[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Rules and Regulations]
[Pages 37935-37953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16335]



[[Page 37935]]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

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


Importation of Beef From a Region in Argentina

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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

DATES: Effective September 1, 2015.

FOR FURTHER INFORMATION CONTACT: Dr. Silvia Kreindel, Senior Staff 
Veterinarian, Regional Evaluation Services Staff, National Import 
Export Services, 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.
    Because vaccination for FMD may not provide complete protection to 
livestock, and because it can be difficult to quickly detect FMD in 
animals vaccinated for FMD, APHIS does not recognize regions that 
vaccinate animals for FMD as free of the disease. Although there has 
not been a major outbreak of FMD in Argentina since 2001/2002, we do 
not consider Northern Argentina to be free of FMD because of 
Argentina's vaccination program in that region. With few exceptions, 
the regulations prohibit the importation of fresh (chilled or frozen) 
meat of ruminants or swine that originates in or transits a region 
where FMD is considered to exist. One such exception is beef and ovine 
meat \1\ from Uruguay, which is allowed to be imported into the United 
States under certain conditions that mitigate the FMD risks associated 
with these products. The conditions are set out in Sec.  94.29 of the 
regulations.
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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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    In a proposed rule \2\ published in the Federal Register (79 FR 
51508-51514, Docket No. APHIS-2014-0032) on August 29, 2014, we 
proposed to also allow the importation of fresh (chilled or frozen) 
beef from Northern Argentina under those conditions found in Sec.  
94.29 of the regulations. The proposed conditions were as follows:
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    \2\ To view the proposed rule, the supporting risk analysis, 
economic analysis, and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0032.
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     The beef is from animals born, raised, and slaughtered in 
Northern Argentina.
     FMD has not been diagnosed in Northern Argentina within 
the previous 12 months.
     The meat comes from bovines that originated from premises 
where FMD had not been present during the lifetime of any bovines 
slaughtered for the export of beef to the United States.
     The meat comes from bovines that were moved directly from 
the premises of origin to the slaughtering establishment without any 
contact with other animals.
     The meat comes from bovines 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 parts that are, by 
standard practice, part of the animal's carcass that is placed in a 
chiller for maturation after slaughter. The bovine parts that may not 
be imported include all parts of the head, feet, hump, hooves, and 
internal organs.
     All bone and visually identifiable blood clots and 
lymphoid tissue have been removed from the meat.
     The meat has not been in contact with meat from regions 
other than those listed in the regulations as free of rinderpest and 
FMD.
     The meat comes from carcasses that were allowed to 
maturate at 40 to 50 [deg]F (4 to 10 [deg]C) for a minimum of 24 hours 
after slaughter and that reached a pH of below 6.0 in the loin muscle 
at the end of the maturation period. Measurements for pH must be taken 
at the middle of both longissimus dorsi muscles. Any carcass in which 
the pH does not reach less than 6.0 may be allowed to maturate an 
additional 24 hours and be retested, and, if the carcass still has not 
reached a pH of less than 6.0 after 48 hours, the meat from the carcass 
may not be exported to the United States.
     An authorized veterinary official of the Government of 
Argentina certifies on the foreign meat inspection certificate that the 
above conditions have been met.
     The establishment in which the bovines are slaughtered 
allows periodic on-site evaluation and subsequent inspection of its 
facilities, records, and operations by an APHIS representative.
    We solicited comments concerning our proposal for 60 days ending 
October 28, 2014. We reopened and extended the deadline for comments 
until December 29, 2014, in a document published in the Federal 
Register on October 31, 2014 (79 FR 64687-64688, Docket No. APHIS-2014-
0032). We received 295 comments by that date. They were from producers, 
trade associations, veterinarians, representatives of State and foreign 
governments, and individuals. Of those, 62 comments were non-
substantive in nature, with 44 supportive of APHIS' proposal and 18 
opposed. Two commenters requested an extension of the comment period, 
which was granted as detailed above. The remaining comments are 
discussed below by topic.

General Comments

    In May 2007, the World Organization for Animal Health (OIE) 
recognized

[[Page 37936]]

Northern Argentina as being an area free of FMD where vaccination is 
practiced. One commenter stated that OIE recognition of a certain 
status was not sufficient reason for U.S. recognition of that status.
    As a member of the OIE, the United States recognizes OIE 
guidelines, including guidelines on regionalization. OIE's Terrestrial 
Animal Health Code provides internationally accepted guidelines to 
protect animal health by limiting the spread of animal diseases within 
and between countries without unnecessarily restricting international 
trade. APHIS evaluates all requests from countries or regions 
requesting recognition of disease freedom or to export a particular 
commodity consistent with OIE guidelines. In this particular case, the 
request was to export fresh (chilled or frozen) beef. APHIS' evaluation 
of this request was based on science and conducted according to the 
factors identified in 9 CFR 92.2. We did not automatically accept OIE 
recognition of Northern Argentina's disease status as the basis for 
changes to our regulations; rather, we conducted our own evaluation, 
which is detailed in the proposed rule and its accompanying risk 
analysis.
    One commenter said that the definition of Northern Argentina as 
``North of Patagonia South and Patagonia North B'' is vague. The 
commenter added that the proposed rule's subsequent claim that 
``Northern Argentina is bordered by the Atlantic Ocean and shares land 
borders with Bolivia, Brazil, Chile, Paraguay, Uruguay, and the 
Province of R[iacute]o Negro, Argentina'' is confusing as Patagonia is 
not bordered by Bolivia, Brazil, Paraguay, or Uruguay. The commenter 
suggested that the definition of the proposed region be more clearly 
designated by the use of degrees of latitude.
    Figure 12, which is located on page 52 of the risk analysis, is a 
map showing the various regions in Argentina, including Northern 
Argentina. The region under consideration is located north of the 
Patagonia Region; the Patagonia Region includes the region located 
south of the 42nd parallel known as Patagonia South, and the region 
immediately north of the 42nd parallel known as Patagonia North B.\3\ 
The limits of the Patagonia North B region are as follows: In the west 
along the Andes Mountains (international border with the Republic of 
Chile) in the Province of Neuqu[eacute]n; in the north along the 
Barrancas River at the border with the Province of Mendoza; in the 
east, the border with the Province of R[iacute]o Negro; and in the 
south, the 42nd parallel and the southern border with the Province of 
Chubut. The region within the country of Argentina, north of Patagonia 
North B as described above is known as Northern Argentina.
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    \3\ In 2002, Argentina divided the country into four major 
parts: Patagonia South, Patagonia North A, Patagonia North B, and 
Northern Argentina. While the OIE recognized Patagonia North A as 
FMD free without vaccination in 2014, APHIS has made no similar 
determination. For export purposes, APHIS includes Patagonia North A 
in the Northern Argentina region and any fresh (chilled or frozen) 
beef exported from that area would be required to be treated in the 
same manner as beef exported from the smaller, OIE-recognized region 
of Northern Argentina. Northern Argentina as it is discussed in this 
document and the supporting documentation accompanying this final 
rule includes Patagonia North A.
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    It is true that Patagonia is not bordered by Bolivia, Brazil, 
Paraguay, or Uruguay, as Patagonia is located in the south of 
Argentina. Northern Argentina, however, shares land borders with those 
countries as well as being north of the Patagonia Region.
    One commenter stated that the Country of Origin Labeling (COOL) law 
should cover any imports of fresh (chilled or frozen) beef from 
Argentina.
    Under COOL, which is administered by the U.S. Department of 
Agriculture's (USDA) Agricultural Marketing Service, retailers, such as 
full-time grocery stores, supermarkets, and club warehouse stores, are 
required to notify their customers with information regarding the 
source of certain food, including muscle cut and ground meats. Any 
fresh (chilled or frozen) beef imported from Argentina would be subject 
to such requirements.
    Another commenter said that the risks posed by possible unregulated 
beef potentially entering the country far outweigh any short-term 
solutions to consumer demand issues that would result from allowing any 
type fresh (chilled or frozen) beef to be imported from Argentina.
    In accord with the Animal Health Protection Act (AHPA, 7 U.S.C. 
8301 et seq.) and consistent with our international agreements, APHIS 
has analyzed the FMD risks associated with allowing for the importation 
of fresh (chilled or frozen) beef from Northern Argentina. APHIS is 
confident that the required sanitary safeguards will allow fresh 
(chilled or frozen) beef to be imported safely into the United States.
    One commenter stated that APHIS must ensure that cattle from 
Northern Argentina are held to the same health standards as cattle from 
the United States.
    We are confident in our assessment of the capabilities of the 
Argentine sanitary system in maintaining the health of herds in 
Northern Argentina to the standards set out in this rule. Argentina may 
be required either to provide or to allow APHIS to collect additional 
information in order to maintain its authorization to export fresh 
(chilled or frozen) beef if we have reason to believe that events in 
the region or in surrounding regions could affect the risk profile of 
the region under consideration. We also note that APHIS uses a wide 
variety of sources to conduct verification activities in Northern 
Argentina. These sources include the U.S. Embassy, multilateral 
relationships with trading partners, and the OIE.
    We received a number of comments from Argentine beef trade 
organizations. One domestic commenter stated that comments from those 
organizations should not be given any consideration. The commenter 
further stated that American cattle associations should be given the 
power to approve or deny any trade agreements reached by the United 
States and other countries.
    We disagree. Federal agencies must accept and respond to comments 
from all interested parties. The comment regarding international trade 
agreements falls outside the scope of this final rule, as APHIS is not 
entering into a trade agreement with Argentina.
    One commenter said that the importation of fresh (chilled or 
frozen) beef from Northern Argentina was contrary to the recommendation 
put forward by the U.S. Dietary Guidelines Advisory Committee that 
Americans eat more plant-based foods.
    The dietary guidelines released yearly by the U.S. Department of 
Health and Human Services' Office of Disease Prevention and Health 
Promotion and the USDA's Center for Nutrition Policy and Promotion are 
irrelevant to APHIS' mission to protect the nation's animal and plant 
health and to APHIS' determination regarding whether fresh (chilled or 
frozen) beef may be safely imported from Northern Argentina. These 
guidelines are intended for individual use on a voluntary basis; they 
are not broad policy statements or trade directives.

Comments on the Impetus for Rulemaking

    One commenter stated that they believe the motivation for the 
publication of the proposed rule and APHIS' ongoing privileging of 
Argentine interests is tied to Argentina's WTO complaint against the 
United States over our ban of Argentina's animal and meat exports. The 
commenter found it troubling APHIS would place trade

