[Federal Register Volume 68, Number 103 (Thursday, May 29, 2003)]
[Rules and Regulations]
[Pages 31940-31949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13248]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 02-109-3]


Importation of Beef From Uruguay

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations governing the importation of 
certain animals, meat, and other animal products to allow, under 
certain conditions, the importation of fresh (chilled or frozen) beef 
from Uruguay. Based on the evidence presented in a recent risk 
assessment, we believe that fresh (chilled or frozen) beef can be 
safely imported from Uruguay provided certain conditions are met. This 
action will provide for the importation of beef from Uruguay into the 
United States while continuing to protect the United States against the 
introduction of foot-and-mouth disease.

EFFECTIVE DATE: May 29, 2003.

FOR FURTHER INFORMATION CONTACT: Dr. Hatim Gubara, Senior Staff 
Veterinarian, Regionalization Evaluation Services Staff, VS, APHIS, 
4700 River Road Unit

[[Page 31941]]

38, Riverdale, MD 20737-1231; (301) 734-4356.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR part 94 (referred to below as the 
regulations) prohibit or restrict the importation of certain animals 
and animal products into the United States to prevent the introduction 
of various animal diseases, including rinderpest, foot-and-mouth 
disease (FMD), African swine fever, hog cholera, and swine vesicular 
disease. These are dangerous and destructive communicable diseases of 
ruminants and swine. Section 94.1 of the regulations lists regions of 
the world that are considered free of rinderpest or free of both 
rinderpest and FMD. The Animal and Plant Health Inspection Service 
(APHIS) considers rinderpest or FMD to exist in all regions of the 
world not listed.
    On February 10, 2003, we published in the Federal Register a 
proposed rule (68 FR 6673-6677, Docket No. 02-109-1) to amend the 
regulations by allowing the importation of fresh (chilled or frozen) 
beef from Uruguay provided certain conditions were met. In that 
proposed rule, we notified the public of the availability of a risk 
assessment entitled, ``Risk Assessment--Importation of Fresh (chilled 
or frozen) Beef from Uruguay'' (November 2002).
    We solicited comments concerning the proposed rule and the risk 
assessment for 60 days ending April 11, 2003. On April 14, 2003, we 
published in the Federal Register a notice (68 FR 17886, Docket No. 02-
109-2) in which we reopened and extended the comment period for a 
period of 2 weeks ending April 25, 2003. We received a total of 28 
comments by that date. The comments were submitted by domestic cattle 
producers, domestic cattle and livestock associations, a food company, 
a trade association, a State department of agriculture, a State public 
lands council, State veterinarians, foreign livestock associations, a 
representative of a foreign government, and other members of the 
public. Five commenters were supportive of the proposed rule, and three 
additional commenters generally supported the proposed rule provided 
APHIS continues to evaluate the validity and efficacy of the mitigation 
measures. The other commenters expressed concern about the effects of 
the proposed rule and about some of the specific provisions of the 
proposal. These comments are discussed by subject below.

Trade Issues

    Several commenters expressed concern that there would be negative 
economic effects on the domestic cattle industry if fresh beef is 
allowed to be imported from Uruguay. Under its statutory authority, 
APHIS may prohibit or restrict the importation or entry of any animal 
or article in order to prevent the introduction or dissemination of a 
pest or disease of livestock. APHIS does not, however, have authority 
to restrict trade based on its potential economic effects. It should be 
noted, however, that past importations of fresh beef from Uruguay have 
comprised 0.2 percent or less of the total U.S. beef supply.

Equivalency and Verification Issues

    Several commenters expressed concerns that Uruguay's health 
environment, level of management of disease control, and epidemiology 
are not equivalent to those of the United States. Based on our 
evaluation of information obtained from Uruguay, from APHIS site visits 
to that country, and from periodic visits conducted by the U.S. 
Department of Agriculture's (USDA) Food Safety and Inspection Service 
(FSIS), we have concluded that Uruguay's health standards, demonstrated 
ability to implement effective disease control methods in the event of 
an outbreak, and familiarity with modern epidemiology are effective.
    One commenter stated that APHIS ``needs to verify that the Uruguay 
FMD surveillance program is valid and that Uruguay is indeed free of 
the virus'' and that ``if APHIS confirms that FMD has been eliminated 
it must verify that the mitigating measures of de-boning, no blood 
clots, lymphatic tissue, and a pH of 5.8 or less is achieved in 
Uruguay.'' The commenter also stated that ``[i]f these steps are 
verified, a wealth of scientific data indicates beef from Uruguay will 
not pose an FMD threat to the United States.'' Three commenters asked 
if APHIS had evaluated Uruguay's FMD surveillance program, processing 
system, and mitigation measures. One commenter stated that ``APHIS must 
also verify that these mitigating measures are being conducted in an 
adequate manner in Uruguay.* * *'' Three commenters suggested that 
evaluation teams include State laboratory officials, representatives of 
APHIS, the U.S. Food and Drug Administration (FDA), State animal health 
officials, and industry representatives. One commenter stated that more 
stringent inspections by non-Uruguayan officials are needed. Some of 
these commenters asked whether we would develop a verification plan.
    We evaluate each request for initiation or resumption of trade in 
animals or animal products with foreign countries individually. The 
complete review process involves a thorough evaluation of the relevant 
infrastructure of the individual country by technical experts with 
experience in country disease evaluation and risk assessment. The risk 
assessment process, which is detailed below, is implemented 
specifically to evaluate and verify the efficacy of the surveillance 
programs, border controls, processing systems, and other disease 
control measures of the country in question.
    The information is evaluated by personnel from APHIS's National 
Center for Import and Export (NCIE); Centers for Epidemiology and 
Animal Health (CEAH), which is an Office International des Epizooties 
(OIE) collaborating center for risk assessment and surveillance;\1\ 
other Veterinary Services (VS) personnel, as appropriate; personnel 
from the National Veterinary Services Laboratories (NVSL); and 
personnel from APHIS's International Services who have first-hand 
knowledge of the animal health conditions in the region under 
evaluation. APHIS reviews the information provided by foreign 
government officials for completeness and acceptability with regard to 
all of the factors for evaluation listed in 9 CFR 92.2, ``Application 
for recognition of the animal health status of a region.'' Topics 
covered in this review include, but are not limited to, border 
controls, surveillance, slaughter/processing plant controls, and 
security of sample integrity. In addition, the evaluation addresses 
effectiveness of veterinary infrastructure, disease status of the 
region, status of adjacent regions, disease control programs, 
vaccination status, separation of the region from adjacent higher risk 
regions, animal movement controls, livestock demographics and marketing 
practices, laboratory capabilities, and emergency response 
capabilities. APHIS requests additional information, if necessary, and 
seeks relevant information from other sources such as published 
literature.
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    \1\ In 1998, the OIE designated CEAH as a Collaborating Center 
for Risk Analysis and Animal Disease Surveillance Systems. The OIE 
is the international animal health standard-setting organization 
recognized by the World Trade Organization. The role of the 
collaborating center is to provide member countries of the OIE with 
scientific and technical assistance and expert advice on topics 
linked to animal health risk analysis and disease surveillance and 
control.
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    Once the information provided by foreign officials is considered 
sufficient to conclude that the risks are low enough that the 
evaluation may proceed, a site visit to the region is

