Eligibility of the People's Republic of China To Export Siluriformes Fish and Fish Products to the United States
| Published date | 05 November 2019 |
| Citation | 84 FR 59678 |
| Record Number | 2019-24055 |
| Section | Rules and Regulations |
| Court | Food Safety And Inspection Service |
Federal Register, Volume 84 Issue 214 (Tuesday, November 5, 2019)
[Federal Register Volume 84, Number 214 (Tuesday, November 5, 2019)]
[Rules and Regulations]
[Pages 59678-59682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24055]
[[Page 59677]]
Vol. 84
Tuesday,
No. 214
November 5, 2019
Part IIDepartment of Agriculture-----------------------------------------------------------------------Food Safety and Inspection Service-----------------------------------------------------------------------9 CFR Part 557Eligibility of the People's Republic of China, Socialist Republic of
Vietnam, and Thailand To Export Siluriformes Fish and Fish Products to
the United States; Final Rules
Federal Register / Vol. 84 , No. 214 / Tuesday, November 5, 2019 /
Rules and Regulations
[[Page 59678]]
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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: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is amending 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 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
final rule, only raw Siluriformes fish and fish products produced in
certified PRC establishments are eligible for export to the United
States. All such products are subject to re-inspection at U.S. points-
of-entry by FSIS inspectors.
DATES: Effective Date: December 5, 2019.
FOR FURTHER INFORMATION CONTACT: Terri Nintemann, Assistant
Administrator, Office of Policy and Program Development, Food Safety
and Inspection Service, U.S. Department of Agriculture; Telephone:
(202) 205-0495.
SUPPLEMENTARY INFORMATION:
Background
On September 19, 2018, FSIS proposed to amend its regulations at 9
CFR 557.2(b)(1) to add the PRC as a country eligible to export
Siluriformes fish to the United States (83 FR 47524) (for convenience,
in this final 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 in the proposed rule (83 FR 47524), the PRC is not currently
listed in the Code of Federal Regulations (CFR) as eligible to export
Siluriformes fish to the United States. FSIS proposed to add the PRC to
the regulations as eligible to export such products after the Agency
conducted a documentary review of the PRC's laws, regulations, and
Siluriformes fish inspection system, as well as an in-country audit of
the system, and determined that the PRC's Siluriformes fish inspection
system is equivalent to the U.S. system established under the FMIA and
its implementing regulations. This final rule is consistent with the
provisions of the proposed rule.
Statutory and Regulatory Basis for Final Action
As explained in the proposed rule (83 FR 47524), Siluriformes fish
are an amenable species under the FMIA (21 U.S.C. 601(w)(2)). The FMIA
prohibits importation into the United States of adulterated or
misbranded meat and meat food products (21 U.S.C. 620). Under the FMIA
and its implementing regulations, Siluriformes fish imported into the
United States must be from foreign countries that maintain an
inspection system that ensures compliance with requirements equivalent
to the inspection, sanitary, quality, species verification, and residue
standards in the United States, and all other provisions of the FMIA
that are applied to official establishments in the United States. The
regulatory requirements for foreign countries to become eligible to
export Siluriformes fish to the United States are provided in 9 CFR
557.2, which cross-references 9 CFR 327.2, the regulations for the
import of other products also subject to the FMIA.
Section 557.2(a) (cross-referencing 9 CFR 327.2(a)(1), (a)(2)(i),
(a)(2)(ii)(C)-(I), (a)(2)(iii)-(iv), and (a)(3)), requires a foreign
country's inspection system be authorized by legal authority that
imposes requirements equivalent to those of the United States,
specifically with respect to: (1) Official controls by the national
government over establishment construction, facilities, and equipment;
(2) direct official supervision of the preparation of product to assure
that product is not adulterated or misbranded; (3) separation of
establishment operations for product certified for export from product
that is not certified; (4) requirements for sanitation at certified
establishments and for the sanitary handling of product; (5) official
controls over condemned materials; (6) a Hazard Analysis Critical
Control Point (HACCP) system; and (7) any other requirements found in
the FMIA and its implementing regulations.
