Monday, September 19, 2011
Sep 16: In the U.S. Court of Appeals, Second Circuit, Case No. 08-3771. Natural Resources Defense Council, Inc. (NRDC) sought review of an Environmental Protection Agency (EPA) order overruling NRDC's objections to, inter alia, EPA's risk assessments for the pesticide dichlorvos, and denying NRDC's requests for a public evidentiary hearing. Because EPA conducted certain dichlorvos risk assessments without using a tenfold children's safety factor that Congress provided should presumptively apply, and EPA failed to explain why it did not apply this margin of safety, the Appeals Court granted NRDC's petition for review in part, vacated EPA's order in part, and remanded the case for further proceedings.
The Appeals Court indicates that, "In its petition, NRDC requested that EPA revoke all tolerances and cancel all registrations for dichlorvos. NRDC argued, inter alia, that EPA relied on inadequate data in its 2000 preliminary risk assessment, inadequately performed that risk assessment, and failed to apply required safety factors. Despite the numerous issues raised in its petition, we focus here on only the two issues relevant to NRDC's appeal: (1) EPA's reliance on a 1997 intentional human dosing study by A.J. Gledhill; and (2) EPA's failure to provide a legally adequate rationale for applying a children's safety factor lower than the FQPA's presumptive 10X factor."
Importantly, the Appeals Court said, "EPA did not explain how this conclusion related to 'potential pre- and post-natal toxicity and completeness of the data with respect to infants and children.' See 21 U.S.C. § 346a(b)(2)(C)(ii). FQPA requires such an explanation if a 10X children's safety factor is not used. . . Because EPA failed to explain why it did not use a 10X children's safety factor for dichlorvos risk assessments that relied on the Gledhill study, EPA acted in an arbitrary and capricious manner. Accordingly, we vacate those portions of EPA's July 23, 2008 order assessing the risk of dichlorvos based on the Gledhill study, as it was not 'reliable data' on which EPA could base its decision to choose a lower children's safety factor.. ."
On a separate issue, the Appeals Court explains, "NRDC challenges neither the data on which EPA relies, nor the way in which the data relate to infants and children. Instead, NRDC argues that regardless of other evidence of potential endocrine-related effects, EPA must apply the 10X children's safety factor unless it relies on data from its estrogen disruptor screening program. We reject this argument." Explaining further, "FQPA specifies that EPA may apply a children's safety factor of less than 10X if it
determines, 'on the basis of reliable data,' that a margin lower than 10X "will be safe for infants and children. . . Congress did not bar EPA from concluding that it has 'reliable data' regarding potential endocrine-related effects. . . NRDC does not challenge the non-Gledhill risk assessments on any other basis. Therefore, we deny NRDC's request to find arbitrary and capricious the risk assessments not based on the Gledhill study. . ."
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Posted by WIMS at 4:35 PM