Public Health Information System (PHIS) Export Component Country Implementation, 42056-42059 [2017-18848]
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Notices
Federal Register
Vol. 82, No. 171
Wednesday, September 6, 2017
This section of the FEDERAL REGISTER
contains documents other than rules or
proposed rules that are applicable to the
public. Notices of hearings and investigations,
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS–2017–0008]
Public Health Information System
(PHIS) Export Component Country
Implementation
Food Safety and Inspection
Service, USDA.
ACTION: Notice and request for
comments.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is announcing
and requesting comment on its plan to
implement the Public Health
Information System (PHIS) Export
Component. In response to stakeholder
feedback and to ensure sufficient testing
and outreach, FSIS is extending the
implementation date of the PHIS Export
Component to June 29, 2018. FSIS will
first implement the PHIS Export
Component with a limited number of
foreign countries and will expand
implementation to add countries
incrementally.
Hand- or courier-delivered submittals:
Deliver to Patriots Plaza 3, 355 E Street
SW., Room 8–163A, Washington, DC
20250–3700.
Instructions: All items submitted by
mail or electronic mail must include the
Agency name and docket number FSIS–
2017–0008. Comments received in
response to this docket will be made
available for public inspection and
posted without change, including any
personal information, to https://
www.regulations.gov.
Docket: For access to background
documents or to comments received, go
to the FSIS Docket Room at Patriots
Plaza 3, 355 E Street SW., Room
164–A, Washington, DC 20250–3700
between 8:00 a.m. and 4:30 p.m.,
Monday through Friday.
FOR FURTHER INFORMATION CONTACT:
Rachel Edelstein, Deputy Assistant
Administrator, Office of Policy and
Program Development; Telephone: (202)
205–0495, or by Fax: (202) 720–2025.
SUMMARY:
Background
Submit comments on or before
October 6, 2017.
ADDRESSES: FSIS invites interested
persons to submit comments on issues
discussed and outlined in this notice.
Comments may be submitted by one of
the following methods:
Federal eRulemaking Portal: This
Web site provides the ability to type
short comments directly into the
comment field on this Web page or
attach a file for lengthier comments. Go
to https://www.regulations.gov/. Follow
the on-line instructions at that site for
submitting comments.
Mail, CD–ROMs: Send to Docket
Clerk, U.S. Department of Agriculture,
Food Safety and Inspection Service,
Patriots Plaza 3, 1400 Independence
Avenue SW., Mailstop 3782, Room
8–163B, Washington, DC 20250–3700.
On June 29, 2016, the Food Safety and
Inspection Service (FSIS) published the
final rule, ‘‘Electronic Export
Application and Certification Charge;
Flexibility in the Requirements for
Export Inspection Marks, Devices, and
Certificates; Egg Products Export
Certification’’ (81 FR 42225). The rule
can be found online at https://
www.fsis.usda.gov/wps/wcm/connect/
3538b05e-151c-4d82-8664096452a32778/20090026.pdf?MOD=AJPERES, and FSIS
notified the World Trade Organization
of the rule (G/TBT/N/USA/678/Add.1).
The final rule provided for an electronic
export application and certification
system—the Public Health Information
System (PHIS) Export Component—in
the meat, poultry, and egg product
regulations.
When the PHIS Export Component is
incrementally deployed to specific
countries, as outlined below, it will
provide the following improvements:
• FSIS will electronically inventory
and track export certificate information,
which will enable FSIS Inspection
Program Personnel (IPP) to review exact
images (i.e., portable document format
(PDF)) of export certification documents
prior to approval;
• Exporters will be able to
electronically submit, track, and manage
applications for export certificates,
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including capabilities to bundle
multiple applications into a single file;
• Foreign governments will be able to
view all export certificates for product
intended for their country issued by
FSIS in PHIS, as a digital image, through
an FSIS-controlled log-in feature,
Foreign Country Log-in (FCL).
New Implementation Date
The final export rule stated that FSIS
would begin implementing the PHIS
Export Component on June 29, 2017.
However, to ensure sufficient testing
and outreach to all stakeholders, FSIS is
delaying the implementation date of the
PHIS Export Component to June 29,
2018. On March 27, 2017, FSIS held a
PHIS Export Component technical
webinar to share information and solicit
comments on implementation plans.
During and after the webinar, FSIS
received requests from industry to delay
implementation of the system, to ensure
that all stakeholders are prepared and
the system is performing effectively.
After considering these requests, FSIS
agreed to extend the implementation
date for an additional year (June 29,
2018). More information from the March
27 webinar, including audio and
transcripts, can be found on FSIS’s PHIS
Export Component Web page at https://
www.fsis.usda.gov/wps/portal/fsis/
topics/international-affairs/exportingproducts/phis-export-component.
