Dr. Linda P. Fried 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

APR 1 9 2016 

Dean, Mailman School of Public Health 

Rosenfield Bldg., Mail Code: 722 West 

168 14th St., 14th Floor 

New York, NY 10032 

Re: Columbia Center for Children's Environmental Health Epidemiology Study Data 

Dear Dean Fried: 

I am writing to continue the discussion our organizations have previously engaged in 

regarding the importance of the original data from the Columbia Center for Children's 

Environmental Health (CCCEH) epidemiology study in the EPA's assessment of chlorpyrifos 

risk to human health. 

Information is the fundamental currency of environmental science, health science, natural 

resources, and related social science research, all of which are necessary to achieve EPA's · 

mission of protecting human health and the environment. To help fulfill EPA's mission and 

support the regulatory and research goals of state and local governments and research 

institutions, EPA provides substantial financial support for scientific research through it grants 

programs. Every year, EPA awards over $4 billion in funding for grants and other assistance 

agreements. In order for EPA to carry out its mission successfully, however, the public must 

also have confidence that EPA is appropriately using the scientific information it considers -

including information developed through EPA grants programs. Transparency is ultimately the 

key to gaining the public's confidence in EPA's work. It is therefore critical that EPA's 

evaluation of scientific information be as transparent as possible. EPA and the National Institute 

of Environmental Health Sciences (NIEHS) jointly provided funding to the CCCEH between 

1998 and 2003 for its investigation of links between pre- and postnatal exposures to 

environmental toxins and adverse impacts on fetal and early childhood growth and development. 

The work CCCEH has done in studying the long-term health effects of urban pollutants, 

including pesticides, on children raised in minority neighborhoods in inner-city communities 

since 1998 is vitally important in the understanding of organophosphate (OP) pesticide 

exposure 's effect on neurobehavioral development. This is a fundamental issue that EPA has 

been investigating in its review of the insecticide chlorpyrifos, and the results from the CCCEH 

study is a key component of the EPA risk assessment. 

EPA has conducted systematic reviews of the scientific literature on epidemiology 

studies on neurodevelopmental outcomes associated with OP exposure in 2012, 2014, and 2015 . 

Although other studies exist, the most robust epidemiology studies were conducted through three 

major U.S. based prospective birth cohort studies. The CCCEH study used concentration of 

pesticides (including chlorpyrifos) in umbilical cord blood as a measure of exposure, while the 
other two birth cohorts used urinary biomarkers in the mothers to estimate pesticide exposure. 

While the studies using urinary biomarkers provide important supporting information, EPA 

believes the CCCEH study more accurately represents the dose that reaches the target tissue. It 

is for this reason that EPA considers the CCCEH research results most relevant for use in 

quantitative risk assessment. 

On November 6, 2015, EPA proposed the revocation of all chlorpyrifos food residue 

tolerances, in part based on consideration of the CCCEH research. EPA is subject to a courtordered deadline of December 30, 2016, to complete that action, and it is therefore imperative 

that EPA address all outstanding issues associated with this action by that time. EPA has 

recently concluded that the CCCEH research may in fact provide sufficient information to 

establish a new regulatory point of departure based on the neurodevelopmental outcomes 

observed in that research. To that end, EPA has developed an issue paper outlining its proposal 

for the use of the CCCEH study in quantitative risk assessment, and is soliciting feedback from 

the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel 

(SAP) at a meeting from April 19 - 21 , 2016. EPA will also be issuing a notice in connection 

with its proposal to revoke all chlorpyrifos tolerances that will, among other things, ask for 

additional public comment on EPA's increased utilization of the CCCEH research results. 

Although EPA believes that the published results of the CCCEH research strongly 

support EPA's proposal to establish a new regulatory point of departure, it is important to note 

that the CCCEH researchers have, to date, not agreed to submit their underlying raw data to EPA 

to support our evaluation. 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 Columbia spokesperson 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 subjects 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 submit these data 

to EPA, if in fact Columbia is offering to submit its research on chlorpyrifos to EPA so that it 

can be made available to the public (subject of course to any necessary restrictions to protect the 

confidentiality of the subjects in the study), we would welcome that development and will 

provide any assistance necessary to obtain these data. Accordingly, please consider this letter a 

formal request for this information. Please let me know if you have any questions or would like 

to further discuss. I can be reached at housengcr.jack@epa.gov or at 703-308-8163 .