[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)]
[Rules and Regulations]
[Pages 42729-42733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19225]


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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: Final rule.

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SUMMARY: We are amending 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 prepared, we believe 
that bone-in ovine meat can safely be imported from Uruguay provided 
certain conditions are met. This final rule will 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: Effective October 12, 2017.

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. 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.
    On July 1, 2016, we published in the Federal Register (81 FR 43115-
43120, Docket No. APHIS-2015-0050) a

[[Page 42730]]

proposal \1\ to amend the regulations to allow the importation of fresh 
bone-in ovine meat from Uruguay under certain conditions.
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    \1\ To view the proposed rule, the supporting documents, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0050.
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    We solicited comments concerning our proposal for 60 days ending 
August 30, 2016. We received 17 comments by that date. They were from 
producers, importers, exporters, industry and professional 
associations, specialty food retailers, and representatives of local 
and foreign governments. Ten commenters were generally supportive of 
the proposed rule. Four commenters were opposed to the proposed rule 
but did not address specific provisions. The remaining commenters 
raised questions or concerns about the proposed rule and the risk 
analysis. The comments are discussed below.

Risk Analysis

    One commenter stated that previous risk assessments, conducted in 
2002 and 2012, are too old and should not be used to support this 
action. The commenter also stated that the 2014 site visit appears to 
be an update of the 2012 visit.
    The 2014 risk assessment focused on evaluation of factors related 
to the system of mitigations proposed for the select lambs. While 
specific conclusions reached in previous evaluations were not 
necessarily revisited, information collected during the 2014 evaluation 
substantiated our previous conclusions.
    Two commenters stated that before action is taken on this matter, 
an updated and comprehensive quantitative risk analysis should be 
conducted and the results made available to the public for review and 
comment.
    Most of APHIS' risk analyses for FMD have been, and continue to be, 
qualitative in nature. APHIS believes that, when coupled with site 
visit evaluations, qualitative risk analyses provide the necessary 
information to assess the risk of the introduction of FMD through 
importation of commodities such as fresh ovine meat. Quantitative risk 
analysis models may not be the best tool to use to assess the risk of 
FMD posed by exports from a country, such as in cases where the types 
of data required by such models are either unavailable or suffer from a 
high level of parameter uncertainty. In these instances, APHIS' 
approach is to characterize the risk of outbreak qualitatively in order 
to determine what appropriate measures to implement in order to 
mitigate the risk posed to the United States in the event of an 
outbreak in the exporting country (e.g., maturation and pH of meat, no 
diagnosis of FMD in the previous 12 months).
    One commenter stated that a transparent review process for the 
recognition of the animal health status for export countries, to 
include documented management controls and written reporting of site 
visits, would provide livestock stakeholders in the United States with 
the assurance of a rigorous, scientific decisionmaking process for 
assessing and minimizing animal disease risks associated with the trade 
of animals and animal products.
    The risk analysis document, which was made available at the time 
the proposed rule was published, includes all relevant information 
collected during the evaluation process, including during the site 
visit. APHIS encouraged review and comment on this document, especially 
if additional scientific information is available that informs the risk 
determination.
    In the past, site visit reports and other relevant documents have 
either been made available as part of the supporting documentation 
accompanying the proposed rule or upon request. Going forward, these 
documents will routinely be made available at the time of publication.
    One commenter stated that when a product has increased value--in 
this case bone-in lamb meat sales to the United States from Uruguay--
and there are like products in other zones, regions, or areas of lower 
value because they cannot export their products, there is an 
opportunity for transshipment or smuggling. The commenter stated that 
such risk should be measured and included in a quantitative risk 
analysis.
    APHIS notes that this comment could be understood in different 
ways. If the commenter is referring to the potential for illegal 
importation of ovine meat not derived from select lambs from Uruguay, 
we note that the risk of direct smuggling of ovine meat into the United 
States is outside the scope of the risk analysis.
    If the commenter's concern is that animals or their products could 
be smuggled into Uruguay and represented as Uruguayan lambs (or ovine 
meat), we note that all lambs selected for inclusion in the select lamb 
facility originate from source flocks that have been certified by the 
national veterinary authority of Uruguay. Each lamb that enters the 
facility receives an official ear tag by the government authority and 
once the cohort is complete the flock is closed to new entries. The 
national veterinary authority of Uruguay is responsible for oversight 
and audit of the select lamb facility. Traceability is maintained from 
the source flock to the finished, labeled product at the slaughter 
plant.

