[Federal Register Volume 87, Number 193 (Thursday, October 6, 2022)]
[Notices]
[Pages 60641-60642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21729]


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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 87, No. 193 / Thursday, October 6, 2022 / 
Notices  

[[Page 60641]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2022-0005]


Concurrence With World Organization for Animal Health's Risk 
Designation for Bovine Spongiform Encephalopathy for Ireland

AGENCY: Animal and Plant Health Inspection Service, Department of 
Agriculture (USDA).

ACTION: Notice.

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SUMMARY: We are advising the public of our decision to concur with the 
World Organization for Animal Health's (WOAH's) bovine spongiform 
encephalopathy (BSE) risk designation for Ireland. The WOAH recognizes 
Ireland as being of negligible risk for BSE. We are taking this action 
based on our review of information supporting the WOAH's risk 
designation for Ireland.

FOR FURTHER INFORMATION CONTACT: Dr. Rebecca Gordon, Senior Staff 
Officer, Regionalization Evaluation Services, Veterinary Services, 
APHIS, 920 Main Campus Drive, Raleigh, NC, 27606; (919) 855-7741; 
email: [email protected].

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 website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions. The list can also be 
obtained by writing to APHIS at Regionalization Evaluation Services, 
Veterinary Services, APHIS, 4700 River Road Unit 38, Riverdale, MD 
20737-1238.
    Under the regulations, APHIS may classify a region for BSE in one 
of two ways. One way is for regions that have not received a risk 
classification from the World Organization for Animal Health (WOAH) \1\ 
to request classification by APHIS. The other way is for APHIS to 
concur with the classification given to a country or region by the 
WOAH.
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    \1\ On May 28, 2022, the World Organization for Animal Health 
announced a change to its acronym from OIE to WOAH to match its full 
name. See https://www.woah.org/en/the-world-organisation-for-animal-health-launches-its-refreshed-brand-identity/.
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    If the WOAH has classified a region as either BSE negligible risk 
or BSE controlled risk, APHIS will seek information to support 
concurrence with the WOAH classification. This information may be 
publicly available information, or APHIS may request that regions 
supply the same information given to the WOAH. APHIS will announce in 
the Federal Register, subject to public comment, its intent to concur 
with a WOAH classification.
    In accordance with this process, we published a notice \2\ in the 
Federal Register on April 14, 2022 (87 FR 22168- 22169, Docket No. 
APHIS-2022-0005), in which we announced our intent to concur with the 
WOAH risk classification of Ireland as being a region of negligible 
risk for BSE. We solicited comments on the notice for 60 days ending on 
June 13, 2022. We received one comment by that date, from a private 
citizen.
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    \2\ To view the notice, go to www.regulations.gov and enter 
APHIS-2022-0005 in the Search field.
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    The commenter claimed that we provided no evidence to support that 
BSE levels in Ireland's cattle population approach zero.
    Neither the notice nor the conclusions of the WOAH referenced in 
the notice claimed that BSE cases in Ireland approach zero. Rather, the 
WOAH classified Ireland as BSE negligible risk. While negligible risk 
indicates that the occurrence of BSE is very rare, it does not 
translate to zero risk, nor does it imply the expectation or assumption 
that the risk will become zero in the future. Atypical BSE may still be 
detected in countries or regions with a negligible risk status. The 
atypical BSE forms, L-type and H-type, occur spontaneously at very low 
levels in all cattle populations.
    The commenter also stated that relying on slaughterhouses/abattoirs 
to find cases of BSE is an unreliable surveillance method.
    Because there is currently no test to detect BSE in a live animal, 
sampling for BSE is often performed in the slaughterhouse/abattoir 
environment. It may also be performed at rendering or salvage 
facilities, on-farm, at veterinary clinics, or at veterinary diagnostic 
laboratories. Ireland provided documentation for the standard operating 
procedures for active surveillance for BSE in cattle and documented 
that the samples collected are representative of the cattle population 
in the country. Furthermore, Ireland provided documentation that BSE 
surveillance exceeded Type B surveillance minimum requirements in 
Chapter 11.4 of the WOAH Terrestrial Animal Health Code. As the 
commenter provided no information to support the claim that this 
surveillance is unreliable, we continue to concur with the WOAH risk 
classification of Ireland as being a region of negligible risk for BSE.
    The commenter also claimed that laboratories in general lack the 
skills necessary to detect BSE.
    All BSE confirmatory testing in Ireland is carried out in the 
Central Veterinary Research Laboratory in Backweston, which is the 
National Reference Laboratory (NRL) for transmissible spongiform 
encephalopathies in Ireland. The confirmatory tests used are 
histopathology, immunohistochemistry using antibody F89, and immunoblot 
(Biorad TeSeE). All confirmatory and discriminatory tests used are 
accredited to the international standard for laboratories (IS0-17025). 
All rapid

[[Page 60642]]

screening for BSE is conducted with European Union-approved rapid tests 
at Rapid Test Laboratories that are approved and monitored by the NRL. 
Ireland provided documentation that BSE diagnostic procedures and the 
reference laboratory facilities (NRL and Rapid Test Laboratories) meet 
the requirements in the WOAH Manual of Diagnostic Tests and Vaccines 
for Terrestrial Animals. As the commenter provided no information to 
support the claim that these laboratories or tests are unable to 
accurately detect BSE, we continue to concur with the WOAH risk 
classification of Ireland as being a region of negligible risk for BSE.
    Therefore, in accordance with the regulations in Sec.  92.5, we are 
announcing our decision to concur with the WOAH risk classification for 
Ireland.
Congressional Review Act
    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this action 
as not a major rule, as defined by 5 U.S.C. 804(2).
    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 30th day of September 2022.
Anthony Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2022-21729 Filed 10-5-22; 8:45 am]
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