This section of the FEDERAL REGISTER

contains documents other than rules or

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public. Notices of hearings and investigations,

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examples of documents appearing in this

section.

Notices Federal Register

59207 

Vol. 79, No. 190 

Wednesday, October 1, 2014 

1To view the notice and the comments we 

received, go to http://www.regulations.gov/#!docket

Detail;D=APHIS-2013-0064. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2013–0064] 

Concurrence With OIE Risk 

Designations for Bovine Spongiform 

Encephalopathy 

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 regions. 

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 § 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. 

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 

§ 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 

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59208 Federal Register / Vol. 79, No. 190 / Wednesday, October 1, 2014 / Notices 

2The 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. 

3The 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. 

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 

system. 

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. 

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 Ministe ́rio 

da Agricultura, Pecua ́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 permit. 

Therefore, in accordance with the 

regulations in § 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, Slovenia. 

• 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] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2014–0004] 

Availability of an Environmental 

Assessment and Finding of No 

Significant Impact for a Biological 

Control Agent for Soybean Aphid in 

the Continental United States 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service has prepared an 

environmental assessment and finding 

of no significant impact relative to the 

release of Aphelinus rhamni for the 

biological control of the soybean aphid, 

Aphis glycines, in the continental 

United States. Based on its finding of no 

significant impact, the Animal and Plant 

Health Inspection Service has 

determined that an environmental 

impact statement need not be prepared. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Shirley A Wager-Page ́, Chief, Pest 

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