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.

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new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

69851 

Vol. 75, No. 220 

Tuesday, November 16, 2010 

DEPARTMENT OF HOMELAND 

SECURITY 

8 CFR Part 103 

[CIS No. 2490–09; DHS Docket No. USCIS– 

2009–0033] 

RIN 1615–AB80 

U.S. Citizenship and Immigration 

Services Fee Schedule; Correction 

AGENCY: U.S. Citizenship and 

Immigration Services, DHS. 

ACTION: Final rule; correction. 

SUMMARY: The Department of Homeland 

Security corrects an inadvertent error in 

the amendatory language of the final 

rule U.S. Citizenship and Immigration 

Services Fee Schedule published in the 

Federal Register on September 24, 2010. 

DATES: This correction is effective 

November 23, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Timothy Rosado, Acting Chief Financial 

Officer, U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security, 20 Massachusetts 

Avenue, NW., Washington, DC 20529– 

2130, telephone (202) 272–1930. 

SUPPLEMENTARY INFORMATION: 

Need for Correction 

On September 24, 2010, the 

Department of Homeland Security 

(DHS) published a final rule in the 

Federal Register adjusting the U.S. 

Citizenship and Immigration Services 

(USCIS) fee schedule. 75 FR 58962. As 

discussed in the preamble to the final 

rule, DHS determined that the fee for a 

refugee travel document for an adult age 

16 or older should match the fee 

charged for the issuance of a passport to 

a United States citizen ($110 plus a $25 

dollar execution fee). 75 FR at 58964, 

58972. Accordingly, DHS intended to 

reduce the fee for filing Application for 

Travel Document, Form I–131, for a 

refugee travel document to $135 for an 

adult age 16 or older. 

The final rule inadvertently listed a 

fee of $165 for filing an Application for 

Travel Document, Form I–131, for a 

refugee travel document for an adult age 

16 or older. 75 FR at 58987. DHS needs 

to correct that portion of the final rule 

to indicate that an adult age 16 or older 

must submit a fee of $135 with an 

Application for Travel Document, Form 

I–131, to request a refugee travel 

document. No other changes are made 

in this correction. 

Correction of Publication 

■ Accordingly, the publication on 

September 24, 2010 (75 FR 58962) of the 

final rule that was the subject of FR Doc. 

2010–23725 is corrected as follows: 

§ 103.7 [Corrected] 

■ 1. On page 58987, in the first column, 

§ 103.7 is amended by revising the 

dollar figure ‘‘$165’’ in paragraph 

(b)(1)(i)(M)(1) to read: ‘‘$135’’. 

Dated: November 9, 2010. 

Christina E. McDonald, 

Acting Associate General Counsel for 

Regulatory Affairs, Department of Homeland 

Security. 

[FR Doc. 2010–28719 Filed 11–15–10; 8:45 am] 

BILLING CODE 9111–97–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Part 94 

[Docket No. APHIS–2009–0034] 

RIN 0579–AD12 

Changes in Disease Status of the 

Brazilian State of Santa Catarina With 

Regard to Certain Ruminant and Swine 

Diseases 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are amending the 

regulations governing the importation of 

certain animals and animal products by 

adding the Brazilian State of Santa 

Catarina to the list of regions we 

recognize as free of foot-and-mouth 

disease (FMD), rinderpest, swine 

vesicular disease, classical swine fever, 

and African swine fever. We are also 

adding Santa Catarina to the list of 

regions that are subject to certain import 

restrictions on meat and meat products 

because of their proximity to or trading 

relationships with rinderpest- or FMDaffected countries. These actions will 

update the disease status of Santa 

Catarina with regard to FMD, rinderpest, 

swine vesicular disease, classical swine 

fever, and African swine fever while 

continuing to protect the United States 

from an introduction of those diseases 

by providing additional requirements 

for live swine, pork meat, pork 

products, live ruminants, ruminant 

meat, and ruminant products imported 

into the United States from Santa 

Catarina. 

DATES: Effective Date: December 1, 2010. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Silvia Kreindel, Senior Staff 

Veterinarian, Regionalization Evaluation 

Services Staff, National Center for 

Import and Export, VS, APHIS, 4700 

River Road Unit 38, Riverdale, MD 

20737; (301) 734–4356 or (301) 734– 

8419. 

SUPPLEMENTARY INFORMATION: 

Background 

The regulations in 9 CFR part 94 

(referred to below as the regulations) 

govern the importation into the United 

States of specified animals and animal 

products in order to prevent the 

introduction of various animal diseases, 

including rinderpest, foot-and-mouth 

disease (FMD), African swine fever 

(ASF), classical swine fever (CSF), and 

swine vesicular disease (SVD). These 

are dangerous and destructive 

communicable diseases of swine and 

ruminants. 

Section 94.1 of the regulations 

prohibits, with certain exceptions, the 

importation into the United States of 

live swine, live ruminants, and products 

from these species from regions where 

FMD or rinderpest is known to exist. 

