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2 Committee's Approach to Evaluation of Research Progress
Pages 47-63

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From page 47...
... forPM. In establishing its research agenda, the committee used an integrated risk assessment framework that includes sources of air pollution and subsequent effects on health -- a conceptual sequence that is integral to strategies for air pollution control (see Figure 1-1 in Chapter 1)
From page 48...
... Although the committee evaluates the research findings on PM on their contribution to the advancement of scientific knowledge without specific concern for EPA's application, the committee is also mindful of the impact of the research agenda and the resulting research findings on the PM NAAQS, its implementation, and future reviews. BACKGROUND A key step in the use of scientific evidence for policy formulation is gauging research progress resulting in reduction of uncertainty.
From page 49...
... . Although this evaluation and the associated report considered multiple diseases, the primary focus -- and impact -- related to its conclusions on the association between smoking and lung cancer.
From page 50...
... The overarching view of the IARC is that "in the absence of adequate data on humans, it is biologically plausible and prudent to regard agents and mixtures for which there is sufficient evidence of carcinogenicity in experimental animals as if they presented a carcinogenic risk to humans" (IARC 2001)
From page 51...
... The exposure circumstance entails exposures that are probably carcinogenic to humans. This category is used when there is limited evidence of carcinogenicity in humans and sufficient evidence of carcinogenicity in experimental animals.
From page 52...
... In some instances, an agent, mixture, or exposure circumstance may be placed in this group when there is inadequate evidence of carcinogenicity in humans but limited evidence of carcinogenicity in experimental animals together with supporting evidence from other relevant data. Group 3: The agent (mixture or exposure circumstance)
From page 53...
... Like IARC (1972) , the NRC committee viewed epidemiological studies as the most convincing evidence of risk, but animal bioassays were recognized as more commonly available and useful, as long as their results could be extrapolated to humans.
From page 54...
... : The Immunization Safety Review Committee systematically reviews the scientific evidence for a series of selected vaccine safety concerns, assesses the societal importance of the issues, and provides recommendations for further action (IOM 2002)
From page 55...
... The committee recognized that Hill's original intent in regard to the biological plausibility criterion in judging epidemiological causality TABLE 2-2 Evaluation of the Strength of the Evidence on Agent Orange (Are herbicides statistically associated with the health outcome?
From page 56...
... Consequently, the committee separated its evaluation of the literature on biological mechanisms from its judgment of the evidence for causality in population-based studies. The committee then combined the determination about biological mechanisms with its assessment of clinical and epidemiological data to judge whether scientific evidence supported causal relationships between multiple immunizations and immune dysfunctions.
From page 57...
... 57 2002. IOM Source: Committee.
From page 58...
... EPA's Clean Air Scientific Advisory Committee (CASAC) reviews the criteria document and the staff paper, and when CASAC considers that
From page 59...
... Among the challenging aspects of the task are the multiplicity of sourcesof PM, the complexity of airborne PM, the strong possibility that multiple mechanisms are relevant to disease causation, and the lack of specificity for the health outcomes of concern. The committee noted that the evidence evaluation systems that it had reviewed did not cover a number of large scientific issues relevant to the review and implementation of a NAAQS.
From page 60...
... For this report, the committee focuses on the more proximal indicators of progress on the research agenda and the consequences of this work: funding, research initiated, publications, and extent of incorporation of findings of new research motivated by the committee's agenda into the criteria document and staff paper. Even within the life span of the committee, substantial research has been funded, initiated, and published.
From page 61...
... For this report, the committee also assessed the extent to which research initiated at its recommendation has been considered in the criteria document and staff paper. Given the limited time since the committee's firstreport(approximately 6years)
From page 62...
... 62 Research Priorities for Airborne Particulate Matter Committee's Evaluation Process Indicators of Progress Approach Information uncertainty Research recommended Research initiated -Funding available Compare expenditure -Appropriate amount information from EPA with committee's resource estimates Informative quality -Peer-reviewed Evaluate papers collected of reported research publications for criteria document, results NARSTO PM review, and committee workshop Evidence considered -Considered in criteria Evaluate progress in by document reducing key uncertainties EPA (others) -Considered in staff paper Useful for informing -Effect on Assess value to decision a review of -Indicator making standard -Averaging time -Level -Statistical form Useful for implemen- -Considered in imple- Assess value to decision tation of standard mentation plans, e.g., making source apportionment for source and receptor modeling, source controls, and SIPs Change in exposure -Change in emissions -Change in ambient concentration -Change in exposure Decreased -Change in disease disease risk risk, morbidity, or mortality FIGURE 2-3 Schematic representation of process for reducing disease risk through research.
From page 63...
... As it seeks to satisfy the requirements of the Clean Air Act to set standards to protect public health with an "adequate margin of safety," its decisionmaking inherently involves PM concentrations at which effects do not occur with known probability or certainty. Additionally, the health effects of PM and their mitigation are a topic of evident complexity.


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