A Strategy to Stop EPA Science Abuse

There is a way to stop the EPA's abuse of science and prevent their continued aggressive regulatory activity that destroys the economy and causes harm to Americans.  Primarily, we have to hold the EPA to good scientific principles and stop the EPA's overreaching and panic-mongering. 

The method that will work is a well-established judicial and legal demand for good scientific evidence as described in the Daubert supreme court opinion, explained in the book by the Federal Judicial Center -- the Reference Manual on Scientific Evidence.     

The Supreme Court opinion in Daubert v. Merrell Dow, 509 U.S. 579 (1993) set out rules on assessing the reliability of scientific evidence.  To educate judges on how to conduct judicial affairs consistent with the Daubert rules, the Federal Judicial Center published the Reference Manual on Scientific Evidence (RMSE) in 1994.     

Properly used, the RMSE and Daubert will stop the scientific misconduct of the United States EPA and refute their claims that air pollution regulations and other pollution laws  save thousands of lives.  In fact, the environment of America is safe and low-risk, and the EPA is promoting unjustified concerns and panics.

A challenge to EPA science and claims used to justify aggressive regulatory actions will also restore rationality and sensible scientific inquiry to environmental policy-making.

RMSE Content and Acceptance

Based on the Daubert evidentiary dicta, the Federal Judicial Center  (FJC) has published  3 editions of the RMSE (1994, 2000, and 2011) to educate judges on how to be gatekeepers for good science testimony and evidence in the courtroom.      

The RMSE introductory chapters are on the Daubert opinion and how it affects the federal rules of evidence (1975) and testimony under Federal Rules of Evidence Rule 702 ("Testimony by Experts").

The first and second editions of the RMSE are similar -- legal introduction, then science of statistics, multiple regressions, survey research, economic damages, epidemiology, toxicology, DNA evidence.  The second edition added chapters on how science works, medical testimony, and civil engineering.  The third added chapters on exposure science, neuroscience, and mental health evidence while expanding and improving the content and discussions of all the chapters of the second.

The National Research Council (of the National Academies of Science) committee to   evaluate the first and second editions of the RMSE commented in 2009 that the RMSE was an "extremely effective tool for judges, practitioners, and scholars interested in gaining a better understanding of the underpinnings of various scientific disciplines."   One hundred thousand copies of the second edition were sold.  The FJC sponsored workshops on Daubert and the Manual, video programs were broadcast to courthouses over the Federal Judicial Television network, and CDs were sent to judges by request.

Problems with Jon Samet

Jon Samet, M.D., M.S. (Epidemiology), chair of epidemiology at Johns Hopkins, served on the National Research Council Review Committee on the first and second editions of the RMSE.  Dr. Samet is chair of the United States Environmental Protection Agency (U.S. EPA) Clean Air Scientific Advisory Committee, and a well-paid consultant, reviewer, and basic researcher for the EPA.  His financial and professional conflicts are alarming, since he has received millions in grant funding and consultancy fees from the EPA, but he is proposed to be an objective reviewer of EPA research and policy-making. 

Worse than the obvious financial conflicts, Dr. Samet's research and the research he reviews and approves that is sponsored by the EPA violate the scientific rules outlined by the RMSE chapter on epidemiology in the book that he and others praised as members of the National Research Council review committee.

The irony is that one of the authors of the chapter on epidemiology in all three editions of the RMSE was Dr. Samet's predecessor as chair in epidemiology at Johns Hopkins, Leon Gordis, M.D., Dr. P.H.  So Dr. Samet in his professional work alternately praises and then ignores the guidance of Dr. Gordis on basic epidemiology in the RMSE.

RMSE guidance on Epidemiology

The second edition at page 375 recites the Bradford Hill rules of toxicology:

The factors that guide epidemiologists in making judgments about causation

are:

1. temporal relationship;

2. strength of the association;

3. dose-response relationship;

4. replication of the findings;

5. biological plausibility (coherence with existing knowledge);

6. consideration of alternative explanations;

7. cessation of exposure;

8. specificity of the association; and

9. consistency with other knowledge.

