ATI statement on illegal EPA human medical tests

Statement of ATI’s Lead Counsel on American Tradition Institute v. U.S. Environmental Protection Agency

(US District Court, Eastern District of Virginia No. 1:12-cv-1066)

There are few occasions in life that emerge directly from the core of an individual and almost never are those memorialized in a law suit. On Friday, September 21, 2012, I took five copies of a complaint to the Albert V. Bryan U.S. Courthouse in Alexandria, Virginia, filing one of them with the court and having each of the rest stamped and then sent to four senior government officials, Attorney General Eric Holder, U.S. Attorney Neil H. MacBride, EPA Administrator Lisa P. Jackson and EPA General Counsel Scott Fulton. I sent them summons to appear and defend themselves in part because of my first name.

I was named after David Steiner, a man who died of starvation in Buchenwald concentration camp on May 3, 1945. Tattooed on his body was the number 59059. He was witness to horrors that, today, we have a hard time even contemplating, something that I thought would never exist on this planet again – the abhorrent practice of giving human subjects poisons in order to determine what subsequently happens to them.

I have always been deeply affected by the circumstances of my great-uncle’s death. It is a heavy burden to carry the name of such a victim. As I matured, I committed my life to giving to our civilization that which David Steiner was never able to give himself. I have given 37 years of service to the United States, most of that in an effort to protect human health and the environment as a professional at the U.S. Environmental Protection Agency.

I was able to secure a position of responsibility and trust at EPA in large part because the University of North Carolina at Chapel Hill offered me the opportunity to obtain graduate degrees and prepare myself for a career in public service. Until a few weeks ago, I had been a strong supporter of each.

Then Steven Milloy asked me to represent him and other members of the American Tradition Institute who have stories much like mine, or otherwise cannot countenance such human experimentation.

Steve’s story is worse than death. His uncle, Zoran Galkanovic, was incarcerated at the Mauthausen concentration camp. Upon threat of death, Mr. Galkanovic was forced to rise each morning and identify those individuals at the concentration camp too ill to work, knowing they would subsequently be executed that very day. Because of the inhumanity forced on Mr. Galkanovic, Mr. Milloy has accepted as a family responsibility the fight against any government who subjects its citizens to inhumane treatment. Who knew it would be our government? Who knew it would be the U.S. Environmental Protection Agency? Who knew that human experimentation would be done on the campus of the University of North Carolina at Chapel Hill? Who knew it would be an official body of that University that approved this research?

On first blush, I simply could not believe Mr. Milloy. Then I looked carefully at the facts and at the law. This case involves the intentional exposure of human subjects to “fine particulate” matter, also known as PM2.5. EPA obtained their PM2.5 from a diesel truck. It is difficult to overstate the atrocity of this research. EPA parked a truck’s exhaust pipe directly beneath an intake pipe on the side of a building. The exhaust was sucked into the pipe, mixed with some additional air and then piped directly into the lungs of the human subjects. EPA actually has pictures of this gas chamber, a clear plastic pipe stuck into the mouth of a subject, his lips sealing it to his face, diesel fumes inhaled straight into his lungs.

Unbelievable as that may seem, consider the additional fact that EPA has officially concluded that this gas is a genotoxic carcinogen and that there is no exposure level below which it can be considered safe. In fact, EPA Administrator Jackson testified to Congress that of all deaths occurring in the United States, 1 in 4 “is attributable to PM2.5.” She told them “Particulate matter causes premature death. It doesn’t make you sick. It’s directly causal to dying sooner than you should.”

Under the law, under EPA regulations and under EPA policy, this human experimentation is strictly prohibited. To conduct human experimentation, the human subjects must be properly informed of the risks they face and these risks must be less than the potential benefit of the experiment. My family knows how that works too.

Few today know the ravages of Polio, but some of us are old enough to remember it too well. Susan Paidar was a childhood neighbor, the same age as one of my brothers. She died in an iron lung. And, she was one of the last victims of this terrible disease, in small part because of the courage of one of my brothers. In 1952, at age 6, my brother Rick was selected to be in the first human test group for the Salk vaccine. He was offered the possibility of never having to worry about polio again. He was a human subject and there was a real benefit from that human experimentation.

