Ongoing Equivalence Verifications of Foreign Food Regulatory Systems, 5409-5413 [2013-01511]

Agencies

• DEPARTMENT OF AGRICULTURE
• Food Safety and Inspection Service

[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Notices]
[Pages 5409-5413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01511]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2012-0049]


Ongoing Equivalence Verifications of Foreign Food Regulatory 
Systems

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is describing 
the new methodology it is employing to conduct ongoing equivalence 
verifications of the 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) port-of-entry (POE) reinspections. FSIS conducts 
document reviews at least yearly. FSIS conducts on-site system audits 
at least once every three years. FSIS determines the scope and

[[Page 5410]]

frequency of on-site systems audits and POE reinspections through 
analysis of the results of its document reviews and an assessment of a 
country's performance. This performance-based approach allows FSIS to 
direct its resources to foreign food regulatory systems that pose 
greater risk to public health compared to others; make its 
international program more consistent with its domestic inspection 
system; and improve the linkage between POE reinspections and on-site 
audits. As a result, FSIS is able to effectively prevent unsafe imports 
from entering this country.

DATES: Comments on this notice should be received by March 26, 2013.

ADDRESSES: FSIS invites interested persons to submit comments on 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, including 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 8-163A, 
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-2012-0049. 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 comments received, go 
to the FSIS Docket Room at Patriots Plaza 3, 355 E. Street SW., Room 8-
164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT: Mary Stanley, Director, International 
Policy Division, Office of Policy and Program Development, FSIS, USDA, 
South Agriculture Building, Room 2925, 1400 Independence Avenue SW., 
Washington, DC 20250; Telephone: (202) 720-0287, Fax: (202) 720-4929 or 
Email: mary.stanley@fsis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

    The Federal Meat Inspection Act (FMIA) (21 U.S.C. 620) and the 
Poultry Products Inspection Act (PPIA) (21 U.S.C. 466) prohibit the 
importation of meat and poultry products into the United States if such 
products are adulterated or misbranded, and unless they comply with all 
the inspection and other provisions of the Acts and regulations that 
are applied to U.S. domestic products. The Egg Products Inspection Act 
(EPIA) (21 U.S.C. 1046) prohibits the importation of egg products 
unless they have been processed under an approved continuous inspection 
system of the government of the foreign country of origin and comply 
with all other provisions of the Act and regulations that apply to U.S. 
domestic products.
    The USDA has had a comprehensive program to assess foreign meat and 
poultry establishments since 1967. Initially, the Department inspected 
certified foreign establishments to determine whether they were ``at 
least equal to'' comparable U.S. establishments. Department officials 
were stationed in Washington, DC, Argentina, Costa Rica, Australia, New 
Zealand, Denmark, Germany, Belgium, and Canada. This program continued 
until 1988, when it was substantially revised, and all overseas 
auditors were recalled to Washington, DC. On-site establishment 
inspections continued under the revised program based upon past on-site 
audit findings and POE reinspection results.
    In 1994, the concept of equivalence was introduced in the Agreement 
on the Application of Sanitary and Phytosanitary Measures (the SPS 
Agreement), which appears in the Final Act of the Uruguay Round of 
Multilateral Trade Negotiations signed in Marrakech. The SPS Agreement 
became effective in January 1995, concurrently with establishment of 
the World Trade Organization (WTO), which superseded the General 
Agreement on Tariffs and Trade (GATT) as the umbrella organization for 
international trade. Because the U.S. is a signatory to the SPS 
Agreement and a member of the WTO, FSIS amended its regulations to 
require foreign meat and poultry food regulatory systems to be 
``equivalent to'' comparable U.S. requirements (60 FR 38667; July 28, 
1995).
    In the late-1990's, FSIS shifted the emphasis of its on-site audits 
from inspecting establishments to assessing a country's food regulatory 
system. This change was announced in the Federal Register on December 
17, 1999 (64 FR 70690; December 17, 1999). Under this approach, the 
scope of on-site audits was broadened to include country laws and 
documents related to program implementation; records of establishment 
operations, inspection results, and enforcement activities; chemical 
residue controls from farm to slaughter; microbiological and chemical 
testing programs; laboratory support, sampling programs, and sampling 
and testing methodologies; and other U.S. import requirements such as 
pathogen reduction and HACCP programs.
    Statutory requirements for equivalence are set forth in 9 CFR 327.2 
for meat products, 9 CFR 381.196 for poultry products, and 9 CFR 
590.910 for egg products. FSIS has categorized these requirements into 
six ``equivalence components.'' Specifically, FSIS evaluates a 
country's national government to ensure that it is imposing equivalent 
requirements with respect to: (1) Government oversight, (2) statutory 
authority and food safety regulations, (3) sanitation, (4) hazard 
analysis and critical control points (HACCP), (5) chemical residues, 
and (6) microbiological testing programs. This comprehensive process is 
described fully on the FSIS Web site at https://www.fsis.usda.gov/pdf/eqprocess.pdf.
    Any country can apply for eligibility to export meat, poultry, or 
egg products to the U.S. Based on its review of the information and 
documentation that the country submits, FSIS decides whether the 
foreign country's food regulatory system meets all U.S. import 
requirements in the same or an equivalent manner and cumulatively 
provides the same level of public health protection as that attained 
domestically. If so, FSIS plans an on-site audit of the entire foreign 
meat, poultry, or egg products regulatory system. When both the 
document analysis and on-site audit review show that the country meets 
U.S. requirements, FSIS publishes a proposed rule in the Federal 
Register that announces the results of the first two steps and proposes 
to add the country to its list of eligible exporting countries in the 
regulations. After analysis of public comments, FSIS makes a final 
decision about whether the country's system is equivalent based upon 
all available information and publishes a final rule in the Federal 
Register announcing its determination on country eligibility.
    Once a foreign country's inspection system is deemed equivalent,\1\ 
FSIS

