[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Rules and Regulations]
[Pages 37923-37934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16337]



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  Federal Register / Vol. 80, No. 127 / Thursday, July 2, 2015 / Rules 
and Regulations  

[[Page 37923]]



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: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are amending 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, 
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). 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 provides 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: Effective August 31, 2015.

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.
    On December 23, 2013, we published in the Federal Register (78 FR 
77370-77376, Docket No. APHIS-2009-0017) a proposal \1\ to allow, under 
certain conditions, 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).
---------------------------------------------------------------------------

    \1\ To view the proposed rule, the supporting risk assessment, 
economic analysis, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2009-0017.
---------------------------------------------------------------------------

    We solicited comments concerning our proposal for 60 days ending 
February 21, 2014. We reopened and extended the deadline for comments 
until April 22, 2014, in a document published in the Federal Register 
on February 27, 2014 (79 FR 10999, Docket No. APHIS-2009-0017). We 
received 870 comments by that date. They were from producers, trade 
associations, veterinarians, representatives of State and foreign 
governments, and individuals. They are discussed below by topic.

    Note:  In our December 2013 proposed rule, we proposed to amend 
Sec.  94.22 to allow the importation of fresh beef from Brazil 
subject to the conditions already laid out in that section for the 
importation of beef and ovine meat from Uruguay. Because that and 
other sections in part 94 have been redesignated since the 
publication of the proposed rule, in this final rule, we are 
amending Sec.  94.29 instead.

General FMD Risk

    Many commenters, citing the highly contagious nature of FMD, 
expressed the view that we should not allow fresh beef to be imported 
from any country where the disease is present because regionalization 
is not likely to mitigate the risks associated with imports 
effectively. Commenters noted that the FMD virus can travel up to 60 
miles on the wind. Commenters also cited bird fecal matter and people 
traveling between affected and non-affected areas as additional vectors 
for transmission of the virus.
    As noted in the risk assessment accompanying the December 2013 
proposed rule, we considered the epidemiological characteristics of 
FMD. Based on our assessment, we concluded that beef from the exporting 
region of Brazil could safely be imported into the United States, 
provided that FMD has not been diagnosed in that region within the past 
12 months, that there is no commingling of bovines or beef from that 
region with animals or beef from other regions prior to export, and 
that certain additional FMD-mitigation requirements, which include 
removal of bones and certain tissue and chilling of the carcasses until 
they reach a pH level of under 6.0, are met. We evaluated information 
submitted by Brazil's Ministry of Agriculture, Livestock and Food 
Supply (MAPA) and verified the accuracy of that information by 
conducting site visits. We concluded that Brazil has the legal 
framework, animal health infrastructure, movement and border controls, 
diagnostic capabilities, surveillance programs, and emergency response 
capacity to prevent FMD outbreaks within the boundaries of the 
Brazilian export region and, in the unlikely event that one should 
occur, to detect, control, and eradicate the disease. Brazil's active 
and passive surveillance system would allow for rapid detection. In the 
event of an

[[Page 37924]]

outbreak, in the exporting region, Brazil would promptly report 
findings to the World Organization for Animal Health (OIE), and the 
United States would stop importing beef from Brazil. Our findings 
regarding Brazil's disease-control capabilities give us confidence that 
the mitigation methods required under this rulemaking will safely 
permit the importation of fresh beef from Brazil.
    Some commenters cited FMD's 14-day incubation period as an 
additional risk factor. It was suggested that infected cattle may not 
exhibit clinical signs of FMD during the incubation period. According 
to those commenters, such cattle could be slaughtered and enter the 
food chain, with the FMD-infected beef derived from them potentially 
being exported to the United States. Commenters advised us to adopt 
what they stated was the recommendation of the OIE for a 3-week 
quarantine of animals from which beef for export is to be derived and 
for the complete segregation of animals in the export zone from animals 
in adjacent infected zones.
    APHIS disagrees with the commenters. The OIE guidelines do not 
require the quarantine of cattle whose beef is destined for exportation 
from FMD-free regions with vaccination. Article 8.7.24 of the OIE 
Terrestrial Animal Health Code states that veterinary authorities of 
countries importing fresh meat from countries or regions recognized by 
the OIE as FMD-free with vaccination should require the presentation of 
an international veterinary certificate attesting that the entire 
consignment of meat comes from animals which (1) have either been kept 
in the free-with-vaccination region or country or otherwise meet OIE 
requirements for live animal imports under Chapter 8.7 and (2) have 
been slaughtered in an approved abattoir and have been subjected to 
ante- and post-mortem inspections for FMD with favorable results. 
Similarly, under this rulemaking we require that the animals from which 
the meat is derived must have been born and raised in the exporting 
region. Because the animals would have lived only in the exporting 
region, they would be unlikely to have been exposed to the FMD virus, 
and, if exposed, would have been immunized against the particular FMD 
strains that are prevalent in the region. APHIS does recognize the 
possibility, however remote, that because cattle that are in the early 
stages of the FMD incubation period may not show clinical signs of FMD, 
an ante-mortem inspection could fail to detect the disease, and FMD-
infected cattle could be presented for slaughter, processing, and 
export of meat. In our view, however, the additional mitigation 
measures contained in this rulemaking, which include requiring the 
maturation of the beef in a chiller until the pH level in the 
longissimus dorsi is less than 6.0 and the removal of bovine parts, 
such as the head, feet, and internal organs, that are associated with a 
higher FMD risk than muscle tissue will ensure that beef may be safely 
imported into the United States from Brazil.
    Some of the comments expressed reservations about the efficacy of 
the maturation requirements contained in the proposed rule, which 
included chilling of the carcass after slaughter for a minimum of 24 
and a maximum of 48 hours to ensure that the pH in the loin muscle will 
be below 6.0. One commenter stated that chilling beef may be inadequate 
for eliminating the FMD virus, since that virus can remain active in 
blood clots. Another commenter stated that the reduction of pH is not 
included as one of the recognized procedures for the inactivation of 
FMD virus in meat in the OIE Terrestrial Animal Health Code. It was 
suggested that, in order to effectively reduce the risk of FMD virus 
presence in meat, freezing should occur after maturation. According to 
one commenter, however, if freezing occurs too early after slaughter, 
any FMD virus that is present in the meat may survive for months.
    Based on the existing scientific literature, it is generally 
accepted that FMD virus is inactivated at pH 6.0 or below after 
maturation at a temperature of 4 [deg]C. Acidification of skeletal 
muscle that takes place during carcass maturation is normally 
sufficient to inactivate FMD virus in this tissue, even when cattle are 
killed at the height of viremia. Because it is known that the required 
level of acidification cannot be guaranteed under all circumstances, 
measuring of the pH level of the carcass muscle can be used to ensure 
that it has occurred.
    APHIS agrees that chilling alone may not be adequate to eliminate 
the virus. Other tissues, organs, etc., that may harbor FMD virus, such 
as blood clots, heads, feet, viscera, bones, and major lymph nodes, do 
not undergo acidification, allowing the virus to survive the maturation 
process and subsequent low-temperature storage. Under this rulemaking, 
however, as noted previously, these tissues and organs must be removed 
from the carcasses prior to export to the United States.
    Some commenters, though, also questioned the efficacy of those 
mitigation measures. It was stated that their effectiveness had not 
been demonstrated conclusively by the scientific literature. It was 
claimed that there is no agreed safe threshold level in the literature 
for FMD virus contamination for deboned beef. It was also claimed that 
scientific information is lacking on the amount of residual blood clot, 
lymph node, and bone tissue remaining after deboning, which is a 
concern because, as noted above, FMD virus can survive maturation in 
the lymph nodes and bone marrow. Information was also said to be 
lacking on the survivability of the FMD virus in deboned beef from 
carcasses where the normal acidification of skeletal muscle had not 
occurred and on FMD survival in fat tissues.
    APHIS recognizes that blood clots and lymph nodes do not undergo 
acidification. As explained above, however, under this rulemaking, 
these tissues and organs must be removed from the carcasses prior to 
export to the United States. Carcasses in which normal acidification 
has not occurred would not be eligible for export to the United States. 
The rule allows the importation of muscle tissue, but not fat, into the 
United States. The demonstrated efficacy of maturation in inactivating 
the FMD virus in carcasses has already been noted. Even where marbling 
occurs, the maturation process is sufficient to inactivate the FMD 
virus.
    A number of commenters expressed reservations about the 
effectiveness of vaccinating animals as a means of mitigating the risk 
of exposing U.S. livestock to FMD via imported beef. It was stated that 
vaccinated animals may become FMD carriers; that vaccinations are not 
foolproof due to variations in disease strain (FMD has seven distinct 
serotypes), mutations, and differences in susceptibility of organisms; 
and that wildlife cannot be vaccinated. The Government of Nicaragua, in 
comments submitted, claimed that the efficacy of immunization via 
vaccination with strains of attenuated virus remains a subject of 
scientific debate. Commenters further stated that FMD may spread by 
means of contaminated vaccines or the escape of the virus from vaccine 
production facilities. It was suggested that APHIS should stick to its 
previous policy of allowing imports only from regions free of a disease 
without vaccination.
    APHIS acknowledges that vaccination of livestock has certain 
limitations as a risk-mitigation measure and for that reason, does not 
recognize a country that vaccinates for FMD as free of the disease. 
Vaccination of cattle against FMD introduces risks related to the 
immunological response within the vaccinated herd. While a large

