Title 40

SECTION 30.7

30.7 May the EPA Administrator grant exemptions to this part

§ 30.7 May the EPA Administrator grant exemptions to this part?

(a) The Administrator may grant an exemption to this part for a study on a case-by-case basis if he or she determines that greater consideration is warranted because:

(1) Technological or other barriers render sharing of the dose-response data infeasible;

(2) The development of the dose-response data was completed or updated before January 6, 2021;

(3) Making the dose-response data available would conflict with laws and regulations governing privacy, confidentiality, confidential business information, or national security;

(4) A third-party has conducted independent validation of the study's underlying dose-response data through reanalysis; or

(5) The factors used in determining the consideration to afford to the pivotal science indicate full consideration is justified.

(b) When making a decision to grant an exemption, the Administrator may consider input from EPA staff and public commenters. The EPA shall document the rationale for exemptions granted by the Administrator in the significant regulatory action or influential scientific information.

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