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[Federal Register Volume 79, Number 168 (Friday, August 29, 2014)]
[Notices]
[Pages 51528-51535]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20646]

[[Page 51528]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0105]

Notice of Determination of the Foot-and-Mouth Disease and 
Rinderpest Status of a Region of Patagonia, Argentina

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are adding a region of Argentina, consisting of the areas 
of Patagonia South and Patagonia North B, to the lists of regions that 
are considered free of rinderpest and foot-and-mouth disease (FMD). We 
are taking this action because we have determined that this region is 
free of rinderpest and FMD. We are also adding the Patagonia Region to 
the list of regions that are subject to certain import restrictions on 
meat and meat products because of their proximity to or trading 
relationships with rinderpest- or FMD-affected countries. These actions 
update the disease status of the Patagonia Region with regard to 
rinderpest and foot-and-mouth disease while continuing to protect the 
United States from an introduction of those diseases by providing 
additional requirements for any meat and meat products imported into 
the United States from the Patagonia Region of Argentina.

DATES: Effective Date: October 28, 2014.

FOR FURTHER INFORMATION CONTACT: Dr. Silvia Kreindel, Senior Staff 
Veterinarian, Regionalization Evaluation Services, National Import 
Export Services, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 
20737-1231; (301) 851-3300.

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 rinderpest and foot-and-mouth disease (FMD). 
The regulations prohibit or restrict the importation of live ruminants 
and swine, and products from these animals, from regions where 
rinderpest or FMD is 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)(2) of that section as free of rinderpest and FMD.
    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)(3) of that section.
    The regulations in 9 CFR part 92, Sec.  92.2, contain requirements 
for requesting the recognition of the animal health status of a 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 notice published in 
the Federal Register. At the close of the comment period, APHIS will 
review all comments received and will make a final determination 
regarding the request that will be detailed in another notice published 
in the Federal Register.
    In accordance with that process, on January 23, 2014, we published 
in the Federal Register (79 FR 3775-3777, Docket No. APHIS-2013-0105) a 
notice of availability \1\ in which we announced the availability for 
review and comment of our evaluation of the FMD status of the areas of 
Patagonia South and Patagonia North B, referred to below as the 
Patagonia Region of Argentina. Based on this evaluation, we determined 
that that the animal disease surveillance, prevention, and control 
measures implemented by Argentina in the Patagonia Region are 
sufficient to minimize the likelihood of introducing FMD into the 
United States via imports of FMD-susceptible species or products.
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    \1\ To view the notice of availability, the assessments, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0105.
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    However, because of the Patagonia Region's proximity to and trading 
relationships with FMD-affected regions, we found that it is necessary 
to impose certain restrictions in accordance with Sec.  94.11 on the 
importation of meat of any ruminants or swine from the Patagonia 
Region.
    In the same notice we also made available an evaluation assessing 
the rinderpest status of South America for public review and comment. 
Rinderpest has never been established in South America. No South 
American country has ever reported the disease except Brazil, which had 
an outbreak in 1921 that was limited in scope and quickly eradicated. 
Furthermore, the global distribution of rinderpest 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 March 24, 2014, and extended the comment period for an 
additional 30 days, ending April 23, 2014. We received 33 comments by 
that date, from State and national livestock associations and from 
private citizens. The commenters raised a number of issues about our 
proposed action. The comments are discussed below.
    Five commenters specifically addressed our proposal to recognize 
South America as free of rinderpest. All of those commenters expressed 
support for that determination.
    Many commenters raised concerns about the risk analysis for FMD. 
These concerns included concerns about the methodology, scope, hazard 
identification, release assessment, exposure assessment, risk 
estimation, and discussion of geographical details.
    Several commenters stated that the specific methodology and 
measurements used during the site visits to support the qualitative 
risk analysis are not available for review. One commenter expressed 
concern that such documentation was not collected or recorded. That 
commenter also stated that APHIS should develop a protocol to be used 
for site visits so that reviewers' assessments can be analyzed and 
summarized more objectively, and then made available with APHIS' 
conclusions of the risk analysis.
    The purpose of the site visit is to verify and complement the 
information previously provided by the country. APHIS site visits 
consist of an in-depth evaluation of the risk factors identified by 
APHIS in Sec.  92.2 as factors to consider in assessing the risk of the 
relevant animal disease posed by a region.\2\ The

[[Page 51529]]

