NRC 1994 at 220: “If there is reason to believe that risk of adverse biological effects per unit dose depends on age, EPA should present separate risk estimates for adults and children. When excess lifetime risk is the desired measure, EPA should compute an integrated lifetime risk, taking into account all relevant age-dependent variables.

EPA 2005b Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens at 1: “The National Research Council (NRC, 1994) recommended that ‘EPA should assess risks to infants and children whenever it appears that their risks might be greater than those of adults.’ This document focuses on cancer risks from early-life exposure compared with those from exposures occurring later in life. Evaluating childhood cancer and childhood exposures resulting in cancer later in life are related, but separable, issues.”

GAO 2006 at 46: “Legislation can also require EPA to consider potentially susceptible populations and life stages. For example, the Safe Drinking Water Act Amendments mandate that EPA consider risks to groups within the general population that are at greater risk of adverse health effects, including children, the elderly, and people with serious illnesses. In addition, the Food Quality Protection Act contains special provisions for the consideration of risks to children from pesticides. In 1995, EPA’s Science Policy Council called for EPA to consider the risks to infants and children consistently and explicitly as part of its risk assessments. In 1997, the White House issued an executive order that required EPA and other federal agencies to identify and assess environmental health and safety risks that may disproportionately affect children and to ensure that policies, programs, activities, and standards address such disproportionate risks.”

“EPA does not usually explore or consider interindividual variability in key biologic parameters when it uses or evaluates various physiologic or biologically based risk-assessment models (or else evaluates some data but does not report on this in its final public documents). In some other cases, EPA does gather or review data that bear on human variability, but tends to accept them at face value without ensuring that they are representative of the entire population. As a general rule, the larger the number of characteristics with an important effect on risk or the more variable those characteristics are, the larger the sample of the human population needed to establish confidently the mean and range of each of those characteristics.”

EPA 2004b at 42: “Consideration of the variability among humans is a critical aspect of risk assessment. It is the goal of EPA risk assessments to identify all potentially affected populations, including human populations (e.g., gender, nutritional status, genetic predisposition) and life-stages (e.g., childhood, pregnancy, old age) that may be more susceptible to toxic effects or are highly or disproportionately exposed.”

Also at 43: “When data are available to describe toxicological differences for a susceptible population or life-stage, then those data are summarized and analyzed, and the decisions based on this information are presented. It is preferable to have population- and chemical-specific data to describe a susceptibility to toxic effects.”

 

aExample of recommendation from NRC 1983, 1994, or 1996.

bExample of EPA policy bearing on issues raised in the recommendation in the form of written guidelines, reports, or policy memoranda.

cCommentary, practice, or activities related to issues raised in the National Research Council recommendation and related EPA guidance.

dThese guidelines were not specifically in response to the National Research Council report but reflect agency policy related to this topic.



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