[Federal Register Volume 78, Number 6 (Wednesday, January 9, 2013)]
[Rules and Regulations]
[Pages 1718-1723]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00208]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 77
[Docket No. APHIS-2012-0087]
Approved Tests for Bovine Tuberculosis in Cervids
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Interim rule and request for comments.
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SUMMARY: We are adding the CervidTB Stat-Pak[supreg] and DPP[supreg]
tests as official tuberculosis tests for the following species of
captive cervids: Elk, red deer, white-tailed deer, fallow deer, and
reindeer. We are taking this action because we have determined that the
tests can reliably detect the presence or absence of antibodies to
bovine tuberculosis in certain species of captive cervids. This action
is necessary on an immediate basis in order to provide regulated
entities with more options in order to meet the testing requirements
for captive cervids within the regulations.
DATES: This interim rule is effective January 9, 2013. We will consider
all comments that we receive on or before March 11, 2013.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to: http://www.regulations.gov/#!documentDetail;D=APHIS-2012-0087-0001.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2012-0087, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
Supporting documents and any comments we receive on this docket may
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2012-
0087 or in our reading room, which is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 799-7039 before coming.
FOR FURTHER INFORMATION CONTACT: Dr. C. William Hench, Senior Staff
Veterinarian, Eradication and Surveillance Team, National Center for
Animal Health Programs, VS, APHIS, 2150 Centre Avenue, Building B-3E20,
Fort Collins, CO 80526-8117; (970) 494-7378.
SUPPLEMENTARY INFORMATION:
Background
Bovine tuberculosis is a contagious and infectious granulomatous
disease caused by the bacterium Mycobacterium bovis. Although commonly
defined as a chronic debilitating disease, bovine tuberculosis can
occasionally assume an acute, rapidly progressive course. While any
body tissue can be affected, lesions are most frequently observed in
the lymph nodes, lungs, intestines, liver, spleen, pleura, and
peritoneum. Although cattle are considered to be the true hosts of M.
bovis, the disease has been reported in several other species of
livestock, most notably bison and captive cervids. There have also been
instances of infection in other domestic and nondomestic animals, as
well as in humans.
Through the National Cooperative State/Federal Bovine Tuberculosis
Eradication Program, the Animal and Plant Health Inspection Service
(APHIS) of the United States Department of Agriculture (USDA) works
cooperatively with the Nation's livestock industry and State animal
health agencies to eradicate bovine tuberculosis from domestic
livestock in the United States and prevent its recurrence.
Federal regulations implementing this program are contained in 9
CFR part 77, ``Tuberculosis'' (referred to below as the regulations)
and in the ``Uniform Methods and Rules--Bovine Tuberculosis
Eradication,'' which is incorporated by reference within the
regulations. The regulations restrict the interstate movement of
cattle, bison, and captive cervids to prevent the spread of bovine
tuberculosis. Subpart C of the regulations (Sec. Sec. 77.20 to 77.41,
referred to below as the captive cervid regulations) addresses captive
cervids.
Currently, in the captive cervid regulations, there are several
instances in which we require captive cervids to be tested with an
official tuberculosis test. For example, in Sec. 77.35, in order for a
herd of captive cervids to be recognized as accredited, all cervids in
the herd must have tested negative to at least two consecutive official
tuberculosis tests, conducted at 9 to 15 month intervals, with certain,
limited exceptions.
In Sec. 77.20 of the captive cervid regulations, the definition of
official tuberculosis test has provided that the single cervical
tuberculin (SCT) test, a primary test, and comparative cervical
tuberculin (CCT) test, a supplemental test, are recognized by APHIS as
official tuberculosis tests, provided that they are applied and
reported in accordance with the captive cervid regulations.
In the same section, the definitions of single cervical tuberculin
(SCT) test and comparative cervical tuberculin (CCT) test provide how
to apply each test; the sequence in which the tests should be
administered and the manner in which test results should be interpreted
are specified in Sec. 77.34. The individuals who may administer each
test and the reporting requirements for each test are found in Sec.
77.33.
We recently received a request to evaluate the CervidTB Stat-
Pak[supreg] test, a primary test, and Dual Path Platform (DPP)[supreg]
test, a supplemental test, as official tests for bovine tuberculosis in
the following species of captive cervids: Elk, red deer, white-tailed
deer, fallow deer, and reindeer. Based on our evaluation, we have
determined that the tests can reliably detect the presence or absence
of antibodies to bovine tuberculosis in these species of captive
cervids. Accordingly, we are amending the captive cervid regulations to
recognize these two tests as official tuberculosis tests. We discuss
these amendments immediately below, by section.
