[Federal Register Volume 80, Number 35 (Monday, February 23, 2015)]
[Notices]
[Pages 9428-9431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03576]
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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
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Federal Register / Vol. 80, No. 35 / Monday, February 23, 2015 /
Notices
[[Page 9428]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2014-0039]
Document Reviews of Foreign Food Regulatory Systems: New Web-
based Self-Reporting Tool
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Response to comments; notice of availability.
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SUMMARY: FSIS is making available to the public its new Web-based Self-
Reporting Tool (SRT) that it will be sending to foreign countries to
report information on their food regulatory systems for the purpose of
establishing that the systems are, or continue to be, equivalent to
that of the United States' system. The Agency will send a letter to
foreign countries with instructions on how to access and use the Web-
based SRT. FSIS is also responding to the comments on its document
review process for determining and verifying equivalence that the
Agency received in response to the Federal Register notice that it
published on January 25, 2013, on the use of the SRT. FSIS evaluates
the information provided in the SRT and uses it, along with the results
of on-site systems audits and port-of-entry (POE) reinspections, to
make a determination on equivalence.
DATES: On February 17, 2015, FSIS will make available to the public the
new Web-based SRT. To ensure that a complete and up-to-date SRT is
being considered as part of FSIS's annual assessment of country
performance, countries that are currently eligible to export meat,
poultry, and egg products to the United States must submit their
completed SRTs to FSIS before May 18 of 2015 and annually before May 18
thereafter. FSIS will send SRTs to all countries currently eligible to
export meat, poultry, and egg products to the United States on December
1 of each year in the future.
Countries applying for initial equivalence determinations after
February 23, 2015 must submit their completed SRTs within one year of
receiving the SRT.
FOR FURTHER INFORMATION CONTACT: Dr. Daniel L. Engeljohn, Assistant
Administrator, Office of Policy and Program Development; Telephone:
(202) 205-0495.
SUPPLEMENTARY INFORMATION:
Background
In a notice published in the Federal Register of January 25, 2013
(78 FR 5409) (hereafter ``the Federal Register notice''), FSIS
described how it conducts ongoing equivalence verifications of the food
regulatory systems of countries that export meat, poultry, or processed
egg products to the United States. FSIS uses a three-part approach that
includes (1) document reviews, (2) on-site system audits, and (3) POE
reinspections. FSIS determines the scope and frequency of on-site
systems audits based on its analysis of the results of its document
reviews and ongoing assessment of a country's performance. This
performance-based approach allows FSIS to direct its audit resources to
foreign food regulatory systems that appear to pose a greater risk to
public health than other foreign systems.
FSIS invited interested persons to submit comments on its new
methodology by March 26, 2013. FSIS received approximately 31 comments
from foreign countries, trade consulting groups, consumer groups,
private citizens, a trade association representing the meat industry,
and a member of the U.S. Congress. Twelve of those comments concerned
the Agency's document review process. In this notice, FSIS is
responding only to the comments that it received on its document review
process. A summary of comments on the Agency's document review process
and the Agency's responses are below. The Agency will address the other
comments in a future Federal Register document.
On the basis of information provided by commenters, FSIS's
experience in conducting document reviews, and the Agency's analysis of
available SRT data, FSIS has decided to make two changes to its
document review process. The changes are explained below and are
discussed in more detail in the Agency's responses to comments.
Improvements to the Document Review Process
A foreign country interested in exporting to the United States is
required to submit information concerning its food regulatory system to
FSIS (see 9 CFR 327.2(a)(2)(iii), 381.196(a)(2)(iii), and 590.910). As
explained in the January 2013 Federal Register notice, FSIS uses the
equivalence questionnaire, called the SRT, to collect this information
for the Agency's document review of the food regulatory system of
foreign countries that are listed in the regulations as eligible to
export meat, poultry, or egg products to the United States and for
countries interested in becoming eligible (78 FR 5411). The SRT is a
repository for key documents about a foreign food safety inspection
system (e.g., inspection system laws, regulations, and policy
issuances) that FSIS uses, in addition to on-site audits, to verify
whether the laws, regulations, and implementing policies of a foreign
country establish an inspection system that is equivalent to the U.S.
system. It also allows FSIS to evaluate whether a country maintains
system effectiveness and to assess any impacts that an administrative
or legislative change has had on a foreign food regulatory system. FSIS
conducts a document review at least annually.
