As noted recently (Callahan and Sexton 2007), there are four key differences between EPA’s cumulative risk-assessment paradigm and traditional human health risk assessments:
Cumulative risk assessment is not necessarily quantitative.
Cumulative risk assessment by definition evaluates the combined effects of multiple stressors rather than focusing on single compounds.
Cumulative risk assessment focuses on population-based assessments rather than source-based assessments.
Cumulative risk assessment extends beyond chemicals to include psychosocial, physical, and other factors.
In addition, an explicit component of the cumulative risk-assessment paradigm defined by EPA involves an initial planning, scoping, and problem-formulation phase (EPA 2003a), which the committee previously proposed as an important component of any risk assessment in Chapter 3. That involves bringing risk managers, risk assessors, and various stakeholders together early in the process to determine the major factors to be considered, the decision-making context, the timeline and related depth of analysis, and so forth. Planning and scoping ensure that the right questions are asked in the context of the assessment and that the appropriate suite of stressors is considered (NRC 1996).
The committee acknowledges the conceptual framework and broadened definitions of cumulative risk assessment as constituting a move toward making risk assessments more relevant to decision-making and to the concerns of affected communities. Many components of cumulative risk assessment (such as planning and scoping or explicit consideration of vulnerability) should be considered as standard features of any risk assessment in principle. In practice, however, EPA assessments conducted today can fall short of what is possible and what is supported by the agency’s framework, and this chapter is directed at improvements in agency practice.
The chapter considers in detail some of the specific reasons why cumulative risk assessment might be needed, because the risk-management needs will inform necessary revisions of the analytic framework. First, even if the regulatory decision of interest were related to strategies to address a single chemical with a single route of exposure, consideration of other compounds and other factors may be necessary to inform the decision. Ignoring numerous agents or stressors that affect the same toxic process as the chemical of interest and omitting background processes could lead to risk assessments that, for example, assume population thresholds in circumstances when such thresholds may not exist. That issue has been largely addressed in Chapter 5 in relation to the need to evaluate background exposure and vulnerability factors to determine the likelihood that these factors could “linearize” an otherwise nonlinear mode of action (MOA). We do not treat this issue in further detail in this chapter other than to note that it is a crucial component of cumulative risk assessment and that it leads to potentially important exposure-assessment and epidemiologic and toxicologic data requirements.
Second, as alluded to above, the types of questions that are increasingly being asked of EPA require the tools and concepts of cumulative risk assessment. Communities concerned about environmental toxicants often wish to know whether environmental factors can explain observed or hypothesized disease trends or whether specific facilities are associated with important health burdens (and whether specific interventions could reduce those burdens). The relevance of standard risk-assessment methods in settings with vulnerable populations and multiple coexposures is being challenged by stakeholders, especially those with concerns about environmental justice (Israel 1995; Kuehn 1996). Addressing those issues requires an