80 FR 64387 - Notice of Determination of the Classical Swine Fever, Foot-and-Mouth Disease, Rinderpest, and Swine Vesicular Disease Status of Croatia

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 205 (October 23, 2015)

Page Range		64387-64392
FR Document		2015-27092

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.

Federal Register, Volume 80 Issue 205 (Friday, October 23, 2015)

[Federal Register Volume 80, Number 205 (Friday, October 23, 2015)]
[Notices]
[Pages 64387-64392]
From the Federal Register Online [www.thefederalregister.org]
[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 http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0042.
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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.
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\2\ http://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: http://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
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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
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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\ http://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 http://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

Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices 64387

received on the pest risk analysis; (2) DEPARTMENT OF AGRICULTURE those listed in accordance with
the comments on the pest risk analysis paragraph (a) of that section as free of
revealed that no changes to the pest risk Animal and Plant Health Inspection rinderpest and FMD. Section 94.9
analysis were necessary; or (3) changes Service contains requirements governing the
to the pest risk analysis were made in [Docket No. APHIS–2014–0042]
importation of pork and pork products
response to public comments, but the from regions where CSF exists. Section
changes did not affect the overall Notice of Determination of the 94.10 contains importation
conclusions of the analysis and the Classical Swine Fever, Foot-and-Mouth requirements for swine from regions
Administrator’s determination of risk. Disease, Rinderpest, and Swine where CSF is considered to exist and
In accordance with that process, we Vesicular Disease Status of Croatia designates the Animal and Plant Health
published a notice 1 in the Federal Inspection Service (APHIS)-defined
Register on April 28, 2015 (80 FR AGENCY: Animal and Plant Health European CSF region as a single region
23497, Docket No. APHIS–2015–0012), Inspection Service, USDA. of low-risk for CSF. Section 94.31
in which we announced the availability, ACTION: Notice. contains requirements governing the
for review and comment, of a pest risk importation of pork, pork products, and
assessment (PRA) that evaluated the SUMMARY: We are adding Croatia to the swine from the APHIS-defined
risks associated with the importation lists of regions that are considered free European CSF region. We consider CSF
into the continental United States of of foot-and-mouth disease, rinderpest, to exist in all regions of the world
fresh pitahaya fruit from Israel and a and swine vesicular disease, and to the except those listed in accordance with
risk management document (RMD) list of regions considered free or low paragraph (a) of § 94.9 as free of the
prepared to identify phytosanitary risk for classical swine fever. We are disease.
measures that could be applied to the taking this action because we have Section 94.11 of the regulations
commodities to mitigate the pest risk. determined that this region is free of contains requirements governing the
We solicited comments on the PRA foot-and-mouth disease, rinderpest, and importation of meat of any ruminants or
and RMD for 60 days ending on June 29, swine vesicular disease, and is low risk swine from regions that have been
2015. We did not receive any comments for classical swine fever. This action determined to be free of rinderpest and
by that date. establishes the disease status of Croatia FMD, but that are subject to certain
Therefore, in accordance with with regard to foot-and-mouth disease, restrictions because of their proximity to
§ 319.56–4(c)(2)(ii), we are announcing rinderpest, swine vesicular disease, and or trading relationships with rinderpest-
our decision to authorize the classical swine fever while continuing or FMD-affected regions. Such regions
importation of fresh pitahaya fruit from to protect the United States from an are listed in accordance with paragraph
Israel into the continental United States introduction of those diseases. (a) of that section.
DATES: Effective November 23, 2015. Section 94.12 of the regulations
subject to the following phytosanitary
contains requirements governing the
measures: FOR FURTHER INFORMATION CONTACT: Mr.
importation of pork or pork products
• The pitahaya must be imported into Donald Link, Import Risk Analyst, from regions where SVD exists. We
the continental United States in Regionalization Evaluation Services, consider SVD to exist in all regions of
commercial consignments only. National Import Export Services, the world except those listed in
• Each consignment of pitahaya must Veterinary Services, APHIS, 920 Main accordance with paragraph (a) of that
be accompanied by a phytosanitary Campus Drive, Suite 200, Raleigh, NC section as free of SVD.
certificate issued by the national plant 27606; (919) 855–7731; Donald.B.Link@ Section 94.13 contains importation
protection organization of Israel. aphis.usda.gov. requirements governing the importation
• Each consignment of pitahaya is SUPPLEMENTARY INFORMATION: of pork or pork products from regions
subject to inspection upon arrival at the that have been declared free of SVD as
port of entry to the United States. Background
provided in § 94.12(a) but supplement
These conditions will be listed in the The regulations in 9 CFR part 94 their national pork supply by the
Fruits and Vegetables Import (referred to below as the regulations) importation of fresh (chilled or frozen)
Requirements database (available at govern the importation of certain meat of animals from regions where
http://www.aphis.usda.gov/favir). In animals and animal products into the SVD is considered to exist, or have a
addition to these specific measures, United States to prevent the common border with such regions, or
fresh pitahaya fruit from Israel will be introduction of various animal diseases, have trade practices that are less
subject to the general requirements including classical swine fever (CSF), restrictive than are acceptable to the
listed in § 319.56–3 that are applicable foot-and-mouth disease (FMD), United States. Such regions are listed in
to the importation of all fruits and rinderpest, and swine vesicular disease accordance with paragraph (a) of
vegetables. (SVD). The regulations prohibit or § 94.13.
Authority: 7 U.S.C. 450, 7701–7772, and restrict the importation of live Section 94.14 states that no swine
7781–7786; 21 U.S.C. 136 and 136a; 7 CFR ruminants and swine, and products which are moved from or transit any
2.22, 2.80, and 371.3. from these animals, from regions where region in which SVD is known to exist
Done in Washington, DC, this 19th day of these diseases are considered to exist. may be imported into the United States
October 2015. Within part 94, § 94.1 contains except wild swine imported in
Kevin Shea, requirements governing the importation accordance with § 94.14(b).
mstockstill on DSK4VPTVN1PROD with NOTICES

