Notice of Determination of the Classical Swine Fever, Foot-and-Mouth Disease, Rinderpest, and Swine Vesicular Disease Status of Croatia, 64387-64392 [2015-27092]
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Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices
received on the pest risk analysis; (2)
the comments on the pest risk analysis
revealed that no changes to the pest risk
analysis were necessary; or (3) changes
to the pest risk analysis were made in
response to public comments, but the
changes did not affect the overall
conclusions of the analysis and the
Administrator’s determination of risk.
In accordance with that process, we
published a notice 1 in the Federal
Register on April 28, 2015 (80 FR
23497, Docket No. APHIS–2015–0012),
in which we announced the availability,
for review and comment, of a pest risk
assessment (PRA) that evaluated the
risks associated with the importation
into the continental United States of
fresh pitahaya fruit from Israel and a
risk management document (RMD)
prepared to identify phytosanitary
measures that could be applied to the
commodities to mitigate the pest risk.
We solicited comments on the PRA
and RMD for 60 days ending on June 29,
2015. We did not receive any comments
by that date.
Therefore, in accordance with
§ 319.56–4(c)(2)(ii), we are announcing
our decision to authorize the
importation of fresh pitahaya fruit from
Israel into the continental United States
subject to the following phytosanitary
measures:
• The pitahaya must be imported into
the continental United States in
commercial consignments only.
• Each consignment of pitahaya must
be accompanied by a phytosanitary
certificate issued by the national plant
protection organization of Israel.
• Each consignment of pitahaya is
subject to inspection upon arrival at the
port of entry to the United States.
These conditions will be listed in the
Fruits and Vegetables Import
Requirements database (available at
https://www.aphis.usda.gov/favir). In
addition to these specific measures,
fresh pitahaya fruit from Israel will be
subject to the general requirements
listed in § 319.56–3 that are applicable
to the importation of all fruits and
vegetables.
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Authority: 7 U.S.C. 450, 7701–7772, and
7781–7786; 21 U.S.C. 136 and 136a; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 19th day of
October 2015.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2015–27097 Filed 10–22–15; 8:45 am]
BILLING CODE 3410–34–P
1 To view the notice, PRA, and RMD, go to https://
www.regulations.gov/#!docketDetail;D=APHIS2015-0012.
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2014–0042]
Notice of Determination of the
Classical Swine Fever, Foot-and-Mouth
Disease, Rinderpest, and Swine
Vesicular Disease Status of Croatia
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are adding Croatia to the
lists of regions that are considered free
of foot-and-mouth disease, rinderpest,
and swine vesicular disease, and to the
list of regions considered free or low
risk for classical swine fever. We are
taking this action because we have
determined that this region is free of
foot-and-mouth disease, rinderpest, and
swine vesicular disease, and is low risk
for classical swine fever. This action
establishes the disease status of Croatia
with regard to foot-and-mouth disease,
rinderpest, swine vesicular disease, and
classical swine fever while continuing
to protect the United States from an
introduction of those diseases.
DATES: Effective November 23, 2015.
FOR FURTHER INFORMATION CONTACT: Mr.
Donald Link, Import Risk Analyst,
Regionalization Evaluation Services,
National Import Export Services,
Veterinary Services, APHIS, 920 Main
Campus Drive, Suite 200, Raleigh, NC
27606; (919) 855–7731; Donald.B.Link@
aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
The regulations in 9 CFR part 94
(referred to below as the regulations)
govern the importation of certain
animals and animal products into the
United States to prevent the
introduction of various animal diseases,
including classical swine fever (CSF),
foot-and-mouth disease (FMD),
rinderpest, and swine vesicular disease
(SVD). The regulations prohibit or
restrict the importation of live
ruminants and swine, and products
from these animals, from regions where
these diseases are considered to exist.
Within part 94, § 94.1 contains
requirements governing the importation
of ruminants and swine from regions
where rinderpest or FMD exists and the
importation of the meat of any
ruminants or swine from regions where
rinderpest or FMD exists to prevent the
introduction of either disease into the
United States. We consider rinderpest
and FMD to exist in all regions except
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those listed in accordance with
paragraph (a) of that section as free of
rinderpest and FMD. Section 94.9
contains requirements governing the
importation of pork and pork products
from regions where CSF exists. Section
94.10 contains importation
requirements for swine from regions
where CSF is considered to exist and
designates the Animal and Plant Health
Inspection Service (APHIS)-defined
European CSF region as a single region
of low-risk for CSF. Section 94.31
contains requirements governing the
importation of pork, pork products, and
swine from the APHIS-defined
European CSF region. We consider CSF
to exist in all regions of the world
except those listed in accordance with
paragraph (a) of § 94.9 as free of the
disease.
Section 94.11 of the regulations
contains requirements governing the
importation of meat of any ruminants or
swine from regions that have been
determined to be free of rinderpest and
FMD, but that are subject to certain
restrictions because of their proximity to
or trading relationships with rinderpestor FMD-affected regions. Such regions
are listed in accordance with paragraph
(a) of that section.
Section 94.12 of the regulations
contains requirements governing the
importation of pork or pork products
from regions where SVD exists. We
consider SVD to exist in all regions of
the world except those listed in
accordance with paragraph (a) of that
section as free of SVD.
Section 94.13 contains importation
requirements governing the importation
of pork or pork products from regions
that have been declared free of SVD as
provided in § 94.12(a) but supplement
their national pork supply by the
importation of fresh (chilled or frozen)
meat of animals from regions where
SVD is considered to exist, or have a
common border with such regions, or
have trade practices that are less
restrictive than are acceptable to the
United States. Such regions are listed in
accordance with paragraph (a) of
§ 94.13.
Section 94.14 states that no swine
which are moved from or transit any
region in which SVD is known to exist
may be imported into the United States
except wild swine imported in
accordance with § 94.14(b).
The regulations in 9 CFR part 92,
§ 92.2, contain requirements for
requesting the recognition of the animal
health status of a region (as well as for
the approval of the export of a particular
type of animal or animal product to the
United States from a foreign region). If,
after review and evaluation of the
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information submitted in support of the
request, APHIS believes the request can
be safely granted, APHIS will make its
evaluation available for public comment
through a document published in the
Federal Register.
In accordance with that process, on
February 3, 2015, we published in the
Federal Register (80 FR 5728–5729,
Docket No. APHIS–2014–0042) a
notice 1 announcing the availability for
review and comment of our risk
evaluation of the CSF, FMD, rinderpest,
and SVD status of Croatia. Based on this
evaluation, we determined that that the
animal disease surveillance, prevention,
and control measures implemented by
Croatia are sufficient to minimize the
likelihood of introducing CSF, FMD,
rinderpest, and SVD into the United
States via imports of species or products
susceptible to these diseases.
In addition, we determined in our
evaluation that Croatia is low risk for
CSF and therefore eligible to be added
to the APHIS-defined European CSF
region. This region is subject to the
conditions in § 94.31 for pork, pork
products, and swine and § 98.38 for
swine semen. We also determined that
the provisions of § 94.11 for import
conditions for meat or meat products
from ruminants or swine from FMD-free
regions, and § 94.13 for import
conditions for pork or pork products
from SVD-free regions, are applicable to
Croatia.
With respect to rinderpest, the global
distribution of the disease has
diminished significantly in recent years
as a result of the Food and Agriculture
Organization Global Rinderpest
Eradication Program. The last known
cases of rinderpest worldwide occurred
in the southern part of the ‘‘Somali
pastoral ecosystem’’ consisting of
southern Somalia, eastern Kenya, and
southern Ethiopia. In May 2011, the
World Organization for Animal Health
(OIE) announced its recognition of
global rinderpest freedom.
We solicited comments on the notice
of availability for 60 days ending on
April 6, 2015. We received two
comments by that date, both from
national pork industry associations.
Both commenters raised specific
concerns about disease risks regarding
our proposed action to recognize Croatia
as being free of FMD, rinderpest, and
SVD, and low risk for CSF, as this action
would allow for the importation into the
United States of swine, pork, and pork
products from Croatia subject to the
regulations. The comments are
discussed below.
Smuggling of Prohibited Articles
The commenters noted that
international passenger traffic was
identified in the APHIS evaluation as a
key risk factor for the introduction of
the disease hazards. The commenters
stated that limited data exists to
determine the quantity of prohibited
products smuggled into Croatia and that
APHIS obtained estimates of
international passenger traffic from 2006
data that is no longer current. The
commenters requested that we require
Croatia to provide updated information
on passenger traffic in order to
determine if the risk evaluation needs to
be modified.
