No — er, well, it shouldn’t be.
In June 2005, Sen. Barbara Boxer (D-Calif.) and and Rep. Henry Waxman (D-Calif.) took the EPA to task for some rather innocuous human studies involving pesticides. Click here for the Boxer-Waxman report
As recounted in the report’s executive summary, EPA had committed the following misconduct:
Human testing of hazardous substances. The experiments deliberately exposed human subjects to dangerous pesticides, such as organophosphates, which were developed in the 1930s for use in nerve gas, and methyl isothiocyanate, which is closely related to the chemical that killed thousands in Bhopal, India. In one experiment, human subjects were placed in a chamber with vapors of chloropicrin, an active ingredient in tear gas, at levels substantially greater than the federal exposure limit, causing some subjects to experience “severe” adverse effects. An older experiment administered the pesticide carbofuran to human subjects for the explicit objective of determining “the minimum dose necessary to induce toxic effects (e.g. headache, nausea, and vomiting).” In many of the experiments, the subjects were instructed to swallow capsules of toxic pesticides with orange juice or water at breakfast.
Serious deficiencies in informed consent. The informed consent forms used in the experiments do not appear to meet ethical standards. Some used complex jargon that participants would be unlikely to understand. Others failed to disclose the potential risks involved. One experiment exposed subjects to dimethoate, a pesticide that EPA considers a suspected carcinogen, a developmental toxicant, and a neurotoxicant. Yet the informed consent form failed to mention these or any other potential health effects, stating instead that the chemical is “used to protect or cure all kinds of plants” and that “not a single health effect is expected.” The informed consent forms for other experiments repeatedly referred to the pesticide as a “drug,” potentially giving the test subject the false impression that the experiment was for a pharmaceutical product. In some of the experiments, there may not even have been any attempt to obtain informed consent.
Unethical liability waivers. The Common Rule governing medical research provides expressly that “[n]o informed consent … may … waive or appear to waive any of the subject’s legal rights.” Contrary to this requirement, the informed consent forms used in some experiments include explicit waivers of liability. For example, the consent form for the chloropicrin experiment states that the sponsor would not pay “any … form of compensation if you are injured” other than medical costs.
Questionable scientific validity. According to the National Academy of Sciences, “a study cannot be ethically acceptable if it is scientifically invalid.” Yet in many of the experiments that exposed human subjects to harmful pesticides, the number of human subjects involved was too small to provide reliable results. Three of the experiments had just six subjects. One study had a single subject.
Questionable interpretation of results. One experiment dosed eight subjects with the pesticide azinphos-methyl for 28 days, with all eight of the subjects reporting multiple adverse health effects, including headaches, abdominal pain, nausea, coughing, and rashes. In the written report of the experiment, the researchers discounted these events, attributing them variously to “viral illness,” “ward conditions,” or diet. Other studies similarly dismissed unfavorable experimental outcomes.
In the instant case, the EPA has committed all these forms of misconduct — and much worse.
PM2.5 is far more toxic (i.e., any exposure can kill within hours, according to EPA) than the pesticide exposures discussed in the 2005 report. EPA lied about the dangers of diesel exhaust and PM2.5 to study subjects. While the EPA diesel exhaust/PM2.5 experiments could have resulted in the subjects’ deaths, EPA tried cap its liability at $5,000. For a variety of reasons, the studies were not designed to produce scientific or even meaningful results. EPA also falsely presented the tale of the Case Report in Environmental Health Perspectives.
Although both Sen. Boxer’s and Rep. Waxman’s offices have been notified about this EPA human testing, we have not received any acknowledgment or response from them.
Here are some other relevant views:
American Lung Association
- “Particle pollution is comprised of soot, metals, acid, dirt, pollen, and other elements that can be inhaled and become lodged deeply in one’s lungs. Released by sources such as diesel vehicles and equipment, factories, and wood burning stoves, the particles are small enough to penetrate deep into the lungs and into the bloodstream, making soot one of the most dangerous forms of air pollution.” [Emphasis added, from “Vacaville girl testifies at EPA gathering,” July 20, 2012]
Center for American Progress
- “Particle pollution, commonly referred to as ‘soot,’ is one of the deadliest forms of air pollution.” [Emphasis added, from “Soot Pollution 101
What You Need to Know and How You Can Help Prevent It“, August 10, 2012]
Environmental Defense Fund
- “The data on PM2.5 is even more compelling than the data for ozone. Simply stated, it’s one of the worst air pollutants endangering public health.” [Emphasis added, from “Proposed Soot Standards Long Overdue,” June 21, 2012]
Environmental Working Group
- “As a result of The English Patients and subsequent research, EWG is now firmly opposed to direct dosing of human subjects with pesticides, industrial chemicals, or pollutants on both scientific and ethical grounds.