Country Rollout Schedule
On June 29, 2018, FSIS will
implement the PHIS Export Component
with a limited number of countries, and
then gradually expand implementation
to additional countries. Countries will
be added incrementally in groups. This
Notice announces the first group FSIS
intends to include (June 2018; see below
for the Group 1 country list). FSIS will
announce future groups in advance on
the PHIS Export Component Web page
at https://www.fsis.usda.gov/wps/
portal/fsis/topics/international-affairs/
exporting-products/phis-exportcomponent. Initially, only meat
(including Siluriformes) and poultry
products will be included in the PHIS
Export Component; egg products and
casings will be added at a later date,
which FSIS will announce in advance
through the Federal Register, FSIS
Constituent Update, or other
appropriate means.
Beginning on June 29, 2018, FSIS
intends to include Australia, New
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Zealand, and the United Arab Emirates
(UAE) in Group 1 of the PHIS Export
Component. These countries are
familiar with technological changes to
certification systems; use English; and,
in combination, import a moderate
amount of the major product classes
under FSIS’s jurisdiction, giving FSIS
sufficient data to assess system
performance. Selection of these
countries reflects FSIS’s consideration
of public comments received on topics
presented at an April 2, 2015,
conference call, which recommended
implementing one or more smaller
volume, relatively simple certification
countries before moving to higher
volume, complex certification countries.
FSIS welcomes public comment on the
selection of these three countries for
initial implementation, including
feedback on the feasibility of
accommodating these countries’
certification requirements through the
PHIS Export Component process.
In Group 1, FSIS is also including 16
countries that do not maintain meat or
poultry requirements in the FSIS Export
Library: Afghanistan, Andorra,
Bahamas, Bolivia, Burundi, Cape Verde,
Cook Islands, Ethiopia, Gambia, Guinea,
Liberia, Mozambique, Paraguay, San
Marino, Tanzania and Uganda.
Additional countries without export
library requirements will be added to
each group as the Export Component
rollout proceeds. FSIS may accelerate or
decelerate the schedule, depending on
the system’s performance. Based on
FSIS’s experience with implementing
other components of PHIS, unforeseen
implementation issues may arise, such
as the system’s performance, training
concerns, or questions from importing
countries or FSIS IPP. In the first
country group, FSIS will be working
with foreign governments on a moderate
amount of product, rather than on high
product volumes that could more
severely and unnecessarily disrupt
commerce with major trading partners.
Starting with low or mid-range volume
countries will allow FSIS to build a
foundation for more efficient,
subsequent implementation with
higher-volume countries that have more
complex certification processes, for
which effective outreach and
implementation of the PHIS Export
Component will be critical.
Application for Export Certificate
FSIS regulations (9 CFR 322.2 and
381.105) require that the FSIS
Application for Export Certificate (FSIS
Form 9060–6) be submitted to obtain an
FSIS Export Certificate of
Wholesomeness (FSIS Form 9060–5).
FSIS Form 9060–6 provides FSIS with
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important data necessary to certify and
facilitate the export of product.
Beginning on June 29, 2018,
applicants for export certification to
countries included in the Export
Component (e.g. Australia, New
Zealand, UAE, and 16 listed countries)
will complete either (1) an electronic
export application in PHIS (i.e.
individual application or batch of
applications), or (2) send a paper export
application (FSIS Form 9060–6) and any
required supplemental documents to the
FSIS proxy (Urbandale, IA) for data
entry into PHIS. Applicants who choose
to use paper applications can email or
mail the completed application, and any
additional information required by the
foreign country, to FSIS for entry into
PHIS at:
Email: FSCExport.Recon@
fsis.usda.gov.
Mail: U.S. Department of Agriculture,
Food Safety and Inspection Service,
FMD, Financial Services Center, P.O.
Box 9205, Des Moines, IA 50306–9948.
Applicants who choose to use paper
applications can only use fax to send
the completed application (FSIS Form
9060–6) to FSIS when no additional
supplemental documents (e.g. letterhead
certificates) are required by the
importing country in the FSIS Export
Library. Faxes should be sent to: 1–844–
378–1048.
As is done currently, in order for FSIS
to be able to issue a certificate stating
that a shipment meets the country’s
requirements, applicants are required to
submit complete documentation, based
on requirements found in the FSIS
Export Library, to receive the requested
certification.
Regardless of the method the
applicant chooses to submit the
application, the end result of the export
certification process and IPP verification
activities will be the same. Starting no
sooner than January 1, 2019, FSIS will
assess fees for electronic export
certificate applications, as is discussed
below.
The application process will not
change how reimbursable services are
charged by FSIS IPP, as described in the
12,000 Series of FSIS Directives on
Voluntary Inspection (https://
www.fsis.usda.gov/wps/portal/fsis/
topics/regulations/directives/12000series). When requested, FSIS provides
reimbursable inspection services to
accommodate business needs, such as
obtaining export certifications necessary
to meet requirements of importing
countries that are not imposed by FSIS,
and are in addition to FSIS
requirements.
In PHIS, export applicants can
withdraw or cancel an export
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application at any point in the approval
process prior to IPP approving the
export application in PHIS. Once an
application is withdrawn or cancelled
by the applicant in PHIS, that
application is no longer valid for export
and is removed from the PHIS user
interface. Applicants will still be
charged for all applications whether
they are processed or withdrawn.
