EPA Hearing Exercise

There is no substitute for preparation for a Congressional Hearing, just like for a debate, a deposition or a trial. Just like preparing for a test. Must know the material and plan the strategy to accomplish the goal.

Congressional oversight depends on scholarship and preparation. My impression is that congressmen are either too busy or overwhelmed and don’t use their resources well. In the past year I have watched congressional physicians and certainly less qualified or knowledgeable congressmen fail to put the challenges in a proper context when EPA official or researcher witnesses appeared and in all cases, I think the physician congressman was not well advised or supported in the effort—I cannot imagine that they would fail to be effective if they were better prepared.
I cannot countenance some of the ineffectual examinations or excuse it because of a lack of resources or intelligence. Congress has a pick of experts available to them and great lawyers and academics at the top of their game, to compose a proper strategy and content for examination of a witness.
However in the 2 years I have watched the Congress closely I have been repeatedly disappointed and it means we have lost opportunities to rein in the rogue agency that is the US EPA.
This week a hearing featuring a solo performance by the new US EPA Administrator was intended to raise the issue of “secret science” which is epidemiology that is preformed without publication of methods and data sets.
Lamar Smith, Chair of the Space Science and Technology House Committee intends to introduce a bill that obligates taxpayer funded researchers to release their research methods and data for review.
This proposal is doomed to failure in the Senate and will not accomplish a proper challenge to misconduct and bad science by the EPA because, in my humble opinion, we already know what we need to know and the slow revelation of science methods and data will just produce quibbling and debate, with no real effort to expose why the EPA sponsors and relies on bad epidemiology.
The simple answer to the problem of bad epidemiology is to apply the rules. In observational studies like the US EPA uses, small associations (RR less than 2, much less) don’t prove anything at all, so a small association is the best they can do with “secret science?” That’s as good as a null finding and does not support their claims of saving hundreds of thousands of lives. There is another major reason their studies are scientific junk—they have no plausible mechanism for small particle exposures causing disease or death at the levels of ambient pollution that they intend to regulate.
From the 2nd edition of the Federal Judicial Center’s Reference Manual on Scientific Evidence (2000 West Publishing)
Reference Manual on Scientific Evidence
Page 384
The threshold for concluding that an agent was more likely than not the
cause of an individual’s disease is a relative risk greater than 2.0. Recall that a
relative risk of 1.0 means that the agent has no effect on the incidence of disease.
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 ex-
posed 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. 139 A substantial number of courts
in a variety of toxic substances cases have accepted this reasoning.

For the 3rd Edition (2013 National Academies Press)

. How Strong Is the Association Between the Exposure and
Disease?155
The relative risk is one of the cornerstones for causal inferences.156 Relative risk measures the strength of the association. The higher the relative risk, the greater the likelihood that the relationship is causal.157 For cigarette smoking, for example, the estimated relative risk for lung cancer is very high, about 10.158 That is, the risk of lung cancer in smokers is approximately 10 times the risk in nonsmokers.
A relative risk of 10, as seen with smoking and lung cancer, is so high that it is extremely difficult to imagine any bias or confounding factor that might account for it. The higher the relative risk, the stronger the association and the lower the chance that the effect is spurious. Although lower relative risks can reflect causality, the epidemiologist will scrutinize such associations more closely because there is a greater chance that they are the result of uncontrolled con- founding or biases.

E. Is the Association Biologically Plausible (Consistent with
Existing Knowledge)?165
Biological plausibility is not an easy criterion to use and depends upon existing knowledge about the mechanisms by which the disease develops. When biological plausibility exists, it lends credence to an inference of causality. For example, the conclusion that high cholesterol is a cause of coronary heart disease is plausible because cholesterol is found in atherosclerotic plaques. However, observations have been made in epidemiological studies that were not biologically plausible at the time but subsequently were shown to be correct.166 When an observation is inconsistent with current biological knowledge, it should not be discarded, but

