UPDATE: A new website chronicles the issue here http://epahumantesting.com/
Exclusive to WUWT by David W. Schnare
Statement of ATI’s Lead Counsel
on
American Tradition Institute v. U.S. Environmental Protection Agency
(US District Court, Easter 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 traveled 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.
=============================================================
Steve Milloy will have a related major announcement tomorrow at junkscience.com
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The list of issues identified provided at this page developed by Steve Milloy seems most “interesting”:
http://epahumantesting.com/the-shocking-revelations-of-the-epa-documents/
There do seem to be a lot of potential problems with the EPA’s harmful human testing, informed consent, research ethics, public claims about the research, etc.
The lawsuit may force the EPA to either (1) renounce the claim that any and all exposure to PM2.5 fine particulates is harmful, or else (2) denounce and repudiate their own research proceedings which did indeed appear to expose subjects to harms, and without informed consent or adequate consideration of human well being. [of course one can get into debates about hazardous vs. harmful, but since the EPA has staked out a clear-cut position they don’t seem to have room to maneuver]
Also, EPA admin Lisa Jackson’s various claims, such as that tightly regulating PM2.5 would be equal to “a cure for cancer” will come under more intense scrutiny, we may hope.
This lawsuit does seem to be an ingenious way to put the EPA on the spot to answer whether or not their experimentation was harmful to human test subjects. They will try hard to obfuscat, both to the court and to “the court of public opinion.” The EPA and it’s allies MUST be compelled to give as yes-or-no answer to a simple binary question:
Was this experimentation on human subjects hazardous to the subjects? YES or NO?
If it weren’t for my respect for A.W., I’d dismiss this out of hand. Hope you haven’t made a grievous mistake Anthony. My first thought was “wow.” My second thought, perhaps 10 seconds later, was this is just a major load of b.s.
J.Hansford says:
September 24, 2012 at 2:03 am
“The real facts are that the healthiest people live in the cities….. undisputed fact.”
Bunkum. The healthiest people live in suburbs and it’s due to lifestyles and income. Rural residents are the poorest and the farthest removed from hospitals and emergency care. Rural residents are also more likely to be smokers, drinkers, and overweight compounding the problems. Suburb dwellers are the wealthiest, are well served by nearby hospitals and emergency care, eat better, have lower stress levels, less violence, fewer accidents, and the air is cleaner.
It sounds like WUWT has been victimized by a con artist or someone who is mentally ill.
Rather casual way to get certification of no risk to subjects:
http://epahumantesting.files.wordpress.com/2012/09/other3p657.gif
What they were getting approval for (from one pulmonologist who did not review all of the study details) was exposure up to 600 mcg/meter 3 for max. of 6 min.
They compare that to exposure over 24 hours in an urban center on a smoggy day. BUT getting all of the exposure in 6 min. (compared to 24 hrs) seems like a drastic difference. Especially for particulates which the EPA repeatedly claims have no lower bound on hazard. Is it really enough to get one such casual “consult” from a pulmonologist to certify the safety of such an experiment?
In fact, Milloy finds that exposure in some cases went up to 750 mcg/meter 3
In any case, did the researchers take adequate account of possible effects when receiving all of one’s “24 hour” exposure in only 6 min. or less?
Anthony, I don’t agree with some of the over-the-top criticisms here about this article (that it should never have been posted or worse… etc.). However, I do think it is important to get a follow-up article posted asap from someone who can give a dispassionate overview of the scientific, ethical, and legal issues without personal references. It’s not that the Nazi comparison on human experimentation may not prove relevant in the end, but that the reader new to the matter (as I was) can have no basis for judging the discussion of Nazi research, ethics of research etc. in relation to the EPA case until the latter has been presented in detail. Thus, the touching personal testimony of David W. Schnare is asking the reader to be deeply moved by the history recounted without (yet) knowing how it compares with the current case to be discussed later. I think that is what some readers are finding emotionally manipulative and inflammatory.