[[Page 37925]]

percentage of individual animals in the herd may fully respond to FMD 
vaccination, some animals may have a limited response, resulting in 
partial or no immunity. Still, the scientific literature and decades of 
epidemiological, surveillance, and trade data indicate that the 
combination of vaccination and the mitigation measures we require under 
this rulemaking, (e.g., inspection, removal of certain tissue from the 
carcasses, and maturation), are adequate to appropriately minimize the 
risk of introduction of FMD into the United States via the importation 
of fresh beef from countries that vaccinate for FMD. In 2003, APHIS 
authorized the importation of fresh beef under the same conditions that 
are found in this rule from Uruguay, a region that, like the exporting 
region of Brazil covered under this rule, is free of FMD with 
vaccination. The importation of such Uruguayan beef has not been 
associated with an increased risk of FMD. Further, as we described in 
the risk assessment and will discuss in greater detail later in this 
document, Brazil has an effective vaccination program. Quality control 
measures are in place to ensure that the FMD virus will not be spread 
by contaminated vaccines or insufficient biosecurity measures at 
vaccine production facilities. FMD vaccine production in Brazil 
complies with international guidelines.
    Some commenters expressed reservations about APHIS' ability to 
prevent the introduction of FMD into the United States via beef imports 
from Brazil and to respond to an outbreak should one occur. It was 
stated that APHIS has neither the physical and financial resources to 
adequately inspect Brazilian beef production and processing sites or to 
control an outbreak in the United States. Additionally, some commenters 
stated that production and distribution of appropriate vaccines could 
prove challenging in the event of an outbreak in the United States.
    We disagree with some of these comments. In carrying out our 
safeguarding mission, APHIS works to ensure the continued health and 
welfare of our nation's livestock and poultry. One important aspect of 
this work is making sure we can readily detect foreign animal diseases, 
such as FMD, and respond efficiently and effectively when faced with an 
outbreak. APHIS partners with other Federal, State, and local 
government agencies and private cooperators to expand the pool of 
available resources we can draw on in an emergency. We recognize that, 
depending on the size and scope of an outbreak, the production and 
distribution of vaccines could prove challenging. While we do have a 
resource in the North American Foot-and-Mouth Disease Vaccine Bank, 
which stores many types of inactivated FMD virus antigens, this 
resource might be overwhelmed in the face of a large and expanding 
outbreak. APHIS continues to discuss this issue and engage our 
stakeholders in planning and preparation for any response.
    As discussed later in this document and in the risk assessment, we 
consider the feeding of FMD-contaminated waste to susceptible animals, 
particularly swine, to be the most likely pathway for the transmission 
of the disease. A commenter representing the pork industry questioned 
whether budget cuts to APHIS and State animal health staffs have had a 
negative effect on the ability to carry out the regulatory activities 
outlined in the Swine Health Protection Act (SHPA), and if so, whether 
the resulting reduction in regulatory activities had decreased the 
number of inspections and searches for unlicensed garbage-feeding 
operations to a level lower than that we found in a pathway analysis we 
conducted in 1995 to estimate the likelihood of exposing swine to 
infected waste.
    Budget cuts to APHIS have necessitated a reordering of priorities 
in relation to SHPA-related activities. We have deemphasized or passed 
on to State partners or other cooperators lower-yield activities, such 
as visiting restaurants to inquire about garbage-disposal methods, in 
favor of allowing inspectors to spend more time interacting with and 
educating swine producers and conducting inspections. The regular 
presence of APHIS inspectors in U.S. garbage feeding facilities 
provides opportunities to educate operators on disease signs and 
reporting requirements and to conduct direct observation of animals for 
signs of illness. APHIS believes, therefore, that the presence of 
animal products infected with FMD or other reportable conditions 
entering the United States would be detected more quickly in these 
types of premises than in other, unregulated premises.

Brazilian Disease Control Measures

    Many commenters opposed the December 2013 proposed rule on the 
grounds that, contrary to the conclusions of our risk assessment, 
Brazil's existing disease-control measures are inadequate to prevent 
producers in that country from exporting FMD-contaminated beef to the 
United States. Commenters expressed concerns about, among other things, 
Brazil's vaccination program, testing and disease reporting protocols, 
slaughter plant procedures, veterinary infrastructure, international 
border and internal movement controls, and the possibility of wildlife 
infecting the Brazilian cattle herd with FMD.
    We have already noted that some commenters questioned the efficacy 
of vaccination as a means of combatting the spread of FMD. A number of 
commenters also expressed reservations specific to Brazil's vaccination 
procedures. It was stated that Brazil's reported 77 to 99 percent 
vaccination rate is inadequate for preventing the spread of FMD, that 
not all Brazilian States vaccinate, and that the lowest vaccination 
rate in the exporting region is in Mato Grosso, which has the country's 
highest cattle population. It was suggested, as noted above, that FMD 
could spread in Brazil through contaminated vaccines or escapes of the 
virus from vaccine production facilities. In addition, one commenter 
expressed concern about the qualifications of some individuals 
administering vaccinations in Brazil, noting that farmers may vaccinate 
their own animals or hire professionals who do not have to be 
registered with or accredited by the Brazilian Government to do the job 
for them.
    In Brazil, vaccination is used to prevent the transmission of the 
FMD virus in the event that the disease were to be introduced in the 
region. Vaccination of cattle and buffalo is required in the exporting 
region. The aim of the vaccination program is to immunize at least 80 
percent of bovines in a region in order to provide the protection and 
herd immunity needed to stop the spread of disease. While our risk 
assessment indicated that there was 76 percent coverage of bovines 
under 12 months of age in Mato Grosso, the much higher vaccination 
rates for bovines over that age, which represent most of the bovine 
population in the State, means that the overall vaccination rate there 
well exceeds 80 percent. More recent data described in a peer reviewed 
Journal, indicates that the vaccination coverage in Brazil as a whole 
exceeded 95 percent during the 2007-2011 (http://dx.doi.org/10.1098/rstb.2012.0381). All FMD vaccines produced or used in Brazil must 
follow OIE guidelines, including being tested for quality and safety by 
government officials. APHIS did not detect any evidence to suggest that 
unacceptable biologics or vaccines are being used in Brazil. 
Vaccination records are verified by local veterinary unit (LVU) 
personnel and may also be verified by field inspectors visiting 
individual premises. Despite the fact that Brazilian State or

[[Page 37926]]

