Dr. Linda P. Fri e d UNITED STATES ENVIRONME NTA L PROTECTION AGE NCY WASH I NGTON, D

. C

. 20460


## APR 1 9 2016

Dean , Ma ilm an Schoo l of Public Health Ro senfie ld B ld g., Mail Code: 722 West 168 1 4th St. , 14th Floor New York , NY 1 0032
R e: Co lumbia Center for C h ildren ' s En vironmental Heal th E pidemiol ogy S tud y Data
D ear D ean Fried:
I am writ ing to continue the discu ss io n our organi zation s ha v e pre viou s ly engaged in regarding the importance of the origina l data from the Columbia Ce nter for Chi ldre n ' s E n v ironme ntal Health (CCCEH) epidemiology s tudy in th e EPA ' s assessment of chlorpyrifos risk to human health.
Information is th e fu ndamental currency of environmental scien ce , h ea lth sc ience, natural re so urces , and re lat ed so ci al sc ience researc h , all of w hi ch are necessary to ac hi eve EPA ' s · mission of pro tec tin g hum an health and the e n v iro nm e nt. To h e lp fulfill EP A ' s mi ss ion and s upp ort the regulatory and r esearc h goa ls of stat e and loca l governmen ts and researc h institution s , EP A prov id es s ubstantial finan c ial s upport for sc ie ntific research through it grants program s. Eve ry year, EPA award s over $4 billi on in fundin g f or grants and other assistance agreeme nt s. In order for EPA to carry o ut its m iss ion success full y , how ever , the public mu st also ha ve confi dence that EP A is approp ri ately u s ing the scie nt i fi c information it considers

- including i nformatio n deve l oped through EPA grant s programs. Transparency is u ltimate l y the key to gaining the public' s confidence in EPA 's wo rk. It is th erefore critical th at E PA 's evaluation of sc ientific information be as tran sparent as possib le. EPA and the National In stitut e of E n vironmental Health Sciences (N IEH S) jointly provid e d funding to the CCCE H between 1 998 and 2003 for its in ves t igati on of link s between pre- and postnatal exposu res to e nvi ronmenta l t oxins and adver se impacts on f etal and early childhood growth and deve l opmen t. The work CCCE H has d o ne in stu dying the lo ng -term health effec t s of u rban po llu tants , includin g p es ti cides, o n c hildre n raised in minority nei ghbo rhoo d s in inner-city communities s inc e 1998 i s v itally important in the under standing of organophosp hate (OP) pe sti c ide ex po s ure ' s effe ct on neurobehavioral deve lopment. Thi s i s a fundamental iss ue that E PA h as been investigating in i ts re v iew of the in sectic id e chlorpyrifos , and the re su lts from the CC CEH stu d y i s a key component of the EPA risk assess ment.
EPA has conducted sys tematic reviews of the sc i e nti fic literatur e o n ep id e miology studi es on ne urodevelopmental o utcom es associated with OP exposure in 20 1 2 , 20 14 , and 2 015

. Although o th er s tudi es ex i st , t h e most robu s t epidemiolo gy stu di es were conducted throu g h three maj o r U.S. based prospective birth cohort st udi es. Th e CCCE H study us ed co nc e ntrati o n of pesticides (i n c luding ch lorpyr if

os) in umb il ical co rd blo o d a s a measure of exposure , w hil e theother two birth cohorts u sed urinary biomarke rs in the mothers to estimate pestic ide exposure. While the studies using urinary biomarkers provide important supporting information, EPA believes th e CCCE H study more accurately rep resents the do se that reach es th e target tissue. It is for this reason that EPA considers the CCCEH research results most rele vant for use in quanti tat i ve risk assessment.
On November 6, 20 1 5 , EPA propo sed the revocation of all chlorpyrifos food residue tolerances, in part based o n consideration of the CCCEH research. EPA i s subjec t to a courtordered deadline of December 30, 2016, to complete that action , and it is therefore imperative that EPA address all outstanding issues assoc iated with thi s action b y that time. E PA has recently concluded that the CCCEH research may in fact provide s ufficient information to establish a new regulatory point of departure based on the ne urod eve lopmental o ut co mes observed in that research. To that end , EPA has d eve loped an iss ue paper outlining its propo sal for the u se of the CCCEH study in quantitative risk assessment , and is soliciting feedback from the Federal Insecticide , Fungicide , and Rode nticide Act (FIFRA) Scientific Advisory Panel (SAP) at a meeting from April 19

- 21 , 2016. EPA will al so be issuing a notice in connection with its proposal to revoke all chlorpyrifos tolerances that w ill , among other things , ask for additional pub li c comment on EPA's increased utilization of the CCCEH researc h results. Although EPA believes that the published results of the CCCE H research strong l y support E PA ' s propo sal to establish a new regu latory point of departure, it i s important to note that the CCCEH research ers have, to date , not agreed to subm it their underlying raw data to EPA to support our eval uation

. While a team from EPA met with CCCEH staff in 2013 to discuss the conduct of the research and the raw data results, there is concern that in spite of our rigorous scientific analysis, the EPA has not been able to address our transparency goals as well as public feedback regarding access to the original ( " raw") data. We were therefore pleased when we read the recent remarks of Co lumbi a spo kesperson Peter Taback in a Bloomberg BNA article noting that Columbia has offered to make its data available "under protocols that ensure the confidentiality of the children who are the s ubjects of our research. If we have a formal request from EPA, we will, of course , share all data that were gathered with the support of the U.S. government. " While we are unaware of any previous offer from Columbia to s ubmit these data to EPA, if in fact Columbia is offering to s ubmit its research on chlorpyrifos to EPA so that it can be m ade available to the public (subject of co urse to any necessary restrictions to protec t the confidentiality of th e subjects in the study), we wou ld welcome that development and wi ll provide any assistance necessary to obtain th ese data. Accordingly, please co n s id er this letter a formal request for this information. Please let me know if you ha ve any question s or would li ke to further discuss. I can be reac hed at housengcr.jack@epa.gov or at 703-308-8163

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