83_FR_47710 83 FR 47528 - Eligibility of the Socialist Republic of Vietnam To Export Siluriformes Fish and Fish Products to the United States

83 FR 47528 - Eligibility of the Socialist Republic of Vietnam 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 Range47528-47532
FR Document2018-20376

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

Federal Register, Volume 83 Issue 182 (Wednesday, September 19, 2018)
[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Proposed Rules]
[Pages 47528-47532]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20376]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 557

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


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

AGENCY: Food Safety and Inspection Service, USDA.

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

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

ADDRESSES: FSIS invites interested persons to submit comments on the 
proposed rule. Comments may be submitted by one of the following 
methods:
     Federal eRulemaking Portal: This website provides the 
ability to type short comments directly into the comment field on this 
web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, 1400 
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
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-2018-0029. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, 
call (202)720-5627 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant 
Administrator, Office of Policy and 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 Vietnam as a country eligible to export Siluriformes fish and fish 
products to the United States (for convenience, in this proposed rule, 
``Siluriformes fish and fish products'' will be shortened to 
``Siluriformes fish''). Although Vietnam has been allowed to export 
these products to the United States under the conditions described 
below, Vietnam is not currently listed in the Code of

[[Page 47529]]

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

Transitional Period

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

Statutory and Regulatory Basis for Proposed Action

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

[[Page 47530]]

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

Evaluation of Vietnam's Siluriformes Fish Inspection System

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

[[Page 47531]]

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

Executive Orders 12866 and 13563, and the Regulatory Flexibility Act

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

Expected Costs of the Proposed Rule

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

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

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

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

Regulatory Flexibility Act Assessment

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

Executive Order 13771

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

Paperwork Reduction Act

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

[[Page 47532]]

inspection practices and procedures to assist the country in organizing 
its materials. This information collection was approved under OMB 
number 0583-0153. The proposed rule contains no other paperwork 
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 ``Socialist Republic of 
Vietnam'' in alphabetical order to the list of countries in paragraph 
(b)(1).

Paul Kiecker,
Acting Administrator.
[FR Doc. 2018-20376 Filed 9-14-18; 4:15 pm]
 BILLING CODE 3410-DM-P



