[Federal Register Volume 84, Number 214 (Tuesday, November 5, 2019)]
[Rules and Regulations]
[Pages 59685-59689]
From the Federal Register Online via the Government Publishing Office [http://www.gpo.gov/]
[FR Doc No: 2019-24058]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 557

[Docket No. FSIS-2018-0031]
RIN 0583-AD74


Eligibility of Thailand 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 Thailand as a country 
eligible to export Siluriformes fish and fish products to the United 
States. FSIS has reviewed Thailand's laws, regulations, and inspection 
system as implemented and has determined that Thailand'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 Thailand 
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 Thailand as a country eligible to export raw 
Siluriformes fish to the United States (83 FR 47532) (for convenience, 
in this final rule, ``Siluriformes fish and fish products'' will be 
shortened to ``Siluriformes fish''). Although Thailand has been allowed 
to export these products to the United States under the conditions 
described in the proposed rule (83 FR 47533), Thailand 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 Thailand 
to the regulations as eligible to export such products after the Agency 
conducted a documentary review of Thailand's laws, regulations, and 
Siluriformes fish inspection system, as well as an in-country audit of 
the system, and determined that Thailand's Siluriformes fish inspection 
system 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 45733), 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 the inspection, sanitary, quality, species verification, and residue 
standards requirements in the United

[[Page 59686]]

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 that 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 
establishment operations for product certified for export from product 
that is not certified; (4) requirements for sanitation at certified 
establishments and for the 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 Thailand's Siluriformes Fish Inspection System

    As discussed in the proposed rule (83 FR 47534), in April 2017, 
based on Thailand's request, FSIS conducted a document review of 
Thailand'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 Thailand's laws, 
regulations, and inspection procedures, FSIS concluded that Thailand'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.
    Accordingly, between May 7 and 11, 2018, FSIS proceeded with an 
initial on-site audit of Thailand's Siluriformes fish inspection 
system. The purpose of the on-site audit was to verify whether 
Thailand's Department of Fisheries (DOF), the Central Competent 
Authority (CCA) for food inspection, effectively implemented a 
Siluriformes fish inspection system equivalent to that of the United 
States. FSIS's initial audit included four slaughter and processing 
establishments that were exporting Siluriformes fish to the U.S., at 
that time, and one cold storage facility connected to one of the 
establishments. However, during the visits to the four establishments, 
none were processing Siluriformes fish for export to the United States. 
As discussed in the proposed rule (83 FR 47534), the May 2018 audit 
identified several deficiencies that FSIS requested the DOF address. 
FSIS sent the DOF the draft final audit report, and advised that for 
FSIS to verify the full implementation of Thailand's Siluriformes fish 
inspection system, it would be necessary to schedule a follow-up on-
site audit. FSIS conducted the follow-up audit between August 27 and 
31, 2018, visiting the three certified processing establishments 
exporting Siluriformes fish to the United States at that time (Thailand 
had delisted one processing establishment prior to the follow-up 
audit). Based on the follow-up audit, FSIS concluded that, as 
implemented, Thailand's inspection system for Siluriformes fish is 
equivalent to that of the United States.
    For more detailed information on FSIS's evaluation of Thailand's 
Siluriformes fish inspection system, see the proposed rule (83 FR 
47534) and for the full audit reports, 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 Thailand's Siluriformes fish 
inspection system is equivalent to the United States inspection system. 
Therefore, FSIS is amending its Siluriformes fish inspection 
regulations to list Thailand 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, 
Thailand 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 Thailand 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 must be exported to the country of origin, destroyed, or converted 
to animal food (subject to approval of the U.S. Food and Drug 
Administration (FDA)), depending on the violation. FSIS import re-
inspection activities can be found on the Agency's website at: http://
www.fsis.usda.gov/wps/portal/fsis/topics/international-

[[Page 59687]]

affairs/importing-products/port-of-entry-procedures.

Responses to Comments

    FSIS received 23 comments from producers, a distributor, trade 
associations, a consumer interest group, a commercial workers union, 
and individuals. The issues raised in the comments and the Agency 
responses are summarized below.