For all countries not yet included in
the Export Component, applicants
should follow current export
application procedures.
Of note, to make the application (FSIS
Form 9060–6) more user-friendly,
prepare for its use in both a paper and
electronic format, better align with
commonly accepted international
(Codex Alimentarius, CAC/GL 38–2001)
guidance and ensure importing country
requirements are met, FSIS has revised
the data elements within FSIS form
9060–6: Application for Export
Certificate. Industry is not to use this
revised application until June 29, 2018.
Furthermore, FSIS is eliminating a
previously approved form associated
with the 9060–6—the Product List (FSIS
Form 9080–4). Certain limited data
elements related to product information
will be moved from FSIS Form 9080–4
to FSIS Form 9060–6 (HACCP Category;
Maturity Less than 30 months (beef
only); Frozen/Shelf-Stable).
Electronic Export Application Fee
The PHIS Export Component will
provide new service options to
exporters, enabling them to
electronically submit, track, and manage
their export applications. Therefore, to
cover the costs of providing the
electronic application and certification
service, FSIS established a formulabased fee for electronic export
applications submitted in PHIS, under
the authority of the Agricultural
Marketing Act (7 U.S.C. 1622(h)) and
implementing FSIS regulations (9 CFR
350.7; 350.3(b); 362.2(b); 362.5).
The final export rule stated that the
formula-based fee for electronic export
applications would apply on June 29,
2017; however, to ensure system
performance and the accuracy of
estimates in the fee formula, FSIS will
not begin assessing the fee prior to
January 1, 2019, and will recalculate the
fee based on the best available estimates
for costs and number of applications.
The updated fee will be published in
the Federal Register no later than 30
days prior to its assessment.
As stated in the final export rule, the
final electronic export application fee
formula is as follows:
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The formula elements, summarized
below, are the sum of labor and IT costs,
divided by the total number of export
applications.
Labor Costs
Æ Technical Support: This cost
includes Service Desk support such as
resolving user problems with the
application services, identifying web
browser compatibility issues, and fees
from establishments and facilities that
request this service.
Æ Export Library Maintenance: This
cost includes funding two full-time
employees to provide Export Library
functions, includes the writing, testing,
and maintenance of complex business
rules for evaluating the export
application that is submitted into the
PHIS export system. The business rules
allow the system to determine product
eligibility before the system accepts the
application and transmits it to
inspection program personnel. The
business rules also facilitate the type of
export certification required by the
foreign government that will be issued
when the application is accepted.
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IT Cost
Æ Ongoing Operations &
Maintenance: This cost includes
improvements and necessary repairs to
keep the system responsive to users’
needs, including modifying the
application based on changes in
requirements or user needs, adding
functionality based on foreign
regulatory changes, upkeep of the
system to ensure a secure operating
environment that protects the data, and
costs to operate the system components.
This cost may increase in future years
based on General Services
Administration (GSA) schedule
increases in labor rates and other
factors.
Æ Level 2 eAuthentication: This cost
is currently zero, but may increase in
future years based on a variety of
factors, including the number of export
business customers annually.
Number of Export Applications: This
estimate is the approximate total
number of export applications
submitted to FSIS annually.
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FSIS Export Certificate of
Wholesomeness
On June 29, 2018, the PHIS Export
Component will have the ability to
digitally sign export certificates (FSIS
Form 9060–5) from the FSIS certifying
official. This feature will provide an
additional layer of security for the
exporter and the importing country’s
government. At the time the signature is
applied, PHIS will execute security
checks to validate that the digital
signature is that of the FSIS certifying
official. The digital signature will
include the printed name of the FSIS
certifying official, and the time and date
that the signature was applied. This
feature, along with other security
features of the PHIS export component,
such as FSIS-controlled security paper
on which certificates will be printed,
will provide maximum assurance that
export certificates are authentic.
FSIS may also provide certificates
signed by FSIS certifying officials with
an ink signature, as is done currently.
The export certificate, signed either
digitally or with an ink signature, will
be printed from PHIS on security paper
(81⁄2″ × 11″), and given to the exporter.
FSIS will scan copies of all signed
certification documents (e.g. 9060–5,
supplemental letterhead certificates)
into PHIS before releasing the signed
original certification documents to the
exporter. Unless specified that a digital
signature is required or allowed in the
FSIS Export Library, FSIS certifying
officials will sign all export documents
with an ink signature, as is done
currently. Any supplemental
documents, such as letterhead
certificates, will be printed on standard
81⁄2″ × 11″ white copy paper.
Of note, FSIS has made limited
revisions to data elements in the FSIS
Form 9060–5 to better align with
commonly accepted international
(Codex Alimentarius, CAC/GL 38–2001)
guidance and to ensure importing
country requirements are met. When
additional space for products or
statements is necessary with a 9060–5,
PHIS will also generate FSIS Form
9060–5A (product continuation page),
which is an existing addendum that
FSIS has aligned with the revised 9060–
5; and FSIS Form 9060–5B (remarks
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continuation page), a new addendum to
provide more space for additional
attestations, when required by the
importing country. These updated
certification documents will be
implemented with the PHIS Export
Component, on June 29, 2018.
