Click here to sign the Open Letter.

The federal Environmental Protection Agency’s (EPA) proposed rule “Strengthening Transparency in Regulatory Science,” banning the agency’s use of “secret science” in formulating regulations, should be adopted. It is badly needed to assure American taxpayers that the EPA is truly acting in their best interests. Objections are groundless.

Strengthening Transparency in Regulatory Science (STRS) provides that “When promulgating significant regulatory actions, the Agency shall ensure that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation.” It codifies what was intended in the Secret Science Reform Act of 2015, and the Honest and Open New EPA Science Treatment Act of 2017 (HONEST Act), both of which passed the House but never came up for vote in the Senate.

The rule is important to the integrity of EPA regulations because of a widely recognized crisis: Scientific studies, including those subjected to peer review, frequently are found to be irreproducible or to have false findings because they fail to meet high standards for data archiving, valid statistical analysis, experiment procedures, and other elements of valid research. Scientists widely acknowledge the reality of this crisis.[i]

Click here to sign the Open Letter.

Some opponents of STRS argue that peer review ensures the quality of studies published in refereed journals. But this widespread perception is false. As Richard Smith wrote in “Classical peer review: an empty gun,” published in Breast Cancer Review:

… almost no scientists know anything about the evidence on peer review. It is a process that is central to science—deciding which grant proposals will be funded, which papers will be published, who will be promoted, and who will receive a Nobel prize. We might thus expect that scientists, people who are trained to believe nothing until presented with evidence, would want to know all the evidence available on this important process. Yet not only do scientists know little about the evidence on peer review but most continue to believe in peer review, thinking it essential for the progress of science. Ironically, a faith based rather than an evidence based process lies at the heart of science.

Smith quotes Drummond Rennie, deputy editor of the Journal of the American Medical Association and intellectual father of the international congresses of peer review held quadrennially starting in 1989, as saying, “If peer review was a drug it would never be allowed on the market.”

We have particular interest in epidemiological studies of risks associated with certain toxins and climate studies related to anthropogenic global warming (AGW), also known as anthropogenic climate change (ACC). Many EPA regulations address these two concerns. Scientific societies and journals have often failed to maintain high standards of objectivity and research procedures related to both. Nonetheless, the EPA has formulated regulations based in whole or in part on such studies without adequately assessing them to see whether they meet high standards.[ii]

For example, the EPA has long regulated exposure to nuclear radiation on the basis of the linear no-threshold (LNT) dose-response model. Yet that model arose from a paper, “Genetic Effects of Atomic Radiation,” by the National Academies of Science Committee on the Biological Effects of Atomic Radiation, published in Science in 1956, which has since been severely criticized by many peer-reviewed publications. As the National Association of Scholars points out in a letter to EPA Administrator Scott Pruitt supporting STRS, “This is a consequential matter that bears on a great deal of national public policy, as the LNT model has served as the basis for risk assessment and risk management of radiation and chemical carcinogens for decades. A reassessment of that model could profoundly alter many regulations from the [EPA], the Nuclear Regulatory Commission, and other government agencies.”[iii]

In these circumstances, it is essential that all scientific studies used by regulators to justify regulations meet the highest standard of credibility. That is the aim of STRS.

Click here to sign the Open Letter.

As the EPA pointed out in announcing the proposed rule, “The benefits of EPA ensuring that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation are that it will improve the data and scientific quality of the Agency’s actions and facilitate expanded data sharing and exploration of key data sets; this is consistent with the conclusions of the National Academies.”

In addition to the claim that peer review alone is sufficient quality control, opponents of the proposed rule raise two primary objections. Both fail.

The most common, and on first blush credible, objection is that the rule would prevent the EPA from using studies that involved confidential information, such as personal health data or corporate proprietary information. In an open letter to EPA Administrator Scott Pruitt, the political-activist Union of Concerned Scientists (UCS) argued, “there are multiple valid reasons why requiring the release of all data does not improve scientific integrity and could actually compromise research, including intellectual property, proprietary, and privacy concerns.”[iv]

We wonder whether such critics have even read the proposed rule. Section 30.5 expressly states:

Where the Agency is making data or models publicly available, it shall do so in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national and homeland security.

And Section 30.9 says:

The Administrator may grant an exemption to this subpart on a case-by-case basis if he or she determines that compliance is impracticable because:

(a) It is not feasible to ensure that all dose response data and models underlying pivotal regulatory science is publicly available in a manner sufficient for independent validation, in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national and homeland security; or

(b) It is not feasible to conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions for reasons outlined in OMB Final Information Quality Bulletin for Peer Review (70 FR 2664), Section IX.

