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National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterMay 2020

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

By Catherine Sprankle

ICCVAM public forum May 21: Registration open

ICCVAM will hold a public forum on Thursday, May 21 from 9:00 a.m. - 4:00 p.m. EDT. This event is held annually to share information and facilitate direct communication of ideas and suggestions from stakeholders. This year the public forum will be presented via webcast only due to restrictions on in-person gatherings amid ongoing public health concerns. NICEATM staff and ICCVAM members will give presentations on current activities related to the development and validation of alternative test methods and approaches, including activities relevant to implementation of the strategic roadmap for establishing new approaches to evaluate the safety of chemicals and medical products in the United States.

Registration is required to view the public forum webcast and will be open through the end of the meeting on May 21. 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 8. More information about the meeting and links to registration are available at https://ntp.niehs.nih.gov/go/iccvamforum-2020.

New NICEATM webpage highlights regulatory applications of 3Rs

U.S. federal agencies take an active role in facilitating the successful adoption and use of new approach methodologies to replace, reduce, and refine animal use in testing (referred to as “3Rs” approaches). A new page on the NTP website provides examples of how agencies have applied 3Rs approaches to testing requirements. The page is available at https://ntp.niehs.nih.gov/go/3rs-apps.

The page includes two actions taken in February by regulatory agencies.

  • In February, the U.S. Food and Drug Administration (FDA) issued draft guidance on “Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics.” This guidance includes several specific recommendations on assessing potential for dermal sensitization:
    • FDA no longer recommends that sponsors conduct the murine local lymph node assay to assess the sensitization potential of topical drug products due to the limitations of the assay.
    • As an alternative to accepted guinea pig tests, FDA will consider a battery of in silico, in chemico, and in vitro studies that have been shown to adequately predict human skin sensitization with an accuracy similar to existing in vivo methods.
  • The U.S. Environmental Protection Agency (EPA) announced the designation of 20 chemical substances as low priority under the Toxic Substances Control Act. A low-priority designation means that risk evaluation for these substances is not warranted at this time. Information used to support the designation for each chemical included 3Rs approaches:
    • Data from in vitro high-throughput screening assays used in the EPA ToxCast program.
    • Predictions of toxicity generated using quantitative structure-activity relationship models.
    • Predictions of toxicity generated using read-across, a computational technique that uses toxicity data from a tested chemical to predict toxicity for an untested chemical.

NICEATM compiled a summary of 3Rs approaches used to designate these substances as low priority, and this information is available on the NTP webpage.

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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