[[Page 31942]]

scheduled. In addition to representation by VS personnel, the site 
review team also includes field personnel from APHIS's International 
Services, a State veterinarian, and, if a quantitative model is used to 
assess risk, individuals with expertise in quantitative risk analysis 
techniques.
    We believe that the disease evaluation expertise of personnel from 
NCIE and CEAH, with input as appropriate from other APHIS units for 
additional expertise in quantitative risk analysis techniques and in-
country conditions, and the foreign animal disease (FAD) laboratory 
expertise of NVSL are adequate for these evaluations. We do not include 
FDA personnel, as FAD evaluations are not within the FDA's authority or 
expertise. We do not include State laboratory personnel since FAD 
laboratory expertise is provided by NVSL.
    Industry representatives have not historically participated in 
APHIS evaluations. APHIS believes that it is not appropriate to include 
industry commodity groups on country evaluation teams for several 
reasons, but primarily because industry participation might make it 
appear that the review is not impartial. Inclusion of industry 
representatives might generate the appearance of, and potential for, 
conflicts of interest between the U.S. and foreign industry interests. 
In addition, APHIS questions whether information would be provided 
freely by foreign governments and commercial interests if U.S. industry 
representatives were present. In this regard, the site visit teams 
typically include visits to commercial facilities that might be 
unwilling to openly exchange commercial or proprietary information, 
which is critical to the verification and evaluation process. Also from 
a practical standpoint, industry representation would be necessarily 
limited to a very few individuals representing a very limited spectrum 
of the industry, thereby possibly providing a competitive advantage for 
participants. Further, inclusion of industry representation on a team 
that will provide recommendations to the agency could raise concerns 
under the Federal Advisory Committee Act unless the team was formally 
chartered as a Federal advisory committee. This would not be feasible 
for site visit teams.
    The information obtained from these reviews is used to conduct an 
assessment of the risk of importation of the requested commodity. The 
risk assessments APHIS prepares are made available for public review 
prior to any final rulemaking. All comments from the public are 
considered in the final decisionmaking process.
    Uruguay's surveillance program, border controls, and processing and 
slaughter controls, as well as its implementation of various mitigation 
measures, have all been evaluated during our site visits in preparation 
for the risk assessment. Evidence of the effectiveness of the measures 
being taken is presented in the risk assessment. Periodic visits to the 
slaughtering establishments are also conducted by FSIS. Although we do 
not conduct scheduled, annual visits to the processing plants, we note 
that we have an APHIS representative who is permanently located in 
Uruguay, and that all processing plants approved for export must allow 
periodic on-site evaluation and subsequent inspection of their 
facilities, records, and operations by an APHIS representative at our 
request. We will continue to monitor the situation in Uruguay and will 
conduct reinspections if we feel they are necessary.
    We do not consider it necessary to establish a specific 
verification plan for Uruguay. In fact, on March 6, 2003, we published 
in the Federal Register (68 FR 10667, Docket No. 01-036-1) a proposed 
rule that, if made final, will reinforce our current authority to 
reevaluate regions when there is a reason for concern.
    Several commenters asked whether we will provide for reinspection 
of fresh beef from Uruguay at the U.S. port of first arrival to verify 
that all mitigation measures, including measurement of pH levels, have 
been effectively and adequately carried out. Based on the evidence in 
the risk assessment and the site visit report regarding Uruguay's 
effective implementation of the required mitigation measures, 
reinspection would be unlikely to provide additional risk mitigation. 
Reinspection at the port of first arrival would be a valid safeguard 
only if it could provide verification of the pH level of the beef at 
the time of maturation. Variations in pH levels during cold storage, 
freezing, and transport, however, would make it very difficult to 
obtain data that can be correlated with pH levels at the time of 
maturation. Therefore, the type of reinspection upon arrival suggested 
by the commenters would offer no additional protection. Inspectors at 
the port of first arrival will, however, monitor all shipments that 
come into the United States and verify that the beef is accompanied by 
the foreign meat inspection certificates required under this rule to 
ensure that all requirements have been met.
    One commenter stated that we should enforce documentation measures 
to protect against the possibility of transshipment (i.e., beef from 
Uruguay being shipped through another FMD-affected country while en 
route to the United States). The regulations in Sec.  94.1(d) provide 
conditions that must be met in order for fresh (chilled or frozen) meat 
that enters a port or otherwise transits a region where rinderpest or 
FMD exists to be eligible for importation into the United States. Those 
conditions include certification requirements and safeguarding 
measures, including the use of official seals, to prevent the meat from 
coming into contact with any other cargo or being handled during 
transit. However, the provisions of Sec.  94.1(d) apply specifically to 
the transshipment of fresh (chilled or frozen) meat of ruminants or 
swine raised and slaughtered in a region free of FMD and rinderpest. 
Therefore, in response to this comment, we are amending Sec.  94.1(d) 
in this final rule to provide that the conditions in that paragraph 
also apply to fresh (chilled or frozen) beef from Uruguay. We are also 
amending paragraph (b) of Sec.  94.1, which refers to the provisions of 
paragraph (d), to reflect this change.

