[Federal Register Volume 79, Number 168 (Friday, August 29, 2014)]
[Proposed Rules]
[Pages 51508-51514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20643]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / 
Proposed Rules  

[[Page 51508]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. APHIS-2014-0032]
RIN 0579-AD92


Importation of Beef From a Region in Argentina

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations governing the 
importation of certain animals, meat, and other animal products to 
allow, under certain conditions, the importation of fresh (chilled or 
frozen) beef from a region in Argentina located north of Patagonia 
South and Patagonia North B, referred to as Northern Argentina. Based 
on the evidence in a recent risk assessment, we believe that fresh 
(chilled or frozen) beef can be safely imported from Northern Argentina 
provided certain conditions are met. This proposal would provide for 
the importation of beef from Northern Argentina into the United States 
while continuing to protect the United States against the introduction 
of foot-and-mouth disease.

DATES: We will consider all comments that we receive on or before 
October 28, 2014.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0032.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0032, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-
0032 or in our reading room, which is located in Room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Silvia Kreindel, Senior Staff 
Veterinarian, Regionalization Evaluation Services, National Import 
Export Services, Veterinary Services, APHIS, 4700 River Road Unit 38, 
Riverdale, MD 20737-1231; (301) 851-3313.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR part 94 (referred to below as the 
regulations) prohibit or restrict the importation of certain animals 
and animal products into the United States to prevent the introduction 
of various diseases, including rinderpest, foot-and-mouth disease 
(FMD), African swine fever, classical swine fever, and swine vesicular 
disease. These are dangerous and destructive communicable diseases of 
ruminants and swine. Section 94.1 of the regulations contains criteria 
for recognition by the Animal and Plant Health Inspection Service 
(APHIS) of foreign regions as free of rinderpest or free of both 
rinderpest and FMD. Section 94.11 restricts the importation of 
ruminants and swine and their meat and certain other products from 
regions that are declared free of rinderpest and FMD but that 
nonetheless present a disease risk because of the regions' proximity to 
or trading relationships with regions affected by rinderpest or FMD. 
Regions APHIS has declared free of FMD and/or rinderpest, and regions 
declared free of FMD and rinderpest that are subject to the 
restrictions in Sec.  94.11, are listed on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.
    APHIS considers rinderpest or FMD to exist in all regions of the 
world not listed as free of those diseases on the Web site. On June 26, 
1997, we published in the Federal Register a final rule (62 FR 34385-
34394, Docket No. 94-106-5) allowing, under certain conditions, the 
importation of fresh (chilled or frozen) beef from Argentina. These 
conditions were laid out in Sec.  94.21 of the regulations. However, on 
March 12, 2001, Argentina reported to the World Organization for Animal 
Health (OIE) and the United States that they had detected an outbreak 
of FMD in a herd of 300 young bulls in the Province of Buenos Aires. 
Argentina's Servicio Nacional de Sanidad y Calidad Agroalimentario 
(SENASA) subsequently reported the spread of FMD to 15 of the country's 
23 Provinces. In an interim rule published in the Federal Register on 
June 4, 2001 (66 FR 29897-29899, Docket No. 01-032-1), and effective 
retroactively to February 19, 2001, we removed Sec.  94.21 and removed 
Argentina from the list in Sec.  94.1 of regions declared to be free of 
both rinderpest and FMD. APHIS adopted the interim rule without change 
as a final rule in a document published in the Federal Register on 
December 11, 2001 (66 FR 63911, Docket No. 01-032-2). Although there 
has not been a major outbreak of FMD since 2001/2002, we do not 
consider Northern Argentina to be free of FMD because of Argentina's 
vaccination program in that region.
    With few exceptions, the regulations prohibit the importation of 
fresh (chilled or frozen) meat of ruminants or swine that originates in 
or transits a region where FMD is considered to exist. One such 
exception is beef and ovine meat \1\ from Uruguay, which conducts FMD 
vaccinations of cattle. The regulations allow the importation of fresh 
beef and ovine meat from Uruguay into the United States provided that 
the following additional conditions have been met:
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    \1\ The provisions allowing the importation of ovine meat from 
Uruguay were added in a final rule published in the Federal Register 
(78 FR 68327-68331) on November 14, 2013, and effective on November 
29, 2013.
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     The meat is beef or ovine meat from animals born, raised, 
and slaughtered in Uruguay.
     FMD has not been diagnosed in Uruguay within the previous 
12 months.
     The meat comes from bovines or sheep that originated from 
premises where FMD had not been present during the lifetime of any 
bovines or sheep slaughtered for the export of beef and ovine meat to 
the United States.
     The meat comes from bovines or sheep that were moved 
directly from the premises of origin to the slaughtering