162. In Kehm v. Procter & Gamble Co., 580 F. Supp. 890, 901 (N.D. Iowa 1982), aff’d, 724 F.2d
613 (8th Cir. 1983), the court remarked on the persuasive power of multiple independent studies, each of which reached the same finding of an association between toxic shock syndrome and tampon use.
163. This may not be the legal standard, however. Cf. Smith v. Wyeth-Ayerst Labs. Co., 278
F. Supp. 2d 684, 710 n.55 (W.D.N.C. 2003) (observing that replication is difficult to establish when there is only one study that has been performed at the time of trial).
164. See Cadarian v. Merrell Dow Pharms., Inc., 745 F. Supp. 409, 412 (E.D. Mich. 1989) (holding a study on Bendectin insufficient to support an expert’s opinion, because “the study’s authors themselves concluded that the results could not be interpreted without independent confirmatory evidence”).
165. A number of courts have adverted to this criterion in the course of their discussions of causation in toxic substances cases. E.g., In re Phenylpropanolamine (PPA) Prods. Liab. Litig., 289 F. Supp. 2d 1230, 1247–48 (W.D. Wash. 2003); Cook v. United States, 545 F. Supp. 306, 314–15 (N.D. Cal. 1982) (discussing biological implausibility of a two-peak increase of disease when plotted against time); Landrigan v. Celotex Corp., 605 A.2d 1079, 1085–86 (N.J. 1992) (discussing the existence vel non of biological plausibility); see also Bernard D. Goldstein & Mary Sue Henifin, Reference Guide on Toxicology, Section III.E, in this manual.
166. See In re Rezulin Prods. Liab. Litig., 369 F. Supp. 2d 398, 405 (S.D.N.Y. 2005); In re
Phenylpropanolamine (PPA) Prods. Liab. Litig., 289 F. Supp. 2d 1230, 1247 (W.D. Wash. 2003).
604
Reference Guide on Epidemiology
the observation should be confirmed before significance is attached to it. The saliency of this factor varies depending on the extent of scientific knowledge about the cellular and sub cellular mechanisms through which the disease process works. The mechanisms of some diseases are understood quite well based on the available evidence, including from toxicological research, whereas other mechanism explanations are merely hypothesized—although hypotheses are sometimes accepted under this factor.167