[[Page 5411]]

continues to evaluate the country's inspection system to ensure 
equivalence is maintained. FSIS performs this activity through a three-
part process, involving: (1) Document reviews, (2) on-site system 
audits, and (3) POE reinspections.
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    \1\ FSIS regulations list 46 countries as eligible to export 
meat, nine countries as eligible to export poultry, and two 
countries as eligible to export egg products to the United States 
(see 9 CFR 327.2(b), 381.196(b), and 590.910(b)). However, some of 
these countries have outstanding issues that will require additional 
document submission and review, as well as on-site equivalence 
verification prior to resuming exports. In 2012, only 29 countries 
actively exported meat, poultry, and egg products to the United 
States. FSIS maintains a list of eligible countries, along with 
their status and whether they are approved to export meat, poultry, 
and egg products to the United States: https://www.fsis.usda.gov/pdf/Countries_Products_Eligible_for_Export.pdf.
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    In 2008, FSIS held a public meeting with the National Advisory 
Committee on Meat and Poultry Inspection (NACMPI) to review and discuss 
international equivalence and the approach to verifying the equivalence 
of foreign food regulatory systems as the means of ensuring the safety 
of imported food products (73 FR 48190; August 18, 2008). FSIS 
requested NACMPI's guidance on: (1) Whether elements of the ``triad of 
protection'' (i.e., document reviews, on-site audits, and POE 
reinspections) should be changed; (2) Whether regulatory information 
and compliance history from foreign countries should affect audits and 
re-inspections; and (3) Whether the scope and frequency of on-site 
audits and POE re-inspections should be adjusted based on the 
capability of a country to share useful regulatory information and 
compliance history.
    After reviewing all comments and materials presented at the 
meeting, NACMPI recommended that FSIS maintain its three-part approach 
to equivalence but direct Agency resources according to the relative 
risks and historical compliance presented by each foreign food 
regulatory system. NACMPI stated that considering the foreign food 
regulatory system's past performance provides a more objective and 
efficient method of allocating FSIS resources to address food safety 
risks and public health concerns than conducting annual on-site audits. 
NACMPI also recommended that FSIS standardize its methods for the 
collection of information from foreign governments, collaborate with 
the Codex Alimentarius Commission (CODEX) concerning the Codex 
Committee on Food Import and Export Inspection and Certification 
Systems' new work on guidance for on-site audits,\2\ and incorporate 
specific elements into its ongoing verification activities. These 
specific elements included the use of the three-tiered approach based 
on risk. With respect to audits, NACMPI recommended the standardized 
application of on-site audit criteria and an historical evaluation of 
the trading country's on-site audit outcomes. As for document reviews, 
it recommended an assessment of the exporting country's on-going 
ability and willingness to share data, as well as the quality of data 
shared. Finally, with respect to POE re-inspections, NACMPI recommended 
the targeting of high-risk product and high-risk imports for sampling 
and other verification activities during reinspection. NACMPI also 
recommended that FSIS maintain open communication with all involved in 
the import process.
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    \2\ Guidelines for the Design, Operation, Assessment and 
Accreditation of Food Import and Export Inspection and Certification 
(CAC/GL 26-1997).
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New Approach

