[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Proposed Rules]
[Pages 43115-43120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15625]


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 Proposed Rules
                                                 Federal Register
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 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. 81, No. 127 / Friday, July 1, 2016 / Proposed 
Rules  

[[Page 43115]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. APHIS-2015-0050]
RIN 0579-AE21


Importation of Bone-In 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 by 
allowing, under certain conditions, the importation of bone-in ovine 
meat from Uruguay. Based on the evidence in a risk assessment that we 
have prepared, we believe that bone-in ovine meat can safely be 
imported from Uruguay provided certain conditions are met. This 
proposal would provide for the importation of bone-in 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 
August 30, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0050.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0050, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-
0050 or in our reading room, which 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) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Stephanie Kordick, Import Risk 
Analyst, Regional Evaluation Services, National Import Export Services, 
VS, APHIS, 920 Main Campus Drive, Suite 200, Raleigh, NC; (919) 855-
7733; [email protected].

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 diseases, including rinderpest, foot-and-mouth disease 
(FMD), African swine fever, classical swine fever, and swine vesicular 
disease. These are dangerous and destructive communicable diseases of 
ruminants and swine. Section 94.1 of the regulations contains criteria 
for recognition by the Animal and Plant Health Inspection Service 
(APHIS) of foreign regions as free of rinderpest or free of both 
rinderpest and FMD. Section 94.11 restricts the importation of 
ruminants and swine and their meat and certain other products from 
regions that are declared free of rinderpest and FMD but that 
nonetheless present a disease risk because of the regions' proximity to 
or trading relationships with regions affected by rinderpest or FMD. 
Regions APHIS has declared free of FMD and/or rinderpest, and regions 
declared free of FMD and rinderpest that are subject to the 
restrictions in Sec.  94.11, are listed on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml.
    APHIS considers rinderpest or FMD to exist in all regions of the 
world not listed as free of those diseases on the Web site. APHIS 
considers Uruguay to be free of rinderpest. However, APHIS does not 
consider Uruguay to be free of FMD because Uruguay vaccinates cattle 
against FMD. With few exceptions, the regulations prohibit the 
importation of fresh (chilled or frozen) meat of ruminants or swine 
that originates in or transits a region where FMD is considered to 
exist. One such exception is beef and ovine meat from Uruguay and 
specified regions of Argentina and Brazil. The regulations in Sec.  
94.29 allow the importation of fresh beef and ovine meat into the 
United States from these regions provided that the following additional 
conditions have been met:
     The meat is beef from animals born, raised, and 
slaughtered in the exporting regions of Argentina or Brazil, or is beef 
or ovine meat from animals born, raised, and slaughtered in Uruguay.
     FMD has not been diagnosed in the exporting region within 
the previous 12 months.
     The meat comes from bovines or sheep that originated from 
premises where FMD had not been present during the lifetime of any 
bovines or sheep slaughtered for the export of beef and ovine meat to 
the United States.
     The meat comes from bovines or sheep that were moved 
directly from the premises of origin to the slaughtering establishment 
without any contact with other animals.
     The meat comes from bovines or 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.
     The meat consists only of bovine or 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.
     All bone and visually identifiable blood clots and 
lymphoid tissue have been removed from the meat.
     The meat has not been in contact with meat from regions 
other than those listed in the regulations as free of rinderpest and 
FMD.
     The meat comes from carcasses that were allowed to 
maturate at 40 to 50[emsp14][deg]F (4 to 10 [deg]C) for a minimum of 24 
hours after slaughter and that reached a pH of below 6.0 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 less than 6.0 may be allowed to maturate an 
additional 24 hours and be retested, and, if the carcass still has not 
reached a pH of less than 6.0 after 48