Rinderpest or FMD exists in all regions 

of the world except for certain regions 

that are listed as free of rinderpest or 

free of both rinderpest and FMD in 

§ 94.1. Section 94.11 of the regulations 

lists regions of the world that have been 

determined to be free of rinderpest and 

FMD, but that are subject to certain 

restrictions because of their proximity to 

or trading relationships with rinderpestor FMD-affected regions. Section 94.8 of 

the regulations restricts the importation 

into the United States of pork and pork 


jlentini on DSKJ8SOYB1PROD with RULES
69852 Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Rules and Regulations 

1To view the proposed rule, supporting and 

related documents, and the comments received, go 

to http://www.regulations.gov/fdmspublic/ 

component/main?main=DocketDetail&d=APHIS2009-0034. 

products from regions where ASF is 

known to or reasonably believed to 

exist. ASF is known to or reasonably 

believed to exist in those regions of the 

world listed in § 94.8. Section 94.9 of 

the regulations restricts the importation 

into the United States of pork and pork 

products from regions where CSF is 

known to exist, and § 94.10 prohibits, 

with certain exceptions, the importation 

of live swine from regions where CSF is 

known to exist. Sections 94.9 and 94.10 

provide that CSF exists in all regions of 

the world except the regions listed in 

those sections. Section 94.12 of the 

regulations restricts the importation into 

the United States of pork and pork 

products from regions where SVD is 

known to exist. SVD exists in all regions 

of the world except for certain regions 

that are listed as free of SVD in that 

section. 

On April 16, 2010, we published in 

the Federal Register a proposal 1 (75 FR 

19915–19920, Docket No. APHIS–2009– 

0034) to amend the regulations by 

adding Santa Catarina to the list in 

§ 94.1 of regions that are free of 

rinderpest and FMD, the list in § 94.11 

of regions that are declared to be free of 

rinderpest and FMD but that are subject 

to certain restrictions because of their 

proximity to or trading relationships 

with rinderpest or FMD-affected 

regions, the lists in §§ 94.9 and 94.10 of 

regions that are free of CSF, and the list 

in § 94.12 of regions that are free of 

SVD. We also proposed to exclude Santa 

Catarina from the list in § 94.8 of regions 

where ASF is known to or reasonably 

believed to exist. 

We solicited comments concerning 

our proposal for 60 days ending June 15, 

2010. We received 87 comments by that 

date. They were from U.S. ranchers and 

cattle producers, U.S. industry and trade 

organizations, a Tribal association, a 

consumer organization, State 

departments of agriculture, Brazilian 

trade and industry associations, a 

Brazilian Government agency, the 

Canadian embassy, and private citizens. 

They are discussed below by topic. 

One commenter stated that Animal 

and Plant Health Inspection Service 

(APHIS) lacks the ability to design and 

implement effective risk mitigation 

techniques. Several commenters stated 

their belief that the proposed rule was 

not consistent with the APHIS’ mission 

of protecting U.S. agriculture. 

Commenters voiced concern about the 

reliance on administrative barriers to 

protect against disease introduction and 

stated that amending the regulations 

would put the United States at risk for 

an outbreak of FMD. 

We disagree. APHIS considers all 

regions in the world to be affected by 

FMD (§ 94.1) until APHIS conducts an 

evaluation and concludes that the 

region or country is free of FMD and 

therefore able to export FMDsusceptible commodities to the United 

States. While there is always some 

degree of disease risk associated with 

the movement of animals and animal 

products, APHIS regulatory safeguards 

will provide effective protection against 

the risks associated with the 

importation of ruminants, swine, or 

their products from the Brazilian State 

of Santa Catarina. These safeguards 

include subjecting animals and animal 

products from Santa Catarina to certain 

restrictions because of the region’s 

proximity to FMD affected countries 

(§ 94.11), certification that ruminants 

and swine have been kept in a region 

entirely free of FMD and rinderpest (for 

ruminants) and FMD, rinderpest, CSF, 

SVD, and ASF (for swine) for 60 days 

prior to export (§§ 93.405 and 93.505), 

and a minimum quarantine of 30 days 

from the date of arrival at the port of 

entry for most imported ruminants 

(§ 93.411) and 15 days for all imported 

swine (§ 93.510). 

APHIS’ evaluations are based on 

science and conducted according to the 

11 factors identified in § 92.2, 

‘‘Application for recognition of the 

animal health status of a region,’’ which 

include veterinary and disease control 

infrastructures, disease status of the 

export region and adjacent regions, and 

animal movement controls. Based on 

these factors, as discussed in the 

proposed rule and its underlying risk 

evaluation, we have determined that 

ruminants, swine, and their products 

can be safely imported into the United 

States from Santa Catarina. 

Regionalization recognizes that pest 

and disease conditions may vary across 

a country as a result of ecological, 

environmental, and quarantine 

differences and adapts import 

requirements to the health conditions of 

the specific area or region where a 

commodity originates. Many 

commenters rejected the concept of 

regionalization, stating that World 

Organization for Animal Health (OIE) 

recognition of FMD-free status was not 

sufficient reason for U.S. recognition of 

FMD-free status. Some commenters 

indicated that regionalization is not 

scientific. One commenter stated that 

APHIS lacks the ability to accurately 

assess the risk of FMD and the 

effectiveness of regionalization-based 

risk mitigations. One commenter 

opposed following World Trade 

Organization (WTO) guidelines. One 

commenter opposed making decisions 

based on OIE’s Terrestrial Animal 

Health Code. 

As a signatory to the WTO’s Sanitary 

and Phytosanitary Agreement, the 

United States is committed to following 

WTO guidelines, including guidelines 

on regionalization. OIE’s Terrestrial 

Animal Health Code provides 

internationally accepted guidelines to 

protect animal health by limiting the 

spread of animal diseases within and 

between countries without 

unnecessarily restricting international 

trade. APHIS evaluates all requests from 

countries or regions requesting 

recognition of disease freedom 

consistent with OIE guidelines. 

