Risk Assessment/Risk Management Is a Three-Step Process: In Defense of EPA's Risk Assessment Guidelines

1988 ◽  
Vol 7 (4) ◽  
pp. 543-549 ◽  
Author(s):  
Bernard D. Goldstein
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Risk Management ◽  
Science Policy ◽  
Priority Setting ◽  
Risk Assessments ◽  
Appropriate Use ◽  
Step Process ◽  
The Past ◽  
Assessment Guidelines

The purpose of this article is to focus on the appropriate use and development of risk assessment and to point out that many of the perceived shortcomings, in fact, represent limitations imposed by the framework in which it is being used and failure to understand the situations for which risk assessment is suited. Risk assessment/risk management is really a three-step not a two-step process. The first step, preceding risk assessment, is science policy, in which the guidelines for the generic performance of risk assessments are established. The benefits of risk assessment to appropriate environmental regulation not only are direct, in terms of improved decision making and priority setting, but also they have the major indirect value of focusing research efforts on crucial uncertainties in a manner that has not been possible in the past.

Science-policy in environmental and health risk assessment: if we cannot do without, can we do better?

2006 ◽  
Vol 25 (1) ◽  
pp. 29-43 ◽  
Author(s):  
P F Ricci ◽  
L A Cox ◽  
T R MacDonald
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Risk Management ◽  
Health Risk ◽  
Human Health ◽  
Empirical Evidence ◽  
Health Risk Assessment ◽  
Science Policy ◽  
The Us ◽  
Us Epa

How can empirical evidence of adverse effects from exposure to noxious agents, which is often incomplete and uncertain, be used most appropriately to protect human health? We examine several important questions on the best uses of empirical evidence in regulatory risk management decision–making raised by the US Environmental Protection Agency (EPA)'s science–policy concerning uncertainty and variability in human health risk assessment. In our view, the US EPA (and other agencies that have adopted similar views of risk management) can often improve decision–making by decreasing reliance on default values and assumptions, particularly when causation is uncertain. This can be achieved by more fully exploiting decision–theoretic methods and criteria that explicitly account for uncertain, possibly conflicting scientific beliefs and that can be fully studied by advocates and adversaries of a policy choice, in administrative decision–making involving risk assessment. The substitution of decision–theoretic frameworks for default assumption–driven policies also allows stakeholder attitudes toward risk to be incorporated into policy debates, so that the public and risk managers can more explicitly identify the roles of risk–aversion or other attitudes toward risk and uncertainty in policy recommendations. Decision theory provides a sound scientific way explicitly to account for new knowledge and its effects on eventual policy choices. Although these improvements can complicate regulatory analyses, simplifying default assumptions can create substantial costs to society and can prematurely cut off consideration of new scientific insights (e.g., possible beneficial health effects from exposure to sufficiently low ‘hormetic’ doses of some agents). In many cases, the administrative burden of applying decision–analytic methods is likely to be more than offset by improved effectiveness of regulations in achieving desired goals. Because many foreign jurisdictions adopt US EPA reasoning and methods of risk analysis, it may be especially valuable to incorporate decision–theoretic principles that transcend local differences among jurisdictions.

Initiating and Managing Risk Assessments within a Risk Analysis Framework: FDA/CFSAN'S Practical Approach

2004 ◽  
Vol 67 (9) ◽  
pp. 2058-2062 ◽  
Author(s):  
ROBERT L. BUCHANAN ◽  
SHERRI DENNIS ◽  
MARIANNE MILIOTIS
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Risk Management ◽  
Risk Analysis ◽  
Risk Assessments ◽  
Analysis Framework ◽  
Regulatory Decision ◽  
Managing Risk ◽  
Risk Managers ◽  
The U.S

Management of risk analysis involves the integration and coordination of activities associated with risk assessment, risk management, and risk communication. Risk analysis is used to guide regulatory decision making, including trade decisions at national and international levels. The U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition (CFSAN) formed a working group to evaluate and improve the quality and consistency of major risk assessments conducted by the Center. Drawing on risk analysis experiences, CFSAN developed a practical framework for initiating and managing risk assessments, including addressing issues related to (i) commissioning a risk assessment, (ii) interactions between risk managers and risk assessors, and (iii) peer review.

