Advancing Risk Assessment

Advancing Risk Assessment

As a college student, I have never understood how the risk assessment process is impacted by challenges to the assessment’s credibility and timeliness, disconnects between information needs of decision-makers and available data, and inadequate resources. However, through the philosophy class, I have found out that every aspect of human life entails risk but how humans deal with the risk solely depends on how they understand the menace. Besides, I have also found out that risk assessment process is used by the American Environmental Protection Agency (EPA), as well as other State and Federal industries and agencies to analyze potential risks that are found in our environment. As such, I find risk assessment essential since it informs humans of a wide range of technological and regulatory for protecting water and air to ensure the safety of drugs, consumer products like toys, and safety of food. Nonetheless, with rapid development of large scientific data that stem from advancement in the fields of biomarkers ad genomics, it has led to risk assessment complexity due to the decision that the assessment supports. The large quantities of data have led questions on how the challenge can be addressed.

While large quantities of scientific data, there has been an increase in the complexity of risk assessment. However, through the philosophy class, I have understood that the emerging scientific advances hold a greater promise and step in humanizing risk assessments. Before coming up with a risk assessment plan that is consistent to inform the decision-making process, the assessment process should involve the knowledge of risk assessors, distinct stakeholders, and risk managers, who will help determine decision making context and depth and timeline that is needed to ensure that right assessment questions are asked. By emphasizing on scope and planning, problem formulation has portrayed a risk assessment that is accepted and useful to decision-makers. While EPA’s use of this part of the risk assessment has been inconsistency, the agency should focus on the design of the formative stage of planning and scooping, just as it is articulated in the agency’s guidance for cumulative and ecological risk assessment. The element of scoping and planning is essential in describing a clear set of options that can be considered in making decisions.

With uncertainty and variability of the risk assessment process, it is essential for distinct agencies involved in planning and scoping the assessment to be knowledgeable of the risk analyzed, as well as characteristics of the target population. Just as the risk assessment should be closely tied to the question that is handled, the level of detail should be appropriate to inform particular risk management decisions appropriately. As such, the required nature and extent of analysis should be made based on the scoping and planning phase of the risk assessment. Lack of consistency in treating uncertainty is among different components that can make overall communication of uncertain and misleading. Since unpredictability in human susceptibility has not received consistent or sufficient attention in most EPA health risk assessment, the agency should direct its energy towards a long term goal that quantifies population variability explicitly in dose-response relationships and exposure assessment. In a short term, I found out that distinct agencies should adopt tiered approach when choosing the level of detail that can be used in variability and uncertainty assessment and that they should be made explicit at the planning phase.

There are distinct risk assessment methodologies that have been used to analyze the effects of diseases like cancer, as well as noncancerous impacts. For cancer, medical researchers have assumed that there is no dose threshold of the impact with the smallest exposure having health effects. On the other hand, for noncancerous impacts like birth defects and or asthma, the risk analysis of assessment has tried to determine dose threshold that has been found to unlikely occur in exposed population. For that reason, a unified approach to dose-response assessment has been recommended for both cancer and non-cancer effects, whereby a scientifically feasible approach should be implemented. The approach for the assessment should include systematic modelling of the background illness exposure and processes, vulnerable population, and techniques of actions that can affect the chemical’s dose-response relationship among humans. Previous studies have shown that risk-specific dose that offers data on the percentage of population that is projected to be either below or above an acceptable defined risk that is characterized with a particular degree of confidence. When the risk-specific dose is used, it will allow managers to weigh and use alternative options based on the percentage of a given population to determine quantitative estimate for distinct risk management options. Therefore, with widespread public health utility and application of reference dose, redefined reference dose can be used since it has been aided risk management options or decisions.

Through the reading, I found out that most scientific delays and controversies regarding the completion of some of the risk assessment originated from long debates about adequacy of information that support the application of assumption made with the unavailability of chemical-specific data or alternative approach that can be used in place of the default model. As such, established defaults should follow risk assessment stages when chemical-specific information is not available. Although EPA for many years has not established a general and clear guidance regarding the level of evidence that is required for researchers to justify the application of agent-specific data that cannot resort to a default. With numerous challenges and defaults at EPA, the agency should expand and continue using best but most contemporary science that can help revise and support default assumptions. For that reason, the study shows that EPA, as an agency should develop a formal process that can involve stakeholders when coming up with a risk-based decision-making framework.

After analyzing the study, I find it essential to undertake a cumulative risk assessment as described by EPA assessment, which includes the use of combined risks that are posed by aggregate exposure of a given stressor or agent. As such, I found out that while the agency, EPA, has applied the use of cumulative risk assessment in a distinct context, the assessment process should be expanded to comprise considerations of vulnerability, background risk factors, and non-chemical stressors. Because of the complexity of regarding numerous factors concurrently, there is a need for the use of simplified risk assessment tools like software packages, databases, as well as distinct modelling resources, that can allow stakeholders and communities undertake assessment that increases stakeholder participation in the process. For that reason, the assessment of cumulative human health risk should draw greater intuition from social epidemiology and ecological risk assessment that have had to cope up with such issues. The involvement of greater stakeholder is also essential since it ensures that the risk assessment process is clear and transparent with decision-making processes being efficient, credible, and effective. However, while EPA has made significant or greater progress in creating guidance and program documents that are related to the involvement of stakeholders, the agency must adhere to its formulated guidance. The creation of a formal process for stakeholder involvement during risk assessment can result in a better decision making procedure that is based on policies of an organization.

Besides, I discovered that when an organization does not have sufficient resources and structure that can help with the risk assessment process to make an informed decision, it will be problematic for the management to implement the recommendation of a given report that is tantamount for culture change transformation in both decision making and assessment of an agency. For that reason, moving forward will require cross-program communication and coordination, training of employees to guarantee requisite expertise, and commitment to leadership. Therefore, by initiating a senior-level strategic examination of risk-related processes and structure, a risk assessment agency will be guaranteed that it has the institutional capacity that can carry out recommendations, as well as develop capacity-building strategy that entails budget estimates. It is essential to adopt an expanded risk assessment report framework characterized with similar scores to that of the Red Book Model but with difference in final and preliminary steps. The framework starts with the provision of a signal for potential harm like suspicious disease constellation or results of industrial contamination. By shifting risk decisions, a risk assessment will be able to layout information that is required during the risk assessment process.