Evaluations are based on science and 

conducted according to the 11 factors 

identified in § 92.2. We have not 

automatically accepted OIE recognition 

of disease status as the basis for changes 

to our regulations; rather, we first 

conduct our own evaluation, such as 

that detailed in the proposed rule and 

its accompanying risk evaluation. 

One commenter said that allowing 

regionalization in one region and not 

another would be a double standard, 

especially as regions neighboring Santa 

Catarina within Brazil have applied for 

recognition of disease-free status. 

APHIS has established protocols for 

evaluating requests from other countries 

and regions for recognition of FMD or 

other disease freedom. Section 92.2 of 

the regulations provides for any country 

to request a change in the animal health 

status of a region. APHIS evaluates all 

requests based on sound science and 

internationally recognized guidelines 

established by the OIE and considers the 

unique characteristics of each region in 

its evaluation. APHIS has not received 

a request from Brazil for disease-free 

status for any regions that neighbor 

Santa Catarina; should APHIS receive 

such a request, APHIS would evaluate it 

in accordance with established 

procedures. APHIS is currently 

evaluating a request from Brazil for 

several Brazilian States, including States 

neighboring Santa Catarina, to export 

boneless beef under certain conditions 

designed to protect against the 

introduction of FMD into the United 

States. This request, however, does not 

involve declaring any Brazilian States 

free of disease. 

Commenters also objected to linking 

this rule with a WTO negotiated 

settlement over a Brazilian cotton 

dispute. In this long-running dispute 

brought by the Government of Brazil 

against the United States, the WTO 

found that certain U.S. agricultural 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Rules and Regulations 69853 

subsidies, including cotton subsidies, 

are inconsistent with the United States’ 

WTO commitments. As part of a 

negotiated settlement of this dispute 

with Brazil, the United States agreed to 

publish a proposed rule to recognize the 

State of Santa Catarina as free of FMD, 

rinderpest, CSF, ASF, and SVD. 

While we acknowledge that 

publication of the proposed rule was 

part of a WTO negotiated settlement, the 

settlement did not affect the 

methodology or the conclusions in our 

risk evaluation. Our decision was based 

on our own evaluation of the disease 

status of Santa Catarina, which was 

conducted according to the 11 factors 

identified in § 92.2. We would not 

propose to recognize any region as free 

of a disease or diseases unless our 

evaluation of the region’s disease status 

supported it, consistent with our 

statutory responsibility under the 

Animal Health Protection Act (7 U.S.C. 

8301 et seq.) 

Several commenters said that trade 

relations should be equitable. 

Commenters stated that trade 

restrictions the Government of Brazil 

has imposed against the United States 

were unfair, with one commenter noting 

that the Brazilian Government closed its 

borders to the importation of live cattle 

from the United States in 2003 due to 

an incidence of bovine spongiform 

encephalopathy. Another commenter 

expressed frustration at the Brazilian 

Government’s trichinosis-related import 

restrictions on U.S. pork, which the 

commenter stated were not based on 

science. 

APHIS agrees with the commenters 

that trade relations should be equitable. 

APHIS’ regionalization decisions, 

however, are based on science and not 

on reciprocal trade agreements. We note 

that the United States has benefited 

from regionalization when certain 

animal diseases have been detected in 

specific areas of our own country. We 

will continue to work with the Brazilian 

Government to resolve animal healthrelated barriers to trade. 

Many commenters expressed concern 

with the Brazilian Government’s ability 

to maintain Santa Catarina’s FMD-free 

status and asked whether the Brazilian 

authorities have the resources and 

infrastructure necessary for enforcement 

of laws and regulations. Many 

commenters noted that FMD outbreaks 

have occurred in regions that APHIS 

had recognized as free, and some 

commenters stated that the risk 

evaluation does not conclusively 

determine that the Brazilian authorities 

could maintain Santa Catarina’s FMDfree status. One commenter expressed 

concern regarding the Brazilian 

authorities’ ability to respond to an 

FMD outbreak. One commenter stated 

APHIS lacked the ability to predict 

potential FMD outbreaks. 

Because disease situations are fluid, 

no country, not even the United States, 

can guarantee perpetual freedom from a 

disease. Therefore, APHIS’ risk 

evaluation considers whether a 

country’s animal health authorities can 

quickly detect, respond to, and report 

changes in disease situations. For the 

reasons explained in the proposed rule 

and its underlying risk evaluation, we 

concluded that the local authorities in 

Santa Catarina have the legal 

framework, animal health infrastructure, 

movement and border controls, 

diagnostic capabilities, surveillance 

programs, and emergency response 

systems necessary to detect, report, and 

control an outbreak of FMD, CSF, SVD, 

or ASF should one occur in Santa 

Catarina. To amplify this conclusion, we 

have updated the risk evaluation to 

make it clear that authorities in Brazil 

have responded to past outbreaks of 

FMD in a timely manner by declaring 

sanitary emergency alerts and 

intensifying biosecurity, control, 

prevention, and surveillance within 

high-risk areas. 

When a reportable animal disease 

outbreak does occur in a region 

previously recognized by APHIS as free 

of that disease, APHIS has the authority 

to take immediate action to prohibit or 

restrict imports of animals and animal 

products. APHIS has acted in 

accordance with that authority when 

regions have experienced FMD 

outbreaks. 

Many commenters expressed concern 

that Brazil, in its entirety, is not free of 

FMD. 

