This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

77883 

Vol. 88, No. 218 

Tuesday, November 14, 2023 

FEDERAL LABOR RELATIONS 

AUTHORITY 

5 CFR Part 2424 

Negotiability Proceedings; Correction 

AGENCY: Federal Labor Relations 

Authority. 

ACTION: Correcting amendment. 

SUMMARY: The Federal Labor Relations 

Authority is correcting its regulations 

regarding negotiability proceedings. 

DATES: Effective November 14, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Thomas Tso at ttso@flra.gov or at (771) 

444–5779. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2023–19269, appearing in the Federal 

Register of Tuesday, September 12, 

2023, on pages 62456–57, instruction 7 

revised § 2424.22, but the regulatory text 

inadvertently failed to retain 

§ 2424.22(d), which was not a part of the

revision, in the revised text. Section

2424.22(d) simply cross-references a

general definition of ‘‘Service’’ in

§ 2424.2(g), which, in turn, crossreferences the general obligations for 

service in part 2429. Accordingly, this 

correcting amendment is not a 

substantive change. The correcting 

amendment retains the regulatory text 

that was not part of the intended 

revisions in FR Doc. 2023–19269 and 

inadvertently omitted. This document 

corrects the final regulations. 

List of Subjects in 5 CFR Part 2424 

Administrative practice and 

procedure, Government employees, 

Labor management relations. 

For the reasons set out in the 

preamble, the Federal Labor Relations 

Authority corrects 5 CFR part 2424 by 

making the following correcting 

amendment: 

PART 2424—NEGOTIABILITY 

PROCEEDINGS 

■ 1. The authority citation for part 2424 

continues to read as follows:

Authority: 5 U.S.C. 7134. 

■ 2. Amend § 2424.22 by adding 

paragraph (d) to read as follows:

§ 2424.22 Exclusive representative’s

petition for review; purpose; divisions;

content; service.

* * * * * 

(d) Service. The petition for review,

including all attachments, must be 

served in accord with § 2424.2(g). 

Dated: November 6, 2023. 

Thomas Tso, 

Solicitor and Federal Register Liaison. 

[FR Doc. 2023–24820 Filed 11–13–23; 8:45 am] 

BILLING CODE 6727–01–P 

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-andmouth 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; 

AskRegionalization@usda.gov. 

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, § 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 

§ 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 § 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 § 94.29 of the 

regulations and include the following: 


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77884 Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Rules and Regulations 

1To view the proposed rule, supporting 

documentation, and comments that we received, go 

to https://www.regulations.gov/docket/APHIS-2018- 

0007. 

2To view the SPS Agreement, go to https://

www.wto.org/english/tratop_e/sps_e/spsagr_e.htm. 

3To view the APHIS Strategic Plan, go to https:// 

www.aphis.usda.gov/aphis/banner/aboutaphis/sa_

overview/ct_about_aphis. 

• 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 § 94.1(a). 

• The meat came from carcasses that 

were allowed to maturate at 40 to 50 °F 

(4 to 10 °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. 

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

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 


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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 onfarm 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 


khammond on DSKJM1Z7X2PROD with RULES
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4To view the statute containing the Congressional 

repeal of COOL, go to https://www.congress.gov/ 

bill/114th-congress/house-bill/2029/text. 

5The 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. 

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 countryof-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. 

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. 

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 


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Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Rules and Regulations 77887 

6To view the economic analysis, go to https://

www.regulations.gov/docket/APHIS-2018-0007/ 

document. 

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, salmonellaridden 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 grassfinished 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. 

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 grainfed 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 


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77888 Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Rules and Regulations 

7To view the environmental assessment, go to 

https://www.regulations.gov/docket/APHIS-2018- 

0007. 

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-ratequota 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. 

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 

■ 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. 

■ 2. Amend § 94.29 as follows: 

■ a. In the introductory text, by adding 

the words ‘‘fresh (chilled or frozen) beef 

from Paraguay;’’ after the word 

‘‘Tocantins;’’; 

■ b. In paragraph (a)(1), by adding the 

words ‘‘or in Paraguay;’’ after the word 

‘‘Brazil’’; 

■ c. In paragraph (b), by adding the 

words ‘‘in Paraguay (for beef from 

Paraguay),’’ after the words ‘‘(for beef 

from Brazil),’’; and 

■ d. By revising the OMB citation at the 

end of the section. 

The revision reads as follows: 

§ 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 


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