Eligibility of the Republic of Korea To Export Poultry Products to the United States, 16656-16661 [2014-06652]
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16656
Federal Register / Vol. 79, No. 58 / Wednesday, March 26, 2014 / Rules and Regulations
pepo Pat., a pathogenic fungus;
Synchytrium endobioticum (Schilb.)
Percival, a pathogenic fungus that
causes potato wart disease; and
Thecaphora solani (Thirum. & M.
O’Brien) Mordue, a pathogenic fungus
that causes potato smut.
(a) The national plant protection
organization (NPPO) of Mexico must
provide a bilateral workplan to APHIS
that details the activities that the NPPO
of Mexico will, subject to APHIS’
approval of the workplan, carry out to
meet the requirements of this section.
The bilateral workplan must include
and describe the quarantine pest survey
intervals and other specific
requirements as set forth in this section.
(b) The potatoes may be imported in
commercial consignments only.
(c) The potatoes must be produced by
a grower who is registered in a
certification program administered by
the NPPO of Mexico. The program must
require the producer to use only seed
that has been certified by the NPPO of
Mexico as free of R. solanacearum race
3 biovar 2, R. bunodes, R. pepo, S.
endobioticum, and T. solani to produce
the potatoes. The program must also
require the potatoes to be grown in an
enclosed environment or alternatively
must require the field in which the
potatoes are grown to be surveyed for
quarantine pests and tested for R.
solanacearum race 3 biovar 2 at regular
intervals in accordance with the
bilateral workplan.
(d) The potatoes must be packed for
export in packinghouses that are
registered with the NPPO of Mexico and
to which the NPPO of Mexico has
assigned a unique identifying number.
(e) After harvest but prior to packing,
the potatoes must be washed, cleaned of
soil and debris, and treated with a
sprout inhibitor in accordance with the
bilateral workplan.
(f) A biometric sample of potatoes
must be taken from each consignment of
potatoes destined for export to the
United States in accordance with a
protocol jointly agreed upon by APHIS
and the NPPO of Mexico and specified
within the bilateral workplan. The
sample must be visually inspected for
evidence of sprouting, as well as
evidence of C. decolora, E. cognatus, N.
aberrans, R. bunodes, R. pepo, and T.
solani. A portion of the potatoes must
then be cut open, inspected for evidence
of E. cognatus, N. aberrans, R.
solanacearum race 3 biovar 2, and T.
solani, and submitted to a laboratory
approved by the NPPO of Mexico for
testing for R. solanacearum race 3
biovar 2. Potatoes may not be shipped
to the United States until the results of
this testing are obtained. If any potatoes
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are found to be sprouting, or any
evidence of these quarantine pests is
found, or any potatoes have nonnegative test results for R. solanacearum
race 3 biovar 2, the entire consignment
of potatoes will be prohibited from
importation into the United States. For
purposes of this section, a potato is
considered to be sprouting when it
exhibits green sprouts, regardless of the
degree of elongation of the sprout.
(g) Each consignment of potatoes
shipped from Mexico to the United
States must be transported following
inspection from the packinghouse to the
port of first arrival into the United
States in a means of conveyance sealed
with an agricultural seal affixed by an
individual authorized by the NPPO of
Mexico to do so. If the seal is broken en
route, an inspector at the port of first
arrival will take remedial measures
jointly agreed to by APHIS and the
NPPO of Mexico and specified in the
bilateral workplan.
(h) Each consignment of potatoes
shipped from Mexico to the United
States must be accompanied by a
phytosanitary certificate, issued by the
NPPO of Mexico, that states that the
potatoes have been produced in
accordance with this section, and have
been inspected and tested and found
free of the quarantine pests listed in the
introduction to this section. The
phytosanitary certificate must also
specify the number of the packinghouse
in which the potatoes were packed.
(i) If quarantine pests are discovered
on potatoes from Mexico at a port of
first arrival into the United States, the
potatoes will be traced back to the
packinghouse in which they were
packed using the packinghouse number
specified on the phytosanitary
certificate.
(1) The packinghouse must identify
the grower from which the potatoes
originated, and the grower must identify
the place of production in which the
potatoes were grown. That place of
production will be suspended from the
export program for potatoes to the
United States for at least the remainder
of the shipping season. The suspension
will continue into subsequent shipping
seasons until APHIS and the NPPO of
Mexico jointly agree that the plant pest
risk at the place of production is
adequately mitigated.
(2) If the grower is unable to identify
the place of production in which the
potatoes were grown, that grower will
be suspended from the export program
for potatoes to the United States for at
least the remainder of the shipping
season. The suspension will continue
into subsequent shipping seasons until
the APHIS and the NPPO of Mexico
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jointly agree that the plant pest risk at
the grower is adequately mitigated.
(3) If the packinghouse is unable to
identify the grower from which the
potatoes originated, that packinghouse
will be suspended from the export
program for potatoes to the United
States for at least the remainder of the
shipping season. The suspension will
continue into subsequent shipping
seasons until the APHIS and the NPPO
of Mexico jointly agree that the plant
pest risk at the packinghouse is
adequately mitigated.
(Approved by the Office of Management and
Budget under control number 0579–0413)
Done in Washington, DC, this 20th day of
March 2014.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2014–06619 Filed 3–25–14; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 381
[Docket No. FSIS–2012–0019]
RIN 0583–AD49
Eligibility of the Republic of Korea To
Export Poultry Products to the United
States
Food Safety and Inspection
Service, USDA.
ACTION: Final rule.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is amending
the Federal poultry products inspection
regulations to add the Republic of Korea
(Korea) to the list of countries eligible to
export poultry products to the United
States. FSIS has reviewed Korea’s
poultry laws, regulations, and
inspection system, as implemented, and
has determined that they are equivalent
to the Poultry Products Inspection Act
(PPIA), the regulations implementing
this statute, and the U.S. food safety
system for poultry.
Under this final rule, slaughtered
poultry or parts or other products
thereof processed in certified Korean
establishments will be eligible for
export to the United States. All such
products will be subject to re-inspection
at United States ports of entry by FSIS
inspectors.
DATES: Effective Date: May 27, 2014.
FOR FURTHER INFORMATION CONTACT: Dr.
Andreas Keller, Director, International
Equivalence Staff, Office of Policy and
SUMMARY:
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Program Development; Telephone: (202)
720–0082.
SUPPLEMENTARY INFORMATION:
Background
On November 27, 2012, FSIS
proposed to add the Republic of Korea
(Korea) to the list of countries eligible to
export poultry products to the United
States (77 FR 70724). This final rule is
consistent with the provisions of the
proposed rule.
As explained in the proposal, section
17 of the PPIA (21 U.S.C. 466) prohibits
importation into the United States of
slaughtered poultry, or parts or products
thereof, of any kind unless they are
healthful, wholesome, fit for human
food, not adulterated, and contain no
dye, chemical, preservative, or
ingredient that renders them
unhealthful, unwholesome, unfit for
human food, or otherwise adulterated.
Under the PPIA and the regulations that
implement it, poultry products
imported into the United States must be
produced under standards for safety,
wholesomeness, and labeling accuracy
that are equivalent to those of the
United States. Section 381.196 of Title
9 of the Code of Federal Regulations
(CFR) sets out the procedures by which
foreign countries may become eligible to
export poultry and poultry products to
the United States.
Section 381.196(a) requires that the
standards of a foreign country’s poultry
inspection system, its legal authority for
the inspection system, and the
regulations implementing the system be
equivalent to those of the United States.