Country-specific letterhead
certificates, and other required
supplemental documentation, will not
be produced by PHIS. Applicants will
complete any required supplemental
documents (e.g. letterhead certificates)
and upload them to the electronic
application in PHIS, or include the
supplemental documents with the
export package they send to the FSIS
proxy.
Batch Processing
The PHIS Export Component will
allow exporters to bundle multiple
applications, including any
supplemental documents (e.g. letterhead
certificates) required by the importing
country, into a single file, known as
batch processing. To maintain system
functionality, FSIS reserves the right to
place limits on batch processing as
needed or required by PHIS. FSIS
intends to test batch processing with
industry users before implementation to
ensure functionality. Upon
implementation, FSIS will provide help
desk support for batch processing issues
(see FSIS’s PHIS Export Component
Web page at https://www.fsis.usda.gov/
wps/portal/fsis/topics/internationalaffairs/exporting-products/phis-exportcomponent for updates).
Level 2 eAuthentication/Foreign
Country Log-In
When the PHIS Export Component is
implemented, foreign government
officials will have the capability to view
all export certificates issued by FSIS in
PHIS, as a digital image, for product
destined for the government’s country,
through an FSIS-controlled log-in
feature (Foreign Country Log-in, FCL).
In addition, the original certificates will
be printed on paper and will arrive with
the shipment, whether FSIS inspection
personnel apply the signature digitally
or with ink. Importing government
officials will be able to compare digital
certificate copies in the FCL with the
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Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices
original certification documents arriving
at the country’s port of entry, to verify
that the digital certificate copies align
with the original certificates arriving
with the shipment. A Level 2
eAuthentication account is necessary to
access the FCL. An eAuthentication
account is the way for a user to interact
with USDA Web site portals and
applications using a verified identity for
each User ID and profile. Prior to
implementation of the PHIS Export
Component, FSIS will provide further
guidance on this process.
USDA Export Stamp
The USDA export stamp bears the
export certificate number, and is used to
link the consignment to the
corresponding export certificate.
Beginning on the applicability date of
June 29, 2018, FSIS is changing the
number of digits in the serial number
that appears on both the export stamp
and the corresponding export certificate
from six to seven numbers. Use of an
alternative, alpha-numeric unique
identifier in place of the USDA export
stamp will be implemented with the
PHIS Export Component on June 29,
2018.
eCert
In the future, FSIS also intends to
support electronic export certification
(eCert) in PHIS. eCert is the governmentto-government transmission of
certification data and is the electronic
equivalent of a paper certificate. When
developed and implemented, electronic
export certification will allow FSIS to
transfer certification data directly to the
foreign government’s competent
authority’s certification system.
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Group 1 (June 29, 2018)
• Export Library:
1. Australia
2. New Zealand
3. UAE
• Non-Export Library:
1. Afghanistan
2. Andorra
3. Bahamas
4. Bolivia
5. Burundi
6. Cape Verde
7. Cook Islands
8. Ethiopia
9. Gambia
10. Guinea
11. Liberia
12. Mozambique
13. Paraguay
14. San Marino
15. Tanzania
16. Uganda
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USDA Nondiscrimination Statement
No agency, officer, or employee of the
USDA shall, on the grounds of race,
color, national origin, religion, sex,
gender identity, sexual orientation,
disability, age, marital status, family/
parental status, income derived from a
public assistance program, or political
beliefs, exclude from participation in,
deny the benefits of, or subject to
discrimination any person in the United
States under any program or activity
conducted by the USDA.
To file a complaint of discrimination,
complete the USDA Program
Discrimination Complaint Form, which
may be accessed online at https://
www.ocio.usda.gov/sites/default/files/
docs/2012/Complain_combined_6_8_
12.pdf, or write a letter signed by you
or your authorized representative.
Send your completed complaint form
or letter to USDA by mail, fax, or email:
Mail: U.S. Department of Agriculture,
Director, Office of Adjudication, 1400
Independence Avenue SW.,
Washington, DC 20250–9410.
Fax: (202) 690–7442.
Email: program.intake@usda.gov.
Persons with disabilities who require
alternative means for communication
(Braille, large print, audiotape, etc.)
should contact USDA’s TARGET Center
at (202) 720–2600 (voice and TDD).
Additional Public Notification
FSIS will announce this notice online
through the FSIS Web page located at
https://www.fsis.usda.gov/federalregister.
FSIS will also make copies of this
Federal Register publication available
through the FSIS Constituent Update,
which is used to provide information
regarding FSIS policies, procedures,
regulations, Federal Register notices,
FSIS public meetings, and other types of
information that could affect or would
be of interest to constituents and
stakeholders. The Update is
communicated via Listserv, a free
electronic mail subscription service for
industry, trade groups, consumer
interest groups, health professionals,
and other individuals who have asked
to be included. The Update is also
available on the FSIS Web page. In
addition, FSIS offers an electronic mail
subscription service which provides
automatic and customized access to
selected food safety news and
information. This service is available at
https://www.fsis.usda.gov/subscribe.