                                                47528             Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules

                                                http://www.fsis.usda.gov/federal-                         For the reasons set out in the                         Under this proposal, only raw
                                                register.                                               preamble, FSIS is proposing to amend 9                Siluriformes fish and fish products
                                                  FSIS also will make copies of this                    CFR part 557 as follows:                              produced in certified Vietnamese
                                                publication available through the FSIS                                                                        establishments would be eligible for
                                                Constituent Update, which is used to                    PART 557—IMPORTATION                                  export to the United States. All such
                                                provide information regarding FSIS                                                                            products would continue to be subject
                                                                                                        ■ 1. The authority citation for part 557              to re-inspection at U.S. points-of-entry
                                                policies, procedures, regulations,
                                                                                                        continues to read as follows:                         by FSIS inspectors.
                                                Federal Register notices, FSIS public
                                                meetings, and other types of information                  Authority: 21 U.S.C. 601–602, 606–622,              DATES: Submit comments on or before
                                                that could affect or would be of interest               624–695; 7 CFR 2.7, 2.18, 2.53.                       October 19, 2018.
                                                to our constituents and stakeholders.                   ■ 2. In § 557.2, revise paragraph (b)(1) to           ADDRESSES: FSIS invites interested
                                                Constituent Updates are available on the                read as follows:                                      persons to submit comments on the
                                                FSIS web page. Through the web page,                                                                          proposed rule. Comments may be
                                                FSIS is able to provide information to a                § 557.2 Eligibility of foreign countries for
                                                                                                        importation of fish and fish products into
                                                                                                                                                              submitted by one of the following
                                                much broader, more diverse audience.                                                                          methods:
                                                                                                        the United States.
                                                In addition, FSIS offers an email                                                                                • Federal eRulemaking Portal: This
                                                subscription service which provides                     *     *      *    *     *                             website provides the ability to type
                                                automatic and customized access to                        (b)(1) It has been determined that fish             short comments directly into the
                                                selected food safety news and                           and fish products from the following                  comment field on this web page or
                                                information. This service is available at:              countries covered by foreign inspection               attach a file for lengthier comments. Go
                                                http://www.fsis.usda.gov/subscribe.                     certificates of the country of origin as              to http://www.regulations.gov. Follow
                                                Options range from recalls to export                    required by § 557.4, are eligible under               the on-line instructions at that site for
                                                information, regulations, directives, and               the regulations in this subchapter for                submitting comments.
                                                notices. Customers can add or delete                    entry into the United States after                       • Mail, including CD–ROMs, etc.:
                                                subscriptions themselves and have the                   inspection and marking as required by                 Send to Docket Clerk, U.S. Department
                                                option to password protect their                        the applicable provisions of this part:               of Agriculture, Food Safety and
                                                accounts.                                               Peoples Republic of China.                            Inspection Service, 1400 Independence
                                                                                                        *     *      *    *     *                             Avenue SW, Mailstop 3758, Room 6065,
                                                USDA Non-Discrimination Statement
                                                                                                        Paul Kiecker,                                         Washington, DC 20250–3700.
                                                  No agency, officer, or employee of the                                                                         • Hand- or courier-delivered
                                                                                                        Acting Administrator.
                                                USDA shall, on the grounds of race,                                                                           submittals: Deliver to 1400
                                                color, national origin, religion, sex,                  [FR Doc. 2018–20379 Filed 9–14–18; 4:15 pm]
                                                                                                                                                              Independence Avenue SW, Room 6065,
                                                gender identity, sexual orientation,                    BILLING CODE 3410–DM–P
                                                                                                                                                              Washington, DC 20250–3700.
                                                disability, age, marital status, family/                                                                         Instructions: All items submitted by
                                                parental status, income derived from a                                                                        mail or electronic mail must include the
                                                public assistance program, or political                 DEPARTMENT OF AGRICULTURE
                                                                                                                                                              Agency name and docket number FSIS–
                                                beliefs, exclude from participation in,                 Food Safety and Inspection Service                    2018–0029. Comments received in
                                                deny the benefits of, or subject to                                                                           response to this docket will be made
                                                discrimination any person in the United                 9 CFR Part 557                                        available for public inspection and
                                                States under any program or activity                                                                          posted without change, including any
                                                conducted by the USDA.                                  [Docket No. FSIS–2018–0029]                           personal information, to http://
                                                How To File a Complaint of                                                                                    www.regulations.gov.
                                                                                                        RIN [0583–AD74]                                          Docket: For access to background
                                                Discrimination
                                                                                                                                                              documents or comments received, call
                                                   To file a complaint of discrimination,               Eligibility of the Socialist Republic of              (202)720–5627 to schedule a time to
                                                complete the USDA Program                               Vietnam To Export Siluriformes Fish                   visit the FSIS Docket Room at 1400
                                                Discrimination Complaint Form, which                    and Fish Products to the United States                Independence Avenue SW, Room 6065,
                                                may be accessed online at http://                       AGENCY:  Food Safety and Inspection                   Washington, DC 20250–3700.
                                                www.ocio.usda.gov/sites/default/files/                  Service, USDA.                                        FOR FURTHER INFORMATION CONTACT:
                                                docs/2012/Complain_combined_6_8_                                                                              Roberta Wagner, Assistant
                                                                                                        ACTION: Proposed rule.
                                                12.pdf, or write a letter signed by you                                                                       Administrator, Office of Policy and
                                                or your authorized representative.                      SUMMARY:   The Food Safety and                        Program Development; Telephone: (202)
                                                   Send your completed complaint form                   Inspection Service (FSIS) is proposing                205–0495.
                                                or letter to USDA by mail, fax, or email:               to amend the Siluriformes fish                        SUPPLEMENTARY INFORMATION:
                                                   Mail: U.S. Department of Agriculture,                inspection regulations to list the
                                                Director, Office of Adjudication, 1400                  Socialist Republic of Vietnam (Vietnam)               Background
                                                Independence Avenue SW, Washington,                     as a country eligible to export                          FSIS is proposing to amend its
                                                DC 20250–9410.                                          Siluriformes fish and fish products to                regulations at 9 CFR 557.2(b)(1) to add
                                                   Fax: (202) 690–7442.                                 the United States. FSIS is proposing this             Vietnam as a country eligible to export
                                                   Email: program.intake@usda.gov.                      action because the Agency has reviewed                Siluriformes fish and fish products to
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                                                   Persons with disabilities who require                Vietnam’s laws, regulations, and                      the United States (for convenience, in
                                                alternative means for communication                     inspection system as implemented and                  this proposed rule, ‘‘Siluriformes fish
                                                (Braille, large print, audiotape, etc.),                has determined that Vietnam’s                         and fish products’’ will be shortened to
                                                should contact USDA’s TARGET Center                     Siluriformes fish inspection system is                ‘‘Siluriformes fish’’). Although Vietnam
                                                at (202) 720–2600 (voice and TDD).                      equivalent to the system that the United              has been allowed to export these
                                                                                                        States has established under the Federal              products to the United States under the
                                                List of Subjects in 9 CFR Part 557
                                                                                                        Meat Inspection Act (FMIA) and its                    conditions described below, Vietnam is
                                                   Imported products.                                   implementing regulations.                             not currently listed in the Code of


