[Federal Register Volume 77, Number 243 (Tuesday, December 18, 2012)]
[Notices]
[Pages 74845-74846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-30344]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2011-0754; FRL- 9525-5]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request
AGENCY: Environmental Protection Agency.
ACTION: Notice.
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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), 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 extend the current approval for the
Information Collection Request (ICR) entitled ``Pesticide Data Call-In
Program'' and identified as EPA ICR No. 2288.02 and OMB Control No.
2070-0174. The ICR, which is abstracted below, describes the nature of
the information collection and its estimated burden and cost, and is
available in the docket for additional public review and comment.
DATES: Additional comments may be submitted on or before January 17,
2013.
ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OPP-2011-0754, to (1) EPA online using http://www.regulations.gov (our
preferred method), by mail to the OPP Docket, Environmental Protection
Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001, and (2) OMB by mail to the 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 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; email
address: [email protected].
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures under the PRA (44
U.S.C. 3501 et seq.), as prescribed in 5 CFR 1320.12. On October 12,
2012 (77 FR 62232), EPA sought comments on this ICR pursuant to 5 CFR
1320.8(d). Given the nature of this request, EPA did not consider new
public comments. As required by the PRA, EPA is hereby soliciting
additional comments on this ICR, which 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-2011-0754, which is available for online viewing at
http://www.regulations.gov. Additional instructions on commenting or
visiting the docket, along with more information about dockets
generally, is available at http://www.epa.gov/dockets.
Title: Pesticide Data Call-In Program.
ICR numbers: EPA ICR No. 2288.02, OMB Control No. 2070-0174.
ICR Status: EPA is requesting a short renewal of the currently
approved ICR. The submitted ICR package is unchanged from that which is
currently approved. This extension will provide additional time to
allow EPA to finish restructuring the ICR and related improvements to
the electronic forms and instructions, as well as to consult with
stakeholders and OMB on those changes and the corresponding adjustments
to the burden estimates. This extension is necessary because the ICR
covers ongoing activities that are required to support the statutorily
mandated pesticide reviews.
The ICR, which is abstracted below, describes the nature of the
information collection and its estimated burden and cost. The existing
approval is scheduled to expire on November 30, 2012. 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
[[Page 74846]]
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 first time. FIFRA section 4 directs EPA to use FIFRA
section 3(c)(2)(B) authority to obtain the required data. Although the
Reregistration Eligibility Decisions are complete, the Agency may still
need to issue DCIs 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 a 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 parts 158 and 161.
Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to range from 59
to 13,636 hours per response, depending on the review program and type
of DCI issued. Burden is defined in 5 CFR 1320.3(b). The ICR provides a
detailed explanation of this estimate, which is only briefly summarized
here:
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: 1643.
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 ICR
is unchanged from that currently approved by OMB.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2012-30344 Filed 12-17-12; 8:45 am]
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