EPA's new air rule made illegal by human experiments

Don’t take my word for it… take EPA’s.

On page 69 of the final rule for EPA’s new National Ambient Air Quality Standards (NAAQS) for fine particulate matter (PM2.5) the EPA states:

As was true in the last two reviews, evidence from epidemiological, controlled human exposure and animal toxicological studies played a key role in the Integrated Science Assessment’s evaluation of the scientific evidence. [Emphasis added]

The “controlled human exposure” studies are the illegal human studies that JunkScience.com has been spotlighting.

According to the EPA’s Human Studies Review Board, human studies are “fundamentally unethical” if:

… the research was intended to seriously harm participants, or if it failed to obtain informed consent, or if it was fundamentally unethical for other reasons.

While we contend that the studies are fundamentally unethical for all three reasons, the easiest reason to prove is the EPA’s failure to obtain informed consent. No study subjects were informed that the experiments could kill them. For example, consider the following risk disclosure about PM2.5 made to subjects in the ongoing CAPTAIN experiment:

During the exposure to the concentrated air pollution particles, you may experience some minor degree of airway irritation, cough, and shortness of breath or wheezing.

But EPA has determined that, among other serious health calamities, inhalation of PM2.5 can cause sudden death.

So there can be no question that EPA failed to obtain informed consent from study subjects and, therefore, that the EPA’s “controlled human exposure” studies are fundamentally unethical.

EPA’s own regulations bar the use of “fundamentally unethical studies.” Subpart Q of EPA’s version of the Common Rule states:

§ 26.1704 Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults conducted before April 7, 2006.

Except as provided in § 26.1706, in actions within the scope of § 26.1701, EPA shall not rely on data from any research initiated before April 7, 2006, if there is clear and convincing evidence that the conduct of the research was fundamentally unethical (e.g., the research was intended to seriously harm participants or failed to obtain informed consent), or was significantly deficient relative to the ethical standards prevailing at the time the research was conducted. This prohibition is in addition to the prohibition in § 26.1703.

§ 26.1705 Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults conducted after April 7, 2006.

Except as provided in § 26.1706, in actions within the scope of § 26.1701, EPA shall not rely on data from any research initiated after April 7, 2006, unless EPA has adequate information to determine that the research was conducted in substantial compliance with subparts A through L of this part, or if conducted in a foreign country, under procedures at least as protective as those in subparts A through L of this part. This prohibition is in addition to the prohibition in § 26.1703.

§ 26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable research.

This section establishes the exclusive criteria and procedure by which EPA may decide to rely on data from research that is not acceptable under the standards in §§ 26.1703 through 26.1705. EPA may rely on such data only if all the conditions in paragraphs (a) through (d) of this section are satisfied:

(a) EPA has obtained the views of the Human Studies Review Board concerning the proposal to rely on the otherwise unacceptable data,

(b) EPA has provided an opportunity for public comment on the proposal to rely on the otherwise unacceptable data,

(c) EPA has determined that relying on the data is crucial to a decision that would impose a more stringent regulatory restriction that would improve protection of public health, such as a limitation on the use of a pesticide, than could be justified without relying on the data, and

(d) EPA publishes a full explanation of its decision to rely on the otherwise unacceptable data, including a thorough discussion of the ethical deficiencies of the underlying research and the full rationale for finding that the standard in paragraph (c) of this section was met.

So EPA’s “fundamentally unethical” controlled human exposure studies that occurred before April 7, 2006 are flatly barred from use. “Fundamentally unethical” studies after April 7, 2006 must satisfy the public notice and comment provisions of §26.1706 — none of which did EPA do.

Conclusion: In its recent PM2.5 rulemaking, the EPA admitted relying on studies that are “fundamentally unethical” in violation of Subpart Q of the Common Rule. The EPA’s rulemaking, therefore, is illegal.

16 thoughts on “EPA's new air rule made illegal by human experiments”

  1. I wonder how the EPA methods and actions compare to another federal regulator in a different field, the SEC and investment. I think the EPA enforcement effort could be much larger in both regulatory and criminal actions. The SEC relies on the courts and civil actions for its regulatory enforcement and it tends to limit their actions. Does the EPA have its own regulatory adjudication panels similar to the IRS? I don’t know if they do, but that would make them a total runaway monstrosity.

    There is also another difference concerning the environment – a non-existent role for self regulation. Environmental regulation is not structured around a quasi-voluntary (in investment, you must, for the most part, be a member of a self regulator) structure where the government is more of a last resort. For environment, government is the first and only resort. (Small difference I know based on how a securities exchange or FINRA (securities self-regulator) takes their marching orders from the government and the membership has ever diminishing input. But the model of limited government at least originally existed.)