    In 2009, in response to NACMPI's recommendations, FSIS modified its 
three-part method for verifying the equivalence of foreign food 
regulatory systems by developing a performance-based approach for 
determining the scope and frequency of its on-site systems audits and 
POE reinspections. Thus, FSIS transitioned from an annual on-site audit 
to less frequent on-site audits based on performance. FSIS makes 
information about all on-site audits available to the public on its Web 
site.
    It took FSIS some time to work through the mechanics of this 
transition. Fully training its auditors and other aspects of the 
transition occurred over a period of years rather than on a fixed date. 
Preparation of this notice to announce this transition also took longer 
than contemplated. Now that the transition is fully in place, FSIS is 
announcing it to the public.

Document Reviews

    As part of the transition, FSIS developed the Self-Reporting Tool 
(SRT), which structures the criteria used to assess each component of 
initial and on-going equivalence through a series of questions. FSIS 
uses the SRT to collect information for the Agency's document review of 
a foreign country's food safety system. FSIS conducts these document 
reviews at least annually. Along with responses to the questions in the 
SRT, FSIS asks exporting countries to submit their inspection system 
laws, regulations, and policy issuances to support their answers. FSIS 
asks countries to update this information as changes in U.S. domestic 
policy warrant the need for additional information from foreign 
governments to demonstrate that an equivalent inspection system is 
being maintained, or as changes are made in the foreign country's 
system. Also through the SRT, FSIS requests that foreign governments 
report what actions they take when non-compliant products are shipped. 
The SRT affords countries the opportunity to advise FSIS of any new 
controls they have implemented since their last submission (e.g., 
microbial baseline studies, ongoing risk assessments, internal audit 
programs) to demonstrate the effectiveness of their food safety 
regulatory systems.
    The SRT represents a significant improvement over the collection 
mechanisms used by FSIS in the past. FSIS previously used the Self-
Assessment Tool (SAT), which was limited to initial equivalence 
requests and not updated on a regular basis. Unlike the SAT, the SRT 
collects information for both the initial and ongoing equivalence 
verification processes. Doing so makes it easier for countries to 
update their information. In addition, it allows FSIS to standardize 
its collection of information. This standardization improves the 
quality of information that FSIS receives and, thus, improves FSIS's 
ability to evaluate a country's performance.
    The SRT permits FSIS to identify key documents on which to evaluate 
system effectiveness and to assess any impacts that an administrative 
or legislative change has had on a foreign regulatory system. It also 
enables FSIS to monitor corrective actions that countries take in 
response to shipping non-compliant product to the U.S. The current and 
detailed information that the SRT provides allows FSIS to conduct more 
comprehensive assessments of foreign countries' food safety regulatory 
systems while remaining at USDA Headquarters in Washington, DC. These 
comprehensive assessments allow FSIS to use its resources more 
effectively and efficiently, both on and off site, while still ensuring 
the safety of imported products.

On-Site Systems Audits

    Under this new approach, FSIS conducts on-site audits of countries 
eligible to export product to the U.S. at least once every three years. 
The new approach provides for at least the same level of public health 
protection as FSIS's previous approach with annual on-site audits. 
During an on-site systems audit, an FSIS auditor (or an audit team, 
when necessary) verifies that the national government is adequately 
implementing the country's food safety laws and regulations, and that 
through its oversight of its inspection personnel, the government is 
verifying that establishments' process controls (e.g.,