We agree with the commenter that
limited data exists regarding smuggling
of prohibited products into Croatia.
Such data is by its nature limited
because the intent of smuggling is to
avoid disclosure, documentation, or
inspection. We also acknowledge the
volume of international passenger traffic
into Croatia and agree that the
introduction of prohibited products into
Croatia could play a role in the
transmission of animal diseases. As the
commenters requested, we have
provided more recent data for passenger
traffic into Croatia.
Data available from the World Bank
indicates that 9,111,000, 9,927,000, and
10,369,000 international inbound
tourists (overnight visitors) entered
Croatia in 2010, 2011, and 2012,
respectively.2 Additional data published
by the Organisation for Economic
Cooperation and Development (OECD) 3
(see Table 1) indicates total inbound
tourism and primary countries of origin
for arriving passengers.
TABLE 1—INBOUND TOURISM: TOTAL ARRIVALS AND PRIMARY COUNTRIES OF ORIGIN, CROATIA, 2008–2012
2008
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Total Intl Arrivals (x1000) .....................................................
Top Markets (x1000).
Germany .......................................................................
Slovenia ........................................................................
Italy ...............................................................................
Austria ...........................................................................
Czech Republic .............................................................
2009
2010
2011
2012
8,665
8,694
9,111
9,927
10,369
1,405
985
1,009
692
589
1,463
963
1,058
776
579
1,525
1,017
1,018
810
606
1,661
1,100
1,150
892
638
1,853
1,054
1,051
946
647
While the above data indicates that
Croatia has seen an increase in the
number of international arrivals over the
period indicated, the data does not
change our conclusions in the risk
evaluation. The updated number of
arrivals does not differ substantially
from the 2006 number we used in the
risk evaluation. Additionally, the
primary countries of origin listed in
Table 1 for arriving passengers are other
European Union (EU) Member States
that APHIS recognizes to be free of FMD
and rinderpest and low risk for CSF.
Germany, Slovenia, Austria, and the
Czech Republic are also free of SVD, as
are several regions of Italy. We
determined in the Croatia risk
evaluation and previous swine disease
status assessments of the EU and
individual Member States that the
animal health rules governing trade and
travel between Member States mitigate
the risk of contagious animal disease
transmission through international
passenger traffic.
We conclude that the risk of virus
introduction into Croatia via the
pathway of intentionally smuggled or
unintentionally carried prohibited
products is effectively mitigated by
implementing EU-level and Croatian
national policies regarding commodities
for personal consumption and by the
interdiction efforts of Croatia’s Border
Veterinary Inspection and International
1 To view the notice of availability, risk
evaluation, environmental assessment, and
comments we received, go to https://www.
regulations.gov/#!docketDetail;D=APHIS-20140042.
2 https://data.worldbank.org/indicator/ST.
INT.ARVL. The data on inbound tourists refer to the
number of arrivals, not to the number of people
traveling. Thus a person who makes several trips to
a country during a given period is counted each
time as a new arrival.
3 Organisation for Economic Co-operation and
Development (2014), ‘‘Croatia’’, in OECD Tourism
Trends and Policies 2014, OECD Publishing. (Data
cited by OECD was sourced from Croatian Bureau
of Statistics data on tourism: https://www.dzs.hr/
default_e.htm.)
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Trade (BVIITS) and Customs
departments. As described in the risk
analysis, BVIITS and Customs are the
Croatian authorities responsible for the
inspection and confiscation and
disposal of prohibited animal products
at Croatia’s points of entry.
Furthermore, in addition to border
controls, we determined in our risk
assessment that Croatia has systems in
place for surveillance and early
detection of CSF, FMD, SVD, and
rinderpest should any of these diseases
be introduced via incoming passenger
traffic into Croatia or any other
pathway.
Disease Detection and Surveillance
The commenters stated concerns over
the ability of commercial swine
operations in Croatia to conduct
surveillance for and detect foreign
animal diseases. As evidence, the
commenters cited in the risk evaluation
a reference to an interview we
conducted with the operator of a
company-owned swine fattening farm,
in which the operator seemed more
aware of potential production impacts
than on the clinical signs that would
accompany an outbreak of CSF or SVD.
The commenters asked if APHIS is
confident that the level of awareness of
swine operations in Croatia is sufficient
for early detection of trade-limiting
foreign animal diseases of swine. They
recommended that prior to announcing
a decision on Croatia’s disease status,
we should require Croatia to provide us
with verification that the industry has
been provided with the training or
educational materials necessary to assist
in active disease surveillance.
We reply that APHIS is confident in
the level of awareness for swine
diseases in Croatia’s commercial swine
operations. This particular commercial
fattening farm represents Croatia’s high
intensity, high biosecurity, vertically
integrated production and marketing
system. Given the advanced swine
husbandry standards, premises
monitoring by company veterinarians,
swine disease training, awareness and
sampling, APHIS considers it highly
likely that a trade-limiting swine disease
in Croatia would be quickly detected
and contained. Additionally, we
consider Croatia’s commercial swine
production system to be the most likely
source of pork or pork products for
export to the United States, and
consider the risk of undetected CSF-,
FMD-, or SVD-contaminated products
being sourced from this production
chain to be low.
Regarding this particular commercial
farm and farm operator, despite the
observation the commenters cited in the
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risk evaluation, the same farm operator
seemed knowledgeable of farm
operations, company procedures, and
Croatian veterinary and legal
requirements. As noted on page 43 of
the risk evaluation, we also observed
evidence of strong operational,
biosecurity, and recordkeeping practices
on that farm, as well as strong veterinary
oversight. State veterinary authorities
reported that the farm receives
educational information distributed by
Croatia’s Ministry of Agriculture,
Fisheries, and Rural Development
(MAFRD) and that company officials
have attended swine disease symposia
organized by the MAFRD Veterinary
Directorate, which is the central
competent authority for animal health
and veterinary services in Croatia. In
addition, a company veterinarian visits
the premises every 2 weeks on average
or when called to provide veterinary
care. We also observed that the
authorized veterinarian for this farm
visits regularly to issue health
certificates and movement documents.
Overall, our Croatia risk evaluation
determined that Croatia has an effective
surveillance system in place for
detection of swine diseases, including
surveillance strategies for the
commercial swine sector. We agree with
the commenters that early disease
detection is a core element of all tradeparticipating countries and we saw no
evidence that Croatia was lacking in this
regard.
Small Farms and Backyard Premises
The commenters noted that we
considered the disease risk posed by the
small, family-operated breeding farm we
visited (and backyard premises in
general) to be different from that of
vertically integrated commercial swine
production systems, particularly with
respect to animal disease traceability,
animal sampling, and biosecurity. The
commenters recommended that, before
making a decision on Croatia’s disease
status, we require Croatia to provide a
plan for risk reduction for small farms
and backyard premises that addresses
improving pre-harvest traceability,
disease and biosecurity awareness, and
disease sampling strategies that aid in
early detection of trade-limiting foreign
animal diseases.
In reply, we do consider the disease
risk posed by small family-operated
breeding farms and backyard premises
to differ from the risk associated with
Croatia’s vertically integrated
commercial swine production systems.
However, we also observed measures
that mitigate the risks associated with
the small family-operated breeding farm
we visited, including satisfactory
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operational, husbandry, and biosecurity
standards. The farm controlled and
catalogued on- and off-farm movements
of animals, people, and supplies, and
satisfied animal disease traceability
requirements. Additionally, this farm
was included in Croatia’s swine disease
surveillance program, as are other small
farms in Croatia.
Regarding risk reduction plans, we
note that Croatia does have such a plan
in place for CSF in the form of
legislation that places additional
restrictions on swine, pork, and pork
products produced in or moving from
the counties of Vukovar-Srijem, SisakMoslavina, Karlovac, and BrodPosavina, which are considered higher
risk for CSF due to past serological
events for CSF in feral swine. The
family-operated breeding farm visited
by APHIS was in Karlovac County and
thus subject to these additional
restrictions. As noted in the risk
evaluation,4 the additional risk
reduction measures include specific
biosecurity requirements such as
cleaning and disinfection of vehicles
and equipment. Additional measures
also require that domestic swine from
premises situated in the higher-risk
counties can be marketed within Croatia
if they undergo clinical examination
and sampling procedures prior to
movement from the premises of origin.