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                                                                  Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules                                             47529

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


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                                                47530             Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules

                                                evaluated by FSIS to determine its                      Evaluation of Vietnam’s Siluriformes                  provided examples of monitoring forms
                                                eligibility to export Siluriformes fish to              Fish Inspection System                                and procedures, and stated that these
                                                the United States. This evaluation                         In August 2017, Vietnam requested                  documents showed that operational
                                                consists of two processes: A document                   that FSIS conduct a review of its                     sanitation monitoring in establishments
                                                review and an on-site review. The                       Siluriformes fish inspection system and               was performed and documented in
                                                document review is an evaluation of the                 submitted the documentation to                        accordance with the establishment’s
                                                laws, regulations, and other written                    formally establish its eligibility to                 Sanitation Standard Operating
                                                materials used by the country to affect                 export Siluriformes fish to the United                Procedures once every one or two hours
                                                its inspection program. FSIS requests                   States. FSIS conducted a document                     depending on production stage and
                                                that countries provide information                                                                            establishments sanitation procedure.
                                                                                                        review of Vietnam’s Siluriformes fish
                                                about their inspection systems through                                                                        FSIS agrees that this frequency of
                                                                                                        inspection system to determine whether
                                                the SRT. The SRT can be found on the                                                                          monitoring is sufficient. The frequency
                                                                                                        that system was equivalent to that of the
                                                FSIS website at 2016 Siluriformes SRT.                                                                        and documentation of the monitoring of
                                                                                                        United States. FSIS concluded, based
                                                The SRT is a standardized questionnaire                                                                       the sanitation operations must replicate
                                                                                                        review of the submitted documentation,
                                                that FSIS provides to foreign                                                                                 the frequency and monitoring in the
                                                                                                        that Vietnam’s laws, regulations, control
                                                                                                                                                              written sanitation procedures.
                                                governments to gather information that                  programs, and procedures were                            In response to the finding that one
                                                characterizes foreign inspection                        equivalent to those of the United States.             establishment’s hazard analysis
                                                systems. Through the SRT, FSIS collects                    Accordingly, in May 2018, FSIS                     identified the shipping step, but not all
                                                information on practices and procedures                 proceeded with an on-site audit of                    potential hazards associated with that
                                                in six areas, known as equivalence                      Vietnam’s Siluriformes fish inspection                step, NAFIQAD explained that the
                                                components: (1) Government Oversight                    system. FSIS audited eight of the 13                  establishment did not identify the
                                                (e.g., Organization and Administration),                establishments currently exporting                    hazards because the product had been
                                                (2) Government Statutory Authority and                  Siluriformes fish to the U.S. The on-site             frozen and transported outside of the
                                                Food Safety and Other Consumer                          audit also included visits to two farms               factory and that the establishment is
                                                Protection Regulations (e.g., Inspection                where fish were raised and pre-harvest                revising its HACCP plan to include the
                                                System Operation, Product Standards                     operations were conducted. The                        hazard of pathogen growth.
                                                and Labeling), (3) Government                           purpose of the on-site audit was to                      In addition to the corrective actions
                                                Sanitation, (4) Government HACCP                        verify whether NAFIQAD effectively                    discussed above, FSIS reviewed
                                                Systems, (5) Government Chemical                        implemented a Siluriformes fish                       Vietnam’s corrective action plan for all
                                                Residue Testing Programs, and (6)                       inspection system equivalent to that of               of the audit findings and concluded that
