81_FR_52965 81 FR 52811 - Concurrence With OIE Risk Designations for Bovine Spongiform Encephalopathy

81 FR 52811 - Concurrence With OIE Risk Designations for Bovine Spongiform Encephalopathy

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 81, Issue 154 (August 10, 2016)

Page Range52811-52812
FR Document2016-18985

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 14 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.

Federal Register, Volume 81 Issue 154 (Wednesday, August 10, 2016)
[Federal Register Volume 81, Number 154 (Wednesday, August 10, 2016)]
[Notices]
[Pages 52811-52812]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-18985]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2015-0055]


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 14 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 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, 2015 (80 FR 75849, Docket No. APHIS-
2015-0055), in which we announced our intent to concur with the OIE 
risk designations for 16 regions. The OIE recognizes these regions as 
being of negligible risk for BSE. We solicited comments on the notice 
for 60 days ending on February 2, 2016. We received two comments by 
that date, from a private citizen and a representative of a foreign 
government.
---------------------------------------------------------------------------

    \1\ To view the notice and the comments we received, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0055.
---------------------------------------------------------------------------

    One commenter stated that if a product is being imported only for 
use in pet food, then the BSE risk status of the exporting region 
should not be an issue.
    We disagree that bovine products imported for use in pet food do 
not pose a risk for introducing or spreading BSE in the United States. 
It is possible that pet foods could be used for cattle feed, either by 
accidental misfeeding of pet foods to cattle or by misusing salvage pet 
food for cattle. Farms that raise multiple species (e.g. dogs, swine, 
and cattle) present a particular risk for misfeeding.
    The other commenter stated that the United States does not 
recognize all the OIE's risk designations for BSE, noting that the 
United States still considers several countries as controlled risk 
regions though the OIE has classified them as negligible risk.
    As we explained above, Sec.  92.5 of the regulations provides two 
ways that APHIS may classify a region for BSE. One way is for countries 
that have not received a risk classification from the 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.
    The length of APHIS's review of information in support of 
concurrence depends on a number of factors, including whether the 
information is publicly available, and, if it is not publicly 
available, how quickly a country responds to our request for 
information. This notice updates APHIS' list of regions recognized as 
negligible risk for BSE to include all the regions for which we have 
been able to review information. We intend to announce concurrence with 
additional countries recognized by the OIE in a future notice.
    One commenter noted that while the OIE guidelines call for removal 
of specified risk materials (SRMs) from animals older than 30 months of 
age, our regulations require the removal of SRMs from animals 30 months 
of age or older. The commenter stated that while this is not a 
significant difference from an epidemiological perspective, it creates 
a major problem for certification through the veterinary services of 
exporting countries and presents a barrier to trade.
    APHIS notes that the wording ``30 months of age or older'' is 
consistent with Food Safety and Inspection Service (FSIS) and U.S. Food 
and Drug Administration (FDA) regulations as well as with Canadian 
regulations. We also note that anyone wishing to import bovine products 
into the United States must also meet FSIS or FDA requirements as well 
as APHIS requirements. We do not anticipate that this difference will 
have a significant impact on trade.

[[Page 52812]]

    In the December 2015 notice, we mistakenly announced our intent to 
recognize Romania as a region of negligible risk for BSE. In December 
2014, the OIE suspended Romania's status as a negligible risk region 
because Romania reported a case of atypical BSE. Since then, the OIE 
has announced its intent to reinstate Romania's status as a region of 
negligible risk for BSE. We will be seeking information to verify 
Romania's status and will announce our intent to concur with the OIE's 
designation in a future notice.
    Also in the December 2015 notice, we announced our intent to 
recognize France as a region of negligible risk for BSE in concurrence 
with the OIE. Since then, France has confirmed a case of classical BSE 
in a 5-year-old cow. Accordingly, the OIE has suspended France's status 
as a region of negligible risk for BSE and reinstated its status as a 
region of controlled risk effective March 25, 2016. For this reason we 
have removed France from the list of regions of negligible risk for BSE 
in this document. We will continue to recognize France as a region of 
controlled risk for BSE.
    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: Bulgaria, Cyprus, 
Czech Republic, Estonia, Hungary, India, Korea (Republic of), Latvia, 
Liechtenstein, Luxembourg, Malta, Portugal, Slovakia, and Switzerland.

