83_FR_47714 83 FR 47532 - Eligibility of Thailand To Export Siluriformes Fish and Fish Products to the United States

83 FR 47532 - Eligibility of Thailand To Export Siluriformes Fish and Fish Products to the United States

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

Federal Register Volume 83, Issue 182 (September 19, 2018)

Page Range47532-47536
FR Document2018-20380

The Food Safety and Inspection Service (FSIS) is proposing to amend the Siluriformes fish inspection regulations to list Thailand 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 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 proposal, only raw Siluriformes fish and fish products produced in certified Thailand 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.

Federal Register, Volume 83 Issue 182 (Wednesday, September 19, 2018)
[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Proposed Rules]
[Pages 47532-47536]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20380]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 557

[Docket No. FSIS-2018-0031]
RIN [0583-AD75]


Eligibility of Thailand To Export Siluriformes Fish and Fish 
Products to the United States

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to 
amend the Siluriformes fish inspection regulations to list Thailand 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 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 proposal, only raw Siluriformes fish and fish products 
produced in certified Thailand 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 
methods:
     Federal eRulemaking Portal: This website provides the 
ability to type short comments directly into the comment field on this 
web page or to 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-
3700.
     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-2018-0031. 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.

FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant 
Administrator, Office of Policy and

[[Page 47533]]

Program Development; Telephone: (202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    FSIS is proposing to amend its regulations at 9 CFR 557.2(b)(1) to 
add Thailand 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 Thailand has been allowed to export 
these products to the United States under the conditions described 
below, Thailand is not currently listed in the Code of 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 
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.
    Thailand submitted its initial documentation in February 2016, 
which allowed it to continue exporting Siluriformes fish during the 
transitional period. In April 2017, Thailand 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 on at least a quarterly basis for each 
foreign establishment eligible to export 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. As a result of 
the testing, FSIS found a residue violation in a shipment of 
Siluriformes fish exported from Thailand. 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 the Thailand Department of Fisheries (DOF), the central 
competent authority for food inspection, of the residue violation, and 
in response, DOF stated that the processor would be suspended until DOF 
inspectors could re-audit the processor's HACCP system.

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 and fish products 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 Thailand 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 
establishment 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--

[[Page 47534]]

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 
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 Self Reporting Tool (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. Countries found 
eligible to export Siluriformes fish to the United States are listed 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. commerce.

Evaluation of Thailand's Siluriformes Fish Inspection System

    In April 2017, Thailand 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 Thailand's 
Siluriformes fish inspection system to determine whether it was 
equivalent to that of the United States. FSIS concluded, based review 
of the submitted documentation, that Thailand'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 
Thailand's Siluriformes fish inspection system. The purpose of the on-
site audit was to verify that DOF effectively implemented a 
Siluriformes fish inspection system equivalent to that of the United 
States. FSIS audited each of the four establishments then certified to 
export Siluriformes fish to the United States, one pre-harvest 
operation, and one cold storage facility. During the visits to the four 
establishments, none were producing Siluriformes fish for export to the 
United States. However, FSIS auditors were able to conduct observation 
of DOF inspection at two of the four establishments and to perform 
document reviews.
    The May 2018 audit of Thailand's Siluriformes fish inspection 
system identified several deficiencies that the DOF was requested to 
address. Among other things, the audit found that the DOF did not have 
regulatory requirements for establishments to maintain daily records 
documenting the monitoring of the Sanitation Standard Operating 
Procedures (SOPs), although the establishments did document and 
maintain sanitation records. Also, the DOF did not have regulatory 
requirements for establishments to develop HACCP verification 
procedures for direct observation of monitoring activities and 
corrective actions, resulting in no performance of the procedure by the 
establishments. Furthermore, because only two out of the four 
establishments FSIS visited during the May 2018 audit were operational, 
auditors were unable to verify the full implementation of Thailand's 
food safety inspections system. At the audit exit meeting, the DOF 
committed to addressing the preliminary findings.
    On June 27, 2018, FSIS sent the DOF the draft final audit report, 
and advised that, in order to verify the full implementation of 
Thailand's Siluriformes fish inspection system, it would be necessary 
to schedule a follow up on-site visit.
    On June 28, 2018, FSIS sent a follow-up letter proposing a follow-
up on-site audit of Thailand's Siluriformes fish inspection system in 
August 2018. The letter explained that the objective of the follow-up 
audit was to verify any corrective actions or changes to Thailand's 
food safety inspection system as a result of the findings of the first 
audit and that the scope of the audit would be limited to aspects of 
Thailand's national inspection system.
    FSIS conducted the follow-up audit between August 27 and 31, 2018, 
visiting the three establishments currently certified to export 
Siluriformes fish to the United States (Thailand delisted one 
establishment prior to the follow-up audit). The follow-up audit 
focused on the inspections system's ability to control hazards and 
prevent non-compliances that threaten food safety. FSIS auditors 
visited all three establishments certified by the DOF to export 
products to the United States. During this audit, all certified 
establishments were able to perform operations. The FSIS auditors were 
able to see production of Siluriformes fish, in addition to the 
implementation of corrective actions in response to the deficiencies 
found in the May onsite audit.
    The FSIS auditors determined that Thailand's food safety inspection 
system governing fish of the order Siluriformes and their products are 
being implemented as documented in the SRT and according to their 
corrective actions responses. A review and analysis of each component 
with corrective actions by the FSIS auditors did not identify any 
findings representing an immediate threat to public health.
    In summary, FSIS has completed the document review, on-site audit, 
follow-up audit with verification of corrective actions as part of the 
equivalence

