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However, for the 76 cases in which sponsors provided WoE arguments, the U.S. EPA rejected 34 of those claims.
Sponsors substituted ECOSAR data in place of animal tests only 29 times in the absence of analog test data, and the U.S. EPA rejected 11 of the proposed substitutions.
The U.S. EPA rejected one of the in vivo tests entirely and recommended use of the in vitro test instead in 13 cases (Table 3); however, 22 in vivo CAD tests still were performed, killing 1,100 animals (Table 4).
Notwithstanding its own guidance that participants need not develop certain data for chemicals that were solely CSIs, the U.S. EPA rejected 33 of 74 sponsor claims that testing for repeated dose and reproductive toxicity was not needed based on a chemical's classification as a CSI.
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Of the 334 tests proposed by sponsors in original test plans, the U.S. EPA accepted 223, rejected 49 as not needed, and substituted 62 tests that used fewer or no animals (Table 3).
In some situations the U.S. EPA accepted or rejected proposed animal-savings measures based on the sponsor meeting certain conditions, such as supplying study details in a robust summary or locating additional studies.
Contrary to its own guidance to "… conduct a thoughtful, qualitative analysis rather than use a rote checklist approach" (Wayland 1999), the U.S. EPA sometimes applied a more narrow definition of program requirements when it rejected existing toxicity and exposure data and instead recommended new animal tests.
The committee rejected the use of any protective adjustment factor to account for the possibility of nonliver cancer risk (U.S. EPA 2000aa).
In Upton's upside-down world, "EPA's regulations are a backdoor attempt by unelected bureaucrats to implement the highly unpopular cap-and-trade legislation that was rejected last year". .
Photograph: ULI DECK/EPA Important news from Germany: the German Constitutional Court has rejected an attempt to delay its eagerly-awaited decision on the legality of Europe's new bailout fund.
Rejected again.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com