The information in the SRT allows FSIS to conduct a comprehensive
assessment of a foreign country's food safety regulatory system. These
comprehensive assessments inform the Agency's determination of whether
a country's system should be found equivalent and the country eligible
to export product into the United States. FSIS also assesses
information in the SRT on an ongoing basis to verify whether a country
maintains equivalence.
In the past, the SRT was available in a Microsoft Word format, and
once completed by the country, it was submitted to FSIS along with
corresponding supporting documentation either by mail or email
communication. A PDF copy of the Microsoft Word version of the SRT is
available on FSIS's Web site at: http://www.fsis.usda.gov/wps/wcm/
connect/
[[Page 9429]]
7893547e-d0d2-4fa9-a984-fdc17228bfcd/SRT.pdf?MOD=AJPERES. On February
17, 2015, FSIS will launch a Web-based version of the SRT within its
Public Health Information System (PHIS) to more efficiently capture up-
to-date information about foreign food regulatory systems. PHIS is a
comprehensive Web-based data-analytics and inspection system that
automates and replaces many of FSIS's paper-based processes.
The Web-based SRT will be beneficial for countries exporting meat,
poultry, and egg products to the United States; countries interested in
exporting product to the United States and applying for equivalence;
and FSIS personnel. With the Web-based SRT, countries can link
supporting documentation to each question. With the Microsoft Word
version, the supporting documentation is provided as a supplement to
the SRT. As a result, during the review process, FSIS must sift through
documents to match up information with the corresponding questions in
the SRT. FSIS anticipates that use of the Web-based SRT will decrease
the time it takes the Agency to review an SRT submission and thereby
allow for a quicker response to an equivalence request.
Using PHIS as a platform for the SRT allows for a more secure
exchange of information between FSIS and foreign countries because
countries will be accessing the SRT through a secure USDA Web site that
requires a unique ID and password acquired through an authentication
process. To guarantee that the security of the Web-based SRT in PHIS is
maintained and to gain access to the system, each potential user will
have to register for a USDA eAuthentication (eAuth) Level 2 account and
complete the authentication process. FSIS will send a letter to foreign
countries with instructions on obtaining an eAuth account and using the
Web-based version of the SRT. FSIS strongly encourages countries to use
the Web-based SRT. However, the use of the Web-based SRT is voluntary,
and FSIS will continue to accept the current Microsoft Word version of
the SRT. To ensure that the transition to the Web-based SRT is as
seamless as possible, FSIS pre-entered into PHIS the SRT responses and
supporting documentation that countries actively exporting meat,
poultry, or egg products to the United States have provided to FSIS.
FSIS requests that countries review the pre-entered responses for
completeness and accuracy.
In addition to a Web-based version of the SRT, foreign countries
will note that the revised SRT asks fewer and more targeted questions
necessary for FSIS to verify system equivalence. FSIS expects countries
to answer all the targeted questions in the SRT to facilitate the
review process. FSIS may not be able to make an equivalence
determination without answers to all of these questions.
The SRT also includes questions for FSIS to use in assessing how
frequently to conduct on-site audits of the country. FSIS refers to
these questions as level of advancement (LOA) questions. As explained
in the Federal Register notice, the sum of the LOA responses is one of
the factors that FSIS considers as part of an annual analysis of
country performance to determine the frequency and scope of on-site
audits (78 FR 5412). FSIS uses the results from the analysis to place
exporting countries into one of three categories, based on food safety
performance, with corresponding audit frequencies: Well-performing
countries are to be audited every three years.
Average-performing countries are to be audited every two years.
