EPA denies Milloy charge of conducting unethical human experiments; Facts show otherwise

Wayne Cascio, director of EPA’s Environmental Public Health Division, responds to Steve Milloy’s Washington Times commentary accusing EPA of conducting unethical human experiments or, in the alternative, exaggerating the dangers of airborne fine particulate matter.

Cascio’s letter is below. Milloy’s comments are in bolded brackets. We have been busy on this issue since the Washington Times commentary was published and will have much more to say soon.


Air-pollution studies important for health
May 1, 2012, The Washington Times

Steve Milloy’s recent Op-Ed (“Did Obama’s EPA relaunch Tuskegee experiments?” Commentary, April 25) makes allegations about critical scientific research into how air pollution might contribute to abnormal heart rhythms. [I accused EPA of either: (1) conducting unethical human experimentation or exaggerating the dangers of fine airborne particulate matter (PM2.5). It must be one or the other; it can’t be neither, according to EPA’s own documents.]

The Environmental Protection Agency’s (EPA) research into the health impacts of air pollution has helped to build healthier communities, provide new technology and develop new solutions to protect and manage air quality. [This is irrelevant propaganda.] In the case of research into fine-particle pollution, more than 50 clinical studies over the past decade involving human volunteers have been published by scientists from the EPA, many U.S. universities and medical centers. These describe cardiac effects in humans exposed to this harmful pollution. [So EPA admits to exposing humans to “harmful pollution.” This is per se unethical human research as there is no individual or societal benefit from exposing humans to known harm (more on the “known” part, below). Also, it appears that the levels of PM2.5 that EPA exposed the study subjects to (as high as 21 times the EPA 24-hour standard of 35 micrograms/cubic meter) are the highest levels humans have ever been exposed to in an experimental setting.]

The EPA follows the Common Rule, which requires the ethical review and oversight of human research by an independent institutional review board (IRB) to ensure that any risks to study volunteers are minimized and justified. The EPA follows strict human safety protocols for all of its studies and these protocols are reviewed and approved by the IRB before any human study is conducted. Precautions are taken throughout the volunteer’s participation to ensure his safety. In the case of the EPA’s research on particle pollution, scientists studied biological changes that carry no or minimal risk while providing evidence for the reasons that particle pollution can lead to serious health problems. [The EPA clearly states in its most recent scientific document on PM2.5 that short-term exposure (i.e., hours or days) to PM2.5 can cause heart attack and/or death. As pointed out in the op-ed, Lisa Jackson’s recent congressional testimony about PM2.5 is even more dire. There is no provision in either the Common Rule or EPA’s other ethical requirements and guidance that permits the intentional exposure of human subjects to the risk of heart attack and/or death. In fact, the purpose of the Common Rule et al. is to prevent such experimentation. Moreover, it is not at all clear that EPA informed the study subjects that the experiments could cause heart attack or death. Finally, EPA’s IRB did not review these experiments before they occurred, in violation of EPA’s own rules.]

The EPA has established health-based standards for fine-particulate matter, and these protect the public from serious health problems, including aggravated asthma, increased hospital admissions, heart attacks and premature death. [More irrelevant propaganda.] Individuals particularly sensitive to fine-particle exposure include people with heart or lung disease, older adults and children. [The lone case report published by EPA scientists involved a 58-year old woman with heart problems and a family history of heart disease (her father died at age 57). Experimenting on this study subject is unethical2.]

In the United States, a heart attack occurs every 34 seconds and more than 2,200 people die of cardiovascular disease each day. It is estimated that tens of thousands of premature deaths and nonfatal heart attacks are triggered by air pollution, and this emphasizes the importance of research in this field. The health scientists and staff at the EPA are privileged to provide safe, ethical, unbiased and state-of-the-art inhalation science in support of the Clean Air Act as we work to define and understand the risks of air pollution to the American people. [Yet more irrelevant propaganda.]



Environmental Public Health Division

Environmental Protection Agency

Greenville, N.C.