Surveillance and Testing

    One commenter stated that more information is needed on the 
specific procedures used by the Veterinary Laboratories Division of 
Uruguay (DILAVE). The commenter stated that information should be 
published on the laboratory quality control procedures, the proper use 
of positive and negative controls, and other procedures in place to 
routinely assess the quality and accuracy of the current diagnostic 
testing procedures used. The commenter also stated that while FMD test 
kits are validated by laboratories approved by the World Organization 
for Animal Health (OIE), the labs using the test kits should provide 
evidence of annual or more frequent blind testing for accuracy by an 
independent agency.
    Information about laboratory procedures and practices at DILAVE 
were evaluated as part of the 2002 and 2012 evaluations. These 
procedures were determined to be satisfactory as a result of those 
evaluations. Updated information was provided as part of the current 
evaluation; DILAVE has since updated its quality assurance program, 
hiring a quality manager and achieving International Organization for 
Standardization (ISO) 9001:2008 certification and ISO/IEC17025-2005 
accreditation, which help ensure compliance with laboratory standards. 
DILAVE continues to use OIE-validated test kits for its FMD testing. 
Therefore, APHIS maintains confidence in Uruguay's laboratory capacity 
for the detection of FMD virus.
    One commenter expressed concern about the serological surveillance 
conducted in Uruguay. The commenter stated that the term ``systematic 
sampling'' is used but not well-defined. The commenter also stated that 
depending on the type of ``systematic sampling'' used, significant bias 
could be introduced that would lessen the likelihood of selecting and 
detecting an FMD infected animal. As an example, the commenter stated 
that the assumption of a 0.5 percent prevalence among herds means that 
a sampling scheme could miss testing an infected herd or flock for 
every 200 herds sampled and that a very large number of herds would 
have to be sampled to ensure that the population does not include a few 
infected herds. The commenter noted that APHIS states that since FMD is 
a highly contagious disease, most animals in a herd would

[[Page 42731]]

