Congressional Republicans want greater public access to scientific data used as a basis for determining the need for air pollution regulations.
Some call it appropriate – and needed – scientific transparency, while others note that publishing data such as individual patient’s medical records is against the law.
Looking across the entire government, more data than ever is publically available.
The Environmental Subcommittee of the House Science, Space and Technology Committee, at a Feb. 11 hearing, looked at “secret science” at the Environmental Protection Agency (EPA).
SST chair Lamar Smith (R-Texas) explained the hearing intended to get information regarding the proposed bill, H.R. 4012, the Secret Science Reform Act of 2014. The proposed legislation grew out of unsuccessful attempts by the committee to gain raw patient data from health studies conducted in the 1980s.
The studies are part of the scientific justification for various rules implemented by EPA under the Clean Air Act.
Smith’s underlying goal is to limit the application of the Clean Air Act; the recent draft rule limiting CO2 emissions from new power plants is based on EPA’s responsibilities under the act.
H.R. 4012 would require that the EPA not issue any rules or regulations unless all scientific and technical information used to support the action is publically available in a format that would allow “independent analysis and substantial reproduction of research results.”
Bill proponents say the legislation will make EPA’s science more transparent and accessible to the masses.
Opponents, however, say the bill would bar EPA from using the best available science to inform regulations, because EPA cannot release certain data including patients’ medical records.
The background history is interesting, if obtuse: In August 2013 Smith issued a subpoena for EPA data from the Harvard Six Cities study – a 1974-92 monitoring of over 8,000 individuals that assessed the relationship between particulate pollution and mortality – and from the American Cancer Society’s 1982-2004 Cancer Prevention Study II.
EPA has not provided what Smith considers adequate data – the individual health records. Sen. David Vitter (R-La.), ranking member on the Senate Committee on Environment and Public Works, has been waging a coordinated fight for the data.
The testimony and discussion during the hearing focused on several different topics:
♦ The high cost to industry of EPA regulations.
♦ The pros and cons of increased access to EPA data.
♦ How to assure patient confidentiality in reviewing raw data from epidemiological studies.
♦ Raymond J. Keating, chief economist at the Small Business and Entrepreneurship Council, quoted reports that show the cost to Americans of complying with government regulations exceeded over $1 trillion in 2012.
♦ John D. Graham, dean of the School of Public and Environmental Affairs at Indiana University, testified “a series of reports from the National Research Council/National Academy of Sciences over the last 15 years has documented persistent shortcomings in the quality, transparency and reproducibility of the [EPA’s] agency’s scientific determinations.”
♦ Louis Anthony Cox Jr., chief sciences officer, Next Health Technologies; clinical professor-biostatistics and informatics at the Colorado Health Sciences Center; and president, Cox Associates, summed up the arguments around open access to data: Independent analysis of raw data is important to assure the study conclusions are sound. The arguments against releasing raw data are the data could be used by unscrupulous parties to manufacture doubt or release of the information could threaten the privacy of the study population.
♦ Ellen Kovner Silbergeld, professor at the Johns Hopkins Bloomberg School of Public Health, made the point that for scientific studies you want to see the work validated by independent studies; reassessing the data of published studies is less beneficial because the peer review process generally assures the data has not been misinterpreted.
The Natural Resources Defense Council sent a letter to the House committee opposing the draft legislation on the basis that, while restricting the information EPA can use in developing regulations, another section of the bill shields industry from releasing data used for pesticide registrations, certification of vehicle emissions and other filings to EPA.
The federal government already has taken steps to make scientific data more accessible or transparent.
EPA’s existing scientific integrity policy:
- Prohibits all EPA employees from suppressing, altering or otherwise impeding the timely release of scientific findings or conclusions.
- States the expectation that the agency will continue to expand and promote access to scientific information by making it available online in open formats in a timely manner – including access to data and non-proprietary models underlying agency policy decisions.
These policies reflect government-wide procedures issued by the Office of Management and Budget (OMB). Among other requirements, OMB requires that all data produced under a government grant or award be available using a Freedom of Information Act (FOIA) request.
Unfortunately, FOIA requests may be complicated, time consuming and frequently unsuccessful.
In 2009 the federal government initiated policies to make government information and data easily accessible to the public. The outgrowth of this policy is DATA.GOV, the federal government website, which contains about 90,000 datasets including non-federal data that may have licensing restrictions.
Unfortunately, the data sets are not easy to search, and lack explanatory information.