As the Agency’s request for public comment explained:

[C]oncerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the Federal government. Nothing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections. Other federal agencies have developed tools and methods to de-identify private information for a variety of disciplines. The National Academies have noted that simple data masking, coding, and de-identification techniques have been developed over the last half century and that “Nothing in the past suggests that increasing access to research data without damage to privacy and confidentiality rights is beyond scientific reach.”

The UCS letter asserted that concerns about transparency and certainty raised by supporters of the rule “are phony issues that weaponize ‘transparency’ to facilitate political interference in science-based decision making, rather than genuinely address either.” But the irreproducibility crisis is real, not phony. Further, enhanced transparency works against politicization, not for it. This objection is so patently invalid as to suggest that those who offer it are themselves weaponizing confidentiality to facilitate their own political interference in science-based decision making.

A second common objection, raised in the same letter and again credible on first blush, is that “many public health studies cannot be replicated, as doing so would require intentionally and unethically exposing people and the environment to harmful contaminants or recreating one-time events (such as the Deepwater Horizon oil spill).” But what need to be replicable in studies of such events are not the events themselves but the procedures used to collect and analyze data and make inferences from them.

Click here to sign the Open Letter.

Consider, for example, a study that used tree-rings as proxy temperature measurements and purported to find that neither the Medieval Warm Period nor the Little Ice Age had occurred but that a rapid and historically unprecedented warming had begun in the late 19^th century—a study that became iconic for claims of dangerous AGW driven by human emissions of carbon dioxide. No one needed to use a time machine to return to the 11^th through 20^th centuries and regrow trees to recognize that the authors had committed confirmation fallacy by excluding certain data and misused a statistical procedure, resulting in false results. All anyone needed was access to the raw data and the computer code used to analyze it. Yet the study lead author’s long refusal to allow access to raw data and computer code delayed discovery of these errors for years, during which the Intergovernmental Panel on Climate Change, the public, and governments all over the world were led to believe its claims and formulate expensive policies based partly on them.[v]

A few other objections have been raised against the proposed rule, and all are easily rebutted:

• The EPA should be able to use all available scientific research, even if it is not transparent and replicable, and excluding some may cripple its ability to protect us. On the contrary, using scientific research that is non-transparent and non-replicable increases the likelihood that policy will be grounded on false information.
• Some existing regulations are based on studies that could not have been used had this rule been in force, and implementing it could lead to rescinding those regulations and thus endangering the public. If enough of the research did satisfy the rule to justify the regulations, they need not be rescinded. If the regulations could not be justified by research that does satisfy the rule, then there is no reason to think the regulations actually protect the public, and they should be rescinded, eliminating their cost, which itself raises risks to the public.[vi]
• Some studies rely on funding from sources that restrict disclosure of underlying data, and the rule would prohibit the EPA’s use of those. That is precisely why the rule is needed. The funders should change their policies; their refusal suggests they have something to hide.

In conclusion, the EPA’s proposed rule “Strengthening Transparency in Regulatory Science,” banning the agency’s use of “secret science” in formulating regulations, survives objections. Its adoption and implementation will improve, not harm, the EPA’s mission to protect Americans from real environmental risks. It will also reduce the risks caused by unjustified but costly regulations.

Initial Expert Signers as of 5 p.m. Eastern Time, May 22, 2018:

(Institutional affiliation is for identification only.)

