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CRE Watch List: Special Projects
Human Volunteer Research
United States Government Resources
U.S. Congress
Recommendations for legislative action contained in the May 18, 2001 final report of the National Bioethics Advisory Commission.
Pediatric studies provisions of S. 838, introduced May 7, 2001 ("The Best Pharmaceuticals for Children Act")
- Statement by Senators Dodd and DeWine on introduction of S. 838
U.S. Environmental Protection Agency
CRE Files Human Test Data Petition at EPA
EPA's Pesticides Office has refused to consider clinical human test data in establishing No Observed Adverse Effects Levels during pesticide review and registration. On August 30, 2001, CRE petitioned EPA to return to its prior practice of considering clinical human test data when establishing pesticide NOAELs. CRE's petition explains that the Pesticides Office cannot refuse to consider clinical human test data without a rulemaking in accordance with all applicable laws and executive orders.
Click
to read CRE's Human Test Data petition.
EPA Pesticides Program Policy on Use of Human Volunteer Test Data
- Read
CRE's press release.
- Read
CRE's white paper.
- Read CRE letter to EPA Administrator
Browner on EPA's own use of human test data. (pdf)
- Read EPA response to CRE letter
concerning EPA's own use of human test data. (pdf)
- Read CRE letter to EPA concerning
the need for interagency coordination in any review of policy on human
testing. (pdf)
- Read CRE letter to Director
of HHS Office of Human Research Protections and Chair of the interagency
human testing policy committee concerning the need for interagency coordination
of any policy review or change. (pdf)
- Read
CRE letter to EPA Administrator Browner on the need to submit a proposed
rule on human testing to OMB for review as a "significant regulatory
action under E.O. 12866, and the need to submit any final rule to Congress
for review as a "major rule" under the Congressional Review Act."
- Submit comments.
Use of Human Volunteer Test Data by EPA Programs
- EPA study of human volunteer inhalation exposure to MTBE.
- FY200 Annual Report of EPA’s National Health and Environmental Effects Research Laboratory (NHEERL)
- EPA Human Studies Division and Facility
- Perchlorate
U. S. Department of Health and Human Services
Use of Human Volunteer Test Data by DHHS Programs
Agency for Toxic Substances and Disease Registry, DHHS (ATSDR)
Health Hazard Assessment for tetrachlorethylene (PCE) at DoD research facility at Natick, MA (1997)
National Institutes of Health, DHHS (NIH)
Funding of human volunteer study of thyroid effects of perchlorate in drinking water: Lawrence, J. E. et al., "The Effect of Short-Term Low-Dose Perchlorate on Various Aspects of Thyroid Function", Thyroid 10(8):659-63 (2000).
Perchlorate
National Institute for Occupational Safety and Health, DHHS/CDC (NIOSH)
IDLH (immediately dangerous to life or health concentration) for 1,1,2 trichloro1,2,2 trifluoroethane (1995)
Organic Solvent Neurotoxicity (1987)
Office of Human Research Protections (OHRP)
- Federal Register notice of establishment of OHRP
- OHRP website
- OHRP workshop June 21-22, 2001 (Charleston, SC)
The National Human Research Protections Advisory Committee (NHRPAC), OHRP Advisory Committee
- NHRPAC Homepage
Department of Defense
Effects of carbon monoxide on cardiac response during exercise (2001)
Perchlorate
NASA and the National Research Council (National Academy of Sciences)
Use of Human Volunteer Test Data by NASA and the Government Research Arm of the National Academy of Sciences (NRC)
Spacecraft Maximum Allowable Concentrations ("SMAC"s) for dichlorodiflouromethane (freon 12) and 4-methyl-2-pentanone (2000)
Government Committees
The Federal Inter-Agency committee, the Human Subjects Research Subcommittee of the Committee on Science of the National Science and Technology Council (HSRS)
- Subcommittee roster
The National Bioethics Advisory Commission (NBAC)
- NBAC website
- NBAC issues final recommendations May 18, 2001
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Background
Materials