REGULATORY RISK

BogenKT. 1988. Pharmacokinetics for regulatory risk analysis The case of trichloroethylene. Regul Toxicol Pharmacol 8 447-466. 

Forbes VE, Hommen U, Thorbek P et al (2010) Ecological models in support of regulatory risk assessments of pesticides developing a strategy for the future. Int Environ Assess Manage 6 191-193... 

Most scientists would hold that these unknowns and uncertainties in the regulatory risk-assessment model would tend to favor risk overestimation rather than underestimation or accurate prediction. While this view seems correct, it must be admitted that there is no epidemiological method available to test the hypothesis of an extra lifetime cancer risk of about 10 per 1000 000 from methylene chloride in drinking water. The same conclusion holds for most environmental carcinogens. It is also the case that more uncertainties attend the risk assessment process than we have indicated above. 

Batch processing is familiar to both the industry and its regulators and therefore any change was seen as carrying a high regulatory risk. 

During the last 10 years it has been attempted to develop in vitro methods as alternative methods in the study of effects where animal models have previously been necessary. Such effects include skin and eye irritation and specific organ damage. Validation programs have been launched, and some of the above-mentioned methods have been sufficiently validated for use in regulatory risk assessment of chemical substances and may now for certain purposes be used as stand-alone evidence. Results from nonvahdated methods can in some cases be used as supportive evidence to human and animal data. 

ECETOC. 2002. The use ofTZS estimates and alternative methods in the regulatory risk assessment of nonthreshold carcinogens in the European Union. Technical Report No. 83. Brussels ECETOC. 

This brief survey of the FDA regulation of pharmaceutical products demonstrates the breadth and depth of FDA activity in this field. Although there are repeated calls for reform of the IND/NDA system, it appears unlikely that any substantial change will occur in the near future. It is therefore important that any person who enters the prescription drug industry in the United States be fully informed about the requirements, understand the regulatory risks involved, and comply adequately with all of the FDA requirements. 

Moolgavkar SH (1995) When and how to combine results from multiple epidemiological studies in risk assessment. In Graham JD ed. The role of epidemiology in regulatory risk assessment. Amsterdam, Elsevier Press. 

What, then, is the conscientious executive to do The most reasonable course for him would be to employ a heavy additional risk premium when evaluating any chemical that meets all presently known tests and that shows strong commercial potential. If the product passes even this hurdle, it may still eventually encounter regulatory difficulties, but the chances are high that it will have repaid its development cost and produced a profit for the company by the time these difficulties emerge. The impact of such a "regulatory risk premium" would be to slow—but not necessarily stop—new product development. 

Comber, M.H.I., Walker, J.D., Watts, C. and Hermens, J. (2003) Quantitative structure-activity relationships for predicting potential ecological hazard of organic chemicals for use in regulatory risk assessments. Environ Toxicol Chem, 22, 1822-1828. 

It follows that TVOC is difficult to use for normal regulatory risk assessment the scientific basis for this is just too small and no D-R relations have been established. TVOC at this point should only be used for screening and not for definitive conclusions. In addition, TVOC should only be associated with sensory irritation and only if there are substantial indications that VOC is a problem. In each specific case, if unusual compounds and concentrations are identified, the use of TVOC should be stopped. If TVOC is in the mg/m3 range, additional alternative methods should be used to draw any conclusions. 

Inform management of compliance status, regulatory risk, and civil liability... 

Ecological Models for Regulatory Risk Assessments of Pesticides ... 

Risk assessment evaluates risk in terms of hazard and exposure, but reference to risk levels must account for different perceptions of risk as well as scientific uncertainties in risk assessment. In short, this research project considers the importance of social and institutional processes in influencing risk perceptions and risk acceptability. This book therefore takes a constrained relativist approach by incorporating risk perceptions in the research framework. An unconstrained relativist perspective would imply that no scientific study is reliable or robust. By contrast, a constrained relativist approach can provide a useful basis for examining the different social and cultural factors involved in regulatory risk management. 

SPORT focussed on risk assessment evaluation and did not examine regulatory risk management decision-making for restriction and authorisation. 

In terms of regulatory risk management, the SOMS does not detail rules for EU action corresponding to each hazard and use categorisation. Similarly, while the RCEP presents a wide and detailed set of recommendations to make increased use of a wide range of risk management and policy instruments, it does not present these as a formalised structure for EU decision-making. 

As a first step, relevant consumer uses would need to be listed (listed uses). Safe and permissible uses would then be removed from subsequent EU regulatory risk reduction processes12. While companies must follow recommendations, regulatory risk reduction may deem it necessary to supplement these with more prescriptive duties. 

Tool to compare proposals for authorisation, restriction and other regulatory risk reduction options. 

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