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considerations ahead of food safety and animal health. Another 
commenter postulated that the proposed action is intended to decrease 
the cost of beef for the American consumer at the risk of the United 
States livestock industry.
    We undertook this rulemaking at the request of Argentina and in 
accordance with APHIS' regulations, the United States' obligations 
under its international trade agreements, and the findings of our risk 
analysis that fresh beef could safely be imported into the United 
States from Northern Argentina under certain conditions. Our decision 
was based on a scientific evaluation of the disease situation in 
Northern Argentina, which we conducted in accordance with Sec.  92.2. 
We would not propose to allow for the importation of a commodity from 
any region unless our evaluation of the region's disease situation and 
sanitary capabilities supported it, consistent with our statutory 
responsibility under the AHPA.
    Another commenter wanted to know if the importation of fresh 
(chilled or frozen) beef from Argentina would result in a benefit to 
another portion of the American economy via the export of products to 
Argentina.
    We do not believe this rule favors one portion of the American 
economy over another and the commenter did not provide evidence 
suggesting that such an effect would occur.
    Under the agreements reached in the GATT was a provision that, upon 
approval of the USDA, Argentina would be authorized to ship an 
additional 20,000 metric tons (MT) of fresh (chilled or frozen) beef to 
the United States under the U.S. import quota system. One commenter 
said that the quota reached during the Uruguay Round is insignificant 
when compared to the existing security and financial stability of the 
U.S. beef market as a whole and that security and stability should not 
be jeopardized via the importation of fresh (chilled or frozen) beef 
from Argentina.
    The commenter's point regarding import quotas reached at the GATT 
is beyond the scope of the rulemaking. APHIS evaluates the sanitary or 
phytosanitary risk of importing a given commodity independent of 
considerations of existing import quotas.
    One commenter cited Argentina's willingness to export meat to 
Russia as problematic since the United States and the European Union 
(EU) member nations currently have trade sanctions in place against 
that country. The commenter said that APHIS should not be allowing for 
trade with a country openly mitigating the effects of those food 
sanctions.
    Another commenter postulated that the importation of fresh (chilled 
or frozen) beef represents a quid pro quo arrangement between the 
Democratic Party and its financial backers. The commenter stated that 
the rule would serve to benefit these parties monetarily and is not 
scientifically substantiated. The commenter concluded that scientific 
evidence contrary to the proposed action has been ignored by APHIS.
    Under the AHPA and its predecessor statutes, APHIS' primary 
responsibility with regard to international import trade has always 
been to identify and manage the sanitary risks associated with 
importing commodities. When we determine that the risk associated with 
the importation of a commodity can be successfully mitigated, it is our 
obligation under the international trade agreements to which the United 
States is signatory to make provisions for the importation of that 
commodity. Under our international trade agreements, APHIS considers 
market access requests from countries and regions. Approval or denial 
of these requests, as mandated by the AHPA and consistent with our 
Nation's trade agreements, are not and cannot be made along political 
lines. They must be made as a result of sound science. A detailed 
discussion of the scientific basis for this rule may be found in the 
risk analysis and in this document. Additionally, the commenter 
provided no examples or evidence to support the claim that APHIS has 
ignored any contrary scientific findings regarding FMD in Northern 
Argentina.
    Many commenters said that no trade is worth jeopardizing the safety 
of U.S. livestock and wildlife. The commenters pointed to the trade 
deficit as proof that the United States should not prioritize 
importation of commodities and concluded that APHIS should be investing 
in domestic rather than foreign agriculture.
    As stated above, our principal task related to international trade 
is to identify and manage the risks associated with importing 
commodities. Moreover, under the international trade agreements to 
which the United States is signatory, APHIS' decisionmaking regarding 
the safe importation of commodities must be based on scientific 
sanitary considerations. APHIS has determined that the import of the 
commodity at issue does not jeopardize U.S. animal health.

Comments on U.S. Production

    Several commenters 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. Another commenter stated that APHIS 
should focus on domestic agriculture, national animal identification, 
and labeling of all food products instead of international trade.
    Consistent with our international obligations, APHIS considers 
market access requests from countries and regions. U.S. demand for 
these products is not a part of the consideration of such requests. 
Before such requests are granted, we must first assess the animal 
disease risks to U.S. herds posed by imports by evaluating the 
requesting country's or region's disease status and the efficacy of its 
risk mitigation measures. The United States and many other member 
countries are a part of the rules-based international trading system, 
which has benefitted all those countries through the maintenance of 
open international markets. Regarding the comment that APHIS focus on 
domestic activities, APHIS and other Federal agencies currently operate 
programs in the areas of focus specified by the second commenter, 
namely domestic agriculture, national animal identification, and food 
product labeling.
    One commenter characterized the proposed rule as an attempt by 
APHIS 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.
    As noted in our previous responses, APHIS' consideration of 
Argentina's market access request is a scientific inquiry into whether 
fresh (chilled or frozen) beef from Northern Argentina can be safely 
imported. APHIS does not consider the impact on short-term beef prices. 
The commenter's second statement is a hypothetical one based on an 
unsupported presumption 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.
    Another commenter said that American cattle are not fed animal 
proteins, which are prohibited in ruminant feeds.
    Although bovine spongiform encephalopathy (BSE)-related concerns 
were not within the scope of the FMD risk-specific risk analysis 
completed regarding the importation of beef (chilled or frozen) from 
Northern Argentina, we do note that Argentina also bans the feeding of 
ruminant proteins to ruminants in line with OIE guidelines concerning 
BSE.

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Comments on APHIS Oversight

    One commenter said that APHIS does not appear to have a mitigation 
plan in place if FMD were to be introduced into the United States as a 
result of this proposal or otherwise. Two other commenters stated that 
there is no FMD vaccine currently available in the United States.
    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. Specifics of our FMD response plan may be found in a 
document entitled ``USDA APHIS Foot-and-Mouth Disease (FMD) Response 
Plan: The Red Book'' (September 2014), which is designed to provide 
strategic guidance on responding to an FMD outbreak. The plan gives 
direction to emergency responders at the local, State, Tribal, and 
Federal levels to facilitate FMD control and eradication efforts in 
domestic livestock in the United States and may be found on the 
Internet at http://www.aphis.usda.gov/animal_health/emergency_management/downloads/fmd_responseplan.pdf.
    As to the commenters' point regarding availability of the FMD 
vaccine, we recognize that, depending on the size and scope of an FMD 
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 (NAFMDVB), 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. In the event that the United States experiences an FMD 
outbreak in which a specific strain is identified, the USDA will notify 
the NAFMDVB, which will request the manufacturing of finished vaccine 
from approved suppliers, based on the stockpiled antigens.
    One commenter recommended that APHIS conduct annual audits of the 
Argentine system as we do domestically in order to continually verify 
split-state disease status and regional disease programs. Another 
commenter stated that the USDA's Food Safety and Inspection Service 
(FSIS) must determine Argentina's equivalency to U.S. food safety 
standards in order for specific processing facilities to be eligible to 
export fresh (chilled or frozen) beef to the United States; any 
imported beef must follow FSIS labeling regulations; and shipments of 
fresh (chilled or frozen) beef from Northern Argentina is subject to 
examination by U.S. inspectors before being allowed to enter the 
country.
    Under the provisions of Sec.  92.2(g), APHIS may require Argentina 
to submit additional information pertaining to animal health status or 
allow APHIS to conduct additional information collection activities in 
order to maintain its authorization to export to the United States. 
Specifically, we ask for additional information if they report suspect 
or known cases of disease to the OIE; if we receive public information 
about suspect or known cases of disease; if the region that was 
previously evaluated has been re-defined; if there are public reports 
stating changes in the veterinary authority, budgets, or controls in 
border areas; if we receive reports or evidence of smuggling from 
neighboring countries; if there are outbreaks or suspect cases in 
border regions; or if there are changes in any of the other factors we 
consider when preparing a risk analysis. We do not require submission 
of additional information on a regular schedule because we are 
concerned primarily with events that could potentially affect the risk 
status of the region under consideration.
    FSIS makes determinations of equivalence by evaluating whether 
foreign food regulatory systems attain the appropriate level of 
protection provided by our domestic system. Thus, while foreign food 
regulatory systems need not be identical to the U.S. system, any 
imported meat is subject to the inspection, sanitary, quality, species 
identification, and residue standards applied to products produced 
domestically. FSIS evaluates foreign food regulatory systems for 
equivalence through document reviews and on-site audits. Imported meat 
is subject to reinspection at the port of first entry into the United 
States.

Comments on Argentine Oversight

    One commenter stated that we did not adequately address the 
significance of the Argentine Government's failure to provide prompt 
notification of its widespread FMD outbreaks in 2000. The commenter 
suggested that Argentine officials were not subject to any type of 
sanctions that would prevent the recurrence of a similar failure to 
notify APHIS of any future FMD outbreaks. Another commenter, citing 
what they characterized as Argentina'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 Argentina's compliance with our required risk mitigation 
measures. Two commenters further stated that APHIS has not adequately 
described how it will continue to provide oversight and/or monitor 
Argentina's animal health infrastructure indefinitely, to ensure that 
the country will maintain adequate controls to prevent the spread of 
FMD from other regions of Argentina or from neighboring countries to 
the exporting area.
    The regulations in Sec.  92.2 provide for monitoring of regions 
after APHIS authorizes imports from such regions. If we determine that 
necessary measures have not been fully implemented or maintained, we 
will take appropriate remedial action to ensure that the importation of 
fresh (chilled or frozen) beef from Northern Argentina does not result 
in the importation of FMD into the United States. Contrary to the 
commenter's assertion, the consequence of Argentina's failure to notify 
APHIS of the FMD outbreak in 2000/2001 was a provisional suspension of 
the beef trade with Argentina. In the future, indications of 
noncompliance may result in similar actions. Incidents would be 
evaluated by APHIS on a case-by-case basis.
    Many commenters stated that Argentina has shown a trend of 
decreasing compliance in audits conducted by FSIS between 2005 and 
2009. The commenters stated that Argentina's history of compliance 
issues could influence its ability to consistently and successfully 
enforce control measures within Northern Argentina in order to 
successfully mitigate the risk from the possible entry of FMD into this 
region from the surrounding higher-risk areas. The commenters asked if 
APHIS consulted with FSIS as part of its evaluation, and if so, what 
was FSIS' feedback. Several commenters asked that the comment period on 
the proposed rule be extended until FSIS posted its most recent audit 
report for review by stakeholders.
    The purpose of APHIS' evaluation was to assess the FMD situation in 
Northern Argentina and to evaluate Argentina's ability to prevent, 
detect, control, report, and manage FMD within its borders. Based on 
its site visits and other documentation and information, APHIS 
concluded that Argentina's legal framework, animal health 
infrastructure,

[[Page 37939]]

movement and border controls, diagnostic capabilities, surveillance 
programs, and emergency response capacity are sufficient to detect, 
prevent, control, and eradicate FMD outbreaks within the boundaries of 
Northern Argentina. Moreover, with respect to Northern Argentina, APHIS 
concluded that the Argentine veterinary authority is capable of 
complying with our requirements. Nevertheless, based on the comments, 
APHIS has reviewed the last six FSIS audits conducted in Argentina at 
the slaughter level, including the most recent audit, which was 
finalized in July 2014. The FSIS audits concluded that ante-mortem 
inspection processes, which are relevant to the detection of FMD during 
the slaughter process, were conducted satisfactorily. We did not extend 
the comment period pursuant to the release of any future FSIS audit 
reports. As stated previously, the initial 60-day public comment period 
was extended by 60 days, providing stakeholders with a total of 120 
days to share information relevant to the rule. In addition, given the 
contents of the last six reports, APHIS has no reason to believe that 
additional reports would be inconsistent.
    One commenter said that little is known about the Argentine beef 
industry, including such factors as animal care standards, 
antimicrobial use, and environmental protection issues. The commenter 
said that we may be unintentionally supporting practices in these areas 
that have been determined to be harmful.
    Contrary to the commenter's assertion, we thoroughly examined the 
infrastructure and efficacy of the Argentine bovine production and 
export system and detailed all aspects in our risk analysis. We 
subsequently determined that it is robust and capable of meeting the 
standards for exportation set forth by APHIS. Results of the 
environmental assessment we conducted to evaluate the possible 
environmental impacts of the rulemaking did not suggest that the rule 
would lead to adverse environmental impacts and the commenter provided 
no evidence to the contrary. FSIS's last six audits of the Argentine 
system at the slaughter level, which include a review of food safety 
practices, animal care standards, and antimicrobial use, concluded that 
the system is satisfactory.
    Another commenter expressed concern about the financial stability 
of Argentina, which the commenter proposed could compromise the 
Servicio Nacional de Sanidad y Calidad Agroalimentario's (SENASA) 
ability to provide adequate sanitary surveillance and support a 
rigorous food safety inspection system. The commenter said that recent 
news reports speculating as to whether Argentina will default on its 
international loans suggest that the Argentine Government may not be 
able to adequately fund its own operations.
    As described in the risk analysis, SENASA reported that its 2013 
budget was 1.3 billion pesos (approximately $200.7 million). SENASA 
officials described the system as self-sufficient because user fees are 
required for almost every service SENASA provides, including slaughter 
surveillance, issuances of certificates, and laboratory tests. The 
budget for the laboratory is 60 million pesos (approximately $12 
million). APHIS finds no reason to believe that the funding will 
change, as stable funding for the FMD control and eradication programs 
in Argentina has been in place for over a decade.
    One commenter said that it is unrealistic to expect that Argentine 
beef will be uniformly processed and inspected under ideal 
circumstances as required by the standards set out in the proposed 
rule. The commenter viewed it as unrealistic to expect that the APHIS-
approved criteria for sanitary safety to be foolproof. Another 
commenter said that Argentina has participated in a regional plan to 
eradicate FMD in all of South America since 1987 and APHIS should 
encourage Northern Argentina and neighboring countries to continue in 
their efforts and commitment to eradication of the disease so that 
vaccination is no longer necessary. The commenter said that, after this 
milestone is reached, Argentina's request to export fresh (chilled or 
frozen) beef to the United States could then be considered. The 
commenter concluded that if trade is permitted from a country or area 
of higher risk (e.g., FMD free with vaccination) to a country or area 
of lower risk (e.g., FMD free without vaccination), then there is 
little incentive for the vaccinating country or area to take the extra 
effort required to truly eradicate the disease, and global eradication 
is likely to be delayed.
    We have determined that the Argentine production and export system 
is robust and capable of meeting the standards for exportation set 
forth by APHIS. APHIS does not adopt a zero tolerance for risk for 
international trade in meat products. Our risk analysis process is 
designed to determine whether a product may be imported safely into the 
United States. If, based on our risk analysis, we conclude that the 
production system in the country in question is insufficient to provide 
an appropriate level of protection, then we will not authorize the 
importation of the particular commodity. As described in the risk 
analysis, APHIS concluded that the surveillance, prevention, and 
control measures implemented by Argentina are sufficient to minimize 
the risk of introducing FMD into the United States for the purpose of 
beef imports. Since 2002, Argentina has taken a targeted approach to 
eradicating FMD one region at a time and harmonizing FMD-related 
regulations with neighboring countries. We therefore disagree with the 
commenter's conclusion that there is little incentive to eradicate the 
disease, as Argentina gives us no reason to believe that this targeted 
approach will not continue in the future. Any risk of FMD introduction 
into the exporting region is mitigated by this approach due to local 
regulations, standardized vaccination schedules, and other 
harmonization measures involved in regionalization. Consistency of 
approach allows for effective surveillance and monitoring.
    One commenter suggested that APHIS conduct further surveillance of 
the Argentine program prior to any consideration of allowing for the 
importation of fresh (chilled or frozen) beef from Argentina. The 
commenter stated that three site visits made to the region in question 
are inadequate to fully understand the Argentine production system.
    APHIS evaluated the information provided by Argentina since the 
application was first submitted in 2003, and conducted site visits as 
part of the verification process. We do not make our determinations 
based solely on site visits but rather on all the information gathered 
during the evaluation process, which, in the case of Argentina, lasted 
over 10 years. We are confident in our conclusion that the system in 
Northern Argentina is robust and that fresh (chilled or frozen) beef 
produced under the conditions stipulated may safely be imported into 
the United States.

