[Federal Register Volume 82, Number 153 (Thursday, August 10, 2017)]
[Notices]
[Pages 37418-37421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16832]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2015-0102]
Notice of Determination of the Classical Swine Fever, Swine
Vesicular Disease, African Swine Fever, Foot-and-Mouth Disease, and
Rinderpest Status of Malta
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are adding the Republic of Malta to the lists of regions
considered to be free of swine vesicular disease (SVD), African swine
fever (ASF), foot-and-mouth disease (FMD), and rinderpest, and to the
list of regions considered free or low risk for classical swine fever
(CSF), subject to conditions in the regulations governing the
importation of certain animals and animal products into the United
States. Based on our evaluation of the animal health status of Malta,
which we made available to the public for review and comment through a
previous notice, the Administrator has determined that Malta is free of
SVD, ASF, FMD, and rinderpest, and is low risk for CSF. This action
establishes the disease status of Malta with regard to SVD, ASF, FMD,
rinderpest, and CSF while continuing to protect the United States from
introduction of those diseases.
DATES: This change in disease status will be recognized on September
11, 2017.
FOR FURTHER INFORMATION CONTACT: Dr. Chip Wells, Senior Staff
Veterinarian, Regionalization Evaluation Services,
[[Page 37419]]
National Import Export Services, VS, APHIS, USDA, 4700 River Road Unit
38, Riverdale, MD 20737-1231; [email protected]; (301) 851-
3317.
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, African swine fever (ASF), 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.
The regulations in 9 CFR 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 information submitted in support of the request,
the Animal and Plant Health Inspection Service (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 May 13, 2016, we published in
the Federal Register (81 FR 29834-29836, Docket No. APHIS-2015-0102) a
notice \1\ announcing the availability for review and comment of our
risk evaluation of the FMD, rinderpest, ASF, CSF, and SVD status of the
Republic of Malta. Based on this evaluation, we determined that the
animal disease surveillance, prevention, and control measures
implemented by Malta are sufficient to minimize the likelihood of
introducing FMD, rinderpest, ASF, CSF, 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 the comment we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0102.
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We also determined in our evaluation that Malta 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 of Sec. 94.13 for import conditions for pork or pork products from
SVD-free regions, are applicable to Malta. With respect to rinderpest,
the global distribution of the disease has diminished significantly. 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 July 12, 2016, and received one comment by that date. The
commenter, representing a national pork industry association, expressed
concern over the risk of allowing imports into the United States of
live swine, pork and pork products from Malta. The commenter stated
that any incursion of FMD, CSF, ASF, or SVD into the United States
resulting from such imports would precipitate an immediate and costly
loss of export markets for these commodities. The comment is discussed
below.
Disease Surveillance
The commenter disagreed with our determination that passive disease
surveillance conducted by the veterinary authority of Malta is
sufficient to mitigate the risk to the United States from importations
of swine, pork, and pork products.
The commenter noted that in the risk analysis, we cited Malta's
``lack of capacity or intention for developing exports'' to support our
conclusion that passive disease surveillance would be sufficient to
detect any cases of CSF, SVD, ASF, FMD, or rinderpest. In challenging
our conclusion, the commenter cited two articles. One article noted
Malta's efforts to improve the health and management of its pigs in
order to compete with European Union (EU) pork production standards,
and reported that surplus swine are exported from Malta to Sicily for
finishing and producing Parma ham.\2\ The other article stated that
Malta was engaged in discussions with other EU Member States about
exporting pork.\3\ The commenter asked if the information contained in
these articles is significant enough for APHIS to reconsider its risk
evaluation and require Malta to undertake active disease surveillance
of its swine before recognizing Malta as being free of SVD, ASF, and
FMD and adding Malta to the APHIS-defined European CSF region.
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\2\ ACMC Ltd., April 18, 2011.
\3\ Malta Independent, March 19, 2014: http://www.independent.com.mt/articles/2014-03-19/news/plans-to-export-pork-put-on-the-back-burner-4309385218/.
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We acknowledge the commenter's concerns but do not consider the
information presented in the articles to be sufficient to reconsider
the findings of our risk evaluation. APHIS considers both active and
passive surveillance activities when evaluating the animal health
system of a region.\4\ In the case of Malta, APHIS noted its long
history of disease freedom (over 33 years) based on the results of both
periodic active (most recently in 2007 and 2010) and passive
surveillance; its geographic isolation and lack of land borders;
movement controls based on EU Member State standards; requirements for
farmers and private veterinarians to file notice of any suspected cases
of diseases of concern; frequent farm visits by official veterinarians
(about every 2 weeks); as well as its small livestock population and
limited capacity to enlarge the scope or size of its animal and animal
product export market. These factors lead APHIS to conclude that the
constraints upon enlargement of the Maltese swine industry have not
changed, and that a primarily passive surveillance program will be
sufficient to detect incursions of these diseases early enough to avoid
introduction into the United States.
