82 FR 42729 - Importation of Bone-In Ovine Meat From Uruguay
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 82, Issue 175 (September 12, 2017)
Animal and Plant Health Inspection Service
Federal Register Volume 82, Issue 175 (September 12, 2017)
| Page Range | 42729-42733 | |
| FR Document | 2017-19225 |
[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)] [Rules and Regulations] [Pages 42729-42733] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-19225] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- 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\ --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- 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
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a mealybug; Cryptosporiopsis kaki and the fruit must be segregated from DEPARTMENT OF AGRICULTURE
(Hara) Weinlm, a fungus; Homonopsis fruit intended for other markets.
illotana (Kennel), a moth; Lobesia Animal and Plant Health Inspection
(3) All damaged or diseased fruit must
aeolopa (Meyrick), a moth; fungi Service
be culled at the packinghouse.
Mycosphaerella nawae Hiura & Ikata,
Pestalotia diospyri Syd. and P. Syd., (4) Boxes or other containers in which 9 CFR Part 94
Pestalotiopsis acaciae (Thumen) the fruit is shipped must be marked to
[Docket No. APHIS–2015–0050]
Yokoyama & Kaneko, Pestalotiopsis identify the place of production where
crassiuscula Steyaert, Phoma kakivora the fruit originated and the RIN 0579–AE21
Hara, and Phoma loti Cooke; packinghouse where it was packed.
Ponticulothrips diospyrosi (Haga & Importation of Bone-In Ovine Meat
(5) The NPPO of Japan must monitor From Uruguay
Okajima), a thrip; Pseudococcus cryptus packinghouse operations to verify that
(Hempel), a mealybug; Scirtothrips the packinghouses are complying with AGENCY: Animal and Plant Health
dorsalis (Hood), a thrip; Stathmopoda the requirements of the systems Inspection Service, USDA.
masinissa (Meyrick), a moth; ACTION: Final rule.
approach. If the NPPO of Japan finds
Tenuipalpus zhizhilashviliae (Reck), a
mite; and Thrips coloratus (Schmutz), a that a packinghouse is not complying
SUMMARY: We are amending the
thrip. with the requirements of this section, no
regulations governing the importation of
(a) General requirements. (1) The fruit from the packinghouse will be
certain animals, meat, and other animal
national plant protection organization eligible for export to the United States products by allowing, under certain
(NPPO) of Japan must provide an until APHIS and the NPPO of Japan conditions, the importation of bone-in
operational workplan to APHIS that conduct an investigation and ovine meat from Uruguay. Based on the
details the activities that the NPPO of appropriate remedial actions have been evidence in a risk assessment that we
Japan will, subject to APHIS’ approval implemented. prepared, we believe that bone-in ovine
of the workplan, carry out to meet the (d) Sampling. Inspectors from the meat can safely be imported from
requirements of this section. The NPPO of Japan must inspect a biometric Uruguay provided certain conditions are
operational workplan must include and sample of the fruit from each met. This final rule will provide for the
describe the quarantine pest survey consignment at a rate to be determined importation of bone-in ovine meat from
intervals and other specific Uruguay into the United States, while
by APHIS. The inspectors must visually
requirements as set forth in this section. continuing to protect the United States
(2) Commercial consignments. inspect for quarantine pests listed in the
operational workplan required by against the introduction of foot-and-
Persimmons from Japan may be mouth disease.
imported in commercial consignments paragraph (a) of this section and must
cut fruit to inspect for quarantine pests DATES: Effective October 12, 2017.
only.
(b) Places of production requirements. that are internal feeders. If quarantine FOR FURTHER INFORMATION CONTACT: Dr.
