EPA fails to challenge allegations made at National Academy of Sciences hearing on illegal human experiments?

It seems EPA has not yet responded to the allegations we made at the August 24, 2016 National Academy of Sciences public meeting on EPA’s illegal human experiments.

Does this mean we win?

Below is the letter I sent today inquiring why EPA has yet to respond to our charges.

Click here for our testimony at the hearing.

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Dear Dr. Hiatt and NAS committee members,

I am writing concerning the status of your report on EPA’s human experiments program.

It appears that EPA has not responded to the Aug. 24 testimony offered by myself, Dr. John Dunn, and Dr. Stan Young.

A copy of the public docket for your committee (received today, Oct. 19, from the NAS and pasted below) indicates no comment submissions from EPA since December 2015.

Has EPA communicated with the committee about or since the August 24 public meeting?

If EPA has supplied additional information or a response to your committee and/or its members concerning the August 24 testimony, I am requesting: (1) acknowledgement that said information/response has been made by EPA; and (2) the information be placed immediately in the public docket.

I look forward to your response.

Sincerely,

Steve Milloy
JunkScience.com

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Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants

Pin# DELS-BEST-14-05

List of Materials for the Public Access File

1a. U.S. EPA
Physiological Changes in Adults with Metabolic Syndrome Exposed to Concentrated Ultrafine Chapel Hill Air Particles (XCON)
· Application for Institutional Review Board approval
· Consent to Participate in a Research Study
Received 19 November 2014

1b. U.S. EPA
Appendix B to XCON: “Statistical considerations for the proposed study
Received 27 April 2015

2. U.S. EPA
Mechanisms by which Air Pollution Particles Exacerbate Asthma in Older Adults with Mild Asthma (KINGCON)
· Application for Institutional Review Board approval
· Consent to Participate in a Research Study
Received 19 November 2014

3. U.S. EPA
Cardioprotective Effects of Omega-3 Fatty Acids Supplementation in Healthy Older Subjects Exposed to Air Pollution Particles (OMEGACON)
· Application for Institutional Review Board approval
· Consent to Participate in a Research Study
Received 19 November 2014

4. U.S. EPA
Cardiopulmonary Responses to Exposure to Ozone and Diesel Exhaust with Moderate Exercise in Healthy Adults (DEPOZ)
· Application for Institutional Review Board approval
· Consent to Participate in a Research Study
Received 19 November 2014

5. U.S. EPA
Effects of Sequential Exposure to Nitrogen Dioxide and Ozone in Healthy Adult Human Volunteers (ENDZONE)
· Application for Institutional Review Board approval
· Consent to Participate in a Research Study
Received 19 November 2014

6. U.S. EPA
The Interaction of Social Factors with Air Pollution (SOZIAL)
· Application for Institutional Review Board approval
· Consent to Participate in a Research Study
Received 19 November 2014

7. U.S. EPA
Effects of Wood Smoke Particles on Influenza-Induced Nasal Inflammation in Normal Volunteers (WOODSIE)
· Application for Institutional Review Board approval
· Consent to Participate in a Research Study
Received 19 November 2014

8. U.S. EPA
Epigenetic Effect Modifications with Ozone Exposure on Healthy Volunteers (GEMINOZ)
· Application for Institutional Review Board approval
· Consent to Participate in a Research Study
Received 19 November 2014

9. U.S. EPA
Pages 14, 19, and 21 from Section 1.5 “EPA Framework for Causal Determination”; EPA’s Integrated Science Assessment for Particulate Matter (December 2009)
Received 19 November 2014

10. U.S. EPA
List of Publications of Possible Relevance/Interest to NAS Task Order
Received 19 November 2014

11a. Letter from Congressman Paul Broun requesting an EPA OIG review of EPA’s controlled human exposure studies.

