‘No Safe Level of Exposure’: EPA’s Human Experiments With Par=culate Ma@er Presenta(on to the Na(onal Academy of Sciences Commi7ee on Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants By Steve Milloy, MHS, JD, LLM Publisher JunkScience.com, milloy@me.com Senior Legal Fellow, Energy & Environment Legal Ins(tute August 24, 2016 EMBARGOED UNTIL AUGUST 24, 2016 AT 1 13:00 ET
Steve Milloy • Publisher, award-winning JunkScience.com • Senior Legal Fellow, Energy & Environment Legal Ins(tute – Public interest, 501(c)(3), www.eelegal.org • Educa(on – BA, Natural Sciences, Johns Hopkins University – MHS, Biosta(s(cs, Johns Hopkins Univ. School of Public Health – JD, University of Bal(more, – LLM, Securi(es Regula(on, Georgetown University • Consultant (environment/public health), author, former mutual fund manager & coal company execu(ve • Bio at h7p://www.junkscience.com/about EMBARGOED UNTIL AUGUST 24, 2016 AT 2 13:00 ET
Dedicated to Haiyan ‘Nicole’ Wan 1977-1996 EMBARGOED UNTIL AUGUST 24, 2016 AT 3 13:00 ET
EPA’s Human Experiments • Substances experimented with: – Par=culate ma@er (PM, PM 2.5 ) – Diesel exhaust (95% PM 2.5 ) – Ozone (smog) – Combina(ons of above – Chlorine gas and other substances EMBARGOED UNTIL AUGUST 24, 2016 AT 4 13:00 ET
Imagining PM EMBARGOED UNTIL AUGUST 24, 2016 AT 5 13:00 ET
Sources of PM – Natural EMBARGOED UNTIL AUGUST 24, 2016 AT 6 13:00 ET
Sources of PM - Manmade EMBARGOED UNTIL AUGUST 24, 2016 AT 7 13:00 ET
PM Lethality: Any Exposure Can Kill, Within Hours • From EPA’s 2009 PM 2.5 “Integrated Scien(fic Assessment”: EMBARGOED UNTIL AUGUST 24, 2016 AT 8 13:00 ET
PM Lethality (cont’d): No Safe Exposure • Former EPA CASAC Chair Jonathan Samet in New England J. Med. (July 11, 2011). EMBARGOED UNTIL AUGUST 24, 2016 AT 9 13:00 ET
PM Lethality (cont’d): Death from Any Exposure • Le7er from then-EPA air chief Gina McCarthy to House Energy Commi7ee (Feb. 3, 2012) EMBARGOED UNTIL AUGUST 24, 2016 AT 10 13:00 ET
PM Lethality (cont’d): Death Within Hours of Exposure • From EPA 2004 Integrated Scien(fic Assessment for PM 2.5 : EMBARGOED UNTIL AUGUST 24, 2016 AT 11 13:00 ET
PM Lethality (cont’d): Just Death. No Sickness. • During a September 22, 2011 hearing of the Oversight and Inves(ga(ons Subcommi7ee of the House Energy and Commerce Commi7ee, Administrator Jackson tes(fied: – “Par%culate ma-er causes premature death . It doesn’t make you sick. It’s directly causal to dying sooner than you should .” EMBARGOED UNTIL AUGUST 24, 2016 AT 12 13:00 ET
PM Lethality (cont’d): 1 Out of 5 Deaths Caused by PM • From September 22, 2011 House hearing (transcript): – REP. MARKEY: How would you compare it to the fight against cancer, reducing parDculate maEer? – MS. JACKSON: Yeah, I was briefed not long ago. If we could reduce parDculate maEer to healthy levels it would have the same impact as finding a cure for cancer in our country. – REP. MARKEY: Could you say that sentence one more Dme? – MS. JACKSON: Yes, sir . If we could reduce par%culate ma-er to levels that are healthy we would have an iden%cal impact to finding a cure for cancer . • Annual US cancer mortality – ~570,000 – ~ 20+% of all US deaths annually EMBARGOED UNTIL AUGUST 24, 2016 AT 13 13:00 ET
