[Federal Register: February 10, 2003 (Volume 68, Number 27)]
[Proposed Rules]
[Page 6673-6677]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10fe03-26]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 94
[Docket No. 02-109-1]
Importation of Beef From Uruguay
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the regulations governing the
importation of certain animals, meat, and other animal products by
allowing, under certain conditions, the importation of fresh (chilled
or frozen) beef from Uruguay. Based on the evidence 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 would 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.
DATES: We will consider all comments that we receive on or before April
11, 2003.
ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comment (an original and three copies) to: Docket
No. 02-109-1, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. 02-109-1. If you use e-mail,
address your comment to regulations@aphis.usda.gov. Your comment must
be contained in the body of your message; do not send attached files.
Please include your name and address in your message and ``Docket No.
02-109-1'' on the subject line.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
[[Page 6674]]
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Hatim Gubara, Senior Staff
Veterinarian, Regionalization Evaluation Services Staff, VS, APHIS,
4700 River Road Unit 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 November 1, 1995, we published in the Federal Register a final
rule (60 FR 55440-55443, Docket No. 95-050-2) adding Uruguay to the
list in Sec. 94.1 of regions considered to be free of rinderpest and
FMD and to the list in Sec. 94.11 of regions that, although free of
rinderpest and FMD, are subject to certain restrictions on importation
of meat and other animal products. On October 26, 2000, Uruguay's
Ministry of Livestock, Agriculture and Fisheries notified us of an FMD
outbreak in the northern Uruguayan department of Artigas and
immediately prohibited the movement of all animals and animal products
throughout the department. On November 20, 2000, Uruguay sent a team of
veterinary officials to the United States to provide us with detailed
information on the outbreak history, measures taken to eradicate the
disease, movement controls, monitoring and surveillance, and other
relevant activities. In an interim rule published in the Federal
Register on December 13, 2000 (65 FR 77771-77773, Docket No. 00-111-1),
and effective retroactively to October 1, 2000, we removed the
Uruguayan department of Artigas from the list of regions considered to
be free of rinderpest and FMD.
On April 24, 2001, FMD was clinically confirmed in the Uruguayan
department of Soriano, near Uruguay's border with Argentina. The
disease subsequently spread to additional departments. Uruguay's
Ministry of Livestock, Agriculture and Fisheries notified the United
States Department of Agriculture and the Office International des
Epizooties that, as of August 21, 2001, there had been 2,057 confirmed
cases of FMD in 18 departments of Uruguay, including Artigas and
Soriano. In response to the outbreak, the Ministry of Livestock,
Agriculture and Fisheries began a stamping out campaign on April 24,
2001, that continued until it was suspended on April 30, 2001. The
government of Uruguay also issued a ban on the movement of all animals
susceptible to FMD; began an emergency ring vaccination campaign on
April 26, 2001; established a containment zone with strategic
vaccination; applied strict sanitary measures within the outbreak
areas; placed fixed control and disinfection posts on the main access
routes to the affected areas; and suspended all export health
certificates for ruminants and swine.
On July 13, 2001, we published in the Federal Register an interim
rule (66 FR 36695-36697, Docket No. 00-111-2), effective retroactively
to April 2, 2001, that amended the regulations by removing Uruguay from
the list of regions considered free of rinderpest and FMD and from the
list of regions that, although rinderpest and FMD-free, are subject to
certain restrictions on the importation of meat and other animal
products. That action was necessary because FMD had been confirmed in
18 departments of Uruguay. The effect of the interim rule was to
prohibit or restrict the importation of any ruminants or swine and any
fresh (chilled or frozen) meat and other products of ruminants or swine
into the United States from Uruguay.
Although we removed Uruguay from the list of regions considered to
be free of rinderpest and FMD, we recognized in the interim rule that
Uruguay's Ministry of Livestock, Agriculture, and Fisheries responded
immediately to the detection of the disease by imposing restrictions on
the movement of ruminants, swine, and ruminant and swine products from
the affected areas and by initiating measures to control and eradicate
the disease. We also stated that we intended to reassess the situation
to determine whether it was necessary to continue to prohibit or
restrict the importation of ruminants or swine and any fresh (chilled
or frozen) meat and other products of ruminants or swine from Uruguay.