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laboratory testing programs, sanitation standard operating procedures, 
and HACCP) are effective. When the FSIS auditor determines that 
controls are not being implemented as designed, and there is 
significant question as to whether the products produced are safe, 
unadulterated, and properly labeled and packaged, he or she takes 
appropriate action.
    The frequency and scope of on-site audits are based on the results 
of FSIS's country performance assessment. The performance assessment 
focuses on each eligible country's overall food safety performance 
relative to the performance of other eligible countries. The first step 
in the assessment is a statistical analysis of compliance data from POE 
reinspections and previous on-site audits of the country's government 
offices, establishments, and laboratories. Because a single, composite 
measure cannot completely characterize a country's performance, FSIS 
incorporates a number of supplemental, qualitative factors into its 
assessment.
    The supplemental factors are derived from the Codex Alimentarius 
Commissions' Guidelines on the Judgment of Equivalence of Sanitary 
Measures associated with Food Inspection and Certification systems 
(CAC/GL 53-2003), and the principles outlined in the joint Food and 
Agricultural Office of the United Nations (FAO) and World Health 
Organization (WHO) publication Assuring Food Safety and Quality: 
Guidelines for Strengthening National Food Control Systems.\3\ These 
factors include: The results of audits, inspections, and field 
examinations conducted by FSIS and third countries; the use of risk 
analysis principles; the impact of organizational, structural, or 
administrative change in an exporting country's competent authority; 
the availability of contingency plans in the country for containing and 
mitigating the effects of food safety emergencies; the competent 
authority's willingness and ability to take appropriate actions to 
manage food safety incidents; and the effectiveness of foodborne 
disease surveillance systems. For each supplemental factor, FSIS 
assigns a level of advancement (LOA) to measure the foreign food 
regulatory system's ability to demonstrate compliance with that 
supplemental factor. FSIS assigns countries LOA levels 1, 2, or 3, with 
3 being the highest level.
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    \3\ FAO/WHO. 2003. Assuring Food Safety and Quality: Guidelines 
for Strengthening National Food Control Systems. Food and Nutrition 
Paper No. 76. Food and Agriculture Organization of the United 
Nations. Rome, Italy (available at: https://www.who.int/foodsafety/publications/fs_management/guidelines_foodcontrol/en/).
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    For example, one supplemental factor that FSIS evaluates is whether 
the Agency has knowledge that an exporting country applies risk 
analysis principles in its food safety system. A country that could not 
demonstrate that its risk management decisions are generally supported 
by a scientific risk assessment would receive a level one LOA. A 
country that could demonstrate that its risk management decisions are 
generally supported by scientific principles and evidence, including 
risk assessments, would receive a level two LOA. A country that could 
demonstrate that it consistently bases its risk management decisions on 
risk assessments would receive a level three LOA.
    FSIS uses the statistical analysis results and the LOA assignments 
to characterize a country's recent food safety performance as well-
performing, average-performing, or adequately-performing (i.e., the 
country is eligible to export meat, poultry, and egg products to the 
U.S., but its performance has not reached the same level of confidence 
as that of its peers).
    In general, countries that are performing well receive less 
frequent, more narrowly defined on-site audits, while ``adequately-
performing'' countries receive more frequent and more comprehensive 
audits. FSIS selects the specific facilities to be audited (i.e., 
government offices, establishments, and laboratories) by evaluating the 
volume of products that are produced, the relative hazards associated 
with those products, the government's compliance history, and previous 
POE reinspection results. When selecting establishments to visit during 
an on-site systems audit, FSIS directs its resources to establishments 
with larger production volumes, that produce product associated with a 
higher level of risk,\4\ that produce product identified during 
previous on-site audits as being non-compliant, or that produce product 
for which there were positive microbiological or residue POE 
reinspection results.
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    \4\ For example, raw ground beef is considered to be a 
``riskier'' product than raw intact beef because the contaminated 
meat surface is broken into small fragments and spread throughout 
the ground product.
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    As noted above, FSIS schedules on-site systems audits at a minimum 
frequency of once every three years. Under this approach, adequately 
performing countries receive audits every year, average-performing 
countries receive audits every two years, and countries that are 
performing well receive audits every three years. This frequency is 
based on NACMPI's recommendation that FSIS adopt a risk-informed 
approach. It is also based on FSIS's determination, in light of the 
audits that it has conducted over the years, that annual visits are not 
necessary to countries whose systems are performing in an average way 
or well. Visits every two or three years to these countries, given the 
other information that is available to FSIS, provide the necessary 
assurance that products of these foreign systems generally will be 
safe, unadulterated, and properly labeled and packaged. FSIS welcomes 
comment on this judgment.
    In addition to the periodic audits, FSIS conducts more targeted 
``for cause'' audits. The Agency conducts these audits in response to 
repetitive POE findings of public health significance or other 
conditions representing a lack of process control within a country's 
food safety system.

