E7-4529. Agency Information Collection Activities; Proposed Collection; Comment Request; Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting; EPA ICR No. 1693.05, OMB Control No. 2070-0142

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: “Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting” and identified by EPA ICR No. 1693.05 and OMB Control No. 2070-0142, is scheduled to expire on October 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 May 14, 2007.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2006-0860, 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-2006-0860. 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 available in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. 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:

Joseph Hogue, 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 producers and importers of plant-incorporated protectants. These entities may be classified under the following North American Industrial Classification System (NAICS) codes:

• Pesticides and other agricultural chemical manufacturing (NAICS code 32532).
• Research and development in the physical, engineering, and life sciences (NAICS code 54171).
• Biological products (except diagnostic) manufacturing (NAICS code 325414).
• Colleges, universities, and professional schools (NAICS code 611310).
• Farm supplies wholesalers (NAICS code 422910).
• Flower, nursery stock, and florists' supplies (wholesalers) (NAICS code 422930).

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

ICR numbers: EPA ICR No. 1693.05, OMB Control No. 2070-0142.

ICR status: This ICR is currently scheduled to expire on October 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: This ICR covers the two information collection related provisions contained in a final rule, which the Agency promulgated on July 19, 2001 (66 FR 37771), that addresses the regulatory status of pesticidal substances that are produced by plants (plant-incorporated protectants). A plant-incorporated protectant is defined in the final rule as “the pesticidal substance that is intended to be produced and used in a living plant and the genetic material necessary for the production of such a substance.” The final rule accomplishes two things: It exempts many, but not all, plant-incorporated protectants from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and it imposes two new requirements on manufacturers of some plant-incorporated protectants.

Registrants sometimes include in a submission to EPA for registration of a plant-incorporated protectant, information that they claim to be CBI. CBI is protected by FIFRA and cannot be released to the public. One provision of the final rule requires registrants that make CBI claims to substantiate such claims when they are made, rather than provide it later upon request by EPA. Submission of this information is required in order to obtain the benefit of prompt registration of a plant-incorporated protectant. Early substantiation of CBI claims will enable the Agency to promptly release information supporting plant-incorporated protectants registration decisions, without delaying registrations.

The other information collection provision of the final rule requires manufacturers of plant-incorporated protectants exempted from the requirements of registration to report adverse effects of the plant-incorporated protectant to the Agency. Such reporting will allow the Agency to determine whether further action is needed to prevent unreasonable adverse effects to the environment. Submission of this information is mandatory.

This ICR, therefore, discusses the paperwork burdens associated with the requirement for registrants to substantiate CBI claims when they are made, and the requirement for manufacturers of plant-incorporated protectants exempted from registration requirements under the final rule to report adverse effects to the Agency within 30 days.

Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 7 hours for an adverse effects report and 21.5 hours for substantiation of a CBI claim, per response. 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: The total number of respondents is estimated to be 14 per year for substantiation of a CBI claim, and only one response for an adverse effects report over the three year period for this ICR renewal.

Frequency of response: On occasion.

Estimated total average number of responses for each respondent: One.

Estimated total annual burden hours: 303 hours.

Estimated total annual costs: $30,853. This is an estimated burden cost of $30,853 with no additional cost for capital investment or maintenance and operational costs.

IV. Are There Changes in the Estimates From the Last Approval?

There is no change in the total estimated respondent burden (303 hours) compared with that identified in the ICR currently approved by OMB. In previous renewal cycles, the Agency only adjusted the labor rates to account for inflation. However, for this renewal, Agency economists have completely re-estimated labor rates, benefits, and overhead costs for both respondents and Agency personnel. This Agency analysis completed in July 2006 resulted in a decrease in estimated labor rates for industry. The new analysis also resulted in management and technical estimated Agency labor rates decreasing and clerical rates increasing. The Agency believes this is a more realistic estimate of the average respondent and Agency costs. Therefore, estimated total annual respondent costs have decreased by $6,693, from $27,572 to $20,879, and annual Agency labor costs have increased by $111, from $9,863 to $9,974. This change is an adjustment.

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: March 6, 2007.

James B. Gulliford,

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