U.S. regulatory agencies are charged to protect human and animal health and the environment. To do this, agencies must determine the hazards presented by substances such as pesticides, consumer products, and workplace chemicals. Testing these substances provides information about possible hazards and enables informed decisions about responsible use, storage, and disposal.
Many currently accepted test methods use laboratory animals. Alternative test methods are methods that replace animal use with non-animal test systems or lower species, reduce the number of animals required for a specific test procedure, or refine animal use to enhance animal well-being and lessen or avoid pain and distress. Collectively, the principles of replacement, reduction, or refinement of animal use for scientific research or product safety testing are referred to as the 3Rs. More recently, the term “new approach methodologies” has been adopted as a broadly descriptive reference to any non-animal technology, methodology, approach, or combination of these that can be used to provide information on chemical hazard and risk assessment.
The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3) established the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) to
“establish, wherever feasible, guidelines, recommendations, and regulations that promote the regulatory acceptance of new or revised scientifically valid safety testing methods that protect human and animal health and the environment while reducing, refining, and replacing animal tests and ensuring human safety and product effectiveness.”
The ICCVAM Authorization Act states that the purposes of ICCVAM are to:
ICCVAM is a permanent interagency committee of NIEHS under the National Toxicology Program Interagency Center for the Evaluation of Alternative Methods (NICEATM).
The ICCVAM Authorization Act directs ICCVAM to carry out the following duties:
NICEATM, an office within the NIEHS Division of NTP, provides technical and scientific support for ICCVAM and ICCVAM workgroup activities, peer review panels, expert panels, workshops, and validation efforts.
In addition to providing support for ICCVAM, NICEATM:
NICEATM Staff
NIEHS
Warren Casey, Ph.D., DABT, Senior Toxicologist; Director
Nicole Kleinstreuer, Ph.D., Deputy Director
Elizabeth Maull, Ph.D., Toxicologist
Matthew Stout, Ph.D., Toxicologist, Project Officer
NICEATM Contract Staff (Integrated Laboratory Systems, Inc.)
David Allen, Ph.D., Principal Investigator
Steven Morefield, M.D., Project Manager
Jaleh Abedini, M.S.
Shannon Bell, Ph.D.
Patricia Ceger, M.S., DABT
Xiaoqing Chang, Ph.D., DABT
Neepa Choksi, Ph.D.
Amber Daniel, M.S.
Jon Hamm, Ph.D.
Agnes Karmaus, Ph.D.
Isabel Lea, Ph.D.
Kamel Mansouri, Ph.D.
Jason Phillips (subcontractor, Sciome LLC)
John Rooney, Ph.D.
Catherine Sprankle, M.S.
Judy Strickland, Ph.D., DABT
James Truax, M.S.
The ICCVAM Authorization Act established the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM advises the Director of NIEHS, NICEATM, and ICCVAM about NICEATM and ICCVAM activities.
SACATM, which is directed by its charter to meet at least once each fiscal year, met in September 2018 and September 2019.
Roster of SACATM Members 2018-2019
Name |
Title |
Company |
Appointment End Year |
---|---|---|---|
Michael B. Bolger, Ph.D. |
Chief Scientist |
Simulations Plus, Inc., Lancaster, CA |
2020 |
Joseph L. Charest, Ph.D. |
Biomedical Solutions Program Manager |
The Charles Stark Draper Laboratory, Inc., Cambridge, MA |
2022 |
Amy Clippinger, Ph.D. |
Director |
PETA International Science Consortium Ltd., Washington, DC |
2022 |
Kelly P. Coleman, Ph.D., DABT, RAC |
Distinguished Scientist and Technical Fellow |
Medtronic PLC, Minneapolis, MN |
2020 |
K. Nadira De Abrew, Ph.D. |
Senior Scientist (Toxicologist) |
The Procter & Gamble Company, Cincinnati, OH |
2022 |
Sean C. Gehen, Ph.D., DABT |
Regulatory Sciences Team Leader |
Corteva Agriscience, Indianapolis, IN |
2022 |
Hisham K. Hamadeh, Ph.D., DABT, M.B.A. |
Vice President, Global Head of Data Sciences |
Genmab US, Inc., Princeton, NJ |
2019 |
William P. Janzen |
Executive Director of Lead Discovery |
Epizyme, Inc., Cambridge, MA |
2018 |
Lawrence Milchak, Ph.D., DABT |
Senior Manager, Toxicology and Strategic Services |
3M Corporation, St. Paul, MN |
2019 |
Pamela Spencer, Ph.D., DABT |
Director of Regulatory and Product Stewardship |
ANGUS Chemical Company, Buffalo Grove, IL |
2019 |
ClarLynda Williams-Devane, Ph.D. |
Associate Professor of Mathematics and Computer Science; Discipline Coordinator of Bioinformatics |
Fisk University |
2020 |
Wei Xu, Ph.D. |
Associate Professor, Department of Oncology |
McArdle Laboratory for Cancer Research, University of Wisconsin at Madison, |
2018 |
Hao Zhu, Ph.D. |
Assistant Professor, Department of Chemistry |
Rutgers University, Camden, NJ |
2019 |