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\4\ APHIS did cite in its risk assessment that it concludes that
Malta might benefit from an active CSF surveillance program in order
to limit any spread of disease within the island's swine population,
but noted that this benefit might be limited if Malta's emergency
response would be to completely depopulate its swine herd.
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The commenter also expressed concern about diseases of swine in
Malta that present symptoms similar to those caused by FMD, CSF, ASF,
and SVD. The commenter noted that Malta vaccinates swine for Circo
Virus, Pig Wasting Disease, Atrophic Rhinitis, Enzootic Pneumonia, and
Porcine Reproductive and Respiratory Syndrome, and that these diseases
are therefore likely to be present in Malta's pig populations. For this
reason, the commenter stated that FMD, SVD, CSF, and ASF should be
considered as differential diagnoses whenever case-compatible lesions
and other signs of disease are observed and reported in pigs. The
commenter further noted that, since 2002, the Veterinary Regulation
Directorate of Malta has reported no suspicious cases with such case-
compatible signs. The commenter concluded that the lack of such reports
suggests that passive surveillance may not be adequate for early
disease detection, as producers and veterinarians in Malta are likely
seeing case-compatible lesions and other signs
[[Page 37420]]
of disease but are not reporting them. The commenter asked APHIS if
this lack of reporting warrants requiring an active surveillance
program to detect FMD, SVD, rinderpest, CSF, and ASF in Malta before
APHIS recognizes Malta as free of these diseases and adds it to the
APHIS-defined European CSF region.
We acknowledge that an active surveillance program provides some
benefits for early detection of these diseases but have determined that
passive surveillance is sufficient to ensure early disease detection in
Maltese swine, particularly in combination with other factors. For
instance, Maltese regulations prohibit the movement of swine that are
not considered healthy regardless of whether any specific disease has
been diagnosed. Furthermore, APHIS concludes that Malta has the
capacity to handle initial serology screening and has a plan to obtain
confirmatory testing at EU community laboratories for diseases under
evaluation.
APHIS does agree with the commenter that FMD, SVD, CSF, and ASF
should be considered during passive surveillance program investigations
of cases where case-compatible lesions or other signs are present. We
also agree that a review of more frequent suspicious case
investigations would increase confidence in the quality of Malta's
passive surveillance program. However, we found no indications of
failure through passive surveillance to detect FMD, SVD, CSF, and ASF.
The commenter also raised questions about our statement in the risk
analysis that we ``consider the conditions in Malta to be equivalent to
the conditions of other EU Member States for which APHIS imposes
additional special restrictions on the importation of susceptible
animals and their products.'' The commenter cited a version of the OIE
Terrestrial Animal Health Code,\5\ which states that for domestic pigs,
appropriate surveillance, capable of detecting the presence of
infection even in the absence of clinical signs, is required for
determining CSF status. The commenter suggested that APHIS' decision
not to require an active surveillance program in recognizing Malta's
CSF status is inconsistent with surveillance requirements for other
countries in the APHIS-defined European CSF region. Based on this
information, the commenter asked APHIS to consider requiring Malta to
implement active surveillance to detect FMD, SVD, CSF, and ASF as a
condition of recognizing its disease status.
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\5\ Chapter 15.2, Article 15.2.2, ``General criteria for the
determination of the CSF status of a country, zone or compartment.''
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We disagree with the commenter's point that APHIS' disease
surveillance requirements for Malta are inconsistent with those
required of other EU Member States. The commenter has cited
surveillance requirements from an outdated version of the OIE
Terrestrial Animal Health Code. Chapter 15.2.2 of the current version
\6\ of the OIE manual recommends appropriate surveillance in accordance
with Article 15.2.26, which states that ``surveillance strategies
employed for demonstrating freedom from CSF at an acceptable level of
confidence should be adapted to the local situation.'' We have
determined that the local conditions in Malta are equivalent to those
of EU Member States where APHIS imposes additional special restrictions
on the importation of susceptible livestock. The application of the
requirements of Sec. 94.11 for FMD and rinderpest, Sec. 94.13 for
SVD, and Sec. Sec. 94.31 and 98.38 for CSF will mitigate risk for
these diseases in Malta at a level consistent with that of other EU
Member States authorized to export swine, pork, and pork products to
the United States.
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\6\ OIE Terrestrial Animal Health Code, 25th Edition, 2016:
http://www.oie.int/index.php?id=169&L=0&htmfile=chapitre_csf.htm.