Technical Questions

    Two commenters expressed concern about the risk posed by formerly 
exposed cattle who can carry the FMD virus in the oropharynx, where it 
can persist for between 30 and 36 months and be preserved by 
refrigeration or freezing. According to Thomson (1994) \2\, recovered 
cattle or vaccinated cattle that had been exposed to diseased animals, 
the FMD virus was found only in the pharyngeal area of carriers, and in 
only minute quantities. This virus usually is bound to antibodies and 
virus inhibitors. In general, carriers have high levels of circulating 
antibodies. Carrier animals do not have the virus in the blood 
(viremia), bone marrow, lymph nodes, or muscle tissue. In addition, the 
head, in which the oropharynx is located, is one of the bovine parts 
that is prohibited importation.
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    \2\ Thomson, G., ``Foot-and-Mouth Disease,'' Infectious Diseases 
of Livestock (ed. Coetzer, Thomson and Tustin). Chapter 2, pp 825-
852, Oxford University Press. Capt Town, South Africa, 1994.
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    We proposed that beef imported from Uruguay must come from bovine 
carcasses that were allowed to maturate for a minimum of 36 hours after 
slaughter and that reached a pH of 5.8 or less in the loin muscle at 
the end of the maturation period. We also proposed that any carcass in 
which the

[[Page 31943]]

pH did not reach 5.8 after 36 hours could maturate an additional 24 
hours and be retested. If the carcass had not reached a pH of 5.8 or 
less after 60 hours, the meat from the carcass could not be exported to 
the United States. Several commenters stated that, based on OIE 
standards, standards of specific international markets, and cited 
studies, the minimum maturation time for beef from countries where 
vaccination is practiced should be 24 hours rather than the 36 hours 
that we proposed, with an additional 12 hours allowed for beef that had 
not reached 5.8 or less after 24 hours. The commenters stated that a 
minimum maturation time of 36 hours is cost prohibitive and 
logistically difficult to maintain. One of the commenters stated that 
the pH level in beef tends to rise when maturation time exceeds 24 
hours.
    We are making no changes based on these comments. The scientific 
literature available to us does not support the statement that the pH 
level in beef tends to rise when maturation time exceeds 24 hours. 
Available literature showed that there is a gradual trend towards lower 
pH with time and that the pH averages 5.6 to 5.8 after 48 hours of 
aging, although the pH does tend to rise slightly after 72 to 96 hours 
of maturation.\3\ Other research indicated that, although the FMD virus 
survived for 24 hours in beef stored at 4 [deg]C, the virus was 
inactivated by the third day after the pH had declined.\4\
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    \3\ Cottral et al., ``The Survival of Foot-and-Mouth Disease 
Virus in Cured and Uncured Meat,'' American Journal of Veterinary 
Research, 1960, pp 288-297.
    \4\ Henderson, W. and Brooksby, J., ``The Survival of Food-and-
Mouth Disease in Meat and Offal,'' Journal Hyg. Camb., 1948, 
46(4):394-402.
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    The data used in our risk assessment for the proposed rule change 
comes from our site visits and from data provided by Uruguay. Because 
all plants in Uruguay currently operate according to the European 
Union's (EU) requirement of a minimum of 24 hours of maturation and a 
pH level of less than 6.0, the only data available to us were for the 
number of carcasses in Uruguay that failed to meet that level. That 
rejection rate was used in assessing the proportion of viremic 
carcasses that could pass undetected through the processing system. 
However, because the current rejection rate is based on a pH threshold 
of less than 6.0, APHIS' requirement of pH 5.8 could increase the 
rejection rate by an unknown amount. Since we are requiring a minimum 
maturation time of 36 hours, and the literature indicates a gradual 
trend towards lower pH over time, we considered it unlikely that the 
rejection rate will increase significantly. Using that information, we 
concluded that fresh beef could be imported from Uruguay in accordance 
with the conditions described in the proposed rule without an 
unacceptable risk of FMD being present in the beef. Because no data are 
available to us regarding the rejection rate at pH 5.8 or less after a 
minimum of 24 hours of maturation, we are retaining the requirement 
that fresh beef from Uruguay undergo maturation for a minimum of 36 
hours and reach a pH of 5.8 or less.
    One commenter stated that pH measurements should be taken at the 
middle of both longissimus dorsi muscles. Although we did not specify 
this requirement in the proposed rule because it is common practice, 
for clarity's sake we are including it in the final rule.
    Because of the importance of proper pH measurements, one commenter 
asked (1) how we will verify that Uruguayan processing plants use the 
best available pH testing technology, (2) if we will initiate an 
approved pH meter standard, (3) if we will require the processing 
plants to have standard operating procedures for the use of pH meters 
on file, and (4) if we will require them to record pH meter serial 
numbers and document their meter standardization. Another commenter 
requested that a certified U.S. veterinary official oversee all pH 
testing and verify that conditions at slaughter facilities are 
equivalent to U.S. standards. One commenter requested that APHIS 
require the presence of a full-time APHIS or FSIS inspector to ensure 
that all processing is done in compliance with U.S. standards.
    The pH control in Uruguay is regulated under the Government of 
Uruguay's Procedure 2001/2, ``Generic procedure for maturation and pH 
control in bovine and ovine meat and offal'' and Circular 2002/4, 
``Procedure for official verification of the calibration of pH 
measuring devices for meat.'' The former procedure specifies time and 
temperature for the maturation process and requires that all meat 
processed for export be pH-tested. The latter procedure requires 
calibration of pH measuring devices at the beginning of each workday 
and after every 200 measurements. Other Uruguayan requirements include 
official control of the preparation and storage of buffer solutions.
    As noted in our site visit report, we evaluated pH control 
procedures at the San Jacinto plant, which exports to the EU and to 
other countries, during the July 2002 site visit to Uruguay. We 
verified that the instrument used to measure pH is calibrated according 
to the manufacturer's specifications. There is a laboratory in the 
plant where pH calibration takes place on a daily basis. Calibration 
and rejection records were examined and verified. All records were 
found to be adequate. In addition, we verified that pH testing is done 
by plant personnel under strict supervision by official inspectors. We 
concluded that adequate pH measuring technologies are available at 
export plants and that calibration of devices and control of pH 
inspection is carried out under the control of official authorities. 
Based on this evidence, we do not believe it is necessary for this rule 
to require an additional approved pH meter standard or to specifically 
require every plant keep its standard operating procedures for the use 
of pH meters on file, to record pH meter serial numbers, and to 
document their meter standardization, since these measures are already 
required by the Uruguayan government and all of the necessary 
documentation and procedures are already on file in each plant. Nor do 
we consider continuous APHIS supervision of the process necessary. 
However, this rule provides that APHIS reserves the right to conduct 
reinspections at any time that we feel it is necessary.
    One commenter noted that, according to two studies,\5\ pH can 
change slightly during cold storage. As a result, although beef may 
have achieved a pH of 5.8 or less in Uruguay, upon arrival in the 
United States the pH level may have increased slightly. The commenter 
requested that APHIS develop a project to collect pH data from specific 
lots of beef destined for export to the United States and then to 
verify the pH upon departure and arrival in order to establish a 
baseline of pH changes during transport. This baseline could then be 
used to verify that the beef had reached a pH of 5.8 during the 
maturation process in Uruguay.
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    \5\ Sair, L. and Cook, W.H., Canadian Journal of Research, 16 
(section D, No. 9: 255-267), 1938.
    Wierbicki, E., et al., Food Technology, (8): 506-511, 1954.
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    The variations in pH level fluctuations would make it difficult, if 
not impossible, to correlate the pH levels of beef arriving in the 
United States with the pH levels that had been achieved at maturation 
in Uruguay. We do not believe that a project of this type would offer 
meaningful data or provide additional protection. Additionally, for the 
reason discussed previously, we consider the pH readings reported by 
Uruguayan officials to be sufficient.
    One commenter noted that although the risk assessment states that