[[Page 47535]]

process, and determined that all outstanding issues have been resolved. 
FSIS has concluded that, as implemented, Thailand's inspection system 
for Siluriformes fish is equivalent to that of the United States. The 
full report on Thailand'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, Thailand intends to certify three establishments as 
eligible to export Siluriformes fish to the United States. Thailand's 
eligibility applies to the export of raw Siluriformes fish only. Should 
this rule become final, the government of Thailand 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 Thailand's government are 
meeting the United States requirements through verification audits of 
Thailand's Siluriformes fish inspection system.
    Although a foreign country may be listed in FSIS regulations as 
eligible to export Siluriformes fish products to the United 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 Thailand 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 Thailand'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 Thailand 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 
associated with it because the rule would maintain existing trade 
between the United States and Thailand in Siluriformes fish. The United 
States has historically imported Siluriformes fish from Thailand. Over 
the last 5 years, total sales from Thailand Siluriformes fish imports 
only averaged 0.017 percent of U.S. domestic production, and 
constituted only 0.009 percent of total United States consumption, 
Table 1. In 2016, Thailand exported 3.5 times more Siluriformes fish to 
the United States than average, but these exports still accounted for 
only 0.027 percent of total domestic 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 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 \1\ from                0.04         0.02         0.01         0.21         0.04         0.06
 Thailand.........................
Thailand as % of U.S. Imports.....       0.012%       0.005%       0.003%       0.052%       0.010%       0.017%
Thailand as % of U.S. Domestic           0.012%       0.005%       0.003%       0.054%       0.010%       0.017%
 Production.......................
Thailand as % of U.S. Consumption.       0.006%       0.002%       0.002%       0.027%       0.005%       0.009%
----------------------------------------------------------------------------------------------------------------
Data Source: U.S. Census Bureau Trade Data.
\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/.
\3\ U.S. Consumption data is assumed to equal Imports + Domestic Production-Exports.

Expected Benefits of the Proposed Rule

    If finalized, this rule would result in the continued opportunity 
for trade between the United States and Thailand. The volume of trade 
is likely to continue to be small 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 products. The rule would, therefore, maintain 
choices for U.S. consumers and promote economic competition.

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

[[Page 47536]]

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 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 that country in 
organizing its materials. This information collection was approved 
under OMB number 0583-0153. The proposed rule contains no other 
paperwork requirements.

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: program.intake@usda.gov.
    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:

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 in paragraph (b)(1).

Paul Kiecker,
Acting Administrator.
[FR Doc. 2018-20380 Filed 9-14-18; 4:15 pm]
 BILLING CODE 3410-DM-P