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APHIS evaluated multiple factors regarding Malta's animal health
system and determined that the country's reliance primarily on passive
surveillance is adequate for Malta to detect incursions of CSF. For
this reason, we determined that the likelihood is low of CSF being
introduced into the United States through movement of infected animals
or contaminated animal products from Malta. We consider our evaluation
of Malta to be consistent with the current OIE recommendation to
determine that an acceptable level of confidence be adapted to the
local situation.
Waste Feeding
The commenter also raised concerns about the risk of disease
transmission from the practice of feeding garbage and other waste to
swine raised for export. The commenter noted that in the risk
evaluation, APHIS stated that ``waste feeding, specifically, feeding
FMD-contaminated meat products to swine, is regarded as the most likely
pathway for exposure of susceptible livestock to imported contaminated
meat products.'' The commenter added that APHIS affirmed this
determination again in a 2001 pathways assessment.\7\ The commenter
asked what level of confidence does APHIS have that the assessments
adequately reflect the current risk to the U.S. pork industry, and
suggested that the 1995 work be repeated using more current data. The
commenter also asked whether APHIS is confident that swine diseases
will be detected in licensed and unlicensed garbage-feeding operations
and what the estimated time is for detection in each of these
operations.
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\7\ USDA-APHIS-VS, Pathway assessment of foot-and-mouth disease
(FMD) risk to the United States: An evaluation in response to
international FMD outbreaks in 2001. United States Department of
Agriculture, Animal and Plant Health Inspection Service, Veterinary
Services, Centers for Epidemiology and Animal Health. 2001. A copy
of the document can be obtained by contacting the person listed
under FOR FURTHER INFORMATION CONTACT.
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We remain confident that the risk evaluations cited by the
commenter provide an accurate account of risks to the current U.S. pork
industry. If contaminated meat products were imported from Malta and
managed to make it into plate waste, U.S. garbage feeding regulations
are sufficient to mitigate that risk. Treatment of food waste fed to
swine is covered under the Swine Health Protection Act \8\ (SHPA)
regulations in 9 CFR part 166 and supported by APHIS' Veterinary
Service (VS) Swine Health Program. 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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\8\ 7 U.S.C. 3801.
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In the 1995 study cited by the commenter, 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. Furthermore,
the findings of the 2001 APHIS survey the commenter cited, which showed
a substantial reduction in waste-feeding operations, indicated that the
risk of FMD exposure via feeding of contaminated waste to swine was
continuing to decline.
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
[[Page 37421]]
exposure of domestic swine to CSF, FMD, SVD, and rinderpest from food
waste originating from Malta.
Environmental Assessment
The commenter noted that in the supporting documents provided for
this notice, the environmental assessment (EA) we used to support this
notice was a May 2011 EA for the importation of swine and swine
commodities from Slovakia. The commenter also noted that we used an
amended finding of no significant impact (FONSI) from importation of
swine and swine commodities from Slovakia as the basis for the amended
finding related to Malta. The commenter asked us to explain how it is
justifiable to use an EA conducted for another country to amend the
finding to Malta.
Since 2006, we have recognized the CSF, FMD, SVD, and rinderpest
status for EU Member States Latvia, Lithuania, Poland, the Czech
Republic, Slovakia, Slovenia, Estonia, and Hungary.
Given that the EU applies and ensures enforcement of the same
disease mitigation requirements across all of its Member States, we
recognized that the single-state EAs we were conducting were redundant
and thus unnecessary with respect to meeting the requirements of the
National Environmental Policy Act (NEPA). After consulting with Agency
specialists on NEPA compliance, we conducted an environmental impact
analysis comparison of the Slovakia EA and similar proposed actions for
other EU Member States. We determined that the environmental analysis
of the Slovakia EA is sufficiently similar to cover the proposed action
for Malta. The 2011 Slovakia EA stated that for any like or 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 action regarding Malta.
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 Malta is an EU Member State
and because we have determined that Malta is free of SVD, FMD, and
rinderpest, and at low risk for CSF, we conclude that the ``like or
similar action'' environmental analyses approach as presented in the
2011 Slovakia EA and FONSI is appropriate to use with respect to Malta.
Based on the evaluation and the reasons given in this document in
response to comments, we are recognizing Malta as free of FMD,
rinderpest, ASF, and SVD, and low risk for CSF. The lists of regions
free of or at low risk of these diseases or where these diseases
currently exist are available on the APHIS Web site at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/ct_animal_disease_status or by contacting
the person listed under FOR FURTHER INFORMATION CONTACT.
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 4th day of August 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-16832 Filed 8-9-17; 8:45 am]
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