UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

APR 0 7 2016 

Cindy Baker Smith 

Senior Vice President and Director of Global Regulatory Affairs 

AMY AC Chemical Corporation 

4695 MacArthur Court, Suite 1200 

Newport Beach, CA 92660 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

Re: Petition by AMY AC to Postpone the Scheduled April 19-2 1, 2016 Meeting of the FIFRA 

Scientific Adv ~o ~anel, Chlorpyrifos: Analysis of Biomonitoring Data 

Dear Ms.~, , ~ I am writing in response to your letter of March 29, 2016, in which you petitioned the EPA Office of 

Pesticide Programs (OPP) to postpone the meeting of the Federal Insecticide, Fungicide and Rodenticide 

Act (FIFRA) Scientific Advisory Panel (SAP) on April 19-21 , 2016, concerning OPP's use of the 

Columbia University epidemiology study (Columbia study). You stated 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 the 

EPA's proposal to establish a regulatory point of departure for chlorpyrifos, based upon observed 

adverse neurodevelopmental outcomes. By this response, I am denying your petition. Accordingly, the 

EPA will not postpone the SAP meeting currently scheduled for April 19-21, 2016. 

In your letter, you suggest that it is premature for the SAP to evaluate the EPA's approach for deriving a 

point of departure based in part on the Columbia study until the SAP has first resolved whether the 

Columbia study is sufficiently credible to support its use for that purpose. The agency has twice 

presented the Columbia study to the SAP and in neither case did the SAP suggest that its review was 

premature or inappropriate, absent submission of the underlying data from that study. In fact, the SAP 

recommended that the EPA find ways to use existing epidemiological studies, and in particular the 

Columbia study, to inform the dose-response assessment for chlorpyrifos - which is precisely what EPA 

has done in the white paper it has developed for the SAP's review this month. As with past reviews, the 

EPA believes that the SAP can consider the reliability of the relevant data while addressing the EPA's 

charge questions on the appropriate use of the epidemiology data. Indeed, that consideration would seem 

to be an integral part of the SAP's assessment. In any case, to the extent you do not believe that the 

EPA's charge questions have sufficiently raised your precise concerns regarding EPA's rei iance on the 

Columbia study without possessing the underlying data from that study, commenters at the SAP are 

certainly free to raise any concerns they may have about the reliability of the data for use in quantitative 

risk assessment directly to the SAP at the meeting. Therefore, we see no reason why this issue must be 

addressed in advance of the currently scheduled SAP meeting. 
You also assert that the EPA's 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, the EPA's 

policy for implementing the Information Quality Act. The EPA disagrees that the use of the Columbia 

study is inconsistent with EPA poli cy. The EPA policies recognize that decisions about which specific 

studies to rely upon in setting regulatory standards must ultimately be made on a case-by-case basis. The 

Columbia study is published, peer-reviewed research that"the EPA concludes represents sound, relevant 

science. The EPA is not required to disregard - nor will it disregard -- such a study solely because the 

EPA does not possess the raw data underlying that peer reviewed research. 

Your letter also appears to suggest that the 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. The EPA is 

aware of no provision in the APA or other applicable laws that directs the agency to reject the results of 

scientific literature simply because the EPA does not possess underlying raw data. To the contrary, the 

United States Cour1 of Appeals for the District of Columbia Circuit has twice upheld the EPA's use of 

published epidemiology data in setting regulatory standards in circumstances where, as here, the EPA 

did not possess the underlying raw data for that research. See Coalition ojBalle1y Recyclers Association 

v. EPA, 604 F.3d 6 13 (D.C. Cir. 2010) (EPA "appropriately considered the Lanphear study and was not 

required to obtain and make public the data underlying the Lanphear study"); American Trucking Assoc., 

Inc. v. EPA., 283 F.3d 355 (D.C. Cir. 2002) ("[W]e agree with EPA that requiring agencies to obtain and 

publicize the data underlying all studies on which they rely '"would be impractical and unnecessary. "'). 

The EPA therefore believes its use and consideration of the Columbia study is consistent with its 

obligations under federal Jaw. 

I must also coJTect a factual eiTor in your letter. While you correctly note that OPP did meet with the 

Columbia investigators on April 15, 2013, you incorrectly assert that "the nature of that discussion is 

completely undocumented." In Appendix 6 (pages 384-396) to EPA's Revised Human Health Risk 

Assessment (RHHRA) for chlorpyrifos, the EPA surnmarized the April 15, 2013 discussions between 

the EPA staff and the Columbia investigators and, specifically, the EPA explained in detail its original 

concerns regarding the need for raw data and how those concerns had been resolved. As you are likely 

aware, in early 2015, the EPA provided an extensive period for public comment on the RHHRA, 

including Appendix 6. 

Finally, you note that in a March 1, 2016 response to a FOIA request from Dow AgroSciences LLC, the 

EPA did disclose some raw data from the Columbia study. The EPA received that infonnation in August 

2015 from Professor Dana Barr at Emory University, and not the Columbia study investigators. The 

EPA contacted Dr. Barr who provided what information she held in her possession. The information 

provided by Dr. Barr on chlorpyrifos was collected in 2007 and 2008 and does not represent the data 

presented by Columbia University investigators in their chlorpyrifos publications. The data were 

therefore deemed to be unusable. 
As a result, the EPA did not consider these data in connection with either its November 6, 2015 proposal 

to revoke chlorpyrifos tolerances, nor did the EPA consider this information in developing the white 

paper supporting the agency's upcoming presentation to the SAP. Accordingly, the EPA does not intend 

to delay the SAP to afford an additional period to review these materials. 

Please do not hesitate to contact Yu-Ting Guilaran at 703-308-0052 if you have any questions. 

irector 

cc: Fred Jenkins 

Yu-Ting Guilaran