Click to access 2012%2010%2018%20Broun%20to%20Elkins%20re%20PM2.5.pdf

Received 14 November 2014

11b. EPA OIG Report
“Improvements to EPA Policies and Guidance Could Enhance Protection of Human Study Subjects”
Report No. 14-P-0154; March 31, 2014
https://www.epa.gov/office-inspector-general/report-improvements-epa-policies-and-guidance-could-enhance-protection
Received 19 September 2014

11c. U.S. EPA
EPA Follow Up to OIG Report No. 14-P-0154 [“Improvements to EPA Policies and Guidance Could Enhance Protection of Human Study Subjects,” Published March 31, 2014]
Received 27 April 2015

12. U.S. EPA
Epigenetic effects of diesel exhaust and ozone exposure (LAMARCK)
· Application for Institutional Review Board approval
· Consent to Participate in a Research Study
Received 4 May 2015

13. U.S. EPA
Possible Sources of Data/Information In Support of NAS Deliberations on Risk in EPA Exposure Research
Received 12 May 2015

14. U.S. EPA
Summary of exposure studies conducted from 2000 to present.
Received 19 May 2015

15. U.S. EPA
EPA guidance on reviewing and reporting unanticipated problems involving risks to subjects or others and adverse events
Received 19 May 2015

16. U.S. EPA
Integrated Science Assessments for Particulate Matter (December 2009)
Received 19 May 2015
Available from the Internet at: http://www.epa.gov/ncea/isa/

17. U.S. EPA
Integrated Science Assessments for Ozone and Related Photochemical Oxidants (February 2013)
Received 19 May 2015
Available from the Internet at: http://www.epa.gov/ncea/isa/

18. U.S. EPA
Integrated Science Assessments for Oxides of Nitrogen – Health Criteria (July 2008)
Received 19 May 2015
Available from the Internet at: http://www.epa.gov/ncea/isa/

19. U.S. EPA
Integrated Science Assessment for Oxides of Nitrogen–Health Criteria (Second External Review Draft
January 2015)
Received 19 May 2015
Available from the Internet at: http://www.epa.gov/ncea/isa/

20. U.S. EPA
Calculation of absolute risk of cardiovascular events during 2 hour chamber study.
Received 19 May 2015

21. U.S. EPA
List of final publications using data from controlled human exposures from 2000-2015
Received 28 May 2015

22. U.S. EPA
Three-part document:
a. NHEERL Fact Sheet, November 25, 2013; Addressing the Relevance and Implications of the IARC Air Pollution Carcinogenicity Report for ORD Human Studies
b. Agenda for Workshop on EPA Controlled Human Exposures; Chapel Hill, NC; December 12, 2013
c. Comments Following the EPA Workshop on Air Pollution Clinical Studies
Received 28 May 2015

23. U.S. EPA
PowerPoint presentations to the committee by EPA representatives on 1 June 2015:
a. “EPA Research Overview”
b. “Foundations of the NAS Charge: Ethical Issues in Foreseeable Risk”
Received 1 June 2015

24. U.S. EPA
PowerPoint presentations to the committee by EPA representatives on 1 June 2015:
a. How are Controlled Human Exposure Studies Used in Support of the National Ambient Air Quality Standards (NAAQS)?
b. How are Controlled Exposure Studies Done?
c. Regulation and Oversight of EPA Human Subjects Research, with Particular Reference to Controlled Exposure Studies?
Received 1 June 2015

25. U.S. EPA
Exposure study data on adverse events or observations for KINGCON, DEPOZ, OMEGACON, and XCON
Received 15 June 2015

26. U.S. EPA
Clean Air Research
Multi-Year Plan 2008-2012 report (June 2008)
Received 15 June 2015

27. U.S. EPA
Air, Climate, and Energy
Strategic Research Action Plan 2012-2016 (June 2012)
Received 15 June 2015

28. U.S. EPA
Air, Climate, and Energy
Strategic Research Action Plan, 2016-2019 (Draft- May 2015)
Received 15 June 2015

29. U.S. EPA
Human Health Risk Assessment
Strategic Research Action Plan 2012-2016 (June 2012)
Received 15 June 2015

30. U.S. EPA
Human Health Risk Assessment
Strategic Research Action Plan, 2016-2019 (Preliminary Draft- 2 July 2014)
Received 15 June 2015