                                                47532             Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules

                                                inspection practices and procedures to                  States under any program or activity                  SUMMARY:    The Food Safety and
                                                assist the country in organizing its                    conducted by the USDA.                                Inspection Service (FSIS) is proposing
                                                materials. This information collection                                                                        to amend the Siluriformes fish
                                                                                                        How To File a Complaint of
                                                was approved under OMB number                                                                                 inspection regulations to list Thailand
                                                                                                        Discrimination
                                                0583–0153. The proposed rule contains                                                                         as a country eligible to export
                                                no other paperwork requirements.                           To file a complaint of discrimination,             Siluriformes fish and fish products to
                                                                                                        complete the USDA Program                             the United States. FSIS is proposing this
                                                E-Government Act                                        Discrimination Complaint Form, which                  action because the Agency has reviewed
                                                  FSIS and the U.S. Department of                       may be accessed online at http://                     Thailand’s laws, regulations, and
                                                Agriculture (USDA) are committed to                     www.ocio.usda.gov/sites/default/files/                inspection system as implemented and
                                                achieving the purposes of the E-                        docs/2012/Complain_combined_6_8_                      has determined that Thailand’s
                                                Government Act (44 U.S.C. 3601, et                      12.pdf, or write a letter signed by you               Siluriformes fish inspection system is
                                                seq.) by, among other things, promoting                 or your authorized representative.                    equivalent to the system that the United
                                                the use of the internet and other                          Send your completed complaint form                 States has established under the Federal
                                                information technologies and providing                  or letter to USDA by mail, fax, or email:             Meat Inspection Act (FMIA) and its
                                                increased opportunities for citizen                        Mail: U.S. Department of Agriculture,              implementing regulations.
                                                access to Government information and                    Director, Office of Adjudication, 1400                   Under this proposal, only raw
                                                services, and for other purposes.                       Independence Avenue SW, Washington,                   Siluriformes fish and fish products
                                                                                                        DC 20250–9410.                                        produced in certified Thailand
                                                Additional Public Notification                             Fax: (202) 690–7442.
                                                  Public awareness of all segments of                      Email: program.intake@usda.gov.                    establishments would be eligible for
                                                rulemaking and policy development is                       Persons with disabilities who require              export to the United States. All such
                                                important. Consequently, FSIS will                      alternative means for communication                   products would continue to be subject
                                                announce this Federal Register                          (Braille, large print, audiotape, etc.),              to re-inspection at U.S. points-of-entry
                                                publication and officially notify the                   should contact USDA’s TARGET Center                   by FSIS inspectors.
                                                World Trade Organization’s Committee                    at (202) 720–2600 (voice and TDD).                    DATES: Submit comments on or before
                                                on Sanitary and Phytosanitary Measures                                                                        October 19, 2018.
                                                                                                        List of Subjects in 9 CFR Part 557
                                                (WTO/SPS Committee) in Geneva,                                                                                ADDRESSES: FSIS invites interested
                                                Switzerland, of this proposal on-line                     Imported products.                                  persons to submit comments on the
                                                through the FSIS web page located at:                     For the reasons set out in the                      proposed rule. Comments may be
                                                http://www.fsis.usda.gov/federal-                       preamble, FSIS is proposing to further                submitted by one of the following
                                                register.                                               amend 9 CFR part 557, as proposed to                  methods:
                                                  FSIS also will make copies of this                    be amended elsewhere in this issue of                    • Federal eRulemaking Portal: This
                                                publication available through the FSIS                  the Federal Register, as follows:                     website provides the ability to type
                                                Constituent Update, which is used to                                                                          short comments directly into the
                                                provide information regarding FSIS                      PART 557—IMPORTATION
                                                                                                                                                              comment field on this web page or to
                                                policies, procedures, regulations,                      ■ 1. The authority citation for part 557              attach a file for lengthier comments. Go
