Assuring Access to Data for Chemical... [Environ Health Perspect. 2012] - PubMed - NCBI

Use the link to access more information about the article.  The abstract reads as follows: "BACKGROUND: A database for studies used for 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 Environmental Protection Agency (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 EPA in 2002 - 2012 and 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 EPA were for raw data. Both of these were fulfilled under the FOIA, not the IQA. Barriers to EPA's proactive collection of all such data include: costs to EPA and researchers, significant time burdens for researchers, and major regulatory delays. EPA regulatory authority in this area is weak, especially for research conducted in the past, not funded by the US government, and/or conducted abroad. EPA is also constrained by industry confidential business information (CBI) claims for regulatory testing data under US chemical and pesticide laws. The NIH 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."