What Is Risk 

 Management? 



tolerances. Foods not distributed through interstate commerce are 

 primarily a state responsibility, not FDA's. Previously, procedures 

 for assessing risks from the consumption of contaminated fish and 

 shellfish have not been standardized among agencies — or some- 

 times, even among programs within a single agency. In addition, 

 risk assessment procedures for other problems, such as con- 

 tamination of drinking water, have been better developed than 

 those for consumption of contaminated aquatic organisms. The 

 1987 National Estuary Program guidance manual explains how to 

 apply general EPA risk assessment policies to the particular 

 "exposure route" (mechanism of human exposure) of eating fish 

 and shellfish. 



The EPA risk assessment process is based on estimating the 

 highest probability, given uncertain technical information, of risks 

 to humans. The process uses a combination of empirical data 

 (observational data) on the long-term, chronic effects of toxic 

 chemicals, and models for extrapolating from high doses to low 

 doses and from animals to humans. In most cases, empirical data 

 are available only for animal test species. This is primarily because 

 it is hard to obtain long-term (a generation or lifetime) observations 

 of human health effects like cancer, and human data are only rarely 

 available, in cases where accidental exposures have occurred. 



Risk management is the application of the results of risk assess- 

 ment by regulatory agencies to formulate public policy. For ex- 

 ample, regulatory agencies may use the results of risk assessment 

 studies to develop public health advisories to limit consumption of 

 particular fish species where contaminant levels are relatively low, 

 or to ban such consumption where levels are higher. In general, 

 the process and outcomes of risk management are case-specific 

 because technical, socioeconomic, and political issues must be 

 considered, and these factors are case-specific. Risk management 

 requires policy makers at federal, state, and local levels to balance 

 these public concerns. 



In the National Estuary Program and other EPA or state programs 

 for fresh, estuarine or marine waters, the results of health risk 

 assessment for fish or shellfish consumption generally may be 

 used in risk management to do the following: 



• Identify problem areas, problem pollutants, and problem fish or 

 shellfish species (and problem weight or length classes within 

 species, if relevant); 



• Develop guidelines and criteria for contaminant concentrations 

 that would be used to develop fish and shellfish consumption 

 advisories in cooperation with FDA and state governments; and 



• Provide public information in cooperation with FDA or state 

 governments. 



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