31. U.S. EPA
Sustainable and Healthy Communities
Strategic Research Action Plan 2012-2016 (June 2012)
Received 15 June 2015

32. U.S. EPA
Sustainable and Healthy Communities
Strategic Research Action Plan, 2016-2019 Preliminary Draft (2 July 2014)
Received 15 June 2015

33. U.S. EPA
Two-part document:
a. PowerPoint slide Oversight of Human Exposure Studies
b. Managerial and Scientific Oversight of Exposure Studies
Received 2 July 2015

34. U.S. EPA
Procedures for Generating and Monitoring Exposure Air Mixtures
TRC Cover note for NAS docs (June 2015)
Received 2 July 2015

35. U.S. EPA
Study Candidates’ Reasons for Accepting or Declining Participation (June 2015)
Received 2 July 2015

36. U.S. EPA
Statistical Considerations for XCON (June 2015)
Received 2 July 2015

37. U.S. EPA
Exposure Study Design (June 2015)
Received 14 July 2015

38. U.S. EPA
Participants’ Comprehension of Risk-related Information
Received 14 July 2015

39. U.S. EPA
Madden et al. 2014. Diesel exhaust modulates ozone-induced lung function decrements in healthy human
Volunteers. Particle and Fibre Toxicology 11:37
Received 25 June 2015

40. U.S. EPA
Devlin et al. 2014. Controlled Exposure of Humans with Metabolic Syndrome to Concentrated Ultrafine Ambient Particulate Matter Causes Cardiovascular Effects. Toxicological Sciences 140(1).
Received 25 June 2015

41. U.S. EPA
Ghio et al. 2012. Case Report: Supraventricular Arrhythmia after Exposure to Concentrated Ambient Air Pollution Particles. Environmental Health Perspectives 120 (2).
Received 25 June 2015

42. U.S. EPA
Tong et al. 2015. Dietary Supplementation with Olive Oil or Fish Oil and Vascular Effects of Concentrated Ambient Particulate Matter Exposure in Human Volunteers. Environmental Health Perspectives. Advanced publication 1 May 2015. http://dx.doi.org/10.1289/ehp.1408988 .
Received 25 June 2015

43. U.S. EPA
Tong et al. 2012. Omega-3 Fatty Acid Supplementation Appears to Attenuate Particulate Air Pollution–Induced Cardiac Effects and Lipid Changes in Healthy Middle-Aged Adults. Environmental Health Perspectives 120(7).
Received 25 June 2015

44. U.S. EPA
Participant Recruitment for Studies
Received 13 Aug 2015

45. U.S. EPA
Statistical considerations for XCON
Received 21 Sept 2015

46. U.S. EPA
Request for Additional Information, dated October 7, 2015
Received 23 Nov 2015

47. U.S. EPA
Additional information on adverse events in controlled exposure studies
Received 23 Nov 2015

48. U.S. EPA
Study Justification Document
Received 23 Nov 2015

49. U.S. EPA
Minimal Risk Follow-Up
Received 7 Dec 2015

50. U.S. EPA
Vierra et al. 2016. “Respiratory Filter Reduces the Cardiovascular Effects Associated with Diesel Exhaust Exposure”
Received 6 Jan 2016

51. U.S. EPA
Participant Demographics and Exposure Parameters
Received 26 Apr 2016

52. Steve Milloy
JunkScience.com
Comment on “Assessing Toxicologic Risks to Human Subjects Used in Controlled Exposure Studies of Environmental Pollutants”
Received 16 June 2016

53. Steve Milloy
JunkScience.com
The EPA’s secret whitewash
Washington Times Analysis/Opinion, 24 July, 2016
Received August 3, 2016

54. Stan Young
Email, dated July 25, 2016
Comments to the committee with three attachments:
54a. Comments on South Coast Air Quality and Acute Mortality
54b. Young Short Bio
54c. Young 2011 Karr Deming Significance
Received July 25, 2016

