This oral history is one in a series that looks at the history of the Toxic Substances Control Act from the perspectives of the individuals involved in its creation, implementation, and execution.

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.”