13 thoughts on “EPA denies Milloy charge of conducting unethical human experiments; Facts show otherwise”

  1. Some of the photo’s of the experiments I’ve seen purport to have humans breathing diesel exhaust in a “fine particulate” study. What was done to treat the exhaust to remove other contaminants such as NOx, CO, VOC, SO2, lead, acrolein, formaldehyde and the host of other combustion products EPA has me consider in permit applications? A “clean” diesel engine will have 300-500 ppmv NOx and100-200 ppmv CO along with the PM and other contaminants. If they run the exhaust through an oxidative catalyst the exhaust will still be in the 20ppmv CO range. If they use SCR to reduce NOx, the exhaust will still have 10-30 ppmv in it. The exhaust temperature runs in the neighborhood of 1000°F. The amount of nasties and, sometimes the distribution of nasties, in diesel exhaust depends on the load.

    If the experiments were to obtain PM2.5 from diesel exhaust, how did they control the particulate level? What other common diesel exhaust components were controlled and measured? The whole thing seems to be crude. Your PM2.5 source from an on-road engine in a truck?

  2. Why don’t they do a comparison study of deaths caused by air quality problems in a place like China, which clearly lacks any strong standard of air quality controls and rules like the US does, and most likely should have a lot more deaths caused by a greater concentration of particulates than exists in the US. To claim that tens of thousands of deaths are caused by ambient air conditions in probably some of the least polluted air on the planet is ridiculous. Where is the historical data comparing past US death rates from particulates to current death rates.

  3. Not really. It’s pretty obvious that the EPA decided that PM2.5 was deathly poisonous (based either on preliminary testing or presumption) and then did these tests to support that theory. The malfeasance occurred when they did not get the desired results, and instead of acting like scientists and revising or retracting their conclusions, hid the data, published the one case in which there was any action, and then bolstered their rhetoric by saying that PM2.5 was deadlier than cancer, something completely unsupported by the data.

  4. Of course, there is another possibility. Its entirely possible the EPA made up the story in its entirety to provide support for their position.

  5. Keep digging this administration must learn that we have a rule of law!!!!

  6. Once again “Experts” study death while ignoring life. It is better in the minds of the experts to prevent death than it is to allow life. Preventing virtual deaths is even more desirable.

    One of the ironies of “cleaner” diesel is that the particulates seem to get smaller. “Dirty” diesel emissions weren’t as dangerous as clean diesel because they dropped out of the air so quickly.

    But once again the magical Excel sticks its head into the arena and managers who can type big numbers into cells can quickly get a virtual number of dead. We don’t need to actually find body bags. Just need a number on a spreadsheet.

  7. Imagine what things would be like if the experiment gave the results intended, and that some of the people involved actually died.

    A good question: did the EPA have a medical ‘crash cart’ on hand during this experiment, for dealing with potentially fatal cardiovascular/pulmonary events?

    If not, either the EPA was criminally negligent, or didn’t really expect to see any results from the experiment.

  8. “Finally, EPA’s IRB did not review these experiments before they occurred, in violation of EPA’s own rules.”

    How do we know this? If this is so, somebody at EPA is in big trouble.

  9. From here it looks like they tightened their own noose just a little bit more. I don’t think they will be able to wiggle out of this one.

  10. Looks like you hit them where it hurts. The answer is so weak I cannot imagine that the author himself believes in what he is saying.

    Either EPA representatives clearly lied to America and Congress about the “hours of exposure leads to death. Not Sickness. Death”, or they knowingly and willingly risked the lives of their test subjects.

    Also, I have to disagree with you slightly on one comment. Using someone with a genuinely horrific medical history is acceptable if they know the risks. If not for the coverup of negative results and the ludicrous propaganda, I’d agree with it. The real risk, as everyday experience with smokers and the dust-exposed has shown, is quite low to nonexistent for immediate death, so it’s reasonable to investigate the allegations that the already-sick are negatively affected.

  11. Looks like a bureaucratic non-answer to charges of unethical experimentation from here – and I worked for a bureaucracy. “We’re saving lives, so leave us alone while we don’t leave you alone.” As close to confirmation as a bureau can get that they exaggerate the dangers they protect you from.

    At least with the mafia, they protect you from something tangible like a fire or vandalism. But what a racket to protect you from fear of your neighbor and yourself. No end.

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