    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 4th day of August, 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-18985 Filed 8-9-16; 8:45 am]
 BILLING CODE 3410-34-P



                                                                             Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices                                           52811

                                                    These conditions will be listed in the                categories are defined in § 92.1. Any                 cattle) present a particular risk for
                                                  Fruits and Vegetables Import                            region that is not classified by APHIS as             misfeeding.
                                                  Requirements database (available at                     presenting either negligible risk or                    The other commenter stated that the
                                                  http://www.aphis.usda.gov/favir/). In                   controlled risk for BSE is considered to              United States does not recognize all the
                                                  addition to these specific measures,                    present an undetermined risk. The list                OIE’s risk designations for BSE, noting
                                                  pomegranates from Peru will be subject                  of those regions classified by APHIS as               that the United States still considers
                                                  to the general requirements listed in                   having either negligible risk or                      several countries as controlled risk
                                                  § 319.56–3 that are applicable to the                   controlled risk can be accessed on the                regions though the OIE has classified
                                                  importation of all fruits and vegetables.               APHIS Web site at https://                            them as negligible risk.
                                                    Authority: 7 U.S.C. 450, 7701–7772, and               www.aphis.usda.gov/aphis/ourfocus/                      As we explained above, § 92.5 of the
                                                  7781–7786; 21 U.S.C. 136 and 136a; 7 CFR                animalhealth/animal-and-animal-                       regulations provides two ways that
                                                  2.22, 2.80, and 371.3.                                  product-import-information/ct_animal_                 APHIS may classify a region for BSE.
                                                    Done in Washington, DC, this 4th day of
                                                                                                          disease_status. The list can also be                  One way is for countries that have not
                                                  August, 2016.                                           obtained by writing to APHIS at                       received a risk classification from the
                                                  Kevin Shea,
                                                                                                          National Import Export Services, 4700                 OIE to request classification by APHIS.
                                                                                                          River Road Unit 38, Riverdale, MD                     The other way is for APHIS to concur
                                                  Administrator, Animal and Plant Health
                                                  Inspection Service.
                                                                                                          20737.                                                with the classification given to a
                                                                                                             Under the regulations, APHIS may                   country by the OIE. If the OIE has
                                                  [FR Doc. 2016–18987 Filed 8–9–16; 8:45 am]
                                                                                                          classify a region for BSE in one of two               recognized a country as either BSE
                                                  BILLING CODE 3410–34–P
                                                                                                          ways. One way is for countries that have              negligible risk or BSE controlled risk,
                                                                                                          not received a risk classification from               APHIS will seek information to support
                                                                                                          the World Organization for Animal                     our concurrence with the OIE
                                                  DEPARTMENT OF AGRICULTURE
                                                                                                          Health (OIE) to request classification by             classification. This information may be
                                                  Animal and Plant Health Inspection                      APHIS. The other way is for APHIS to                  publicly available information, or
                                                  Service                                                 concur with the classification given to a             APHIS may request that countries
                                                                                                          country by the OIE.                                   supply the same information given to
                                                  [Docket No. APHIS–2015–0055]                               If the OIE has recognized a country as             the OIE.
                                                                                                          either BSE negligible risk or BSE                       The length of APHIS’s review of
                                                  Concurrence With OIE Risk                               controlled risk, APHIS will seek
                                                  Designations for Bovine Spongiform                                                                            information in support of concurrence
                                                                                                          information to support our concurrence                depends on a number of factors,
                                                  Encephalopathy                                          with the OIE classification. This                     including whether the information is
                                                  AGENCY:  Animal and Plant Health                        information may be publicly available                 publicly available, and, if it is not
                                                  Inspection Service, USDA.                               information, or APHIS may request that                publicly available, how quickly a
                                                  ACTION: Notice.                                         countries supply the same information                 country responds to our request for
                                                                                                          given to the OIE. APHIS will announce                 information. This notice updates
                                                  SUMMARY:   We are advising the public of                in the Federal Register, subject to                   APHIS’ list of regions recognized as
