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Heartland Institute Comments to EPA on Strengthening Transparency in Regulatory Science

June 20, 2018

'We applaud this proposed rule and find that governing statutes and Executive Orders, not to mention the basics of the scientific method, authorize the proposed Rule and, indeed, have long required it.'

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The Environmental Protection Agency (EPA) issued this proposed Rule for Notice and Comment Rulemaking on April 30, 2018. EPA proposes the Rule intending to strengthen the transparency and integrity of EPA regulatory science. The proposed Rule provides that EPA should ensure that data and models underlying scientific studies pivotal to EPA regulations are publicly available in a manner sufficient for independent validation, especially concerning regulations for which the public is likely to bear the cost of compliance. The availability of scientific study methods and data will be crucial to assuring the integrity of the science used to justify policy and regulations.

We applaud this proposed rule and find that governing statutes and Executive Orders, not to mention the basics of the scientific method, authorize the proposed Rule and, indeed, have long required it. In not following the proposed Rule in the past, EPA has been flouting governing statutes and Executive Orders, departing from the scientific method, particularly in matters of toxicology and epidemiology, and abusing its authority by ignoring and discarding valid objections to EPA adopted science and the derivative policy and regulatory actions.


The proposed Rule provides that for science pivotal to its significant regulatory actions, EPA will ensure the data and models underlying the science are publicly available in a manner sufficient for validation and analysis. This new policy is needed because EPA admits to having not previously implemented these policies and guidance in a robust and consistent manner. Examples where EPA previously has fallen short include the public health research used to implement and defend the small particulate matter (PM2.5), corporate average fuel economy (CAFE), ozone, and carbon dioxide (CO2) standards.

EPA’s admitted reliance on “secret science” (science that cannot be properly vetted and evaluated for reliability) occurs at a time when Nature, PLOS, Science, The Economist, and others report half or more of published research on public health issues cannot be replicated. This “replication crisis” is genuine, and even more broad and critical than the sources cited by EPA for this proposed Rule are willing to admit. A scientific publishing industry has been created by lavish government funding of politically directed research. Examples include studies finding a human impact on climate, or an association between ambient small particle and ozone levels in the air and public health. It may take generations before the effects of this scientific misconduct can be overcome.

The root cause of EPA’s science malfunction has been corruption of EPA’s peer review process and intentional adoption of scientific methods that exaggerate public health and environmental risks. Peer review for EPA has become “pal review,” with insiders funded by EPA grants reviewing the work of fellow EPA-funded scientists. Both sides of this crony arrangement, individuals as well as their institutions, are beneficiaries of millions of dollars in government funding. At the same time, EPA-sponsored reviewers censure and exclude scientists who disagree with the agency’s reigning political agenda. That perverts the whole point of peer review, turning it into a tool used to shut out anyone who disagrees instead of a process forcing scientists to defend their work against critics. The widespread replication crisis is a strong argument for the proposed Rule, since unreliable science has affected most of the world’s leading science journals and professional journals as well as national academies of science. It is naïve to think such scientific malfeasance does not impact politically hot subject areas that are also hot spots for generous government.

One scientific finding that has been suppressed by the corruption of peer review, which is singled out by EPA in its call for comments, is evidence of non-linearity in the concentration-response function for many pollutants. That objectionable linearity is particularly important for regulatory actions aimed at the low levels of ambient concentration of alleged toxins and carcinogens. The entire regulatory model is precariously perched on an invalid assumption of linearity at even the very low, ambient, real-world levels. The resulting scientific crisis continuing to build must be openly confronted with transparent analysis, and revised or repealed entirely based on a fresh look and rational valid evaluations of linear no threshold risk management.

EPA’s new policy of scientific integrity and transparency should be applied to computer climate models that currently prevail in EPA’s funded, published, and cited climate science. The continued use of default models, without consideration of alternatives or model uncertainty, creates a false scientific justification for EPA actions, policies, and regulatory burdens. Arbitrary choices made by EPA officials have resulted in assumptions about model accuracy that have been proven incorrect, unable to recreate past climate history or project future climate changes. All EPA-adopted models have predicted a much higher rate of temperature sensitivity to CO2 than has been recorded by temperature observations. Such direct proof of model inadequacies cannot be ignored and must be addressed before policy and regulatory actions are proposed.

Table of Contents

I. Background. (Page 3)

II. The Proposed Rule Is Necessary for the Transparency and Integrity of EPA Science. (Page 4)

III. EPA’s Scientific Breakdown Has Been Due to Collapse of the Integrity of EPA Peer Review, Which the New Rule Can Help Fix. (Page 6)

IV. Part of the Crisis in EPA Science Involves Stubborn Insistence on Assumptions of Linearity in Dose Response Models, Which the Rule Will Help Fix. (Page 7)

V. The New Rule Will Help Fix EPA’s Troubled History with Models, Particularly Concerning Climate Change. (Page 8)

VI. Because of EPA’s Troubled History in Following the Practices and Policies of Transparency and Integrity in Regulatory Activity, It Has Made Many Errors Relating to Economic and Public Health Impacts of Its Regulatory Policies. (Page 11) 

A. EPA versus the Scientific Method: Given its constrained mission, flawed paradigm, political pressures on it to chase the impossible goal of zero risk, and evidence of actual corruption, we can have no confidence in any science produced by EPA in justification of its regulations. (Page 12)

B. EPA makes many assumptions about relationships between air pollution and human health often in flagrant violation of the basic requirements of the scientific method. (Page 15)

C. Observational studies cited by EPA and other air quality regulators are unreliable, and in any case fail to show relative risks (RR) that would suggest a causal relationship between air pollution and adverse human health effects. (Page 22)

D. Circumstantial Evidence Cited By EPA and Other Air Quality Regulators Is Easily Refuted By Pointing to Contradictory Evidence Showing No Harmful Effects Of Air Pollution. (Page 34)

E. It is unlikely that air pollution caused by fossil fuels kills anyone in the United States though it may be a legitimate health concern in developing countries that rely on biofuels and burning coal without emission control technologies. (Page 36)

VII. Conclusion. (Page 37)

VIII. About The Heartland Institute. (Page 38)


Given the Environmental Protection Agency’s constrained mission, flawed paradigm, political pressures to chase the impossible goal of zero risk, and evidence of actual corruption, we can have no confidence in any science it produces in justification of its regulations.

In the face of extensive evidence of EPA’s failure to abide by its own rules regarding transparency and integrity of science, and now the agency’s own admission that this failure is widespread within the agency due to a culture of disrespect for the scientific method and independent peer review, a new set of rules is desperately needed.

The proposed Rule regarding regulatory science provides a solid foundation for correcting errors in economics and the science of public health. That is why we applaud the proposed Rule and urge EPA to move swiftly to its final adoption.

John Dale Dunn, M.D., J.D., is an emergency physician in Brownwood, Texas. He is board-certified in emergency medicine and legal medicine and has been an inactive attorney for 35 years.
Peter Ferrara, J.D., is the senior fellow for legal affairs at The Heartland Institute and senior advisor for entitlement reform and budget policy at the National Tax Limitation Foundation.