[Federal Register Volume 78, Number 6 (Wednesday, January 9, 2013)]
[Rules and Regulations]
[Pages 1718-1723]
From the Federal Register Online via the Government Publishing 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