Risk assessment activities

All too often, the Agency s proposals appeared to seek information for its own sake. As a result, EPA s reporting proposals often required the submission of data that are of questionable validity or limited relevance in EPA s risk assessment activities under other TSCA provisions. They also called for far more information than EPA had the capability to process and evaluate in a reasonable period of time. 

By the way, the committee rejected the suggestion that risk assessment activities be institutionally separated from the risk management activities of regulatory agencies. It recognized the potential problem of the distortion of science, but proposed other, less drastic means to minimize that problem. The committee s thinking on this important matter will emerge in the later chapters of the book. 

The United Nations (UN) is the superior international organization, which, among many other activities, participates in chemical risk assessment. The UN chemical risk assessment activities are carried out via specialized agencies, see Figure 2.1. 

Risk assessment activities of IPCS, specifically the production of Concise International Chemical Assessment Documents (ClCADs), are supported financially by ... 

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. 

According to the National Research Council of the National Academy of Science, risk assessment consists of four broad but interrelated components hazard identification, dose-response assessment, exposure assessment, and risk characterization, as depicted in Figure 24.1. The reader should, however, be aware that these risk assessment activities can provide research needs that improve the accuracy of estimating the risk or probability of an adverse outcome. 

Risk assessment activities of IPCS are supported financially by the Department of Health and Department for Environment, Food Rural Affairs, United Kingdom Environmental Protection Agency, Food and Drug Administration, and National Institute of Environmental Health Sciences, USA European Commission German Federal Ministry of Environment, Nature Conservation and Nuclear Safety Health Canada Japanese Ministry of Health, Labour and Welfare and Swiss Agency for Environment, Forests and Landscape. 

However, there has also been some discussions about the suitabihty of risk acceptance criteria to assess and control risks, see Aven and Vinnem (2005). One concern is that the introduction of pre-determined criteria may give the wrong focus to risk assessment activities, i.e., on meeting risk criteria rather than on obtaining overall safe and cost-effective solutions and measures. 

The activities in the proposed approach are to identify possible safety measures, to evaluate and categorise their effects, predict their costs and to categorise cost-effectiveness. Information about these dimensions provides support for deciding what measures to implement. The above-mentioned activities are described in Sections 3.2 to 3.5 below. To carry out the method, also the planning and risk assessment activities in Fig. 1 should be carried out. These... 

The planning and risk assessment activities in Fig. 1, as well as the identification of potential risk reducing measures in Fig. 2, are in hne with a typical coarse risk assessment, as described in for example Aven (2008) and Aven et al. (2008). When applying the proposed method, the following activities should be carried out ... 

ESC Limited has appiied its 100+ combined years of technicai safety know-howto deveiop ProSET The Compiete Process Safety Evaiuation Tooiset, a famiiy of moduies aiiowing the user to compiete risk assessment activities as part of the Functionai Safety Lifecycie, as required by intemationai standards such as iEC 61508 and iEC 61511. 

Safety risk assessment activity supports safety optimisation and risk management in several respects. In particular, PRA is used ... 

Establish an effective safety management system/process. Nominate key roles/ responsibilities. Define approval signatories - especially for safety reports. Establish independent verification/audit to reduce chance of undetected error. Establish a workforce-wide commitment to product integrity. Learn from previous mistakes. Initiate a documentary audit trail (identify, log and track all hazards). Airworthiness and safety must be foremost in the minds of the entire organisation. Furthermore, as many legal cases turn on documentation, it is essential that risk assessment activities and choices are documented and that records are kept. ... 

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