Under the current regulations, the importation of fresh (chilled or
frozen) beef from Uruguay is prohibited. Because Uruguay took
immediate, effective measures to control and eradicate FMD after the
initial outbreak; continues to employ control measures, including a
vaccination program, movement controls (especially control of movement
to slaughter), maturation, de-boning, ante- and post-mortem
inspections, pH testing, and national and international border
controls; and has not had a confirmed case of FMD in over a year, the
government of Uruguay requested that APHIS consider allowing the export
of fresh (chilled or frozen) beef to the United States.
In response to this request, APHIS prepared a risk assessment,
which can be viewed on the Internet at http://www.aphis.usda.gov/vs/ncie/reg-request.html.
To view the document, follow the link entitled,
``Information previously submitted by Regions requesting export
approval and their supporting documentation.'' At the next screen,
click on the triangle beside ``Uruguay/Animals and Animal Products/
Foot-and-Mouth Disease,'' then on the triangle beside ``Response by
APHIS.'' A link will then appear for ``Risk Assessment--Importation of
Fresh (chilled or frozen) Beef from Uruguay (November 2002).''
Following that link will allow you to view the assessment. You may also
request paper copies of this document by calling or writing the person
listed under FOR FURTHER INFORMATION CONTACT. Please refer to Docket
No. 02-109-1 when requesting copies. The risk assessment is also
available in our reading room. (Information on the location and hours
of the reading room may be found at the beginning of this document
under ADDRESSES.) The risk assessment process also included a site
visit in July 2002 during which a team of APHIS representatives
reviewed Uruguay's animal health infrastructure, vaccination program,
movement controls, slaughter procedures, and national and international
border controls. (The site visit report is available along with the
risk assessment as discussed above). Under the Animal Health Protection
Act (7 U.S.C. 8301 et seq.), the Secretary of Agriculture may prohibit
the importation of any animal or article if the Secretary determines
that the prohibition is necessary to prevent the introduction into or
dissemination within the United States
[[Page 6675]]
of any pest or disease of livestock. Based on the risk assessment, the
site visit, and information provided by the government of Uruguay, we
have determined that it is not necessary to prohibit the importation of
fresh (chilled or frozen) beef from Uruguay, provided certain stringent
requirements are met.
On May 5, 2001, the government of Uruguay initiated the first round
of a vaccination program. Four rounds have been completed to date, and
one round of calf vaccinations for calves born between 2000 and 2001
was completed in November of 2001. The vaccination program will
continue until May 2003, at which time the government of Uruguay plans
to evaluate its vaccination policy. Although there has not been a
confirmed case of FMD in Uruguay since August 21, 2001, this ongoing
vaccination program makes additional mitigating measures necessary in
order to ensure protection against the introduction of FMD into the
United States from the importation of fresh (chilled or frozen) beef
from Uruguay. When animals are vaccinated for FMD, it can be difficult
to distinguish between serological responses that are caused by the FMD
virus and responses that are caused by the vaccinations. Further, if
the disease is present in a region, symptoms in a vaccinated animal can
be suppressed and may not manifest themselves at a clinical level. To
mitigate these additional risk factors, we are proposing to require the
mitigating measures discussed below, which we have determined will
protect against the introduction of FMD into the United States from the
importation of fresh (chilled or frozen) beef from Uruguay.