Definitions (Sec. 77.20)
As we mentioned previously, prior to issuance of this interim rule,
the definition of official tuberculosis test in Sec. 77.20 of the
captive cervid regulations specified that only the SCT and CCT tests
are official tuberculosis tests. We are amending the definition of
official tuberculosis test so that it specifies that the CervidTB Stat-
Pak[supreg] and DPP[supreg] tests are also official tuberculosis tests.
We are also adding definitions of CervidTB Stat-Pak[supreg] test
and Dual Path Platform (DPP[supreg]) test to Sec. 77.20. We are
defining CervidTB Stat-Pak[supreg] test as: ``A serological assay to
determine the presence of antibodies to bovine tuberculosis (M. bovis)
in elk, red deer, white-tailed deer, fallow deer, and
[[Page 1719]]
reindeer, in which a blood sample taken from a captive cervid is placed
on a strip containing an antibody-detecting reagent. The sample is then
diluted by using a buffer solution. Once sufficient time has elapsed,
the strip indicates if antibodies are present in the sample.'' We are
defining Dual Path Platform (DPP[supreg]) test as: ``A serological
assay to determine the presence of antibodies to bovine tuberculosis
(M. bovis) in elk, red deer, white-tailed deer, fallow deer, and
reindeer, in which a blood sample taken from a captive cervid and a
buffer solution are placed on a strip. The diluted sample then migrates
to another strip, which contains an antibody-detecting reagent. This
latter strip indicates if antibodies are present in the sample.''
The definition of designated accredited veterinarian in Sec. 77.20
has stated that a designated accredited veterinarian is an accredited
veterinarian who is trained and approved by cooperating State and
Federal animal health officials to conduct the SCT test on captive
cervids. As we discuss at greater length below, we are also allowing
designated accredited veterinarians to draw the blood samples needed
for the CervidTB Stat-Pak[supreg] and DPP[supreg] tests. Accordingly,
we are amending the definition of designated accredited veterinarian to
specify that designated accredited veterinarians may draw such samples.
Finally, prior to issuance of this interim rule, the definitions of
negative, reactor, and suspect in Sec. 77.20 presupposed that only the
SCT and CCT tests are official tuberculosis tests for purposes of
classifying captive cervids according to these classifications. We are
amending these definitions to reflect that the CervidTB Stat-
Pak[supreg] and DPP[supreg] tests are now also considered official
tuberculosis tests for such purposes.
Testing Procedures for Tuberculosis in Captive Cervids (Sec. 77.33)
Section 77.33 of the captive cervid regulations specifies, among
other things, who may administer official tuberculosis tests, which
diagnostic laboratories have been approved by APHIS, the reporting
requirements for each test, and how the tests will be interpreted.
Paragraph (a) of Sec. 77.33 provides the approved testers for each
official tuberculosis test. Prior to issuance of this interim rule, the
section had specified that official tuberculosis tests may only be
given by a veterinarian employed by the State in which the test is
administered or by a veterinarian employed by USDA, except that
designated accredited veterinarians, for whom correct application of
the SCT test is part of their accreditation training, could conduct the
SCT test. Because collecting blood samples is also part of such
training, and because both the CervidTB Stat-Pak[supreg] and
DPP[supreg] test are serological assays that rely on blood samples, we
are amending paragraph (a) of Sec. 77.33 to specify that designated
accredited veterinarians may also draw blood for the CervidTB Stat-
Pak[supreg] or DPP[supreg] test. The veterinarian who draws the sample
will then ship it to the National Veterinary Services Laboratories
(NVSL) in Ames, IA, for testing using these tests.
(Paragraph (b) of Sec. 77.33 specifies that, with one, limited
exception, histopathology and culture results for all tuberculosis
diagnoses will only be accepted from NVSL. While we recognize that both
the CervidTB Stat-Pak[supreg] and DPP[supreg] tests could be
administered outside of NVSL, we would need to evaluate any use of the
tests outside of NVSL at length in order to assess the likely
reliability of test results for tests administered in such a manner.
Pending the conclusion of such evaluations, we will require the tests
to be administered by NVSL.)