As discussed in the proposed rule, the 

importation of meat and other products 

from ruminants or swine into the United 

States from Santa Catarina would 

continue to be subject to certain 

restrictions because of Santa Catarina’s 

proximity to or trading relationships 

with FMD-affected countries and 

regions. For example, we require that 

only inspected, authorized 

establishments be used to prepare 

products, and we prohibit using 

slaughterhouses that receive meat or 

animals from FMD- or rinderpestaffected areas. These restrictions 

mitigate the risk that products from 

FMD-free regions would be commingled 

with products from affected regions. 

Furthermore, border controls are 

proving effective at keeping FMD out of 

Santa Catarina from surrounding 

countries and regions. 

Several commenters raised the issue 

of the possibility of animals from areas 

that do not have disease-free status 

being moved into Santa Catarina. Some 

commenters also expressed concern that 

regionalization would increase the 

incentive to illegally import cattle into 

Santa Catarina. One commenter 

requested enforcement by Brazilian 

authorities and monitoring by APHIS of 

entry of animals from adjacent areas. 

One commenter requested information 

regarding Table 6 in the risk evaluation 

and why illegal trafficking of small 

herds was not being detected. 

In our evaluation, conducted 

according to the 11 factors identified in 

§ 92.2, we concluded that the local 

authorities in Santa Catarina have 

adequate controls at ports of entry for 

legal importation of species and 

products that could carry the diseases 

under evaluation (FMD, CSF, ASF, and 

SVD). The local authorities in Santa 

Catarina also have the legal framework 

and authority to deal with the entry of 

illegal animals or animal products into 

the State; we evaluated the controls of 

local authorities in Santa Catarina for 

the movement of animals into the State 

and concluded that risk from illegal 

importations from affected regions to be 

sufficiently mitigated. Accordingly, we 

have determined that APHIS monitoring 

of the movement of animals into Santa 

Catarina is unnecessary. 

The table mentioned by the 

commenter, which appears on page 40 

of the risk evaluation, depicts the results 

of border inspections conducted during 

2005 and 2006 and does not contain any 

references to or inferences about illegal 

trafficking of smaller herds. The 

pathway of illegal cattle trafficking is 

hard to quantify by definition. 

We consider exposure of susceptible 

U.S. animals to illegally imported 

infected live animals from Santa 

Catarina to be highly unlikely. In Santa 

Catarina, individual cattle identification 

is mandatory for the entire herd, making 

it extremely unlikely that any cattle that 

might be illegally imported into Santa 

Catarina could end up being exported to 

the United States. Furthermore, the 

local authorities in Santa Catarina 

require strict inventory control of 

animals at the farm and require 

producers to receive a permit prior to 

any animal movement, including 

movement to slaughter. This process 

includes a visit to the farm by the local 

veterinary unit to verify the 

identification of any animals going to 

slaughter and also check for signs of 

disease in the herd. So even if an animal 

were somehow smuggled into Santa 

Catarina, it could not move anywhere 

else, nor could any of its herd members, 

without a movement document that 

contains particulars about the animal 


jlentini on DSKJ8SOYB1PROD with RULES
69854 Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Rules and Regulations 

2The article can be viewed at http://en.

mercopress.com/2010/05/21/growing-concern-inuruguay-with-brazilian-delay-in-fmd-vaccinationtimetable. 

(including the individual animal 

identification). 

Several commenters expressed 

concern with the reliance of the local 

authorities in Santa Catarina on 

administrative barriers rather than 

geographic barriers to prevent FMD. 

We have determined that the 

administrative barriers in Santa Catarina 

are effective. As discussed in the 

proposed rule and its underlying risk 

evaluation, the local authorities in Santa 

Catarina enforce both geographic and 

administrative barriers. The use of these 

two types of barriers combined has 

prevented the introduction of the 

diseases under evaluation into Santa 

Catarina. 

Many commenters expressed concern 

with delays in FMD vaccinations to 

regions surrounding Santa Catarina, 

referencing a May 2010 article in 

MercoPress 2 that outlined a growing 

concern in Uruguay with the Brazilian 

Government’s delay in carrying out its 

FMD vaccination timetable for those 

States in Brazil that are considered to be 

FMD-free with vaccination. 

Under § 94.11 of the regulations, 

animals and animal products are subject 

to certain restrictions because of a 

region’s proximity to FMD-affected 

regions or countries; as APHIS 

restrictions do not distinguish between 

regions or countries that vaccinate for 

FMD and those that are affected with 

the disease, the vaccination status of 

regions surrounding Santa Catarina is 

not germane. 

Two commenters wanted to know 

what APHIS’ response would be should 

the disease status of countries or States 

contiguous to Santa Catarina change. 

The regulations in § 92.2(a) provide 

that regions recognized as disease-free 

may be required to submit additional 

information pertaining to animal health 

status or allow APHIS to conduct 

additional information collection 

activities once regionalization is 

established. In the event that the disease 

status of a region bordering Santa 

Catarina changed, APHIS would require 

Brazilian authorities to submit 

additional information as necessary 

regarding Santa Catarina’s animal health 

status and response to the situation. 

Because of Santa Catarina’s proximity to 

or trading relationships with FMDaffected areas, the importation of meat 

and other animal products from 

ruminants or swine into the United 

States from Santa Catarina will already 

be subject to the restrictions in § 94.11. 

It should be noted that recent changes 

in the disease status of surrounding 

areas have not affected Santa Catarina; 

there was no evidence of FMD viral 

activity in cattle or other species in 

Santa Catarina during or after the 2000– 

2001 and 2005–2006 outbreaks in other 

areas of Brazil. 