Adequately-performing countries are to be audited every year. Thus, the
completeness of a country's SRT contributes to FSIS's assessment of
that country's performance and to FSIS's determination of the
appropriate audit frequency for that country. Countries with incomplete
SRTs will not be considered ``well-performing'' because they will not
have provided the Agency enough information to give the Agency
confidence in their food safety systems. FSIS will provide more
information on LOAs in a subsequent Federal Register notice that
addresses all comments received in the January 2013 Federal Register
notice and provides additional updates on the FSIS equivalence
determination process.
To ensure that a complete and up-to-date SRT is being considered as
part of FSIS's annual assessment of country performance, countries must
submit their completed SRTs to FSIS before May 18, 2015, and on an
annual basis moving forward. If a country submits partial or inaccurate
information, FSIS personnel will follow up with additional questions
until all outstanding issues are resolved. FSIS must have complete and
accurate information to verify that the foreign country's food
regulatory system is robust, transparent, and science-based. If a
country does not provide FSIS with documentation showing its system is
equivalent, or if it continues to submit inadequate documentation, FSIS
will not have sufficient information to determine the viability of the
food safety system and may have to pursue a series of actions directed
at product presented for reinspection (e.g., intensified testing for
microbial adulterants, indicator organisms, chemical residues, or
species) to address the absence of a government-supplied explanation of
inspection system controls. In addition, FSIS likely would begin
refusing to list establishments newly certified by the foreign
government, or to relist certified establishments, because of a lack of
confidence in the government-supplied explanation of its inspection
system. FSIS may conduct specially designed in-country audits to obtain
information. FSIS may, within a reasonable period of time, refuse entry
to products exported from that country. Finally, if it becomes
necessary, FSIS will take steps to remove the country from the list of
countries eligible to export meat, poultry, or processed egg products.
Any country can apply for eligibility to export meat, poultry, or
egg products to the United States. The application process begins with
a letter to FSIS from a foreign country asking for consideration to
export its products for sale in the United States. FSIS responds to
these letters with a standard package that contains information on the
SRT and information on gaining eAuthentication. More information on how
to apply for initial equivalence is available on FSIS's Web site at:
http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/equivalence/equivalence-process-apply-for-initial-equivalence.
FSIS asks that a foreign country applying for initial equivalence
submit a complete SRT to FSIS in PHIS within one year of receiving the
questionnaire. If FSIS needs additional information, or if FSIS's
regulations change, the Agency will request that the country update its
SRT to provide additional information to demonstrate that the country
has an equivalent food regulatory system to the United States' system.
If FSIS's document review supports that the foreign country's food
regulatory system may be equivalent to the United States' system, the
Agency will conduct an on-site audit.
However, if a foreign government applying for initial equivalence
does not submit a complete SRT or fails to respond to additional
requests for information within one year of receiving the SRT, FSIS
will not be able to determine that the country maintains an inspection
system equivalent to FSIS's system and will discontinue its analysis.
FSIS will accept information submitted in any one of the three
official languages of the World Trade Organization (WTO)--English,
French, or Spanish. Please note that it may take
[[Page 9430]]
the Agency a longer period of time to review documents submitted in
French or Spanish because the information will have to be translated.
Summary of Comments
Comment: Several commenters were pleased to see improvements in the
document review process; however, they asked FSIS to provide more
guidance on how the SRT will be used. They also asked the Agency to
share the content of the SRT with the public. A few commenters asked
FSIS to clarify whether the document review process is limited to the
information collected in the SRT, or if it also includes information
from other sources. The commenters asked FSIS to explain how data
outside the SRT would be used in the document review process, how the
Agency would validate the quality of data, and how often FSIS would
collect and use the data. One commenter stated that both the National
Advisory Committee on Meat and Poultry Inspection's (NACMPI's)
recommendations and the Codex document cited in the Federal Register
notice (78 FR 5409) support third-party audits as a means of informing
importing countries about the knowledge, experience, and confidence of
an exporting country's food regulatory system.
Response: The SRT is used to inform a determination that a country
has or has not met the United States' level of protection and is
eligible to export product into the United States. It is reviewed on an
ongoing basis to verify whether the country maintains equivalence. FSIS
requires countries to update the SRT at least annually and as changes
are made in the foreign country's food regulatory system.
