[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Rules and Regulations]
[Pages 77883-77888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24782]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. APHIS-2018-0007]
RIN 0579-AE73


Importation of Fresh Beef From Paraguay

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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

SUMMARY: We are amending the regulations governing the importation of 
certain animals, meat, and other animal products by allowing, under 
certain conditions, the importation of fresh (chilled or frozen) beef 
from Paraguay. Based on the evidence from a risk analysis, we have 
determined that fresh beef can safely be imported from Paraguay, 
provided certain conditions are met. This final rule will provide for 
the importation of fresh beef from Paraguay into the United States, 
while continuing to protect the United States against the introduction 
of foot-and-mouth disease.

DATES: Effective December 14, 2023.

FOR FURTHER INFORMATION CONTACT: Dr. Ingrid Kotowski, Import Risk 
Analyst, Regionalization Evaluation Services, VS, APHIS, 920 Main 
Campus Drive, Suite 200, Raleigh, NC 27606; (919) 855-7732; 
[email protected].

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 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. Under most circumstances, Sec.  94.1 of the 
regulations prohibits the importation of live ruminants and swine and 
fresh (chilled or frozen) meat derived from ruminants and swine 
originating in, or transiting through, a region where FMD exists. 
Section 94.11 restricts the importation of ruminants and swine and 
their meat and certain other products from regions that are declared 
free of FMD but that nonetheless present a disease risk because of the 
regions' proximity to or trading relationships with regions affected 
with FMD. Regions that the Animal and Plant Health Inspection Service 
(APHIS) has declared free of FMD and regions declared free of FMD that 
are subject to the restrictions in Sec.  94.11 are listed on the APHIS 
website at https://www.aphis.usda.gov/animalhealth/disease-status-of-regions.
    The regulations do allow for certain exceptions to the prohibitions 
contained in Sec.  94.1. These exceptions include allowing the 
importation of fresh (chilled or frozen) beef and ovine meat from 
Uruguay and fresh beef from certain regions of Argentina and a region 
of Brazil, subject to certain conditions. While there have been FMD 
outbreaks in the past in those regions, the disease is not currently 
known to exist in any of them. We do not recognize those exporting 
regions as FMD-free, however, because the Argentine, Brazilian, and 
Uruguayan governments all require that cattle be vaccinated for FMD. 
The conditions for the importation of beef and ovine meat from Uruguay 
and beef from the exporting regions of Argentina and Brazil are set out 
in Sec.  94.29 of the regulations and include the following:

[[Page 77884]]

     The meat is derived from animals born, raised, and 
slaughtered in the exporting region.
     FMD has not been diagnosed in the exporting region within 
the previous 12 months.
     The meat comes from bovines or sheep that originated from 
premises where FMD has not been present during the lifetime of any 
bovines and sheep slaughtered for the export of meat to the United 
States.
     The meat comes from bovines or sheep that were moved 
directly from the premises of origin to the slaughtering establishment 
without any contact with other animals.
     The meat comes from bovines or sheep that received ante-
mortem and post-mortem veterinary inspections, paying particular 
attention to the head and feet, at the slaughtering establishment, with 
no evidence found of vesicular disease.
     The meat consists only of bovine 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.
     All bone and visually identifiable blood clots and 
lymphoid tissue have been removed from the meat to be exported (bone-in 
ovine meat from Uruguay may be imported under certain conditions listed 
in the regulations, however).
     The meat has not been in contact with meat from regions 
other than those listed in accordance with Sec.  94.1(a).
     The meat came from carcasses that were allowed to maturate 
at 40 to 50 [deg]F (4 to 10 [deg]C) for a minimum of 24 hours after 
slaughter and that reached a pH below 6.0 in the loin muscle at the end 
of the maturation period. Measurements for pH must be taken at the 
middle of both longissimus dorsi muscles. Any carcass in which the pH 
does not reach less than 6.0 may be allowed to maturate an additional 
24 hours and be retested, and, if the carcass still has not reached a 
pH of less than 6.0 after 48 hours, the meat from the carcass may not 
be exported to the United States.
     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.
     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.
    Historically, trade in fresh (chilled or frozen) beef from Paraguay 
has not been allowed because APHIS has considered Paraguay to be a 
country that vaccinates for FMD. However, in response to a request from 
the Government of Paraguay that we allow fresh (chilled or frozen) beef 
to be imported into the United States from that country, we conducted a 
risk analysis. APHIS gathered data to support this analysis from 
records of the Servicio Nacional de Calidad y Salud Animal (SENACSA), 
from publicly available information, and from published scientific 
literature. In addition, APHIS conducted site visits to Paraguay in 
December 2008 and July 2014 to verify the information submitted by 
SENACSA and to collect additional data. APHIS drafted the risk analysis 
in 2018 and periodically reviewed the risk profile of Paraguay to 
determine whether the conclusions were still valid, with the last such 
review occurring in 2022.
    Our risk analysis concluded that the overall risk associated with 
importing fresh beef from Paraguay is low and that Paraguay has the 
infrastructure and emergency response capabilities needed to 
effectively report, contain, and eradicate FMD in the event of an 
outbreak and to do so in a timely manner. We further concluded that 
Paraguay is able to comply with U.S. import restrictions on the 
specific products from affected areas.
    Based on the evidence documented in our risk analysis, we concluded 
that fresh (chilled or frozen) beef could be safely imported from 
Paraguay, provided certain conditions are met.
    Accordingly, on March 27, 2023, we published in the Federal 
Register (88 FR 18077-18086, Docket No. APHIS-2018-0007) a proposal \1\ 
to amend the regulations to allow the importation of fresh beef from 
Paraguay under certain conditions.
---------------------------------------------------------------------------