[[Page 51509]]

establishment without any contact with other animals.
     The meat comes from bovines or sheep that received ante-
mortem and post-mortem veterinary inspections, paying particular 
attention to the head and feet, at the slaughtering establishment, with 
no evidence found of vesicular disease.
     The meat consists only of bovine or ovine parts that are, 
by standard practice, part of the animal's carcass that is placed in a 
chiller for maturation after slaughter. The bovine and ovine parts that 
may not be imported include all parts of the head, feet, hump, hooves, 
and internal organs.
     All bone and visually identifiable blood clots and 
lymphoid tissue have been removed from the meat.
     The meat has not been in contact with meat from regions 
other than those listed in the regulations as free of rinderpest and 
FMD.
     The meat comes from carcasses that were allowed to 
maturate at 40 to 50 [deg]F (4 to 10 [deg]C) for a minimum of 24 hours 
after slaughter and that reached a pH of below 6.0 in the loin muscle 
at the end of the maturation period. Measurements for pH must be taken 
at the middle of both longissimus dorsi muscles. Any carcass in which 
the pH does not reach less than 6.0 may be allowed to maturate an 
additional 24 hours and be retested, and, if the carcass still has not 
reached a pH of less than 6.0 after 48 hours, the meat from the carcass 
may not be exported to the United States.
     An authorized veterinary official of the Government of 
Uruguay certifies on the foreign meat inspection certificate that the 
above conditions have been met.
     The establishment in which the bovines and sheep are 
slaughtered allows periodic on-site evaluation and subsequent 
inspection of its facilities, records, and operations by an APHIS 
representative.
    In response to a request from the Government of Argentina that we 
reconsider our decision to prohibit the importation of fresh (chilled 
or frozen) beef into the United States from Northern Argentina in light 
of improvements Argentina has made in its FMD detection and eradication 
procedures, we conducted a risk analysis of that region, which can be 
viewed on the Internet on the Regulations.gov Web site or in our 
reading room.\2\ For the risk analysis, we evaluated information 
provided by SENASA in accordance with Sec.  92.2 regarding the 
country's FMD status, reviewed published scientific literature, and 
conducted five site visits to the proposed exporting region. We 
concluded that Argentina has infrastructure and emergency response 
capabilities adequate to effectively contain, eradicate, and report FMD 
in the event of an outbreak in a timely manner. We further concluded 
that Argentina is able to comply with U.S. import restrictions on the 
specific products from affected areas. Based on the evidence documented 
in our recent risk assessment, we believe that fresh (chilled or 
frozen) beef can be safely imported from Northern Argentina, provided 
certain conditions are met. Accordingly, we are proposing to amend the 
regulations in Sec.  94.29 to allow the importation of fresh beef from 
Northern Argentina. Under this proposed rule, fresh beef from Northern 
Argentina would be subject to the same import conditions imposed on 
fresh beef and ovine meat from Uruguay.
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    \2\ Instructions on accessing Regulations.gov and information on 
the location and hours of the reading room may be found at the 
beginning of this document under ADDRESSES. You may also request 
paper copies of the risk analysis by calling or writing to the 
person listed under FOR FURTHER INFORMATION CONTACT.
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    In this proposed rule, we are also giving notice that we would add 
Argentina to the list of regions that we recognize as free of 
rinderpest, which can be viewed at http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/importexport?1dmy&urile=wcm%3apath%3a/aphis_content_library/sa_our_focus/sa_animal_health/sa_import_into_us/sa_entry_requirements/ct_rinderpest. 
Historically, rinderpest virus has never become established in North 
America, Central America, the Caribbean Islands, or South America.

Miscellaneous

    Our proposed addition of the exporting region of Northern Argentina 
to the regulations in Sec.  94.29 necessitates a few minor editorial 
changes to Sec.  94.1, where, currently, reference is made to the 
importation of fresh beef and ovine meat from Uruguay under Sec.  
94.29.