In addition to a foreign country's legal authority and regulatory
requirements, the inspection program must achieve a level of public
health protection equivalent to that achieved by the U.S. inspection
program. Specifically, the inspection program organized and
administered by the national government must impose requirements
equivalent to those of the United States with respect to: (1)
Organizational structure and staffing, so as to ensure uniform
enforcement of the requisite laws and regulations in all certified
establishments; (2) ultimate control and supervision by the national
government over the official activities of employees or licensees; (3)
competent, qualified inspectors; (4) enforcement and certification; (5)
administrative and technical support; (6) inspection, sanitation,
quality, species verification, and residue standards; and (7) any other
inspection requirements required by the regulations in Subchapter F--
Mandatory Inspection of Fish of the Order Siluriformes and Products of
Such Fish, which cross-references 9 CFR 327.2(a)(2)(i).
Annually, the foreign country certifies the establishments as
having met the required standards and notifies FSIS about
establishments that are certified or removed from certification (9 CFR
557.2, cross-referencing 9 CFR 327.2(a)(3)).
Evaluation of the PRC Siluriformes Fish Inspection System
As discussed in the proposed rule (83 FR 47524), in March 2017,
based on the PRC's request, 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. Based on its review
of the submitted documentation, which included the PRC's laws,
regulations, and inspection procedures, FSIS concluded that the PRC's
inspection system is equivalent to those of the United States for raw
Siluriformes fish products, specifically Siluriformes fish that fall
within the FSIS product categories ``Raw Product--Intact'' and ``Raw
Product--Non-Intact.'' Both product categories are defined in the
``FSIS Product Categorization'' document, which was developed to assist
foreign governments in accurately identifying the type of meat and
poultry products exported to the U.S. This document can be found on the
FSIS website at: https://www.fsis.usda.gov/shared/PDF/FSIS_Product_Categorization.pdf.
Accordingly, from May 28 to June 4, 2018, FSIS proceeded with an
initial on-site audit of the PRC's Siluriformes fish inspection system.
The purpose of the on-site audit was to verify whether the PRC's
General Administration of Customs (GACC), the Central Competent
Authority (CCA) for food inspection, effectively implemented a
Siluriformes fish inspection system equivalent to that
[[Page 59679]]
of the United States. The PRC currently exports only raw Siluriformes
fish to the United States.
The audit did not identify any deficiencies that represented an
immediate threat to public health, but did identify deficiencies that
could lead to product contamination if not adequately addressed. In the
audit exit meeting, GACC committed to address the findings as
presented. For more detailed information on FSIS's evaluation of the
PRC's Siluriformes fish inspection system see the proposed rule (83 FR
47524) and for the full audit report, go to: https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports.
From November 26 through December 13, 2018, FSIS performed a
follow-up audit in response to the deficiencies identified in the
initial on-site audit. During the initial audit, FSIS was only able to
observe processing in two out of the six audited establishments. In the
follow-up audit, the FSIS auditors visited seven out of ten
establishments exporting products to the United States at that time. At
the time of the follow-up audit, all seven establishments were
processing Siluriformes fish. The FSIS auditors observed the production
of Siluriformes fish, in addition to the implementation of corrective
actions to the inspection system deficiencies noted during the initial
on-site audit. FSIS did not identify any deficiencies that represented
an immediate threat to public health and has determined that the
proposed corrective actions are adequate. For the full audit report, go
to: https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/eligible-countries-products-foreign-establishments/foreign-audit-reports.
Final Rule
After considering the comments received on the proposed rule,
discussed below, FSIS concludes that the PRC's Siluriformes fish
inspection system is equivalent to the United States inspection.
Therefore, FSIS is amending its Siluriformes fish inspection
regulations to list as the People's Republic of China as a country
eligible to export Siluriformes fish to the United States. As stated
above, under FSIS's Siluriformes fish import regulations, the PRC must
certify to FSIS that those establishments that wish to export
Siluriformes fish to the United States are operating under requirements
equivalent to those of the United States (9 CFR 557.2(a)).
