E8-22493. Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Pesticide Data Call-In Program; EPA ICR No. 2288.01, OMB Control No. 2070-New

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act (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 and consolidate three existing approved Information Collection Requests (ICRs). The consolidation ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost. These ICRs are scheduled to expire on Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This ICR describes the nature of the information collection and its estimated burden and cost.

DATES:

Additional comments may be submitted on or before October 24, 2008.

ADDRESSES:

Submit your comments, referencing docket ID number EPA-HQ-OPP-2007-0923, to (1) EPA online using http://www.regulations.gov (our preferred method), by mail Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 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:

Cameo Gianne Smoot, Field and External Affairs Division, 7506P, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703-305-5454; fax number: 703-308-5884; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On January 16, 2008 (73 FR 2907), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received one comment and has addressed the comment received in the supporting statement. A copy of the public comment is part of the docket for this action. 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-2007-0923, which is available for online viewing at http://www.regulations.gov, or in person viewing at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is [phone].

Use EPA's electronic docket and comment system at http://www.regulations.gov, to submit or view public comments, 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: Pesticide Data Call-In Program.

ICR Numbers: EPA ICR No. 2288.01, OMB Control No. 2070-new.

ICR Status: This ICR consolidates and renews the information collection activities described in the following currently approved ICRs, which are each scheduled to expire on September 30, 2008: “Data Call-Ins for the Special Review and Registration Review Programs” (EPA ICR No. 0922.07, OMB Control No. 2070-0057); “Data Generation for Pesticide Reregistration” (EPA ICR No. 1504.05, OMB Control No. 2070-0107); and “Data Acquisition for Anticipated Residue and Percent of Crop Treated” (EPA ICR No. 1911.02, OMB Control No. 2070-0164). Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. 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 Federal Register when approved, are listed in 40 CFR part 9, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), every pesticide product must be registered with EPA. An applicant for registration must supply data to demonstrate that the pesticide product will not cause “unreasonable adverse effects” on humans or to the environment. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA must determine, from data supplied by the applicant or registrant, that the level of pesticide residues in food and feed will be safe for human consumption, defined as “a reasonable certainty that no harm” will result from exposures to pesticide residues. Although data is provided with the initial applications, the Agency issues Data Call-Ins (DCIs) when it has determined that more information is necessary to make the necessary decision pursuant to the mandates in FIFRA and FFDCA.

The programs represented in this proposed ICR renewal and consolidation share a common statutory authority, section 3(c)(2)(B) of FIFRA, which authorizes EPA to require pesticide registrants to generate and submit data to the Agency, when such data are needed to maintain an existing registration of a pesticide. EPA's determination that additional data are needed can occur for various reasons, with the following four reasons being the most common:

(1) Reregistration program. Section 4 of FIFRA requires EPA to re-assess the health and safety data for all pesticide active ingredients registered before November 1, 1984, to “reregister” them, i.e., determine whether these “older” pesticides meet the criteria for registration that would be expected of a pesticide being registered today for the first time. FIFRA section 4 directs EPA to use FIFRA section 3(c)(2)(B) authority to obtain the required data. While most Reregistration Eligibility Decisions are expected to be completed by 2008, the Agency may still need to issue DCIs after FY 2008 to close out the program.

(2) Registration review program. Section 3(g) of FIFRA contains provisions to help achieve the goal of reviewing each pesticide every 15 years to assure that the pesticide continues to pose no risk of unreasonable adverse effects on human health or the environment. FIFRA section 3(g) instructs EPA to use the FIFRA section 3(c)(2)(B) authority to obtain the required data.

(3) Special review program. Though rare, EPA may conduct a Special Review if EPA believes that a pesticide poses risks of unreasonable adverse effects on human health or the environment. Section 3(c)(2)(B) of FIFRA provides a means of obtaining any needed data.

(4) Anticipated residue/percent crop treated information. Under section 408 of FFDCA, before a pesticide may be used on food or feed crops, the Agency must establish a tolerance for the pesticide residues on that crop or established an exemption from the requirement to have a tolerance. Section 408(b)(2)(E) and (F) of FFDCA authorize the use of anticipated or actual residue (ARs) data and percent crop treated (PCT) data to establish, modify, maintain, or revoke a tolerance for a pesticide. The FFDCA requires that if AR data are used, data must be reviewed five years after a tolerance is initially established. If PCT data are used, the FFDCA affords EPA the discretion to obtain additional data if any or all of several conditions are met.

The Agency issues DCIs when it has determined that more information is necessary to make decision about pesticides pursuant to the mandates in FIFRA and FFDCA. Agency decisions requiring additional data are based on the data requirements set forth in 40 CFR parts 150 through 180, with the majority of the data requirements captured in 40 CFR part 158.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to range form 59 to 13,636 hours per response, depending on the review program and type of DCI issued. 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. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/Affected Entities: Entities potentially affected by this ICR include pesticide registrants, which may be identified by the North American Industrial Classification System (NAICS) code 32532, pesticide and other agricultural chemical manufacturing.

Frequency of Collection: On Occasion.

Estimated No. of Potential Respondents: 1,643.

Estimated No. of Total Annual Responses: 184.

Estimated Total Annual Burden on Respondents: 262,301 hours.

Estimated Total Annual Costs: $12,506,726.

Changes in the Estimates: The total estimated burden for this consolidated renewal ICR is 262,301 hours, which reflects a net decrease of 106,030 hours per year for this consolidated renewal ICR over the combined burden estimates for the currently approved ICRs. The primary cause of this reduction is the fact that EPA's Reregistration program is ending and that the Agency thus expects to issue fewer reregistration DCIs. The decreased burden associated with the reduction in the number of reregistration DCIs that will be issued is somewhat offset by an expected burden increase related to increase in the number of registration review DCIs that will be issued. These changes are adjustments. The Agency is also including a new category of DCIs for enforcement and unanticipated incidents. Although EPA expects that the issuance of this type of DCI will be rare, the related burdens represent a program change. The Supporting Statement includes detailed analyses of these revised estimates.

Dated: September 15, 2008.

Sara Hisel-McCoy,

Director, Collection Strategies Division.