[Federal Register Volume 79, Number 190 (Wednesday, October 1, 2014)]
[Pages 59207-59208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-23407]

                                                Federal Register

This section of the FEDERAL REGISTER contains documents other than rules 
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statements of organization and functions are examples of documents 
appearing in this section.


Federal Register / Vol. 79, No. 190 / Wednesday, October 1, 2014 / 

[[Page 59207]]


Animal and Plant Health Inspection Service

[Docket No. APHIS-2013-0064]

Concurrence With OIE Risk Designations for Bovine Spongiform 

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.


SUMMARY: We are advising the public of our decision to concur with the 
World Organization for Animal Health's (OIE) bovine spongiform 
encephalopathy (BSE) risk designations for 15 regions. The OIE 
recognizes these regions as being of either negligible risk for BSE or 
of controlled risk for BSE. We are taking this action based on our 
review of information supporting the OIE's risk designations for these 

FOR FURTHER INFORMATION CONTACT: Dr. Silvia Kreindel, Senior Staff 
Veterinarian, Regionalization Evaluation Services, National Import 
Export Services, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 
20737-1231; (301) 851-3300.

SUPPLEMENTARY INFORMATION: The regulations in 9 CFR part 92 subpart B, 
``Importation of Animals and Animal Products; Procedures for Requesting 
BSE Risk Status Classification With Regard to Bovines'' (referred to 
below as the regulations), set forth the process by which the Animal 
and Plant Health Inspection Service (APHIS) classifies regions for 
bovine spongiform encephalopathy (BSE) risk. Section 92.5 of the 
regulations provides that all countries of the world are considered by 
APHIS to be in one of three BSE risk categories: Negligible risk, 
controlled risk, or undetermined risk. These risk categories are 
defined in Sec.  92.1. Any region that is not classified by APHIS as 
presenting either negligible risk or controlled risk for BSE is 
considered to present an undetermined risk. The list of those regions 
classified by APHIS as having either negligible risk or controlled risk 
can be accessed on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. The list can also be 
obtained by writing to APHIS at National Import Export Services, 4700 
River Road Unit 38, Riverdale, MD 20737.
    Under the regulations, APHIS may classify a region for BSE in one 
of two ways. One way is for countries that have not received a risk 
classification from the World Organization for Animal Health (OIE) to 
request classification by APHIS. The other way is for APHIS to concur 
with the classification given to a country by the OIE.
    If the OIE has recognized a country as either BSE negligible risk 
or BSE controlled risk, APHIS will seek information to support our 
concurrence with the OIE classification. This information may be 
publicly available information, or APHIS may request that countries 
supply the same information given to the OIE. APHIS will announce in 
the Federal Register, subject to public comment, its intent to concur 
with an OIE classification.
    In accordance with that process, we published a notice \1\ in the 
Federal Register on December 4, 2013 (78 FR 72859-72860, Docket No. 
APHIS-2013-0064), in which we announced our intent to concur with the 
OIE risk designations for 15 regions. In the notice we mistakenly 
stated that we intended to concur with the risk designations for 14 
regions; the correct number is 15. The regions listed in the notice, 
however, were correct. The OIE recognizes these regions as being of 
either negligible risk for BSE or of controlled risk for BSE. We 
solicited comments on the notice for 60 days ending on February 3, 
2014. We received three comments by that date, from two private 
citizens and a foreign industry association.

    \1\ To view the notice and the comments we received, go to 

    One commenter expressed general concern that the risk designations 
did not accurately reflect the actual risk of BSE, but the commenter 
did not address the specific details of the OIE process or of any 
region's designation. Another commenter expressed concern that the OIE 
process is not transparent and there is insufficient detail in the OIE 
summaries to make an adequate determination of BSE risk. This commenter 
stated that APHIS should undertake its own assessment of BSE status 
rather than accepting the OIE risk designation.
    The summaries are the only information the OIE makes publicly 
available. Countries may make their BSE dossiers publicly available, in 
whole or in part, or they may share their dossiers with other countries 
upon request. For this reason, before announcing our intent to concur 
with the OIE classification, APHIS verifies that the information can be 
provided to us, or is publicly available, for review to support our 
concurrence with the OIE classification. APHIS' intention is to follow 
the OIE's BSE guidelines while ensuring that OIE-recognized countries 
apply adequate BSE risk mitigation measures assuring that bovines and 
bovine commodities destined for export pose a negligible risk for BSE, 
and that the country complies with OIE requirements for the specific 
BSE country recognition. If the information is not publicly available 
and the country does not provide the information, then we will not 
recognize the country's BSE status. APHIS thus has greater confidence 
in the outcomes of the evaluations and will have the necessary 
documentation to support or defend recognition decisions. The process 
we use is described in the regulations in Sec.  92.5.
    The information provided in the OIE dossier is more comprehensive 
than what appears in the summaries of the OIE Scientific Commission, 
and includes information about the likelihood that the disease could 
have been introduced into the country though the importation of bovine 
or bovine commodities in the last 7 years, the likelihood that the 
agent could have been recycled in as meat-and-bone meal or greaves for 
the last 8 years, the awareness, notification and laboratory 
capabilities of the region, BSE surveillance in the region, and the 
history of BSE in the region.
    One commenter stated that, according to the OIE summary reports, 
the evaluation for Brazil was provided by the OIE in February 2012. The 
commenter also stated that in December