These requirements include: (1) Antemortem and post-mortem inspection
performed or supervised by a
veterinarian; (2) national government
controls over establishment
construction, facilities, and equipment;
(3) verification of slaughtering of
poultry and processing of poultry
products by inspectors to ensure that
product is not adulterated or
misbranded; (4) separation of
establishments certified to export from
those not certified; (5) maintenance of a
single standard of inspection and
sanitation throughout certified
establishments; (6) requirements for
sanitation and for sanitary handling of
product at certified establishments; (7)
controls over condemned product; (8) a
Hazard Analysis and Critical Control
Point (HACCP) system; and (9) any
other requirements under the PPIA and
its implementing regulations (9 CFR
381.196(a)(2)(ii)).
The country’s inspection program
must also impose requirements
equivalent to those of the United States
with respect to: (1) Organizational
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structure and staffing in certified
establishments to ensure uniform
enforcement of laws and regulations; (2)
national government control and
supervision over the official activities of
employees or licensees; (3) qualified
inspectors; (4) enforcement and
certification authority; (5)
administrative and technical support;
(6) inspection, sanitation, quality,
species verification, and residue
standards; and (7) any other inspection
requirements (9 CFR 381.196(a)(2)(i)).
Inclusion of the country in 9 CFR
381.196 generally implies that the
country has a regulatory system
equivalent to that of the United States
for slaughter and further processing of
poultry for all nine processing
categories referred to in 9 CFR 417.2
(Slaughter; raw product—ground; raw
product—not ground; thermally
processed—commercially sterile; not
heat treated—shelf stable; heat treated—
shelf stable; fully cooked—not shelf
stable; heat-treated but not fully
cooked—not shelf stable; and product
with secondary inhibitors—not shelf
stable). However, FSIS recognizes that,
at the time of the initial equivalence
request, a country may not expect to
manufacture and export products to the
United States that meet the
requirements of each of these processing
categories. Even so, FSIS determines
whether the foreign country has
equivalent government oversight,
statutory authority and food safety
regulations, sanitation performance
standards, hazard analysis and critical
control point systems, chemical residue
control and microbiological testing
programs, and the infrastructure in
place to ensure that, if products in any
of the nine processing categories were to
be exported, the products would meet
United States standards of safety and
wholesomeness.1
1 At this time, FSIS is taking steps to publish on
its Web site a chart that identifies which of the nine
processing categories FSIS specifically reviewed in
FSIS in-country audits, and which the Public
Health Inspection System (PHIS) is set up to allow
to be imported into the U.S. This PHIS-based chart
will also reflect any processing category limitations
as a result of animal health restrictions for that
foreign country, as provided for in 9 CFR part 94.
Because FSIS public health policies may change
subsequent to the time at which the foreign country
is listed in 9 CFR 327.2 or 381.196, or a foreign
country may decide to later certify product
exported to the U.S. from a processing category not
listed for that country on the PHIS-based chart,
FSIS will determine whether an in-country audit is
necessary before FSIS modifies the PHIS-based
chart. Regarding a foreign country’s initial request
for equivalence for egg products in accordance with
9 CFR 590.910, all the requirements in part 590
must be met as there are no similar processing
categories as provided for livestock and poultry
products.
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16657
Evaluation of the Korean Poultry
Inspection System
In 2005, the government of Korea
requested approval for the importation
of Korean poultry products into the
United States. Korea stated that its
immediate intention was to export two
types of ginseng chicken stew products
to the United States. FSIS then began to
evaluate Korea’s inspection system to
determine whether it is equivalent to
the United States system.
FSIS conducted a document review to
evaluate the laws, regulations, and other
documentation used by Korea to execute
its poultry inspection program. FSIS
examined the information submitted by
Korea to verify that the following
critical points relating to equivalence
were addressed satisfactorily with
respect to standards, activities,
resources, and enforcement: (1)
Government Oversight; (2) Statutory
Authority and Food Safety Regulations;
(3) Sanitation; (4) HACCP Systems; (5)
Chemical Residue Testing Programs;
and (6) Microbiological Testing
Programs. The document review was
satisfactory to FSIS, and FSIS scheduled
an on-site review to evaluate all aspects
of Korea’s inspection program.
In 2008, FSIS conducted an on-site
audit of Korea’s poultry inspection
system and identified systemic
deficiencies within five equivalence
components. In response to this audit,
Korea submitted a corrective action plan
that addressed FSIS’s findings.
In 2010, FSIS conducted a
comprehensive on-site audit to
determine whether Korea had
satisfactorily implemented all the laws,
regulations, and other issuances that
FSIS found to be equivalent during the
document analysis, and whether the
findings of the previous audit had been
addressed. The 2010 audit revealed that
Korea had fully implemented the
corrective action plan that it had
submitted in response to the 2008 audit.
Nonetheless, the new audit identified
new systemic deficiencies in three
equivalence components: Statutory
Authority and Food Safety Regulations,
Chemical Residue Testing Programs,
and Microbiological Testing Programs.
During the audit, establishments made
changes to address some deficiencies.
In addition to the actions taken during
the audit, Korea submitted a corrective
action plan on how it would incorporate
the actions it took during the audit into
its food safety system. FSIS reviewed
this corrective action plan and, for the
reasons explained below, concluded
that Korea had satisfactorily addressed
the findings of 2010 audit.
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Consequently, on November 27, 2012,
FSIS published a proposed rule to find
that Korea’s poultry inspection system
(slaughter and processing) is equivalent
to the United States’ poultry inspection
system and proposing to add the
Republic of Korea (Korea) to the list of
countries eligible to export poultry
products to the United States. For more
detailed information on FSIS’s
evaluation of the Korean poultry
inspection system, see the proposed rule
(77 FR 70724) and for the full audit
report go to https://www.fsis.usda.gov/
wps/portal/fsis/topics/internationalaffairs/importing-products/eligiblecountries-products-foreignestablishments/foreign-audit-reports.
render the product economically
adulterated. Products that pass reinspection will be stamped with the
official mark of inspection and allowed
to enter United States commerce. If they
do not meet United States requirements,
they will be refused entry and within 45
days will have to be returned 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 Web
site at https://www.fsis.usda.gov/wps/
portal/fsis/topics/international-affairs/
importing-products/port-of-entryprocedures/fsis-import-reinspection/ct_
index9.
Final Rule
After considering the comments
received on the proposed rule and
discussed below, FSIS concludes that
Korea’s poultry inspection system is
equivalent to the United States’
inspection system for poultry and
poultry products. Therefore, FSIS is
amending its poultry products
inspection regulations to add Korea to
the list of countries eligible to export
poultry products to the United States (9
CFR 381.196(b)). Under FSIS’s import
regulations, the government of Korea
must certify to FSIS that those
establishments that wish to export
poultry products to the United States
are operating under requirements
equivalent to those of the United States
(9 CFR 381.196(a)).
Although a foreign country may be
listed in FSIS regulations as eligible to
export poultry to the United States, the
exporting country’s products must also
comply with all other applicable
requirements of the United States. These
requirements include restrictions under
9 CFR part 94 of the Animal and Plant
Health Inspection Service (APHIS)
regulations, which also regulate the
importation of poultry products from
foreign countries into the United States.
