Agency Information Collection Activities; Submission to OMB; Comment Request; EPA ICR No. 1693.03/OMB Control No. 2070-0142; Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting

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 the following Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval: Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting; EPA ICR No. 1693.03; OMB Control No. 2070-0142. The ICR, which is abstracted below, describes the nature of the information collection activity and its expected burden and costs.

DATES:

Additional comments may be submitted on or before September 2, 2004.

FOR FURTHER INFORMATION CONTACT:

Cameo Smoot, Field and External Affairs Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5454; fax number: (703) 305-5884; e-mail address: smoot.cameo@epa.gov.

ADDRESSES:

Submit your comments, referencing docket ID number OPP-2003-0298, to (1) EPA online using EDOCKET (our preferred method), by e-mail to opp-docket@epa.gov, or by mail to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Mailcode: 7502C, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

SUPPLEMENTARY INFORMATION:

EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. The Federal Register document, required under 5 CFR 1320.8(d), soliciting comments on this collection of information was published on October 15, 2003 (67 FR 66392). EPA received no comments on this ICR during the 60-day comment period.

EPA has established a public docket for this ICR under Docket ID No. OPP-2003-0298, which is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at http://www.epa.gov/edocket . Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified above.

Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice. Please note, EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 (May 31, 2002), or go to www.epa.gov/edocket.

ICR Title: Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting

ICR Status: This is a request for extension of an existing approved collection that is currently scheduled to expire on July 31, 2004. EPA is asking OMB to approve this ICR for three years. Under 5 CFR 1320.12(b)(2), the Agency may continue to conduct or sponsor the collection of information while the submission is pending at OMB.

Abstract: On January 16, 2001, EPA promulgated a final rule that addresses the regulatory status of pesticidal substances that are produced by plants (plant-incorporated protectants). This Information Collection Request (ICR) covers the two information collection related provisions contained in the final rule: the provision that requires registrants that make Confidential Business Information (CBI) claims to substantiate such claims when they are made, and the provision that requires manufacturers of plant-incorporated protectants exempted from requirements of registration under the final rule to report adverse effects to the Agency.

Burden Statement: The annual “respondent” burden for this ICR is estimated to average about 22 hours per response. According to the Paperwork Reduction Act, “burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For this collection, it is the time reading the regulations, planning the necessary data collection activities, conducting tests, analyzing data, generating reports and completing other required paperwork, and storing, filing, and maintaining the data. The 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 number for this information collection appears at the beginning and the end of this document. In addition OMB control numbers for EPA's regulations, after initial display in the final rule, are listed in 40 CFR part 9.

The following is a summary of the burden estimates taken from the ICR:

Respondents/affected entities: Persons or companies involved with agricultural biotechnology that may develop and market plant incorporated protectants.

Estimated total number of potential respondents: 14.

Frequency of response: On occasion.

Estimated total/average number of responses for each respondent: 1.

Estimated total annual burden hours: 303.

Estimated total annual burden costs: $27,572.

Changes in the ICR Since the Last Approval: The total estimated annual respondent burden for this ICR has decreased 1,067 hours, from 1,370 hours to 303; and the cost has decreased $92,420, from $119,992 to $27,572, because the previous ICR included an estimated 1,067 hours for respondents to familiarize themselves with the requirements of the rule, which was promulgated in 2001. This decrease is explained more fully in the ICR.

List of Subjects:

• EPA, pesticides, pesticide registration, information collection