U.S. Environmental Protection Agency 

Office of Chemical Safety and Pollution Prevention (OCSPP) 

1200 Pennsylvania Avenue, N.W. (Mailcode 7101 M) 

Washington, D.C. 20460

OPPTS-RCS-OMB-7f (revised 11/15/2010)

If you have any questions about this regulatory action or this documentation, please call the contact:

Name: eMail: Phone:

Title of

Action:

Documentation of Changes Made During Review Under Executive Order 12866

Docket #: EPA-HQ- FRL#: RIN: 2070-

This action was submitted to the Office of Management and Budget (OMB) for review under Executive Order 12866, entitled 

Regulatory Planning and Review (58 FR 51735, October 4, 1993). According to section 6(a)(3)(E) of the Executive Order, 

whenever the Agency makes publicly available an action that was reviewed under Executive Order 12866, the Agency is also 

required to:

(1) Make available to the public a copy of the information that was provided to OMB's Office of Information and Regulatory 

Affairs (OIRA) for review under the Executive Order, i.e., the text of the draft action and, if applicable, an assessment 

of the potential costs and benefits; as well as additional information required for those actions that are determined to 

be economically significant under section 3(f) of the Executive Order (see section 6(a)(3)(B) & (C)); 

(2) Identify for the public any substantive changes made to the draft submitted to OMB, using a method that is complete, 

clear and simple; and

(3) Identify for the public those substantive changes made at the suggestion or recommendation of OIRA/OMB.

For this action, were substantive changes made during the review? [Check the appropriate answer.]

Yes. [The information identified in items 1-3 below is included in the docket, as applicable.]

No. [Only the information identified in item 1 below is included in the docket.]

Accordingly, the Agency has included the following information in the public docket for this 

action: [Check the appropriate box(es).]

(2) Documentation of any substantive changes that were made to the draft document that was 

submitted to OIRA/OMB for review, when compared with what completed review, using one of the 

following methods (select one):

(1) A copy of the information that was submitted to OIRA for review under the Executive Order.

(3) Documentation of those substantive changes made at the suggestion or recommendation of 

OMB, if any, are identified in the document using one of the following methods (select one):

(a) A copy of the draft document submitted, with redline and strikeout to show all the substantive 

changes that were made during the review.

(b) A document that identifies the substantive changes that were made during the review, with 

page and paragraph references to the draft document that was submitted.

(a) Through attributions to OMB in the redline and strikeout version or other document identifying 

the changes made at OMB's recommendation. 

(c) Other (please describe):

(b) Other (please describe):

Please also see the note on page 2 of this form.

Kelly Sherman sherman.kelly@epa.gov 703-305-8401

Final Rule: EPA's Rule on Protections for Subjects in Human Research Involving Pesticides

OPP-2010-0785 9353-4 AJ76

Recommendations for change during the review are received through and discussed with OMB before 

being made, and are not easily attributable to any specific interagency review participant.
02/08/2013

Page 2

EO 12866 Documentation related to the following action:

Final Rule: EPA's Rule on Protections for Subjects in 

Human Research Involving Pesticides

(RIN 2070-AJ76; FRL-9353-4; EPA Docket ID #: EPA-HQ-OPP-2010-0785)

NOTE:

Under Executive Order 12866 (58 FR 51735, October 4, 1993), 

EPA submitted this action to OMB for review under Executive 

Orders 12866 and 13563 (76 FR 3821, January 21, 2011) on two 

occasions. As such, the documentation for each review is 

represented as two separate attachments. 

The attachments apply to the reviews as follows:

Attachment #1 – Review Period: 02/01/13 – 02/08/13

Attachment #2 – Review Period: 11/07/11 – 06/08/12