[[Page 31944]]

vaccinating twice with an oil adjuvant vaccine offers 99 percent 
protection, the proposed rule does not require any specific vaccine or 
number of vaccinations. The commenter questioned whether changes in 
Uruguay's choice of vaccine or the number of doses would affect the 
efficacy of the mitigation measure and affect the outcome of the risk 
assessment. The commenter also asked if we would change the import 
requirements and mitigation measures if Uruguay decides to stop 
vaccinating in the future.
    Because Uruguay responded so quickly to the outbreak of FMD in 
April 2001, officials there did not have the opportunity to test 
different FMD vaccines to determine which was most effective. Uruguay 
used trivalent vaccines from Brazil and Paraguay and bivalent vaccines 
from Colombia and Argentina that had been approved and certified in 
their respective country of origin by the competent sanitary authority. 
In all cases, safety and efficacy tests used were those established by 
the regional reference agency, the Pan American FMD Center (PANAFTOSA). 
Once the outbreak was under control, however, Uruguay's Ministry of 
Livestock, Agriculture, and Fisheries, together with PANAFTOSA, 
conducted tests on a variety of vaccines in order to determine which 
would be most effective for use in the ongoing vaccination program. We 
have reviewed the results of these tests and have found Uruguay's 
choice of vaccine, which offered a protection level of 99.7 percent 
after revaccination, to be adequate and effective. We do not believe it 
is necessary to require the use of a particular vaccine in this rule, 
as it is unlikely that Uruguay will choose a less efficacious vaccine 
in the future. However, we will continue to monitor the situation and 
make any necessary adjustments to the mitigation measure requirements 
if any changes occur.
    As stated in the site visit report, under Uruguayan law, cattle are 
not allowed to be moved until they have been vaccinated against FMD 
twice. All cattle that are moved within Uruguay are required to be 
accompanied by a certificate that contains information about the date, 
brand, and series of vaccine that was used. Because this dosage 
requirement is already in place, we do not believe it is necessary to 
add this requirement to the rule. We will continue to monitor the 
situation and will reassess the situation and the risk level if any 
changes in Uruguay's vaccination requirements occur.
    One commenter, referring to the scenarios presented in the risk 
assessment, asked about the expected incursions of FMD using a scenario 
of over 100 undetected herds.
    We believe the commenter has misinterpreted the scenarios presented 
in the risk assessment. First, we note that the risk assessment never 
states that the data refer to potential ``incursions'' of FMD. The 
results from the scenarios described in the risk assessment were 
derived from the negative binomial distribution, which calculates the 
number of years before the first importation of FMD-infected beef, not 
the first outbreak or case of FMD, from such imports. Second, the 
commenter appears to assume that we are comparing scenarios with a 
maximum of 35 undetected, infected herds versus a maximum of 62 
undetected, infected herds. In our risk assessment, we developed two 
scenarios. The first scenario, which we believe is the most realistic, 
offers data for a situation involving between 1 and 35 undetected, 
infected herds. This scenario was run using a uniform distribution of 
values rather than point values, which means that every value within 
the range of 1 to 35 has an equal likelihood of occurrence. The second 
scenario, which we believe is less realistic but necessary in order to 
capture the full range of possible uncertainty, offers data for a 
situation involving between 1 and 62 undetected, infected herds, with a 
most likely value of 35 undetected, infected herds.
    In order to reasonably evaluate a scenario for over 100 undetected, 
infected herds, we also had to present point value results at 35 and at 
62 undetected herds. The results are presented in table 1, below. These 
results represent the number of years until the first importation of 
FMD-infected beef from Uruguay, not the first expected incursion of 
FMD.

                              Table 1.--Risk Scenario for Over 100 Undetected Herds
----------------------------------------------------------------------------------------------------------------
                                                                   Point estimate of the number of infected and
                                                                                 undetected herds
                                                                 -----------------------------------------------
                                                                        35              62              100
----------------------------------------------------------------------------------------------------------------
Mean number of years until the first importation of FMD-infected          10,500           5,900           3,700
 beef from Uruguay..............................................
Most likely number of years until the first importation of FMD-            6,200             550             510
 infected beef from Uruguay.....................................
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    The results show that for an average of 100 undetected, infected 
herds per year in Uruguay, the most likely number of years until the 
first importation of FMD-infected beef is 510. However, based on past 
history, we believe that it is likely that FMD would be detected before 
the number of undetected infected herds reached 100. Therefore, we do 
not believe that this risk scenario offers any realistic information 
about the risk of importing fresh (chilled or frozen) beef from 
Uruguay.

Serological Surveillance

    One commenter noted that APHIS did not discuss FMD infection in 
feral species in Uruguay. The commenter asked if surveillance has been 
done in feral populations. Although the information available to us 
indicates that there is no surveillance of wildlife populations in 
Uruguay, we have no evidence that indicates that feral animal 
populations in Uruguay are infected with FMD. To our knowledge, 
infections of FMD in wildlife were not a factor in the spread of FMD, 
nor were wildlife populations reservoirs of infection in past 
outbreaks. We have concluded that authorities in Uruguay are conducting 
adequate surveillance for FMD to detect the disease if it were to be 
reintroduced into the country. While there was no specific information 
presented to show that susceptible feral animals in Uruguay are free of 
FMD, the active surveillance program includes domestic animals that may 
be exposed to feral animal populations.
    One commenter inquired whether there were any results available 
from surveillance in susceptible species other than bovine. Uruguay has 
conducted surveillance of sheep, as discussed below. There has been no 
active surveillance of swine in Uruguay, partly because there are only 
approximately 300,000 pigs in the entire country. During the past 
outbreak, only 112 pigs were affected by FMD. Based on the small 
population of swine, combined with the fact that the FMD virus that was 
present in Uruguay affects

