[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Proposed Rules]
[Pages 10266-10269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4138]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / 
Proposed Rules

[[Page 10266]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. APHIS-2008-0085]
RIN 0579-AD17


Importation of Ovine Meat 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 to 
allow, under certain conditions, the importation of fresh (chilled or 
frozen) ovine meat from Uruguay. Based on the evidence in a risk 
assessment that we have prepared, we believe that fresh (chilled or 
frozen) ovine meat can safely be imported from Uruguay provided certain 
conditions are met. These actions would provide for the importation of 
ovine meat 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 
25, 2011.

ADDRESSES: You may submit comments by either of the following methods:
    <bullet> Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0085 to submit or view comments and 
to view supporting and related materials available electronically.
    <bullet> Postal Mail/Commercial Delivery: Please send one copy of 
your comment to Docket No. APHIS-2008-0085, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2008-0085.
    Reading Room: 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., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Silvia Kreindel, Senior Staff 
Veterinarian, Regionalization Evaluation Services Staff, VS, APHIS, 
4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-8419.

SUPPLEMENTARY INFORMATION:

Background

    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 of any pest or disease of livestock.
    Pursuant to this Act, the Animal and Plant Health Inspection 
Service (APHIS) of the United States Department of Agriculture (USDA) 
regulates the importation of animals and animal products into the 
United States to guard against the introduction of animal diseases not 
currently present or prevalent in this country. The regulations in 9 
CFR part 94 (referred to below as the regulations) prohibit or restrict 
the importation of specified animals and animal products to prevent the 
introduction into the United States of various animal diseases, 
including rinderpest and foot-and-mouth disease (FMD). These are 
dangerous and destructive communicable diseases of ruminants and swine.
    Section 94.1 of the regulations lists regions of the world that are 
declared free of rinderpest and FMD. Section 94.11 lists regions that 
have been determined to be free of rinderpest and FMD, but that are 
subject to certain restrictions because of their proximity to or 
trading relationships with rinderpest- or FMD-affected regions.
    In a final rule effective and published in the Federal Register on 
May 29, 2003 (68 FR 31940-31949, Docket No. 02-109-3), we amended the 
regulations to authorize the importation of fresh beef from Uruguay, a 
region of the world that we do not recognize as free of FMD, under 
certain conditions. Those conditions, found in Sec.  94.22 of the 
regulations, require that the meat come from bovines that have been 
born, raised, and slaughtered in Uruguay, that the bovines have not 
been exposed to FMD on their premises of origin or through contact with 
bovines from other premises, that the bovines are subject to 
inspections and processing designed to detect FMD and remove 
potentially affected body parts, that the beef is subject to a 
maturation process designed to deactivate the FMD virus, that Uruguay 
is free of FMD for a year prior to the export of the beef, and that the 
beef has not come in contact with meat from FMD-affected regions.
    In 2006, Uruguay's Ministry of Livestock, Agriculture, and 
Fisheries (MGAP) submitted information to APHIS in support of their 
request that we amend the regulations to allow the importation of fresh 
ovine meat into the United States.
    In response to this request, APHIS prepared a risk assessment, 
which can be viewed on the Internet on the Regulations.gov Web site or 
in our reading room.\1\ This assessment pays close attention, in 
particular, to the role sheep played in the last outbreak of FMD in 
Uruguay in 2001, and the likelihood that FMD has been introduced into 
the domestic ovine population within the country since that time. In 
addition, as part of our evaluation of the risks associated with 
Uruguay's request, APHIS conducted a site visit in Uruguay in March 
2007.
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    \1\ Instructions on accessing Regulations.gov and information on 
the location and hours of the reading room may be found at the 
beginning of this document under ADDRESSES. You may also request 
paper copies of the risk assessment by calling or writing the person 
listed under FOR FURTHER INFORMATION CONTACT.
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    Based on the risk assessment and the site visit, we have determined 
that it is not necessary to prohibit the importation of fresh (chilled 
or frozen) ovine meat from Uruguay, provided certain requirements, 
similar to those described above for fresh beef and discussed later in 
this document, are met. These requirements would be

[[Page 10267]]

nearly identical to the existing requirements for the importation of 
beef; hence we are proposing to revise Sec.  94.22 to authorize the 
importation of both beef and ovine meat from Uruguay into the United 
States.

Mitigation Measures for the Importation of Ovine Meat From Uruguay

    There are several risk factors associated with the importation of 
ovine meat from Uruguay. We discuss our proposed mitigation measures 
for these risk factors in the following paragraphs.

Uruguayan Origin of Ovine Meat; Restrictions on Contact With Meat of a 
Different Region of Origin

    Currently, paragraph (a) of Sec.  94.22 requires that beef from 
Uruguay must come from bovines that have been born, raised, and 
slaughtered in Uruguay. Likewise, paragraph (h) of Sec.  94.22 
currently requires that beef from Uruguay not have been in contact with 
meat from regions other than those listed in Sec.  94.1(a)(2), which 
lists regions declared to be free of both rinderpest and FMD. We would 
subject ovine meat from Uruguay to these same requirements. As 
documented in our assessment, Brazil and Argentina, countries that 
border Uruguay, both experienced outbreaks of FMD as recently as 2006, 
and FMD is under control, but endemic, in the region of South America 
surrounding Uruguay.