Risk Analysis

    Drawing on data submitted by the Government of Argentina and 
observations from our site visits to the region under consideration, we 
have conducted a risk analysis of the animal health status of that 
region relative to FMD. Our risk analysis was conducted according to 
the eight factors identified in Sec.  92.2, ``Application for 
recognition of the animal health status of a region'': The scope of the 
evaluation being requested, veterinary control and oversight, disease 
history and vaccination practices, livestock demographics and 
traceability, epidemiological separation from potential sources of 
infection, surveillance, diagnostic laboratory capabilities, and 
emergency preparedness and response.\3\
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    \3\ Prior to 2012, Sec.  92.2(b) listed 11 factors. In 2012, 
APHIS consolidated the 11 factors into 8 in order to simplify the 
regulations and facilitate the application process. Since the 
evaluation of the proposed exporting region of Argentina began 
before the consolidation, however, the risk assessment follows the 
11-factor format. The topics addressed by the 11 factors are 
encapsulated in the 8. Appendix II of the risk assessment describes 
the similarities between the 8 and 11 factors. Observations and 
information collected during the site visits were considered in the 
risk assessment as well.
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    A summary evaluation of each factor is discussed below. Based on 
our analysis of these factors, we have determined that fresh (chilled 
or frozen) beef can be safely imported into the United States from 
Northern Argentina.

Scope of the Evaluation Being Requested

    We conducted our risk analysis in response to an official request 
from Argentina that APHIS allow the importation of fresh (chilled or 
frozen) beef into the United States from a region in Argentina located 
north of Patagonia South and Patagonia North B, referred to as Northern 
Argentina. Given the history of FMD in Argentina and the fact that 
Argentina vaccinates its cattle population in most Provinces against 
FMD, APHIS conducted this risk analysis to evaluate the potential for 
FMD introduction and establishment through importation of beef from 
Northern Argentina. Data and background information were obtained from 
Argentine animal health officials. Much of the supporting information 
for this analysis consists of records obtained from SENASA. In 
addition, APHIS conducted five site visits to Argentina in 2003, 2005, 
2006, 2009, and 2013 to verify and complement the information provided 
by Argentina.

Veterinary Control and Oversight

    At the time of the 2001 outbreak detailed above, epidemiological 
investigations revealed areas in SENASA's veterinary controls and 
oversight that were in need of improvement. As a result, SENASA was 
reorganized. The new structure was intended to increase the efficiency 
and effectiveness of the existing system. Issues addressed included 
centralization of command and control of animal health programs, 
enhancements in the internal monitoring and

[[Page 51510]]

communications, improved compliance with international standards and 
certification requirements, and an increased emphasis on border 
controls.
    APHIS reviewed Argentina's FMD control and eradication program 
during our site visits in 2003, 2005, 2006, 2009, and 2013, and 
concluded that the program is effective at the local and national 
levels. We concluded that SENASA could detect disease quickly, limit 
its spread, and report it promptly.
    APHIS considers that SENASA has sufficient legal authority to carry 
out official control, eradication, and quarantine activities. SENASA 
has a system of official veterinarians and support staff in place for 
carrying out field programs and for import controls. Field activities 
are coordinated through the national animal health office. Review of 
veterinary infrastructure with SENASA officials confirmed the presence 
of a system adequate for rapid detection and reporting of FMD and for 
carrying out surveillance and eradication programs. Field offices 
appeared to be appropriately staffed for the regions covered. The 
technical infrastructure is adequate, and advanced technologies are 
utilized in conducting several animal health programs, including the 
FMD program. Import controls are sufficient to protect international 
borders at principal crossing points, and sufficient controls exist to 
prevent the introduction of international waste into the country. Field 
personnel appeared to be adequately trained in FMD detection and 
control or to have had experience dealing with epidemiological 
investigations during FMD outbreaks. It is expected that they would 
suspect FMD if they were to see clinical signs compatible with the 
disease. With regard to indemnity procedures, we concluded that 
adequate funds are available to compensate owners for depopulated 
animals and that indemnity provisions can be extended to all animals 
potentially exposed to FMD, not only those confirmed as infected. 
Generally, we were favorably impressed with the census information, 
coverage of premises in the export region, the recordkeeping for 
individual premises, the control of vaccination, and the movement 
controls documented at the local level.

