The EPA Human Experiments:

Agency Scientists Ignore Rules for the Protection of Human Subjects Established After World War II and Tuskegee Syphilis Experiments

Overview

Since at least 2004 and up through the Obama administration, the U.S. Environmental Protection Agency (EPA) has been secretly testing highly toxic/lethal air pollutants on unhealthy human study subjects for the sole purpose of finding out what harm would be caused by the exposures. In no case, were the human study subjects fully informed of the dangers posed by the experimentation, nor were they intended to benefit from the experimentation.

The mere approval and conduct of these experiments (in which the EPA treated human beings as guinea pigs for toxicity testing), not to mention the EPA’s failure to obtain informed consent from the study subjects, violates virtually every regulation established since World War II, including federal regulations and EPA’s own rules, concerning the protection of human subjects used in scientific experimentation. EPA may also incur criminal and civil liabilities from this conduct.

What are the EPA experiments?

EPA has conducted/is conducting at least four separate projects in which already-unhealthy study subjects were/are being exposed to high-levels of diesel exhaust and toxic air pollution particles (known as “PM_2.5”). “High-levels” means exposures 10-20 times greater than EPA regulatory standards.

• XCON Study. Starting in 2004, the EPA exposed adults with metabolic syndrome (including the elderly) to high levels of toxic PM_2.5.
• OMEGACON Study. Starting in 2007, the EPA exposed older adults to high levels of diesel exhaust (which contains PM_2.5 and other “toxic” substances) and then “treated” them with omega-3 fatty acids to see if whatever harm caused by PM2.5 was mitigated. In 2008, the diesel exhaust was replaced by plain PM_2.5.
• KINGCON Study. Starting in 2008, the EPA exposed older adults with moderate asthma to PM_2.5.
• CAPTAIN Study. The EPA is now recruiting older adults (including the elderly up to 75 years) to “… find out if a component of ambient air pollution to which we are all exposed, particulate matter (PM), produced by car and coal-fired power plants, increases the risks of changes in the heart and whether genotype will lessen the risks caused by PM.

How were these experiments discovered?

A series of document requests pursuant to the Freedom of Information Act were made during 2011-2012 by JunkScience.com publisher Steve Milloy.

What does EPA say about PM_2.5 and diesel exhaust?

• Official Scientific Assessments.EPA’s uses these documents to justify regulatory action. According to EPA’s assessments:

  — Any inhalation of PM_2.5 can kill (i.e., there is no “safe” exposure”).
  — Inhalation of PM_2.5 can kill within mere hours of the exposure.
  — PM2.5 is a likely cause of cancer by inhalation.
  — Diesel exhaust is composed of PM_2.5.
  — Diesel exhaust is a likely cause of cancer by inhalation.

• Regulatory Actions. EPA has regulated PM2.5 since 1997 on the basis that it kills people, including on a short-term basis (i.e., hours or days). EPA issued the Cross-State Air Pollution Rule and the Mercury Air Toxics Standard in 2011, asserting that the rules, by reducing PM_2.5 from coal power plant emissions, would prevent up to 320,000 deaths per year.
• Congressional Testimony.EPA Administrator Lisa Jackson testified before Congress in September 2011 that:
  — “Particulate matter causes premature death. It doesn’t make you sick. It’s directly causal to dying sooner than you should.”
  — “If we could reduce particulate matter to levels that are healthy we would have an identical impact to finding a cure for cancer.” [i.e., cancer kills about 570,000 in the U.S. annually]

What are the applicable regulations and codes of conduct?

Summarized below are some key points from either landmark or relevant codes of conduct for scientific experiments involving humans.

• Nuremberg Code. Issued by the Nuremberg Tribunal following the “doctor’s trial,” in which Nazi physicians participating in concentration camp-based human experiments were convicted of a variety of offenses, including failure to obtain informed consent from human study subjects, the Nuremberg Code: (1) requires that “informed consent” be obtained from study subjects and (2) prohibits dangerous experimentation (i.e., that in which there is pre-existing reason to believe death or injury might occur).
• The Common Rule. Developed in the wake of the infamous Tuskegee syphilis experiments, these federal regulations require also informed consent and require that any risks imposed on subjects must be reasonable in relation to anticipated benefits, if any, that they may obtain. The Common Rule also establishes the requirement and role of an institutional review board in approving and monitoring experiments.
• EPA Order 1000.17. Enhancing the protection of human subjects provided the Common Rule, EPA Order 1000.17 establishes a presumption against the approval of an experiment involving the risk of substantial injury from the conduct of the experiment.
• North Carolina civil and criminal law. All the experiments were conducted at an EPA facility housed at the University of North Carolina School of Medicine (UNC) and all experiments were approved by a required-by-regulation and UNC-convened institutional review board (IRB). Failure to obtain the “informed consent” of the study subjects means that the intentional exposure of the human study subjects to toxic substances could constitute assault and battery. “Consent” obtained by omission or misrepresentation could also be fraud. Assault and battery, and fraud carry civil and criminal penalities.

