Dose-response assessment management

In the dose-response assessment to determine a dosage that is risk-free for human health, the JFCFA has never used mathematical models to extrapolate risks at low dose and determine a virtually safe dose, on the grounds that the lack of validation would produce very different results. However, the IFCFA could usefully address this matter in its deliberations. When progress in this area permits selection from various validated models, this exercise should no longer be solely associated with risk assessment but will also incorporate an element of risk management. 

Risk assessment is frequently described as involving four components - hazard identification, exposure assessment, dose-response assessment, and risk characterization. Risk assessment may be an input to risk management. 

ASSESSMENT OF RISKS TO HUMANS EXPOSED TO PESTICIDES 2 The Four Steps in Risk Assessment 2 Hazard Identification 2 Dose-Response Assessment 3 Margin of Safety Approach 3 Quantitative Risk Assessment 3 Exposure Assessment 4 Risk Characterization 4 RISK MANAGEMENT 5 ADVANCES IN DATA INTERPRETATION 5 Probabilistic Approaches 5 Recognition of the Tier Approach 5 Aggregate Exposure 6 Cumulative Exposure 6 Impact of New Scientific Advances 7 Post-Registration Monitoring 7 HARMONIZATION OF REGULATORY APPROACHES SUMMARY 9... 

In 1983, the National Research Council of the (US) National Academy of Sciences published a report titled Risk Assessment in the Federal Government Managing the Process this work has had a marked influence on the risk assessment process used by regulatory agencies worldwide. The risk assessment process, in this report, consists of four components hazard identification, dose-response assessment, exposure assessment, and risk characterization. 

Risk characterization is the final step of the risk assessment process as laid out in the classic National Research Council report Risk Assessment in the Federal Government Managing the Process. In this step, the risk from a specific agent (chemical or physical) or group of agents in a particular setting is evaluated. This evaluation is based on a comparison of the results of the dose-response assessment for these agents with the outcome of the exposure... 

Risk assessment is a process where the magnitude of a specific risk is characterized so that decision-makers can conclude whether the potential hazard is sufficiently great that it needs to be managed or regulated, reduced or removed. The National Research Council (NRC, 1983) of the National Academy of Sciences (NAS) first described the process of human health risk assessment, with an update in 1994 and 1996, as a four-component paradigm (i.e., hazard identification, dose-response assessment, exposure assessment, and risk characterization), with risk communication as a fifth area of study. The first four components are described briefly below. 

The first publication of standardized risk assessment concepts and terminology was written by the National Academy of Sciences in 1983 [8], This paper outlines four basic steps of risk management (1) hazard identification, (2) dose-response assessment, (3) exposure assessment, and (4) risk characterization. In the first step, a scientist attempts to identify the harm a compound could cause. 

Risk assessment is quantitative and differs from risk management, which involves weighing options to reduce the risk. The risk assessment process begins with identifying the potential hazards and their occurrence in a specihc environment (i.e., exposure assessment), their toxicity (i.e., dose-response), and a characterization of the risk (NRC, 1994). Risk assessment determines the probability of realizing harm as a result of exposure to a given hazard. 

However, as summarized below, there are important differences in the ways that the dose-response relationships for radionuclides and hazardous chemicals are used in risk assessment and risk management. 

It is important that both the qualitative and quantitative characterization be clearly communicated to the risk manager. The qualitative characterization includes the quality of the database, along with strengths and weaknesses, for both health and exposure evaluations the relevance of the database to humans the assumptions and judgements that were made in the evaluation and the level of confidence in the overall characterization. The quantitative characterization also includes information on the range of effective exposure levels, dose-response estimates (including the uncertainty factors applied), and the population exposure estimates. Kimmel et al. (2006) reviewed many of the components of the risk characterization for reproductive and developmental effects and provided a comprehensive list of issues to be considered for each of the components of the risk assessment. 

See also Carcinogen Classification Schemes Dose-Response Relationship Exposure Assessment Exposure Criteria Hazard Identification Risk Assessment, Ecological Risk Based Corrective Action (RBCA) Risk Characterization Risk Communication Risk Management Uncertainty Analysis. 

See also Dose-Response Relationship Exposure Assessment Risk Assessment, Human Health Risk Management. 

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