Environmental Factor

February 2011


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NTP alternatives center holds workshops on best safety testing

By Debbie McCarley and Cathy Sprankle
February 2011

Rear Admiral William Stokes, D.V.M.

Stokes, above, also serves as the executive director of ICCVAM. (Photo courtesy of NICEATM)

Thanks to the recent endorsement of several alternative testing methods, federal public health agencies and regulated industry now have important new tools for assessing the safety of chemicals and products.

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The new test methods were the topic of two workshops on Best Practices for Regulatory Safety Testing Jan. 19-20 in Bethesda, Md., organized by the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). NICEATM and ICCVAM recommended the test methods to agencies after comprehensive review of their scientific validity.

The workshops addressed current best practices for safety testing necessary to determine whether chemicals and products may cause eye injuries and allergic contact dermatitis (ACD). Both types of injuries continue to have a significant impact on public health.  For example, household cleaners and other chemical products are the leading cause of consumer-product-related eye injuries in children under 10. Skin diseases, including allergic skin reactions, comprise the most common category of occupational disease, and ACD accounts for an estimated 7 million health care visits each year in the United States.

Since their establishment in 1997, NICEATM and ICCVAM have contributed to the adoption of 40 alternative safety testing methods.

Ensuring worker and consumer safety

In his opening remarks, Rear Admiral William Stokes, D.V.M., NICEATM director, emphasized the important role of ICCVAM and NICEATM in translating new science from the bench into accepted and standardized test methods, such as those discussed at the workshops. "These methods can now be used as public health tools to help prevent diseases and injuries to consumers and workers by ensuring appropriate labeling of hazardous chemicals and products," Stokes said. "The methods also minimize or avoid animal use and improve animal welfare where it is still necessary to use animals." 

More than 70 scientists from industry, academia, and federal research and regulatory agencies gathered at the National Institutes of Health (NIH) campus for each workshop. Both workshops, which were also webcast, were co-sponsored by the Society of Toxicology and the Society for Risk Analysis.

An interagency research initiative

Stokes also highlighted the NIH and U.S. Food and Drug Administration (FDA) joint regulatory science research initiative launched last year by NIH Director Francis Collins, M.D., Ph.D., and Margaret Hamburg, M.D., FDA commissioner (see press release(http://www.nih.gov/news/health/sep2010/od-27.htm) Exit NIEHS). The initiative seeks to accelerate the development of new tools and approaches to more efficiently and effectively evaluate product safety, efficacy, and quality. Four initial grants were awarded, including one to develop an in vitro test battery to determine the potential for chemicals and products to cause eye injuries. 

Applying new methods - a case study approach

Eugene Elmore, Ph.D., a scientist from the University of California, Irvine and member of the federal advisory committee for NICEATM and ICCVAM, noted, "The workshop not only provided an important opportunity to explain how the new methods can be used for regulatory safety decisions, but also provided important information on how to properly conduct and interpret the assays. The successful conduct of in vitro assays requires careful adherence not only to all aspects of the protocol, but also to all aspects of good cell culture practices."  

Each workshop featured several case studies to allow participants to gain experience in selecting appropriate test methods and interpreting results from actual studies. Each workshop also included roundtable discussions with regulatory agencies and concluded with presentations on promising in vitro and in chemico methods in the validation pipeline. They were also the focus of many of the 35 poster presentations available for viewing throughout both workshops.

Responses from participants were overwhelmingly positive. One commented that the workshop was "an extremely helpful mechanism to bring industry and regulators up to speed and on the same page regarding what [test methods] are available, how they work, and to what extent regulators are willing to consider them."

Presentations from the workshops are available on the NICEATM-ICCVAM Web site(http://iccvam.niehs.nih.gov/meetings/Implement-2011/ImplmtnWksp.htm). Plenary session presentations were webcast and are available for viewing as archival webcasts on the NIH videocast(http://videocast.nih.gov/) Exit NIEHS home page; a link to the archived webcast will also be available on the NICEATM-ICCVAM Web site(http://iccvam.niehs.nih.gov/meetings/Implement-2011/ImplmtnWksp.htm).

(Debbie McCarley is the Special Assistant to Rear Admiral William Stokes, D.V.M., D.A.C.L.A.M., director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods. Cathy Sprankle is a communications specialist with ILS, Inc., support contractor for NICEATM.)

speakers and staff at the Jan. 20 workshop
Shown, left to right, are the speakers and staff at the Jan. 20 workshop on allergic contact dermatitis: Stokes; Darrell Boverhof, Ph.D., The Dow Chemical Company; Michael Woolhiser, Ph.D., The Dow Chemical Company; ICCVAM Vice Chair Joanna Matheson, Ph.D., Consumer Product Safety Commission; Abby Jacobs, Ph.D., Food and Drug Administration; ICCVAM Chair Jodie Kulpa-Eddy, Ph.D., Department of Agriculture; David Allen, Ph.D., principal investigator, ILS, Inc. supporting NICEATM; Judy Strickland, Ph.D., toxicologist, ILS, Inc., supporting NICEATM; Hitoshi Sakaguchi, Ph.D., Kao Corporation; Eleni Salicru, Ph.D., toxicologist, ILS, Inc. supporting NICEATM. (Photo courtesy of NICEATM)

Background on the Workshops

The NICEATM-ICCVAM Five-Year Plan(http://iccvam.niehs.nih.gov/docs/5yearplan.htm) issued in 2008 included the promotion of the regulatory acceptance and use of scientifically sound alternative test methods as a major objective. The Best Practices Workshops implement this objective by creating awareness and encouraging consideration and use of newly available accepted alternative safety testing methods. The two workshops are the first in a series on Best Practices for Regulatory Safety Testing, sponsored by NICEATM and ICCVAM, an interagency committee administered by NICEATM.



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