Chutzpah: EPA Lied About its Human Pollution Experiments

On Friday, December 14, 2012 The Environmental Protection Agency (EPA) announced new tighter outdoor air quality standards for (fine particulate matter) PM2.5. The new standard calls for a maximum of 12 micrograms per cubic meter. 

However, the announcement published in the Federal Register contains blatant false claims (i.e., lies) denying that it uses diabetics, asthmatics, and people with known cardiovascular disease and respiratory disease from EPA’s toxic pollution inhalation experiments. Footnote 53, on page 115 of the Final Rule  states:

"the EPA excludes from its controlled human exposure studies involving exposure to PM2.5 any individual with a significant risk factor for experiencing adverse effects from such exposure. Thus, the EPA excludes a priori the following categories of persons: those with a history of angina, cardiac arrhythmias, and ischemic myocardial infarction or coronary bypass surgery; those with a cardiac pacemaker; those with uncontrolled hypertension (greater than 150 systolic and 90 diastolic); those with neurogenetive diseases; those with a history of bleeding diathesis; those taking betablockers; those using oral anticoagulants; those who are pregnant, attempting to become pregnant, or breastfeeding; those who have experienced a respiratory infection within four weeks of exposure; those experiencing eye or abdominal surgery within six weeks of exposure; those with active allergies; those with a history of chronic illnesses such as diabetes, cancer, rheumatologic diseases, immunodeficiency state, known cardiovascular disease, or chronic respiratory diseases; smokers." [Emphasis added]

 

But EPA documents, some posted on EPA’s website, refute the above claim. 

  • For example, the "2008 Progress Report: Human Clinical Studies of Concentrated Ambient Ultrafine and Fine Particles," RE: EPA Grant Number R832415C003, states:
    "Three human exposure protocols will be conducted using the Harvard ultrafine ambient particle concentrator, in collaboration with the Aerosol Generation and Analysis Facility Core. The first protocol will examine effects in healthy subjects, the second protocol will examine effects in age-matched subjects with type 2 diabetes, and the third protocol will assess the role of pretreatment with the cyclooxygenase inhibitor aspirin in preventing the cardiovascular effects of ultrafine/fine particle exposure."


  • "Human clinical exposures to concentrated ambient ultrafine particles The Harvard ultrafine particle concentrator has been installed in a dedicated room in the Kornberg Medical Research Building at the University of Rochester Medical Center, and is fully operational. We have completed construction of a negative-pressure inhalation chamber, which is housed within our new exposure facility. We have initiated human clinical exposures to concentrated ambient ultrafine particles, using the concentrator and the exposure chamber. Installation and maintenance of the concentrator and exposure system requires close collaboration with Dr. Oberdörster, Research Core #1, and the Aerosol Generation & Analysis Core."

Ultrafine particles (UFP) are considered more dangerous than PM2.5.  The EPA has determined that UFP can cause sudden death.
Yet, in this EPA-funded experiment elderly diabetic subjects were exposed to 50 micrograms per cubic meter. The experiment was conducted at the University of Rochester PM Center, whose director is Gunter Oberdorster.  

In April 1996, Nicole Wan, a 19-year old student at the University of Rochester died as a subject in an air pollution inhalation experiment for which she was to receive $150. She was apparently overdosed with a lethal dose of the anesthetic, lidocaine during a bronchoscopy. The experiment was funded by the U.S. National Institute of Environmental Health Science. An investigation by the New York State Department of Health found the researchers at fault: 

"Rearch protocols for this project were not clearly stated and, in some instances, researchers did not follow approved protocols," said Dr. DeBuono. "As a result, a number of  opportunities were missed to minimize the risks to volunteers. When healthy volunteers undergo a research procedure that provides no clinical benefits to them, researchers must pay strict attention to minimizing their potential risk of harm."

With generous funding from the EPA, epa-u_rochester_check_8_mill.jpg

the University of Rochester has apparently expanded its non-therapeutic toxic pollutant exposure experiments on hesalthy students to testing concentrated air pollution particles on diabetics, asthmatics, and patients recovering from heart attacks. 

2. Inhalation of carbon Ultra Fine Particles in diabetics

"We have completed our study of the effects of inhalation of ultrafine carbon particles in subjects with diabetes. Diabetics have vascular endothelial dysfunction which may increase their risk for adverse cardiovascular effects from airborne particles. Type 2 diabetics, age 30-60, without clinical cardiovascular disease and not on “statin” medications, were exposed to filtered air or 50 μg/m3 carbon UFP (count median diameter ~30 nm, GSD 1.8) by mouthpiece for two hours, in a randomized double-blind cross-over study. Exposures were separated by at least two weeks. Nineteen subjects completed the study."
A preliminary analysis of the findings was published in abstract form and presented at the 2007 American Thoracic Society International Conference. Compared with air exposure, UFP exposure increased platelet expression of CD40 ligand (CD40L) (Figure 4), a marker of platelet activation and a key molecule in the development of atherosclerosis.

"We concluded that inhalation of carbon UFP for 2 hours may transiently activate vascular endothelium and/or platelets in subjects with type 2 diabetes. This finding supports the hypothesis that exposure to ambient UFP may increase the potential for vascular thrombosis in patients with severe vascular disease or ulcerated atherosclerotic plaques".

Documents also show that EPA researchers or EPA-funded researchers have experimented on asthmatics and people with heart disease.
EPA-funded researchers at the University of Rochester apparently have experimented on patients recovering from heart attacks.

"75 patients taking part in a cardiac rehabilitation program will be studied. Patients from an active cardiac rehabilitation program within the University of Rochester Medical Center are offered enrollment in the health effects study as they enter the Cardiac Rehabilitation program. These are patients who have had a recent coronary event such as myocardial infarction or unstable angina leading to coronary stenting."

"The program involves supervised, graded twice or thrice weekly exercise sessions for a total of 10 weeks. As part of the rehabilitation protocol, vital signs and a standard 12 lead EKG will be performed. In addition to the regularly electrophysiologically monitored exercise of the rehabilitation program, subjects will undergo continuously recorded Holter ECG recordings performed and analyzed by the Cardiac Core allowing evaluation of a series of ECG parameters at rest, during exercise, and during immediate post-exercise period. Venous blood samples will be obtained once per week and analyzed by the Vascular & Inflammation Core for acute phase reactants (fibrinogen and C-reactive protein) previously found to vary with ultrafine particle exposure, as well as complete blood counts."

Concurrently, ultrafine particle number and particle mass will be measured continuously at a central measuring site in downtown Rochester. Other EPA Criteria Pollutants are also measured in eastern Rochester as well. In addition, one-third of the patients are being asked to do personal particle count monitoring in their car to and from the rehab facility and in their homes for 48 hours using a portable nuclei counter (TSI model 3781). Levels of ambient ultrafine and fine particles will then be associated with health data from the cardiac rehabilitation panel study.

Reality check: 

Read more: EPA Diesel Gas & Pollutant Human Inhalation Experiments
Lawsuit Filed Against EPA for Immoral Human Experiments

Vera Sharav