Although a foreign country may be listed in FSIS regulations as
eligible to export Siluriformes fish to the United States, the
exporting country's products must also comply with all other applicable
requirements of the United States. Accordingly, Siluriformes fish
exported to the United States from the PRC will continue to be subject
to re-inspection by FSIS at U.S. points-of-entry for, but not limited
to, transportation damage, product and container defects, labeling,
proper certification, general condition, and accurate count. In
addition, FSIS will continue to conduct other types of re-inspection
activities, such as taking product samples for laboratory analysis to
detect drug and chemical residues and pathogens, as well as to identify
product species and composition. Products that pass re-inspection will
be stamped with the official mark of inspection and allowed to enter
U.S. commerce. If they do not meet U.S. requirements, they will be
refused entry and within 45 days must be exported to the country of
origin, destroyed, or converted to animal food (subject to approval of
the U.S. Food and Drug Administration (FDA)), depending on the
violation. FSIS import re-inspection activities can be found on the
Agency's website at: http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/port-of-entry-procedures.
Responses to Comments
FSIS received 29 comments from individuals, Siluriformes fish and
fish product producers from the PRC and the United States, trade
associations, a commercial workers union, a frozen storage corporation,
and a consumer interest group. The issues raised in the comments and
the Agency responses are summarized below.
The Effectiveness of the PRC's Inspection System and Ongoing
Verification of Compliance
Comment: Comments from six individual consumers, a U.S.
Siluriformes fish and fish products producer, a labor group, two trade
associations, and a consumer group questioned whether the PRC's
Siluriformes fish inspection system was truly equivalent to that of the
United States, and whether Siluriformes fish processed under that
system would be safe for consumption in the United States. One of the
two trade association that questioned whether the PRC's regulatory and
inspections systems are equivalent to that of the United States
submitted peer-reviewed articles concerning the use of antibiotics in
aquaculture.
Response: FSIS made its equivalence determination for the PRC's
Siluriformes fish inspection system based on sound science and in
accordance with U.S. international obligations and its own equivalence
process. FSIS has an in-depth and rigorous equivalence process, through
which it systematically determines whether a foreign country's
inspection system achieves a level of public health protection
equivalent to that achieved by the U.S. inspection system. Accordingly,
the equivalence process does not require the exporting country to
develop and implement the same procedures as those of the United
States. Once a country is considered to have an equivalent food safety
inspection system, the FSIS equivalence process includes performing an
annual records review and on-going on-site audits of the country's
inspection system at least every three years to verify whether the
country's inspection system continues to be equivalent to FSIS's
inspection system.
Regarding antibiotic residues as discussed above, FSIS performs an
annual records review for each country that has been deemed to have an
equivalent inspection system to that of the United States which
includes, in part, a review of the country's sampling and testing for
residues; in short, FSIS annually verifies the adequacy of each
equivalent country's reside testing program. In addition, FSIS conducts
point-of-entry re-inspection of all imported Siluriformes fish, which
can include product sampling and testing for microbial, chemical and
other hazards. FSIS may conduct laboratory analysis for the detection
of chemical residues that may result from the use of drugs and
pesticides, or from incidents involving environmental contaminants.
FSIS analyzes imported Siluriformes fish for over 100 chemical
compounds, which include drugs, aminoglycosides, antifungal drugs,
metals and pesticides. Products that pass re-inspection are stamped
with the official mark of inspection and allowed to enter U.S.
commerce. If they do not meet U.S. requirements, they are refused entry
into U.S. commerce and must be re-exported, destroyed, or converted to
animal food.
On-Site Audit
Comment: The commercial workers union and the consumer interest
group expressed concerns over the deficiencies found during the initial
on-site audit and the number of PRC establishments audited.
[[Page 59680]]
Response: The results of the initial on-site audit, conducted from
May 28 through June 4, 2018, were shared with the PRC's CCA. The CCA
provided corrective actions to address the deficiencies that were
deemed adequate by FSIS.
On November 26 through December 13, 2018, FSIS performed a follow-
up audit of the PRC's food safety system governing fish and fish
products of the order Siluriformes, in response to the deficiencies
identified during the initial on-site audit (May 28 through June 4,
2018). During the initial audit, FSIS was only able to observe
processing of Siluriformes fish in two out of the six audited
establishments. In the follow-up audit, the FSIS auditors visited seven
out of the ten establishments that then exported products to the United
States. At the time of this audit, all seven establishments were
processing Siluriformes fish. The FSIS auditors observed the processing
of Siluriformes fish products, in addition to the implementation of
corrective actions to the inspection system deficiencies noted during
the initial on-site audit. FSIS did not identify any deficiencies that
represented an immediate threat to public health and determined that
the proposed corrective actions were adequate.
