Regulatory Options

To overcome these hurdles, various forms of best practice guidance can be devised and disseminated [132, 205-207]. Compared with 

34 A classic example of this occurred in the USA, when the 1970 Clean Air Act required electric generating companies to install emission abatement technology to limit sulfur emissions. Faced with significant investment costs, some companies switched from higher- to lower-quality coal. The result was an increase in sulfur emissions from dirty coal , offsetting any reductions from the end-of-pipe desulfurisation process [209]. 

A ban on the production, marketing or use of a chemical offers the most stringent type of regulatory control. Prohibition provides clear-cut cases for product liability and enforcement, thereby minimising exposures resulting from poor regulatory compliance or irresponsible chemical use. Product or process35 bans can be in the form of restrictions or authorisations. Restrictions allow all uses of a chemical with the exception of those decided on a case-by-case basis. Under authorisation systems, all uses of a chemical are banned unless exempted. 

Permitting schemes can be viewed as authorisation systems, but they usually only control production. To control the marketing of chemicals, certification schemes exist under which companies can sell only to certified, licensed, or trained customers. The costs for conforming to a certification scheme can be particularly high for SME3S [132] and certification schemes may be inappropriate in sectors where there is a high turnover of staff [132], 

It is often argued that economic instruments37 provide greater flexibility to companies for achieving emission limit values or other 

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The sidebar discussion presents the order of regulatory options within the SCREEN model for point sources. 

There are two downwash options available with this model, a regulatory and a non-regulatory option. Both are summarized below. 

Evaluation of public health, economic, social, political consequences of regulatory options... 

Decision-making process involving considerations of political, social, economic, and technical factors with relevant risk assessment information relating to a hazard so as to develop, analyze, and compare regulatory and non-regulatory options and to select and implement appropriate regulatory response to that hazard. 

Therefore, to be marketed as a pharmaceutical, a botanical must traverse the modern regulatory process resulting in an approved NDA. The fact that no botanical is currently NDA-approved has caused many to speculate whether a botanical could ever make it through the rigorous U.S. drug development process, and still others to ask why one would choose to pursue this avenue, given the panoply of regulatory options already available to botanicals in the United States. 

USEPA performed post hoc cost-benefit calculations and sensitivity analyses for several regulatory options (41). Population exposure calculations were prepared for pre- and postregulation scenarios, and risks were calculated by using the CAG multistage model. A cost of 200,000 per cancer case avoided was assumed on the basis of both earnings and social value. 

The second section presents other regulatory and non-regulatory options. Some of these have already been instituted at the Federal or State level, and others are in the form of proposals. 

REGULATORY OPTIONS-BASED ON EXISTING STATE PROGRAMS... 

Following are additional regulatory and non-regulatory options which have been suggested to help mitigate the scrap tire problem. Some of these have been... 

Nastech has indicated it will continue to work with the agency to understand the data requirements and regulatory options, but the final resolution remains presently unknown. This case study highlights the fact that demonstration of sameness of therapeutic proteins is more complex than for other drugs and that true biogenerics may be hard to come by due to the complexity in establishing sameness versus similarity. 

The final objective of the research project was to develop a framework for decision-making under REACH. Applying the framework should result in a predictable set of regulatory options to control the use of... 

A 247-page draft TGD for producing an Annex XV dossier was published in May 2006 as part of RIP 4.4 [495], which formed the basis for other guidance in 2007. It presents an excellent, highly technical explanation of how to consider alternative regulatory options. For instance, after explaining the interaction of REACH procedures, how to assess information for the harmonisation of classification and labelling... 

Method to recommend appropriate regulatory options, including target-setting. 

Risk descriptors (according to risk assessment conclusions) VII Regulatory options (guidance)... 

Socio-economic analyses of regulatory options appear far more relevant at national and local levels. In particular, this decisionmaking tool has the potential to identify businesses that may require particular financial or technical support to help them to conform with new regulatory demands (Section 2.4.5). Unfortunately, according... 

Once submitted, the Annex XV dossier should be compared with other proposals for substance inclusion in the authorisation process. If a substance is consequently identified as being of comparatively very low priority, other regulatory options should be proposed and the Annex XV dossier revised accordingly. 

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