UNITED STATES ENVIRONMENTAL PROTECT I ON AGENC Y WASHING TO N , D
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OFFICE OF CHE M ICAL SAFETY AND POLLUTION PREVE NTION
Aaron Colange lo , Esq. Senior Attorney Natural Resources Defense Council 1152 15th Street NW, Suite 300 Washington, D.C
. 20005 Margaret Reeves, Ph.D.

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# s 2012

Senior Scientist/Program Coordinator (Env ironmental Health and Workers' Rights) Pesticide Action Network North America 49 Powell Street, Suite 500 San Francisco , CA 941 02 Re: Chlorpyrifos petition dated September 12 , 2007 Dear Mr. Colangelo and Dr. Reeves: I am writing to provide you with an update on the U.S. Environmental Protection Agency ' s (EPA) plans for further responding to the petition dated September 12,2007 (Petition) , submitted jointly by the Natural Resources Defense Council (NRDC) and Pesticide Action Network North America (PANNA). The petition specifically requested that EPA revoke all tolerances and cancel a ll registrations for the insecticide chlorpyrifos. As you are aware , in a letter dated July 16th of this year, EPA provided you with a partial response to six of the 10 claims raised in the petition and outlined its intended approac h for completing work on the remaining four claims. At the same time , EPA partially granted your petition with its response to one part of your inhalation exposure risk claim, announcing that EPA was taking action to address risks from primary spray drift by lim iting application rates and imposing buffer zones around sensitive sites adjacent to agricultural applications. I am pleased to announce that registrants have submitted draft amended labels for all agricultural use products to implement these additional use limita tion s. EPA anticipates its approval ofthese 41 amended labels by December 31 , 2012. In the partial response , we also informed you that EPA intended to provide its written response to the remaining issues by December 20 12. We noted that it was our intention that the response be informed by the recommendations of the July 2012 FIFRA Scientific Advisory



### 1Panel (SAP or Panel) report 1 that addressed issues relevant to three of petitioners' remaining four claims

- - that EPA failed to quantitatively incorporate data exhibiting long- lasting effects from early life exposure to chlorpyrifos in children; that EPA disregarded data demonstrating that there is no evidence of a safe level of exposure during pre-birth and early life stages; and that EPA failed to cite or quantitatively incorporate studies and clinical reports suggesting potential adverse effects below 10% cholinesterase inhibition. Further, we also noted in the partial response that our work on the volatilization component of the fourth remaining claim (inhalation exposure) was also ongoing and would be impacted by the results ofthe SAP report. However, because EPA had just received the SAP report prior to the release of the partial response, EPA had not completed its review of the SAP's recommendations at that time. Thus, the extent and nature of the work necessary to address those recommendations was an uncertainty. The recent SAP report contained several recommendations which require additional analyses by EPA to address the toxicology issues raised in your petition. Specifically, the SAP recommended that EPA conduct a dose reconstruction analysis of potential exposures to women and children studied in the Columbia University-sponsored epidemiology study2 as an approach to aid in assessi ng the degree to which individuals in the cohort may or may not have experienced acetylcholinesterase inhibition. In addition, the Panel recommended that additional analyses ofthe epidemiological data be conducted, particularly in the areas of biological marker of exposure data and multi-chemical exposures. E PA has made progress on the dose reconstruction analysis
. However, the analysis ofthe biomarker of exposure data and evaluation of the multi-chemical exposures suggested by the Panel necessitate that EPA obtain the raw data from the epidemiology study. At this time, EPA only has access to summary information provided by the publications, but has been working to obtain the original data from the study authors to conduct the needed analyses
. Two additional considerations have necessitated further analysis ofthe toxicology issues raised in your petition. First, members of the Panel expressed concern during the oral deliberations that scientific experts in diagnostic and analytic tools, like those used to assess neuro- and motor development ofthe children in the epidemiology studies , were not included on the Panel. Second, after the SAP was held, a new epidemiology study from the Columbia University researchers describing the results ofmagnetic resonance imaging (MRI) on a subset of children in the cohort was published
. Between August 2012 and October 2012, EPA solicited comments from scientists within the federal government who have expertise in these two scientific areas and i s currently evaluating this input. With respect to the volatility of chlorpyrifos, EPA has reviewed a new field volatility study recently submitted by Dow AgroSciences in response to the data call

- in requirements for the chlorpyrifos regi stration review. EPA is currently working to complete its assessment ofthe

1 Available at http: //www.epa.gov / scipoly/sap / meetings/20 12/april/ 041 0 12minutes.pdf 2 Raub , V., Arunaj adai, S., Horton, M
. , Perera, F., Hoepner, L., Barr, D
. B., & Whyatt, R
. (2011). Seven-year neurodevelopmental scores and prenatal exposure to chlorpyrifos, a common agricultural pesticide. Environ Health Perspect , 119(8), 1196-1201. doi: 10.1289 /ehp.l003160; Raub, V. A., Garfinkel , R., Perera
. F
. P., Andrews, H. F., Hoepner, L., Barr, D. B. , Whyatt , R. W. (2006). Impact of prenatal chlorpyrifos exposure on neurodevelopment in the first 3 years of life among inner-city children. Pediatrics, 118(6), e1845-1859. doi: 10.1542 /peds.2006-0338
. 2potential risks associated with volatilizati on from chlorpyrifos application s. The scope and co ntent ofthi s on-going assessment is informed by recent risk assessments of field volati lity of fumigant pesticides 3
, Dow AgroSciences' recently s ubmitted chlorpyrifos fie ld vo latility study coupled with existing volatilit y data found in the open literature , EPA modeling tools, and the report and recommendations from the 2009 SAP meeting4 on pesticide volatilization where chlorpyrifos was one of the case studies pre sented. While EPA has been working dilige ntly, as outlined in the preceding p arag raphs , and has made s ignificant progress in addressing the re commendations of the SAP and completing our response to all four remaining claims in your petition , E PA will not be in a position to provide a complete response t o the petition this month , as we previously believed
. E PA currently intend s to provide a further re sponse to the petition by the end ofJanuary 2013 that w i ll address some, but likely not all , of the four remaining claims. To the extent certain issues remain unaddressed , the January 2013 response w ill explain the additional work we will be doing and will set forth our anticipated timeline for completing the re s pon se.

Steven P
. Bradbury, Ph.D. Director, Office of Pesticide Programs

3 The assessments can be found in the dockets for each fumigant. Four of which are provided here chlorop icrinEPA- H Q-OPP-2007

- 0350 ; dazomet- EPA-HQ-OPP-2005-0128; metam so dium/potas s ium

- EPA- H Q-OPP -2005- 0 125 ; and m et

h yl bro mi de- EPA-HQ-OPP- 2005-0123
. 4Available at http ://www.epa.gov / scipoly / sap/meetings / 2009/ december / 120309meetingminutes
. pdf
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