REGULATORY DECISIONMAKING

Over the last 10 years a lot of efforts have been made to implement probabilistic methods for environmental risk assessments (ERA) into regulatory decisionmaking schemes. ECOFRAME in the US (www.epa.gov/oppefedl/ecorisk) was the first and largest project in this area, the EU-project EUFRAM (vww.eufram. com) is a comparable initiative. Whereas on the effect side, several examples exist where species sensitivity distributions (SSDs) were used for regulatory decisionmaking, comparable cases on the exposure side are rare. 

As a second step, prior to entering the risk descriptors into the decisionmaking matrix, a potential risk that requires particular regulatory attention needs to be excluded from further decision-making (Figure 5.10). Reasons for excluding potential risks include ... 

The method for prioritisation has been devised for EU decisionmaking in terms of executing decisions, a wide number of actors can often be expected to be involved. Regulatory action covers a broad... 

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... 

Tickner, Joel is Research Assistant Professor in the Department of Work Environment at the School of Health and Environment, University of Massachusetts Lowell. His scholarly interests include development of innovative scientific methods and policies to implement a precautionary and preventive approach to decisionmaking under uncertainty. His teaching and research focus on regulatory science and policy, risk assessment, and cleaner production. 

In most industrial sectors there is a new legislative trend that calls for the increased use of alternative approaches in regulatory safety assessment. Such driving forces strive to substitute conventional animal-based approaches with a different format of decisionmaking combining in vitro and in silico approaches using the up-to-date scientific and technological developments in the alternative methods of the twenty-first century. 

It is appropriate to acknowledge here that neither author is a clinician. The first author is a professional statistician and the second a professional educator, medical writer, and research methodologist. We are also both clinical trial-ists The first author is experienced in statistical aspects of clinical trials, and the second in writing regulatory clinical documentation. At various points throughout this book, we discuss how the discipline of Statistics provides the rational evidence for making clinical decisions. On several occasions we use hypothetical data, show how statistical analyses of these data and the associated statistical interpretations can form the rational basis for clinical decisionmaking, and illustrate what the hypothetical... 

The Army has developed a mix of semi-permanent facilities and mobile systems to meet its obligations under the CWC to destroy all recovered NSCWM by 2007. Before the systems can be operated, however, the Army must establish their technical effectiveness and safety, obtain the necessary regulatory approvals for operation at each site where NSCWM is located, and provide opportunities for the various public stakeholder groups to be involved in the decisionmaking process. 

---