(1) All places of production that pests are detected in this inspection, the Stephanie Kordick, Import Risk Analyst,
participate in the export program must consignment will be prohibited from Regional Evaluation Services, National
be approved by and registered with the export to the United States. Import Export Services, VS, APHIS, 920
Japan NPPO. Main Campus Drive, Suite 200, Raleigh,
(e) Phytosanitary certificate. Each NC; (919) 855–7733;
(2) The NPPO of Japan must visit and consignment of persimmons must be
inspect the place of production monthly Stephanie.K.Kordick@aphis.usda.gov.
accompanied by a phytosanitary
beginning at blossom drop and SUPPLEMENTARY INFORMATION:
certificate of inspection issued by the
continuing until the end of the shipping
Japan NPPO with an additional Background
season for quarantine pests. Appropriate
pest controls must be applied in declaration stating that the fruit in the The regulations in 9 CFR part 94
accordance with the operational consignment were grown, packed, and (referred to below as the regulations)
workplan. If the NPPO of Japan finds inspected and found to be free of pests prohibit or restrict the importation of
that a place of production is not in accordance with the requirements of certain animals and animal products
complying with the requirements of this 7 CFR 319.56–79. into the United States to prevent the
section, no fruit from the place of (Approved by the Office of Management and introduction of various diseases,
production will be eligible for export to Budget under control number 0579–0455) including rinderpest, foot-and-mouth
the United States until APHIS and the disease (FMD), African swine fever,
Done in Washington, DC, this 6th day of classical swine fever, and swine
NPPO of Japan conduct an investigation September 2017.
and appropriate remedial actions have vesicular disease. These are dangerous
been implemented. Michael C. Gregoire, and destructive communicable diseases
(3) Harvested fruit must be Acting Administrator, Animal and Plant of ruminants and swine. Section 94.1 of
transported to the packinghouse in Health Inspection Service. the regulations contains criteria for
containers marked to identify the place [FR Doc. 2017–19226 Filed 9–11–17; 8:45 am] recognition by the Animal and Plant
of production from which the BILLING CODE 3410–34–P Health Inspection Service (APHIS) of
consignment of fruit originated. foreign regions as free of rinderpest or
(c) Packinghouse requirements. (1) All free of both rinderpest and FMD. APHIS
packinghouses that participate in the considers Uruguay to be free of
pmangrum on DSK3GDR082PROD with RULES1
export program must be approved by rinderpest. However, APHIS does not
and registered with the Japanese NPPO. consider Uruguay to be free of FMD
(2) During the time the packinghouse because Uruguay vaccinates cattle
is in use for exporting persimmons to against FMD.
the United States, the packinghouse On July 1, 2016, we published in the
may only accept persimmons from Federal Register (81 FR 43115–43120,
registered approved production sites Docket No. APHIS–2015–0050) a
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be infected. The commenter stated that One commenter stated that in the national surveillance program in
this assumption may not be true for executive summary of an audit report Uruguay in its 2012 evaluation,
sheep raised in a country with a carried out by the European concluding that the measures were
reasonably aggressive vaccination Commission (EC) in March 2012 ‘‘effective and rigorous.’’ Although
program being practiced in cattle. concerning the animal health controls national surveillance was not re-
Uruguay’s national serologic for FMD in Uruguay, three outstanding evaluated in the October 2015 risk
surveillance program for FMD has been issues were noted as weakening the assessment, documents provided by
addressed in prior evaluations. The system of FMD controls in Uruguay. The Uruguay support these conclusions,
active surveillance component of the first of these was insufficient attention demonstrating the continued legal
program has included herd level testing paid to targeting official on-the-spot requirements for notification of
within the bovine and ovine controls on FMD vaccination and suspicious cases of FMD on the part of
populations, using both systematic and deficient official reporting of those all livestock owners and workers and an
random selection of animals, depending controls. Without appropriate targeting, ongoing awareness program. In addition
on the study and the year. APHIS adequate vaccination coverage in all to these requirements for animal owners
determined that the overall sampling areas with an increased risk of FMD and handlers, clinical inspection of
scheme was rigorous. Furthermore, cannot be ensured. livestock is conducted by official
under the proposed system of As we explained in the proposed rule, personnel during routine farm visits, at
mitigations, additional FMD testing is Uruguay vaccinates cattle against FMD, points of animal concentration such as
conducted in 100 percent of lambs upon but does not vaccinate sheep. APHIS auctions and at sanitary posts within the
entry into the select lamb facility evaluated factors related to the proposed country, resulting in inspection of over
followed by herd level testing within system of mitigations for sheep in the 1 million head per year. APHIS also
the facility prior to slaughter. 2014 risk assessment. The cattle notes that passive surveillance within
Two commenters stated that the vaccination program was not re- the population of lambs designated for
claims of sensitivity of the FMD virus evaluated at this time; however, in our slaughter for export is carried out within
antibody test for sheep are not previous evaluations we determined the select lamb facility by the two full
supported by the studies, as cited. The that the vaccination program for cattle time employees assigned to the facility,
Sharma study 2 cited in the risk analysis in Uruguay was robust. Additionally, as described in the risk analysis. APHIS
did not examine sheep, and therefore, the report cited in this comment believes that surveillance activities
there is no scientific basis in that study determined that the observed carried out in the national livestock
to support that the assay would have a deficiencies were compensated by the population of Uruguay and the select
99 percent sensitivity in sheep. The high level of cooperation observed lamb facility are sufficient to detect
commenters stated that the Brocchi among farmers, and that annual surveys FMD if present.
