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.
Step 7 : Integrate the evidence to develop hazard identification conclusions.
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.
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.
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.
When the data support a health effect, the level-of-evidence conclusion for human data from step 6 ("high," "moderate," or "low") is considered together with the level of evidence for nonhuman animal data to reach one of four hazard identification conclusions.
Here we explain the framework developed by OHAT that uses procedures to integrate multiple evidence streams including observational human study findings, experimental animal toxicology results, and other relevant data in developing hazard identification conclusions or state-of-the-science evaluations regarding health effects from exposure to environmental substances.
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".
Again, any impact of other relevant data on the hazard identification conclusion is considered.