One commenter indicated the need 

for precautions to ensure that the 

importation of animals or animal 

products does not result in the 

introduction of animal disease to the 

United States. One commenter 

expressed concern that animal products 

could be imported before a disease 

outbreak is diagnosed in the exporting 

country. 

Animals and animal products from 

Santa Catarina will continue to be 

subject to certain restrictions because of 

the region’s proximity to FMD-affected 

countries and regions (§ 94.11). 

Furthermore, current APHIS regulations 

require certification that ruminants and 

swine have been kept in a region 

entirely free of FMD, CSF, SVD, and 

ASF for 60 days prior to export 

(§§ 93.405 and 93.505). They also 

require a minimum quarantine of 30 

days from the date of arrival at the port 

of entry for most imported ruminants 

(§ 93.411) and 15 days for all imported 

swine (§ 93.510). These requirements 

increase the likelihood of disease 

detection in exported animals. 

Considered with the protections 

afforded by the safeguards contained in 

§ 94.11, the certification and quarantine 

requirements for imported animals will 

effectively mitigate the risk associated 

with the importation of ruminants, 

swine, and their products from Santa 

Catarina. 

One commenter wanted to know what 

parameters APHIS used to define early 

detection of the diseases being 

evaluated, indicating that APHIS should 

better describe the estimated 

confidence, prevalence, and time to 

detection. 

As we explained in the risk 

evaluation, the local authorities in Santa 

Catarina have surveillance programs in 

cattle and swine for the early detection 

of FMD, CSF, SVD, and ASF. Local 

veterinary units visit farms to conduct 

regular inspections, and they also check 

for signs of disease in the herd before 

the movement of any animals to 

slaughter. Ruminants and swine in 

Santa Catarina are not vaccinated for 

FMD or CSF, which means that clinical 

signs of disease would be more apparent 

in individual animals as well as herds. 

The ability to rapidly confirm a 

disease outbreak via laboratory analysis 

is also necessary for early disease 

detection. We determined that Brazilian 

animal health authorities have the 

diagnostic capability to adequately test 

for all the diseases under evaluation. 

Furthermore, early disease detection 

is linked directly to OIE guidelines for 

notification of suspected notifiable 

diseases. As a member of the OIE, the 

Brazilian Government is obligated to 

follow OIE guidelines for suspected 

notifiable diseases, which include 

immediate notification of the 

organization of any FMD outbreak or 

other important epidemiological event. 

The notification must include the 

reason for the notification, the name of 

the disease, the affected species, the 

geographical area affected, the control 

measures applied, and any laboratory 

tests carried out or in progress. We have 

updated the risk evaluation to reflect the 

fact that the 2005–2006 FMD outbreaks 

that occurred in the States of Mato 

Grosso do Sul and Parana were reported 

to the OIE and trading partners 

immediately after confirmation. 

Several commenters requested 

scientific data showing the 11 

requirements for regionalization have 

been met by the local authorities in 

Santa Catarina. 

The 11 factors in § 92.2(b) also 

include information that is not scientific 

in nature, such as demographics and the 

authority of the veterinary services 

organization in the region. Section 

92.2(d) says that we will share with the 

public all the information we receive in 

alignment with 92.2(b) and affirm that 

we did so. Thus, to the extent that any 

of the factors are addressed through 

scientific data, the data has been shared 

already. 

One commenter said the risk 

evaluation was insufficient and 

requested a quantitative risk assessment 

as required under APHIS’ regulations in 

9 CFR part 92, which govern the 

importation of animals and animal 

products and provide procedures for 

requesting recognition of regions, and 

APHIS guidance documents. One 

commenter said we did not adequately 

address biosecurity measures or 

livestock demographics and marketing 

practices in our risk evaluation. 

APHIS’ evaluations are based on 

science and conducted according to the 

11 factors identified in § 92.2, which 

include biosecurity measures, livestock 

demographics, and marketing practices. 

Neither the regulations in 9 CFR part 92 

nor APHIS guidance documents require 

a quantitative risk assessment or 

indicate that one is needed here. The 

commenter did not specify how the 

results of the risk evaluation would be 

improved by a quantitative risk 

assessment. 


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Some commenters requested 

additional information on animal 

identification and segregation methods 

in Santa Catarina. Other commenters 

indicated that animal identification 

could not prevent or control disease. 

Additional information on Brazil’s 

animal identification system can be 

found at http://www.agricultura.gov.br/ 

portal/page?_pageid=33,5459468&

_dad=portal&_schema=PORTAL. For 

the reasons explained in the proposed 

rule and its underlying risk evaluation, 

we concluded that the local authorities 

in Santa Catarina have an identification 

system that will allow it to comply with 

the certification requirements in § 94.11, 

which requires certification that meat 

and other products intended for export 

to the United States have not been 

commingled with meat or products not 

eligible for export to the United States. 

To be eligible for certification, meat or 

other animal products must originate 

from a region free from rinderpest and 

FMD. Animal identification is only one 

of the factors considered in determining 

whether the local authorities in Santa 

Catarina can detect, report, and control 

outbreaks of the diseases under 

evaluation. We agree that animal 

identification does not in and of itself 

prevent or control animal disease, but 

an effective animal identification system 

is a valuable tool for animal disease 

prevention and control efforts, which is 

why we evaluate it. 

Some commenters indicated the local 

authorities in Santa Catarina should 

require tattoos rather than backtags for 

their animal identification system, as 

this is how swine in the United States 

are identified. 

