Tag Archives: risk regulation

Sally Katzen

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Collection: Perspectives on Modern Regulatory Governance
Dates of interview: October – November 2012
Interviewer: Edward Balleisen and Jonathan Wiener
Interview length: ~8 hours
Transcript: (PDF)
Location of interview: Kenan Institute for Ethics, Duke University, Durham, NC

Brief biography: Sally Katzen was the administrator of the Office of Information and Regulatory Affairs (OIRA) during the Clinton Administration from 1993 to 1998.  Katzen completed her undergraduate degree at Smith College and went on to the University of Michigan School of Law, where she served as editor-in-chief of the Michigan Law Review.  Katzen was the first woman to hold such a position on any major law review.  After completing law school, Katzen became a partner at Wilmer, Cutler & Pickering, where she specialized in administrative law and regulation.  Katzen first entered government service as the General Counsel of the Council on Wage and Price Stability from 1979 to 1981, and later returned to public service as the administrator of the Office of Information and Regulatory Affairs (OIRA) from 1993 to 1998.  Since leaving OIRA, Katzen has held various positions in academia, government service, and the private sector; she is currently a Senior Advisor at the Podesta Group and a visiting professor at the New York University School of Law.

Brief summary: These interviews survey an incredibly broad range of topics in regulatory governance and law, spanning from the early days of television regulation to air quality standards to food safety rules, and outlining key institutional connections between the Council on Wage and Price Stability and the modern OIRA.  In addition to its value to scholars interested in the process and possibilities of effective regulatory policymaking, these interviews (particularly the first one) provide a valuable account of the experiences of women in the legal profession in the mid-twentieth century.

Time range of discussion: 1963-2012

(Keywords coming soon)

John D. Graham

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Collection: Perspectives on Modern Regulatory Governance
Dates of interview: March 2, 2016 and April 21, 2016
Interviewer: Ashton Merck, Edward Balleisen (Jonathan Wiener – first interview only)
Interview length: Two sessions of approximately two hours each
Transcript: (PDF)
Location of interview: Kenan Institute for Ethics, Duke University, Durham, NC

Brief biography: John D. Graham was the administrator of the Office of Information and Regulatory Affairs (OIRA) from 2001-2006. Graham holds an M.A. in Public Affairs from Duke University and a B.A. from Wake Forest University, and received his Ph.D. in Urban and Public Affairs from Carnegie Mellon University. Graham is a leading scholar in the field of risk analysis and cost-benefit analysis, authoring or co-authoring 10 books and over 200 articles. Graham founded the Harvard Center for Risk Analysis in 1989 and directed it until he left for OIRA in 2001. After leaving OIRA, Graham became an academic administrator; Graham is currently the Dean of the School for Public and Environmental Affairs at Indiana University.

Brief summary: The first interview provides an overview of Graham’s early life and professional trajectory as an academic, concluding with his nomination for the position of OIRA Administrator, and describing the experience of the Senate confirmation process. The second interview discusses Graham’s tenure as OIRA administrator, including several significant changes to OIRA’s policies and practices, as well as the substance of several key regulations that were subjected to OIRA review during Graham’s term in office. The interview includes a discussion of Graham’s career since completing his service in government, and some reflections on the past and future of regulatory review.

Time range of discussion: 1978-2015

Agencies mentioned:
Office of Management and Budget
Office of Information and Regulatory Affairs
Council on Competitiveness
Council on Wage and Price Stability
Occupational Safety and Health Administration
Environmental Protection Agency
National Transportation and Highway Safety Administration
Office of Science and Technology Policy

Institutions mentioned:
Brookings Institution
Center for Science and the Public Interest
Harvard University Kennedy School of Government
Harvard Center for Risk Analysis
Harvard School of Public Health
ILSI International Life Sciences Institute
Indiana University School of Public and Environmental Affairs
Mercatus Center
National Academy of Sciences
National Science Foundation
Office of Economic Cooperation and Development
Pardee RAND School
Resources for the Future
Union of Concerned Scientists

Firms mentioned:
BASF/Bayer, Cummins Engine, DuPont, Dow Chemical, Rohm and Haas, Shell

Legislation, rules, and judicial rulings mentioned:
Circular A-4
Information Quality Act
REACH (EU)
Sarbanes-Oxley Act
Industrial Union Department, AFL-CIO v. American Petroleum Institute, et al. 448 U.S. 607 (1980) (the “benzene decision”)
Motor Vehicle Manufacturers Association of the United States, Inc., et al. v. State Farm Automobile Insurance Company et al., 463 U.S. 29 (1983)

Locations mentioned:
Carnegie Mellon University
Duke University
Harvard University
Washington, D.C.