Administrator, Animal and Plant Health of ruminants and swine from regions The regulations in 9 CFR part 92,
Inspection Service. where rinderpest or FMD exists and the § 92.2, contain requirements for
[FR Doc. 2015–27097 Filed 10–22–15; 8:45 am] importation of the meat of any requesting the recognition of the animal
BILLING CODE 3410–34–P
ruminants or swine from regions where health status of a region (as well as for
rinderpest or FMD exists to prevent the the approval of the export of a particular
1 To view the notice, PRA, and RMD, go to http:// introduction of either disease into the type of animal or animal product to the
www.regulations.gov/#!docketDetail;D=APHIS- United States. We consider rinderpest United States from a foreign region). If,
2015-0012. and FMD to exist in all regions except after review and evaluation of the

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64388 Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices

information submitted in support of the With respect to rinderpest, the global determine the quantity of prohibited
request, APHIS believes the request can distribution of the disease has products smuggled into Croatia and that
be safely granted, APHIS will make its diminished significantly in recent years APHIS obtained estimates of
evaluation available for public comment as a result of the Food and Agriculture international passenger traffic from 2006
through a document published in the Organization Global Rinderpest data that is no longer current. The
Federal Register. Eradication Program. The last known commenters requested that we require
In accordance with that process, on cases of rinderpest worldwide occurred Croatia to provide updated information
February 3, 2015, we published in the in the southern part of the ‘‘Somali on passenger traffic in order to
Federal Register (80 FR 5728–5729, pastoral ecosystem’’ consisting of determine if the risk evaluation needs to
Docket No. APHIS–2014–0042) a southern Somalia, eastern Kenya, and be modified.
notice 1 announcing the availability for southern Ethiopia. In May 2011, the We agree with the commenter that
review and comment of our risk World Organization for Animal Health limited data exists regarding smuggling
evaluation of the CSF, FMD, rinderpest, (OIE) announced its recognition of of prohibited products into Croatia.
and SVD status of Croatia. Based on this global rinderpest freedom. Such data is by its nature limited
evaluation, we determined that that the We solicited comments on the notice
animal disease surveillance, prevention, because the intent of smuggling is to
of availability for 60 days ending on
and control measures implemented by avoid disclosure, documentation, or
April 6, 2015. We received two
Croatia are sufficient to minimize the inspection. We also acknowledge the
comments by that date, both from
likelihood of introducing CSF, FMD, volume of international passenger traffic
national pork industry associations.
rinderpest, and SVD into the United into Croatia and agree that the
Both commenters raised specific
States via imports of species or products introduction of prohibited products into
concerns about disease risks regarding
susceptible to these diseases. Croatia could play a role in the
our proposed action to recognize Croatia
In addition, we determined in our transmission of animal diseases. As the
as being free of FMD, rinderpest, and
evaluation that Croatia is low risk for commenters requested, we have
SVD, and low risk for CSF, as this action
CSF and therefore eligible to be added provided more recent data for passenger
would allow for the importation into the
to the APHIS-defined European CSF traffic into Croatia.
United States of swine, pork, and pork
region. This region is subject to the products from Croatia subject to the Data available from the World Bank
conditions in § 94.31 for pork, pork regulations. The comments are indicates that 9,111,000, 9,927,000, and
products, and swine and § 98.38 for discussed below. 10,369,000 international inbound
swine semen. We also determined that tourists (overnight visitors) entered
the provisions of § 94.11 for import Smuggling of Prohibited Articles Croatia in 2010, 2011, and 2012,
conditions for meat or meat products The commenters noted that respectively.2 Additional data published
from ruminants or swine from FMD-free international passenger traffic was by the Organisation for Economic
regions, and § 94.13 for import identified in the APHIS evaluation as a Cooperation and Development (OECD) 3
conditions for pork or pork products key risk factor for the introduction of (see Table 1) indicates total inbound
from SVD-free regions, are applicable to the disease hazards. The commenters tourism and primary countries of origin
Croatia. stated that limited data exists to for arriving passengers.

