Assuring Access to Data for Chemical Evaluations
Lynn R. Goldman1 and Ellen K. Silbergeld2
1School of Public Health and Health Services, The George Washington University, Washington, DC, USA; 2Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
Background: A database for studies used for U.S. Environmental Protection Agency (EPA) pesticide and chemical reviews would be an excellent resource for increasing transparency and improving systematic assessments of pesticides and chemicals. There is increased demand for disclosure of raw data from studies used by the U.S. EPA in these reviews.
Objectives: Because the Information Quality Act (IQA) of 2001 provides an avenue for request of raw data, we reviewed all IQA requests to the U.S. EPA in 2002–2012 and the U.S. EPA’s responses. We identified other mechanisms to access such data: public access databases, the Freedom of Information Act (FOIA), and reanalysis by a third party.
Discussion: Only two IQA requests to the U.S. EPA were for raw data. Both of these were fulfilled under FOIA, not the IQA. Barriers to the U.S. EPA’s proactive collection of all such data include costs to the U.S. EPA and researchers, significant time burdens for researchers, and major regulatory delays. The U.S. EPA regulatory authority in this area is weak, especially for research conducted in the past, not funded by the U.S. government, and/or conducted abroad. The U.S. EPA is also constrained by industry confidential business information (CBI) claims for regulatory testing data under U.S. chemical and pesticide laws. The National Institutes of Health Clinical Trials database systematically collects statistical data about clinical trials but not raw data; this database may be a model for data from studies of chemicals and pesticides.
Conclusions: A database that registers studies and obtains systematic sets of parameters and results would be more feasible than a system that attempts to make all raw data available proactively. Such a proposal would not obviate rights under the IQA to obtain raw data at a later point.
Key words: access to information; chemicals, hazardous; pesticides; review, systematic.
Environ Health Perspect 121:149–152 (2013). http://dx.doi.org/10.1289/ehp.1206101 [Online 11 December 2012]
Address correspondence to L.R. Goldman, School of Public Health and Health Services, The George Washington University, 2175 K St., NW, Suite 500, Washington, DC 20037 USA. Telephone: (202) 994-5179. E-mail: goldmanL@gwu.edu
The authors declare they have no actual or potential competing financial interests.
Received 4 October 2012; Accepted 5 December 2012; Online 11 December 2012.
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