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e-CFR data is current as of January 15, 2021

Title 40Chapter ISubchapter APart 26Subpart P → §26.1604


Title 40: Protection of Environment
PART 26—PROTECTION OF HUMAN SUBJECTS
Subpart P—Review of Proposed and Completed Human Research


§26.1604   EPA review of completed human research.

(a) When considering, under any regulatory statute it administers, data from completed research involving intentional exposure of humans to a pesticide, EPA must thoroughly review the material submitted under §26.1303, if any, and other available, relevant information and document its conclusions regarding the scientific and ethical conduct of the research.

(b) EPA shall submit its review of data from human research covered by subpart Q, together with the available supporting materials, to the Human Studies Review Board if EPA decides to rely on the data and:

(1) The data are derived from research initiated after April 7, 2006, or

(2) The data are derived from research initiated before April 7, 2006, and the research was conducted for the purpose of identifying or measuring a toxic effect.

(c) In its discretion, EPA may submit data from research not covered by paragraph (b) of this section to the Human Studies Review Board for their review.

(d) EPA shall notify the submitter of the research of the results of the EPA and Human Studies Review Board reviews.

[71 FR 6168, Feb. 6, 2006. Redesignated at 78 FR 10544, Feb. 14, 2013 and amended at 78 FR 10545, Feb. 14, 2013]

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