Comments on General Disease Risk

    One commenter claimed that it would be a poor decision to allow 
beef to be imported from Northern Argentina into the United States due 
to the risk associated with FMD, rinderpest, African swine fever, 
classical swine fever, and swine vesicular disease. The commenter 
observed that these diseases can be transferred from infected animals 
or meats from Argentina to animals in the United States.
    The commenter's categorization of APHIS' proposed action is 
incorrect insofar as we only proposed to import fresh (chilled or 
frozen) beef from

[[Page 37940]]

Northern Argentina and not any species of live animal. Further, no 
South American country has ever reported an outbreak of rinderpest 
except Brazil, which had an outbreak in 1921 that was limited in scope 
and quickly eradicated. Furthermore, the global distribution of 
rinderpest has diminished significantly in recent years as a result of 
the Food and Agriculture Organization Global Rinderpest Eradication 
Program. The last known cases of rinderpest worldwide occurred in the 
southern part of the ``Somali pastoral ecosystem'' consisting of 
southern Somalia, eastern Kenya, and southern Ethiopia. In May 2011, 
the OIE announced its recognition of global rinderpest freedom. 
Finally, African swine fever, classical swine fever, and swine 
vesicular disease are diseases only associated with pigs and not 
transmissible to cattle or other bovine species. A detailed discussion 
of FMD in Argentina may be found in the risk analysis and in this final 
rule under the subheading ``Comments on FMD Risk.''
    Another commenter stated that the United States would put all 
cloven hoofed animals in the United States, both domestic and wild, at 
risk for diseases not controlled in Northern Argentina.
    APHIS disagrees with the commenter. Our evaluation shows that 
Argentina, as discussed in the risk analysis, has taken the necessary 
action to address FMD issues and the commenter provided no evidence or 
specifics concerning any other diseases.

Comments on 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.
    One commenter noted that Argentina's last significant FMD outbreak, 
which caused the loss of its countrywide FMD free status in 2001, was 
linked specifically to the movement of cattle across its northern 
borders with Bolivia and Paraguay, which were not free of FMD. The 
commenter added that cattle from Bolivia and Paraguay were sold in 
Argentine markets at a discount due to their inability to be sold 
legally in Argentina and this practice allowed for the spread of FMD 
into the Argentine domestic cattle population. Another commenter said 
that the acknowledgement of a risk of reintroduction of FMD from 
exporting regions into the export area as mentioned in the risk 
analysis is cause for concern.
    Our evaluation is centered on the safety of a particular 
commodity--fresh (chilled or frozen) beef, not live animals--in terms 
of potential introduction of FMD into the United States. However, most 
of the countries in South America have been recognized by the OIE as 
being FMD free with (Uruguay) or without vaccination (Chile and Guyana) 
or with free regions with vaccination (Argentina, Bolivia, Brazil, 
Colombia, and Peru) or without vaccination (Argentina, Bolivia, Brazil, 
Colombia, and Peru). No outbreaks have been reported in Brazil since 
2006, Paraguay since 2012, or Bolivia since 2007. In that regard, the 
risk of introduction from neighboring countries is low. Any risk of 
introduction is mitigated by the coordinated regional approach to FMD 
eradication among those countries. In our risk analysis, we also detail 
the many enhancements enacted by SENASA in its border control 
activities along the northern borders with Bolivia, Paraguay, and 
Brazil.
    As stated in the risk analysis accompanying the proposed rule, we 
considered the epidemiological characteristics of FMD that are relevant 
to the risk that may be associated with importing beef from the export 
region of Northern Argentina. Based on our assessment, we concluded 
that beef from Northern Argentina could safely be imported into the 
United States, subject to certain mitigation requirements, which 
include removal of bones and certain tissue as well as chilling of 
carcasses until they reach a pH level of under 6.0. We evaluated 
information submitted by SENASA and verified the accuracy of that 
information through site visits. As detailed in the risk analysis, 
SENASA underwent extensive reorganization in the wake of the FMD 
outbreak in 2001. The new structure was designed to increase the 
efficiency and effectiveness of the existing system. Based on our 
assessment of this system, we concluded that Argentina 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 export 
region and, in the unlikely event that one should occur, to detect, 
control, and eradicate the disease. Argentina's active and passive 
surveillance system would allow for rapid detection. In the event of an 
outbreak, in the exporting region, Argentina would promptly report 
findings to the OIE, and the United States would stop importing beef 
from Northern Argentina. Our findings regarding Argentina's disease-
control capabilities give us confidence that the mitigation methods 
required under this rulemaking will be effective in preventing the 
introduction of FMD into the United States via the importation of fresh 
beef from Northern Argentina.
    Another commenter stated that the risk analysis does not provide 
detailed information about the level and efficacy of the FMD 
vaccination programs in Northern Argentina.
    The vaccination rates in Northern Argentina reached over 99 percent 
between 2008 and 2012. In addition, the region of Northern Argentina 
has several overlapping controls to ensure compliance with vaccination 
calendars through matching vaccination records to movement permits and 
census data and through field inspections. As detailed in the risk 
analysis, vaccination of cattle is mandatory in the area north of the 
42nd parallel with the exception of Patagonia North B (the area 
adjacent to Patagonia South, a region without vaccination) and 
recently, Patagonia North A and the summer pastures (zona veranadas) of 
Calingasta Valleys in the Province of San Juan. The technical 
requirements for the vaccination program are established by SENASA and 
vaccination can only be performed by authorized personnel who are 
trained, registered, and accredited/audited by SENASA. Vaccination 
coverage rates have been over 97 percent in the region above the 42nd 
parallel (with the exception of Patagonia North B, and most recently 
Patagonia North A, in which vaccination is not conducted) since 2001. 
In the unlikely event that unvaccinated susceptible animals are exposed 
to the FMD virus, these animals will develop clinical signs that will 
be easily detected in the field and during ante-mortem and postmortem 
inspection. This will trigger a response that includes epidemiological 
investigation, movement restrictions, and submission of samples for 
laboratory analysis. If the laboratory reports the case as positive for 
FMD, Argentina will notify the international authorities and its 
trading partners, and trade will cease.
    One commenter claimed that the regionalization process has eroded 
the sanitary safety of the United States with regard to FMD. The 
commenter stated that a blanket prohibition on the importation of meat 
from countries that have experienced outbreaks of FMD is by far the 
more effective option. The commenter concluded that the change from 
APHIS' previous policy involving such a prohibition to our current

[[Page 37941]]

regionalization approach was motivated by trade pressures.
    Regionalization recognizes that pest and disease conditions may 
vary across a country as a result of ecological, environmental, and 
quarantine differences, and adapts import requirements to the health 
conditions of the specific area or region where a commodity originates. 
This final rule is predicated on a risk analysis document that provides 
a scientific basis for potential importation of chilled (fresh or 
frozen) beef from Northern Argentina. Without this document, APHIS 
would not have proposed this action. Political and economic interests 
may stimulate consideration of the expansion of trade of agricultural 
commodities between countries, but all APHIS decisionmaking concerning 
sanitary restrictions on trade is based on sound science, not on trade 
pressures.
    Many commenters stated that the last FMD outbreak in Argentina was 
detected in February 2006 in an area near the border with Paraguay and 
that this area of Paraguay continues to have active virus present that 
can serve as a source of new outbreaks in cattle. According to 
officials in Argentina, illegal movement of animals from neighboring 
countries, as well as mechanical transmission of the virus, introduced 
the FMD virus into Argentina during the 2000/2001, 2003, and 2006 
outbreaks. These officials acknowledge that even where there are 
barriers or checkpoints, people, cars, and animal products can cross 
both domestic and international borders illegally. The commenters 
concluded that the potential for the FMD virus to cross the border, 
particularly by passenger car or foot traffic, remains. Another 
commenter said that the risk analysis did not adequately describe the 
degree to which the region is separated from high risk regions by 
physical and other barriers.
    In the risk analysis, 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 the risk analysis 
and the environmental assessment, Northern Argentina 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, Argentina 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 Argentina's borders with Bolivia, Paraguay, and Brazil. 
Border control and security in Northern Argentina are discussed in 
detail in the risk analysis. APHIS examined these issues during all of 
its site visits. Based on those visits and other documents and 
information that APHIS has obtained and made available with the risk 
analysis, APHIS is confident that Argentina's border controls with 
respect to Northern Argentina are sufficient to prevent the 
introduction of FMD into the region.
    Some commenters questioned the efficacy of the Argentine system in 
controlling illegal entry of livestock and wildlife interactions, 
specifically citing potential transmission via feral swine populations 
in the northern border regions with Bolivia and Paraguay. Several 
commenters stated that reviews of European Commission Food and 
Veterinary Office (EC FVO) audits identified points of concern in the 
areas of border control, particularly those along the border with 
Bolivia, animal identification, vaccination controls, and other 
concerns. Another commenter stated that Argentina has demonstrated non-
compliance in the course of routine USDA and EC FVO audits in the past.
    We do not agree that wildlife-livestock interactions in Argentina 
play a significant role in the transmission of FMD. Although several 
South American wild animal species are susceptible to FMD, research 
into FMD in South America has determined that wildlife populations, 
including feral swine, do not play a significant role in the 
maintenance and transmission of FMD. During outbreak situations, 
wildlife may become affected by FMD; however, as discussed in the 
environmental assessment and the risk analysis, the likelihood that 
they would become carriers under field conditions is rare. Therefore, 
it is unlikely that FMD would be introduced into Northern Argentina 
through movement of infected wildlife. Further, Argentina's biosecurity 
measures, surveillance activities, and response capabilities, which we 
evaluated in our risk analysis, would mitigate the already low risk of 
the FMD virus spreading from wildlife to livestock in the exporting 
region of Northern Argentina.
    We have made additions to the risk analysis that address the 
commenters' point regarding the EC FVO audits.\4\ As described in the 
updated risk analysis, at the time the risk analysis that accompanied 
the proposed rule was finalized, no FMD outbreaks had been reported in 
South America for over 3 years. Based on the history of the disease in 
the continent, Argentina's veterinary infrastructure, and SENASA's 
prompt response to the FMD outbreaks that occurred in neighboring 
countries (Brazil 2006, Bolivia, 2007, and Paraguay 2011/12), APHIS 
concluded that it is unlikely that the disease could be reintroduced 
from adjacent areas into the export region. Our review of the most 
recent EC FVO report, from 2014, revealed that the EC FVO had concluded 
that the official FMD control system in place for Argentina is reliable 
and meets EU requirements. APHIS has also concluded that the veterinary 
infrastructure, surveillance, prevention, and control measures 
implemented by Argentina are sufficient to minimize the risk of 
introducing FMD into the United States for the purpose of beef imports. 
Further, the 2012 EC FVO report specifically states that, ``the FMD 
vaccination programme covers more than 80% of the susceptible 
population.''
---------------------------------------------------------------------------

