To: The Honorable Andrew Wheeler
"The supplement to the notice expands the scope of the original rule such that the provisions will apply not only to the dose-response data and models, but to all data and models “underlying pivotal regulatory science and pivotal science which support significant regulatory decisions and influential scientific information.” Furthermore, the rule would also apply to historical data and analyses, which would potentially remove from consideration well-supported studies that were conducted under specific confidentiality agreements to protect participant privacy. This expansion of scope to encompass essentially all scientific information considered by the agency, in the context of nearly any potential rulemaking or revisions, is highly problematic given that many fundamental questions remain concerning how the agency will apply the rule to important sources of data. "
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