Regulatory concepts discussed:
cost-benefit analysis
impact assessment
prompt letter
return letter
risk assessment

People mentioned:
Nancy Beck
Eula Bingham
James Blumstein
Joshua Bolten
Stephen Breyer
James S. Coleman
Susan Collins
Robert W. Crandall
Mitch Daniels
Tom Daschle
Bob Dole
Dick Durbin
Christopher Edley, Jr.
John Evans
Harvey Fineberg
Arthur Finkelstein
Steven Garber
Newt Gingrich
Wendy Gramm
Laura Green
Thomas Grumbly
Patricia Gwaltney (McGinnis)
Jim Hammond
Dennis Hastert
Jeff Holmstead
Al Hubbard
Bennett Johnston
Sally Katzen
Lester Lave
Carl Levin
Joseph Lieberman
Charles Lindblom
Trent Lott
Granger Morgan
Daniel Patrick Moynihan
Paul Noe
Howard Raiffa
William Reilly
William Ruckelshaus
Eileen Serene
Olympia Snowe
Cass Sunstein
Kimberly Thompson
Fred Thompson
James Vaupel
Arnold Weber
Milt Weinstein
Christie Todd Whitman
Jonathan Wiener

Selected bibliography for additional background:

  • Graham, John D., and James W. Vaupel. “The Value of a Life: What Difference Does It Make?” In Risk/Benefit Analysis in Water Resources Planning and Management, 233–43. Springer US, 1981.
  • Graham, John D., and Patricia Gorham. “NHTSA and Passive Restraints: A Case of Arbitrary and Capricious Deregulation.” Administrative Law Review, 1983, 193–252.
  • Tengs, Tammy O., Miriam E. Adams, Joseph S. Pliskin, Dana Gelb Safran, Joanna E. Siegel, Milton C. Weinstein, and John D. Graham. “Five-Hundred Life-Saving Interventions and Their Cost-Effectiveness.” Risk Analysis 15, no. 3 (1995): 369–90.
  • Graham, John D. “The Perils of the Precautionary Principle: Lessons from the American and European Experience.” Vol. 818. Heritage Foundation, 2004.
  • Graham, John D., Paul R. Noe, and Elizabeth L. Branch. “Managing the Regulatory State: The Experience of the Bush Administration.” Fordham Urban Law Journal 33 (2005): 953.
  • Bagley, Nicholas, and Richard L. Revesz. “Centralized Oversight of the Regulatory State.” Columbia Law Review 106, no. 6 (2006): 1260–1329.
  • Graham, John D. “Saving Lives through Administrative Law and Economics.” University of Pennsylvania Law Review, 2008, 395–540.
  • Wiener, Jonathan Baert, and John D. Graham. Risk vs. Risk: Tradeoffs in Protecting Health and the Environment. Harvard University Press, 2009.

Select newspaper articles

  • Stephen Power, Jacob M. “Redrawing the Lines: Bush’s Rules Czar Brings Long Knife to New Regulations — `Smart’ Style Helps to Disarm Critics while Developing Business-Friendly Agenda — Outdoing EPA on Emissions.” Wall Street Journal, Jun 12, 2002, Eastern edition.
  • Cindy Skrzycki, “Nominee’s Business Ties Criticized,” The Washington Post, May 15, 2001, E01.
  • “Graham’s Cracker.” Wall Street Journal, Jun 27, 2001, Eastern edition.
  • Ellen Nakashima, “Influence of Industry on Rules Agency Questioned,” The Washington Post, March 13, 2002, A27.
  • Ellen Nakashima, “For Bush’s Regulatory ‘Czar,’ The Equation Is Persuasion; Graham Wields Cost-Benefit Analysis For, Against Rules,” The Washington Post, May 10, 2002, 35.
  • ———. “Regulations Face Stiffer Review in Win for Bush Business Allies.” Wall Street Journal, Aug 29, 2003, Eastern edition.
  • Judith Weinraub, “The Hidden Fat; Some scientists have known about the dangers of trans fats for more than two decades. What took the government so long?” The Washington Post, September 10, 2003, F01.
  • McKinnon, John D. “How U.S. Rules are made is Still a Murky Process.” Wall Street Journal, Oct 22, 2003, Eastern edition.
  • Alex Fryer, “Bush administration’s gatekeeper weighs costs, benefits of new regulations.” Seattle Times, September 29, 2004.
  • Cindy Skrzycki, “Report Sheds Light on Changing Role of Regulation,” The Washington Post, January 25, 2005, E01.
  • Rick Weiss, “’Data Quality’ Law Is Nemesis Of Regulation,” The Washington Post, August 16, 2004, A1.
  • Cindy Skrzycki, “Looking Back on the Presidents’ Policy Wonks,” The Washington Post, November 1, 2005, D01.

