[Federal Register Volume 78, Number 246 (Monday, December 23, 2013)]
[Proposed Rules]
[Pages 77370-77376]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30464]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. APHIS-2009-0017]
RIN 0579-AD41


Importation of Beef From a Region in Brazil

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 by 
allowing, under certain conditions, the importation of fresh (chilled 
or frozen) beef from a region in Brazil (the States of Bahia, Distrito 
Federal, Espirito Santo, Goias, Mato Grosso, Mato Grosso

[[Page 77371]]

do Sul, Minas Gerais, Parana, Rio Grande do Sul, Rio de Janeiro, 
Rondonia, Sao Paulo, Sergipe, and Tocantins). Based on the evidence in 
a recent risk assessment, we have determined that fresh (chilled or 
frozen) beef can be safely imported from those Brazilian States 
provided certain conditions are met. This action would provide for the 
importation of beef from the designated region in Brazil 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 
February 21, 2014.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!documentDetail;D=APHIS-2009-0017-0001.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2009-0017, 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-2009-
0017 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, Regional Evaluation Services Staff, National Center for 
Import and Export, VS, 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 animal 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 with 
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 November 
16, 2010, we published in the Federal Register (75 FR 69851-69857, 
Docket No. APHIS-2009-0034) a final rule that, among other things, 
recognized the Brazilian State of Santa Catarina as free of rinderpest 
and FMD. APHIS does not consider the rest of Brazil to be free of FMD 
because Brazil vaccinates against FMD.
    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. 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.
     Foot-and-mouth disease 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 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 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 Brazil that we 
allow fresh (chilled or frozen) beef to be imported into the United 
States from a region within that country, 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 Brazil's Ministry of 
Agriculture, Livestock and Food Supply (MAPA) 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 Brazil has infrastructure

[[Page 77372]]

and emergency response capabilities adequate to effectively contain and 
eradicate FMD in the event of an outbreak and to comply with U.S. 
import restrictions on 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 the region 
in Brazil composed of the States of Bahia, Distrito Federal, Espirito 
Santo, Goias, Mato Grosso, Mato Grosso do Sul, Minas Gerais, Parana, 
Rio Grande do Sul, Rio de Janeiro, Rondonia, Sao Paulo, Sergipe, and 
Tocantins, provided certain conditions are met. Accordingly, we are 
proposing to amend the regulations in Sec.  94.22 to allow the 
importation of fresh beef from that region in Brazil. Under this 
proposed rule, fresh beef from that region of Brazil would be subject 
to the same import conditions under Sec.  94.22 as 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 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 
Brazil to the list of regions that we recognize as free of rinderpest, 
which can be viewed at http://www.aphis.usda.gov/import_export/animals/animal_import/animal_imports_rinderpest.shtml. Historically, 
rinderpest virus has never become established in North America, Central 
America, the Caribbean Islands, or South America. A brief incursion 
into Brazil occurred in 1921 but was limited in scope and quickly 
eradicated.

Miscellaneous

    Our proposed addition of the exporting region of Brazil to the 
regulations in Sec.  94.22 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.  94.22.

Risk Analysis

    Drawing on data submitted by the Government of Brazil 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 Brazil 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), maturated, deboned beef can be safely imported into the 
United States from this region in Brazil.

Scope of the Evaluation Being Requested

    We conducted our risk analysis in response to an official request 
from Brazil that APHIS allow the importation of fresh (chilled or 
frozen), maturated, deboned beef into the United States from a 
designated region consisting of 14 Brazilian States. The region 
includes the States of Bahia, Distrito Federal, Esp[iacute]rito Santo, 
Goi[aacute]s, Mato Grosso, Mato Grosso do Sul, Minas Gerais, 
Paran[aacute], Rio Grande do Sul, Rio de Janeiro, Rond[ocirc]nia, 
S[atilde]o Paulo, Sergipe, and Tocantins.
    Given the history of FMD in Brazil and the fact that Brazil 
vaccinates its cattle population in most States against FMD, APHIS 
conducted this risk analysis to evaluate the potential for FMD 
introduction and establishment through importation of beef from Brazil. 
Data and background information were obtained from Brazilian animal 
health officials. Much of the supporting information for this analysis 
consists of records obtained from MAPA. In addition, APHIS conducted 
five site visits to Brazil, in 2002, 2003, 2006, 2008, and 2013, to 
verify and complement the information provided by Brazil.

