Government Looks to Regulatory Science to Reduce Dependence on Animals in Preclinical Testing

Posted 13 June 2012 | By

The US Department of Health and Human Services (DHHS) is looking ahead to assess the needs of its toxicology program, which it says is a key driver in the adoption of regulatory science-based technologies.

In a report released for public comment in May 2012, DHHS, working with more than a dozen other federal agencies known as the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), said better methods are needed to assess the benefits and risks of products intended for human consumption without relying on animal testing.

"The field of toxicology is evolving from a system based largely on animal testing toward one based on the integration of data from a wide range of sources, including in vitro methods that evaluate changes in biological pathways predictive of adverse outcomes and in chemico and in silico methods," explained DHHS in its Federal Register posting announcing the release of the document.

To better assess those needs, DHHS' National Toxicology Program's (NTP) has released a draft of a new five-year plan that describes the program's intent to cultivate four core strategies: foster, develop, validate and promote the regulatory acceptance of toxicology-based testing methods.

NTP's report places a high level of emphasis on regulatory science initiatives, which focus on the development of validated tools, standards and approaches to assess the safety and efficacy of regulated products. Through the use of improved use of science, models, best practices and technologies, the group said it hopes to be able to allow agencies to not only reduce their dependence on animal-based testing, but also get products to market even faster than they did before through the use of better, more reliable testing methods.

To do this, NTP said the burden will be on its program to provide "high quality scientific evaluations of the validation status of test methods" to promote the adoptions of its toxicology testing methods.

Comments on the draft plan are due by 31 July 2012, and may be submitted by sending an email to 

Read more:

NTP - Draft Five-Year Plan (2013-2017) for the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods and the Interagency Coordinating Committee on the Validation of Alternative Methods

The NICEATM-ICCVAM Five-Year Plan (2013-2017)


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