In the section describing the mandatory benefit that must be offered to the human subjects, EPA’s PM2.5 “informed consent” baldly states “there is no benefit.” Worse, the form never informs the subjects that they will be inhaling diesel fumes, never tells them the gas is a carcinogen, never tells them about all the other toxic substances in diesel exhaust pouring into their lungs, never tells them that because PM2.5 is genotoxic, it might cause disease in children they might wish to have.

Medical ethicist, Professor John D. Dunn, MD, JD, called EPA’s human experimentation “scandalously unethical and immoral” and said “There can be no further tolerance of this misconduct.” This is not the EPA I knew. This is not the University of North Carolina I knew. This is not the American Tradition of our nation. But, this is why I travelled to the U.S. Courthouse in Alexandria, Virginia – to put a stop to it.

David W. Schnare, Esq., MSPH, PhD.
Director
Environmental Law Center
American Tradition Institute.

Read the complaint and declarations here.
For additional details see here.

EPA sued over illegal human medical experiments

WASHINGTON — American Tradition Institute’s Environmental Law Center filed a federal lawsuit Friday seeking to stop illegal human medical experiments conducted by the Environmental Protection Agency.

The suit, filed in United States District Court in Alexandria, Virginia, describes in detail how six EPA employees at the University of North Carolina at Chapel Hill Medical School intentionally pumped what they termed “lethal” amounts of diesel exhaust, specifically small particulate matter termed “PM2.5,” directly into the lungs of human volunteers who were not properly advised of the risks.

“It is difficult to overstate the atrocity of this research. EPA parked a truck’s exhaust pipe directly beneath an intake pipe on the side of a building. The exhaust was sucked into the pipe, mixed with some additional air and then piped directly into the lungs of the human subjects,” said ATI Environmental Law Center Director Dr. David Schnare.

Dr. Schnare was previously a 34-year EPA attorney and holds a Ph.D. in Environmental Management from the University of North Carolina-Chapel Hill and a Master of Science in Public Health-Environmental Science from the University of North Carolina, where the experiments were conducted.

 “EPA actually has pictures of this gas chamber, a clear plastic pipe stuck into the mouth of a subject, his lips sealing it to his face, diesel fumes inhaled straight into his lungs.”

Scientific assessments of PM2.5 conducted in 2004 and 2009 by the EPA determined there is no safe level of exposure.  Nevertheless, the EPA pumped it directly into the lungs of humans, including an obese volunteer and a volunteer with chronic asthma.

The EPA violated numerous federal laws by failing to properly inform volunteers of the risks or that the EPA has previously determined their level of exposure to PM2.5 was potentially lethal. 

Additionally, the experiments violate federal laws requiring the potential benefits to the subjects outweigh the risks to the subjects.

Also, federal law requires volunteers in medical studies to be fully informed of any “reasonably foreseeable risks or discomforts to the subjects. [45 CFR 46.116 and 40 CFR 26.116 (a)(2)]

A review of the consent forms by Dr. John Dale Dunn, a policy advisor to the American Council on Science and Health, confirms subjects were not properly informed of the risks or that their exposure was potentially lethal.

Additionally, federal law prohibits medical experiments on humans imposing risks that are not reasonable in relation to the anticipated benefits. [45 CFR 46.111 and 40 CFR 26.111(a)(2)]  Those laws prohibit including possible long-range effects of applying knowledge gained the research when weighing risks and benefits.

The EPA admits there is no potential benefit to directly inhaling diesel fumes.

 Dr. Dunn called EPA’s human experimentation “scandalously unethical and immoral” and said “There can be no further tolerance of this misconduct.”

The suit, ATI v. EPA, names EPA, EPA administrator Lisa Jackson as defendants.  It seeks to immediately halt the experiments, halt any similar experiments, to declare the EPA did not provide sufficient information to victims, to halt expenditures for the study, to suspend use of the UNC Medical IRB unit, to prohibit the EPA from using information from the study and to suspend implantation of any rules under the Clean Air Act to control fine particulate matter until it is ensured they are not based on information gathered from illegal medical experiments.