                                                  our decision to concur with the World                   public comment, its intent to concur                  negligible risk for BSE to include all the
                                                  Organization for Animal Health’s (OIE)                  with an OIE classification.                           regions for which we have been able to
                                                  bovine spongiform encephalopathy                           In accordance with that process, we                review information. We intend to
                                                  (BSE) risk designations for 14 regions.                 published a notice 1 in the Federal                   announce concurrence with additional
                                                  The OIE recognizes these regions as                     Register on December 4, 2015 (80 FR                   countries recognized by the OIE in a
                                                  being of negligible risk for BSE. We are                75849, Docket No. APHIS–2015–0055),                   future notice.
                                                  taking this action based on our review                  in which we announced our intent to                     One commenter noted that while the
                                                  of information supporting the OIE’s risk                concur with the OIE risk designations                 OIE guidelines call for removal of
                                                  designations for these regions.                         for 16 regions. The OIE recognizes these              specified risk materials (SRMs) from
                                                  FOR FURTHER INFORMATION CONTACT: Dr.                    regions as being of negligible risk for               animals older than 30 months of age,
                                                  Roberta Morales, Senior Staff                           BSE. We solicited comments on the                     our regulations require the removal of
                                                  Veterinarian, Regionalization Evaluation                notice for 60 days ending on February                 SRMs from animals 30 months of age or
                                                  Services, National Import Export                        2, 2016. We received two comments by                  older. The commenter stated that while
                                                  Services, VS, APHIS, 920 Main Campus                    that date, from a private citizen and a               this is not a significant difference from
                                                  Drive, Suite 200, Raleigh, NC 27606;                    representative of a foreign government.               an epidemiological perspective, it
                                                  (919) 855–7735.                                            One commenter stated that if a                     creates a major problem for certification
                                                                                                          product is being imported only for use                through the veterinary services of
                                                  SUPPLEMENTARY INFORMATION: The
                                                                                                          in pet food, then the BSE risk status of              exporting countries and presents a
                                                  regulations in 9 CFR part 92 subpart B,
                                                                                                          the exporting region should not be an                 barrier to trade.
                                                  ‘‘Importation of Animals and Animal
                                                                                                          issue.
                                                  Products; Procedures for Requesting                                                                             APHIS notes that the wording ‘‘30
                                                                                                             We disagree that bovine products
                                                  BSE Risk Status Classification With                                                                           months of age or older’’ is consistent
                                                                                                          imported for use in pet food do not pose
                                                  Regard to Bovines’’ (referred to below as                                                                     with Food Safety and Inspection Service
                                                                                                          a risk for introducing or spreading BSE
                                                  the regulations), set forth the process by                                                                    (FSIS) and U.S. Food and Drug
                                                                                                          in the United States. It is possible that
                                                  which the Animal and Plant Health                                                                             Administration (FDA) regulations as
                                                                                                          pet foods could be used for cattle feed,
                                                  Inspection Service (APHIS) classifies                                                                         well as with Canadian regulations. We
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                                                                                                          either by accidental misfeeding of pet
                                                  regions for bovine spongiform                                                                                 also note that anyone wishing to import
                                                                                                          foods to cattle or by misusing salvage
                                                  encephalopathy (BSE) risk. Section 92.5                                                                       bovine products into the United States
                                                                                                          pet food for cattle. Farms that raise
                                                  of the regulations provides that all                                                                          must also meet FSIS or FDA
                                                                                                          multiple species (e.g. dogs, swine, and
                                                  countries of the world are considered by                                                                      requirements as well as APHIS
                                                  APHIS to be in one of three BSE risk                      1 To view the notice and the comments we            requirements. We do not anticipate that
                                                  categories: Negligible risk, controlled                 received, go to http://www.regulations.gov/           this difference will have a significant
                                                  risk, or undetermined risk. These risk                  #!docketDetail;D=APHIS-2015-0055.                     impact on trade.


