[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Proposed Rules]
[Pages 47528-47532]
From the Federal Register Online via the Government Publishing Office [http://www.gpo.gov/]
[FR Doc No: 2018-20376]



Food Safety and Inspection Service

9 CFR Part 557

[Docket No. FSIS-2018-0029]
RIN [0583-AD74]

Eligibility of the Socialist Republic of Vietnam To Export 
Siluriformes Fish and Fish Products to the United States

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.


SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
amend the Siluriformes fish inspection regulations to list the 
Socialist Republic of Vietnam (Vietnam) as a country eligible to export 
Siluriformes fish and fish products to the United States. FSIS is 
proposing this action because the Agency has reviewed Vietnam's laws, 
regulations, and inspection system as implemented and has determined 
that Vietnam's Siluriformes fish inspection system is equivalent to the 
system that the United States has established under the Federal Meat 
Inspection Act (FMIA) and its implementing regulations.
    Under this proposal, only raw Siluriformes fish and fish products 
produced in certified Vietnamese establishments would be eligible for 
export to the United States. All such products would continue to be 
subject to re-inspection at U.S. points-of-entry by FSIS inspectors.

DATES: Submit comments on or before October 19, 2018.

ADDRESSES: FSIS invites interested persons to submit comments on the 
proposed rule. Comments may be submitted by one of the following 
     Federal eRulemaking Portal: This website 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, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, 1400 
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
     Hand- or courier-delivered submittals: Deliver to 1400 
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2018-0029. 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 comments received, 
call (202)720-5627 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700.

Administrator, Office of Policy and Program Development; Telephone: 
(202) 205-0495.



    FSIS is proposing to amend its regulations at 9 CFR 557.2(b)(1) to 
add Vietnam as a country eligible to export Siluriformes fish and fish 
products to the United States (for convenience, in this proposed rule, 
``Siluriformes fish and fish products'' will be shortened to 
``Siluriformes fish''). Although Vietnam has been allowed to export 
these products to the United States under the conditions described 
below, Vietnam is not currently listed in the Code of

[[Page 47529]]

Federal Regulations (CFR) as eligible to export Siluriformes fish to 
the United States.

Transitional Period

    On December 2, 2015, FSIS published the final rule, ``Mandatory 
Inspection of Fish of the Order Siluriformes and Products Derived from 
Such Fish'' (80 FR 75590). The final rule established a mandatory FSIS 
inspection system for fish of the order Siluriformes and products 
derived from these fish. The final regulations implemented the 
provisions of the 2008 and 2014 Farm Bills, which amended the FMIA, 
mandating FSIS inspection of Siluriformes fish.
    The final rule provided an 18-month period, from March 1, 2016, to 
September 1, 2017, for both the U.S. domestic Siluriformes fish 
industry and international trading partners to transition from the 
regulatory requirements of the U.S. Food and Drug Administration (FDA), 
the agency formerly responsible for regulatory oversight of 
Siluriformes fish, to the regulatory requirements of FSIS. By March 1, 
2016, FSIS required foreign countries to submit written documentation 
identifying a list of establishments that had been exporting and would 
continue exporting Siluriformes fish to the United States. In addition, 
by March 1, 2016, FSIS required foreign countries to submit written 
documentation to demonstrate that they had laws or other legal measures 
in place that provide authority to regulate the growing and processing 
of fish for human food, and to assure compliance with FDA's good 
manufacturing practices, Hazard Analysis and Critical Control Point 
(HACCP) requirements, sanitation control procedures, and other 
regulatory requirements in 21 CFR part 123, Fish and Fishery Products.
    FSIS recognized the foreign countries' initial documentation until 
the end of the transitional period on September 1, 2017. Foreign 
countries that wished to continue exporting after September 1, 2017, 
were required to submit documentation substantiating the equivalence of 
their Siluriformes fish inspection system to that of the United States. 
Foreign countries that submitted complete equivalence documentation by 
September 1, 2017, were permitted to continue exporting Siluriformes 
fish until such time that FSIS determines if their Siluriformes fish 
inspection systems are equivalent to the U.S. system.
    Vietnam submitted its initial documentation in February 2016, which 
allowed it to continue exporting Siluriformes fish during the 
transitional period. In August 2017, Vietnam submitted a completed 
Self-Reporting Tool (SRT), the questionnaire that FSIS uses to assess 
the equivalence of a foreign country's food safety inspection system.
    FSIS stated in the final rule that, during the transitional period, 
it would reinspect imported Siluriformes fish and test for species 
identification and residues at least on a quarterly basis for each 
foreign establishment that exported Siluriformes fish to the U.S. (80 
FR 75608). FSIS conducted random and targeted sampling and testing of 
imported Siluriformes fish during the transitional period, and on 
August 2, 2017, began reinspecting all shipments of Siluriformes fish, 
with random sampling for species and residue testing. During the 
testing, FSIS found residue violations in shipments of Siluriformes 
fish exported from Vietnam. When imported product fails FSIS testing, 
the product is refused entry and the designated competent authority of 
the foreign government's inspection system is notified and further 
shipments of product from the foreign establishment are placed under 
either an increased or intensified level of sampling. FSIS notified 
Vietnam's National Agro-Forestry-Fisheries Quality Assurance Department 
(NAFIQAD), the central competent authority for food inspection, of the 
residue violations, and in response, NAFIQAD investigated to determine 
the cause of the violations and provided corrective actions.

