Document ID: EPA-HQ-OPP-2006-0860-0001
Agency: epa
Document Type: Notice
Title: 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
Posted Date: 2007-03-14T04:00Z

[Federal Register: March 14, 2007 (Volume 72, Number 49)]
[Notices]               
[Page 11862-11864]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14mr07-45]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0860; FRL-8115-3]

 
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.

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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 (703) 305-5805.
    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

[[Page 11863]]

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 (703) 305-5805.

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: (703) 308-9072; fax number: (703) 305-5884; e-
mail address: hogue.joe@epa.gov.

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

[[Page 11864]]

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.
[FR Doc. E7-4529 Filed 3-13-07; 8:45 am]

BILLING CODE 6560-50-S