The swine must also test negative for
CSF within the 7 days prior to
movement, and no swine must have
been introduced to the premises within
30 days prior to movement. Domestic
swine from higher-risk counties must be
accompanied by a health certificate that
includes the number of swine, place of
origin, date of clinical examination, and
disease sampling and diagnostic test
results.
The additional risk reduction
measures stipulate that fresh meat, meat
preparations, or meat products
consisting of or containing meat of
swine originating from premises in
Karlovac, Vukovar-Srijem, and SisakMoslavina Counties may be marketed
and sold outside of these counties only
if no evidence of CSF has been recorded
in the previous 12 months on the
premises and the premises is located
outside a protection or surveillance
zone. The swine are required to have
resided for at least 90 days on the
premises, and no swine are permitted to
have been introduced into the premises
within the previous 30 days before
dispatch to slaughter. Under the
additional risk reduction measures,
Croatia also requires each premises to be
4 Section 4, ‘‘Active Disease Control Programs,’’
page 19.
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inspected by an authorized veterinarian,
including appropriate clinical
examination and sampling of animals,
twice per year. If swine are moved
directly to slaughter, the animals are
required to be clinically examined and
sampled by an authorized veterinarian,
culminating in a signed health
certificate. Finally, the additional
restrictions prevent semen, ova, and
embryos from swine from these higherrisk counties from being marketed
outside of those counties.
Animal Movement Safeguards
The commenters stated concern about
the movement of swine within Croatia,
noting that swine can be kept in
livestock markets for no more than 12
hours and must be returned to the
premises if not sold in that time. The
commenters noted that commingling of
swine outside of a production system or
premises of origin at a market presents
an elevated risk of disease transmission.
For this reason, the commenters asked
APHIS to clarify what, if any,
regulations apply to reporting that
animal movement back to the premises
of origin and if there are any quarantine
or movement restrictions or disease
monitoring placed on that animal. The
commenters recommended that APHIS
ensure that reporting takes place for
animal movement back to the premises
of origin, that there are quarantine or
movement restrictions as necessary, and
that official monitoring for disease be in
place and verified by Croatia.
We agree with the commenters that
commingling of potentially infected but
undetected swine in markets could
contribute to rapid transmission and
spread of contagious swine diseases. We
acknowledged on page 46 of our risk
evaluation that backyard premises with
a single pig are exempt from most of
Croatia’s premises and animal
registration requirements and that this
presents a gap in animal disease
traceability. We also acknowledged that
backyard premises may present a
biosecurity gap as some may not always
conduct animal disease sampling or
collect, analyze, and respond to changes
in production data.
However, we consider it unlikely that
animals/products from small farms or
backyard premises will enter the export
chain, as the movement and marketing
patterns of Croatia’s small farms and
family premises are local and domestic
in scope. Additionally, we concluded
from our risk evaluation that the risk of
disease transmission in small farm and
backyard premises is mitigated at the
premises and market levels. Although
these premises are exempt from entry in
the Croatian Agricultural Agency’s Farm
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Register database, they must report the
purchase of any pig to the competent
veterinary organization at the time of
delivery. Moreover, as the pig is most
likely fed and fattened for personal
consumption, we consider it unlikely
that the pig would be moved off of a
single- or double-swine backyard
premises. Any swine that do move from
a small premises require a movement
permit and corresponding health
certificate, and would most likely enter
the local livestock market and be subject
to the regulations enforced there.
Livestock market regulations include
the requirement that each animal
consignment arriving to the market must
be accompanied by a veterinary health
certificate, issued within 30 days prior
to movement, indicating veterinary
inspection was performed prior to
animals leaving the premises, as well as
a travel document indicating that the
transport vehicle underwent cleaning
and disinfection.
Finally, the risk associated with an
infected animal arriving at an animal
market and being sent back to the
premises of origin is also mitigated by
veterinary inspection and corresponding
documentation prior to animals moving
to the market, as well as by the
requirement that transport vehicles be
disinfected.
Disease risk is further mitigated by
other control measures that can be
implemented in the event that a
contagious animal disease is suspected
or confirmed. The measures we
observed included disinfection
wheelbaths for vehicles and footbaths
for people, and requiring that employees
don personal protective clothing prior to
entering the sale and transfer part of the
market. Animal disease awareness
educational pamphlets and contingency
plans were on display in the market
office, and the market has participated
in disease outbreak simulation
exercises.
Overall, we determined that Croatia
has a sufficient infrastructure in place
for reporting movement of pigs,
including livestock markets, and
concluded that disease monitoring took
place at all critical points of Croatia’s
movement and marketing channels.
Surveillance for African Swine Fever
The commenters noted that Croatia
conducts active surveillance for CSF,
SVD, and FMD. However, they asked if
we could determine whether active or
passive surveillance is conducted for
African swine fever (ASF), and whether
the veterinary authority in Croatia rules
out ASF in swine that present for
inspection with case-compatible lesions.
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We do not currently consider Croatia
affected with ASF and did not conduct
an evaluation of Croatia’s ASF status.
Thus, as the commenters acknowledged,
passive and active surveillance for ASF
are not specifically related to the risk
assessment, which was conducted
specifically for CSF, FMD, SVD, and
rinderpest. However, we did conclude
that Croatia maintains effective CSF and
FMD emergency response plans, so if a
disease investigation was triggered by
case-compatible lesions we consider it
highly likely that ASF would be
appropriately confirmed or ruled out by
Croatian veterinary officials.
We acknowledge that ASF has been a
concern in the EU and in areas adjacent
to the EU. The EU has laid down
prevention and control measures 5 to be
applied where ASF is suspected or
confirmed, either in agricultural
establishments or in wild boars. As an
EU Member State, Croatia is required to
implement EU-mandated prevention
and control measures for all swine
diseases, including ASF. APHIS
continues to monitor the ASF situation
in the EU, and Croatia would be subject
to any restrictive action that APHIS
takes towards the EU or individual
Member States to mitigate the risk of
introduction of ASF.
CSF Testing Methods
The commenters stated that the
methods of investigation and testing in
Croatia for suspected cases of CSF
included in the risk evaluation appear
to be inconsistent with the laboratory
methods conducted in the United States
that ensure rapid detection of CSF from
samples submitted from a farm. The
commenters suggested that this
inconsistency could result in a
significant delay in confirming the
presence of CSF on farms in Croatia
with case-compatible lesions and
recommended that the competent
veterinary authority of Croatia be
required to improve laboratory detection
methods so they are equivalent to those
used in the United States.
Under OIE guidelines, APHIS import
risk analyses are required to assess
whether the end result of a sanitary
measure or standard, in this case CSF
detection methodology and disease
confirmation, is equivalent to the end
result of the importing country’s
measure or standard. While Croatia’s
CSF investigation and testing
procedures may diverge slightly from
U.S. protocols, we concluded from
information gathered during the site
visit that Croatia’s CSF diagnostic
5 https://eur-lex.europa.eu/LexUriServ/LexUriServ.
do?uri=CELEX:02002L0060-20080903:EN:NOT.
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testing protocols are in accordance with
international standards and their end
result would be rapid detection of CSF.
We determined that Croatia’s laboratory
system was capable of quickly and
accurately receiving, processing, and
completing diagnostic tests on samples
received. We also determined that these
labs were able to accurately diagnose
CSF, FMD, and SVD, distinguish them
from differential diagnoses, and quickly
communicate test results to the Croatian
Veterinary Directorate and back to the
field. Finally, we determined that
Croatia’s epidemiological investigations
will capably trigger an appropriate
surveillance response that would result
in timely and accurate diagnosis of CSF.
Contaminated Food Waste
The commenters questioned our
determination that contaminated food
waste from Croatia poses a low disease
risk to swine in the United States,
noting that the risk findings we cited to
help support this determination were
conducted in 1995 and 2001 and do not
reflect current risks to the U.S. pork
industry.
One risk the commenters cited was
the increased interstate trade of swine
from States that allow the regulated
feeding of garbage. The commenters
recommended that the 1995 assessment
be repeated using more recent data.
To the commenter’s point, if
contaminated meat products were
imported from Croatia and managed to
make it into plate waste, U.S. garbage
feeding regulations will mitigate that
risk. In 1995, we conducted a pathway
analysis to estimate the likelihood of
exposing domestic swine to infected
waste. With 95 percent confidence, we
estimated that 0.023 percent or less of
plate and manufacturing waste would
be inadequately processed prior to
feeding to swine. Based on this
percentage, less than 1 part in 4,300 of
imported beef fed to swine as plate or
manufacturing waste is likely to be
inadequately cooked. The findings of a
2001 APHIS survey, which showed a
substantial reduction in waste-feeding
operations, further indicated that the
risk of FMD exposure via feeding of
contaminated waste to swine was
continuing to decline.