Statutory and Regulatory Basis for Proposed Action

    Siluriformes fish are an amenable species under the FMIA (21 U.S.C. 
601(w)(2)). The FMIA prohibits importation into the United States of 
adulterated or misbranded meat and meat food products (21 U.S.C. 620). 
Under the FMIA and its implementing regulations, Siluriformes fish 
imported into the United States must be from foreign countries that 
maintain an inspection system that ensures compliance with requirements 
equivalent to all the inspection, sanitary, quality, species 
verification, and residue standards, and all other provisions of the 
FMIA which are applied to official establishments in the United States. 
The regulatory requirements for foreign countries to become eligible to 
export Siluriformes fish to the United States are provided in 9 CFR 
557.2, which cross-references 9 CFR 327.2, the regulations for the 
import of other products also subject to the FMIA. As noted above, FSIS 
has allowed Vietnam to continue shipping product while FSIS made the 
determination concerning whether the country's inspection system is 
equivalent to that of FSIS.
    Section 557.2(a) (cross-referencing 9 CFR 327.2(a)(2)(i), 
(a)(2)(i), (a)(2)(ii)(C)-(I), (a)(2)(iii)-(iv), and (a)(3)), requires a 
foreign country's inspection system be authorized by legal authority 
that imposes requirements equivalent to those of the United States, 
specifically with respect to: (1) Official controls by the national 
government over establishment construction, facilities, and equipment; 
(2) direct official supervision of the preparation of product to assure 
that product is not adulterated or misbranded; (3) separation of 
establishments operations for product certified for export from product 
that is not certified; (4) requirements for sanitation at certified 
establishments and for sanitary handling of product; (5) official 
controls over condemned materials; (6) a HACCP system; and (7) any 
other requirements found in the FMIA and its implementing regulations.
    In addition to a foreign country's legal authority and regulatory 
requirements, the inspection program must achieve a level of public 
health protection equivalent to that achieved by the U.S. program. 
Specifically, the inspection program organized and administered by the 
national government must impose requirements equivalent to those of the 
United States with respect to: (1) Organizational structure and 
staffing, so as to ensure uniform enforcement of the requisite laws and 
regulations in all certified establishments; (2) ultimate control and 
supervision by the national government over the official activities of 
employees or licensees; (3) competent, qualified inspectors; (4) 
enforcement and certification; (5) administrative and technical 
support; (6) inspection, sanitation, quality, species verification, and 
residue standards; and (7) any other inspection requirements required 
by the regulations in Subchapter F--Mandatory Inspection of Fish of the 
Order Siluriformes and Products of Such Fish, which cross-references 9 
CFR 327.2(a)(2)(i)).
    The foreign country's inspection system must ensure that 
establishments preparing Siluriformes fish for export to the United 
States comply with requirements equivalent to those of the FMIA and the 
regulations promulgated thereunder. The foreign country certifies the 
establishments as having met the required standards and notifies FSIS 
about establishments that are certified or removed from certification.
    As discussed above, a foreign country's inspection system must be

