[Federal Register Volume 77, Number 198 (Friday, October 12, 2012)]
[Pages 62232-62234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-25145]



[EPA-HQ-OPP-2011-0754; FRL-9365-5]

Agency Information Collection Activities; Proposed Renewal of an 
Approved Collection; Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.


SUMMARY: In compliance with the Paperwork Reduction Act (PRA), 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). The ICR, entitled: ``Pesticide Data Call-
In Program'' and identified by EPA ICR No. 2288.02 and OMB Control No. 
2070-0174, is currently scheduled to expire on November 30, 2012. 
Before submitting the ICR to OMB for review and approval, EPA is 
soliciting comments on specific aspects of the ICR.

DATES: Comments must be received on or before December 11, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2011-0754, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

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-
0001; telephone number: (703) 305-5454; fax number: (703) 308-5884; 
email address: smoot.cameo@epa.gov.


I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), 
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.

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    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 
    1. Explain your views as clearly as possible and provide specific 
    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 

    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.
    Title: Pesticide Data Call-In Program.
    ICR number: EPA ICR No. 2288.01.
    OMB control number: OMB Control No. 2070-0174.
    ICR status: This ICR is currently scheduled to expire on November 
30, 2012. EPA will be seeking a short renewal of the currently approved 
ICR. This short renewal will provide additional time to allow EPA to 
finish working to restructure the ICR, improve the electronic forms and 
instructions, and consult with stakeholders and OMB on those ICR 
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.
    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: 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 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 establish 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 
parts 158 and 161.
    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 is defined in 5 CFR 1320.3(b). The ICR provides a 
detailed explanation of this estimate, which is only briefly summarized 
    Frequency of collection: On occasion.
    Estimated number of potential respondents: 1,643.
    Estimated number of total annual responses: 184.
    Estimated total annual burden on respondents: 262,301 hours.

[[Page 62234]]

    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.

IV. What is the next step in the process for this ICR?

    EPA intends to submit the ICR to OMB for review and a short term 
approval (i.e., 12 months) pursuant to 5 CFR 1320.12. EPA will issue 
another Federal Register document 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 

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: October 4, 2012.
 James Jones,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
[FR Doc. 2012-25145 Filed 10-11-12; 8:45 am]