[[Page 31945]]

primarily cattle, and that swine react differently to FMD in general, 
we do not consider swine to be critical as the primary focus of 
serological surveillance.
    One commenter asked whether the results of the sampling of sheep 
that was scheduled to be completed by May 2002 were available. A 
serological survey of the sheep population of Uruguay was conducted 
between May and August 2002. The survey was designed to detect virus 
activity in 1 percent of the sheep population and to identify sheep 
flocks with 5 percent or more infected sheep. Three groups were defined 
for sampling by geographical strata based on distance from the nearest 
FMD focus in previous outbreaks: Stratum I-less than 5 km, stratum II-
5-10 km, and stratum III-greater than 10 km. Within each group, sheep 
operations were randomly selected in proportion to flock size.
    The survey sampled 18,296 sheep from 340 flocks. Using the Virus 
Infection Associated Antigen (VIAA) test, the estimated seroprevalence 
for antibodies to the FMD virus was 0.16 percent. The results show a 
decline from a previous survey. By geographic area, the seroprevalence 
was 0.23 percent in stratum I, 0.08 percent in stratum II, and 0.04 
percent in stratum III. A subsequent epidemiological investigation of 
the 20 seropositive animals concluded that the positive results were 
due to residual antibodies from exposure during the previous epidemic.
    Because unvaccinated sheep were not involved in large numbers 
during the most recent outbreak of FMD, one commenter questioned the 
utility of using unvaccinated sheep as sentinels for the virus. We 
agree that sheep were not a major factor in the establishment and 
spread of FMD during the 2001 outbreak in Uruguay. In addition, the 
available evidence suggests that sheep may not be good sentinels for 
detecting the presence of clinical disease. However, the serological 
evidence provided by Uruguay indicates that sheep may serve as 
serological sentinels based on the data on seroconversion that were 
received during surveys conducted in 2001. Monitoring the fluctuations 
in the levels of antibodies that the sheep develop will give scientists 
and veterinarians a warning about the presence of FMD.
    One commenter asked if serosampling since February 2002 has 
continued to show a decline in prevalence. Serological sampling of the 
cattle population in November 2002 indicated a decline in FMD 
prevalence compared to previous surveys. As stated in the risk 
assessment, Uruguay conducted two serological surveys in 2001 and 2002 
in the cattle population, using the 3ABC enzyme-linked immunosorbent 
assay (ELISA) to detect antibodies against FMD non-structural protein. 
The seroprevalence of FMD was estimated to be 9.26 percent in 2001 and 
2.3 percent in February 2002.
    Using the 3B ELISA test for non-structural antibodies to the FMD 
virus, the estimated seroprevalence in November 2002 was 1.98 percent. 
Sera positive on the 3B ELISA were retested using the 3A ELISA in order 
to increase specificity, resulting in an adjusted seroprevalence 
estimate of 0.65 percent. This indicates that there is a declining 
trend of non-structural antibodies.
    One commenter asked whether the USDA had looked at the test kit 
variation for the 3ABC ELISA test. We have evaluated test results 
obtained by Uruguay in their serological survey conducted in February 
2002 in cattle. The data were obtained using two different 3ABC ELISA 
kits (United Biomedical Incorporated (UBI) and Pirbright 3ABC ELISA 
kits) and the Virus Infection Associated Antigen (VIAA) test. The types 
of tests and the results obtained during that survey are provided in 
table 2. The FMD prevalence estimates provided by Uruguay were based on 
results obtained using the UBI kit. After retesting of serum samples 
using the Pirbright 3ABC ELISA kit and the VIAA test, the data showed a 
three-fold reduction in the number of positive samples. However, the 
number of positive samples in the two additional tests were quite 
comparable. In order to maximize the risk estimates, APHIS used the 
prevalence estimates that were obtained using the UBI kit in the 
quantitative risk assessment.

                            Table 2.--Serological Sampling in Cattle in Uruguay 2002
----------------------------------------------------------------------------------------------------------------
                                                                           Holdings with positive sera--
                   Regions\*\                        Holdings    -----------------------------------------------
                                                      sampled           UBI       Pirbright 3ABC       VIAA
----------------------------------------------------------------------------------------------------------------
Stratum I (< 5 km)..............................              59              18               7              10
Stratum II (5-10 km)............................              65              16               6               5
Stratum III (10 km)..................              75              15               5              2
----------------------------------------------------------------------------------------------------------------
\*\ Regions for sampling were established based on their distance from the nearest FMD focus in the previous
  outbreaks.

    One commenter noted that the site visit report states that 
``[a]lthough the team felt that positive 3ABC ELISA tests may not be a 
result of field virus, that possibility cannot be totally excluded,'' 
and asked if more serological surveys will be done to exclude the 
possibility of circulating FMD virus.
    We will continue to monitor the situation in Uruguay and will 
evaluate the results of serological surveys being conducted by Uruguay. 
We evaluated data from the two previous serological surveys conducted 
in 2001 and 2002 and concluded that serological surveillance and 
sampling schemes were adequate. In addition, APHIS concluded that the 
official national laboratory in Montevideo, which is the only 
laboratory approved to carry out FMD serological testing in Uruguay, 
has the capacity to run valid serological tests for FMD.
    Based on the serological data provided by Uruguay, APHIS could not 
exclude the possibility that positive 3ABC ELISA tests are due to field 
virus. APHIS believes that this possibility cannot be excluded under 
any circumstances. In the July 2002 site visit report, APHIS mentioned 
that the positive results were likely due to the use of partially 
purified or unpurified vaccines, or to false-positive tests for the 
following reasons: (1) There was a declining pattern of FMD prevalence 
in the two surveys, which indicates that the positive response may not 
be due to infection; (2) the distribution of the positive holdings was 
quite comparable among the three different geographical regions (strata 
I, II, and III), which suggested false-positive tests since both strata 
II and III did not include any farms with registered FMD cases at any 
time during the outbreaks; and (3) when the sera were further processed 
by the central laboratory using 3ABC ELISA kits from a different 
source, in addition to the VIAA test, the number of positives was 
markedly reduced (see