Federal personnel do not physically observe all vaccinations, records 
in LVU offices that were reviewed by APHIS indicated that vaccination 
coverage was quite complete, reaching almost 100 percent.
    Many commenters expressed concern about Brazil's disease-testing 
and reporting standards, citing delays in reporting a 2010 case of 
bovine spongiform encephalopathy (BSE) and in conducting the required 
testing in the wake of the detection and sending the OIE lab samples. 
It was also noted that during the time between the discovery of the 
case and the reporting of it, Brazil continued shipping processed meat 
to the United States.
    APHIS agrees that the delays in the testing and reporting of the 
atypical BSE case detected in Brazil were problematic. Representatives 
of APHIS and the U.S. Department of Agriculture's Food Safety and 
Inspection Service (FSIS) visited Brazil in February 2013 to evaluate 
the BSE laboratory infrastructure, emergency response capabilities, and 
BSE-related mitigations at the slaughter level. In addition, as a 
result of the delays in testing and reporting of this case, MAPA 
conducted audits of the laboratories to identify areas for change and 
improvement and subsequently implemented several new procedures to 
assure the timely testing of samples and reporting of results. These 
included the addition of a second laboratory to conduct 
immunohistochemistry tests, the expansion of testing capabilities, and 
the development of an inter-laboratory data management system to issue 
reports, record improper samples, and flag delays in sample receipt, 
completion, and notification of test results.
    To evaluate Brazil's FMD-related laboratory capabilities, APHIS' 
risk assessment included site visits to various diagnostic laboratories 
in Rio Grande do Sul, Par[aacute], Recife, and Pernambuco in 2002, 
2008, and 2013. Based on those visits, APHIS concluded that Brazil has 
the diagnostic capability to adequately test samples for the presence 
of the FMD virus. Staffing was sufficient at the facilities, and staff 
members were well-trained and motivated. Laboratory equipment was 
adequate for diagnosing FMD, and quality control activities included 
routine monitoring and calibrating of the equipment. The tests used to 
investigate evidence of viral activity were consistent with OIE 
guidelines. The laboratories also had effective and efficient 
recordkeeping systems for storage and retrieval of data, and were able 
to turn samples around quickly.
    Some commenters claimed that Brazil has failed to report detections 
of FMD within its cattle population and, therefore, could not be relied 
upon to report such detections in the future.
    We disagree with the commenters. During the FMD outbreaks in 2005 
and 2006, MAPA demonstrated that it has the capability to detect 
disease quickly, limit its spread, and report promptly. FMD cases were 
quickly identified, the disease was contained, and international 
authorities were notified in a timely manner. Further, as stated in our 
risk assessment, we did not detect any evidence to suggest that active 
outbreaks of FMD exist in the export region. Despite occasional 
outbreaks of FMD in Brazil and in neighboring countries of South 
America, APHIS considers the disease to be under control in the export 
region.
    It was also noted that the protocols in place for reporting disease 
within Brazil depend on self-reporting by producers, which some 
commenters view as an unreliable method.
    While passive disease surveillance in Brazil relies on self-
reporting, producers, veterinarians, and others are required by law to 
report clinical signs of FMD to veterinary authorities. Failure to 
comply with FMD reporting requirements may result in penalties or 
fines.
    Many commenters, noted that the exporting zone in Brazil borders 
FMD-affected regions, including the affected zone in Brazil, as well as 
Paraguay, Bolivia, and Argentina, and is not separated from all those 
regions by physical or geographic barriers. Commenters pointed out that 
there has been a history of FMD incursions in Brazil from neighboring 
countries and that as long as FMD remains endemic in South America, the 
possibility of reintroduction from those neighboring countries exists. 
Concerns were expressed about the adequacy of Brazil's border control 
measures. Commenters stated, among other things, that Brazil's border 
with Peru is not fixed and secure, that Brazil does not effectively 
control cattle coming in from Paraguay, and that there have been 
eyewitness accounts of unmanned Brazilian border inspection posts. A 
commenter stated that there was a discrepancy between our risk 
assessment and our environmental assessment in the way we characterized 
the physical barriers between the exporting region and affected regions 
and the possibility of virus transmission across those barriers. It was 
stated in the environmental assessment that some areas that APHIS 
regards as barriers could actually be wildlife disease reservoirs, but 
that the risk assessment contained no such statement.
    In the risk assessment, we discussed the disease status of regions 
adjacent to the export region, the separation of those regions from the 
export region, and border controls. As noted in both that document and 
the environmental assessment, the exporting region has many natural 
barriers, such as large rivers, mountains, forests, and semiarid areas, 
along its international and internal borders. Even in relatively remote 
frontier areas, where there may be less surveillance and monitoring 
than in more populous ones, those geographic barriers restrict animal 
movement and human traffic, thereby preventing the spread of disease. 
In addition, Brazil collaborates with neighboring countries to 
harmonize FMD-related programs and restrictions. Mechanisms have been 
established to provide for immediate notification between these 
countries if an outbreak occurs. High-risk surveillance areas have been 
established on Brazil's borders with Argentina and Paraguay. 
Additionally, as discussed in greater detail below, research has 
determined that wildlife has not played a significant role in the 
maintenance and transmission of FMD in South America. We have added a 
statement to that effect to the environmental assessment, under the 
heading ``Regulatory Control of FMD.''
    One commenter suggested that we add to the final rule a requirement 
for a geographic buffer zone, i.e., a disease-free area, surrounding 
the export region. The commenter did not specify whether such a zone 
should apply to adjacent areas in Brazil or neighboring countries, or 
both.
    Some of the same natural barriers, described above, that separate 
Brazil from neighboring countries also are present along the boundaries 
between the export region and other Brazilian States. Brazil's national 
FMD program provides for surveillance and reporting in the exporting 
area as well as in the adjacent Brazilian States. Buffer zones are 
already employed under Brazil's FMD program in areas where no natural 
barriers exist, along with enhanced border patrols. In addition, 
APHIS's site-visit team did not find any laboratory evidence that FMD 
currently exists anywhere in Brazil.
    Some commenters stated that uncontrolled or inadequately controlled 
movement of wildlife in South America generally, and countries 
bordering Brazil in particular, may pose a risk of spreading FMD into 
the exporting zone of Brazil.

[[Page 37927]]

