The American Chemistry Council and animal welfare organizations say a draft
interagency plan to validate alternative toxicological tests is vague, fails to
provide leadership to modernize toxicity tests, and is disconnected from
“There are few concrete goals in the plan and no timeframes for achieving
progress,” People for the Ethical Treatment of Animals and the Physicians
Committee for Responsible Medicine said in comments on the plan.
The chemistry council called the plan disappointing due to its lack of
concrete activities to develop scientific confidence in the relevance and
reliability of alternatives tests prior to their use in regulatory programs.
ACC, PETA, and the Physicians Committee were commenting on the draft 2013-2017
five-year plan developed by the National Toxicology Program's Interagency
Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the
Interagency Coordinating Committee on the Validation of Alternative Methods
(ICCVAM). Comments were due Aug. 13 (36 CRR 661, 6/18/12).
The Scientific Advisory Committee on Alternative Toxicological Methods, which
advises ICCVAM, will discuss the five-year plan when it meets in Research
Triangle Park, N.C., Sept. 5-6.
The plan describes the center's and the committee's plans to promote
development and regulatory use of “alternative tests,” which reduce the numbers
of animals used in toxicity tests, refine how animals are used to reduce
suffering and obtain better information, or replace animals as testing subjects
Types of tests described in the plan include robotic high-throughput
screening assays, which quickly evaluate the biological effects of chemicals on
genes and cells; computational methods, which use computer modeling to screen
chemicals for potential toxicity; and a three-dimensional cell culture test,
which grows cells in three dimensions, allowing them to more accurately mimic
“Tests using cells, cellular components, and tissues--preferably of human
origin--rather than whole animals” were called for in the National Academies
2007 report Toxicity Testing in the
21st Century: A Vision and a Strategy, which the five-year plan
The report said such tests are needed because current laboratory animal test
methods, which were developed 50 to 60 years ago, cause animals to suffer and
die while producing results that involve controversial assumptions and
extrapolations as scientists attempt to predict human toxicity. The tests fail
to offer insights that would allow scientists to predict how chemical exposures
do or do not lead to certain health effects; and cannot address the backlog of
industrial chemicals that have yet to be evaluated under the current testing
system, the academies report said.
Notwithstanding that recommendation, “ICCVAM has shown little innovation in
and made few contributions to developing 21st century toxicology validation
methods,” PETA and the Physicians Committee said.
ACC said the five-year plan seems to position ICCVAM as a body that will
react to federal agencies' efforts to modernize toxicology, “not as a central
body for leading the effort, across agencies, to coordinate the scientific
evaluation of new, improved, and advanced alternative methods.”
The draft five-year plan describes ways the center and committee intend to
evaluate the performance of such tests, and facilitate regulatory acceptance and
use of them.
Yet the chemistry council, PETA, and the Physicians Committee said the report
fails to show how ICCVAM will serve the regulatory needs of agencies such as
As an example, both the council and animal welfare organizations pointed to
EPA's Endocrine Disruptor Screening Program, which has needed quick test methods
to screen chemicals for their potential to affect the endocrine system.
“The draft five-year plan for endocrine appears to be divorced from the work
of the EPA,” ACC said.
There is a “disconnect” between EPA's needs and ICCVAM's work, Kristie
Sullivan, director for regulatory testing issues at the Physicians Committee,
told BNA Aug. 16.
More than a decade ago, when the interagency committee was conceived, EPA's
“Endocrine Disruptor Screening Program was used as an example of a program that
would benefit from the creation of ICCVAM, yet in the subsequent years, ICCVAM
has barely made a contribution,” PETA and the Physicians Committee said.
In the 1990s animal welfare organizations lobbied Congress to create ICCVAM,
yet they have become disheartened by it, Jessica Sandler, senior director for
regulatory testing at PETA, told BNA.
In March animal rights groups asked the National Institute of Environmental
Health Sciences, which manages NTP, to replace ICCVAM's director, alleging that
the committee had failed to review alternatives to animal testing in a timely
manner (35 CRR 271, 3/14/11).
ICCVAM has “gone from being the darling of the animal protection community to
being our Frankenstein monster,” she said. “ For years now, ICCVAM has been an
obstacle to the implementation of non-animal test methods, with companies
acutely aware that bringing a new method to ICCVAM for validation was the kiss
of death for that method.”
By Pat Rizzuto
The draft NICEATM-ICCVAM Five-Year Plan 2013-2017 and comments on the
document are available at http://iccvam.niehs.nih.gov/docs/5yearplan.htm.
Information about the Scientific Advisory Committee on Alternative
Toxicological Methods' September meeting is available at http://ntp.niehs.nih.gov/?objectid=652555EC-F1F6-975E-792DD9BEF9BE0190.