[[Page 43116]]

hours, the meat from the carcass may not be exported to the United 
States.
     An authorized veterinary official of the government of the 
exporting region certifies on the foreign meat inspection certificate 
that the above conditions have been met.
     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.
    In response to an official request from the Government of Uruguay 
that APHIS allow the importation of fresh (chilled or frozen) bone-in 
ovine meat into the United States from Uruguay, we have conducted a 
risk analysis of their proposed select lamb program, which can be 
viewed on the Regulations.gov Web site or in our reading room.\1\ The 
Government of Uruguay has proposed an exemption from the FMD deboning 
mitigation required in Sec.  94.29(g) for ovine meat from a select 
group of lambs that would be subject to additional mitigations, 
including individual animal testing for FMD virus, individual animal 
identification with both visual and radio frequency identification 
(RFID) ear tags, and segregation of selected lambs from other FMD-
susceptible animals following testing. For the risk analysis, we 
evaluated information provided by Uruguay's Ministry of Livestock, 
Agriculture, and Fisheries (MGAP), reviewed scientific literature, and 
conducted a site visit to the proposed exporting region. We concluded 
that Uruguay possesses the necessary barriers to introduction of FMD, 
as well as the ability to detect an introduction, prevent its spread, 
and eradicate FMD, should it occur. We further concluded that, because 
of the measures in place in Uruguay, the likelihood that lambs selected 
for exemption from the deboning requirement would be exposed to FMD 
from susceptible Uruguayan livestock or wildlife is very low. When 
subjected to the proposed select lamb measures, including multiple 
tests for FMD virus, individual identification, and segregation in a 
protected facility, followed by maturation of carcasses, we conclude 
that the likelihood that bone-in meat derived from the selected lambs 
would be contaminated with FMD virus is negligible. Based on the 
evidence documented in our risk assessment, we believe that fresh 
(frozen or chilled) bone-in ovine meat can be safely imported from 
Uruguay, provided certain conditions are met. Accordingly, we are 
proposing to amend the regulations in Sec.  94.29 to allow the 
importation of fresh bone-in ovine meat from Uruguay under certain 
conditions.
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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 analysis by calling or writing to the 
person listed under FOR FURTHER INFORMATION CONTACT.
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Risk Analysis

    Drawing on information provided by the Government of Uruguay and 
observations from our site visit, we have conducted a risk analysis 
that evaluates the likelihood of entry of FMD as a result of importing 
fresh (frozen or chilled) bone-in ovine meat from Uruguay derived from 
lambs subjected to the measures included in Uruguay's proposed select 
lamb program. A summary of the evaluation is discussed below.
    The risk analysis was conducted in accordance with World 
Organization for Animal Health (OIE) standards for import risk 
analysis. Under OIE standards, the first step of an import risk 
analysis is hazard identification, which is the identification of 
pathogenic agents associated with the commodity that could result in 
adverse consequences if imported with the commodity. FMD virus is the 
only hazard considered in this analysis.
    Following the hazard identification step, a risk assessment is 
conducted. The risk assessment evaluates the likelihood of entry, 
establishment, and spread of the specified hazard as a result of 
importing the commodity, and the consequences of exposure to the 
hazard. It usually consists of four parts: Entry assessment, exposure 
assessment, consequence assessment, and risk estimation. However, if 
the likelihood of entry of, or exposure to, the hazard is determined to 
be negligible, the assessment may be concluded. Because the entry 
likelihood for the commodity under evaluation in this assessment was 
determined to be negligible, exposure and consequence assessments were 
not necessary and the risk assessment was concluded with an estimation 
of negligible risk.
    Based on our analysis, we have determined that fresh (frozen or 
chilled) bone-in ovine meat can be safely imported into the United 
States from Uruguay under certain conditions.

Entry Assessment

    The entry assessment estimates the likelihood of an imported 
commodity being infected or contaminated with a hazard. For the purpose 
of our risk analysis, entry refers to the introduction of live FMD 
virus into the United States through imports of fresh, maturated ovine 
meat from Uruguayan lambs that have not been vaccinated against FMD and 
have been subjected to the proposed mitigations as described below, in 
addition to restrictions specified in 9 CFR 94.29 with the exception of 
deboning.
    The entry assessment is divided into two sections. First, we 
conducted a review of Uruguay's overall FMD status and FMD program. 
This review was based on APHIS' 2002 and 2007 evaluations in 
combination with updated information from 2014. Second, we provide 
additional information about, and an evaluation of the proposed select 
lamb program.

