```

[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Rules and Regulations]
[Pages 69851-69857]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28976]

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

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 FMD-affected 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 Sec.  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 rinderpest- or FMD-affected regions. Section 94.8 of the 
regulations restricts the importation into the United States of pork 
and pork

[[Page 69852]]

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 Sec.  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 Sec.  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 Sec.  94.1 of 
regions that are free of rinderpest and FMD, the list in Sec.  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 Sec. Sec.  94.9 and 94.10 of regions that are free of CSF, and 
the list in Sec.  94.12 of regions that are free of SVD. We also 
proposed to exclude Santa Catarina from the list in Sec.  94.8 of 
regions where ASF is known to or reasonably believed to exist.
---------------------------------------------------------------------------

    \1\ To view the proposed rule, supporting and related documents, 
and the comments received, go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2009-0034.
---------------------------------------------------------------------------

    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 (Sec.  94.1) until APHIS conducts an evaluation and 
concludes that the region or country is free of FMD and therefore able 
to export FMD-susceptible 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 (Sec.  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 
(Sec. Sec.  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 (Sec.  93.411) and 15 days for all imported swine (Sec.  
93.510).
    APHIS' evaluations are based on science and conducted according to 
the 11 factors identified in Sec.  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[hyphen]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 
Sec.  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

[[Page 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 Sec.  
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 
health-related 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 FMD-free 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 rinderpest-affected 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 Sec.  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

[[Page 69854]]

(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.
---------------------------------------------------------------------------

    \2\ The article can be viewed at http://en.mercopress.com/2010/05/21/growing-concern-in-uruguay-with-brazilian-delay-in-fmd-vaccination-timetable.
---------------------------------------------------------------------------

    Under Sec.  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 Sec.  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 FMD-affected 
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 Sec.  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 (Sec.  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 (Sec. Sec.  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 (Sec.  93.411) and 15 days for all 
imported swine (Sec.  93.510). These requirements increase the 
likelihood of disease detection in exported animals. Considered with 
the protections afforded by the safeguards contained in Sec.  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 Sec.  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 Sec.  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.

[[Page 69855]]

    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 Sec.  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, Sec.  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 FMD-free 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

[[Page 69856]]

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 peer-reviewed 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.

[[Page 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.

0
Accordingly, we are amending 9 CFR part 94 as follows:

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, EXOTIC NEWCASTLE 
DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, SWINE 
VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED 
AND RESTRICTED IMPORTATIONS

0
1. The authority citation for part 94 continues to read as follows:

    Authority:  7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

Sec.  94.1  [Amended]

0
2. In Sec.  94.1, paragraph (a)(2) is amended by adding the words ``the 
Brazilian State of Santa Catarina,'' after the word ``Bermuda,''.

Sec.  94.8  [Amended]

0
3. In Sec.  94.8, the introductory text is amended by adding the words 
``(except the State of Santa Catarina)'' after the word ``Brazil''.

Sec.  94.9  [Amended]

0
4. In Sec.  94.9, paragraph (a) is amended by adding the words ``the 
Brazilian State of Santa Catarina;'' after the word ``Australia;''.

Sec.  94.10  [Amended]

0
5. In Sec.  94.10, paragraph (a) is amended by adding the words ``the 
Brazilian State of Santa Catarina;'' after the word ``Australia;''.

Sec.  94.11  [Amended]

0
6. In Sec.  94.11, paragraph (a) is amended by adding the words ``the 
Brazilian State of Santa Catarina,'' after the word ``Belgium,''.

Sec.  94.12  [Amended]

0
7. In Sec.  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
```