[[Page 47530]]

evaluated by FSIS to determine its eligibility to export Siluriformes 
fish to the United States. This evaluation consists of two processes: A 
document review and an on-site review. The document review is an 
evaluation of the laws, regulations, and other written materials used 
by the country to affect its inspection program. FSIS requests that 
countries provide information about their inspection systems through 
the SRT. The SRT can be found on the FSIS website at 2016 Siluriformes 
SRT. The SRT is a standardized questionnaire that FSIS provides to 
foreign governments to gather information that characterizes foreign 
inspection systems. Through the SRT, FSIS collects information on 
practices and procedures in six areas, known as equivalence components: 
(1) Government Oversight (e.g., Organization and Administration), (2) 
Government Statutory Authority and Food Safety and Other Consumer 
Protection Regulations (e.g., Inspection System Operation, Product 
Standards and Labeling), (3) Government Sanitation, (4) Government 
HACCP Systems, (5) Government Chemical Residue Testing Programs, and 
(6) Government Microbiological Testing Programs. FSIS evaluates the 
information submitted to verify that the critical points in the six 
equivalence components are addressed satisfactorily with respect to 
standards, activities, resources, and enforcement. If the document 
review is satisfactory, an on-site review is scheduled using a multi-
disciplinary team to evaluate all aspects of the country's inspection 
program. This comprehensive process is described more fully on the FSIS 
website at http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/equivalence/equivalence-process-overview.
    Under the regulations, foreign countries must be listed in the CFR 
as eligible to export Siluriformes fish to the United States. FSIS 
engages in rulemaking to list a country as eligible to export 
Siluriformes fish to the United States in the regulations at 9 CFR 
557.26(b)(1). Once listed, the eligible country is required to certify 
that establishments meet the requirements to export Siluriformes fish 
to the United States and to ensure that products from these 
establishments are safe, wholesome, and not misbranded. To verify that 
products imported into the United States are safe, wholesome, and 
properly labeled and packaged, FSIS conducts 100 percent re-inspection 
of those products at points-of-entry before they enter the U.S. 

Evaluation of Vietnam's Siluriformes Fish Inspection System

    In August 2017, Vietnam requested that FSIS conduct a review of its 
Siluriformes fish inspection system and submitted the documentation to 
formally establish its eligibility to export Siluriformes fish to the 
United States. FSIS conducted a document review of Vietnam's 
Siluriformes fish inspection system to determine whether that system 
was equivalent to that of the United States. FSIS concluded, based 
review of the submitted documentation, that Vietnam's laws, 
regulations, control programs, and procedures were equivalent to those 
of the United States.
    Accordingly, in May 2018, FSIS proceeded with an on-site audit of 
Vietnam's Siluriformes fish inspection system. FSIS audited eight of 
the 13 establishments currently exporting Siluriformes fish to the U.S. 
The on-site audit also included visits to two farms where fish were 
raised and pre-harvest operations were conducted. The purpose of the 
on-site audit was to verify whether NAFIQAD effectively implemented a 
Siluriformes fish inspection system equivalent to that of the United 
States. Vietnam currently exports only raw Siluriformes fish to the 
United States.
    The audit of Vietnam's Siluriformes fish inspection system did not 
identify any deficiencies that represented an immediate threat to 
public health. The audit did find that NAFIQAD inspectors were not 
identifying the establishment's failures to adequately document results 
of operational sanitation monitoring in all of the establishments FSIS 
visited. Specifically, at each establishment audited, the FSIS auditors 
found that the establishments were documenting operational sanitation 
monitoring; however, it was not at the frequency prescribed in the 
establishment's sanitation procedures. The audit also found that, in 
one establishment, the hazard analysis identified the shipping step in 
its process, but did not identify all potential hazards associated with 
that step.
    On June 29, 2018, FSIS sent NAFIQAD the draft final audit report, 
and requested a written response regarding any corrective actions 
undertaken and changes made to Vietnam's Siluriformes fish inspection 
system. On August 10, 2018, NAFIQAD responded with written comments and 
corrective actions.
    In response to the finding that NAFIQAD inspectors did not identify 
establishment's failure to adequately document results of operational 
sanitation monitoring, NAFIQAD provided examples of monitoring forms 
and procedures, and stated that these documents showed that operational 
sanitation monitoring in establishments was performed and documented in 
accordance with the establishment's Sanitation Standard Operating 
Procedures once every one or two hours depending on production stage 
and establishments sanitation procedure. FSIS agrees that this 
frequency of monitoring is sufficient. The frequency and documentation 
of the monitoring of the sanitation operations must replicate the 
frequency and monitoring in the written sanitation procedures.
    In response to the finding that one establishment's hazard analysis 
identified the shipping step, but not all potential hazards associated 
with that step, NAFIQAD explained that the establishment did not 
identify the hazards because the product had been frozen and 
transported outside of the factory and that the establishment is 
revising its HACCP plan to include the hazard of pathogen growth.
    In addition to the corrective actions discussed above, FSIS 
reviewed Vietnam's corrective action plan for all of the audit findings 
and concluded that all have been satisfactorily addressed.
    In summary, FSIS has completed the document review, on-site audit, 
and verification of corrective actions as part of the equivalence 
process, and all outstanding issues have been resolved. FSIS has 
concluded that, as implemented, Vietnam's inspection system for 
Siluriformes fish is equivalent to that of the United States. The full 
report on Vietnam's Siluriformes fish inspection system can be found on 
the FSIS website at http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports/foreign-audit-reports.
    At this time, Vietnam intends to certify thirteen establishments as 
eligible to export Siluriformes fish to the United States. Vietnam's 
eligibility applies to the export of raw Siluriformes fish only. Should 
this rule become final, the government of Vietnam must certify to FSIS 
those establishments that wish to export Siluriformes fish to the 
United States and that operate in accordance with requirements 
equivalent to that of the United States (9 CFR 557.2(a)). FSIS will 
verify that the establishments certified by Vietnam's government are 
meeting the United States requirements through verification audits of 
Vietnam's Siluriformes fish inspection system.
    Although a foreign country may be listed in FSIS regulations as 
eligible to export Siluriformes fish to the United

