83 FR 47524 - Eligibility of the People's Republic of China 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 Range		47524-47528
FR Document		2018-20379
The Food Safety and Inspection Service (FSIS) is proposing to amend the Siluriformes fish inspection regulations to list the People's Republic of China (PRC) 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 the PRC's laws, regulations, and inspection system as implemented and has determined that the PRC'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 PRC establishments would be eligible for export to the United States. All such products would continue to be subject to re-inspection at United States 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 47524-47528]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20379]



[[Page 47523]]

Vol. 83

Wednesday,

No. 182

September 19, 2018

Part IV





Department of Agriculture





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Food Safety and Inspection Service





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9 CFR Part 557





 Eligibility of the People's Republic of China, Thailand, and the 
Socialist Republic of Vietnam To Export Siluriformes Fish and Fish 
Products to the United States; Proposed Rules

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

[[Page 47524]]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 557

[Docket No. FSIS-2018-0030]
RIN [0583-AD73]


Eligibility of the People's Republic of China 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 People's 
Republic of China (PRC) 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 the PRC's laws, regulations, and 
inspection system as implemented and has determined that the PRC'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 PRC establishments would be eligible for export 
to the United States. All such products would continue to be subject to 
re-inspection at United States points-of-entry by FSIS inspectors.

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

ADDRESSES: FSIS invites interested persons to submit comments on the 
proposed rule. Comments may be submitted by one of the following 
methods:
     Federal eRulemaking Portal: This website provides the 
ability to type short comments directly into the comment field on this 
web page or to attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, 1400 
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
     Hand- or courier-delivered submittals: Deliver to 1400 
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2018-0030. 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 the PRC 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 the PRC has been allowed to export 
these products to the United States under the conditions described 
below, the PRC is not currently listed in the Code of Federal 
Regulations (CFR) as eligible to export Siluriformes fish to the United 
States.

Transitional Period

    On December 2, 2015, FSIS published the final rule, ``Mandatory 
Inspection of Fish of the Order Siluriformes and Products Derived from 
Such Fish'' (80 FR 75590). The final rule established a mandatory 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 transition 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.
    The PRC submitted its initial documentation in March 2017, which 
allowed it to continue exporting Siluriformes fish during the 
transitional period. In August 2017, the PRC submitted a 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 the PRC. When imported product fails FSIS testing, 
the product is refused entry and the designated competent authority of 
the foreign government's inspection system is notified and further 
shipments of product from the foreign establishment are placed under 
either an increased or intensified level of sampling. FSIS notified the 
General Administration of Customs People's Republic of China (GACC), 
the PRC's central competent authority for food inspection, of the

[[Page 47525]]

residue violations. In response, GACC completed investigations to 
determine the cause of the violations and implemented corrective 
actions as necessary.

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 the PRC to continue shipping Siluriformes fish while FSIS 
made the determination concerning whether the country's inspection 
system is equivalent to that of FSIS.
    Section 557.2(a) (cross-referencing 9 CFR 327.2(a)(2)(i), 
(a)(2)(i), (a)(2)(ii)(C)-(I), (a)(2)(iii)-(iv), and (a)(3)), requires a 
foreign country's inspection system be authorized by legal authority 
that imposes requirements equivalent to those of the United States, 
specifically with respect to: (1) Official controls by the national 
government over establishment construction, facilities, and equipment; 
(2) direct official supervision of the preparation of product to assure 
that product is not adulterated or misbranded; (3) separation of 
establishment operations for product certified for export from product 
that is not certified; (4) requirements for sanitation at certified 
establishments and for sanitary handling of product; (5) official 
controls over condemned materials; (6) a HACCP system; and (7) any 
other requirements found in the FMIA and its implementing regulations.
    In addition to a foreign country's legal authority and regulatory 
requirements, the inspection program itself 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 
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 six equivalence components are 
addressed satisfactorily with respect to standards, activities, 
resources, and enforcement. If the document review is satisfactory, an 
on-site audit is scheduled using a multi-disciplinary team to evaluate 
all aspects of the country's inspection program. This comprehensive 
equivalence determination 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 the PRC Siluriformes Fish Inspection System