Options range from recalls to export
information to regulations, directives,
and notices. Customers can add or
delete subscriptions themselves, and
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42059
have the option to password protect
their accounts.
Done at Washington, DC, on: August 31,
2017.
Paul Kiecker,
Acting Administrator.
[FR Doc. 2017–18848 Filed 9–5–17; 8:45 am]
BILLING CODE 3410–DM–P
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS–2017–0028]
Availability of FSIS Compliance
Guideline for Minimizing the Risk of
Shiga Toxin-Producing Escherichia
Coli (STEC) and Salmonella in Raw
Beef (Including Veal) Processing
Operations
Food Safety and Inspection
Service, USDA.
ACTION: Notice of availability and
request for comment.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is announcing
the availability of and requesting
comments on the updated compliance
guideline for small and very small
businesses on reducing STEC and
Salmonella in beef and veal operations.
The new guideline will assist small
and very small beef (including veal)
processing establishments understand
and comply with the regulatory
requirements associated with
controlling STEC and Salmonella in raw
non-intact beef products and beef
products intended for non-intact use.
The guideline also includes information
for establishments and retail stores on
developing and maintaining records
associated with the production of
ground beef.
DATES: Submit Comments on or before
November 6, 2017.
ADDRESSES: A downloadable version of
the compliance guideline is available to
view and print at https://
www.fsis.usda.gov/wps/portal/fsis/
topics/regulatory-compliance/
compliance-guides-index once copies of
the guideline have been published.
FSIS invites interested persons to
submit comments on this guidance.
Comments may be submitted by one of
the following methods:
Federal eRulemaking Portal: This
Web site provides the ability to type
short comments directly into the
comment field on this Web page or
attach a file for lengthier comments. Go
to https://www.regulations.gov/. Follow
the on-line instructions at that site for
submitting comments.
SUMMARY:
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Agencies
[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42056-42059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18848]
========================================================================
Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
========================================================================
Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 /
Notices
[[Page 42056]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2017-0008]
Public Health Information System (PHIS) Export Component Country
Implementation
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice and request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
and requesting comment on its plan to implement the Public Health
Information System (PHIS) Export Component. In response to stakeholder
feedback and to ensure sufficient testing and outreach, FSIS is
extending the implementation date of the PHIS Export Component to June
29, 2018. FSIS will first implement the PHIS Export Component with a
limited number of foreign countries and will expand implementation to
add countries incrementally.
DATES: Submit comments on or before October 6, 2017.
ADDRESSES: FSIS invites interested persons to submit comments on issues
discussed and outlined in this notice. Comments may be submitted by one
of the following methods:
Federal eRulemaking Portal: This Web site provides the ability to
type short comments directly into the comment field on this Web page or
attach a file for lengthier comments. Go to https://www.regulations.gov/. Follow the on-line instructions at that site for
submitting comments.
Mail, CD-ROMs: Send to Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400
Independence Avenue SW., Mailstop 3782, Room 8-163B, Washington, DC
20250-3700.
Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3,
355 E Street SW., Room 8-163A, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2017-0008. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to https://www.regulations.gov.
Docket: For access to background documents or to comments received,
go to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room
164-A, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m.,
Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Deputy Assistant
Administrator, Office of Policy and Program Development; Telephone:
(202) 205-0495, or by Fax: (202) 720-2025.
Background
On June 29, 2016, the Food Safety and Inspection Service (FSIS)
published the final rule, ``Electronic Export Application and
Certification Charge; Flexibility in the Requirements for Export
Inspection Marks, Devices, and Certificates; Egg Products Export
Certification'' (81 FR 42225). The rule can be found online at https://www.fsis.usda.gov/wps/wcm/connect/3538b05e-151c-4d82-8664-096452a32778/2009-0026.pdf?MOD=AJPERES, and FSIS notified the World Trade
Organization of the rule (G/TBT/N/USA/678/Add.1). The final rule
provided for an electronic export application and certification
system--the Public Health Information System (PHIS) Export Component--
in the meat, poultry, and egg product regulations.
When the PHIS Export Component is incrementally deployed to
specific countries, as outlined below, it will provide the following
improvements:
FSIS will electronically inventory and track export
certificate information, which will enable FSIS Inspection Program
Personnel (IPP) to review exact images (i.e., portable document format
(PDF)) of export certification documents prior to approval;
Exporters will be able to electronically submit, track,
and manage applications for export certificates, including capabilities
to bundle multiple applications into a single file;
Foreign governments will be able to view all export
certificates for product intended for their country issued by FSIS in
PHIS, as a digital image, through an FSIS-controlled log-in feature,
Foreign Country Log-in (FCL).
