[Federal Register Volume 84, Number 214 (Tuesday, November 5, 2019)]
[Rules and Regulations]
[Pages 59682-59685]
From the Federal Register Online via the Government Publishing Office [http://www.gpo.gov/]
[FR Doc No: 2019-24057]


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DEPARTMENT OF AGRICULTURE

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: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending 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 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 final rule, only raw Siluriformes fish and fish 
products produced in certified Vietnamese establishments are eligible 
for export to the United States. All such products are subject to re-
inspection at U.S. points-of-entry by FSIS inspectors.

DATES: Effective Date: December 5, 2019.

FOR FURTHER INFORMATION CONTACT: Terri Nintemann, Assistant 
Administrator, Office of Policy and Program Development, Food Safety 
and Inspection Service, U.S. Department of Agriculture; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On September 19, 2018, FSIS proposed to amend its regulations at 9 
CFR 557.2(b)(1) to add Vietnam as a country eligible to export 
Siluriformes fish to the United States (83 FR 47528) (for convenience, 
in this final 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 in the proposed rule (83 FR 47529), Vietnam is not currently 
listed in the Code of Federal Regulations (CFR) as eligible to export 
Siluriformes fish to the United States. FSIS proposed to add Vietnam to 
the regulations as eligible to export such products after the Agency 
conducted a documentary review of Vietnam's laws, regulations, and 
Siluriformes fish inspection system, as well as an in-country audit of 
the system, and determined that it is equivalent to the U.S. system 
established under the FMIA and its implementing regulations. This final 
rule is consistent with the provisions of the proposed rule.

Statutory and Regulatory Basis for Final Action

    As explained in the proposed rule (83 FR 45729), 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 requirements in the United States, and all other 
provisions of the FMIA that 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.
    Section 557.2(a) (cross-referencing 9 CFR 327.2(a)(1), (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 Hazard Analysis Critical 
Control Point (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. inspection 
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).
    Annually, the foreign country certifies the establishments as fully 
meeting the required standards and notifies FSIS about establishments 
that are removed from certification (9 CFR 557.2, cross-referencing 9 
CFR 327.2(a)(3)).

Evaluation of Vietnam's Siluriformes Fish Inspection System

    As discussed in the proposed rule (83 FR 47530), in August 2017, 
based on Vietnam's request, 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. Based on its review 
of the submitted documentation, which included Vietnam's laws, 
regulations, and inspection procedures, FSIS concluded that Vietnam's 
inspection system is equivalent to that in the United States for raw 
Siluriformes fish products, specifically Siluriformes fish that fall 
within the FSIS product categories ``Raw Product--Intact'' and ``Raw 
Product--Non-Intact.'' Both product categories are defined in the 
``FSIS Product Categorization'' document, which was developed to assist 
foreign governments in accurately identifying the type of meat and 
poultry products exported to the U.S., this document can be found on 
the FSIS website at: https://www.fsis.usda.gov/shared/PDF/FSIS_Product_Categorization.pdf.

[[Page 59683]]

    Accordingly, in May 2018, FSIS proceeded with an on-site audit of 
Vietnam's Siluriformes fish inspection system. The purpose of the on-
site audit was to verify whether Vietnam's National Agro-Forestry-
Fisheries Quality Assurance Department (NAFIQAD), the central competent 
authority for food inspection, effectively implemented a Siluriformes 
fish inspection system equivalent to that of 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.
    For more detailed information on FSIS's evaluation of Vietnam's 
Siluriformes fish inspection system, see the proposed rule (83 FR 
47528) and for the full audit report, go to: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports.

Final Rule

    After considering the comments received on the proposed rule, 
discussed below, FSIS concludes that Vietnam's Siluriformes fish 
inspection system is equivalent to the United States inspection system. 
Therefore, FSIS is amending its Siluriformes fish inspection 
regulations to list Vietnam as a country eligible to export 
Siluriformes fish to the United States (9 CFR 557.2(b)(1)). As is 
stated above, under FSIS's Siluriformes fish import regulations, 
Vietnam must certify to FSIS that those establishments that wish to 
export Siluriformes fish to the United States are operating under 
requirements equivalent to those of the United States (9 CFR 557.2(a)).
    Although a foreign country may be listed in FSIS regulations as 
eligible to export Siluriformes fish to the United States, the 
exporting country's products must also comply with all other applicable 
requirements of the United States. Accordingly, Siluriformes fish 
exported from Vietnam will continue to be subject to re-inspection by 
FSIS 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 will continue 
to conduct other types of re-inspection activities, such as taking 
product samples for laboratory analysis to detect drug and chemical 
residues and pathogens, as well as to identify product species and 
composition. 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 and must be exported to the country of origin, destroyed, or 
converted to animal food (subject to approval of the Food and Drug 
Administration (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/port-of-entry-procedures.

