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National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterMay 2021

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)

By Catherine Sprankle

Registration open for ICCVAM Public Forum May 27

NICEATM will host a virtual public forum presented by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) on Thursday, May 27 from 9:00 a.m. until about 4:30 p.m. EDT. This event is held annually to share information and facilitate direct communication of ideas and suggestions from stakeholders. NICEATM, ICCVAM, and a number of ICCVAM agencies will describe activities both to advance new approaches to safety testing of chemicals and medical products and to reduce the amount of testing required.

Registration is required to view the public forum webcast and will be open through the end of the meeting on May 27. Interested persons may also register to present oral public statements with associated slides on topics relevant to ICCVAM's mission. Requests to present oral statements during the meeting will be accepted on a first-come, first-served basis as time permits. The deadline for registering to present oral public statements is May 14.

CPSC issues proposed guidance on use of alternative methods, comments due
June 14

In a March 31 Federal Register notice, the U.S. Consumer Product Safety Commission (CPSC), an ICCVAM member agency, requested comment on its “Proposed Guidance for Industry and Test Method Developers: CPSC Staff Evaluation of Alternative Test Methods and Integrated Testing Approaches and Data Generated from Such Methods to Support FHSA Labeling Requirements.”

CPSC has developed this guidance, building on its Animal Testing Policy, to assist stakeholders in determining what test methods are deemed reliable for determining compliance with the labeling requirements under the Federal Hazardous Substances Act (FHSA). This includes clarification of CPSC informational requirements and process for evaluating new approach methodologies and integrated approaches to testing and assessment. More information about the draft guidance and instructions on how to submit comments are available in the Federal Register notice. Comments are due June 14.

FDA to hold Science Forum May 26-27

The U.S. Food and Drug Administration (FDA), an ICCVAM member agency, will present the 2021 FDA Science Forum virtually on Wednesday and Thursday, May 26-27. The event allows the public to view the research and collaboration ongoing at FDA, and how FDA researchers use novel science and technologies to inform FDA’s regulatory decision-making and drive innovation.

The theme of this year’s forum is “Science as the Foundation for Protecting and Promoting Public Health,” and one of the topic areas is “Tools to Effectively Use Big Data.” The forum will feature a keynote address by National Institute of Allergy and Infectious Diseases Director Anthony Fauci.

NICEATM paper describes variability in skin irritation data

To establish appropriate benchmarks for understanding the performance of new approach methodologies, the reference standard animal tests should be well characterized. To assess variability in the rabbit skin irritation test, NICEATM analyzed data from 990 substances tested at least twice each. The analysis found that chemicals classified as moderate irritants at least once were classified as mild or non-irritants at least 40% of the time when tested repeatedly. This analysis indicates that variability present in the rabbit skin irritation test should be considered when evaluating non-animal alternative methods as potential replacements.

Rooney et al. 2021. Analysis of variability in the rabbit skin irritation assay. Reg Toxicol Pharmacol. https://doi.org/10.1016/j.yrtph.2021.104920.

New review article describes non-animal approaches to eye irritation testing

Acting NICEATM Director Nicole Kleinstreuer and other NICEATM scientists are co-authors on a new review article in Cutaneous and Ocular Toxicology that describes available non-animal test methods and their relevance to eye anatomy and mechanisms of eye irritation in humans. Combinations of the reviewed methods may be used in development of human-relevant integrated testing approaches.

Clippinger et al. 2021. Human-relevant approaches to assess eye corrosion/irritation potential of agrochemical formulations. Cutan Ocul Toxcol. https://doi.org/10.1080/15569527.2021.1910291

NICEATM meeting activities

  • NICEATM will be presenting four posters at the 19th International Workshop on (Quantitative) Structure-Activity Relationships in Environmental and Health Sciences (QSAR 2021), which will be held virtually June 7-10. The meeting program is available and registration is open; the registration deadline is May 8. Acting NICEATM Director Nicole Kleinstreuer, NICEATM computational chemist Kamel Mansouri, and senior toxicologist Agnes Karmaus (ILS, contractor supporting NICEATM) are serving on the organizing committee for QSAR 2021. NICEATM presentations at QSAR 2021 will describe NICEATM tools and data resources for development and evaluation of new chemical safety testing approaches.
  • Posters presented by NICEATM at the Society of Toxicology (SOT) annual meeting, held virtually from March 12-16, are available on the NTP website. A full list of SOT activities by NICEATM and ICCVAM members is available on this page.

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The Update Newsletter is produced by NTP Office of Policy, Review, and Outreach. The text is not copyrighted and can be reprinted without permission. If you use parts of the Update Newsletter in your publication, we ask that you provide us with a copy for our records. We welcome your comments and suggestions.

Director of Office of Policy, Review, and Outreach and Editor-in-Chief: Mary Wolfe | Managing Editor: Anna Lee Mosley