                                                Government Microbiological Testing                      the United States. Vietnam currently                  all have been satisfactorily addressed.
                                                Programs. FSIS evaluates the                            exports only raw Siluriformes fish to the                In summary, FSIS has completed the
                                                information submitted to verify that the                United States.                                        document review, on-site audit, and
                                                critical points in the six equivalence                     The audit of Vietnam’s Siluriformes                verification of corrective actions as part
                                                components are addressed satisfactorily                 fish inspection system did not identify               of the equivalence process, and all
                                                with respect to standards, activities,                  any deficiencies that represented an                  outstanding issues have been resolved.
                                                resources, and enforcement. If the                      immediate threat to public health. The                FSIS has concluded that, as
                                                document review is satisfactory, an on-                 audit did find that NAFIQAD inspectors                implemented, Vietnam’s inspection
                                                site review is scheduled using a multi-                 were not identifying the establishment’s              system for Siluriformes fish is
                                                disciplinary team to evaluate all aspects               failures to adequately document results               equivalent to that of the United States.
                                                of the country’s inspection program.                    of operational sanitation monitoring in               The full report on Vietnam’s
                                                This comprehensive process is                           all of the establishments FSIS visited.               Siluriformes fish inspection system can
                                                described more fully on the FSIS                        Specifically, at each establishment                   be found on the FSIS website at http://
                                                website at http://www.fsis.usda.gov/                    audited, the FSIS auditors found that                 www.fsis.usda.gov/wps/portal/fsis/
                                                wps/portal/fsis/topics/international-                   the establishments were documenting                   topics/international-affairs/importing-
                                                affairs/importing-products/equivalence/                 operational sanitation monitoring;                    products/eligible-countries-products-
                                                equivalence-process-overview.                           however, it was not at the frequency                  foreign-establishments/foreign-audit-
                                                                                                        prescribed in the establishment’s                     reports/foreign-audit-reports.
                                                   Under the regulations, foreign                       sanitation procedures. The audit also                    At this time, Vietnam intends to
                                                countries must be listed in the CFR as                  found that, in one establishment, the                 certify thirteen establishments as
                                                eligible to export Siluriformes fish to the             hazard analysis identified the shipping               eligible to export Siluriformes fish to the
                                                United States. FSIS engages in                          step in its process, but did not identify             United States. Vietnam’s eligibility
                                                rulemaking to list a country as eligible                all potential hazards associated with                 applies to the export of raw Siluriformes
                                                to export Siluriformes fish to the United               that step.                                            fish only. Should this rule become final,
                                                States in the regulations at 9 CFR                         On June 29, 2018, FSIS sent                        the government of Vietnam must certify
                                                557.26(b)(1). Once listed, the eligible                 NAFIQAD the draft final audit report,                 to FSIS those establishments that wish
                                                country is required to certify that                     and requested a written response                      to export Siluriformes fish to the United
                                                establishments meet the requirements to                 regarding any corrective actions                      States and that operate in accordance
                                                export Siluriformes fish to the United                  undertaken and changes made to                        with requirements equivalent to that of
                                                States and to ensure that products from                 Vietnam’s Siluriformes fish inspection                the United States (9 CFR 557.2(a)). FSIS
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                                                these establishments are safe,                          system. On August 10, 2018, NAFIQAD                   will verify that the establishments
                                                wholesome, and not misbranded. To                       responded with written comments and                   certified by Vietnam’s government are
                                                verify that products imported into the                  corrective actions.                                   meeting the United States requirements
                                                United States are safe, wholesome, and                     In response to the finding that                    through verification audits of Vietnam’s
                                                properly labeled and packaged, FSIS                     NAFIQAD inspectors did not identify                   Siluriformes fish inspection system.
                                                conducts 100 percent re-inspection of                   establishment’s failure to adequately                    Although a foreign country may be
                                                those products at points-of-entry before                document results of operational                       listed in FSIS regulations as eligible to
                                                they enter the U.S. commerce.                           sanitation monitoring, NAFIQAD                        export Siluriformes fish to the United


