National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterJuly 2018

NTP Interagency Center for the Evaluation of Alternative Toxicological Methods

By Catherine Sprankle

NICEATM requests information on technologies for detection and measurement of botulinum neurotoxin

NICEATM requests available data and information on approaches and/or technologies currently used for detection and measurement of botulinum neurotoxin (BoNT). Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to detect the presence of BoNT and measure potency of BoNT preparations. The deadline for receipt of the requested information is July 11.

Respondents to this request should provide information on any activities relevant to the development or validation of alternatives to in vivo test methods currently used by federal agencies for regulatory and other decision contexts. NICEATM also requests available data from in vivo BoNT tests used for similar applications as the proposed alternative, such as distinguishing between BoNT serotypes in biological matrix samples or measuring the potency of therapeutic BoNT preparations.

EPA releases strategic plan to promote alternative methods

The U.S. Environmental Protection Agency (EPA) has published its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program. The document describes how EPA will promote development and implementation of methods and strategies that reduce, refine, or replace vertebrate animal testing to provide chemical safety information required under the Toxic Substances Control Act (TSCA).

The Strategic Plan was developed by the EPA Office of Pollution Prevention and Toxics in collaboration with other EPA offices and input from stakeholder groups, including ICCVAM and NICEATM. Public input for the Strategic Plan was solicited during its development, including at a November 2017 meeting co-organized with NICEATM.

Agenda and registration available for workshop on rabies vaccine testing

A preliminary agenda and registration are available for a workshop on Implementing Non-animal Approaches to Human and Veterinary Vaccine Testing: Achieving Scientific and Regulatory Success for Rabies and Beyond. The workshop will be held October 16-17 at the Natcher Conference Center, National Institutes of Health, Bethesda, Maryland. It is co-organized by NICEATM and the International Alliance for Biological Standardization. The workshop is open to the public, there is no registration charge, and participants may attend in person or view a webcast.

Testing to ensure effectiveness and safety of vaccines often requires the use of large numbers of animals. However, technological advances have led to the development of methods that could reduce or eliminate the need for animal testing. This workshop will bring together scientific and regulatory leaders from government, academia, and industry to develop recommendations to advance alternative methods for human and veterinary rabies vaccine testing. Workshop sessions will also spotlight state-of-the-science animal alternatives for other antigens and future possibilities for advancing animal reduction and replacement initiatives.

Report available from BioMed21 workshop

The June 2017 BioMed21 workshop, co-organized by NICEATM and the Human Toxicology Project Consortium, examined actions needed to implement a human systems-biology approach to understanding disease and improving interventions. The report from the workshop has been published in the journal Drug Discovery Today.

Journal issues focused on alternatives to animal testing

The June issue of the journal Applied In Vitro Toxicology focused on in silico and in vitro approaches to assess toxicity of inhaled substances. A roundtable discussion summarized in one article included ICCVAM co-chair Emily Reinke, Department of Defense, and David Allen, ILS, principal investigator on the NICEATM support contract. Other articles in the issue, which includes both reviews and original research, were authored by NICEATM collaborators and grantees of the National Institute of Environmental Health Sciences.

A special issue of the journal Toxicology In Vitro published in May describes the conduct and results of an international study to evaluate reconstructed human epidermis models for skin irritation testing. These models have the potential to replace animal use for this purpose.

FDA issues guidance on nonclinical testing of cancer drugs

In a June 18 Federal Register notice, the FDA announced the release of a Q&A to help stakeholders interpret international guidance on nonclinical evaluation of cancer drugs. The Q&A includes statements about reduction of animal use or use of in vitro alternatives in these studies. The Q&A is available on the FDA website.

Translations of U.S. strategic roadmap available

The Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States has been translated into Chinese, Japanese, Korean, and Portuguese. The translated documents are available on request from NICEATM. For further information, contact NICEATM at niceatm@niehs.nih.gov.

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