At page 376, relative risk (measure of effect) is discussed:

The relative risk is one of the cornerstones for causal inferences. 116 Relative risk measures the strength of the association. The higher the relative risk, the greater the likelihood that the relationship is causal. 117 For cigarette smoking, for example, the estimated relative risk for lung cancer is very high, about 10. 118 That is, the risk of lung cancer in smokers is approximately ten times the risk in nonsmokers.

Page 384 exposes Dr. Samet and EPA scientific error on observational air pollution studies:

When the relative risk reaches 2.0, the agent is responsible for an equal number of cases of disease as all other background causes. Thus, a relative risk of 2.0 (with certain qualifications noted below) implies a 50% likelihood that an exposed individual's disease was caused by the agent. A relative risk greater than 2.0 would permit an inference that an individual plaintiff's disease was more likely than not caused by the implicated agent[.]

No study by the EPA or Dr. Jon Samet has ever demonstrated a human health effect from air pollution with a relative risk of two or more, which means that Dr. Samet and the EPA researchers he approves and works with produce unreliable science with weak associations that could easily be false positives in the range of confounders or even background rate of events (noise).  That is not the way to do good science, and no one can claim that such science informs rational regulatory policy-making.   

All the EPA studies (including those done by Samet and his associates) used to claim that the EPA is saving lives or to justify air pollution regulations have weak associations that prove nothing and are unreliable -- i.e., they are within the "noise" (normal variability) range for the premature death endpoint that they report.  Samet and his EPA researcher colleagues are harvesting "deaths" from the normal variability of day-to-day events and calling them deaths from air pollution.  It's nonsense, and they must know it.

Now the EPA and Dr. Samet assert the theory of "no threshold" to air pollution toxicology.  Chemical toxicology still is based on thresholds.  "No threshold" chemical air pollutant toxicology turns the Clean Air Act on its head and nullifies and abandons the Clean Air Act strategy intended by the Congress.

The EPA human health effects on science cannot be defended, and the aggressive air pollution regulatory regime is based on a scientific house of cards that can be brought down by an effective legal and political/legislative challenge.   

-Steve Milloy, MHS, J.D., LLM and John Dale Dunn, M.D., J.D.

There is a way to stop the EPA's abuse of science and prevent their continued aggressive regulatory activity that destroys the economy and causes harm to Americans.  Primarily, we have to hold the EPA to good scientific principles and stop the EPA's overreaching and panic-mongering. 

The method that will work is a well-established judicial and legal demand for good scientific evidence as described in the Daubert supreme court opinion, explained in the book by the Federal Judicial Center -- the Reference Manual on Scientific Evidence.     

The Supreme Court opinion in Daubert v. Merrell Dow, 509 U.S. 579 (1993) set out rules on assessing the reliability of scientific evidence.  To educate judges on how to conduct judicial affairs consistent with the Daubert rules, the Federal Judicial Center published the Reference Manual on Scientific Evidence (RMSE) in 1994.     

Properly used, the RMSE and Daubert will stop the scientific misconduct of the United States EPA and refute their claims that air pollution regulations and other pollution laws  save thousands of lives.  In fact, the environment of America is safe and low-risk, and the EPA is promoting unjustified concerns and panics.

A challenge to EPA science and claims used to justify aggressive regulatory actions will also restore rationality and sensible scientific inquiry to environmental policy-making.

RMSE Content and Acceptance

Based on the Daubert evidentiary dicta, the Federal Judicial Center  (FJC) has published  3 editions of the RMSE (1994, 2000, and 2011) to educate judges on how to be gatekeepers for good science testimony and evidence in the courtroom.      

The RMSE introductory chapters are on the Daubert opinion and how it affects the federal rules of evidence (1975) and testimony under Federal Rules of Evidence Rule 702 ("Testimony by Experts").

The first and second editions of the RMSE are similar -- legal introduction, then science of statistics, multiple regressions, survey research, economic damages, epidemiology, toxicology, DNA evidence.  The second edition added chapters on how science works, medical testimony, and civil engineering.  The third added chapters on exposure science, neuroscience, and mental health evidence while expanding and improving the content and discussions of all the chapters of the second.