55. Stan Young
Email, dated Aug 8, 2106
Comments to the committee with one attachment:
55a. Young Short Bio
Received August 8, 2016

56. John Dunn
Email, dated July 27, 2016
Comments to the committee
56a. EPA’s Unethical Air Pollution Experiments
Received July 27, 2016

57. John Dunn
Email dated July 28, 2016
Comments to the committee with 8 attachments:
57a. Berlin Code of Ethics
57b. German adopted code for Human Experimentation
57c. Nuremberg Code
57d. Belmont Report
57e.Declaration of Helsinki World Medical Assoc
57f. California Laws on Human Experimentation
57g. declaration Cascio highlighted
57h. declaration case highlighted
Received July 29, 2016

58. John Dunn
Email dated July 29, 2016
Comments to the committee with 8 attachments
58a. Berlin Code of Ethics
58b. German adopted code for Human Experimentation
58c. Nuremberg Code
58d. Belmont Report
58e.Declaration of Helsinki World Medical Assoc
58f. California Laws on Human Experimentation
58g. declaration Cascio highlighted
58h. declaration case highlighted
Received July 29, 2016

59. John Dunn
Email dated July 28, 2016
Comments to the committee with 2 attachments
59a. declaration Devlin highlighted
59b. let to congress
Received July 29, 2016

60. John Dunn
Email dated July 28, 2016
Comments to the committee with 10 attachments
60a. Letter to Deans
60b. Declarations of Wayne Cascio
60c. Declaration of Martin Case
60d. Declaration of Robert Devlin
60e. Appendix B
60f. Appendix C Letter to NIH
60g. Appendix C Tilson to Dunn
60h. Appendix D
60i. Reference Guide on Epidemiology
60j. Reference Guide on Toxicology
Received July 29, 2016

61. John Dunn
Email dated July 31, 2016
Comments to the committee with 1 attachment
61a. The EPA’s secret whitewash
Received July 31, 2016

62. John Dunn
Email dated August 1, 2016
Comments to the committee with 3 attachments
62a. GRADE working group
62b. GRADE group article 9
62c. Declaration Devlin
Received August 1, 2016

63. Committee Chair’s Opening Remarks and Presentation from Steve Milloy
Audio recording
Committee’s Information-Gathering Session via Webinar
August 24, 2016

63a. Steve Milloy
Slide presentation to the committee on August 24, 2016:
“ ‘No Safe Level of Exposure’ EPA’s Human Experiments With: Particulate Matter:”
Received August 22, 2016

64. Presentation from John Dunn
Audio recording
Committee’s Information-Gathering Session via Webinar
August 24, 2016

64a. John Dunn
Materials presented to the committee on August 24, 2016
Received August 23, 2016

65. Presentation of Stan Young and Discussion
Audio recording
Committee’s Information-Gathering Session via Webinar
August 24, 2016

65a. Stan Young
Slide presentation to the committee, with notes, on August 24, 2016
“Doublethink: Two incompatible positions.”
Received August 23, 2016

66. Public Comment Period
Audio recording
Committee’s Information-Gathering Session via Webinar
August 24, 2016

66a. James Enstrom
Materials presented to the committee on August 24, 2016
Received August 24, 2016

66b. Albert Donnay
Slide presentation to the committee on August 24, 2016
“Public Comments of Albert Donnay, MS, MHS”
Received August 24, 2016

67. Albert Donnay
Written testimony to the committee on August 24, 2016
Received August 23, 2016

68. James Enstrom
Letter to Robert Hiatt, dated August 30, 2016
Received August 30, 2016

69. John Dunn
Email dated September 5, 2016
EPA misconduct and NAS complicity?
Received September 5, 2016

70. Stan Young
Email dated October 3, 2016
Paper accepted in the journal Risk Analysis
Received October 3, 2016

71. Stan Young
Manuscript: “Local Control Strategy: Simple Analyses of Air Pollution
Data can Reveal Heterogeneity in Longevity Outcomes”
Received October 3, 2016