Treatment of food waste to be fed to
swine is covered under the Swine
Health Protection Act 6 (SHPA)
regulations in 9 CFR part 166 and
supported by APHIS’ Veterinary Service
(VS) Swine Health Program (SHP).
Under the regulations, waste feeder
operations must be licensed and
regularly inspected by APHIS
67
U.S.C. 3801.
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inspectors. In addition to other
safeguards, the licensing process
requires that producers adequately cook
the waste fed to swine using methods
designed to destroy foreign animal
disease agents.
We acknowledge that waste feeding
continues to be a potential pathway for
transmission of swine diseases and that
interstate trade patterns are subject to
change. We maintain, however, that the
1995 and 2001 risk findings, combined
with existing SHPA requirements,
indicate to us a low likelihood of
exposure of domestic swine to CSF,
FMD, SVD, and rinderpest from food
waste originating from Croatia.
Verification of Garbage Heating
Requirements
The commenters noted that the SHPA
requires licensed facilities to have
quarterly or bi-yearly temperature
checks of garbage-cooking equipment
for a minimum of two and a maximum
of four temperature checks each fiscal
year. The commenters asked how many
of the licensed garbage feeders actually
were temperature checked twice in 2014
by a regulatory official. They indicated
concerns with the records licensed
facilities maintain to verify that they are
meeting cooking time and temperature
requirements on days they are not
inspected, and recommended that we
determine what records licensed
facilities maintain in order to provide
such verification to State and Federal
animal health officials.
While we require that licensed U.S.
garbage-feeding facilities observe all
garbage heating requirements under the
SHPA regulations, cooking temperature
and treatment requirements are outside
the scope of this risk evaluation.
Regulations addressing these practices
are contained in 9 CFR part 166 and
include provisions for inspection of
heating equipment and records.
Garbage-feeding facilities suspected of
violating the regulations for storing and
heating garbage for feeding are subject to
license suspension or revocation.
Unlicensed Garbage Feeders
The commenters presented data from
APHIS–VS reports to the U.S. Animal
Health Association’s Transmissible
Diseases of Swine Committee indicating
that, from 2009 to 2013, the number of
non-licensed garbage feeders found by
State and Federal animal health
authorities in searches for non-licensed
feeders was 104, 142, 68, 125, and 160,
respectively. The commenters asked if
APHIS has any supporting information
on estimates of the number of
unlicensed garbage-feeding facilities.
Citing the disease risk posed by
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64391
unlicensed garbage-feeding operations,
the commenters expressed concern with
our level of confidence that foreign
animal diseases can be detected
promptly in unlicensed garbage-feeding
operations and asked if our emphasis on
finding non-licensed feeders increased
or decreased over the past couple of
years. Procedures for the handling,
processing, and feeding of food waste to
swine in the United States are subject to
our swine health protection regulations
in 9 CFR part 166. Compliance with the
regulations has improved in recent
years, thereby reducing the probability
of survival of FMD virus in the food
waste. Searches for non-licensed
garbage feeding facilities are regularly
conducted using several different
techniques as part of the duties of
APHIS animal health staff, as well as
State animal health and other State
agency staff. During fiscal year 2014,
animal health and other inspectors
conducted 28,774 searches for nonlicensed garbage feeding facilities with
122 documented non-licensed facilities
identified, which indicates that
unlicensed activity is infrequent.
When unlicensed garbage feeding
facilities are identified, the
unauthorized activity is documented,
and the facility is brought into
compliance. Depending on the State, all
swine on such premises may be
quarantined and tested for foreign
animal diseases. Information on the
number of inspections conducted to
detect unlicensed garbage feeding
facilities, the number of unlicensed
facilities identified, and resolution of
cases resulting from such identification
are captured at the State level and
evaluated by APHIS on a regular basis.
Given the regular monitoring of these
facilities and their relatively small
number, we stand by the conclusions
we reached in our 1995 risk analysis
cited above.
SHPA Budget
The commenters stated a concern that
budget cuts to APHIS–VS and State
animal health officials have negatively
affected the ability to effectively carry
out the regulatory activities supporting
the SHPA. They also expressed concern
that the reduction in such activities has
reduced the number of inspection and
searches for unlicensed garbage-feeding
operations to a level that is lower than
what was indicated in the 1995 risk
analysis.
Budget cuts to APHIS have
necessitated a reordering of priorities in
relation to SHPA-related activities. We
have deemphasized or passed on to
State partners or other cooperators
lower-yield activities, such as visiting
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64392
Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
restaurants to inquire about garbagedisposal methods, in favor of allowing
inspectors to spend more time
interacting with and educating swine
producers and conducting inspections.
The regular presence of APHIS
inspectors in U.S. garbage feeding
facilities provides opportunities to
educate operators on disease signs and
reporting requirements and to conduct
direct observation of animals for signs of
illness. APHIS believes, therefore, that
the presence of animal products
infected with FMD or other reportable
conditions entering the United States
would be detected more quickly in these
types of premises than in other,
unregulated premises.
Environmental Assessment
The commenters noted that the
environmental assessment (EA)
provided with this rulemaking was the
May 2011 EA for the importation of
swine and swine commodities from
Slovakia. They also noted that APHIS
provided a supporting document that
was an amended finding of no
significant impact (FONSI) from
importation of swine and swine
commodities from Croatia that uses the
EA from Slovakia as the basis for the
amended finding related to Croatia. The
commenters requested that APHIS
expand on how it is justifiable to use an
EA prepared for other countries and
apply it to Croatia.
APHIS has conducted animal health
status evaluations for multiple EU
Member States for swine diseases. Since
2006 we have recognized the CSF, FMD,
SVD, and/or rinderpest status for EU
Member States Latvia, Lithuania,
Poland, the Czech Republic, Slovakia,
Slovenia, Estonia, and Hungary, and for
certain countries that have entered into
agricultural equivalence agreements
with the EU. In each case, we
determined that measures are in place to
mitigate the risk of CSF, SVD, FMD,
and/or rinderpest introduction into the
United States through importation of
swine, swine commodities, ruminants,
and ruminant commodities from
countries or regions that we recognize as
low risk for CSF and free of SVD, FMD,
and rinderpest.
Given that the EU applies and ensures
enforcement of the same disease
mitigation requirements across all EU
Member States, we recognized that the
single-state evaluations we were
conducting were redundant and thus
unnecessary with respect to meeting the
requirements of the National
Environmental Protection Act (NEPA).
After we consulted with Agency
specialists on NEPA, we did an
environmental impact analysis
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Jkt 238001
comparison of the 2011 Slovakia EA
analysis in regards to the proposed
action of this notice for the EU Member
State Croatia and determined that the
environmental analyses of the Slovakia
EA were similar and sufficient to cover
the proposed action for Croatia. The
2011 Slovakia EA stated that for any
like/similar future regionalization
actions proposed for EU Member States,
APHIS would incorporate the Slovakia
EA by reference in a new FONSI issued
for a proposed new action for an EU
Member State. That is what we have
done for this proposed action for
Croatia.
Additionally, we determined that
future proposed actions of this nature
pose negligible environmental impacts
to each EU Member State or country that
has entered into an agricultural
equivalency agreement with the EU,
provided that a disease assessment finds
them to be free of or a low risk for
relevant diseases. As Croatia is an EU
Member State and because we have
determined that Croatia is free of SVD,
FMD, and rinderpest, and at low risk for
CSF, we believe that the ‘‘like/similar
action’’ environmental analyses
approach as presented in the 2011
Slovakia EA/FONSI is appropriate to
use for the proposed action for Croatia.
Based on the evaluation and the
reasons given in this document in
response to comments, we are
recognizing Croatia as free of FMD,
rinderpest, and SVD, and low risk for
CSF. The lists of regions recognized as
free or at low risk of these diseases can
be found by visiting the APHIS Web site
at https://www.aphis.usda.gov/wps/
portal/aphis/ourfocus/importexport and
following the link to ‘‘Animal or Animal
Product.’’ Copies of the lists are also
available via postal mail, fax, or email
upon request to the Regionalization
Evaluation Services, National Import
Export Services, Veterinary Services,
Animal and Plant Health Inspection
Service, 4700 River Road Unit 39,
Riverdale, Maryland 20737.