Veterinary Control and Oversight

    APHIS reviewed Brazil's FMD control and eradication program during 
its site visits in 2002, 2003, 2006, 2008, and 2013, and concluded that 
the program is effective at the local and national levels. We 
determined that MAPA could detect disease quickly, limit its spread, 
and report it promptly. This capacity was in evidence in the FMD 
outbreaks in 2005 and 2006, when the cases were quickly identified, 
disease was contained, and international authorities were notified in a 
timely manner.
    APHIS considers that MAPA has sufficient legal authority to carry 
out official control, eradication, and quarantine activities. MAPA has 
a system of official veterinarians and support staff in place for 
carrying out field programs and for import controls and animal 
quarantine. Field activities are coordinated through the State 
Agricultural Secretariat offices. Review of veterinary infrastructure 
with MAPA officials demonstrated an infrastructure adequate for rapid 
detection of FMD and for carrying out surveillance and eradication 
programs. Field offices appeared to be adequately 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 or to 
have had some experience with clinical signs of FMD. It is expected 
that they would suspect FMD if they were to see clinical signs of it. 
With regard to indemnity procedures, we concluded that sufficient funds 
may be available to compensate owners for depopulated animals and that 
indemnity provisions can be extended to exposed animals. 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 the Brazilian States of Rio Grande Do 
Sul in 2000-2001 and in Paran[aacute] and Matto Grosso do Sul in 2005-
2006. In the course of evaluating the potential disease risk posed by 
importation of fresh beef from the export region into the United 
States, we did not detect any evidence to suggest that active outbreaks 
of FMD exist in the proposed exporting region.
    Vaccination of cattle and buffalo is mandatory in the proposed 
export region. Other species are not vaccinated on a regular basis in 
Brazil. Vaccination coverage was reported to range between 76 and 99.9 
percent in the export region.
    The vaccine used is an inactivated, trivalent, oil-based vaccine. 
All FMD vaccines produced or used in Brazil must be tested for quality 
and safety by the official service. Quality control tests

[[Page 77373]]

of each batch of the vaccine are conducted in two laboratories, located 
in Recife (Pernambuco State) and Porto Alegre, and strictly follow 
international standards as set by the World Organization for Animal 
Health (OIE).
    We concluded that Brazil 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

    Agriculture in Brazil supports the economy, and agricultural 
commodities constitute 37 percent of total exports. The domestic animal 
population consists of 183,000,000 cattle, 1,100,000 buffaloes, 
14,800,000 sheep, 12,100,000 goats, and 33,000,000 pigs. Of these 
amounts, 84 percent of the cattle population and the premises that hold 
them 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. 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.
    Brazil has an efficient and effective traceability system, which 
includes a voluntary national identification system for cattle and 
buffalo being exported to different countries, including the European 
Union (EU). A unique 17-digit identification code is given to each 
animal and is registered in a national database managed by MAPA. The 
use of this national identification system enhances Brazil's ability to 
certify the origin of animals entering the export channels.
    The auction system in the country is well-organized and tightly 
controlled by the official service. In addition, there is no evidence 
to suggest that major movements of animals into export channels occur 
through the auction system.
    Adequate controls and inspection measures exist at slaughter 
facilities in Brazil. 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 
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 Brazil.
    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 facilities are integrated 
within these operations and are under adequate official control and 
inspection.
    We concluded that Brazil 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 also exists and is considered adequate to control import and 
export of beef products.

Epidemiological Separation From Potential Sources of Infection

    Adjacent regions that were considered in our risk analysis were an 
affected zone in Brazil adjacent to the export region and the 
neighboring countries of Paraguay, Uruguay, Bolivia, and Argentina. The 
most recent outbreak in the adjacent region of Brazil occurred in June 
2004 in the State of Par[aacute], Monte Alegre district. APHIS does not 
consider the countries of South America to be FMD-free, with the 
exception of Chile. Outbreaks have occurred in Argentina, Uruguay, and 
Paraguay, all 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, and Peru.
    There is a history of introduction of disease into Brazil from 
neighboring countries (2000-2002). According to Brazilian officials, 
illegal movement of animals from neighboring countries, as well as 
mechanical transmission of the virus resulted in introducing the 
disease into Brazil. In 2000 and 2001, Brazil became vulnerable to the 
introduction of the disease due its presence in Argentina. Brazil 
successfully instituted emergency measures in 2002 when an outbreak 
occurred in Paraguay near its border with Brazil. Similar actions in 
2003 appear to have resulted in preventing the introduction of the 
disease from Argentina and Paraguay and in 2011 from Paraguay. 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 Brazil are stringent. MAPA 
requires that all cattle owners identify their animals with a unique 
brand. Sheep and swine are identified by a brand in the ear. 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 relatively high, as noted above.
    There is good cooperation between Brazilian Federal agencies and 
their international counterparts at land border crossings. At some 
border locations, authorities from Brazil and the neighboring countries 
were present, which increased efficiency and effectiveness in 
controlling movement of animals and animal products.
    Movement controls at international land checkpoints appear to be 
adequate. Movement control measures and biosecurity at airports and 
seaports were impressive.
    APHIS attempts to target the riskiest border crossings (and other 
areas) during site visits as an example of a type 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 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 Brazil 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. 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 and 
buffaloes are inspected every 6 months by vaccinators and official 
veterinarians, when the bovines gather in corrals for vaccination. 
Local veterinary unit personnel carry out special visits to certain 
herds that are classified as ``risky'' by the official