                                                Federal Register notices, FSIS public                   continues to read as follows:                         to http://www.regulations.gov. Follow
                                                meetings, and other types of information                                                                      the on-line instructions at that site for
                                                that could affect or would be of interest                 Authority: 21 U.S.C. 601–602, 606–622,
                                                                                                        624–695; 7 CFR 2.7, 2.18, 2.53.                       submitting comments.
                                                to our constituents and stakeholders.                                                                            • Mail, including CD–ROMs, etc.:
                                                Constituent Updates are available on the                                                                      Send to Docket Clerk, U.S. Department
                                                                                                        § 557.2   [Amended]
                                                FSIS web page. Through the web page,                                                                          of Agriculture, Food Safety and
                                                FSIS is able to provide information to a                ■  2. Section 557.2 is amended by adding
                                                                                                        ‘‘Socialist Republic of Vietnam’’ in                  Inspection Service, 1400 Independence
                                                much broader, more diverse audience.                                                                          Avenue SW, Mailstop 3758, Room 6065,
                                                In addition, FSIS offers an email                       alphabetical order to the list of countries
                                                                                                        in paragraph (b)(1).                                  Washington, DC 20250–3700.
                                                subscription service which provides                                                                              • Hand- or courier-delivered
                                                automatic and customized access to                      Paul Kiecker,                                         submittals: Deliver to 1400
                                                selected food safety news and                           Acting Administrator.                                 Independence Avenue SW, Room 6065,
                                                information. This service is available at:              [FR Doc. 2018–20376 Filed 9–14–18; 4:15 pm]           Washington, DC 20250–3700.
                                                http://www.fsis.usda.gov/subscribe.                     BILLING CODE 3410–DM–P                                   Instructions: All items submitted by
                                                Options range from recalls to export
                                                                                                                                                              mail or electronic mail must include the
                                                information, regulations, directives, and
                                                                                                                                                              Agency name and docket number FSIS–
                                                notices. Customers can add or delete                    DEPARTMENT OF AGRICULTURE                             2018–0031. Comments received in
                                                subscriptions themselves and have the
                                                                                                                                                              response to this docket will be made
                                                option to password protect their                        Food Safety and Inspection Service
                                                                                                                                                              available for public inspection and
                                                accounts.
                                                                                                                                                              posted without change, including any
                                                                                                        9 CFR Part 557
                                                USDA Non-Discrimination Statement                                                                             personal information, to http://
                                                  No agency, officer, or employee of the                [Docket No. FSIS–2018–0031]                           www.regulations.gov.
                                                USDA shall, on the grounds of race,                     RIN [0583–AD75]                                          Docket: For access to background
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                                                color, national origin, religion, sex,                                                                        documents or comments received, call
                                                gender identity, sexual orientation,                    Eligibility of Thailand To Export                     (202) 720–5627 to schedule a time to
                                                disability, age, marital status, family/                Siluriformes Fish and Fish Products to                visit the FSIS Docket Room at 1400
                                                parental status, income derived from a                  the United States                                     Independence Avenue SW, Room 6065,
                                                public assistance program, or political                                                                       Washington, DC 20250–3700.
                                                                                                        AGENCY:  Food Safety and Inspection
                                                beliefs, exclude from participation in,                 Service, USDA.                                        FOR FURTHER INFORMATION CONTACT:
                                                deny the benefits of, or subject to                                                                           Roberta Wagner, Assistant
                                                                                                        ACTION: Proposed rule.
                                                discrimination any person in the United                                                                       Administrator, Office of Policy and


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                                                                  Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules                                             47533

