Congress & Federal Records
1990
Orphan Drug Amendments of 1990 (H.R. 4638) — House Report 101-635.
Committee on Energy and Commerce (Mr. Dingell). July 27, 1990.
Committee report accompanying H.R. 4638, revising the orphan drug provisions of the Federal Food, Drug, and Cosmetic Act and the Orphan Drug Act. Relevant to succimer’s regulatory context — succimer (Chemet) was approved by FDA in January 1991 as an orphan drug for severe pediatric lead poisoning.
1991
Lead Poisoning — Hearings before the Subcommittee on Health and the Environment, Committee on Energy and Commerce.
Serial No. 102-28. April 25 and July 26, 1991. 676 pages.
Two-day congressional hearing on childhood lead poisoning, including H.R. 2840 (bill to amend the Public Health Service Act to reduce human exposure to lead in residences, schools for young children, and day care centers, including exposure to lead in drinking water). Testimony from 26 individuals and organizations on the inadequacy of federal lead-poisoning response. Contemporaneous with CDC’s 1991 lowering of the BLL level of concern to 10 µg/dL.
1993
Draft Executive Order on Federal Actions to Address Environmental Justice in Minority and Low-Income Communities.
August 23–24, 1993. Clinton Presidential Library, FOIA No. 2012-0769-F.
Working materials for Executive Order 12898. Includes memo from Pam McElwee (Special Assistant) to HUD re: interagency working group co-chair role, and September 1993 letter from Robert Bullard, Bunyan Bryant, Beverly Wright et al. requesting DOE support for “Health Research Needs to Eliminate Environmental Injustices” conference (February 1994). Names NIEHS, EPA, ATSDR, NIH, and NIOSH as sponsors.
Statement of Kenneth Olden, Ph.D., Director, National Institute of Environmental Health Sciences.
Testimony before the Subcommittee on Technology, Environment, and Aviation, Committee on Science, Space, and Technology, U.S. House of Representatives. 103rd Congress. November 9, 1993.
Testimony on the NIEHS Superfund Basic Research Program. Discusses hazardous waste site remediation, biomarkers for toxic exposure, and pediatric environmental health research priorities. Does not specifically address lead or TLC.
Statement of Kenneth Olden, Ph.D., Director, National Institute of Environmental Health Sciences and National Toxicology Program.
Testimony before the Subcommittee on Technology, Environment, and Aviation, Committee on Science, Space, and Technology, U.S. House of Representatives. 103rd Congress. November 16, 1993.
Testimony on federal risk assessment research methodology, NIEHS/NTP structure, and recommendations for improving risk assessment. Does not specifically address lead or TLC.
1994
February 1994 Administrative Records (Kathleen McGinty, Deputy Director).
Clinton Presidential Library, FOIA No. 2012-0769-F. 171 pages.
Archive of White House correspondence, meeting lists, and administrative materials related to environmental policy coordination under McGinty’s office. Contemporaneous with TLC trial enrollment period and emerging environmental justice initiatives. Contains withdrawal/redaction sheets.
1995
H.R. 1022 — Risk Assessment and Cost-Benefit Act of 1995.
Passed February 28, 1995.
Regulatory reform legislation requiring federal agencies to conduct scientifically objective risk assessments and cost-benefit analyses for major rules affecting human health, safety, and the environment. Governs the framework under which lead exposure risk assessments are conducted.
Testimony on Behalf of Appropriations for the National Institute of Environmental Health Sciences and the NIEHS-Supported Environmental Health Sciences Centers Program.
Subcommittee on Labor-HHS-Education Appropriations, U.S. House of Representatives. 104th Congress. January 27, 1995.
Merchant (Director, Department of Preventive Medicine and Environmental Health, University of Iowa; President, Association of University Environmental Health Sciences Centers) testifies that lead poisoning is epidemic, affecting at least 3 million children. Cites research from Environmental Health Sciences Centers at Harvard and University of Cincinnati—both TLC clinical center sites.
Testimony on NIEHS Appropriations for Fiscal Year 1996.
Subcommittee on Labor-HHS-Education Appropriations, U.S. House of Representatives. 104th Congress, 1st Session. 1995.
Kenneth Olden (NIEHS Director) testifies on NIEHS budget priorities during the active enrollment period of the TLC trial. Scanned document; 14 pages.
1996
Prepared Statement on Cancer, Genetics, and the Environment.
Senate Committee on Labor and Human Resources. March 6, 1996.
Joint statement from the directors of the National Center for Human Genome Research (Collins), National Cancer Institute (Klausner), and NIEHS (Olden). Covers Human Genome Project, cancer genetics, environmental influences on cancer, risk assessment, and transgenic animal models. Olden discusses environmental health research frameworks relevant to understanding toxic exposures in vulnerable populations.
2001
Minutes of the National Advisory Environmental Health Sciences Council, 103rd Regular Meeting.
May 21, 2001. Rodbell Auditorium, NIEHS, Research Triangle Park, NC.
Council meeting chaired by Kenneth Olden. Held 10 days after the TLC primary results were published in the New England Journal of Medicine (May 10, 2001).