UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , D

. C

. 20460


## APR 0 7 2016

Cindy Baker Smith Senior Vice President and Di rector of Global Regulatory Affairs AMYAC Chemical Corporati on 4695 MacArthur Court , Suite 1200 Newport B each , CA 92660 OFF I CE OF CHEMICAL SAFETY A ND PO LL U TI O N P REV E N T IO N

Re: Petition by AMYAC to P ostpone the Sc hedule d Ap ril 1 9-2 1 , 20 1 6 Meeting of the FIFRA Scienti fic**Adv ~o** **~anel,** Chlorpyrifos : Anal ysis of Biomonitoring Data 

### Dear

# Ms.~,**, ~**  I am writing in response to yo ur letter of March 29 , 2016 , in whi ch you petitioned the EPA Office of P esticide Programs (OPP) to postpone the meeting of the Federal Insecticide , Fung i c id e and Rodenticide Act (FIFRA) Scientific A d v i so ry Panel (SAP) o n April 19-21 , 2016, co nc ernin g OPP ' s use of the Co l umb i a University epidem i o logy study (Co lumbi a stud y)

. You stated that the meeting shou ld be postponed because the SAP and affected stake holders have not yet r ece ived or had an opportunity to review all of the und erl ying data for th e Columbia study

-- the study that i s of greatest relevance to the EPA's proposal to establish a regulatory point of departure for chlorpyrifos , based up on observed adverse neurodevelopmental outco mes . By this response , I am denying your petition. Accordingly, the EPA will not postpo ne t he SAP meetin g c urrently schedu l ed for Apri l 19-21 , 2016. In your le tter , yo u suggest that it i s premature fo r the SAP to evaluate th e EPA ' s approac h for deriving a po int of departure based in par t on the Co lumbia study until the SAP has first resolved whether the Co lumb i a study is suffic ient ly cred ibl e to su pport i ts use for that purpose. The agency has twice presented the Co lumbi a stud y to the SAP and in neither case did the SAP suggest that it s rev i ew was premature o r in app ropriate , absent submission of th e underlying data from that study

. In fact , the SAP recommended that the EPA find ways to use existing ep id emio l og i ca l studies , and in parti cu lar the Columb ia study, to inform the dose-response assessment fo r chlorpyr i fos

- which is precisely what EPA has done in th e white paper it has developed for the SAP ' s r eview this month

. As w ith past reviews , the EPA be li eves that th e SAP can consider th e re li abi li ty of the re levant data while addressing the EPA ' s charge questions on the appropriate u se of the epidemio logy data
. Ind eed , that cons id er ati o n wou l d seem to be an integral part of the SAP ' s assessment. In any case , to the exte nt you do not believe that the EPA's c h arge qu estions have sufficientl y raised your precise concern s regarding EPA ' s r e i iance on the Columbia study w i tho ut possessing the underlying data from that study, comme nte rs at th e SAP are certainl y free to raise any concerns they may have about the reliability of the data for use in quantitative ri sk assessment directly to the SAP at the meeting. Therefore , we see no reason why th is i ss ue must be addressed in advance of the curre ntl y sche dul ed SA P meeting.You also assert that the EPA's proposal to use the Co lumbi a st ud y in developing a regulatory point of departure is at odds w ith both Adm ini strat io n and EPA policy , including , amo ng oth e r things , the EPA ' s policy fo r impl ementing the In format io n Quality Act. The EPA d isag rees t hat the use of the Columbia study is inconsiste nt w i th E P A po li cy . The E P A po l ic ies recognize that decisions about wh ic h spec ifi c studi e s to rely upon in s e tt in g regu latory standards must ultimately be made on a case-by-case basis. Th e Columb ia study i s pub li shed , peer-re viewed research that"the E P A co ncludes represents sound , relevant science

. The EPA is not r equ ired to disre gard

- nor will it disre ga rd

-- such a study solely b e cause the EPA does not possess th e r aw data underlying that pee r reviewed research. You r lette r also appears to s uggest that the EPA ' s co n s id e rat io n of the Col um bia study , in the absence of access to the raw data, m ay run afou l of Admi ni strative Procedure Act (A P A) stand ards

. Th e EPA is aware of no prov is ion in the APA o r other app l icab le laws that directs the agency to reject the results of sc ientific literature si mpl y because the EPA does not possess underlying raw data. To the contrary , the Un i ted States Cour1 of Appeals for the District of Co lumbi a C ircui t has twice upheld the E P A ' s u se of published ep id emio lo gy data in setting regulatory standards in c ircumstances where , as here, the EPA did not possess the underlying raw data for that researc h. See 

### Coalition ojBa ll e1y R e cycler s Ass ociation v. 

### EPA , 604 F
. 3d 6 1 3 (D

. C. C ir. 20 1 0) (EP A "approp ri ate ly considered the Lanphear study and was not required to obtai n and make public the data underlying the Lanph ear study " ) ; 

### American Truckin g Ass oc. , Inc. v. EPA. , 283 F.3d 355 (D

. C

. C ir. 2002) ("[W ] e ag ree w i th EPA that req uirin g age ncies to obtain and publicize the data underlying all stud ies on w hi c h they re l y '" wo uld be impractical and unnecessary. "' ). The EPA therefore believes its use and cons ider ation of the Col umbi a study is co n s i stent with its obligations under federal Jaw. I must a l so coJTect a factual eiTor in yo ur letter. While you correctly note that OPP d i d meet with the Columb ia investigators o n Ap ril 15 , 2013, you in co rrect ly asse rt that "the nature of that discussion is complete l y undocumente d. " In Append ix 6 (pages 384

- 396) to EPA ' s Revised Human Health Risk Assessment (RHHRA) for c hl o rp yri fos, the E PA s urnmari zed the Apri l 15, 20 1 3 discussions between the EPA staff and th e Col umbi a investigato r s a nd , spec i fica ll y, the EPA exp lain ed in detail i ts original concerns rega rdin g the need for raw data and h ow those concerns h ad been resolved. As you are likely aware , in early 2015 , the EPA prov id ed a n extensive period for p ub li c co mm ent o n the RHHRA, including Appendix 6
. Finally , you note that in a March 1 , 2016 response to a FO IA reques t from Dow AgroSciences LLC , the E P A did disclose so me raw data from the Columb i a study

. The EPA received that infonnation in August 2015 from Professor Dana Barr at Emory U niversity , and not th e Co lumbi a study investigators

. The E PA contacted Dr. Barr w ho provided what informatio n s he held in h er possession

. T he information provided by Dr. Barr on chlorpyrifos was collected in 2007 and 2008 and does not represent the data prese nted by Columbia U niversity investigators in th eir ch lorpyrifos publications

. The data were therefore deemed to be unusable.As a result, the EPA did not consider these data in connecti on with either its November 6 , 2015 proposal to revoke chlorpyrifos tolerances, nor did the EPA cons id er this in formation in developin g the white paper supporting the agency ' s upcoming presentation to the SAP. Accord i ngly , 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