Responses to Comments

    FSIS received 41 comments from fish and seafood importers, 
distributors, processors and wholesalers; trade associations; fish 
exporting companies; a domestic processor; a consumer interest group; a 
commercial workers union; a foreign country; a cold storage warehousing 
firm; and individuals. The issues raised in the comments and the Agency 
responses are summarized below.

The Effectiveness of Vietnam's Inspection System and Ongoing 
Verification of Compliance

    Comment: Comments from two trade associations, the commercial 
workers union, the consumer interest group, the domestic processor, and 
an individual questioned whether Vietnam's Siluriformes fish inspection 
system is equivalent to that of the United States and whether 
Siluriformes fish processed under that system would be safe for 
consumption in the United States. One of the two trade associations 
submitted peer-reviewed articles concerning the use of antibiotics in 
aquaculture, citing several peer-reviewed articles.
    Response: FSIS made its equivalence determination based on sound 
science and in accordance with U.S. international obligations. FSIS has 
an in-depth and rigorous equivalence process, through which it 
systematically determines whether a foreign country's inspection system 
achieves a level of public health protection equivalent to that 
achieved in the United States. Accordingly, the equivalence process 
does not require the exporting country to develop and implement the 
same procedures as those of the United States. Once a country is 
considered to have an equivalent food safety system, the FSIS 
equivalence process includes performing an annual records review and 
on-site audits at least every three years to verify whether the 
country's system continues to be equivalent to FSIS's system.
    Regarding antibiotic residues, and as discussed above, FSIS 
conducts Point-of-Entry reinspection of all imported Siluriformes fish, 
which can include product sampling and testing for microbial, chemical 
and other hazards. FSIS may conduct laboratory analysis for the 
detection of drug and chemical residues that may have resulted from the 
use of drugs and pesticides, or from incidents involving environmental 
contaminants. FSIS analyzes imported Siluriformes fish for over 100 
compounds which includes drugs, aminoglycosides, antifungal drugs, 
metals and pesticides. Products that pass re-inspection are stamped 
with the official mark of inspection and allowed to enter U.S. 
commerce. If they do not meet U.S. requirements, they are refused entry 
into U.S. commerce and must be exported, destroyed, or converted to 
animal food.

On-Site Audit

    Comment: The commercial workers union and the consumer interest 
group expressed concerns over the deficiencies found during the on-site 
audit and the limited number of Vietnamese establishments audited. In 
addition, these two commenter expressed concern over the number of 
establishments that were delisted prior to the on-site audit.
    Response: The results of the on-site audit were shared with 
Vietnam's Central Competent Authority (CCA). Notably, FSIS auditors did 
not identify any findings that represented a potential to endanger 
public health. The CCA has made changes to the inspection system to 
address the findings.
    Prior to the on-site audit, Vietnam requested that FSIS remove 49 
establishments from the list of 62 establishments eligible to export 
Siluriformes fish, because these establishments had not exported 
significant amounts of product to the United States. The remaining 13 
exporting establishments have actively exported to the United States 
since FSIS assumed regulatory jurisdiction over Siluriformes fish; the 
others did not export a significant amount of product. FSIS' on-site 
audit included eight of the 13 establishments and two cold storage 
facilities, which export most of the Siluriformes fish to the United 
States.
    It is important to note that FSIS equivalence determinations are 
based on the foreign country's inspection system, not on an individual 
establishment's system. 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 supporting regulations. Vietnam's inspection system meets 
these

[[Page 59684]]

requirements. The foreign country certifies the establishments as 
meeting the required standards and notifies FSIS about establishments 
that are certified or removed from certification.