It is important to note that FSIS equivalence determinations are
based on the foreign country's inspection system, not on an individual
establishment's system. To be eligible to export Siluriformes fish to
the United States, the foreign country's inspection system must ensure
that establishments preparing these products for export to the United
States comply with requirements equivalent to those of the FMIA and
supporting regulations. The PRC's inspection system meets these
requirements. The foreign country certifies the establishments as
meeting the required standards and notifies FSIS about establishments
that are certified or removed from certification. The PRC's inspection
system currently meets all these requirements. FSIS will verify that
the system continues to meet requirements through annual CCA
submissions, on-going audits, and point-of-entry re-inspection and
sampling and testing.
Executive Orders (E.O.s) 12866 and 13563
E.O. 12866 and 13563 direct agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). E.O. 13563 emphasizes the
importance of quantifying both costs and benefits, of reducing costs,
of harmonizing rules, and of promoting flexibility. This final rule has
been designated 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 Final Rule
This final regulatory impact analysis updates the preliminary
regulatory impact analysis by including the most recent year's (2018)
trade data. As shown in Table 1, in 2018, the PRC accounted for
approximately 5.9 percent of Siluriformes fish imports and represented
only 3.6 percent of Siluriformes fish consumption in the United States.
The final rule is not expected to change the PRC's market share or to
impose any cost on industry or consumers, because the final rule will
maintain historical trade.
Table 1--Summary of Siluriformes Sales *
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2014 2015 2016 2017 2018 5 Year average
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Millions of Dollars
-----------------------------------------------------------------------------------------------
Total U.S. Imports \1\.................................. $346.66 $351.13 $405.61 $381.89 $547.10 $406.48
Total U.S. Domestic Production \2\...................... $351.94 $363.61 $385.99 $379.71 $360.40 $368.33
Total U.S. Exports \1\.................................. $4.00 $4.95 $4.80 $6.18 $3.89 $4.76
Total U.S. Consumption \3\.............................. $694.60 $709.79 $786.80 $755.43 $903.61 $770.04
Total U.S. Imports from the PRC \1\..................... $36.19 $32.06 $37.46 $38.35 $32.20 $35.25
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The PRC as % of U.S. Imports............................ 10.4% 9.1% 9.2% 10.0% 5.9% 8.7%
The PRC as % of U.S. Domestic Production................ 10.3% 8.8% 9.7% 10.1% 8.9% 9.6%
The PRC as % of U.S. Consumption........................ 5.2% 4.5% 4.8% 5.1% 3.6% 4.6%
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Data Source: U.S. Census Bureau Trade Data.
* Numbers in table may not sum to totals due to rounding.
\1\Import and Export Data Accessed from USDA Foreign Agricultural Service: Global Agricultural Trade System: https://apps.fas.usda.gov/gats/default.aspx/
.
\2\ U.S. Production Data Accessed from USDA National Agricultural Statistics Service: Quick Stats: https://quickstats.nass.usda.gov/results/6F6BAB14-7014-365B-ACEA-CA35C184329B?pivot=short_desc.
\3\ U.S. Consumption data is assumed to equal Imports + Domestic Production - Exports.
Expected Benefits of the Final Rule
This final rule will maintain the Siluriformes fish trade between
the United States and the PRC and its associated benefits. As shown in
Table 2, the United States is the PRC's largest foreign customer of
Siluriformes fish, purchasing on average 60 percent of their total
frozen catfish and frozen catfish fillets exports from 2016 to 2018. As
shown in Table 1, the U.S. consumes more Siluriformes fish than it
produces. U.S. production meets approximately half of U.S. total
demand. Maintaining current trade flows will 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.