POE Reinspections

    FSIS's POE activities monitor the effectiveness of exporting 
countries' inspection systems and overall food safety programs. All 
shipments of meat, poultry, and egg products that enter the U.S. must 
be presented to an FSIS inspector either at one of the approximately 
130 official FSIS import facilities located at major ocean ports and 
land border crossings, or at an alternative location designated by the 
Agency (see 9 CFR 327.6, 381.199, and 590.925). FSIS reinspects every 
shipment for eligibility through certification by the national 
government, acceptable condition of the product, and labeling 
compliance. In addition, FSIS performs more detailed, random 
reinspections that include physical examination of product and of 
hermetically sealed containers, as well as microbiological and chemical 
testing. If products meet FSIS's standards, they are marked as 
``Inspected and Passed'' and released into U.S. commerce. However, if 
FSIS identifies non-compliant products, it notifies both the government 
of the country that exported the products and the importer, marks the 
products as ``Refused Entry,'' and prohibits the products from entering 
U.S. commerce.
    In order to focus its resources on the products that may pose the 
greatest threat to public health, FSIS uses the country performance 
assessment described above, and other factors such as product type and 
species, to determine the scope and frequency of the randomly assigned 
POE activities such as pathogen testing, food chemistry

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sampling, and species verification. In addition, on May 29, 2012, FSIS 
launched a comprehensive, Web-based data analytics system called the 
Public Health Information System (PHIS) as part of its efforts to 
collect, consolidate, and analyze data. PHIS builds upon the previous 
Automated Import Inspection System (AIIS) used by FSIS since 1979 
through the increased integration of FSIS's existing data streams. PHIS 
also enables FSIS to collect information from external sources through 
an electronic interface with Customs and Border Protection's Automated 
Commercial Environment (ACE), including foreign government electronic 
certification systems. These enhancements further support a 
performance-based approach to POE reinspection.
    As with AIIS, PHIS automatically schedules a more intensive 
reinspection (i.e., increased follow-up sampling) of shipments from 
foreign establishments that produce products failing reinspection at 
POE, or products identified as the sole raw material source for ground 
beef that has tested positive for pathogenic STEC in the U.S. PHIS 
provides the ability to automatically adjust frequencies for pathogen 
testing, food chemistry sampling, and species verification based on a 
particular countries performance classification.
    If non-compliant imported shipments are detected, FSIS works with 
the government of the country that exported the product to ensure that 
appropriate corrective actions are effected. As indicated previously, 
the foreign government reports through the SRT what actions it will 
take when non-compliant products are shipped. That information serves 
as the basis for FSIS's follow-up verification activities.
    If a country makes any modifications to its inspection system, FSIS 
requires that the country update its responses to FSIS's SRT 
accordingly (see 9 CFR 327.2(a)(2)(iii), 381.196(a)(2)(iii), and 
590.910(a)). Changes to the SRT may affect the results of a country's 
performance assessment, which then may affect the scope and frequency 
of subsequent equivalence verification activities. Thus, FSIS's 
performance-based approach improves the linkage between POE 
reinspections and on-site audits.
    Furthermore, if repeated failures from a particular establishment 
indicate a loss of process control, and FSIS finds that the foreign 
country's corrective actions are not effective, FSIS will take action 
to suspend the eligibility of the establishment and may conclude that a 
``for cause'' on-site audit is necessary. When multiple establishments 
in a country repeatedly fail POE reinspections, FSIS will consider 
elevating its action to a system level that could affect the 
eligibility of the foreign inspection system.

Additional Public Notification

    FSIS will announce this notice on-line through the FSIS Web page 
located at https://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.
    FSIS also will 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 available on the FSIS Web 
page. Through the Listserv and the Web page, FSIS is able to provide 
information to a much broader and 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 https://www.fsis.usda.gov/News_&_Events/Email_Subscription/. 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.

USDA Nondiscrimination Statement

    The U.S. Department of Agriculture (USDA) prohibits discrimination 
in all its programs and activities on the basis of race, color, 
national origin, gender, religion, age, disability, political beliefs, 
sexual orientation, and marital or family status. (Not all prohibited 
bases apply to all programs.)
    Persons with disabilities who require alternative means for 
communication of program information (Braille, large print, audiotape, 
etc.) should contact USDA's Target Center at 202-720-2600 (voice and 
TTY).
    To file a written complaint of discrimination, write USDA, Office 
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue 
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY). 
USDA is an equal opportunity provider and employer.

    Done in Washington, DC, on January 18, 2013.
Alfred V. Almanza,
Administrator.
[FR Doc. 2013-01511 Filed 1-24-13; 8:45 am]
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