[[Page 47531]]

States, the exporting country's products must be found to comply with 
all other applicable requirements of the United States. Accordingly, 
Siluriformes fish exported from Vietnam will continue to be subject to 
re-inspection at U.S. points-of-entry for, but not limited to, 
transportation damage, product and container defects, labeling, proper 
certification, general condition, and accurate count. In addition, FSIS 
is, and will continue, to conduct other types of re-inspection 
activities, such as taking product samples for laboratory analysis for 
the detection of drug and chemical residues, pathogens, species, and 
product composition for a subset of Vietnam's Siluriformes fish 
imported into the United States. Products that pass re-inspection will 
be stamped with the official mark of inspection and allowed to enter 
U.S. commerce. If they do not meet U.S. requirements, they will be 
refused entry and within 45 days must be exported to the country of 
origin, destroyed, or converted to animal food (subject to approval of 
FDA), depending on the violation. The import re-inspection activities 
can be found on the FSIS website at http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/phis-import-component/phis-implementation-letter-to-importers/ct_index.

Executive Orders 12866 and 13563, and the Regulatory Flexibility Act

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order (E.O.) 13563 emphasizes the importance of quantifying both costs 
and benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This proposed rule has been designated as a ``non-
significant'' regulatory action under section 3(f) of E.O. 12866. 
Accordingly, the rule has not been reviewed by the Office of Management 
and Budget under E.O. 12866.

Expected Costs of the Proposed Rule

    If this rule is finalized, establishments in Vietnam would be 
listed as eligible to export raw Siluriformes fish to the United 
States. Adoption of this rule is not expected to have quantified costs 
because the proposed rule maintains the existing trade in Siluriformes 
fish between the United States and Vietnam. The United States has 
historically imported Siluriformes fish from Vietnam. Therefore, market 
conditions, including prices and supplies, are not expected to be 
impacted by this rule. From 2013 to 2017, 90.5 percent of total 
Siluriformes fish imports to the United States were from Vietnam, Table 
1. Vietnamese Siluriformes fish accounted for 45.7 percent of U.S. 
consumption, Table 1.