animal disease risks are identified in the risk analysis from the 
information gathered on these factors during the site visits and APHIS' 
document review, and whenever mitigations are considered necessary, 
such mitigations are discussed in the risk analysis.
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    \2\ The risk analysis for the Patagonia Region includes an in-
depth assessment of the 11 factors used by APHIS to evaluate the 
animal health status of a region prior to 2012. In 2012, APHIS 
consolidated the 11 factors listed in Sec.  92.2(b) into 8 factors. 
APHIS introduced this simplification in order to facilitate the 
application process; however, since the evaluation of the Patagonia 
Region started before 2012, and the topics addressed by the 11 
factors are encapsulated in the 8, this analysis follows the 11 
factor format.
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    APHIS has also published guidance on our approach to implementing 
our regionalization process and the way in which we apply risk analysis 
to the decision-making process for regionalization. This document can 
be found on the APHIS Web site at http://www.aphis.usda.gov/
importexport/animals/downloads/
regionalizationprocess.pdf.
    Site visit findings are thoroughly described throughout the risk 
analysis, including visits to local offices (pages 21-22), airports 
(pages 33-34), border controls (pages 37-38), farms (page 43), and 
laboratories (pages 60-64).
    One commenter stated that APHIS should regard the eight factors as 
more than a simple checklist for reviewers and that consistent 
implementation of the factors should be completely verified.
    APHIS agrees with the commenter. When conducting a site visit, 
APHIS verifies that all the factors related to the FMD control and 
eradication program, including prevention, controls, surveillance, and 
reporting, are in place and that the country has strong veterinary 
authority and infrastructure to carry out the FMD program.
    Some commenters stated that according to the risk analysis, APHIS 
only conducted three site visits to the Patagonia Region. The 
commenters stated that APHIS should maintain a more active and robust 
presence in the region.
    APHIS believes that its site visits to the Patagonia Region, in 
conjunction with the other documentation and information APHIS has 
reviewed, provided APHIS with sufficient information to correctly 
determine the region's FMD status. As a member of the OIE, Argentina 
must immediately notify the OIE of any suspect cases of FMD that may 
occur in the future. In addition, under Sec.  92.2, a region that is 
granted a specific animal health status may be required to submit 
additional information pertaining to that animal health status, or to 
allow APHIS to conduct additional information collection activities in 
order to maintain its animal health status.
    One commenter stated that the hazard identification appears to be 
lacking information, and that APHIS seems to consider that FMD is the 
only hazard of concern. The commenter also stated that the risk 
analysis does not provide detailed information about the different 
serotypes of the FMD virus, does not discuss the efficacy of the FMD 
vaccination programs in regions surrounding Patagonia, and does not 
mention virus survival in commodities of concern, such as sheep and 
lamb embryos and semen. The commenter stated further that the risk 
analysis does not provide any details regarding the onset of clinical 
signs for the different species or focus on subclinical disease or the 
species, such as sheep, that may display mild clinical signs that can 
go unnoticed and undetected.
    APHIS notes that Argentina requested FMD status recognition; 
therefore the risk analysis focuses on the FMD status of the region and 
not on other hazards. Appendix I of the risk analysis describes the 
different serotypes of the FMD virus. In the risk analysis APHIS also 
describes the disease status of adjacent regions, including the FMD 
outbreaks that occurred in 2003 and 2006, and the eradication and 
control programs in adjacent regions.
    The vaccination rates in the adjacent region of Northern Argentina 
reached over 99 percent between 2008 and 2012. In addition, the region 
of Northern Argentina has several overlapping controls to ensure 
compliance with vaccination calendars through matching vaccination 
records to movement permits and census data and through field 
inspections. We have updated the risk analysis to add the following to 
the discussion of the disease status of adjacent regions: ``Vaccination 
of cattle is mandatory in the area north of the 42nd parallel with the 
exception of Patagonia North B (the area adjacent to Patagonia South, a 
region without vaccination) and recently, Patagonia North A and the 
summer pastures (zona veranadas) of Calingasta Valleys in the province 
of San Juan. The Servicio Nacional de Sanidad y Calidad Agroalimentaria 
(SENASA) is the Government of Argentina's enforcement authority and 
regulating body for planning, implementing, and controlling actions to 
eradicate FMD. SENASA establishes the technical requirements for the 
vaccination program. Vaccination can only be performed by authorized 
personnel who are trained, registered, and accredited/audited by 
SENASA. Vaccination coverage rates have been over 97 percent in the 
region above the 42nd parallel (with the exception of Patagonia North 
B, and most recently Patagonia North A, in which vaccination is not 
conducted) since 2001.''
    On page 71 of the risk analysis, we described embryos as presenting 
a negligible risk of infecting an exposed recipient with the FMD virus, 
as the zona pellucida is an important barrier against pathogens, and 
only embryos with an intact zona pellucida may be imported into the 
United States under the provisions of Sec.  98.3(h). On page 72 of the 
document we described semen as presenting a likelihood of exposure of 
susceptible animals to this virus if the semen is collected from an 
infected animal. However, based on the conclusion of the release 
assessment that diseased animals are not likely to exist in the 
Patagonia Region or, if they do, are not likely to go undetected, APHIS 
considers it unlikely that U.S. animals would be exposed to infected 
semen from the Patagonia Region.
    APHIS looked at clinical disease in all the relevant species, 
including those, like swine, that are not expected to be exported from 
the Patagonia Region. Clinical disease in sheep is discussed in 
Appendix I. APHIS has updated the risk assessment to add the following 
to the Appendix: ``The incubation period in sheep is similar to that 
observed in bovines, and has been reported to be 1 to 12 days, with 
most cases appearing in 2-8 days.'' We understand that subclinical 
disease or species-specific symptoms may result in unnoticed and 
undetected viral infection. However, because no vaccination is carried 
out in the Patagonia Region, any cattle or swine in that region exposed 
to the FMD virus would act as good sentinels of an outbreak.
    One commenter stated that the release (entry) assessment focuses on 
the factors in Sec.  92.2 rather than providing a description of all 
the biological pathways necessary for an importation activity to 
introduce the disease into the United States. The commenter stated that 
this section could be strengthened by a detailed chronological list of 
FMD outbreak information for the Patagonia Region and the bordering 
regions to include the year of the outbreak, epidemiological disease 
spread information, risk factors, maps, and the controls implemented 
during the outbreak.
    When preparing a risk analysis, APHIS evaluates the relevant 
pathways as described by the scientific literature and supported by the 
OIE. Therefore, on page 70 of the risk analysis, APHIS has described 
the biological pathway that it

