Notice2021-17660
Electronic Option for Submitting Foreign Purchaser Acknowledgement Statement of Unregistered Pesticides Under the Federal Insecticide, Fungicide and Rodenticide Act; Notice of Availability
Primary source
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Published
August 18, 2021
Issuing agencies
Environmental Protection Agency
Abstract
EPA is announcing the availability of an electronic option for submitting the Foreign Purchaser Acknowledgement Statement (FPAS) for unregistered pesticides as required under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). As an alternative to the hardcopy approach, which is still available, EPA is also now accepting the required notifications electronically using EPA's electronic document submission system, the Central Data Exchange (CDX). Use of CDX to prepare and submit the required notifications to EPA will help streamline and reduce the administrative costs and burdens associated with submitting paper-based statements for both the submitters and the Agency.
Full Text
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<title>Federal Register, Volume 86 Issue 157 (Wednesday, August 18, 2021)</title>
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[Federal Register Volume 86, Number 157 (Wednesday, August 18, 2021)]
[Notices]
[Pages 46246-46248]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-17660]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2021-0424; FRL-8721-01-OCSPP]
Electronic Option for Submitting Foreign Purchaser
Acknowledgement Statement of Unregistered Pesticides Under the Federal
Insecticide, Fungicide and Rodenticide Act; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is announcing the availability of an electronic option for
submitting the Foreign Purchaser Acknowledgement Statement (FPAS) for
unregistered pesticides as required under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). As an alternative to the
hardcopy approach, which is still available, EPA is also now accepting
the required notifications electronically using EPA's electronic
document submission system, the Central Data Exchange (CDX). Use of CDX
to prepare and submit the required notifications to EPA will help
streamline and reduce the administrative costs and burdens associated
with submitting paper-based statements for both the submitters and the
Agency.
DATES: An FPAS may be submitted electronically using CDX as of August
18, 2021.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0424, is available online at
<a href="http://www.regulations.gov">http://www.regulations.gov</a> or in-person at the Office of Pesticide
Program Docket (OPP Docket), Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744.
Please note that due to the public health concerns related to
COVID-19, the EPA/DC and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on the EPA/DC and docket access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT: For technical information contact: Zoe
Emdur, Office of Program Support, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001: Telephone number:
(703) 347 0529; email address: <a href="/cdn-cgi/l/email-protection#6500080110174b1f0a00250015044b020a13"><span class="__cf_email__" data-cfemail="583d353c2d2a7622373d183d2839763f372e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, import, or distribute in commerce chemical substances and
mixtures. The following North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities.
Potentially affected entities may include, but are not limited to the
following:
<bullet> Basic Chemical Manufacturing (NAICS 3251);
<bullet> Resin, Synthetic Rubber, and Artificial and Synthetic
Fibers and Filaments Manufacturing (NAICS 3252);
<bullet> Pesticide, Fertilizer, and Other Agricultural Chemical
Manufacturing (NAICS 3253); and
<bullet> Other Chemical Product and Preparation Manufacturing
(NAICS 3251).
If you have any questions regarding the applicability of this
action to a particular entity, consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.
B. What action is the Agency taking?
The Agency is announcing the availability of an electronic option
for use by those who must submit an FPAS under FIFRA 17(a)(2). EPA is
providing an electronic option as part of the broader Federal
government efforts to move to modern, electronic methods of information
collection, which streamline processes and reduce overall burdens for
all involved.
Currently, an FPAS can only be submitted to the Agency in hardcopy
using regular mail, requiring the Agency to manually scan and process
submissions. The modernization of the FPAS process will allow the
option for users to prepare and submit their notifications to the
Agency electronically using a web-based application. To file
electronically, submitters must use the EPA provided application. To
access the application, users must complete a one-time registration
with EPA's CDX (<a href="https://cdx.epa.gov/">https://cdx.epa.gov/</a>). CDX is the Agency's portal for
submitting information to EPA in a secure online manner. Electronic
submissions of an FPAS will be done via the Pesticide Submission Portal
(``PSP'' or ``Pesticide Portal'') which is
[[Page 46247]]
accessed through EPA's CDX. Registered CDX users will be able to select
``FPAS Submission'' for a dropdown menu and upload one or more
attachments for their submission. When registering, a user will need to
ensure they are registering for the PSP data flow which will provide
them access to the FPAS reporting application. (Note: Users who have
previously registered with CDX are able to add ``PSP'' to their current
registration.) This reporting tool is compatible with Windows, Mac,
Linux, and UNIX based computers, and uses ``Extensible Markup
Language'' (XML) specifications for efficient data transmission across
the internet.
C. What is the Agency's authority for taking this action?
FIFRA section 17(a)(2) and 40 CFR 168.75 require that any person
exporting unregistered pesticides must obtain and submit to EPA a
statement, known as an FPAS, signed by the foreign purchaser prior to
export, acknowledging that the purchaser understands that the pesticide
is not registered for use in and cannot be sold in the United States.