New Implementation Date
The final export rule stated that FSIS would begin implementing the
PHIS Export Component on June 29, 2017. However, to ensure sufficient
testing and outreach to all stakeholders, FSIS is delaying the
implementation date of the PHIS Export Component to June 29, 2018. On
March 27, 2017, FSIS held a PHIS Export Component technical webinar to
share information and solicit comments on implementation plans. During
and after the webinar, FSIS received requests from industry to delay
implementation of the system, to ensure that all stakeholders are
prepared and the system is performing effectively. After considering
these requests, FSIS agreed to extend the implementation date for an
additional year (June 29, 2018). More information from the March 27
webinar, including audio and transcripts, can be found on FSIS's PHIS
Export Component Web page at https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/phis-export-component.
Country Rollout Schedule
On June 29, 2018, FSIS will implement the PHIS Export Component
with a limited number of countries, and then gradually expand
implementation to additional countries. Countries will be added
incrementally in groups. This Notice announces the first group FSIS
intends to include (June 2018; see below for the Group 1 country list).
FSIS will announce future groups in advance on the PHIS Export
Component Web page at https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/phis-export-component.
Initially, only meat (including Siluriformes) and poultry products will
be included in the PHIS Export Component; egg products and casings will
be added at a later date, which FSIS will announce in advance through
the Federal Register, FSIS Constituent Update, or other appropriate
means.
Beginning on June 29, 2018, FSIS intends to include Australia, New
[[Page 42057]]
Zealand, and the United Arab Emirates (UAE) in Group 1 of the PHIS
Export Component. These countries are familiar with technological
changes to certification systems; use English; and, in combination,
import a moderate amount of the major product classes under FSIS's
jurisdiction, giving FSIS sufficient data to assess system performance.
Selection of these countries reflects FSIS's consideration of public
comments received on topics presented at an April 2, 2015, conference
call, which recommended implementing one or more smaller volume,
relatively simple certification countries before moving to higher
volume, complex certification countries. FSIS welcomes public comment
on the selection of these three countries for initial implementation,
including feedback on the feasibility of accommodating these countries'
certification requirements through the PHIS Export Component process.
In Group 1, FSIS is also including 16 countries that do not
maintain meat or poultry requirements in the FSIS Export Library:
Afghanistan, Andorra, Bahamas, Bolivia, Burundi, Cape Verde, Cook
Islands, Ethiopia, Gambia, Guinea, Liberia, Mozambique, Paraguay, San
Marino, Tanzania and Uganda. Additional countries without export
library requirements will be added to each group as the Export
Component rollout proceeds. FSIS may accelerate or decelerate the
schedule, depending on the system's performance. Based on FSIS's
experience with implementing other components of PHIS, unforeseen
implementation issues may arise, such as the system's performance,
training concerns, or questions from importing countries or FSIS IPP.
In the first country group, FSIS will be working with foreign
governments on a moderate amount of product, rather than on high
product volumes that could more severely and unnecessarily disrupt
commerce with major trading partners. Starting with low or mid-range
volume countries will allow FSIS to build a foundation for more
efficient, subsequent implementation with higher-volume countries that
have more complex certification processes, for which effective outreach
and implementation of the PHIS Export Component will be critical.
Application for Export Certificate
FSIS regulations (9 CFR 322.2 and 381.105) require that the FSIS
Application for Export Certificate (FSIS Form 9060-6) be submitted to
obtain an FSIS Export Certificate of Wholesomeness (FSIS Form 9060-5).
FSIS Form 9060-6 provides FSIS with important data necessary to certify
and facilitate the export of product.
Beginning on June 29, 2018, applicants for export certification to
countries included in the Export Component (e.g. Australia, New
Zealand, UAE, and 16 listed countries) will complete either (1) an
electronic export application in PHIS (i.e. individual application or
batch of applications), or (2) send a paper export application (FSIS
Form 9060-6) and any required supplemental documents to the FSIS proxy
(Urbandale, IA) for data entry into PHIS. Applicants who choose to use
paper applications can email or mail the completed application, and any
additional information required by the foreign country, to FSIS for
entry into PHIS at:
Email: FSCExport.Recon@fsis.usda.gov.
Mail: U.S. Department of Agriculture, Food Safety and Inspection
Service, FMD, Financial Services Center, P.O. Box 9205, Des Moines, IA
50306-9948.
Applicants who choose to use paper applications can only use fax to
send the completed application (FSIS Form 9060-6) to FSIS when no
additional supplemental documents (e.g. letterhead certificates) are
required by the importing country in the FSIS Export Library. Faxes
should be sent to: 1-844-378-1048.
As is done currently, in order for FSIS to be able to issue a
certificate stating that a shipment meets the country's requirements,
applicants are required to submit complete documentation, based on
requirements found in the FSIS Export Library, to receive the requested
certification.
Regardless of the method the applicant chooses to submit the
application, the end result of the export certification process and IPP
verification activities will be the same. Starting no sooner than
January 1, 2019, FSIS will assess fees for electronic export
certificate applications, as is discussed below.
The application process will not change how reimbursable services
are charged by FSIS IPP, as described in the 12,000 Series of FSIS
Directives on Voluntary Inspection (https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/directives/12000-series). When
requested, FSIS provides reimbursable inspection services to
accommodate business needs, such as obtaining export certifications
necessary to meet requirements of importing countries that are not
imposed by FSIS, and are in addition to FSIS requirements.
