Agency Information Collection Activities; Proposed Renewal and Consolidation of Several Currently Approved Collections; 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 (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request to renew and consolidate several existing approved Information Collection Requests (ICRs) to the Office of Management and Budget (OMB). Before submitting the consolidated ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of this information collection. The consolidated ICR, entitled: “Pesticide Data Call-In Program” (identified by EPA ICR No. 2288.01 and OMB Control No. 2070-new), will consolidate the following currently approved ICRs: “Data Call-Ins for the Special Review and Registration Review Programs” (identified by EPA ICR No. 0922.07 and OMB Control No. 2070-0057); “Data Generation for Pesticide Reregistration” (identified by EPA ICR No. 1504.05 and OMB Control No. 2070-0107); and “Data Acquisition for Anticipated Residue and Percent of Crop Treated” (identified by EPA ICR No. 1911.02 and OMB Control No. 2070-0164).

DATES:

Comments must be received on or before March 17, 2008.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2007-0923, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2007-0923. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov . Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:

Cameo Smoot, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5454; fax number: (703) 305-5884; e-mail address: smoot.cameo@epa.gov.

SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested in?

Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits comments and information to enable it to:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.

2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

3. Enhance the quality, utility, and clarity of the information to be collected.

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

II. What Should I Consider when I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible and provide specific examples.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the collection activity.

7. Make sure to submit your comments by the deadline identified under DATES.

8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

III. What Do I Need to Know About the PRA?

Under the PRA, an Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information subject to PRA approval 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 preamble of the final rule, are further displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instruments or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in a list at 40 CFR part 9.1.

The PRA defines burden to mean 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 which have subsequently changed; 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.

IV. What ICR Does this Request Apply to?

Title: Pesticide Data Call-In Program.

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

ICR status: This ICR reflects the consolidation of the following currently approved ICRs: “Data Call-Ins for the Special Review and Registration Review Programs” (identified by EPA ICR No. 0922.07 and OMB Control No. 2070-0057); “Data Generation for Pesticide Reregistration” (identified by EPA ICR No. 1504.05 and OMB Control No. 2070-0107); and “Data Acquisition for Anticipated Residue and Percent of Crop Treated” (identified by EPA ICR No. 1911.02 and OMB Control No. 2070-0164). These ICRs are all scheduled to expire on June 30, 2008.

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.

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:

The 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 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, Reregistration Eligibility Decisions are expected to be completed by 2006 for food-use pesticide ingredients and 2008 for non-food use pesticide ingredients, the Agency may still need to issue DCIs after FY 2008 to close out the program

The 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.

The 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.

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.

In addition, EPA is seeking public review and comment on a draft document that describes the methodology it uses to estimate the paperwork burden hours and costs for entities responding to DCIs. EPA's methodology for estimating paperwork burden hours and costs for DCI recipients uses the average cost of the specific test that generates the data requested as the basis for estimating the paperwork burden activities. Once the estimated test costs are established, the Agency estimates the paperwork burden hours and costs as a percentage of the test cost. The document describing the methodology, and a spreadsheet with available test cost estimates listed by name and guideline number, is available in the docket.

Burden statement: The average annual public reporting and recordkeeping burden for this consolidated ICR varies depending on the review program and the specific data being sought through the DCI. The consolidated ICR, a copy of which is available in the docket, provides a detailed explanation of the Agency's estimated burden for issuing DCIs under these review programs, which is only briefly summarized here:

Estimated total number of potential respondents: 1,643.

Frequency of response: On occasion.

Estimated total average number of responses for each respondent: Ranges from 1 to 16.

Estimated total annual burden hours: 240,490 hours.

Estimated total annual costs: $10,974,873. This ICR does not involve any capital investment or maintenance and operational costs.

V. Are There Changes in the Estimates from the Last Approvals?

The consolidation of the currently approved ICRs is expected to result in an overall decrease of 134,274 hours in the total estimated combined respondent burden that is currently approved by OMB. This decrease reflects an anticipated reduction in the number of DCIs EPA plans to issue relating to the reregistration review program, which is expected to come to a close during the approval period for the next ICR. This reduction may be offset to some extent by an anticipated increase in DCIs related to the registration review program. This change is considered to be an adjustment.

VI. What is the Next Step in the Process for this ICR?

EPA will consider the comments received and amend the consolidated ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

If you have any questions about this ICR or the approval process, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

List of Subjects

• Environmental protection
• Reporting and recordkeeping requirements