Organization 



Background 



Administration (FDA) action levels] related to risk assess- 

 ment, and information sources for updating these Vcilues 



• Provide guidance on presentation of risk assessment results 



• Summarize assumptions and uncertainties of the recom- 

 mended procedure for risk assessment. 



The guidance provided in this manual is directed primarily at risk 

 assessment related to recreational fisheries. Although assessment of 

 human health risks from commercial fisheries products is not ad- 

 dressed specifically in the examples provided herein, the concepts 

 discussed throughout the manual are relevant to risk analysis for 

 commercial fisheries. 



This manual provides guidance only, and does not constitute a 

 regulatory requirement of any kind. The technical content is consistent 

 with approved EPA procedures for risk assessment, as published in 

 the Federal Register (U.S. EPA 1986a-e). The guidance manual is 

 intended to describe what EPA believes to be the most scientifically 

 defensible methods for assessing environmental health risks. These are 

 the methods EPA will use in conducting health risk assessments re- 

 quired in its statutorily mandated programs. The relationship between 

 these procedures and risk assessment approaches used by FDA is 

 described briefly in the background section below. 



Background information on available health risk assessment guidance 

 and use of this manual is provided in the remainder of this introduction. 

 An overview of risk assessment is provided in the following section, 

 including a discussion of the distinction between risk assessment and 

 risk management, and a review of their possible uses. The major steps 

 of the risk assessment process recommended herein are described in 

 subsequent sections. Guidance is provided on mathematical models 

 used to estimate chemical exposure and risk. Sources of information 

 on toxic chemicals and model variables are noted. Finally, suggestions 

 for presentation of risk assessment results are provided and uncertain- 

 ties are summarized. 



Risk analysis encompasses both risk assessment and risk management. 

 Risk assessment is a scientifically based procedure to estimate the 

 probability of adverse health effects from a specific exposure to a toxic 

 agent. Risk assessment differs from risk management, although both 

 are elements of regulatory decision-making (National Research Coun- 

 cil 1983). Risk assessment provides the scientific basis for public policy 

 and action. In risk management, risks are interpreted in light of legis- 

 lative, socioeconomic, technical, and political factors, and appropriate 

 controls are determined. Risk management often involves evaluating 

 risks relative to potential benefits associated with an activity and 

 defining an acceptable risk level (i.e., the maximum risk considered 

 tolerable). For example, a ri.sk manager might weigh the risks as- 

 sociated with chemical contamination of fish and shellfish against the 

 health benefits (e.g., decreased risk of heart disease) associated with 

 consumption of fish and shellfish in place of red meat. 



