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Animal welfare scientists reveal infrequent and inconsistent acceptance of existing data by EPA to satisfy endocrine disruptor testing requirements
Date:11/1/2013

would consider OSRI submitted by test order recipients and third parties and determine whether it satisfied data requirements of the EDSP. OSRI is existing data that is either functionally equivalent to information obtained from the Tier 1 assays (i.e., data from assays that perform the same function as EDSP Tier 1 assays) or provides evidence of a potential effect on the endocrine system.

Most of the 52 chemicals in the first round of Tier 1 testing under the EDSP were pesticides for which there is a wealth of existing toxicity data. This data includes results of guideline animal tests conducted under 40 CFR Part 158 data requirements to support pesticide registration as well as research studies published in the peer-reviewed literature. Guideline studies generally include two-generation reproduction toxicity studies in rodents; 28-day, 90-day, and 1-year chronic exposure studies in rodents and dogs; and reproduction and life-cycle studies in fish and birds. With so many of these chemicals already being extensively tested, acceptance of OSRI is a primary means for avoiding duplicative data collection and minimizing further animal use.

The authors found that, due to a lack of clear guidance from the EPA, OSRI submissions by test order recipients were quite variable in their length and content. Some respondents requested waivers based on OSRI for all Tier 1 tests while others did not seek any waivers at all. Of the 412 waivers sought, the EPA granted only 93an overall OSRI acceptance rate of 23 percent. The 49 waivers for in vivo tests and 20 waivers for in vitro assays that use tissues collected from animals spared 3325 animals. However, at least 27,731 animals were estimated to have been used to perform the Tier 1 tests eventually required by the EPA after rejecting OSRI, with additional animals being used by laboratories in preparation for conducting the Tier 1 tests.

Despite language in the laws creating the EDSP that provides for the u
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Contact: Tasgola Bruner
TasgolaB@peta.org
770-518-1675
People for the Ethical Treatment of Animals
Source:Eurekalert

Page: 1 2 3

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