Disease History and Vaccination Practices

    Outbreaks of FMD occurred in Northern Argentina in 2000/2001, with 
isolated instances occurring in 2003 and 2006. In the course of 
evaluating the potential disease risk posed by importation of fresh 
(chilled or frozen) beef into the United States from the export region, 
we did not detect any evidence to suggest that active outbreaks of FMD 
exist in the proposed exporting region.
    Vaccination of cattle is mandatory in the proposed export region 
(except for the Patagonia North A region and the summer pastures (zona 
veranadas) of Calingasta Valley in the Province of San Juan). Other 
susceptible species are vaccinated only in strategic areas (e.g., the 
borders with Paraguay and Bolivia due to the disease status of those 
countries) and emergency situations. Local SENASA veterinarians 
certify, control, and audit the vaccination campaigns. Further, local, 
regional, and central SENASA services are responsible for setting 
vaccination schedules, which are determined using a regionalization 
method in order to account for differing ecological features, 
production types, and animal movement and flow. Vaccination coverage 
was reported to range between 98.9 percent and 100 percent in the 
proposed export region, with vaccination rates at 100 percent for the 
2012 campaign that APHIS reviewed.
    The vaccine used is an inactivated, trivalent, oil-based vaccine. 
All FMD vaccines produced or used in Argentina must be tested for 
quality and safety by the official SENASA laboratory. Quality control 
tests of each batch of the vaccine are conducted in the diagnostic 
laboratory in Buenos Aires and strictly follow international standards 
as set forth by the OIE. All vials are identified with technical and 
manufacturer brand labels, a sequential number, and an official stamp 
stating the series and the expiration date. Trucks used for 
transportation of the vaccine are equipped with temperature sensors to 
ensure a cold chain during transportation. A cold chain ensures that 
the vaccine is kept at the temperature specified by its manufacturer as 
necessary to maintain its viability and efficacy on a continuous basis 
throughout the shipping process.
    We concluded that Argentina conducts its FMD vaccine production 
programs appropriately and in accordance with international standards. 
There is a system of controls to ensure compliance with vaccination 
calendars through matching vaccination records to movement permits and 
census data, and through field inspections. There is also a system in 
place for levying fines for noncompliance.

Livestock Demographics and Traceability

    Cattle production is the primary livestock production system in 
Argentina. The domestic livestock population consists of approximately 
57 million head of cattle, 13 million sheep, 2.3 million goats, and 2.3 
million pigs. Of these, approximately 98 percent of the cattle 
population and premises are located within the proposed export area.
    We did not identify significant risk pathways that would cause us 
to consider commercial operations in the proposed export region as a 
likely source for introducing FMD into the United States. The larger 
commercial operations are likely to be the source of beef exports from 
the export region. Based on its review of the information, APHIS 
considers the beef industry in the export region to be well-organized 
and committed to the production of quality product and to preventing 
FMD outbreaks.
    Argentina has an efficient and effective traceability system, which 
includes a compulsory national individual identification system for 
cattle being exported to different countries, including the European 
Union (EU). Individual identification is unique and permanent. Since 
the process by which meat is certified for export to the EU is 
identical to the process we are proposing here, Argentinean inspectors 
have experience and training in the types of procedures that would be 
necessary for export to the United States. The use of this national 
identification system enhances Argentina's ability to certify the 
origin of animals entering the export channels.
    We note that the auction system in the country is well organized 
and tightly controlled by the official veterinary service. However, 
there is no evidence to suggest that major movements of animals into 
export channels occur through the auction system. Instead, bovines 
destined for export to the EU are shipped directly from the farm to the 
exporting slaughter facility.
    Adequate controls and inspection measures exist at slaughter 
facilities in Argentina. Ante-mortem and post-mortem inspections are 
carried out satisfactorily. APHIS evaluated pH controls, maturation, 
and deboning procedures at three plants in the proposed export zone 
that export to the EU and elsewhere. Every carcass destined for the EU 
is tested to ensure that the pH is not greater than 5.9, which is the 
EU requirement. If greater, the carcass is diverted to local 
consumption. APHIS examined maturation records and verified actual

[[Page 51511]]

rejected and approved seals. APHIS considers pH testing and calibration 
of pH meters to be critical mitigation measures in assessing the risk 
of importing the FMD virus in beef from Northern Argentina.
    The biosecurity measures applied at the facilities APHIS visited 
were adequate, and there is a high level of awareness of and compliance 
with these measures. In addition, processing for slaughter facilities 
are under adequate official control and inspection.
    We concluded that Argentina has adequate control of inspection 
activities in slaughter facilities and can certify compliance with our 
import requirements. A comparable system for control of commercial 
shipments of fresh and frozen beef under similar conditions to the EU 
also exists and is considered adequate to control the specific 
conditions for exporting the commodity under consideration.