    In March 2017, the PRC submitted an initial equivalence application 
and requested that FSIS conduct a review of PRC's Siluriformes fish 
inspection system to establish eligibility to export Siluriformes fish 
to the United States. FSIS conducted a document review of the PRC's 
Siluriformes fish inspection system to determine whether that system 
was equivalent to that of the United States. FSIS concluded, based on 
review of the submitted documentation, that the PRC's laws, 
regulations, control programs, and procedures were equivalent to those 
of the United States.
    Accordingly, FSIS proceeded with an on-site audit of the PRC's 
Siluriformes fish inspection system in May 2018, to verify whether the 
PRC's GACC effectively implemented a Siluriformes fish inspection 
system equivalent to that of the United States. The PRC currently only 
exports raw Siluriformes fish. FSIS auditors visited six of the 14 
slaughter and raw processing establishments currently certified as 
eligible by the GACC to export Siluriformes fish and fish products to 
the United States and two pre-harvesting farms that provide raw fish to 
two of the audited establishments.

[[Page 47526]]

    The audit did not identify any deficiencies that represented an 
immediate threat to public health. The audit did identify deficiencies 
that could lead to product contamination if not adequately addressed. 
The auditors identified deficiencies regarding government oversight. 
Specifically, in one audited provincial office, the GACC inspection 
personnel did not document all noncompliances identified during their 
verification activities. The auditors also identified deficiencies 
involving sanitation. Specifically, in one establishment, rusted pipes 
and loose silicone were observed on the overhead structures on the 
ceiling over exposed products in the production areas. In another 
establishment, beaded condensate was observed over exposed product in 
several production areas.
    In addition, the auditors identified deficiencies regarding HACCP. 
Specifically, in all six establishments audited, establishments' 
ongoing verification activities did not include direct observations of 
monitoring activities. In five out of the six establishments audited, 
establishment verification records did not include the times or results 
of the verification activities. In four of the six establishments 
audited, corrective action records did not include all four parts of 
the corrective actions to be followed in response to a deviation from a 
critical limit. Lastly, in two establishments out of the six audited, 
monitoring records did not include the initials or signature of the 
establishment employee making the entry.
    In summary, in the audit exit meeting, GACC committed to address 
the findings as presented. FSIS auditors will perform a follow-up audit 
in November 2018 to verify implementation of the PRC's corrective 
action plan and ensure that all outstanding issues have been resolved. 
Because none of these outstanding issues present an immediate public 
health threat, FSIS is proposing to list the PRC as eligible to ship 
Siluriformes fish to the United States. FSIS will post the follow-up 
audit on its website, will request comments on the follow up audit, and 
will consider those comments in developing the final rule.
    The full report on the PRC'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, the PRC intends to certify fourteen establishments as 
eligible to export product to the U.S. The establishments intend to 
export raw Siluriformes fish. Should this rule become final, the 
government of the PRC 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 
the PRC's government are meeting the United States requirements through 
verification audits of the PRC's Siluriformes fish inspection system.
    Although a foreign country may be listed in FSIS regulations as 
eligible to export Siluriformes fish to the United States, the 
exporting country's products must be found to comply with all other 
applicable requirements of the United States. Accordingly, Siluriformes 
fish exported from the PRC 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 PRC'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

    As shown in Table 1, the PRC accounted for approximately 10 percent 
of Siluriformes fish imports and represented only 3.6 to 5.2 percent of 
Siluriformes fish consumption in the United States. The proposed rule 
is not expected to change the PRC's market share. If finalized, the 
proposed rule is not expected to have any cost to industry or 
consumers, because the proposed rule would maintain historical trade.

                                     Table 1--Summary of Siluriformes Sales
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                                                                                                        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         4.00         4.95         4.80         6.18         4.92
U.S. Consumption of U.S.                  98.7%        98.9%        98.6%        98.8%        98.4%        98.7%
 Production.......................
Total U.S. Consumption \3\........      $715.46      $694.60      $709.79      $786.80      $755.43      $732.41
Total U.S. Imports from the PRC          $25.97       $36.19       $32.06       $37.46       $38.35       $34.01
 \1\..............................
The PRC as % of U.S. Imports......         7.1%        10.4%         9.1%         9.2%        10.0%         9.2%
The PRC as % of U.S. Domestic              7.3%        10.3%         8.8%         9.7%        10.1%         9.3%
 Production.......................

