[Federal Register Volume 77, Number 243 (Tuesday, December 18, 2012)]
[Pages 74845-74846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-30344]



[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.


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, 

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 
    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]