82 FR 37041 - Concurrence With OIE Risk Designations for Bovine Spongiform Encephalopathy
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service Federal Register Volume 82, Issue 151 (August 8, 2017)
Animal and Plant Health Inspection Service
Federal Register Volume 82, Issue 151 (August 8, 2017)
| Page Range | 37041-37042 | |
| FR Document | 2017-16674 |
[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)] [Notices] [Pages 37041-37042] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16674] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \1\ To view the notice and the comment we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0092. --------------------------------------------------------------------------- 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
![Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices 37041
Total Burden Hours: 5,894. Rural Utilities Service DEPARTMENT OF AGRICULTURE
Ruth Brown, Title: Telecommunications System Animal and Plant Health Inspection
Departmental Information Collection Construction Policies and Procedures. Service
Clearance Officer.
OMB Control Number: 0572–0059. [Docket No. APHIS–2016–0092]
[FR Doc. 2017–16702 Filed 8–7–17; 8:45 am]
BILLING CODE 3410–34–P
Summary Of Collection: The Rural
Electrification Act of 1936 (RE Act), 7 Concurrence With OIE Risk
U.S.C. 901 et seq., was amended in 2002 Designations for Bovine Spongiform
DEPARTMENT OF AGRICULTURE by Title IV, Rural Broadband Access, by Encephalopathy
Farm Security and rural Investment Act, AGENCY: Animal and Plant Health
Submission for OMB Review; which authorizes Rural Utilities Service Inspection Service, USDA.
Comment Request (RUS) to provide loans and loan ACTION: Notice.
August 3, 2017. guarantees to fund the cost of
construction, improvement, or SUMMARY: We are advising the public of
The Department of Agriculture has
acquisition for facilities and equipment our decision to concur with the World
submitted the following information
for the provision of broadband service Organization for Animal Health’s (OIE)
collection requirement(s) to Office of
in eligible rural communities in the bovine spongiform encephalopathy
Management and Budget (OMB) for
States and territories of the United (BSE) risk designations for seven
review and clearance under the
States. Title VI of the RE Act requires regions. The OIE recognizes these
Paperwork Reduction Act of 1995,
that loans are granted only to borrowers regions as being of negligible risk for
Public Law 104–13. Comments are
who demonstrated that they will be able BSE. We are taking this action based on
requested regarding (1) whether the
to repay in full within the time agreed. our review of information supporting
collection of information is necessary
the OIE’s risk designations for these
for the proper performance of the RUS has established certain standards
regions.
functions of the agency, including and specification for materials,
whether the information will have equipment and construction to assure FOR FURTHER INFORMATION CONTACT: Dr.
practical utility; (2) the accuracy of the that standards are maintained; loans are Roberta Morales, Senior Staff
agency’s estimate of burden including not adversely affected, and loans are Veterinarian, Regionalization Evaluation
the validity of the methodology and used for intended purposes. Services, National Import Export
assumptions used; (3) ways to enhance Services, VS, APHIS, 920 Main Campus
Need and Use of the Information: Drive, Suite 200, Raleigh, NC 27606;
the quality, utility and clarity of the
information to be collected; (4) ways to RUS has developed specific forms for (919) 855–7735.
minimize the burden of the collection of borrowers to use when entering into
SUPPLEMENTARY INFORMATION: The
information on those who are to contracts for goods or services. The
regulations in 9 CFR part 92 subpart B,
respond, including through the use of information collected is used to ‘‘Importation of Animals and Animal
appropriate automated, electronic, implement certain provisions of loan Products; Procedures for Requesting
mechanical, or other technological documents about the borrower’s BSE Risk Status Classification With
collection techniques or other forms of purchase of materials and equipment Regard to Bovines’’ (referred to below as
information technology. and the construction of its broadband the regulations), set forth the process by
Comments regarding this information system and is provided on and as which the Animal and Plant Health
collection received by September 7, needed basis or when the individual Inspection Service (APHIS) classifies
2017 will be considered. Written borrower undertakes certain projects. regions for bovine spongiform
comments should be addressed to: Desk The standardization of the forms has encephalopathy (BSE) risk. Section 92.5
Officer for Agriculture, Office of resulted in substantial savings to of the regulations provides that all
Information and Regulatory Affairs, borrowers by reducing preparation of countries of the world are considered by
Office of Management and Budget the documentation and the costly APHIS to be in one of three BSE risk
(OMB), New Executive Office Building, review by the government. categories: Negligible risk, controlled
725—17th Street NW., Washington, DC Description of Respondents: Business risk, or undetermined risk. These risk
20502. Commenters are encouraged to categories are defined in § 92.1. Any
or other for-profit; Not-for-profit
submit their comments to OMB via region that is not classified by APHIS as
institutions.