We hope that the committee will see that human subject experiments with pesticides, industrial chemicals and pollutants are so ethically compromised, so biased in conduct and intent, so scientifically questionable, and such an ethical burden for the regulators that you will recommend that they never be done.” [from “Statement on Human Testing Before NAS Committee“, January 8, 2003].
Natural Resources Defense Council
- “Today, EPA proposed updated National Ambient Air Quality Standards (NAAQS) for particulate matter of 2.5 micrometers in diameter or smaller (“PM2.5” or fine particle pollution). Particulate matter kills thousands of people every year, and today’s announcement is an important step forward that will have enormous benefits for the American public.
EPA followed the science and the law with today’s proposal to tighten clean air standards for the tiniest and most dangerous particles. [Emphasis added, from “EPA Proposes More Protective Health Standards For Soot Pollution,” June 15, 2012]
- “With this new proposal, EPA has cut the incentive for pesticide manufacturers to conduct unethical, and often unscientific, human experiments…” [from “EPA Proposes Stronger Protections for People in Pesticide Experiments,” January 21, 2011]
New York Times.
- “In a welcome move that will make the air that Americans breathe cleaner, the Environmental Protection Agency proposed on Friday to tighten standards governing fine particles, commonly known as soot. Released by sources like diesel trucks and power plants, these microscopic specks can lodge in the lungs and bloodstream and cause respiratory and heart ailments.” [Emphasis added, from an editorial entitled “Deadly Particles“, June 20, 2012]
Physicians Committee for Responsible Medicine
- “Curiosity is a powerful human motivation which can lead well-meaning people to actions that are harmful, and even fatal, as a look at the most extreme cases clearly shows. When psychiatrist Robert Jay Lifton studied the experimenters responsible for the most hideous Nazi crimes, he found that, while some were clearly sadists, most were ordinary people in circumstances that permitted the full unfolding of human curiosity, propelling human aggression into the machinery of death.
The growth of technology only makes vigilance more necessary. Like growing human beings, growing science has strength that exceeds its control. And, like everyone else, scientists have to learn inhibition and restraint and can occasionally fail to inhibit an impulse of curiosity.
As governmental bodies review evidence of past abuses, the airing of buried secrets may improve vigilance against future abuses. But abuses will continue as long as there are experiments on subjects who are not in a position to give full informed consent and as long as technology provides novel ways of affecting their lives.” [From “Human Experiments: Redrawing the Ethical Boundaries“]
- “Ethical issues in human research generally arise in relation to population groups that are vulnerable to abuse. For example, much of the ethically dubious research conducted in poor countries would not occur were the level of medical care not so limited. Similarly, the cruelty of the Tuskegee experiments clearly reflected racial prejudice. The NIH experiments on short children were motivated to counter a fundamentally social problem, the stigma of short stature, with a profitable pharmacologic solution. The unethical military experiments during the Cold War would have been impossible if GIs had had the right to abort assignments or raise complaints. As we address the ethical issues of human experimentation, we often find ourselves traversing complex ethical terrain. Vigilance is most essential when vulnerable populations are involved.” [From Human Experimentation: An Introduction to the Ethical Issues]
- “We oppose unethical human experiments.” [From “About PCRM“]
Physicians for Social Responsibility.
- “…PM2.5, one of coal’s deadliest pollutants…” [from “Code Black Declared in Iowa.”]
- “Not only have adverse health effects have been documented at or near the proposed standards for PM2.5; just as importantly, there does not appear to be any no observable effect level (NOEL). That is, health-damaging effects from PM2.5 are observed at low levels, and there is no threshold below which exposure seems to be safe. Because there is no NOEL for PM2.5 and increasing evidence that transient concentration peaks pose significant health threats, PSR does not believe that the current 24-hour standard of 35µg/m3 fulfills the mission of EPA to protect human health. Similarly, the proposed reduction in the annual standard from the current level of 15 µg/m3 to between 12-13µg/m3 is welcome but overdue and insufficient to protect health adequately.” [from “Particulate Matter: Stronger Protection Is Necessary,” Aug. 22, 2012]
- “The intentional dosing of human beings, including children with pesticides is unethical and truly shocking…” [from “Human Testing Exposing Children to Chemicals, October 20, 2008]
NEXT: To be announced.