In PHIS, export applicants can withdraw or cancel an export
application at any point in the approval process prior to IPP approving
the export application in PHIS. Once an application is withdrawn or
cancelled by the applicant in PHIS, that application is no longer valid
for export and is removed from the PHIS user interface. Applicants will
still be charged for all applications whether they are processed or
withdrawn.
For all countries not yet included in the Export Component,
applicants should follow current export application procedures.
Of note, to make the application (FSIS Form 9060-6) more user-
friendly, prepare for its use in both a paper and electronic format,
better align with commonly accepted international (Codex Alimentarius,
CAC/GL 38-2001) guidance and ensure importing country requirements are
met, FSIS has revised the data elements within FSIS form 9060-6:
Application for Export Certificate. Industry is not to use this revised
application until June 29, 2018. Furthermore, FSIS is eliminating a
previously approved form associated with the 9060-6--the Product List
(FSIS Form 9080-4). Certain limited data elements related to product
information will be moved from FSIS Form 9080-4 to FSIS Form 9060-6
(HACCP Category; Maturity Less than 30 months (beef only); Frozen/
Shelf-Stable).
Electronic Export Application Fee
The PHIS Export Component will provide new service options to
exporters, enabling them to electronically submit, track, and manage
their export applications. Therefore, to cover the costs of providing
the electronic application and certification service, FSIS established
a formula-based fee for electronic export applications submitted in
PHIS, under the authority of the Agricultural Marketing Act (7 U.S.C.
1622(h)) and implementing FSIS regulations (9 CFR 350.7; 350.3(b);
362.2(b); 362.5).
The final export rule stated that the formula-based fee for
electronic export applications would apply on June 29, 2017; however,
to ensure system performance and the accuracy of estimates in the fee
formula, FSIS will not begin assessing the fee prior to January 1,
2019, and will recalculate the fee based on the best available
estimates for costs and number of applications. The updated fee will be
published in the Federal Register no later than 30 days prior to its
assessment.
As stated in the final export rule, the final electronic export
application fee formula is as follows:
[[Page 42058]]
[GRAPHIC] [TIFF OMITTED] TN06SE17.000
The formula elements, summarized below, are the sum of labor and IT
costs, divided by the total number of export applications.
Labor Costs
[cir] Technical Support: This cost includes Service Desk support
such as resolving user problems with the application services,
identifying web browser compatibility issues, and fees from
establishments and facilities that request this service.
[cir] Export Library Maintenance: This cost includes funding two
full-time employees to provide Export Library functions, includes the
writing, testing, and maintenance of complex business rules for
evaluating the export application that is submitted into the PHIS
export system. The business rules allow the system to determine product
eligibility before the system accepts the application and transmits it
to inspection program personnel. The business rules also facilitate the
type of export certification required by the foreign government that
will be issued when the application is accepted.
IT Cost
[cir] Ongoing Operations & Maintenance: This cost includes
improvements and necessary repairs to keep the system responsive to
users' needs, including modifying the application based on changes in
requirements or user needs, adding functionality based on foreign
regulatory changes, upkeep of the system to ensure a secure operating
environment that protects the data, and costs to operate the system
components. This cost may increase in future years based on General
Services Administration (GSA) schedule increases in labor rates and
other factors.
[cir] Level 2 eAuthentication: This cost is currently zero, but may
increase in future years based on a variety of factors, including the
number of export business customers annually.
Number of Export Applications: This estimate is the approximate total
number of export applications submitted to FSIS annually.
FSIS Export Certificate of Wholesomeness
On June 29, 2018, the PHIS Export Component will have the ability
to digitally sign export certificates (FSIS Form 9060-5) from the FSIS
certifying official. This feature will provide an additional layer of
security for the exporter and the importing country's government. At
the time the signature is applied, PHIS will execute security checks to
validate that the digital signature is that of the FSIS certifying
official. The digital signature will include the printed name of the
FSIS certifying official, and the time and date that the signature was
applied. This feature, along with other security features of the PHIS
export component, such as FSIS-controlled security paper on which
certificates will be printed, will provide maximum assurance that
export certificates are authentic.
FSIS may also provide certificates signed by FSIS certifying
officials with an ink signature, as is done currently. The export
certificate, signed either digitally or with an ink signature, will be
printed from PHIS on security paper (8\1/2\'' x 11''), and given to the
exporter. FSIS will scan copies of all signed certification documents
(e.g. 9060-5, supplemental letterhead certificates) into PHIS before
releasing the signed original certification documents to the exporter.
Unless specified that a digital signature is required or allowed in the
FSIS Export Library, FSIS certifying officials will sign all export
documents with an ink signature, as is done currently. Any supplemental
documents, such as letterhead certificates, will be printed on standard
8\1/2\'' x 11'' white copy paper.