[[Page 51530]]

believes is most likely to result in the release of FMD into the United 
States, which is exposure through the importation of FMD-infected sheep 
meat. APHIS also discusses the history of FMD outbreaks in the 
Patagonia Region and neighboring regions in sections 2 and 3 of the 
entry assessment. APHIS does not believe a description of all the 
biological pathways that could possibly introduce FMD into the United 
States is necessary or helpful in determining the likelihood of release 
because not all pathways will lead to the introduction of active virus 
through the importation of susceptible commodities.
    In conducting an animal disease status evaluation in a foreign 
region, APHIS focuses on the likelihood that the region is free of the 
hazard(s) by evaluating, for example, the official veterinary capacity 
and authority, surveillance systems, and import controls, in place in 
the exporting country. APHIS believes that an analysis of these factors 
provides a robust analysis of the likelihood of release of FMD into the 
United States. Given that there is a very low likelihood that FMD is 
present in the Patagonia Region or would be introduced into Argentina 
without detection, the corresponding entry likelihood into the United 
States is considered also to be very low.
    One commenter stated that the exposure assessment does not discuss 
the potential transmission of FMD within and from quarantine 
facilities.
    We are confident that the exposure assessment appropriately 
describes the biological pathways necessary for exposure of animals and 
humans in the United States to FMD, and that APHIS' regulatory 
safeguards will provide effective protection against the risks 
associated with the importation of ruminants or their products from the 
Patagonia Region of Argentina. These safeguards include subjecting 
animals and animal products from the region to certain restrictions 
because of the region's proximity to FMD-affected countries (Sec.  
94.11); certification that ruminants and swine have been kept in a 
region entirely free of FMD and rinderpest (for ruminants) for 60 days 
prior to export (Sec. Sec.  93.405 and 93.505); and a minimum 
quarantine of 30 days from the date of arrival at the port of entry for 
most imported ruminants (Sec.  93.411), and 15 days for all imported 
swine (Sec.  93.510).
    One commenter stated that sufficient data is lacking for the 
plausible risk exposure pathways mentioned in the exposure assessment.
    In the risk analysis, the exposure pathways are defined for the 
importation of sheep meat, genetic materials, and susceptible live 
ruminants. We anticipate that these are the commodities that will be 
exported to the United States based on the information provided in 
Argentina's application, our knowledge of the livestock industry in the 
Patagonia Region, and what commodities are exported from the Patagonia 
Region now.
    One commenter stated that there is a disparity in the risk levels 
for embryos in the exposure assessment with the documentation as 
negligible on page 71 and low on page 72.
    The risk of transmission of FMD via embryos is negligible. APHIS 
will correct the wording on page 72.
    The commenters stated that the risk analysis does not include 
sufficient detail for geographical landmarks outlining the Patagonia 
Region or maps with the necessary level of detail to be useful.
    APHIS disagrees. The geographic landmarks outlining the Patagonia 
Region are described on page 27 of the risk analysis. This description 
also includes a discussion of the area and climate. Figure 1 is a map 
of Argentina showing different provinces (including oceans and 
neighboring countries) and Figure 2 shows the regionalization status as 
defined by the OIE after Patagonia North B was recognized as free 
without vaccination in May 2007.
    One commenter stated that the risk analysis review and general 
assessment process do not seem to be completely transparent and are not 
documented satisfactorily for thorough outside analysis, but did not 
identify specific aspects of the process that seemed opaque.
    APHIS is confident that the review and assessment process is 
appropriately explained and documented in the risk analysis document.
    Several commenters stated that APHIS should prepare a quantitative 
risk analysis and make it available for public review. Some commenters 
stated that the qualitative format for the risk analysis is subjective 
and fails to objectively quantify the probability of risk and 
adequately assess the magnitude of the consequences. One commenter 
noted that APHIS prepared a quantitative risk analysis in 2002 for 
importation of beef from Uruguay and asked why APHIS chose to prepare a 
qualitative risk analysis for the Patagonia Region.
    APHIS believes that a qualitative analysis is appropriate in this 
situation. APHIS' evaluations are based on science and conducted 
according to the factors identified in Sec.  92.2, which include 
biosecurity measures, livestock demographics, and marketing practices. 
As explained in the risk analysis, we conducted an in-depth evaluation 
of the 11 factors used by APHIS to evaluate the animal health status of 
a region prior to 2012. The factors include: (1) The authority, 
organization, and infrastructure of the veterinary services 
organization in the region; (2) Disease status; (3) The status of 
adjacent regions with respect to the agent; (4) The extent of an active 
disease control program, if any, if the agent is known to exist in the 
region; (5) The vaccination status of the region; (6) The degree to 
which the region is separated from adjacent regions of higher risk 
through physical or other barriers; (7) The extent to which movement of 
animals and animal products is controlled from regions of higher risk, 
and the level of biosecurity regarding such movements; (8) Livestock 
demographics and marketing practices in the region; (9) The type and 
extent of disease surveillance in the region; (10) Diagnostic 
laboratory capacity; and (11) Policies and infrastructure for animal 
disease control in the region. Neither the regulations in 9 CFR part 92 
nor APHIS guidance documents require a quantitative risk analysis or 
indicate that one is needed here.
    Most of APHIS' risk analyses have been, and continue to be, 
qualitative in nature. Over time, APHIS has come to use qualitative 
risk assessments given the limitations of quantitative models, although 
APHIS recognizes that quantitative risk analysis models can be useful 
in cases where the risk management questions or information cannot be 
addressed with a qualitative model. When coupled with site visit 
evaluations, APHIS believes that qualitative risk analyses provide the 
necessary information to assess risk of disease introduction through 
importation. Additionally, quantitative modes are resource-intensive 
and take a much longer time to complete. Quantitative models also tend 
to be data-intensive, and the types of data needs required by such 
models are often not available or adequate under most circumstances. At 
the same time that quantitative models are data-intensive, they are 
also necessarily developed using a set of assumptions that may not 
always adequately represent the biological situation in question, thus 
resulting in a wide range of uncertainty in interpretation of the model 
outcomes. Quantitative models also require constant updating, which is 
dependent on availability of current research and data, and thus these 
models may not

