Notice2024-12626
Pesticides; Draft Pesticide Registration Notice; Revised Procedures for Citing Data To Support Pesticide Registrations (EPA Forms No. 8570-34 and 8570-35); Notice of Availability and Request for Comment
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Published
June 10, 2024
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA or "Agency") is announcing the availability of and seeking public comment on a draft Pesticide Registration Notice (PR Notice) 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 draft PR Notice, will supersede PR Notice 98-5, entitled "New forms for the Certification with Respect to Citation of Data" dated June 12, 1998. The Agency is eliminating the instructions provided in PR Notice 98-5 that required registrants to submit two versions of EPA Form No. 8570-35 ("Data Matrix"), and the use of paper submissions. The changes in procedure 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 procedures to request additional information.
Full Text
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<title>Federal Register, Volume 89 Issue 112 (Monday, June 10, 2024)</title>
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[Federal Register Volume 89, Number 112 (Monday, June 10, 2024)]
[Notices]
[Pages 48893-48894]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12626]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2023-0398; FRL-8944-01-OCSPP]
Pesticides; Draft Pesticide Registration Notice; Revised
Procedures for Citing Data To Support Pesticide Registrations (EPA
Forms No. 8570-34 and 8570-35); Notice of Availability and Request for
Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA or ``Agency'') is
announcing the availability of and seeking public comment on a draft
Pesticide Registration Notice (PR Notice) 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 draft PR Notice, will supersede PR Notice 98-5,
entitled ``New forms for the Certification with Respect to Citation of
Data'' dated June 12, 1998. The Agency is eliminating the instructions
provided in PR Notice 98-5 that required registrants to submit two
versions of EPA Form No. 8570-35 (``Data Matrix''), and the use of
paper submissions. The changes in procedure 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 procedures to request
additional information.
DATES: Comments must be received on or before July 10, 2024.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0398, through the <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions for submitting
comments. Do not submit electronically any information you consider to
be CBI or other information whose disclosure is restricted by statute.
Additional instructions on commenting or 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#f69f989184979bd89397849ab6938697d8919980"><span class="__cf_email__" data-cfemail="5f3631382d3e32713a3e2d331f3a2f3e71383029">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
This action is directed to the general public, although this action
may be of particular interest to those persons who are required to
submit data in support of pesticide registrations under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other
entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
II. What is the Agency's authority for taking this action?
Pesticide registration activities are governed by FIFRA, 7 U.S.C.
136 et seq.
III. What guidance does this PR Notice provide?
This draft PR Notice provides updated guidance to registrants and
applicants (hereinafter ``registrants'') concerning their submission of
the forms used for citing data to support pesticide registrations. The
forms themselves that are currently in use are not being changed. 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.
In addition, EPA has determined that 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. Because none of the
information on EPA Form No. 8570-35 is CBI, the Agency is able to
release the form in response to a Freedom of Information Act (FOIA)
request.
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 draft 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'').
IV. Do PR Notices contain binding requirements?
The draft 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
[[Page 48894]]
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.
V. 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, use the link <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: June 4, 2024.
Edward Messina,
Director, Office of Pesticide Programs.
[FR Doc. 2024-12626 Filed 6-7-24; 8:45 am]
BILLING CODE 6560-50-P
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