Paragraph (d) of Sec. 77.33 provides reporting requirements for
the various official tuberculosis tests for captive cervids. Paragraph
(d)(1) of Sec. 77.33 contains reporting requirements for the SCT and
CCT tests. A number of these reporting requirements pertain only to
tests that are intradermally administered and require interpretation of
palpation at the injection site, as both the SCT and CCT tests are, and
are thus not applicable to the CervidTB Stat-Pak[supreg] and
DPP[supreg] tests.
Accordingly, we are adding a paragraph (d)(2) to Sec. 77.33. This
paragraph provides that, for the CervidTB Stat-Pak[supreg] and
DPP[supreg] tests, the veterinarian who draws blood from the captive
cervid must submit a request to NVSL to perform the CervidTB Stat-
Pak[supreg] and, if necessary, the DPP[supreg] test on the blood
sample.
The request must be on a form specified by APHIS for such requests.
The form, currently Veterinary Services (VS) form 10-4, ``Specimen
Submission,'' is available at: http://www.aphis.usda.gov/library/forms/#vs. The completed form, including appendices, must be sent along with
the blood samples to the address provided by NVSL on their Web site,
http://www.aphis.usda.gov/animal_health/lab_info_services/about_nvsl.shtml. The veterinarian must also fill out the relevant portions
of a test record; this record is currently VS form 6-22, ``Tuberculosis
Test Record.'' The form may be obtained by contacting the local area VS
office, information regarding which is available at http://www.aphis.usda.gov/animal_health/area_offices/. This record must be
sent to the offices of the State and Federal animal health officials in
the State.
Paragraph (e) of Sec. 77.33 contains information regarding
interpretation of test results. We are amending paragraph (e) to
specify that interpretation of CervidTB Stat-Pak[supreg] and
DPP[supreg] test results will be in accordance with the relevant
paragraphs of Sec. 77.34.
Official Tuberculosis Tests (Sec. 77.34)
As we mentioned previously, Sec. 77.34 of the captive cervid
regulations contains requirements regarding the sequence in which
official tuberculosis tests should be administered and the manner in
which test results should be interpreted for purposes of the captive
cervid regulations. Requirements regarding the SCT test, a primary test
for tuberculosis, are contained in paragraph (a) of Sec. 77.34;
requirements regarding the CCT, a supplemental test, are in paragraph
(b). We are adding requirements regarding the CervidTB Stat-Pak[supreg]
test, a primary test, to paragraph (a) of Sec. 77.34, and requirements
regarding the DPP[supreg] test, a supplemental test, to paragraph (b).
As amended, paragraph (a) of Sec. 77.34 specifies that the
CervidTB Stat-Pak[supreg] test is a primary test that may be used in
individual captive elk, red deer, white-tailed deer, fallow deer, and
reindeer, and in herds of these species that are of unknown tuberculous
status. It further requires, with limited exceptions, that each captive
cervid that has non-negative test results to the CervidTB Stat-
Pak[supreg] test must be classified as a suspect and retested with the
DPP[supreg] test; a captive cervid that has non-negative test results
to the CervidTB Stat-Pak[supreg] test must not be retested using the
SCT or CCT test. (We are also adding reciprocal language to the
paragraph to specify that each captive cervid that responds to the SCT
test must not be retested with the CervidTB Stat-Pak[supreg] or
DPP[supreg] tests.) Finally, it allows the CervidTB Stat-Pak[supreg]
test to be used in affected herds of captive elk, red deer, white-
tailed deer, fallow deer, and reindeer, and in herds of these species
that have received captive cervids from an affected herd; in such
instances, each captive cervid that has non-negative test results to
the CervidTB Stat-Pak[supreg] test must be classified as a reactor,
unless the designated tuberculosis epidemiologist (DTE), the State or
Federal epidemiologist designated by the Administrator of APHIS to make
[[Page 1720]]
decisions concerning the interpretation of diagnostic tests in a State,
determines that the captive cervid should be classified as a suspect
because of possible exposure to a tuberculous animal. This is
consistent with our current protocol for interpretation of test results
for SCT tests administered to captive cervids from such herds.
We are specifying that most captive cervids that have non-negative
test results to the CervidTB Stat-Pak[supreg] test must be classified
as suspects and retested using the DPP[supreg] test. This is because of
the nature of the CervidTB Stat-Pak[supreg] test. The CervidTB Stat-
Pak[supreg] test produces results that indicate the presence or absence
of antibodies for bovine tuberculosis in blood drawn from a captive
cervid. It does not, however, indicate the level at which these
antibodies have been determined to be present in the blood. Moreover,
because the CervidTB Stat-Pak[supreg] test does not have a specificity
level of 100 percent, there is a degree of uncertainty regarding non-
negative test results provided by the test.
