Risk assessment process activities

Aside from the Premanufacture Notification (PMN) requirements. Section 5 rules have not been used to a great extent. Nearly all of the compliance activity since July of 1979 has been geared toward meeting PMN requirements. Whether the agency s failure to use the subsections of 5 that are designed to restrict potentially harmful substances from reaching the marketplace has resulted from lack of real necessity, a failure in the Agency s risk assessment process, or an inherent non-workability in the Law itself, remains to be seen. 

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. 

Vi 3 Risk assessment not investigated Assumes harmonised risk assessment process Limits the ability for the research to examine the detailed inter-linking of risk assessment and management activities - The research considers aspects of risk assessment that are relevant to risk management - The current focus of REACH is on risk assessment many aspects of risk management appear neglected... 

The risk assessment process was organized by NAS into four primary activities, as shown in Figure 9.31. 

There is an ongoing effort to improve the risk assessment process. Changes often provide for integration of more of the underlying science to reduce uncertainty as well as exploring new approaches to evaluating risk. The following are examples of areas of current interest and activity. 

The third step in the risk assessment process is exposure assessment. In exposure assessment, the intake of a toxic agent from the environment is quantified using any combination of oral, inhalation, and dermal routes of exposure. This assessment may include a component for each route, such as when an assessor would investigate the potential impact of a point source of pollution. In this case, the magnitude of exposure depends on the amount of chemical used or released, chemical fate and transport, chemical concentration at the point of exposure, the routes and rates of uptake, the duration, the exposure setting (location and number of potential receptors, land use and human activities that could lead to exposure), and characteristics of receptors potentially exposed to the chemical. 

Ecological risk assessments evaluate ecological effects caused by human activities such as draining of wetlands or release of chemicals. The term "stressor" is used here to describe any chemical, physical, or biological entity that can induce adverse effects on individuals, populations, communities, or ecosystems. Thus, the ecological risk assessment process must be flexible while providing a logical and scientific structure to accommodate a broad array of stressors. 

Risk assessment and risk management are two processes where the activities can be shared. At the beginning of the risk assessment process, managers can help to ensure that the risk assessment will provide relevant information for making decisions on the issues under consideration, while the risk assessor can ensure that the risk manager addresses all relevant ecological concerns. 

The National Institute of Public Health, Department of Air Hygiene supports an Expert Group for Ambient Air Hygiene. The activities comprise the processing of expert opinions, health risk assessments, legislative activities, tuition, and consulting. 

EPA is naturally interested in producing risk assessments of the highest possible quality. This requires that each assessment is sensitive to site-specific conditions, while using procedures that are consistent with those of other agency-sponsored assessments. Both inconsistency in approach and lack of technical quality (such as insensitivity to local conditions) represent problems in the risk assessment process. EPA is actively engaged in several efforts to maintain quality and consistency in risk assessment, in the face of distinctly limited professional resources. 

The training of professional personnel in the risk assessment process is an ongoing activity at EPA. However, classroom training is only a partial answer to EPA s risk assessment dilemma. It lessens, but has not eliminated, the pressure of EPA to review technical reports with less experienced professional personnel. The development of a computer software system, Risk Assistant, to assist environmental personnel in conducting risk assessments and reviewing assessments generated by contractors, represents a complementary approach to increasing the technical quality and consistency of risk assessments. 

The Pesticide Risk Assessment Peer Review Unit (PRAPeR) of the European Food Safety Authority (EFSA) is responsible for the peer review of initial risk assessments of active substances. For each substance, a member state carries out this initial risk assessment, which is presented in a draft assessment report (DAR) that is then peer reviewed by experts across the European Union (EU) in a process... 

The guidelines are written to provide guidance on Agency policy for assessing cancer risk. They draw heavily upon the National Research Council ( ) approach to assessing risk by dividing the risk assessment process into four activities Hazard... 

As mentioned before, the regulatory evaluation of plant protection products in the EU is carried out by EU-authorities and member states together. The active substances are evaluated on the EU-level whereas the authorization of products falls imder the responsibility of member states. At the EU-level, the European Food and Safety Authority (EFSA) organizes the risk assessment process in close connection with experts from member states and a committee of independent scientists mainly from academia. Based on the outcome of this risk assessment, the European Commission together with representatives from member states... 

The risk assessment process involves not only teachers, but also pupils. Griffin (p. 4, 1996) rightly recognises it is about Educating children and young people in the principles and techniques of conducting risk assessment which will equip them with a skill which is not only transferable to a variety of educational activities, but even more importantly, a skill essential for Hfe . 

Residual risk is defined as the risk remaining after preventive measures have been taken. No matter how effective the preventive actions, there will always be residual risk if an activity continues. Attaining zero risk is not possible. If the residual risk is not acceptable, the action outline set forth in the foregoing hazard analysis and risk assessment process would be applied again. 

There are numerous ways to calculate how much safety is going to cost. The risk assessment process, especially the risk expectation model or dollars at risk, is one method this chapter has explored. Before describing the varions methods available to calculate safety costs, it is important to note that there are other, less tangible activities that can affect safety costs. Their costs can be calculated using normal engineering economics methods. 

The risk assessment process will vary depending upon an organisation s activities. It may be that the assessment will be a highly technical and complex scientific analysis, such as in the case of COMAH site activities (a site defined under the Control of Major Accident Hazards Regulations 1999). At the other end of the scale, the assessment may simply be a fairly succinct analysis of the hazards, risks and control measures relating to the work activities conducted in a small office environment. 

The third stage of the risk assessment process involves identifying who could be harmed (i.e. who is at risk) and how. When considering who is at risk, it is important to consider all those who may be affected by the activity or be on the premises, as well as those who are directly involved. Groups of people who could be at risk may include the following ... 

The Commission ultimately interpreted its mandate broadly as a clear need to modify the traditional approaches used to assess and reduce risks " Building on previous mcxlels of risk assessment, the Commission sought to add important new dimensions to the risk management process, actively engaging stakeholders in the process. ... 

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