                                                Program Development; Telephone: (202)                   continue exporting after September 1,                 inspection system that ensures
                                                205–0495.                                               2017, were required to submit                         compliance with requirements
                                                SUPPLEMENTARY INFORMATION:                              documentation substantiating the                      equivalent to all the inspection,
                                                                                                        equivalence of their Siluriformes fish                sanitary, quality, species verification,
                                                Background                                              inspection system to that of the United               and residue standards, and all other
                                                   FSIS is proposing to amend its                       States. Foreign countries that submitted              provisions of the FMIA which are
                                                regulations at 9 CFR 557.2(b)(1) to add                 complete equivalence documentation by                 applied to official establishments in the
                                                Thailand as a country eligible to export                September 1, 2017, were permitted to                  United States. The regulatory
                                                Siluriformes fish and fish products to                  continue exporting Siluriformes fish                  requirements for foreign countries to
                                                the United States (for convenience, in                  until such time that FSIS determines if               become eligible to export Siluriformes
                                                this proposed rule, ‘‘Siluriformes fish                 their Siluriformes fish inspection                    fish and fish products to the United
                                                and fish products’’ will be shortened to                systems are equivalent to the U.S.                    States are provided in 9 CFR 557.2,
                                                ‘‘Siluriformes fish’’). Although Thailand               system.                                               which cross-references 9 CFR 327.2, the
                                                has been allowed to export these                           Thailand submitted its initial                     regulations for the import of other
                                                products to the United States under the                 documentation in February 2016, which                 products also subject to the FMIA. As
                                                conditions described below, Thailand is                 allowed it to continue exporting                      noted above, FSIS has allowed Thailand
                                                not currently listed in the Code of                     Siluriformes fish during the transitional             to continue shipping product while
                                                Federal Regulations (CFR) as eligible to                period. In April 2017, Thailand                       FSIS made the determination
                                                export Siluriformes fish to the United                  submitted a completed Self-Reporting                  concerning whether the country’s
                                                States.                                                 Tool (SRT), the questionnaire that FSIS               inspection system is equivalent to that
                                                                                                        uses to assess the equivalence of a                   of FSIS.
                                                Transitional Period
                                                                                                        foreign country’s food safety inspection                 Section 557.2(a) (cross-referencing 9
                                                   On December 2, 2015, FSIS published                  system.                                               CFR 327.2(a)(2)(i), (a)(2)(i), (a)(2)(ii)(C)–
                                                the final rule, ‘‘Mandatory Inspection of                  FSIS stated in the final rule that,                (I), (a)(2)(iii)–(iv), and (a)(3)), requires a
                                                Fish of the Order Siluriformes and                      during the transitional period, it would              foreign country’s inspection system be
                                                Products Derived from Such Fish’’ (80                   reinspect imported Siluriformes fish                  authorized by legal authority that
                                                FR 75590). The final rule established a                 and test for species identification and               imposes requirements equivalent to
                                                mandatory inspection system for fish of                 residues on at least a quarterly basis for            those of the United States, specifically
                                                the order Siluriformes and products                     each foreign establishment eligible to                with respect to: (1) Official controls by
                                                derived from these fish. The final                      export Siluriformes fish to the U.S. (80              the national government over
                                                regulations implemented the provisions                  FR 75608). FSIS conducted random and                  establishment construction, facilities,
                                                of the 2008 and 2014 Farm Bills, which                  targeted sampling and testing of                      and equipment; (2) direct official
                                                amended the FMIA, mandating FSIS                        imported Siluriformes fish during the                 supervision of the preparation of
                                                inspection of Siluriformes fish.                        transitional period, and on August 2,                 product to assure that product is not
                                                   The final rule provided an 18-month                  2017, began reinspecting all shipments                adulterated or misbranded; (3)
                                                period, from March 1, 2016, to                          of Siluriformes fish, with random                     separation of establishment operations
                                                September 1, 2017, for both the U.S.                    sampling for species and residue testing.             for product certified for export from
                                                domestic Siluriformes fish industry and                 As a result of the testing, FSIS found a              product that is not certified; (4)
                                                international trading partners to                       residue violation in a shipment of                    requirements for sanitation at certified
                                                transition from the regulatory                          Siluriformes fish exported from                       establishments and for sanitary
                                                requirements of the U.S. Food and Drug                  Thailand. When imported product fails                 handling of product; (5) official controls
                                                Administration (FDA), the agency                        FSIS testing, the product is refused                  over condemned materials; (6) a HACCP
                                                formerly responsible for regulatory                     entry and the designated competent                    system; and (7) any other requirements
                                                oversight of Siluriformes fish, to the                  authority of the foreign government’s                 found in the FMIA and its
                                                regulatory requirements of FSIS. By                     inspection system is notified and further             implementing regulations.
                                                March 1, 2016, FSIS required foreign                    shipments of product from the foreign                    In addition to a foreign country’s legal
                                                countries to submit written                             establishment are placed under either                 authority and regulatory requirements,
                                                documentation identifying a list of                     an increased or intensified level of                  the inspection program must achieve a
                                                establishments that had been exporting                  sampling. FSIS notified the Thailand                  level of public health protection
                                                and would continue exporting                            Department of Fisheries (DOF), the                    equivalent to that achieved by the U.S.
                                                Siluriformes fish to the United States. In              central competent authority for food                  program. Specifically, the inspection
                                                addition, by March 1, 2016, FSIS                        inspection, of the residue violation, and             program organized and administered by
                                                required foreign countries to submit                    in response, DOF stated that the                      the national government must impose
                                                written documentation to demonstrate                    processor would be suspended until                    requirements equivalent to those of the
                                                that they had laws or other legal                       DOF inspectors could re-audit the                     United States with respect to: (1)
                                                measures in place that provide authority                processor’s HACCP system.                             Organizational structure and staffing, so
                                                to regulate the growing and processing                                                                        as to ensure uniform enforcement of the
                                                of fish for human food, and to assure                   Statutory and Regulatory Basis for                    requisite laws and regulations in all
                                                compliance with FDA’s good                              Proposed Action                                       certified establishments; (2) ultimate
                                                manufacturing practices, Hazard                           Siluriformes fish are an amenable                   control and supervision by the national
                                                Analysis and Critical Control Point                     species under the FMIA (21 U.S.C.                     government over the official activities of
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                                                (HACCP) requirements, sanitation                        601(w)(2)). The FMIA prohibits                        employees or licensees; (3) competent,
                                                control procedures, and other regulatory                importation into the United States of                 qualified inspectors; (4) enforcement
                                                requirements in 21 CFR part 123, Fish                   adulterated or misbranded meat and                    and certification; (5) administrative and
                                                and Fishery Products.                                   meat food products (21 U.S.C. 620).                   technical support; (6) inspection,
                                                   FSIS recognized the foreign countries’               Under the FMIA and its implementing                   sanitation, quality, species verification,
                                                initial documentation until the end of                  regulations, Siluriformes fish imported               and residue standards; and (7) any other
                                                the transitional period on September 1,                 into the United States must be from                   inspection requirements required by the
                                                2017. Foreign countries that wished to                  foreign countries that maintain an                    regulations in Subchapter F—