All animals imported into the United 

States must be identified with approved 

identification upon entering interstate 

commerce. In 9 CFR part 71 of our 

regulations governing the interstate 

movement of animals within the United 

States, § 71.19 includes backtags as an 

approved method of identification for 

swine moving to slaughter in the United 

States. 

One commenter requested more 

explanation regarding mitigation efforts 

for risky herds of cattle and an 

explanation as to why they would 

remain free of FMD. 

The local authorities in Santa Catarina 

take a proactive approach to addressing 

the risks posed by risky herds, defined 

as herds with one or more of the 

following risk factors: A high volume of 

movement of animals or products; 

proximity to animal or waste gathering 

facilities (including slaughterhouses, 

landfills, feedmills, and border areas); or 

containing over 100 animals. As we 

explained in the risk evaluation, local 

veterinary personnel carry out 

supplemental inspections of herds 

classified as ‘‘risky’’ by the official 

service. Other mitigation measures 

include enhanced surveillance activities 

(both active and passive) which include 

serologic testing and are designed to 

demonstrate freedom from FMD. 

One commenter requested a 

comparison of educational requirements 

for accredited veterinarians in Brazil 

and the United States. 

Accredited veterinarians in Brazil 

undergo training similar to that required 

in the United States. During the site 

visit, APHIS was able to corroborate that 

official and accredited veterinarians in 

Brazil are able to detect, recognize, and 

report diseases and to follow protocols 

for disease prevention and eradication. 

One commenter requested an 

explanation for the high percentage of 

vesicular lesion ruleouts that are toxic 

in nature, i.e., why so many vesicular 

lesions, a possible indicator of FMD, 

were from toxic causes. 

Because Santa Catarina does not 

contain any endemic vesicular diseases, 

vesicular lesions that occur must 

thereby be caused by some other means. 

The definitive diagnoses for suspicious 

lesions were generally due to traumatic 

injury or ingestion of caustic or toxic 

plants. We are providing this 

information in the risk evaluation to 

clarify this matter. 

One commenter indicated that a 

discussion of serological monitoring for 

FMD and CSF at slaughter was missing 

from the proposed rule and risk 

evaluation. 

While there is no serological 

monitoring for FMD or CSF at slaughter, 

the local authorities in Santa Catarina 

do not vaccinate for FMD or CSF. 

Therefore, any cattle or swine in the 

region exposed to the FMD or CSF virus 

can be considered sentinels for these 

diseases, precluding the need for 

serological monitoring. 

One commenter requested more 

information regarding the plan to 

eradicate FMD in South America (the 

Plano Hemisferico de Eradicacai de 

Febre Aftosa). 

Additional information on the plan 

can be found at http://www.fao.org/Ag/ 

againfo/commissions/docs/research_

group/erice/APPENDIX_06.pdf. It 

should be noted that, as we explained 

in the risk evaluation, the OIE 

recognized Santa Catarina as an FMDfree zone where vaccination is not 

practiced in 2007. 

One commenter expressed concern 

that Santa Catarina does not have a 

diagnostic laboratory. 

It is not unusual for countries to have 

only a few reference laboratories located 

throughout the country to perform 

diagnostic testing, with standard 

laboratories located in specific States or 

regions to perform more routine testing. 

The United States, for example, uses 

such a system. As we explained in the 

risk evaluation, Brazilian animal health 

authorities have the diagnostic 

capability to adequately test for all the 

diseases under evaluation. 

Several commenters noted that we 

indicated, in the preamble to the 

proposed rule, that the last case of FMD 

in Brazil was in 2005 when it actually 

occurred in 2006. 

The risk evaluation correctly 

indicated that the last FMD outbreak in 

Brazil started in 2005 and ended in 

2006. While we agree that the dates of 

that outbreak were incompletely 

reported in the proposed rule, this does 

not affect our risk evaluation or its 

conclusions. 

Several commenters stated that we 

failed to discuss wildlife and feral swine 

and their possible role in transmitting 

FMD and CSF. Commenters also 

expressed concern regarding 

consumption of garbage by free-ranging 

swine. 

The role of wild boar in the 

transmission of CSF is considered on 

page 73 of the risk evaluation. We agree 

that the risk evaluation did not address 

the FMD risk associated with wildlife 

and feral swine populations and have 

updated the risk evaluation to address 

this omission. Although several South 

American wild animal species are 

susceptible to FMD, research into FMD 

in South America has determined that 

wildlife populations, including feral 

swine, do not play a significant role in 

the maintenance and transmission of 

FMD. During outbreak situations, 

wildlife may become affected by FMD; 

however, the likelihood that they would 

become carriers under field conditions 

is rare. Therefore, it is unlikely that 

FMD would be introduced into Santa 

Catarina through movement of infected 

wildlife. 

Furthermore, the local authorities in 

Santa Catarina prohibit feeding garbage 

to animals. In the event that these laws 

were circumvented, other factors 

evaluated in the risk assessment, 

including biosecurity measures, 

surveillance activities, and response 

capabilities, would mitigate disease 

risks. 

Several commenters addressed risks 

beyond the diseases evaluated in the 

proposed rule. Commenters expressed 

concern that residues of drugs, such as 

Ivermectin or pharmaceutical products 

would be present in the meat of animals 

from Santa Catarina. Other commenters 

questioned the adequacy of Brazil’s food 


jlentini on DSKJ8SOYB1PROD with RULES
69856 Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Rules and Regulations 

safety standards and inspection 

practices. 