email to: OIRA_Submission@ presenting either negligible risk or
OMB.EOP.GOV or fax (202) 395–5806 Number of Respondents: 110. controlled risk for BSE is considered to
and to Departmental Clearance Office, Frequency of Responses: Reporting: present an undetermined risk. The list
USDA, OCIO, Mail Stop 7602, On occasion. of those regions classified by APHIS as
Washington, DC 20250–7602. Copies of having either negligible risk or
Total Burden Hours: 8,807.
the submission(s) may be obtained by controlled risk can be accessed on the
calling (202) 720–8958. Charlene Parker, APHIS Web site at https://
An agency may not conduct or Departmental Information Collection www.aphis.usda.gov/aphis/ourfocus/
sponsor a collection of information Clearance Officer. animalhealth/animal-and-animal-
asabaliauskas on DSKBBXCHB2PROD with NOTICES
unless the collection of information [FR Doc. 2017–16641 Filed 8–7–17; 8:45 am] product-import-information/ct_animal_
displays a currently valid OMB control BILLING CODE 3410–15–P
disease_status. The list can also be
number and the agency informs obtained by writing to APHIS at
potential persons who are to respond to National Import Export Services, 4700
the collection of information that such River Road, Unit 38, Riverdale, MD
persons are not required to respond to 20737.
the collection of information unless it Under the regulations, APHIS may
displays a currently valid OMB control classify a region for BSE in one of two
number. ways. One way is for countries that have
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![37042 Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
not received a risk classification from regulating animal feed. The FDA has • Regions of negligible risk for BSE:
the World Organization for Animal established regulations in 21 CFR part Costa Rica, Germany, Lithuania,
Health (OIE) to request classification by 589 that prohibit mammalian protein in Mexico, Namibia, Romania, and Spain.
APHIS. The other way is for APHIS to ruminant feed (which includes a Authority: 7 U.S.C. 1622 and 8301–8317;
concur with the classification given to a ruminant-to-ruminant feed ban) and the 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7
country by the OIE. use of tissues that have the highest risk CFR 2.22, 2.80, and 371.4.
If the OIE has recognized a country as for carrying the BSE agent in all animal Done in Washington, DC, this 2nd day of
either BSE negligible risk or BSE feed. These high risk cattle materials, August 2017.
controlled risk, APHIS will seek known as specified risk materials Michael C. Gregoire,
information to support our concurrence (SRM), include the brains and spinal
Acting Administrator, Animal and Plant
with the OIE classification. This cords from cattle 30 months of age and Health Inspection Service.
information may be publicly available older.
[FR Doc. 2017–16674 Filed 8–7–17; 8:45 am]
information, or APHIS may request that To assess and monitor for compliance BILLING CODE 3410–34–P
countries supply the same information with the feed ban, the FDA established
given to the OIE. APHIS will announce the ruminant feed ban inspection
in the Federal Register, subject to program and guidance to assist both the DEPARTMENT OF AGRICULTURE
public comment, its intent to concur FDA and State investigators. Feed mill
with an OIE classification. and rendering plant inspections Animal and Plant Health Inspection
In accordance with that process, we conducted since 1998 indicate a very Service
published a notice 1 in the Federal high level of compliance with the feed
Register on January 23, 2017 (82 FR [Docket No. APHIS–2016–0035]
ban. Summaries of inspections can be
7786, Docket No. APHIS–2016–0092), in viewed on the FDA Web site at https://
which we announced our intent to Notice of Availability of Treatment
www.fda.gov/AnimalVeterinary/ Evaluation Document for Aircraft
concur with the OIE risk designations GuidanceComplianceEnforcement/
for seven regions. The OIE recognizes Treatments for Certain Hitchhiking
ComplianceEnforcement/ Pests
these regions as being of negligible risk BovineSpongiformEncephalopathy/
for BSE. We solicited comments on the ucm114507.htm. The FDA also AGENCY: Animal and Plant Health
notice for 60 days ending on March 24, established a feed testing program in Inspection Service, USDA.