Under this final rule, all slaughtered
poultry, or parts and products thereof,
exported to the United States from
Korea will be subject to re-inspection at
the United States ports 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 conduct other
types of reinspection activities, such as
incubation of canned products to ensure
product safety and taking product
samples for laboratory analysis to detect
any drug or chemical residues or
pathogens that may render the product
unsafe or any species or product
composition violations that would
Summary of Comments and Responses
FSIS received four comments in
response to the proposed rule. One
individual and a consumer advocacy
organization opposed the rule, and one
individual and three trade associations,
representing the poultry and egg
products industries, submitted a single
comment that supported the proposed
rule.
Following is a discussion of the
relevant issues raised in the comments
and FSIS’s responses.
Comment: One individual stated that
all poultry from Korea should be banned
in the United States. The individual was
concerned about the safety of food from
foreign countries, including Korea, and
animal welfare and inhumane slaughter
in Korea. The individual argued that the
United States should not import any
food from any country.
Response: Under the PPIA, if a
country maintains a poultry safety
inspection system that is equivalent to
that of the United States, it is entitled
to ship poultry products to the United
States should it seek to do so.
FSIS has conducted a thorough
review of Korea’s laws, regulations,
written procedures, policies, and other
official documents, including evaluating
whether poultry slaughter
establishments maintained good
commercial practices consistent with
those required in United States poultry
slaughter establishments (see 9 CFR
381.65(a)–(b)). These practices ensure
that poultry is humanely slaughtered. In
addition, FSIS conducted two on-site
verification audits of Korea’s poultry
inspection system. Taking the findings
of the two audits together, FSIS has
determined that Korea’s poultry
inspection system is equivalent to the
United States inspection system for
poultry and poultry products. The
comment has not presented any basis on
which FSIS could make a contrary
determination.
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As stated above, for Korea to be
eligible to export poultry to the United
States, it must implement and maintain
a poultry inspection system that is
equivalent to the United States’ system.
To determine whether Korea maintains
an equivalent inspection system, FSIS
uses a three-part approach that includes
(1) on-going document reviews, (2)
periodic on-site system audits, and (3)
ports of entry re-inspections. If Korea
fails to maintain a poultry inspection
system that is equivalent to the United
States’ system, FSIS will act to suspend
or terminate its eligibility to export to
this country.
Comment: A consumer advocacy
organization stated that, although Korea
will initially export only two types of
chicken stew, the proposed rule
understated the magnitude of future
exports to the United States because
Korea is being added to the list of
countries eligible to export poultry
products to the United States with no
restrictions.
Response: FSIS has no basis for
finding that it understated the
magnitude of future exports from Korea
to the United States. As described in
more detail in the Economic Analysis
below, Korea will initially export only
two types of chicken stew products to
the United States. Because of the limited
market in the United States for these
products, the projected export volume
of these products from Korea is likely to
be very small, and thus the impact on
the United States economy is likely to
be very small as well.
However, it is true that Korea would
not be precluded from exporting other
poultry products to the U.S. in the
future if those products meet all
applicable APHIS and FSIS
requirements for the products, and
Korea certifies that the producing
establishments comply with Korean
requirements that FSIS has found to be
equivalent to applicable FSIS
requirements (9 CFR 381.196(a)).
Therefore, FSIS agrees that the longterm economic impact of this rule could
be more significant than the immediate
impact. FSIS does not have any data,
however, that it could use to project the
long term impact.
Comment: The consumer advocacy
organization also argued that Korea
should not be added to the list of
countries eligible to export poultry
products because FSIS’s 2010 audit
found deficiencies in Korea’s inspection
system, and FSIS did not conduct
another onsite audit to verify that Korea
implemented corrective actions in
response to the 2010 audit.
Response: During the 2010 on-site
audit of Korea’s poultry inspection
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system, FSIS auditors found that Korea
had implemented the corrective actions
that it had proffered in response to the
2008 on-site audit findings. In addition,
Korea provided records demonstrating
that these corrective action plans had
been implemented in a manner
consistent with FSIS’ inspection
requirements. This finding provides a
basis for confidence that Korea will
implement all corrective actions it
promises in an acceptable manner.
As the commenter indicated, the
auditors found two new problems with
the Korean system. The first problem
identified by the auditors was in the
Statutory Authority and Food Safety
Regulations component: Korea’s central
competent authority (CCA), the Ministry
for Food, Agriculture, Forestry and
Fisheries, was not requiring
establishments to maintain conditions
that would allow the government
inspectors to inspect adequately each
carcass. Specifically, FSIS found that:
(a) One of the three establishments
audited did not have conveniently
located controls (e.g., start-stop
switches) that would permit government
inspection program personnel to stop
the line to conduct a protracted postmortem inspection of carcasses when
necessary or to prevent adulterated
product from entering the chill tank; (b)
during the on-site review of records, the
Korean inspection regulations did not
require inspection stations to have
online hand-rinsing facilities with a
continuous flow of water within easy
access for inspection personnel and
establishment personnel to prevent
incidental cross-contamination of
carcasses resulting from post-mortem
inspection procedures, and one
establishment audited did not have such
online hand-rinsing facilities; and (c)
the three establishments audited had 52
footcandles (540 Lux) of lighting at postmortem inspection stations, in
compliance with Korea’s inspection
regulation, while the United States
requires at least 200 foot-candles (2,152
Lux) of shadow-free lighting, with a
minimum color-rendering index value
of 85, for a system configuration similar
to Korea’s inspection system and line
speed (Streamlined Inspection System
(SIS)).
When FSIS discussed these findings
with Korea’s CCA during the on-site
audit, Korea’s government inspectors at
the establishments instructed the
establishments to make the changes
necessary to conform to United States
requirements for the conditions under
which government inspection personnel
are to perform their inspections. The
establishments proposed immediate
corrective actions, and Korean
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government inspectors accepted
establishments’ proposals. In the
establishment that did not have
conveniently located controls, it
implemented immediate corrective
action by relocating the controls (e.g.,
start-stop switches) to a convenient
location. All the three establishments
adjusted lighting at post-mortem
inspection stations to 200 foot-candles
of shadow-free lighting with a minimum
color index value of 85. In addition,
Korea immediately revised its export
requirements for the U.S. to require
export facilities to have inspection
stations with online hand-rinsing
facilities. This document was provided
to the auditor before the conclusion of
the audit. Korea subsequently provided
records, including a photograph,
showing that the audited establishment
without on-line hand-rinsing facilities
had installed such facilities.
FSIS auditors verified the immediate
corrective actions while still in Korea.
However, the auditors told Korea that it
needed to submit a comprehensive
corrective action plan that included a
systematic solution to prevent
recurrence of these deficiencies.
Following the audit, in July of 2011,
Korea provided supporting
documentation demonstrating that it
had issued new requirements for: (1)
Inspection stations to have conveniently
located controls (e.g., start-stop
switches); (2) online hand- rinsing
facilities with a continuous flow of
water within easy access; and (3) 200
foot-candles of shadow-free lighting
with a minimum color-rendering index
value of 85. These requirements,
together with the immediate corrective
actions taken by the establishments and
with Korea’s history of taking effective
action to resolve deficiencies found in
an audit, provide a basis for FSIS to
have confidence that the deficiencies
that the auditors found in the
establishments have been corrected and
will not recur.
The second problem regarding the
implementation of laboratory quality
systems within Korea’s National
Residue Program and Microbiological
Testing Program was identified in two
equivalence components, Chemical
Residue Testing Programs and
Microbiological Testing Programs.
Specifically, the CCA did not have
adequate control over the
implementation of quality systems in
the government laboratories that are part
of Korea’s poultry inspection system.
