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National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterSeptember 2020

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

By Catherine Sprankle

Virtual SACATM meeting reaches wide audience

The Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) met virtually in a public webcast on September 2-3. In presentations at the meeting, scientists from the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods, (NICEATM), member agencies of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), and NICEATM and ICCVAM collaborators described advances in alternatives to animal use. Over 200 people viewed or participated in the webcast, making it likely the most broadly viewed SACATM meeting ever.

Recognizing the occasion of ICCVAM’s 20th anniversary, SACATM members and commenters praised ICCVAM’s work to advance alternatives to animal testing, and also noted that there were many opportunities for further progress. Specific areas mentioned included genotoxicity and carcinogenicity, pyrogen testing, and replacement of animal use for antibody production. Broader themes identified for focus included how agencies should measure reduction of animal use, international harmonization, and effective communication of agency acceptance of alternatives to animal testing. Presentations from the meeting will be available soon on the NTP website, and minutes posted following their review by the committee.

SACATM meets annually to advise NICEATM, ICCVAM, and the director of the National Institute of Environmental Health Sciences regarding statutorily mandated duties of ICCVAM and activities of NICEATM.

Symposium webinar September 30 on kinetically derived maximum dose

A symposium webinar on “Opportunities and Challenges in Using the Kinetically Derived Maximum Dose Concept to Refine Risk Assessment” will be held Wednesday, September 30, from 8:00 a.m. to 1:00 p.m. EDT. The symposium is organized by NICEATM, the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs, and the Health and Environmental Sciences Institute.

The kinetically derived maximum dose (KMD) refers to the dose at which a departure from linear pharmacokinetics is observed. In contrast to its routine use in pharmaceutical development, consideration of the KMD in the design or interpretation of animal toxicity studies for environmental chemicals is rare. Interest is growing in use of the KMD to interpret animal dose-response data or set top dose in chronic toxicity studies of these chemicals, but many technical and scientific issues hinder its proper use. The purpose of this symposium is to highlight these commonly raised issues and provide the background information needed to develop more consistent, transparent approaches to support broader KMD application in risk assessment.

NICEATM activities at ASCCT annual meeting

The 9th annual meeting of the American Society for Cellular and Computational Toxicology (ASCCT) will be held virtually on October 20-22 and no registration fee charged. The conference will focus on the science and policy considerations needed to enable the EPA to eliminate reliance on mammalian tests to make regulatory decisions by 2035. The program will feature plenary speakers, panel discussions, oral and poster presentations drawn from submitted abstracts, and opportunities for early-career scientists through a mentoring session and poster awards.  Registration is available on the ASCCT website and the program will be available soon.

At this year’s ASCCT annual meeting, NICEATM’s work will be featured with talks on “Providing Insight into Chemical Activity Through Data Curation and Assay Annotation” and compliation of a “Human Reference Database for Skin Sensitization.” NICEATM scientists will also present six posters, one of which will be featured in a flash presentation, a format that enables poster presenters to share their work in a 3-minute oral presentation to a broader audience. A full list of NICEATM’s activities at ASCCT is available on the NTP website.

FDA solicits proposals for alternative methods webinar series

The Office of the Chief Scientist at the U.S. Food and Drug Administration (FDA) is launching a webinar series on alternative methods and soliciting proposals on new methods for inclusion. The webinar series supports FDA’s commitment to promote novel technologies and potentially incorporate them into its regulatory review, as applicable.

Test method developers selected to participate in this webinar series will have the opportunity to introduce their new technology to FDA, with individual FDA programs having the option to contact them for further information. Please note: Participation in FDA’s webinar series does not constitute FDA’s endorsement of a new method or oblige FDA to assist the developer in qualifying a new method for regulatory use.

To apply for participation in the webinar series, please submit the following information to alternatives@fda.gov:

  • A description of the new method, including origin of cells or species of animal if appropriate.
  • A description of the proposed context of use for the new method.
  • A description of the regulatory issue/gap where the new method could have an impact.
  • Data from use of the new method, including any publications.

FDA will respond within 60 days to each webinar proposal submission.

FIFRA SAP to meet in September

EPA will convene a virtual public peer-review meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) on September 15-18. Panelists will consider and review the use of new approach methodologies (NAMs) for deriving extrapolation factors and evaluating developmental neurotoxicity for human health risk assessment. Registration information is available on the EPA website.

The FIFRA SAP provides independent scientific advice, information, and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on human health and the environment. At this meeting, EPA is seeking advice and recommendations from the FIFRA SAP on scientific issues associated with:

  • The evaluation and utility of NAMs as part of a weight-of-evidence evaluation of developmental neurotoxicity potential.
  • The use of in vitro acetylcholinesterase inhibition data for developing interspecies and/or intraspecies data-derived extrapolation factors for organophosphate pesticides.

NICEATM and partners present webinar series on animal-free antibodies

NICEATM, the PETA International Science Consortium Ltd. (PETA-ISC), and the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) are co‑organizing a series of free webinars where experts will address the application and benefits of recombinant antibodies. This series of six webinars began in July and will continue into 2021.

The second webinar in the series is Wednesday, September 16 from 10:00-11:00 a.m. EDT. Alison Gray of Afability will discuss how animal-free antibodies are developed, how they mimic the mechanistic principles evolved by nature, and the challenges that have slowed their replacement. João Borroso of EURL ECVAM will share a summary of the findings from a 2018 EURL ECVAM Scientific Advisory Committee meeting that included a review of the validity and benefits of using animal-free technology to produce affinity reagents and the subsequent EURL ECVAM recommendation.

Registration for two upcoming webinars is available on the PETA-ISC website. Both webinars are at 10:00-11:00 a.m. EDT.

  • Webinar 3, “Application of Animal-free Antibodies,” is Thursday, October 15. Giulio Russo of Abcalis will discuss replacement of animal serum-derived secondary antibodies with animal-free multiclonal antibodies. Charu Chandrasekara, Canadian Centre for Alternatives to Animal Methods, will describe her experience with replacement of animal-derived affinity reagents.
  • Webinar 4, “Accessibility of Recombinant Antibodies”, is Thursday, November 12. Pierre Cosson, University of Geneva, and Michael Fiebig, Absolute Antibody, will describe their institutions’ antibody production activities.

Recent publications

  • A paper co-authored by Acting NICEATM Director Nicole Kleinstreuer and NICEATM computational chemist Kamel Mansouri (ILS, contractor supporting NICEATM) describes a minimal set of assays that can identify chemicals with androgen receptor activity in initial screening. Agonist batteries of as few as six assays and antagonist batteries of as few as five assays were shown to yield balanced accuracies of 95% or better relative to a previously described set of 11 assays.
    Judson et al. 2020. Selecting a minimal set of androgen receptor assays for screening chemicals. Reg Toxicol Pharmacol. DOI: 1016/j.yrtph.2020.104764.
  • A paper co-authored by Kleinstreuer describes Pred-Skin, a web tool that integrates multiple quantitative structure-activity relationship models to predict whether chemicals might be skin sensitizers with the potential to cause allergic contact dermatitis. Pred-Skin was developed in collaboration with scientists at the University of North Carolina at Chapel Hill and the Universidade Federal de Goiás.
    Borba et al. 2020. Pred-Skin: a web portal for accurate prediction of human skin sensitizers. Chem Res Toxicol. https://doi.org/10.1021/acs.chemrestox.0c00186.

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The Update Newsletter is produced by NTP Office of Liaison, Policy, and Review. 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 Liaison, Policy, and Review and Editor-in-Chief: Mary Wolfe | Managing Editor: Anna Lee Mosley