National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterApril 2016

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

By Catherine Sprankle

NICEATM presents webinar series on inhalation toxicity


NICEATM and the PETA International Science Consortium (PISC) are co-hosting a webinar series on Alternative Approaches for Acute Inhalation Toxicity to Address Global Regulatory and Non-regulatory Data Requirements.

The first webinar, Current Testing Practices: Regulatory Requirements and Non-regulatory Testing, was held March 29 and featured presentations by Jon Hotchkiss, Ph.D., from the Dow Chemical Company, and Ian Indans from United Kingdom Chemicals Regulation Directorate. Slides from the webinar will be posted on the NICEATM website by April 8.

The second webinar planned for April 26 is titled State-of-the-Science, Practical Application, and Dosimetry Considerations for In Vitro and Ex Vivo Methods. It will feature presentations by Annie Jarabek, Ph.D., from EPA, and Marianna Gaca from British American Tobacco. Future webinars will be presented monthly through August and include discussion of in silico and other non-testing approaches, adverse outcome pathways, and the additivity approach for hazard classification of mixtures.

Registration for the webinar series is still available; you need only register once to attend all remaining webinars. Visit the NICEATM website for more information on the webinar series.

ICCVAM public forum


The next ICCVAM public forum is scheduled for Wednesday, May 25, 2016, from 9:00 a.m. to 4:00 p.m. at the National Institutes of Health Natcher Conference Center in Bethesda, Maryland. Representatives of the ICCVAM agencies will be present to hear ideas and suggestions from interested stakeholders and the public.

NICEATM staff and ICCVAM members will present on current activities related to the development and validation of test methods and approaches that may replace, reduce, or refine animal use. Time will be set aside following each presentation for attendees to ask questions. The agenda also includes a public comment session for participants to make oral statements on topics relevant to ICCVAM’s mission and current activities.

Interested persons can attend in person or view the meeting remotely via webcast. While participants viewing the webcast will be able to submit statements via email, those wishing to make a public statement are encouraged to attend in person to enable face-to-face dialog with ICCVAM members. More information is available on the NICEATM website. For planning purposes, those planning to attend in person are encouraged to register by May 13.

Kleinstreuer to deliver keynote at the Pan-American Conference for Alternative Methods


NICEATM Deputy Director Nicole Kleinstreuer, Ph.D. will deliver the keynote address “Fit-for-Purpose Validation: The Key to Regulatory Acceptance of Alternative Methods in the United States” at the first Pan-American Conference for Alternative Methods on April 12-14. The focus for the conference is the so-called “Six Rs”: replacement, reduction, refinement, read-across, relevance, and roadmaps. The conference, which is being held in Baltimore, Maryland, should bring together experts and stakeholders from across the Americas. Additional information is available at http://caat.jhsph.edu/programs/workshops/PanAmerican/index.html.

New EPA guidance for testing pesticides will reduce animal testing


In a March 17 press release, the U.S. Environmental Protection Agency (EPA) announced publication of two guidance documents and initiation of a pilot program, to support the goal of significantly reducing animal use for acute effects testing. EPA is one of the 15 members of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), which NICEATM supports.

The draft EPA guidance document Retrospective Analysis & Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations provides a rationale for waiving all acute dermal toxicity studies for pesticide formulations, thereby eliminating animal use for this purpose. The guidance document includes a summary of a retrospective analysis of oral and dermal acute lethality studies conducted by NICEATM and the EPA Office of Pesticide Products (OPP), which is used to support the policy statement in the document.

The new EPA guidance document Process for Establishing & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies for FIFRA Regulatory Use, describes a transparent, stepwise process for evaluating and implementing alternative methods to reduce or replace animal use for six-pack studies. These studies test for acute oral, dermal, and inhalation toxicity; skin and eye irritation; and skin sensitization. If animal tests are used, six-pack studies can require over 100 animals per chemical tested. The guidance document discusses the three major phases of the evaluation and implementation process and the implications for reporting information required under specific sections of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Establishment of this process and the clear articulation of related reporting requirements address challenges associated with adopting alternative methods.

In an open letter to stakeholder, OPP Director Jack Housenger announced availability of the two guidance documents and a pilot program to evaluate alternative approaches for classifying the toxicity of mixtures. Under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Mixtures Equation Pilot, OPP will accept the submission of oral and inhalation toxicity data paired with calculations done in accordance with GHS as support for the evaluation of pesticide product formulations in lieu of animal testing.

The two documents, Housenger’s letter to stakeholders, and instructions for submitting comments on the draft guidance document are available on the EPA website. EPA is accepting comments on the draft guidance until May 16.

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