2017. We received one comment by that 2001. The FDA’s highest priority for ACTION: Notice of availability and
date, from a private citizen. sample selection is given to finished request for comments.
The commenter expressed concern products intended for ruminants, and
that there is no process for verifying feed ingredients that may reasonably be SUMMARY: We are advising the public
whether ruminant-to-ruminant feed expected to be later used in ruminant that we have determined that it is
bans are effectively enforced. feed. necessary to immediately add to the
As part of its risk assessment process, Plant Protection and Quarantine
the OIE considers the likelihood that the The commenter also expressed Treatment Manual two new chemical
BSE agent either could be introduced concern that products from cattle treatments for targeting regulated pests
into or spread within a country through slaughtered at 36 months of age pose a in the cargo holds of aircraft. We have
contaminated commodities, including health risk to consumers. prepared a treatment evaluation
animal feed and feed ingredients. They The commenter is correct that certain document that describes the new
consider both the production of bovine products and live cattle from treatment schedules and explains why
processed animal proteins from specific countries with a higher risk of we have determined that they are
domestic livestock, and the use of BSE release may carry BSE infectivity effective at neutralizing certain target
imported processed animal proteins, and therefore present a health risk to pests. We are making the treatment
animal feed, and feed ingredients when consumers if no measures are taken to evaluation document available to the
assessing that risk. APHIS reviews mitigate that risk. For this reason, the public for review and comment.
similar information before concurring OIE also describes specific requirements DATES: We will consider all comments
with the OIE designation. for certain commodities originating from that we receive on or before October 10,
Once recognized as either negligible regions of controlled and undetermined 2017.
or controlled risk for BSE by the OIE, a risk.
ADDRESSES: You may submit comments
country must submit data on APHIS regulations require
surveillance results and feed controls by either of the following methods:
implementation of and compliance with • Federal eRulemaking Portal: Go to
for the previous 12 months annually to very similar requirements for both live http://www.regulations.gov/
maintain that status. If a country fails to bovines and bovine commodities in a #!docketDetail;D=APHIS-2016-0035.
provide that data in a timely manner, or region before we concur with the OIE’s • Postal Mail/Commercial Delivery:
the data shows changes that increase the BSE risk designation. These Send your comment to Docket No.
risk of BSE introduction or spread, the requirements mitigate the risk of APHIS–2016–0035, Regulatory Analysis
country’s risk designation may be exposure to a negligible level. Therefore, and Development, PPD, APHIS, Station
changed. In the event that a country’s countries with either controlled or 3A–03.8, 4700 River Road Unit 118,
risk status is demoted by the OIE, undetermined risk statuses must
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Riverdale, MD 20737–1238.
APHIS would also change its risk demonstrate that they have the authority Supporting documents and any
designation for the country. to conduct oversight of the compliance
Within the United States, the Food comments we receive on this docket
with such requirements. may be viewed at http://
and Drug Administration (FDA) is the
Therefore, in accordance with the www.regulations.gov/
Federal agency responsible for
regulations in § 92.5, we are announcing #!docketDetail;D=APHIS-2016-0035 or
1 To view the notice and the comment we our decision to concur with the OIE risk in our reading room, which is located in
received, go to http://www.regulations.gov/ classifications of the following Room 1141 of the USDA South
#!docketDetail;D=APHIS-2016-0092. countries: Building, 14th Street and Independence
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Document Created: 2017-08-08 00:17:23
Document Modified: 2017-08-08 00:17:23
| 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 | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 82 FR 37041 |
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