Eligibility of the People's Republic of China To Export Siluriformes Fish and Fish Products to the United States, 47524-47528 [2018-20379]
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Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules
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
Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule.
AGENCY:
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 pointsof-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 https://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
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SUMMARY:
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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 https://
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
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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
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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
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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
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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 https://
www.fsis.usda.gov/wps/portal/fsis/
topics/international-affairs/importingproducts/equivalence/equivalenceprocess-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.
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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 https://
www.fsis.usda.gov/wps/portal/fsis/
topics/international-affairs/importingproducts/eligible-countries-productsforeign-establishments/foreign-auditreports/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 reinspection 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 reinspection activities can be found on the
FSIS website at https://
www.fsis.usda.gov/wps/portal/fsis/
topics/international-affairs/importingproducts/phis-import-component/phisimplementation-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
2013
2014
2015
2016
2017
5 Year
average
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Millions of dollars
Total U.S. Imports 1 ..........................................................
Total U.S. Domestic Production 2 ....................................
Total U.S. Exports 1 .........................................................
U.S. Consumption of U.S. Production .............................
Total U.S. Consumption 3 ................................................
Total U.S. Imports from the PRC 1 ..................................
The PRC as % of U.S. Imports .......................................
The PRC as % of U.S. Domestic Production ..................
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$363.42
356.73
4.69
98.7%
$715.46
$25.97
7.1%
7.3%
Fmt 4701
$346.66
351.94
4.00
98.9%
$694.60
$36.19
10.4%
10.3%
Sfmt 4702
$351.13
363.61
4.95
98.6%
$709.79
$32.06
9.1%
8.8%
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$405.61
385.99
4.80
98.8%
$786.80
$37.46
9.2%
9.7%
19SEP3
$381.89
379.71
6.18
98.4%
$755.43
$38.35
10.0%
10.1%
$369.74
367.60
4.92
98.7%
$732.41
$34.01
9.2%
9.3%
Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Proposed Rules
47527
TABLE 1—SUMMARY OF SILURIFORMES SALES—Continued
2013
2014
2015
2016
2017
5 Year
average
Millions of dollars
The PRC as % of U.S. Consumption ..............................
3.6%
5.2%
4.5%
4.8%
5.1%
4.6%
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
U.S. Dollars
[in millions]
Partner Country *
2015
World ................................................................................
United States ...................................................................
Cote d Ivoire ....................................................................
Hong Kong .......................................................................
Congo, Dem. Rep ............................................................
Congo ...............................................................................
Ghana ..............................................................................
Cameroon ........................................................................
Korea, South ....................................................................
Thailand ...........................................................................
Angola ..............................................................................
Mali ...................................................................................
Zambia .............................................................................
$49.30
30.87
0.61
7.24
2.30
2.26
0.04
3.62
0.64
0.07
1.03
0.0
0.33
2016
Share
(%)
2017
$50.40
35.92
5.74
7.05
1.92
0.75
0.14
0.09
0.36
0.05
0.12
0.32
0.31
2015
$41.30
27.32
4.14
2.40
2.07
1.33
1.04
0.57
0.40
0.37
0.12
0.12
0.04
100%
63
1
15
5
5
0
7
1
0
2
0
1
2016
100%
71
11
14
4
1
0
0
1
0
0
1
1
2017
100%
66
10
6
5
3
3
1
1
1
0
0
0
Data Source: Global Trade Atlas—International Import and Export Commodity Trade Data (numbers reported by Chinese Customs) https://
www.gtis.com/gta_3d/scripts/commodity.cfm.
Regulatory Flexibility Act Assessment
Paperwork Reduction Act
E-Government Act
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.
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.
FSIS and the U.S. Department of
Agriculture (USDA) are committed to
achieving the purposes of the EGovernment 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.
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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.
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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:
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https://www.fsis.usda.gov/federalregister.
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:
https://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.
amozie on DSK3GDR082PROD with PROPOSALS3
How To File a Complaint of
Discrimination
List of Subjects in 9 CFR Part 557
Imported products.
19:00 Sep 18, 2018
PART 557—IMPORTATION
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.
2. In § 557.2, revise paragraph (b)(1) to
read as follows:
■
§ 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 § 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
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 557
[Docket No. FSIS–2018–0029]
RIN [0583–AD74]
To file a complaint of discrimination,
complete the USDA Program
Discrimination Complaint Form, which
may be accessed online at https://
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).
VerDate Sep<11>2014
For the reasons set out in the
preamble, FSIS is proposing to amend 9
CFR part 557 as follows:
Jkt 244001
Eligibility of the Socialist Republic of
Vietnam To Export Siluriformes Fish
and Fish Products to the United States
Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule.
AGENCY:
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.
SUMMARY:
PO 00000
Frm 00006
Fmt 4701
Sfmt 4702
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 https://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 https://
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
E:\FR\FM\19SEP3.SGM
19SEP3
]]>Agencies
[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)]
[Proposed Rules]
[Pages 47524-47528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20379]
[[Page 47523]]
Vol. 83
Wednesday,
No. 182
September 19, 2018
Part IV
Department of Agriculture
-----------------------------------------------------------------------
Food Safety and Inspection Service
-----------------------------------------------------------------------
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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://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 https://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
https://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
----------------------------------------------------------------------------------------------------------------
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%
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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) https://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]]
https://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: https://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 https://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
