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National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterSeptember 2022

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

By Catherine Sprankle

Webinars consider population variability and susceptible populations

NICEATM is presenting an October 26-27 symposium webinar on using NAMs to address variability and susceptibility across populations. The symposium will identify information needs for population variability and susceptibility and consider where NAMs could be designed or improved to fill those needs. A key goal of the symposium is to engage a broad range of stakeholders, including representatives of nongovernmental organizations focused on environmental and consumer protection. Information about the symposium and links to register are available on the NTP website.

An ongoing webinar series presented by NICEATM in partnership with the Physicians Committee for Responsible Medicine (PCRM) is providing background information in advance of the symposium. The first webinar on July 19 focused on the capabilities of various in vitro human skin models. The next webinar, scheduled for September 12, will consider the topic “Clinical Trials on Chips to Tackle Rare Diseases.” Information about the webinar series and recordings of past webinars are available on the PCRM website.

NIEHS small business funding opportunities for alternative methods development

NIEHS is providing funding for small businesses to support development of toxicity screening, testing, and modeling approaches that support Tox21 and other NTP goals. Areas of high priority include development of:

  • Tools for exposure assessments such as sensors and computational tools and methods.
  • Tools for evaluating environmental health and safety of engineered nanomaterials.
  • Biomonitoring technologies and biological response markers of exposure and response.
  • Assays and model systems for screening compounds for toxicity.

This funding is being offered as part of the Omnibus Solicitation of the National Institutes of Health, Centers for Disease Control and Prevention, and FDA for small business grant applications. The first deadline for applications under this announcement is September 5.

NIEHS is also offering small businesses funding to develop resources and approaches that reflect the variability in responses to chemical exposures based on genetic diversity in the human population. The goal of this funding opportunity is to enhance the capability of introducing genetic diversity in toxicity testing. Applications for this funding are due November 8.

The National Institutes of Health (NIH) offers an Applicant Assistance Program to assist small businesses to prepare and submit grant applications to NIEHS and other NIH Institutes and Centers. The goal of this program is to increase the number of applications submitted by underrepresented small businesses and to increase the number of these applications that are free of errors or omissions and are deemed complete, compliant, and responsive to the review criteria. Only U.S. for-profit companies are eligible for the program, and participating companies must not have received an SBIR or STTR award since 2013. Apply by September 22.

EPA to hold NAMs conference October 12-13

A draft agenda is available for the U.S. Environmental Protection Agency’s (EPA’s) “2022 Conference on the State of the Science on Development and Use of New Approach Methods (NAMs) for Chemical Safety Testing.” The conference will be held in-person at EPA headquarters in Washington, DC on October 12-13. A virtual option will also be available. Register by Friday, October 2.

In 2019, EPA committed to developing and implementing a work plan to reduce the use of vertebrate animals in chemical testing while ensuring protection of human health and the environment. To report progress on these activities, EPA hosts regular conferences to provide updates and solicit input from interested stakeholders. The conferences highlight the state of the science on the development and use of NAMs for chemical safety testing.

Recent NICEATM and ICCVAM publications

  • NICEATM has developed a set of in silico models that can predict eye irritation hazard classification for chemicals and mixtures. Evaluation of the models suggest that they will be particularly useful for identifying substances that do not require classification for eye irritation.
    Sedykh et al. 2022. Mixtures-inclusive in silico models of ocular toxicity based on United States and international hazard categories. Chem Res Toxicol 35(6):992-1000.
  • ICCVAM agency scientists from NIEHS, CPSC, the National Institute of Standards and Technology, and the U.S. Department of Defense coauthored a paper describing a technical framework for enabling high-quality measurements in NAMs. Application of this framework can support optimizing reproducibility of NAMs, thereby supporting meeting research and regulatory needs.
    Petersen et al. 2022. Technical framework for enabling high-quality measurements in new approach methodologies (NAMs). ALTEX https://doi.org/10.14573/altex.2205081.
  • A recent paper describing advancements in the development of the electrophilic allergen screening assay (EASA) is the cover article of the latest issue of the journal Toxics. The EASA, which measures protein binding to estimate a chemical’s likelihood of causing skin sensitization, is the subject of an ongoing ICCVAM validation study.
    Petersen et al. 2022. Development of a 96-well electrophilic allergen screening assay for skin sensitization using a measurement science approach. Toxics 10(5):257.
  • ICCVAM members from three U.S. federal agencies collaborated with international counterparts to develop a framework to establish scientific confidence in NAMs for regulatory use. The framework addresses five essential elements: fitness for purpose, human biological relevance, technical characterization, data integrity and transparency, and independent review. Universal uptake of this framework would facilitate the timely development and use of NAMs by the international community.
    van der Zalm et al. 2022. A framework for establishing scientific confidence in new approach methodologies. Arch Toxicol.
  • A new paper in Toxicological Sciences describes PreS/MD, a computational tool that predicts whether extractables and leachables from a medical device might induce a response in a commonly used animal test to predict allergic reactions. Acting NICEATM Director Nicole Kleinstreuer is a coauthor on the paper. PreS/MD is freely available at https://presmd.mml.unc.edu/.
    Alves et al. 2022. PreS/MD: Predictor of Sensitization hazard for chemical substances released from Medical Devices. Tox Sci.

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