[Federal Register Volume 68, Number 27 (Monday, February 10, 2003)]
[Proposed Rules]
[Pages 6673-6677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3228]


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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 [email protected]. 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