Extension without change of a currently approved collection
No
Regular
12/31/2025
Requested
Previously Approved
36 Months From Approved
04/30/2026
385
803
2,551,600
9,746,496
0
0
This ICR covers the information collection (IC) 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). EPA regulates the use of pesticides under the authority of two federal statutes: FIFRA and the Federal Food, Drug and Cosmetic Act (FFDCA) , both as amended by the Food Quality Protection Act (FQPA) of 1996. 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. FIFRA also requires EPA to assess whether the continued registration of a pesticide causes unreasonable adverse effects on human health or the environment and to decide whether to pursue appropriate regulatory measures. EPA uses the DCIs issued under this ICR to acquire the data necessary to support registration review. 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 to human health and the environment, including effects to non-target organisms, federally threatened and endangered (listed) species, and to 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 section 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. 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. This ICR describes how DCIs are issued and presents the Agencyâs estimates of the information collection burden and costs associated with issuing DCIs.
There is a decrease of 7,194,896 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. The number of Maintenance DCIs have increased by 45 and the number of estimated Registration Review DCIs have decreased by 227. The Agency has determined that Resistance Management Plan DCIs, will decrease from 237 to 1. These changes are considered an adjustment.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
2288ss21.docx
2288.21 Attachment F -Transmittal Email.pdf