We are requiring that this corroboratory testing use the
DPP[supreg] test because both the CervidTB Stat-Pak[supreg] and the
DPP[supreg] are serological tests that can be conducted in succession
within a laboratory environment, and because the specificity of the
DPP[supreg] test, in conjunction with the sensitivity of the CervidTB
Stat-Pak[supreg], gives us a high degree of confidence regarding our
ultimate determination of the tested cervid's disease status.
As amended, paragraph (b) of Sec. 77.34 specifies that the
DPP[supreg] test is a supplemental test that may only be used in order
to retest captive cervids that have been classified as suspects after
being tested with the CervidTB Stat-Pak[supreg] test, and may not be
used as a primary test. It further specifies that a captive cervid that
has non-negative test results to its first DPP[supreg] test must be
classified as a suspect, unless the DTE determines, based on
epidemiological evidence, that the captive cervid should be classified
as a reactor.
A captive cervid classified as a suspect on its first DPP[supreg]
test may be retested using the DPP[supreg] test to evaluate a new blood
sample drawn from the cervid no less than 30 days after this first
DPP[supreg] test. A captive cervid that has non-negative test results
on two successive DPP[supreg] tests must be classified as a reactor.
If a captive cervid has non-negative test results to its first
DPP[supreg] test and is classified as a suspect, the owner of the
cervid will have the option of having the cervid taken for slaughter or
necropsy for a final determination of status or of having the cervid
retested, using the DPP[supreg] test, no less than 30 days later. (In
the intervening period, a quarantine of the herd will remain in effect
prohibiting the interstate movement of captive cervids from the herd.
We discuss this at greater length later in this document.) If the
cervid again has non-negative test results to the DPP[supreg] test
after 30 days, it is reasonable to classify the cervid as a reactor.
This is consistent with our current policy for captive cervids that
have non-negative test results to the CCT test.
Interstate Movements (Sec. 77.39)
Section 77.39 of the captive cervid regulations contains
restrictions on the interstate movement of captive cervid herds
involved in an epidemiological investigation or subject to affected
herd management.
Paragraph (a) of Sec. 77.39 contains restrictions on the
interstate movement of herds containing a cervid classified as a
suspect. Paragraph (a)(1) of Sec. 77.39 contains restrictions on the
movement of the suspect itself. We are amending paragraph (a)(1) to
specify that, if a captive cervid is classified as a suspect on the
CervidTB Stat-Pak[supreg] test, it must be quarantined until it is
slaughtered or retested and found negative for tuberculosis based on
the DPP[supreg] test. It further specifies that, if a captive cervid is
classified as a suspect on an initial DPP[supreg] test, it must be
slaughtered or quarantined for no less than 30 days and retested using
the DPP[supreg] test. If it has non-negative test results to this
second DPP[supreg] test, it must be classified as a reactor, with the
attendant movement restrictions of such a classification.
We are requiring cervids classified as suspects to be quarantined
because any cervid classified as a suspect may potentially be infected
with bovine tuberculosis. Allowing its interstate movement other than
directly to slaughter or necropsy may contribute to the spread of
tuberculosis.
Paragraph (a)(2) of Sec. 77.39 contains restrictions on the
interstate movement of all other cervids in a herd that contains a
suspect. Prior to issuance of this interim rule, the paragraph had
specified that a herd containing a suspect must remain under quarantine
until the suspect is retested using a supplemental test or is inspected
at slaughter or necropsied and found negative. However, it did not
specify that the DPP[supreg] test is one of the supplemental tests that
may be administered to the animal. We are amending paragraph (a)(2)
accordingly.
Paragraph (e) of Sec. 77.39 contains restrictions on the
interstate movement of herds that have received captive cervids from an
affected herd. Prior to issuance of this interim rule, the introductory
text of the paragraph had specified that if a herd receives captive
cervids from an affected herd, the receiving herd must be placed under
quarantine, and the captive cervids from the affected herd of origin
must be considered exposed to tuberculosis, and must be slaughtered,
necropsied, or tested with the SCT test. We are amending the paragraph
so that it provides that the exposed cervids may also be tested using
the CervidTB Stat-Pak[supreg] test.