    \1\ To view the proposed rule, supporting documentation, and 
comments that we received, go to https://www.regulations.gov/docket/APHIS-2018-0007.
---------------------------------------------------------------------------

    We solicited comments concerning our proposal for 60 days, ending 
May 26, 2023. We received 152 comments by that date. They were from 
producers, importers, exporters, industry and professional 
associations, and representatives of local and foreign governments. 
Thirty-two commenters were generally supportive of the proposed rule. 
The remaining commenters raised questions or concerns about the 
proposed rule and the risk analysis. The comments are discussed below.

General Comments

    One commenter stated that the rule is antithetical to the United 
States Department of Agriculture's (USDA's) statutory directive to 
``strengthen [America's] family farm system'' (7 U.S.C. 2204).
    The statute in question directs the Secretary of Agriculture to 
``advise the President, other members of his Cabinet, and the Congress 
on policies and programs designed to improve the quality of life for 
people living in the rural and nonmetropolitan regions'' of the United 
States, and authorizes the Secretary to initiate or expand research and 
development efforts related to solution of problems the Secretary may 
determine has an effect upon the economic development or the quality of 
life in rural areas, among other stated duties. It does not represent 
an overriding ministerial obligation. This rulemaking was issued 
pursuant to a different statute, the Animal Health Protection Act 
(AHPA, 7 U.S.C. 8301-8317), which is not mutually contradictory with 
the statute cited by the commenter.
    One commenter stated that the rule is being driven by World Trade 
Organization (WTO) commitments, rather than AHPA obligations. The 
commenter cited a statement from the environmental assessment (EA) that 
was issued in support of the proposed rule as evidence of this, and 
stated that this is the sole statement made in the proposed rule or its 
supporting documents regarding the impetus for the rule. Similarly, a 
commenter stated that the proposed rule is driven by the APHIS 2022 
Strategic Plan (goal # 4) as an effort to facilitate international 
trade and open up markets.
    The United States is a member of the WTO and a co-signatory to the 
WTO's Agreement on the Application of Sanitary and Phytosanitary 
Measures (SPS Agreement), which governs, among other things, 
international trade in animal products.\2\ Additionally, the commenter 
is correct that goal # 4 of APHIS' Strategic Plan is trade-related: To 
maintain and expand the safe trade of agricultural products nationally 
and internationally.\3\
---------------------------------------------------------------------------

    \2\ To view the SPS Agreement, go to https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm.
    \3\ To view the APHIS Strategic Plan, go to https://www.aphis.usda.gov/aphis/banner/aboutaphis/sa_overview/ct_about_aphis.
---------------------------------------------------------------------------

    APHIS is committed to upholding the principles of the SPS 
Agreement. The statement from the EA cited by the commenter 
acknowledges this, and states that the analyses conducted in support of 
the rule adhered to these