[[Page 59208]]

2012, it was learned that a cow from Brazil that was sampled for 
testing in December 2010 tested positive for BSE. The commenter noted 
that immunohistochemistry (IHC) tests were not completed until June 
2012, and it was another 6 months before a confirmatory test was 
completed at the Community Reference Laboratory in Weybridge, United 
Kingdom. The commenter stated that the lack of specific information 
regarding the OIE evaluation of the surveillance system made it 
difficult to determine if this was a one-time error or a failure of the 
    APHIS agrees that the delays in the testing and reporting of the 
atypical BSE case detected in Brazil were problematic. In response to 
these concerns, the OIE Scientific Commission requested that Brazil 
provide all relevant information for their meeting in February 2013. At 
that meeting, the OIE Scientific Commission affirmed that the 
identification of this single case of BSE did not put Brazil's or its 
trading partners' animal and public health at risk because the animal 
was destroyed and no parts of it had entered the food or feed chain. 
However, the OIE was also concerned about the delay before Brazil sent 
the clinical samples for a confirmatory diagnosis and requested more 
detailed information on the procedures for processing samples and the 
improvement of the surveillance system in the country, so that they 
could further monitor compliance by Brazil with international 
standards.\2\ At a subsequent meeting in September 2013, the OIE 
assessed the additional information provided by Brazil.\3\ The OIE was 
satisfied with the evidence submitted but also concluded that Brazil 
should submit the results of the proficiency tests conducted for 2013 
to the OIE as soon as they became available.

    \2\ The report of the OIE scientific commission meeting in 
February 2013 can be viewed at http://www.oie.int/fileadmin/Home/eng/Internationa_Standard_Setting/docs/pdf/SCAD/A_SCAD_Feb2013.pdf. The discussion of the BSE case 
in Brazil appears on pages 13-14.
    \3\ The report of the OIE scientific commission meeting in 
September 2013 can be viewed at http://www.oie.int/fileadmin/Home/eng/Internationa_Standard_Setting/docs/pdf/SCAD/A_SCAD_Sept2013.pdf. The discussion of the BSE case 
in Brazil appears on page 7.

    In addition, representatives of APHIS and the United States 
Department of Agriculture's Food Safety and Inspection Service visited 
Brazil in February 2013 to evaluate the BSE laboratory infrastructure, 
emergency response, and BSE-related mitigations at the slaughter level. 
APHIS' review of the epidemiological and laboratory reports, including 
the report from the confirmatory tests conducted at Weybridge, shows 
that Brazil's first BSE case was most consistent with the atypical form 
of the disease. In addition, as a result of the delays in testing and 
reporting of this case, Brazil's Minist[eacute]rio da Agricultura, 
Pecu[aacute]ria e Abastecimento conducted audits of the laboratories to 
identify areas for change and improvement, and has implemented several 
new procedures to assure the timely testing of samples and reporting of 
results. Corrective actions include addition of a second lab to conduct 
IHC tests, expansion of testing capabilities to include Western Blot, 
and the development of an inter-laboratory data management system which 
will issue reports, record improper samples, and flag delays in sample 
receipt, completion, and notification of test results. Samples will be 
forwarded for IHC testing immediately after the immunofluorescence test 
for rabies is completed, rather than waiting for the animal inoculation 
tests to be completed.
    We note that Brazil detected a suspected case of BSE in a 12-year-
old cow in April 2014. The Brazilian authorities carried out the 
required epidemiological investigation in accordance with OIE 
guidelines. In May 2014, tests at the OIE reference laboratory in 
Weybridge confirmed that it was an atypical case of BSE.
    Brazil still meets the criteria for a negligible risk region. In 
Article 11.5.3 of the Terrestrial Animal Health Code, the OIE requires, 
among other things, that if there has been an indigenous case of BSE in 
a region, every indigenous case was born more than 11 years ago. The 
cow in which BSE was detected was over 11 years of age. Therefore, this 
most recent case will not affect Brazil's negligible risk status.
    One commenter stated that India should be included in the list of 
regions of negligible risk for BSE.
    Our review of information in support of concurrence with the OIE 
designation for India is ongoing; we have requested the OIE dossier but 
have not yet received it. When our review is complete, if the findings 
support concurrence with the OIE designation, we will publish a notice 
in the Federal Register announcing our preliminary concurrence with the 
OIE's designation for India and provide the public with an opportunity 
to comment.
    One commenter stated that the United States should be included on 
this list of regions of negligible risk for BSE because some raw 
material may be exported from the United States and then reimported 
after processing abroad.
    When APHIS assesses the disease status of a region, it is to 
determine whether imports can be safely allowed from that region. For 
this reason we do not typically include the United States in the lists 
of regions recognized for any given disease status. In the event that 
raw material was exported for processing, we could allow it to be 
reimported under conditions that would be specified on the import 
    Therefore, in accordance with the regulations in Sec.  92.5, we are 
announcing our decision to concur with the OIE risk classifications of 
the following countries:
     Regions of negligible risk for BSE: Austria, Belgium, 
Brazil, Colombia, Israel, Italy, Japan, the Netherlands, Singapore, 
     Regions of controlled risk for BSE: Bulgaria, Costa Rica, 
Croatia, Nicaragua, Taiwan.

    Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

    Done in Washington, DC, this 26th day of September 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-23407 Filed 9-30-14; 8:45 am]