Paragraph (e)(3) of Sec. 77.39 has provided that, if all these
exposed captive cervids test negative for tuberculosis, the receiving
herd may be released from quarantine, but must be retested with the SCT
test 1 year after release from quarantine in order for captive cervids
from the herd to continue to be moved interstate. We are amending the
paragraph so that it also allows the cervids to be retested using the
CervidTB Stat-Pak[supreg] test.
Paragraph (f) of Sec. 77.39 contains restrictions on the movement
of captive cervids from herds suspected of being the source of
tuberculosis. Prior to issuance of this interim rule, the paragraph had
specified the restrictions that must be placed on the herd if any of
the captive cervids in the herd respond to the SCT test. The paragraph
now also specifies the restrictions that must be placed on the herd if
any of the animals in the herd have non-negative test results to the
CervidTB Stat-Pak[supreg] test.
Immediate Action
Immediate action is warranted to provide regulated entities who
must have their captive cervids tested in order to comply with the
captive cervid regulations with additional testing options. Under these
circumstances, the Administrator has determined that prior notice and
opportunity for public comment are contrary to the public interest and
that there is good cause under 5 U.S.C. 553 for making this rule
effective less than 30 days after publication in the Federal Register.
We will consider comments we receive during the comment period for
this interim rule (see DATES above). After the comment period closes,
we will publish another document in the Federal Register in which we
will respond to the comments we receive and finalize or, as necessary,
revise the provisions of this interim rule.
[[Page 1721]]
Executive Order 12866 and Regulatory Flexibility Act
This interim rule is subject to Executive Order 12866. However, for
this action, the Office of Management and Budget has waived its review
under Executive Order 12866.
In accordance with the Regulatory Flexibility Act, we have analyzed
the potential economic effects of this action on small entities.
This rule adds the CervidTB Stat-Pak[supreg] and DPP[supreg] tests
as official tuberculosis tests for captive cervids. The current
official tuberculosis tests are the SCT and CCT tests. It is APHIS
policy that owners are responsible for assuming the costs associated
with primary official tuberculosis tests for bovine tuberculosis in
captive cervids; the Agency assumes the cost of corroboratory testing.
Bovine tuberculosis testing using the SCT test, including veterinary
fees, costs about $10 to $15 per head. We have estimated bovine
tuberculosis testing using the CervidTB Stat-Pak[supreg] test,
including veterinary fees, to cost approximately $13 to $15 per head.
Owners of captive cervids will not be required to now use the CervidTB
Stat-Pak[supreg] test instead of the SCT test, but may choose to do so
if they determine such use to be cost-effective for their operations.
That being said, we do anticipate that producers may, in certain
instances, experience benefits because of the availability of the
CervidTB Stat-Pak[supreg] and DPP[supreg] tests as official
tuberculosis tests for captive cervids. This is because of the nature
of the CervidTB Stat-Pak[supreg] and DPP[supreg] tests. As serological
tests, they are relatively easy to administer, in comparison to the SCT
and CCT tests, and do not require the animals to be held for a
significant period of time while the test is applied. There is thus a
lower risk of misapplication of the tests and morbidity due to handling
of the animals during application.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. It has no preemptive effect.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this rule have been submitted
for approval to the Office of Management and Budget (OMB). Please send
written comments to the Office of Information and Regulatory Affairs,
OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please
state that your comments refer to Docket No. APHIS-2012-0087. Please
send a copy of your comments to: (1) Docket No. APHIS-2012-0087,
Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700
River Road, Unit 118, Riverdale, MD 20737-1238, and (2) Clearance
Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue
SW., Washington, DC 20250. A comment to OMB is best assured of having
its full effect if OMB receives it within 30 days of publication of
this rule.
This rule requires individuals who wish to have their cervids
tested to fill out an application.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology; e.g., permitting electronic
submission of responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average 0.13 hours per response.
Respondents: Captive cervid producers.
Estimated annual number of respondents: 975.
Estimated annual number of responses per respondent: 2.
Estimated annual number of responses: 1,950.
Estimated total annual burden on respondents: 253 hours. (Due to
averaging, the total annual burden hours may not equal the product of
the annual number of responses multiplied by the reporting burden per
response.)
Copies of this information collection can be obtained from Mrs.
