The Assessment Process

The conservation of mass law finds a major application during the performance of pollution-prevention assessments. As described earlier, a pollution-prevention assessment is a systematic, planned procedure with the objective of identifying methods to reduce or ehminate waste. The assessment process should characterize the selected waste streams and processes (Ref. 11)—a necessaiy ingredient if a material balance is to be performed. Some of the data required for the material balance calciilation may be collected during the first review of site-specific data however, in some instances, the information may not be collected until an actual site walk-through is performed. 

Criteria such as those suggested above can be usefully applied to the implementation strategy you have selected. In assessing your current PSM status, you will have gained considerable insight into which facilities warrant priority attention similarly, the assessment process sheds light on those PSM elements whose improvement will yield the most productive results. 

To the extent possible, involve local facility management and employees in the assessment process. If appropriate, discuss your preliminary findings with the Acuity manager before compiling a final report. 

The decentralised procedure can be used in cases where the product has never been authorised in any of the Member States, and the applicant wishes to obtain a license in a number of states simultaneously. The applicant must submit applications with the complete dossier to the Competent Authorities of each of the Member States where authorisation is desired. A single Member State should be chosen as the reference state to undertake the scientific assessment ofthe complete dossier, while the other states are designated as concerned states. The review process has many parallels vhth the centralised procedure, in that similar time lines exist, the reference State plays the role ofthe rapporteur, and the concerned States replace the CHMP. Once all States have validated that the dossiers are complete, the reference State is allowed 70 days to review the dossier and prepare a preliminary assessment report, which is circulated to the concerned Member States and the applicant. Comments from the concerned Member States and applicant responses are collected so that by day 120 the reference State may issue a draft assessment report together vhth draft SPC, label and leaflet texts. The clock may be stopped until requested responses from the applicant are received. The application then enters the second step in the assessment process, during which all the concerned Member States consider the... 

Identify systems that require validation based on all applicable risk factors. Document the assessment process and the prioritization sequence that will be followed to address these systems and include justifications for systems that do not require validation. 

Some points to consider related to the six basic elements listed above are included in table 5.1. The manner in which the vulnerability assessment is performed is determined by each individual water/wastewater utility. Throughout the assessment process it is important to remember that the ultimate goal is twofold to safeguard public health and safety and to reduce the potential for disruption of a reliable supply of chemicals. 

During the assessment process, there is a documented interactive dialogue between each assessor and the applicant to clarify points that are complex or ambiguous or to enable the applicant to provide additional raw data, statistical appendices and detailed protocols to facilitate the assessment process. However, none of the various parts of the dossier is self-standing or independent of others. There are areas within each, which are intricately linked to the others. In preparing a comprehensive and integrated regulatory assessment report, it is important that these areas of common interest are appropriately addressed. 

FIGURE 2.2 How the unit of analysis relates to other components of the assessment process. 

A tabular approach to identifying appropriate biological, spatial, and temporal scales for different components of the assessment process, illustrated for a hypothetical assessment of risks to birds from a corn insecticide (see also Figure 2.2)... 

To avoid wasting resources by overretining assessments, avoid paralysis by analysis, and reassure stakeholders that the assessment process is finite, criteria are needed for deciding when to stop. 

Communication between risk managers, risk assessors, and analysts is essential from the start of the assessment process, not just in communicating results. For example, the choice of uncertainty analysis methods will be dependent on 1) the questions posed by decision makers, 2) the closeness of the risk estimate and its bounds to thresholds of acceptability or unacceptability, 3) the type of decision that must be made, and 4) the consequences of the decision. 

Any questions asked by regulatory assessors should be answered as thoroughly and explicitly as possible. It is not productive to be grudging in either the tone or the nature of the response as this will only slow down the assessment process and can lead to additional questions being asked. 

A third principle of this chapter is that the assessment process in child psychiatry has unique challenges, including the use and consideration of multiple informants and the developmental level of the child. These challenges lead to the fourth principle, which is that successful treatment requires education and collaboration with the family and others involved with the child. Treatment of developmental neurobiology affects the environment that surrounds the child, and treatment of the surrounding environment in turn affects developmental neurobiology. This interaction implies that early and effective intervention can alter the developmental trajectory of a child with a mental disorder. 

Risk assessment starts with risk identification, a systematic use of available information to identify hazards (i.e., events or other conditions that have the potential to cause harm). Information can be from a variety of sources including stakeholders, historical data, information from the literature, and mathematical or scientific analyses. Risk analysis is then conducted to estimate the degree of risk associated with the identified hazards. This is estimated based on the likelihood of occurrence and resultant severity of harm. In some risk management tools, the ability to detect the hazard may also be considered. If the hazard is readily detectable, this may be considered a factor in the overall risk assessment. Risk evaluation determines if the risk is acceptable based on specified criteria. In a quality system environment, criteria would include impact on the overall performance of the quality system and the quality attributes of the finished product. The value of the risk assessment depends on how robust the data used in the assessment process is judged to be. The risk assessment process should take into account assumptions and reasonable sources of uncertainty. Risk assessment activities should be documented. 

The hardest part of engineering risk assessment has turned out to be the prediction of the modes of failure. Serious accidents at nuclear installations, such as those at Three Mile Island or at Chernobyl, have been caused by modes of failure that had not been analysed at all. For example, the report of the Presidents Commission on the Accident at Three Mile Island (Presidents Commission, 1979, p9) highlighted that the concentration of the assessment process on more obvious large break scenarios meant that the eventual mode of failure, which was a result of a chain of a number of more minor events, was not even considered. Despite the use of significant resources in the design process, the risk assessment had been unable to characterize the complex system adequately, a system that was totally human-made and defined. In particular, the risk assessment process had not been able to identify modes of failure caused by humans involved in the operations of the reactor behaving in unexpected ways. 

Risk assessment of chemicals does not, in practice, estimate the incidence and severity of the adverse effects likely to occur in the human population or environmental compartment due to actual or predicted exposure to a substance — the definition of risk characterization in Article 2 of Directive 93/67/EEC. The assessment process hinges on being able to say that there is a threshold below which the chemical has no adverse effects, in other words on being able to derive a no-effect level. Recent debates, discussed later, challenge the idea that there normally is such a threshold. 

Risk evaluation in the assessment process focuses on weighing the health and environmental threats posed by an identified hazard. First, the possibility and probability that a person will actually experience an adverse effect as a result of the existence of the environmental hazard and exposure to it must be weighed and, secondly, the number of persons who might be exposed must be considered. 

A circumstance worth mentioning at this point is the response appropriate to deal with nuisance and esthetic issues such as odor or noise when no hazard can be identified. A risk classification of "insignificant," with respect to health or the environment, would likely be selected and no response justified in the case of a disposal site evaluation where only odor is the problem. In these instances, appropriate responses should be developed using a process which reflects the economic, social and political impacts of the problem rather than the assessment process being described which has been developed to deal with hazards to health. 

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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