Authority: 7 U.S.C. 450, 7701–7772, 7781–
7786, and 8301–8317; 21 U.S.C. 136 and
136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
371.4.
Done in Washington, DC, this 19th day of
October 2015.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2015–27092 Filed 10–22–15; 8:45 am]
BILLING CODE 3410–34–P
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DEPARTMENT OF COMMERCE
International Trade Administration
[A–570–928]
Uncovered Innerspring Units From the
People’s Republic of China:
Affirmative Preliminary Determination
of Circumvention of the Antidumping
Duty Order
Enforcement and Compliance,
International Trade Administration,
Department of Commerce.
SUMMARY: The Department of Commerce
(‘‘the Department’’) preliminarily
determines that uncovered innerspring
units (‘‘innersprings units’’) completed
or assembled in Malaysia by Goldon
Bedding Manufacturing Sdn. Bhd.
(‘‘Goldon’’) using components from the
People’s Republic of China (‘‘PRC’’), and
exported to the United States, are
circumventing the antidumping duty
order on innersprings from the PRC, as
provided in section 781(b) of the Tariff
Act of 1930, as amended (‘‘the Act’’).1
DATES: Effective Date: October 23, 2015.
FOR FURTHER INFORMATION CONTACT:
Susan Pulongbarit, AD/CVD Operations,
Office V, Enforcement and Compliance,
International Trade Administration,
U.S. Department of Commerce, 14th
Street and Constitution Avenue NW.,
Washington, DC 20230; telephone:
(202) 482–4031.
SUPPLEMENTARY INFORMATION:
AGENCY:
Background
On December 31, 2014, the
Department initiated an
anticircumvention inquiry on imports of
innersprings from the PRC exported by
Goldon.2 On January 12, 2015, the
Department issued a circumvention
inquiry questionnaire.3 On January 22,
2015, we placed information on the
record confirming Goldon’s receipt of
the questionnaire.4 The Department has,
1 See Uncovered Innerspring Units from the
People’s Republic of China: Notice of Antidumping
Duty Order, 74 FR 7661 (February 19, 2009)
(‘‘Order’’).
2 See Uncovered Innerspring Units From the
People’s Republic of China: Initiation of
Anticircumvention Inquiry on Antidumping Duty
Order, 79 FR 78792 (December 31, 2014)
(‘‘Initiation’’).
3 See Letter from the Department, to Goldon,
regarding ‘‘Uncovered Innerspring Units from the
People’s Republic of China: Circumvention Inquiry
Questionnaire,’’ dated January 12, 2015
(‘‘Circumvention Questionnaire’’).
4 See Memo to the File, through Scot T. Fullerton,
Program Manager, Office V, AD/CVD Operations,
Enforcement and Compliance, from Steven
Hampton, International Trade Compliance Analyst,
Office V, AD/CVD Operations, Enforcement and
Compliance, regarding ‘‘Uncovered Innerspring
Units from the People’s Republic of China:
Anticircumvention Inquiry Questionnaire:
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Agencies
[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Pages 64387-64392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27092]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2014-0042]
Notice of Determination of the Classical Swine Fever, Foot-and-
Mouth Disease, Rinderpest, and Swine Vesicular Disease Status of
Croatia
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are adding Croatia to the lists of regions that are
considered free of foot-and-mouth disease, rinderpest, and swine
vesicular disease, and to the list of regions considered free or low
risk for classical swine fever. We are taking this action because we
have determined that this region is free of foot-and-mouth disease,
rinderpest, and swine vesicular disease, and is low risk for classical
swine fever. This action establishes the disease status of Croatia with
regard to foot-and-mouth disease, rinderpest, swine vesicular disease,
and classical swine fever while continuing to protect the United States
from an introduction of those diseases.
DATES: Effective November 23, 2015.
FOR FURTHER INFORMATION CONTACT: Mr. Donald Link, Import Risk Analyst,
Regionalization Evaluation Services, National Import Export Services,
Veterinary Services, APHIS, 920 Main Campus Drive, Suite 200, Raleigh,
NC 27606; (919) 855-7731; Donald.B.Link@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 94 (referred to below as the
regulations) govern the importation of certain animals and animal
products into the United States to prevent the introduction of various
animal diseases, including classical swine fever (CSF), foot-and-mouth
disease (FMD), rinderpest, and swine vesicular disease (SVD). The
regulations prohibit or restrict the importation of live ruminants and
swine, and products from these animals, from regions where these
diseases are considered to exist.
Within part 94, Sec. 94.1 contains requirements governing the
importation of ruminants and swine from regions where rinderpest or FMD
exists and the importation of the meat of any ruminants or swine from
regions where rinderpest or FMD exists to prevent the introduction of
either disease into the United States. We consider rinderpest and FMD
to exist in all regions except those listed in accordance with
paragraph (a) of that section as free of rinderpest and FMD. Section
94.9 contains requirements governing the importation of pork and pork
products from regions where CSF exists. Section 94.10 contains
importation requirements for swine from regions where CSF is considered
to exist and designates the Animal and Plant Health Inspection Service
(APHIS)-defined European CSF region as a single region of low-risk for
CSF. Section 94.31 contains requirements governing the importation of
pork, pork products, and swine from the APHIS-defined European CSF
region. We consider CSF to exist in all regions of the world except
those listed in accordance with paragraph (a) of Sec. 94.9 as free of
the disease.
Section 94.11 of the regulations contains requirements governing
the importation of meat of any ruminants or swine from regions that
have been determined to be free of rinderpest and FMD, but that are
subject to certain restrictions because of their proximity to or
trading relationships with rinderpest- or FMD-affected regions. Such
regions are listed in accordance with paragraph (a) of that section.
Section 94.12 of the regulations contains requirements governing
the importation of pork or pork products from regions where SVD exists.
We consider SVD to exist in all regions of the world except those
listed in accordance with paragraph (a) of that section as free of SVD.
Section 94.13 contains importation requirements governing the
importation of pork or pork products from regions that have been
declared free of SVD as provided in Sec. 94.12(a) but supplement their
national pork supply by the importation of fresh (chilled or frozen)
meat of animals from regions where SVD is considered to exist, or have
a common border with such regions, or have trade practices that are
less restrictive than are acceptable to the United States. Such regions
are listed in accordance with paragraph (a) of Sec. 94.13.
Section 94.14 states that no swine which are moved from or transit
any region in which SVD is known to exist may be imported into the
United States except wild swine imported in accordance with Sec.
94.14(b).
The regulations in 9 CFR part 92, Sec. 92.2, contain requirements
for requesting the recognition of the animal health status of a region
(as well as for the approval of the export of a particular type of
animal or animal product to the United States from a foreign region).
If, after review and evaluation of the
[[Page 64388]]
information submitted in support of the request, APHIS believes the
request can be safely granted, APHIS will make its evaluation available
for public comment through a document published in the Federal
Register.
In accordance with that process, on February 3, 2015, we published
in the Federal Register (80 FR 5728-5729, Docket No. APHIS-2014-0042) a
notice \1\ announcing the availability for review and comment of our
risk evaluation of the CSF, FMD, rinderpest, and SVD status of Croatia.
Based on this evaluation, we determined that that the animal disease
surveillance, prevention, and control measures implemented by Croatia
are sufficient to minimize the likelihood of introducing CSF, FMD,
rinderpest, and SVD into the United States via imports of species or
products susceptible to these diseases.
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\1\ To view the notice of availability, risk evaluation,
environmental assessment, and comments we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2014-0042.
---------------------------------------------------------------------------
In addition, we determined in our evaluation that Croatia is low
risk for CSF and therefore eligible to be added to the APHIS-defined
European CSF region. This region is subject to the conditions in Sec.
94.31 for pork, pork products, and swine and Sec. 98.38 for swine
semen. We also determined that the provisions of Sec. 94.11 for import
conditions for meat or meat products from ruminants or swine from FMD-
free regions, and Sec. 94.13 for import conditions for pork or pork
products from SVD-free regions, are applicable to Croatia.
With respect to rinderpest, the global distribution of the disease
has diminished significantly in recent years as a result of the Food
and Agriculture Organization Global Rinderpest Eradication Program. The
last known cases of rinderpest worldwide occurred in the southern part
of the ``Somali pastoral ecosystem'' consisting of southern Somalia,
eastern Kenya, and southern Ethiopia. In May 2011, the World
Organization for Animal Health (OIE) announced its recognition of
global rinderpest freedom.