[[Page 31946]]

table 2). The 101 total positive sera from the UBI kit were distributed 
among 49 different holdings that were scattered all over the country 
with no geographical or epidemiological relationship. We used the 
higher prevalence estimates based on 101 positive animals in our 
quantitative risk assessment in order to maximize the risk estimate.
    One commenter asked what the future follow-up procedures for 
serosamples found to be positive using the 3ABC ELISA test will be and 
how we will ensure that 3ABC positive serology cases trigger follow-up 
testing for virus isolation by OIE approved methods.
    In bovine sampling, Uruguay has been using the UBI ELISA test kit 
to identify 3B FMD non-structural antibodies. According to the 
manufacturer's recommendation, the ELISA test for the detection of 3A 
FMD non-structural antibodies is used as a confirmatory test. As stated 
in the site visit report, this testing and retesting strategy has been 
followed in Uruguay. In cases in which positive animals persist after 
the two rounds of tests, Uruguayan officials proceed with clinical 
investigation of the susceptible species in order to confirm or reject 
any suspected presence of the disease.
    One commenter asked what the scientific basis was for the statement 
in the risk assessment that fully protected animals are unlikely to 
become viremic. According to the commenter, a 2002 Pirbright Laboratory 
study showed that vaccinated swine will become viremic and shed virus 
despite their lack of clinical signs.
    First, we note that our risk assessment was conducted specifically 
to determine the risk level associated with beef from Uruguay. The word 
``animal'' throughout the risk assessment refers exclusively to the 
bovine species from which beef is derived.
    Second, based on several different transmission studies,\6\ a case 
can be made for the lack of significant viremia in vaccinated cattle. 
The findings of these studies suggest that higher immunity levels due 
to multiple applications of FMD vaccine or increased duration between 
vaccination and virus challenge result in reduced virus production or 
none at all.
---------------------------------------------------------------------------

    \6\ Barnett, P.V. and Carabin, H., A review of emergency foot-
and-mouth disease (FMD) vaccines. Vaccine, (2002), 20:1505-1514.
    Doel, T.R., Natural and vaccine-induced immunity to foot-and-
mouth disease: the prospect for improved vaccines. Revue 
Scientifique et Technique, OIE, (1996), 15(3):883-911.
    Donaldson, A.I. and Kitching, R.P., Transmission of foot-and-
mouth disease by vaccinated cattle following natural challenge. 
Research in Veterinary Science, (1989), 46:9-14.
    Sellers, R.F., Herniman, K.A.J., and Gumm, I.D., The airborne 
dispersal of foot-and-mouth virus from vaccinated and recovered 
pigs, cattle and sheep after exposure to infection. Research in 
Veterinary Science, (1977), 23:70-75.
---------------------------------------------------------------------------

    We also note that swine respond differently than cattle do to the 
FMD virus. The study cited by the commenter relates to vaccinated 
swine, which were not largely affected by the strain of the virus that 
was present in Uruguay, and is not pertinent to this rule. However, we 
welcome any additional information or data that the commenter can 
provide, and we will review all such information as appropriate.
    One commenter asked whether we had reviewed Uruguay's surveillance 
data to determine if Uruguay satisfies the OIE's ``FMD-free with 
vaccination'' status requirements. Although we do take international 
standards into consideration, we conduct independent risk assessments 
using our own stringent criteria as detailed previously. This rule 
relates to determining what mitigation measures would be effective in 
protecting the United States from the introduction of FMD in light of 
the fact that Uruguay does vaccinate, and this rule does not address 
whether Uruguay can be considered FMD-free with vaccination according 
to OIE standards.
    One commenter expressed concern that FMD is often carried in 
animals that show no signs of disease until they are under stress. The 
commenter wanted to know how we would protect against this. We note 
that animals that show signs of FMD when under stress will do so as a 
consequence of viremia. All of our mitigation measures specifically 
target viremic animals.

General Questions

    Several commenters expressed concern that the last outbreak of FMD 
was too recent for Uruguay to be considered a safe source of imported 
beef. Two of these commenters stated that we should require a longer 
disease-free waiting period, ranging from 3 to 5 years, and one 
commenter suggested that we conduct periodic, independent verification 
of the disease-free status of Uruguay during that waiting period. One 
commenter stated that we need to evaluate and take into consideration 
both the FMD status of Uruguay and the longevity of its disease-free 
status.
    Our risk assessment process is thorough and rigorous. All of the 
evidence in our risk assessment and site visit report indicates that 
Uruguay is effectively controlling FMD and has established adequate 
precautions, including border and movement controls and surveillance 
and vaccination programs, to ensure the safety of the commodity it 
wishes to export. Further, the mitigation measures that we require 
offer additional protection against the introduction of FMD into the 
United States from the importation of fresh (chilled or frozen) beef 
from Uruguay. We do not consider a 3 to 5 year disease-free waiting 
period to be either necessary or required by international requirements 
or standards.
    One commenter noted that vampire bats are common in South America 
and asked if we had taken into account the fact that they could spread 
disease among cattle and how we planned to protect against this 
possibility. The commenter did not provide data to support the 
hypothesis that vampire bats are a transmission issue for FMD in 
Uruguay, and we are unaware of any such evidence.
    One commenter noted that some of the supporting documents that 
accompanied the proposed rule were made available only in Spanish. The 
commenter stated that expenses to the reader are incurred when 
countries do not supply us with translated documents.
    Although we were unable to identify the supporting documentation to 
which the commenter referred, the regulations in 9 CFR 92.2, which 
relate to applications by regions for recognition of the animal health 
status of that region, require that countries supply supporting 
documents in English. While we occasionally post supporting documents 
in a foreign language, these are usually documents obtained and 
discussed during site visits. In these instances, oral translation was 
provided to the site visit team, but no English language version of the 
document was made available. We have not always required written 
translations of such documents since the information in them, which was 
presented orally during the site visit, is included in the site visit 
report.
    Two commenters stated that Uruguay should establish agreements with 
its neighboring countries and trading partners to ensure that they 
receive timely information about the presence of FMD in those 
countries. We agree that FMD in South America presents a regional 
challenge and that an effective regional approach is necessary to 
reduce the risk of disease spread from the region. Such a regional 
approach does exist. As noted in our site visit report, Uruguay, 
Argentina, and Brazil participate in the Cuenca del Plata FMD program 
under the auspices of PANAFTOSA. The main objective of the Cuenca del 
Plata program is to eradicate FMD with a regional, harmonized approach. 
Shortly after FMD outbreaks in 2001 in Argentina, Uruguay, and

[[Page 31947]]

