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