[[Page 77885]]

principles. Additionally, a stated purpose of the APHIS Strategic Plan 
is to ``outline the goals, objectives, and performance measures that 
set the direction'' for APHIS in the coming years.
    However, neither the SPS Agreement nor the APHIS Strategic Plan 
prompted the proposed rule. Rather, the proposed rule was driven by 
Paraguay's request to export fresh beef to the United States and 
subsequently APHIS' evaluation of that request. Based on a risk 
analysis, APHIS determined that fresh beef can be imported from 
Paraguay under certain conditions. These include verifying FMD has not 
been diagnosed in Paraguay in the past 12 months, the meat comes from 
premises where FMD has not been present during the lifetime of any of 
the animals, and the animals were inspected before and after death, 
among others. Authorizing the importation of animal products subject to 
mitigations to address the disease risk to livestock that the products 
may otherwise present is entirely consistent with the AHPA, the 
authority under which the proposed rule was issued. Finally, contrary 
to the first commenter's assertion, this was stated repeatedly in the 
proposed rule and its supporting documents.
    One commenter stated that APHIS' risk factors used for evaluating 
countries, which the commenter stated undergird our risk analyses 
relative to FMD, were developed to meet WTO obligations and World 
Organization for Animal Health (WOAH) commitments rather than AHPA 
obligations and do not mitigate risk. Additionally, the commenter 
stated that, in the past, APHIS miscalculated the FMD risk of importing 
beef from multiple countries (Argentina, Japan, South Africa, and South 
Korea) using these factors. The commenter pointed to outbreaks of FMD 
in the countries in question shortly after our evaluations. The 
commenter indicated that, based on previous experience, the risk 
factors should not be used for evaluations of a region's FMD risk.
    The commenter appears to be referring to the provisions of 
paragraph (b) of 9 CFR 92.2. Under those provisions, requests for APHIS 
recognition of animal health status of a region must include the 
following eight categories of information, or factors:
     Scope of the evaluation being requested.
     Veterinary control and oversight.
     Disease history and vaccination practices.
     Livestock demographics and traceability.
     Epidemiological separation from potential sources of 
infection.
     Surveillance.
     Diagnostic laboratory capabilities.
     Emergency preparedness and response.

The factors are used to analyze the risk for import requests and not 
intended to have mitigative effect or to specify final agency action. 
We use this framework of eight information categories (or ``factors'') 
to ensure consistent and thorough information gathering for our 
analysis of a region's health status.
    One of the factors, emergency preparedness and response, includes 
an assessment of the ability of the foreign region to quickly detect 
and contain disease incursions and to promptly notify the United States 
and other trading partners of such incursions. This factor is germane 
in the event of an outbreak in the region. To that end, APHIS routinely 
monitors the international animal health situation, and as import risk 
levels change over time, APHIS adjusts its import requirements as 
necessary. In other words, the factors facilitate actively monitoring 
the disease status of our trading partners and taking appropriate 
action, as warranted, if the disease status changes.
    The effectiveness of this approach, supported by robust, science-
based import risk assessments, rigorous APHIS import regulations, and 
APHIS' ability to take immediate trade-restrictive action when needed, 
is demonstrated by the continued FMD freedom of the United States. The 
effectiveness of the approach is also underscored, rather than 
undercut, by the examples that the commenter cites regarding 
importation of beef from Argentina, Japan, South Africa, and South 
Korea. Incursions of FMD into those countries were rapidly detected and 
communicated to trading partners, and APHIS accordingly promptly 
restricted importation of relevant animal commodities. Moreover, the 
incursion of FMD into the countries is not indicative of a failure in 
our evaluations, as the evaluations never reached a conclusion that FMD 
could not be introduced into the countries in question.
    One commenter stated that Paraguayan husbandry and on-farm 
practices were not assessed. Others stated that Paraguayan producers 
may be allowed to use vaccines, biologics, parasite controls, or growth 
hormones that are banned in the United States.
    We conducted multiple evaluations through on-farm inspections 
during APHIS site visits and detailed review of relevant documentation. 
Additionally, during the risk analysis, APHIS evaluated animal 
husbandry and on-farm practices in Paraguay. Our risk analysis 
evaluated Paraguay's request in a manner consistent with our statutory 
authority, which pertains to pests and diseases of livestock, and 
determined that fresh beef can be safely imported from Paraguay under 
certain conditions, which were set forth in the proposed rule as 
regulatory requirements. With that being said, USDA's Food Safety and 
Inspection Service (FSIS) and the Food and Drug Administration evaluate 
beef imports for the possible human health risks mentioned by the 
commenter.
    Two commenters stated that imports should only be authorized from 
countries with the same food safety regulations and animal husbandry 
practices as our own, because otherwise Paraguayan producers are given 
an unfair competitive advantage over U.S. producers that have to abide 
by U.S. food safety regulations and animal husbandry practices. One of 
the commenters was also concerned about Paraguayan beef being 
contaminated as a result of not being listed by the U.S. Anti-Doping 
Agency as having tighter regulations and higher quality standards for 
its meats.
    FSIS is entrusted with making sure the food safety regulations of 
other countries are equivalent to those of the United States. With 
regard to animal husbandry and on-farm practices, under the Animal 
Health Protection Act, APHIS may prohibit or restrict imports only to 
the extent necessary to prevent the introduction into or dissemination 
within the United States of any pest or disease of livestock. We assess 
the risk of the importation of animals, animal products, and other 
articles from countries based, in part, on their own practices, and 
identify appropriate mitigations based on this assessment of risk.
    A commenter stated that the rule will hasten deforestation in 
Paraguay and cited three articles in support of this comment.
    While one of the articles cited by the commenter does correlate 
beef exports from the Chaco region of Paraguay to an increased risk of 
deforestation, the article does not provide the data that led to this 
conclusion and also indicates that other beef-producing municipalities 
in Paraguay do not share this risk. Moreover, the other articles cited 
by the commenter cite multiple factors leading to deforestation in the 
Chaco region, including increased planting of soy and other crops, 
increased demand within Paraguay for beef and leather, producers' 
unlawful appropriation of land for personal gain, and changing