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                                                                       Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules                                                     47531

                                                States, the exporting country’s products                             animal food (subject to approval of                     ‘‘non-significant’’ regulatory action
                                                must be found to comply with all other                               FDA), depending on the violation. The                   under section 3(f) of E.O. 12866.
                                                applicable requirements of the United                                import re-inspection activities can be                  Accordingly, the rule has not been
                                                States. Accordingly, Siluriformes fish                               found on the FSIS website at http://                    reviewed by the Office of Management
                                                exported from Vietnam will continue to                               www.fsis.usda.gov/wps/portal/fsis/                      and Budget under E.O. 12866.
                                                be subject to re-inspection at U.S.                                  topics/international-affairs/importing-
                                                                                                                     products/phis-import-component/phis-                    Expected Costs of the Proposed Rule
                                                points-of-entry for, but not limited to,
                                                transportation damage, product and                                   implementation-letter-to-importers/ct_                    If this rule is finalized, establishments
                                                container defects, labeling, proper                                  index.
                                                                                                                                                                             in Vietnam would be listed as eligible
                                                certification, general condition, and                                Executive Orders 12866 and 13563, and                   to export raw Siluriformes fish to the
                                                accurate count. In addition, FSIS is, and                            the Regulatory Flexibility Act                          United States. Adoption of this rule is
                                                will continue, to conduct other types of                                Executive Orders 12866 and 13563                     not expected to have quantified costs
                                                re-inspection activities, such as taking                             direct agencies to assess all costs and                 because the proposed rule maintains the
                                                product samples for laboratory analysis                              benefits of available regulatory                        existing trade in Siluriformes fish
                                                for the detection of drug and chemical                               alternatives and, if regulation is                      between the United States and Vietnam.
                                                residues, pathogens, species, and                                    necessary, to select regulatory                         The United States has historically
                                                product composition for a subset of                                  approaches that maximize net benefits                   imported Siluriformes fish from
                                                Vietnam’s Siluriformes fish imported                                 (including potential economic,                          Vietnam. Therefore, market conditions,
                                                into the United States. Products that                                environmental, public health and safety                 including prices and supplies, are not
                                                pass re-inspection will be stamped with                              effects, distributive impacts, and                      expected to be impacted by this rule.
                                                the official mark of inspection and                                  equity). Executive Order (E.O.) 13563                   From 2013 to 2017, 90.5 percent of total
                                                allowed to enter U.S. commerce. If they                              emphasizes the importance of                            Siluriformes fish imports to the United
                                                do not meet U.S. requirements, they will                             quantifying both costs and benefits, of                 States were from Vietnam, Table 1.
                                                be refused entry and within 45 days                                  reducing costs, of harmonizing rules,                   Vietnamese Siluriformes fish accounted
                                                must be exported to the country of                                   and of promoting flexibility. This                      for 45.7 percent of U.S. consumption,
                                                origin, destroyed, or converted to                                   proposed rule has been designated as a                  Table 1.