demonstrated that immunity levels in The third issue noted by the
study 3 cited in the risk analysis did
the national cattle population clearly commenter in the EC report was non-
examine sheep but reported in the
exceeded the OIE recommended target validated sensitivity of the combination
abstract a 99 percent sensitivity only for
of 80 percent, demonstrating adequate of diagnostic tests used to carry out the
cattle.
vaccine coverage. sero-epidemiological checks conducted
Although the number of sheep tested The commenter noted that the second since 2007 aimed at proving the absence
in the Brocchi study was too small to issue identified in the EC report was a of virus circulation in cattle and ovine
derive statistical conclusions, because very limited contribution of passive populations. APHIS notes that the EC
results in sheep mirrored those in cattle, surveillance to the detection and report addressed Uruguay’s use of the
with a detection rate of 100 percent 20 notification of suspect cases of vesicular ELISA 3A and 3B tests to detect NSP,
days post-infection, the authors diseases. rather than the 3ABC NSP test, as
concluded that the findings of the study APHIS evaluated the contribution of recommended by the Pan American
indicated ‘‘performances [for sheep passive surveillance to the overall Foot and Mouth Disease Center. As
were] similar to those observed for described in the risk assessment,
cattle,’’ which was 99 percent overall. In by ELISA.’’ Journal of Virological Methods, 125(2): Uruguay is currently using the 3ABC
addition, many peer-reviewed articles 153–163.
NSP ELISA, the recommended
have demonstrated that the 3ABC non- Blanco, E., Romero, L.J., El Harrach, M. and
screening test, in this cohort of lambs.
structural protein (NSP) enzyme-linked Sánchez-Vizcaı́no, J.M., 2002. ‘‘Serological evidence
of FMD subclinical infection in sheep population In addition, although APHIS did not re-
immunosorbent assay (ELISA) has during the 1999 epidemic in Morocco.’’ Veterinary evaluate the national FMD surveillance
adequate diagnostic sensitivity when Microbiology, 85(1): 13–21. program in the current risk assessment,
used in sheep, including both those Bruderer, U., Swam, H., Haas, B., Visser, N.,
documentation received from Uruguay
with clinically apparent and subclinical Brocchi, E., Grazioli, S., Esterhuysen, J.J., Vosloo,
W., Forsyth, M., Aggarwal, N. and Cox, S., 2004. demonstrate that the recommended
disease.4 ‘‘Differentiating infection from vaccination in foot- protocol was put in place beginning in
and-mouth-disease: evaluation of an ELISA based late 2012, after the conclusion of the
2 Sharma, G.K., J.K. Mohapatra, et al. (2014). on recombinant 3ABC.’’ Veterinary Microbiology,
‘‘Comparative evaluation of non-structural protein- 101(3): 187–197.
report.
antibody detecting ELISAs for foot-and-mouth Lu, Z., Cao, Y., Guo, J., Qi, S., Li, D., Zhang, Q.,
One commenter stated that a readily
disease sero-surveillance under intensive Ma, J., Chang, H., Liu, Z., Liu, X. and Xie, Q., 2007. available and up-to-date FMD vaccine
vaccination.’’ Journal of Virological Methods 207: ‘‘Development and validation of a 3ABC indirect bank for the United States with the
22–28. ELISA for differentiation of foot-and-mouth disease capacity to meet the demands of a type
3 Brocchi, E., I. Bergmann, et al. (2006). virus infected from vaccinated animals.’’ Veterinary
3 or greater FMD outbreak should be a
pmangrum on DSK3GDR082PROD with RULES1
‘‘Comparative evaluation of six ELISAs for the Microbiology, 125(1): 157–169.