EPA transmits the FPAS notification to the government of the importing
country via per-shipment notifications or annual summary reports.
The exporter is required to send a copy of the purchaser
acknowledgment statement to EPA within 7 days of having shipped the
pesticide, along with a signed statement that the shipment did not
occur prior to receipt of the purchaser acknowledgment statement. In
addition, if the exporter chooses the annual reporting option, he or
she must include a statement that the FPAS is for the first shipment of
a pesticide to a particular purchaser in a specific country, and that
the exporter will report this information annually. Where an exporter
chooses to comply with the annual summary reporting option, a summary
must be sent after the end of the calendar year which lists all
shipments of a particular pesticide shipped to a particular foreign
purchaser. It is not required for the statement to be submitted to EPA
in time to enable EPA to notify the importing country prior to arrival
of the pesticide.
When exporting pesticides that are not registered in the U.S.,
manufacturers must submit a FPAS to EPA either per shipment or on an
annual basis. EPA will then use this information to notify the
Designated National Authority of the importing country. The FPAS must
include the following items:
The name, address, and EPA identification number (i.e., EPA company
number or establishment number), if applicable, of the exporter.
<bullet> The name and address of the foreign purchaser.
<bullet> The identity of the product and the active ingredient(s),
including:
<bullet> The Chemical Abstract Services Registry (CAS) number for
each active ingredient;
<bullet> The chemical nomenclature for each active ingredient as
used by the International Union of Pure and Applied Chemists (IUPAC);
and
<bullet> Other chemical or common names that could help EPA better
identify the product (i.e., EPA's chemical PC code).
<bullet> If known or reasonably ascertainable, the country or
countries of the final destination of the export shipment (i.e., where
the exported pesticide is intended to be used), if different from the
country of the foreign purchaser's address.
<bullet> Signed and dated statement from the foreign purchaser
acknowledging that the product is not registered for use in the United
States and cannot be sold in the United States.
<bullet> The exporter must submit a signed certification affirming
that the export did not occur until the statement signed by the foreign
purchaser was obtained by the exporter.
<bullet> Any foreign purchaser signing a statement in their own
language must have the appropriate English translation accompanying it
when submitted to the EPA.
For electronic reporting, the Government Paperwork Elimination Act
(GPEA) (44 U.S.C. 3504) requires Executive agencies to provide, when
practicable, for the option of the electronic maintenance, submission,
or disclosure of information as a substitute for paper; and the use and
acceptance of electronic signatures.
D. What are the anticipated benefits of CDX reporting and use of PSP?
EPA encourages submitters of an FPAS to adopt the electronic option
as the preferred submission method. Use of the electronic option
reduces the paperwork burden for submitters by reducing the cost and
time required to review, edit, and transmit data to the Agency in a
hardcopy format, as well as the cost to mail that hardcopy to EPA and
to retain required records related to that hardcopy submission. PSP,
the web-based reporting tool, enables efficient data transmittal and
reduces errors with built-in validation procedures. PSP also allows
submitters to share a draft submission within their organization, and
more easily save an electronic copy of that submission for the required
records or future use. The resource and time requirements for EPA to
review and process these export notifications will also be reduced,
including increased efficiencies in communicating with submitters, as
well as the storage and retrieval of submissions.
II. Electronic Reporting Procedures
This unit provides an overview of CDX, PSP, and the FPAS web-based
reporting tool. It also provides instructions for the electronic
process for FPAS notifications. As a reminder, the requirements are set
in the regulations implementing the statutory mandate in FIFRA that
appear in 40 CFR 168.75.
A. What is CDX?
CDX is EPA's point of entry for environmental data submissions to
the Agency. CDX also provides the capability for submitters to access
their data using web services. CDX enables EPA to work with
stakeholders, including governments, regulated industries, and the
public to enable streamlined, electronic submission of data via the
internet. To report under the procedures discussed in this notice,
submitters would register with CDX, select the PSP option, and access
reporting of FPAS. More information about CDX is available online at:
<a href="http://www.epa.gov/cdx/">http://www.epa.gov/cdx/</a>.
B. What is PSP?
PSP is a web-based reporting tool for the submission of forms,
reports, and other documents including FPAS notifications,
electronically to the Agency. The tool is available for use with
Windows, Mac, Linux, and UNIX computer systems, using ``Extensible
Markup Language'' (XML) specifications for efficient data transmission
across the internet. CISS provides user-friendly navigation, works with
CDX to secure online communication, creates a completed Portable
Document Format (PDF) for review prior to submission, and enables data,
reports, and other information to be submitted easily as PDF
attachments, or by other electronic standards, such as XML. As
currently implemented, one or more representatives from each facility
must establish an account with EPA's CDX to prepare, transmit, certify,
and submit forms, reports, and other documents.
C. How will the FPAS be submitted via the internet using CDX?
Once registered with EPA's CDX, submitters of FPAS notifications
will select the PSP Program and use ``FPAS submission'' to prepare a
data file for submission.
