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National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterMarch 2021

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

By Catherine Sprankle

Update available: EPA list of alternative test methods

The U.S. Environmental Protection Agency (EPA) has updated the list of new approach methodologies (NAMs) that the agency will consider for the purpose of satisfying information requirements under the Toxic Substances Control Act (TSCA). Updates reflect changes made to test guidelines issued by the Organisation for Economic Co-operation and Development. Other updates consider guidance on acute systemic toxicity testing waivers issued by the EPA Office of Pesticide Programs, and availability of a new expert system to predict carcinogenicity of organic chemicals, fibers, metals, and polymers.

A 2016 update of TSCA required EPA to issue a list of methods and approaches that do not use vertebrate animals to develop new data or information required under TSCA. EPA also developed the “Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program.” Information about the NAMs list and the Strategic Plan is available on the EPA website.  

EURL ECVAM issues status report on alternatives

The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) has issued its 2020 “Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches.” The status report describes research, development, and validation activities, as well as initiatives that promote the regulatory and international adoption and use of alternative approaches and their dissemination. Activities described in the report include:

  • Developing guidance for moving from traditional animal tests to non-animal assays for vaccine quality control.
  • Validating methods to identify substances with the potential to affect the thyroid signaling pathway, damage DNA, induce skin and respiratory sensitization, or harm fish.
  • Exploring how to apply existing toxicity information to predicting different toxicity endpoints.

EURL ECVAM, which is part of the European Commission's Joint Research Centre, coordinates research and validation studies on alternatives to animal testing within the European Union. EURL ECVAM also shares knowledge about and promotes use of alternative methods.

Slides and video available from ICCVAM January 26 webinar

Materials are now available from the January 26 webinar on “Non-animal Approaches for Mixtures Assessment.” The purpose of this webinar was to present key insights and ongoing activities in the area of mixtures toxicity testing. The webinar was presented by NICEATM on behalf of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), which receives support from NICEATM This was the latest in ICCVAM’s Communities of Practice webinar series.

The webinar included presentations from staff of three ICCVAM agencies, including Cynthia Rider from the National Institute of Environmental Health Sciences (NIEHS), Patricia Ruiz from the Agency for Toxic Substances and Disease Registry, and Kristin Isaacs from EPA.

Special issue of Frontiers in In Vitro Toxicology on new approach methodologies

Frontiers in In Vitro Toxicology has launched a new research topic, Chemical Testing Using New Approach Methodologies (NAMs). The journal is actively looking for research contributions on this topic for an upcoming special issue. Contributions should be related to the use of NAMs to meet or support regulatory requirements for chemical toxicity testing. Submissions will be put online as they are accepted and the journal will also put together a special e-book of the issue after the deadline.

The optional deadline to submit an abstract is March 31, 2021.  Manuscripts are due by July 31, 2021. To submit your abstract or manuscript and for more information about this research topic visit the journal’s website.

Chemical Research in Toxicology special issue focuses on computational toxicology

The discipline of computational toxicology encompasses the use of computational tools to support integrative approaches to toxicological research and chemical safety assessments. Computational approaches can be applied to predictive modeling, analyses of complex data sets, and extrapolation and translation among evidence streams, particularly those from new approach methodologies that rely upon alternatives to animal testing.

Chemical Research in Toxicology has published a special issue focusing on computational toxicology. The issue includes 38 contributions from experts in the field, as well as three reviews and perspectives, 34 research articles and one ToxWatch. Acting NICEATM Director Nicole Kleinstreuer is a co-editor of the special issue and co-author of three research articles. Other co-authors of articles appearing in the issue include Brian Berridge, principal representative to ICCVAM from NIEHS, and Suzanne Fitzpatrick, principal representative to ICCVAM from the U.S. Food and Drug Administration.

Workshop report available: Application of NAMs in support of read-across

Read-across is a computational technique that uses toxicity data from data-rich chemicals to predict toxicity for an untested or data-poor chemical. The use of NAMs in support of read-across approaches for regulatory purposes is a main goal of the European Union’s EU-ToxRisk project. At a 2019 workshop, scientists from regulatory agencies, industry, and academia met to discuss this issue and consider case studies in which read-across had been applied to specific regulatory problems. Grace Patlewicz, EPA, chair of the ICCVAM Read Across Workgroup, is a co-author of the workshop report.

Rovida et al. NAM-supported read-across: from case studies to regulatory guidance in safety assessment. ALTEX. 

New toxicity prediction model provides broader and improved predictions

A publication coauthored by Acting NICEATM Director Nicole Kleinstreuer describes computational models that use a variety of multitask approaches to predict acute systemic toxicity. The accuracy of the new models improves upon previous models. The new models also provide toxicity predictions for species such as dog, chicken, and rabbit.

Jain et al. 2021. Large-scale modeling of multispecies acute toxicity end points using consensus of multitask deep learning models. J Chem Inf Model.

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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