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 that APHIS recognizes to be free of FMD transmission through international
Croatia has seen an increase in the and rinderpest and low risk for CSF. passenger traffic.
number of international arrivals over the Germany, Slovenia, Austria, and the We conclude that the risk of virus
period indicated, the data does not Czech Republic are also free of SVD, as introduction into Croatia via the
change our conclusions in the risk are several regions of Italy. We pathway of intentionally smuggled or
evaluation. The updated number of determined in the Croatia risk unintentionally carried prohibited
arrivals does not differ substantially evaluation and previous swine disease products is effectively mitigated by
from the 2006 number we used in the status assessments of the EU and implementing EU-level and Croatian
risk evaluation. Additionally, the individual Member States that the national policies regarding commodities
primary countries of origin listed in animal health rules governing trade and for personal consumption and by the
mstockstill on DSK4VPTVN1PROD with NOTICES

Table 1 for arriving passengers are other travel between Member States mitigate interdiction efforts of Croatia’s Border
European Union (EU) Member States the risk of contagious animal disease Veterinary Inspection and International
1 To view the notice of availability, risk 2 http://data.worldbank.org/indicator/ST. 3 Organisation for Economic Co-operation and

evaluation, environmental assessment, and INT.ARVL. The data on inbound tourists refer to the Development (2014), ‘‘Croatia’’, in OECD Tourism
comments we received, go to http://www. number of arrivals, not to the number of people Trends and Policies 2014, OECD Publishing. (Data
regulations.gov/#!docketDetail;D=APHIS-2014- traveling. Thus a person who makes several trips to cited by OECD was sourced from Croatian Bureau
0042. a country during a given period is counted each of Statistics data on tourism: http://www.dzs.hr/
time as a new arrival. default_e.htm.)

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Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices 64389