    \4\ A full account of Argentina's response to the 2012 EC audit 
may be found on the Internet at http://ec.europa.eu/food/fvo/audit_reports/details.cfm?rep_id=3099.
---------------------------------------------------------------------------

    In terms of the specifically mentioned Argentine border with 
Bolivia, local veterinarians in the Bolivian border region, as 
coordinated and supervised by the SENASA Coordinator of Animal Health, 
have instituted additional measures to strengthen sanitary controls in 
that area, including:
     Enhancing controls concerning transhumant animals (i.e., 
animals moved from one grazing ground to another, usually seasonally), 
which include periodic visits to areas with higher likelihood of 
transhumance and the application of sanitary measures (e.g., compulsory 
vaccinations, frequent visits with owners to discuss health-related 
issues).
     Revising and updating the registry of subsistence 
producers to improve the vaccination controls and animal movements in 
the region.
     Increasing the frequency of vaccinator audits, and 
implementing additional sanitary measures such as movement restrictions 
in irregular cases (e.g., an animal lacking paperwork or an animal 
whose ownership is unknown).
     Increasing animal movement controls on roads, which 
include both fixed and mobile checkpoints.
     Identifying risk areas related to the possible presence of 
swine in rubbish

[[Page 37942]]

dumps and other places of exposure to sources of irregular feeding, and 
implementing responsive sanitary measures according to those findings.
     Continuing awareness campaigns and education for the 
community on FMD and animal health in general, in order to minimize the 
risk of introduction of the FMD virus in the region.
    As stated previously, the regulations in Sec.  92.2 provide for 
monitoring of regions after APHIS authorizes imports. If we determine, 
via audit or other means, that the required measures have not been 
fully implemented or maintained, or that SENASA is unable to certify 
that the specific certification requirements are met, we will take 
appropriate remedial action to ensure that the importation of fresh 
(chilled or frozen) beef from Northern Argentina does not result in the 
importation of FMD into the United States.
    Several commenters said that APHIS had concluded in the risk 
analysis and the proposed rule that there is a risk of reintroduction 
of FMD from adjacent areas into the export region, as long as the 
disease is endemic in the overall region in South America. The 
commenters stated that even though the risk of introducing FMD to the 
United States is low, if all of the conditions are met as outlined in 
the proposed rule, the risk is still present and must be viewed in 
light of the devastation it would cause to the U.S. beef industry if an 
FMD outbreak were to occur.
    We took this information into account in our risk analysis and 
determined that the Argentine production and export system is robust 
and capable of meeting the standards for exportation set forth by 
APHIS. APHIS does not adopt a zero tolerance for risk for international 
trade in meat products. Our risk analysis process is designed to 
determine whether a product can be imported safely into the United 
States. If, based on our risk analysis, we conclude that the production 
system in the country in question is insufficient to provide an 
appropriate level of protection, then we will not authorize the 
importation of the particular commodity. That is not the conclusion we 
reached regarding the importation of fresh (chilled or frozen) beef 
from Northern Argentina.
    Several commenters questioned the efficacy of Argentina's internal 
animal movement controls. One commenter claimed that there is no 
required branding program or other animal identification program. The 
commenter further stated that non-symptomatic carriers of FMD exist in 
South America and therefore a qualified laboratory is required to 
identify these carriers. Another commenter stated that in a large, 
diverse nation such as Argentina, it is quite possible for FMD virus to 
have been circulating among various species in various regions 
undetected for long periods of time. A third commenter said that it is 
common practice in the beef industry to ship livestock from place to 
place and, as a result, the risk of cattle from outside the designated 
area being transshipped through the area then to the United States is 
tremendous. The commenter asserted that all imports cannot be inspected 
and tested. Another commenter stated that greater market opportunities 
and the resulting higher prices offered in the export region might 
foster illegal animal movements into that region from the surrounding 
countries.
    We do not agree with these comments. Based on our review of the 
veterinary infrastructure in Argentina, we determined that SENASA, 
which oversees animal movement within the country, has the legal 
authority, technical capabilities, and personnel to implement the FMD 
program within Argentina. Movement controls in Argentina are stringent. 
We evaluated these controls and concluded that cattle movements follow 
particular requirements, which are described in detail in the risk 
analysis, and that cattle whose beef is destined to be exported to the 
United States are required to be accompanied by documentation at 
slaughter showing that they were born and raised in the Northern 
Argentina region. APHIS evaluated the system and concluded that SENASA 
has the ability to certify that this requirement has been met.
    As described in the risk analysis, in 2007, Argentina instituted a 
compulsory cattle identification program, requiring that all calves 
born after September 2007 carry official tags (Resolution 754/2006). 
Resolution 563/2012 requires that bovines from the older age groups be 
individually identified. At the time of the 2013 site visit, SENASA 
reported that the entire Argentine herd was individually identified. 
Individual identification of bovines is unique and permanent. The 
number of tags needed is requested by the animal owner and is 
crosschecked at the local office to the inventory in the integrated 
management system for animal health (Sistema Integrado de 
Gesti[oacute]n en Sanidad Animal--SIGSA). The animals' owner is 
responsible for applying the tags and then notifying the local office 
as to which tags have been used. The color of tags issued to cattle 
holders is determined by the FMD status of the region in which the 
cattle reside. Green tags are used in regions that are FMD-free without 
vaccination, yellow for regions that are FMD-free with vaccination, red 
in buffer areas, and blue tags are used for tag replacement purposes 
only. SENASA requires that all premises with agricultural animal 
production register with SENASA and obtain a RENSPA (Registro National 
Sanitario de Productores Agropecuarios or National Sanitary Registry of 
Agricultural Producers) number. The local SENASA office must issue an 
animal movement permit (DT-e), which is required whenever animals are 
moved. The local SENASA office is responsible for verifying that the 
vehicle transporting the animals has been cleaned and disinfected as 
required by law. Any inspection associated with animal movement 
involves checking the documents and verifying the animal information, 
as well as clinical observation of animal health.
    Argentina's surveillance system includes active surveillance (which 
involves ongoing laboratory-based testing). We are confident that the 
SENASA laboratory, which is responsible for the screening and 
confirmatory diagnosis of FMD, is fully capable of carrying out those 
responsibilities.
    Any beef product that is imported into the United States from 
Argentina must be certified by SENASA as meeting all requirements set 
out in the regulations. This certification must accompany each shipment 
and is subject to review by the U.S. Customs Border and Protection 
(CBP) officials that cover each port of entry into the United States. 
Any shipments not meeting that requirement are refused entry and CBP 
reserves the right to question documentation or packaging at the port 
of entry based upon inspection. Imported meat products are then 
forwarded to an FSIS Inspection House for re-inspection. We are 
confident that these measures supply the necessary level of inspection 
required to minimize the risk of introducing FMD into the United 
States.
    Some of the commenters did not believe the requirement for chilling 
the carcass after slaughter would be an effective mitigation against 
the FMD virus. One commenter stated that chilling beef may be 
inadequate for eliminating the virus, since that virus can remain 
active in blood clots. Two commenters said that research shows that the 
FMD virus can survive in frozen bone for up to 6 months.
    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,

[[Page 37943]]

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, bones, and organs must be removed from 
the carcasses prior to export to the United States. We have also added 
a more detailed discussion of viral inactivation to the risk analysis.
    Two 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 
recognition of the animal health status of a region,'' we concluded 
that Argentina 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, Argentina 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 
Argentina, APHIS would implement critical prevention measures to 
respond to the outbreak, including alerting CBP inspectors at all ports 
of entry. Because Sec.  94.29(b) of this final rule 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 allowing it to be imported.
    One commenter said that Argentina is surrounded by FMD positive 
countries and inquired about the disease status of southern Argentina. 
Another commenter stated that reliance on natural barriers to protect 
against FMD is an inadequate prevention tool for a region that shares 
multiple borders with countries known to have FMD or are FMD free with 
vaccination.
    No FMD outbreaks have been reported in South America since 2012. 
Most South American countries have been recognized by the OIE as being 
FMD free with vaccination (Uruguay) or without vaccination (Chile and 
Guyana) or with free regions with vaccination (Argentina, Bolivia, 
Brazil, Colombia, Peru) or without vaccination (Argentina, Bolivia, 
Brazil, Colombia, Peru). No outbreaks have been reported in Brazil 
since 2006, in Paraguay since 2012, and in Bolivia since 2007. In that 
regard, the risk of introduction from neighboring countries is low. Any 
risk is of introduction is mitigated by following a regional approach 
to FMD eradication. APHIS acknowledges many enhancements in border 
control activities along the northern borders with Bolivia, Paraguay, 
and Brazil.
    Further, Argentina does not solely rely on natural barriers to 
protect the export region from FMD; rather, it is one of many elements 
that contribute to Argentina's overall sanitary security. As long as 
FMD is considered endemic only in small areas of South America, there 
is a very low risk of reintroduction of FMD from those small, adjacent 
affected areas into the export region and therefore a low likelihood 
that beef destined for the United States could originate from or be 
commingled with animals or animal products from affected neighboring 
areas.
    In the event FMD were to be introduced into the northwest of 
Argentina, the consequences would not be major (as demonstrated in the 
Tartagal outbreak, 2003) mainly due to the low animal density, low 
animal movements, and effective veterinary infrastructure in the area. 
The FMD outbreak that occurred in 2006 shows that SENASA is able to 
immediately notify and contain the disease, even before confirming 
diagnosis. APHIS acknowledges that SENASA has adopted several measures 
to prevent the introduction of the FMD virus from the south of Brazil, 
Bolivia, and Paraguay. Both Argentina and the OIE divide the areas 
south of Northern Argentina into three major parts: Patagonia North A, 
Patagonia North B, and Patagonia South. Patagonia North A was 
recognized by the OIE as FMD free without vaccination in 2014, however, 
as stated in footnote 3, APHIS has made no similar determination. For 
export purposes, APHIS includes Patagonia North A in the Northern 
Argentina region and any fresh (chilled or frozen) beef exported from 
that area would be required to be treated in the same manner as beef 
exported from the slightly smaller region known to Argentina and the 
OIE as Northern Argentina. On August 29, 2014, we published in the 
Federal Register (79 FR 51528-51535, Docket No. APHIS-2013-0105) \5\ a 
notice that we were adding Patagonia North B and Patagonia South to the 
list of regions that APHIS considers free of FMD.
---------------------------------------------------------------------------

    \5\ To view that notice and its supporting documentation, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0105.
---------------------------------------------------------------------------

    One commenter specifically cited the feral swine population of 
Texas as a potential vector for the rapid spread of FMD if it were to 
enter into the United States via the importation of fresh (chilled or 
frozen) beef from Argentina.
    FMD susceptible scavengers, such as feral swine, might ingest 
discarded FMD-contaminated meat, such as raw meat trimmings, and become 
infected. The frequency of scavenging incidents is similar to risk 
factors analyzed in connection with the waste feeding pathway (e.g., 
the amount of imported, contaminated, uncooked meat in household 
garbage). Therefore, we consider the risk of the scavenging pathway to 
be equivalent to or lower than that of the waste feeding pathway. We 
have updated the exposure assessment section of the risk analysis to 
include further discussion of the risk related to susceptible scavenger 
and waste feeding of swine.
    Another commenter cited the practice of some cowboys in the 
Patagonia Region who capture and sell feral cattle stating, that cattle 
of this type are not tested and therefore could be carriers of FMD.
    Feral cattle that are captured and enter the Argentine beef 
production system must come into compliance with the Argentine FMD 
program requirements, including compulsory vaccination and 
identification, as is necessary for cattle from any other source in 
Argentina. Vaccination campaigns take special consideration of the 
distribution and reach of feral populations.