[[Page 77886]]

climatic conditions. The articles provide no direct evidence that this 
rulemaking specifically will hasten deforestation in Paraguay.
    Several commenters stated that FMD was a high-risk disease, and 
that APHIS failed to characterize the current risk of introduction of 
FMD into the United States or the cumulative effect of authorizing 
additional imports from a country that vaccinates for FMD.
    We agree that FMD is a high-risk disease; however, neither the 
proposed rule nor its supporting documentation characterized it 
otherwise.
    With regard to characterizing the current risk of introduction of 
FMD into the United States or the cumulative effect of authorizing 
additional imports from a country that vaccinates for FMD, the 
commenter misunderstands how APHIS assesses FMD risk. APHIS looks at 
each market access request as a distinct request, and tailors 
mitigations based on the unique circumstances of the exporting country, 
which may or may not be commensurate with previously evaluated 
countries. We do not authorize imports unless we believe the disease 
risk of that import can be adequately mitigated.
    One commenter stated that APHIS should only authorize trade if it 
presents zero risk of transmitting diseases of livestock.
    All trade, whether domestic or international, involves a degree of 
risk, however miniscule. The commenter's request would have the effect 
of a de facto prohibition on the importation and interstate movement of 
livestock and animal products.
    Finally, several commenters stated that the rule needed to include 
country-of-origin labeling, or COOL.
    In 2015, Congress repealed the legislation authorizing the 
Executive branch to implement COOL for muscle cuts of beef and pork and 
ground beef and pork.\4\ Moreover, COOL has never been administered by 
APHIS within the USDA, but by the USDA's Agricultural Marketing 
Service.
---------------------------------------------------------------------------

    \4\ To view the statute containing the Congressional repeal of 
COOL, go to https://www.congress.gov/bill/114th-congress/house-bill/2029/text.
---------------------------------------------------------------------------

