[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Pages 42056-42059]
From the Federal Register Online via the Government Publishing Office [http://www.gpo.gov/]
[FR Doc No: 2017-18848]

                                                Federal Register

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appearing in this section.


Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / 

[[Page 42056]]


Food Safety and Inspection Service

[Docket No. FSIS-2017-0008]

Public Health Information System (PHIS) Export Component Country 

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 http://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 
    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 http://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.


    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 
     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 
    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 
    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 
    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 
    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/

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 
    As stated in the final export rule, the final electronic export 
application fee formula is as follows:

[[Page 42058]]


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.


    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 http://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 http://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 http://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]