Document ID: EPA-HQ-OPP-2010-0281-0001
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting
Posted Date: 2010-05-05T04:00Z

[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]               
[Page 24690-24692]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my10-77]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0281; FRL-8821-1]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Plant-Incorporated Protectants; CBI Substantiation and 
Adverse Effects Reporting; EPA ICR No. 1693.06, 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. 1693.06 and 
OMB Control No. 2070-0142, is scheduled to expire on January 31, 2011. 
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 July 6, 2010.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2010-0281, 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 Facility'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-
2010-0281. 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

[[Page 24691]]

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: Scott Drewes, Field and External 
Affairs Division (7506P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 347-0107; fax number: (703) 305-5884; e-
mail address: drewes.scott@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 Information Collection Activity or ICR Does This Action Apply 
to?

    Affected entities: Entities potentially affected by this ICR 
include producers and importers of plant-incorporated protectants 
(PIPs). The North American Industrial Classification System (NAICS) 
codes for respondents under this ICR include: Pesticide and other 
agricultural chemical manufacturing (NAICS code 325320), biological 
products (except diagnostic) manufacturing (NAICS code 325414), farm 
supplies wholesalers (NAICS code 422910), flower, nursery stock, and 
florists's suppliers (NAICS code 422930), research and development in 
the physical, engineering, and life sciences (NAICS code 541710), and 
colleges, universities, and professional schools (NAICS code 611310).
    Title: Plant-Incorporated Protectants; CBI Substantiation and 
Adverse Effects Reporting.
    ICR numbers: EPA ICR No. 1693.06, OMB Control No. 2070-0142.
    ICR status: This ICR is currently scheduled to expire on January 
31, 2011. 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 Code of Federal Regulations (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 
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: This ICR addresses the two information collection 
requirements described in regulations pertaining to pesticidal 
substances that are produced by plants (PIPs) and which are codified in 
40 CFR part 174. A PIP is defined 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.'' Many, but 
not all, PIPs are exempt from registration requirements under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 
Registrants sometimes include in a submission to EPA for registration 
of a PIP information that they claim to be CBI. CBI is protected by 
FIFRA and generally cannot be released to the public. Under 40 CFR part 
174, whenever a registrant claims that information submitted to EPA in 
support of a registration application for PIPs contains CBI, the 
registrant must substantiate such claims when they are made, rather 
than provide it later upon request by EPA. In addition, manufacturers 
of PIPs that are otherwise exempted from the requirements of 
registration must report adverse effects of the PIP 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.
    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

[[Page 24692]]

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: 18.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 
One for each registration application, experimental use permit, or 
reporting of adverse effects.
    Estimated total annual burden hours: 389 hours.
    Estimated total annual costs: $26,875.00. This includes an annual 
cost of $26,721 for CBI substantiations and $154 for adverse effects 
reporting.

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

    There is an increase of 86 hours in the total estimated respondent 
burden compared with that identified in the ICR currently approved by 
OMB. This increase reflects an increase in the number of PIP 
applications during the last 2 years. EPA expects that this higher 
level of activity will continue. 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: April 27, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2010-10413 Filed 5-4-10; 8:45 am]
BILLING CODE 6560-50-S