E6-17763. Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Unreasonable Adverse Effects Information Under FIFRA Section 6(a)(2); EPA ICR No. 1204.10, OMB Control No. 2070-0039

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 an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR, entitled: “Submission of Unreasonable Adverse Effects Information Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 6(a)(2)” and identified by EPA ICR No. 1204.10 and OMB Control No.2070-0039, is scheduled to expire on May 31, 2007. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection.

DATES:

Comments must be received on or before December 26, 2006.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2006-0616, 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 Building), 2777 S. Crystal Drive, 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 telephone number is [phone].

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2006-0616. 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 Federal 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. 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 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].

FOR FURTHER INFORMATION CONTACT:

Kathryn Boyle, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone] e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested In?

Pursuant to section 3506(c)(2)(A) of the 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 Information Collection Activity or ICR Does This Action Apply To?

Affected entities: Entities potentially affected by this action are anyone who holds or ever held a registration for a pesticide product issued under FIFRA section 3 or 24(c). The North American Industrial Classification System (NAICS) code is 325320 (Pesticide and Other Agricultural Chemical Manufacturing).

Title: Submission of Unreasonable Adverse Effects Information Under FIFRA Section 6(a)(2).

ICR numbers: EPA ICR No. 1204.10, OMB Control No. 2070-0039.

ICR status: This ICR is currently scheduled to expire on May 31, 2007. 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: Section 6(a)(2) of FIFRA requires pesticide registrants to submit information to the Agency which may be relevant to the balancing of the risks and benefits of a pesticide product. The statute requires the registrant to submit any factual information that it acquires regarding adverse effects associated with its pesticidal products, and it is up to the Agency to determine whether or not that factual information constitutes an unreasonable adverse effect. Responses to this collection are mandatory. The authority for this information collection is section 6(a)(2) of FIFRA. Compliance regulations are contained in 40 CFR part 159. CBI submitted to EPA in response to this information collection is protected from disclosure under FIFRA section 10.

Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 97.3 hours per registrant (respondent). 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 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.

The ICR provides a detailed explanation of this estimate, which is only briefly summarized here:

Estimated total number of potential respondents: 1,720 registrants.

Frequency of response: As needed.

Estimated total average number of responses for each respondent: For submission of studies: Less than 1. For submission of incident reports: 1 to 3, since incidents are usually reported as aggregate statistics.

Estimated total annual burden hours: 167,316 hours.

Estimated total annual costs: $9,809,591. There are no capital expenditures or operation and maintenance costs associated with this information collection activity.

IV. Are There Changes In the Estimates from the Last Approval?

This ICR renewal request reflects an increase of approximately 11,677 burden hours to an annual respondent burden of 167,316 hours at a cost of $9,809,591 (in 2006 dollars). Thus, the costs decreased. The change in burden reflects a number of adjustments. First, for this renewal ICR, there are now fewer registrants of active products (1,720 versus 1,877) and therefore fewer employees to be trained (17,200 versus 18,770) than reflected in the existing ICR.

The hours used to calculate total burden hours and costs are unchanged from the existing ICR. Total burden hour estimates associated with studies are reduced because the estimated number of study submissions is reduced from 325 studies to 240. Burden estimates associated with the number of incident reports, however, are increased because of the increased volume of incident reporting (17%). Overall, considering both the decrease in studies and the increase in incidents, the total burden hours increased minimally from 155,639 to 167,316.

V. What is the Next Step in the Process for This ICR?

EPA will consider the comments received and amend the 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

Dated: October 5, 2006.

James B. Gulliford,

Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.