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always represent the current state of scientific information. Finally, 
uncertainty in the results or outcomes of quantitative models also 
arises from a large number of sources, including problem specification, 
conceptual or computational model construction and model 
misspecification, estimation of input values, and other model 
misspecification issues.
    One commenter asked what types of training programs are given to 
SENASA personnel stationed at the border checkpoints and patrolling in 
the areas along the border.
    The training of SENASA border personnel is described on page 30 of 
the risk analysis. The border personnel are trained on a number of 
topics, including legal framework, national and international 
zoosanitary status, epidemiological characterization of the region, and 
import and export procedures.
    Two commenters expressed concern that Argentina's border control 
and security between the Patagonia Region and neighboring regions have 
not been adequately verified.
    Border control and security in the Patagonia Region are discussed 
on pages 27 through 37 of the risk analysis. APHIS looked at these 
issues during all of its site visits. Based on those visits and other 
documents and information that APHIS has obtained and made available 
with the risk analysis, APHIS is confident that Argentina's border 
controls with respect to the Patagonia Region are sufficient to prevent 
the introduction of FMD into the region.
    One commenter stated that in addition to assessing the risk of 
disease directly from animals and animal products from the Patagonia 
Region, it is also important to measure and address risk due to 
potential economic incentives to trans-ship animals and animal 
products. Two additional commenters expressed concern that because 
Argentina consumes a large portion of the meat that is produced in the 
country, and because there is transit between regions for access and 
delivery of beef and meat products, there is a greater risk of 
contamination and infection across regional boundaries.
    As we explained above, APHIS has assessed the border controls and 
security of the Patagonia Region and we are confident that these are 
sufficient to prevent the introduction of FMD into the region. We also 
note that Argentina has effective and appropriate requirements for the 
importation of susceptible commodities into the Patagonia Region. These 
are discussed on page 69 of the risk analysis.
    One commenter asked what disinfection methods are used against the 
FMD virus at the border points.
    As explained on page 38 of the risk analysis, disinfection methods 
include spraying vehicles with disinfectants that are effective against 
the FMD virus. Among other effective disinfectants, SENASA uses the 
following: 5.25 percent sodium hypochlorite, 3 percent acetic acid, 4 
percent potassium peroxymonosulfate and 1 percent sodium chloride, and 
4 percent sodium carbonate.
    One commenter stated that SENASA reports that all producers, animal 
caretakers, and transporters were well-versed in recognizing clinical 
signs of FMD in livestock. The commenter asked how these individuals 
were trained to recognize clinical and subclinical signs of FMD, and if 
there is any accreditation or certification process for their training. 
The commenter also asked if there was any verification process for 
their reported FMD recognition skills.
    APHIS notes that ``subclinical disease'' means that there are no 
observable clinical signs of the disease. The training requirements for 
official and non-official veterinarians are described on page 19 of the 
risk analysis, and the training requirements for SENASA personnel are 
described on page 20. In all cases the training is in line with the 
main strategies in Argentina's FMD National Eradication Plan. In 
addition, different components of FMD outreach and awareness programs 
(e.g., radio advertisement, presentations to industry, etc.) remind 
producers of vaccination campaigns, clinical signs compatible with the 
disease, and compulsory reporting of suspect cases.
    With respect to verification of disease recognition skills, SENASA 
has a training and promotion program, which includes the performance of 
drills. The training is carried out by the Bureau of Epidemiology. In 
addition, the Field General Coordination holds meetings to provide 
updates on the information, methodology, and standards that the local 
veterinarians should know. Training records are maintained by the 
Bureau of Human Resources and Training in which official agents get 
credits for the various classes they attend. The credits are added up 
in a score that is used towards promotions in the organization. The 
Bureau of Human Resources and Training coordinates the training 
activities of each of the National Bureaus through training 
consultants. In the case of the National Bureau of Animal Health, two 
professionals work as consultants who lead the 22 training delegates of 
the provinces who coordinate, audit, and guide the process of teaching 
official veterinarians. This training program is described in the risk 
analysis on page 67.
    Three commenters stated that over half the sheep in Argentina 
reside in the Patagonia Region. The sheep are generally raised in 
extensive management systems and since FMD clinical signs are 
relatively subtle in sheep, it is important that data be collected for 
public review on which specific diagnostic practices and risk 
mitigation measures are used at border crossings to prevent FMD from 
entering Patagonia. One commenter asked specifically how APHIS will 
ensure that there are enhanced surveillance systems in place that will 
preclude the virus circulating in the sheep population undetected.
    The commenters are correct that sheep are the predominant livestock 
species in the Patagonia Region. Almost 60 percent of the sheep in 
Argentina reside in Patagonia. The livestock density is less than one 
animal per hectare. Due to extensive husbandry practices and low animal 
density, contact between sheep and other species and with other sheep 
is minimized, reducing the risk of disease spread in the event that the 
FMD virus was introduced into the region. As we explained above, no 
vaccination is carried out in the Patagonia Region, so any cattle or 
swine in that region exposed to the FMD virus would act as good 
sentinels of an outbreak.
    Border control and security in the Patagonia Region are discussed 
on pages 27 through 37 of the risk analysis. SENASA conducts 
serological surveillance (testing blood serum for viral activity) of 
sheep and cattle. This is an effective indicator of the FMD situation 
because the FMD susceptible species are not vaccinated against FMD. 
Furthermore, for sheep, premises identification is required, either by 
eartag, which includes the CUIG (Clave Unica de Identification 
Ganadera--Unique Holding Identification Code) number of the farm, or 
ear notch. The eartag color and shape may be selected by the farmer 
(the color is not specific to the FMD status of the region as in 
cattle). Ear notches are controlled by and registered with SENASA to 
ensure that they are unique. SENASA requires all premises with 
agricultural animal production to register with SENASA and obtain a 
RENSPA (Registro Nacional Sanitario de Productores Agropecuarios--
National Sanitary Registry of Ag-Producers) number, an alphanumeric 
identifier that encodes information about individual premises.