While residue and microbiological
testing methods appeared to be
implemented in an appropriate manner,
Korea’s CCA was not verifying that the
quality control and assurance programs
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16659
implemented by the government
laboratories were adequate. For
example, the frequency and the
documentation of equipment
verification, calibration, and
maintenance related to relevant testing
methods varied among the laboratories
and were not consistent with
international standards. Therefore,
Korea did not consistently implement
adequate standards for the laboratories.
Following the 2010 audit, Korea
submitted documents showing that it
had implemented quality control and
assurance programs. The documentation
provided shows that Korea adopted
procedures consistent with U.S.
procedures to ensure that laboratory
equipment and materials are
appropriately verified, calibrated, and
maintained to meet program
requirements (Accreditation Guide 04/
10, quality system recommendation in
accordance with ISO/IEC 17025
international standards). Korea
submitted documents to show that the
Korean CCA has adequately trained
laboratory managers and staff in the
quality control and assurance program
procedures. Records show that Korea
has audited the government laboratories
involved in poultry inspection at least
once per year, and that the laboratories
are meeting Korea’s quality system
requirements. FSIS’s review of
proficiency testing reports for the year
2012 submitted by Korea in September
2013 found that the participating
Korean government laboratories are
effectively using the FSIS laboratory
testing methods to ensure that products
eligible for export to the U.S. are free of
contamination. The documents that
Korea submitted to FSIS collectively
demonstrate that the Korea CCA has
effectively implemented procedures in
its quality control and assurance
programs that are equivalent to U.S.
procedures.
Comment: Finally, the consumer
advocacy organization stated that FSIS
should not find Korea equivalent when
FSIS is not performing annual audits of
all countries currently listed as eligible
to export to the United States.
Response: FSIS will conduct on-site
audits of Korea’s inspection system each
year for the next three years. After three
years, FSIS will reassess how frequently
it needs to conduct on-site audits of
Korea’s system. Additionally, all
product imported from Korea will be
subject to FSIS re-inspection.
Executive Order 12866 and Regulatory
Flexibility Act
This rule has been reviewed under
Executive Order 12866 by the Office of
Management and Budget (OMB) and has
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been determined to be not significant for
purposes of E.O. 12866.
Economic Impact Analysis
This rule adds Korea to the list of
countries eligible to export poultry
products into the United States. Korea
will export two types of ginseng chicken
stew products to the United States.
Given the limited market in the United
States for this product, and the
projected export volume of this product
from Korea, the impact on the United
States economy is likely to be very
small. According to data from Korea,
only two Korean establishments will
export ginseng chicken stew to the
United States. The average combined
annual production of these two
establishments is 3.2 million pounds
(2006–2010 average), and their projected
total export volume to the United States
will be about 380,000 pounds in year
one (the first year of exporting to the
United States), gradually increasing to
about 2.25 million pounds in year five,
according to the Korean data.
Ginseng chicken stew is sold
commercially in frozen pouches. The
United States market for ginseng
chicken stew is so small that no data on
domestic production, consumption, or
importation could be found. Using label
application data, FSIS identified two
official establishments that produce and
sell ginseng chicken stew. On the basis
of information from these
establishments, FSIS believes (1) they
are very likely the only two
establishments that are producing
ginseng chicken stew in the United
States, (2) the market for ginseng
chicken stew is limited, (3) the annual
production is about 18,000 pouches for
one establishment and 10,000 pouches
for the other, and (4) each pouch weighs
about two pounds. Therefore, the
combined production of these two
establishments is about 56,000 pounds
per year ((18,000 + 10,000) × 2). The
special flavor and taste make ginseng
chicken stew unlikely to be a substitute
for other kinds of chicken stew in the
United States. Therefore, although this
rule may affect these two United States
establishments, the impact to the United
States economy is likely to be
insignificant.
Expected benefits from this rule will
be primarily for consumers in the form
of more choices in the marketplace. As
mentioned above, the volume of trade
stimulated by the rule is likely be so
small as to have little effect on supply
and prices. Another potential benefit of
this rule would result in efficiency gains
of United States poultry producers due
to the increased competition from
Korea.
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The cost of this rule will be incurred
by domestic producers in the form of
competition from Korea. The two
establishments that are currently
producing ginseng chicken stew are
likely to encounter competition
pressure, for the projected import
volume in year one is already 6.8 times
the combined production volume of
these two establishments. The imported
volume, however, is likely to have little
impact on the overall United States
economy. Also, these two
establishments may change their
production mix if they find it difficult
to compete with imports.
countries wanting to export poultry and
poultry products 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 Korea with questionnaires
asking for detailed information about
the country’s inspection practices and
procedures to assist that country in
organizing its materials. This
information collection was approved
under OMB number 0583–0094.
Effect on Small Entities
The FSIS Administrator has made a
determination that this rule will not
have a significant impact on a
substantial number of small entities, as
defined by the Regulatory Flexibility
Act (5 U.S.C. 601). As mentioned above,
the expected trade volume will be very
small, and the effect will be on only two
very small establishments that produce
ginseng chicken stew domestically.
E-Government Act
FSIS and the United States
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.
Potential Long-Term Effect
When foreign countries apply for
eligibility of their meat, poultry, or egg
products for entry into this country,
FSIS determines whether their
inspection systems are equivalent to the
system maintained by the United States.
FSIS does not make equivalence
determinations on the basis of particular
products; rather, the equivalence
decision is based on the evaluation of
the countries’ inspection systems.
Although Korea indicates that it
intends to export two types of ginseng
chicken stew products for now, it would
not be precluded from exporting other
poultry products in the future if the
products meet all applicable APHIS and
FSIS requirements for those products. If
additional Korean establishments export
product to the United States, the longterm economic impact could be more
significant. However, no data is
available to assess such future impacts.
Executive Order 12988
This rule has been reviewed under
Executive Order 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
retroactive proceedings will be required
before parties may file suit in court
challenging this rule.
Paperwork Reduction Act
No new paperwork requirements are
associated with this final rule. Foreign
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Additional Public Notification
FSIS will officially notify the World
Trade Organization’s Committee on
Sanitary and Phytosanitary Measures
(WTO/SPS Committee) in Geneva,
Switzerland, of this rule and will
announce it on-line through the FSIS
Web page located at: https://
www.fsis.usda.gov/wps/portal/fsis/
topics/regulations/federal-register/
interim-and-final-rules.
FSIS also will make copies of this
Federal Register 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. The Update is
communicated via Listserv, a free email
subscription service consisting of
industry, trade, and farm groups,
consumer interest groups, allied health
professionals, scientific professionals,
and other individuals who have
requested to be included. The Update
also is available on the FSIS Web page.
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 to regulations, directives,
and notices. Customers can add or
delete subscriptions themselves, and
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Federal Register / Vol. 79, No. 58 / Wednesday, March 26, 2014 / Rules and Regulations
have the option to password protect
their accounts.
USDA Nondiscrimination Statement
USDA prohibits discrimination in all
its programs and activities on the basis
of race, color, national origin, gender,
religion, age, disability, political beliefs,
sexual orientation, and marital or family
status. (Not all prohibited bases apply to
all programs.) Persons with disabilities
who require alternative means for
communication of program information
(Braille, large print, audiotape, etc.)
should contact USDA’s Target Center at
(202) 720–2600 (voice and TTY).
To file a written complaint of
discrimination, write USDA, Office of
the Assistant Secretary for Civil Rights,
1400 Independence Avenue SW.,
Washington, DC 20250–9410 or call
(202) 720–5964 (voice and TTY). USDA
is an equal opportunity provider and
employer.
