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:

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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):

Jeff Kempter kempter.carlton@epa.gov 703-305-5448

Declaration of Prion as a Pest under FIFRA and Amendment of EPA’s Regulatory Definition of 

Pests to Include Prion; Proposed Rule (NPRM)

OPP-2010-0427 8850-4 AJ26

Changes were made to address suggestions submitted by or through OMB. See also separate 

documentation of responses to comments from USDA & FDA received under FIFRA mandated reviews.