Celeste Sickles, APHIS' Information Collection Coordinator, at (301)
851-2908.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the Internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this rule, please contact Mrs. Celeste Sickles,
APHIS' Information Collection Coordinator, at (301) 851-2908.
List of Subjects in 9 CFR Part 77
Animal diseases, Bison, Cattle, Reporting and recordkeeping
requirements, Transportation, Tuberculosis.
Accordingly, we are amending 9 CFR part 77 as follows:
PART 77--TUBERCULOSIS
0
1. The authority citation for part 77 continues to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
0
2. Section 77.20 is amended as follows:
0
a. In the definition of designated accredited veterinarian, by adding
the words ``or draw blood for the CervidTB Stat-Pak[supreg] test and
DPP[supreg] test'' after the words ``(SCT) test'';
0
b. In the definitions of negative, reactor, and suspect, by removing
the words ``the SCT test or the CCT test,'' and adding the words ``an
official tuberculosis test'' in their place;
0
c. By revising the definition of official tuberculosis test; and
0
d. By adding, in alphabetical order, definitions of CervidTB Stat-
Pak[supreg] test and Dual Path Platform (DPP[supreg]) test.
The revision and additions read as follows:
Sec. 77.20 Definitions.
* * * * *
CervidTB Stat-Pak[supreg] test. A serological assay to determine
the presence of antibodies to bovine tuberculosis (M.
[[Page 1722]]
bovis) in elk, red deer, white-tailed deer, fallow deer, and reindeer,
in which a blood sample taken from a captive cervid is placed on a
strip containing an antibody-detecting reagent. The sample is then
diluted by using a buffer solution. Once sufficient time has elapsed,
the strip indicates if antibodies are present in the sample.
* * * * *
Dual Path Platform (DPP[supreg]) test. A serological assay to
determine the presence of antibodies to bovine tuberculosis (M. bovis)
in elk, red deer, white-tailed deer, fallow deer, and reindeer, in
which a blood sample taken from a captive cervid and a buffer solution
are placed on a strip. The diluted sample then migrates to another
strip, which contains an antibody-detecting reagent. This latter strip
indicates if antibodies are present in the sample.
* * * * *
Official tuberculosis test. Any of the following tests for bovine
tuberculosis in captive cervids, applied and reported in accordance
with this part:
(1) The single cervical tuberculin (SCT) test.
(2) The comparative cervical tuberculin test (CCT) test.
(3) The CervidTB Stat-Pak[supreg] test.
(4) The Dual Path Platform (DPP[supreg]) test.
* * * * *
0
3. Section 77.33 is amended as follows:
0
a. In paragraph (a), introductory text, by removing the words
``paragraph (a)(1)'' and adding the words ``paragraphs (a)(1) or
(a)(2)'' in their place;
0
b. In paragraph (a)(1), by removing the words ``in Sec. 77.34(a)(2)''
and adding the words ``in Sec. 77.34(a)(1)(ii)'' in their place;
0
c. By adding a new paragraph (a)(2);
0
d. By adding a new paragraph (d)(2); and
0
e. By adding new paragraphs (e)(3) and (e)(4).
The additions read as follows:
Sec. 77.33 Testing procedures for tuberculosis in captive cervids.
(a) * * *
(2) A designated accredited veterinarian may draw blood for the
CervidTB Stat-Pak[supreg] or DPP[supreg] test.
* * * * *
(d) * * *
(2) CervidTB Stat-Pak[supreg] and DPP[supreg] test. For the
CervidTB Stat-Pak[supreg] and DPP[supreg] test, the veterinarian who
draws blood from the captive cervid must submit a form specified by
APHIS for such requests to NVSL to perform the CervidTB Stat-
Pak[supreg] and, if necessary, DPP[supreg] test on the blood sample.
The form is available at http://www.aphis.usda.gov/library/forms/#vs.
The completed form, including any appendices, must be sent along with
the blood samples to the address provided at the following Web site:
http://www.aphis.usda.gov/animal_health/lab_info_services/about_nvsl.shtml. The veterinarian must also fill out the relevant portions
of a test record. This form may be obtained by contacting the local
area VS office, information regarding which is available at http://www.aphis.usda.gov/animal_health/area_offices/. This record must be
sent to the offices of the State and Federal animal health officials in
the State.
(e) * * *
(3) Interpretation of CervidTB Stat-Pak[supreg] test results will
be in accordance with the classification requirements described in
Sec. 77.34(a).