For my own view, I think it is crucial to understand the history of human experimentation and development of standards of research ethics, but one needs to establish all the facts of what has actually been done under the aegis of the EPA before one can know how or whether such historic (Nazi) comparisons could be relevant.
This is a pretty interesting thread in light of the Dr. L. kerfuffle. It would seem an ideal situation to test whether CAGW skeptics always accept any potential conspiracy which fits their self-interest. Bashing the EPA would surely be high on the lists of subjects that should attract skeptics. But here most of the skeptics are acting like… skeptics. I have to admit that I was/am doubtful like many of the others here. Don’t know that I’ll have time to more than observe from the sidelines, but this seems to be a definitive proof that skeptics are equal opportunity doubters.
http://hero.epa.gov/index.cfm?action=reference.details&reference_id=4638
Not sure if this applies, but it is an interesting article on studying pm2.5 from canada in 2000
one more if I may, I had not seen the summary page on Steve Milloy’s special site on EPA Human Testing, but it gives the kind of overview of the matter that I think a lot of us are seeking:
http://epahumantesting.com/summary/
Whatever is being done through a university, it needs IRB approval. There is no one in the research triangle who is going to take IRB approval lightly, after Duke got its federally sponsored resch totally shut down due to a problem with one federally funded study, in 1999.
Procedures in the IRB have to match actual procedures, or the investigators are in trouble.
Either procedures at Chapel Hill are following protocol as on file with IRB, or not.
If they are, you simply look at the research protocol to see what is happening. No issue or mystery.
If procedures as on file with IRB are unethical – risks outweighing benefit, or potential harms not being disclosed, or enticements excessively influencing the decision to participate, then this will be obvious, and things will be halted quickly. It is unlikely an unethical study ever made it past IRB, however.
If procedures are not following what is ‘on file’ with the IRB, simply bringing this to the attn of the University should bring the issue to be investigated very quickly.
The IRB people know how to audit a study. They can be on the case within a day if there is enough fear and panic behind an allegation.
This adds up to: highly unlikely that participants are being connected to a deisel exhaust pipe just to see what happens.
I sifted through Milloy’s FOIA results and his analyis last week. My reaction was similar to Skiphil 4 posts above. Their objective is to make the EPA play by it’s own rules. They use EPA words, pictures and information to demonstrate that they didn’t conduct themselves as required according to their own statements. The EPA and UNC apparently did not believe what the EPA had stated publicly as fact. The EPA rules they seek to hold the EPA to are hyperbolic and hypocryphal.
Looking at the documents, I concluded that the EPA was already on record with its highly exaggerated assertions as fact and: (1) targeted at risk volunteers to get some big results to back up their big assertions, and (2) the disclosure consent forms obtained in the FOIA requests did not describe the EPAs stated position and conclusions at that time to the targets while misleadingly describing possible minor and temporary side effects. It’s surprising they didn’t get more strong adverse and life threatening results than the few they did get. My wfe is overweight, has trouble breathing, and regularly needed an inhaler to deal with diesel fumes in Union Station. She fit the advertisement for subjects and easily could have been hospitalized if not worse.
The public release by the attorney is just that – to get attention for the project. I’m hoping they dont over do it, but the EPA and all of media have ignored Milloy and what is in the FOIA responses by the EPA so far. Hoping it will go away, but now it isn’t. I’d say ATI called their bluff and this isn’t their first poker game.
This smacks to me of sounding like the sort of conspiracy theory Lewandowsky would endorse.
This is one of the few articles I have read on WUWT over the last few years whose veracity I have doubted.
From Ian H on September 23, 2012 at 11:16 pm:
Who are you talking to? You’re on the Watts Up With That? web site, not the ATI site, nor are there ATI people here to address.