Epidemiological Separation From Potential Sources of Infection

    Northern Argentina is bordered by the Atlantic Ocean and shares 
land borders with Bolivia, Brazil, Chile, Paraguay, Uruguay, and the 
Province of R[iacute]o Negro, Argentina. The Province of R[iacute]o 
Negro, Argentina, is located in ``Patagonia North B,'' which is an FMD 
surveillance area situated to the south of Northern Argentina. The most 
recent outbreak of FMD in Patagonia North B occurred in 1994. APHIS 
does not consider the countries of South America to be FMD-free, with 
the exception of Chile. Outbreaks have occurred in Uruguay and 
Paraguay, both countries that had been classified by the OIE as ``free 
without vaccination'' or ``free with vaccination'' prior to the 
outbreaks. FMD has not been eradicated from Colombia, Bolivia, Ecuador, 
Venezuela, or Peru.
    There is a history of introduction of disease into Argentina from 
neighboring countries. According to Argentinean officials, illegal 
movement of animals from neighboring countries as well as mechanical 
transmission of the virus resulted in the introduction of the disease 
into Argentina prior to the 2001 outbreak discussed previously. APHIS 
concluded that as long as FMD is endemic in the overall region in South 
America, there is a risk of reintroduction from adjacent areas into the 
proposed exporting region.
    Domestic movement controls within Argentina are stringent. SENASA 
requires that all cattle owners identify their animals with a unique 
animal identification number, which is kept with the cattle via ear 
tags. Sheep are not required to be individually identified; however, in 
the event the farm is approved for export to the EU, premises 
identification is required, either by ear tag, which includes the 
unique identification number of the farm, or ear notch. There is a 
system of permits in place to control animal movement, which works well 
at the local level. Movement controls are linked to vaccination 
records, and vaccination coverage in the export region evaluated by 
APHIS is high, as noted above.
    There is good cooperation between Argentine Federal agencies and 
their international counterparts at land border crossings. Argentina is 
separated from most of Chile by the Andes Mountains and operates a 
joint surveillance program for monitoring animal movements across the 
border with the Chilean government. The OIE recognizes Chile as FMD-
free without vaccination and, as a result, SENASA does not consider the 
Chilean border a high-risk region. The Brazilian border is also 
considered by SENASA to be a low-risk region, subject to a joint FMD 
surveillance program with the Brazilian government.
    SENASA has identified the Paraguayan and Bolivian borders as the 
most vulnerable for the potential introduction of FMD into Argentina. 
As a result, those areas have received enhanced support from SENASA in 
the form of increased surveillance and border control activities. 
Agreements are also in place between SENASA and its counterparts in 
Paraguay and Bolivia for such coordinated border control activities as 
vaccinations, surveillance, animal census, education, and animal 
identification.
    Movement controls at international land checkpoints as well as 
movement control measures and biosecurity at airports and seaports 
appear to be adequate.
    During site visits, APHIS attempts to target the riskiest border 
crossings (and other areas) as an example of ``maximized risk 
scenario,'' in order to address similar, but theoretically lower, risks 
in the remainder of the export region. APHIS assumes that if the 
riskiest pathways are sufficiently mitigated, the overall spectrum of 
risk issues should be acceptable. Using this assumption and visiting 
the areas of highest risk in the proposed export region, APHIS 
concluded that movement control measures for live animals are 
relatively robust at both domestic and international checkpoints.

Surveillance

    The animal health service in Argentina has a surveillance system 
that covers all national territory. All official service field staff, 
community participants, and private sector veterinarians are trained 
and required to look for signs of vesicular diseases (e.g., excessive 
salivation, difficulty walking, etc.). If FMD is suspected, it must be 
immediately reported to the local unit or to the veterinary authority 
that would notify the local unit. Cattle are inspected every 6 months 
by vaccinators and official veterinarians, when the bovines are 
gathered in corrals for vaccination. Other susceptible species are not 
vaccinated except for the area located 25 kilometers south of the 
Argentina/Bolivia and Argentina/Paraguay border, where all susceptible 
species are vaccinated twice a year. Animals are individually inspected 
for signs of vesicular disease by personnel from the official service 
before slaughtering. Other body parts, including the tongue and feet, 
are examined during post-mortem inspection. All animals coming into 
fairs, auctions, or exhibitions are clinically inspected by the 
official veterinarians. The clinical inspection of animals in transit 
is carried out at checkpoints and border control points by official 
personnel. The conditions under which animals move are based on the 
animal health status of the Province of origin or the country sharing 
borders with the export region.
    Argentina has a two-phase surveillance system that effectively uses 
active and passive surveillance. Phase I relies on active surveillance 
to document freedom from disease. Active surveillance is carried out by 
means of targeted sero-epidemiological surveys in specific ``high-
risk'' areas within the zone that SENASA considers FMD-free. The 
surveys aim to prove that the zone remains free of viral activity. 
Serological testing is also conducted whenever there is suspicion of 
the disease. Phase II begins once freedom from infection has been 
established. The main goals in this phase are to prevent the 
reintroduction of the disease, maintain good sanitary conditions, and 
provide technical grounds to demonstrate the continual absence of 
disease and viral activity in the zone. Passive surveillance is the 
primary type employed in Phase II, although active surveillance is also 
used. Passive surveillance activities include observations made during: 
(1) Animal movement control activities and trade of animal products, 
(2) farm inspections, (3) slaughterhouse inspection, and (4) 
inspections during livestock fairs. Data on the above activities are 
collected annually. Passive surveillance takes advantage of the

