Agency Information Collection Activities; Submission to OMB; Comment Request; EPA ICR No. 1504.05; OMB Control No. 2070-0107; Data Generation for Pesticide Reregistration

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: Data Generation for Pesticide Reregistration; EPA ICR No. 1504.05; OMB Control No. 2070-0107. 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 October 28, 2004.

FOR FURTHER INFORMATION CONTACT:

Nathanael Martin, Field and External Affairs Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-6475; fax number: (703) 305-5884; e-mail address: martin.nathanael@epa.gov.

ADDRESSES:

Submit your comments, referencing docket ID number OPP-2004-0110, 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 June 2, 2004 (69 FR 31095). EPA received one public comment on this ICR during the 60-day comment period and has addressed it in the ICR.

EPA has established a public docket for this ICR under Docket ID No. OPP-2004-0110, 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 http://www.epa.gov/edocket .

ICR Title: Data Generation for Pesticide Reregistration.

ICR Status: This is a request for extension of an existing approved collection that is currently scheduled to expire on September 30, 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: This information collection activity enables EPA to fulfill the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended in 1988, which mandates that EPA reregister pesticides originally registered before November 1, 1984. Section 4 of FIFRA, as amended, establishes a process and a schedule for the development of the information EPA needs (e.g., various scientific studies related to certain pesticides) to assess whether the reregistration of a pesticide or pesticide product would cause an unreasonable adverse effect on human health or the environment. Pesticide registrants seeking reregistration must generate and report the required data according to specified time tables.

This information collection will also enable EPA to collect certain company data about pesticide registrants that may be needed in order to verify eligibility for certain waivers and exemptions. The information collection allows EPA's Office of Pesticide Programs (OPP) to obtain data needed by OPP scientists to assess and characterize pesticide risks, and for risk managers to determine whether and under what conditions pesticides may be reregistered and to reassess existing tolerances as required by Section 408 of the Federal Food Drug and Cosmetic Act to ensure that they meet the standards established by law. Data collected may consist of toxicology studies, residue chemistry studies, fish and wildlife studies, environmental fate studies, or other data needed to analyze the potential risks associated with pesticide chemicals and products. This collection also supports the Agency's reassessment of food tolerances associated with reregistration. Responses to this information collection activity are generally required in order to maintain a benefit (i.e., in order to reregister certain pesticides).

Burden Statement: The annual “respondent” burden for this ICR is estimated to average about 596 hours per response to an EPA request for confirmatory data, 2,560 hours per response for an EPA request for product-specific data, 596 hours per response for any voluntarily submitted data considered to be “low burden” and 3,587 hours per response for any voluntarily submitted data considered to be “high burden.” 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 following is a summary of the burden estimates taken from the ICR:

Respondents/affected entities: Pesticide and other agricultural chemical manufacturing (NAICS 325320), e.g., Businesses engaged in the manufacture of pesticides.

Estimated total number of potential respondents: 1,565.

Frequency of response: As needed.

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

Estimated total annual burden hours: 275,063.

Estimated total annual labor costs: $24,529,295.

Changes in the ICR since the last approval: The estimated annual burden for this ICR has increased by 184,338 hours (from 90,725 hours to 275,063 hours) related primarily to an increase of the average number of chemicals for which EPA will annually request certain data before they may be reregistered. This increase is an adjustment and is explained in detail in the ICR.