detection of antibodies to the non-structural S<rensen, K.J., Madsen, K.G., Madsen, E.S., Salt, priority action for the agency.
proteins of foot-and-mouth disease virus.’’ Vaccine J.S., Nqindi, J. and Mackay, D.K.J., 1998. We recognize that, depending on the
24(47): 6966–6979. ‘‘Differentiation of infection from vaccination in size and scope of an FMD outbreak, the
4 Armstrong, R.M., Cox, S.J., Aggarwal, N., foot-and-mouth disease by the detection of production and distribution of vaccines
Mackay, D.J., Davies, P.R., Hamblin, P.A., Dani, P., antibodies to the non-structural proteins 3D, 3AB
Barnett, P.V. and Paton, D.J., 2005. ‘‘Detection of and 3ABC in ELISA using antigens expressed in
could prove challenging. While we do
antibody to the foot-and-mouth disease virus baculovirus.’’ Archives of Virology, 143(8): 1461– have a resource in the North American
(FMDV) non-structural polyprotein 3ABC in sheep 1476. Foot-and-Mouth Disease Vaccine Bank
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![Federal Register / Vol. 82, No. 175 / Tuesday, September 12, 2017 / Rules and Regulations 42733
(i) Be segregated from other FMD- termination insurance program under § 4002.1 Board of Directors, Chair, and
susceptible livestock at a select lamb Title IV of the Employee Retirement Representatives of Board Members.
facility operated under the authority of Income Security Act of 1974 (ERISA). (a) Composition and responsibilities
the national veterinary authority of Section 4002(b)(3) of ERISA gives PBGC of the Board of Directors—(1) Board.
Uruguay; power to adopt, amend, and repeal, by Section 4002(d)(1) of ERISA establishes
(ii) Be subjected to an FMD testing the board of directors, bylaws. Section the Board membership as the Secretaries
scheme approved by the Administrator; 4002(f) of ERISA provides that the board of Labor (Chair), the Treasury, and
and of directors may alter, supplement, or Commerce. A person who, at the time of
(iii) Be individually identified with repeal any existing bylaw, and may a meeting of the Board of Directors, is
official unique identification that is part adopt additional bylaws from time to serving in an acting capacity as, or
of a national traceability system time as may be necessary. PBGC’s performing the duties of, a Member of
sufficient to ensure that only the bylaws are set forth in 29 CFR part 4002. the Board of Directors will serve as a
products of select lambs meeting all PBGC’s Board of Directors (the Member of the Board of Directors with
required criteria are exempt from the Secretaries of Labor, the Treasury, and the same authority and effect as the
deboning requirement. Commerce) voted to amend the bylaws designated Secretary.
(3) Select lambs and their products (2) Chair of the Board. As Chair of the
at a meeting of the Board of Directors on
must not be commingled with other Board, the Secretary of Labor will
September 7, 2017. This rule replaces
animals and their products within the preside over all Board meetings. As a
the old bylaws with the new bylaws in
slaughter facility. direct report to the Board under section
PBGC’s regulations.
* * * * * 4002(d)(4) of ERISA, the Inspector
(Approved by the Office of Management and Compliance With Rulemaking General of the Corporation reports to the
Budget under control numbers 0579–0372, Guidelines Board through the Chair. The
0579–0414, 0579–0428, and 0579–0449) Participant and Plan Sponsor Advocate
This is a rule of ‘‘agency organization, also reports to the Board through the
Done in Washington, DC, this 6th day of
September 2017.
procedure, or practice’’ and is limited to Chair.