Comments on the Risk Analysis Development Process

    The risk analysis for Northern Argentina includes an in-depth 
evaluation of the 11 factors used by APHIS to evaluate the animal 
health status of a region prior to 2012. In August 2012, APHIS 
consolidated the 11 factors listed in Sec.  92.2(b) into 8 factors. 
APHIS introduced this simplification in order to facilitate the 
application process; however, since the evaluation of the Northern 
Argentina started before 2012, and the topics

[[Page 37944]]

addressed by the 11 factors are encapsulated in the 8, this analysis 
follows the 11 factor format. One commenter objected to our use of the 
11 factor format. The commenter characterized the reason for the change 
as the fact that ``the list of 11 factors can be confusing.'' The 
commenter said that the use of the 11 factor analysis is arbitrary and 
contrary to APHIS' current regulations and should not be permitted.
    We disagree. As stated in the proposed rule, the topics addressed 
by the 11 factors are encapsulated in the 8. Appendix II of the risk 
analysis describes the correspondence between the 8 and 11 factors. The 
commenter's assertion that APHIS amended its evaluation factors because 
they were confusing is an incomplete assessment of the situation at the 
time of the August 2012 rule. Specifically, we said that the 11 factor 
list could be confusing because the information requested in some of 
the factors overlapped with information requested in other factors. We 
therefore amended the list so as not to receive redundant information 
from requesting countries. Given that the development of our risk 
analysis took years and given that the 11 factors are included in the 8 
factors, rewriting the analysis in the way the commenter suggests would 
involve a time-consuming, non-substantive consolidation process, which 
is not warranted under the circumstances.
    Some commenters questioned the methodology we employed for the site 
visits to Argentina. 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 analysis 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 Argentina. 
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.
    The purpose of the site visit is to verify and complement the 
information previously provided by the country. APHIS site visits 
consist of an in-depth evaluation of the risk factors identified by 
APHIS in Sec.  92.2 to consider in assessing the risk of the relevant 
animal disease posed by a region. The animal disease risks identified 
in the risk analysis come from the information gathered pertaining to 
these factors during the site visits and APHIS' document review; and 
whenever mitigations are considered necessary, such mitigations are 
discussed in the risk analysis.
    APHIS has also published guidance on our approach to implementing 
our regionalization process and the way in which we apply risk analysis 
to the decisionmaking process for regionalization. This document can be 
found on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/downloads/regionalization_process.pdf. Site visit findings are 
thoroughly described throughout the risk analysis.
    Two other commenters stated that a request for information had been 
made under the Freedom of Information Act (FOIA) to APHIS related to 
the site visits to Argentina and documented reporting procedures and 
established methodology used to conduct those site visits. The 
commenters said that the rule should not be finalized until the 
commenters receive, review, and have the opportunity to make additional 
comments based on the information obtained through FOIA.
    We disagree with the commenter's suggestion. As stated previously, 
the initial 60-day public comment period was extended by 60 days, 
providing stakeholders with a total of 120 days to share information 
relevant to each rule. FOIA requests are processed and fulfilled 
separately from the regulatory process.\6\
---------------------------------------------------------------------------

    \6\ For more information on the APHIS FOIA process you may visit 
http://www.aphis.usda.gov/wps/portal/aphis/resources?1dmy&urile=wcm%3apath%3a/aphis_content_library/sa_resources/sa_laws_and_regulations/sa_foia/ct_foia.
_____________________________________-

    Two commenters said that some citations in the risk analysis, such 
as references to APHIS internal publications or unpublished reports, 
did not seem credible because those sources were not readily available 
to stakeholders for review. The commenters added that each of the 
primary supporting documents included with the rule on Regulations.gov 
should have been explicitly referenced in the risk analysis.
    We disagree. The information referenced and the conclusions reached 
are thoroughly described in the risk analysis. In addition, the final 
risk analysis includes further discussion and references regarding some 
of the issues about which other commenters had questions.
    Two commenters raised issues regarding the scope of our risk 
analysis. 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 analysis in accordance with chapter 2.1 of 
the OIE Terrestrial Animal Health Code, ``Import Risk Analysis.'' The 
Code recommends that risk analyses 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 analysis of Northern Argentina, we followed the 
steps listed in the OIE Terrestrial Animal Health Code. Where there are 
differences, 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.

Comments on the U.S. Governmental Accountability Office Audit

    Many commenters stated that the U.S. Government Accountability 
Office (GAO) has accepted a request submitted by several members of 
Congress to review the APHIS country review and verification process 
and the risk analysis used to formulate this proposed rule. The 
commenters said that no further action on the rule should be taken 
until the GAO review is completed. One commenter stated that a USDA 
Office of the Inspector General (OIG) review is also a possibility and 
that APHIS should wait for the reports from both bodies before 
proceeding with further action.
    While an audit has been requested, that request has not been 
processed by the GAO. The GAO is an independent agency and, as such, 
its audit process exists independently of the APHIS regulatory process. 
If, in the future, the GAO conducts such an audit and releases findings 
and recommendations, APHIS will review them and adjust our process 
accordingly. As for the OIG audit referenced by the commenter, at this 
time such a request has not been submitted. If it is submitted in the 
future, the OIG will conduct the audit independently of APHIS, and we 
will take any findings into consideration at the time they are 
released.

[[Page 37945]]

Comments on the University of Minnesota Report

    Several commenters made reference to a report released by a third-
party scientific review team from the University of Minnesota College 
of Veterinary Medicine, Center for Animal Health and Food Safety, and 
the Center for Veterinary Population Medicine which evaluated the APHIS 
risk analysis. The commenters stated that the report found limited or 
lacking scientific methodological approaches in performing the risk 
analysis, poorly defined scope regarding the specific animal types and 
products for the risk analysis, lack of sufficient detail for 
geographical landmarks outlining the region, and maps lacking the 
necessary level of detail to be useful to determine the region.
    We have not been made privy to this report and therefore cannot 
provide a detailed response to topics beyond those cited by the 
commenters. Both APHIS and the OIE support the use of a qualitative 
risk analysis model for the purpose of animal health status evaluation. 
In the OIE's ``Handbook on Import Risk Analysis for Animal and Animal 
Products,'' qualitative risk analyses, such as the one that informs our 
decision to allow for the importation of fresh (chilled or frozen) beef 
from Northern Argentina, are cited as both an appropriate and the most 
common type of assessment used to support import decisions. The risk 
factors evaluated by APHIS and described in detail in the risk analysis 
are almost identical to those evaluated by the OIE.\7\ Additionally, we 
disagree that the specific animal types and products are undefined. The 
sole product under consideration for importation in the risk analysis 
is fresh (chilled or frozen) beef that has been matured and deboned in 
accordance with the regulations. We also disagree with the claims 
regarding lack of geographical detail. As described previously, figure 
12, which is located on page 52 of the risk analysis, is a map showing 
the various regions in Argentina, including Northern Argentina. The 
region under consideration is located north of the Patagonia Region, 
which includes the region located south of the 42nd parallel known as 
Patagonia South, and the region immediately north of the 42nd parallel 
known as Patagonia North B. The full description of the area is found 
earlier in this document. We have also added further description of the 
area to the risk analysis.
---------------------------------------------------------------------------

    \7\ You may find a detailed list of the OIE factors on the 
Internet at http://www.oie.int/fileadmin/Home/eng/Health_standards/tahc/2010/en_chapitre_selfdeclaration.htm.
---------------------------------------------------------------------------

Comments on the Risk Analysis

    Some commenters stated that APHIS should prepare a quantitative 
risk analysis for beef from Northern Argentina and make it available 
for public review. Commenters took the position that the qualitative 
risk analysis 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 analysis 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 analysis for Northern Argentina.
    One commenter stated that although the commenter recognized that 
the analysis was qualitative, some categories that define what USDA 
considers ``low'' risk would be helpful and are necessary for a clear 
understanding of the risk associated with importation of a given 
commodity.
    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 properly assess the risk of the introduction of FMD 
through importation of commodities such as fresh beef. Quantitative 
risk analysis models are not the best tool to use to assess the risk of 
FMD posed by exports from a country where the types of data required by 
such models are unavailable or inadequate. In these instances, APHIS 
characterizes the risk of potential 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).
    Contrary to the assertion that a qualitative analysis should define 
an explicit level of risk or a range of risk, the relative flexibility 
afforded by a qualitative analysis allows us to evaluate commodity 
import programs in a holistic manner.
    Some commenters viewed the documentation supporting our risk 
analysis as insufficient. It was further noted that some of those 
supporting documents were in Spanish. 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.
    APHIS acknowledges that some of the documents used as references in 
the risk analysis were submitted to APHIS in Spanish; APHIS personnel 
were able to read and evaluate these documents without the necessity of 
translation into English. In most instances, the same or related data 
were provided in English in other documents or verbally presented to 
APHIS during site visits. However, the information provided by 
Argentina and the conclusions reached are thoroughly described in 
English in the risk analysis that was made available for public review 
and comment.
    As stated in the proposed rule, although there has not been a major 
outbreak of FMD since 2001/2002, APHIS does not consider Northern 
Argentina to be free of FMD because of the vaccination program in that 
region. One commenter stated that the sanitary security of the United 
States would be more effectively protected by continuing only to allow 
for importation from countries that are certified as FMD free without 
vaccination.
    We disagree with the commenter. Our conclusion regarding the 
decision to allow for the importation of fresh (chilled or frozen) beef 
from Northern Argentina was reached based upon our understanding of the 
disease situation in that region and the efficacy of mitigation 
measures for beef. It has been 9 years since the last FMD detection of 
any size in Northern Argentina; and the changes in SENASA's 
infrastructure following earlier outbreaks, as detailed in the risk 
analysis provide adequate protection against the importation of FMD 
into the United States via fresh (chilled or frozen) beef from Northern 
Argentina.
    Another commenter observed that the source for APHIS' report that 
SENASA had officially inspected over 31 million cattle and sheep in 
2009 was noted as being a discussion between APHIS and SENASA officials 
during APHIS' 2005 site visit. The commenter questioned the reliability 
of this source.
    The date of the discussion regarding inspection that took place 
during the site visit was incorrect in the risk analysis that 
accompanied the proposed rule. We have corrected the reference in the 
updated risk analysis to indicate that the discussion occurred during 
APHIS' 2009 site visit.
    Another commenter asked that APHIS address the impact of FMD on the 
economy and individuals, the duration

