Don R. Clay

Born: June 26, 1937 | Washington Courthouse, OH, US

Don R. Clay graduated from Ohio State University, and after a brief stint at Monsanto Company, entered the US Army serving two years. After several years working in operations research, Clay began work in the Bureau of Drugs at the US Food and Drug Administration spending several years as Deputy Assistant Commissioner of Planning and Evaluation before leaving for the US Consumer Product Safety Commission’s Office of Program Planning and Evaluation. His work included being liaison among the EPA, OSHA, CPSC, and the FDA.  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). 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. 

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Interview Details

Interview no.: Oral History 0684
No. of pages: 34
Minutes: 85

Interview Sessions

Jody A. Roberts and Kavita D. Hardy
16 March 2012
Kock Industries, Inc., Washington, DC

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 US 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 US 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 US Environmental Protection Agency (EPA), the Occupational Safety and Health Administration (OSHA), the US 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 US 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

Year Institution Degree Discipline
1960 Ohio State University BS Chemical Engineering
1960 Ohio State University MS Chemical Engineering

Professional Experience

Monsanto Company

1960 to 1961

US Army

1961 to 1963
Second Lieutenant

Operations Research, Inc.

1963 to 1968

Research Management Corporation

1968 to 1970
Program Director

Resource Allocation, Inc.

1970 to 1971
Executive Vice President

Commission on the Organization of the Government of the District of Columbia

1971 to 1972
Group Leader

US Food and Drug Administration

1972
Planning and Evaluation, Bureau of Drugs
1972 to 1974
Deputy Assistant Commissioner, Planning and Evaluation

Consumer Product Safety Commission

1974 to 1976
Director, Office of Program Planning and Evaluation
1976 to 1981
Deputy Associate Executive Director, Engineering Sciences

US Environmental Protection Agency

1981 to 1985
Director, Office of Toxic Substances
1985 to 1986
Acting Assistant Administrator, Office of Pesticides and Toxic Substances
1986 to 1989
Deputy Assistant Administrator, Office of Air and Radiation
1989 to 1993
Assistant Administrator, Solid Waste and Emergency Response

Don Clay Associates, Inc.

1993 to 1998
President

Koch Industries, Inc.

1998 to 2000
Director of Environmental and Regulatory Affairs
2000 to 2009
Vice President, Environmental and Regulatory Affairs

Honors

Year(s) Award
1983

Administrator’s Award, US Environmental Protection Agency

1987

Presidential Rank Award, Meritorious Executive, US Government

1988

Presidential Rank Award, Distinguished Executive, US Government

Table of Contents

Education and Early Career
1

BS and MS in Chemical Engineering from Ohio State University.  Monsanto Company in Springfield, Massachusetts.  Air defense simulation modeling in US Army at Fort Bliss, Texas.  Operations Research, Inc. Program Director at Research Management Corporation. Executive Vice President at Resource Allocation, Inc. US Food and Drug Administration Bureau of Drugs. Planning and Evaluation; then Deputy Assistant Commissioner of Planning and Evaluation; several years there. US 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.

US Evironmental 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 US 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 Director of the Institute for Research at the Science History Institute. He received his PhD and MS in Science and Technology Studies from Virginia Tech and holds a BS 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 was a research assistant in the Environmental History and Policy Program at the Chemical Heritage Foundation. She received a BA in chemistry and in economics from Swarthmore College.