Risk Analysis Comments

    As noted previously, the proposed rule was based on a risk analysis 
that we prepared regarding Paraguay's export request. We received 
several comments concerning the risk analysis.
    One commenter stated that, in 2017, the Government Accountability 
Office (GAO) conducted an audit of APHIS' risk analysis practices and 
indicated areas for improvement with APHIS' risk evaluations in terms 
of timeliness and transparency. The commenter stated that the Paraguay 
evaluation appeared to have been conducted before APHIS implemented 
GAO's recommendations.
    While Paraguay's evaluation was initiated before the GAO audit, the 
risk analysis was completed in 2018, after APHIS had addressed the GAO 
audit recommendations and incorporated them into policies and 
practices.
    Several commenters stated that the risk analysis was based on 
outdated information on the potential for FMD exposure from Paraguayan 
beef. Two commenters pointed specifically to the site visits, which 
took place in 2008 and 2014, as being out of date. Another commenter 
stated that that there are no official site visit reports from the 
APHIS in-country visits in 2008 and 2014. The commenter stated that 
APHIS should not proceed with this rulemaking until new site visits 
have occurred and an updated risk analysis is conducted based off the 
official site visit reports, and stakeholders are allowed time to 
review the results of the updated risk analysis.
    We disagree with these assessments of the risk analysis. While the 
risk analysis included data from site visits to Paraguay in 2008 and 
2014, it also included a review of more recent data provided by 
Paraguay, and APHIS periodically reviewed the risk profile of Paraguay 
after the risk analysis was drafted to determine whether the 
conclusions were still valid, with the last such review occurring in 
2022. Additionally, for context, FMD has not been detected in Paraguay 
in more than 10 years. As noted in the risk assessment, the overall 
structure and resources of SENACSA have significantly increased and 
been strengthened in reaction to the FMD outbreak in 2012. Moreover, 
the incidence of FMD in South America has decreased steadily over the 
past 20 years, suggesting a continued decrease in risk of FMD incursion 
into Paraguay from neighboring countries. Currently, all countries in 
South America except Venezuela are recognized by WOAH as FMD free, 
either with or without vaccination.
    APHIS documented the findings of its 2008 and 2014 site visits in 
formal correspondence to Paraguay following the site visits, including 
requests for additional information and clarification of issues 
identified. Consistent with overall Agency policy, these government-to-
government documents are maintained internally and not publicly posted. 
However, the totality of our evaluation and findings were documented in 
the risk analysis.
    One commenter stated that 2021 data \5\ regarding FMD vaccination 
maintained by Paraguay was voluntarily submitted and incomplete. The 
commenter also provided a table of testing data for FMD that, the 
commenter contested, still showed the presence of FMD in Paraguay.
---------------------------------------------------------------------------

    \5\ The commenter cited the following website containing the 
data: https://www.senacsa.gov.py/index.php/Temas-pecuarios/sanidad-animal/programas-sanitarios/fiebre-aftosa. Please note that the page 
cited is in Spanish.
---------------------------------------------------------------------------

    The data evaluated by the commenter was indeed incomplete and 
voluntarily submitted, but the site does not claim that this 
vaccination data is the data maintained by SENACSA to support claims of 
FMD freedom. To that end, it is worth noting, as we did previously, 
that FMD has not been detected in Paraguay in more than 10 years. In 
this regard, we note that the commenter misread the tables regarding 
testing for FMD. As we stated in the risk analysis that accompanied the 
proposed rule, samples in Paraguay are screened for FMD using an Enzyme 
Linked Immunosorbent Assay 3ABC Nonstructural Protein Antibody (ELISA) 
test; if they are reactive, they are sent for confirmatory testing 
using an Electroimmunotransfer Blot Assay (EITB) test. While several 
samples were reactive to the ELISA screening test, none were reactive 
to the confirmatory EITB test.
    Moreover, it is also worth noting that, based on the dossier 
Paraguay submitted to WOAH, WOAH still considers Paraguay free of FMD 
with vaccination. Additionally, the commenter appears to equate FMD 
freedom with vaccinating cattle for FMD, and to assume that our 
evaluation presumed vaccination as one of Paraguay's mitigation 
measures for FMD. This misunderstands our evaluation. Vaccination for 
FMD was not part of our mitigation structure, but rather why we 
considered mitigations for FMD risk to be warranted. A possible 
downtick in vaccination in Paraguay does not alter our mitigation 
strategy for beef from Paraguay.
    One commenter stated that according to the risk analysis, most 
funding for Paraguay's FMD program comes from user fees, including fees 
from the movement of cattle, which means the success of the program is 
based on private sector support. The commenter expressed concern that 
APHIS has not taken into consideration the impact of economic downturns 
from the global pandemic that may limit Paraguay's overall 
capabilities. The commenter suggested that APHIS should re-evaluate the 
economic strength of the cattle and beef sector in Paraguay and review 
the

[[Page 77887]]