[[Page 77374]]

service. Animals are individually inspected by personnel from the 
official service for signs of vesicular disease 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 sanitary status of the State of 
origin or the country sharing borders with the export region.
    Brazil 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 the Brazilian Department of Animal 
Health considers FMD-free. The surveys aim to prove that the zone 
remains free of viral activity. Serological testing is also conducted 
whenever there is a suspicion of 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 
community structure in Brazil and relies heavily on the participation 
of the community. Brazilian animal health 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 Brazil led APHIS to 
conclude that the Brazilians 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 
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 August 2010, 
appears well designed and executed.

Diagnostic Laboratory Capabilities

    MAPA has four laboratories under its direct supervision that 
perform diagnostic tests for FMD and other vesicular diseases. These 
laboratories are located in the States of Rio Grande do Sul, 
Par[aacute], Minas Gerais, and Pernambuco. In addition, the Pan-
American Foot-and-Mouth Disease Center Laboratory (PANAFTOSA) in Rio de 
Janeiro is the reference laboratory for FMD in Brazil and neighboring 
countries. At the time of our 2013 site visit, only the laboratory in 
Par[aacute] processed infectious material. PANAFTOSA's laboratory work 
involving any infectious material is performed at the Par[aacute] 
laboratory.
    Based on laboratory site visits conducted in 2002, 2008, and 2013, 
we concluded that Brazil has the diagnostic capability to adequately 
test samples for the presence of the FMD virus. The laboratories in Rio 
Grande do Sul, Par[aacute], Minas Gerais, and Pernambuco have 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 at the facilities visited in 
2002, 2008, and 2013 were well-trained and motivated. Samples are 
turned around quickly.

Emergency Preparedness and Response

    Brazil's efficient and effective traceability system is an 
important component of its emergency response capacity. As noted above, 
Brazil uses a voluntary national identification system, which includes 
individual animal identification numbers, for cattle and buffalo that 
are destined for export. In addition, Brazil uses a mandatory 
identification system to track the entire animal population of the 
country by lot. That system proved to be extremely effective during the 
2005-2006 FMD outbreaks in the traceback of all contacts.
    Brazil 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 State level.
    APHIS concluded that adequate legal authority, funding, personnel, 
and resources exist at both the State and Federal levels to carry out 
emergency response measures. The emergency response is both rapid and 
effective, as shown following the FMD outbreaks in Rio Grande do Sul in 
2000-2001 and Mato Grosso do Sul and Parana in 2005-2006.
    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 a region of Brazil under the conditions enumerated above. 
It also establishes that Brazil has adequate veterinary infrastructures 
in place to prevent, control, and manage FMD and outbreaks. Therefore, 
we are proposing to amend Sec.  94.22 to allow the importation of fresh 
beef from a region of Brazil under the conditions described above.

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    This proposed rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866 and 13563, which direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, and equity). Executive Order 13563 emphasizes the importance 
of quantifying both costs and benefits, of reducing costs, of 
harmonizing rules, and of promoting flexibility. The economic analysis 
also provides an initial regulatory flexibility analysis that examines 
the potential economic effects of this rule on small entities, as 
required by the Regulatory Flexibility Act. The economic analysis is 
summarized below. 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

[[Page 77375]]