(4) Interpretation of DPP[supreg] test results will be in
accordance with the classification requirements described in Sec.
77.34(b).
* * * * *
0
4. Section 77.34 is revised to read as follows:
Sec. 77.34 Official tuberculosis tests.
(a) Primary tests. (1) Single cervical tuberculin (SCT) test. (i)
The SCT test is a primary test that may be used in individual captive
cervids and in herds of unknown tuberculous status. Each captive cervid
that responds to the SCT test must be classified as a suspect until it
is retested with the CCT test and is either found negative for
tuberculosis or is classified as a reactor, unless, with exception of a
designated accredited veterinarian, the testing veterinarian determines
that the captive cervid should be classified as a reactor based on its
response to the SCT test. A designated accredited veterinarian must
classify a responding captive cervid as a suspect, unless the DTE
determines, based on epidemiological evidence, that the captive cervid
should be classified as a reactor. A captive cervid that responds to
the SCT test must not be retested using the CervidTB Stat-Pak[supreg]
or DPP[supreg] tests.
(ii) The SCT test is a primary test that may be used in affected
herds and in herds that have received captive cervids from an affected
herd. When used with affected herds or in herds that have received a
captive cervid from an affected herd, the SCT test may only be
administered by a veterinarian employed by the State in which the test
is administered or employed by USDA. In affected herds or herds that
have received captive cervids from an affected herd, each captive
cervid that responds to the SCT test must be classified as a reactor,
unless the DTE determines, based on epidemiological evidence, that the
cervid should be classified as a suspect because of possible exposure
to a tuberculous animal.
(2) CervidTB Stat-Pak[supreg] test. (i) The CervidTB Stat-
Pak[supreg] test is a primary test that may be used in individual
captive elk, red deer, white-tailed deer, fallow deer, and reindeer,
and in herds of these species that are of unknown tuberculous status.
Except as specified in paragraph (a)(2)(ii) of this section, each
captive cervid that has non-negative test results to the CervidTB Stat-
Pak[supreg] test must be classified as a suspect and retested with the
DPP[supreg] test. A captive cervid that has non-negative test results
to the CervidTB Stat-Pak[supreg] test must not be retested using the
SCT or CCT test.
(ii) The CervidTB Stat-Pak[supreg] test is a primary test that may
be used in affected herds of captive elk, red deer, white-tailed deer,
fallow deer, and reindeer, and in herds of these species that have
received captive cervids from an affected herd. In such herds, each
captive cervid that has non-negative test results to the CervidTB Stat-
Pak[supreg] test must be classified as a reactor, unless the DTE
determines that the captive cervid should be classified as a suspect
because of possible exposure to a tuberculous animal.
(b) Supplemental tests. (1) Comparative cervical tuberculin (CCT)
test.
(i) The CCT test is a supplemental test that may only be used in
order to retest captive cervids that have been classified as suspects
after being tested with the SCT test. The CCT test may be used in
affected herds only after the herd has tested negative to at least two
whole herd SCT tests and only with the prior written consent of the
DTE. The CCT test may not be used as a primary test.
(ii) A captive cervid tested with the CCT test must be classified
as negative if it has a response to the bovine PPD tuberculin that is
less than 1 mm.
(iii) Unless the testing veterinarian determines that the captive
cervid should be classified as a reactor because of possible exposure
to a tuberculous animal, a captive cervid tested with the CCT test must
be classified as a suspect if:
(A) It has a response to the bovine PPD tuberculin that is greater
than 2 mm and that is equal to the response to the avian PPD
tuberculin; or
(B) It has a response to the bovine PPD tuberculin that is equal to
or greater than 1 mm and equal to or less than 2 mm and that is equal
to or greater than
[[Page 1723]]
the response to the avian PPD tuberculin.
(iv) A captive cervid tested with the CCT test must be classified
as a reactor if:
(A) It has a response to the bovine PPD tuberculin that is greater
than 2 mm and that is at least 0.5 mm greater than the response to the
avian PPD tuberculin; or
(B) It has been classified as a suspect on two successive CCT
tests.
(C) Any exceptions to the reactor classification under the
conditions in paragraph (b)(1)(iv) of this section must be justified by
the testing veterinarian in writing and have the concurrence of the
DTE.
(2) Dual Path Platform (DPP[supreg]) test. (i) The DPP[supreg] test
is a supplemental test that may only be used in order to retest captive
cervids that have been classified as suspects after being tested with
the CervidTB Stat-Pak[supreg] test. The DPP[supreg] test may not be
used as a primary test.