    Although several South American wild animal species are susceptible 
to FMD, research into FMD in South America has determined that wildlife 
populations, including feral swine, do not play a significant role in 
the maintenance and transmission of FMD. During outbreak situations, 
wildlife may become affected by FMD; however, the likelihood that they 
would become carriers under field conditions is rare. Therefore, it is 
unlikely that FMD would be introduced into the exporting region through 
movement of infected wildlife. Further, Brazil's biosecurity measures, 
surveillance activities, and response capabilities, which we evaluated 
in our risk assessment, would mitigate the already low risk of the FMD 
virus spreading from wildlife to livestock in the exporting region of 
Brazil.
    One commenter stated that Brazil is OIE certified as FMD free in 
just 2 of 26 States and relaxed its vaccination regimen almost 2 years 
ago.
    The OIE currently recognizes the Brazilian State of Santa Catarina 
as FMD-free without vaccination. In addition, however, the OIE 
recognizes States and zones within Brazil as FMD-free with vaccination. 
The area so recognized by the OIE, which largely coincides with part of 
the APHIS exporting region, may be viewed on the OIE Web site at http://www.oie.int/animal-health-in-the-world/official-disease-status/fmd/list-of-fmd-free-members/.
    A commenter stated that beef from Brazil may not meet Canada's 
import requirements and therefore could not be commingled with U.S. 
beef being shipped to Canada. The commenter expressed concern that U.S. 
beef exporters wishing to export beef to Canada could be negatively 
affected as a result of this rule.
    The commenter's statement is correct but is not germane to the 
current rulemaking. Brazil does not export beef to Canada. U.S. 
exporters wishing to export beef to Canada have a legal obligation to 
meet that country's requirements by not commingling beef that is 
eligible for export to Canada, with beef that is not.
    Some commenters questioned the efficacy of Brazil's internal animal 
movement controls. Noting that greater market opportunities and the 
resulting higher prices offered in the export region might foster 
illegal animal movements into that region from affected regions in 
Brazil, commenters questioned whether there were sufficiently stringent 
procedures in place in Brazil to restrict such movements. It was 
further stated that a European Commission (EC) audit found deficiencies 
in those controls. Some commenters also stated that Brazil does not 
require animal identification and that its voluntary traceability 
program and applies only to cattle whose meat is intended for countries 
that require traceability from birth, which the United States does not. 
That group of commenters included the Government of Nicaragua, which 
suggested that Brazil's ``unreliable'' traceability system could hinder 
its response to an outbreak of FMD, potentially allowing the disease to 
spread to other countries. One commenter expressed some doubt as to 
whether Brazil's traceability system, even if relatively effective, 
could aid in combatting an FMD outbreak, since traceability was not 
documented as effective in combatting FMD outbreaks in the United 
Kingdom.
    We do not agree with these comments. Based on our review of the 
veterinary infrastructure in Brazil, we determined that MAPA, which 
oversees animal movement within the country, has the legal authority, 
technical capabilities, and personnel to implement the FMD program 
within Brazil. Movement controls in Brazil are stringent. As described 
in the risk assessment, MAPA requires that all cattle owners identify 
their animals with a unique brand. Sheep and swine are identified by a 
brand in the ear. Each LVU keeps a registry of brands and a complete 
registry of the cattle holdings in the region, with animal populations 
listed by age group and sex. The registry of holdings is updated at 
least twice per year, during the vaccination period, or when the 
animals are moved to another place. The LVU must issue an animal 
movement permit (GTA), which is required whenever animals are moved. 
The staff of the LVU is responsible for verifying that the vehicle 
transporting the animals has been cleaned and disinfected as required 
by law. A copy of the GTA is sent to the destination. Any inspection 
associated with animal movement involves checking the documents and 
verifying the animal information, as well as clinical observation of 
animal health. The EC Food and Veterinary Office (FVO) audits conducted 
in 2012 and 2013 found that post-mortem inspection were carried out in 
line with the EU requirements, that FMD related mitigation were 
conducted appropriately, and that Hazard Analysis Critical Control 
Points plans including traceability and maturation were implemented and 
verified by the veterinary authority were found to be satisfactory. In 
its most recent audit, conducted in October 2014, the EC FVO reported 
that that FMD-related requirements were met, and that Brazilian 
officials were able to demonstrate full traceability to farms of 
origin.
    Other commenters expressed broader concerns about Brazil's disease-
control activities, highlighting occasions when, the commenters 
suggested, Brazil may have failed to comply with safety standards. It 
was stated that, in the past, Brazil has failed to maintain equivalent 
safety standards for cooked products exported to the United States, 
causing FSIS to suspend imports of such products, that FSIS has not 
allowed imports from Santa Catarina, which we recognize as FMD-free, on 
the grounds that Brazil's microbiological and residue testing programs 
are deficient, and that repeated audits by FSIS and the EC have shown a 
failure on Brazil's part to promptly institute and maintain corrective 
action for deficiencies noted in previous audits. Commenters suggested 
that the results of those audits indicate that Brazil lacks either the 
willingness or the infrastructure to execute the consistent management 
controls needed to sufficiently mitigate the risk of the introduction 
of FMD into the United States through the importation of fresh beef. 
One commenter suggested that there was a dearth of veterinarians in 
Brazil who had the necessary training and expertise to manage a 
national FMD program.
    As discussed in the risk assessment, APHIS evaluated the veterinary 
infrastructure of Brazil and concluded that MAPA has a system of 
official veterinarians and support staff in place for carrying out 
field programs and implementing import controls and animal quarantine. 
Additionally, MAPA has sufficient legal authority to carry out official 
control, eradication, and quarantine activities. We also determined 
that Brazil's technical infrastructure was adequate for rapid detection 
of FMD and for carrying out surveillance and eradication programs and 
that advanced technologies are utilized in conducting several animal 
health programs. Import controls are sufficient to protect 
international borders at principal crossing points.
    A number of commenters expressed misgivings about Brazil's 
slaughter-plant procedures. It was suggested that Brazilian slaughter 
plants may be deficient on both sanitary and humane grounds. One 
commenter expressed doubt that, given Brazil's previous compliance 
issues, APHIS can be certain that beef imported from Brazil would have 
the lymph nodes removed in all cases, as required under this 
rulemaking. One commenter stated that if a pH meter at a Brazilian 
slaughter

[[Page 37928]]

plant is faulty, infected beef may be exported to United States.
    The commenters did not present specific evidence regarding 
deficiencies on sanitary or humane grounds at Brazilian slaughter 
plants. APHIS evaluated Brazil's ability to carry out slaughter-related 
mitigation measures, including ante-mortem and postmortem inspections 
and deboning and removal of lymph nodes from beef carcasses. We 
concluded that MAPA will be able to enforce compliance with our 
inspection and slaughter-plant processing procedures. Our assessment of 
Brazil's veterinary system included an evaluation of the likelihood of 
compliance with the pH requirement. Brazilian authorities monitoring 
slaughter plants calibrate the pH meters frequently. Beef that does not 
reach the required pH is not allowed to be exported to the United 
States and is diverted to the Brazilian domestic market.
    A few commenters expressed BSE-related concerns about importing 
fresh beef from Brazil. One commenter stated that some countries have 
banned or restricted beef imports from Brazil due to concerns about 
safety, particularly regarding BSE. Another commenter questioned 
whether Brazil tests for E. coli and BSE.
    These comments are beyond the scope of the present rulemaking, 
which contains FMD-related import restrictions. The risk assessment 
supporting the rulemaking specifically examined the potential risk of 
introducing FMD into the U.S. cattle population by allowing imports of 
fresh beef from Brazil under certain conditions. We would note, 
however, that the OIE currently recognizes Brazil as a negligible-risk 
country for BSE, a designation APHIS concurred with in a notice \2\ 
published in the Federal Register on October 1, 2014 (79 FR 59207-
59208, Docket No. APHIS-2013-0064). Should circumstances arise that 
would dictate a change in Brazil's BSE classification to a less 
favorable one, APHIS would require BSE mitigations for imports of beef 
as appropriate to the adjusted risk classification.
---------------------------------------------------------------------------

    \2\ To view the notice and the comments we received, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0064.
---------------------------------------------------------------------------

    Some commenters, citing what they characterized as Brazil's spotty 
record of compliance with safety standards, recommended that APHIS 
consider the development of an ongoing oversight protocol, beyond the 
usual port-of-entry testing, to monitor Brazil's compliance with our 
required risk mitigation measures. It was stated that APHIS has not 
adequately described how it will continue to provide oversight and/or 
monitor Brazil's animal health infrastructure indefinitely, to ensure 
that the country will maintain adequate controls to prevent the spread 
of FMD from other regions of Brazil or from neighboring countries to 
the exporting area.
    The regulations in Sec.  92.2 provide for such monitoring of 
regions after we recognize them for animal health status. We may 
require such a region to submit additional information pertaining to 
its animal health status and may also conduct additional site visits or 
other information collection activities in order to monitor the 
region's continued compliance with our requirements.
    As discussed in greater detail below in the section pertaining to 
issues raised regarding our risk assessment, the findings from that 
assessment led us to conclude that the most likely pathway of exposure 
of domestic livestock to the FMD virus in beef was through feeding of 
contaminated food waste to swine. A commenter representing the pork 
industry questioned whether APHIS has current data regarding the level 
of biosecurity, security, veterinary care, routine health observations, 
and knowledge of disease reporting pathways in garbage-fed populations 
in Brazil. According to the commenter, such data are necessary to meet 
the goal of a foreign animal disease preparation and response plan. The 
commenter further enquired about the level of confidence APHIS has 
regarding the education provided to licensed garbage feeders and 
whether biosecurity and veterinary care protocols and disease reporting 
procedures are being followed in Brazil.
    Licensed garbage feeders are generally provided with education by 
MAPA during routine inspections by Brazilian animal health regulatory 
staff on topics including the importance of proper cooking, signs of 
foreign animal diseases, appropriate biosecurity measures, etc. 
Mandatory inspections conducted by MAPA at least quarterly provide 
confidence in the ability of licensed garbage feeding operations to 
maintain biosecurity and reporting requirement protocols. Demonstration 
of adequate facilities and equipment is a requirement for obtaining and 
maintaining licensure.
    One commenter cited the refusal of countries other than the United 
States whose producers are represented under the Five Nations Beef 
Alliance to accept Brazilian beef as a reason for not allowing it to be 
imported into the United States. The Five Nations Beef Alliance 
consists of the national beef cattle producers' organizations of 
Australia, Canada, Mexico, and New Zealand--our top livestock trading 
partners--as well as the United States. The commenter recommended that 
no Brazilian beef be imported into the United States until all the 
members of the Five Nations Beef Alliance decide that such imports are 
safe.
    We do not agree with this comment. The Five Nations Beef Alliance 
is an industry association that lobbies on behalf of the beef industry 
in support of its economic interests. Our international trade 
agreements permit us to impose only those sanitary and phytosanitary 
measures necessary to protect human, animal, or plant life or health on 
the basis of scientific principles and evidence. We cannot take such 
actions for economic reasons alone or on the basis of the actions of 
industry associations.
    Some commenters stated that any beef we import from Brazil should 
be labeled as such, thus enabling U.S. consumers to make informed 
decisions regarding their beef purchases.
    Country of origin labeling is already required under the 
Agricultural Marketing Service regulations in 7 CFR part 65.
    A commenter stated that there was a lack of information on disease 
serotypes and strains outside the export zone.
    APHIS disagrees with the commenter. In our risk assessment, under 
Factor 3, ``Disease Status of Adjacent Regions'' (pp. 23 to 29), we 
describe FMD outbreaks that occurred in the countries and Brazilian 
States adjacent to the export area, including the serotypes involved in 
the outbreaks over the last 10 years.