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.
    This proposed rule would amend the regulations governing the 
importation of certain animals, meat, and other animal products by 
allowing, under certain conditions, the importation of fresh (chilled 
or frozen) beef from a region in Brazil composed of the States of 
Bahia, Distrito Federal, Esp[iacute]rito Santo, Goi[aacute]s, Mato 
Grosso, Mato Grosso do Sul, Minas Gerais, Paran[aacute], Rio Grande do 
Sul, Rio de Janeiro, Rond[ocirc]nia, S[atilde]o Paulo, Sergipe, and 
Tocantins.
    Effects of the proposed rule are estimated using a partial 
equilibrium model of the U.S. agricultural sector. Economic impacts are 
estimated based on interactions among the grain, livestock, and 
livestock product sectors. Annual imports of fresh (chilled or frozen) 
beef from Brazil are expected to range between 20,000 and 65,000 metric 
tons (MT), with volumes averaging 40,000 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 that about two-thirds of the beef 
imported from Brazil would displace beef that would otherwise be 
imported from other countries. Thus, the net increase in beef imports 
would correspond to about one-third of the quantity supplied by Brazil 
under each of the three scenarios.
    The model shows that if the United States were to import 40,000 MT 
of beef from Brazil, total U.S. beef imports would increase by less 
than 1 percent. Due to the increase in supply, it is estimated that the 
wholesale price of beef, the retail price of beef, and the price of 
cattle (steers) would decline by 0.11 percent, 0.04 percent, and 0.14 
percent, respectively. Changes in U.S. beef production, consumption, 
and exports in response to these very small price declines would be 
inconsequential: Beef production would decrease by 0.01 percent, beef 
consumption would increase by 0.06 percent, and beef exports would 
increase by 0.11 percent. The 20,000 MT and 65,000 MT import scenarios 
show similarly small quantity and price effects.
    The fall in beef prices and resulting decline in U.S. production 
would translate into reduced returns for producers in the livestock and 
beef processing sectors. Under the 40,000 MT import scenario, cattle 
producers and beef processors are estimated to incur declines in 
welfare of 0.68 percent and 0.14 percent, respectively.
    The shift by consumers to beef due to the price decline would cause 
downward pressure on the prices of pork and other meats. The largest of 
these market declines, though still very small, would be for swine and 
pork. It is estimated for the 40,000 MT import scenario that the 
welfare of swine producers and pork processors would decline by 0.02 
percent and 0.01 percent, respectively.
    The decline in beef prices because of imports from Brazil would 
benefit consumers. It is estimated for the 40,000 MT import scenario 
that the welfare of beef consumers would increase by 0.16 percent. 
Consumers of pork and other animal products would benefit negligibly.
    The model indicates that, when the gains of beef consumers and the 
losses of producers are accounted for, the net welfare gain would be 
equivalent to about $185 million, whereas pork producer welfare losses 
would slightly outweigh pork consumer gains. For all modeled sectors, 
the net welfare change would be positive, with consumer gains of $354 
million outweighing producer losses of $165 million.
    Welfare effects for the 20,000 MT and 65,000 MT import scenarios 
are similar to those described. For all three scenarios, welfare gains 
are shown to be greater than welfare losses, with the net benefits 
increasing broadly in proportion to the quantity of beef imported from 
Brazil. The greater the volume of imports, the greater the welfare 
benefits would be for consumers and the greater the losses for 
producers.
    While most of the establishments affected by this rule would be 
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 a region in Brazil, 
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-
2009-0017. Please send a copy of your comments to: (1) Docket No. 
APHIS-2009-0017, Regulatory Analysis and Development, PPD, APHIS, 
Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238, 
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.
    Currently, APHIS allows imports of fresh (chilled or frozen) beef 
and ovine meat from Uruguay, provided that the meat is imported subject 
to conditions specified in 9 CFR 94.22. Under Sec.  94.22, APHIS must 
collect information, prepared by an authorized certified official of 
the Government of Uruguay, certifying that specific conditions for 
importation have been met.

[[Page 77376]]

    This proposed rule would allow the importation of fresh (chilled or 
frozen) beef from a region in Brazil (the States of Bahia, Distrito 
Federal, Esp[iacute]rito Santo, Goi[aacute]s, Mato Grosso, Mato Grosso 
do Sul, Minas Gerais, Paran[aacute], Rio Grande do Sul, Rio de Janeiro, 
Rond[ocirc]nia, S[atilde]o Paulo, Sergipe, and Tocantins) under the 
same conditions currently applied to Uruguay.
    APHIS is asking OMB to approve its use of this information 
collection activity to facilitate its ability to ensure that beef 
products from Brazil can be imported safely into the United States.
    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 hour per response.
    Respondents: Authorized veterinary officials employed by the 
Government of Brazil.
    Estimated annual number of respondents: 1,606.
    Estimated annual number of responses per respondent: 1.
    Estimated annual number of responses: 1,606.
    Estimated total annual burden on respondents: 1,606 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 as follows:
0
a. In paragraph (b)(4), by removing the words ``from Uruguay''.
0
b. In paragraph (d), introductory text, by removing the words ``from 
Uruguay''.
0
3. Section 94.22 is revised to read as follows:


Sec.  94.22  Restrictions on importation of fresh (chilled or frozen) 
beef from Brazil and fresh beef and ovine meat from Uruguay.

    Notwithstanding any other provisions of this part, fresh (chilled 
or frozen) beef from a region in Brazil composed of the States of 
Bahia, Distrito Federal, Esp[iacute]rito Santo, Goi[aacute]s, Mato 
Grosso, Mato Grosso do Sul, Minas Gerais, Paran[aacute], Rio Grande do 
Sul, Rio de Janeiro, Rond[ocirc]nia, S[atilde]o Paulo, Sergipe, and 
Tocantins, 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 Brazil or in 
Uruguay.
    (b) Foot-and-mouth disease has not been diagnosed in the exporting 
region of Brazil 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 under Sec.  94.1(a).
    (i) 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 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.

    Done in Washington, DC, this 13th day of December 2013.
 Edward Avalos,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2013-30464 Filed 12-18-13; 8:45 am]
BILLING CODE 3410-34-P