Attachment D

2195.06__Attachment D.docx

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

Attachment D

OMB: 2070-0169

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EPA ICR No. 2195.06 OMB Control No. 2070-0169


ATTACHMENT D


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.—

* * * *

  1. STANDARD.—

    1. GENERAL RULE.—

* * * *

(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)


  1. ACTION ON ADMINISTRATORS OWN INITIATIVE.—

    1. GENERAL RULE.—The Administrator may issue a regulation—

* * * *

(C) establishing general procedures and requirements to implement this section.

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleEPA ICR No
AuthorJHOGUE
File Modified0000-00-00
File Created2022-04-27

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