Risk Assessment

    A large number of commenters voiced reservations about both the 
methodology we used to conduct our risk assessment of the proposed 
exporting region of Brazil and the conclusions we reached in that 
document.
    Some commenters noted that, in the past, APHIS has characterized 
other countries, (e.g., Argentina, Japan, and South Korea), as low-risk 
countries for FMD, and that, soon after we did so, outbreaks of the 
disease occurred in those countries.
    Because disease situations are fluid and no country, not even the 
United States, can guarantee perpetual freedom from a disease, APHIS' 
risk analyses consider whether a country can quickly detect, respond, 
and report changes in disease situations. In our evaluation, conducted 
according to the factors identified in Sec.  92.2, ``Application for

[[Page 37929]]

recognition of the animal health status of a region,'' we concluded 
that the specified region of Brazil has the legal framework, animal 
health infrastructure, movement and border controls, diagnostic 
capabilities, surveillance programs, and emergency response systems 
necessary to detect, report, control, and manage FMD outbreaks.
    As a member of OIE, Brazil is obligated to immediately notify the 
organization of any FMD outbreak or other important epidemiological 
event. The notification must include the reason for the notification, 
the name of the disease, the affected species, the geographical area 
affected, the control measures applied, and any laboratory tests 
carried out or in progress.
    Upon notification of an FMD outbreak in the exporting region of 
Brazil, APHIS would implement critical prevention measures to respond 
to the outbreak, including alerting U.S. Customs and Border Protection 
inspectors at all ports of entry. Because Sec.  94.29(b) requires that 
FMD must not have been diagnosed in the exporting region within the 
past 12 months, fresh beef from the region would no longer meet our 
requirements, and we would immediately stop importation.
    Some commenters questioned the methodology we employed for the site 
visits to Brazil. It was claimed that there is no obvious evidence of 
any established protocol or methodology to allow for consistency and 
assurance in the quality of the APHIS site visit reviews and that 
documentation pertaining to the visits was lacking or unavailable for 
public review. According to one commenter, documents pertaining to the 
specific methodology and measurements used during the site visits to 
support the qualitative risk assessment should have been available for 
the public to review. It was stated that without sufficient 
documentation, there was no way to distinguish between data obtained 
from the site visits and data supplied by the Government of Brazil. It 
was recommended that APHIS develop a protocol, which it should make 
available to the public, to be used for site visits so that our 
assessments can be analyzed and summarized more objectively.
    APHIS' site visits consist of an in-depth evaluation of the eight 
factors identified in Sec.  92.2 (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) as factors to consider in assessing the risk 
of transmission of an animal disease to U.S. livestock via the 
importation of animals or animal products from a foreign region. Risk 
factors are identified from the information gathered on these topics, 
and applicable mitigations are discussed. The regulations in Sec.  92.2 
are publically available at: http://www.gpo.gov/fdsys/pkg/FR-2012-07-27/html/2012-18324.htm. Further information on site visits is available 
in a guidance document regarding APHIS' approach to implementing its 
regionalization process and the way in which APHIS applies risk 
analysis to the decisionmaking process for regionalization. This 
document is available to the public at: http://www.aphis.usda.gov/import_export/animals/downloads/regionalization_process.pdf.
    Our five site visits to Brazil, conducted in 2002, 2003, 2006, 
2008, and 2013, included visits to Federal, State, and local veterinary 
offices, farms, border control stations, and diagnostic laboratories. 
The findings from these visits are discussed thoroughly in the risk 
assessment document. As noted in that document, the scope of the 2002 
site visit included verification of FMD outbreak controls, an overview 
of the surveillance program and laboratory capabilities, vaccination 
practices and eradication activities, and movement and border controls. 
The focus of the 2003 site visit was to collect data that APHIS used in 
its risk assessment. The focus of the 2006 site visit was to evaluate 
the FMD situation following the 2005-2006 outbreak in Paran[aacute] and 
Mato Grosso do Sul. The focus of the 2008 visit was to evaluate the 
Brazilian State of Santa Catarina for freedom from classical swine 
fever, FMD, African swine fever, and swine vesicular disease. Finally, 
the scope of the 2013 visit included the evaluation of the FMD 
diagnostic capabilities, FMD laboratories, and vesicular disease 
emergency response.
    Another issue raised in regard to our site visits was that not all 
of the factors for animal health status were reviewed during each of 
the site visits by APHIS. It was stated that because each site visit 
had a different focus, some of the information our site-visit teams 
obtained may now be out of date. For example, one commenter claimed 
that some risk factors associated with the importation of beef from 
Brazil, such as movement and border controls, appeared not to have been 
verified through site visits since the 2002 visit.
    Even though a site visit may have a particular focus, all factors 
are evaluated during each visit, with emphasis on changes implemented 
since the previous one. Any observed changes in risk are noted in the 
risk assessment. If no changes are noted, then no changes are made to 
that factor in the risk assessment, and the original date for which 
risk was described is maintained. In the example noted below, movement 
and border controls were verified in site visits subsequent to 2002. 
However, since no significant changes were noted in risk, the 2002 date 
was retained to indicate when the initial observation was made.
    Some commenters viewed the documentation supporting our risk 
assessment as insufficient. It was further noted that some of those 
supporting documents were in Portuguese. As a result, according to the 
commenters, transparency was lacking regarding our research methodology 
and the manner in which we arrived at our conclusions. It was also 
claimed that the documents we did make available lacked consistency and 
evidence of verification of our findings.
    All of the documents that were provided by the Government of Brazil 
have been shared with stakeholders who requested them. APHIS 
acknowledges that some of the documents used as references in the risk 
analysis were submitted to APHIS in Portuguese; however, APHIS 
personnel involved in the evaluation had sufficient language skills to 
read those documents without requiring that they be translated into 
English. In addition, in most instances, the same or related data were 
provided in other documents or verbally presented to APHIS during site 
visits. The information provided by Brazil and the conclusions reached 
are thoroughly described in the risk analysis that was made available 
for public review and comment.
    Some commenters stated that APHIS should prepare a quantitative 
risk assessment for beef from Brazil and make it available for public 
review. Commenters took the position that the qualitative risk 
assessment methodology that we employed is too subjective because it 
fails to quantify objectively the probability of risk and adequately 
assess the magnitude of the consequences of a disease outbreak. Noting 
that APHIS prepared a quantitative risk assessment in 2002 in support 
of the rulemaking allowing the importation of fresh beef from Uruguay, 
commenters questioned why APHIS chose to prepare only a qualitative 
risk assessment for Brazil.