FMD budget for the past 5 years to have a more accurate assessment of 
Paraguay's capabilities to fund efforts to combat and control an FMD 
outbreak.
    In the proposed rule, APHIS proposed to apply numerous conditions 
to the importation of fresh beef from Paraguay that currently apply to 
fresh beef or ovine meat from specified regions that APHIS does not 
recognize as FMD free. These conditions are designed to mitigate the 
risk of introduction of FMD virus into the United States and protect 
America's livestock health, and have been demonstrated in the past to 
successfully address FMD risk. We have confidence that these 
mitigations will be effective in addressing the possible FMD risk 
associated with the importation of beef from Paraguay.
    However, we do acknowledge the challenges FMD programs face 
worldwide, including the possible economic downturns cited by the 
commenter; while economic downturns may not always have animal health 
implications, in some instances they may. To that end, shipments of 
animal products are inspected for regulatory compliance at ports of 
entry and are subject to remedial measures, including destruction, if 
they are found to be noncompliant. Moreover, APHIS routinely monitors 
the animal health statuses of foreign regions for evidence that our 
previous conclusions may no longer be germane, and adjusts import 
requirements as warranted if the import risk level changes. This 
process strengthens assurances that our import procedures continue to 
appropriately mitigate the risk of foreign animal disease introduction 
over time by maintaining a high level of vigilance and, if necessary, 
adjusting safeguards when new information or situations arise.
    Some commenters expressed concerns with trusting our sanitary 
restrictions. One commenter stated that despite a 2-year ban issued by 
FSIS against JBS, a meat processing company in Brazil, after JBS 
shipped rotten, salmonella-ridden beef to the United States, JBS 
continued to export beef. The commenter stated that USDA's actions with 
JBS indicate that our sanitary restrictions are not absolute. Another 
commenter noted that Brazil has announced it will no longer vaccinate 
its cattle herd for FMD. The commenter further stated that ``USDA's 
lack of response to Brazil's repeated offenses sends the message to 
neighboring countries that actions like that are permissible, even for 
countries with a history of FMD.'' The commenter expressed concern that 
Paraguay might follow suit and stop vaccinating its cattle for FMD.
    The actions of FSIS are outside the scope of this rulemaking. 
However, meat products are inspected at ports of entry for compliance 
with APHIS requirements, and APHIS monitors the animal health status of 
foreign regions on an ongoing basis. Regarding vaccination, as stated 
in the proposed rule, FMD vaccination presents an FMD risk in terms of 
immunological response. Accordingly, the proposed rule was not 
predicated on Paraguay's vaccination regime but rather the results of 
its import risk analysis.
    One of the above commenters stated that Brazil plays a leading role 
in Paraguay's beef industry, particularly in terms of ownership of 
their slaughterhouses. The commenter asked if APHIS evaluated 
slaughterhouses as part of our analysis.
    APHIS did evaluate slaughterhouses as part of our analysis. The 
results of the APHIS evaluation indicate that Paraguay has effective 
animal health and animal disease emergency response systems in place.
    One commenter noted political instability in Paraguay and asked if 
this had disrupted their sanitary systems.
    We have no evidence that political instability has disrupted 
Paraguay's sanitary efforts; however, as noted above, we constantly 
monitor our trading partners for shifts in disease status.
    A commenter noted a shift from grass-finished to grain-finished 
cattle in Paraguay and cited a USDA report in support of this 
assertion. The commenter suggested this shift could affect the 
conclusions of our risk assessment.
    As the commenter noted, this shift is incremental and grass-fed 
beef still accounts for the majority of beef production in Paraguay, a 
fact that many commenters underscored. The article cited by the 
commenter also supports the gradual nature of this shift, noting that 
specific natural weather conditions in Paraguay had been a primary 
factor in the shift, as producers resorted to alternative feeds such as 
hay, forage, and grains to finish their cattle. The report suggests 
this shift was driven by a specific need, rather than indicative of an 
overall trend in production practices.
    Finally, the manner in which cattle are finished in Paraguay also 
does not materially impact the conclusions of the risk analysis or the 
mitigation structure of the proposed rule; grain-finishing is not 
generally correlated with FMD risk. We likewise note that the 
mitigations of the proposed rule that are specifically intended to 
denature FMD or remove FMD risk, particularly the maturation and 
deboning processes, are similarly effective regardless of whether the 
beef is grass-fed or grain-finished.