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                                                47534             Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules

                                                Mandatory Inspection of Fish of the                     rulemaking to list a country as eligible.             for direct observation of monitoring
                                                Order Siluriformes and Products of                      Countries found eligible to export                    activities and corrective actions,
                                                Such Fish, which cross-references 9                     Siluriformes fish to the United States                resulting in no performance of the
                                                CFR 327.2(a)(2)(i)).                                    are listed in the regulations at 9 CFR                procedure by the establishments.
                                                   The foreign country’s inspection                     557.26(b)(1). Once listed, the eligible               Furthermore, because only two out of
                                                system must ensure that establishments                  country is required to certify that                   the four establishments FSIS visited
                                                preparing Siluriformes fish for export to               establishments meet the requirements to               during the May 2018 audit were
                                                the United States comply with                           export Siluriformes fish to the United                operational, auditors were unable to
                                                requirements equivalent to those of the                 States and to ensure that products from               verify the full implementation of
                                                FMIA and the regulations promulgated                    these establishments are safe,                        Thailand’s food safety inspections
                                                thereunder. The foreign country certifies               wholesome, and not misbranded. To                     system. At the audit exit meeting, the
                                                the establishments as having met the                    verify that products imported into the                DOF committed to addressing the
                                                required standards and notifies FSIS                    United States are safe, wholesome, and                preliminary findings.
                                                about establishments that are certified                 properly labeled and packaged, FSIS                      On June 27, 2018, FSIS sent the DOF
                                                or removed from certification.                          conducts 100 percent re-inspection of                 the draft final audit report, and advised
                                                   As discussed above, a foreign                        those products at points-of-entry before              that, in order to verify the full
                                                country’s inspection system must be                     they enter the U.S. commerce.                         implementation of Thailand’s
                                                evaluated by FSIS to determine its                                                                            Siluriformes fish inspection system, it
                                                eligibility to export Siluriformes fish to              Evaluation of Thailand’s Siluriformes                 would be necessary to schedule a follow
                                                the United States. This evaluation                      Fish Inspection System                                up on-site visit.
                                                consists of two processes: A document                      In April 2017, Thailand requested that                On June 28, 2018, FSIS sent a follow-
                                                review and an on-site review. The                       FSIS conduct a review of its                          up letter proposing a follow-up on-site
                                                document review is an evaluation of the                 Siluriformes fish inspection system and               audit of Thailand’s Siluriformes fish
                                                laws, regulations, and other written                    submitted the documentation to                        inspection system in August 2018. The
                                                materials used by the country to affect                 formally establish its eligibility to                 letter explained that the objective of the
                                                its inspection program. FSIS requests                   export Siluriformes fish to the United                follow-up audit was to verify any
                                                that countries provide information                      States. FSIS conducted a document                     corrective actions or changes to
                                                about their inspection systems through                  review of Thailand’s Siluriformes fish                Thailand’s food safety inspection
                                                the Self Reporting Tool (SRT). The SRT                  inspection system to determine whether                system as a result of the findings of the
                                                can be found on the FSIS website at                     it was equivalent to that of the United               first audit and that the scope of the
                                                2016 Siluriformes SRT. The SRT is a                     States. FSIS concluded, based review of               audit would be limited to aspects of
                                                standardized questionnaire that FSIS                    the submitted documentation, that                     Thailand’s national inspection system.
                                                provides to foreign governments to                      Thailand’s laws, regulations, control                    FSIS conducted the follow-up audit
                                                gather information that characterizes                   programs, and procedures were                         between August 27 and 31, 2018,
                                                foreign inspection systems. Through the                 equivalent to those of the United States.             visiting the three establishments
                                                SRT, FSIS collects information on                          Accordingly, in May 2018, FSIS                     currently certified to export
                                                practices and procedures in six areas,                  proceeded with an on-site audit of                    Siluriformes fish to the United States
                                                known as equivalence components: (1)                    Thailand’s Siluriformes fish inspection               (Thailand delisted one establishment
                                                Government Oversight (e.g.,                             system. The purpose of the on-site audit              prior to the follow-up audit). The
                                                Organization and Administration), (2)                   was to verify that DOF effectively                    follow-up audit focused on the
                                                Government Statutory Authority and                      implemented a Siluriformes fish                       inspections system’s ability to control
                                                Food Safety and Other Consumer                          inspection system equivalent to that of               hazards and prevent non-compliances
                                                Protection Regulations (e.g., Inspection                the United States. FSIS audited each of               that threaten food safety. FSIS auditors
                                                System Operation, Product Standards                     the four establishments then certified to             visited all three establishments certified
                                                and Labeling), (3) Government                           export Siluriformes fish to the United                by the DOF to export products to the
                                                Sanitation, (4) Government HACCP                        States, one pre-harvest operation, and                United States. During this audit, all
                                                Systems, (5) Government Chemical                        one cold storage facility. During the                 certified establishments were able to
                                                Residue Testing Programs, and (6)                       visits to the four establishments, none               perform operations. The FSIS auditors
                                                Government Microbiological Testing                      were producing Siluriformes fish for                  were able to see production of
                                                Programs. FSIS evaluates the                            export to the United States. However,                 Siluriformes fish, in addition to the
                                                information submitted to verify that the                FSIS auditors were able to conduct                    implementation of corrective actions in
                                                critical points in the six equivalence                  observation of DOF inspection at two of               response to the deficiencies found in the
                                                components are addressed satisfactorily                 the four establishments and to perform                May onsite audit.
                                                with respect to standards, activities,                  document reviews.                                        The FSIS auditors determined that
                                                resources, and enforcement. If the                         The May 2018 audit of Thailand’s                   Thailand’s food safety inspection
                                                document review is satisfactory, an on-                 Siluriformes fish inspection system                   system governing fish of the order
                                                site review is scheduled using a multi-                 identified several deficiencies that the              Siluriformes and their products are
                                                disciplinary team to evaluate all aspects               DOF was requested to address. Among                   being implemented as documented in
                                                of the country’s inspection program.                    other things, the audit found that the                the SRT and according to their
                                                This comprehensive process is                           DOF did not have regulatory                           corrective actions responses. A review
                                                described more fully on the FSIS                        requirements for establishments to                    and analysis of each component with
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                                                website at http://www.fsis.usda.gov/                    maintain daily records documenting the                corrective actions by the FSIS auditors
                                                wps/portal/fsis/topics/international-                   monitoring of the Sanitation Standard                 did not identify any findings
                                                affairs/importing-products/equivalence/                 Operating Procedures (SOPs), although                 representing an immediate threat to
                                                equivalence-process-overview.                           the establishments did document and                   public health.
                                                   Under the regulations, foreign                       maintain sanitation records. Also, the                   In summary, FSIS has completed the
                                                countries must be listed in the CFR as                  DOF did not have regulatory                           document review, on-site audit, follow-
                                                eligible to export Siluriformes fish to the             requirements for establishments to                    up audit with verification of corrective
                                                United States. FSIS engages in                          develop HACCP verification procedures                 actions as part of the equivalence


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                                                                       Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules                                                      47535

