[Federal Register Volume 86, Number 60 (Wednesday, March 31, 2021)]
[Notices]
[Pages 16718-16720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06608]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2020-0693; FRL-10021-09]


Agency Information Collection Activities; Proposed Renewal of an 
Existing Collection and Request for Comment; Pesticide Data-Call-In 
Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this 
document announces the availability of and solicits public comment on 
an Information Collection Request (ICR) that EPA is planning to submit 
to the Office of Management and Budget (OMB). The ICR, entitled 
``Pesticide Data-Call-In Program'' and identified by EPA ICR No. 
2288.04 and OMB Control No. 2070-0174, represents the renewal of an 
existing ICR that is scheduled to expire on November 30, 2021. Before 
submitting the ICR to OMB for review and approval under the PRA, EPA is 
soliciting public comments on specific

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aspects of the proposed information collection that is summarized in 
this document. The ICR and accompanying material are available in the 
docket for public review and comment.

DATES: Comments must be submitted on or before June 1, 2021.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2020-0693, by using the Federal eRulemaking 
Portal at 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Carolyn Siu, Mission Support Division, 
Office of Program Support, (P75601), Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 
(703) 347-1249; email address: [email protected].

SUPPLEMENTARY INFORMATION:

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.
    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 information collection activity or ICR does this action apply 
to?

    Title: Pesticide Data-Call-In Program.
    ICR number: EPA ICR No. 2288.04.
    OMB control number: OMB Control No. 2070-0174.
    ICR status: This ICR is currently scheduled to expire on November 
30, 2021. 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 covers the information collection activities 
associated with the issuance of data-call-ins (DCIs) under section 
3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA), 7 U.S.C. 136 et seq. EPA regulates the use of pesticides under 
the authority of two federal statutes: FIFRA and the Federal Food, Drug 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a. In general, before 
manufacturers can sell pesticides in the United States, EPA must 
evaluate the pesticides thoroughly to ensure that they meet federal 
safety standards to protect human health and the environment. EPA 
grants a ``registration'' or license that permits a pesticide's 
distribution, sale, and use only after the company meets the scientific 
and regulatory requirements.
    In evaluating a pesticide registration application, EPA assesses a 
wide variety of potential human health and environmental effects 
associated with the use of the product. Applicants, or potential 
registrants, must generate or provide the scientific data necessary to 
address concerns pertaining to the identity, composition, potential 
adverse effects, and environmental fate of each pesticide. The data 
allow EPA to evaluate whether a pesticide has the potential to cause 
harmful effects on certain non-target organisms and endangered species 
(including humans, wildlife, and plants) and on surface water or ground 
water.
    Through a rigorous scientific and public process, EPA specifies the 
kinds of data and information necessary to make regulatory judgments 
about the risks and benefits of pesticide products under FIFRA sections 
3, 4 and 5, as well as the data and information needed to determine the 
safety of pesticide chemical residues under FFDCA section 408. The 
regulations in 40 CFR part 158 describe the minimum data and 
information EPA typically requires to support an application for 
pesticide registration or amendment; support the reregistration of a 
pesticide product; support the maintenance of a pesticide registration 
by means of the data call-in process (e.g., as used in the registration 
review program); or establish or maintain a tolerance or exemption from 
the requirements of a tolerance for a pesticide chemical residue.
    As described in 40 CFR 158.30, however, FIFRA provides EPA with 
flexibility to require, or not require, data and information for the 
purposes of making regulatory judgments for individual pesticide 
products, thereby allowing for the data required to be modified on an 
individual basis to fully characterize the use and properties, 
characteristics, or effects of specific pesticide products under 
review. The Agency encourages each applicant to consult with EPA to 
discuss the data requirements particular to its product prior to and 
during the registration process. In addition, the Agency cautions 
applicants that the data routinely required by the regulations may not 
be sufficient to permit EPA to evaluate the potential of the product to 
cause unreasonable adverse effects on man or the environment. EPA may, 
therefore, require the submission of additional data or information 
beyond that specified in the regulations if such data or information 
are needed to evaluate a pesticide product as required by FIFRA and 
FFDCA.
    EPA uses the DCIs issued under this ICR to acquire the data that 
has been deemed necessary for the Agency's statutorily mandated review 
of a pesticide's registration, which require it to assess whether the 
continued registration of an existing pesticide causes an unreasonable 
adverse effect on human health or the environment and whether the 
Agency will pursue appropriate regulatory measures. The key program 
areas are described in more detail in this ICR, along with the Agency's 
estimates of the information collection burden and costs associated 
with issuing DCIs under those key program areas.
    Form numbers: EPA For No. 8570-4, 8574-27, 8570-28, 8570-32, 8579-
34,

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8570-35, 8570-36, 8570-37, 6300-3, and 6300-4.
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to range between 
20 and 8,182 hours per response, depending on the details associated 
with the individual DCIs. Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related 
materials, provides a detailed explanation of the collection activities 
and the burden estimate that is only briefly summarized here:
    Respondents/affected entities: Entities potentially affected by 
this ICR are pesticide registrants and are identified by the North 
American Industrial Classification System (NAICS) code 325320, 
Pesticide and Other Agricultural Chemical Manufacturing.
    Respondent's obligation to respond: Mandatory under FIFRA section 
3(c)(2)(B).
    Estimated total number of potential respondents: 122.
    Frequency of response: On occasion.
    Estimated total annual burden hours: 1,091,617 hours.
    Estimated total annual cost: $84,846,448.

III. Are there changes in the estimates from the last approval?

    There is an increase of 465,948 hours in the total estimated 
respondent burden compared with that identified in the ICR that was 
approved by OMB. This increase reflects EPA's correction of a clerical 
error associated with the approved hours entered into the tracking 
system (causing a burden of 58,206 hours to be approved rather than the 
625,669 burden hours requested in the submitted ICR), and an increase 
in the estimated DCIs issued over the next three years from 663 to 802 
that will require data generation thus raising the average of DCIs 
issued annually from 221 to 267. Other factors include the addition of 
high-test costs for certain DCIs, and an increase in non-government 
wage rates. This is increase qualifies as an adjustment.
    In addition, OMB has requested that EPA move towards using the 18-
question format for ICR Supporting Statements used by other federal 
agencies and departments and is based on the submission instructions 
established by OMB in 1995, replacing the alternate format developed by 
EPA and OMB prior to 1995. EPA intends to update this Supporting 
Statement during the comment period to reflect the 18-question format, 
and has included the questions in an attachment to this Supporting 
Statement. In doing so, the Agency does not expect the change in format 
to result in substantive changes to the information collection 
activities or related estimated burden and costs.

    Authority: 44 U.S.C. 3501 et seq.

    Dated: March 25, 2021.
Michal Freedhoff,
Acting Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2021-06608 Filed 3-30-21; 8:45 am]
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