National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterJuly 2015

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

By Catherine Sprankle

EPA requests comment on use of high-throughput assays for EDSP

In a June 19 Federal Register notice, the Environmental Protection Agency (EPA) requested comments on a plan to use validated ToxCast/Tox21 high-throughput assays and an associated computational model in its Endocrine Disruptor Screening Program (EDSP). These methods would be an alternative to three Tier 1 tests currently used to assess estrogenic activity. The EPA is required to test substances for estrogenic activity as part of a larger effort to characterize how chemicals in the environment may interfere with the normal function of hormones, potentially causing health problems in humans and animals.

Described as “groundbreaking” in an EPA press release, the use of high-throughput assays and computational methods should accelerate the pace of screening, decrease costs, and reduce animal testing. The EPA plan was developed and validated by EPA and NICEATM scientists, and is described in detail in the journal Environmental Science and Technology (Browne et al. 2015; DOI: 10.1021/acs.est.5b02641). Comments on the plan are requested by August 18.

NICEATM director strengthens ties with international colleagues

NICEATM Director Warren Casey, Ph.D., presented updates on activities of NICEATM and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) at ASIATOX 2015 on June 23–26 in Jeju City, South Korea. ICCVAM is an interagency committee of the federal government supported by NICEATM.

While in Korea, Casey attended the International Workshop on Validation Management for Alternative Test Methods hosted by the Korean Center for the Validation of Alternative Methods (KoCVAM). KoCVAM, which coordinates the evaluation of alternative test methods in South Korea, is part of the National Institute of Food and Drug Safety Evaluation within the South Korean Food and Drug Administration. KoCVAM is a partner with NICEATM, ICCVAM, and organizations from Japan, Europe, and Canada in the International Cooperation on Alternative Test Methods (ICATM).

Casey also attended an ICATM coordination meeting hosted by KoCVAM in conjunction with the ASIATOX meeting. ICATM coordination meetings take place several times a year and provide an opportunity for the member organizations to discuss activities in their major areas of cooperation. Regular interactions allow the ICATM partners to develop good communications and working relationships, which support collaborations on test method development, validation, and implementation.

NICEATM supports stem cell workshop

NICEATM helped to organize a June 1–2 workshop on “Good Cell Culture Practices for Induced Pluripotent Stem Cells” hosted by the Johns Hopkins University Center for Alternatives to Animal Testing. The goal of the workshop was to produce a guidance document outlining consensus standards on culturing and maintenance of embryonic or induced pluripotent stem cells. David Allen, Ph.D., a NICEATM support contractor, was among the experts invited to participate in the workshop, which built on existing guidance for good cell culture practices by addressing the unique properties of stem cells.

The workshop reviewed the existing guidance and current best practices for producing and maintaining stem cells and stem cell-based assay systems. Using principles set forth in the existing guidance, workshop attendees prepared an outline to generate a final guidance document on stem cell-based assay development. This document is in preparation and will be submitted for publication later this year.

NICEATM scientist presents to california EPA on computational methods

Nicole Kleinstreuer, Ph.D., a NICEATM support contractor, gave a presentation titled "Integrated computational approaches to the assessment of skin sensitization potential of chemicals” at an April 21 symposium for regulators at the California Environmental Protection Agency. The focus of the half-day symposium was advances in skin sensitization categorization using in vitro and in silico methods.

Kleinstreuer’s presentation included summaries of computational approaches developed by NICEATM and ICCVAM to identify substances with the potential to cause allergic contact dermatitis. These projects are part of a larger international effort to develop integrated testing strategies, which are anticipated to replace animal use in the identification of potential skin sensitizers within the next few years.

EPA updates guidance on non-animal eye irritation tests

EPA has updated its guidance document, which describes a non-animal testing scheme for assessing eye irritation potential of EPA-registered antimicrobial cleaning products. The testing scheme uses the bovine corneal opacity and permeability (BCOP), EpiOcular, and cytosensor microphysiometer assays to identify Toxicity Category I, II, and III eye irritants for antimicrobial cleaning products.

EPA established the use of the non-animal testing scheme in 2013 after considering an ICCVAM evaluation and recommendations on the scheme and studies submitted by product registrants.

ICCVAM advisory committee to meet September 2

The Scientific Advisory Committee on Alternative Toxicological Methods, ICCVAM’s external advisory committee, will hold its annual meeting on September 2 in the Rodbell Auditorium at NIEHS. Preregistration is required to attend the meeting in person or view the webcast. An agenda, other materials, and links to register will be available soon on the NTP website.

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