Previous Evaluations of Uruguay's FMD Program

    APHIS has evaluated Uruguay's FMD control measures in beef (in 
2002) and ovine meat (in 2007). As part of those evaluations, we 
reviewed and analyzed various components essential to the exclusion, 
detection, and control of FMD for their ability to constitute an 
effective FMD program. This program includes entry controls at 
Uruguay's border, national surveillance in susceptible species, 
traceability systems, as well as other measures. As a result of those 
evaluations, and with the inclusion of updated information from 2014, 
we concluded that Uruguay has the veterinary and regulatory 
infrastructure to adequately monitor and control the possible incursion 
of FMD.

Proposed Select Lamb Program

    The Government of Uruguay has requested an exemption from the FMD 
deboning mitigation required in 9 CFR 94.29(g) for ovine meat. They 
have piloted and presented to APHIS an alternative that involves three 
main elements: Individual animal testing for FMD, individual 
identification (visual and RFID) that is part of the national 
traceability system, and separation of select lambs from other FMD-
susceptible animals. This program exists within the framework of 
Uruguay's national FMD program, which includes entry controls at 
Uruguay's borders, routine serologic surveillance, clinical 
surveillance, an effective movement and traceability system, a 
competent diagnostic laboratory, vaccination of its cattle population, 
a robust official veterinary services agency with knowledgeable 
personnel, and an effective preparedness and response system for FMD.
    Uruguay's animal health authority, the General Directorate of 
Livestock Services (DGSG), is responsible for general oversight and 
auditing of the select lamb program and also has a

[[Page 43117]]

direct role in some aspects of the program, including approval of 
source farms, application of identification devices, and collection and 
submission of blood for FMD testing. However, officials with the 
Uruguayan Wool Secretariat (SUL) are responsible for most of the day-
to-day activities at the facility where the select lambs are housed.
    Uruguay would only be permitted to export bone-in ovine meat from 
select lambs provided that FMD is not introduced into the country and 
the rest of the requirements in Sec.  94.29 are met.

Sourcing of Select Lambs

    Only sheep that have never been vaccinated against FMD would be 
considered for participation in the select lamb program. Although 
Uruguay vaccinates its cattle population against FMD as part of a 
nationwide systematic campaign, vaccination of sheep has been 
prohibited in Uruguay since 1988.
    Source farms for the select lamb program are member establishments 
of SUL. They must maintain records demonstrating a history of good 
production practices with good animal health standards, animal welfare 
standards, and environmental measures. Only a few farms are used to 
source lambs for each season. Lambs are purchased from the farms by 
SUL. Once SUL has selected the source farms, they inform DGSG and 
request approval for movement to the select lamb facility. DGSG 
verifies that there are no movement restrictions or animal health 
concerns in the proposed source farms. If approved, DGSG registers the 
farms as providers to the select lamb facility in Uruguay's Animal 
Health Information System (SISA). SISA is a comprehensive electronic 
database that incorporates data from public and private sources at the 
local, regional, and national levels.
    Requiring DGSG approval of source farms and only selecting farms 
with good animal health and welfare standards reduces the likelihood 
that FMD is present in source flocks for the select lamb facility. In 
combination with national FMD control measures, including routine 
national serosurveillance, awareness programs and notification 
requirements for FMD, and import controls at Uruguay's border, the 
likelihood that FMD virus-infected lambs are selected for inclusion in 
the proposed program is very low.

Identification of Select Lambs

    Official, unique identification tags (visual tag in the left ear 
and RFID tag in the right ear) are applied to all select lambs before 
entry to the select lamb facility. The identification number of each 
lamb is verified at multiple steps within the select lamb program. The 
tags, in conjunction with information captured in Uruguay's National 
Livestock Information System (SNIG) and SISA, provide for traceability 
of lambs and ensure their health status from their place of birth to 
slaughter.
    Applying individual identification tags to the select lambs helps 
provide assurance that only FMD test-negative lambs are ultimately 
exempted from the deboning requirement. The unique identification 
number of the select lambs is linked to their individual FMD test 
status in SISA, allowing verification of each animal's health status 
upon entry into the select lamb facility and again at the slaughter 
plant. Incorporation of the animals' identification tag numbers into 
SNIG also helps ensure that the final product can be traced back to the 
source farm of each lamb exempted from the deboning requirement.