Trade (BVIITS) and Customs risk evaluation, the same farm operator operational, husbandry, and biosecurity
departments. As described in the risk seemed knowledgeable of farm standards. The farm controlled and
analysis, BVIITS and Customs are the operations, company procedures, and catalogued on- and off-farm movements
Croatian authorities responsible for the Croatian veterinary and legal of animals, people, and supplies, and
inspection and confiscation and requirements. As noted on page 43 of satisfied animal disease traceability
disposal of prohibited animal products the risk evaluation, we also observed requirements. Additionally, this farm
at Croatia’s points of entry. evidence of strong operational, was included in Croatia’s swine disease
Furthermore, in addition to border biosecurity, and recordkeeping practices surveillance program, as are other small
controls, we determined in our risk on that farm, as well as strong veterinary farms in Croatia.
assessment that Croatia has systems in oversight. State veterinary authorities Regarding risk reduction plans, we
place for surveillance and early reported that the farm receives note that Croatia does have such a plan
detection of CSF, FMD, SVD, and educational information distributed by in place for CSF in the form of
rinderpest should any of these diseases Croatia’s Ministry of Agriculture, legislation that places additional
be introduced via incoming passenger Fisheries, and Rural Development restrictions on swine, pork, and pork
traffic into Croatia or any other (MAFRD) and that company officials products produced in or moving from
pathway. have attended swine disease symposia the counties of Vukovar-Srijem, Sisak-
organized by the MAFRD Veterinary Moslavina, Karlovac, and Brod-
Disease Detection and Surveillance Posavina, which are considered higher
Directorate, which is the central
The commenters stated concerns over competent authority for animal health risk for CSF due to past serological
the ability of commercial swine and veterinary services in Croatia. In events for CSF in feral swine. The
operations in Croatia to conduct addition, a company veterinarian visits family-operated breeding farm visited
surveillance for and detect foreign the premises every 2 weeks on average by APHIS was in Karlovac County and
animal diseases. As evidence, the or when called to provide veterinary thus subject to these additional
commenters cited in the risk evaluation care. We also observed that the restrictions. As noted in the risk
a reference to an interview we authorized veterinarian for this farm evaluation,4 the additional risk
conducted with the operator of a visits regularly to issue health reduction measures include specific
company-owned swine fattening farm, certificates and movement documents. biosecurity requirements such as
in which the operator seemed more Overall, our Croatia risk evaluation cleaning and disinfection of vehicles
aware of potential production impacts determined that Croatia has an effective and equipment. Additional measures
than on the clinical signs that would surveillance system in place for also require that domestic swine from
accompany an outbreak of CSF or SVD. detection of swine diseases, including premises situated in the higher-risk
The commenters asked if APHIS is surveillance strategies for the counties can be marketed within Croatia
confident that the level of awareness of commercial swine sector. We agree with if they undergo clinical examination
swine operations in Croatia is sufficient the commenters that early disease and sampling procedures prior to
for early detection of trade-limiting detection is a core element of all trade- movement from the premises of origin.
foreign animal diseases of swine. They participating countries and we saw no The swine must also test negative for
recommended that prior to announcing evidence that Croatia was lacking in this CSF within the 7 days prior to
a decision on Croatia’s disease status, regard. movement, and no swine must have
we should require Croatia to provide us been introduced to the premises within
with verification that the industry has Small Farms and Backyard Premises
30 days prior to movement. Domestic
been provided with the training or The commenters noted that we swine from higher-risk counties must be
educational materials necessary to assist considered the disease risk posed by the accompanied by a health certificate that
in active disease surveillance. small, family-operated breeding farm we includes the number of swine, place of
We reply that APHIS is confident in visited (and backyard premises in origin, date of clinical examination, and
the level of awareness for swine general) to be different from that of disease sampling and diagnostic test
diseases in Croatia’s commercial swine vertically integrated commercial swine results.
operations. This particular commercial production systems, particularly with The additional risk reduction
fattening farm represents Croatia’s high respect to animal disease traceability, measures stipulate that fresh meat, meat
intensity, high biosecurity, vertically animal sampling, and biosecurity. The preparations, or meat products
integrated production and marketing commenters recommended that, before consisting of or containing meat of
system. Given the advanced swine making a decision on Croatia’s disease swine originating from premises in
husbandry standards, premises status, we require Croatia to provide a Karlovac, Vukovar-Srijem, and Sisak-
monitoring by company veterinarians, plan for risk reduction for small farms Moslavina Counties may be marketed
swine disease training, awareness and and backyard premises that addresses and sold outside of these counties only
sampling, APHIS considers it highly improving pre-harvest traceability, if no evidence of CSF has been recorded
likely that a trade-limiting swine disease disease and biosecurity awareness, and in the previous 12 months on the
in Croatia would be quickly detected disease sampling strategies that aid in premises and the premises is located
and contained. Additionally, we early detection of trade-limiting foreign outside a protection or surveillance
consider Croatia’s commercial swine animal diseases. zone. The swine are required to have
production system to be the most likely In reply, we do consider the disease resided for at least 90 days on the
source of pork or pork products for risk posed by small family-operated premises, and no swine are permitted to
mstockstill on DSK4VPTVN1PROD with NOTICES

export to the United States, and breeding farms and backyard premises have been introduced into the premises
consider the risk of undetected CSF-, to differ from the risk associated with within the previous 30 days before
FMD-, or SVD-contaminated products Croatia’s vertically integrated dispatch to slaughter. Under the
being sourced from this production commercial swine production systems. additional risk reduction measures,
chain to be low. However, we also observed measures Croatia also requires each premises to be
Regarding this particular commercial that mitigate the risks associated with
farm and farm operator, despite the the small family-operated breeding farm 4 Section 4, ‘‘Active Disease Control Programs,’’

observation the commenters cited in the we visited, including satisfactory page 19.

