[Federal Register: May 29, 2003 (Volume 68, Number 103)]
[Rules and Regulations]
[Page 31940-31949]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29my03-2]
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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
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Point estimate of the number of infected and
undetected herds
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35 62 100
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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