UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

VIA EMAIL 

George R. Oliver, Ph.D. 

Regulatory Manager 

Dow AgroSciences LLC 

9330 Zionsville Road 

Indianapolis, IN 46268 

APR 1 5 2016 OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Re: Dow AgroSciences LLC"s Petition to Postpone the April2016 FIFRA SAP and Request to 

Reopen Previous Comment Periods 

Dear Mr. Oliver: 

1 am writing in response to your letters of March 30, 2016 and April 4, 2016. In your 

March 30, 2016 letter, you submitted a request to EPA to explain its reliance 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 Human Health Risk Assessment (RHHRA) for 

Chlorpyrifos and the Proposed Rule to Revoke all Chlorpyrifos Tolerances ('·proposed rule"). In 

your Apri14, 2016letter, you petitioned the EPA Office ofPesticide Programs (OPP) to 

postpone the meeting of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) 

Scientific Advisory Panel (SAP) on Aprill9-2 1, 2016, conceming OPP's use ofthe Columbia 

study. Similar to a petition the agency received from AMV AC, your petition states that the 

meeting should be postponed because the SAP and affected stakeholders have not yet received or 

had an opportunity to review all of the underlying data for the Columbia study-- the study that is 

of greatest relevance to EPA's proposal to establish a regulatory point of departure for 

chlorpyrifos based upon observed adverse neurodcvelopmental outcomes. Both the AMV AC 

and DAS petitions (I) state the proposal to use the Columbia study in developing a regulatory 

point of departure is at odds with both Administration 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 Columbia study, in the absence of access to the raw data, may run 

afoul of Administrative Procedure Act (APA) standards; and (3) that following a March I, 2016 

response to a FOIA request from Dow AgroSciences (DAS) LLC, EPA disclosed and utilized 

some raw data from the Columbia study in its decision to propose to revoke tolerances and in the 

Chlorpyrifos issue paper. As the agency has responded to these concerns in denying AMV AC's 

petition, the April 7. 2016 response to AMVAC"s petition is attached, addressing those similar 

points of concern raised 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 denying your petition. Accordingly, EPA will not 

postpone the SAP meeting currently scheduled for April 19-21, 2016. 

First, in response to your March 30, 2016 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-HQ-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 for the purposes of documenting the 

support for EPA's proposed rule. For further response on the issue of access to the raw data, 

please 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, which will reopen a comment period on the 

proposed rule (80 FR 69079, Nov. 6, 2015). The purpose of the notice is 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 will make available all new and 

modified analyses completed after the proposal. 

In response to your Af>ril 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 consideration as the agency 

develops its final rule. EPA believes 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 additional public comment on it proposed revisions to the toxicological end point for 

chlorpyrifos. For this reason, as noted, EPA intends to seek additional public comment through 

the notice on the proposed rule and the materials presented to the SAP in connection with EPA 

proposal to revoke all chlorpyrifos tolerances. EPA will then review and respond to relevant 

comments on both the proposed rule and on the notice in connection with its final action. This 

approach ensures that stakeholders and the public have the ability to comment on data and 

analyses supporting EPA's proposed action while using Agency resources efficiently. 

You also assert that the SAP should be postponed until EPA addresses prior SAP 

concerns. EPA believes it is also unnecessary to develop further responses to the reports of prior 

SAPs in order for EPA to properly seek additional input from the SAP on EPA's proposed · 

revisions to its point of departure for chlorpyrifos. There is simply no requirement in federal law 

that compels EPA to develop final responses to the recommendations of the SAP and there is 

certainly no provision 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 from 
the past SAPs identified 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 procedural requirements under the FA CA. 

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 materials, the 

majority of the materials have been available 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 additional SAP review of EPA's revised assessment would provide an important additional 

opportunity for public input and peer review of EPA's scientific 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 outlined above, your petition to postpone the April 19-21 SAP is denied. 

Attachment: Response to the Petition by AMV AC 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