Risk Paradigm

[Eustacio Gadit]

EPAconnects environmental exposures, adverse outcomes, and risk reduction actions using a risk paradigm. The risk paradigm includes both risk characterization and risk management. Risk characterization is made up of four critical steps:

Each of these four steps is needed to understand the risk to human or environmental health associated with a specific chemical or other hazard. Risk management, in turn, incorporates understanding treatment, remediation, and control options; regulatory requirements on a federal, state, and local level; and other social and economic factors that might impact the success of an individual risk management plan.

EPA uses risk assessment to characterize the nature and magnitude of health risks to humans and ecological receptors from chemical contaminants and other stressors that may be present in the environment.

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To estimate potential health impacts associated with environmental exposures, EPA scientists and others have spent more than two decades developing an extensive set of risk assessment methods, tools, and data to estimate environmental health risks. Although significant uncertainties remain, this risk assessment methodology has been extensively peer-reviewed, is widely used and understood by the scientific community, and continues to expand and evolve as scientific knowledge advances.

EPA's framework for assessing and managing risks reflects the risk assessment and risk management paradigm set forth by the National Academy of Sciences (NRC) in 1983 [ , ], shown in Figure 1 below. The NRC concluded that risk assessment and risk management are "two distinct elements" between which agencies should maintain a clear conceptual distinction. The 1983 NRC report identified four steps integral to any risk assessment: 1) hazard identification, 2) dose-response assessment, 3) exposure assessment, and 4) risk characterization. The NRC paradigm for risk assessment serves as the basis for OAQPS risk assessments under the air toxics program.

Within the NRC paradigm, the evaluation of toxicity in a risk assessment is based on two sequential analyses. The first is the hazard identification, which identifies contaminants that may pose health hazards at environmentally relevant concentrations, and qualitatively describes the effects that may occur in humans. The second analysis is the human health dose-response assessment, which characterizes the relationship between the exposure to a pollutant and the resultant health effects.

Hazard Identification. The types of effects relevant to each chemical (e.g., cancer, or effects other than cancer) are determined as part of the hazard identification. Factors such as the experimental route of exposure, the type and severity of the effects, the biological plausibility of findings, and the consistency of findings across studies all contribute to the hazard identification statement.

Dose-Response Assessment. Generally, the dose-response assessment consists of two parts: the evaluation of data in the observable range, and the extrapolation from the observable range to low doses/risks. Recent terminology refers to the result of analysis in the observable range as the "point of departure" from which extrapolation begins. The approaches used for evaluation in the observable range are similar for all types of effects, but EPA's current extrapolation methods differ for effects concluded to have linear and nonlinear modes of action. Further details of dose-response assessment are provided in the web pages on risk assessment for carcinogenicity and other endpoints.

The nature of the dose-response assessment typically varies among pollutants. Sufficient data may exist for some criteria air pollutants, such as ozone or carbon monoxide, so that relatively complete dose-response relationships can be characterized. In such cases, there is no need for extrapolation to lower doses because adequate human health effects data are available at environmentally relevant levels. However, this has not often been the case for air toxics. Epidemiologic and toxicologic data for air toxics have typically resulted from exposure levels that were high relative to environmental levels.

The paper considers case studies from the Caribbean, Latin America, East Asia, India and others to propose a framework for the provision of expert advice to governments and the subsequent communication of risk to populations. It also considers cultural aspects that differ between regions, as communication of risk may be diverse even in neighbouring countries affected by the same hazard event but who assess and respond to risk differently. Complex and systemic risks, such as those considered by the Sendai Framework, require consideration of the effect of international borders on public receipt of risk messages: risk communication is not one-size-fits-all.

This paper study undertakes to investigate the foundations and recent evolution of this phenomenon of vaccine hesitancy (and refusal) using a broad, inductive, and interdisciplinary approach with a focus on the role of risk perception and trust in risk/benefit assessment.

Overall, this research makes a significant contribution to the study of vaccine hesitancy by identifying the complexity of the underlying issues, the inadequacy of current responses, as well as a need for a comprehensive interdisciplinary approach to improve both local and global public health policies.

Even though this research aims to consider the phenomenon of vaccine hesitancy in a globally relevant framework, some aspects are uniquely associated with the United States, including the quantitative clergy-trust dimension of this study.

In fact, it seems useful to mention that the 2019 WHO document was published at a time when the United States had withdrawn from the organization under the Presidency of Donald Trump who served between 2016 and 2020. This was a time when polarization and distrust became obvious features of American society, right in time for the inception of the COVID-19 pandemic (December 2019).

Not only individuals but also medical doctors and public health administration were put in the difficult position to make important decisions based on a complex if not impossible risk/benefit assessment. Taking account this unique situation and the aftermath thereof, this research aims to consider the issue of vaccine hesitancy in the post-COVID-19 era.

Public health issues are rarely solved or fully understood from a single disciplinary perspective. Addressing the complex social, behavioral, and biological phenomena that influence health requires the application of perspectives from seemingly disparate disciplines (Golembiewski et al., 2018).

The interconnectedness of public health and other disciplines (economics, ethics, international law) has been illustrated throughout the course of the COVID-19 pandemic: economic considerations, diplomatic interferences, legal disputes, mental health implications of lockdowns and even unintended public health consequences such as delayed immunizations, screenings and treatments.

As our literature review and inductive analysis has revealed, this research affirms the need to a comprehensive interdisciplinary approach to better under the phenomenon of vaccine hesitancy, especially in the post COVID-19 era.

The obvious application to immunization policies as been explored by many researchers, including Jones and colleagues in The Health Belief Model as an Explanatory Framework in Communication Research: Exploring Parallel, Serial, and Moderated Mediation (Jones et al., 2015). In this case, HBM was considered in the case of the H1N1 vaccination campaign. Others, such as Nexoe, Kragstrup, and Sogaard (1999) found that the HBM components of perceived severity, perceived barriers, and perceived benefits were mutually significant predictors of influenza vaccination acceptance. The Jones study confirms the need for a comprehensive interdisciplinary approach as the relationship between information exposure and behavior/decision was recognized to be complex and hierarchical:

Vaccine hesitancy is not a new phenomenon since it can be traced to the very beginning of the vaccine era, with a full spectrum of positions ranging from absolute vaccine refusal and its flipside on the public policy side, namely mandatory vaccination enforced by the State. It is well documented that entire towns refused to pursue the smallpox eradication campaign (using the smallpox vaccine developed by Edward Jenner), and controversy remains regarding the safety and efficacy of the initial small box vaccine considering the primitive technological and medical context (Schwartz, 2012). The polio vaccine, which was welcome with immense relief by the US population as a whole, was not a complete success story. Vaccine advocate Dr Paul Offit expresses surprise that the vaccine hesitancy or vaccine refusal movement did not gain significant traction at the time, in view of the admitted medical errors which resulted in a large number of vaccine-caused cases of paralysis (Offit, 2010). Offit goes on to document the rise of the anti-vaccination movement to the DTP shot (Shot in the Dark documentary by Barbara Fisher and Harris Coulter) and the creation of what became the influential (and vaccine adverse) National Vaccine Information Center in the United States.

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