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The Toxic Substances Control Act:
from the perspective of Don R. Clay

  • Born: June 26, 1937, Washington Courthouse, Ohio

  Interview Details

Interview no.: 0684
Interview Date: March 16, 2012
Location: Koch Industries, Inc., Washington, D.C.
Interviewers: Jody A. Roberts and Kavita D. Hardy
No. of pages: 43
Minutes: 85

  Abstract of Interview

Don R. Clay received bachelor’s and master’s degrees in chemical engineering from the Ohio State University, where he was required to participate in the Reserve Officers’ Training Corps. He took a job at Monsanto Company, but after six months entered the U.S. Army, serving two years at Fort Bliss, Texas, performing air defense simulation modeling. On his return to Monsanto he decided he did not like the way chemical engineering was done there, and he went to Operations Research, Inc. For a number of years there and at several subsequent companies he worked in operations research.

Leaving those companies Clay began work in the Bureau of Drugs at the U.S. Food and Drug Administration (FDA); there he spent several years as Deputy Assistant Commissioner of Planning and Evaluation. Next he took his talents and experience to the U.S. Consumer Product Safety Commission’s Office of Program Planning and Evaluation. His risk assessment work included being liaison among the U.S. Environmental Protection Agency (EPA), the Occupational Safety and Health Administration (OSHA), the U.S. Consumer Product Safety Commission (CPSC), and the FDA, which gave him a chance to learn more about the EPA. Frustrated with the bureaucracy at the FDA, Clay moved to the Office of Toxic Substances, where he became Acting Assistant Administrator of what is now the Office of Pesticides and Toxic Substances (OPTS). Asbestos occupied much of his attention there, but only emberizing ash was banned. Industry testing was legislated. PCBs became regulated. Nevertheless, Clay’s disenchantment with having to “look for causes” led him to the Office of Air and Radiation (OAR) and, for his final position with the EPA, to Assistant Administrator of the Office of Solid Waste and Emergency Response (OSWER). After about five years, Clay believes, one becomes stale and should move to a different area; he chose OAR because it had interesting problems. Clay received a number of government honors, and he now works in the private sector.

Clay discusses the cultural differences among agencies; their different goals and processes; the differences between career staff and political appointees; and the difficulties of the regulatory process itself. He talks about what he perceives as successes and failures, focusing on asbestos regulation. He says that asbestos was never regulated, and that the costs of determining that it would not be regulated—he cites schools causing illness by tearing out the asbestos—far outweighed the benefits, especially since the market has itself eliminated asbestos. On the other hand, emberizing ash was done away with. In fact, he believes that in his day decisions were taken on the basis of benefits exceeding costs, whereas now bodies “just do it” (regulate). This he attributes to a more recent politicization of the process, citing the return of the formaldehyde debate. He talks about his relationship with the U.S. Congress and the influence of the European laws known as REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals). He notes that legislation is usually enacted within two months of a general election.

Scientists ask, “What is the risk?” but consumers ask, “Is it safe?” Reconciling these two approaches in order to determine the optimum amount and kind of regulation is not an easy job. Clay’s philosophy and practice have always been to “do the right thing.”

  Education

1960 B.S., Chemical Engineering, Ohio State University
1960 M.S., Chemical Engineering, Ohio State University

  Professional Experience

The Monsanto Company, Springfield, Massachusetts

1960 - 1961

U.S. Army, Fort Bliss, Texas

1961 - 1963

Second Lieutenant

Operations Research, Inc., Silver Spring, Maryland

1963 - 1968

Research Management Corporation

1968 - 1970

Program Director

Resource Allocation, Inc.

1970 - 1971

Executive Vice President

Commission on the Organization of the Government of the District of Columbia, Washington, D.C.

1971 - 1972

Group Leader

U.S. Food and Drug Administration, Washington, D.C.

1972 - 1972

Planning and Evaluation, Bureau of Drugs

U.S. Food and Drug Administration, Washington, D.C.

1972 - 1974

Deputy Assistant Commissioner, Planning and Evaluation

U.S. Consumer Product Safety Commission, Washington, D.C.

1974 - 1976

Director, Office of Program Planning and Evaluation

U.S. Consumer Product Safety Commission, Washington, D.C.

