2011-1657. Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting; EPA ICR No. 1693.07, OMB Control No. 2070-0142

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.

DATES:

Additional comments may be submitted on or before February 25, 2011.

ADDRESSES:

Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2010-0281, to (1) EPA online using http://www.regulations.gov (our preferred method), or by mail to: EPA Docket Center, Environmental Protection Agency, Pesticide Public Regulatory Docket at Potomac Yard, 7502P, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Scott Drewes, Field and External Affairs Division, Office of Pesticide Programs, 7506P, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703-347-0107; fax number: 703-305-5884; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

EPA has submitted the following ICR to OMB for review and approval according to the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), and the procedures prescribed in 5 CFR 1320.12. On May 5, 2010, EPA sought comments on this renewal ICR (75 FR 24690) pursuant to 5 CFR 1320.8(d). EPA received one comment, which is addressed in the ICR. Any additional comments on this ICR should be submitted to EPA and OMB within 30 days of this notice.

EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OPP-2010-0281, which is available for online viewing at http://www.regulations.gov,, or in person viewing at the Pesticides Public Regulatory Docket, One Potomac Yard, 2777 S. Crystal Drive, Room S-4400, Arlington, VA 22202. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for this docket is 703-305-5805.

Use EPA's electronic docket and comment system at http://www.regulations.gov to submit or view public comments, to access the index listing of the contents of the docket, and to access those documents in the docket that are available electronically. Once in the system, select “docket search,” then key in the docket ID number identified above. Please note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing at http://www.regulations.gov as EPA receives them and without change, unless the comment contains copyrighted material, confidential business information (CBI), or other information whose public disclosure is restricted by statute. For further information about the electronic docket, go to http://www.regulations.gov.

Title: Plant-Incorporated Protectants; CBI Substantiation and Reporting Risk/Benefit Information.

ICR Numbers: EPA ICR No. 1693.07, OMB Control No. 2070-0142.

ICR Status: The current OMB approval for this ICR is scheduled to expire on January 31, 2011. Under OMB regulations at 5 CFR 1320.12(b)(2), the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This ICR is for an ongoing information collection activity. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Final Rule and in the Federal Register when approved, are listed in 40 CFR part 9 or by other appropriate means, such as on the related collection instrument or form, if applicable.

Abstract: This ICR addresses the two information collection requirements described in regulations pertaining to pesticidal substances that are produced by plants (plant-incorporated protectants (PIPs)) and which are codified in 40 CFR part 174. A PIP is defined as “the pesticidal substance that is intended to be produced and used in a living plant and the genetic material necessary for the production of such a substance.” Many, but not all, PIPs are exempt from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Registrants sometimes include in a submission to EPA for registration of a PIP information that they claim to be confidential business information (CBI). CBI is protected by FIFRA and generally cannot be released to the public unless authorized after following the procedures in 40 CFR part 2. Under 40 CFR part 174, whenever a registrant claims that information submitted to EPA in support of a registration application for PIPs contains CBI, the registrant must substantiate such claims when they are made. In addition, manufacturers of PIPs that are otherwise exempted from the requirements of registration must report risk benefit information of the PIP to the Agency. Such reporting will allow the Agency to determine whether further action is needed to prevent unreasonable adverse effects to public health and the environment. Submission of this information is mandatory and supplied on occasion.

Burden Statement: The annual respondent burden for the collection of information associated with the substantiation at the time of submission for CBI claims related to a PIP registration application is estimated to average 21.5 hours per submission, and the annual respondent burden for the collection of information associated with the reporting of adverse effects for exempted PIPs is estimated to average 7 hours per submission. Burden is defined in 5 CFR 1320.3(b). The following is a summary of the burden and cost information for this ICR:

Respondents/Affected Entities: Producers and importers of PIPs.

Estimated Number of Respondents: 18.

Frequency of Response: On occasion.

Estimated Total Annual Hour Burden: 389.

Estimated Total Annual Cost: $26,875.00.

Changes in the Estimates: There is an increase of 86 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This increase is an adjustment resulting from an increase in the estimated number of PIPs applications. EPA expects that the level of activity will continue.

Dated: January 20, 2011.

John Moses,

Director, Collection Strategies Division.