Gee, let’s look at an example with equivalent potential harm. EPA recruits volunteers to test the effects of contaminated water, for which the batch the samples are drawn from was (accidentally?) contaminated with HIV-containing bodily fluids. Afterwards the participants were unharmed, or at least no more harmed than if they had deep-tongue kissed an AIDS patient. So no harm, no foul, anyone complaining can go pound sand.
For right or wrong, an HIV-infected person who knowingly exposes someone else can be charged and convicted with felonious assault, assault with a deadly weapon, even bio-terrorism. The possibility of death is there, even if remote, thus it is an attack with something that can cause death.
The EPA exposed these people to that which they said can kill. Even if the chance of (eventual, long drawn-out) death is remote, it was still there.
Thus the EPA has committed felonious assault, assault with a deadly weapon, etc. And you say ATI has no case without demonstrating damages? If someone threatened you with a gun or knife, if you weren’t harmed would you blow it off and say nothing actionable happened? What if it were “just a scratch”?
===
Joe Guillim said on September 24, 2012 at 5:39 am:
Maybe, but the regulars know to ignore them.
😉
Brad says:
September 24, 2012 at 2:34 am
James-
Yes, I did go to your website…and for background I have both a Ph.D. and a J.D. I find the site to be scientifically poor and the arguments based on bombast with little fact, I also find the site legally insufficient ……….
===============================================
Fair enough Brad. I’m not sure you’re entirely familiar with Milloy’s history. Given his history, I think being dismissive is naive. He’s been on the EPA for over 20 years. He’s fought with them and won in the past. While I agree, the presentation to the public could be refined, Milloy has been at it for so long, he knows when he’s got something huge.
Isn’t the largest source of PM2.5 road dust?
And they invented PM2.5 as super-dangerous because their previous evil particulate matter PM10 turned out to be 90% road dust?
http://www.epa.gov/cgi-bin/broker?_service=data&_debug=0&_program=dataprog.national_1.sas&polchoice=PM
PMx is just fabricated excuses to kill off coal mines.
Experimentation on human beings is absolutely illegal if not done with proper ethics reviews.
The NIH hold the historical basis for this principle. It is called the Nuremberg Code and was the result of the Trails at Nuremberg following WWII and the Nazi experiments that were conducted on prisoners.
http://history.nih.gov/research/downloads/nuremberg.pdf
A state, any state including the United States, may not subject a person to potential injury if alternative methods exist to render the information even if the subject agrees. And if the subject has not been informed, then the experimenter should be jailed.
From what I have read on this, it is right up there with Josef Mengele in principle.
Zeke & Intrepid_wanders:
“Yes, your easy answer could be correct, but the problem is not just with fossil hydrocarbons. PM2.5 is not the threshold of “asthma sufferers”. It goes down to PM6 for pollen, but what about mold? Has the EPA whipped that issue? Is there no longer a threat of the modernization of homes using drywall and the mold increase? I ask this because asthma baffles a lot of the medical community in why “cleaner communities” seem to have the highest occurrence of asthma related illness.”
Wonder if the asthma increase may be related to house air “tightness” or low air exchange rate. I have a 14 year old house and my CO2 meter routinely registers over 1000ppm and that with only 2 people. The newer ones are probably a lot tighter. Good for energy savings but the other stuff, like mold, Particulate Matter, carpet organics etc. doesn’t get moved out very fast. Would be interesting to see asthma studies done relative to historical indoor living conditions as houses say 50 years ago typically had much higher air exchange rates.
This is also one side of the CO2 increase never mentioned, as increases in the outside CO2 level will drive up indoor levels by an approximate like amount, e.g. my indoor levels would be about 1200ppm for 600 ppm outside.
Apparently EPA has been caught at this before back in 2005:
http://epahumantesting.files.wordpress.com/2012/09/human-pesticide-experiments-june-2005.pdf
Hmmmm … was this/is this part of the EPA’s move to ban the more efficient internal combustion engine, the diesel power plant?