Testing of Select Lambs

    Individual testing of select lambs for antibodies to FMD virus is 
done prior to movement off the source farm. Veterinarians with the 
local animal health division of DGSG collect blood samples from select 
lambs at the source farm, apply identification tags, and record data in 
SNIG. Samples are sent to the central laboratory of the Veterinary 
Laboratories Division of DGSG for FMD testing. If all tests of select 
lambs in the source flock are negative, the lambs would move to the 
select lamb facility. If any animal were to test positive to the 
screening test, the entire group of lambs would be held while follow-up 
testing is conducted in the test-positive animals. If these follow-up 
test results are negative, the remaining lambs would be released to the 
select lamb facility; however, lambs that tested positive to the 
screening test (but negative on subsequent testing) would not be 
allowed to move to the facility. If the follow-up test is positive, 
then movement of any animals off of the source farm would be prohibited 
and an investigation conducted to determine if there is evidence of FMD 
virus circulation within the source farm. Test results are reported 
within approximately 1 day of submission. Movement of FMD-test negative 
lambs to the select lamb facility must occur within 7 days after 
testing.
    Following FMD sample collection and application of ear tags, select 
lambs are isolated from other animals at the source farm prior to 
movement to the select lamb facility. The lambs remain segregated from 
other FMD-susceptible animals from sampling through slaughter and after 
slaughter their carcasses remain in separate channels throughout 
processing.
    The sensitivity of the FMD antibody test used to screen select 
lambs prior to entry to the segregated facility is greater than 99 
percent. Because the lambs originate from a small number of farms, with 
several lambs selected from each farm, and due to the highly contagious 
nature of FMD, antibodies to FMD virus are expected to be present in 
more than one select lamb if the source farm were affected, increasing 
the likelihood of detection. Because cattle are vaccinated for FMD in 
Uruguay and routine surveillance for FMD is conducted in cattle and 
sheep, it is unlikely that source flocks would be affected with FMD, 
increasing the likelihood further that lambs testing negative to the 
screening test truly are negative.
    After the lambs have entered the select lamb facility, the flock is 
subjected to a second round of testing at the herd level, using the 
same tests for screening and confirmation as in the individual testing. 
This is done to increase confidence that select lambs were not exposed 
to FMD on the source farm shortly before initial testing, when 
incubating FMD infection prior to production of antibodies might result 
in a false negative response to the first round of testing. Because it 
is possible that the production of antibodies to FMD virus following 
exposure of susceptible animals may take several days, the herd level 
test would be performed no sooner than 28 days after entry of the lambs 
to the select lamb facility, to allow time for production of antibodies 
in potentially infected animals. The second round of testing would have 
to be conducted on a sample of lambs large enough to allow for 
detection of FMD if it were present in at least 5 percent of the 
animals in the flock, at a confidence level of 95 percent. As above, 
because of the highly contagious nature of FMD, it is likely that the 
disease would spread within the flock to greater than 5 percent of the 
lambs if FMD were introduced from one of the source flocks; therefore, 
this level of sampling should provide for an additional level of safety 
in assuring that FMD is not present in the select lamb population.

Management of Lambs Within the Select Lamb Facility

    The select lamb facility is located in Cerro Colorado, in the 
interior of Uruguay. The facility is owned by SUL and has been used for 
research in the past for projects such as crossbreeding for more 
productive wool and meat-type sheep and improved fertility.

