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.
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.