[[Page 37946]]

of the disease, meat inspection procedures, and uncertainties about 
Argentine sanitary security.
    These topics and more are covered by the risk analysis. Further, we 
would note that in 2003 APHIS authorized the importation of fresh 
(chilled or frozen) beef under the same conditions that are found in 
this rule from Uruguay, a region that, like Northern Argentina, is free 
of FMD with vaccination. Since that time, importation of Uruguayan beef 
has not been associated with an increased risk of FMD.
    Some of the commenters expressed reservations about the efficacy of 
the maturation requirements contained in the proposed rule, which 
included chilling 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 observed that the risk analysis and the 
environmental assessment that accompanied the proposed rule were 
inconsistent concerning whether the FMD virus is totally inactivated as 
stated in the risk analysis, or whether a small proportion of the virus 
particles that are relatively resistant to the effects of heat and pH 
in most populations would remain, as stated in the environmental 
assessment. The commenter concluded that, if the latter situation were 
true, the presence of even a small number of virus particles undermined 
APHIS' claim that the risk posed by the importation of chilled (fresh 
or frozen) beef from Northern Argentina is low since the virus would 
not be truly inactivated.
    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. This rule requires that measurements for pH 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 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. We have updated the risk analysis and 
the environmental assessment based on this comment to include further 
references and explanation of the issue.
    One commenter noted that both the rate of pH fall and the ultimate 
pH achieved in the muscle tissue are influenced by factors such as 
species, type of muscle in an animal, genetic variability between 
animals, administration of drugs which affect metabolism, environmental 
factors prior to slaughter such as feeding or stress, and post-mortem 
temperature. The commenter stated that therefore a precise protocol 
must be followed, and expressed doubt that Argentine producers would be 
capable of adhering to this protocol.
    Contrary to the commenter's point regarding different muscle types 
reaching varying pH levels, we have specified that pH readings must be 
taken from the longissimus dorsi muscle. Additionally, transportation 
and carcass resting both influence the likelihood that the muscle 
tissue will reach the required pH level since, as stated previously, 
acidification of the skeletal muscles takes place during this time. 
Even if one or more of the various influencing factors were to affect 
the pH of the muscle tissue, any carcasses that do not reach the 
required pH level will not be allowed to be exported into the United 
States, regardless of how that level was reached. As stated previously, 
we have added more discussion on the maturation process and the 
effectiveness of the process in FMD virus inactivation to the final 
risk analysis.
    Two commenters said that the proposed mitigations involving the 
maturation of the fresh beef and deboning appeared inconsistent with 
the OIE guidelines for FMD risk mitigation. The commenters stated that 
the proposed requirements established deboning and maturation as two 
separate and unrelated mitigations, but the OIE recommendations clearly 
state that deboning should occur after the meat has matured and reached 
a pH less than 6.0 at the middle of both longissimus dorsi muscles.
    While it was always our intention--and is our practice concerning 
importation of fresh (chilled or frozen) beef from Uruguay--that 
deboning occur after the meat had matured and reached the required pH 
level, we have amended, for clarification purposes, the language in 
this final rule describing this process.
    The same commenters pointed out that neither the proposed rule nor 
the risk analysis provided information regarding freezing procedures, 
even though the product proposed for import was chilled or frozen beef.
    Both chilling and freezing of meat after maturation are standard 
industry practices, crucial for food safety and quality regardless of 
the final destination of the meat. The procedure is as follows: After 
slaughter, beef carcasses are kept in the chilling rooms at appropriate 
refrigeration temperatures (carcasses will begin chilling within 1 hour 
from bleed-out). As previously stated, bovine carcasses are then 
required to maturate at 40 to 50[emsp14][deg]F (4 to 10 [deg]C) for a 
minimum of 24 hours and must reach a pH below 6.0 in the loin muscle at 
the end of this period. Measurements for pH must be taken at the middle 
of both longissimus dorsi muscles. The maturation process critical for 
FMD virus inactivation via pH drop is temperature dependent, which is 
why we specified the required temperature range in the proposed rule.
    The process of carcass fabrication begins immediately after a 
carcass leaves the chilling room and takes place in the deboning room 
where beef cuts are obtained and blood clots and lymph nodes are 
removed under environmental refrigeration temperatures. These 
temperatures vary but are generally less than 50[emsp14][deg]F (10 
[deg]C). Carcass temperature (usually between 4 and 7 [deg]C) and pH 
are controlled before the carcass enters the deboning room in order to 
ensure compliance with SENASA authorities and the specifications of 
importing countries. After the carcass is processed into cuts of meat, 
those cuts are packed and stored either in a chiller separate from the 
chiller used for carcass maturation, or in a freezer. A description of 
the inactivation process has been added to the final risk analysis.
    Another commenter observed that, unlike the risk analysis APHIS 
completed concerning the importation of fresh (chilled or frozen) beef 
from Brazil, the risk analysis for Northern Argentina does not disclose 
the number of practicing veterinarians in Argentina, instead stating 
that SENASA employs 1,054 veterinarians. The commenter said that the 
absence of the total number of veterinarians in Argentina made a true 
picture of the veterinarian-to-livestock ratio in Argentina impossible. 
The commenter further stated that the SENASA-employed veterinarian-to-
livestock population ratio of approximately 1 government-employed 
veterinarian for each 54,080 head of cattle suggests that Argentina 
lacks an adequate number of veterinarians to effectively monitor the 
health of Argentina's cattle herd. The commenter said that APHIS should 
explain the discrepancy in approach between the risk analyses for 
Brazil and Northern Argentina.
    In conducting our evaluation of any animal health program, APHIS is 
mainly concerned with the veterinary authority

[[Page 37947]]

of the responsible organization and its available resources for 
conducting emergency response, vaccination, enforcing movement 
restrictions, etc. We evaluate the veterinary infrastructure and 
authority in the context of detection and prevention of FMD, which 
includes the ability of the veterinary authority to certify that the 
required mitigations are met. That evaluation may or may not include 
number of veterinarians. Brazil provided that number with its 
application and Argentina did not. As in the United States, many 
veterinarians in Argentina operate mixed veterinary practices that 
encompass care of both large and small animals in varying proportion. 
Therefore, any information provided regarding total number of 
veterinary practices in Argentina would be misleading. Consequently, we 
do not consider the number to be a significant aspect of a country's 
sanitary infrastructure; however, we do provide such information in the 
risk analysis if it is included in the information provided to us.
    The same commenter stated that, in the risk analysis accompanying 
APHIS' proposal to declare the State of Santa Catarina, Brazil, free of 
FMD, APHIS disclosed the type and quantity of high-risk imports that 
were known to enter Santa Catarina, the numbers and origins of FMD-
susceptible animals that had entered Santa Catarina for breeding 
purposes, swine movement into and within the State of Santa Catarina, 
and imports of animals and products from FMD-susceptible animals into 
the State of Santa Catarina. The commenter said that these data enabled 
reviewers to evaluate the risk and formulate opinions regarding the 
specific import practices of the state that had requested to export 
FMD-susceptible animals and products to the United States and observed 
that APHIS provided no comparable data in the risk analysis 
accompanying the Argentine proposed rule.
    The commenter specifically cited a statement from the risk analysis 
that ``an area near the border with Paraguay [is] considered endemic 
for FMD [and] [t]his endemic area appears to have active virus present 
in restricted niches or patches, which could potentially lead to 
outbreaks in cattle populations with low FMD immunity,'' and concluded 
that APHIS knows that it is likely, if not highly likely, that an 
active FMD virus is present in Northern Argentina.
    As described in the two risk analyses, both the State of Santa 
Catarina, Brazil, and the region of Northern Argentina follow OIE 
guidelines for the importation of FMD-susceptible commodities. The 
particular imports as well as the guidelines followed are different 
since both regions have different status. Argentina is a net exporter 
of cattle, and the number of imported cattle is insignificant. 
According to SENASA, the last importation of cattle from Paraguay 
(which was for breeding purposes only) occurred in 2010 (11 head), no 
cattle imports have been reported from Brazil or Bolivia since 2010, 
and Argentina's imports from Uruguay are generally less than 200 head 
of cattle per year. The primary imports of beef into Argentina are from 
Uruguay under the same type of conditions that are currently in place 
for the importation of fresh (chilled or frozen) beef from Uruguay into 
the United States.
    The risk analysis we performed pursuant to declaring the State of 
Santa Catarina free of FMD specifically evaluated the disease situation 
for four swine diseases, including FMD. The State of Santa Catarina is 
a major swine-producing state, and an assessment of swine movements was 
critical to our analysis. In the case of Northern Argentina, swine 
imports into the region are negligible as Argentina is not a major 
swine-producer. According to SENASA, 1,521 swine were imported into 
Argentina in 2014, all of which were from Brazil.
    Further, the commenter has taken the statement about the Paraguay-
Argentina border out of its original context in the risk analysis. The 
statement refers to the situation in Argentina in a particular area at 
the time of the most recent FMD outbreak in Argentina, which was 9 
years ago. The current epidemiological situation and evidence supports 
APHIS' conclusion that either the disease does not exist in that region 
or that the vaccination coverage is high and the disease is under 
control. At the time the State of Santa Catarina, Brazil, risk analysis 
was finalized in August 2010, there were other regions of South America 
experiencing outbreaks. As a result, our consideration of risk for the 
State of Santa Catarina, Brazil, was based in part on the disease 
situation in the surrounding region, which differs here since there has 
been no outbreak of FMD reported in South America for the past 3 years.
    One commenter stated that farmers who own property spanning the 
borders between Argentina and Paraguay and Argentina and Bolivia are of 
particular concern as this increases the potential for animal movements 
across the borders. The commenter added that nomadic people in the area 
would also be likely to move animals without proper documentation. 
Another commenter specifically cited the border with Paraguay as being 
of continuing concern given that the risk analysis identified illegal 
movement of livestock from Paraguay as a likely source of historical 
FMD introduction to Argentina.
    Argentina 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 
Argentina's borders with Brazil, Paraguay, and Bolivia. This program 
includes: Strengthening infrastructure of the veterinary services; 
harmonizing procedures for control, prevention, and eradication of FMD; 
harmonizing vaccination procedures in areas of geographic contiguity; 
and conducting vaccinations under APHIS supervision. That being said, 
in response to the comment we are adding a clarifying statement to both 
the risk analysis and the environmental assessment to emphasize that if 
FMD exists at all in South America, it likely does so only in very 
small regions as evidenced by the lack of reports of the disease over 
the past 3 years.
    One commenter said that the nature of the border control and 
biosecurity measures in place between the Northern Argentina region and 
neighboring countries was not clearly described in the risk analysis. 
Another commenter stated that while APHIS described enhancements to the 
border control activities and infrastructure in the Provinces of 
Formosa, Salta, and Jujuy, we failed to explain what enhancements were 
made in the Provinces of Misiones, Chaco, and Corrientes.
    As stated in the risk analysis, border control activities include, 
but are not limited to, vaccinations, surveillance, animal census, 
education, and animal identification. Contrary to the second 
commenter's assertion, enhancements made to border control activities, 
which include activities that occur in the Provinces of Misiones, 
Chaco, and Corrientes since they are located on the border of 
Argentina, are described in the risk analysis as follows: Following the 
recommendations of the OIE mission that visited Argentina, Brazil, and 
Paraguay in December 2006, the heads of the veterinary services and the 
Pan American Foot-and-Mouth Disease Center defined an area of high-
level surveillance within the border regions of Argentina, Brazil, 
Paraguay, and Bolivia. Initially the program was intended to last 2 
years and be subjected to periodic reviews and evaluations. During the 
2009 and 2013 site visits,

[[Page 37948]]

SENASA reported that the program was still effectively operating, with 
a redefinition of the high surveillance area in 2013 to include the 
border regions of Argentina, Paraguay, and Bolivia. Most of the 
financing has been obtained from the World Bank and the Inter-American 
Development bank. Among others, the general actions include:
     Strengthening infrastructure of the veterinary services;
     Harmonizing procedures for control, prevention, and 
eradication of FMD;
     Harmonizing vaccination procedures in areas of geographic 
contiguity; and
     Conducting vaccinations under APHIS supervision.
    The same commenter observed that APHIS included data on the buffalo 
population in our risk analyses for both the State of Santa Catarina, 
Brazil, and for the 14 additional Brazilian States that have requested 
to export fresh (chilled or frozen) beef to the United States, as 
buffalo are an FMD-susceptible species. The commenter noted that there 
is no mention of buffalo in the Northern Argentina risk analysis 
despite the existence of Internet advertisements for hunting water 
buffalo in Argentina. The commenter concluded that, for such 
advertisements to exist there must be a significant population of water 
buffalo in the region, which represent a risk of FMD transmission.
    In 2014, the buffalo population in Argentina was less than 94,000 
head \8\ and vaccination and movement requirements for those buffalo 
are identical to those for cattle. We have added an explanation to this 
effect in the final risk analysis.
---------------------------------------------------------------------------