‘‘agency organization, management, or (3) Board responsibilities. Except as
Michael C. Gregoire,
personnel matters.’’ Accordingly, this provided in paragraph (b) of this
Acting Administrator, Animal and Plant rule is exempt from notice and public
Health Inspection Service. section, the Board may not delegate any
comment requirements under 5 U.S.C. of the following responsibilities—
[FR Doc. 2017–19225 Filed 9–11–17; 8:45 am]
553(b) and the requirements of (i) Voting on an amendment to these
BILLING CODE 3410–34–P Executive Order 12866 and Executive bylaws.
Order 13771. Because no general notice (ii) Approval of the Annual Report,
of proposed rulemaking is required, the which includes the Annual
PENSION BENEFIT GUARANTY Regulatory Flexibility Act does not Management Report (AMR) (and its
CORPORATION apply to this rule. See 5 U.S.C. 601(2), components the financial statements,
603, 604. management’s discussion and analysis,
29 CFR Part 4002
PBGC finds good cause exists for annual performance report and
Bylaws of the Pension Benefit making the bylaws set forth in this rule independent auditor’s report), the
Guaranty Corporation effective less than 30 days after Chair’s message, and other
publication because the amendments documentation in conformance with
AGENCY: Pension Benefit Guaranty were adopted by the Board of Directors guidance issued by the Office of
Corporation. on September 7, 2017. Management and Budget (OMB).
ACTION: Final rule. (iii) Approval of the Corporation’s
List of Subjects in Part 4002 Investment Policy Statement.
SUMMARY: The Pension Benefit Guaranty (iv) Approval of all reports or
Corporation is amending its bylaws Administrative practice and recommendations to the Congress
regulation to conform to changes in the procedure, Organization and functions required by Title IV of ERISA.
bylaws adopted by the Board of (government agencies). (v) Approval of any policy matter
Directors. (other than administrative policies) that
■ Accordingly, 29 CFR part 4002 is
DATES: Effective September 12, 2017. revised to read as follows: would have a significant impact on the
FOR FURTHER INFORMATION CONTACT:
pension insurance program.
PART 4002—BYLAWS OF THE (vi) Review of reports from the
Judith R. Starr (starr.judith@pbgc.gov),
PENSION BENEFIT GUARANTY Corporation’s Inspector General that the
General Counsel, Pension Benefit
CORPORATION Inspector General deems appropriate to
Guaranty Corporation, 1200 K Street
deliver to the Board.
NW., Washington, DC 20005–4026; 202– Sec. (4) Investment Policy Statement
326–4400, ext. 3083; Hilary Duke 4002.1 Board of Directors, Chair, and review. The Board must review the
(duke.hilary@pbgc.gov), Attorney, Representatives of Board Members. Corporation’s Investment Policy
Regulatory Affairs Division, Office of 4002.2 Quorum. Statement at least every two years and
the General Counsel, 202–326–4400, 4002.3 Meetings.
approve the Investment Policy
extension 3839. (TTY and TDD users 4002.4 Place of meetings; use of conference
call communications equipment. Statement at least every four years.
may call the Federal relay service toll- (b) Designation of and responsibilities
pmangrum on DSK3GDR082PROD with RULES1
free at 800–877–8339 and ask to be 4002.5 Voting without a meeting.
4002.6 Conflict of interest. of Board Representatives and Alternate
connected to 202–326–4400, extension Representatives—(1) Board
4002.7 Director of the Corporation and
3083 or to 202–326–4400, extension senior officers. Representatives. A Board
3839.) 4002.8 Emergency procedures. Representative, as designated under
SUPPLEMENTARY INFORMATION: The 4002.9 Seal. section 4002(d)(3) of ERISA, may act for
Pension Benefit Guaranty Corporation 4002.10 Authority and amendments. all purposes under these bylaws, except
(PBGC) administers the pension plan Authority: 29 U.S.C. 1302(b)(3), 1302(f). that an action of a Board Representative
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Document Created: 2018-10-24 14:14:35
Document Modified: 2018-10-24 14:14:35
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | Effective October 12, 2017. | |
| 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] | |
| FR Citation | 82 FR 42729 | |
| RIN Number | 0579-AE21 | |
| CFR Associated | Animal Diseases; Imports; Livestock; Meat and Meat Products; Milk; Poultry and Poultry Products and Reporting and Recordkeeping Requirements |
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