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                                                  52812                      Federal Register / Vol. 81, No. 154 / Wednesday, August 10, 2016 / Notices

                                                     In the December 2015 notice, we                      importation of fresh figs (Ficus carica)                 • Each consignment of figs must be
                                                  mistakenly announced our intent to                      from Peru into the continental United                 accompanied by a phytosanitary
                                                  recognize Romania as a region of                        States. Based on the findings of a pest               certificate issued by the national plant
                                                  negligible risk for BSE. In December                    risk analysis, which we made available                protection organization (NPPO) of Peru;
                                                  2014, the OIE suspended Romania’s                       for the public to review and comment                     • Each consignment of figs must be
                                                  status as a negligible risk region because              through a previous notice, we have                    treated in accordance with 7 CFR part
                                                  Romania reported a case of atypical                     concluded that the application of                     305; and
                                                  BSE. Since then, the OIE has announced                  designated phytosanitary measures will                   • Each consignment of figs is subject
                                                  its intent to reinstate Romania’s status                be sufficient to mitigate the risks of                to inspection upon arrival at the port of
                                                  as a region of negligible risk for BSE. We              introducing or disseminating plant pests              entry to the United States.
                                                  will be seeking information to verify                   via the importation of fresh figs from                   We solicited comments on the PRA
                                                  Romania’s status and will announce our                  Peru.                                                 and RMD for 60 days, ending on May
                                                  intent to concur with the OIE’s                                                                               13, 2016. We received four comments by
                                                                                                          DATES:   Effective August 10, 2016.
                                                  designation in a future notice.                                                                               that date, from a State department of
                                                     Also in the December 2015 notice, we                 FOR FURTHER INFORMATION CONTACT:      Ms.
                                                                                                                                                                agriculture, the Peruvian Government,
                                                  announced our intent to recognize                       Claudia Ferguson, Senior Regulatory
                                                                                                                                                                the Peruvian embassy, and a U.S. port
                                                  France as a region of negligible risk for               Policy Specialist, Regulatory
                                                                                                                                                                of entry.
                                                  BSE in concurrence with the OIE. Since                  Coordination and Compliance, Imports,
                                                                                                          Regulations, and Manuals, PPQ, APHIS,                    Three of the commenters supported
                                                  then, France has confirmed a case of                                                                          the importation of fresh figs from Peru
                                                  classical BSE in a 5-year-old cow.                      4700 River Road, Unit 133, Riverdale,
                                                                                                          MD 20737–1231; (301) 851–2352;                        into the continental United States.
                                                  Accordingly, the OIE has suspended                                                                               One commenter pointed out that the
                                                  France’s status as a region of negligible               Claudia.Ferguson@aphis.usda.gov.
                                                                                                                                                                notice would allow figs from Peru to be
                                                  risk for BSE and reinstated its status as               SUPPLEMENTARY INFORMATION: Under the
                                                                                                                                                                irradiated in the United States. The
                                                  a region of controlled risk effective                   regulations in ‘‘Subpart–Fruits and                   commenter expressed concern that this
                                                  March 25, 2016. For this reason we have                 Vegetables’’ (7 CFR 319.56–1 through                  could present a risk of introducing
                                                  removed France from the list of regions                 319.56–75, referred to below as the                   quarantine pests that could follow the
                                                  of negligible risk for BSE in this                      regulations), the Animal and Plant                    pathway of figs from Peru into the
                                                  document. We will continue to                           Health Inspection Service (APHIS)                     United States, and that such
                                                  recognize France as a region of                         prohibits or restricts the importation of             introduction would present a significant
                                                  controlled risk for BSE.                                fruits and vegetables into the United                 risk to States in which the pests could
                                                     Therefore, in accordance with the                    States from certain parts of the world to             become established. For this reason, the
                                                  regulations in § 92.5, we are announcing                prevent plant pests from being                        commenter stated that irradiation
                                                  our decision to concur with the OIE risk                introduced into or disseminated within                should either have to take place in Peru
                                                  classifications of the following                        the United States.                                    or in areas of the United States north of
                                                  countries:                                                 Section 319.56–4 contains a
                                                                                                                                                                the 39th parallel, in which the pests
                                                     • Regions of negligible risk for BSE:                performance-based process for
                                                                                                                                                                could not become established.
                                                  Bulgaria, Cyprus, Czech Republic,                       approving the importation of certain
                                                                                                                                                                   We appreciate the commenter’s
                                                  Estonia, Hungary, India, Korea                          fruits and vegetables that, based on the
                                                                                                                                                                concern regarding irradiation of the figs
                                                  (Republic of), Latvia, Liechtenstein,                   findings of a pest risk analysis, can be
                                                                                                                                                                in areas of the United States where