“The banning our slowspeed engines” (Such as the Lister and Listeroid derivatives capable of running on diesel as well as veggie oil)
http://www.utterpower.com/the-banning-our-slowspeed-engines/
It should be noted that the importation of any given engine or powerplant requires testing by the EPA, no matter the quantity be it “1” or 1 zillion (this means submission of the subject engine[s} plus mail-in the required 5-figure dollar amount for testing + yearly fees) … the price-impact effect on the lower quantities should be apparent …
EPA IN REGULATORY PRETZEL WITH A BUSINESS PARTNER
http://www.peer.org/news/news_id.php?row_id=1599&title=EPA%20IN%20REGULATORY%20PRETZEL%20WITH%20A%20BUSINESS%20PARTNER&subtitle=Navistar%20Licensing%20EPA%20Diesel%20Emissions%20Technology%20That%20Does%20Not%20Work
Actions in the EU:
Peugeot Opposes Proposal to Ban Diesel in Cities, Parisien Says
http://www.bloomberg.com/news/2012-09-17/peugeot-opposes-proposal-to-ban-diesel-in-cities-parisien-says.html
Ban Diesel
http://bandiesel.blogspot.co.uk/2011/06/gdi-technology-reproduces-diesel.html
Norway May Ban Diesel Cars
http://www.tnp.no/norway/panorama/3129-norway-may-ban-diesel-cars
Ban Diesel?
http://www.autocar.co.uk/forum/whats-new/ban-diesel
.
Not sure from where the “1 in 4 is attributable to PM2.5” comes. Milloy’s own site indicates that it was alledgedly 1 in 20:
http://junksciencecom.files.wordpress.com/2012/06/dunn-nc-med-board.pdf
Is the above (in bold) anywhere close to being an “appeal to authority” (argumentum ad verecundiam)?
“Trust us, we’re from the faculty and we have approved this research.”
BTW, where does one go to be first trained then certified as an ‘ethicist’?
I might add, this is what John Dale Dunn (MD JD, Consultant Emergency Services/Peer Review, Civilian Faculty, Emergency Medicine Residency, Carl R. Darnall Army Med Center, Fort Hood, Texas) in part, had to say about this:
.
For once, I agree with Mosher. Weird.
****
Brad says:
September 24, 2012 at 2:40 am
Do you remember when acid rain was killing forests on the East Coast (and that was actually true and not just politically based “science”).
****
I was generous of what you’d previously said (PhD & all), until the above statement gave it away. Are you aware of what the final analyses the EPA itself came up with, was presented to Congress, & subsequently ignored?
Seems odd that this would be announced on WUWT before its announced on the American Tradition Institute blog. Anyone know if this is a class action suit?
http://www.atinstitute.org/blog/
Con or not? That is the question.
Once again, the comments section of WUWT turns out to be as informing, or more even more informing, than the original posting.
The introduction was indeed over the top, but this is the social networking age. And in the social networking age it takes “over the top” to get something circulated broadly. Why does Drudge succeed? Partly because he has a knack for writing over the top headlines that pull readers to pages that they would never read if the headline he used was from the linked article itself.
So, I started with 90% “con” (because of the over the top presentation, the lack of details, and the general unbelievability of the matter), and with 10% “not con” (because it’s here on WUWT and articles here tend to be reasonably well vetted.)
But, after reading many of the comments, and especially those from people who know the participants in the matter, I’m now at 95% “not con”, reserving 5% “con” because I really don’t want to believe even the EPA would do something as ridiculous as the actions described in the posting, and because I haven’t followed the provided links myself.
The overall quality of commenting at WUWT is excellent and highly informative, a classic example of applying the strategy “Build it and they will come.” Thanks, Anthony (again.)
Mosher is playing the ‘long bet’ … you know how those can work out (often ‘played’ with little money riding and w/o doing series study so as to ascertain realistic odds) …
.