Standards cost implications

However, applicability of the bottom-up approach is limited primarily by cost implications to conduct ecosystem risk assessment following accurately the formal U.S. EPA procedure, an assessor must spent huge amounts of time and money on collecting necessary input data, data processing and interpreting the outputs. Of importance, very specific data are often required that cannot be easily obtained with the help of standard environmental monitoring studies. 

A rigorous assessment of the costs and benefits of setting a standard will be necessary for standards that are to be legally binding and could have serious cost implications. However, standards that are advisory or provisional will require less detailed social and economic analysis. There is certainly more leeway in examining the costs to industry of complying with a standard that it is not obliged to meet. 

The business environment might be under rapid change, so that the cost implications of the standard could change and assumptions in the standardsetting process become invalid. 

Many government and commercial impairment testing systems can be implemented on standard commercially available personal computer platforms (e.g., PC, Macintosh). Despite software and hardware advancements that have minimized the differences across platforms, it is still important to consider carefully the hardware and software requirements needed to support a system, as these specifications may have important implications for the accuracy of stimulus presentation and the precision of performance measures. In addition, there may be differential costs associated with the hardware and software specifications. The speed of the computer processor is one important specification that requires careful consideration. Other concerns include the amount of memory that is needed to present the test and record the results, the manner in which the data are to be stored, the size and portability of the computer, and the video-display requirements. Some systems... 

Clearly, we must develop standards that are sensitive to the social and economic context so that we can be confident that a new standard strikes a sensible balance between the environmental benefits that arise from the standard and the costs and implications of meeting it. 

The future of psychopharmacotherapy may include creative dietary or other pharmacological manipulations of the CYP enzyme system to achieve a positive treatment response. Recently, it was demonstrated that levels of cyclosporine (an expensive immunosuppressive agent) were dramatically increased in patients who were concomitantly administered grapefruit juice (Hollander et al. 1995). In other studies, paroxetine and fluoxetine were used to raise desipramine levels in superextensive me-tabolizers who were nonresponsive to standard doses (Kraus et al. 1996). Also, the authors used fluvoxamine to augment olanzapine and clozapine concentrations when a lack of response was obtained at standard or upper-level doses. Because per-pill costs of many of today s newer-generation psychoactive compounds often prove prohibitive, use of dietary and pharmacological CYP inhibitors could have significant pharmacoeconomic implications. 

It is expected to become in the near future a standard addition to LCA, in order to evaluate the economic implications of a product s life cycle. Hunkeler and Rebitzer [85] have indicated that LCC is an assessment of all costs associated with the life cycle of a product that are directly covered by any one or more of the actors in the product life cycle (supplier, producer, user/consumer, end-of-life actor), with complementary inclusion of externalities that are anticipated to be internalized in the decision-relevant future. For example, a product manufacturer should include in an LCC study the costs incurred by the user of his product. 

So change is upon us. Slower than other industry verticals (like capital markets and financial services)—reflecting the very conservative and risk adverse nature of the life sciences industry. But there are still insufficient standards in place with a number of relatively new regulatory implications such as 21 CFR Part 11 and HIPAA—further complicated by varying interpretations of these regulations. And change itself is costly and resource intensive and must deal with behavioral modification and human nature s resistance to change. 

ABSTRACT The Dutch government is in the process of revising its national flood safety policy. The current Dutch Flood Defense Act lays down design standards for the Dutch flood defenses. These standards have been based on/rationahzed by economic optimizations in which investment costs are balanced against the discounted value of (potential) future losses. Loss of life is not considered separately. This paper presents the results of a research project that evaluated the potential roles of two risk metrics individual and societal risk. These metrics are already used in the in the Dutch major hazards pohcy for the evaluation of risks to the public. Individual risk concerns the annual probabihty of death of an average, unprotected person. Societal risk concerns the probability of a multi-fatality event. This paper discusses technical aspects of the use of individual and societal risk metrics in flood risk management, as well as policy implications. 

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