[[Page 51512]]

community structure in Argentina and relies heavily on the 
participation of the community. SENASA officials have carefully and 
methodically thought about each component of their surveillance system, 
and their two-stage cluster sampling design is appropriate, efficient, 
scientifically valid, and simple to implement. All technical aspects of 
that design were addressed properly.
    Observations made during recent site visits to Argentina led APHIS 
to conclude that the Argentine authorities were particularly effective 
in their FMD educational campaigns and that the country's FMD 
eradication strategy and surveillance practices have been fully 
communicated, understood, and embraced by all animal health officials 
in the country. This was made evident by the high degree of consistency 
in implementation and execution of the program at every local 
veterinary unit visited. In addition, the serological surveillance 
plan, updated in 2013, appears well designed and executed.

Diagnostic Laboratory Capabilities

    SENASA has one laboratory, located in Buenos Aires, under its 
direct supervision that performs diagnostic tests for FMD and other 
vesicular diseases. Based on laboratory and site visits conducted in 
2003, 2005, 2006, 2009, and 2013, we concluded that Argentina has the 
diagnostic capability to adequately test samples for the presence of 
the FMD virus. The laboratory in Buenos Aires has adequate quality 
control activities; adequate laboratory equipment, which is routinely 
monitored and calibrated; sufficient staff; and an effective and 
efficient recordkeeping system for storage and retrieval of data. The 
tests used to investigate evidence of viral activity are consistent 
with OIE guidelines. The staff members appear to be well-trained and 
motivated. Samples were turned around in a timely manner.

Emergency Preparedness and Response

    Argentina's efficient and effective traceability system is an 
important component of its emergency response capacity. As noted above, 
Argentina uses a mandatory national identification system, which 
includes individual animal identification numbers, for cattle that are 
destined for export. In addition, Argentina uses a mandatory 
identification system to track the entire cattle population in the 
country by lot. That system proved to be effective during the 2003 and 
2006 FMD outbreaks in the traceback of all contacts.
    Argentina relies heavily on community notification of FMD 
outbreaks, as that tends to be the most efficient way to locate 
disease. Once notification occurs, the Federal contingency plan for FMD 
is extensive and thorough, and a significant degree of necessary 
autonomy is built in at the Provincial level.
    APHIS concluded that adequate legal authority, funding, personnel, 
and resources exist at both the Provincial and Federal levels to carry 
out emergency response measures. The emergency response is both rapid 
and effective, as shown following the FMD outbreaks in Northern 
Argentina in 2003 and 2006.
    The above findings are detailed in the risk analysis document 
summarized above. The risk analysis explains the factors that have led 
us to conclude that fresh (chilled or frozen) beef may be safely 
imported from Northern Argentina under the conditions enumerated above. 
It also establishes that Argentina has adequate veterinary 
infrastructures in place to prevent, control, report, and manage FMD 
and outbreaks. Therefore, we are proposing to amend Sec.  94.29 to 
allow the importation of fresh beef from Northern Argentina under the 
conditions described above.

