Notice2025-05866
Pesticide Registration Notice 2025-1; Revised Procedures for Citing Data To Support Pesticide Registrations (EPA Forms No. 8570-34 and 8570-35); Notice of Availability
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Published
April 4, 2025
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or Agency) is announcing the availability of Pesticide Registration Notice (PR Notice) 2025-1, entitled "Revised Procedures for Citing Data to Support Pesticide Registrations (EPA Forms No. 8570-34 and 8570-35)." PR Notices are issued by the Office of Pesticide Programs (OPP) to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. This PR Notice supersedes PR Notice 98-5, entitled "New forms for the Certification with Respect to Citation of Data" dated June 12, 1998. The revised procedures eliminate the requirement to submit two paper versions of the completed data matrix form and establishes electronic online submissions. EPA anticipates that these changes will reduce burden for the registrants and the Agency.
Full Text
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<title>Federal Register, Volume 90 Issue 64 (Friday, April 4, 2025)</title>
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[Federal Register Volume 90, Number 64 (Friday, April 4, 2025)]
[Notices]
[Pages 14835-14837]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-05866]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2023-0398; FRL-8944-02-OCSPP]
Pesticide Registration Notice 2025-1; Revised Procedures for
Citing Data To Support Pesticide Registrations (EPA Forms No. 8570-34
and 8570-35); Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA or Agency) is
announcing the availability of Pesticide Registration Notice (PR
Notice) 2025-1, entitled ``Revised Procedures for Citing Data to
Support Pesticide Registrations (EPA Forms No. 8570-34 and 8570-35).''
PR Notices are issued by the Office of Pesticide Programs (OPP) to
inform pesticide registrants and other interested persons about
important policies, procedures, and registration related decisions, and
serve to provide guidance to pesticide registrants and OPP personnel.
This PR Notice supersedes PR Notice 98-5, entitled ``New forms for the
Certification with Respect to Citation of Data'' dated June 12, 1998.
The revised procedures eliminate the requirement to submit two paper
versions of the completed data matrix form and establishes electronic
online submissions. EPA anticipates that these changes will reduce
burden for the registrants and the Agency.
DATES: PR Notice 2025-1 is effective upon signature.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2023-0398, is available online at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional instructions for visiting the
docket, along with more information about dockets generally, is
available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: Earl Ingram, Office of Chemical Safety
and Pollution Prevention (7603M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 566-1381; email address: <a href="/cdn-cgi/l/email-protection#3b52555c495a56155e5a49577b5e4b5a155c544d"><span class="__cf_email__" data-cfemail="21484f4653404c0f4440534d614451400f464e57">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this
proposed action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
Pesticide registration activities are governed by the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq.
C. What action is the Agency taking?
EPA is announcing the availability of PR Notice 2025-1, entitled
``Revised
[[Page 14836]]
Procedures for Citing Data to Support Pesticide Registrations (EPA
Forms No. 8570-34 and 8570-35).'' PR Notices are issued by the Office
of Pesticide Programs (OPP) to inform pesticide registrants and other
interested persons about important policies, procedures, and
registration related decisions, and serve to provide guidance to
pesticide registrants and OPP personnel.
This PR Notice provides updated guidance to registrants and
applicants (both of which are referred to in this notice as
``registrants'') concerning their submission of the forms used for
citing data to support pesticide registrations. This PR Notice will
supersede PR Notice 98-5, entitled ``New forms for the Certification
with Respect to Citation of Data'' dated June 12, 1998, that announced
the availability of these forms to use for citation of data to support
pesticide registrations, which were newly established in 1998 to
streamline the forms previously used. With this PR Notice, OPP is
revising the procedures established in 1998. Specifically, OPP is
eliminating the instruction in PR Notice 98-5 that registrants submit
two versions of EPA Form 8570-35 (``Data Matrix''), i.e., one the
``Internal Agency Use Copy'' and the other the ``Public File Copy''.
Consistent with federal mandates that direct agencies to adopt
electronic submissions, OPP is also eliminating the instruction to use
paper submissions as described in PR Notice 98-5 because these forms
can be completed and submitted electronically.
Pursuant to existing regulations none of the information provided
on EPA Form No. 8570-35 is confidential. EPA regulations at 40 CFR
152.119(c) require that, when requested, the Agency provides the form
to the public for inspection after a product is registered. The
information in the data matrix form is specified by EPA regulations at
40 CFR 152.119(b):
``Materials that will be publicly available include an
applicant's list of data requirements, the method used by the
applicant to demonstrate compliance for each data requirement, and
the applicant's citations of specific studies in the Agency's
possession if applicable.''
CBI claims for information submitted under EPA's data requirements
in 40 CFR part 158 is strictly limited in 40 CFR 158.33 to
manufacturing or quality control processes, the details of any methods
for testing, detecting, or measuring the quantity of any deliberately
added inert ingredient of a pesticide, and the identity or percentage
quantity of any deliberately added inert ingredient of a pesticide,
pursuant to FIFRA section 10(d)(1) (A) through (C). None of this
information is reported in the data matrix form.
In addition, OPP is eliminating the instruction to use paper
submissions as described in PR Notice 98-5 because these forms can be
completed and submitted electronically. This PR Notice provides updated
instructions for completing and submitting these forms electronically
through the Pesticide Submission Portal (PSP) that OPP established to
allow registrants to create and submit packages electronically in lieu
of submitting multiple paper copies. The PSP is accessed through the
EPA's Central Data Exchange (CDX) Network (<a href="https://cdx.epa.gov/">https://cdx.epa.gov/</a>), which
is a web-based system used for various electronic environmental data
submissions to EPA.