Economic Comments

    We received a number of comments regarding the Initial Regulatory 
Flexibility Analysis and Regulatory Impact Analysis (RIA) that 
accompanied the proposed rule. These comments are addressed within the 
RIA that accompanies this final rule.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, without 
change.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been determined to be not significant for the 
purposes of Executive Order 12866 and, therefore, has not been reviewed 
by the Office of Management and Budget.
    In accordance with 5 U.S.C. 604, we have performed a final 
regulatory flexibility analysis, which is summarized below, regarding 
the economic effects of this final rule on small entities. Copies of 
the full analysis are available on the Regulations.gov \6\ website (see 
footnote 6 in this document for a link to Regulations.gov) or by 
contacting the person listed under FOR FURTHER INFORMATION CONTACT.
---------------------------------------------------------------------------

    \6\ To view the economic analysis, go to https://www.regulations.gov/docket/APHIS-2018-0007/document.
---------------------------------------------------------------------------

    This final rule will allow importation of fresh beef from Paraguay 
into the United States under specified conditions. With few exceptions, 
APHIS' regulations in 9 CFR part 94 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. APHIS does not 
consider Paraguay as free of FMD because Paraguay vaccinates against 
FMD.
    The United States is the world's largest beef producer, primarily 
of grain-fed beef for the domestic and export markets. Over the 5-year 
period, 2018 to 2022, the United States produced an annual average of 
about 12 million metric tons of beef, exported about 1.4 million metric 
tons, and imported about 1.4 million metric tons. Most U.S. beef 
imports are products from grass-fed cattle. These products are 
processed together with higher-fat trimmings from U.S. grain-fed beef 
to produce ground beef. Canada, Australia, New Zealand, and Mexico 
historically have been the largest sources of U.S. beef imports.
    Paraguay's cattle industry is one of the country's major 
agricultural

[[Page 77888]]

activities. Along with soybeans, beef is one of Paraguay's leading 
exports. Ongoing structural changes to the country's beef industry are 
occurring, as cattle ranching is displaced from traditional production 
areas by increased soybean acreage and grain is increasingly used to 
supplement beef cattle feeding regimes. About 65 percent of Paraguayan 
beef was exported over the 5 years, 2018-2022 (372,000 of 582,000 MT), 
a quantity equivalent to approximately 26 percent of U.S. fresh beef 
imports for the same period.
    As a measure of possible impacts of fresh beef imports from 
Paraguay, we consider import volumes of 3,250 to 6,500 MT, that is, 5 
to 10 percent of the Other Countries or Areas tariff-rate-quota of 
65,005 MT. For each of the annual import levels, we modeled changes in 
U.S. consumption, production, and price, deriving annual consumer and 
producer welfare effects. The results of the analysis indicate that 
consumer gains of $14 million to $27 million would outweigh producer 
losses of $12 million to $24 million, yielding annual net social 
welfare gains of $1.6 million to $3 million. We also expect a portion 
of the beef imported from Paraguay will displace beef that would 
otherwise be imported from other countries.
    Small entities in the United States are predominant among 
enterprises that would be affected by this rulemaking. They include 
beef and cattle producers, as well as feedlots and slaughter 
facilities. Of the 882,692 farms in the United States with cattle and 
calves, 711,827 sold cattle and calves, 729,046 were classified as beef 
cow farms, and 54,599 had milk cows. Based on these data and Small 
Business Administration standards, the majority of these entities are 
small.

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 
(chilled or frozen) beef from Paraguay under the conditions specified 
in this final rule will not have a significant impact on the quality of 
the human environment. Based on the finding of no significant impact, 
APHIS 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 website.\7\ Copies of the 
environmental assessment and finding of no significant impact are also 
available for public inspection at USDA, room 1620, 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.
---------------------------------------------------------------------------

    \7\ To view the environmental assessment, go to https://www.regulations.gov/docket/APHIS-2018-0007.
---------------------------------------------------------------------------

Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as not a major rule, as defined by 5 U.S.C. 804(2).

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 0579-0487, 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 final rule, please contact Mr. Joseph Moxey, 
APHIS' Paperwork Reduction Act Coordinator, at (301) 851-2483.

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--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. 1633, 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. Amend Sec.  94.29 as follows:
0
a. In the introductory text, by adding the words ``fresh (chilled or 
frozen) beef from Paraguay;'' after the word ``Tocantins;'';
0
b. In paragraph (a)(1), by adding the words ``or in Paraguay;'' after 
the word ``Brazil'';
0
c. In paragraph (b), by adding the words ``in Paraguay (for beef from 
Paraguay),'' after the words ``(for beef from Brazil),''; and
0
d. By revising the OMB citation at the end of the section.
    The revision reads as follows:


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

* * * * *

(Approved by the Office of Management and Budget under control 
numbers 0579-0372, 0579-0414, 0579-0428, 0579-0449, and 0579-0487)


    Done in Washington, DC, this 3rd day of November 2023.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2023-24782 Filed 11-13-23; 8:45 am]
BILLING CODE 3410-34-P