Extension without change of a currently approved collection
No
Regular
12/31/2025
Requested
Previously Approved
36 Months From Approved
12/31/2025
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 Agency’s 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.
$1,709,134
No
No
No
No
No
No
No
Carolyn Siu 202 566-1205
siu.carolyn@epa.gov
No
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