The changes in procedure presented in this PR Notice are necessary
updates to reflect current operations established to help reduce the
burden associated with completing, submitting and processing these
forms for both applicants and the Agency, as well as to provide
improved efficiencies for providing public access to the information
without the extra burden associated with the use of formal requests for
the additional information contained in the ``Internal Agency Use
Copy'' of EPA Form 8570-35 (``Data Matrix''). In 2024, OPP received a
total of 3,309 Data Matrices. The current process for submitting Data
Matrices requires respondents to fill out and submit a secondary copy
of EPA Form 8570-34. According to the Form's PRA Burden statement it
takes anywhere between 0.25 to 1.25 hours to fill out the form. In
2024, the total burden sum of all respondents was a total range of
1,654.5 to 8,273 hours to fill out and submit the forms. With this PRN,
respondents will only need to submit just one form instead of two,
halving the total sum burden by 50% between 827.25 and 4,136.5 hours.
II. Background
In the Federal Register of June 10, 2024 (89 FR 48893; FRL-8944-01-
OCSPP), EPA solicited public comments on the draft PR Notice. EPA
received two public comments: Bayer CropScience (Bayer) provided
comments that are addressed in this unit. The other comment was not
relevant to this PR Notice, so EPA is not providing a specific response
to that comment.
Comment: Bayer requested clarity as to how the Agency plans to
administer the update of data matrices in existing registration jackets
and asked if there will there be a need for registrants to provide
updated data matrices.
Response: There is no need for registrants to provide updated data
matrices. This PR applies only to data matrices going forward. The
existing data matrices will not be considered obsolete but will be used
by OPP staff as needed.
Comment: Bayer asked why EPA previously required a redacted form
when we claim there is no CBI on the form.
Response: There is no historical evidence for why this was done;
however, it led to confusion as registrants thought the material on the
form might be CBI. Since the Agency does not now believe that there is
a need for separate internal use and public file copies of the data
matrix, EPA is now clarifying this to prevent continued confusion.
Comment: Bayer requested that we be more careful with use of the
terms ``registrant'' and ``applicant'' and revise the PR Notice to
replace ``registrant'' with ``applicant.''
Response: The FR notice and the PR notice expressly use the term
``registrant'' to cover both registrants and applicants.
Comment: Bayer requested clearer language on page 3 of the proposed
PR Notice to indicate whether both the Data Matrix and Certification
with Respect to Citation of Data forms need to be submitted
electronically.
Response: In response to this comment, EPA edited the language on
page 3 to clarify that both forms will now be submitted electronically.
Comment: Bayer commented that they believe the Agency has
misinterpreted what qualifies for CBI claims, with EPA referencing only
the regulations implemented under 40 CFR 158.33 related to
manufacturing or quality controls processes and inert ingredients.
Bayer stated the following sections should also qualify for protection
as confidential: (1) Information submitted in connection with an
application for tolerance or exemption to the same extent (40 CFR
158.33(b)(2)); (2) Information related to plant incorporated
protectants substantiated at the time of application (40 CFR
158.33(b)(1)); and (3) Properly designated safety and efficacy
information (40 CFR 158.33(d)(1)).
Response: Bayer misreads 40 CFR 158.33(b)(2)), which merely
provides that information submitted with an application for a tolerance
or exemption is subject to the same confidentiality provisions as
information submitted under FIFRA. Likewise, Bayer misreads 40 CFR
158.33(d)(1), which (in part) subjects allowable CBI claims pertaining
to plant-incorporated protectants to an
[[Page 14837]]
upfront substantiation requirement. Lastly, EPA agrees that under 40
CFR 158 section 158.33(d)(1), information properly designated by the
submitter as FIFRA section 10(d)(1)(A), (B), or (C) may be considered
for confidential protection; however, as discussed in the draft PR
notice, none of the information provided on EPA Form No. 8570-35 is
within the scope of FIFRA section 10(d)(1) (A), (B), or (C).
III. Do PR Notices contain binding requirements?
The PR Notice discussed in this document is intended to provide
guidance to EPA personnel and decision makers and to pesticide
registrants. While the requirements in the statutes and Agency
regulations are binding on EPA and the applicants, this PR Notice is
not binding on either EPA or pesticide registrants, and EPA may depart
from the guidance where circumstances warrant and without prior notice.
Likewise, pesticide registrants may assert that the guidance is not
appropriate generally or not applicable to a specific pesticide or
situation.
IV. Are these forms approved under the Paperwork Reduction Act (PRA)?
According to the PRA, 44 U.S.C. 3501 et seq., an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires approval under the PRA, unless
it has been approved by the Office of Management and Budget (OMB) and
displays a currently valid OMB control number. The information
collection activities associated with EPA Forms 8570-34 and 8570-35 and
the activities described in this PR Notice are already approved by OMB
under the PRA and are contained in the Information Collection Requests
(ICRs) entitled ``Consolidated Pesticide Registration Submission
Portal'' identified as EPA ICR No. 2624.01 and approved under OMB
Control No. 2070-0226; and the ``Pesticide Data Call-in Program''
identified as EPA ICR No. 2288 and approved under OMB Control No. 2070-
0174. For additional information about these ICRs, go to <a href="https://www.reginfo.gov/public/">https://www.reginfo.gov/public/</a> and search on the applicable OMB control
number.
Authority: 7 U.S.C. 136 et seq.
Dated: March 28, 2025.
Edward Messina,
Director, Office of Pesticide Programs.
[FR Doc. 2025-05866 Filed 4-3-25; 8:45 am]
BILLING CODE 6560-50-P
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