Of note, FSIS has made limited revisions to data elements in the
FSIS Form 9060-5 to better align with commonly accepted international
(Codex Alimentarius, CAC/GL 38-2001) guidance and to ensure importing
country requirements are met. When additional space for products or
statements is necessary with a 9060-5, PHIS will also generate FSIS
Form 9060-5A (product continuation page), which is an existing addendum
that FSIS has aligned with the revised 9060-5; and FSIS Form 9060-5B
(remarks continuation page), a new addendum to provide more space for
additional attestations, when required by the importing country. These
updated certification documents will be implemented with the PHIS
Export Component, on June 29, 2018.
Country-specific letterhead certificates, and other required
supplemental documentation, will not be produced by PHIS. Applicants
will complete any required supplemental documents (e.g. letterhead
certificates) and upload them to the electronic application in PHIS, or
include the supplemental documents with the export package they send to
the FSIS proxy.
Batch Processing
The PHIS Export Component will allow exporters to bundle multiple
applications, including any supplemental documents (e.g. letterhead
certificates) required by the importing country, into a single file,
known as batch processing. To maintain system functionality, FSIS
reserves the right to place limits on batch processing as needed or
required by PHIS. FSIS intends to test batch processing with industry
users before implementation to ensure functionality. Upon
implementation, FSIS will provide help desk support for batch
processing issues (see FSIS's PHIS Export Component Web page at https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/exporting-products/phis-export-component for updates).
Level 2 eAuthentication/Foreign Country Log-In
When the PHIS Export Component is implemented, foreign government
officials will have the capability to view all export certificates
issued by FSIS in PHIS, as a digital image, for product destined for
the government's country, through an FSIS-controlled log-in feature
(Foreign Country Log-in, FCL). In addition, the original certificates
will be printed on paper and will arrive with the shipment, whether
FSIS inspection personnel apply the signature digitally or with ink.
Importing government officials will be able to compare digital
certificate copies in the FCL with the
[[Page 42059]]
original certification documents arriving at the country's port of
entry, to verify that the digital certificate copies align with the
original certificates arriving with the shipment. A Level 2
eAuthentication account is necessary to access the FCL. An
eAuthentication account is the way for a user to interact with USDA Web
site portals and applications using a verified identity for each User
ID and profile. Prior to implementation of the PHIS Export Component,
FSIS will provide further guidance on this process.
USDA Export Stamp
The USDA export stamp bears the export certificate number, and is
used to link the consignment to the corresponding export certificate.
Beginning on the applicability date of June 29, 2018, FSIS is changing
the number of digits in the serial number that appears on both the
export stamp and the corresponding export certificate from six to seven
numbers. Use of an alternative, alpha-numeric unique identifier in
place of the USDA export stamp will be implemented with the PHIS Export
Component on June 29, 2018.
eCert
In the future, FSIS also intends to support electronic export
certification (eCert) in PHIS. eCert is the government-to-government
transmission of certification data and is the electronic equivalent of
a paper certificate. When developed and implemented, electronic export
certification will allow FSIS to transfer certification data directly
to the foreign government's competent authority's certification system.
Group 1 (June 29, 2018)
Export Library:
1. Australia
2. New Zealand
3. UAE
Non-Export Library:
1. Afghanistan
2. Andorra
3. Bahamas
4. Bolivia
5. Burundi
6. Cape Verde
7. Cook Islands
8. Ethiopia
9. Gambia
10. Guinea
11. Liberia
12. Mozambique
13. Paraguay
14. San Marino
15. Tanzania
16. Uganda
USDA Nondiscrimination Statement
No agency, officer, or employee of the USDA shall, on the grounds
of race, color, national origin, religion, sex, gender identity, sexual
orientation, disability, age, marital status, family/parental status,
income derived from a public assistance program, or political beliefs,
exclude from participation in, deny the benefits of, or subject to
discrimination any person in the United States under any program or
activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program
Discrimination Complaint Form, which may be accessed online at https://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your
authorized representative.
Send your completed complaint form or letter to USDA by mail, fax,
or email:
Mail: U.S. Department of Agriculture, Director, Office of
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.
Fax: (202) 690-7442.
Email: program.intake@usda.gov.
Persons with disabilities who require alternative means for
communication (Braille, large print, audiotape, etc.) should contact
USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Additional Public Notification
FSIS will announce this notice online through the FSIS Web page
located at https://www.fsis.usda.gov/federal-register.
FSIS will also make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, and other types of information
that could affect or would be of interest to constituents and
stakeholders. The Update is communicated via Listserv, a free
electronic mail subscription service for industry, trade groups,
consumer interest groups, health professionals, and other individuals
who have asked to be included. The Update is also available on the FSIS
Web page. In addition, FSIS offers an electronic mail subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at https://www.fsis.usda.gov/subscribe. Options range from recalls to export
information to regulations, directives, and notices. Customers can add
or delete subscriptions themselves, and have the option to password
protect their accounts.
Done at Washington, DC, on: August 31, 2017.
Paul Kiecker,
Acting Administrator.
[FR Doc. 2017-18848 Filed 9-5-17; 8:45 am]
BILLING CODE 3410-DM-P