                                                                                                           TABLE 1—SUMMARY OF SILURIFORMES FISH SALES
                                                                                                                                                                                                               5 Year
                                                                                                                                   2013               2014            2015           2016         2017        average

                                                                                                                                                                       Millions of dollars

                                                Total U.S.     Imports 1
                                                                     ..........................................................        $363.42        $346.66          $351.13        $405.61      $381.89      $369.74
                                                Total U.S. Domestic Production 2 ....................................                   356.73         351.94           363.61         385.99       379.71       367.60
                                                Total U.S. Exports 1 .........................................................            4.69           3.99             4.95           4.80         6.18         4.92
                                                Total U.S. Consumption 3 ................................................               715.46         694.60           709.79         786.80       755.43       732.41
                                                Total U.S. Imports from 1 Vietnam ...................................                   335.03         309.53           318.40         367.65       342.96       334.71
                                                Vietnam as % of U.S. Imports .........................................                  92.2%          89.3%            90.7%          90.6%        89.8%        90.5%
                                                Vietnam as % of U.S. Domestic Production ....................                           93.9%          87.9%            87.6%          95.3%        90.3%        91.1%
                                                Vietnam as % of U.S. Consumption ................................                       46.8%          44.6%            44.9%          46.7%        45.4%        45.7%
                                                  Data Source: U.S. Census Bureau Trade Data.
                                                  1 Import and Export Data Accessed from USDA Foreign Agricultural Service: Global Agricultural Trade System: 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                               would maintain choices for consumers                    rule facilitates regulatory cooperation
                                                                                                                     in the United States.1                                  with foreign governments. Therefore, if
                                                   The proposed rule may qualitatively                                                                                       finalized as proposed, this rule is
                                                benefit industry by maintaining market                               Regulatory Flexibility Act Assessment
                                                                                                                                                                             expected to be an E.O. 13771
                                                stability and continued opportunity for                                 The FSIS Administrator has made a                    deregulatory action.
                                                trade between the United States and                                  preliminary determination that this
                                                Vietnam. Consumers in the United                                     proposed rule would not have a                          Paperwork Reduction Act
                                                States would continue to have access to                              significant economic impact on a                          No new paperwork requirements are
                                                more choices when purchasing                                         substantial number of small entities in                 associated with this proposed rule.
                                                Siluriformes fish, specifically of the                               the United States, as defined by the                    Foreign countries wanting to export
                                                family Pangasius, which are native to                                Regulatory Flexibility Act (5 U.S.C. 601,               Siluriformes fish to the United States
                                                Vietnam, The People’s Republic of                                    et seq.) because, as stated above, the rule             are required to provide information to
                                                China, and other neighboring Asian                                   would maintain existing trade.                          FSIS certifying that their inspection
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                                                nations. Pangasius have a different                                  Executive Order 13771                                   system provides standards equivalent to
                                                flavor, color and texture than other                                                                                         those of the United States, and that the
                                                                                                                       Consistent with E.O. 13771 (82 FR                     legal authority for the system and their
                                                Siluriformes fish found in the United                                9339, February 3, 2017), this proposed
                                                States. The Siluriformes fish trade                                                                                          implementing regulations are equivalent
                                                between the United States and Vietnam                                  1 Sea Grant Delaware Seafood Health Facts:
                                                                                                                                                                             to those of the United States. FSIS
                                                                                                                     Making Smart Choices accessed on 7/27/2018
                                                                                                                                                                             provided Vietnam with a questionnaire,
                                                                                                                     https://www.seafoodhealthfacts.org/description-         referred to as the SRT, asking for
                                                                                                                     top-commercial-seafood-items/pangasius.                 detailed information about the country’s


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                                                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
amozie on DSK3GDR082PROD with PROPOSALS3




                                                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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Document Created: 2018-09-19 02:55:46
Document Modified: 2018-09-19 02:55:46
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 47528 
RIN Number0583-AD74

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