[[Page 47527]]

 
The PRC as % of U.S. Consumption..         3.6%         5.2%         4.5%         4.8%         5.1%         4.6%
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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

    Should this proposed rule become final, the Siluriformes fish trade 
between the United States and the PRC, and its associated benefits, 
would be maintained. As shown in Table 2, the United States is the 
PRC's largest foreign customer of Siluriformes fish, purchasing 63 to 
71 percent of their total exports from 2015 to 2017. As shown in Table 
1, the U.S. consumes 98.7 percent of all Siluriformes fish that it 
produces. U.S. production meets half of U.S. total demand. Maintaining 
current trade flows would help keep consumer prices for Siluriformes 
fish affordable and meet the large U.S. demand for these products. 
Additionally, the PRC provides several species of Siluriformes fish 
that are not produced domestically, allowing for greater product 
diversity and consumer choice.

                          Table 2--Chinese Siluriformes Export Market Share by Country
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                                          U.S. Dollars [in millions]                     Share (%)
         Partner Country *         -----------------------------------------------------------------------------
                                        2015         2016         2017         2015         2016         2017
----------------------------------------------------------------------------------------------------------------
World.............................       $49.30       $50.40       $41.30         100%         100%         100%
United States.....................        30.87        35.92        27.32           63           71           66
Cote d Ivoire.....................         0.61         5.74         4.14            1           11           10
Hong Kong.........................         7.24         7.05         2.40           15           14            6
Congo, Dem. Rep...................         2.30         1.92         2.07            5            4            5
Congo.............................         2.26         0.75         1.33            5            1            3
Ghana.............................         0.04         0.14         1.04            0            0            3
Cameroon..........................         3.62         0.09         0.57            7            0            1
Korea, South......................         0.64         0.36         0.40            1            1            1
Thailand..........................         0.07         0.05         0.37            0            0            1
Angola............................         1.03         0.12         0.12            2            0            0
Mali..............................          0.0         0.32         0.12            0            1            0
Zambia............................         0.33         0.31         0.04            1            1            0
----------------------------------------------------------------------------------------------------------------
Data Source: Global Trade Atlas--International Import and Export Commodity Trade Data (numbers reported by
  Chinese Customs) http://www.gtis.com/gta_3d/scripts/commodity.cfm.

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.). The expected 
trade volume is expected to remain within historical bounds, with 
little or no effect on U.S. establishments, regardless of size.

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 the PRC with a questionnaire, referred to as the 
SRT, asking for detailed information about the country's inspection 
practices and procedures to assist the country in organizing its 
materials. This information collection was approved under OMB number 
0583-0153. The 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:

[[Page 47528]]

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: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

List of Subjects in 9 CFR Part 557

    Imported products.

    For the reasons set out in the preamble, FSIS is proposing to amend 
9 CFR part 557 as follows:

PART 557--IMPORTATION

0
1. The authority citation for part 557 continues to read as follows:

    Authority: 21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 2.7, 2.18, 
2.53.

0
2. In Sec.  557.2, revise paragraph (b)(1) to read as follows:


Sec.  557.2   Eligibility of foreign countries for importation of fish 
and fish products into the United States.

* * * * *
    (b)(1) It has been determined that fish and fish products from the 
following countries covered by foreign inspection certificates of the 
country of origin as required by Sec.  557.4, are eligible under the 
regulations in this subchapter for entry into the United States after 
inspection and marking as required by the applicable provisions of this 
part: Peoples Republic of China.
* * * * *

Paul Kiecker,
Acting Administrator.
[FR Doc. 2018-20379 Filed 9-14-18; 4:15 pm]
 BILLING CODE 3410-DM-P
47524 Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules

DEPARTMENT OF AGRICULTURE Agency name and docket number FSIS– addition, by March 1, 2016, FSIS
2018–0030. Comments received in required foreign countries to submit
Food Safety and Inspection Service response to this docket will be made written documentation to demonstrate
available for public inspection and that they had laws or other legal
9 CFR Part 557 posted without change, including any measures in place that provide authority
[Docket No. FSIS–2018–0030] personal information, to http:// to regulate the growing and processing
www.regulations.gov. of fish for human food, and to assure
RIN [0583–AD73] Docket: For access to background compliance with FDA’s good
documents or comments received, call manufacturing practices, Hazard
Eligibility of the People’s Republic of (202)720–5627 to schedule a time to Analysis and Critical Control Point
China To Export Siluriformes Fish and visit the FSIS Docket Room at 1400 (HACCP) requirements, sanitation
Fish Products to the United States Independence Avenue SW, Room 6065, control procedures, and other regulatory
AGENCY: Food Safety and Inspection Washington, DC 20250–3700. requirements in 21 CFR part 123, Fish
Service, USDA. FOR FURTHER INFORMATION CONTACT: and Fishery Products.
Roberta Wagner, Assistant FSIS recognized the foreign countries’
ACTION: Proposed rule.
Administrator, Office of Policy and initial documentation until the end of
SUMMARY: The Food Safety and Program Development; Telephone: (202) the transition period on September 1,
Inspection Service (FSIS) is proposing 205–0495. 2017. Foreign countries that wished to
to amend the Siluriformes fish continue exporting after September 1,
SUPPLEMENTARY INFORMATION: 2017, were required to submit
inspection regulations to list the
People’s Republic of China (PRC) as a Background documentation substantiating the
country eligible to export Siluriformes equivalence of their Siluriformes fish
FSIS is proposing to amend its inspection system to that of the United
fish and fish products to the United regulations at 9 CFR 557.2(b)(1) to add
States. FSIS is proposing this action States. Foreign countries that submitted
the PRC as a country eligible to export complete equivalence documentation by
because the Agency has reviewed the Siluriformes fish and fish products to
PRC’s laws, regulations, and inspection September 1, 2017, were permitted to
the United States (for convenience, in continue exporting Siluriformes fish
system as implemented and has this proposed rule, ‘‘Siluriformes fish
determined that the PRC’s Siluriformes until such time that FSIS determines if
and fish products’’ will be shortened to their Siluriformes fish inspection
fish inspection system is equivalent to ‘‘Siluriformes fish’’). Although the PRC
the system that the United States has systems are equivalent to the U.S.
has been allowed to export these system.
established under the Federal Meat products to the United States under the The PRC submitted its initial
Inspection Act (FMIA) and its conditions described below, the PRC is documentation in March 2017, which
implementing regulations. not currently listed in the Code of allowed it to continue exporting
Under this proposal, only raw Federal Regulations (CFR) as eligible to Siluriformes fish during the transitional
Siluriformes fish and fish products export Siluriformes fish to the United period. In August 2017, the PRC
produced in certified PRC States. submitted a Self-Reporting Tool (SRT),
establishments would be eligible for
Transitional Period the questionnaire that FSIS uses to
export to the United States. All such
assess the equivalence of a foreign
products would continue to be subject On December 2, 2015, FSIS published country’s food safety inspection system.
to re-inspection at United States points- the final rule, ‘‘Mandatory Inspection of FSIS stated in the final rule that,
of-entry by FSIS inspectors. Fish of the Order Siluriformes and during the transitional period, it would
DATES: Submit comments on or before Products Derived from Such Fish’’ (80 reinspect imported Siluriformes fish
October 19, 2018. FR 75590). The final rule established a and test for species identification and
ADDRESSES: FSIS invites interested mandatory FSIS inspection system for residues at least on a quarterly basis for
persons to submit comments on the fish of the order Siluriformes and each foreign establishment that exported
proposed rule. Comments may be products derived from these fish. The Siluriformes fish to the U.S. (80 FR
submitted by one of the following final regulations implemented the 75608). FSIS conducted random and
methods: provisions of the 2008 and 2014 Farm targeted sampling and testing of
• Federal eRulemaking Portal: This Bills, which amended the FMIA, imported Siluriformes fish during the
website provides the ability to type mandating FSIS inspection of transitional period, and on August 2,
short comments directly into the Siluriformes fish. 2017, began reinspecting all shipments
comment field on this web page or to The final rule provided an 18-month of Siluriformes fish, with random
attach a file for lengthier comments. Go period, from March 1, 2016, to sampling for species and residue testing.
to http://www.regulations.gov. Follow September 1, 2017, for both the U.S. During the testing, FSIS found residue
the on-line instructions at that site for domestic Siluriformes fish industry and violations in shipments of Siluriformes
submitting comments. international trading partners to fish exported from the PRC. When
• Mail, including CD–ROMs, etc.: transition from the regulatory imported product fails FSIS testing, the
Send to Docket Clerk, U.S. Department requirements of the U.S. Food and Drug product is refused entry and the
of Agriculture, Food Safety and Administration (FDA), the agency designated competent authority of the
Inspection Service, 1400 Independence formerly responsible for regulatory foreign government’s inspection system
amozie on DSK3GDR082PROD with PROPOSALS3