PM Lethality (cont’d): Air in LA, NY & EPA Experiments May Kill • Declara(on of clinical studies coordinator for EPA’s CAPTAIN study: EMBARGOED UNTIL AUGUST 24, 2016 AT 14 13:00 ET
PM Lethality (cont’d): Deadly Within Hours, No Safe Exposure EMBARGOED UNTIL AUGUST 24, 2016 AT 15 13:00 ET
PM Lethality (Cont’d): EPA-Funded Researcher Renounces PM Experiments • Ajer Brook’s EPA-funded human experiments with PM were reported in the Detroit News (July 23, 2013): – “I’m not going to do (these tests) because I don’t believe in exposing people. I’ve shown PM2.5 is bad for you.” EMBARGOED UNTIL AUGUST 24, 2016 AT 16 13:00 ET
EPA Regulates on the Basis that PM Kills EMBARGOED UNTIL AUGUST 24, 2016 AT 17 13:00 ET
PM Is Most Toxic Substance? As Lethal As A Bullet to the Brain? • EPA says any exposure to PM can kill in as li7le as hours – no safe exposure. • Even radia(on and chemical carcinogens regulated on the basis of the linear no- threshold model (LNT) ‘only’ have cancer as the health endpoint. • No known poison kills on an ‘any exposure’ basis. EMBARGOED UNTIL AUGUST 24, 2016 AT 18 13:00 ET
No Disclosure of the Nature of PM’s Lethality to IRBs • EPA staff researchers and EPA-funded university researchers did NOT provide any of this toxicity informa=on or equivalent to any Ins=tu=onal Review Board (IRB). – At most, occasional, vague, soj-pedaled and/or glancing men(on of PM’s correla(on with ‘mortality ’ – IRBs only given impression of ‘minimal risk.’ • From Common Rule: EMBARGOED UNTIL AUGUST 24, 2016 AT 19 13:00 ET
EPA’s Human Experiments Exhaust from Idling Diesel Truck… EMBARGOED UNTIL AUGUST 24, 2016 AT 20 13:00 ET
EPA Human Experiments (cont’d): … Pumped Into Chamber Containing Study Subject EMBARGOED UNTIL AUGUST 24, 2016 AT 21 13:00 ET
Who Does EPA Say Are Most Vulnerable to The Effect of PM? EMBARGOED UNTIL AUGUST 24, 2016 AT 22 13:00 ET
Who Are EPA’s Human Subjects? The Elderly EMBARGOED UNTIL AUGUST 24, 2016 AT 23 13:00 ET
Who Are EPA’s Subjects? (cont’d): Even More Elderly EMBARGOED UNTIL AUGUST 24, 2016 AT 24 13:00 ET
Who Are EPA’s Subjects? (cont’d): Even More Elderly EMBARGOED UNTIL AUGUST 24, 2016 AT 25 13:00 ET
Who Are EPA’s Subjects? (cont’d): Children EMBARGOED UNTIL AUGUST 24, 2016 AT 26 13:00 ET
Who Are EPA’s Subjects? (cont’d) • Diesel exhaust par(cles sprayed up noses of children. EMBARGOED UNTIL AUGUST 24, 2016 AT 27 13:00 ET
Who Are EPA’s Subjects? (cont’d) • How old were the children? EMBARGOED UNTIL AUGUST 24, 2016 AT 28 13:00 ET
Who Are EPA’s Subjects? (cont’d) • EPA-funded researchers described risk to Ins(tu(onal Review Board as ‘minimal.’ EMBARGOED UNTIL AUGUST 24, 2016 AT 29 13:00 ET