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64390 Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices

inspected by an authorized veterinarian, Register database, they must report the We do not currently consider Croatia
including appropriate clinical purchase of any pig to the competent affected with ASF and did not conduct
examination and sampling of animals, veterinary organization at the time of an evaluation of Croatia’s ASF status.
twice per year. If swine are moved delivery. Moreover, as the pig is most Thus, as the commenters acknowledged,
directly to slaughter, the animals are likely fed and fattened for personal passive and active surveillance for ASF
required to be clinically examined and consumption, we consider it unlikely are not specifically related to the risk
sampled by an authorized veterinarian, that the pig would be moved off of a assessment, which was conducted
culminating in a signed health single- or double-swine backyard specifically for CSF, FMD, SVD, and
certificate. Finally, the additional premises. Any swine that do move from rinderpest. However, we did conclude
restrictions prevent semen, ova, and a small premises require a movement that Croatia maintains effective CSF and
embryos from swine from these higher- permit and corresponding health FMD emergency response plans, so if a
risk counties from being marketed certificate, and would most likely enter disease investigation was triggered by
outside of those counties. the local livestock market and be subject case-compatible lesions we consider it
to the regulations enforced there. highly likely that ASF would be
Animal Movement Safeguards
Livestock market regulations include appropriately confirmed or ruled out by
The commenters stated concern about the requirement that each animal Croatian veterinary officials.
the movement of swine within Croatia, consignment arriving to the market must We acknowledge that ASF has been a
noting that swine can be kept in be accompanied by a veterinary health concern in the EU and in areas adjacent
livestock markets for no more than 12 certificate, issued within 30 days prior to the EU. The EU has laid down
hours and must be returned to the to movement, indicating veterinary prevention and control measures 5 to be
premises if not sold in that time. The inspection was performed prior to applied where ASF is suspected or
commenters noted that commingling of animals leaving the premises, as well as confirmed, either in agricultural
swine outside of a production system or a travel document indicating that the establishments or in wild boars. As an
premises of origin at a market presents transport vehicle underwent cleaning EU Member State, Croatia is required to
an elevated risk of disease transmission. and disinfection. implement EU-mandated prevention
For this reason, the commenters asked and control measures for all swine
Finally, the risk associated with an
APHIS to clarify what, if any, diseases, including ASF. APHIS
infected animal arriving at an animal
regulations apply to reporting that continues to monitor the ASF situation
market and being sent back to the
animal movement back to the premises in the EU, and Croatia would be subject
premises of origin is also mitigated by
of origin and if there are any quarantine to any restrictive action that APHIS
veterinary inspection and corresponding
or movement restrictions or disease takes towards the EU or individual
monitoring placed on that animal. The documentation prior to animals moving
to the market, as well as by the Member States to mitigate the risk of
commenters recommended that APHIS introduction of ASF.
ensure that reporting takes place for requirement that transport vehicles be
animal movement back to the premises disinfected. CSF Testing Methods
of origin, that there are quarantine or Disease risk is further mitigated by The commenters stated that the
movement restrictions as necessary, and other control measures that can be methods of investigation and testing in
that official monitoring for disease be in implemented in the event that a Croatia for suspected cases of CSF
place and verified by Croatia. contagious animal disease is suspected included in the risk evaluation appear
We agree with the commenters that or confirmed. The measures we to be inconsistent with the laboratory
commingling of potentially infected but observed included disinfection methods conducted in the United States
undetected swine in markets could wheelbaths for vehicles and footbaths that ensure rapid detection of CSF from
contribute to rapid transmission and for people, and requiring that employees samples submitted from a farm. The
spread of contagious swine diseases. We don personal protective clothing prior to commenters suggested that this
acknowledged on page 46 of our risk entering the sale and transfer part of the inconsistency could result in a
evaluation that backyard premises with market. Animal disease awareness significant delay in confirming the
a single pig are exempt from most of educational pamphlets and contingency presence of CSF on farms in Croatia
Croatia’s premises and animal plans were on display in the market with case-compatible lesions and
registration requirements and that this office, and the market has participated recommended that the competent
presents a gap in animal disease in disease outbreak simulation veterinary authority of Croatia be
traceability. We also acknowledged that exercises. required to improve laboratory detection
backyard premises may present a Overall, we determined that Croatia methods so they are equivalent to those
biosecurity gap as some may not always has a sufficient infrastructure in place used in the United States.
conduct animal disease sampling or for reporting movement of pigs, Under OIE guidelines, APHIS import
collect, analyze, and respond to changes including livestock markets, and risk analyses are required to assess
in production data. concluded that disease monitoring took whether the end result of a sanitary
However, we consider it unlikely that place at all critical points of Croatia’s measure or standard, in this case CSF
animals/products from small farms or movement and marketing channels. detection methodology and disease
backyard premises will enter the export confirmation, is equivalent to the end
Surveillance for African Swine Fever
chain, as the movement and marketing result of the importing country’s
patterns of Croatia’s small farms and The commenters noted that Croatia measure or standard. While Croatia’s
mstockstill on DSK4VPTVN1PROD with NOTICES