All of this information on rules of epidemiology in observational studies is clearly and cogently discussed in the Federal Judicial Center’s Reference Manual on Scientific Evidence, 3rd Ed. (2012 National Academies Press) Chapter on Epidemiology.
There are many areas of Misconduct of the EPA and a fine list was included in a speech by former Chair of the Energy and Commerce Committee of the House Joe Barton in an opening statement speech he gave to the Energy and Commerce US EPA budget hearings in late February of 2012.
I take this list from an essay Steve Milloy and I wrote for American Thinker. I give Credit to Committee Policy advisor Anita Bradley, for composing the speech for Congressman Barton.
The link to the speech is at:
http://junkscience.com/2012/03/02/joe-barton-on-the-epa-budget-for-fy-2013/
Thanks Anita Bradley, probably the most effective challenge to the EPA’s overreach that was pronounced in the Congress for at least a decade.
_____________________
Congressman Barton’s opening statement ticked off the following list of problems he had with the US EPA, including agency:
1. Failure to comply with Obama Executive Order 13563 requiring regulations that promote economic growth, innovation, competitiveness and jobs with the least burdensome tools for achieving regulatory ends, taking “into account benefits and costs, both quantitative and qualitative” (quoting from the Executive order);
2. Promulgation of power plant regulations that have driven energy costs higher without reasonable justification;
3. Failure to Congressional criticism of regulatory actions, including requests for public health and economic research data and justifications of policy decisions;
4. Disregard of blatant conflicts of interest among its science advisers who receive tens of millions of dollars in research grants from the agency wile also posturing as independent reviewers of agency science;
5. Failure to require that its sponsored researchers follow established rules of public health research with respect to toxicology and epidemiology;
6. Inappropriate reliance on the precautionary principle;
7. Circumvention of Congressional oversight; and
8. Grant-giving to advocacy groups that then enter into collusive lawsuits and aggressive regulatory requests that promote the agency’s agenda and expand its regulatory and political power.
Now there is much to be said about the items listed, however my experience is that hearings accomplish very little because an efficient and goal directed examination of a reluctant or uncooperative (hostile) witness is a work of art.
I know a little about the issues, and I am an attorney, with a little knowledge of examining witnesses, so I am compelled to suggest that the hearings this week accomplished very little. I am not looking for Perry Mason moments, but sometimes a good examination of a witness can achieve important things. That requires strategic thinking before and then proper tactics during the hearing.
The examination of the US EPA administrator by anyone intent on challenging the policy making and regulatory regime on air pollution (climate and carbon dioxide is not well suited for this discussion) that is considered to be excessive, means identifying the critical foundations for EPA policy making, the places where it is based on bad science and the places where other misconduct of the EPA discredits the agency and its operations.
Congressman Barton’s list above is excellent but too ambitious, and the only item I would concentrate is the key to everything that the US EPA does because it is their golden fleece—they claim that they are saving hundreds of thousands of lives. That is based on their population research. My simple focus and proposal on hearing strategy and tactics is restricted to item 5. Other areas of vulnerability on US EPA conduct and operations are in the rest of the list, but the key to their extraordinary power and reach is that they claim they are trying to save hundreds of thousands of lives from air pollution emitted from energy plants, industrial activities and gas or diesel fueled engines
The Examination should establish clearly from the mouth of the administrator
1. The EPA asserts that small particle air pollution causes hundreds of thousands of premature deaths in America every year.
2. The regulation of small particle air pollution is an essential element of the air pollution regulatory regime of the EPA and the benefits of small particle regulation are the major contributor to EPA estimates of benefits of their air pollution regulatory regime.
3. The basis for the claim that small particles air pollution causes hundreds of thousands of deaths is epidemiological studies that show “associations” of air pollution with premature deaths in observational population studies.
4. That recently the EPA has added carcinogenicity to the dangers of small particle air pollution.
5. That the EPA has adopted the position that there is no safe level of small particle air pollution.
Once those 5 points are conceded by the Administrator the examination can become a noose around the EPA Neck of their own construction.
Proposed script for the take down of the Administrator or the Air chief for US EPA.
Examiner
Good Morning Madam, Thank you for making yourself available today for this hearing.
I trust you have seen, read and analyzed the three documents that I have made a part of the record that will be the focus of my brief examination today.
I will proceed.
1. Do you agree with the testimony of US EPA Administrator Jackson in House Committee hearings in 2012 that small particle pollution causes death and is a toxin comparable in effect with cancer? (See endnote 1 below)
2. Do you agree with Jon Samet, MD Chair of the Clean Air Scientific Advisory Committee of the US EPA, when he said in the New England Journal of Medicine that there is no safe level of small particle air pollution? (See endnote 2 below)
3. Do you agree with the Declarations under penalty of perjury by US EPA research official Eugene Cascio MD that small particle human exposure experiments were and are being conducted at 10 domestic and 6 foreign Medical Institutions sponsored by and funded by US EPA in many cases? (See endnote 3 below)
Cascio says in his declaration
