On March 17, the Environmental Protection Agency announced in a letter to stakeholders from the Director of the Office of Pesticide Programs that to "better ensure protection of human health ... its immediate goal is to significantly reduce the use of animals" in pesticides testing requirements collectively called the "6-pack."
The 6-pack includes three acute lethal dose oral, inhalation, and dermal toxicity tests. These tests are considered poisoning tests which assess the dose at which 50 percent of the animals in the test are killed by the test chemical. Also included are the Draize eye and skin irritation tests, and skin sensitization.
Understanding the potential effects of chemicals on humans for these serious effects is important to protecting workers and the public, and it is essential that regulatory requirements keep pace with scientific progress. Alternative methods can save time and resources and often use human tissues, offering more accurate predictions of human toxicity.
The EPA letter accompanies the finalization of guidance outlining a process to evaluate and implement alternative test methods, the release of a draft policy to waive the acute dermal toxicity tests for formulated pesticide products, and the initiation of several data analyses which will support the reduction or replacement of other 6-pack tests.
"We support EPA's efforts to replace these animal tests with methods which are more relevant to human toxicity and more humane," says Kristie Sullivan, M.P.H., director of regulatory testing issues for the Physicians Committee. "Waiving the Dermal LD50 is an excellent way to kick off this initiative and will save around 3,000 animals each year. We applaud registrants who have proactively facilitated this project and encourage all registrants to support these efforts and submit internal data which would fortify and hasten EPA's analyses."
The Physicians Committee has been a driving force in the stakeholder process described by the letter, which includes EPA, nonprofit, industry, and test-method developers working cooperatively to accomplish the goal of remaking the 6-pack.
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For an interview with Kristie Sullivan, please contact Dania DePas at 202-527-7382 or DDePas@PCRM.org.
Founded in 1985, the Physicians Committee for Responsible Medicine is a nonprofit organization that promotes preventive medicine, conducts clinical research, and encourages higher standards for ethics and effectiveness in education and research.