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    This proposed rule has been determined to be not significant for 
the purposes of Executive Order 12866 and, therefore, has not been 
reviewed by the Office of Management and Budget.
    In accordance with 5 U.S.C. 603, we have performed an initial 
regulatory flexibility analysis, which is summarized below, regarding 
the economic effects of this proposed rule on small entities. Copies of 
the full analysis are available by contacting the person listed under 
FOR FURTHER INFORMATION CONTACT or on the Regulations.gov Web site (see 
ADDRESSES above for instructions for accessing Regulations.gov).
    Based on the information we have, there is no reason to conclude 
that adoption of this proposed rule would result in any significant 
economic effect on a substantial number of small entities. However, we 
do not currently have all of the data necessary for a comprehensive 
analysis of the effects of this proposed rule on small entities. 
Therefore, we are inviting comments on potential effects. In 
particular, we are interested in determining the number and kind of 
small entities that may incur benefits or costs from the implementation 
of this proposed rule.
    Our analysis examines potential economic impacts of a proposed rule 
that would allow fresh (chilled or frozen) beef from Northern Argentina 
to be imported into the United States provided certain conditions are 
met. Economic effects of the rule for both U.S. producers and consumers 
are expected to be very small. Producers' welfare would be negatively 
affected, but not significantly. Gains for consumers would outweigh 
producer losses, resulting in a net benefit to the U.S. economy.
    The United States is the largest beef producer in the world and yet 
still imports a significant quantity. U.S. beef import volumes from 
1999 to 2013 averaged 0.9 million metric tons (MT) or roughly 11 
percent of U.S. production. Most of the beef imported by the United 
States is from grass-fed cattle and is processed with trimmings from 
U.S. grain-fed cattle to make ground beef. Australia, Canada, and New 
Zealand are the main foreign suppliers of beef to the United States.
    Effects of the proposed rule are estimated using a partial 
equilibrium model of the U.S. agricultural sector. Economic impacts are 
estimated based on intra-sectoral linkages among the grain, livestock, 
and livestock product sectors. Annual imports of fresh (chilled or 
frozen) beef from Argentina are expected to range between 16,000 and 
24,000 MT, with volumes averaging 20,000 MT. Quantity, price and 
welfare changes are estimated for these three import scenarios. The 
results are presented as average annual effects for the 5-year period 
2014-2018.
    The model indicates less than 10 percent of the beef imported from 
Argentina would displace beef that would otherwise be imported from 
other countries, in particular, from Australia, Canada, Mexico, New 
Zealand, and Uruguay. If the United States were to import 20,000 MT of 
beef from Argentina, total U.S. beef imports would increase by 1.35 
percent. Due to the supply increase, the wholesale price of beef, the 
retail price of beef, and the price of cattle (steers) are estimated to 
decline by 0.22, 0.08, and 0.24 percent, respectively. U.S. beef 
production would decline by 0.01 percent while U.S. beef consumption 
and exports would increase by 0.12 and 0.22 percent, respectively. The 
16,000 MT and 24,000 MT scenarios show similar quantity and price 
effects.
    The fall in beef prices and the resulting decline in U.S. beef 
production would translate into reduced returns to capital and 
management in the livestock and beef sectors. Under the 20,000 MT 
import scenario, producers would experience a decline in surplus of 
$7.63 million or 0.42 percent, while

[[Page 51513]]

consumers would benefit from the decrease in price by an increase in 
their surplus of $130.24 million or 0.30 percent. The overall impact 
would be a net welfare gain of $122.61 million or 0.27 percent for the 
beef sector.
    The 16,000 MT and 24,000 MT scenarios show similar welfare impacts, 
with net benefits increasing broadly in proportion to the quantity of 
beef imported. The largest impact would be for the beef sector, but 
consumers of pork would also benefit neglibly. While most of the 
establishments that would be affected by this rule are small entities, 
based on the results of this analysis, APHIS does not expect the 
impacts to be significant. APHIS welcomes information that the public 
may provide regarding potential economic effects of the proposed rule.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
importation of fresh (chilled or frozen) beef from Northern Argentina 
under the conditions described in this proposed rule, we have prepared 
an environmental assessment. The environmental assessment was prepared 
in accordance with: (1) The National Environmental Policy Act of 1969 
(NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the 
Council on Environmental Quality for implementing the procedural 
provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations 
implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing 
Procedures (7 CFR part 372).
    The environmental assessment may be viewed on the Regulations.gov 
Web site or in our reading room. (A link to Regulations.gov and 
information on the location and hours of the reading room are provided 
under the heading ADDRESSES at the beginning of this proposed rule.) In 
addition, copies may be obtained by calling or writing to the 
individual listed under FOR FURTHER INFORMATION CONTACT.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. APHIS-
2014-0032. Please send a copy of your comments to: (1) APHIS, using one 
of the methods described under ADDRESSES at the beginning of this 
document, and (2) Clearance Officer, OCIO, USDA, Room 404-W, 14th 
Street and Independence Avenue SW., Washington, DC 20250. A comment to 
OMB is best assured of having its full effect if OMB receives it within 
30 days of publication of this proposed rule.
    APHIS' animal import regulations in Sec. Sec.  94.1 and 94.29 will 
place certain restrictions on the importation of fresh (chilled or 
frozen) beef from Northern Argentina into the United States. Under 
these regulations, APHIS must collect information, prepared by an 
authorized certified official of the Government of Argentina, 
certifying that specific conditions for importation have been met.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 1.3 hours per response.
    Respondents: Federal animal health authorities in Argentina and 
exporters of beef and beef products from Argentina to the United 
States.
    Estimated annual number of respondents: 88.
    Estimated annual number of responses per respondent: 1.
    Estimated annual number of responses: 88.
    Estimated total annual burden on respondents: 114 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
851-2908.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