“Between 2000 and 2012 environmental research scientists in the US and abroad published 61 controlled human exposure studies in peer-reviewed scientific journals related to PM exposures. These controlled human exposure studies encompassed a variety of common air pollutants including: concentrated air particles, dilute diesel exhaust, wood smoke, and ultrafme carbon and zinc particles. Only 8, or 13% of these studies were conducted and published by the US EPA. The balance of studies, or 87% of all controlled human exposure studies to PM were approved, conducted and published by non-EPA scientists. Other institutions who have or are conducting such studies include: the University of Rochester School of Medicine and Dentistry, Rochester, NY; University of Michigan, Ann Arbor, MI; University of Washington, Seattle, WA; University of Southern California, Los Angeles, CA; Rutgers The State University and University of Medicine and Dentistry ofNew Jersey­ Robert Wood Johnson Medical School,Piscataway, NJ. All ofthese studies have been approved by Institutional Review Boards as conforming to the provisions of the Common Rule. In addition, similar studies involving controlled human exposure to PM are conducted by non-domestic institutions including the University of Toronto, Toronto, Ontario, Canada; University of Edinburgh, Edinburgh, UK, Goteborg University, Goteborg, Sweden; Umea University, Umea, Sweden; University of Copenhagen, Denmark, and the University of Southampton, Southampton, UK.
4. Do you approve and agree with the conduct of the experiments sponsored and funded by EPA as described by Martin Case Ph D that includes not providing a written consent that includes the warnings of small particle toxicity, as declared by Martin Case PhD in his Declaration under penalty of perjury? (See endnote 5 below)
At Paragraph 14.
I provide participants with information about fine particles (PM2.s). I say that PM2.s are particles so small that they are able past through your airways and go deep into your lungs, these particles are so small that your usual lining and cilia of your airways are not able to prevent these particles from passing into your lungs, Therefore, if you are a person that for example lives in a large city like Los Angeles or New York, and it’s been a very hot day, and you can see the haze in the air, and you happen to be someone that works outside, and if you have an underlying unknown health condition, or, you may be older in age; the chances are that you could end up in the emergency room later on that night, wondering what’s wrong, possibly having cardiac changes that could lead to a heart attack; there is the possibility you may die from this.
5. Do you agree with Robert Devlin Ph D, lead US EPA researcher on the human experimentation project in North Carolina when he says in his declaration to the court under penalty of perjury, that the human experiments are necessary because the epidemiological evidence is not reliable proof of toxicity of small particles? See Endnote 6 below)
Beginning in pargraph 6
Epidemiological studies typically use data from large populations of people with varying susceptibility to PM2.5 and evaluate the relationship between short or long-term changes in ambient levels ofPM2.5, e.g. changes in the 24-hour average level ofPM2.5 measured at monitors in a metropolitan area, with changes in mortality and morbidity such as the numbers of emergency department visits and hospital admissions. This generally involves the use of complex statistical methods to evaluate the mathematical relationship between variations in measured ambient air pollution levels and health data.
7. Epidemiological observations are the primary tool in the discovery of risks to public health such as that presented by ambient PM2.5. However, epidemiological studies do not generally provide direct evidence of causation. They indicate the existence or lack of a statistical relationship between ambient levels of PM2.5 and adverse health outcomes. Large population studies cannot assess the biological mechanisms (called biological plausibility) that could explain how inhaling ambient air pollution particles can cause illness or death in susceptible individuals. This sometimes leaves open the question of whether the observed association in the epidemiological study is causal or whether PM2.5 is merely a marker for some other unknown substance.
8. Controlled human exposure studies conducted by EPA scientists and EPA funded scientists at multiple universities in the United States fill an information gap that cannot be filled by large population studies. In 1998 the Committee on Research Priorities for Airborne Particulate Matter was established by the National Research Council in response to a request from Congress. The committee was charged with producing four reports over a five-year period which describe a conceptual framework for an integrated national program of particulate-matter research and identified the most critical research needs linked to key policy-related scientific uncertainties. Excerpts from their most recent report (published in 2004) are attached as Exhibit
1 to this Declaration. On page 36 the Committee says:
Controlled human exposure studies offer the opportunity to study small numbers of human subjects under carefully controlled exposure conditions and gain valuable insights into both the relative deposition of inhaled particles and the resulting health effects. Individuals studied can range from healthy people to individuals with cardiac or respiratory diseases of varying degrees of severity. In all cases, the specific protocols defining the subjects, the exposure conditions, and the evaluation procedures must be reviewed and approved by institutional review boards providing oversight for human experimentation. The exposure atmospheres studied vary, ranging from well-defined, single-component aerosols (such as black carbon or sulfuric acid) to atmospheres produced by recently developed particle concentrators, which concentrate the particles present in ambient air. The concentrations of particles studied are limited by ethical considerations and by concern for the range of concentrations, from the experimental setting to typical ambient concentration, over which findings need to be extrapolated.
Madam Adminstrator (or Air chief), How can US EPA sponsor human experiments that expose subjects to premature death?
How can you excuse not knowing such experiments were being conducted for a decade or more funded by US EPA and conducted in US EPA labs in some cases?
This is a good one, at the hearing this past week Ms. McCarthy claimed she didn’t know about human experiments and then she said that she knew they were conducted in an ethical manner..
http://junkscience.com/2013/11/14/epa-administrator-has-no-knowledge-of-inhumane-experiments
Madam, Tell the committee and the audience right here and now—is the US EPA misrepresenting the toxicity of small particle pollution?
or
Is the US EPA sponsoring and funding human exposure experiments that might kill or injure unknowing and uninformed experimental subjects?
Last 2 questions.
1. If the US EPA has been successful in convincing the congress and the public that small particles are lethal, why was or is the human experimentation necessary?
2. Madam, will you announce a suspension of these human exposure experiments until they are properly investigated.by a non EPA investigation agency in coordination with the FBI?
References for the matters of the examination:
1) Lisa Jackson states Small particle air pollution is the most toxic substance on earth.