Brazil, PANAFTOSA conducted inspection visits in the three countries 
and issued recommendations to strengthen and improve the existing FMD 
programs.
    In addition, Uruguay has reviewed its own FMD strategy and has 
increased the authority of local offices in border areas, improved 
communication between local offices, developed a communication and 
education program for producers, and established a National Honorary 
Animal Health Commission with the participation of producers and both 
private and official veterinarians. The regional situation has greatly 
improved since 2001.
    It is evident that Uruguay's government is committed to 
strengthening and improving its information systems for FMD 
surveillance and eradication in the region. Uruguay is continually 
reviewing and improving its regional coordination agreements. As a 
matter of national policy, Uruguay is coordinating with neighboring 
countries to establish common strategies for combating FMD and for 
direct information exchange between both official and private sectors.
    We carefully considered the regional situation as an integral part 
of assessing Uruguay's FMD status, and we are continually monitoring 
the FMD situation in South America. We believe that Uruguay, Argentina, 
and Brazil have an effective cooperative, regional approach to FMD 
surveillance and control programs, and that each of these countries is 
committed to transparency and to collaboration in controlling and 
eradicating FMD.
    A few commenters asked what guarantee we have that FMD has been 
eradicated in Uruguay. As noted in our site visit report, we have no 
evidence of the presence of the FMD virus in Uruguay, and have 
concluded that Uruguay has the ability to detect, control, and respond 
to FMD outbreaks in an effective way. The mitigation measures that we 
have put in place protect against the introduction of FMD into the 
United States.
    A few commenters expressed concern that Uruguay is not able to 
determine where every beef animal is located or to confirm whether wild 
cattle are pastured on the same ranches with domestic cattle or that 
every herd is FMD-free. All cattle in Uruguay are identified with tags 
for movement that indicate the farm and herd of origin. All shipments 
of cattle must be accompanied by certificates that indicate that each 
animal has been vaccinated twice, and information about the date, 
brand, and series of vaccine that was used must also be on the 
certificate. In addition, Uruguay's ongoing surveillance program, 
combined with all of the movement control measures, provide adequate 
levels of surveillance for FMD in herds in Uruguay. Also, international 
trade agreements entered into by the United States provide that we 
should not require more of our trading partners than we carry out 
ourselves. The United States does not have a system that allows us to 
determine where every beef animal is located.
    One commenter asked what guarantee we have that the mitigating 
measures are effective. The scientific literature supporting the 
efficacy of the mitigation measures such as the requirement that 
carcasses reach a pH level of 5.8 or below and the requirement that all 
bones, major lymph nodes, and blood clots be removed, is cited in the 
risk assessment. In addition, these measures comply with or exceed 
international standards for importing fresh (chilled or frozen) beef 
from countries that vaccinate against FMD. The OIE prescribes that the 
meat reach a pH level below 6.0 during the first 24 hours of 
maturation. Our requirement of a pH level of 5.8 or below provides a 
margin of safety and ensures the complete inactivation of the FMD 
virus.
    One commenter requested that we provide details about the FSIS 
export plant approval process, Hazard Analysis and Critical Control 
Point (HACCP) related equivalency, and resampling procedures used to 
verify microbiological and residue requirements monitored upon arrival 
in the United States.
    The FSIS regulations related to imported products are found in 9 
CFR part 327. In those regulations, Sec.  327.2(a)(2)(i) requires 
foreign countries to have a system of meat inspection that provides 
standards equivalent to those of the Federal system of meat inspection 
in the United States in areas that include, but are not limited to, 
ultimate control and supervision by the national government; the 
assignment of competent, qualified inspectors; and inspection, 
sanitation, quality, species verification, and residue standards.
    The requirement listed in Sec.  327.2(a)(2)(ii)(H) states that the 
foreign country must have an HACCP system as described in 9 CFR part 
417. The regulations in Sec.  327.2(a)(3) require a responsible 
official of the foreign meat inspection system to certify processing 
plants as eligible to participate in an export program according to all 
FSIS regulations contained within 9 CFR part 327. Sections 327.5 and 
327.6 list the regulations and instructions related to importer 
applications for inspection of products for entry and related to 
reinspection of imported products. The actual procedures that FSIS uses 
for sampling and reinspection are detailed in that agency's Import 
Manual of Procedures. Information about FSIS requirements, procedures, 
and regulations can also be obtained on the Internet at http://www.fsis.usda.gov.
    One commenter asked whether Uruguay's bovine spongiform 
encephalopathy (BSE) safeguarding system is equivalent to that of the 
United States. Although the intent of the proposal was to address the 
risk of importing fresh beef from Uruguay in the absence of other 
diseases, not to assess the risk of BSE in Uruguay, it should be noted 
that there is no evidence of which we are aware that BSE is a concern 
in Uruguay. Canada has evaluated Uruguay and found it to be low risk 
for BSE. Through our tricountry agreement with Canada and Mexico, we 
accept Canada's evaluation for our purposes. Furthermore, Uruguay has 
had minimal, if any, imports from Europe, and therefore minimal 
potential exposure to BSE. Additionally, regulations are set forth in 
Sec.  94.18 of the regulations to guard against the introduction of BSE 
into the United States. We will continue to monitor the health status 
of Uruguay, and will reassess the situation if we determine that BSE 
has become a cause for concern with respect to Uruguay.
    A few commenters asked how we will ensure that all biologicals, 
chemotherapeutics, extra-label usage, and pesticides in raw feed 
production are used under an approval system equivalent to ours. The 
issues raised by the commenters are beyond the scope of this rulemaking 
and deal primarily with products and practices that are under the 
purview of the FSIS and FDA and outside of our regulatory authority.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule with the 
changes discussed in this document.

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. Immediate 
implementation of this rule is warranted to relieve certain 
restrictions on the importation of fresh (chilled or frozen) beef from 
Uruguay that are no longer necessary. Therefore, the Administrator of 
the Animal and Plant Health Inspection Service has determined that this 
rule should be

[[Page 31948]]

effective upon publication in the Federal Register.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The 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.
    This rule amends the regulations governing the importation of 
certain animals, meat, and other animal products to allow, under 
certain conditions, the importation of fresh (chilled or frozen) beef 
from Uruguay. Based on the evidence documented in our recent risk 
assessment, we believe that fresh (chilled or frozen) beef can be 
safely imported from Uruguay provided certain conditions are met. This 
action provides for the importation of beef from Uruguay into the 
United States while continuing to protect the United States against the 
introduction of FMD.
    This rule reopens the U.S. market to Uruguayan beef producers. Beef 
producers and importers in the United States should not experience any 
notable economic effects as a result of these changes because the 
United States has imported only a small amount of beef from Uruguay in 
the past (table 3).