    Then again, Dodd-Frank largely sets up uber-regulation at or above the level of the Fed and above the SEC and CFTC, so that pretty much puts government in complete control with self-regulatory agencies charged with promulgating and enforcing the government instructions at a more invasive level and without the (also diminshing) constitutional protections against government. Like the credit “bubble,” the environment will have disasters attributable to and covered up by the government.

    Heads, government wins. Tails, everything else loses. (This didn’t start out as a rant, really.)

  2. Let’s also remember that EPA already regulates PM essentially to the max — or at least what it thinks it can get away with politically. So these experiments have no real regulatory value — despite EPA’s claims to the contrary. They are all risk with no benefit.

  3. Another major problem with this, and why I was so infuriated when the paper was not retracted after Milloy brought forth evidence that the negative results were hidden. This is literally elementary school level science basics that are being violated.

  4. The problem, Paul, is that data is readily available on long term continuous exposure to PM. We call them smokers. As there are endless studies on the health effects of smoking, and many more studies on the effect of black lung silicosis and large quantities of data on smoke inhalation patients as well as general urban air exposure. All the bases are covered (toxic smoke, silica dust, and black carbon smoke).

    If this was something rare or unusual, I could understand your argument, but ethics is quite clear. Potentially damaging human testing can be done only if data cannot be obtained in another fashion. There is no need for this testing because the medical history is saturated with this. Therefore, this human testing is unethical.

  5. These experiments cannot be justified. Scientists ought not use people — especially the poor, sick, old and children — as guinea pigs. That our government still does this is even more appalling.

  6. The only way to justify the experiment would be to use the Null hypothesis. In a sense one would have to conclude that the opposite is true. Which is to say that PM is harmless. However, this negates the rhetoric. So to keep to the mantra that PM is harmful a game has to be played. It’s like putting a piece of paper in a box that say’s “Every thing in this box is false.”

  7. Uh…no. EPA says PM kills… and that one-in-four deaths are caused by PM. I suppose what you’re trying to get at is that EPA’s risk estimates are based on populations. EPA has tried that lame-o excuse, too. But of course, populations are made of people, who are the ones at risk of dying. And no one can risk their life or health in a nontherapeutic experiment. Past the sudden death possibility, EPA says PM causes a whole host of other heath problems to individuals…. none of which are disclosed to study subjects. You should check out some of the documents at EPAHumanTesting.com.

  8. I think you’re conflating the term “all-cause mortality” with the legal idea of significant risk of death or harm. Your argument hinges on the allegation that the EPA was putting these people’s lives at non-negligible risk. To support this, you state that the EPA itself has determined that “There is no safe level of PM2.5 in the air we breathe. In other words, any PM2.5 in the air incerases [sic] the death rate”. However, you have to recognize that those findings are based on an ESTIMATE of “all cause mortality” which was generated by compiling daily increases in PM2.5 levels and cross-indexing local mortality rates in the relevant cities. So while you might take issue with the validity of such an indirect measure, you can’t really say it indicates the risk associated with exposing healthy individuals in a medically controlled setting with monitoring equipment and physicians on hand. Such a setting significantly alters the risk from exposure to PM2.5.

    In short, you would have to demonstrate that, in the research settings provided by the EPA, there was known and immediate danger to the person’s health or the potential for long term damage and harm. After reviewing the EPA document on exposure risks and skimming some of the source material, it doesn’t seem to me that you have a particularly compelling case.

    On a completely different note, it is a very neat strategy you’ve employed here. Either they repudiate their own research that PM2.5 is dangerous, or they muddle through the somewhat complicated reasoning above, likely to involve lots of boring numbers and facts, which will sound like backpedaling and hedging.

  9. That is a distinction without a difference. Congress has essentially delegated authority to EPA to write and enforce laws — thought those “laws” are called “regulations.” If you don’t believe me, violate an EPA regulation or order and see how fast you get prosecuted as a criminal.

  10. There’s regulations, and there’s regulations about writing regulations.If you violate the regulation about writing regulations, then your regulation is invalid.

    In non-repetitive terms, you have to obey the rules when writing rules. Laws are not formed in a vacuum, but in the context of other laws. If there is a fundamental inconsistency, especially if the prior rule is written specifically to prevent the actions of the new rule (such as this one), then the new rule is invalid.

    If not, then these rules would be merely a facade, easily swept away at their first inconvenience, as appears to be happening now.

  11. A regulation is not a law, even though it functions in much the same way, and can be voided by courts as can laws. Laws are passed by legislature. Regulations are issued by organizations like EPA under the aegis of laws like CAA, but they are not the laws themselves.

  12. A law or regulation can be on the books and still be illegal… that’s a prerequisite in fact for a law/regulation to be overturned by a court. If/when the EPA rule is challenged in court, the rationale in the post would be a grounds for voiding it.

  13. They have passed a law. That makes it a law.

    Faulty logic doesn’t invalidate laws, you have to repeal them.

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