List of Subjects in 9 CFR Part 381
Imported products.
For the reasons set out in the
preamble, FSIS is amending 9 CFR part
381 as follows:
PART 381—POULTRY PRODUCTS
INSPECTION REGULATIONS
1. The authority citation for part 381
continues to read as follows:
■
Authority: 7 U.S.C. 138f, 450; 21 U.S.C.
451–470; 7 CFR 2.7, 2.18, 2.53.
§ 381.196
2. Amend § 381.196(b) to add the
‘‘Republic of Korea’’ in alphabetical
order to the list of countries.
■
Done at Washington, DC, on March 20,
2014.
Alfred V. Almanza,
Administrator.
[FR Doc. 2014–06652 Filed 3–25–14; 8:45 am]
BILLING CODE 3410–DM–P
FEDERAL ELECTION COMMISSION
11 CFR Parts 4, 100, 102, 104, 110, 111,
and 114
[Notice 2014–07]
Federal Election Campaign Act Rules;
Corrections
Federal Election Commission.
ACTION: Correcting amendments.
emcdonald on DSK67QTVN1PROD with RULES
AGENCY:
The Commission is making
technical corrections to various sections
of its regulations.
DATES: Effective March 26, 2014.
FOR FURTHER INFORMATION CONTACT: Ms.
Amy L. Rothstein, Assistant General
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16:11 Mar 25, 2014
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Background
The existing rules that are the subject
of these corrections are part of the
continuing series of regulations that the
Commission has promulgated to
implement the Federal Election
Campaign Act of 1971, as amended, 2
U.S.C. 431 et seq. (‘‘FECA’’). The
Commission is promulgating these
corrections without advance notice or
an opportunity for comment because
they fall under the ‘‘good cause’’
exemption of the Administrative
Procedure Act. 5 U.S.C. 553(b)(B). The
Commission finds that notice and
comment are unnecessary here because
these corrections are merely
typographical and technical; they effect
no substantive changes to any rule. For
the same reason, these corrections fall
within the ‘‘good cause’’ exception to
the delayed effective date provisions of
the Administrative Procedure Act and
the Congressional Review Act. 5 U.S.C.
553(d)(3), 808(2). Accordingly, these
corrections are effective upon
publication in the Federal Register. The
Commission is not required to submit
these corrections for congressional
review. See 2 U.S.C. 438(d)(1), (4).
Corrections to FECA Rules in Chapter
I of Title 11 of the Code of Federal
Regulations
[Amended]
SUMMARY:
Counsel, Ms. Joanna S. Waldstreicher,
Attorney, or Mr. Eugene Lynch,
Paralegal, 999 E Street NW.,
Washington, DC 20463, (202) 694–1650
or (800) 424–9530.
SUPPLEMENTARY INFORMATION:
A. Correction to 11 CFR 4.8
The Commission is correcting an
erroneous citation in paragraph (a) of
this section by replacing the reference to
11 CFR 4.6(d) with 11 CFR 4.7(h).
Paragraph (a) refers to notification
‘‘pursuant to § 4.6(d)’’ that a request for
inspection or a copy of a record has
been denied, but section 4.6 addresses
the discretionary release of records by
the Commission, not notification of a
denial of access to records. Moreover,
section 4.6 does not contain a paragraph
(d). Section 4.7(h) concerns the
notification to a person who has been
denied access to records.
B. Correction to 11 CFR 100.1
This section lists the statutes
implemented by subchapter A of
chapter I of the Commission’s
regulations. The list in this section is
currently incomplete. To encompass all
relevant statutes, the Commission is
revising this section to note that
subchapter A implements FECA, as
amended, 2 U.S.C. 431 et seq.
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16661
C. Correction to 11 CFR 100.18
This section defines the term ‘‘the
Act’’ as used in the Commission’s
regulations to include the Federal
Election Campaign Act of 1971 and each
subsequent amendment to it. The list of
amendments in this section is currently
incomplete. To encompass all relevant
statutes, the Commission is revising this
section to define ‘‘the Act’’ as FECA, as
amended, 2 U.S.C. 431 et seq.
D. Correction to 11 CFR 100.29
The Commission is correcting a
typographical error in paragraph (c) of
this section by italicizing the first
instance of the word ‘‘electioneering,’’
so that the entire phrase ‘‘electioneering
communication’’ is italicized and not
just the word ‘‘communication.’’
E. Corrections to 11 CFR 100.52
The Commission is correcting
typographical errors in two citations in
paragraph (a) of this section by
replacing the references to 11 CFR
100.72 and 100.73 with 11 CFR 100.82
and 100.83, respectively. Section
100.52(a) excludes ‘‘a loan made in
accordance with 11 CFR 100.72 and
100.73’’ from the definition of
‘‘contribution.’’ Sections 100.72 and
100.73, however, concern the ‘‘testing
the waters’’ and media exceptions to the
definition of ‘‘contribution,’’ not loans.
The Commission is therefore replacing
the references to sections 100.72 and
100.73 in 11 CFR 100.52(a) with
references to sections 100.82 and
100.83, which concern bank loans and
brokerage loans and lines of credit.
The Commission is also correcting an
erroneous citation in paragraph (b)(5) of
this section by replacing the reference to
11 CFR 110.4(a) with a reference to 11
CFR 110.20. Section 100.52(b)(5) states
that payments of interest on loans to a
political committee ‘‘shall be made from
funds subject to the prohibitions of
section 110.4(a).’’ Section 110.4(a)
previously prohibited foreign nationals
from making contributions or
expenditures, but that provision was
moved to section 110.20 in 2003, and
section 110.4(a) was reserved. The
Commission is therefore replacing the
reference to 11 CFR 110.4(a) with a
reference to section 110.20, which also
conforms this citation to the citation in
a corresponding provision in the same
paragraph.
F. Correction to 11 CFR 100.82
The Commission is correcting a
typographical error in a citation in
paragraph (f) of this section by replacing
the reference to 11 CFR 100.73 with 11
CFR 100.83. Section 100.82(f) states that
‘‘this section shall not apply to loans
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Agencies
[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Rules and Regulations]
[Pages 16656-16661]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06652]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 381
[Docket No. FSIS-2012-0019]
RIN 0583-AD49
Eligibility of the Republic of Korea To Export Poultry 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
Federal poultry products inspection regulations to add the Republic of
Korea (Korea) to the list of countries eligible to export poultry
products to the United States. FSIS has reviewed Korea's poultry laws,
regulations, and inspection system, as implemented, and has determined
that they are equivalent to the Poultry Products Inspection Act (PPIA),
the regulations implementing this statute, and the U.S. food safety
system for poultry.
Under this final rule, slaughtered poultry or parts or other
products thereof processed in certified Korean establishments will be
eligible for export to the United States. All such products will be
subject to re-inspection at United States ports of entry by FSIS
inspectors.
DATES: Effective Date: May 27, 2014.
FOR FURTHER INFORMATION CONTACT: Dr. Andreas Keller, Director,
International Equivalence Staff, Office of Policy and
[[Page 16657]]
Program Development; Telephone: (202) 720-0082.
SUPPLEMENTARY INFORMATION:
Background
On November 27, 2012, FSIS proposed to add the Republic of Korea
(Korea) to the list of countries eligible to export poultry products to
the United States (77 FR 70724). This final rule is consistent with the
provisions of the proposed rule.
As explained in the proposal, section 17 of the PPIA (21 U.S.C.