                                                  Luxembourg, Malta, Portugal, Slovakia,                  safely imported subject to one or more
                                                                                                                                                                quarantine plant pests that could
                                                  and Switzerland.                                        of the designated phytosanitary
                                                                                                                                                                potentially follow the pathway of
                                                    Authority: 7 U.S.C. 1622 and 8301–8317;               measures listed in paragraph (b) of that
                                                                                                                                                                importation of the figs from Peru could
                                                  21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7               section.
                                                                                                                                                                become established. Indeed, our
                                                  CFR 2.22, 2.80, and 371.4.                                 In accordance with that process, we
                                                                                                                                                                regulations governing the approval of
                                                    Done in Washington, DC, this 4th day of               published a notice 1 in the Federal
                                                                                                                                                                irradiation facilities in the United
                                                  August, 2016.                                           Register on March 14, 2016 (81 FR
                                                                                                                                                                States, which are found in 7 CFR 305.9,
                                                  Kevin Shea,                                             13310–13311, Docket No. APHIS–2016–
                                                                                                                                                                require that, if an irradiation facility is
                                                  Administrator, Animal and Plant Health                  0011), in which we announced the
                                                                                                                                                                located in a State where quarantine
                                                  Inspection Service.                                     availability, for review and comment, of
                                                                                                                                                                pests that are targeted by irradiation
                                                                                                          a pest risk assessment (PRA) that
                                                  [FR Doc. 2016–18985 Filed 8–9–16; 8:45 am]                                                                    could become established, then it must
                                                                                                          identifies pests of quarantine
                                                  BILLING CODE 3410–34–P                                                                                        take additional safeguards, specified
                                                                                                          significance that could follow the
                                                                                                                                                                within that section, in order to address
                                                                                                          pathway of importation of figs from
                                                                                                                                                                this pest risk. However, because § 305.9
                                                  DEPARTMENT OF AGRICULTURE                               Peru into the continental United States.
                                                                                                                                                                also allows irradiation treatment for
                                                                                                          Based on the PRA, a risk management
                                                                                                                                                                imported commodities to take place
                                                  Animal and Plant Health Inspection                      document (RMD) was prepared to
                                                                                                                                                                within the United States, and does not
                                                  Service                                                 identify phytosanitary measures that
                                                                                                                                                                preclude it from taking place in States
                                                                                                          could be applied to the figs to mitigate
                                                  [Docket No. APHIS–2016–0011]                                                                                  where establishment of quarantine pests
                                                                                                          the pest risk. The RMD recommended
                                                                                                                                                                is possible, such as areas south of the
                                                  Notice of Decision To Authorize the                     that all of the following phytosanitary
                                                                                                                                                                39th parallel, we cannot grant the
                                                  Importation of Fresh Figs From Peru                     measures be applied to the importation
                                                                                                                                                                commenter’s request.
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                                                  Into the Continental United States                      of figs from Peru into the continental
                                                                                                                                                                   Therefore, in accordance with
                                                                                                          United States:
                                                                                                                                                                § 319.56–4(c)(2)(ii), we are announcing
                                                  AGENCY:  Animal and Plant Health                           • The figs must be imported as
                                                  Inspection Service, USDA.                                                                                     our decision to authorize the
                                                                                                          commercial consignments only;
                                                  ACTION: Notice.
                                                                                                                                                                importation of figs from Peru into the
                                                                                                            1 To view the notice, PRA, RMD, and comments        continental United States subject to all
                                                  SUMMARY:  We are advising the public of                 we received, go to http://www.regulations.gov/        of the following phytosanitary
                                                  our decision to authorize the                           #!docketDetail;D=APHIS-2016-0011.                     measures:


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Document Created: 2016-08-10 01:59:42
Document Modified: 2016-08-10 01:59:42
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactDr. 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 Citation81 FR 52811 

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