Comment on EPA's Proposed Rule to Strengthen Transparency in Regulatory Science
Agency Comments
May 25, 2018
Environmental Protection Agency (EPA) EPA Docket Center (EPA/DC) 1200 Pennsylvania Avenue, NW Washington, DC 20460
Comment on EPA’s Proposed Rule to Strengthen Transparency in Regulatory Science Docket ID No. EPA-HQ-OA-2018-0259
Background
Citizens Against Government Waste (CAGW) is a private, nonpartisan, nonprofit, organization representing more than one million members and supporters nationwide. CAGW’s mission is to eliminate waste, fraud, abuse, mismanagement, and inefficiency in government. Founded in 1984 by the late industrialist J. Peter Grace and syndicated columnist Jack Anderson, CAGW was established to follow up on the work of the President’s Private Sector Survey on Cost Control, also known as the Grace Commission.
On behalf of CAGW’s members and supporters, I write in strong support of the April 30, 2018 proposed rule to strengthen the transparency of EPA regulatory science. For too long, the EPA has promulgated costly and burdensome regulations based on studies where the underlying data is not publicly available for peer review and independent analysis. Taxpayers should not be forced to shoulder the cost and burdens of EPA regulations for which the data used to promote a policy decision is not publicly available.
Science Should Be Reproducible to be Reliable
A February 22, 2017 BBC News report, “Most scientists can’t replicate studies by their peers,” disturbingly recounted that, “more than two-thirds of researchers have tried and failed to reproduce another scientist’s experiments.” According to the article, Dr. Tim Errington, who runs the Reproducibility Project at the University of Virginia, attempted to repeat the findings in five landmark cancer studies. His team was only able to confirm two of the original studies’ findings. Dr. Errington said, “it’s worrying because replication is supposed to be a hallmark of scientific integrity.”
Dr. Errington’s comment does not just apply to cancer research, it also applies to all research, including environmental and climate studies.
When the EPA announced the proposed rule, there was immediate pushback from some environmental advocacy organizations and public health scientists. Many of the arguments in opposing the EPA’s transparency rules are surreal. An April 24, 2018 Washington Post article stated, “Many scientists argue that applying a standard to public health and environmental studies that is not currently required by peer-reviewed journals would limit the information the EPA could take into account when crafting federal limits on everything from power-plant emissions to which chemicals can be used in agriculture and in homes. Some researchers collect personal data from subjects but pledge to keep it confidential - as was the case in a major 1993 study by Harvard University that established the link between fine particle air pollution and premature deaths. That practice would not be allowed under the new rule.”
It is troubling that underlying data within public health and environmental studies is not required by peer-reviewed journals. Declaring that it would be impossible to use a study, such the one mentioned above because some data is confidential, is a red herring. It is possible to protect personal data from subjects because names, residences and other private information can be redacted and aggregated. Other agencies within the federal government, like the Department of Health and Human Services, routinely protect confidential and sensitive information.
The Washington Post article discussed how 985 scientists signed a letter organized by the Union of Concerned Scientists (UCS), which urged EPA Administrator Scott Pruitt not to go ahead with the proposed rule, because “There are ways to improve transparency in the decision-making process, but restricting the use of science would improve neither transparency nor the quality of EPA decision-making … If fully implemented, this proposal would greatly weaken EPA’s ability to comprehensively consider the scientific evidence across the full array of health studies.”
The Washington Post quoted the UCS’s Center for Science and Democracy Director Andrew Rosenberg, who said, “First, they came after the agency’s independent science advisers, and now, they’re going after the science itself…what is transparent is the unabashed takeover of EPA leadership by individuals who have demonstrated disinterest in helping communities combat pollution by using the best available science.”
These are insincere arguments. The proposed rule “does not directly regulate any entity outside the federal government” and would be of interest “to entities that conduct research and other science activity relevant to EPA’s regulatory activity.” In other words, researchers should be prepared to release their underlying data if they want their research to be considered by the EPA to promulgate regulations.
One would naturally assume “independent advisers” do not have a conflict of interest. But when scientists who receive EPA grants also serve on one of the agency’s advisory boards, a conflict is created. These conflicts were eliminated when Administrator Pruitt issued a new directive in October 2017, that scientists who receive an EPA grant, or reap a substantial benefit from a grant, could not also serve on an advisory committee. The scientists would be given the option of either ending their grants or to continue to advise EPA, but not both.
One would also assume “best available science” is that in which the underlying data can be examined and duplicated. Although the UCS letter argued that some of the studies could not be replicated because it would require “intentionally and unethically exposing people and the environment to harmful contaminants or recreating one-time events,” it is conceivable that most, if not all studies could be replicated in the lab with research animals, since this type of research is conducted all the time, or could be duplicated using other scientific models.
Furthermore, the proposed rule states the administrator can “exempt significant regulatory decisions on a case-by-case basis if he or she determines that compliance is impracticable because it is not feasible to ensure that all dose response data and models underlying pivotal regulatory science are publicly available in a fashion that is consistent with law, protects privacy and confidentiality, and is sensitive to national and homeland security, or in instances where OMB’s [Office of Management and Budget] Information Quality Bulletin for Peer Review provides for an exemption (Section IX).”