[[Page 43118]]

    The facility is approximately 315 hectares in size and is 
surrounded by a double wire fence system, with 5 feet separating the 2 
fences. The external fence is approximately 6 feet high, and the 
internal fence is approximately 4 feet high and electrified. The area 
around the fence line is clear cut and herbicide is regularly applied 
along the fence line. The voltage of the internal fence is checked 
daily; if fewer than 3,000 volts are measured, the entire fence line is 
checked and the low-voltage problem is identified and resolved. The 
property is divided into 30 pastures separated by single fencing. Each 
pasture can hold approximately 300 lambs.
    There is a single point of entry into the facility, allowing for 
application of biosecurity measures. Authorization and registration is 
required for entry of all animals, personnel, vehicles, and equipment. 
Tires and undercarriages of vehicles are disinfected upon entry in the 
facility. Visitors are required to use footbaths and wear coveralls and 
booties in order to access the facility.
    The property has facilities dedicated to working with sheep. There 
are facilities for loading and unloading of animals, isolation, 
introduction of material and equipment, storage of food and veterinary 
products, waste and carcass disposal, water supply, etc. The isolation 
facilities are used for each newly introduced group of select lambs. 
Lambs from different source flocks may enter the facility over a period 
of a few days; however, the facility operates on an all-in, all-out 
basis, and once the lambs within a production group have been 
assembled, the facility is closed to new entries.
    Two employees of SUL work exclusively at the facility, evaluating 
the lambs and checking the fence line on a daily basis. They receive 
training in animal health, hygiene, and biosecurity. Technical 
supervision is provided by a DGSG-accredited veterinarian employed by 
SUL and dedicated to the facility.
    Once every 30 days each lamb is weighed and receives an individual 
visual inspection. The employees check that the ear tags are in place, 
and re-sort the lambs based on changes in weight, if necessary. If 
lambs are moved to a different pasture, the SUL veterinarian is 
informed and he or she, in turn, notifies DGSG of the change so that 
SNIG can be updated.
    The select lambs are sheared 1 month prior to slaughter. Shearing 
equipment is dedicated to the facility and remains on-site. All work 
vehicles and working animals (two herding dogs, one guard dog, and one 
horse) used within the facility remain on the facility.
    Each lamb that dies prior to slaughter is necropsied by the SUL 
veterinarian. At the time of our site visit in 2014, the cohort of 
lambs at the facility had less than 3 percent mortality. Mortality is 
usually due to Pasteurella pneumonia and weather-related issues. If 
there is any question or concern about the diagnosis, the carcass is 
sent to the regional DGSG laboratory for additional evaluation.
    There are no livestock adjacent to the facility; surrounding farms 
are mostly used for timber. If movement of livestock into these areas 
were proposed, MGAP would not allow it (they have the authority and 
ability to control all livestock movement in the country).
    The select lamb facility provides housing for the lambs in a manner 
that prevents commingling with other livestock. Facility biosecurity 
measures, particularly the electrified fencing, reduce, but do not 
eliminate the potential for contact with wild animals. Free-roaming 
deer and peccaries, which are FMD-susceptible animals, are present in 
Uruguay. Because of measures in Uruguay to prevent the entry of FMD 
into the country and to detect it if it were present, APHIS considers 
the facility's biosecurity measures to be adequate to preserve the 
identity, traceability, and health status of the select lambs. If FMD 
were to be detected anywhere in Uruguay, meat exports from animals 
housed in the facility would be halted immediately. The intense 
management practices at the select lamb facility would also allow for 
ample opportunity to detect signs of FMD in the select lambs, even if 
the signs were subtle.

