UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D

. C

. 20460

VIA EMAIL George R. Oliver, Ph.D. R

egula tory Manager Dow AgroSciences LLC 9330 Z ionsv ill e R oad Indianapolis , IN 46268 

## APR 1 5 2016 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREV E NTION

Re: Dow AgroScience s LLC"s Petition to Postpone the April2016 FIFRA SAP and R equest to Reopen Pr evious Comment Periods
Dear Mr. Oliver:
1 am writing in re spo nse to your letters of March 30, 2016 and Ap ril 4 , 2016

. In your M arch 30, 2016 letter, you s ubmitted a request to EPA to explain its r el iance on the Columbia University epidemiology study (Columbia study) in the absence of access to the raw data and to reopen the comment periods for the Revised Hum an Hea lth Risk Assessment (RHHRA) for C hlorp yrifos and the Proposed Rule to Revoke all Chlorpyrifos Tolerances ( ' ·proposed rule " ). In your Apri 1 4, 2016letter , you petitioned the EPA Office ofPesticide Programs (OPP) to postpone the meeting of the Federal Insecticide , Fungicide and Rodenticide Act (FIFRA) Sc ie ntific Advisory Panel (SAP) on Aprill9-2 1, 2016, conceming OPP 's use ofthe Columbia s tudy . Simil ar to a petition the agency received from AMVAC , your petition s tates that the meeting should b e postponed because the SAP and affected stakeholders have not yet received or had an opportunity t o r ev iew a ll of th e unde rl y in g data fo r the Columbia study-

- the study that i s of g r eatest relevance t o EPA's proposal to estab li s h a regulatory point of departure for chlorpyrifos based upon observed adverse neurodcvelopmental outcomes. Both the AMVAC and DAS petiti ons ( I ) s tate the proposal to use the Columbia study in de ve loping a regulatory point of departure is at odds with both Adm ini s tration and EPA policy, including , among other things , EPA ' s policy for implementing the Information Quality Act ; (2) appear to suggest that EPA's consideration of the Col umbia study , in the absence of access to the r aw data , may run afoul of Administrative Procedure Act (APA) standard s; and (3) that following a March I , 2016 re s ponse to a FOIA req ue st from Dow AgroSciences (DAS) LLC , EPA disc losed a nd utilized some raw data from the Co lumbia study in its decision to propose to revoke to lerances and in the Ch lorp yrifos issue paper. As the agency has responded to these concerns in denying AMVAC ' s pe tition , the Apr il 7. 2016 response to AMVAC"s petition is attached , addressing those similar points of concern rai sed by DAS.Your petition also suggests that the SAP meeting should be postponed until the ( 1) EPA responds to DAS comments on the Chlorpyrifos Revised Human Health Risk Assessment and the proposed tolerance revocation ; (2) EPA has fully addressed the concerns of prior Scientific Advisory Panels; and (3) stakeholders and the public have had more time to review the materials presented to the SAP. By this response , I am deny in g your petition

. Accordingly , EPA will not postpone the SAP meeting currently scheduled for Apri l 19-21 , 2016. First, in response to your March 30 , 20 1 6 letter, EPA did not in fact rely on any of the raw data provided to DAS via the FOIA request in developing the proposed rule. EPA relied upon the published summaries in conjunction with the results of our discussions with the study authors , which were included in the docket (EPA -H Q-OPP

- 2008

- 0850). To the extent EPA provided information under the FOIA that was broader than the scope of the request, it was done in the interests of completeness and transparency and not fo r the purposes of documenting the support for EPA's proposed rule. For further response on the issue of access to the raw data, p l

ease refer to the attached April 7 , 2016 denial of AMVAC ' s petition. Regarding the matter of reopening comment periods for the RHHA and proposed**r~le ,**  the agency intends to issue a notice this spring , whic h will r eopen a comment period on the proposed rule (80 FR 69079, Nov. 6 , 2015). The purpose of the notice i s to obtain public comment on additional information and analyses that may be relevant to the development of a final rule. As specified in the proposed rule , this notice wi ll make avai lable all new and mod ified analyses completed after the proposal.
In response to your Af>ri l 4 , 2016 letter, it is important to clarify that the notice focuses on the additional analyses since the RHHRA but that public comments from the RHHRA, proposed revocation , and notice comment periods will be taken into cons ideration as the agency develops its fina l rule. EPA be li eves it is unnecessary to respond to earlier comments on the RHHRA and the proposed revocation in order tG> se

_ ek input from the FIFRA SAP to further inform the rulemaking action. EPA believes the more appropriate course of action is for EPA to seek add itional public comment on it proposed revisions to the tox icological end point for chlorpyr ifos. For this reason, as noted , EPA intends to seek additional pub li c comment through the notice on the proposed ru le and the materials presented to the SAP in connection with EPA proposal to revoke all chlorpyrifos to lerances
. EPA will then review and respond to relevant comments on both the proposed rule and on the notice in connection with its fina l action. Th i s approach ensures that stakeholders and the public have the ability to comment on data and analyses s upporting E PA ' s proposed action while using Agency resources efficiently.
You also assert that the SAP should be postponed until EPA addresses prior SAP concerns
. EPA bel ieves it is also unnecessary to develop further responses to the reports of prior SAPs in order for EPA to prop erly seek additional input from the SAP on EPA ' s proposed · revisions to its point of departure for ch lorpyrifos

. There is simply no requirement in federal law that compe ls EPA to develop final responses to the recommendations of the SAP and there is certainly no provis ion of federal law or regulation that suggests it is inappropriate to seek the opinion of a new SAP panel until the EPA first finalizes its position with respect to the recommendations of prior, related panels. In any case , in large measure , EPA's white paper developed for the April 19-21 SAP meeting addresses the reconunendations and concerns fromthe past SAPs ident ified in your letter and puts these matters before the SAP in order to evaluate the appropriateness of EPA's approach for addressing the SAP ' s recommendations.
Your letter also suggests that EPA is violating procedura l requ irements under the FACA. EPA believes the schedule provided for the April 19

- 21 SAP provides a reasonable period for interested persons to read the materials and formulate comments for the SAP. While there were some technical issues that resulted in a short delay in docketing some of these material s, the majority of the materi a ls have been avai lable for review through the docket since March 29 , 2015. Furthermore, the agency immediately honored all requests to obtain any of the materials that were delayed in posting to the docket. Finally , as you may know , EPA is under a courtordered deadline to complete final action on its proposal to revoke all chlorpyrifos tolerances by December 30 , 2016. Notwithstanding this constraint , and while not required by law, EPA judged that additiona l SAP review of EPA's revised assessment would provide an important additional opportunity for public input and peer review of EPA's sc ientific evaluation supporting its proposal. Given the court-ordered time limitation , however, EPA is not in a position to extend the rulemaking schedule further by rescheduling the SAP meeting later this month

. For the reasons outl ined above , your petition to postpone the April 19-21 SAP is denied.

Attachment: Response to the Petition by AMVAC Postpone the Scheduled April 19-21 , 2016 Meeting of the FIFRA Scientific Advisory Panel Meeting, Chlorpyrifos: Analysis of Biomonitoring Data ; April 7 , 2016

cc: Fred Jenkins Yu

-Ting Guilaran