Mitigation Measures
The proposed changes to the regulations include several additional
conditions that would have to be met before importation of fresh
(chilled or frozen) beef from Uruguay into the United States would be
allowed. An authorized veterinary official of the government of Uruguay
would have to certify that the following conditions have been met:
[sbull] The meat is beef from bovines that have been born, raised,
and slaughtered in Uruguay;
[sbull] FMD has not been diagnosed in Uruguay within the previous
12 months;
[sbull] The beef came from bovines that originated from premises
where FMD has not been present during the lifetime of any bovines
slaughtered for the export of meat to the United States;
[sbull] The beef came from bovines that were moved directly from
the premises of origin to the slaughtering establishment without any
contact with other animals;
[sbull] The beef came from bovines that received ante- and post-
mortem veterinary inspections, paying particular attention to the head
and feet, at the slaughtering establishment, with no evidence found of
vesicular disease;
[sbull] 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;
[sbull] All bone and visually identifiable blood clots and lymphoid
tissue have been removed from the beef;
[sbull] The beef has not been in contact with meat from regions
other than those listed in Sec. 94.1(a)(2); and
[sbull] The beef came from bovine carcasses that have been allowed
to maturate at 40 to 50 [deg]F (4 to 10 [deg]C) for a minimum of 36
hours after slaughter and have reached a pH of 5.8 or less in the loin
muscle at the end of the maturation period. 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.
In addition to these proposed requirements, Sec. 94.21(l) of this
proposed rule would also require the establishment in which the bovines
are slaughtered to allow periodic on-site evaluation and subsequent
inspection of its facilities, records, and operations by an APHIS
representative.
Ante- and Post-Mortem Inspections
Among the proposed additional requirements that would have to be
met for the importation of fresh (chilled or frozen) beef from Uruguay
is the proposed requirement in Sec. 94.21(e) of this proposed rule
that the beef come from bovines that received ante-mortem and post-
mortem veterinary inspections, paying particular attention to the head
and feet, at the slaughtering establishment. Because FMD has a short
incubation period, if animals were infected with FMD at a premises of
origin, it is likely that lesions would be visible in at least a few of
those animals at the slaughtering establishment prior to slaughter.
Similarly, post-mortem inspection of carcasses would be likely to
identify any lesions and vesicles in animals infected with FMD. Since
the lesions associated with FMD occur primarily on the feet and in the
mouth, particular attention must be paid to the head and feet during
these inspections. Because ante- and post-mortem inspections are
important in reducing disease risk, we are proposing explicit
requirements for ante- and post-mortem inspections for bovines
slaughtered for the export of fresh (chilled or frozen) beef from
Uruguay to the United States.
Restrictions on Certain Bovine Parts
In this proposed rule, Sec. 94.21(f) would provide that certain
bovine parts would continue to be prohibited importation into the
United States. Specifically, no part of the animal's head, feet, hump,
hooves, or internal organs would be allowed entry into the United
States. While portions of a bovine's head, feet, hump, hooves, and
internal organs may reach the necessary pH level during the required
maturation process (see ``Maturation Process''), these items can
contain lymph tissue, depot fat, and blood clots that may potentially
harbor FMD virus that is not inactivated. When we refer to fresh
(chilled or frozen) beef in proposed Sec. 94.21, we mean only the
traditional cuts of meat obtained from a bovine's carcass.
Bone, Blood Clots, and Lymphoid Tissue
The proposed requirement in Sec. 94.21(g) of this proposed rule
states that all bone, blood clots, and lymphoid tissue must be removed
from the beef that is to be exported from Uruguay to the United States.
The removal of these parts is necessary because any FMD virus these
parts might potentially harbor may not be inactivated by the maturation
process described in the following paragraph. Although we consider the
removal of these parts necessary, we recognize that meat may contain
small portions of blood clots or lymphoid tissue that are not visually
identifiable as such. Because such small parts are unlikely to harbor
any FMD virus that is not inactivated by the maturation process, and
because we recognize that it would be difficult, if not impossible, to
remove parts of blood clots or lymphoid tissue that are not
recognizable as such, we have specified in the proposed requirement
that all bone and ``visually identifiable'' blood clots and lymphoid
tissue be removed.
