Control of chemicals in Sweden: an example of misuse of the “precautionary principle”

Abstract

With a background in biochemistry and radiation biology, I started to get involved in the control of chemicals area by battling the use of alkyl-mercury compounds in Swedish agriculture during the years 1964–1965 (C.-G. Rosén, H. Ackefors, and R. Nilsson, 1966, Seed dressing compounds based on organic mercury—economic aspects and health hazards, Svensk Kemisk Tidskrift 78, 8–19), and subsequently I acted as the sole technical advisor to the plaintiffs for the thalidomide children in Sweden for 4 years, ending in a 100 million US dollar (present value) settlement with the producers in 1969 (H. Sjöström and R. Nilsson, 1991, Thalidomide and the Power of the Drug Companies, Penguin, London, Feltrinelli, Milano, Iwanami Shoten, Tokyo Fisher Verlag, Berlin). I joined the Swedish EPA in 1974 and became head of the toxicological unit of the Products Control Division, where I was instrumental inter alia in pushing through regulations on reductions of lead in gasoline as well as the first general restrictions in world on the use of cadmium (R. Nilsson, 1989, Cadmium—an Analysis of Swedish Regulatory Experience, Report to the OECD Chemicals Group and Management Committee, January 1989). Since 1986 responsibility for control of chemicals was largely taken over from the Swedish EPA by the newly created National Chemicals Inspectorate (KEMI), an agency that employs me in the capacity of toxicologist. In between, I have been working for the OECD Chemicals Program as well as for WHO (IPCS) in various capacities and as a consultant in risk assessment for the US chemical industry under the Superfund Program. I was also associated with the Ministries of Environment of the governments of Iran and India. With respect to the latter, part of my recommendations were incorporated in the new Indian laws and regulations on chemicals that were issued subsequent to the Bhopal disaster (R. Nilsson, 1988, Procedures and Safeguards for Notification and Handling of Hazardous Chemicals in India, Report to WHO South-East Asia Region, SEA/EH/391, April 1988). As a consequence of a decreasing role for science in regulatory affairs, and a corresponding increasing influence from politics, for the past 8 years I have devoted myself mainly to research-oriented activities in my capacity as adjunct professor of molecular toxicology and risk assessment at the Stockholm University. In international collaboration, my projects have been supported by the Directorate General for Science, Research and Development of the Commission of the European Communities, the US Chemical Manufacturers’ Association, the Coulston Foundation (Alamogordo, State of New Mexico), L’Oreal, Merck Co., and in the past to a limited extent also by my own agency, the National Swedish Chemicals Inspectorate. However, my position as member of the executive board for the International Society of Regulatory Toxicology and Pharmacology in the United States, which I held for 5 years, as well as my role as technical advisor in products liability litigation, reflects my continued interest in the “politics of chemical risk.” In this context my critical comments with respect to the current regulatory policy for control of chemicals have caused considerable concern within the Swedish regulatory establishment (R. Nilsson, M. Tasheva, and B. Jaeger, 1993. Why different regulatory decisions when the scientific information base is similar? I. Human risk assessment, Regul. Toxicol. Pharmacol. 17, 292–332; R. Nilsson, 1994, Problems in the regulation of carcinogenic chemicals in an international perspective. III. Critical assessment of regulatory approaches. Rev. Int. Contam. Ambiental, México City, 10, 99–199; R. Nilsson, 1998, Integrating Sweden into the European Union: Problems concerning chemicals control. In The Politics of Chemical Risk—Scenarios for a Regulatory Future, R. Bal and Halffman, Eds, pp. 159–171, Kluwer Academic, Dordrecht).