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EPA Administrator Pruitt Proposes Rule To Strengthen Science Used In EPA Regulations

04/24/2018
Contact Information: 
EPA Press Office (press@epa.gov)

WASHINGTON (April 24, 2018) – Today, U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt signed a proposed rule to strengthen the science used in regulations issued by EPA. The rule will ensure that the regulatory science underlying Agency actions is fully transparent, and that underlying scientific information is publicly available in a manner sufficient for independent validation.

“The era of secret science at EPA is coming to an end,” said EPA Administrator Scott Pruitt. “The ability to test, authenticate, and reproduce scientific findings is vital for the integrity of rulemaking process. Americans deserve to assess the legitimacy of the science underpinning EPA decisions that may impact their lives.”

This proposed rule is in line with the scientific community’s moves toward increased data sharing to address the “replication crisis”—a growing recognition that a significant proportion of published research may not be reproducible.  The proposal is consistent with data access requirements for major scientific journals like Science, Nature, and Proceedings of the National Academy of Sciences as well as recommendations from the Bipartisan Policy Center’s Science for Policy Project and the Administrative Conference of the United States’ Science in the Administrative Process Project.

The proposed rule builds upon President Trump’s executive orders on regulatory reform and energy independence:

  • Executive Order 13777, issued in March 2017, provides that regulatory reform efforts shall attempt to identify “those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard of reproducibility.”

  • Executive Order 13783, also issued in March 2017, provides that “It is the policy of the United States that necessary and appropriate environmental regulations comply with the law, are of greater benefit than cost, when permissible, achieve environmental improvements for the American people, and are developed through transparent processes that employ the best available peer-reviewed science and economics.”

Chairman Lamar Smith (R-TX): “Administrator Pruitt’s announcement ensures that data will be secret no more. For too long, the EPA has issued rules and regulations based on data that has been withheld from the American people. It’s likely that in the past, the data did not justify all regulations. Today, Administrator Pruitt rightfully is changing business as usual and putting a stop to hidden agendas.”

Senator Mike Rounds (R-SD): “Sound, reliable science is vital to helping us make important policy decisions that impact the health of American families and their livelihoods. Inserting new levels of transparency in the EPA rulemaking process will help make the agency more accountable to the American people and help everyone understand the impact of EPA’s decisions.  Today’s directive is a significant step toward making sure these decisions are not made behind closed doors with information accessible only to those writing the regulations, but rather in the full view of those who will be affected.”

Dr. Edward J. Calabrese, Professor, Environmental Health Sciences, University of Massachusetts: “The proposal represents a major scientific step forward by recognizing the widespread occurrence of non-linear dose responses in toxicology and epidemiology for chemicals and radiation and the need to incorporate such data in the risk assessment process.”

Dr. Louis Anthony (Tony) Cox, President, Cox Associates; Member, National Academy of Engineering; and Editor-in-Chief of the Journal Risk Analysis: “I believe that transparency and independent reproducibility of analyses and conclusions are bedrock principles of sound science.  Some commentators have expressed concerns that making the data behind policy conclusions and recommendations accessible and transparent might threaten the privacy of individuals. But this concern can be fully met by applying current privacy-protection techniques for data analysis. These techniques have been developed and used successfully for years at the Census Bureau and elsewhere. Thus, we can have the scientific benefits of accessible data while protecting individual privacy.” 

Dr. Jason Scott Johnston, Director, Olin Law and Economics Program, University of Virginia School of Law: “EPA’s proposed rule, Strengthening Transparency in Regulatory Science, is badly needed. “Best practice" among peer-edited scientific journals is to require that data and statistical routines used in published papers be posted online and/or made publicly available. To apply the same standards to research that EPA says justify regulations affecting billions of dollars in economic activity and millions of human lives is essential for those regulations to truly be scientifically based.”  

Bruno Pigott, Commissioner of the Indiana Department of Environmental Management (IDEM): “IDEM supports transparency in rulemaking. Good, sound science leads to better regulations.”

Dr. George Wolff, Principal Scientist, Air Improvement Resource, Inc., and former Chairman of EPA’s Clean Air Scientific Advisory Committee (1992 – 1996): “In the development of regulations based on environmental studies, numerous subjective assumptions and choices must be made regarding the selection of data and models that have a profound impact on the strength of any statistical associations and even whether the associations are positive or negative. The appropriateness of the assumptions and choices are not adequately evaluated in the standard peer review process. That is why it is essential that the data and models be placed in the public domain for a more rigorous evaluation by qualified experts. The proposed regulation, Strengthening Transparency in Regulatory Science, will provide an opportunity for such evaluations.”

Read the April 30, 2018 Proposed Rule: Strengthening Transparency in Regulatory Science (PDF) link in the Federal Register.

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