1. Timothy Ball, Ph.D. (Historical Climatology), Climatologist (ret.), University of Winnipeg
2. Glenn Barkley, Ph.D. (Physical Chemistry)
3. Calvin Beisner, Ph.D. (History), Founder & National Spokesman, Cornwall Alliance for the Stewardship of Creation
4. Edwin Berry, Ph.D. (Physics), CEO, Climate Physics LLC, Certified Consulting Meteorologist
5. David Black, Ph.D. (Legal Medicine—Forensic Toxicology), Clinical Assistant Professor, Vanderbilt University
6. Sonja Boehmer-Christiansen, Ph.D. (International Relations/Environmental & Marine Pollution), Emeritus Reader, Department of Geography and Geology, University of Hull, UK, and Editor, Energy & Environment (ret.)
7. James C. Bowers, Ph.D. (Engineering), Professor of Engineering, University of South Florida
8. Roger Burtner, Ph.D. (Geology), Principal, Remote Sensing Exploration, Research Associate, Chevron Oil Field Research Company (ret.)
9. Charles Clough, M.S. (Atmospheric Physics), Chief, U.S. Army Atmospheric Effects Team, Aberdeen Proving Ground (ret.), Lt. Col., U.S. Air Force Reserve Weather Officer (ret.), President, Biblical Framework Ministries, Adjunct Professor, Chafer Theological Seminary
10. Patrick Coyne, Ph.D. (Agriculture), Professor Emeritus, Agricultural Research Center, Kansas State University
11. Joseph D’Aleo, M.S. (Meteorology), Chief Climatologist/Meteorologist, Weatherbell Analytics
12. John Droz, M.S. (Physics), Physicist, Alliance for Wise Energy Decisions
13. John Dunn, M.D., J.D. (Medicine and Law), emergency medicine faculty physician, Carl R. Darnall Army Medical Center
14. James Enstrom, Ph.D. (Physics), Research Professor (ret.), University of California at Los Angeles
15. Neil L. Frank, Ph.D. (Meteorology), Director National Hurricane Center (1974–1987), Chief Meteorologist, WHOU-TV (1987–2008) (ret.)
16. Albrecht Glatzle, Dr.Sc. (Agriculture), Agro-biologist, Asociacion Rural del Paraguay
17. William Green III, M.Div., Founder & CEO, CLIR (Confraternidad Latinoamericana de Iglesias Reformadas) Publishing
18. Wayne A. Grudem, Ph.D., New Testament, Research Professor, Phoenix Seminary
19. Gary Habermas, Ph.D. (Philosophy), Distinguished Research Professor of Apologetics and Philosophy, Chair, Department of Philosophy, Liberty University
20. William Happer, Ph.D. (Physics), Cyrus Fogg Brackett Professor of Physics Emeritus, Princeton University; Director, Office of Science, U.S. Department of Energy, 1991–1993
21. Barbara Hoshiko, Ph.D. (Nurse Education), Emeritus Professor of Nursing, Kent State University
22. Vijay Jayaraj, M.Sc. (Environmental Science & Climate Change), Research Associate for Developing Countries, Cornwall Alliance for the Stewardship of Creation
23. Peter Jones, Ph.D. (New Testament), Executive Director, truthXchange, Emeritus Professor of New Testament, Westminster Theological Seminary
24. Bernard Kepshire Jr., Ph.D. (Fisheries Biology), Oregon Department of Fish and Wildlife, Oregon State University (ret.)
25. Henrik Krabbendam, Th.D. (Biblical Studies), Emeritus Professor of Biblical Studies, Covenant College
26. Edward Krug, Ph.D. (Soil Science), retired research scientist, University of Illinois at Champaign-Urbana
27. Tom Lehman, Ph.D. (Economics), Professor of Economics, Indiana Wesleyan University
28. Jay Lehr, Ph.D. (Groundwater Hydrology), Science Director, Heartland Institute, former Executive Director, National Association of Groundwater Scientists and Engineers
29. Philip Lestmann, Ph.D. (Mathematics), former Professor of Mathematics, Bryan College
30. Richard Lindzen, Ph.D. (Applied Mathematics), Alfred P. Sloan Professor of Meteorology, Emeritus, Massachusetts Institute of Technology
31. Anthony Lupo, Ph.D. (Atmospheric Science), Professor of Atmospheric Science, University of Missouri
32. George Mears, M.E. (Environmental Engineering), Hydrologist/Environmental Engineer
33. Michael Oard, M.S. (Atmospheric Science), meteorologist, National Weather Service (ret.)
34. William Moore, Ph.D. (Historical Theology), Pastor, Cornerstone Baptist Church, Clinton, SC
35. Philip Pennance, Ph.D. (Chemical Physics), Department of Mathematics, University of Puerto Rico
36. Chad Rodekohr, Ph.D. (Mechanical Engineering), Associate Professor of Physics, Presbyterian College
37. James Rust, Ph.D. (Nuclear Engineering), Professor of Nuclear Engineering (ret.), Georgia Institute of Technology
38. Richard Sauer, M.S. (Environmental Engineering), owner, Sauer Engineering
39. John Shanahan, Ph.D. (Engineering), President, Environmentalists for Nuclear – USA
40. Thomas P. Sheahen, Ph.D. (Physics), Chairman, Science and Environmental Policy Project
41. David Shormann, Ph.D. (Aquatic Science), STEM educator, DIVE, LLC
42. Roy W. Spencer, Ph.D. (Meteorology), Principal Research Scientist, Earth System Science Center, University of Alabama, Huntsville, AL, and U.S. Science Team leader for the Advanced Microwave Scanning Radiometer flying on NASA’s Aqua satellite
43. John Swayze, Ph.D. (Medicinal Chemistry), organic/medicinal/agricultural chemist (ret.)
44. Paul Taylor, M.S. (Environmental Sciences), Professor and Environmental Scientist, California State University, Northridge

Sign the letter now!

