This article analyzes the role of different kinds of information for minimizing or eliminating the risks due to the production, use, and disposal of chemical substances and contrasts it with present and planned (informational) regulation in the United States and the European Union, respectively. Some commentators who are disillusioned with regulatory approaches have argued that informational tools should supplant mandatory regulatory measures unflatteringly described as “command and control.” Critics of this reformist view are concerned with the lack of technology-innovation forcing that results from informational policies alone. We argue that informational tools can be made more technology inducing – and thus more oriented towards environmental innovations – than they are under current practices, with or without complementary regulatory mechanisms, although a combination of approaches may yield the best results. The conventional approach to chemicals policy envisions a sequential process that includes three steps of (1) producing or collecting risk-relevant information, (2) performing a risk assessment or characterization, followed by (3) risk management practices, often driven by regulation. We argue that such a sequential process is too static, or linear, and spends too many resources on searching for, or generating information about present hazards, in comparison to searching for, and generating information related to safer alternatives which include input substitution, final product reformulation, and/or process changes. These pollution prevention or cleaner technology approaches are generally acknowledged to be superior to pollution control. We argue that the production of risk information necessary for risk assessment, on the one hand, and the search for safer alternatives on the other hand, should be approached simultaneously in two parallel quests. Overcoming deficits in hazard-related information and knowledge about risk reduction alternatives must take place in a more synchronized manner than is currently being practiced. This parallel approach blurs the alleged bright line between risk assessment and risk management, but reflects more closely how regulatory agencies actually approach the regulation of chemicals. These theoretical considerations are interpreted in the context of existing and planned informational tools in the United States and the European Union, respectively. The current political debate in the European Union concerned with reforming chemicals policy and implementing the REACH (Registration, Evaluation and Authorization of Chemicals) system is focused on improving the production and assessment of risk information with regard to existing chemicals, although it also contains some interesting risk management elements. To some extent, REACH mirrors the approach taken in the U.S. under the Toxics Substances Control Act (TSCA) of 1976. TSCA turned out not to be effectively implemented and provides lessons that should be relevant to REACH. In this context, we discuss the opportunities and limits of existing and planned informational tools for achieving risk reduction.
Regulatory review of the environmental risk assessment of veterinary medicinal products in the European Union, with particular focus on the centralised authorisation procedure
