Lifting the Veil of Secrecy
Following the nomination hearing for Gina McCarthy to lead the U.S. Environmental Protection Agency (EPA), the EPW Republican Senators reiterated five concerns they have with the Agency and the expected responses, in order to ensure that transparency is more than a buzzword. The Senators hope to restore public confidence that EPA will stop undermining public trust behind a veil of secrecy. Below is a detailed explanation of request number three of five. Click here to read all five initial requests.
Transparency through Data Access
Transparency Request #3: Share the secret data that forms the basis of new rules and regulations
Request in full: That underlying data used to promulgate Clean Air Act rules be made public so the public can independently examine cost/benefit and other issues. That the EPA release a full set of data files for the American Cancer Society Study; the Harvard Six Cities Study; HEI/Krewski et al. 2009; Laden et al. 2006; Lepeule 2012; and Jerrett 2009. This request includes the coding of Personal Health Information (PHI).
EPA Opposes Public Release of Underlying Data since 1997
Since 1997, Congress has requested the underlying data for particulate matter studies (PM2.5) be made available to Congress and the public. Then-EPA Administrator Carol Browner opposed full public release of the data, citing confidentiality concerns and the importance of limiting access to those researchers with legitimate scientific inquiry qualifications.
In response to the continued reticence by EPA to publicly release the data, the Shelby amendment, a rider to the FY1999 Omnibus Appropriations Act, granted the federal government the right to "obtain, reproduce, publish or otherwise use the data produced from a federal grant [and to] authorize others to receive, reproduce, publish, or otherwise use" such data for federal purposes.
The war over the secret data began with two prospective cohort studies, the Harvard Six Cities Study (as reported by Dockery et al 1993) and the American Cancer Society (ACS) Study (as reported in Pope et al 1995). EPA relied on these two studies to support the 1997 PM2.5 National Ambient Air Quality Standard (NAAQS), despite significant questions over their validity. Since then, EPA has relied on updates from these same two studies to support the 2012 PM2.5 NAAQS and other major rules.
The Harvard Six Cities study is a long-term cohort study of the health effects associated with airborne pollutants. Subjects were randomly selected from six U.S. cities that had a wide range of levels of ambient particles and gaseous pollutants. The American Cancer Society Study was initiated in 1982 and was designed to study the impact of various factors on cancer development. The original prospective cohort included approximately 1.2 million men and women recruited from all 50 U.S. States, the District of Columbia, and Puerto Rico. It looked at the relationship between mortality and ambient air pollution.
In 2000, a reanalysis of both the Harvard Six Cities Study and the American Cancer Society study was conducted by the Health Effects Institute (HEI) to substitute for the full release of the data. While the reanalysis answered some initial questions regarding the data, not all of the original data and protocols were used, requiring extrapolations in order to fill in the gaps. The HEI report raised new questions that have yet to be answered.
In 2004, the National Research Council issued a report that recommended that EPA discontinue relying on the two data sets. Despite the NRC report and the lack of public access, EPA continued to rely on these studies to justify conclusions that exposure to ambient levels of ozone and PM2.5 cause chronic mortality and to calculate extraordinarily high benefit estimates to justify costly air regulations including: MATS (Mercury and Air Toxics Hazardous Pollutant Rule for Utilities); Boiler MACT; CSAPR (Cross State Air Pollution Rule); SO2 and Ozone NAAQS; and Tier III. OMB estimates that the PM benefits alone from these studies represent between 61 to 80 percent of the estimated benefits for all government regulations.
EPA Stalls Congressional Inquiries
In a March 4, 2013 letter to EPA, Ranking Member Vitter and Chairman of the House Science, Space, and Technology Committee Lamar Smith requested the underlying data from additional long term cohort studies that rely on updates from the Harvard Six Cities Study and the American Cancer Society Study. This letter repeated multiple communications from Congress requesting the release of the underlying data which are the basis for nearly all the health and benefit claims from CAA rulemaking in this Administration.
On April 10, 2013, EPW Republican Members in a letter to current Assistant Administrator for the Office of Air & Radiation and EPA Administrator nominee, Gina McCarthy, echoed the March 4th letter by requesting that underlying data from these studies which are relied upon in the promulgation of Clean Air Act rules be made public so as to be independently examined. The request included the coding of Personal Health Information (PHI) where necessary.
EPA, in response to the March 4th letter, re-sent inadequate data previously provided to the House Science, Space and Technology Committee. The Agency admitted the data provided are not sufficient to replicate analysis. Furthermore, the Agency provided multiple excuses for not obtaining and providing the data that are inconsistent with Administration guidance and the Shelby Amendment.
EPA stated that the complete set of data underlying the studies is not held by EPA but held by the scientific researchers that conducted the relevant research. OMB guidance (A-110), however, states that the federal government retains the right to "obtain, reproduce, publish or otherwise use the data" produced from a federal grant and to "authorize others to receive, reproduce, publish or otherwise use" such data for federal purposes. In addition to this broad authority to obtain all federally funded research data, the OMB guidance also stipulates that in response to a FOIA request, the federal awarding agency (in this case, EPA) shall request and the recipient shall provide to the funding agency the research data so that the agency can make the data available through procedures established under FOIA.
EPA Uses Semantics to Avoid Transparency
While the OMB circular excludes personal and confidential data from the definition of the research data that would be released as a result of a FOIA request, the language is clear that the funding agency, not the research institution, should make the determination of whether the disclosure of the data "would constitute a clearly unwarranted invasion of personal privacy" in implementing FOIA. As the Federal Register Notice on the final changes to A-110 made clear, it was not OMB's intent "to transfer authority to determine which records are exempt from mandatory disclosure under FOIA from Federal Agencies to recipients." In other words, the determination regarding the confidentiality of the data is made by the federal agency, not the grant recipient.
EPA also stated that some of the data cannot be released in their original format because they would identify specific individuals. The Congressional requests, however, ask that EPA investigate measures to remove all PHI from the data prior to release. This is not a novel undertaking. The U.S. Department of Health and Human Services recently issued guidelines on how to de-identify medical records in order to implement elements of the new healthcare law. Additionally, one of the research institutions stripped personal identifiers and released information on deaths that were originally obtained from the National Death Index (NDI), providing evidence that data containing personal information can be de-identified and released.
EPA also stated that it is unwilling to obtain and release certain data because it was funded through a mixture of public and private money. However, the OMB final Federal Register notice for A-110 makes clear that the data access provisions apply to mixed (public/private) funding research efforts, "...the amended Circular shall apply to all Federally-funded research, regardless of the level of funding or whether the award recipient is also using non-Federal funds..." EPA's mixed funding excuse is clearly refuted by OMB's language in the final Federal Register Notice issued in October of 1999.