Executive Orders (E.O.s) 12866 and 13563

    Executive Orders (E.O.) 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). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility. 
This final 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 Final Rule

    This final regulatory impact analysis updates the preliminary 
regulatory impact analysis by including the most recent year's (2018) 
trade data. This final rule is not expected to have quantified costs 
because it 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 2014 to 2018, 91.2 percent of total Siluriformes fish 
imports to the United States were from Vietnam, Table 1. Vietnamese 
Siluriformes fish accounted for 48.1 percent of U.S. consumption, Table 
1.

                                                      Table 1--Summary of Siluriformes Fish Sales *
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                                                               2014            2015            2016            2017            2018       5 Year average
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                                                                                                Millions of Dollars
                                                         -----------------------------------------------------------------------------------------------
Total U.S. Imports \1\..................................         $346.66         $351.13         $405.61         $381.89         $547.10         $406.48
Total U.S. Domestic Production \2\......................         $351.94         $363.61         $385.99         $379.71         $360.40         $368.33
Total U.S. Exports \1\..................................           $4.00           $4.95           $4.80           $6.18           $3.89           $4.76
Total U.S. Consumption \3\..............................         $694.60         $709.79         $786.80         $755.43         $903.61         $770.04
Total U.S. Imports from \1\ Vietnam.....................         $309.53         $318.40         $367.65         $342.96         $514.76         $370.66
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Vietnam as % of U.S. Imports............................           89.3%           90.7%           90.6%           89.8%           94.1%           91.2%
Vietnam as % of U.S. Domestic Production................           87.9%           87.6%           95.3%           90.3%          142.8%          100.6%
Vietnam as % of U.S. Consumption........................           44.6%           44.9%           46.7%           45.4%           57.0%           48.1%
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Data Source: U.S. Census Bureau Trade Data.
* Numbers in table may not sum to totals due to rounding.
\1\ Import and Export Data Accessed from USDA Foreign Agricultural Service: Global Agricultural Trade System: https://appfas.usda.gov/gats/default.aspx/
  .
\2\ U.S. Production Data Accessed from USDA National Agricultural Statistics Service: Quick Stats: https://quickstats.nass.usda.gov/results/6F6BAB14-7014-365B-ACEA-CA35C184329B?pivot=short_desc/.
\3\ U.S. Consumption data is assumed to equal Imports + Domestic Production - Exports.

Expected Benefits of the Final Rule

    This final 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 will 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 will maintain choices for 
consumers in the United States.\1\
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    \1\ Sea Grant Delaware Seafood Health Facts: Making Smart 
Choices accessed on 7/27/2018. Available at: https://www.seafoodhealthfacts.org/description-top-commercial-seafood-items/pangasius.
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Regulatory Flexibility Act Assessment

    The FSIS Administrator certifies that, for the purposes of the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.), this final rule will 
not have a significant economic impact on a substantial number of small 
entities in the United States because, as stated above, the final rule 
will maintain existing trade.

Executive Order 13771

    Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), this 
final rule facilitates regulatory cooperation with foreign governments. 
Therefore, this final rule is an E.O. 13771 deregulatory action.

Paperwork Reduction Act

    No new paperwork requirements are associated with this final 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 
(Self Reporting Tool), asking for detailed information about the 
country's inspection practices and procedures to assist the country in 
organizing its materials. This information collection was approved 
under OMB number 0583-0153. The final rule contains no other paperwork 
requirements.

Executive Order 12988, Civil Justice Reform

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this rule: (1) All State and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
no retroactive effect will be given to this rule; and (3) no 
administrative proceedings will be required before parties may file 
suit in court challenging this rule.

[[Page 59685]]

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 on-line through the FSIS web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS will also announce and provide a link to it 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. The 
Constituent 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.

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 amends 9 CFR part 557 
as follows:

PART 557--IMPORTATION

0
 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, 2.53.


Sec.  557.2  [Amended]

0
2. Section 557.2 is amended by adding ``Socialist Republic of Vietnam'' 
in alphabetical order to the list of countries at the end of paragraph 
(b)(1).

    Done at Washington, DC.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-24057 Filed 11-4-19; 8:45 am]
BILLING CODE 3410-DM-P