CHEMICAL REGULATORY SYSTEMS

Figure 5.6 Alternative chemical regulatory systems to REACH (a) Dutch Strategy on Management of Substances (SOMS adapted from [316] (b) UK RCEP Chemicals Strategy... 

The most frequently used BFRs are polybrominated diphenylethers (PBDEs), tetrabromobisphenol A (TBBPA), and hexabromocyclododecane (HBCD). The use of FRs has been growing rapidly in recent years. BFRs are the most often used FRs, and their market is still growing. However, the estimated annual use of OPFRs in Western Europe was almost twice that of all BFRs combined. Many FRs have been banned for use because of their potential toxicity, environmental occurrence, and accumulation in human tissue. FRs taken off the market are likely to be replaced by others. Although the REACH (registration, evaluation, authorization and restriction of chemicals) regulatory system has been introduced in Europe to improve protection of human health and the environment, it is still necessary to monitor FRs in environmental samples [84, 88]. 

Leukotrienes and Prostanoids. Arachidonic acid (AA) (213) and its metabohtes are iavolved ia cellular regulatory processes ia all three principal chemical signaling systems endocrine (see Hormones), immune, and neuronal (62). FoUowiag receptor activation or iacreased iatraceUular... 

The substances we have described in this book turn out to be, for the most part, minor threats to our health. There are, however, perhaps thousands of these threats, and so a regulatory system has evolved to reduce the risks of individual substances to very low levels. There is considerable work yet to be done, to learn the toxic properties of many poorly tested chemicals, and to assess their health risks, but once this is done, regulatory officials have available strong weapons (which they do not always choose to deploy) to reduce exposures when necessary. The burden for exposure reduction falls not on exposed individuals (as in the case of lifestyle factors), but rather upon those who have caused the exposures to occur. 

A vital objective of future European chemicals policy is to avoid uncontrolled handling of hazardous substances. Assessment of each individual application on the basis of the individual substances involved (as provided for by the current regulatory system) is not an apt strategy, as the number of assessment and management cases that it produces is much too high. Quantitative risk analyses are only taken into account in the case of substances with clearly definable effect thresholds and controllable application conditions. For 90% of the market actors the particular product or application system must possess intrinsically safe properties, as most companies have neither closed systems nor the reqnired skills to deal with hazardons snbstances. 

Toxicity/symptoms nervous system, range of problems depending on chemical Regulatory facts RfDs exist for many insecticides. Regulated by EPA. General facts billions of pounds used every year in agriculture and around the home... 

In Chapter 10 1 consider how assessments of chemicals for their riskiness could fit into a regulatory system. But first I turn to the ethical and political presuppositions of risk-based regulatory systems. Why is there such an insistence that regulation be risk-based ... 

The types of harm that chemicals have the capacity to cause (in other words their hazards) are qualitatively different and not commensurate with each other. At one extreme are effects that require reasonably high concentrations of the substance, are immediate and localized (for example flammability, explosivity, corrosiveness and acute toxicity). The causal relationship between a particular chemical exposure and such effects is usually obvious, or at least easy to demonstrate. Those affected generally include those who deal directly with the chemical and it is often possible to handle and store the chemical in such a way that harm is avoided. The existing European Union (EU) regulatory system, dating from the 1967 dangerous substances directive (Council Directive 67/548/EEC) was clearly set up with... 

Our Stolen Future convinced me that we should be much more worried about synthetic chemicals than we generally are. So when I decided to do a PhD in philosophy in 2000, I chose to look at the regulation of chemicals, to see why the regulatory system was so ill equipped to deal with the issues raised by endocrine disruption. I felt that treating chemicals as isolated entities was part of the problem, so my research became an investigation into how we think about and publicly assess technologies, taking synthetic chemicals as an example. This book is the result of that research. 

This paper examines the impact of regulation on pharmaceutical innovation in the United States and the methodological problems involved when one attempts to measure pharmaceutical innovation. Data describing the rate and manner of passage of new chemical entities (NCEs) through the U.S. regulatory system and the national origin of NCEs marketed in the U.S. are presented. 

In July 2002, Dr. Nilsson accepted an appointment as professor in toxicology at the Nofer Institute of Occupational Medicine WHO Collaborating Centre in Lodz, Poland. As part of his responsibility, he advises the new Polish government about creating and supervising a modern regulatory system for chemicals control. 

In the first stage of the process, the independent body selects QSARs that are potentially useful in the context of a specific regulatory system, such as the future Registration, Evaluation and Authorization of Chemicals (REACH) system in the EU (European Commission, 2001). The selection could be based on a review of the scientific literature, or on the assessment of dossiers submitted by the proponents of QSAR models, such as industry, academia, or regulatory bodies. 

Such was the Committee 17 report. As its name suggests, this was a seventeen-member scientific review body convened by the EMS Executive Council to review research in mutagen detection and in population monitoring, assess the risk implications of the data derived from these testing and monitoring systems, and recommend directions for future research and for chemical regulatory policy. The committee s final report was published in Science in 1975 under... 

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