[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)]
[Notices]
[Pages 37041-37042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16674]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2016-0092]


Concurrence With OIE Risk Designations for Bovine Spongiform 
Encephalopathy

AGENCY: Animal and Plant Health Inspection Service, 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 (OIE) bovine spongiform 
encephalopathy (BSE) risk designations for seven regions. The OIE 
recognizes these regions as being of negligible 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. Roberta Morales, Senior Staff 
Veterinarian, Regionalization Evaluation Services, National Import 
Export Services, VS, APHIS, 920 Main Campus Drive, Suite 200, Raleigh, 
NC 27606; (919) 855-7735.

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 https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/ct_animal_disease_status. 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

[[Page 37042]]

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 January 23, 2017 (82 FR 7786, Docket No. APHIS-
2016-0092), in which we announced our intent to concur with the OIE 
risk designations for seven regions. The OIE recognizes these regions 
as being of negligible risk for BSE. We solicited comments on the 
notice for 60 days ending on March 24, 2017. We received one comment by 
that date, from a private citizen.
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    \1\ To view the notice and the comment we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0092.
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    The commenter expressed concern that there is no process for 
verifying whether ruminant-to-ruminant feed bans are effectively 
enforced.
    As part of its risk assessment process, the OIE considers the 
likelihood that the BSE agent either could be introduced into or spread 
within a country through contaminated commodities, including animal 
feed and feed ingredients. They consider both the production of 
processed animal proteins from domestic livestock, and the use of 
imported processed animal proteins, animal feed, and feed ingredients 
when assessing that risk. APHIS reviews similar information before 
concurring with the OIE designation.
    Once recognized as either negligible or controlled risk for BSE by 
the OIE, a country must submit data on surveillance results and feed 
controls for the previous 12 months annually to maintain that status. 
If a country fails to provide that data in a timely manner, or the data 
shows changes that increase the risk of BSE introduction or spread, the 
country's risk designation may be changed. In the event that a 
country's risk status is demoted by the OIE, APHIS would also change 
its risk designation for the country.
    Within the United States, the Food and Drug Administration (FDA) is 
the Federal agency responsible for regulating animal feed. The FDA has 
established regulations in 21 CFR part 589 that prohibit mammalian 
protein in ruminant feed (which includes a ruminant-to-ruminant feed 
ban) and the use of tissues that have the highest risk for carrying the 
BSE agent in all animal feed. These high risk cattle materials, known 
as specified risk materials (SRM), include the brains and spinal cords 
from cattle 30 months of age and older.
    To assess and monitor for compliance with the feed ban, the FDA 
established the ruminant feed ban inspection program and guidance to 
assist both the FDA and State investigators. Feed mill and rendering 
plant inspections conducted since 1998 indicate a very high level of 
compliance with the feed ban. Summaries of inspections can be viewed on 
the FDA Web site at https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/ComplianceEnforcement/BovineSpongiformEncephalopathy/ucm114507.htm. The FDA also established 
a feed testing program in 2001. The FDA's highest priority for sample 
selection is given to finished products intended for ruminants, and 
feed ingredients that may reasonably be expected to be later used in 
ruminant feed.
    The commenter also expressed concern that products from cattle 
slaughtered at 36 months of age pose a health risk to consumers.
    The commenter is correct that certain bovine products and live 
cattle from specific countries with a higher risk of BSE release may 
carry BSE infectivity and therefore present a health risk to consumers 
if no measures are taken to mitigate that risk. For this reason, the 
OIE also describes specific requirements for certain commodities 
originating from regions of controlled and undetermined risk.
    APHIS regulations require implementation of and compliance with 
very similar requirements for both live bovines and bovine commodities 
in a region before we concur with the OIE's BSE risk designation. These 
requirements mitigate the risk of exposure to a negligible level. 
Therefore, countries with either controlled or undetermined risk 
statuses must demonstrate that they have the authority to conduct 
oversight of the compliance with such requirements.
    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: Costa Rica, Germany, 
Lithuania, Mexico, Namibia, Romania, and Spain.

    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 2nd day of August 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-16674 Filed 8-7-17; 8:45 am]
 BILLING CODE 3410-34-P