Rule2023-24782
Importation of Fresh Beef From Paraguay
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 14, 2023
Effective
December 14, 2023
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 218 (Tuesday, November 14, 2023)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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;
<a href="/cdn-cgi/l/email-protection#fbba8890a99e9c9294959a9792819a8f929495bb8e889f9ad59c948d"><span class="__cf_email__" data-cfemail="eeaf9d85bc8b898781808f8287948f9a878180ae9b9d8a8fc0898198">[email protected]</span></a>.
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 <a href="https://www.aphis.usda.gov/animalhealth/disease-status-of-regions">https://www.aphis.usda.gov/animalhealth/disease-status-of-regions</a>.
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]]
<bullet> The meat is derived from animals born, raised, and
slaughtered in the exporting region.
<bullet> FMD has not been diagnosed in the exporting region within
the previous 12 months.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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).
<bullet> The meat has not been in contact with meat from regions
other than those listed in accordance with Sec. 94.1(a).
<bullet> 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.
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov/docket/APHIS-2018-0007">https://www.regulations.gov/docket/APHIS-2018-0007</a>.
---------------------------------------------------------------------------
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 <a href="https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm">https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm</a>.
\3\ To view the APHIS Strategic Plan, go to <a href="https://www.aphis.usda.gov/aphis/banner/aboutaphis/sa_overview/ct_about_aphis">https://www.aphis.usda.gov/aphis/banner/aboutaphis/sa_overview/ct_about_aphis</a>.
---------------------------------------------------------------------------
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:
<bullet> Scope of the evaluation being requested.
<bullet> Veterinary control and oversight.
<bullet> Disease history and vaccination practices.
<bullet> Livestock demographics and traceability.
<bullet> Epidemiological separation from potential sources of
infection.
<bullet> Surveillance.
<bullet> Diagnostic laboratory capabilities.
<bullet> 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 <a href="https://www.congress.gov/bill/114th-congress/house-bill/2029/text">https://www.congress.gov/bill/114th-congress/house-bill/2029/text</a>.
---------------------------------------------------------------------------
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: <a href="https://www.senacsa.gov.py/index.php/Temas-pecuarios/sanidad-animal/programas-sanitarios/fiebre-aftosa">https://www.senacsa.gov.py/index.php/Temas-pecuarios/sanidad-animal/programas-sanitarios/fiebre-aftosa</a>. 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 <a href="http://Regulations.gov">Regulations.gov</a> \6\ website (see
footnote 6 in this document for a link to <a href="http://Regulations.gov">Regulations.gov</a>) or by
contacting the person listed under FOR FURTHER INFORMATION CONTACT.
---------------------------------------------------------------------------
\6\ To view the economic analysis, go to <a href="https://www.regulations.gov/docket/APHIS-2018-0007/document">https://www.regulations.gov/docket/APHIS-2018-0007/document</a>.
---------------------------------------------------------------------------
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 <a href="http://Regulations.gov">Regulations.gov</a> 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 <a href="https://www.regulations.gov/docket/APHIS-2018-0007">https://www.regulations.gov/docket/APHIS-2018-0007</a>.
---------------------------------------------------------------------------
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on November 14, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.