                                                process, and determined that all                                     U.S. points-of-entry for, but not limited               effects, distributive impacts, and
                                                outstanding issues have been resolved.                               to, transportation damage, product and                  equity). Executive Order (E.O.) 13563
                                                FSIS has concluded that, as                                          container defects, labeling, proper                     emphasizes the importance of
                                                implemented, Thailand’s inspection                                   certification, general condition, and                   quantifying both costs and benefits, of
                                                system for Siluriformes fish is                                      accurate count. In addition, FSIS is, and               reducing costs, of harmonizing rules,
                                                equivalent to that of the United States.                             will continue, to conduct other types of                and of promoting flexibility. This
                                                The full report on Thailand’s                                        re-inspection activities, such as taking                proposed rule has been designated as a
                                                Siluriformes fish inspection system can                              product samples for laboratory analysis                 ‘‘non-significant’’ regulatory action
                                                be found on the FSIS website at http://                              for the detection of drug and chemical                  under section 3(f) of E.O. 12866.
                                                www.fsis.usda.gov/wps/portal/fsis/                                   residues, pathogens, species, and                       Accordingly, the rule has not been
                                                topics/international-affairs/importing-                              product composition for a subset of                     reviewed by the Office of Management
                                                products/eligible-countries-products-                                Thailand’s Siluriformes fish imported                   and Budget under E.O. 12866.
                                                foreign-establishments/foreign-audit-                                into the United States. Products that
                                                reports/foreign-audit-reports.                                       pass re-inspection will be stamped with                 Expected Costs of the Proposed Rule
                                                   At this time, Thailand intends to                                 the official mark of inspection and
                                                certify three establishments as eligible                             allowed to enter U.S. commerce. If they                    If this rule is finalized, establishments
                                                to export Siluriformes fish to the United                            do not meet U.S. requirements, they will                in Thailand would be listed as eligible
                                                States. Thailand’s eligibility applies to                            be refused entry and within 45 days                     to export raw Siluriformes fish to the
                                                the export of raw Siluriformes fish only.                            must be exported to the country of                      United States. Adoption of this rule is
                                                Should this rule become final, the                                   origin, destroyed, or converted to                      not expected to have quantified costs
                                                government of Thailand must certify to                               animal food (subject to approval of                     associated with it because the rule
                                                FSIS those establishments that wish to                               FDA), depending on the violation. The                   would maintain existing trade between
                                                export Siluriformes fish to the United                               import re-inspection activities can be                  the United States and Thailand in
                                                States and that operate in accordance                                found on the FSIS website at http://                    Siluriformes fish. The United States has
                                                with requirements equivalent to that of                              www.fsis.usda.gov/wps/portal/fsis/                      historically imported Siluriformes fish
                                                the United States (9 CFR 557.2(a)). FSIS                             topics/international-affairs/importing-                 from Thailand. Over the last 5 years,
                                                will verify that the establishments                                  products/phis-import-component/phis-                    total sales from Thailand Siluriformes
                                                certified by Thailand’s government are                               implementation-letter-to-importers/ct_                  fish imports only averaged 0.017
                                                meeting the United States requirements                               index.                                                  percent of U.S. domestic production,
                                                through verification audits of Thailand’s                                                                                    and constituted only 0.009 percent of
                                                Siluriformes fish inspection system.                                 Executive Orders 12866 and 13563, and                   total United States consumption, Table
                                                   Although a foreign country may be                                 the Regulatory Flexibility Act                          1. In 2016, Thailand exported 3.5 times
                                                listed in FSIS regulations as eligible to                               Executive Orders 12866 and 13563                     more Siluriformes fish to the United
                                                export Siluriformes fish products to the                             direct agencies to assess all costs and                 States than average, but these exports
                                                United States, the exporting country’s                               benefits of available regulatory                        still accounted for only 0.027 percent of
                                                products must be found to comply with                                alternatives and, if regulation is                      total domestic consumption, Table 1.
                                                all other applicable requirements of the                             necessary, to select regulatory                         These amounts are unlikely to have any
                                                United States. Accordingly, Siluriformes                             approaches that maximize net benefits                   substantive effect on U.S. production or
                                                fish exported from Thailand will                                     (including potential economic,                          prices for domestically harvested
                                                continue to be subject to re-inspection at                           environmental, public health and safety                 Siluriformes fish.

                                                                                                           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 1 from Thailand ..................................                     0.04           0.02             0.01           0.21         0.04          0.06
                                                Thailand as % of U.S. Imports ........................................                 0.012%         0.005%           0.003%         0.052%       0.010%        0.017%
                                                Thailand as % of U.S. Domestic Production ...................                          0.012%         0.005%           0.003%         0.054%       0.010%        0.017%
                                                Thailand as % of U.S. Consumption ...............................                      0.006%         0.002%           0.002%         0.027%       0.005%        0.009%
                                                  Data Source: U.S. Census Bureau Trade Data.
                                                  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/.
                                                  3 U.S. Consumption data is assumed to equal Imports + Domestic Production¥Exports.
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                                                Expected Benefits of the Proposed Rule                               Siluriformes fish production or prices.                 Regulatory Flexibility Act Assessment
                                                                                                                     U.S. consumers, however, are expected
                                                  If finalized, this rule would result in                            to continue to have access to more                        The FSIS Administrator has made a
                                                the continued opportunity for trade                                  choices when purchasing Siluriformes                    preliminary determination that this
                                                between the United States and                                        products. The rule would, therefore,                    proposed rule would not have a
                                                Thailand. The volume of trade is likely                              maintain choices for U.S. consumers                     significant economic impact on a
                                                to continue to be small and is expected                              and promote economic competition.                       substantial number of small entities in
                                                to have little or no effect on U.S.                                                                                          the United States, as defined by the


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                                                47536             Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules

                                                Regulatory Flexibility Act (5 U.S.C. 601                important. Consequently, FSIS will                    How To File a Complaint of
                                                et seq.) because, as stated above, the rule             announce this Federal Register                        Discrimination
                                                would maintain existing trade.                          publication and officially notify the
                                                                                                                                                                 To file a complaint of discrimination,
                                                Executive Order 13771                                   World Trade Organization’s Committee
                                                                                                                                                              complete the USDA Program
                                                                                                        on Sanitary and Phytosanitary Measures
                                                   Consistent with E.O. 13771 (82 FR                                                                          Discrimination Complaint Form, which
                                                                                                        (WTO/SPS Committee) in Geneva,
                                                9339, February 3, 2017), this proposed                                                                        may be accessed online at http://
                                                                                                        Switzerland, of this proposal on-line
                                                rule facilitates regulatory cooperation                                                                       www.ocio.usda.gov/sites/default/files/
                                                                                                        through the FSIS web page located at:
                                                with foreign governments. Therefore, if                                                                       docs/2012/Complain_combined_6_8_
                                                                                                        http://www.fsis.usda.gov/federal-
                                                finalized as proposed, this rule is                                                                           12.pdf, or write a letter signed by you
                                                                                                        register.
                                                expected to be an E.O. 13771                                                                                  or your authorized representative.
                                                deregulatory action.                                      FSIS also will make copies of this                     Send your completed complaint form
                                                                                                        publication available through the FSIS                or letter to USDA by mail, fax, or email:
                                                Paperwork Reduction Act                                 Constituent Update, which is used to                     Mail: U.S. Department of Agriculture,
                                                  No new paperwork requirements are                     provide information regarding FSIS                    Director, Office of Adjudication, 1400
                                                associated with this proposed rule.                     policies, procedures, regulations,                    Independence Avenue SW, Washington,
                                                Foreign countries wanting to export                     Federal Register notices, FSIS public                 DC 20250–9410.
                                                Siluriformes fish to the United States                  meetings, and other types of information
                                                are required to provide information to                  that could affect or would be of interest                Fax: (202) 690–7442.
                                                FSIS certifying that their inspection                   to our constituents and stakeholders.                    Email: program.intake@usda.gov.
                                                system provides standards equivalent to                 Constituent Updates are available on the                 Persons with disabilities who require
                                                those of the United States, and that the                FSIS web page. Through the web page,                  alternative means for communication
                                                legal authority for the system and their                FSIS is able to provide information to a              (Braille, large print, audiotape, etc.),
                                                implementing regulations are equivalent                 much broader, more diverse audience.                  should contact USDA’s TARGET Center
                                                to those of the United States. FSIS                     In addition, FSIS offers an email                     at (202) 720–2600 (voice and TDD).
                                                provided Thailand with a questionnaire,                 subscription service which provides                   List of Subjects in 9 CFR Part 557
                                                referred to as the self-reporting tool                  automatic and customized access to
                                                (SRT), asking for detailed information                  selected food safety news and                             Imported products.
                                                about the country’s inspection practices                information. This service is available at:              For the reasons set out in the
                                                and procedures to assist that country in                http://www.fsis.usda.gov/subscribe.                   preamble, FSIS is proposing to further
                                                organizing its materials. This                          Options range from recalls to export                  amend 9 CFR part 557, as proposed to
                                                information collection was approved                     information, regulations, directives, and             be amended elsewhere in this issue of
                                                under OMB number 0583–0153. The                         notices. Customers can add or delete                  the Federal Register, as follows:
                                                proposed rule contains no other                         subscriptions themselves and have the
                                                paperwork requirements.                                 option to password protect their                      PART 557—IMPORTATION
                                                E-Government Act                                        accounts.
                                                                                                                                                              ■ 1. The authority citation for part 557
                                                  FSIS and the U.S. Department of                       USDA Non-Discrimination Statement                     continues to read as follows:
                                                Agriculture (USDA) are committed to
                                                achieving the purposes of the E-                          No agency, officer, or employee of the                Authority: 21 U.S.C. 601–602, 606–622,
                                                Government Act (44 U.S.C. 3601, et                      USDA shall, on the grounds of race,                   624–695; 7 CFR 2.7, 2.18, 2.53.
                                                seq.) by, among other things, promoting                 color, national origin, religion, sex,
                                                the use of the internet and other                       gender identity, sexual orientation,                  § 557.2    [Amended]
                                                information technologies and providing                  disability, age, marital status, family/              ■  2. Section 557.2 is amended by adding
                                                increased opportunities for citizen                     parental status, income derived from a                ‘‘Thailand’’ in alphabetical order to the
                                                access to Government information and                    public assistance program, or political               list of countries in paragraph (b)(1).
                                                services, and for other purposes.                       beliefs, exclude from participation in,
                                                                                                        deny the benefits of, or subject to                   Paul Kiecker,
                                                Additional Public Notification                          discrimination any person in the United               Acting Administrator.
                                                  Public awareness of all segments of                   States under any program or activity                  [FR Doc. 2018–20380 Filed 9–14–18; 4:15 pm]
                                                rulemaking and policy development is                    conducted by the USDA.                                BILLING CODE 3410–DM–P
amozie on DSK3GDR082PROD with PROPOSALS3




                                           VerDate Sep<11>2014   19:00 Sep 18, 2018   Jkt 244001   PO 00000   Frm 00014   Fmt 4701   Sfmt 9990   E:\FR\FM\19SEP3.SGM    19SEP3



Document Created: 2018-09-19 02:56:00
Document Modified: 2018-09-19 02:56:00
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesSubmit comments on or before October 19, 2018.
ContactRoberta Wagner, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205-0495.
FR Citation83 FR 47532 
RIN Number0583-AD75

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