The Most Toxic Substance on Earth

2) Samet J, The clean air act and health — a clearer view from 2011,
N Engl J Med 2011; 365:198-201 July 21, 2011.
http://junkscience.com/2013/10/24/human-exposed-to-carcinogen/
3) Eugene Cascio declaration. American Traditions Institute v. US EPA in Federal District Court Alexandria Division Eastern District Virginia. Civil Action No. 1:12-CV-1066-AJT-TCB.
4) http://junksciencearchive2.files.wordpress.com/2013/10/14-1-us-declarations-in-opp-to-tro.pdf
5) Martin Case declaration American Traditions Institute v. US EPA in Federal District Court Alexandria Division Eastern District Virginia. Civil Action No. 1:12-CV-1066-AJT-TCB.
http://junkscience.com/2012/10/05/epa-admits-to-court-human-subjects-may-die-from-air-pollution-experiments/
6) Robert Devlin declaration in the lawsuit American Traditions Institute v. US EPA in Federal District Court Alexandria Division Eastern District Virginia. Civil Action No. 1:12-CV-1066-AJT-TCB.
7) This is the comprehensive document on the declarations that includes all the EPA officials, Cascio, Case, Devlin and others.

Click to access 14-1-us-declarations-in-opp-to-tro.pdf

Additional references of interest to this group of readers but not subject matter for the discussion of the hearing exam.
.
Article on carcinogenesis of small particles.
Kelland K, Nebehay S, Air pollution a leading cause of cancer – U.N. agency
Oct. 17 2013 Reuters on line. Oct, 17, 2013.
http://mobile.reuters.com/article/idUSBRE99G0BB20131017?irpc=932
Article on the original eXperiment that attracted Milloy and Dunn to the human experimentation project.
We found out that US EPA was exposing people with varying degrees of medical problems to high level of small particulate air pollution in chambers at a University of North Carolina co-sponsored EPA lab.
Ghio A, Bassett M, Montilla T, et. al. Case Report: Supraventricular Arrhythmia after Exposure to Concentrated Ambient Air Pollution Particles, Environ Health Perspect. 120(2): 275–277. February, 2012, Published online 2011 September 6, 2013. doi: 10.1289/ehp.1103877
http://www.ncbi.nlm.nih.gov/pmc/?term=10.1289/ehp.1103877
Milloy S, Did Obama’s EPA relaunch Tuskegee experiments? Human trials vainly tried to prove air pollution is deadly. Washington Times, Tuesday, April 24, 2012.
Milloy S, EHP refuses to investigate EPA researcher misconduct
Posted on November 5, 2012,
http://junkscience.com/2012/11/05/ehp-refuses-to-investigate-epa-researcher-misconduct/
Milloy S, EPA Inspector General Asked to Investigate Illegal Human Experimentation
Posted on May 14,2012
http://junkscience.com/2012/05/14/epa-inspector-general-asked-to-review-illegal-human-experimentation/
Article by Milloy and Dunn Environmental protection agency’s air pollution research: unethical and illegal.
http://www.jpands.org/jpands1704.htm
and an essay by Dunn at American Thinker
http://www.americanthinker.com/2012/06/epas_unethical_air_pollution_experiments.html