466) prohibits importation into the United States of slaughtered
poultry, or parts or products thereof, of any kind unless they are
healthful, wholesome, fit for human food, not adulterated, and contain
no dye, chemical, preservative, or ingredient that renders them
unhealthful, unwholesome, unfit for human food, or otherwise
adulterated. Under the PPIA and the regulations that implement it,
poultry products imported into the United States must be produced under
standards for safety, wholesomeness, and labeling accuracy that are
equivalent to those of the United States. Section 381.196 of Title 9 of
the Code of Federal Regulations (CFR) sets out the procedures by which
foreign countries may become eligible to export poultry and poultry
products to the United States.
Section 381.196(a) requires that the standards of a foreign
country's poultry inspection system, its legal authority for the
inspection system, and the regulations implementing the system be
equivalent to those of the United States. These requirements include:
(1) Ante-mortem and post-mortem inspection performed or supervised by a
veterinarian; (2) national government controls over establishment
construction, facilities, and equipment; (3) verification of
slaughtering of poultry and processing of poultry products by
inspectors to ensure that product is not adulterated or misbranded; (4)
separation of establishments certified to export from those not
certified; (5) maintenance of a single standard of inspection and
sanitation throughout certified establishments; (6) requirements for
sanitation and for sanitary handling of product at certified
establishments; (7) controls over condemned product; (8) a Hazard
Analysis and Critical Control Point (HACCP) system; and (9) any other
requirements under the PPIA and its implementing regulations (9 CFR
381.196(a)(2)(ii)).
The country's inspection program must also impose requirements
equivalent to those of the United States with respect to: (1)
Organizational structure and staffing in certified establishments to
ensure uniform enforcement of laws and regulations; (2) national
government control and supervision over the official activities of
employees or licensees; (3) qualified inspectors; (4) enforcement and
certification authority; (5) administrative and technical support; (6)
inspection, sanitation, quality, species verification, and residue
standards; and (7) any other inspection requirements (9 CFR
381.196(a)(2)(i)).
Inclusion of the country in 9 CFR 381.196 generally implies that
the country has a regulatory system equivalent to that of the United
States for slaughter and further processing of poultry for all nine
processing categories referred to in 9 CFR 417.2 (Slaughter; raw
product--ground; raw product--not ground; thermally processed--
commercially sterile; not heat treated--shelf stable; heat treated--
shelf stable; fully cooked--not shelf stable; heat-treated but not
fully cooked--not shelf stable; and product with secondary inhibitors--
not shelf stable). However, FSIS recognizes that, at the time of the
initial equivalence request, a country may not expect to manufacture
and export products to the United States that meet the requirements of
each of these processing categories. Even so, FSIS determines whether
the foreign country has equivalent government oversight, statutory
authority and food safety regulations, sanitation performance
standards, hazard analysis and critical control point systems, chemical
residue control and microbiological testing programs, and the
infrastructure in place to ensure that, if products in any of the nine
processing categories were to be exported, the products would meet
United States standards of safety and wholesomeness.\1\
---------------------------------------------------------------------------
\1\ At this time, FSIS is taking steps to publish on its Web
site a chart that identifies which of the nine processing categories
FSIS specifically reviewed in FSIS in-country audits, and which the
Public Health Inspection System (PHIS) is set up to allow to be
imported into the U.S. This PHIS-based chart will also reflect any
processing category limitations as a result of animal health
restrictions for that foreign country, as provided for in 9 CFR part
94. Because FSIS public health policies may change subsequent to the
time at which the foreign country is listed in 9 CFR 327.2 or
381.196, or a foreign country may decide to later certify product
exported to the U.S. from a processing category not listed for that
country on the PHIS-based chart, FSIS will determine whether an in-
country audit is necessary before FSIS modifies the PHIS-based
chart. Regarding a foreign country's initial request for equivalence
for egg products in accordance with 9 CFR 590.910, all the
requirements in part 590 must be met as there are no similar
processing categories as provided for livestock and poultry
products.
---------------------------------------------------------------------------
Evaluation of the Korean Poultry Inspection System
In 2005, the government of Korea requested approval for the
importation of Korean poultry products into the United States. Korea
stated that its immediate intention was to export two types of ginseng
chicken stew products to the United States. FSIS then began to evaluate
Korea's inspection system to determine whether it is equivalent to the
United States system.
FSIS conducted a document review to evaluate the laws, regulations,
and other documentation used by Korea to execute its poultry inspection
program. FSIS examined the information submitted by Korea to verify
that the following critical points relating to equivalence were
addressed satisfactorily with respect to standards, activities,
resources, and enforcement: (1) Government Oversight; (2) Statutory
Authority and Food Safety Regulations; (3) Sanitation; (4) HACCP
Systems; (5) Chemical Residue Testing Programs; and (6) Microbiological
Testing Programs. The document review was satisfactory to FSIS, and
FSIS scheduled an on-site review to evaluate all aspects of Korea's
inspection program.
In 2008, FSIS conducted an on-site audit of Korea's poultry
inspection system and identified systemic deficiencies within five
equivalence components. In response to this audit, Korea submitted a
corrective action plan that addressed FSIS's findings.
In 2010, FSIS conducted a comprehensive on-site audit to determine
whether Korea had satisfactorily implemented all the laws, regulations,
and other issuances that FSIS found to be equivalent during the
document analysis, and whether the findings of the previous audit had
been addressed. The 2010 audit revealed that Korea had fully
implemented the corrective action plan that it had submitted in
response to the 2008 audit. Nonetheless, the new audit identified new
systemic deficiencies in three equivalence components: Statutory
Authority and Food Safety Regulations, Chemical Residue Testing
Programs, and Microbiological Testing Programs. During the audit,
establishments made changes to address some deficiencies.
In addition to the actions taken during the audit, Korea submitted
a corrective action plan on how it would incorporate the actions it
took during the audit into its food safety system. FSIS reviewed this
corrective action plan and, for the reasons explained below, concluded
that Korea had satisfactorily addressed the findings of 2010 audit.
[[Page 16658]]
Consequently, on November 27, 2012, FSIS published a proposed rule
to find that Korea's poultry inspection system (slaughter and
processing) is equivalent to the United States' poultry inspection
system and proposing to add the Republic of Korea (Korea) to the list
of countries eligible to export poultry products to the United States.
For more detailed information on FSIS's evaluation of the Korean
poultry inspection system, see the proposed rule (77 FR 70724) 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.
Final Rule
After considering the comments received on the proposed rule and
discussed below, FSIS concludes that Korea's poultry inspection system
is equivalent to the United States' inspection system for poultry and
poultry products. Therefore, FSIS is amending its poultry products
inspection regulations to add Korea to the list of countries eligible
to export poultry products to the United States (9 CFR 381.196(b)).
Under FSIS's import regulations, the government of Korea must certify
to FSIS that those establishments that wish to export poultry products
to the United States are operating under requirements equivalent to
those of the United States (9 CFR 381.196(a)).
Although a foreign country may be listed in FSIS regulations as
eligible to export poultry to the United States, the exporting
country's products must also comply with all other applicable
requirements of the United States. These requirements include
restrictions under 9 CFR part 94 of the Animal and Plant Health
Inspection Service (APHIS) regulations, which also regulate the
importation of poultry products from foreign countries into the United
States.