We solicited comments on the notice of availability for 60 days
ending on April 6, 2015. We received two comments by that date, both
from national pork industry associations. Both commenters raised
specific concerns about disease risks regarding our proposed action to
recognize Croatia as being free of FMD, rinderpest, and SVD, and low
risk for CSF, as this action would allow for the importation into the
United States of swine, pork, and pork products from Croatia subject to
the regulations. The comments are discussed below.
Smuggling of Prohibited Articles
The commenters noted that international passenger traffic was
identified in the APHIS evaluation as a key risk factor for the
introduction of the disease hazards. The commenters stated that limited
data exists to determine the quantity of prohibited products smuggled
into Croatia and that APHIS obtained estimates of international
passenger traffic from 2006 data that is no longer current. The
commenters requested that we require Croatia to provide updated
information on passenger traffic in order to determine if the risk
evaluation needs to be modified.
We agree with the commenter that limited data exists regarding
smuggling of prohibited products into Croatia. Such data is by its
nature limited because the intent of smuggling is to avoid disclosure,
documentation, or inspection. We also acknowledge the volume of
international passenger traffic into Croatia and agree that the
introduction of prohibited products into Croatia could play a role in
the transmission of animal diseases. As the commenters requested, we
have provided more recent data for passenger traffic into Croatia.
Data available from the World Bank indicates that 9,111,000,
9,927,000, and 10,369,000 international inbound tourists (overnight
visitors) entered Croatia in 2010, 2011, and 2012, respectively.\2\
Additional data published by the Organisation for Economic Cooperation
and Development (OECD) \3\ (see Table 1) indicates total inbound
tourism and primary countries of origin for arriving passengers.
---------------------------------------------------------------------------
\2\ https://data.worldbank.org/indicator/ST.INT.ARVL. The data on
inbound tourists refer to the number of arrivals, not to the number
of people traveling. Thus a person who makes several trips to a
country during a given period is counted each time as a new arrival.
\3\ Organisation for Economic Co-operation and Development
(2014), ``Croatia'', in OECD Tourism Trends and Policies 2014, OECD
Publishing. (Data cited by OECD was sourced from Croatian Bureau of
Statistics data on tourism: https://www.dzs.hr/default_e.htm.)
Table 1--Inbound Tourism: Total Arrivals and Primary Countries of Origin, Croatia, 2008-2012
----------------------------------------------------------------------------------------------------------------
2008 2009 2010 2011 2012
----------------------------------------------------------------------------------------------------------------
Total Intl Arrivals (x1000)..... 8,665 8,694 9,111 9,927 10,369
Top Markets (x1000).
Germany..................... 1,405 1,463 1,525 1,661 1,853
Slovenia.................... 985 963 1,017 1,100 1,054
Italy....................... 1,009 1,058 1,018 1,150 1,051
Austria..................... 692 776 810 892 946
Czech Republic.............. 589 579 606 638 647
----------------------------------------------------------------------------------------------------------------
While the above data indicates that Croatia has seen an increase in
the number of international arrivals over the period indicated, the
data does not change our conclusions in the risk evaluation. The
updated number of arrivals does not differ substantially from the 2006
number we used in the risk evaluation. Additionally, the primary
countries of origin listed in Table 1 for arriving passengers are other
European Union (EU) Member States that APHIS recognizes to be free of
FMD and rinderpest and low risk for CSF. Germany, Slovenia, Austria,
and the Czech Republic are also free of SVD, as are several regions of
Italy. We determined in the Croatia risk evaluation and previous swine
disease status assessments of the EU and individual Member States that
the animal health rules governing trade and travel between Member
States mitigate the risk of contagious animal disease transmission
through international passenger traffic.
We conclude that the risk of virus introduction into Croatia via
the pathway of intentionally smuggled or unintentionally carried
prohibited products is effectively mitigated by implementing EU-level
and Croatian national policies regarding commodities for personal
consumption and by the interdiction efforts of Croatia's Border
Veterinary Inspection and International
[[Page 64389]]
Trade (BVIITS) and Customs departments. As described in the risk
analysis, BVIITS and Customs are the Croatian authorities responsible
for the inspection and confiscation and disposal of prohibited animal
products at Croatia's points of entry. Furthermore, in addition to
border controls, we determined in our risk assessment that Croatia has
systems in place for surveillance and early detection of CSF, FMD, SVD,
and rinderpest should any of these diseases be introduced via incoming
passenger traffic into Croatia or any other pathway.
Disease Detection and Surveillance
The commenters stated concerns over the ability of commercial swine
operations in Croatia to conduct surveillance for and detect foreign
animal diseases. As evidence, the commenters cited in the risk
evaluation a reference to an interview we conducted with the operator
of a company-owned swine fattening farm, in which the operator seemed
more aware of potential production impacts than on the clinical signs
that would accompany an outbreak of CSF or SVD. The commenters asked if
APHIS is confident that the level of awareness of swine operations in
Croatia is sufficient for early detection of trade-limiting foreign
animal diseases of swine. They recommended that prior to announcing a
decision on Croatia's disease status, we should require Croatia to
provide us with verification that the industry has been provided with
the training or educational materials necessary to assist in active
disease surveillance.
We reply that APHIS is confident in the level of awareness for
swine diseases in Croatia's commercial swine operations. This
particular commercial fattening farm represents Croatia's high
intensity, high biosecurity, vertically integrated production and
marketing system. Given the advanced swine husbandry standards,
premises monitoring by company veterinarians, swine disease training,
awareness and sampling, APHIS considers it highly likely that a trade-
limiting swine disease in Croatia would be quickly detected and
contained. Additionally, we consider Croatia's commercial swine
production system to be the most likely source of pork or pork products
for export to the United States, and consider the risk of undetected
CSF-, FMD-, or SVD-contaminated products being sourced from this
production chain to be low.
Regarding this particular commercial farm and farm operator,
despite the observation the commenters cited in the risk evaluation,
the same farm operator seemed knowledgeable of farm operations, company
procedures, and Croatian veterinary and legal requirements. As noted on
page 43 of the risk evaluation, we also observed evidence of strong
operational, biosecurity, and recordkeeping practices on that farm, as
well as strong veterinary oversight. State veterinary authorities
reported that the farm receives educational information distributed by
Croatia's Ministry of Agriculture, Fisheries, and Rural Development
(MAFRD) and that company officials have attended swine disease symposia
organized by the MAFRD Veterinary Directorate, which is the central
competent authority for animal health and veterinary services in
Croatia. In addition, a company veterinarian visits the premises every
2 weeks on average or when called to provide veterinary care. We also
observed that the authorized veterinarian for this farm visits
regularly to issue health certificates and movement documents.
Overall, our Croatia risk evaluation determined that Croatia has an
effective surveillance system in place for detection of swine diseases,
including surveillance strategies for the commercial swine sector. We
agree with the commenters that early disease detection is a core
element of all trade-participating countries and we saw no evidence
that Croatia was lacking in this regard.
Small Farms and Backyard Premises
The commenters noted that we considered the disease risk posed by
the small, family-operated breeding farm we visited (and backyard
premises in general) to be different from that of vertically integrated
commercial swine production systems, particularly with respect to
animal disease traceability, animal sampling, and biosecurity. The
commenters recommended that, before making a decision on Croatia's
disease status, we require Croatia to provide a plan for risk reduction
for small farms and backyard premises that addresses improving pre-
harvest traceability, disease and biosecurity awareness, and disease
sampling strategies that aid in early detection of trade-limiting
foreign animal diseases.
In reply, we do consider the disease risk posed by small family-
operated breeding farms and backyard premises to differ from the risk
associated with Croatia's vertically integrated commercial swine
production systems. However, we also observed measures that mitigate
the risks associated with the small family-operated breeding farm we
visited, including satisfactory operational, husbandry, and biosecurity
standards. The farm controlled and catalogued on- and off-farm
movements of animals, people, and supplies, and satisfied animal
disease traceability requirements. Additionally, this farm was included
in Croatia's swine disease surveillance program, as are other small
farms in Croatia.