Processing of Select Lambs at the Slaughter Facility

    All lambs at the select lamb facility are processed at the San 
Jacinto slaughter plant. The plant has two separate slaughter lines, 
one for beef and one for sheep. Staff at the plant are trained to work 
both lines, but only one line--either beef or sheep--is run per day. 
The sheep capacity is 4,200 per shift. All lambs from the select lamb 
facility are processed in a single day and no other animals are 
processed at the plant on that day. This significantly reduces the 
possibility that a non-select lamb would be exempted from deboning. 
Additionally, the only sheep in Uruguay that have ear tag 
identification devices are the select lambs, and each ear tag is 
electronically read at the slaughter plant to ensure it belongs to a 
select lamb that has been housed at the SUL facility and tested 
negative for FMD.
    Lambs in each lot are assigned a sequential number at the slaughter 
plant corresponding to the order of slaughter. This number and the date 
of slaughter are linked to the animals' individual tag number to allow 
trace back of each carcass and the products produced from it to the 
farm of origin and test results of the lamb.
    When the select lambs arrive at the plant, the accompanying 
transport documents are examined before off-loading occurs, and seals 
are inspected by DGSG officials to ensure that they are intact and 
match the paperwork. Then the lambs are unloaded, checked to ensure ear 
tags are in place, and moved into pens where ante-mortem inspection is 
conducted. If any physical abnormalities are observed, a notation is 
made on the pen card. Ante-mortem inspection is relatively cursory; 
however, post-mortem inspection is much more thorough, with up close 
visual inspection of each lamb's oral cavity, interdigital spaces, and 
coronary band. Any animals that die prior to slaughter are necropsied 
on-site by an official veterinarian and disposed of through rendering. 
If any discrepancies with respect to the identification of the select 
lambs are noted, all of the meat from the entire lot would be diverted 
to the domestic market or would be required to be deboned prior to 
export.
    Following slaughter, carcasses of select lambs are kept in chilling 
rooms with only carcasses of other select lambs for the duration of 
maturation. To ensure that the temperature inside the chilling room 
remains within the desired range throughout the maturation process, the 
chamber temperature is measured several times: When staff begins 
loading the carcass into the chamber, when loading has been completed, 
and every 30 minutes until the chamber is opened after 24 hours have 
passed. All temperature data points are captured on a chart that 
becomes part of the official record. If the temperature falls outside 
of the required zone (between 4 and 10 [deg]C) at any point in the 
process, all of the carcasses in the chamber are rejected for export 
and redirected to domestic consumption.
    At the conclusion of the maturation period, a DGSG veterinary 
inspector checks the pH of the longissimus dorsi muscle of every 
carcass. If the pH is 6.0 or higher, the carcass is rejected for 
export. The pH meters are calibrated daily by the plant's internal 
laboratory.
    Following processing, all meat products derived from the select 
lambs are affixed with labels identifying those products as having been 
derived from select lambs that are exempted from the deboning 
requirement. The labels

[[Page 43119]]

contain sufficient information to be able to trace each package of meat 
to the date of slaughter and premises of origin of the animal from 
which it was derived.
    Requiring identification of select lambs with uniquely numbered ear 
tags that are linked to the FMD test history and status of the lambs in 
the SISA database helps ensure that only meat from select lambs will be 
exempted from the deboning requirement prior to export to the United 
States. Prohibiting slaughter of other animals on the day that select 
lambs are processed at the San Jacinto slaughter plant will also 
contribute to this assurance. Additional procedures, such as the 
requirement that lambs pass a clinical examination from an accredited 
veterinarian prior to shipment to the slaughter plant and receive a 
thorough post-mortem examination by a DGSG veterinarian at the plant, 
and that the carcasses of the select lambs undergo maturation, which is 
verified through pH evaluation of every carcass, routine temperature 
checks in the maturation chamber, and daily checks of pH meters, 
further reduce the likelihood that meat produced from select lambs and 
exported to the United States would be contaminated with FMD virus to a 
negligible level. Accordingly, we are proposing to amend the 
regulations in Sec.  94.29 to allow the importation of fresh bone-in 
ovine meat from Uruguay under certain conditions.