Under this final rule, all slaughtered poultry, or parts and
products thereof, exported to the United States from Korea will be
subject to re-inspection at the United States ports 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 conduct other types of reinspection
activities, such as incubation of canned products to ensure product
safety and taking product samples for laboratory analysis to detect any
drug or chemical residues or pathogens that may render the product
unsafe or any species or product composition violations that would
render the product economically adulterated. Products that pass re-
inspection will be stamped with the official mark of inspection and
allowed to enter United States commerce. If they do not meet United
States requirements, they will be refused entry and within 45 days will
have to be returned 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
Web site at https://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/importing-products/port-of-entry-procedures/fsis-import-reinspection/ct_index9.
Summary of Comments and Responses
FSIS received four comments in response to the proposed rule. One
individual and a consumer advocacy organization opposed the rule, and
one individual and three trade associations, representing the poultry
and egg products industries, submitted a single comment that supported
the proposed rule.
Following is a discussion of the relevant issues raised in the
comments and FSIS's responses.
Comment: One individual stated that all poultry from Korea should
be banned in the United States. The individual was concerned about the
safety of food from foreign countries, including Korea, and animal
welfare and inhumane slaughter in Korea. The individual argued that the
United States should not import any food from any country.
Response: Under the PPIA, if a country maintains a poultry safety
inspection system that is equivalent to that of the United States, it
is entitled to ship poultry products to the United States should it
seek to do so.
FSIS has conducted a thorough review of Korea's laws, regulations,
written procedures, policies, and other official documents, including
evaluating whether poultry slaughter establishments maintained good
commercial practices consistent with those required in United States
poultry slaughter establishments (see 9 CFR 381.65(a)-(b)). These
practices ensure that poultry is humanely slaughtered. In addition,
FSIS conducted two on-site verification audits of Korea's poultry
inspection system. Taking the findings of the two audits together, FSIS
has determined that Korea's poultry inspection system is equivalent to
the United States inspection system for poultry and poultry products.
The comment has not presented any basis on which FSIS could make a
contrary determination.
As stated above, for Korea to be eligible to export poultry to the
United States, it must implement and maintain a poultry inspection
system that is equivalent to the United States' system. To determine
whether Korea maintains an equivalent inspection system, FSIS uses a
three-part approach that includes (1) on-going document reviews, (2)
periodic on-site system audits, and (3) ports of entry re-inspections.
If Korea fails to maintain a poultry inspection system that is
equivalent to the United States' system, FSIS will act to suspend or
terminate its eligibility to export to this country.
Comment: A consumer advocacy organization stated that, although
Korea will initially export only two types of chicken stew, the
proposed rule understated the magnitude of future exports to the United
States because Korea is being added to the list of countries eligible
to export poultry products to the United States with no restrictions.
Response: FSIS has no basis for finding that it understated the
magnitude of future exports from Korea to the United States. As
described in more detail in the Economic Analysis below, Korea will
initially export only two types of chicken stew products to the United
States. Because of the limited market in the United States for these
products, the projected export volume of these products from Korea is
likely to be very small, and thus the impact on the United States
economy is likely to be very small as well.
However, it is true that Korea would not be precluded from
exporting other poultry products to the U.S. in the future if those
products meet all applicable APHIS and FSIS requirements for the
products, and Korea certifies that the producing establishments comply
with Korean requirements that FSIS has found to be equivalent to
applicable FSIS requirements (9 CFR 381.196(a)). Therefore, FSIS agrees
that the long-term economic impact of this rule could be more
significant than the immediate impact. FSIS does not have any data,
however, that it could use to project the long term impact.
Comment: The consumer advocacy organization also argued that Korea
should not be added to the list of countries eligible to export poultry
products because FSIS's 2010 audit found deficiencies in Korea's
inspection system, and FSIS did not conduct another onsite audit to
verify that Korea implemented corrective actions in response to the
2010 audit.
Response: During the 2010 on-site audit of Korea's poultry
inspection
[[Page 16659]]
system, FSIS auditors found that Korea had implemented the corrective
actions that it had proffered in response to the 2008 on-site audit
findings. In addition, Korea provided records demonstrating that these
corrective action plans had been implemented in a manner consistent
with FSIS' inspection requirements. This finding provides a basis for
confidence that Korea will implement all corrective actions it promises
in an acceptable manner.
As the commenter indicated, the auditors found two new problems
with the Korean system. The first problem identified by the auditors
was in the Statutory Authority and Food Safety Regulations component:
Korea's central competent authority (CCA), the Ministry for Food,
Agriculture, Forestry and Fisheries, was not requiring establishments
to maintain conditions that would allow the government inspectors to
inspect adequately each carcass. Specifically, FSIS found that: (a) One
of the three establishments audited did not have conveniently located
controls (e.g., start-stop switches) that would permit government
inspection program personnel to stop the line to conduct a protracted
post-mortem inspection of carcasses when necessary or to prevent
adulterated product from entering the chill tank; (b) during the on-
site review of records, the Korean inspection regulations did not
require inspection stations to have online hand-rinsing facilities with
a continuous flow of water within easy access for inspection personnel
and establishment personnel to prevent incidental cross-contamination
of carcasses resulting from post-mortem inspection procedures, and one
establishment audited did not have such online hand-rinsing facilities;
and (c) the three establishments audited had 52 footcandles (540 Lux)
of lighting at post-mortem inspection stations, in compliance with
Korea's inspection regulation, while the United States requires at
least 200 foot-candles (2,152 Lux) of shadow-free lighting, with a
minimum color-rendering index value of 85, for a system configuration
similar to Korea's inspection system and line speed (Streamlined
Inspection System (SIS)).
When FSIS discussed these findings with Korea's CCA during the on-
site audit, Korea's government inspectors at the establishments
instructed the establishments to make the changes necessary to conform
to United States requirements for the conditions under which government
inspection personnel are to perform their inspections. The
establishments proposed immediate corrective actions, and Korean
government inspectors accepted establishments' proposals. In the
establishment that did not have conveniently located controls, it
implemented immediate corrective action by relocating the controls
(e.g., start-stop switches) to a convenient location. All the three
establishments adjusted lighting at post-mortem inspection stations to
200 foot-candles of shadow-free lighting with a minimum color index
value of 85. In addition, Korea immediately revised its export
requirements for the U.S. to require export facilities to have
inspection stations with online hand-rinsing facilities. This document
was provided to the auditor before the conclusion of the audit. Korea
subsequently provided records, including a photograph, showing that the
audited establishment without on-line hand-rinsing facilities had
installed such facilities.
FSIS auditors verified the immediate corrective actions while still
in Korea. However, the auditors told Korea that it needed to submit a
comprehensive corrective action plan that included a systematic
solution to prevent recurrence of these deficiencies.
Following the audit, in July of 2011, Korea provided supporting
documentation demonstrating that it had issued new requirements for:
(1) Inspection stations to have conveniently located controls (e.g.,
start-stop switches); (2) online hand- rinsing facilities with a
continuous flow of water within easy access; and (3) 200 foot-candles
of shadow-free lighting with a minimum color-rendering index value of
85. These requirements, together with the immediate corrective actions
taken by the establishments and with Korea's history of taking
effective action to resolve deficiencies found in an audit, provide a
basis for FSIS to have confidence that the deficiencies that the
auditors found in the establishments have been corrected and will not
recur.