These issues are beyond the scope of 

the Animal Health Protection Act. The 

U.S. Food and Drug Administration and 

the United States Department of 

Agriculture’s Food Safety and 

Inspection Service have oversight of 

these issues, and we coordinate with 

these agencies as needed. 

One commenter indicated that 

tuberculosis and brucellosis should be 

considered in the proposed rule. 

The analysis of these issues is beyond 

the scope of the proposed rule, which 

focused on specific diseases addressed 

by our regulations in 9 CFR part 94. 

Measures to prevent the introduction by 

imported live animals of bovine 

tuberculosis and brucellosis, along with 

other livestock diseases, are addressed 

by our regulations in 9 CFR part 93. 

Several commenters raised issues in 

response to the economic analysis. One 

commenter requested an analysis of 

possible changes to market prices in 

Santa Catarina due to the 

implementation of a final rule. One 

commenter requested an analysis of 

marketing pressures in Santa Catarina 

and movement and marketing practices. 

One commenter requested a peerreviewed economic analysis on the 

impact of a foreign animal disease 

outbreak in the United States. One 

commenter requested a more thorough 

explanation of the number of years it 

would take for producers to recover to 

pre-event prices should FMD or CSF be 

introduced into the United States. 

The analysis of market prices, 

marketing pressures, and impacts of 

foreign animal disease outbreaks is not 

required under the Regulatory 

Flexibility Act. The Regulatory 

Flexibility Act requires an economic 

analysis to examine the potential 

economic effects of an action on small 

entities in the United States, and we 

determined that the factors cited by the 

commenters do not need to be analyzed 

in order to determine those effects. A 

2008 report on the economic impacts of 

a foreign animal disease outbreak, 

developed by USDA’s Economic 

Research Service, is available at http:// 

www.ers.usda.gov/publications/err57/ 

err57.pdf. We have determined that the 

requirements in this final rule will 

effectively mitigate the risk of 

introducing FMD or CSF into the United 

States via imports from Santa Catarina. 

One commenter requested a risk/ 

benefit analysis in connection with the 

potential impact on the U.S. gross 

domestic product. Several commenters 

expressed concerns about negative 

economic impacts as a result of the 

proposed rule, including negative 

impacts on U.S. cattle and beef 

producers, pork producers, and rural 

economies. One commenter requested 

an analysis of possible changes to 

market prices in the United States. 

Under the Animal Health Protection 

Act, we have the authority to prohibit or 

restrict the importation of animals and 

animal products only when necessary to 

prevent the introduction into or 

dissemination within the United States 

of any pest or disease of livestock. We 

do not have the authority to restrict 

imports on the grounds of potential 

economic effects on domestic entities 

that could result from increased 

imports. While the final rule is not 

expected to result in beef or other 

ruminant meat exports to the United 

States of any appreciable quantity, we 

have, however, considered the possible 

negative economic impacts with respect 

to pork in the final economic analysis 

and determined that the rule will not 

have a significant impact on a 

substantial number of small entities. 

Several commenters expressed 

concern that the potential imports of 

beef were understated in the economic 

analysis, noting that Santa Catarina has 

more cattle operations than any single 

State in the United States. Commenters 

stated that Brazil is the largest beef 

exporter in the world, that the 

representation of the Brazilian cattle 

industry was not accurate, and that the 

potential for beef exports should be 

included in the analysis based on beef 

harvesting or processing facilities. 

We disagree with the commenters. 

The analysis discusses and references 

information on the size of the cattle 

industry in Brazil. As discussed in the 

proposed rule and its underlying 

analysis, Santa Catarina contains less 

than 2 percent of Brazil’s cattle, most of 

which are dairy animals, and the final 

rule is not expected to result in beef or 

other ruminant meat exports to the 

United States of any appreciable 

quantity. 

Many commenters expressed concern 

with the economic and other impacts of 

an FMD outbreak in the United States. 

Commenters also indicated we did not 

analyze the impact of an FMD outbreak 

on U.S. wildlife. 

As discussed in the environmental 

assessment, we evaluated the nature of 

each disease, its causal agent, and its 

potential impacts on the physical 

environment as well as the health of 

human, livestock, and wildlife 

populations in the United States. 

One commenter said the 

environmental assessment was deficient 

because it lacked multiple scenarios and 

modeling needed to consider all 

potential effects to the human 

environment. 

In the environmental assessment, we 

considered the potential effects to the 

human environment in accordance with 

the National Environmental Policy Act, 

including the natural and physical 

environment and the relationship of 

people with that environment. The 

environmental assessment is a threshold 

analysis that does not require ‘‘multiple 

scenarios and modeling.’’ The lack of 

modeling has no affect on the findings 

in the EA. If a proposed action has the 

potential to significantly impact the 

environment, then an environmental 

impact statement is prepared, which 

involves a more comprehensive 

environmental analysis of the proposal 

and reasonable alternatives and might 

require such detail. 

One commenter said we lacked data 

needed to respond to an FMD outbreak, 

including data on how the disease 

would spread to wildlife. 

These issues have been studied 

extensively and APHIS has detailed 

contingency and preparedness action 

plans developed for use should there be 

an outbreak of FMD or another animal 

disease. The environmental assessment 

discusses, cites, and references credible 

scientific information on the five viruses 

of concern (including FMD) and how 

they could be spread to wildlife. 

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. 

Effective Date 

This is a substantive rule that relieves 

restrictions and, pursuant to the 

provisions of 5 U.S.C. 553, may be made 

effective less than 30 days after 

publication in the Federal Register. 

