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We wish to acknowledge and express our appreciation to those who provided written and oral comments. Both the public comments and recommendations and comments and recommendations of the FAC were considered in revising the report. These revisions addressed the use of technical terminology, clarification where needed, the inclusion of additional data, and minor editorial changes. Based on the comments and recommendations, FDA determined that it was not necessary to significantly revise the report or its findings. The specific comments made regarding the strengths and weakness of each approach will inform any decision as to whether to establish thresholds and, if so, which approach to use. The Agency also appreciates the suggestion that it may be possible to combine the safety assessment-based approach and the risk assessment-based approach to provide quantitative information on the uncertainties associated with thresholds established using the available published LOAELs and NOAELs. The Agency also takes note of the discussions that addressed issues beyond the scope of this report that may become relevant if a decision is made to establish thresholds.

Revised Threshold Report Page 11 of 108

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