The second problem regarding the implementation of laboratory
quality systems within Korea's National Residue Program and
Microbiological Testing Program was identified in two equivalence
components, Chemical Residue Testing Programs and Microbiological
Testing Programs. Specifically, the CCA did not have adequate control
over the implementation of quality systems in the government
laboratories that are part of Korea's poultry inspection system. While
residue and microbiological testing methods appeared to be implemented
in an appropriate manner, Korea's CCA was not verifying that the
quality control and assurance programs implemented by the government
laboratories were adequate. For example, the frequency and the
documentation of equipment verification, calibration, and maintenance
related to relevant testing methods varied among the laboratories and
were not consistent with international standards. Therefore, Korea did
not consistently implement adequate standards for the laboratories.
Following the 2010 audit, Korea submitted documents showing that it
had implemented quality control and assurance programs. The
documentation provided shows that Korea adopted procedures consistent
with U.S. procedures to ensure that laboratory equipment and materials
are appropriately verified, calibrated, and maintained to meet program
requirements (Accreditation Guide 04/10, quality system recommendation
in accordance with ISO/IEC 17025 international standards). Korea
submitted documents to show that the Korean CCA has adequately trained
laboratory managers and staff in the quality control and assurance
program procedures. Records show that Korea has audited the government
laboratories involved in poultry inspection at least once per year, and
that the laboratories are meeting Korea's quality system requirements.
FSIS's review of proficiency testing reports for the year 2012
submitted by Korea in September 2013 found that the participating
Korean government laboratories are effectively using the FSIS
laboratory testing methods to ensure that products eligible for export
to the U.S. are free of contamination. The documents that Korea
submitted to FSIS collectively demonstrate that the Korea CCA has
effectively implemented procedures in its quality control and assurance
programs that are equivalent to U.S. procedures.
Comment: Finally, the consumer advocacy organization stated that
FSIS should not find Korea equivalent when FSIS is not performing
annual audits of all countries currently listed as eligible to export
to the United States.
Response: FSIS will conduct on-site audits of Korea's inspection
system each year for the next three years. After three years, FSIS will
reassess how frequently it needs to conduct on-site audits of Korea's
system. Additionally, all product imported from Korea will be subject
to FSIS re-inspection.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866 by the
Office of Management and Budget (OMB) and has
[[Page 16660]]
been determined to be not significant for purposes of E.O. 12866.
Economic Impact Analysis
This rule adds Korea to the list of countries eligible to export
poultry products into the United States. Korea will export two types of
ginseng chicken stew products to the United States. Given the limited
market in the United States for this product, and the projected export
volume of this product from Korea, the impact on the United States
economy is likely to be very small. According to data from Korea, only
two Korean establishments will export ginseng chicken stew to the
United States. The average combined annual production of these two
establishments is 3.2 million pounds (2006-2010 average), and their
projected total export volume to the United States will be about
380,000 pounds in year one (the first year of exporting to the United
States), gradually increasing to about 2.25 million pounds in year
five, according to the Korean data.
Ginseng chicken stew is sold commercially in frozen pouches. The
United States market for ginseng chicken stew is so small that no data
on domestic production, consumption, or importation could be found.
Using label application data, FSIS identified two official
establishments that produce and sell ginseng chicken stew. On the basis
of information from these establishments, FSIS believes (1) they are
very likely the only two establishments that are producing ginseng
chicken stew in the United States, (2) the market for ginseng chicken
stew is limited, (3) the annual production is about 18,000 pouches for
one establishment and 10,000 pouches for the other, and (4) each pouch
weighs about two pounds. Therefore, the combined production of these
two establishments is about 56,000 pounds per year ((18,000 + 10,000) x
2). The special flavor and taste make ginseng chicken stew unlikely to
be a substitute for other kinds of chicken stew in the United States.
Therefore, although this rule may affect these two United States
establishments, the impact to the United States economy is likely to be
insignificant.
Expected benefits from this rule will be primarily for consumers in
the form of more choices in the marketplace. As mentioned above, the
volume of trade stimulated by the rule is likely be so small as to have
little effect on supply and prices. Another potential benefit of this
rule would result in efficiency gains of United States poultry
producers due to the increased competition from Korea.
The cost of this rule will be incurred by domestic producers in the
form of competition from Korea. The two establishments that are
currently producing ginseng chicken stew are likely to encounter
competition pressure, for the projected import volume in year one is
already 6.8 times the combined production volume of these two
establishments. The imported volume, however, is likely to have little
impact on the overall United States economy. Also, these two
establishments may change their production mix if they find it
difficult to compete with imports.
Effect on Small Entities
The FSIS Administrator has made a determination that this rule will
not have a significant impact on a substantial number of small
entities, as defined by the Regulatory Flexibility Act (5 U.S.C. 601).
As mentioned above, the expected trade volume will be very small, and
the effect will be on only two very small establishments that produce
ginseng chicken stew domestically.
Potential Long-Term Effect
When foreign countries apply for eligibility of their meat,
poultry, or egg products for entry into this country, FSIS determines
whether their inspection systems are equivalent to the system
maintained by the United States. FSIS does not make equivalence
determinations on the basis of particular products; rather, the
equivalence decision is based on the evaluation of the countries'
inspection systems.
Although Korea indicates that it intends to export two types of
ginseng chicken stew products for now, it would not be precluded from
exporting other poultry products in the future if the products meet all
applicable APHIS and FSIS requirements for those products. If
additional Korean establishments export product to the United States,
the long-term economic impact could be more significant. However, no
data is available to assess such future impacts.
Executive Order 12988
This rule has been reviewed under Executive Order 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
retroactive proceedings will be required before parties may file suit
in court challenging this rule.
Paperwork Reduction Act
No new paperwork requirements are associated with this final rule.
Foreign countries wanting to export poultry and poultry products 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 Korea with questionnaires asking for detailed
information about the country's inspection practices and procedures to
assist that country in organizing its materials. This information
collection was approved under OMB number 0583-0094.
E-Government Act
FSIS and the United States 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
FSIS will officially notify the World Trade Organization's
Committee on Sanitary and Phytosanitary Measures (WTO/SPS Committee) in
Geneva, Switzerland, of this rule and will announce it on-line through
the FSIS Web page located at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/interim-and-final-rules.
FSIS also will make copies of this Federal Register 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. The Update is communicated via Listserv, a free email
subscription service consisting of industry, trade, and farm groups,
consumer interest groups, allied health professionals, scientific
professionals, and other individuals who have requested to be included.
The Update also is available on the FSIS Web page. 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 to regulations, directives,
and notices. Customers can add or delete subscriptions themselves, and
[[Page 16661]]
have the option to password protect their accounts.
USDA Nondiscrimination Statement
USDA prohibits discrimination in all its programs and activities on
the basis of race, color, national origin, gender, religion, age,
disability, political beliefs, sexual orientation, and marital or
family status. (Not all prohibited bases apply to all programs.)
Persons with disabilities who require alternative means for
communication of program information (Braille, large print, audiotape,
etc.) should contact USDA's Target Center at (202) 720-2600 (voice and
TTY).
To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue
SW., Washington, DC 20250-9410 or call (202) 720-5964 (voice and TTY).
USDA is an equal opportunity provider and employer.
List of Subjects in 9 CFR Part 381
Imported products.
For the reasons set out in the preamble, FSIS is amending 9 CFR
part 381 as follows:
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
0
1. The authority citation for part 381 continues to read as follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7,
2.18, 2.53.
Sec. 381.196 [Amended]
0
2. Amend Sec. 381.196(b) to add the ``Republic of Korea'' in
alphabetical order to the list of countries.
Done at Washington, DC, on March 20, 2014.
Alfred V. Almanza,
Administrator.
[FR Doc. 2014-06652 Filed 3-25-14; 8:45 am]
BILLING CODE 3410-DM-P