    \8\ SENASA, official communication with APHIS, January 23, 2015.
---------------------------------------------------------------------------

    The same commenter stated that APHIS provides no discussion 
regarding the likelihood that wildlife in Argentina has developed a 
natural immunity to the FMD virus. The commenter posited that, with 
such immunity, wildlife could serve as asymptomatic carriers of the 
disease and because Argentina has been vaccinating cattle for FMD for a 
considerable period of time, the transmission of the FMD virus between 
wildlife and domestic livestock would not be expected to result in a 
symptomatic response.
    Other 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. One commenter specifically cited the 
feral swine population in the Gran Chaco region and the endangered and 
protected Chacoan peccary that are allowed to move freely within the 
Gran Chaco as a potential source of wildlife transmission for FMD 
between Northern Argentina, Bolivia, Paraguay, and Brazil.
    The first commenter provided no evidence to support the supposition 
that species of wildlife are likely to become asymptomatic carriers of 
the FMD virus in the particular region under consideration and there is 
no epidemiological data supporting such a claim. As stated previously, 
research into FMD in South America has determined that wildlife 
populations 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 Northern Argentina through movement of 
infected wildlife.
    The epidemiology of the disease in South America over time and the 
information provided in the surveillance section of the risk analysis 
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.
    A commenter said that, while the APHIS risk analysis states that, 
as of 2006, there were 52 eligible plants in Argentina certified to 
export meat to the United States, the most recent FSIS audit of the 
Argentine meat industry states that there are only 14 such 
establishments. The commenter said that APHIS' assessment of risk 
associated was therefore wrongly assuming that the volume of 
potentially export-eligible beef per plant was lower; a situation which 
would allow for more careful oversight within those plants than is 
actually the case given the FSIS data.
    All plants approved by SENASA are federally inspected. Prior to the 
finalization of this rule, only cooked or cured beef was eligible for 
export from Northern Argentina under the regulations in 9 CFR 94.4, due 
to that region's FMD status. In response to the comment we are deleting 
the number of plants since that number will be updated after FSIS 
conducts its equivalence determination. Moreover, the number of 
eligible plants is subject to relatively frequent change, most likely 
due to ongoing compliance cost assessments made by individual owners in 
Argentina. Regardless, we do not make assumptions regarding how much 
beef a plant will produce; rather we evaluate the likelihood that FMD 
could be introduced into the United States via the importation of beef. 
It is unlikely, given the expected low import volume, that beef will be 
imported from Argentina at levels that will overwhelm the existing 
processing infrastructure.
    The same commenter pointed out that the endnote citation listed in 
the risk analysis as supporting an assertion regarding the rate of pH 
change in the longissimus dorsi muscle referred to an FSIS report on 
Argentine plants eligible to export meat to the United States and not 
to any scientific literature.
    The commenter correctly pointed out that our reference number was 
mistaken and we have corrected it in the final risk analysis.

Comments on the Economic Analysis

    One commenter said that the underlying assumption in APHIS' entire 
economic model is that U.S. cattle are grain fed and, therefore, of 
higher quality, while imports from Argentina will be beef from grass 
fed cattle. The commenter characterized these assumptions as false, 
citing the USDA Foreign Agricultural Service's (FAS's) September 2014 
GAIN report, which states that most of the beef currently consumed in 
Argentina is grain fed. The commenter concluded that therefore beef 
from Argentina will be comparable to high-quality U.S. beef and, 
therefore, more competitive in the U.S. market.
    We acknowledge the fact that a large percentage of beef cattle in 
Argentina now complete their feeding regimen in feedlots. It is true 
that the grain fed beef imported from Argentina will be more directly 
competitive with U.S. sourced beef, but the overall conclusion of our 
analysis remains the same: The relatively small quantity of Argentine 
beef expected to be imported will not significantly impact the U.S. 
market. In 2013, Argentina exported approximately 7 percent of its 
total production and consumed the remaining 93 percent. Given 
Argentina's production capacity and its promotion of domestic 
consumption of beef, it is unlikely that

[[Page 37949]]

Argentina's beef will strongly compete in the U.S market. In terms of 
value, the EU continues to be the main destination for Argentina's beef 
exports, as it is able to enter the EU market under the Tariff Quota 
regulated by EC Regulation No. 936/97 of 27 May 1997. Argentina has 
been recently approved by the EU to access the quota for premium 
quality (Beef 481) with no fee. Other countries already authorized 
under this quota are the United States, Australia, Canada, New Zealand, 
and Uruguay. This quota differs from the Tariff Quota regulated by EC 
Regulation No. 936/97 described earlier in this document in that it is 
not allotted by portions to each of the participant nations, but it is 
a general quota for which all the countries involved must compete. 
Argentina's beef exports will therefore most likely be intended for 
multiple locations, not only for the U.S. market.
    The same commenter said that in 2012, the price for heavy fed 
steers in Argentina was $8.80 pesos per live kilo (approximately $0.47 
U.S. dollars per pound) and the price for heavy fed steers in the 
United States in that year was approximately $1.23 U.S. dollars per 
pound. The commenter observed that Argentine cattle are priced at about 
one-third of the price of U.S. cattle and this price differential will 
create incentive for multinational corporations to source beef from 
Argentine cattle and therefore quickly increase supplies of beef 
comparable to U.S. beef in the U.S. market.
    Argentina's proposed export quantity represents less than 1 percent 
of U.S. beef production and is unlikely to have a major impact on the 
U.S. domestic market. In addition, Argentine beef will be exported to 
the United States under a quota, and quantities over that quota will be 
assessed an import duty of 26.4 percent. The EU is the largest market 
for Argentina's beef. Given projected import levels, above-quota 
duties, and existing market patterns, the economic impact of Argentine 
beef imports is likely to be small.
    The same commenter stated that the economic analysis likely ignores 
the extreme sensitivity of U.S. cattle prices to changes in supply. The 
commenter cited studies that show that farm level elasticity of demand 
for slaughter cattle is such that a 1 percent increase in supply can 
reduce prices by up to 2.5 percent. The commenter observed that 
domestic cattle prices jumped $26 per hundredweight after trade 
restrictions were imposed on imports of cattle and beef from Canada in 
2003, thus demonstrating the sensitivity of the market.
    The economic analysis uses a partial equilibrium model for which 
more details can be found in Paarlberg et al.\9\ In mapping 
interactions among the grain, livestock, and livestock product sectors, 
the model assumes price-taking economic decisionmakers who maximize 
well-defined objective functions. Utility maximization for consumers 
yields a set of per capita demand functions. Three sets of parameters 
drive the model: The livestock feed-balance calculator, the revenue 
shares for all industries, and elasticities used in the model solution. 
The livestock feed-balance calculators are critical because they relate 
the stocks and flows of animals for each quarter to the feed supplies 
available, forming the critical vertical linkage between the animal 
agriculture component and the crop component. Elasticities are critical 
parameters and are grouped into several sets. Most own- and cross-price 
elasticities of retail demand are based on estimates from econometric 
models. Cross-price elasticities are non-negative, implying that the 
commodities involved are substitutes. Substitution elasticities 
describe derived demand behaviors and affect supplies of the output 
commodities in the equation from which they are derived. Substitution 
elasticities are either obtained from the literature or generated 
consistent with commonly accepted supply elasticity values.
---------------------------------------------------------------------------

    \9\ 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.
---------------------------------------------------------------------------

    The percentage change in cattle and beef prices in 2003, which was 
because of trade restrictions due to the discovery of BSE in Canada, 
were significantly greater than the percentage price changes expected 
as a result of the importation of fresh (chilled or frozen) beef from 
Argentina. Immediately following the discovery of BSE in Canada in May 
2003, the United States closed its border to imports of Canadian feeder 
cattle, fed cattle, cull cows, and beef. Later in 2003, the United 
States reopened its border to imports of Canadian boneless beef 
obtained from animals less than 30 months of age. Prior to May 2003, 
almost half of the cattle sold in Canada were exported as either live 
animals or meat. In 2002, about 90 percent of Canadian beef exports 
went to the United States and accounted for 55 percent of U.S. beef 
imports.
    In contrast to the relatively sudden loss of such a large traded 
volume of beef in 2003, expected annual imports from Argentina of 
20,000 MT of fresh beef would be the equivalent of less than 2 percent 
of average annual U.S. beef imports and less than 0.2 percent of the 
U.S. beef supply, 2009-2013.
    The commenter cites studies indicating that a 1 percent increase in 
the supply of beef can reduce slaughter cattle prices by up to 2.5 
percent. Other studies, such as Marsh et al. (2005), find a coefficient 
closer to 1.5 (beef price flexibility coefficient at the slaughter-
wholesale market level).\10\ When this coefficient is multiplied by the 
percentage increase in the U.S. beef supply expected with this rule 
(20,000 MT, when assuming no displacement of beef imports from other 
sources), the percentage impact on slaughter cattle prices, 0.25 
percent, is found to be essentially the same as shown in the last row 
of table 3 of the economic analysis.\11\
---------------------------------------------------------------------------

    \10\ Marsh, J.M., G.W. Brester, and V.H. Smith. ``The Impacts on 
U.S. Cattle Prices of Re-Establishing Beef Trade Relations.'' 
Agricultural Marketing Policy Center, Briefing No. 74, February 
2005.
    \11\ The average annual U.S. fresh beef supply (production minus 
exports plus imports), 2009-2013, was 11.85 million MT. Expected 
imports from Argentina in comparison to the U.S. fresh beef supply: 
20,000 MT/11,850,000 = 0.17 percent. Effect on slaughter cattle 
prices of fresh beef imports from Argentina assuming a flexibility 
coefficient of 1.5: (0.17 percent)(1.5) = 0.25 percent.
---------------------------------------------------------------------------

    A commenter expressed the view that the rulemaking would depress 
markets for U.S. producers.
    The commenter did not present data that would support the 
proposition that Argentina's beef exports are likely to increase so 
precipitously as a result of this rulemaking that U.S. producers would 
experience negative effects.
    One commenter stated that the rule did not represent any benefit to 
U.S. producers.
    Using a partial equilibrium model and considering three scenarios 
of 16,000, 20,000 and 24,000 metric tons, there are net welfare gains 
in each scenario. Under the 20,000 MT import scenario, producers would 
experience a decline in surplus of $7.63 million or 0.42 percent, while 
consumers would benefit from the decrease in price by an increase in 
their surplus of $130.24 million or 0.30 percent. The overall impact 
would be a net welfare gain of $122.61 million or 0.27 percent for U.S. 
beef consumers. The net welfare gain for the beef sector would be $0.61 
million or 0.002 percent.
    In the initial regulatory flexibility analysis prepared in 
connection with the proposed rule regarding the economic effects of the 
rule on small entities, we stated that the primary entities affected by 
the rule would be

[[Page 37950]]

cattle producers, feedlots, and slaughter facilities, the majority of 
which were considered to be small businesses. We also stated that there 
could be other categories of small entities affected and invited 
commenters to supply us with any information we might be lacking on the 
number and nature of those entities. Two commenters cited this as 
evidence that APHIS did not adequately prepare for the publication of 
this proposed rule by presenting a full list of potentially affected 
small entities.
    The economic analysis for the proposed rule considered the entities 
that may be directly affected. Under the Regulatory Flexibility Act, 
agencies are required to consider impacts on small entities and request 
additional information if it is not readily available. We estimate that 
cattle (steer) prices and wholesale beef prices are likely to decline 
between about 0.2 and 0.3 percent due to beef imports from Argentina. 
These measures of price effects are industry-wide. How reductions in 
producer surplus because of these price declines may be distributed 
among livestock operations and other affected entities cannot be 
determined from the information available.
    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 August 2014 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 August 2014 
proposed rule, we modeled expected benefits and costs of annual imports 
of fresh (chilled or frozen) beef from Northern Argentina for three 
scenarios: Importation averaging 16,000 MT, 20,000 MT, and 24,000 MT, 
and found that the expected changes in U.S. beef production, 
consumption, and exports would be inconsequential. We have added a 
discussion of the potential impacts of an FMD outbreak for the U.S. 
economy to the final economic analysis. We also note that we examined 
the potential economic and other consequences of an FMD outbreak in the 
United States at some length in the consequence assessment section of 
our risk analysis.
    Several commenters cited the ``Site-Specific Biosafety and 
Biosecurity Mitigation Risk Assessment'' \12\ conducted for the 
Department of Homeland Security's National Bio and Agro-Defense 
Facility and the economic impact models used to estimate the impact of 
an outbreak of FMD, suggesting that APHIS consult those models in our 
own analyses.
---------------------------------------------------------------------------

    \12\ You may view this report on the Internet at http://www.dhs.gov/xlibrary/assets/nbaf_ssra_final_report.pdf.
---------------------------------------------------------------------------

    The report referenced by the commenters shows the cumulative impact 
on the entire industry for a worst case disease scenario. Given the 
risk mitigation measures in place, it is highly unlikely that FMD would 
be introduced into the United States via fresh (chilled or frozen) beef 
from Argentina.