While CAGW agrees that the administrator must have flexibility in such cases, this provision should not end up being a loophole to avoid transparency, and therefore should be used judiciously.
The EPA also requested comments on whether disclosure requirements applicable to dose response data and models should be expanded to cover other types of data, such as economic and environmental impact data and models that are designed to predict the costs, benefits, market impacts and/or environmental effects of specific regulatory interventions on complex economic or environmental systems. CAGW believes it is imperative that this type of information should be applicable to EPA’s proposed transparency requirements, considering the enormous economic effect EPA regulations can have on the U.S. economy.
George Washington University Director of Regulatory Studies Susan Dudley wrote in a May 21, 2017 Forbes.com article, “Critics and Supporters of EPA's Transparent Science Proposal: File Comments On It, But Read It First,” that the EPA transparency proposal “is not as dramatic as either side [of the political divide] would lead one to believe, however. Essentially, it requires that the studies, models, and data underlying significant regulatory decisions are ‘publicly available in a manner sufficient for independent validation.’ Independent validation is the essence of the scientific method, which depends on falsifiable hypotheses, data gathering, replication, dissent, and challenge.”
Ms. Dudley noted that the EPA proposal is “consistent with policies on scientific integrity espoused by previous administrations.” For example, the OMB’s Information Quality Guidelines have been in existence for more than 15 years. And she noted that President Obama encouraged, “transparency in the preparation, identification, and use of scientific and technological information in policymaking” in a March 2009 Presidential Memorandum.
Ms. Dudley argued, “no one is immune to the temptation to spin science” in order to advance a policy goal. Therefore, greater transparency will encourage more openness and fruitful dialogue, enabling everyone to understand and accept why one assumption or model was chosen over another in formulating a rule and to advance a directive.
Conclusion
CAGW agrees that transparency and open discussions are essential for EPA rulemaking. The “2017 Draft Report to Congress on the Benefits and Costs of Federal Regulations and Agency Compliance with the Unfunded Mandates Reform Act,” stated the EPA’s “rules account for over 80 percent of the monetized benefits and over 70 percent of the monetized costs” across the federal government. Considering the vast regulatory power the EPA has over the environment, the U.S. economy, and the health of U.S. citizens, it is only right and proper that the rules it writes are based on the best science and data that is publicly available for scrutinization and analysis.
CAGW commends Administrator Pruitt for his efforts to promote transparency in the EPA’s regulatory science and urges the agency to adopt the proposed rule.
May 25, 2018
Environmental Protection Agency (EPA)
EPA Docket Center (EPA/DC)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Comment on EPA’s Proposed Rule to Strengthen Transparency in Regulatory Science
Docket ID No. EPA-HQ-OA-2018-0259
Background
Citizens Against Government Waste (CAGW) is a private, nonpartisan, nonprofit, organization representing more than one million members and supporters nationwide. CAGW’s mission is to eliminate waste, fraud, abuse, mismanagement, and inefficiency in government. Founded in 1984 by the late industrialist J. Peter Grace and syndicated columnist Jack Anderson, CAGW was established to follow up on the work of the President’s Private Sector Survey on Cost Control, also known as the Grace Commission.
On behalf of CAGW’s members and supporters, I write in strong support of the April 30, 2018 proposed rule to strengthen the transparency of EPA regulatory science. For too long, the EPA has promulgated costly and burdensome regulations based on studies where the underlying data is not publicly available for peer review and independent analysis. Taxpayers should not be forced to shoulder the cost and burdens of EPA regulations for which the data used to promote a policy decision is not publicly available.
Science Should Be Reproducible to be Reliable
A February 22, 2017 BBC News report, “Most scientists can’t replicate studies by their peers,” disturbingly recounted that, “more than two-thirds of researchers have tried and failed to reproduce another scientist’s experiments.” According to the article, Dr. Tim Errington, who runs the Reproducibility Project at the University of Virginia, attempted to repeat the findings in five landmark cancer studies. His team was only able to confirm two of the original studies’ findings. Dr. Errington said, “it’s worrying because replication is supposed to be a hallmark of scientific integrity.”
Dr. Errington’s comment does not just apply to cancer research, it also applies to all research, including environmental and climate studies.
When the EPA announced the proposed rule, there was immediate pushback from some environmental advocacy organizations and public health scientists. Many of the arguments in opposing the EPA’s transparency rules are surreal. An April 24, 2018 Washington Post article stated, “Many scientists argue that applying a standard to public health and environmental studies that is not currently required by peer-reviewed journals would limit the information the EPA could take into account when crafting federal limits on everything from power-plant emissions to which chemicals can be used in agriculture and in homes. Some researchers collect personal data from subjects but pledge to keep it confidential - as was the case in a major 1993 study by Harvard University that established the link between fine particle air pollution and premature deaths. That practice would not be allowed under the new rule.”