(ii) A captive cervid that has non-negative test results to its
first DPP[supreg] test must be classified as a suspect, unless the DTE
determines, based on epidemiological evidence, that the captive cervid
should be classified as a reactor. A captive cervid classified as a
suspect on its first DPP[supreg] test may be retested using the
DPP[supreg] test to evaluate a new blood sample drawn from the cervid
no less than 30 days after this first DPP[supreg] test.
(iii) A captive cervid that has non-negative test results on two
successive DPP[supreg] tests must be classified as a reactor.
0
5. Section 77.39 is amended as follows:
0
a. By adding new paragraphs (a)(1)(iii) and (a)(1)(iv);
0
b. In paragraph (a)(2), by removing the words ``CCT test or the BTB
test'' and adding the words ``CCT test, DPP[supreg] test, or the BTB
test'' in their place;
0
c. By revising paragraph (e), introductory text;
0
d. By revising paragraph (e)(3);
0
e. By revising paragraph (f)(1); and
0
f. In paragraph (f)(2), by adding the words ``or the CervidTB Stat-
Pak[supreg] test'' after the words ``SCT test''.
The revisions and additions read as follows:
Sec. 77.39 Other interstate movements.
(a) * * *
(1) * * *
(iii) A captive cervid classified as a suspect on the CervidTB
Stat-Pak[supreg] test must be quarantined until it is slaughtered or
retested using the DPP[supreg] test and found negative for tuberculosis
based on the DPP[supreg] test.
(iv) A captive cervid classified as a suspect on an initial
DPP[supreg] test must be slaughtered or otherwise must be quarantined
until it is retested using the DPP[supreg] test. A captive cervid that
has negative test results to this second DPP[supreg] test may be
released from quarantine. A captive cervid that has non-negative test
results to this second DPP[supreg] test must be classified as a reactor
and may only be moved in accordance with paragraph (b) of this section.
* * * * *
(e) Herds that have received captive cervids from an affected herd.
If a herd has received captive cervids from an affected herd, the
captive cervids from the affected herd of origin will be considered
exposed to tuberculosis. The exposed captive cervids and the receiving
herd must be quarantined. The exposed captive cervids must be
slaughtered, necropsied, or tested with the SCT test by a veterinarian
employed by the State in which the test is administered or employed by
USDA, or tested with the CervidTB Stat-Pak[supreg] test. Any exposed
captive cervid that responds to the SCT test must be classified as a
reactor and must be inspected at slaughter or necropsied. Any exposed
captive cervid that has non-negative test results to the CervidTB Stat-
Pak[supreg] test must be classified as a reactor and must be inspected
at slaughter or necropsied. Any exposed captive cervid that tests
negative to the SCT or CervidTB Stat-Pak[supreg] test will be
considered as part of the affected herd of origin for purposes of
testing, quarantine, and the five annual whole herd tests required for
affected herds in paragraph (d) of this section.
* * * * *
(3) If all the exposed captive cervids test negative for
tuberculosis, the receiving herd will be released from quarantine if it
is given a whole herd test and is found negative for tuberculosis and
will return to the herd classification in effect before the herd was
quarantined. In addition, the receiving herd will must be retested with
the SCT or CervidTB Stat-Pak[supreg] test 1 year after release from
quarantine in order for captive cervids from the herd to continue to be
moved interstate. Supplemental diagnostic tests may be used if any
captive cervids in the herd show a response to the SCT test or have
non-negative test results to the CervidTB Stat-Pak[supreg] test.
(f) * * *
(1) If the herd is identified as the source of captive cervids
having lesions of tuberculosis and M. bovis has been confirmed by
bacterial isolation from the slaughter animal, all captive cervids in
the herd that respond to the SCT must be classified as reactors. All
captive cervids in the herd that respond to the CervidTB Stat-
Pak[supreg] test must be classified as reactors. If none respond to the
SCT test or have non-negative test results to the CervidTB Stat-
Pak[supreg] test, the herd may be released from quarantine and will
return to the herd classification status in effect before the herd was
quarantined, unless the DTE determines that additional testing is
appropriate to ensure the herd's freedom from tuberculosis.
* * * * *
Done in Washington, DC, this 2nd day of January 2013.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-00208 Filed 1-8-13; 8:45 am]
BILLING CODE 3410-34-P