Particular risk analysis limitations

The performance of systematic risk assessments is a task often taken by federal agencies like US EPA, US FDA, EU EFSA or national institutions. The result of a risk assessment is a starting point for the risk manager, e.g., the ministries, to develop adequate measures, like controls, limits or use restrictions. In the structured approach to the risk analysis the precautionary principle can be particularly relevant to the risk management. It shall be applied in those circumstances where scientific evidence is insufficient or imcertain and when there are indications for concern [95]. In order to prevent a disproportionately intensive use measures based on the precautionary principle should be... 

A management-risk analysis method would not only inform safety cases, it would also be complimentary to an organisation s audit function. For example, a checklist to inform audits could be made of processes or activities that are deemed particularly risky or that rely on assumptions in which there is limited confidence. In addition, the frequency or thoroughness of audits and the focus of safety assessments may also be increased for parts of a management system that are considered similarly risky, or whose failures could lead to particularly severe consequences. In these ways, both the efficiency and the effectiveness of audits and safety assessments could be improved. 

Cardiovascular effects differ in a number of ways from other toxic endpoints associated with human Pb exposures, particularly with respect to Pb neurotoxicity. The focus of attention for neurotoxic effects epidemiologi-cally, medically, and societally has invariably been the very young child, infants and toddlers, and on parallel concerns about prenatal exposures to lead. Lead neurotoxicity in adult humans, by contrast, has had a less voluminous and comprehensive hterature for reasons explained in Chapter 12. By contrast, cardiovascular effects in humans have almost always been evaluated in adult human populations. Data are limited and significant risk analysis attention has not been given to cardiovascular effects in children. 

A particular risk assessment examines those common events or influences that are outside the system(s) concerned but which may violate independence requirements. These particular risks may also influence several zones at the same time, whereas zonal safety analysis (ZSA) is restricted to each specific zone. Some of these risks may also be the subject of specific airworthiness requirements. Some of particular risks result from airworthiness regulations, while others arise from known external threats to the aircraft or systems. Typical particular risks include, but are not limited to the following ... 

A requirement to provide a Substitution Plan with all applications for an authorisation will prevent unnecessary requests for authorisation and focus attention on safer chemicals. If substitution is not currently feasible for a particular use, the use of an authorised chemical would be allowed under a strict risk management regime, providing social need could be demonstrated and a positive cost/benefit analysis provided. The authorisation would be time-limited to allow the development of safer substitutes, and manufacturers and/or users would be required to produce a substitution development plan to enable substitution to take place before the authorisation expires. 

The analysis need not be confined to the estimation of a standard that uses conventional methods of extrapolation (e.g., default assessment factors). It might usefully be accompanied by an analysis of the consequences of exceeding a particular standard. If a standard is proposed that sits within the range of available toxicological or ecotoxicological data or close to the lower limit of experimental data, then we should try to predict what impact an exceedance will have (e.g., excess cancer risk, proportion of species affected, or number of individuals affected). 

Univariate subgroup analysis is of relatively limited value, even when done reliably, in situations where there are multiple determinants of the individual response to treatment. In this situation, targeting treatment using risk models can be useful, particularly in... 

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