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2 Responses to National Academies Recommendations
Pages 5-13

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From page 5...
... process. The committee used that information and recently released IRIS documents to judge the extent to which EPA has adequately addressed recommendations made in previous National Academies reports, primarily Review of EPA's Integrated Risk Information System (IRIS)
From page 6...
... . SYSTEMATIC REVIEW: PROBLEM FORMULATION, PROTOCOL DEVELOPMENT, AND EVIDENCE IDENTIFICATION AND EVALUATION The 2014 report offered many recommendations related to systematic review, including problem formulation, protocol development, evidence identification, and evidence evaluation (Chapters 3‒5, NRC 2014)
From page 7...
... Accordingly, the IRIS program should show how other important methodologic characteristics of a particular study will be evaluated, and EPA should continue to seek and evaluate additional tools that can help to assess study quality. As part of revisions of the IRIS process, EPA is producing assessment plans and systematic-review protocols.
From page 8...
... . Although the 2014 committee recognized that substantial progress had occurred during 2011‒ 2013, it made several additional recommendations to guide the IRIS program toward a more systematic 4 IRIS uses the phrase evidence synthesis to refer to the task of combining evidence from a given evidence stream, such as human or animal, and the phrase evidence integration to refer to the task of combining evidence from different evidence streams.
From page 9...
... When animal or human data are extensive, mechanistic data can be used to evaluate the evidence within or across the animal or human data streams rather than as a third stream of evidence to be analyzed separately and then combined with human and animal evidence. When extensive mechanistic data are available and human and animal data on apical end points are sparse, mechanistic data might be used reliably as a third data stream to identify hazards, as has been done for the dioxin-like polychlorinated biphenyls (IARC 2016)
From page 10...
... An important recommendation in that chapter was to "develop criteria for determining when evidence is sufficient to derive toxicity values." In the workshop, EPA described the overall process and criteria that the agency intends to use to implement that recommendation and indicated that it would develop toxicity values when the evidence-integration conclusion is the "strongest" or a "moderately strong conclusion for a human health effect." As noted, EPA clarified that the agency intends to systematize processes 8 The Bayesian approach is based on the seminal work of Dumouchel and Harris (1983) and recent work of Jones et.
From page 11...
... Furthermore, EPA explained why each study considered in the final assessment did not change the conclusions reached in the 2010 IRIS assessment and did not justify a reassessment of human health effects. Thus, it is clear that EPA is making progress toward improving transparency in its use of systematic review and expert judgment to inform the derivation of toxicity values directly.
From page 12...
... Because new tools and approaches will ultimately be needed to implement past National Academies recommendations, especially for incorporating mechanistic information and for integrating evidence across studies, the committee is encouraged by IRIS program efforts to collaborate with other EPA staff, other government agencies, and academe to have the right mix of expertise to develop new approaches and best practices for conducting assessments. REFERENCES DuMouchel, W.H., and J.E.
From page 13...
... 2015a. Handbook for Conducting a Literature-Based Health Assessment Using OHAT Approach for Systematic Review and Evidence Integration.


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