List of Subjects in 9 CFR Part 94

    Animal diseases, Imports, Livestock, Meat and meat products, Milk, 
Poultry and poultry products, Reporting and recordkeeping requirements.

    Accordingly, we propose to amend 9 CFR part 94 as follows:

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, NEWCASTLE DISEASE, 
HIGHLY PATHOGENIC AVIAN INFLUENZA, AFRICAN SWINE FEVER, CLASSICAL 
SWINE FEVER, SWINE VESICULAR DISEASE, AND BOVINE SPONGIFORM 
ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS

0
1. The authority citation for part 94 continues to read as follows:

    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.


Sec.  94.1  [Amended]

0
2. Section 94.1 is amended in paragraphs (b)(4) and (d) introductory 
text by removing the words ``from Uruguay''.
0
3. Section 94.29 is revised to read as follows:

[[Page 51514]]

Sec.  94.29  Restrictions on importation of fresh (chilled or frozen) 
beef and ovine meat from specified regions.

    Notwithstanding any other provisions of this part, fresh (chilled 
or frozen) beef from a region in Argentina located north of Patagonia 
South and Patagonia North B, referred to as Northern Argentina, and 
fresh (chilled or frozen) beef and ovine meat from Uruguay may be 
exported to the United States under the following conditions:
    (a) The meat is beef or ovine meat from animals that have been 
born, raised, and slaughtered in the exporting region of Argentina or 
in Uruguay.
    (b) Foot-and-mouth disease has not been diagnosed in the exporting 
region of Argentina or in Uruguay within the previous 12 months.
    (c) The meat comes from bovines or sheep that originated from 
premises where foot-and-mouth disease has not been present during the 
lifetime of any bovines and sheep slaughtered for the export of beef 
and ovine meat to the United States.
    (d) The meat comes from bovines or sheep that were moved directly 
from the premises of origin to the slaughtering establishment without 
any contact with other animals.
    (e) The meat comes from bovines or sheep that received ante-mortem 
and post-mortem veterinary inspections, paying particular attention to 
the head and feet, at the slaughtering establishment, with no evidence 
found of vesicular disease.
    (f) The meat consists only of bovine parts or ovine parts that are, 
by standard practice, part of the animal's carcass that is placed in a 
chiller for maturation after slaughter. The bovine and ovine parts that 
may not be imported include all parts of the head, feet, hump, hooves, 
and internal organs.
    (g) All bone and visually identifiable blood clots and lymphoid 
tissue have been removed from the meat.
    (h) The meat has not been in contact with meat from regions other 
than those listed in Sec.  94.1(a).
    (i) The meat came from bovine carcasses that were allowed to 
maturate at 40 to 50 [deg]F (4 to 10 [deg]C) for a minimum of 24 hours 
after slaughter and that reached a pH below 6.0 in the loin muscle at 
the end of the maturation period. Measurements for pH must be taken at 
the middle of both longissimus dorsi muscles. Any carcass in which the 
pH does not reach less than 6.0 may be allowed to maturate an 
additional 24 hours and be retested, and, if the carcass still has not 
reached a pH of less than 6.0 after 48 hours, the meat from the carcass 
may not be exported to the United States.
    (j) An authorized veterinary official of the government of the 
exporting region certifies on the foreign meat inspection certificate 
that the above conditions have been met.
    (k) The establishment in which the bovines and sheep are 
slaughtered allows periodic on-site evaluation and subsequent 
inspection of its facilities, records, and operations by an APHIS 
representative.

(Approved by the Office of Management and Budget under control 
number 0579-0372)

    Done in Washington, DC, this 26th day of August 2014.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-20643 Filed 8-28-14; 8:45 am]
BILLING CODE 3410-34-P