Regarding risk reduction plans, we note that Croatia does have such
a plan in place for CSF in the form of legislation that places
additional restrictions on swine, pork, and pork products produced in
or moving from the counties of Vukovar-Srijem, Sisak-Moslavina,
Karlovac, and Brod-Posavina, which are considered higher risk for CSF
due to past serological events for CSF in feral swine. The family-
operated breeding farm visited by APHIS was in Karlovac County and thus
subject to these additional restrictions. As noted in the risk
evaluation,\4\ the additional risk reduction measures include specific
biosecurity requirements such as cleaning and disinfection of vehicles
and equipment. Additional measures also require that domestic swine
from premises situated in the higher-risk counties can be marketed
within Croatia if they undergo clinical examination and sampling
procedures prior to movement from the premises of origin. The swine
must also test negative for CSF within the 7 days prior to movement,
and no swine must have been introduced to the premises within 30 days
prior to movement. Domestic swine from higher-risk counties must be
accompanied by a health certificate that includes the number of swine,
place of origin, date of clinical examination, and disease sampling and
diagnostic test results.
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\4\ Section 4, ``Active Disease Control Programs,'' page 19.
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The additional risk reduction measures stipulate that fresh meat,
meat preparations, or meat products consisting of or containing meat of
swine originating from premises in Karlovac, Vukovar-Srijem, and Sisak-
Moslavina Counties may be marketed and sold outside of these counties
only if no evidence of CSF has been recorded in the previous 12 months
on the premises and the premises is located outside a protection or
surveillance zone. The swine are required to have resided for at least
90 days on the premises, and no swine are permitted to have been
introduced into the premises within the previous 30 days before
dispatch to slaughter. Under the additional risk reduction measures,
Croatia also requires each premises to be
[[Page 64390]]
inspected by an authorized veterinarian, including appropriate clinical
examination and sampling of animals, twice per year. If swine are moved
directly to slaughter, the animals are required to be clinically
examined and sampled by an authorized veterinarian, culminating in a
signed health certificate. Finally, the additional restrictions prevent
semen, ova, and embryos from swine from these higher-risk counties from
being marketed outside of those counties.
Animal Movement Safeguards
The commenters stated concern about the movement of swine within
Croatia, noting that swine can be kept in livestock markets for no more
than 12 hours and must be returned to the premises if not sold in that
time. The commenters noted that commingling of swine outside of a
production system or premises of origin at a market presents an
elevated risk of disease transmission. For this reason, the commenters
asked APHIS to clarify what, if any, regulations apply to reporting
that animal movement back to the premises of origin and if there are
any quarantine or movement restrictions or disease monitoring placed on
that animal. The commenters recommended that APHIS ensure that
reporting takes place for animal movement back to the premises of
origin, that there are quarantine or movement restrictions as
necessary, and that official monitoring for disease be in place and
verified by Croatia.
We agree with the commenters that commingling of potentially
infected but undetected swine in markets could contribute to rapid
transmission and spread of contagious swine diseases. We acknowledged
on page 46 of our risk evaluation that backyard premises with a single
pig are exempt from most of Croatia's premises and animal registration
requirements and that this presents a gap in animal disease
traceability. We also acknowledged that backyard premises may present a
biosecurity gap as some may not always conduct animal disease sampling
or collect, analyze, and respond to changes in production data.
However, we consider it unlikely that animals/products from small
farms or backyard premises will enter the export chain, as the movement
and marketing patterns of Croatia's small farms and family premises are
local and domestic in scope. Additionally, we concluded from our risk
evaluation that the risk of disease transmission in small farm and
backyard premises is mitigated at the premises and market levels.
Although these premises are exempt from entry in the Croatian
Agricultural Agency's Farm Register database, they must report the
purchase of any pig to the competent veterinary organization at the
time of delivery. Moreover, as the pig is most likely fed and fattened
for personal consumption, we consider it unlikely that the pig would be
moved off of a single- or double-swine backyard premises. Any swine
that do move from a small premises require a movement permit and
corresponding health certificate, and would most likely enter the local
livestock market and be subject to the regulations enforced there.
Livestock market regulations include the requirement that each animal
consignment arriving to the market must be accompanied by a veterinary
health certificate, issued within 30 days prior to movement, indicating
veterinary inspection was performed prior to animals leaving the
premises, as well as a travel document indicating that the transport
vehicle underwent cleaning and disinfection.
Finally, the risk associated with an infected animal arriving at an
animal market and being sent back to the premises of origin is also
mitigated by veterinary inspection and corresponding documentation
prior to animals moving to the market, as well as by the requirement
that transport vehicles be disinfected.
Disease risk is further mitigated by other control measures that
can be implemented in the event that a contagious animal disease is
suspected or confirmed. The measures we observed included disinfection
wheelbaths for vehicles and footbaths for people, and requiring that
employees don personal protective clothing prior to entering the sale
and transfer part of the market. Animal disease awareness educational
pamphlets and contingency plans were on display in the market office,
and the market has participated in disease outbreak simulation
exercises.
Overall, we determined that Croatia has a sufficient infrastructure
in place for reporting movement of pigs, including livestock markets,
and concluded that disease monitoring took place at all critical points
of Croatia's movement and marketing channels.
Surveillance for African Swine Fever
The commenters noted that Croatia conducts active surveillance for
CSF, SVD, and FMD. However, they asked if we could determine whether
active or passive surveillance is conducted for African swine fever
(ASF), and whether the veterinary authority in Croatia rules out ASF in
swine that present for inspection with case-compatible lesions.
We do not currently consider Croatia affected with ASF and did not
conduct an evaluation of Croatia's ASF status. Thus, as the commenters
acknowledged, passive and active surveillance for ASF are not
specifically related to the risk assessment, which was conducted
specifically for CSF, FMD, SVD, and rinderpest. However, we did
conclude that Croatia maintains effective CSF and FMD emergency
response plans, so if a disease investigation was triggered by case-
compatible lesions we consider it highly likely that ASF would be
appropriately confirmed or ruled out by Croatian veterinary officials.
We acknowledge that ASF has been a concern in the EU and in areas
adjacent to the EU. The EU has laid down prevention and control
measures \5\ to be applied where ASF is suspected or confirmed, either
in agricultural establishments or in wild boars. As an EU Member State,
Croatia is required to implement EU-mandated prevention and control
measures for all swine diseases, including ASF. APHIS continues to
monitor the ASF situation in the EU, and Croatia would be subject to
any restrictive action that APHIS takes towards the EU or individual
Member States to mitigate the risk of introduction of ASF.
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\5\ https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:02002L0060-20080903:EN:NOT.
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CSF Testing Methods
The commenters stated that the methods of investigation and testing
in Croatia for suspected cases of CSF included in the risk evaluation
appear to be inconsistent with the laboratory methods conducted in the
United States that ensure rapid detection of CSF from samples submitted
from a farm. The commenters suggested that this inconsistency could
result in a significant delay in confirming the presence of CSF on
farms in Croatia with case-compatible lesions and recommended that the
competent veterinary authority of Croatia be required to improve
laboratory detection methods so they are equivalent to those used in
the United States.
Under OIE guidelines, APHIS import risk analyses are required to
assess whether the end result of a sanitary measure or standard, in
this case CSF detection methodology and disease confirmation, is
equivalent to the end result of the importing country's measure or
standard. While Croatia's CSF investigation and testing procedures may
diverge slightly from U.S. protocols, we concluded from information
gathered during the site visit that Croatia's CSF diagnostic
[[Page 64391]]
testing protocols are in accordance with international standards and
their end result would be rapid detection of CSF. We determined that
Croatia's laboratory system was capable of quickly and accurately
receiving, processing, and completing diagnostic tests on samples
received. We also determined that these labs were able to accurately
diagnose CSF, FMD, and SVD, distinguish them from differential
diagnoses, and quickly communicate test results to the Croatian
Veterinary Directorate and back to the field. Finally, we determined
that Croatia's epidemiological investigations will capably trigger an
appropriate surveillance response that would result in timely and
accurate diagnosis of CSF.
Contaminated Food Waste
The commenters questioned our determination that contaminated food
waste from Croatia poses a low disease risk to swine in the United
States, noting that the risk findings we cited to help support this
determination were conducted in 1995 and 2001 and do not reflect
current risks to the U.S. pork industry.
One risk the commenters cited was the increased interstate trade of
swine from States that allow the regulated feeding of garbage. The
commenters recommended that the 1995 assessment be repeated using more
recent data.
