toxicology risk assessment company serving organizations navigating environmental regulations compliance, helps organizations evaluate how emerging toxicology methods can be used to address data gaps, strengthen risk assessments, and support regulatory decision-making.

What Role Do NAMs Play in Chemical Safety and Regulatory Decision-Making?

Federal agencies are increasingly encouraging development and use of approaches designed to provide mechanistically informative and, where appropriate, more direct human-relevant evidence. Many methods now classified as NAMs have been used in toxicological research for years. What is changing is their expanding sophistication, the availability of integrated computational and biological data, and increasing regulatory interest in using these approaches to inform real-world safety decisions.

Acceptance of NAM-derived evidence remains method-, endpoint- and regulatory-context specific. The challenge is not simply identifying an available NAM but determining whether it can answer the relevant hazard, dose-response, exposure, or risk question; whether the resulting data are sufficiently reliable and biologically relevant, and how those data should be integrated into the broader evidence base.

RHP supports organizations in integrating NAMs with traditional toxicological, exposure, and human-health evidence.

  • Addressing toxicity data gaps for chemicals with limited traditional data
  • Evaluating read-across and analogue suitability
  • Integrating computational predictions, in vitro results, and existing animal or human evidence
  • Prioritizing substances or endpoints for additional testing
  • Evaluating whether available evidence can support a regulatory submission or risk assessment
  • Characterizing uncertainty and determining whether additional testing would materially change the decision

RHP closely tracks evolving federal and state regulatory expectations and brings experience interpreting how agency policy and scientific practice translate into real-world decision-making. As regulators expand their consideration of NAM-derived information, RHP helps clients assess both where these approaches are accepted today and how changing expectations may affect future regulatory strategies.

"NAMs are changing the questions toxicologists can answer and the evidence available to answer them," said Melanie Buser, PhD, DABT, Senior Associate Health Scientist at RHP Risk Management. "But replacing an animal study with a new technology does not automatically produce a better risk assessment. The key is selecting methods that are fit for purpose, integrating them with exposure information and the existing toxicological evidence, and building a weight of evidence that can support the regulatory or business decision at hand.

That integration is central to RHP's approach. The firm combines toxicological evidence with exposure and dose modeling, transparent analytical methods, and uncertainty characterization to translate complex scientific information into decision-relevant conclusions.

About RHP Risk Management

RHP Risk Management delivers science-driven solutions for workplace, product, and environmental health. The company specializes in exposure assessment, toxicology risk evaluation and regulatory compliance support. With certified industrial hygienists, exposure scientist, toxicologists, and epidemiologists, RHP provides defensible opinions and quantitative analysis for complex environmental health questions.

Media Contact

Melanie Buser, RHP Risk Management, 1 708-773-4306, [email protected], https://rhprisk.com/

SOURCE RHP Risk Management

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