family premises are local and domestic conducts active surveillance for CSF, CSF investigation and testing
in scope. Additionally, we concluded SVD, and FMD. However, they asked if procedures may diverge slightly from
from our risk evaluation that the risk of we could determine whether active or U.S. protocols, we concluded from
disease transmission in small farm and passive surveillance is conducted for information gathered during the site
backyard premises is mitigated at the African swine fever (ASF), and whether visit that Croatia’s CSF diagnostic
premises and market levels. Although the veterinary authority in Croatia rules
these premises are exempt from entry in out ASF in swine that present for 5 http://eur-lex.europa.eu/LexUriServ/LexUriServ.

the Croatian Agricultural Agency’s Farm inspection with case-compatible lesions. do?uri=CELEX:02002L0060-20080903:EN:NOT.

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Federal Register / Vol. 80, No. 205 / Friday, October 23, 2015 / Notices 64391

testing protocols are in accordance with inspectors. In addition to other unlicensed garbage-feeding operations,
international standards and their end safeguards, the licensing process the commenters expressed concern with
result would be rapid detection of CSF. requires that producers adequately cook our level of confidence that foreign
We determined that Croatia’s laboratory the waste fed to swine using methods animal diseases can be detected
system was capable of quickly and designed to destroy foreign animal promptly in unlicensed garbage-feeding
accurately receiving, processing, and disease agents. operations and asked if our emphasis on
completing diagnostic tests on samples We acknowledge that waste feeding finding non-licensed feeders increased
received. We also determined that these continues to be a potential pathway for or decreased over the past couple of
labs were able to accurately diagnose transmission of swine diseases and that years. Procedures for the handling,
CSF, FMD, and SVD, distinguish them interstate trade patterns are subject to processing, and feeding of food waste to
from differential diagnoses, and quickly change. We maintain, however, that the swine in the United States are subject to
communicate test results to the Croatian 1995 and 2001 risk findings, combined our swine health protection regulations
Veterinary Directorate and back to the with existing SHPA requirements, in 9 CFR part 166. Compliance with the
field. Finally, we determined that indicate to us a low likelihood of regulations has improved in recent
Croatia’s epidemiological investigations exposure of domestic swine to CSF, years, thereby reducing the probability
will capably trigger an appropriate FMD, SVD, and rinderpest from food of survival of FMD virus in the food
surveillance response that would result waste originating from Croatia. waste. Searches for non-licensed
in timely and accurate diagnosis of CSF. Verification of Garbage Heating garbage feeding facilities are regularly
Requirements conducted using several different
Contaminated Food Waste
techniques as part of the duties of
The commenters questioned our The commenters noted that the SHPA APHIS animal health staff, as well as
determination that contaminated food requires licensed facilities to have State animal health and other State
waste from Croatia poses a low disease quarterly or bi-yearly temperature agency staff. During fiscal year 2014,
risk to swine in the United States, checks of garbage-cooking equipment animal health and other inspectors
noting that the risk findings we cited to for a minimum of two and a maximum conducted 28,774 searches for non-
help support this determination were of four temperature checks each fiscal licensed garbage feeding facilities with
conducted in 1995 and 2001 and do not year. The commenters asked how many 122 documented non-licensed facilities
reflect current risks to the U.S. pork of the licensed garbage feeders actually identified, which indicates that
industry. were temperature checked twice in 2014 unlicensed activity is infrequent.
One risk the commenters cited was by a regulatory official. They indicated When unlicensed garbage feeding
the increased interstate trade of swine concerns with the records licensed facilities are identified, the
from States that allow the regulated facilities maintain to verify that they are unauthorized activity is documented,
