Regulatory decision-making, risk assessment

The EPA relies on a risk assessment approach to make better regulatory decisions. However, risk assessment is a multi-disciplinary process potentially involving the efforts of analytical and environmental chemists, biologists, environmental engineers, statisticians, toxicologists, and others as appropriate (5). It is rarely possible to obtain extensive involvement from professionals in all of the relevant disciplines for any site-specific risk assessment. Staffing limitations mean that the risk assessor in the field must often make do with limited help from professionals in some relevant disciplines. 

Risk Assessment. What is the incidence of the adverse health effects from the chemical agent This crucial question for regulatory decision making might be answered by combining the unit risk assessment with the exposure assessment. As In the exposure assessment, the question must be addressed in the context of one or more specific control policies. 

CRARM (1997). Commission on Risk Assessment and Risk Management. Risk Assessment and Risk Management in Regulatory Decision Making, Final Report (Presidential/Congressional Commission on Risk Assessment and Risk Management, Washington). 

MUNRO, I.C. and KREWSKI, D.R. (1981). Risk assessment and regulatory decision making, Food Cosmet. Toxicol. 19, 549-560. 

Risk characterization concludes the risk assessment process and provides the basis for discussions between the risk assessor and risk manager that pave the way for regulatory decision-making. The purpose of these discussions is to ensure that the results of the risk assessment are clearly and fully presented and to provide an opportunity for the risk manager to ask for any necessary clarification. Proper presentation of the risk assessment is essential to reduce the chance of over- or under-interpretation of the results. To permit the risk manager to evaluate the full range of possibilities contained in the risk assessment, it is important that the risk assessor provide the following types of information ... 

Use of risk assessment in regulatory decision-making Role of risk assessment guidefines... 

U.S. Food and Drug Administration. 2013. Structured approach to benefit-risk assessment in drug regulatory decision-making draft PDUFA V implementation plan. Available from http //www.fda.gov/downloads/forindustry/userfees/ prescriptiondruguserfee/ucm329758.pdf. Accessed August 5,2014. 

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