Freedom of Information documents show EPA hid exculpatory results of particulate tests on live humans, legal bases for rulemaking now in doubt

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4/18/12, "EPA human experiments debunk notion of ‘killer’ air pollution: Agency hides exculpatory results," Steve Milloy, Junk Science

"The U.S. Environmental Protection Agency has conducted air pollution experiments on live human subjects that discredit its claims that fine particulate matter kills people.

JunkScience.com obtained the explosive and heretofore undisclosed results through the Freedom of Information Act (FOIA) and reveal them here for the first time.

Introduction.

Last September, JunkScience.com broke the news that EPA researchers had reported in Environmental Health Perspectives the case study of a woman who allegedly suffered atrial fibrillation after being exposed to concentrated airborne fine particulate matter (PM_2.5) in an experimental setting.

After disposing of the EPA’s effort to link the woman’s atrial fibrillation with her exposure to PM_2.5, we commented:

It’s also worth asking whether this is the only study subject that the EPA has studied. Are there others? What were their results? Do we only get to hear about the one result that could possibly be twisted to fit the EPA agenda?

To answer this question, we filed a Freedom of Information Act request with the agency to see if we could get answers those questions.

Result and Analysis of the FOIA Request.

Below is a copy of the of the response we received from the EPA:

This data sheet shows the following:

• EPA has been conducting air pollution effects tests on human subjects since at least January 2010.
• By the time the EPA researchers had published their September 2011 report in Environmental Health Perspectives, they had conducted 41 such tests.
• Of the 41 human experiments, clinical effects were reported by the EPA in only two study subjects. Both of these are controversial. One is the case study reported in Environmental Health Perspectives, which has been previously debunked. The other study subject flagged by the EPA researchers as experiencing a clinical effect (“a short episode of an elevated heart rate during exposure”), in fact, denied feeling any effects. This reported effect was most probably due to some pre-existing condition or other stressor given the low-level of PM_2.5 to which the study subject was exposed. Certainly the EPA has no reason to believe that was not the case or that the alleged heart rate jump was due to the PM_2.5 exposure.
• The other 39 study subjects were exposed to PM_2.5 levels up to 21 times greater (i.e, up to 750 μg/m³) than the EPA’s own permissible exposure limit for PM_2.5 on a 24-hour basis (i.e, 35 μg/m³). All reported exposures among the 39 study subjects were greater than the EPA’s 24-hour PM_2.5 standard. Seven study subjects were exposed to levels 10 times greater than the EPA’s 24-hour PM_2.5 standard. No clinical effects were reported for any of these exposures.

  Discussion.

  There are at least three points to be made in light of this discovery.

  1. The experimental results provide no evidence that ultra-high exposures to PM_2.5 kill.

  EPA administrator Lisa Jackson testified to Congress last September that,

  [Airborne] particulate matter causes premature death. It doesn’t make you sick. It’s directly causal to dying sooner than you should.

  These experiment results — produced by EPA’s own researchers — in no way support Jackson’s assertion.

  2. The experimental results invalidate EPA’s cost-benefit analyses for its CSAPR and MATS rulemakings.

  The EPA justified the multibillion dollar costs of its Cross-State Air Pollution Rule (CSAPR) and its Mercury Air Toxics Standard (MATS) largely on the basis that the rules would prevent thousands of premature deaths from PM_2.5, thereby purportedly providing tens of billions of dollars in monetized health benefits from “lives saved.”

  But ambient levels of PM_2.5 are typically far below the PM_2.5 levels to which subjects were exposed in this EPA experiment. We reported earlier that the EPA’s 24-hour PM_2.5 of 35 μg/m³ was exceeded only about 0.0096% of the time in the U.S. during 2009.

  Moreover, the EPA experiment provides no evidence that PM_2.5, even at very high exposures, causes any health effects, let alone premature death.

  3. EPA and its researchers have heretofore failed to disclose to the public these significant results.

  Finally, there is the matter of the ethics and perhaps even the legality of the conduct of the EPA and its researchers.

  The EPA’s experimental data on PM_2.5 clearly paint a quite different picture than that provided by the September 2011 report in Environmental Health Perspectives and the agency’s recent PM_2.5-related regulations (i.e., CSAPR and MATS).

  The EPA researchers failed to mention the results from the other 40 human experiments in their Environmental Health Perspectives report. At the very least, their failure to disclose their own contrary results raises serious ethical concerns.

  As an agency, the EPA failed to disclose these stunning results in its CSAPR and MATS rulemakings. This ought to raise concerns about the legal bases for these rulemakings. More than simply ignoring its own negative data, the agency seems to have actually hid them from public view.

  Conclusion.

  In addition to these EPA-conducted experiments, there is other compelling data that casts doubt on the EPA’s claim that PM_2.5 causes premature mortality, including historic air pollution data, current Chinese experience with air quality and the study “Fine Particulate Air Pollution and Total Mortality Among Elderly Californians, 1973–2002.”

The results of JunkScience.com’s FOIA request add to this growing body of evidence.

Given the significant actual costs of the EPA’s PM_2.5-related regulations on society, it is incumbent upon Congress to conduct a thorough investigation of the agency and its PM_2.5 claims."

via Tom Nelson