FSIS personnel may review outside information, such as third-party
audit reports, in preparation for an on-site audit (see FSIS Notice 35-
14, Ongoing Foreign Equivalence Verification Audits). The outside
information could affect the scope of an on-site audit.
Comment: Two commenters were concerned about the amount of time it
takes to complete the SRT. One commenter asked FSIS to reduce the
number of questions in the SRT. Another commenter requested that FSIS
limit the level of detail required for responses. The commenter stated
that the SRT focuses too much on individual components of the foreign
inspection system, rather than taking a more holistic approach to
assessing whether defined food safety outcomes are met. The commenter
recommended that FSIS focus more on an evaluation of whether food
safety and suitability outcomes have been achieved rather than whether
various activities and processes have been replicated. The commenter
suggested that FSIS change the design of the SRT so that it is more
like the ``outcome-focused'' design of the United States Food and Drug
Administration's (FDA's) International Comparability Tool.
Response: FSIS reduced the number of questions in the SRT to focus
on those most necessary to determine or to verify whether a country's
food regulatory system is equivalent and those necessary to help inform
the necessary on-site audit frequency. In the past, the SRT included
approximately 500 questions. The new, streamlined version has
approximately 200 questions. Foreign countries may receive fewer
questions depending on the number of classes of products produced.
In addition, the Web-based version of the SRT is more accessible.
Foreign countries will be able to log onto PHIS at any time to view and
update their responses and supporting documentation. Countries will
also be able to view the status of their individual SRT, as well as a
date and time stamp for each status update.
FDA's International Comparability Tool does not provide the
information that FSIS needs to verify that a foreign country's food
regulatory system is equivalent to FSIS's system. The SRT focuses on
individual components of a foreign food regulatory system and compares
them to components within FSIS's regulations because the Acts and
regulations (9 CFR 372.2, 381.196, and 590.910) require that foreign
countries maintain equivalent requirements to those that apply to
United States domestic meat, poultry, and egg products.
Comment: A few commenters stated that FSIS's review of information
in the SRT should not be a substitute for on-site audits by FSIS
because countries may not always report information fully or
accurately. The commenters argued that FSIS will be forced to rely more
heavily on self-reported data from countries, as well as POE
reinspections, and that these data sources are not an adequate
substitute for in-person inspection.
Response: The SRT is not a substitute for on-site audits. The SRT
is one of three components to FSIS's equivalence process. As mentioned
above and in the January 2013 Federal Register notice, the SRT provides
FSIS with initial information that is verified through periodic on-site
audits and POE reinspections (78 FR 5411). FSIS will get more accurate
information through the SRT that will better inform FSIS's audit
scheduling. In addition, information from the SRT may be used to inform
reinspection assignments. For example, based on information from the
SRT, FSIS may perform targeted testing for residues or pathogens in
product from certain countries.
It should also be noted that every country now eligible to export
meat, poultry, or egg products to the United States has a food
inspection system that FSIS has determined to be equivalent to the FSIS
domestic inspection system. FSIS is committed to protecting the health
of U.S. consumers, and it will continue to make every effort to ensure
that meat, poultry, and egg products imported into the United States
are as safe as products produced in this country.
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: [email protected].
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
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication on-line through the FSIS Web page located at:
http://www.fsis.usda.gov/federal-register.
FSIS also will make copies of this publication available through
the FSIS Constituent Update, which is used to provide information
regarding FSIS
[[Page 9431]]
policies, procedures, regulations, Federal Register notices, FSIS
public meetings, and other types of information that could affect or
would be of interest to our constituents and stakeholders. The Update
is available on the FSIS Web page. Through the Web page, FSIS is able
to provide information to a much broader, more diverse audience. In
addition, FSIS offers an email 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,
regulations, directives, and notices. Customers can add or delete
subscriptions themselves, and have the option to password protect their
accounts.
Done in Washington, DC on: February 18, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-03576 Filed 2-20-15; 8:45 am]
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