REGULATORY APPROACHES

A suspicion-based approach implies that evidence of a chemical hazard or exposure can immediately lead to regulatory action. Hazard-based approaches focus on the sources of a potential risk, attempting risk reduction by limiting the quantities of hazardous material produced and used. A hazard-based approach therefore requires only the hazard of a chemical to be identified. 

A technical-based approach follows the view that risks should be reduced to achieve an adequate level of safety, but does not require a socio-economic analysis of alternative risk management options. Standards are set according to available technology to ensure that certain margins of safety are not exceeded. A risk-benefit approach bases decisions on the results of socio-economic and stakeholder consultation. 

Reasons behind the various approaches may stem from alternative evaluative philosophies or frames used by regulators and stakeholders when analysing chemical risks [257], i.e., the degree of confidence  

In technological risk-reduction measures and the skilled behaviour of the people who manage these systems. 

That nature can cope with the consequences of errors of humans in risk assessment and risk management. 

In 1989, the USNRC issued a new regulation, Early Site Permits Standard Design Certifications and Combined Licenses for Nuclear Power Reactors (lOCFR Part 52) [7] and is currently in the process of developing and issuing design certifications for two evolutionary ALWRs. 

The UK Safely Assessment Principles for Nuclear Power Plants [8J is another example of a consistent safety policy document which is applied to both modem existing and next generation NPPs. Other regulatory activities on the development of safety approaches for future NPPs have also been pursued in some other countries. 

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In the late 1980s attempts were made in California to shift fuel use to methanol in order to capture the air quaHty benefits of the reduced photochemical reactivity of the emissions from methanol-fueled vehicles. Proposed legislation would mandate that some fraction of the sales of each vehicle manufacturer be capable of using methanol, and that fuel suppHers ensure that methanol was used in these vehicles. The legislation became a study of the California Advisory Board on Air QuaHty and Fuels. The report of the study recommended a broader approach to fuel quaHty and fuel choice that would define environmental objectives and allow the marketplace to determine which vehicle and fuel technologies were adequate to meet environmental objectives at lowest cost and maximum value to consumers. The report directed the California ARB to develop a regulatory approach that would preserve environmental objectives by using emissions standards that reflected the best potential of the cleanest fuels. 

VOC Emissions Reduction Approach. The Rule 66-type approach focuses on solvent composition further developments have led to regulatory approaches that emphasize overall VOC emission reduction. Even though the more reactive solvents react near their emission point, all VOC compounds eventually react to form ozone pollution. This may occur some distance downwind, increasing ozone levels in areas which have low artificial emissions. 

Mathai (21) summarized the specialty conference on atmospheric visibility. With the exception of water content of particles and the measurement of organic species, analytical laboratory techniques are readily available for particle analysis. Regulatory approaches to mitigate existing visibility impairment and to prevent further impairment are being formulated. A... 

Parker, L.E., Regulatory approaches to food coloration, in Developments in Food Colors 2, Applied Science Publishers, London, 1984. 

Green Chemistry is the utilization of a set of principles that reduces or eliminates the use or generation of hazardous substances in the design, manufacture and application of chemical processes. This non-regulatory approach for pollution prevention occupies a pivotal position in the management of hazardous substances and has been quite successful as evidenced, for example, in the United States by the Presidential Green Chemistry Challenge Awards. ... 

The policies span a range of regulatory approaches. The main alternative is between command and control (CAC) and market-based (MB) instruments, and a relevant role can also be played by the insurance sector. 

Encouraged by this more flexible regulatory approach, there is an increased willingness within the industry to adopt new technologies. ... 

As what we have termed the regulatory approach is discussed, it should be kept in mind that much of what is done in the conduct of risk assessment is to ensure a high degree of consistency and predictability in the face of scientific uncertainty. There are many scientists who will disagree with the regulatory approach. Sometimes the disagreement arises in specific cases, where evidence has arisen that seems to question one or more of the typical regulatory defaults. Other scientists may find the whole process, because it is dependent upon untested... 

In Chapter 10 we deal with the problem of disease or toxic injury causation in actual individuals the regulatory approach described in this chapter is not especially helpful when we are faced with this type of question. 

A similar set of defaults could be described for the human exposure assessment step. As noted, the regulatory approach tends to target those members of the population who are at the high end of exposures, and in some cases regulators, and other risk assessors, engage in something close to what is known as a worst-case exposure analysis. Here are three simple examples. 

Warner KE, Peck CC, Woosley RL, Henningfield JE, Slade J (1998) Treatment of tobacco dependence innovative regulatory approaches to reduce death and disease preface. Food Drug Law J53(suppl) l-8... 

The successful adoption of QbD, which incorporates PAT, will result in more reliable and efficient manufacturing processes and end products. Perhaps a less obvious but equally important benefit is the pronfise of a more flexible regulatory approach. 

Meisel ML, Costa MC, Pena A (2009) Regulatory approach on environmental risk assessment. Risk management recommendations, reasonable and pmdent alternatives. Ecotoxicol-ogy 18 1176-1181... 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

Such figures indicate the necessity for a global regulatory approach for flavouring material. 

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