2195.04_Attachment D

ATTACHMENT D_2195-04_Applicable Sections of FFDCA 408.pdf

Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects

2195.04_Attachment D

OMB: 2070-0169

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EPA ICR No. 2195.04

OMB Control No. 2070-0169
ATTACHMENT C

Sections 408(b)(2)(A)(ii) and 408(e)(1)(C) of the Federal Food, Drug, and Cosmetic
Act
FFDCA Section 408(b)(2)(A)(ii)
(b) AUTHORITY AND STANDARD FOR TOLERANCE.—
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(2) STANDARD.—
(A) GENERAL RULE.—
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(ii) DETERMINATION OF SAFETY.—As used in this section, the term “safe”, with
respect to a tolerance for a pesticide chemical residue, means that the Administrator
has determined that there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable information.
FFDCA Section 408(e)(1)(C)
(e) ACTION ON ADMINISTRATOR’S OWN INITIATIVE.—
(1) GENERAL RULE.—The Administrator may issue a regulation—
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(C) establishing general procedures and requirements to implement this section.


File Typeapplication/pdf
File TitleEPA ICR No
AuthorJHOGUE
File Modified2012-05-25
File Created2012-05-25

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