Justification for Non-Substantive Change

Request for a Non-Substantive Change

to an Existing Approved Information Collection

(EPA ICR No. 2288.06; OMB Control No. 2070-0174; Pesticide Data Call-in Program and EPA)

I. Introduction

Why is EPA Requesting a Non-Substantive Change?

EPA is requesting a non-substantive change request for the following items:

1. The approved ICRs, entitled “Pesticide Data Call-in Program” account for the Paperwork Reduction Act burden reported as part of the Pesticide Registration (PR) Notice 98-5, guidance for the submission of information to the agency on the Data Matrix and Certification with Respect to Citation of Data forms. The EPA will be publishing a revised PR Notice, which eliminates the use of the “Public File Copy” of Data Matrix Form 8570-35 and will only ask that one version of the Data Matrix be submitted. EPA has also included minor updates to Form 8570-35 itself, including updating the form to the current address and eliminating instructions related to the Public File Copy. See below for a full list of all changes to Form 8570-35. The EPA requests this non-substantive change because this agency action will decrease the use of forms submitted to the EPA.

2. EPA is also requesting a non-substantive change to align the OMB-approved overarching generic (2070-0174) ICR’s three-year burden estimate with the ROCIS table.

II. Description of Non-Substantive Changes

What Information Collection Request (ICR) is EPA changing?

ICR Title:	Pesticide Data Call-in Program (renewal)
ICR Numbers:	EPA ICR No. 2288.05; OMB Control No. 2070-0174

What is the current status of this ICR?

The ICR, Pesticide Data Call-In Program ICR is approved until December 31, 2025.

What are the changes EPA is making for ROCIS?

The burden (hours) in the ROCIS table within the ICR was incorrectly provided as 3,248,832 previously. The correct burden (hours) per the OMB-approved Supporting Statement is 9,746,496, which reflects three-year totals. EPA is therefore requesting a non-substantive change to correct the ROCIS table using the OMB-approved overarching generic ICR’s burden estimate of 9,746,496 hours, and 803 responses for the three-year totals.

What are the changes that EPA is making to this collection of information?

Pesticide Registration Notices (PRNs) are issued by EPA’s Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration related agency decisions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA). PR Notices provide guidance to EPA staff to help ensure consistent agency decision-making, while at the same time do not constrain agency discretion or discourage affected parties from seeking alternatives to agency policy approaches. PR Notice 2003-3 describes the procedures for developing policy guidance documents and explains how the policy guidance documents are used in agency decision-making. Form 8570-35 currently consists of a “Public File Copy” and an “Agency Internal Use Copy.” The forms are identical except the columns for Guideline Reference Number, Guideline Study Name, and MRID Number are blacked out on the “Public File Copy.” Both forms are requested when a pesticide is registered. Neither of the forms contain Confidential Business Information (CBI) and both forms are released under Freedom of Information Act (FOIA) requests. This action will remove the “Public File Copy” since it is redundant under FOIA. Thus, under the new action, only the information under “Agency Internal Use Copy” will be required. The new form will be designated as the “Data Matrix.”

As a guidance document, this document is not binding on either EPA or any outside parties. Non-binding PR Notices are issued by OPP to inform pesticide registrants and other interested persons about important policies, procedures, and general pesticide registration related decisions. In addition to being consistent with EPA’s commitment on being transparent in its decision making for pesticide registrations, providing the guidance in this PR Notice reduces burden and costs for both registrants/applicants and EPA by providing information that facilitates our collective compliance with applicable statutory and regulatory requirements.

Consistent with PR Notice 2003-3, EPA will issue this revised PR Notice in draft for public review and comment, and then issue it in final form.

Did EPA consult with stakeholders about this approach?

EPA has consulted with several pesticide stakeholders such as the Pesticide Registration Improvement Act (PRIA) stakeholder coalition, American Chemistry Council, the Household Consumer Products Association and Croplife.

Will this change impact the annual ICR burden estimate?

For the Data Call-In Program ICR specifically, no, the current ICR annual burden will not change.

As result to the revised PRN, it will not increase the annual ICR burden estimate. This action will not change the scope or content of submissions, nor would it prescribe a format. Rather, this revised guidance provides the option to submit just one version of the Data Matrix instead of two, eliminating the redundancy of submitting two forms containing the same information. Those that choose to submit one form may experience some savings related to materials (paper, ink, etc.).

What is the expected non-paperwork impact of this change?

There is no expected non-paperwork impact of these changes.

How does a singular Data Matrix form help EPA properly perform Agency functions necessary to comply with legal requirements and achieve program objectives?

An individual or entity wanting to obtain a registration for a pesticide product must submit an application package consisting of information relating to the identity and composition of the product, proposed labeling, and supporting data (or compensation for others’ data) for the product, as outlined in 40 CFR part 158. Included in this package is currently an “Internal Use Copy” of the Data Matrix as well as a “Public File Copy,” which is the same form and contains the same information but is partially redacted. The “Internal Use Copy” is made available to the public upon submission of a FOIA request, as it contains no CBI.

EPA also believes this change will decrease confusion. When EPA Form 8570-35 was originally created, the Public File Copy was placed in a binder that was made available for public inspection at the EPA record room. However, once an electronic docket was established, both forms were placed in the docket, and released together upon request. This was both redundant, as both were released at the same time and the Public File Copy was unused by the Agency, and caused confusion among some submitters, creating the mistaken belief that because the Public File Copy was partially redacted, it contained CBI. By eliminating the Public File Copy, EPA will eliminate this redundancy and relieve confusion created by the use of two versions of the Data Matrix.

What changes have been made to the Data Matrix form?

The EPA has updated Form 8750-35 as follows:

• Updated the address on the top of the form,

• Inserted updated Paperwork Reduction Act language,

• Removed language in the form instructions regarding the Public File Copy, and

• Removed language indicating that electronic submissions would not be accepted.