1976 - 1981

Deputy Associate Executive Director, Engineering Sciences

U.S. Environmental Protection Agency, Washington, D.C.

1981 - 1985

Director, Office of Toxic Substances

U.S. Environmental Protection Agency, Washington, D.C.

1985 - 1986

Acting Assistant Administrator, Office of Pesticides and Toxic Substances

U.S. Environmental Protection Agency, Washington, D.C.

1986 - 1989

Deputy Assistant Administrator, Office of Air and Radiation

U.S. Environmental Protection Agency, Washington, D.C.

1989 - 1993

Assistant Administrator, Solid Waste and Emergency Response

Don Clay Associates, Inc., Washington, D.C.

1993 - 1998

President

Koch Industries, Inc., Washington, D.C.

Director of Environmental and Regulatory Affairs

Koch Industries, Inc., Washington, D.C.

Vice President, Environmental and Regulatory Affairs

  Honors

1983

Administrator’s Award, U.S. Environmental Protection Agency

1987

Presidential Rank Award, Meritorious Executive, U.S. Government

1988

Presidential Rank Award, Distinguished Executive, U.S. Government

  Table of Contents

Title and Description Page

Education and Early Career 1

B.S., and M.S. in Chemical Engineering from Ohio State University. Monsanto Company in Springfield, Massachusetts. Air defense simulation modeling in U.S. Army at Fort Bliss, Texas. Operations Research, Inc. Program Director at Research Management Corporation. Executive Vice President at Resource Allocation, Inc. U.S. Food and Drug Administration Bureau of Drugs. Planning and Evaluation; then Deputy Assistant Commissioner of Planning and Evaluation; several years there. U.S. Consumer Product Safety Commission. Director, Office of Program Planning and Evaluation. Deputy Associate Executive Director, Engineering Sciences. IRLG under President Carter. Liaison among EPA, OSHA, CPSC, FDA. Risk assessment. Frustration with bureaucracy. Leaves for EPA.

U.S. Environmental Protection Agency 2

Director, Office of Toxic Substances, then Acting Assistant Administrator, Office of Pesticides and Toxic Substances (OPTS). Discusses cultural differences among agencies. Career staff versus political appointees. Differences in goals and processes. Difficulties of regulation process. Looking for causes.

Perceived successes and failures 4

Failed to regulate asbestos, but got rid of emberizing ash. Costs exceeded benefits of warning about asbestos. Illnesses resulting from asbestos removal. Market eliminated asbestos without regulation. PCB regulation successful. Industry testing legislated.

Decision-making Process 10

Philosophy: “Do the right thing.” Testing difficulties. PMN (premanufacturing notice). Unreasonable risk. Early decisions dependent on analysis of costs versus benefits; now “just do it.” Politicization recent; e.g. formaldehyde redux. Relationship with U.S. Congress. Influence of REACH. General elections as stimulus for legislation. Resources dependent on lawsuits against TSCA; feasibility of suing own department. Advocating for program.

Office of Air and Radiation (OAR); Solid Waste and Emergency Response 25

Career move in OPTS from Acting Assistant Administrator would not be upward, so decided to leave department. Chose OAR for its interesting problems. Found TSCA boring; felt that about five years was right time frame for avoiding staleness. Went to Office of Solid Waste and Emergency Response (OSWER).

Final Thoughts 26

Frustrations with getting things done. Testing process too costly, too drawn out. Defining universe of old chemicals to test impossible. REACH perhaps too onerous for American industry. Confidential business information (CBI) forces necessary tough decisions; boundaries always changing. Basic tension between regulators and consumers.

Index 32

  About the Interviewer

Jody A. Roberts

Jody A. Roberts is the Associate Director for the Center for Contemporary History and Policy and the Manager of the Environmental History and Policy Program at the Chemical Heritage Foundation. Roberts received his Ph.D. and M.S. in Science and Technology Studies from Virginia Tech and holds a B.S. in Chemistry from Saint Vincent College. His research focuses on the intersections of regulation, innovation, environmental issues, and emerging technologies within the chemical sciences.

Kavita D. Hardy

Kavita D. Hardy is a research assistant in the Environmental History and Policy Program at the Chemical Heritage Foundation. She received a B.A. in Chemistry and in Economics from Swarthmore College.

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