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oxicity tests on laboratory effects at lower doses or exposures. Test
animals are conducted to animals are typically observed for overt
evaluate chemicals—including signs of adverse health effects, which
medicines, food additives, and industrial, provide little information about biological
consumer, and agricultural chemicals—for changes leading to such health effects.
their potential to cause cancer, birth Often controversial uncertainty factors
defects, and other adverse health effects. must be applied to account for differences
Information from toxicity testing serves between test animals and humans. Finally,
as an important part of the basis for use of animals in testing is expensive and
public health and regulatory decisions time consuming, and it sometimes raises
concerning toxic chemicals. Current test ethical issues.
methods were developed Today, toxicological
incrementally over the evaluation of chemicals
past 50 to 60 years and is poised to take advan-
are conducted using tage of the on-going
laboratory animals, such revolution in biology
as rats and mice. Using and biotechnology. This
the results of animal revolution is making it
tests to predict human increasingly possible
health effects involves a to study the effects of
number of assumptions chemicals using cells,
and extrapolations that cellular components, and
remain controversial. tissues—preferably of
Test animals are often human origin—rather
exposed to higher doses than whole animals.
than would be expected These powerful new
for typical human approaches should help
exposures, requiring to address a number of
assumptions about challenges facing the
field of toxicity testing. New tests should il- How New Technologies Could Transform
luminate changes at the molecular level, helping Existing Approaches
scientists to better predict how chemical expo-
sures do or do not lead to certain health effects A number of emerging fields and techniques
and how they affect sensitive populations such are contributing major new insights for under-
as children. They should enable rapid screening standing the biologic responses to chemicals in
of chemicals, which could reduce the backlog human tissues. For example, new high-through-
of the large number of industrial chemicals that put techniques developed by the pharmaceutical
have not yet been evaluated under the current industry use efficient automated methods to test
testing system. They should also reduce animal certain biologic activities of thousands of chemi-
use and suffering. cals that used to be studied in animals.
The U.S. Environmental Protection Agency Emerging fields also include systems biology,
(EPA), recognizing that the time has come for a powerful approach that uses computational
more innovative approaches to toxicity testing, models and laboratory data to describe and
asked the National Research Council to develop understand biologic systems as a whole and how
a long-range vision and a they operate. Another impor-
strategy to advance toxicity tant field is bioinformatics,
testing in the 21st Century. which applies computational
The committee’s report pres- techniques to vast amounts of
ents that vision. data to understand how cells
and cell systems work.
Current System Has
Resulted in Expensive Vision for the Future of
Patchwork Approach Toxicity Testing
Figure 1. The committee’s vision for toxicity testing is a process that can include chemical characterization, toxicity
testing, and dose-response and extrapolation modeling as part of broader agency decision-making.
Achieving the Vision: Marshalling the Scien- cision-makers without clear guidance concern-
tific Community ing the potential risks they must address.
To advance the science to realize these im-
The report concludes that substantial ben- provements, the committee recommends that a
efits will result from achieving the vision but new institution be created to foster the kind of
that it will require coordinated efforts and cross-disciplinary research that will be required
resources over the next several decades by sci- to achieve the vision. The report says there
entists from government, industry, universities, would be far less chance of success within
consulting laboratories, and the public interest a reasonable timeframe if the research were
community. EPA has established a National dispersed among different locations and orga-
Center for Computational Toxicology that is nizations without a core institute. Although re-
developing new software and methods for sources to support such an institution may seem
predictive toxicology. The National Institute limited and current testing practices engrained
of Environmental Health Sciences, through the in some sectors, using these new scientific tools
National Toxicology Program’s Roadmap for to generate better information for decision-
the Future has initiated a partnership with the making will result in tangible environmental,
Chemical Genomics Center of the National In- public-health, and economic benefits.
stitutes of Health to develop and begin carrying The field of toxicity testing is at a pivotal
out high- and medium-throughput screening juncture. The vision described in the report
assays to test more chemicals in less time and has the potential not only to improve current
at less cost. Long-standing problems, such as approaches, but to fundamentally transform
the backlog of untested or insufficiently tested them by making them quicker, cheaper, more
chemicals, could be addressed while reducing scientific, and more responsive to existing and
the time-, resource- and animal-intensive nature new challenges faced by environmental health
of the current system that sometimes leaves de- authorities and the public.
Committee on Toxicity Testing and Assessment of Environmental Agents: Daniel Krewski (Chair), Univer-
sity of Ottawa; Daniel Acosta, Jr., University of Cincinnati; Melvin Andersen, The Hamner Institutes for Health
Sciences; Henry Anderson, Wisconsin Division of Public Health; John Bailar III, University of Chicago;
Kim Boekelheide, Brown University; Robert Brent, Thomas Jefferson University; Gail Charnley, Health
Risk Strategies; Vivian Cheung, University of Pennsylvania; Sidney Green, Howard University; Karl Kelsey,
Harvard University; Nancy Kerkvliet, Oregon State University; Abby Li, Exponent, Inc.; Lawrence McCray,
Massachusetts Institute of Technology; Otto Meyer, The National Food Institute; D. Reid Patterson, Reid
Patterson Conculting; William Pennie, Pfizer, Inc.; Robert Scala, Exxon Biomedical Sciences (retired); Gina
Solomon, Natural Resources Defense Council; Martin Stephens, The Humane Society of the United States;
James Yager, Johns Hopkins University; Lauren Zeise, California Environmental Protection Agency. The
project director was Ellen Mantus.
This report brief was prepared by the National Research Council based on the committee’s
report. For more information or copies, contact the Board on Environmental Studies and
Toxicology at (202) 334-3060 or visit http://nationalacademies.org/best. Copies of Toxicity Testing
in the Twenty-first Century: A Vision and a Strategy are available from the National Academies
Press, 500 Fifth Street, NW, Washington, D.C. 20001; (800) 624-6242; www.nap.edu.
This study was supported by funds from the U.S. Environmental Protection Agency.
Permission granted to reproduce this brief in its entirety with no additions or alterations.