[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 [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
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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]
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