This rule relieves certain restrictions 

related to rinderpest, FMD, SVD, CSF, 

and ASF for the importation into the 

United States of live swine, swine 

semen, pork meat, pork products, live 

ruminants, ruminant semen, ruminant 

meat, and ruminant products from Santa 

Catarina. We have determined that 

approximately 2 weeks are needed to 

ensure that APHIS and Department of 

Homeland Security, Bureau of Customs 

and Border Protection, personnel at 

ports of entry receive official notice of 

this change in the regulations. 

Therefore, the Administrator of the 

Animal and Plant Health Inspection 

Service has determined that this rule 

should be effective 15 days after 

publication in the Federal Register. 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Rules and Regulations 69857 

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 the Regulatory 

Flexibility Act, we have analyzed the 

potential economic effects of this action 

on small entities. The analysis is 

summarized below. Copies of the full 

analysis are available on the 

Regulations.gov Web site (see footnote 1 

in this document for a link to 

Regulations.gov) or by contacting the 

person listed under FOR FURTHER

INFORMATION CONTACT. 

The final rule is not expected to result 

in beef or other ruminant meat exports 

to the United States of any appreciable 

quantity. Santa Catarina contains less 

than 2 percent of Brazil’s cattle, most of 

which are dairy animals. Brazil’s sheep 

and goat populations are also 

concentrated in parts of the country 

other than Santa Catarina, and their 

products are nearly entirely destined for 

the domestic market. 

Pork imports from the State of Santa 

Catarina will compete with imports 

from Canada and Denmark, currently 

the United States’ largest suppliers of 

pork. Taking into consideration 

probable partial displacement of pork 

imported from these countries by 

projected imports from Santa Catarina, 

the net increase in U.S. imports 

attributable to this rule is expected to be 

well under 3 percent. Given the United 

States’ position as one of the largest 

pork exporters in the world, the market 

impacts resulting from the small amount 

of imports expected to come from Santa 

Catarina are likely to be minimal. 

Under these circumstances, the 

Administrator of the Animal and Plant 

Health Inspection Service has 

determined that this action will not 

have a significant economic impact on 

a substantial number of small entities. 

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 Santa 

Catarina is free of FMD, rinderpest, 

SVD, CSF, and ASF and that the 

importation of live swine, swine semen, 

pork meat, pork products, live 

ruminants, ruminant semen, ruminant 

meat, and ruminant products into the 

United States from Santa Catarina under 

the conditions specified in this rule will 

not have a significant impact on the 

quality of the human environment. 

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) 

APHIS regulations implementing NEPA 

(7 CFR part 1b), and (4) APHIS’ NEPA 

Implementing Procedures (7 CFR part 

372). 

The environmental assessment and 

finding of no significant impact may be 

viewed on the Regulations.gov Web site 

(see footnote 1 in this document for a 

link to Regulations.gov). Copies of the 

environmental assessment and finding 

of no significant impact are also 

available for public inspection at USDA, 

room 1141, South Building, 14th Street 

and Independence Avenue SW., 

Washington, DC, between 8 a.m. and 

4:30 p.m., Monday through Friday, 

except holidays. Persons wishing to 

inspect copies are requested to call 

ahead on (202) 690–2817 to facilitate 

entry into the reading room. In addition, 

copies may be obtained by writing to the 

individual listed under FOR FURTHER

INFORMATION CONTACT. 

Paperwork Reduction Act 

This final rule contains no 

information collection or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

List of Subjects in 9 CFR Part 94 

Animal diseases, Imports, Livestock, 

Meat and meat products, Milk, Poultry 

and poultry products, Reporting and 

recordkeeping requirements. 

■ Accordingly, we are amending 9 CFR 

part 94 as follows: 

PART 94—RINDERPEST, FOOT-ANDMOUTH DISEASE, EXOTIC 

NEWCASTLE DISEASE, 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. 450, 7701–7772, 7781– 

7786, and 8301–8317; 21 U.S.C. 136 and 

136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 

371.4. 

§ 94.1 [Amended] 

■ 2. In § 94.1, paragraph (a)(2) is 

amended by adding the words ‘‘the 

Brazilian State of Santa Catarina,’’ after 

the word ‘‘Bermuda,’’. 

§ 94.8 [Amended] 

■ 3. In § 94.8, the introductory text is 

amended by adding the words ‘‘(except 

the State of Santa Catarina)’’ after the 

word ‘‘Brazil’’. 

§ 94.9 [Amended] 

■ 4. In § 94.9, paragraph (a) is amended 

by adding the words ‘‘the Brazilian State 

of Santa Catarina;’’ after the word 

‘‘Australia;’’. 

§ 94.10 [Amended] 

■ 5. In § 94.10, paragraph (a) is amended 

by adding the words ‘‘the Brazilian State 

of Santa Catarina;’’ after the word 

‘‘Australia;’’. 

§ 94.11 [Amended] 

■ 6. In § 94.11, paragraph (a) is amended 

by adding the words ‘‘the Brazilian State 

of Santa Catarina,’’ after the word 

‘‘Belgium,’’. 

§ 94.12 [Amended] 

■ 7. In § 94.12, paragraph (a) is amended 

by adding the words ‘‘the Brazilian State 

of Santa Catarina,’’ after the word 

‘‘Belgium,’’. 

Done in Washington, DC this 12th day of 

November 2010. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2010–28976 Filed 11–15–10; 8:45 am] 

BILLING CODE 3410–34–P 


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