EPA Used 10-Year Old Children in Illegal Diesel Exhaust Experiments

JunkScience.com has confirmed through the Freedom of Information Act that the U.S. Environmental Protection Agency paid the University of Southern California (USC) and the University of California, Los Angeles (UCLA) to conduct experiments testing whether exposure to diesel exhaust harms children. These experiments are illegal under the Nuremberg Code, California state law and federal regulations concerning the protection of human subjects in medical research.

Background

Based on documents received by means of FOIA during 2012, JunkScience.com reported that the EPA had for many years conducted illegal scientific experiments in which human study subjects were intentionally exposed to air pollutants the EPA considered lethal at any dose or exposure. These experiments were deemed illegal for two basic reasons: (1) Federal regulations prohibit EPA researchers from placing human study subjects at risk of death; and (2) EPA failed to disclose to the study subjects that their participation in the experiments entailed a risk of death. The EPA Office of Inspector General validated these findings in a March 2014 report.

While all of the foregoing experiments involved adult humans subjects, it came to the attention of JunkScience.com in late 2012 that the EPA-funded researchers at USC may have also experimented on children. Not only do California state law and federal regulations prohibit endangering children in non-therapeutic scientific experiments, but as minors, children cannot provide the legally-required consent to participate in such experiments.

JunkScience.com’s effort to investigate this matter was not only rebuffed by the USC researchers but the EPA also endeavored to cover-up the child experiments in February 2013. After multiple FOIA requests, the EPA finally released some documents to JunkScience.com in December 2014.

What the Documents Show

1. The children were treated as guinea pigs in a non-therapeutic experiment

The experiments on children were part of a larger research project that ran from November 1, 2003 through October 31, 2010. A basic purpose of this project was “to investigate the role of… locally emitted fresh vehicle exhaust in airway inflammation and in asthma occurrence in childhood” and then to “translate the… research findings into public health action and policy…” [p.1].

The children-as-guinea-pigs nature of the experiment is captured in this description from the application for approval submitted by the researchers to the UCLA Institutional Review Board (IRB). [Click image to enlarge]

The experiment involved exposing the children to four different doses of diesel exhaust particles, ranging from 0 to 300 micrograms. The children were exposed to the diesel exhaust particles by nasal spray. A total of 20 children were experimented on in this way.[pp. 7-8]. As revealed in the IRB application, the age range of the children was 10 to 15 years of age. [Click image to enlarge]

These children were considered by the researchers to be more “vulnerable” than adults to the effects of the diesel exhaust particles. [Click image to enlarge]

As disclosed in the consent form, this experiment provided no health benefits to the children. [Click image to enlarge]

The absence of health benefit was reiterated in the assent form to be signed by the children. [Click image to enlarge]

2. The experiments were dangerous and potentially lethal, according to federal and state scientific assessments.

The children were intentionally exposed to diesel exhaust particles. The researchers described this exposure in the IRB application as being of “minimal risk.” [Click image to enlarge]

The level of exposure was described as being equivalent to two days worth of exposure to Los Angeles air. [Click image to enlarge]

The researchers dismissed the health risks of diesel exhaust as limited to lung cancer from high lifetime-long exposures — none of which would occur during the proposed experiments. [Click image to enlarge]

But in 1998 — six years before the experiments — the California Air Resources Board (CARB) released an assessment of diesel exhaust concluding that diesel exhaust can cause cancer and that there is no safe exposure to diesel exhaust, as follows: [Click image to enlarge]

The CARB also identified short-term health effects from diesel exhaust, as follows: [Click image to enlarge]

CARB identified presumably serious immunological responses to diesel exhaust, as follows: [Click image to enlarge]

The CARB also noted that the EPA set the regulatory allowable level for inhalation of diesel exhaust at 5 micrograms per cubic meter. [Click image to enlarge]

But the children in the experiment were exposed to diesel exhaust dose via nasal spray as high as 300 micrograms — 60 times higher than the EPA’s allowable exposure standard.

The CARB also concluded that diesel exhaust is genotoxic, mutagenic, and cause “chromosomal aberrations” and “unscheduled DNA synthesis.” [Click image to enlarge]

In addition to its CARB-determined toxicity, there is the EPA-determined short-term lethality of diesel exhaust. About 95% of diesel exhaust is classified as fine particulate matter, also known as PM_2.5. Around the time of the experiments in question, the EPA issued a scientific assessment in which the EPA determined that any exposure to PM_2.5 could kill within hours of inhalation. A more complete discussion of the EPA-determined lethality of PM_2.5 may be found at EPAHumanTesting.com.

2. The researchers failed to provide the children and their parents legally required informed consent.

Keeping in mind the above-described and CARB/EPA-determined health effects from diesel exhaust and that federal regulations and state laws require that physicians and scientists obtain informed consent from human study subjects, below is the risk disclosure the researchers provided the children.