[[Page 37930]]

    Most of APHIS' risk analyses for FMD have been, and continue to be, 
qualitative in nature. APHIS believes that, when coupled with site 
visit evaluations, qualitative risk analyses provide the necessary 
information to assess the risk of the introduction of FMD through 
importation of commodities such as fresh beef. Quantitative risk 
analysis models may not be the best tool to use to assess the risk of 
FMD posed by exports from a country, such as in cases where the types 
of data required by such models are either unavailable or suffer from a 
high level of parameter uncertainty. In these instances, APHIS' 
approach is to characterize the risk of outbreak qualitatively in order 
to determine what appropriate measures to implement in order to 
mitigate the risk posed to the United States in the event of an 
outbreak in the exporting country (e.g., maturation and pH of beef, no 
diagnosis of FMD in the previous 12 months).
    Some commenters raised issues regarding the scope of our risk 
assessment. It was stated that the release assessment, exposure 
assessment, and consequence assessment appeared to be incomplete with 
regard to the necessary steps and requirements described in the OIE 
Terrestrial Animal Health Code.
    We conducted the risk assessment guided by Chapter 2.1 of the OIE 
Terrestrial Animal Health Code, ``Import Risk Analysis.'' The Code 
recommends that risk assessments include four steps: An entry 
assessment, an exposure assessment, a consequence assessment, and an 
overall risk estimation based on the data compiled in the previous 
three steps. A description of each of those steps is included. In 
conducting our risk assessment of Brazil, we followed the steps listed 
in the OIE Terrestrial Animal Health Code. Where there are differences 
between APHIS' methodology and that described by the OIE, they have 
more to do with terminology than methodology. For example, we refer to 
what the OIE terms the entry assessment as a release assessment.
    Some commenters did not view the eight factors listed Sec.  92.2 as 
sufficiently comprehensive for conducting a risk assessment, suggesting 
that we should have relied on the OIE guidelines instead.
    We did evaluate Brazil using the factors listed in Sec.  92.2. 
These factors, however, are essentially the same as the factors listed 
in Chapter 1.6 of the OIE Terrestrial Animal Health Code. Both Sec.  
92.2 and the OIE Code provide for the evaluation of a region seeking 
recognition for a disease status on the basis of, among other things, 
the region's veterinary infrastructure, disease history, geographical 
separation from affected regions, diagnostic and surveillance 
capabilities, and emergency response planning. Both the OIE Code and 
Sec.  92.2 require the requesting region to provide the same 
documentation.
    In contrast to the comments discussed above, one commenter 
criticized our risk assessment methodology on the grounds that we 
granted too much deference to the OIE guidelines, thus violating our 
statutory mandate to protect U.S. livestock.
    We do not agree with this comment. As noted above, the OIE 
evaluation criteria and those in Sec.  92.2 essentially cover the same 
topics. In addition, the site visits we conduct as part of our risk 
assessment process enable us to verify the requesting country's disease 
status and its ability to maintain that status and to control outbreaks 
if they occur.
    Commenters also took issue with the release assessment for 
suggesting that wildlife does not play a significant role in the 
transmission of FMD. It was claimed that the statement lacked support 
in the scientific literature.
    The epidemiology of the disease in South America over time and the 
information provided in the surveillance section of the risk assessment 
clearly demonstrate that the role of wildlife in disease transmission 
in the area under consideration is insignificant. Many decades of 
experience with the disease have shown no consistent relationship 
between outbreaks in domestic animals and coexistence of susceptible 
wild animals in South America. In addition, results of repeated 
serological testing focusing on cattle as the most susceptible species 
do not reveal evidence of viral activity in domestic ruminants that are 
likely to contact wild animals. If wild animals were carriers or 
reservoirs of FMD, evidence of viral activity would be expected in 
domestic species coexisting in the same regions as infected wild 
animals.
    Some commenters also claimed that the biological pathways for the 
release of pathogens were not described clearly in the release 
assessment.
    We address biological pathways for the release of the FMD virus in 
the exposure assessment, which we discuss in greater detail below.
    Commenters stated that our exposure assessment identified only a 
single exposure pathway: The feeding of FMD-contaminated beef to 
susceptible animals. It was stated that the exposure assessment 
included no discussion of any alternative exposure pathways for FMD, 
such as illegal imports and backyard pig feeding. It was further stated 
that the exposure assessment should have focused on the effects of 
plate waste or manufacturing waste processing for swine feeding on the 
survival of FMD virus.
    There is a general scientific understanding on the main pathway of 
FMD exposure via the importation of fresh beef. This pathway is through 
the feeding of food waste to swine. The likelihood of exposure of FMD-
susceptible species to FMD-infected beef was evaluated by reviewing 
previous studies we conducted. In 1995, we conducted a pathway analysis 
to estimate the likelihood of exposing swine to infected waste. With 95 
percent confidence, we estimated that 0.023 percent or less of plate 
and manufacturing waste would be inadequately processed prior to 
feeding to swine. Based on this percentage, less than 1 part in 4,300 
of imported beef fed to swine as plate or manufacturing waste is likely 
to be inadequately cooked. The findings of a 2001 APHIS survey, which 
showed a substantial reduction in waste-feeding operations, further 
indicated that the risk of FMD exposure via feeding of contaminated 
waste to swine was continuing to decline.
    Some commenters stated that that the pork industry has undergone 
significant changes since we conducted the 1995 risk analysis and 2001 
survey cited above. A commenter representing a national pork producers' 
association questioned the validity of our 1995 pathway analysis in 
particular, stating that the findings are outdated and incomplete. 
Other commenters also expressed skepticism that the 1995 analysis and 
the 2001 survey adequately reflect the current risk to the U.S. pork 
industry of the introduction of FMD into the United States through 
garbage feeding. It was suggested that APHIS needs to consider 
obtaining updated scientific data, independent of the 2001 APHIS waste-
feeder survey, in order to better verify the exposure assessment for 
FMD presented in the risk analysis.
    APHIS acknowledges that the pork industry in general has undergone 
significant changes since 1995; however, the garbage-feeding industry 
in particular, which we discuss in greater detail immediately below, 
has not. In that discussion, we elaborate on our reasons for our 
confidence that the 1995 risk analysis and 2001 survey adequately 
reflect the current risk to the U.S. pork industry from the feeding of 
contaminated food waste to swine.
    One commenter stated that, according to APHIS reports to the U.S. 
Animal Health Association's Transmissible Diseases of Swine Committee, 
from

[[Page 37931]]

2009 to 2013, a number of unlicensed garbage feeders were found each 
year by State and Federal animal health authorities. The commenter 
asked if APHIS has any supporting information that estimates the number 
of unlicensed garbage-feeding facilities.
    Procedures for the handling, processing, and feeding of food waste 
to swine in the United States are subject to our swine health 
protection regulations in 9 CFR part 166. Compliance with the 
regulations has improved in recent years, thereby reducing the 
probability of survival of FMD virus in the food waste. Searches for 
non-licensed garbage feeding facilities are regularly conducted using 
several different techniques as part of the duties of APHIS animal 
health staff, as well as State animal health and other State agency 
staff. When unlicensed garbage feeding facilities are identified, the 
unauthorized activity is documented, and the facility is brought into 
compliance. Depending on the State, all swine on such premises may be 
quarantined and tested for foreign animal diseases. Information on the 
number of inspections conducted to detect unlicensed garbage feeding 
facilities, the number of unlicensed facilities identified, and 
resolution of cases resulting from such identification are captured at 
the State level and evaluated by APHIS on a regular basis. Given the 
regular monitoring of these facilities and their relatively small 
number, we stand by the conclusions we reached in our 1995 risk 
analysis.
    A commenter stated that our consequence assessment should have 
focused on the specific commodity to be imported, as outlined in the 
scope of the risk assessment.
    The consequence assessment did examine at some length the possible 
economic consequences for the cattle industry, as well as other 
livestock industries, that could result from an outbreak of FMD in the 
United States.
    Commenters took issue with the methodology we used for evaluating 
the efficacy of Brazil's movement and border controls. As noted in the 
risk assessment, APHIS assumes that, if the riskiest pathways are 
sufficiently mitigated, then the overall spectrum of risk issues should 
be acceptable. The commenters viewed that assumption as unwarranted.
    We do not agree with this comment. APHIS tries to target the 
riskiest border crossings (and other areas) during site visits as 
examples of a type of ``maximized risk scenario'' in order to address 
similar, but theoretically lower, risks in the remainder of the export 
region. Using this assumption and visiting the areas of highest risk in 
the export region, APHIS concluded that movement control measures for 
live animals are effective at both domestic and international 
checkpoints. The commenters did not present any evidence to support 
their claim that this methodology is flawed.
    A commenter objected to the terminology we used in characterizing 
the FMD risk associated with imports of beef from Brazil. It was stated 
that the characterization of the risk of FMD introduction as ``low'' 
was arbitrary and misleading. The commenter stated that the term 
``low'' actually falls in the middle of the risk spectrum, meaning, in 
the view of the commenter, that the actual risk of FMD introduction 
from Brazil was unacceptably high. The same commenter also stated that 
there was a discrepancy between the risk assessment, which 
characterized the risk as ``low'' and the environmental assessment, 
which characterized the risk as ``extremely unlikely.''
    APHIS disagrees with the commenter. We employ the term ``low'' to 
characterize the risk associated with importing a particular commodity 
when we have determined, based on a risk assessment, that the commodity 
can be safely imported into the United States under certain conditions. 
We base such determinations on our assessment of the exporting region's 
disease-control capabilities, as evaluated in relation to the eight 
factors in Sec.  92.2, and the known efficacy of the risk mitigation 
measures available to us. The statements in the risk assessment and the 
environmental assessment are not contradictory. The environmental 
assessment refers to the risk of introduction of FMD into the United 
States as extremely unlikely. The risk assessment characterizes the 
combined risks of introduction and dissemination of the disease as low.

