Risk Regulation

Chris Whipple, Redistributing Risk, Regulation Journal on Government and Society, American Enterprise Institute, Washington, DC, May/june 1985, pp. 37-44. 

PEC / PNEC < 1 no Risk for this application - no action needed PEC / PNEC 21 there is a Risk regulative Action needed... 

DiMasi,., "Risks, Regulations, and Rewards in New Drug Development in the United States," Regul. Toxicol. Pharmacol. 19, 228-235 (1994). 

TSCA "Unreasonable Risk" Regulations, and Other Restrictions. During the three years that companies have been submitting PMN s to EPA, the Agency has developed a number of means for informally regulating the production and use of certain new chemicals. In addition, 5(f) authorizes EPA to initiate more formal regulatory actions, primarily involving lawsuits. 

Gaylor DW. 1989. Comparison of teratogenic and carcinogenic risks. Regul Toxicol Pharmacol 10 138-143. 

Babich H, Davis DL. 1981. Phenol A review of environmental and health risks. Regul Toxicol Phamacol 1 90-109. 

Once the risks have been determined, the IRB must then assess whether the research involves greater-than-minimal risk. Regulations governing the functions of an IRB allow approval through the expedited review process for research projects that contain no more-than-minimal risk or that involve participants only in one or more approved categories. 

Poortinga, W. and Pidgeon, N.F. (2005). Trust in risk regulation cause or consequence of the acceptability of GM food Risk Anal. 25(1) 199-209. 

There are three basic principles of investing 1) risk and how risk regulates the rate of return, 2) how diversification moderates risk, and 3) growth through compounding, which is even better when it is tax deferred. 

In this introductory chapter we wish to acquaint the reader briefly with the background, scope and structure of the book as well as to provide some pointers for how best to read and use this book. We also highlight some important issues and challenges connected with chemical risk regulation that are addressed by our contributors. 

Risk appraisal thus includes the scientific assessment of the risks to human health and the environment and an assessment of related concerns as well as social and economic implications (Renn and Walker 2007). The appraisal process should be clearly dominated by scientific analyses - but, in contrast to traditional risk regulation models, the scientific process includes both the natural/technical as well as the social sciences, including economics. The risk appraisal comprises two stages ... 

Klinke, A., Dreyer, M., Renn, O., Stirling, A. and van Zwanenberg, P. (2006) Precautionary risk regulation in European governance. Journal of Risk Research 9(4) 373-392. 

Keywords Centralisation Global governance Privatisation REACH Risk regulation... 

The Evolution of European Risk Regulation The Road to REACH... 

The relevance of REACH goes beyond the transformation of EU chemicals safety management. Internally, REACH S institutional design and procedural sequences may well become a model for EU risk regulation generally (Pesendorfer 2006). 

At least as important is the role of REACH in international risk regulation. The Commission makes no secret of its aspirations to promote the REACH approach to chemical safety beyond EU borders. Countries such as Switzerland, Norway, Japan, Canada, Korea, New Zealand and China have apparently expressed a keen interest to learn from REACH. 36 And even in countries where governments have declared no such intention, such as the USA,37 REACH is being used as a yardstick against which to assess domestic chemical risk regulation (Hogue 2007). 

What, then, is the impact or wider political role of SCHER Has it in any discemable way shaped the Commission s risk regulation policies Generally speaking, our study has indicated that SCHER achieves what it is primarily supposed to do - that is, reviewing the scientific quality of risk assessments. By its very nature, it is difficult to say anything conclusive about what kind of policy impact this entails. More often than not, SCHER s opinions grant a lot of leeway to the Commission, particularly in those many cases when data on risks is either unavailable or plagued with severe uncertainties. In those cases, the impact of SCHER has often been a call for more and better data, which has not in any clear way translated into policy. 

In the winter of 1995 we gathered thirty experts in an Amsterdam hotel to get to the bottom of the fundamental misunderstandings over chemical risk regulation. Half of the experts were natural scientists working on chemical risk issues toxicologists,... 

Chemical risk assessment is a means to contain such conflicts. It defines a series of relevant endpoints and exposure processes in the world that we will accept as relevant, while others (such as changing property relations) are not. The boundary between risk assessment and risk regulation is not just a boundary that keeps dirty politics out of disinterested science, but also a boundary that prevents new concerns from making the assessment process unpredictable, for applicants, policy makers, as well as environmentalists. Such new concerns can be new health or environmental... 

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