                                   Table 1--Summary of Siluriformes Fish Sales
                                                                                                        5 Year
                                        2013         2014         2015         2016         2017       average
                                                                 Millions of dollars
Total U.S. Imports \1\............      $363.42      $346.66      $351.13      $405.61      $381.89      $369.74
Total U.S. Domestic Production \2\       356.73       351.94       363.61       385.99       379.71       367.60
Total U.S. Exports \1\............         4.69         3.99         4.95         4.80         6.18         4.92
Total U.S. Consumption \3\........       715.46       694.60       709.79       786.80       755.43       732.41
Total U.S. Imports from \1\              335.03       309.53       318.40       367.65       342.96       334.71
Vietnam as % of U.S. Imports......        92.2%        89.3%        90.7%        90.6%        89.8%        90.5%
Vietnam as % of U.S. Domestic             93.9%        87.9%        87.6%        95.3%        90.3%        91.1%
Vietnam as % of U.S. Consumption..        46.8%        44.6%        44.9%        46.7%        45.4%        45.7%
Data Source: U.S. Census Bureau Trade Data.
\1\ Import and Export Data Accessed from USDA Foreign Agricultural Service: Global Agricultural Trade System:
\2\ U.S. Production Data Accessed from USDA National Agricultural Statistics Service: Quick Stats: https://quickstats.nass.usda.gov/.
\3\ U.S. Consumption data is assumed to equal Imports + Domestic Production - Exports.

Expected Benefits of the Proposed Rule

    The proposed rule may qualitatively benefit industry by maintaining 
market stability and continued opportunity for trade between the United 
States and Vietnam. Consumers in the United States would continue to 
have access to more choices when purchasing Siluriformes fish, 
specifically of the family Pangasius, which are native to Vietnam, The 
People's Republic of China, and other neighboring Asian nations. 
Pangasius have a different flavor, color and texture than other 
Siluriformes fish found in the United States. The Siluriformes fish 
trade between the United States and Vietnam would maintain choices for 
consumers in the United States.\1\

    \1\ Sea Grant Delaware Seafood Health Facts: Making Smart 
Choices accessed on 7/27/2018 https://www.seafoodhealthfacts.org/description-top-commercial-seafood-items/pangasius.

Regulatory Flexibility Act Assessment

    The FSIS Administrator has made a preliminary determination that 
this proposed rule would not have a significant economic impact on a 
substantial number of small entities in the United States, as defined 
by the Regulatory Flexibility Act (5 U.S.C. 601, et seq.) because, as 
stated above, the rule would maintain existing trade.

Executive Order 13771

    Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), this 
proposed rule facilitates regulatory cooperation with foreign 
governments. Therefore, if finalized as proposed, this rule is expected 
to be an E.O. 13771 deregulatory action.

Paperwork Reduction Act

    No new paperwork requirements are associated with this proposed 
rule. Foreign countries wanting to export Siluriformes fish to the 
United States are required to provide information to FSIS certifying 
that their inspection system provides standards equivalent to those of 
the United States, and that the legal authority for the system and 
their implementing regulations are equivalent to those of the United 
States. FSIS provided Vietnam with a questionnaire, referred to as the 
SRT, asking for detailed information about the country's

[[Page 47532]]

inspection practices and procedures to assist the country in organizing 
its materials. This information collection was approved under OMB 
number 0583-0153. The proposed rule contains no other paperwork 

E-Government Act

    FSIS and the U.S. Department of Agriculture (USDA) are committed to 
achieving the purposes of the E-Government Act (44 U.S.C. 3601, et 
seq.) by, among other things, promoting the use of the internet and 
other information technologies and providing increased opportunities 
for citizen access to Government information and services, and for 
other purposes.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication and officially notify the World Trade 
Organization's Committee on Sanitary and Phytosanitary Measures (WTO/
SPS Committee) in Geneva, Switzerland, of this proposal 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 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. Constituent Updates are 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.

USDA Non-Discrimination 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.

How To File a Complaint of Discrimination

    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).

List of Subjects in 9 CFR Part 557

    Imported products.

    For the reasons set out in the preamble, FSIS is proposing to 
further amend 9 CFR part 557, as proposed to be amended elsewhere in 
this issue of the Federal Register, as follows:


1. The authority citation for part 557 continues to read as follows:

    Authority: 21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 2.7, 2.18, 

Sec.  557.2   [Amended]

 2. Section 557.2 is amended by adding ``Socialist Republic of 
Vietnam'' in alphabetical order to the list of countries in paragraph 

Paul Kiecker,
Acting Administrator.
[FR Doc. 2018-20376 Filed 9-14-18; 4:15 pm]