Economic Analysis

    Many commenters expressed concern about the potentially devastating 
economic effect an outbreak of FMD in the United States could have on 
U.S. cattle producers. It was stated that the potential economic risks 
greatly outweigh the benefits of this rulemaking, and that the economic 
analysis accompanying the December 2013 proposed rule failed to take 
into account those potential costs. Some commenters recommended that we 
revise the economic analysis to account for those potential costs. It 
was suggested that we should perform a comprehensive, up-to-date 
economic analysis to identify consequences for all U.S. commodity 
groups potentially affected by an FMD outbreak.
    It is true that an outbreak of FMD in the United States, whatever 
its source, could have very serious effects on the U.S. cattle 
industry. In the economic analysis accompanying the December 2013 
proposed rule, we analyzed expected benefits and costs of annual 
imports of fresh (chilled or frozen) beef from Brazil averaging 40,000 
metric tons (MT), and found that the expected changes in U.S. beef 
production, consumption, and exports would not be significant. We did 
not report on potential impacts of an FMD outbreak for the U.S. economy 
in the economic analysis accompanying the December 2013 proposed rule 
because, in our view, the risk-mitigation measures required of Brazil, 
which include deboning, maturation for at least 24 hours, and pH 
measurements below 6.0 in the loin muscle, will provide for the safe 
importation of beef from Brazil. The revised economic analysis 
accompanying this final rule, however, does analyze those potential 
impacts. We would further note that in the consequence assessment 
section of our risk assessment, we examined the potential economic and 
other consequences of an FMD outbreak in the United States at some 
length.
    Some commenters also pointed out that an FMD outbreak in the United 
States could result in the loss of export markets for U.S. beef. It was 
further claimed that our economic analysis understated the value of 
those export markets.
    An FMD outbreak would likely result in the loss of U.S. beef export 
markets. However, APHIS is confident that the required sanitary 
safeguards will ensure the safe importation of beef from Brazil as a 
result of this rule. Regarding the value of U.S. beef export markets, 
it can be measured differently depending on the combination of bovine 
products and composite prices used. The value can also vary based on 
how shipping and other transactional expenses may be included in 
reported prices. Commenters may consider the reported value of U.S. 
beef exports to be understated because of differences in product and 
price definitions. Nevertheless, attributing a higher value to U.S. 
beef export markets would not change our conclusion that the rule's 
impact on beef exports, as well as other segments of the beef industry, 
will be minor.
    A commenter stated that allowing imports of beef from Brazil may 
cause a loss of consumer confidence in beef, resulting in a loss of 
profits for U.S. producers.

[[Page 37932]]

    This is a hypothetical statement for which the commenter presents 
no supporting evidence.
    A commenter expressed the view that the rulemaking would depress 
markets for U.S. producers and affect export markets because allowing 
imports from Brazil would facilitate Brazil's access to other 
international markets.
    The question of whether or not allowing Brazilian beef to be 
imported into the United States would facilitate Brazilian producers' 
access to other international markets is beyond the scope of our 
economic analysis. The commenter did not present data that would 
support the proposition that Brazil's beef exports are likely to 
increase so precipitously as a result of this rulemaking that U.S. 
exporters would experience negative effects.
    A commenter expressed the concern that the rulemaking would have 
adverse effects not only on U.S. beef producers but on associated 
industries as well.
    Based on how small the volume of beef we project will be exported 
from Brazil to the United States relative to U.S. beef production, we 
anticipate that both U.S. beef producers and associated industries will 
be affected little, if at all, by this rulemaking.
    Commenters questioned our projections regarding the amount of beef 
likely to be imported from Brazil and also expressed doubts about our 
assumption that Brazilian beef imports will mainly displace other 
imports rather than increasing the total volume of beef imports. It was 
stated that because exporting beef to the United States may be 
profitable for Brazilian producers, they are likely to ship more than 
the 40,000 MT of beef to the United States that we estimated they would 
in an average year.
    Our import projections are based on the data we obtain from 
industry and other sources and the use of published models. In the 
preamble to the December 2013 proposed rule, we noted that we did not 
have all of the data necessary for a comprehensive analysis of the 
effects of the proposed rule on small entities, and we solicited 
comments on the potential effects. Because the commenters did not 
supply information that contradicted the data upon which we relied, 
that called into question the model we used, or that supported in any 
way the suggestion that our projections were inaccurate, we did not 
have cause to revise our projections.
    Another commenter, while agreeing with our projection that 
Brazilian beef imports would most likely displace imports from 
elsewhere, questioned why the rulemaking was necessary if those 
existing imports are not problematic and there is no increased demand 
for beef by U.S. consumers.
    The United States and many other member countries are a part of the 
rules-based international trading system, which has benefitted Members 
through the maintenance of open international markets. Under our 
international trade agreements, we consider requests from countries and 
regions to import their animals and/or animal products. Before such 
requests are granted, we must first assess the risks to U.S. herds 
posed by imports by evaluating the requesting country or region's 
disease status and the efficacy of its risk-mitigation measures. The 
United States' and other WTO Members' international trade obligations 
ensure that decisions regarding market access are based on scientific 
principles and risk assessments. U.S. demand for these products is not 
a part of the consideration of such requests.
    One commenter characterized the proposed rule as a misguided 
attempt to remedy short-term beef price increases. The commenter stated 
that the U.S. cattle herd needs to be rebuilt, but the rulemaking may 
discourage producers from restocking.
    The commenter's statement is a hypothetical one and, as such, 
difficult to evaluate. We did not receive any data from this or other 
commenters that would suggest that the rulemaking would discourage U.S. 
cattle producers from restocking.
    A commenter claimed that the rulemaking would result in a larger 
drop in steer prices than the 0.14 percent we projected in the economic 
analysis supporting the December 2013 proposed rule.
    We arrived at that estimate using results from a published economic 
model.\3\ Had the commenter supplied a different set of substantiated 
data, we could have reevaluated our estimate.
---------------------------------------------------------------------------

    \3\ Paarlberg, Philip L., Ann Hillberg Seitzinger, John G. Lee, 
and Kenneth H. Mathews, Jr. Economic Impacts of Foreign Animal 
Disease. Economic Research Report Number 57. USDA ERS, May 2008.
---------------------------------------------------------------------------

    Some commenters suggested that in the event of an FMD outbreak in 
the United States, APHIS should indemnify or otherwise support U.S. 
cattle producers.
    APHIS' ability to pay indemnities is dependent upon the 
availability of funds. In the past, APHIS has indemnified producers 
whose livestock had to be depopulated as part of disease-eradication 
efforts.
    Some commenters objected to the proposed rule because of what they 
perceived as economic favoritism. Commenters claimed that the 
rulemaking favored meat packers and processors at the expense of 
farmers. It was also asserted that the proposed rule favored Brazilian 
producers at the expense of U.S. producers because U.S. producers would 
not be able to compete on price with their Brazilian counterparts, and 
that, therefore, the rule would have the unintended effect of shrinking 
the U.S. cattle herd and expanding Brazil's.
    We undertook this rulemaking at the request of Brazil and in 
accordance with our international trade agreements. We based this 
rulemaking on the findings of our risk assessment that fresh beef could 
safely be imported into the United States from Brazil under certain 
conditions. We do not believe this rule favors one sector or country 
over another, and the commenters did not provide evidence to support 
their claims.