It is troubling that underlying data within public health and environmental studies is not required by peer-reviewed journals. Declaring that it would be impossible to use a study, such the one mentioned above because some data is confidential, is a red herring. It is possible to protect personal data from subjects because names, residences and other private information can be redacted and aggregated. Other agencies within the federal government, like the Department of Health and Human Services, routinely protect confidential and sensitive information.
The Washington Post article discussed how 985 scientists signed a letter organized by the Union of Concerned Scientists (UCS), which urged EPA Administrator Scott Pruitt not to go ahead with the proposed rule, because “There are ways to improve transparency in the decision-making process, but restricting the use of science would improve neither transparency nor the quality of EPA decision-making … If fully implemented, this proposal would greatly weaken EPA’s ability to comprehensively consider the scientific evidence across the full array of health studies.”
The Washington Post quoted the UCS’s Center for Science and Democracy Director Andrew Rosenberg, who said, “First, they came after the agency’s independent science advisers, and now, they’re going after the science itself…what is transparent is the unabashed takeover of EPA leadership by individuals who have demonstrated disinterest in helping communities combat pollution by using the best available science.”
These are insincere arguments. The proposed rule “does not directly regulate any entity outside the federal government” and would be of interest “to entities that conduct research and other science activity relevant to EPA’s regulatory activity.” In other words, researchers should be prepared to release their underlying data if they want their research to be considered by the EPA to promulgate regulations.
One would naturally assume “independent advisers” do not have a conflict of interest. But when scientists who receive EPA grants also serve on one of the agency’s advisory boards, a conflict is created. These conflicts were eliminated when Administrator Pruitt issued a new directive in October 2017, that scientists who receive an EPA grant, or reap a substantial benefit from a grant, could not also serve on an advisory committee. The scientists would be given the option of either ending their grants or to continue to advise EPA, but not both.
One would also assume “best available science” is that in which the underlying data can be examined and duplicated. Although the UCS letter argued that some of the studies could not be replicated because it would require “intentionally and unethically exposing people and the environment to harmful contaminants or recreating one-time events,” it is conceivable that most, if not all studies could be replicated in the lab with research animals, since this type of research is conducted all the time, or could be duplicated using other scientific models.
Furthermore, the proposed rule states the administrator can “exempt significant regulatory decisions on a case-by-case basis if he or she determines that compliance is impracticable because it is not feasible to ensure that all dose response data and models underlying pivotal regulatory science are publicly available in a fashion that is consistent with law, protects privacy and confidentiality, and is sensitive to national and homeland security, or in instances where OMB’s [Office of Management and Budget] Information Quality Bulletin for Peer Review provides for an exemption (Section IX).”
While CAGW agrees that the administrator must have flexibility in such cases, this provision should not end up being a loophole to avoid transparency, and therefore should be used judiciously.
The EPA also requested comments on whether disclosure requirements applicable to dose response data and models should be expanded to cover other types of data, such as economic and environmental impact data and models that are designed to predict the costs, benefits, market impacts and/or environmental effects of specific regulatory interventions on complex economic or environmental systems. CAGW believes it is imperative that this type of information should be applicable to EPA’s proposed transparency requirements, considering the enormous economic effect EPA regulations can have on the U.S. economy.
George Washington University Director of Regulatory Studies Susan Dudley wrote in a May 21, 2017 Forbes.com article, “Critics and Supporters of EPA's Transparent Science Proposal: File Comments On It, But Read It First,” that the EPA transparency proposal “is not as dramatic as either side [of the political divide] would lead one to believe, however. Essentially, it requires that the studies, models, and data underlying significant regulatory decisions are ‘publicly available in a manner sufficient for independent validation.’ Independent validation is the essence of the scientific method, which depends on falsifiable hypotheses, data gathering, replication, dissent, and challenge.”
Ms. Dudley noted that the EPA proposal is “consistent with policies on scientific integrity espoused by previous administrations.” For example, the OMB’s Information Quality Guidelines have been in existence for more than 15 years. And she noted that President Obama encouraged, “transparency in the preparation, identification, and use of scientific and technological information in policymaking” in a March 2009 Presidential Memorandum.
Ms. Dudley argued, “no one is immune to the temptation to spin science” in order to advance a policy goal. Therefore, greater transparency will encourage more openness and fruitful dialogue, enabling everyone to understand and accept why one assumption or model was chosen over another in formulating a rule and to advance a directive.
Conclusion
CAGW agrees that transparency and open discussions are essential for EPA rulemaking. The “2017 Draft Report to Congress on the Benefits and Costs of Federal Regulations and Agency Compliance with the Unfunded Mandates Reform Act,” stated the EPA’s “rules account for over 80 percent of the monetized benefits and over 70 percent of the monetized costs” across the federal government. Considering the vast regulatory power the EPA has over the environment, the U.S. economy, and the health of U.S. citizens, it is only right and proper that the rules it writes are based on the best science and data that is publicly available for scrutinization and analysis.
CAGW commends Administrator Pruitt for his efforts to promote transparency in the EPA’s regulatory science and urges the agency to adopt the proposed rule.
Sincerely,
Tom Schatz
President, CAGW
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