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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 regulatory needs.
“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 altogether.
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 intact tissues.
“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 references.
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 EPA.
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.
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