be infected. The commenter stated that this assumption may not be true 
for sheep raised in a country with a reasonably aggressive vaccination 
program being practiced in cattle.
    Uruguay's national serologic surveillance program for FMD has been 
addressed in prior evaluations. The active surveillance component of 
the program has included herd level testing within the bovine and ovine 
populations, using both systematic and random selection of animals, 
depending on the study and the year. APHIS determined that the overall 
sampling scheme was rigorous. Furthermore, under the proposed system of 
mitigations, additional FMD testing is conducted in 100 percent of 
lambs upon entry into the select lamb facility followed by herd level 
testing within the facility prior to slaughter.
    Two commenters stated that the claims of sensitivity of the FMD 
virus antibody test for sheep are not supported by the studies, as 
cited. The Sharma study \2\ cited in the risk analysis did not examine 
sheep, and therefore, there is no scientific basis in that study to 
support that the assay would have a 99 percent sensitivity in sheep. 
The commenters stated that the Brocchi study \3\ cited in the risk 
analysis did examine sheep but reported in the abstract a 99 percent 
sensitivity only for cattle.
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    \2\ Sharma, G.K., J.K. Mohapatra, et al. (2014). ``Comparative 
evaluation of non-structural protein-antibody detecting ELISAs for 
foot-and-mouth disease sero-surveillance under intensive 
vaccination.'' Journal of Virological Methods 207: 22-28.
    \3\ Brocchi, E., I. Bergmann, et al. (2006). ``Comparative 
evaluation of six ELISAs for the detection of antibodies to the non-
structural proteins of foot-and-mouth disease virus.'' Vaccine 
24(47): 6966-6979.
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    Although the number of sheep tested in the Brocchi study was too 
small to derive statistical conclusions, because results in sheep 
mirrored those in cattle, with a detection rate of 100 percent 20 days 
post-infection, the authors concluded that the findings of the study 
indicated ``performances [for sheep were] similar to those observed for 
cattle,'' which was 99 percent overall. In addition, many peer-reviewed 
articles have demonstrated that the 3ABC non-structural protein (NSP) 
enzyme-linked immunosorbent assay (ELISA) has adequate diagnostic 
sensitivity when used in sheep, including both those with clinically 
apparent and subclinical disease.\4\
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    \4\ Armstrong, R.M., Cox, S.J., Aggarwal, N., Mackay, D.J., 
Davies, P.R., Hamblin, P.A., Dani, P., Barnett, P.V. and Paton, 
D.J., 2005. ``Detection of antibody to the foot-and-mouth disease 
virus (FMDV) non-structural polyprotein 3ABC in sheep by ELISA.'' 
Journal of Virological Methods, 125(2): 153-163.
    Blanco, E., Romero, L.J., El Harrach, M. and S[aacute]nchez-
Vizca[iacute]no, J.M., 2002. ``Serological evidence of FMD 
subclinical infection in sheep population during the 1999 epidemic 
in Morocco.'' Veterinary Microbiology, 85(1): 13-21.
    Bruderer, U., Swam, H., Haas, B., Visser, N., Brocchi, E., 
Grazioli, S., Esterhuysen, J.J., Vosloo, W., Forsyth, M., Aggarwal, 
N. and Cox, S., 2004. ``Differentiating infection from vaccination 
in foot-and-mouth-disease: evaluation of an ELISA based on 
recombinant 3ABC.'' Veterinary Microbiology, 101(3): 187-197.
    Lu, Z., Cao, Y., Guo, J., Qi, S., Li, D., Zhang, Q., Ma, J., 
Chang, H., Liu, Z., Liu, X. and Xie, Q., 2007. ``Development and 
validation of a 3ABC indirect ELISA for differentiation of foot-and-
mouth disease virus infected from vaccinated animals.'' Veterinary 
Microbiology, 125(1): 157-169.
    S[oslash]rensen, K.J., Madsen, K.G., Madsen, E.S., Salt, J.S., 
Nqindi, J. and Mackay, D.K.J., 1998. ``Differentiation of infection 
from vaccination in foot-and-mouth disease by the detection of 
antibodies to the non-structural proteins 3D, 3AB and 3ABC in ELISA 
using antigens expressed in baculovirus.'' Archives of Virology, 
143(8): 1461-1476.
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    One commenter stated that in the executive summary of an audit 
report carried out by the European Commission (EC) in March 2012 
concerning the animal health controls for FMD in Uruguay, three 
outstanding issues were noted as weakening the system of FMD controls 
in Uruguay. The first of these was insufficient attention paid to 
targeting official on-the-spot controls on FMD vaccination and 
deficient official reporting of those controls. Without appropriate 
targeting, adequate vaccination coverage in all areas with an increased 
risk of FMD cannot be ensured.
    As we explained in the proposed rule, Uruguay vaccinates cattle 
against FMD, but does not vaccinate sheep. APHIS evaluated factors 
related to the proposed system of mitigations for sheep in the 2014 
risk assessment. The cattle vaccination program was not re-evaluated at 
this time; however, in our previous evaluations we determined that the 
vaccination program for cattle in Uruguay was robust. Additionally, the 
report cited in this comment determined that the observed deficiencies 
were compensated by the high level of cooperation observed among 
farmers, and that annual surveys demonstrated that immunity levels in 
the national cattle population clearly exceeded the OIE recommended 
target of 80 percent, demonstrating adequate vaccine coverage.
    The commenter noted that the second issue identified in the EC 
report was a very limited contribution of passive surveillance to the 
detection and notification of suspect cases of vesicular diseases.
    APHIS evaluated the contribution of passive surveillance to the 
overall national surveillance program in Uruguay in its 2012 
evaluation, concluding that the measures were ``effective and 
rigorous.'' Although national surveillance was not re-evaluated in the 
October 2015 risk assessment, documents provided by Uruguay support 
these conclusions, demonstrating the continued legal requirements for 
notification of suspicious cases of FMD on the part of all livestock 
owners and workers and an ongoing awareness program. In addition to 
these requirements for animal owners and handlers, clinical inspection 
of livestock is conducted by official personnel during routine farm 
visits, at points of animal concentration such as auctions and at 
sanitary posts within the country, resulting in inspection of over 1 
million head per year. APHIS also notes that passive surveillance 
within the population of lambs designated for slaughter for export is 
carried out within the select lamb facility by the two full time 
employees assigned to the facility, as described in the risk analysis. 
APHIS believes that surveillance activities carried out in the national 
livestock population of Uruguay and the select lamb facility are 
sufficient to detect FMD if present.
    The third issue noted by the commenter in the EC report was non-
validated sensitivity of the combination of diagnostic tests used to 
carry out the sero-epidemiological checks conducted since 2007 aimed at 
proving the absence of virus circulation in cattle and ovine 
populations. APHIS notes that the EC report addressed Uruguay's use of 
the ELISA 3A and 3B tests to detect NSP, rather than the 3ABC NSP test, 
as recommended by the Pan American Foot and Mouth Disease Center. As 
described in the risk assessment, Uruguay is currently using the 3ABC 
NSP ELISA, the recommended screening test, in this cohort of lambs. In 
addition, although APHIS did not re-evaluate the national FMD 
surveillance program in the current risk assessment, documentation 
received from Uruguay demonstrate that the recommended protocol was put 
in place beginning in late 2012, after the conclusion of the report.
    One commenter stated that a readily available and up-to-date FMD 
vaccine bank for the United States with the capacity to meet the 
demands of a type 3 or greater FMD outbreak should be a priority action 
for the agency.
    We recognize that, depending on the size and scope of an FMD 
outbreak, the production and distribution of vaccines could prove 
challenging. While we do have a resource in the North American Foot-
and-Mouth Disease Vaccine Bank