Avenue SW, Mailstop 3758, Room 6065, oversight of Siluriformes fish, to the is notified and further shipments of
Washington, DC 20250–3700. regulatory requirements of FSIS. By product from the foreign establishment
• Hand- or courier-delivered March 1, 2016, FSIS required foreign are placed under either an increased or
submittals: Deliver to 1400 countries to submit written intensified level of sampling. FSIS
Independence Avenue SW, Room 6065, documentation identifying a list of notified the General Administration of
Washington, DC 20250–3700. establishments that had been exporting Customs People’s Republic of China
Instructions: All items submitted by and would continue exporting (GACC), the PRC’s central competent
mail or electronic mail must include the Siluriformes fish to the United States. In authority for food inspection, of the

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Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules 47525

residue violations. In response, GACC administered by the national addressed satisfactorily with respect to
completed investigations to determine government must impose requirements standards, activities, resources, and
the cause of the violations and equivalent to those of the United States enforcement. If the document review is
implemented corrective actions as with respect to: (1) Organizational satisfactory, an on-site audit is
necessary. structure and staffing, so as to ensure scheduled using a multi-disciplinary
uniform enforcement of the requisite team to evaluate all aspects of the
Statutory and Regulatory Basis for
laws and regulations in all certified country’s inspection program. This
Proposed Action
establishments; (2) ultimate control and comprehensive equivalence
Siluriformes fish are an amenable supervision by the national government determination process is described more
species under the FMIA (21 U.S.C. over the official activities of employees fully on the FSIS website at http://
601(w)(2)). The FMIA prohibits or licensees; (3) competent, qualified www.fsis.usda.gov/wps/portal/fsis/
importation into the United States of inspectors; (4) enforcement and topics/international-affairs/importing-
adulterated or misbranded meat and certification; (5) administrative and products/equivalence/equivalence-
meat food products (21 U.S.C. 620). technical support; (6) inspection, process-overview.
Under the FMIA and its implementing sanitation, quality, species verification, Under the regulations, foreign
regulations, Siluriformes fish imported and residue standards; and (7) any other countries must be listed in the CFR as
into the United States must be from inspection requirements required by the eligible to export Siluriformes fish to the
foreign countries that maintain an regulations in Subchapter F— United States. FSIS engages in
inspection system that ensures Mandatory Inspection of Fish of the rulemaking to list a country as eligible
compliance with requirements Order Siluriformes and Products of to export Siluriformes fish to the United
equivalent to all the inspection, Such Fish, which cross-references 9 States in the regulations at 9 CFR
sanitary, quality, species verification, CFR 327.2(a)(2)(i)). 557.26(b)(1). Once listed, the eligible
and residue standards, and all other The foreign country’s inspection country is required to certify that
provisions of the FMIA which are system must ensure that establishments establishments meet the requirements to
applied to official establishments in the preparing Siluriformes fish for export to export Siluriformes fish to the United
United States. The regulatory the United States comply with States and to ensure that products from
requirements for foreign countries to requirements equivalent to those of the these establishments are safe,
become eligible to export Siluriformes FMIA and the regulations promulgated wholesome, and not misbranded. To
fish to the United States are provided in thereunder. The foreign country certifies
9 CFR 557.2, which cross-references 9 verify that products imported into the
the establishments as having met the
CFR 327.2, the regulations for the United States are safe, wholesome, and
required standards and notifies FSIS
import of other products also subject to properly labeled and packaged, FSIS
about establishments that are certified
the FMIA. As noted above, FSIS has conducts 100 percent re-inspection of
or removed from certification.
allowed the PRC to continue shipping As discussed above, a foreign those products at points-of-entry before
