[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

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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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