Comments on Economic Effects

    While specific comments on the initial regulatory flexibility 
analysis are addressed above, we also received a number of comments 
concerning the overall economic effect of the rule as it relates to 
potential costs to U.S. consumers.
    Several commenters stated that an analysis of the long term costs 
to consumers and the livestock industry resulting from an outbreak of 
FMD in the United States was not included in the proposed rule.
    While we agree with the commenters that the consequences of an FMD 
outbreak in the United States would be severe, the likelihood of such 
an outbreak occurring due to exposure of the domestic livestock 
population to chilled (fresh or frozen) beef imported from Northern 
Argentina is low. Therefore, the overall risk of FMD to U.S. animal 
health from imports of these commodities is also low.
    A commenter stated that allowing imports of beef from Northern 
Argentina may cause a loss of consumer confidence in other types of 
meat in addition to beef, resulting in a loss of profits for U.S. 
producers.
    This is a hypothetical statement for which the commenter presents 
no supporting evidence.

Comments on the Environmental Assessment

    One commenter stated that the environmental assessment accompanying 
the proposed rule marginalized empirical evidence demonstrating FMD 
spread in domestic wildlife by relying upon cursory studies.
    There has been no confirmed spread of FMD in wildlife in the United 
States. Due to the lack of epidemiological data on FMD in U.S. 
wildlife, FMD research has had to rely on experimental infections or 
mathematical modeling. While experimental data indicates that many U.S. 
wildlife species are susceptible to FMD, transmission by persistently 
infected livestock or wildlife to susceptible animals has not been 
proven despite decades of worldwide research.
    The same commenter said that the environmental assessment cited an 
11-year-old study to assert that ``experts generally consider the 
transfer of FMD from wildlife to domestic animals to be unlikely,'' 
while, according to FMD disease notifications submitted to the OIE, the 
Republic of South Africa attributed its 2009 outbreak of FMD to contact 
with wild species as did Botswana.
    Apart from the African buffalo (Syncerus caffer) in sub-Saharan 
Africa, wildlife has not been demonstrated to play a significant role 
in the transmission of FMD. More often, wildlife are passively infected 
when outbreaks of FMD occur in domestic livestock, and, in some wild 
ungulates, infection results in severe disease. Efforts to control FMD 
in wildlife may not be successful when the disease is endemic in 
livestock and may cause more harm to wildlife, human livelihoods, and 
domestic animals. Currently in sub-Saharan Africa, the complete 
eradication of FMD on a subcontinental scale in the near term is not 
possible, given the presence of FMD-infected African buffalo and the 
existence of weak veterinary infrastructures in some FMD-endemic 
countries.
    The same commenter reasoned that since the environmental assessment 
states that likely results of an outbreak of FMD in the United States 
would include loss of livestock, rare species, and habitat due to the 
culling process, and the pollution of the environment from mass carcass 
disposals, then APHIS must initiate a Section 7 Consultation with the 
U.S. Fish and Wildlife Service and/or the National Marine Fisheries 
Service (the Services) for a determination by the appropriate Service 
as to whether APHIS' proposed action is likely to adversely affect a 
listed species or its designated critical habitat under the Endangered 
Species Act.

[[Page 37951]]

    APHIS is not required to consult with the Services if we determine 
that an action will not immediately affect listed species or critical 
habitat. As stated previously, in our risk analysis, APHIS concluded 
that Argentina's legal framework, animal health infrastructure, 
movement and border controls, diagnostic capabilities, surveillance 
programs and emergency response systems are adequate to detect and 
control any future FMD outbreaks within the national boundaries of the 
export region of consideration. Although consequences of an FMD 
outbreak in the United States are potentially substantial, the 
likelihood of an outbreak occurring via exposure of the domestic 
livestock population to fresh (chilled or frozen) beef imported from 
Northern Argentina under the required conditions is low. In addition, 
the environmental assessment also concluded that the potential for 
infection of wildlife from the proposed action is unlikely. The United 
States has retained an FMD-free status since 1929, and APHIS is very 
effective at assessing and implementing necessary mitigations to 
prevent FMD outbreaks in this country. In the unlikely event that FMD 
was discovered in the United States (most likely from an illegal 
importation of FMD-infected products or animals) and APHIS were to 
implement an eradication program, we would immediately enter into an 
emergency Section 7 consultation with the Services' offices to 
implement necessary protection measures for federally listed species 
and critical habitat in the eradication area.
    One commenter objected to the environmental assessment's 
description of SENASA's sanitary enhancements as ``adequate'' and 
stated that the level of monitoring must be more than merely 
``adequate.''
    By ``adequate'' monitoring, we mean that APHIS has determined that 
Argentina has established the necessary controls that would allow for 
rapid detection, restrictions, quarantine, and reporting to the 
international community. In the event of such an event, the United 
States could impose the necessary restrictions on potentially affected 
products in a timely manner.
    One commenter asked about the impact of the proposed action on the 
environment in Argentina given that the number of cattle raised in 
Argentina will increase significantly upon finalization of the rule.
    While Executive Order 12114, ``Environmental Effects Abroad of 
Major Federal Actions'' furthers the purpose of the National 
Environmental Policy Act with respect to the environment outside of the 
United States, APHIS' proposed action is importation of fresh (chilled 
or frozen) beef from Northern Argentina into the United States. 
Therefore, the focus of the environmental assessment is to evaluate the 
potential impacts of allowing for the importation of fresh, maturated, 
and deboned beef from Northern Argentina into the United States, and 
not on the sustainability of cattle ranching in Argentina. The 
commenter's presumption regarding increased production may not be 
correct, in that the export of beef from Argentina may result in 
changes to the destination of product rather than substantial increases 
in domestic production.

Comments on Bioterrorism

    Two commenters stated that the importation of fresh (chilled or 
frozen) beef would allow terrorists to intentionally introduce a 
foreign animal disease into the United States.
    Another commenter observed that U.S. Department of Homeland 
Security has classified FMD as a national security issue. The commenter 
said that a terrorist with the intention of crippling the U.S. economy 
might use FMD as a mechanism to do so if the materials were made 
available.
    This is a hypothetical statement for which the commenters presented 
no supporting evidence. Importation of a veterinary select agent or 
toxin such as FMD, which is among those agents and toxins that have 
been determined to have the potential to pose a severe threat to animal 
health or animal products, is strictly regulated by APHIS and the 
Centers for Disease Control and Prevention. With respect to the 
possibility of obtaining FMD virus from imported beef from Northern 
Argentina, as we have detailed elsewhere, we are confident that the 
conditions Argentina will be required to meet in order to import fresh 
(chilled or frozen) beef into the United States will preclude the 
importation of FMD.
    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 region in 
Northern Argentina to be imported into the United States provided 
certain conditions are met. Economic effects of the rule for both U.S. 
producers and consumers are expected to be small. Producers' welfare 
will be negatively affected. Welfare gains for consumers will outweigh 
producer losses, however, 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 Argentina is sufficiently low such 
that 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 or roughly 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 Argentina are expected to range between 16,000 and 24,000 MT, 
with volumes averaging 20,000 MT. Quantity, price, and welfare changes 
are estimated for these three import scenarios. The results are 
presented as average annual effects for the 4-year period, 2015-2018.

[[Page 37952]]

    A portion of the beef imported from Argentina 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 12,955 MT (81 percent of 16,000 MT) under the 16,000 MT scenario; 
15,895 MT (79 percent of 20,000 MT) under the 20,000 MT scenario; and 
19,458 MT (81 percent of 24,000 MT) under the 24,000 MT scenario.
    If the United States imports 20,000 MT of beef from Argentina, 
total U.S. beef imports will increase by 1.3 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 0.32, 0.12, and 
0.35 percent, respectively. U.S beef production will decline by 0.01 
percent, while U.S. beef consumption and exports will increase by 0.1 
and 0.4 percent, respectively. The 16,000 MT and 24,000 MT scenarios 
show similar quantity and price effects.
    The fall in beef prices and the resulting decline in U.S. beef 
production will translate into reduced returns to capital and 
management in the livestock and beef sectors. Under the 20,000 MT 
import scenario, beef producers will experience a welfare decline of 
$13.86 million or 0.4 percent, while consumers will benefit from the 
decrease in price by a welfare gain of $190.97 million or 0.6 percent. 
Cattle producers will experience decline in welfare of $107.05 million 
or 4 percent. The overall impact will be a net welfare gain of $177.11 
million or 0.5 percent for producers and consumers in the beef 
processing sector. For the combined beef and cattle sectors, there will 
be a $70.06 million net welfare gain (0.18 percent net benefit).
    The 16,000 MT and 24,000 MT scenarios show similar welfare impacts, 
with net benefits increasing broadly in proportion to the quantity of 
beef imported. The largest impact will be for the beef sector; 
consumers of pork and poultry meat 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 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 Northern Argentina 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 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.\13\ 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.
---------------------------------------------------------------------------

    \13\ Go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2014-0032. 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 0579-0428, 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.

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


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

    Notwithstanding any other provisions of this part, fresh (chilled 
or frozen) beef from a region in Argentina located north of Patagonia 
South and Patagonia North B, referred to as Northern Argentina (the 
region sometimes referred to as Patagonia North A is included in 
Northern Argentina); 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 animals that have been born, raised, and slaughtered 
in the exporting regions of Argentina or Brazil; or

[[Page 37953]]

    (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 Argentina (for beef from Argentina), the exporting region of 
Brazil (for beef from Brazil), or in Uruguay (for beef or ovine meat 
from 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 and before removal of any bone, 
blood clots, or lymphoid tissue. The bovine and ovine parts that may 
not be imported include all parts of the head, feet, hump, hooves, and 
internal organs.
    (g) All bone and visually identifiable blood clots and lymphoid 
tissue have been removed from the meat.
    (h) The meat has not been in contact with meat from regions other 
than those listed in Sec.  94.1(a).
    (i) The meat came from bovine carcasses that were allowed to 
maturate at 40 to 50 [deg]F (4 to 10 [deg]C) for a minimum of 24 hours 
after slaughter and that reached a pH below 6.0 in the loin muscle at 
the end of the maturation period. Measurements for pH must be taken at 
the middle of both longissimus dorsi muscles. Any carcass in which the 
pH does not reach less than 6.0 may be allowed to maturate an 
additional 24 hours and be retested, and, if the carcass still has not 
reached a pH of less than 6.0 after 48 hours, the meat from the carcass 
may not be exported to the United States.
    (j) An authorized veterinary official of the government of the 
exporting region certifies on the foreign meat inspection certificate 
that the above conditions have been met.
    (k) The establishment in which the bovines and sheep are 
slaughtered allows periodic on-site evaluation and subsequent 
inspection of its facilities, records, and operations by an APHIS 
representative.

    (Approved by the Office of Management and Budget under control 
numbers 0579-0372, 0579-0414, and 0579-0428)

    Done in Washington, DC, this 26th day of June 2015.
Gary Woodward,
Deputy Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2015-16335 Filed 7-1-15; 8:45 am]
BILLING CODE 3410-34-P