[emailpetition id=”4″]
[signaturelist id=”4″]

 

 

 

Endnotes

[i] Among discussions of it are John P.A. Ioannidis’s “Why Most Published Research Findings are False” (PLoS Med 2,8 (2005); Joseph P. Simmons et al., “False-Positive Psychology: Undisclosed Flexibility in Data Collection and Analysis Allows Presenting Anything as Significant,” Psychological Science 22,11 (2011), 1359–66; C. Glenn Begley and Lee M. Ellis, “Drug development: Raise standards for preclinical cancer research,” Nature 483 (2012), 531–33; and David Randall and Christopher Welser, The Irreproducibility Crisis in Modern Science: Causes, Consequences, and the Road to Reform (New York: National Association of Scholars, 2018). After nearly 40 years as a professor and researcher and over 30 years as a peer reviewer for over 30 professional journals, the National Science Foundation, and the National Institutes of Health, Robert Higgs wrote:

Peer review, on which lay people place great weight, varies from being an important control, where the editors and the referees are competent and responsible, to being a complete farce, where they are not. As a rule, not surprisingly, the process operates somewhere in the middle, being more than a joke but less than the nearly flawless system of Olympian scrutiny that outsiders imagine it to be. Any journal editor who desires, for whatever reason, to reject a submission can easily do so by choosing referees he knows full well will knock it down; likewise, he can easily obtain favorable referee reports. … Personal vendettas, ideological conflicts, professional jealousies, methodological disagreements, sheer self-promotion, and a great deal of plain incompetence and irresponsibility are no strangers to the scientific world …. In no event can peer review ensure that research is correct in its procedures or its conclusions.

[ii] The release, in 2009 and 2011, of thousands of emails exchanged by leading proponents of the view that AGW/ACC is historically unprecedented and probably of so great a magnitude as to justify actions costing trillions of dollars to mitigate it revealed widespread corruption of the peer review process to prevent the publication of high-quality papers that questioned that view or to ensure the publication of low-quality papers that affirmed it. Ivan Kenneally wrote in The New Atlantis of those emails:

These behind-the-scenes discussions among leading global-warming exponents are remarkable both in their candor and in their sheer contempt for scientific objectivity. There can be little doubt after even a casual perusal that the scientific case for global warming and the policy that springs from it are based upon a volatile combination of political ideology, unapologetic mendacity, and simmering contempt for even the best-intentioned disagreement.

Such practices and others that feed a dubious perception of strong scientific consensus have been ably documented in numerous publications, including Ross McKitrick’s “Bias in the Peer Review Process: A Cautionary and Personal Account,” A.W. Montford’s Hiding the Decline: A history of the Climategate affair, and David H. Douglass and John R. Christy’s “A Climatology Conspiracy?”

[iii] https://www.regulations.gov/contentStreamer?documentId=EPA-HQ-OA-2018-0259-0039&attachmentNumber=1&contentType=pdf, May 4, 2018.

[iv] https://s3.amazonaws.com/ucs-documents/science-and-democracy/secret-science-letter-4-23-2018.pdf, April 23, 2018.

[v] See Stephen McIntyre and Ross McKitrick, “Hockey Sticks, Principal Components and Spurious Significance,” Geophysical Research Letters 32,3 (12 February 2005), and other linked papers at https://www.rossmckitrick.com/paleoclimatehockey-stick.html.

[vi] Economists have estimated the relationship between a decline in national income and the loss of life that will result. One study indicates that a life is lost, on average, for an income decline of $10 million to $15 million. (Randall Lutter and John F. Morrall III, “Health-Health Analysis: A New Way to Evaluate Health and Safety Regulation,” Journal of Risk and Uncertainty 8,1 (1994): 43–66.) Another approach indicates that it takes a $17 million income decline to result in one lost life. (Randall Lutter, John F. Morrall III, and W. Kip Viscusi, “The Cost-Per-Life-Saved Cutoff for Safety Enhancing Regulations,” Economic Inquiry 37,4 (1999): 599–608.) Still another study concluded that if regulatory costs are borne equally among the public, each $5 million in regulatory costs will induce one fatality, and if borne in proportion to income, each $11.5 million will do so. (Ralph L. Keeney, “Estimating Fatalities Induced by the Economic Costs of Regulations,” Journal of Risk and Uncertainty 14 (1997): 5–23.) This means that some regulations may cost more lives through reduced income than they save by avoiding the risk against which they regulate.