80 FR 9428 - Document Reviews of Foreign Food Regulatory Systems: New Web-based Self-Reporting Tool

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

Federal Register Volume 80, Issue 35 (February 23, 2015)

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.

[Federal Register Volume 80, Number 35 (Monday, February 23, 2015)]
[Notices]
[Pages 9428-9431]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03576]


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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]
BILLING CODE 3410-DM-P