[Federal Register Volume 73, Number 186 (Wednesday, September 24, 2008)]
[Notices]
[Pages 55072-55073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-22493]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0923; FRL-8719-3]


Agency Information Collection Activities; Submission to OMB for 
Review and Approval; Comment Request; Pesticide Data Call-In Program; 
EPA ICR No. 2288.01, OMB Control No. 2070--New

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 
et seq.), this document announces that an Information Collection 
Request (ICR) has been forwarded to the Office of Management and Budget 
(OMB) for review and approval. This is a request to renew and 
consolidate three existing approved Information Collection Requests 
(ICRs). The consolidation ICR, which is abstracted below, describes the 
nature of the information collection and its estimated burden and cost. 
These ICRs are scheduled to expire on Under OMB regulations, the Agency 
may continue to conduct or sponsor the collection of information while 
this submission is pending at OMB. This ICR describes the nature of the 
information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before October 24, 
2008.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OPP-2007-0923, to (1) EPA online using http://www.regulations.gov (our 
preferred method), by mail Office of Pesticide Programs (OPP) 
Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB by mail to: 
Office of Information and Regulatory Affairs, Office of Management and 
Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., 
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Cameo Gianne Smoot, Field and External 
Affairs Division, 7506P, Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: 703-305-5454; fax number: 703-308-5884; e-mail 
address: <a href="/cdn-cgi/l/email-protection#6417090b0b104a070509010b240114054a030b12"><span class="__cf_email__" data-cfemail="1b687674746f35787a767e745b7e6b7a357c746d">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB 
for review and approval according to the procedures prescribed in 5 CFR 
1320.12. On January 16, 2008 (73 FR 2907), EPA sought comments on this 
ICR pursuant to 5 CFR 1320.8(d). EPA received one comment and has 
addressed the comment received in the supporting statement. A copy of 
the public comment is part of the docket for this action. Any 
additional comments on this ICR should be submitted to EPA and OMB 
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID 
No. EPA-HQ-OPP-2007-0923, which is available for online viewing at 
http://www.regulations.gov, or in person viewing 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.
    Use EPA's electronic docket and comment system at http://www.regulations.gov, to submit or view public comments, access the 
index listing of the contents of the docket, and to access those 
documents in the docket that are available electronically. Once in the 
system, select ``docket search,'' then key in the docket ID number 
identified above. Please note that EPA's policy is that public 
comments, whether submitted electronically or in paper, will be made 
available for public viewing at http://www.regulations.gov as EPA 
receives them and without change, unless the comment contains 
copyrighted material, Confidential Business Information (CBI), or other 
information whose public disclosure is restricted by statute. For 
further information about the electronic docket, go to http://www.regulations.gov.
    Title: Pesticide Data Call-In Program.
    ICR Numbers: EPA ICR No. 2288.01, OMB Control No. 2070-new.
    ICR Status: This ICR consolidates and renews the information 
collection activities described in the following currently approved 
ICRs, which are each scheduled to expire on September 30, 2008: ``Data 
Call-Ins for the Special Review and Registration Review Programs'' (EPA 
ICR No. 0922.07, OMB Control No. 2070-0057); ``Data Generation for 
Pesticide Reregistration'' (EPA ICR No. 1504.05, OMB Control No. 2070-
0107); and ``Data Acquisition for Anticipated Residue and Percent of 
Crop Treated'' (EPA ICR No. 1911.02, OMB Control No. 2070-0164). Under 
OMB regulations, the Agency may continue to conduct or sponsor the 
collection of information while this submission is pending at OMB. 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: 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:
    (1) 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 ``reregister'' them, i.e., 
determine whether these ``older'' pesticides meet the criteria for 
registration that would be expected of a pesticide being registered 
today for the

[[Page 55073]]

first time. FIFRA section 4 directs EPA to use FIFRA section 3(c)(2)(B) 
authority to obtain the required data. While most Reregistration 
Eligibility Decisions are expected to be completed by 2008, the Agency 
may still need to issue DCIs after FY 2008 to close out the program.
    (2) 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.
    (3) 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.
    (4) 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.
    Burden Statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to range form 59 
to 13,636 hours per response, depending on the review program and type 
of DCI issued. 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; 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.
    Respondents/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.
    Frequency of Collection: On Occasion.
    Estimated No. of Potential Respondents: 1,643.
    Estimated No. of Total Annual Responses: 184.
    Estimated Total Annual Burden on Respondents: 262,301 hours.
    Estimated Total Annual Costs: $12,506,726.
    Changes in the Estimates: The total estimated burden for this 
consolidated renewal ICR is 262,301 hours, which reflects a net 
decrease of 106,030 hours per year for this consolidated renewal ICR 
over the combined burden estimates for the currently approved ICRs. The 
primary cause of this reduction is the fact that EPA's Reregistration 
program is ending and that the Agency thus expects to issue fewer 
reregistration DCIs. The decreased burden associated with the reduction 
in the number of reregistration DCIs that will be issued is somewhat 
offset by an expected burden increase related to increase in the number 
of registration review DCIs that will be issued. These changes are 
adjustments. The Agency is also including a new category of DCIs for 
enforcement and unanticipated incidents. Although EPA expects that the 
issuance of this type of DCI will be rare, the related burdens 
represent a program change. The Supporting Statement includes detailed 
analyses of these revised estimates.

    Dated: September 15, 2008.
Sara Hisel-McCoy,
 Director, Collection Strategies Division.
[FR Doc. E8-22493 Filed 9-23-08; 8:45 am]
BILLING CODE 6560-50-P


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