[[Page 51532]]

The RENSPA number is structured to identify the province, municipality, 
premises, and various details of the particular premises, such as 
ownership, rental status, or shared occupancy. In association with the 
RENSPA number, census information on all species on the premises and 
permit information showing animal movements are included in a database 
maintained by field officials. This information allows animals from an 
individual premise to be traced effectively, and we are confident that 
SENASA would be able to respond quickly in the event of positive or 
false positive results from serological testing.
    Many commenters stated that Argentina has shown a trend of 
decreasing compliance in audits conducted by the U.S. Department of 
Agriculture's Food Safety and Inspection Service (FSIS) between 2005 
and 2009. One of the commenters stated that Argentina's history of 
compliance issues could influence their ability to consistently and 
successfully enforce control measures within the Patagonia Region in 
order to successfully mitigate the risk from the possible entry of FMD 
into this region from the surrounding higher-risk areas. One commenter 
asked if APHIS consulted with FSIS as part of our evaluation, and if 
so, what was FSIS' feedback.
    The purpose of APHIS' evaluation was to assess the FMD situation in 
the Patagonia Region and to evaluate Argentina's ability to comply with 
the certification requirements for exporting specific FMD-susceptible 
commodities to the United States, including the certification 
requirements in Sec.  94.11 for meat and other animal products imported 
from regions that are considered free of FMD and rinderpest but are 
subject to additional restrictions because of their proximity to or 
trading relationships with regions that are not free of FMD or 
rinderpest. Based on its site visits and other documentation and 
information, APHIS concluded that Argentina's legal framework, animal 
health infrastructure, movement and border controls, diagnostic 
capabilities, surveillance programs, and emergency response capacity 
are sufficient to detect, prevent, control, and eradicate FMD outbreaks 
within the boundaries of the Patagonia Region of Argentina. Moreover, 
with respect to the Patagonia Region, APHIS concluded that the 
Argentine veterinary authority is capable of complying with our 
requirements.
    Nevertheless, based on the comments, APHIS has reviewed the last 
five FSIS audits conducted in Argentina at the slaughter level. The 
FSIS audits concluded that ante-mortem inspection processes, which are 
relevant to the detection of FMD during the slaughter process, were 
conducted satisfactorily.
    One commenter stated that reviews of the European Commission's Food 
and Veterinary Office (EC FVO) audits identified points of concern in 
the areas of border controls, animal identification, vaccination 
controls, and other concerns. The audits evaluated animal health 
controls concerning FMD, related animal health control measures, and 
related certification procedures for fresh bovine and ovine meat 
intended for export to the European Union (EU).
    The overall objective of the EC FVO audits was to assess the animal 
health controls in place in order to verify that guarantees provided by 
the competent authorities of Argentina, concerning the health status of 
the country with regard to FMD, continue to meet the requirements for 
the export of ovine and bovine meat from Argentina to the EU. In 
response to the comments, APHIS reviewed the latest reports. The most 
recent report, from 2012, concluded that the official FMD control 
system in place for Argentina is reliable and meets EU requirements.
    One commenter stated that the 2012 EC FVO audit showed a less than 
satisfactory enforcement of some requirements of the sheep 
identification and movement registration system in the Patagonia 
Region. The commenter also stated that the same audit identified a weak 
official control system along the Bolivian border, which cannot ensure 
the adequate management of risks related to animal movements and 
sufficient verification of satisfactory implementation of vaccination 
campaigns for FMD. The commenter further stated that limited attention 
is being paid to official ``on-the-spot'' controls on FMD vaccination, 
which casts doubt on the adequate fulfillment of the vaccination 
coverage in all areas with an increased risk of FMD.
    As discussed above, the 2012 EC FVO report concluded that Argentina 
meets the requirements set forth by the OIE and the EU for complying 
with both the EU's certification requirements for fresh bovine and 
ovine meat and Articles 8.5.4 and 8.5.5 of the OIE's Terrestrial Animal 
Health Code recognizing an FMD zone where vaccination is not practiced 
and an FMD zone where vaccination is practiced. Furthermore, with 
regard to the commenter's concern that the lack of ``on-the-spot'' 
controls on FMD vaccination would lead to inadequate fulfillment of 
vaccination coverage, as we discussed on page 59 of the risk analysis, 
after the 2012 EC FVO audit, and in collaboration with external animal 
health experts, Argentina revised its surveillance sampling design in 
order to confirm adequate vaccination coverage in its territory. The 
revised sampling design focuses on the effectiveness of various 
vaccination campaign plans as implemented by the local offices. At the 
time of APHIS' November 2013 site visit, over 50 percent of samples had 
already been collected with only two reactors identified. APHIS notes 
that the reactor animals are not suspect for FMD or other diseases; the 
reaction could be related either to immunity as a result of vaccination 
or to the presence of proteins in the vaccine. On completion of the 
study, SENASA expects to be able to compare effectiveness of 
operational implementation of the National Vaccination Plan at the 
local level. Vaccination coverage rates in Northern Argentina have been 
reported at over 97 percent. In reference to the Bolivian border, APHIS 
recognizes that some borders in the northern part of Argentina might be 
porous, and that other mitigations might be required in such areas in 
the event Argentina would request to export a particular commodity into 
the United States. APHIS notes, however, that such borders are located 
over 2,500 miles from the region that is under consideration in this 
notice.
    One commenter stated that the EC FVO audits showed a limited 
contribution of passive surveillance to the detection and notification 
of suspect cases of FMD. The commenter asked if the current system of 
passive surveillance in Argentina is really working, and asked how the 
system of passive surveillance could work effectively if it is not 
actively pursued.
    The reporting of FMD suspect cases is infrequent in the Patagonia 
Region; APHIS believes that this is because FMD is not present in the 
region and other vesicular diseases are rare. As we noted on page 24 of 
the risk analysis, there were no reports of suspect vesicular diseases 
in 2012 or 2013 in the Patagonia Region. To assess the ability of 
veterinary officials at local offices to respond to a suspicious case 
of disease, the site visit team asked to view records of reports of a 
suspected notifiable disease (in this case, mange) during the 2009 site 
visit. The information shared revealed that a visit to the affected 
farm was made within 24 hours of the report, and all animals on the 
farm were inspected, with samples collected and submitted to the 
laboratory on the same day. The farm was immediately quarantined upon 
the report of the suspect case and the quarantine remained in place 
throughout the