Assuming the Conclusions: Risk Assessment in the Development of Cancer Policy

1985 ◽  
Vol 4 (1) ◽  
pp. 31-44 ◽  
Author(s):  
Mark E. Rushefsky
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Policy Development ◽  
Cancer Risk Assessment ◽  
Acceptable Risk ◽  
Policy Documents ◽  
The Face ◽  
Assessment Guidelines ◽  
Objective Determination

This article examines the development of generic cancer risk assessment guidelines, or cancer policy, from 1976-1984. Risk assessment is considered the objective determination of the degree of risk from a substance. Risk management is the subjective determination of acceptable risk. However, uncertainties in the scientific foundations of cancer policy necessitate risk assessment inference choices, for example, over appropriate dose-response extrapolation models. Those choices are only partially scientific; they are also partially political. There is, as a result, an inevitable mixture of facts and values in cancer policy. The article explores ten inference controversies and evaluates how nine cancer policy documents resolved those controversies. It then traces the course of cancer policy development, showing how the Carter and Reagan administrations produced policies with difference emphases and considers several major challenges to cancer policy. The article then provides several justifications for cancer policy in the face of those challenges. It suggests, in the conclusion, that the controversies are unlikely to be resolved by science alone and politics will continue to influence the content of cancer policies.

A Review of the Validity of Juvenile Risk Assessment Across Race/Ethnicity

2018 ◽  
Author(s):  
Christina Campbell ◽  
William Miller
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Ethnic Minorities ◽  
Minority Groups ◽  
Critical Role ◽  
The United States ◽  
Risk Assessments ◽  
Assessment Instruments ◽  
Race Ethnicity ◽  
Racial Ethnic

Juvenile risk assessment instruments have provided juvenile courts with the opportunity to make standardized decisions concerning sentences and intervention needs. Risk assessments have replaced the reliance on professional decision-making practices in which court officials relied on their hunches or previous experience to determine what to do with youth once they became involved in corrections. A primary goal of juvenile risk assessment is to improve case management and help courts focus resources on juveniles who exhibit the greatest intervention needs. Further, juvenile risk assessments play a critical role in estimating which juveniles will likely reoffend by identifying factors that increase the propensity of future offending. Although some researchers believe that the implementation of standardized juvenile risk assessments is a good strategy for reducing biased decision-making for racial/ethnic minorities, other researchers have called into question the extent to which risk assessments overestimate risk for certain juveniles, especially those in minority groups who have a history of being marginalized due to their race, culture, or ethnicity. This article provides an overview of how well juvenile risk assessment instruments predict future delinquency across race and ethnicity. The review suggests that in general, risk assessments do a good job in predicting recidivism across racial/ethnic groups for diverse populations inside and outside the United States. However, there is still some room for improvement concerning the assessment of risk and needs for ethnic minorities. In addition, while there are some studies that do not report the predictive validity of risk assessment scores across race/ethnicity, risk assessments overall seem to be a promising effort to correctly classify and/or identify juveniles who are at greatest risk for future recidivism.

Framework for Identification and Collection of Data Useful for Risk Assessments of Microbial Foodborne or Waterborne Hazards: A Report from the International Life Sciences Institute Research Foundation Advisory Committee on Data Collection for Microbial Risk Assessment

2007 ◽  
Vol 70 (7) ◽  
pp. 1744-1751 ◽  
Author(s):  
ISABEL WALLS
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Risk Management ◽  
Data Collection ◽  
Dose Response ◽  
Management Decision ◽  
Microbial Risk Assessment ◽  
Microbial Risk ◽  
Response Data ◽  
Management Decision Making

A microbial risk assessment (MRA) can provide the scientific basis for risk management decision making. Much data are needed to complete an MRA, including quantitative data for pathogens in foods. The purpose of this document was to provide information on data needs and data collection approaches for MRAs that will be useful for national governments, particularly in developing countries. A framework was developed, which included the following activities: (i) identify the purpose of data collection—this should include stating the specific question(s) to be addressed; (ii) identify and gather existing data—this should include a determination of whether the data are sufficient to answer questions to be addressed; (iii) develop and implement a data collection strategy; (iv) analyze data and draw conclusions; and (v) use data to answer questions identified at the start of the process. The key data needs identified for an MRA were as follows: (i) burden of foodborne or waterborne disease; (ii) microbial contamination of foods; and (iii) consumption patterns. In addition, dose-response data may be necessary, if existing dose-response data cannot be used to estimate dose response for the population of interest. Data should be collected with a view to its use in risk management decision making. Standard sampling and analysis methods should be used to ensure representative samples are tested, and care should be taken to avoid bias when selecting data sets. A number of barriers to data collection were identified, including a lack of clear understanding of the type of data needed to undertake an MRA, which is addressed in this document.

Uncertainty in Risk Assessment, Risk Management and Decision Making.

