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Federal Register / Vol. 86, No. 60 / Wednesday, March 31, 2021 / Notices
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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 EPAHQOPP20200693, 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 COVID19, 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: siu.carolyn@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. What information is EPA particularly interested in?
Pursuant to PRA section 3506c2A
44 U.S.C. 3506c2A, 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 Agencys 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
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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. 20700174.
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 EPAs 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 datacall-ins DCIs under section 3c2B
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 pesticides 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.

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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 Agencys statutorily mandated review of a pesticides 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 Agencys estimates of the information collection burden and costs associated with issuing DCIs under those key program areas.
Form numbers: EPA For No. 85704, 857427, 857028, 857032, 857934,
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