[[Page 51533]]

duration of the investigation. At the initial visit, neighboring farms 
were contacted to alert the owners of the disease suspicion, and the 
owners were told to make their animals available for inspection.
    Finally, APHIS notes that the data provided in our risk analysis 
are more up-to-date than those provided by the EC FVO audits. Further 
surveillance efforts from 2001 to 2013 are described on page 57, 
surveillance efforts specifically in Patagonia North A are described on 
page 58, and other ongoing surveillance efforts on page 59. Based on 
those findings APHIS concluded that the design under which serological 
sampling is conducted in Argentina is both valid and efficient and the 
sampling coverage is adequate and that the serological sampling is 
adequate to detect disease and identify and measure viral activity (if 
any) in the area.
    A commenter stated that the EC FVO audits present wildlife issues 
as a concern for the continued management of FMD risk. The commenter 
stated specifically that this issue required investigations to assess 
the risk associated with the presence of pigs and wild boars in the 
areas neighboring Bolivia and Paraguay, and their possible exposure to 
feeding practices that may carry a risk of introduction of the FMD 
virus.
    Although several South American wild animal species are susceptible 
to FMD, research into FMD in South America has determined that wildlife 
populations, including feral swine, do not play a significant role in 
the maintenance and transmission of FMD. During outbreak situations, 
wildlife may become affected by FMD; however, as we discussed on pages 
15-16 of the environmental assessment, the likelihood that they would 
become carriers under field conditions is rare. Therefore, it is 
unlikely that FMD would be introduced into the Patagonia Region through 
movement of infected wildlife. The active surveillance on wild boars 
conducted in 2013 is described on page 58 of the risk analysis. In the 
serological study conducted in swine, a total of 462 samples were 
collected from 76 establishments in Patagonia North A. The wildlife 
surveillance consisted of a total of 21 samples. All porcine samples 
were tested using the LF ELISA test with negative results.
    Furthermore, feeding garbage to animals is prohibited in Argentina 
unless specific products undergo a cooking process guaranteeing 
destruction of pathogenic organisms (pages 21 and 22 of the risk 
analysis). In the event that these laws were circumvented, other 
factors evaluated in the risk analysis, including biosecurity measures 
and response capabilities, would mitigate disease risks.
    Two commenters stated that wildlife may move across traversable 
national boundaries and infect other wildlife and livestock. One of the 
commenters stated that while the environmental assessment seeks to 
address wildlife issues and FMD risk, there have not been enough 
wildlife studies or efforts to document the natural wildlife movements 
in Patagonia or the surrounding regions. The commenter further stated 
that no ideas have been advanced to identify practical mitigation 
measures for wildlife species.
    As we explained earlier, research into FMD in South America has 
determined that wildlife populations, including feral swine, do not 
play a significant role in the maintenance and transmission of FMD. 
During outbreak situations, wildlife may become affected by FMD; 
however, the likelihood that they would become carriers under field 
conditions is rare and it is unlikely that FMD would be introduced into 
the Patagonia Region through movement of infected wildlife.
    One commenter stated that there are clear weaknesses within 
Argentina's standards of surveillance and management practices, 
specifically inadequate import controls and quarantine procedures, that 
could put the U.S. beef supply at risk.
    APHIS disagrees with the commenter. We found no evidence of 
weakness in the import controls or quarantine procedures in the 
Patagonia Region and are confident that they provide effective 
protection against the introduction of FMD to the region.
    One commenter stated that a November 2013 report confirmed that 
Brazil and Argentina were beginning a second round of vaccination for 
FMD. The commenter stated that this shows that Argentina had not 
previously made serious efforts to address its disease problem.
    There is no vaccination for FMD in the Patagonia Region. APHIS does 
not recognize regions that vaccinate for FMD as free of the disease. 
The vaccination activities that occur in other regions of Argentina and 
in Brazil are part of the FMD control program in those regions.
    One commenter asked how APHIS would monitor and verify compliance 
with the measures and restrictions that APHIS would place on the 
importation of animals and animal products into the United States. The 
commenter stated that in addition to monitoring processing operations 
and sampling, and in addition to OIE reporting requirements, the 
responsible government agencies of the exporting region should be 
required to submit data and status review information regularly, as is 
done in the United States between APHIS and State animal health 
agencies. The commenter stated that these measures, in addition to 
follow-up site visits and risk monitoring, would further assure that 
the appropriate systems and procedures are being followed.
    Under the provisions of Sec.  92.2(g), regions that are granted 
animal health status may be required to submit additional information 
pertaining to animal health status or allow APHIS to conduct additional 
information collection activities in order to maintain that status. 
Specifically, we ask for additional information if they report suspect 
or known cases of disease to the OIE; if we receive public information 
about suspect or known cases of disease; if the region that was 
previously evaluated has been re-defined; if there are public reports 
stating changes in the veterinary authority, budgets, or controls in 
border areas; if there are outbreaks or suspect cases in border 
regions; or if there are changes in any of the other factors we 
consider when preparing a risk analysis. We do not require submission 
of additional information on a regular schedule because we are 
concerned primarily with events that could potentially affect the risk 
status of the region under consideration.
    One commenter stated that there was no indication of ongoing 
verification of risk control measures other than APHIS personnel may 
inspect slaughter establishments periodically. The commenter stated 
that a more routine and rigorous system of verification should be 
established.
    As we explained above, regions that are recognized for animal 
health status may be required either to provide or to allow APHIS to 
collect additional information in order to maintain their status if we 
have reason to believe that events in the region or in surrounding 
regions could affect the risk status of the region under consideration. 
We also note that APHIS uses a wide variety of sources to conduct 
verification activities in the Patagonia Region. These sources include 
the U.S. Embassy, multilateral relationships with trading partners, and 
the OIE.
    One commenter stated that, according to APHIS reports to the U.S. 
Animal Health Association's Transmissible Diseases of Swine Committee, 
from 2009 to 2013 a number of unlicensed garbage feeders were found in 
the United States each year by State and