feeding of garbage. The commenters meeting cooking time and temperature and the facility is brought into
recommended that the 1995 assessment requirements on days they are not compliance. Depending on the State, all
be repeated using more recent data. inspected, and recommended that we swine on such premises may be
To the commenter’s point, if determine what records licensed quarantined and tested for foreign
contaminated meat products were facilities maintain in order to provide animal diseases. Information on the
imported from Croatia and managed to such verification to State and Federal number of inspections conducted to
make it into plate waste, U.S. garbage animal health officials. detect unlicensed garbage feeding
feeding regulations will mitigate that While we require that licensed U.S. facilities, the number of unlicensed
risk. In 1995, we conducted a pathway garbage-feeding facilities observe all facilities identified, and resolution of
analysis to estimate the likelihood of garbage heating requirements under the cases resulting from such identification
exposing domestic swine to infected SHPA regulations, cooking temperature are captured at the State level and
waste. With 95 percent confidence, we and treatment requirements are outside evaluated by APHIS on a regular basis.
estimated that 0.023 percent or less of the scope of this risk evaluation. Given the regular monitoring of these
plate and manufacturing waste would Regulations addressing these practices facilities and their relatively small
be inadequately processed prior to are contained in 9 CFR part 166 and number, we stand by the conclusions
feeding to swine. Based on this include provisions for inspection of we reached in our 1995 risk analysis
percentage, less than 1 part in 4,300 of heating equipment and records. cited above.
imported beef fed to swine as plate or Garbage-feeding facilities suspected of
manufacturing waste is likely to be violating the regulations for storing and SHPA Budget
inadequately cooked. The findings of a heating garbage for feeding are subject to The commenters stated a concern that
2001 APHIS survey, which showed a license suspension or revocation. budget cuts to APHIS–VS and State
substantial reduction in waste-feeding animal health officials have negatively
Unlicensed Garbage Feeders affected the ability to effectively carry
operations, further indicated that the
risk of FMD exposure via feeding of The commenters presented data from out the regulatory activities supporting
contaminated waste to swine was APHIS–VS reports to the U.S. Animal the SHPA. They also expressed concern
continuing to decline. Health Association’s Transmissible that the reduction in such activities has
Treatment of food waste to be fed to Diseases of Swine Committee indicating reduced the number of inspection and
swine is covered under the Swine that, from 2009 to 2013, the number of searches for unlicensed garbage-feeding
Health Protection Act 6 (SHPA) non-licensed garbage feeders found by operations to a level that is lower than
mstockstill on DSK4VPTVN1PROD with NOTICES

regulations in 9 CFR part 166 and State and Federal animal health what was indicated in the 1995 risk
supported by APHIS’ Veterinary Service authorities in searches for non-licensed analysis.
(VS) Swine Health Program (SHP). feeders was 104, 142, 68, 125, and 160, Budget cuts to APHIS have
Under the regulations, waste feeder respectively. The commenters asked if necessitated a reordering of priorities in
operations must be licensed and APHIS has any supporting information relation to SHPA-related activities. We
regularly inspected by APHIS on estimates of the number of have deemphasized or passed on to
unlicensed garbage-feeding facilities. State partners or other cooperators
67 U.S.C. 3801. Citing the disease risk posed by lower-yield activities, such as visiting

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Document Created: 2015-12-14 15:32:40
Document Modified: 2015-12-14 15:32:40

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Effective November 23, 2015.
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; [email protected]
FR Citation		80 FR 64387

80 FR 64387 - Notice of Determination of the Classical Swine Fever, Foot-and-Mouth Disease, Rinderpest, and Swine Vesicular Disease Status of Croatia

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 80, Issue 205 (October 23, 2015)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service