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National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterApril 2020

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

By Catherine Sprankle

ICE version 3.0 now available

On March 11, NICEATM released an update of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. The ICE 3.0 update features improvements to the in vitro to in vivo extrapolation (IVIVE) tool. In response to customer requests, ICE now allows users to upload their own data for IVIVE analyses. A new physiologically based toxicokinetic model has been added, and the output graphics have been improved.

Other new resources in ICE 3.0 include:

  • User interface improvements
  • Organization of Tox21 assays in query setup menus based on modes of action
  • Availability of data from in vitro dermal irritation assays
  • Updated property predictions for over 800,000 chemicals from OPERA (Open Structure-activity/property Relationship App)
  • Mapping of Tox21 assays to controlled terms from the NCI Metathesaurus

NIEHS to present webinar on grant opportunities for NAM development

The National Institute of Environmental Health Sciences (NIEHS) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program, in coordination with NICEATM, will host a webinar-based town hall meeting on “Development of New Approach Methodologies to Reduce Animal Use in Toxicity Testing.” The webinar will be held on April 17 from 1:00-3:00 p.m. EDT.

A key component of the Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States is early interaction between developers of new approach methodologies (NAMs) and end-users, to ensure that the proposed NAMs will meet testing requirements for agency and industry stakeholders. This webinar will facilitate improved communication between method developers, including small business (SBIR/STTR) applicants, and end-users, and provide an opportunity ICCVAM stakeholders to communicate their desired characteristics and requirements for NAMs to assay developers. The agenda will include short presentations from experts from U.S. federal agencies and industries, including pharmaceutical developers, with time allowed for questions from method developers. Presenters include representatives from NICEATM, the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration (FDA), the U.S. Department of Defense, 3M Corporation, and Novartis.

NICEATM and ICCVAM scientists featured in SOT virtual meeting webinars

Over the next few months, the Society of Toxicology (SOT) will present scientific sessions and continuing education (CE) courses as live webinars. These events were originally planned for presentation at SOT’s annual meeting in Anaheim. The SOT website will be updated regularly as webinars are confirmed and registration details become available.

Registration is available for two CE courses that feature topics of potential interest to stakeholders of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), which NICEATM supports. Both courses will be presented on Friday, May 15, from noon-3:30 p.m. EDT. Please note that all CE courses require a paid registration. Those persons who registered to attend a CE course in Anaheim are registered for the webinar course. Registration has now reopened for those not previously registered.

  • An Introduction to New Approach Methodologies (NAMs) and Understanding Their Potential to Support Regulatory Decisions
    This CE course will provide an overview of NAMs along with case studies where they are being used or could potentially be used for regulatory risk assessment. Suzanne Fitzpatrick, FDA principal representative to ICCVAM, is a course co-chair.
  • In Vitro Approaches to Assess the Toxicity of Inhaled Substances
    In this course, speakers from government, contract research organizations, academia, NGOs, and method developers will discuss progress and challenges associated with various approaches for inhalation toxicity testing. ICCVAM Co-chair Emily Reinke, U.S. Department of Defense, is a course co-chair; David Allen, ILS (contractor supporting NICEATM), is a presenter.

Papers due July 31 for special issue of Chemical Research in Toxicology

Papers are being accepted for a special issue of the journal Chemical Research in Toxicology that will focus on computational toxicology. The goal of this special issue is to bring together recent developments in computational toxicology, with equal emphasis given to methodological developments, such as statistical approaches, modeling advances, and computational resources, as well as applications and case studies demonstrating the use of existing and novel methods. In particular, the focus will be on online and freely available tools and open-source software, databases, and recent studies that exemplify success or limitations of the currently used methods. The issue will be edited by Acting NICEATM Director Nicole Kleinstreuer and Weida Tong of the FDA National Center for Toxicological Research.

Submissions are invited in, but are not limited to: curated data sets and models to predict human and environmental toxicity; physiologically based pharmacokinetic modeling; advanced approaches for in vitro to in vivo extrapolation; combining in silico predictions with in vitro and in vivo data; multiscale and agent-based models; harvesting and processing of big, heterogeneous, and nonstandard data (e.g., literature and patent mining, pathway information); toxicogenomics; and systems toxicology. Submissions are due July 31.

EURL ECVAM issues status report on alternatives

The European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) has issued its 2019 “Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches.” EURL ECVAM partners with ICCVAM in the International Cooperation on Alternative Test Methods.

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:

  • Research initiatives to foster mechanistic-based toxicity testing to support risk assessment of chemicals, with a primary focus on repeated dose, developmental, and reproductive toxicity.
  • Exploration of the relationship between chemical exposure and public and environmental health, with particular attention being given to the area of carcinogenicity.
  • Validation of methods to identify substances with the potential to affect the thyroid signaling pathway, damage DNA, or induce skin sensitization.

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.

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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