[[Page 51534]]

Federal animal health authorities. The commenter asked if APHIS has any 
supporting information that estimates the number of unlicensed garbage-
feeding facilities.
    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 staff and 
staff with other State agencies. 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 the 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 unlicensed facilities are 
captured at the State level and evaluated by APHIS on a regular basis. 
We do not find the number of unlicensed garbage-feeding facilities to 
be too large or their existence to pose a risk of FMD given the regular 
monitoring for them.
    One commenter stated that according to the risk analysis, APHIS 
considers the most likely pathway of exposure of domestic livestock to 
FMD is through feeding of contaminated food waste to swine, but that 
APHIS considers the likelihood of exposure of susceptible swine to the 
FMD virus through inadequately processed food waste to be low. The 
commenter stated that this position is based on a 1995 risk analysis 
and a 2001 survey, and that the pork industry has undergone significant 
changes since then. The commenter asked what confidence APHIS has that 
these sources adequately reflect the current risk to the U.S. pork 
industry, and if the 1995 work should be repeated with more current 
data.
    APHIS acknowledges that the pork industry in general has undergone 
significant changes since 1995; however, the garbage-feeding industry 
in particular has not. APHIS is confident that the 1995 risk analysis 
and 2001 survey adequately reflect the current risk to the U.S. pork 
industry from contaminated food waste fed to swine.
    One commenter stated that under the Swine Health Protection Act, 
licensed facilities are required to have two to four temperature checks 
of garbage cooking equipment every year. The commenter asked what 
records licensed facilities maintain in order to verify that they are 
meeting the time and temperature requirements on days when they are not 
inspected, and if those records are adequate to provide assurance to 
APHIS that times and temperatures are being met outside of normal 
inspections.
    During regularly scheduled visits to licensed waste feeding 
operations, inspectors observe the cooking procedure to ensure the 
operator understands the proper procedures and is able to conduct them 
properly. If there are any suspicions that cooking is not being 
properly conducted, the inspector will make additional unscheduled 
visits to ensure that cooking procedures are sufficient to ensure 
inactivation of any pathogens, if present. APHIS believes that this 
approach helps to ensure proper cooking time and temperature even when 
inspectors are not present.
    One commenter asked about APHIS' confidence that FMD would be 
detected early in licensed garbage feeding operations. The commenter 
also asked what we estimated the time for detection would be and if it 
would be adequate to meet the goals of the Foreign Animal Disease 
Preparedness and Response Plan (FAD PReP) for disease detection.
    Because of the routine visits of inspectors to garbage feeding 
facilities, which provide opportunities for education on disease signs 
and requirements for reporting, as well as the opportunity for direct 
observation of signs of illness in animals, APHIS believes that the 
presence of FMD or other reportable conditions would be detected more 
quickly in these types of premises than in other, unregulated premises.
    One commenter stated that effective surveillance for vesicular 
diseases relies on a high level of awareness by producers and 
veterinarians on what clinical signs are consistent with vesicular 
diseases and how to report suspected cases. The commenter asked if 
APHIS had current demographics on the level of biosecurity, security, 
veterinary care, routine health observations, and knowledge of disease 
reporting pathways in garbage-fed populations to meet the goal of a FAD 
PReP. The commenter also asked what level of confidence APHIS has 
regarding the education provided to licensed garbage feeders, whether 
biosecurity and veterinary care protocols are being followed; and 
whether disease reporting procedures are being followed.
    Licensed garbage feeders are generally provided with education 
during routine inspections by animal health regulatory staff on topics 
including the importance of proper cooking, signs of foreign animal 
diseases, appropriate biosecurity measures, etc. Mandatory inspections 
provide confidence in the ability of licensed garbage feeding 
operations to maintain biosecurity and reporting requirement protocols. 
Demonstration of adequate facilities and equipment is a requirement for 
obtaining and maintaining licensure.
    One commenter asked what level of confidence we have that FMD would 
be detected in unlicensed garbage-feeding operations, and what the 
estimated time for detection would be.
    If FMD were to occur in an unlicensed garbage feeding facility, 
APHIS estimates that likelihood of detection would be no different than 
introduction into any swine herd.
    One commenter asked if budget cuts to APHIS and State animal health 
staffs have had a negative effect on the ability to carry out the 
regulatory activities outlined in the Swine Health Protection Act, and 
if the reduction in regulatory activities had decreased the number of 
inspections and searches for unlicensed garbage-feeding operations to a 
level lower than what was used in the 1995 risk analysis.
    While budget cuts to APHIS have resulted in reorganizing priorities 
within the Swine Health Program (SHP), our SHP activities remain at 
recommended levels. The changes made have resulted in shifting of 
lower-yield activities in favor of allowing SHP inspectors to spend 
more time interacting with swine producers. For instance, APHIS no 
longer supports State and Federal employees conducting regular trips to 
restaurants to inquire about garbage disposal. Instead, this activity 
has been passed to other State partners, including public health and 
environmental health employees, who routinely frequent restaurants as 
part of their daily activities. These individuals report to State 
cooperators when they uncover suspicions of unlicensed garbage feeding, 
which allows APHIS inspectors and State cooperators to focus on likely 
violations. This, in turn, allows inspectors to spend more time on 
swine farms, working with producers, providing education, and 
performing inspections, among other duties.
    One commenter stated that according to the sixth edition (2013) of 
the OIE Tool for the Evaluation of Performance of Veterinary Services, 
stability of structures, sustainability of policies, and operational 
funding are listed as critical competencies for institutional and 
financial sustainability. The commenter asked how confident APHIS is 
that the short- and long-term levels of funding for SENASA are adequate 
to carry out their mission related to this proposed rule.