Maturation Process
Paragraph (i) of proposed Sec. 94.21 provides that the beef must
come from bovine carcasses that have been allowed to maturate at 40 to
50 [deg]F (4 to 10 [deg]C) for a minimum of 36 hours after slaughter
and that have reached a pH of 5.8 or less in the loin muscle at the end
of the maturation period. Any carcass in which the pH does not reach
5.8 or less may be allowed to maturate an
[[Page 6676]]
additional 24 hours and be retested. This proposed provision goes on to
state that if the meat does not meet this pH level after 60 hours, it
may not be exported to the United States. This proposed requirement is
based on the fact that the FMD virus in meat is inactivated by
acidification, which occurs naturally during maturation. An acid
environment of a pH of 5.8 or less destroys the virus quickly.
APHIS Inspection of Slaughtering Establishments
Although the proposed conditions in Sec. 94.21 include a provision
in paragraph (j) that an authorized veterinary official of the
government of Uruguay certify that the required conditions for
importation have been met, we are proposing an additional condition in
paragraph (k) that would require establishments in which bovines are
slaughtered to allow periodic APHIS inspection of their facilities,
records, and operations. We continue to believe that, in the great
majority of cases, certification by an authorized veterinary official
of Uruguay will be sufficient verification. However, because of the
possibility of occasional differing interpretations of the regulations,
we consider it advisable to enable APHIS representatives to have access
to slaughtering establishments for periodic inspections of the
establishments and their records and operations.
Based on our assessment, and considering the effective control
measures employed by the government of Uruguay after the initial
outbreak and their ongoing control measures, we have determined that it
is not necessary to prohibit the importation of fresh (chilled or
frozen) beef from Uruguay, as long as the beef meets certain stringent
conditions.
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 1286 and, therefore, has not been reviewed by the Office of
Management and Budget.
This proposed rule would amend the regulations governing the
importation of certain animals, meat, and other animal products by
allowing, under certain conditions, the importation of fresh (chilled
or frozen) beef from 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 would provide for the importation of beef from Uruguay
into the United States while continuing to protect the United States
against the introduction of FMD.
This proposed rule would reopen 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 proposed
changes because the United States has imported only a small amount of
beef from Uruguay in the past (Table 1).
Table 1.--Value of U.S. Supply and Imports of Fresh (Chilled or Frozen) Beef and Uruguay's Share
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U.S. imports Total U.S. imports U.S. supply (domestic
from Uruguay ---------------------------- production + imports -
-------------- exports)
Uruguay's --------------------------
(in millions (in millions share (in (in Uruguay's
of dollars) of dollars) percent) millions of share (in
dollars) percent)
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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
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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
classification, beef cattle ranches and farms having $750,000 or less
in annual revenues, and cattle feedlots having $1,500,000 or less in
annual revenues 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.\1\
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\1\ USDA, National Agricultural Statistics Service, 1997, Census
of Agriculture--United States Data, table 28, page 32.
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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.\2\
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\2\ Unpublished National Agriculture Statistics Service data,
from Changes in the U.S. Feedlot Industry 1994-1999, USDA/APHIS/
NAHMS, August 2000.
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Although this proposed rule could potentially affect a large number
of small beef farms and a relatively small number of small feedlots by
allowing 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 would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) State and
local laws and regulations that are inconsistent with this rule will be
preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings
[[Page 6677]]
will not be required before parties may file suit in court challenging
this rule.
Paperwork Reduction Act
This proposed rule contains no information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects in 9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.
Accordingly, we are proposing to amend 9 CFR part 94 as follows:
PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, HOG
CHOLERA, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND
RESTRICTED IMPORTATIONS
1. The authority citation for part 94 would continue 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.
2. In Sec. 94.1, a new paragraph (b)(4) would be added to read as
follows:
Sec. 94.1 Regions where rinderpest or foot-and-mouth disease exists;
importations prohibited.
* * * * *
(b) * * *
(4) Except as provided in Sec. 94.21 for fresh (chilled or frozen)
beef from Uruguay.
* * * * *
3. A new Sec. 94.21 would be 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. 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 5th day of February, 2003.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-3228 Filed 2-7-03; 8:45 am]
BILLING CODE 3410-34-P