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

    Comment: Comments from trade associations, the consumer interest 
group, the commercial workers union, and individuals questioned whether 
Thailand'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 
trade associations submitted peer-reviewed articles concerning the use 
of antibiotics in aquaculture in Southeast Asia.
    Response: FSIS made its equivalence determination for Thailand's 
Siluriformes fish inspection system based on sound science and in 
accordance with U.S. international obligations and its own equivalence 
process. 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 by the U.S. inspection system. 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 
inspection system, the FSIS equivalence process includes performing an 
annual records review and on-going on-site audits of the country's 
inspection system at least every three years to verify whether the 
country's inspection system continues to be equivalent to FSIS's 
inspection system.
    Regarding antibiotic residues as discussed above, FSIS performs an 
annual records review for each country that has been deemed to have an 
equivalent inspection system to that of the United States which 
includes, in part, a review of the country's sampling and testing for 
residues; in short, FSIS annually verifies the adequacy of each 
equivalent country's residue testing program. In addition, FSIS 
conducts point-of-entry re-inspection 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 chemical residues that may result from the use of 
drugs and pesticides, or from incidents involving environmental 
contaminants. FSIS analyzes imported Siluriformes fish for over 100 
chemical compounds, which include 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 initial 
on-site audit and the number of Thai establishments audited. In 
addition, these two commenters expressed concern over the number of 
establishments that were delisted prior to the initial on-site audit.
    Response: The findings of the initial on-site audit conducted May 
7-11, 2018, were shared with Thailand's CCA. The audit findings did not 
present the potential to endanger public health, as most of the 
findings involved recordkeeping and technical clarifications. The CCA 
committed to addressing the audit findings as presented within 30 days.
    On August 27-31, 2018, FSIS performed a follow-up audit of 
Thailand's food safety system governing Siluriformes fish. The purpose 
of the follow-up audit was to observe the production of Siluriformes 
fish, in addition to the implementation of corrective actions to the 
deficiencies noted during the initial May 2018 audit. Prior to the 
August 2018 follow-up audit, Thailand had requested that FSIS remove 
five establishments from the list of eight establishments eligible to 
export Siluriformes fish to the United States. FSIS's August 2018 on-
site follow-up audit included the three remaining establishments; all 
three establishments were processing Siluriformes fish and were found 
to be performing all operations in accordance with equivalence 
documentation submitted to FSIS by Thailand's CCA.
    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. To be eligible to export Siluriformes fish to 
the United States, the foreign country's inspection system must ensure 
that establishments preparing these products for export to the United 
States comply with requirements equivalent to those of the FMIA and 
supporting regulations. Thailand's inspection system meets these 
requirements. The foreign country certifies the establishments as 
meeting the required standards and notifies FSIS about establishments 
that are certified or removed from certification. Thailand's inspection 
system currently meets all these requirements. FSIS will verify that 
the system continues to meet requirements through annual CCA 
submissions, on-going audits, and point-of-entry re-inspection and 
sampling and testing.

Low-Trade Volume in Thailand and the Associated Cost to the United 
States Economy

    Comment: Three individuals noted that stopping trade with Thailand 
would not impact the United States' economy because Thailand has a low-
trade volume. These commenters also argued that continuing trade with 
Thailand would negatively impact public health and therefore the 
economy. However, several producers supporting the proposed rule stated 
that continued trade with Thailand would maintain certainty in the 
market.
    Response: FSIS agrees that Thailand has a low-trade volume, but 
disagrees that continued trade with Thailand will negatively impact 
public health or the economy. As mentioned above, FSIS ensures a 
foreign country's inspection system achieves an equivalent level of 
public health protection to FSIS's inspection system through a robust 
equivalence process and point-of-entry re-inspection and testing. 
Because Thailand is likely to continue to maintain a low trade volume, 
continued trade with Thailand will not harm the economy and will 
instead provide continued market stability that is beneficial to the 
U.S. economy.

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

    E.O.s 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

[[Page 59688]]

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 Thailand. The United States has historically 
imported Siluriformes fish from Thailand. Therefore, market conditions, 
including prices and supplies, are not expected to be impacted by this 
rule. From 2014 to 2018, total sales from Thailand Siluriformes fish 
imports only averaged 0.016 percent of U.S. domestic production, and 
constituted only 0.008 percent of total U.S. consumption, Table 1. In 
2016, although Thailand exported 3.5 times more Siluriformes fish to 
the United States than their average, Thai Siluriformes fish still only 
accounted for 0.027 percent of total United States Siluriformes fish 
consumption, Table 1. These amounts are unlikely to have any 
substantive effect on U.S. production or prices for domestically 
harvested Siluriformes fish.

                                                         Table 1--Summary of Siluriformes 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 \1\ from Thailand....................           $0.02           $0.01           $0.21           $0.04           $0.02            0.06
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Thailand as % of U.S. Imports...........................          0.005%          0.003%          0.052%          0.010%          0.004%          0.015%
Thailand as % of U.S. Domestic Production...............          0.005%          0.003%          0.054%          0.010%          0.006%          0.016%
Thailand as % of U.S. Consumption.......................          0.002%          0.002%          0.027%          0.005%          0.002%          0.008%
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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://apps.fas.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 will result in the continued opportunity for trade 
between the United States and Thailand. The volume of trade is likely 
to continue to be low and is expected to have little or no effect on 
U.S. Siluriformes fish production or prices. U.S. consumers, however, 
are expected to continue to have access to more choices when purchasing 
Siluriformes fish. The rule will, therefore, maintain choices for U.S. 
consumers and promote economic competition.\1\
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    \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.
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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. The trade volume is expected to remain 
within historical bounds, with little or no effect on all U.S. 
establishments, regardless of size.

Executive Order (E.O.) 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 the 
implementing regulations are equivalent to those of the United States. 
FSIS provided Thailand with a questionnaire, referred to as the Self 
Reporting Tool (SRT), 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 (E.O.) 12988, Civil Justice Reform

    This final rule has been reviewed under E.O. 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.

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

[[Page 59689]]

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 ``Thailand'' 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. 2019-24058 Filed 11-4-19; 8:45 am]
BILLING CODE 3410-DM-P