[[Page 46248]]
1. Registering with CDX. To submit electronically to EPA via CDX, a
user would register with CDX at: <a href="http://cdx.epa.gov/epa_home.asp">http://cdx.epa.gov/epa_home.asp</a>. CDX
registration enables EPA to authenticate user identities and verify
user authorizations.
To register in CDX, the CDX registrant (also referred to as
``Electronic Signature Holder'' or ``Public/Private Key Holder'') would
agree to the Terms and Conditions, provide information about the user
and organization, select a user-name and password, and follow the
procedures outlined in the guidance document for CDX available online
at: <a href="http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf">http://www.epa.gov/cdr/tools/CDX_Registration_Guide_v0_02.pdf</a>.
2. Submission. Those choosing to submit electronically will use PSP
to prepare their submissions. Then the submitter will choose ``FPAS
submission'' from the drop-down which guides users through a ``hands-
on'' process of creating an electronic submission. Once a user
completes the relevant data fields and attaches appropriate PDF files
or other file types, such as XML files, the web-based tool validates
the submission by performing a basic error check and makes sure all the
required fields and attachments are provided and complete.
Further instructions on submitting information and instructions for
uploading PDF attachments or other file types, such as XML will be
available through FPAS reporting guidance available online at: <a href="https://www.epa.gov/pesticide-registration/electronic-submissions-pesticide-applications">https://www.epa.gov/pesticide-registration/electronic-submissions-pesticide-applications</a>.
D. Can CBI be submitted using PSP?
Yes. PSP enables the user to submit CBI and substantiate that CBI
claim in an electronic format. All information sent by the user via CDX
is transmitted securely to protect CBI. PSP also guides the user
through the process of submitting CBI by prompting the user to check a
CBI checkbox if using a form or by submitting a scanned document
containing CBI by bracketing, underlining, or otherwise marking the
confidential information on the document prior to scanning. As with
paper-based submissions, a sanitized copy of any document containing
CBI would be included by the user in the electronic submission. The
FPAS reporting guidance instructs users on how to submit CBI and
substantiate CBI claims information using PSP.
E. How will CBI be protected when submitting via CDX?
The Agency ensures secure transmission of the data, reports, and
other documents sent from the user through the internet via the
Transport Layer Security (TLS) 1.0 protocol. TLS 1.0 is a widely used
approach for securing internet transactions and is endorsed by the
National Institute of Standards and Technology (NIST) as a means for
protecting data sent over the internet. See NIST Special Publication
800-52, ``Guidelines for the Selection and Use of Transport Layer
Security (TLS) Implementations,'' available online at: <a href="http://csrc.nist.gov/publications/nistpubs/800-52/SP800-52.pdf">http://csrc.nist.gov/publications/nistpubs/800-52/SP800-52.pdf</a>.
In addition, PSP enables the submitter to electronically sign,
encrypt, and transmit submissions, which the Agency subsequently
provides back to the user as an unaltered copy of record. This assures
the user that the Agency has received exactly what the user sent to the
Agency. PSP encrypts using a module based on the 256-bit Advanced
Encryption Standard (AES) adopted by NIST. Details about AES can be
found on the NIST website at: <a href="http://csrc.nist.gov/publications/fips/fips197/fips-197.pdf">http://csrc.nist.gov/publications/fips/fips197/fips-197.pdf</a>. EPA may incorporate other encryption modules into
future versions of PSP. Information submitted via CDX is processed
within EPA by secure systems certified for compliance with Federal
Information Processing Standards (FIPS) that are available online at:
<a href="http://www.nist.gov/itl/fips.cfm">http://www.nist.gov/itl/fips.cfm</a>.
III. 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 OMB approval under the PRA,
unless it has been approved by OMB and displays a currently valid OMB
control number. The OMB control numbers for EPA's regulations in title
40 of the CFR, after appearing in the Federal Register, are listed in
40 CFR part 9, and included on the related collection instrument or
form, if applicable.
The information collection requirements associated with the
electronic option for FPAS notifications under FIFRA section 17(a)(2)
and 40 CFR 168.75 were approved by OMB pursuant to the PRA under OMB
Control No. 2070-0027 (EPA ICR No. 0161.15) on August 6, 2021. The
addition of an electronic option for submissions does not change the
requirements or add new burden requiring additional OMB approval. The
annual paperwork burden per FPAS notification is estimated to average
2,940 hours for hardcopy submissions and 1,803 hours for electronic
submissions. This burden estimate includes the time needed to review
instructions, search existing data sources, gather and maintain the
data needed, and complete, review, and submit the required export
notification to EPA. For additional details, please see the Information
Collection Request document that is available in the docket.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for further minimizing respondent burden,
including through the use of automated collection techniques, to the
Director, Regulatory Support Division, Office of Mission Support
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any FPAS notifications
or related questions to this address.
Authority: 7 U.S.C. 136 et seq.
Dated: August 12, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2021-17660 Filed 8-17-21; 8:45 am]
BILLING CODE 6560-50-P
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