[Federal Register Volume 83, Number 16 (Wednesday, January 24, 2018)]
[Notices]
[Pages 3344-3345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01269]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2016-0109; FRL-9971-51-OEI]


Information Collection Request Submitted to OMB for Review and 
Approval; Comment Request; Pesticide Data Call-in Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an 
information collection request (ICR), ``Pesticide Data Call-in 
Program'' (EPA ICR No. 2288.03, OMB Control No. 2070-0174) to the 
Office of Management and Budget (OMB) for review and approval in 
accordance with the Paperwork Reduction Act. This is a reinstatement of 
a previously approved ICR. Public comments were previously requested 
via the Federal Register on August 23, 2017 during a 60-day comment 
period. This notice allows for an additional 30 days for public 
comments. A fuller description of the ICR is given below, including its 
estimated burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before February 23, 
2018.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OPP-2016-0109, to (1) EPA online using www.regulations.gov (our 
preferred method), or by mail to: EPA Docket Center, Environmental 
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460, and (2) OMB via email to 
[email protected]. Address comments to OMB Desk Officer for 
EPA.
    EPA's policy is that all comments received will be included in the 
public docket without change including any personal information 
provided, unless the comment includes profanity, threats, information 
claimed to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Cameo Smoot, Field and External 
Affairs Division, (7596P), EPA, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460; telephone number: (703) 305-5454; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in 
detail the information that the EPA will be collecting, are available 
in the public docket for this ICR. The docket can be viewed online at 
www.regulations.gov or in person at the EPA Docket Center, WJC West, 
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone 
number for the Docket Center is 202-566-1744. For additional 
information about EPA's public docket, visit http://www.epa.gov/dockets.
    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). In general, before manufacturers can sell pesticides in the 
United States, EPA must evaluate the pesticides thoroughly to ensure 
that they meet federal safety

[[Page 3345]]

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 that include: Humans; wildlife; 
plants; and 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; 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 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 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 regulatory measures.
    Respondents/affected entities: Pesticide registrants--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 number of respondents: 122 (total).
    Frequency of response: On occasion.
    Total estimated burden: 615,447 hours (per year). Burden is defined 
at 5 CFR 1320.03(b).
    Total estimated cost: $43,792,523 (per year). There are no capital 
investment or maintenance and operational costs associated with this 
collection.
    Changes in the Estimates: There is an increase of 353,146 hours in 
the total estimated respondent burden compared with that identified in 
the last ICR approved by OMB. The burden increase is a cumulative 
result of the program implementing new methodologies to calculate 
respondent burden, the inclusion of a new information collection 
group--consortium participants--to more accurately reflect the 
respondent burden, renaming and recalculating an existing information 
collection group from Enforcement and Unanticipated Incident activities 
to Maintenance DCIs, and the acceleration of the Registration Review 
Program. All of these activities have contributed to the significant 
increase in number of DCIs to be issued (221 versus 45) annually.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018-01269 Filed 1-23-18; 8:45 am]
 BILLING CODE 6560-50-P