To the commenter's point, if contaminated meat products were
imported from Croatia and managed to make it into plate waste, U.S.
garbage feeding regulations will mitigate that risk. In 1995, we
conducted a pathway analysis to estimate the likelihood of exposing
domestic swine to infected waste. With 95 percent confidence, we
estimated that 0.023 percent or less of plate and manufacturing waste
would be inadequately processed prior to feeding to swine. Based on
this percentage, less than 1 part in 4,300 of imported beef fed to
swine as plate or manufacturing waste is likely to be inadequately
cooked. The findings of a 2001 APHIS survey, which showed a substantial
reduction in waste-feeding operations, further indicated that the risk
of FMD exposure via feeding of contaminated waste to swine was
continuing to decline.
Treatment of food waste to be fed to swine is covered under the
Swine Health Protection Act \6\ (SHPA) regulations in 9 CFR part 166
and supported by APHIS' Veterinary Service (VS) Swine Health Program
(SHP). Under the regulations, waste feeder operations must be licensed
and regularly inspected by APHIS inspectors. In addition to other
safeguards, the licensing process requires that producers adequately
cook the waste fed to swine using methods designed to destroy foreign
animal disease agents.
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\6\ 7 U.S.C. 3801.
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We acknowledge that waste feeding continues to be a potential
pathway for transmission of swine diseases and that interstate trade
patterns are subject to change. We maintain, however, that the 1995 and
2001 risk findings, combined with existing SHPA requirements, indicate
to us a low likelihood of exposure of domestic swine to CSF, FMD, SVD,
and rinderpest from food waste originating from Croatia.
Verification of Garbage Heating Requirements
The commenters noted that the SHPA requires licensed facilities to
have quarterly or bi-yearly temperature checks of garbage-cooking
equipment for a minimum of two and a maximum of four temperature checks
each fiscal year. The commenters asked how many of the licensed garbage
feeders actually were temperature checked twice in 2014 by a regulatory
official. They indicated concerns with the records licensed facilities
maintain to verify that they are meeting cooking time and temperature
requirements on days they are not inspected, and recommended that we
determine what records licensed facilities maintain in order to provide
such verification to State and Federal animal health officials.
While we require that licensed U.S. garbage-feeding facilities
observe all garbage heating requirements under the SHPA regulations,
cooking temperature and treatment requirements are outside the scope of
this risk evaluation. Regulations addressing these practices are
contained in 9 CFR part 166 and include provisions for inspection of
heating equipment and records. Garbage-feeding facilities suspected of
violating the regulations for storing and heating garbage for feeding
are subject to license suspension or revocation.
Unlicensed Garbage Feeders
The commenters presented data from APHIS-VS reports to the U.S.
Animal Health Association's Transmissible Diseases of Swine Committee
indicating that, from 2009 to 2013, the number of non-licensed garbage
feeders found by State and Federal animal health authorities in
searches for non-licensed feeders was 104, 142, 68, 125, and 160,
respectively. The commenters asked if APHIS has any supporting
information on estimates of the number of unlicensed garbage-feeding
facilities. Citing the disease risk posed by unlicensed garbage-feeding
operations, the commenters expressed concern with our level of
confidence that foreign animal diseases can be detected promptly in
unlicensed garbage-feeding operations and asked if our emphasis on
finding non-licensed feeders increased or decreased over the past
couple of years. Procedures for the handling, processing, and feeding
of food waste to swine in the United States are subject to our swine
health protection regulations in 9 CFR part 166. Compliance with the
regulations has improved in recent years, thereby reducing the
probability of survival of FMD virus in the food waste. Searches for
non-licensed garbage feeding facilities are regularly conducted using
several different techniques as part of the duties of APHIS animal
health staff, as well as State animal health and other State agency
staff. During fiscal year 2014, animal health and other inspectors
conducted 28,774 searches for non-licensed garbage feeding facilities
with 122 documented non-licensed facilities identified, which indicates
that unlicensed activity is infrequent.
When unlicensed garbage feeding facilities are identified, the
unauthorized activity is documented, and the facility is brought into
compliance. Depending on the State, all swine on such premises may be
quarantined and tested for foreign animal diseases. Information on the
number of inspections conducted to detect unlicensed garbage feeding
facilities, the number of unlicensed facilities identified, and
resolution of cases resulting from such identification are captured at
the State level and evaluated by APHIS on a regular basis. Given the
regular monitoring of these facilities and their relatively small
number, we stand by the conclusions we reached in our 1995 risk
analysis cited above.
SHPA Budget
The commenters stated a concern that budget cuts to APHIS-VS and
State animal health officials have negatively affected the ability to
effectively carry out the regulatory activities supporting the SHPA.
They also expressed concern that the reduction in such activities has
reduced the number of inspection and searches for unlicensed garbage-
feeding operations to a level that is lower than what was indicated in
the 1995 risk analysis.
Budget cuts to APHIS have necessitated a reordering of priorities
in relation to SHPA-related activities. We have deemphasized or passed
on to State partners or other cooperators lower-yield activities, such
as visiting
[[Page 64392]]
restaurants to inquire about garbage-disposal methods, in favor of
allowing inspectors to spend more time interacting with and educating
swine producers and conducting inspections. The regular presence of
APHIS inspectors in U.S. garbage feeding facilities provides
opportunities to educate operators on disease signs and reporting
requirements and to conduct direct observation of animals for signs of
illness. APHIS believes, therefore, that the presence of animal
products infected with FMD or other reportable conditions entering the
United States would be detected more quickly in these types of premises
than in other, unregulated premises.
Environmental Assessment
The commenters noted that the environmental assessment (EA)
provided with this rulemaking was the May 2011 EA for the importation
of swine and swine commodities from Slovakia. They also noted that
APHIS provided a supporting document that was an amended finding of no
significant impact (FONSI) from importation of swine and swine
commodities from Croatia that uses the EA from Slovakia as the basis
for the amended finding related to Croatia. The commenters requested
that APHIS expand on how it is justifiable to use an EA prepared for
other countries and apply it to Croatia.
APHIS has conducted animal health status evaluations for multiple
EU Member States for swine diseases. Since 2006 we have recognized the
CSF, FMD, SVD, and/or rinderpest status for EU Member States Latvia,
Lithuania, Poland, the Czech Republic, Slovakia, Slovenia, Estonia, and
Hungary, and for certain countries that have entered into agricultural
equivalence agreements with the EU. In each case, we determined that
measures are in place to mitigate the risk of CSF, SVD, FMD, and/or
rinderpest introduction into the United States through importation of
swine, swine commodities, ruminants, and ruminant commodities from
countries or regions that we recognize as low risk for CSF and free of
SVD, FMD, and rinderpest.
Given that the EU applies and ensures enforcement of the same
disease mitigation requirements across all EU Member States, we
recognized that the single-state evaluations we were conducting were
redundant and thus unnecessary with respect to meeting the requirements
of the National Environmental Protection Act (NEPA). After we consulted
with Agency specialists on NEPA, we did an environmental impact
analysis comparison of the 2011 Slovakia EA analysis in regards to the
proposed action of this notice for the EU Member State Croatia and
determined that the environmental analyses of the Slovakia EA were
similar and sufficient to cover the proposed action for Croatia. The
2011 Slovakia EA stated that for any like/similar future
regionalization actions proposed for EU Member States, APHIS would
incorporate the Slovakia EA by reference in a new FONSI issued for a
proposed new action for an EU Member State. That is what we have done
for this proposed action for Croatia.
Additionally, we determined that future proposed actions of this
nature pose negligible environmental impacts to each EU Member State or
country that has entered into an agricultural equivalency agreement
with the EU, provided that a disease assessment finds them to be free
of or a low risk for relevant diseases. As Croatia is an EU Member
State and because we have determined that Croatia is free of SVD, FMD,
and rinderpest, and at low risk for CSF, we believe that the ``like/
similar action'' environmental analyses approach as presented in the
2011 Slovakia EA/FONSI is appropriate to use for the proposed action
for Croatia.
Based on the evaluation and the reasons given in this document in
response to comments, we are recognizing Croatia as free of FMD,
rinderpest, and SVD, and low risk for CSF. The lists of regions
recognized as free or at low risk of these diseases can be found by
visiting the APHIS Web site at https://www.aphis.usda.gov/wps/portal/aphis/ourfocus/importexport and following the link to ``Animal or
Animal Product.'' Copies of the lists are also available via postal
mail, fax, or email upon request to the Regionalization Evaluation
Services, National Import Export Services, Veterinary Services, Animal
and Plant Health Inspection Service, 4700 River Road Unit 39,
Riverdale, Maryland 20737.
Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21
U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
Done in Washington, DC, this 19th day of October 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-27092 Filed 10-22-15; 8:45 am]
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