[[Page 51535]]

    As described on page 17 of the risk analysis, SENASA reported that 
its 2013 budget was 1.3 billion pesos (approximately $200.7 million). 
SENASA officials described the system as self-sufficient because user 
fees are required for almost every service SENASA provides, including 
slaughter surveillance, issuances of certificates, and laboratory 
tests. The budget for the laboratory is 60 million pesos (approximately 
$12 million). APHIS finds no reason to believe that the funding will 
change, as stable funding for the FMD control and eradication programs 
in Argentina has been in place for over a decade.
    One commenter asked whether APHIS' funding levels are adequate to 
carry out the agency's mission, especially verification of practices 
conducted in Patagonia.
    While APHIS' funding levels have decreased in recent years, we are 
still confident in our ability to carry out our mission successfully. 
As we explained above, APHIS uses a wide variety of sources to conduct 
verification activities in the Patagonia Region, including the U.S. 
Embassy, multilateral relationships with trading partners, and the OIE.
    Two commenters stated that some of the supporting documentation is 
in a foreign language and no official translation was provided. One 
commenter stated that while stakeholders could shoulder the cost burden 
to have the material translated, it would not constitute an official 
translation.
    In addition to the risk analysis and other supporting documents, 
APHIS provided the public with documents that were referred to in the 
risk analysis. Some of these documents were provided by the Government 
of Argentina and are in Spanish. These documents include presentations 
that were done at the local offices. For the documents that have not 
been officially translated for the public, APHIS verified the data when 
conducting the site visit. This information, including data analysis 
and conclusions, is thoroughly described throughout the risk analysis 
that was made available for public comment.
    Many commenters noted that there was no economic impact analysis 
associated with this notice. One commenter stated that while an 
economic analysis is not required for risk evaluation notices, the 
economic analysis for the 2007 proposed rule had deficiencies. Others 
stated that infected beef entering the United States could have a 
negative impact on our domestic livestock supply and economy. The 
commenters stated the economic risk of an FMD outbreak to the U.S. 
livestock industry is too great to take any action that increases the 
risk to the domestic cattle herd. These commenters stated that a new 
economic analysis for animals and animal products should be prepared 
and made available to the public for review and comment.
    The commenter is correct that an economic analysis is not required 
for risk evaluation notices. APHIS has determined that susceptible 
commodities imported from the Patagonia Region pose a very low risk of 
introducing FMD into the United States and that these products can be 
safely imported. This determination is based on the lack of FMD virus 
circulating in the Patagonia Region, the Argentine regulatory and 
industry safeguards that would likely arrest the spread of FMD should 
it be introduced into the region and prevent exports of infected 
commodities, and, APHIS' regulatory safeguards, including quarantine of 
live imported animals. As we explained above, we are confident that 
APHIS' regulatory safeguards will provide effective protection against 
the risks associated with the importation of ruminants or their 
products from the Patagonia Region of Argentina.
    One commenter stated that even with a robust emergency management 
system in the United States, the mobility and demographics of 
susceptible livestock and products in the United States would allow for 
the probable spread of FMD to many States before it could be contained. 
The commenter further stated that the accidental introduction of FMD 
into the United States would cost producers, consumers, and governments 
billions of dollars in lost revenue, response overhead, increased 
retail costs, and long-term loss of consumer confidence.
    While we agree with the commenter that the expected consequences of 
an FMD outbreak in the United States would be severe, the likelihood of 
such an outbreak occurring due to exposure of the domestic livestock 
population to FMD-susceptible animals and products imported from the 
Patagonia Region of Argentina is very low. Therefore, the overall risk 
of FMD to U.S. animal health from imports of these commodities is also 
very low.
    The commenter stated that the United States has defended its 
decision to reject beef from Argentina citing general sanitary issues. 
The commenter stated that Argentina demanded that the U.S. market be 
opened to their exports but have not taken appropriate action to 
address their sanitary issues.
    APHIS disagrees with the commenter. Our evaluation shows that 
Argentina, as discussed in the risk analysis, has taken the necessary 
action to address FMD issues.
    Based on the evaluation and the reasons given in this document in 
response to comments, we are recognizing the Patagonia Region of 
Argentina as free of FMD and rinderpest. The lists of regions 
recognized as free 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 38, 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 26th day of August 2014.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-20646 Filed 8-28-14; 8:45 am]
BILLING CODE 3410-34-P
```