FMD Status of Uruguay

    Currently, paragraph (b) of Sec.  94.22 requires that FMD not have 
been diagnosed in Uruguay within the previous 12 months before beef 
from Uruguay is exported to the United States. We would amend the 
paragraph so that it would state that, if FMD is detected anywhere in 
Uruguay, the export of beef and ovine meat from all of Uruguay to the 
United States is prohibited until at least 12 months have elapsed since 
the depopulation, cleaning, and disinfection of the last infected 
premises. The current provision could be construed to state that the 12 
month prohibition begins following diagnosis of the last affected 
animal during an outbreak, while eradication, cleaning, and 
disinfection efforts are still ongoing. This is not the case; it is 
APHIS' policy that the 12 month prohibition begins only after all 
``stamping out'' efforts cease.

Premises of Origin

    Paragraph (c) of Sec.  94.22 currently requires that beef from 
Uruguay exported to the United States come from bovines that originated 
from premises where FMD has not been present during the lifetime of any 
bovines slaughtered for the export of beef to the United States. We 
would modify paragraph (c) so that it would pertain to both bovines and 
sheep. This measure is necessary because sheep that have been exposed 
to FMD on their premises of origin pose an unacceptably high risk of 
spreading the disease.

Movement From the Premises of Origin

    Paragraph (d) of Sec.  94.22 currently requires that beef from 
Uruguay come from bovines that were moved directly from the premises of 
origin to the slaughtering establishment without any contact with other 
animals. We would also subject ovine meat from Uruguay to this 
requirement, which addresses the risk of cattle or sheep coming into 
contact with or commingling during transit to slaughter with animals 
from regions in which FMD is known to exist, or that have not been 
evaluated by APHIS with regard to their FMD status.

Ante- and Post-Mortem Inspections

    Paragraph (e) of Sec.  94.22 currently requires that beef from 
Uruguay come 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. 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 effective in reducing 
disease risk, we are proposing to also require ante- and post-mortem 
inspections for sheep slaughtered for the export of fresh (chilled or 
frozen) ovine meat from Uruguay to the United States.

Restrictions on Certain Ovine Parts

    Paragraph (f) of Sec.  94.22 currently requires that beef from 
Uruguay consist 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. Accordingly, the paragraph prohibits the importation 
of all parts of bovine heads, feet, hump, hooves, or internal organs.
    We would apply this requirement to ovine meat from Uruguay, and 
would therefore authorize the importation into the United States only 
of ovine parts that are, by standard practice, part of the animal's 
carcass that is placed in a chiller for maturation after slaughter. As 
a result, we would continue to prohibit the importation of ovine heads, 
feet, hooves, and internal organs into the United States; sheep have no 
humps.
    While portions of a sheep's head, feet, hooves, and internal organs 
may reach the necessary pH level to inactivate the FMD virus during the 
required maturation process (see the section below titled ``Maturation 
Process''), these items can contain lymph tissue, depot fat, and blood 
clots that may potentially harbor active FMD virus, even after that 
process; hence the need for this requirement.

Bone, Blood Clots, and Lymphoid Tissue

    Paragraph (g) of Sec.  94.22 currently requires all bone and 
visually identifiable blood clots and lymphoid tissue to be removed 
from beef from Uruguay prior to export to the United States. We would 
subject ovine meat from Uruguay to this same requirement.
    The removal of bones and visually identifiable blood clots is 
necessary because any FMD virus these parts might potentially harbor 
may not be inactivated by the maturation process described later in 
this document. Although we consider the removal of these parts to be 
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 that all visually identifiable blood clots and lymphoid 
tissue would have to be removed.

Maturation Process

    Paragraph (i) of Sec.  94.22 currently requires that beef from 
Uruguay come 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. It further states that measurement of the pH 
must be taken at the middle of both longissimus dorsi muscles. Finally, 
it provides that 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 
states that, if the carcass still has not reached a pH of 5.8 or less 
after 60 hours, the meat from the carcass

[[Page 10268]]

may not be exported to the United States. These requirements are 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. Accordingly, we would 
subject ovine meat from Uruguay to these same requirements.