The National Research Council (of the National Academies of Science) committee to   evaluate the first and second editions of the RMSE commented in 2009 that the RMSE was an "extremely effective tool for judges, practitioners, and scholars interested in gaining a better understanding of the underpinnings of various scientific disciplines."   One hundred thousand copies of the second edition were sold.  The FJC sponsored workshops on Daubert and the Manual, video programs were broadcast to courthouses over the Federal Judicial Television network, and CDs were sent to judges by request.

Problems with Jon Samet

Jon Samet, M.D., M.S. (Epidemiology), chair of epidemiology at Johns Hopkins, served on the National Research Council Review Committee on the first and second editions of the RMSE.  Dr. Samet is chair of the United States Environmental Protection Agency (U.S. EPA) Clean Air Scientific Advisory Committee, and a well-paid consultant, reviewer, and basic researcher for the EPA.  His financial and professional conflicts are alarming, since he has received millions in grant funding and consultancy fees from the EPA, but he is proposed to be an objective reviewer of EPA research and policy-making. 

Worse than the obvious financial conflicts, Dr. Samet's research and the research he reviews and approves that is sponsored by the EPA violate the scientific rules outlined by the RMSE chapter on epidemiology in the book that he and others praised as members of the National Research Council review committee.

The irony is that one of the authors of the chapter on epidemiology in all three editions of the RMSE was Dr. Samet's predecessor as chair in epidemiology at Johns Hopkins, Leon Gordis, M.D., Dr. P.H.  So Dr. Samet in his professional work alternately praises and then ignores the guidance of Dr. Gordis on basic epidemiology in the RMSE.

RMSE guidance on Epidemiology

The second edition at page 375 recites the Bradford Hill rules of toxicology:

The factors that guide epidemiologists in making judgments about causation

are:

1. temporal relationship;

2. strength of the association;

3. dose-response relationship;

4. replication of the findings;

5. biological plausibility (coherence with existing knowledge);

6. consideration of alternative explanations;

7. cessation of exposure;

8. specificity of the association; and

9. consistency with other knowledge.

At page 376, relative risk (measure of effect) is discussed:

The relative risk is one of the cornerstones for causal inferences. 116 Relative risk measures the strength of the association. The higher the relative risk, the greater the likelihood that the relationship is causal. 117 For cigarette smoking, for example, the estimated relative risk for lung cancer is very high, about 10. 118 That is, the risk of lung cancer in smokers is approximately ten times the risk in nonsmokers.

Page 384 exposes Dr. Samet and EPA scientific error on observational air pollution studies:

When the relative risk reaches 2.0, the agent is responsible for an equal number of cases of disease as all other background causes. Thus, a relative risk of 2.0 (with certain qualifications noted below) implies a 50% likelihood that an exposed individual's disease was caused by the agent. A relative risk greater than 2.0 would permit an inference that an individual plaintiff's disease was more likely than not caused by the implicated agent[.]

No study by the EPA or Dr. Jon Samet has ever demonstrated a human health effect from air pollution with a relative risk of two or more, which means that Dr. Samet and the EPA researchers he approves and works with produce unreliable science with weak associations that could easily be false positives in the range of confounders or even background rate of events (noise).  That is not the way to do good science, and no one can claim that such science informs rational regulatory policy-making.   

All the EPA studies (including those done by Samet and his associates) used to claim that the EPA is saving lives or to justify air pollution regulations have weak associations that prove nothing and are unreliable -- i.e., they are within the "noise" (normal variability) range for the premature death endpoint that they report.  Samet and his EPA researcher colleagues are harvesting "deaths" from the normal variability of day-to-day events and calling them deaths from air pollution.  It's nonsense, and they must know it.

Now the EPA and Dr. Samet assert the theory of "no threshold" to air pollution toxicology.  Chemical toxicology still is based on thresholds.  "No threshold" chemical air pollutant toxicology turns the Clean Air Act on its head and nullifies and abandons the Clean Air Act strategy intended by the Congress.

The EPA human health effects on science cannot be defended, and the aggressive air pollution regulatory regime is based on a scientific house of cards that can be brought down by an effective legal and political/legislative challenge.   

-Steve Milloy, MHS, J.D., LLM and John Dale Dunn, M.D., J.D.

RECENT VIDEOS