Who Are EPA’s Subjects? (cont’d) • State of California determined in 1998 that diesel exhaust causes cancer and that there is no safe exposure. EMBARGOED UNTIL AUGUST 24, 2016 AT 30 13:00 ET
Who Are EPA’s Subjects? (cont’d) • EPA commenced the process to ban experimen(ng on children in 2003 and finalized the ban in 2006. EMBARGOED UNTIL AUGUST 24, 2016 AT 31 13:00 ET
Who Are EPA’s Subjects? (cont’d) • EPA-funded USC experiments on children occurred during 2004-2005. EMBARGOED UNTIL AUGUST 24, 2016 AT 32 13:00 ET
EPA fails to explain dele=on of kids diesel experiment on from data base • As reported on JunkScience.com (April 25, 2013): EMBARGOED UNTIL AUGUST 24, 2016 AT 33 13:00 ET
Who Are EPA’s Subjects? (cont’d): Unhealthy People –Metabolic Syndrome EMBARGOED UNTIL AUGUST 24, 2016 AT 34 13:00 ET
Who Are EPA’s Subjects? (cont’d): Unhealthy - Older Asthma=cs EMBARGOED UNTIL AUGUST 24, 2016 AT 35 13:00 ET
Who Are EPA’s Subjects? (cont’d): Unhealthy People - Diabe=cs EMBARGOED UNTIL AUGUST 24, 2016 AT 36 13:00 ET
Who Are EPA’s Subjects? (cont’d): Unhealthy People: Heart A@ack Wai=ng to Happen EMBARGOED UNTIL AUGUST 24, 2016 AT 37 13:00 ET
Who Are EPA’s Subjects? (cont’d): Unhealthy People: Heart A@ack Wai=ng to Happen EMBARGOED UNTIL AUGUST 24, 2016 AT 38 13:00 ET
Who Are EPA’s Subjects? (cont’d): Unhealthy People: Heart A@ack Wai=ng to Happen EMBARGOED UNTIL AUGUST 24, 2016 AT 39 13:00 ET
Who Does EPA Say Are Most Vulnerable to Effects of PM? EMBARGOED UNTIL AUGUST 24, 2016 AT 40 13:00 ET
How Much PM Did EPA Expose Study Subjects to? • Recall: There is no safe exposure to PM, according to EPA. • Average U.S. outdoor air has ~ 10 micrograms per cubic meter of PM 2.5, according to EPA. – ‘Minimal risk’ level for Common Rule purposes • EPA acute exposure standard to PM 2.5 is 35 micrograms per cubic meter . – Exceeding standard violates the law EMBARGOED UNTIL AUGUST 24, 2016 AT 41 13:00 ET
How Much PM Did EPA Expose Study Subjects to? • 58 year-old woman spotlighted in the Case Report • 112 micrograms/m 3 is: – 3.2 (mes greater than EPA acute PM standard – 11 (mes greater than ‘minimal risk’ EMBARGOED UNTIL AUGUST 24, 2016 AT 42 13:00 ET
How Much PM Did EPA Expose Study Subjects to? • Diesel exhaust experiments • 300 micrograms/m 3 is: – 8.5 (mes greater than EPA acute PM standard – 30 (mes greater than ‘minimal risk’ EMBARGOED UNTIL AUGUST 24, 2016 AT 43 13:00 ET
How Much PM Did EPA Expose Study Subjects to? • Concentrated PM par(cles • 600 micrograms/m 3 is: – 17 (mes greater than EPA acute PM standard – 60 (mes greater than ‘minimal risk’ EMBARGOED UNTIL AUGUST 24, 2016 AT 44 13:00 ET
How Much PM Did EPA Expose Study Subjects to? • ‘Oops!’ exposure • 750 micrograms/m 3 is: – 21 (mes greater than EPA acute standard – 75 (mes greater than ‘minimal risk’ EMBARGOED UNTIL AUGUST 24, 2016 AT 45 13:00 ET
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