APHIS Inspection of Slaughtering Establishments

    Paragraph (j) of Sec.  94.22 currently requires that an authorized 
veterinary official of the Government of Uruguay certify on the foreign 
meat inspection certificate that the conditions for importation of the 
beef have been met. Similarly, paragraph (k) currently requires that 
the establishment in which the bovines are slaughtered allow periodic 
APHIS inspection of their facilities, records, and operations. We would 
subject ovine meat from Uruguay to these requirements. We believe that, 
in the great majority of cases, certification by an authorized 
veterinary official of Uruguay will be sufficient verification that the 
ovine meat has met the conditions for importation into the United 
States. However, because of the possibility of occasional differing 
interpretations of the regulations, we consider it advisable to have 
provisions within the regulations enabling APHIS representatives to 
have access to slaughtering establishments for periodic inspections.
    Finally, we note that, in addition to the above provisions, any 
ovine meat imported from Uruguay would have to meet the additional 
certification requirements under Sec.  94.11(c). That paragraph 
prohibits the export-approved slaughter establishment from receiving 
FMD-susceptible animals or animal products that originated, 
transported, or commingled with animals or animal products from regions 
that APHIS does not consider as FMD-free.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed 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.
    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) ovine 
meat from Uruguay. Based on the evidence in a recent risk assessment, 
we believe that fresh (chilled or frozen) ovine meat can be safely 
imported from Uruguay provided certain conditions are met.
    We have prepared an economic analysis for this proposed rule. The 
analysis, which considers the number of and type of entities that are 
likely to be affected by this action and the potential economic effects 
on those entities, provides the basis for the Administrator's 
determination that this action would not have a significant impact on a 
substantial number of small entities. The economic analysis may be 
viewed on the Regulations.gov Web site (see ADDRESSES above for 
instructions for accessing Regulations.gov). Copies of the economic 
analysis are also available from the person listed under FOR FURTHER 
INFORMATION CONTACT.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) No 
retroactive effect will be given to this rule and (2) administrative 
proceedings will not be required before parties may file suit in court 
challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. APHIS-
2008-0085. Please send a copy of your comments to: (1) Docket No. 
APHIS-2008-0085, Regulatory Analysis and Development, PPD, APHIS, 
Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238, 
and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and 
Independence Avenue, SW., Washington, DC 20250. A comment to OMB is 
best assured of having its full effect if OMB receives it within 30 
days of publication of this proposed rule.
    We are proposing to amend 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) ovine 
meat from Uruguay. This action would provide for the importation of 
ovine meat from Uruguay into the United States, while continuing to 
protect the United States against the introduction of foot-and-mouth 
disease. Under the proposed regulations, APHIS would collect 
information, provided by an authorized certifying official of the 
Government of Uruguay, certifying that specific conditions for 
importation have been met.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 1.6 hours per response.
    Respondents: Animal health officials of the government of Uruguay.
    Estimated annual number of respondents: 5.
    Estimated annual number of responses per respondent: 1.
    Estimated annual number of responses: 5.
    Estimated total annual burden on respondents: 8 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
851-2908.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Mrs. Celeste 
Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.

[[Page 10269]]

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with 
allowing the importation of ovine meat from Uruguay into the United 
States, we have prepared an environmental assessment. The environmental 
assessment was prepared in accordance with: (1) The National 
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et 
seq.), (2) regulations of the Council on Environmental Quality for 
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) 
APHIS' NEPA Implementing Procedures (7 CFR part 372).
    The environmental assessment may be viewed on the Internet on the 
Regulations.gov Web site and is available for public inspection in our 
reading room. (Instructions for accessing Regulations.gov and 
information on the location and hours of the reading room are provided 
under the heading ADDRESSES at the beginning of this proposed rule.) In 
addition, copies may be obtained by calling or writing to the 
individual listed under FOR FURTHER INFORMATION CONTACT.

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, EXOTIC NEWCASTLE 
DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, SWINE 
VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED 
AND RESTRICTED IMPORTATIONS

    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; 7 CFR 2.22, 2.80, and 371.4.

    2. Section 94.1 is amended by revising paragraph (b)(4) and the 
introductory text of paragraph (d) 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.  94.22 for fresh (chilled or frozen) 
beef and ovine meat 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 
and ovine meat exported from Uruguay in accordance with Sec.  94.22, 
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:
* * * * *
    3. Section 94.22 is revised to read as follows:


Sec.  94.22  Restrictions on importation of beef and ovine meat from 
Uruguay.

    Notwithstanding any other provisions of this part, fresh (chilled 
or frozen) beef and ovine meat from Uruguay may be exported to the 
United States under the following conditions:
    (a) The meat is beef and ovine meat from animals that have been 
born, raised, and slaughtered in Uruguay.
    (b) If foot-and-mouth disease is detected anywhere in Uruguay, the 
export of beef and ovine meat from all of Uruguay to the United States 
is prohibited until at least 12 months have elapsed since the 
depopulation, cleaning, and disinfection of the last infected premises.
    (c) The meat comes from bovines and sheep that originate from 
premises where foot-and-mouth disease has not been present during the 
lifetime of any bovines and sheep slaughtered for the export of beef 
and ovine meat to the United States.
    (d) The meat comes from bovines and sheep that were moved directly 
from the premises of origin to the slaughtering establishment without 
any contact with other animals.
    (e) The meat comes from bovines and sheep 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 meat consists only of bovine parts and ovine parts that 
are, by standard practice, part of the animal's carcass that is placed 
in a chiller for maturation after slaughter. The bovine and ovine parts 
that may not be imported include all parts of the head, feet, hump, 
hooves, and internal organs.
    (g) All bone and visually identifiable blood clots and lymphoid 
tissue have been removed from the meat.
    (h) The meat has not been in contact with meat from regions other 
than those listed in Sec.  94.1(a)(2).
    (i) The meat comes from 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 and sheep 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 18th day of February 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-4138 Filed 2-23-11; 8:45 am]
BILLING CODE 3410-34-P