1988 ◽  
Vol 151 (3) ◽  
pp. 551
Author(s):  
John Matatko ◽  
V. T. Covello ◽  
L. B. Lane ◽  
A. Moghissi ◽  
V. R. R. Uppuluri
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Risk Management

New Risk Assessment Initiatives in Epa

1985 ◽  
Vol 1 (4) ◽  
pp. 7-22 ◽  
Author(s):  
Elizabeth L. Anderson ◽  
Alan M. Ehrlich
Keyword(s):  
Risk Assessment ◽  
Risk Assessments ◽  
Technical Competence ◽  
Assessment Guidelines

This paper describes EPA's recent efforts to ensure consistency and technical competence of the agency's risk assessments. These include five risk assessment guidelines proposed in November 1984 and January 1985 and establishment of a Risk Assessment Forum. The technical provisions of the five guidelines have been outlined.

scholarly journals APPLIED RISK MANAGEMENT IN CONSTRUCTION INDUSTRY: A REVIEW

2020 ◽  
Vol 5 (3) ◽  
pp. 234-240
Author(s):  
Chaiwat Pooworakulchai
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Risk Analysis ◽  
Construction Industry ◽  
Master Planning ◽  
Construction Work ◽  
The Past ◽  
Risk Monitoring ◽  
Complex Manner

Risk management was applied to many organizations. There was a risk of multiple and complex manner in the construction industry, because it has a variety of elements. The application of risk management was therefore used in solving problems that suffer from the past to create an alternative to proper functioning under conditions. This article studied the main application to risk management in the construction industry by the sample texts document. The applying of risk management in the construction industry was 3 stages of risk management which were the risk analysis, risk assessment, risk control and follow-up, which was used to store information in the past and brainstorm by virtue of experience, expert tips and techniques to determine the risk analysis and risk evaluation of a mathematical methodology combined with the master planning of construction work to analyze, evaluate the risk under different condition and situations. Control, risk monitoring and risk assessment were a small amount so it should be a topic of research in future rely on notes and update the plan. The three important things for the applying of risk management in the construction industry were personnel, information and continuous learning.

scholarly journals Assessing Risk and Driving Risk Mitigation for First-of-a-Kind Advanced Reactors

2011 ◽  
Author(s):  
John W. Collins
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Nuclear Power ◽  
Power Plants ◽  
Risk Mitigation ◽  
Assessment Process ◽  
Next Generation ◽  
Risk Assessment Process ◽  
Step Process ◽  
Driving Risk

Planning and decision making amidst programmatic and technological risks represent significant challenges for projects. This presentation addresses the four-step risk assessment process needed to determine a clear path forward to mature needed technology and design, license, and construct advanced first-of-a-kind nuclear power plants, including Small Modular Reactors. This four-step process has been carefully applied to the Next Generation Nuclear Plant.

Formalizing Integrity Management Workflows: Towards Integrity Process Modelling

2018 ◽  
Author(s):  
Alejandro Reyes ◽  
Otto Huisman
Keyword(s):  
Risk Assessment ◽  
Decision Making ◽  
Risk Management ◽  
Business Process ◽  
Asset Management ◽  
Process Model ◽  
Business Processes ◽  
Building Blocks ◽  
Assessment Process ◽  
Integrity Management

Workflows are the fundamental building blocks of business processes in any organization today. These workflows have attributes and outputs that make up various Operational, Management and Supporting processes, which in turn produce a specific outcome in the form of business value. Risk Assessment and Direct Assessment are examples of such processes; they define the individual tasks integrity engineers should carry out. According to ISO 55000, achieving excellence in Asset Management requires clearly defined objectives, transparent and consistent decision making, as well as a long-term strategic view. Specifically, it recommends well-defined policies and procedures (processes) to bring about performance and cost improvements, improved risk management, business growth and enhanced stakeholder confidence through compliance and improved reputation. In reality, such processes are interpreted differently all over the world, and the workflows that make up these processes are often defined by individual engineers and experts. An excellent example of this is Risk Assessment, where significant local variations in data sources, threat sources and other data elements, require the business to tailor its activities and models used. Successful risk management is about enabling transparent decision-making through clearly defined process-steps, but in practice it requires maintaining a degree of flexibility to tailor the process to the specific organizational needs. In this paper, we introduce common building blocks that have been identified to make up a Risk Assessment process and further examine how these blocks can be connected to fulfill the needs of multiple stakeholders, including data administrators, integrity engineers and regulators. Moving from a broader Business Process view to a more focused Integrity Management view, this paper will demonstrate how to formalize Risk Assessment processes by describing the activities, steps and deliverables of each using Business Process Model and Notation (BPMN) as the standard modeling technique and extending it with an integrity-specific notation we have called Integrity Modelling Language or IML. It is shown that flexible modelling of integrity processes based on existing standards and best practices is possible within a structured approach; one which guides users and provides a transparent and auditable process inside the organization and beyond, based on commonalities defined by best practice guidelines, such as ISO 55000.

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