Siluriformes fish while FSIS made the country’s inspection system must be they enter the U.S. commerce.
determination concerning whether the evaluated by FSIS to determine its Evaluation of the PRC Siluriformes Fish
country’s inspection system is eligibility to export Siluriformes fish to Inspection System
equivalent to that of FSIS. the United States. This evaluation
Section 557.2(a) (cross-referencing 9 consists of two processes: A document In March 2017, the PRC submitted an
CFR 327.2(a)(2)(i), (a)(2)(i), (a)(2)(ii)(C)– review and an on-site review. The initial equivalence application and
(I), (a)(2)(iii)–(iv), and (a)(3)), requires a document review is an evaluation of the requested that FSIS conduct a review of
foreign country’s inspection system be laws, regulations, and other written PRC’s Siluriformes fish inspection
authorized by legal authority that materials used by the country to affect system to establish eligibility to export
imposes requirements equivalent to its inspection program. FSIS requests Siluriformes fish to the United States.
those of the United States, specifically that countries provide information FSIS conducted a document review of
with respect to: (1) Official controls by about their inspection systems through the PRC’s Siluriformes fish inspection
the national government over the SRT. The SRT can be found on the system to determine whether that
establishment construction, facilities, FSIS website at 2016 Siluriformes SRT. system was equivalent to that of the
and equipment; (2) direct official The SRT is a standardized questionnaire United States. FSIS concluded, based on
supervision of the preparation of that FSIS provides to foreign review of the submitted documentation,
product to assure that product is not governments to gather information that that the PRC’s laws, regulations, control
adulterated or misbranded; (3) characterizes foreign inspection programs, and procedures were
separation of establishment operations systems. Through the SRT, FSIS collects equivalent to those of the United States.
for product certified for export from information on practices and procedures Accordingly, FSIS proceeded with an
product that is not certified; (4) in six areas, known as equivalence on-site audit of the PRC’s Siluriformes
requirements for sanitation at certified components: (1) Government Oversight fish inspection system in May 2018, to
establishments and for sanitary (e.g., Organization and Administration), verify whether the PRC’s GACC
handling of product; (5) official controls (2) Government Statutory Authority and effectively implemented a Siluriformes
over condemned materials; (6) a HACCP Food Safety and Other Consumer fish inspection system equivalent to that
system; and (7) any other requirements Protection Regulations (e.g., Inspection of the United States. The PRC currently
found in the FMIA and its System Operation, Product Standards only exports raw Siluriformes fish. FSIS
amozie on DSK3GDR082PROD with PROPOSALS3

implementing regulations. and Labeling), (3) Government auditors visited six of the 14 slaughter
In addition to a foreign country’s legal Sanitation, (4) Government HACCP and raw processing establishments
authority and regulatory requirements, Systems, (5) Government Chemical currently certified as eligible by the
the inspection program itself must Residue Testing Programs, and (6) GACC to export Siluriformes fish and
achieve a level of public health Government Microbiological Testing fish products to the United States and
protection equivalent to that achieved Programs. FSIS evaluates the two pre-harvesting farms that provide
by the U.S. program. Specifically, the information submitted to verify that the raw fish to two of the audited
inspection program organized and six equivalence components are establishments.

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Document Created: 2018-09-19 02:56:14
Document Modified: 2018-09-19 02:56:14
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Proposed rule.
Dates		Submit comments on or before October 19, 2018.
Contact		Roberta Wagner, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205-0495.
FR Citation		83 FR 47524
RIN Number		0583-AD73
83 FR 47524 - Eligibility of the People's Republic of China To Export Siluriformes Fish and Fish Products to the United States

DEPARTMENT OF AGRICULTUREFood Safety and Inspection Service

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

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
