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Step 7 : Integrate the evidence to develop hazard identification conclusions.
Hazard identification conclusions may be reached on individual outcomes (health effects) or groups of biologically related outcomes, as appropriate, based on the evaluation's objectives and the available data.
Hazard identification conclusions are reached by integrating the highest level-of-evidence conclusion for a health effect(s) from the human and the animal evidence streams.
The seven-step framework outlines methods to increase transparency and consistency in the process, but it also presents opportunities to increase efficiencies in data management and data display that facilitate the process of reaching and communicating hazard identification conclusions.
Developing evaluations with this approach can improve communication and clarity about how hazard identification conclusions are reached by documenting the source of the data considered, the methods of quality assessment used, and the scientific judgments made during evidence integration.
The outcome of the evaluation includes any hazard identification conclusions reached or data needs identified, along with a detailed rationale outlining how human, animal, and other relevant data contributed to the conclusions.
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Again, any impact of other relevant data on the hazard identification conclusion is considered.
Mechanistic data or another type of other relevant data is not required to reach a final hazard identification conclusion.
If the human level-of-evidence conclusion of no health effect is supported by animal evidence of no health effect, the hazard identification conclusion is "not identified".
Any impact of other relevant data on the hazard identification conclusion derived by integrating the human and nonhuman animal streams is considered next.
If other relevant data provide strong opposition for biological plausibility of the relationship between exposure and the health effect, the hazard identification conclusion may be downgraded.
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