[[Page 59681]]
Table 2--Chinese Siluriformes Export Market Share by Country
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USD in millions Percent share
Partner country -----------------------------------------------------------------------------------------------
2016 2017 2018 2016 2017 2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
World................................................... $50.43 $41.34 $28.74 100 100 100
United States........................................... 35.92 27.32 11.98 71 66 42
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Data Source: Global Trade Atlas--International Import and Export Commodity Trade Data (Numbers reported by Chinese Customs) Commodity: 030324--Catfish,
Frozen and 030462--Catfish Fillets, Frozen.
FSIS downloaded the data from https://www.gtis.com, and it will be available upon request.
Regulatory Flexibility Act Assessment
The FSIS Administrator certifies that, for the purposes of the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.), this final rule will
not have a significant economic impact on a substantial number of small
entities in the United States, because, as stated above, the final rule
will maintain existing trade. The trade volume is expected to remain
within historical bounds, with little or no effect on U.S.
establishments, regardless of size.
Executive Order (E.O.) 13771
Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), this
final rule facilitates regulatory cooperation with foreign governments.
Therefore, this final rule is an E.O. 13771 deregulatory action.
Paperwork Reduction Act
No new paperwork requirements are associated with this final rule.
Foreign countries wanting to export Siluriformes fish to the United
States are required to provide information to FSIS certifying that
their inspection system provides standards equivalent to those of the
United States, and that the legal authority for the system and the
implementing regulations are equivalent to those of the United States.
FSIS provided the PRC with a questionnaire, referred to as the Self
Reporting Tool (SRT), asking for detailed information about the
country's inspection practices and procedures to assist the country in
organizing its materials. This information collection was approved
under OMB number 0583-0153. The rule contains no other paperwork
requirements.
Executive Order (E.O.) 12988, Civil Justice Reform
This final rule has been reviewed under E.O. 12988, Civil Justice
Reform. Under this rule: (1) All State and local laws and regulations
that are inconsistent with this rule will be preempted; (2) no
retroactive effect will be given to this rule; and (3) no
administrative proceedings will be required before parties may file
suit in court challenging this rule.
E-Government Act
FSIS and USDA are committed to achieving the purpose 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 citizens 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 online through the FSIS web page located at:
http://www.fsis.usda.gov/federal-register.
FSIS will also announce and provide a link to it through the FSIS
Constituent Update, which is used to provide information regarding FSIS
policies, procedures, regulations, Federal Register notices, FSIS
public meetings, and other types of information that could affect or
would be of interest to our constituents and stakeholders. The
Constituent Update is available on the FSIS web page. Through the web
page, FSIS is able to provide information to a much broader, more
diverse audience. In addition, FSIS offers an email subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export
information, regulations, directives, and notices. Customers can add or
delete subscriptions themselves, and have the option to password
protect their accounts.
USDA Non-Discrimination Statement
No agency, officer, or employee of the USDA shall, on the grounds
of race, color, national origin, religion, sex, gender identity, sexual
orientation, disability, age, marital status, family/parental status,
income derived from a public assistance program, or political beliefs,
exclude from participation in, deny the benefits of, or subject to
discrimination any person in the United States under any program or
activity conducted by the USDA.
How To File a Complaint of Discrimination
To file a complaint of discrimination, complete the USDA Program
Discrimination Complaint Form, which may be accessed online at: http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your
authorized representative.
Send your completed complaint form or letter to USDA by mail, fax,
or email:
Mail: U.S. Department of Agriculture, Director, Office of
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
Fax: (202) 690-7442.
Email: [email protected].
Persons with disabilities who require alternative means for
communication (Braille, large print, audiotape, etc.), should contact
USDA's TARGET Center at (202) 720-2600 (voice and TDD).
List of Subjects in 9 CFR Part 557
Imported products.
For the reasons set out in the preamble, FSIS amends 9 CFR part 557
as follows:
PART 557--IMPORTATION
0
1. The authority citation for part 557 continues to read as follows:
Authority: 21 U.S.C. 601-602, 606-622, 624-695; 7 CFR 2.7, 2.18,
2.53.
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
[[Page 59682]]
the applicable provisions of this part: People's Republic of China.
* * * * *
Done at Washington, DC.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-24055 Filed 11-4-19; 8:45 am]
BILLING CODE 3410-DM-P