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.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities. The 
analysis is summarized below. Copies of the full analysis are available 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Regulations.gov Web site (see ADDRESSES above for 
instructions for accessing Regulations.gov).
    APHIS is proposing to exempt ovine meat imported from Uruguay from 
the deboning requirement for a select group of lambs subjected to 
additional risk mitigating measures. These measures include testing for 
FMD with negative results, individual animal identification (both 
visual and radio frequency) and traceability, and segregation of 
selected lambs from FMD-susceptible animals following testing.
    In 2013, the Food and Agriculture Organization of the United 
Nations estimated the sheep population in Uruguay to be 7.5 million 
head, generating income both from the sale of wool and sheep meat. With 
the exception of dairy farms, most of the livestock farms in Uruguay 
are mixed, running both beef cattle and sheep. There are approximately 
15,000 farms with sheep, but income from sheep is only a minor 
proportion of total income.
    Uruguay has requested the exemption from the deboning requirement 
specifically to export rack of lamb, which includes the rib bones, to 
the United States. These cuts are higher quality and command a higher 
price than lamb meat which has been deboned as currently required.
    Given the additional risk mitigating measures, Uruguay expects to 
export bone-in meat from up to 6,000 lambs per year. These lambs would 
be between 6-8 months of age at the time of slaughter, producing a 
total carcass weight of lamb meat of about 100 tons per year. While all 
meat from these lambs would be eligible for import under this rule, the 
focus would likely be on rack of lamb, which represents about one 
quarter of this weight, or about 25 tons.
    Over the last 3 years, the United States has imported an average of 
about 46,000 tons of bone-in lamb meat annually, valued at over $419 
million. The vast majority of these imports have been from Australia 
and New Zealand, with small quantities from Canada, Chile, and Iceland. 
Annual imports of 100 tons of bone-in lamb from Uruguay would be 
equivalent to less than \3/10\ of 1 percent of total annual bone-in 
lamb imports into the United States.
    Given the very small quantity of bone-in lamb meat expected to be 
imported from Uruguay, this action would not have a significant 
economic impact on domestic producers or importers, large or small.
    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) All 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 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-
2015-0050. Please send a copy of your comments to: (1) APHIS, using one 
of the methods described under ADDRESSES at the beginning of this 
document, and (2) Clearance Officer, OCIO, USDA, Room 404-W, 14th 
Street and Independence Avenue SW., Washington, DC 20250.
    APHIS' regulations in Sec.  94.29 place certain restrictions on the 
importation of ovine meat from Uruguay into the United States. APHIS is 
proposing to amend Sec.  94.29 to expand the kind of ovine meat allowed 
into the United States to include bone-in lamb. Under these 
regulations, APHIS must collect information, prepared by an authorized 
certified official of the Government of Uruguay, certifying that 
specific conditions for importation have been met. In addition, there 
is an animal identification and testing requirement.
    APHIS is asking OMB to approve its use of these information 
collection activities to ensure that ovine products from Uruguay pose 
negligible risk of introducing FMD among other diseases into the United 
States.
    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).

[[Page 43120]]

    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 0.5 hours per response.
    Respondents: Federal animal health authorities in Uruguay and 
exporters of sheep and ovine meat from Uruguay to the United States.
    Estimated annual number of respondents: 6,006.
    Estimated annual number of responses per respondent: 3.
    Estimated annual number of responses: 18,006.
    Estimated total annual burden on respondents: 9,009 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 Ms. 
Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 
851-2727.

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 Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

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 propose to amend 9 CFR part 94 as follows:

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, NEWCASTLE DISEASE, 
HIGHLY PATHOGENIC AVIAN INFLUENZA, AFRICAN SWINE FEVER, CLASSICAL 
SWINE FEVER, SWINE VESICULAR DISEASE, 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, 7781-7786, and 8301-8317; 
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

0
2. In 94.29, paragraph (g) is revised to read as follows:


Sec.  94.29  Restrictions on importation of fresh (chilled or frozen) 
beef and ovine meat from specified regions.

* * * * *
    (g) All bone and visually identifiable blood clots and lymphoid 
tissue have been removed from the meat; except that bone-in ovine meat 
from Uruguay may be exported to the United States under the following 
conditions:
    (1) The meat must be derived from select lambs that have never been 
vaccinated for FMD;
    (2) The select lambs must be maintained in a program approved by 
the Administrator. Lambs in the program must:
    (i) Be segregated from other FMD-susceptible livestock at a select 
lamb facility operated under the authority of the national veterinary 
authority of Uruguay;
    (ii) Be subjected to an FMD testing scheme approved by the 
Administrator; and
    (iii) Be individually identified with official unique 
identification that is part of a national traceability system 
sufficient to ensure that only the products of select lambs meeting all 
required criteria are exempt from the deboning requirement.
    (3) Select lambs and their products must not be commingled with 
other animals and their products within the slaughter facility.
* * * * *

    Done in Washington, DC, this 24th day of June 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-15625 Filed 6-30-16; 8:45 am]
 BILLING CODE 3410-34-P