What are some of the major violations of the applicable laws and regulations running throughout the EPA experiments?

• Human beings as guinea pigs. Each experiment treated the human subjects as guinea pigs (i.e., all risk of serious harm/death and no personal benefit to the subjects).
• Sick people exposed to a lethal toxin. Each experiment involved EPA intentionally exposing unhealthy/health-impaired/health-compromised adults (including elderly adults) to PM_2.5, a substance the EPA has determined to be one of the most lethal substances known to man.
• Consent obtained through misrepresentation/fraud. In each experiment, the EPA failed to fully disclose to the study subjects the true nature of the dangers posed by inhalation of PM2.5, as previously determined by the EPA in its official scientific assessments and public pronouncements. Some study subjects were not informed about the risk of death from PM_2.5; others were not informed that PM2.5 could kill in hours.
• IRB failure. Because of the manifest guinea pig nature of the experiments, none should ever have been approved by the University of North Carolina institutional review board (IRB). The IRB failed to conduct due diligence on the risks of the PM_2.5 exposures.
• IRB approval obtained through misrepresentation. EPA never disclosed to the IRB the true nature (as previously determined by the EPA) of the dangers posed by inhalation of PM_2.5.

Was anyone actually harmed by these experiments?

In October 2010, a 58-year obese woman with personal and family histories of heart problems (e.g., her father died from heart disease when he was age 57), had her experiment terminated early and was taken by EMTs to the hospital when she experienced cardiac arrthymias in the test chamber. In a September 2011 report of the incident published in the U.S. Government journal Environmental Health Perspectives, the EPA concluded that the subject’s arrhythmia was caused by her exposure to PM_2.5.

Although this incident and the reporting of it are another separate controversy (involving the scientific misconduct of “falsification”), its instant relevance is that, even accepting EPA’s conclusion, the agency failed to amend the consent forms so as to disclose this risk of harm to future study subjects — and there have been at least 17 study subjects since that so-called “adverse event.”

Are any of these studies ongoing?

While it’s not clear that the XCON, OMEGACON and KINGCON studies remain active, the CAPTAIN study is ongoing and EPA is actively recruiting human study subjects on the web site EPAStudies.org.

What might be EPA’s defense to these allegations?

EPA will likely defend itself by asserting that: (Excuse #1) its’ been doing these experiments for a long time and that they are no big deal for; (Excuse #2) it’s obtained approval, including for the consent forms, from a duly-constituted institutional review board (IRB); and (Excuse #3) the human subjects were not exposed to excessive levels of PM_2.5 and diesel exhaust, i.e., the risk was “minimal”.

• Excuse #1. If PM_2.5 and diesel exhaust are as dangerous as EPA asserts they are (i.e., in official scientific assessments and statements to Congress/the public, and in how its regulates them), the EPA clearly has broken federal regulations, its own rules and has civil and criminal liability. If EPA does not have such liability, then PM_2.5 must not be as dangerous as claimed. This then draws into question the validity of its scientific assessments, PM_2.5 regulations and related public statements.
• Excuse #2. First, the University of North Carolina IRB had no business approving these ultrahazardous experiments based on what EPA admitted to it about PM2.5. Second, the EPA withheld vital information from the IRB (i.e., that PM_2.5 can kill within hours of any exposure). Moreover, the UNC seems not to have undertaken any significant due diligence concerning EPA’s assertions about PM_2.5. Third, as a long-time multimillion-dollar recipient of EPA largesse (i.e., contracts and grants), the University of North Carolina has an obvious conflict of interest. It’s not even clear that the IRB is properly constituted or complied with federal regulations.
• Excuse #3. First, according to EPA’s scientific assessments, any exposure to PM_2.5 is too much. Second, the EPA repeatedly tried to tamp down IRB concern about the exposure level by claiming that it was no more that would be experienced by visiting Los Angeles, New York or Mexico City on a smoggy day. But Chapel Hill, NC (the area from where the study subjects were recruited) has air much cleaner than that of such urban areas. Chapel Hill, NC-area residents are not normally exposed to high-levels of toxic PM_2.5. The import of this is that the study subjects were exposed to more than “minimal risk” as that term is defined by federal regulations.

Why did EPA conduct these illegal experiments?

The answer to this question can only be guessed at this point. The toxicity and danger of PM_2.5, as asserted by the EPA, is largely based on suspicious statistical work conducted by agency-paid “researchers.” It could very well be that the EPA was attempting to develop real-life evidence of harm from PM2.5 by “threading the needle” — i.e., conducting experiments in which it hoped to detect some sort of adverse effect from the PM2.5 experiments without causing any significant or actual harm to anyone. Regardless of motive, the EPA’s conduct is still barred by federal regulations and EPA’s own rules — as well as the memory of the Nuremberg tribunal, Tuskegee syphilis experiments, and other crimes against humanity committed in the name of medical science.

What’s next?

Contact Steve Milloy by e-mail at milloy@me.com or by phone 240-205-1243 for a briefing.

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