[[Page 42732]]

(NAFMDVB), which stores many types of inactivated FMD virus antigens, 
this resource might be overwhelmed in the face of a large and expanding 
outbreak. APHIS continues to discuss this issue and engage our 
stakeholders in planning and preparation for any response, including 
identification of options and potential funding sources for expansion 
of the bank. In the event that the United States experiences an FMD 
outbreak in which a specific strain is identified, the United States 
Department of Agriculture will notify the NAFMDVB, which will request 
the manufacturing of finished vaccine from approved suppliers, based on 
the stockpiled antigens.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, without 
change.

Executive Orders 12866 and 13771 and Regulatory Flexibility Act

    This final 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. Further, because this final 
rule is not significant, it is not a regulatory action under Executive 
Order 13771.
    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 
on the Regulations.gov Web site (see footnote 1 in this document for a 
link to Regulations.gov) or by contacting the person listed under FOR 
FURTHER INFORMATION CONTACT.
    With this rule, APHIS will exempt sheep 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 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 that 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 will 
be between 6-8 months of age at the time of slaughter, producing a 
total carcass weight of lamb meat of about 100 metric tons (MT) per 
year. While all meat from these lambs will be eligible for import under 
this rule, the focus will likely be on rack of lamb, which represents 
about one quarter of this weight, or about 25 MT.
    From 2012 through 2015, the United States imported an average of 
about 43,300 MT of bone-in lamb meat annually, valued at over $427 
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 MT 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 will 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 will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 2 CFR chapter IV.)

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    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 final rule, which were 
filed under 0579-0449, have been submitted for approval to the Office 
of Management and Budget (OMB). When OMB notifies us of its decision, 
if approval is denied, we will publish a document in the Federal 
Register providing notice of what action we plan to take.

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 rule, please contact Ms. Kimberly Hardy, 
APHIS' Information Collection Coordinator, at (301) 851-2483.

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 amending 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. Section 94.29 is amended as follows:
0
a. By revising paragraph (g); and
0
b. By revising the OMB citation at the end of the section.
    The revisions 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:

[[Page 42733]]

    (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.
* * * * *
(Approved by the Office of Management and Budget under control 
numbers 0579-0372, 0579-0414, 0579-0428, and 0579-0449)

    Done in Washington, DC, this 6th day of September 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-19225 Filed 9-11-17; 8:45 am]
 BILLING CODE 3410-34-P