        Table 3.--Value of U.S. Supply and Imports of Fresh (Chilled or Frozen) Beef and Uruguay's Share
----------------------------------------------------------------------------------------------------------------
                                  U.S. imports         Total U.S. imports             U.S. supply (domestic
                                  from Uruguay  -------------------------------- production + imports - exports)
              Year              ----------------                                --------------------------------
                                                  (In millions)     Uruguay's                        Uruguay's
                                  (In millions)                       share       (In millions)        share
----------------------------------------------------------------------------------------------------------------
1997...........................           $37.5        $1,407.9            2.7%          $22,941            0.2%
1998...........................            29.2         1,609.8            1.8%           23,184            0.1%
1999...........................            43.5         1,907.7            2.3%           23,846            0.2%
2000...........................            40.9         2,221.0            1.8%           24,000           0.2%
----------------------------------------------------------------------------------------------------------------
 Sources: Imports and Exports: U.S. Department of Commerce, Bureau of the Census, as reported by the World Trade
  Atlas. Domestic production: Calculated from quantities reported in Table 7-72 of Agricultural Statistics 2000,
  with a wholesale price for the 3 years conservatively approximated at $90 per hundredweight.

    Uruguay's share in the value of U.S. imports of fresh (chilled or 
frozen) beef has been very small. From 1997 to 2000, Uruguayan exports 
accounted for only 1.8 to 2.7 percent of total U.S. imports of fresh 
(chilled or frozen) beef. During the same period, imports from Uruguay 
accounted for 0.2 percent or less of the value of the U.S. supply 
(domestic production plus imports minus exports) of fresh (chilled or 
frozen) beef.

Impact on Small Entities

    According to the Small Business Administration's (SBA) size 
standards, beef cattle ranches and farms having $750,000 or less in 
annual revenue, and cattle feedlots having $1,500,000 or less in annual 
revenue, are considered small entities. The number of farms and ranches 
with beef herds in the United States in 1997 was reported to be 
766,991, and 99.8 percent of these beef farms could be categorized as 
small according to the SBA's criteria.\7\ It is impossible to determine 
from published data how many U.S. cattle feedlots could be categorized 
as small according to the SBA's criteria. Industry analysts suggest 
that feedlots with a capacity of roughly 1,000 head of cattle would 
have annual revenues of approximately $1,500,000. In 2000, roughly 18 
percent (2,508) of cattle feedlots in the United States would have been 
considered small by SBA standards.\8\
---------------------------------------------------------------------------

    \7\ USDA, National Agricultural Statistics Service, 1997, Census 
of Agriculture-United States Data table 28, page 32.
    \8\ Unpublished National Agricultural Statistics Service data, 
from Changes in the U.S. Feedlot Industry 1994-1999, USDA/APHIS/
NAHMS, August 2000.
---------------------------------------------------------------------------

    Although this rule could potentially affect a large number of small 
beef farms and a relatively small number of small feedlots because it 
allows Uruguayan beef into the U.S. market, it is not expected to have 
a significant economic effect on these entities because the import 
volumes involved are low.
    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.

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, FOWL PEST (FOWL 
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL 
SWINE FEVER, 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, and 8301-8317; 21 U.S.C. 136 
and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, 
and 371.4.

0
2. In Sec.  94.1, paragraph (b)(2) and the introductory text of 
paragraph (d) are revised and a new paragraph (b)(4) is added to read 
as follows:


Sec.  94.1  Regions where rinderpest or foot-and-mouth disease exists; 
importations prohibited.

* * * * *
    (b) * * *
    (2) Except as provided in paragraph (d) of this section for fresh 
(chilled or frozen) meat of ruminants or swine that is otherwise 
eligible for importation under this part but that enters a port or 
otherwise transits a region where

[[Page 31949]]

rinderpest or foot-and-mouth disease exists; and
* * * * *
    (4) Except as provided in Sec.  94.21 for fresh (chilled or frozen) 
beef from Uruguay.
* * * * *
    (d) Except as otherwise provided in this part, fresh (chilled or 
frozen) meat of ruminants or swine raised and slaughtered in a region 
free of foot-and-mouth disease and rinderpest, as designated in 
paragraph (a)(2) of this section, and fresh (chilled or frozen) beef 
exported from Uruguay in accordance with Sec.  94.21, which during 
shipment to the United States enters a port or otherwise transits a 
region where rinderpest or foot-and-mouth disease exists may be 
imported provided that all of the following conditions are met:
* * * * *

0
3. A new Sec.  94.21 is added to read as follows:


Sec.  94.21  Restrictions on importation of beef from Uruguay.

    Notwithstanding any other provisions of this part, fresh (chilled 
or frozen) beef from Uruguay may be exported to the United States under 
the following conditions:
    (a) The meat is beef from bovines that have been born, raised, and 
slaughtered in Uruguay.
    (b) Foot-and-mouth disease has not been diagnosed in Uruguay within 
the previous 12 months.
    (c) The beef came from bovines that originated from premises where 
foot-and-mouth disease has not been present during the lifetime of any 
bovines slaughtered for the export of beef to the United States.
    (d) The beef came from bovines that were moved directly from the 
premises of origin to the slaughtering establishment without any 
contact with other animals.
    (e) The beef came from bovines that received ante-mortem and post-
mortem veterinary inspections, paying particular attention to the head 
and feet, at the slaughtering establishment, with no evidence found of 
vesicular disease.
    (f) The beef consists only of bovine parts that are, by standard 
practice, part of the animal's carcass that is placed in a chiller for 
maturation after slaughter. Bovine parts that may not be imported 
include all parts of bovine heads, feet, hump, hooves, and internal 
organs.
    (g) All bone and visually identifiable blood clots and lymphoid 
tissue have been removed from the beef.
    (h) The beef has not been in contact with meat from regions other 
than those listed in Sec.  94.1(a)(2).
    (i) The beef came from bovine carcasses that were allowed to 
maturate at 40 to 50[deg] F (4 to 10[deg] C) for a minimum of 36 hours 
after slaughter and that reached a pH of 5.8 or less in the loin muscle 
at the end of the maturation period. Measurements for pH must be taken 
at the middle of both longissimus dorsi muscles. Any carcass in which 
the pH does not reach 5.8 or less may be allowed to maturate an 
additional 24 hours and be retested, and, if the carcass still has not 
reached a pH of 5.8 or less after 60 hours, the meat from the carcass 
may not be exported to the United States.
    (j) An authorized veterinary official of the Government of Uruguay 
certifies on the foreign meat inspection certificate that the above 
conditions have been met.
    (k) The establishment in which the bovines are slaughtered allows 
periodic on-site evaluation and subsequent inspection of its 
facilities, records, and operations by an APHIS representative.

    Done in Washington, DC, this 21st day of May 2003.
Bobby R. Acord,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-13248 Filed 5-28-03; 8:45 am]
BILLING CODE 3410-34-P