Miscellaneous Comments

    In addition to the issues already discussed in this document, 
commenters raised a few others that did not fit neatly into any of the 
above categories.
    One commenter recommended that we allow the importation of fetal 
bovine serum from Brazil.
    That comment is beyond the scope of the present rulemaking, which 
concerns the FMD status of Brazil and the importation of Brazilian 
beef.
    Other commenters suggested that the rulemaking may lead to 
deforestation and/or environmental degradation.
    The commenters did not explain how the rulemaking would have those 
effects. USDA prepared an environmental assessment, but the focus of 
the environmental assessment is to evaluate the potential impacts of 
allowing for the importation of fresh, maturated, and deboned beef from 
a region in Brazil into the United States, and not on increased 
deforestation in Brazil.
    One commenter stated that the rulemaking does not comply with our 
statutory obligation to develop rural America.
    The commenter did not cite any particular statute to support the 
claim that we were not meeting our statutory obligations.
    Commenters writing on behalf of an association representing 
Hispanic and Native American livestock producers claimed that the 
rulemaking violates the civil rights and fair trade rights of minority 
livestock producers.
    As we noted in the economic analysis accompanying the December 2013 
proposed rule, we do not anticipate that

[[Page 37933]]

the rulemaking will have a significant economic effect on any livestock 
producers. In the absence of economic or competitive harm, we do not 
see this rule as violating the rights of any group.

Miscellaneous

    We are making an editorial change to Sec.  94.29(a) for the sake of 
clarity. In the December 2013 proposed rule, the paragraph read as 
follows: ``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.'' As written, that paragraph could be interpreted to indicate 
that not only beef but also ovine meat could be imported from the 
exporting region of Brazil. Since ovine meat may not be imported from 
Brazil under Sec.  94.29, we have edited the paragraph in this final 
rule to read as follows: ``The meat is: (1) Beef from Brazil derived 
from animals that have been born, raised, and slaughtered in the 
exporting region of Brazil; or (2) Beef or ovine meat from Uruguay 
derived from animals that have been born, raised, and slaughtered in 
Uruguay.''
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
change discussed in this document.

Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    This final rule has been determined to be economically 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 a final 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 on the Regulations.gov 
Web site (see footnote 1 in this document for a link to 
Regulations.gov) or by contacting the person listed under FOR FURTHER 
INFORMATION CONTACT.
    This analysis examines potential economic impacts of a final rule 
that will allow fresh (chilled or frozen) beef from a designated region 
in Brazil 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 small. Welfare gains for 
consumers will outweigh producer losses, resulting in a net benefit to 
the U.S. economy. APHIS has concluded that the risk of exposing U.S. 
livestock to FMD via fresh beef imports from Brazil is sufficiently low 
so that such imports are safe.
    The United States is the largest beef producer in the world, and 
yet still imports a significant quantity. Annual U.S. beef import 
volumes from 1999 to 2013 averaged 0.9 million MT, equivalent to 11 
percent of U.S. production. Much 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 final 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 Brazil are expected to range between 20,000 and 65,000 MT, 
with volumes averaging 40,000 MT. Quantity, price, and welfare changes 
are estimated for three import scenarios. The results are presented as 
average annual effects for the 4-year period, 2015-2018.
    A portion of the beef imported from Brazil will displace beef that 
would otherwise be imported from other countries. The model indicates 
that the net annual increase in U.S. fresh beef imports will be 15,894 
MT (79 percent of 20,000 MT) under the 20,000 MT scenario; 32,000 MT 
(80 percent of 40,000 MT) under the 40,000 MT scenario; and 52,654 (81 
percent of 65,000 MT) under the 65,000 MT scenario.
    If the United States imports 40,000 MT of beef from Brazil, total 
U.S. beef imports will increase by 2.8 percent. Due to the supply 
increase, the wholesale price of beef, the retail price of beef, and 
the price of cattle (steer) are estimated to decline by 0.65, 0.26, and 
0.70 percent, respectively. U.S beef production will decline by 0.03 
percent while U.S. beef consumption and exports will increase by 0.2 
and 0.7 percent, respectively. The 20,000 MT and 65,000 MT scenarios 
show similar quantity and price effects.
    The fall in beef prices and the resulting decline in U.S. beef 
production will translate into reduced returns to capital and 
management in the livestock and beef sectors. Under the 40,000 MT 
import scenario, beef processors will experience a decline in surplus 
of $28.85 million or 0.85 percent, while consumers will benefit from 
the decrease in price by an increase in their surplus by $387.50 
million or 1.14 percent. Cattle producers will experience decline in 
welfare of $216.01 million or 8 percent. The overall impact will be a 
net welfare gain of $358.36 million or 1 percent for producers and 
consumers in the beef processing sector. For the combined beef and 
cattle sectors, there will be a $142 million net welfare gain (0.36 
percent net benefit).
    The 20,000 MT and 65,000 MT scenarios show similar welfare impacts, 
with net benefits increasing broadly in proportion to the quantity of 
beef imported. The largest impact will be for the beef sector, but 
consumers of pork and poultry meat sectors will benefit negligibly. 
While most of the establishments that will be affected by this rule are 
small entities, based on the results of this analysis, APHIS does not 
expect the impacts on small entities to be significant.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

National Environmental Policy Act

    An environmental assessment and finding of no significant impact 
have been prepared for this final rule. The environmental assessment 
provides a basis for the conclusion that the importation of fresh beef 
from a region in Brazil under the conditions specified in this rule 
will not have a significant impact on the quality of the human 
environment. Based on the finding of no significant impact, the 
Administrator of the Animal and Plant Health Inspection Service has 
determined that an environmental impact statement need not be prepared.
    The environmental assessment and finding of no significant impact 
were prepared in accordance with: (1) The National Environmental Policy 
Act of

[[Page 37934]]

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 and finding of no significant impact 
may be viewed on the Regulations.gov Web site.\4\ Copies of the 
environmental assessment and finding of no significant impact are also 
available for public inspection at USDA, Room 1141, South Building, 
14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. 
and 4:30 p.m., Monday through Friday, except holidays. Persons wishing 
to inspect copies are requested to call ahead on (202) 799-7039 to 
facilitate entry into the reading room. In addition, copies may be 
obtained by writing to the individual listed under FOR FURTHER 
INFORMATION CONTACT.
---------------------------------------------------------------------------

    \4\ Go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2009-0017. The environmental assessment and finding of no 
significant impact will appear in the resulting list of documents.
---------------------------------------------------------------------------

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 final rule, which were 
filed under 0579-0414, have been submitted for approval to the Office 
of Management and Budget (OMB). When OMB notifies us of its decision, 
if approval is denied, we will publish a document in the Federal 
Register providing notice of what action we plan to take.

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 rule, please contact Ms. Kimberly Hardy, 
APHIS' Information Collection Coordinator, at (301) 851-2727.

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 are amending 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. In Sec.  94.1, paragraphs (b)(4) and (d), introductory text, are 
amended by removing the words ``from Uruguay''.

0
3. Section 94.29 is revised to read as follows:


Sec.  94.29  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:
    (1) Beef from Brazil derived from animals that have been born, 
raised, and slaughtered in the exporting region of Brazil, or
    (2) Beef or ovine meat from Uruguay derived from animals that have 
been born, raised, and slaughtered 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.

(Approved by the Office of Management and Budget under control 
numbers 0579-0372 and 0579-0414)

    Done in Washington, DC, this 26th day of June 2015.
 Gary Woodward,
Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2015-16337 Filed 7-1-15; 8:45 am]
BILLING CODE 3410-34-P