From the consent form, signed by the parents: [Click image to enlarge]

Note that the consent form:

• Fails to disclose the EPA-determined short-term risk of death from inhalation to diesel exhaust.
• Fails to disclose that there is no safe exposure to diesel exhaust, even though the form cites the CARB conclusion about diesel exhaust being a carcinogen;
• Fails to disclose the CARB-determined short-term health effects from exposure to diesel exhaust;
• Fails to disclose the CARB-determined immunological effects of diesel exhaust;
• Fails to disclose that the children would be exposed to diesel exhaust at a level 60 times higher than EPA allows; and
• Fails to disclose that CARB determined diesel exhaust is genotoxic, mutagenic, and causes “chromosomal aberrations” and “unscheduled DNA synthesis.”

Below is the description of the risks in the assent form signed by the children (who were not legally competent and so this had no legal meaning). [Click image to enlarge]

Moving past the likelihood of the children’s inability to understand and appreciate the risks described, the assent form fails to mention any of the risks determined by CARB.

3. These experiments are illegal based on California state law.

Because the Nuremberg Code developed after the post-World War II trials of Nazi physicians are unenforceable in California, the state developed its own laws covering human experimentation. See California Codes of Health and Safety Section 24170-24179.5 The purpose of the law is to “from unauthorized, needless, hazardous, or negligently performed medical experiments on human beings.” [Section 24171(d)]

Each and every medical experiment performed in violation of any provision of the California law is a separate and actionable offense. [Section 24176(e)] Punishment includes fines of up to $10,000 per offense and/or imprisonment.

The experiments conducted by USC/UCLA researchers are “medical experiments” covered by the law as they involve the “penetration or damaging of tissues of a human subject.” [Section 24174(a)]

Researchers must provide study subjects with a:

… description of any attendant discomforts and risks reasonably to be expected from the experiment.

The researchers failed to disclose to the study subjects the health risk of diesel exhaust as determined by CARB, including that there is no safe level of exposure to diesel exhaust. [Section 24172(c)]

Based on the mandatory risk disclosures, the researchers were then required to obtain the informed consent of the study subjects. [Section 24173] As discussed previously, the disclosures were not made. So it was impossible for the study subjects to provide the required informed consent.

Despite the foregoing, the experiments themselves are illegal since informed consent from someone other than the study subject,

… shall only be for medical experiments related to maintaining or improving the health of the human subject or related to obtaining information about a pathological condition of the human subject.

These experiments were not related to improving or maintaining the health of the children and, in fact, only needlessly exposed the children to new health risks. [Section 24175(e)].

4. The experiments are illegal based on federal law.

The protection of human subjects in scientific research is covered by the federal Common Rule as adopted by individual federal agencies, including the EPA, which funded the current experiments. EPA has also adopted protections in addition to the Common Rule.

To avoid redundant discussion, the EPA version of the Common Rule and its additional protections similarly bar the treatment of human beings as guinea pigs in non-therapeutic scientific experiments and require disclosure of risks and the obtaining of informed consent. As discussed previously, all these provisions were violated by the USC/UCLA experiments.

Discussion

EPA and CARB have both determined that diesel exhaust is lethal, carcinogenic and otherwise toxic. EPA’s characterization of the PM_2.5 component renders diesel exhaust essentially one of the most deadly substances known to man in that any exposure can kill within hours. While JunkScience.com disagrees with this characterization, EPA and CARB nonetheless regulate diesel exhaust and PM_2.5 on this basis. For the purposes of EPA’s human experiments, if diesel exhaust is deadly when it comes from an exhaust pipe, then it is also deadly in a medical clinic and science laboratory. Regulators says there is no safe exposure to diesel exhaust and, for the purposes of discussing human experiments, we take them at their word.

Given this context, the conduct of the EPA, USC, UCLA and researchers in intentionally exposing children as young as 10 years old without informed consent to a deadly substance is quite clearly illegal, not to mention heinous and barbaric. That the EPA and USC apparently attempted to conceal these facts from the public once they were discovered underscores the criminality of the conduct. The only defense the EPA has to these charges would be admissions that its and the CARB’s pronouncements on the lethality and toxicity of diesel exhaust and PM_2.5 are not true.

In essence, EPA and CARB have been caught lying to someone about something. If they have lied to the public and Congress about the toxicity of diesel exhaust and PM_2.5, then two things should happen:

• All regulatory programs relying on the false science should be reviewed and amended to reflect what the science actually shows; and
• An investigation of how this false science came to pass should be undertaken by an independent prosecutor.

If EPA and CARB have not lied about the science, then the EPA and the researchers conducted flatly illegal experiments and lied to the children and other human subjects involved in the experiments. In this case, the institutions and individuals involved should be investigated, and subject to civil and criminal liability as prescribed by law.