National Institutes of Health Oral Histories

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Project description: The National Institutes of Health have conducted more than 100 interviews, some conducted by the History Associates and some conducted by oral historians on staff at the Office of NIH History.

Regulatory significance: Many of the interviews are highly technical discussions of medical techniques and research, but some of them discuss the evolution of safety regulations for hospitals, medical devices, and diseases like HIV/AIDS.

Interview dates: ~1964-2009

Digital access: Transcripts of many of the interviews are available online.

Physical access: Researchers will need to call or email to make an appointment to visit the Office of NIH History in Bethesda, Maryland.

Link: http://history.nih.gov/archives/oral_histories.html

Food and Drug Administration Oral History Program

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Collection description: The FDA began its oral history program in the mid 1970s, interviewing staff members towards the end of their careers. Per the oral history program’s description, “Though the program’s early focus was on agency staff directly connected to enforcement work, the History Office today collects oral histories from staff at all levels and across the agency.” More detailed information on the program can be found here.

Regulatory significance: This is a rich collection that explores in great detail the regulatory process from frontline monitoring to higher level rule-making.

Dates: 1974 – present

Digital access: Partial and full transcripts of many of these interviews can be found on the FDA website.

Physical access: Tapes and transcripts of the oral histories are deposited in the History of Medicine Division of the National Library of Medicine, in Bethesda, Maryland.

Interviewees: ~150

EPA History Program

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Collection description: According to EPA Order 1000.27 the “EPA History Program” dated March 1992, the EPA must conduct an Oral History Program. Michael H. Gorn and Dennis Williams served as the first historians of the EPA, and conducted the five oral history interviews with administrators and a deputy administrator.

Regulatory significance: Though few in number, the interviews provide rich details on the early history of the EPA and its structural dynamics. Many interviews include comments on the EPA’s relationship with the White House, Congress, OMB, regulated industries, public interest groups, and state and local government. They also include insightful discussions of regulatory conflicts over pesticides, industry emissions, crises like Love Canal, and scientific determinations.

Dates: 1992 – 1995

Digital access: Only interviews with five former agency heads are available online, with William Ruckelshaus, Russell Train, Alvin Alm, William K. Reilly, and Douglas M. Costle.

Chemical Heritage Foundation Oral History Program

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Repository description: The Chemical Heritage Foundation has collected over 425 oral history interviews with leading figures in chemistry and related fields at its Center for Oral History. Projects include the chemical history of electronics, the chemical industry, polymers, and women in science.

Regulatory significance: At least one project is explicitly focused on the creation and implementation of the Toxic Substances Control Act. A few other interviews appear to speak to public and private regulation of chemicals.

Location: Philadelphia, Pennsylvania

Dates: 1981 – Present

Digital access: Most digital transcripts are only available for a $5 fee.

URL: http://www.chemheritage.org/discover/collections/oral-histories/index.aspx

The Financial Crisis

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Project description: Conducted by PBS Frontline with Duke University’s DeWitt Wallace Center for Media and Democracy, this collection of more than 20 interviews includes many prominent academics, businessmen, and regulators regarding the financial crisis of 2007-2008.

Regulatory significance: These interviews are some of the first available specifically on the financial crisis of 2007-2008. The series presents a variety of perspectives on the crisis and the role of regulation (and deregulation) both in causing the crisis and in its response.

Repository: Duke University, DeWitt Wallace Center for Media and Democracy

Interview dates: 2009-2012

Digital access: Edited transcripts are available online, though navigating them is made more cumbersome by the construct of the Frontline website. Approximately eight interviews are available in full as video.

Link: http://www.pbs.org/wgbh/pages/frontline/oral-history/financial-crisis/