[Federal Register Volume 79, Number 145 (Tuesday, July 29, 2014)]
[Rules and Regulations]
[Pages 43923-43927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17877]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 77
[Docket No. APHIS-2014-0027]
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 amending the regulations regarding official
tuberculosis tests for captive cervids to remove the CervidTB Stat-
Pak[supreg] as an official bovine tuberculosis test for the following
species of captive cervids: Elk, red deer, white-tailed deer, fallow
deer, and reindeer. We are also amending the regulations to specify
that the Dual Path Platform (DPP)[supreg] test, which was previously a
supplemental test to be used in conjunction with the CervidTB Stat-
Pak[supreg], is now considered a primary test, as well. We are taking
this action because the CervidTB Stat-Pak[supreg] is no longer being
produced, and because we have determined that the DPP[supreg] test can
reliably be used as a primary test for bovine tuberculosis in certain
species of captive cervids. This action is necessary on an immediate
basis so that the regulations do not continue to authorize usage of a
discontinued test, yet still provide regulated entities with options in
order to meet the testing requirements for captive cervids within the
regulations.
DATES: This interim rule is effective July 29, 2014. We will consider
all comments that we receive on or before September 29, 2014.
ADDRESSES: You may submit comments by either of the following methods:
[[Page 43924]]
Federal eRulemaking Portal: Go to: http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0027.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2014-0027, 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-2014-
0027 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. Owen Henderson, Senior Staff
Cervid Tuberculosis Disease Specialist, Cervid Health Program, Sheep,
Goat, Cervid, and Equine Health Center, Surveillance, Preparedness, and
Response Services, VS, APHIS, 2150 Centre Avenue, Building B-3-123,
Fort Collins, CO 80526-8117; (970) 494-7317.
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, prior to issuance
of this interim rule, the definition of official tuberculosis test
listed the following as official tests for bovine tuberculosis in
captive cervids:
The single cervical tuberculin (SCT) test, a primary test.
The comparative cervical tuberculin test (CCT) test, a
supplemental test.
The CervidTB Stat-Pak[supreg] test, a primary test.
The Dual Path Platform (DPP[supreg]) test, a supplemental
test.
We specified that the SCT and CCT tests were official tuberculosis
tests for all species of captive cervids in a final rule published in
the Federal Register on December 31, 1998 (63 FR 72104-72129, Docket
No. 92-076-2). We added the CervidTB Stat-Pak[supreg] and DPP[supreg]
tests as official tuberculosis tests for captive elk, red deer, white-
tailed deer, fallow deer, and reindeer in an interim rule \1\ published
in the Federal Register on January 9, 2013 (78 FR 1718-1723, Docket No.
APHIS-2012-0087).
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\1\ To view the interim rule, its supporting documents, or the
comments that we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2012-0087.
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We solicited comments concerning the interim rule for 60 days
ending March 11, 2013. We received 11 comments by that date. They were
from captive cervid producers, an organization representing captive
cervid producers within the United States, and an organization
representing veterinarians within the United States. All commenters
supported the rule.
Since the interim rule was published, however, production of the
CervidTB Stat-Pak[supreg] has been discontinued. For this reason, in
this interim rule, we are amending the captive cervid regulations to
remove the CervidTB Stat-Pak[supreg] from the list of official
tuberculosis tests.
When we were informed that the CervidTB Stat-Pak[supreg] test would
be discontinued, we began to evaluate the possible use of the
DPP[supreg] test as a primary test, with the intent of determining
whether the DPP[supreg] test could be used in lieu of the CervidTB
Stat-Pak[supreg] test once the latter ceased to be produced. We have
determined that it can be used in such a manner. Accordingly, this rule
also amends the captive cervid regulations to establish a testing
protocol in which the DPP[supreg] test is used as both a primary and
supplemental test for bovine tuberculosis in elk, red deer, white-
tailed deer, fallow deer, and reindeer. Below, we discuss the changes
we are making to the captive cervid regulations, 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 listed the
CervidTB StatPak[supreg] as an official tuberculosis test. We are
amending the definition of official tuberculosis test to remove the
CervidTB StatPak[supreg] from the official tuberculosis tests listed in
the definition.
Section 77.20 also provides definitions of each official
tuberculosis test. We are removing the definition of CervidTB Stat-
Pak[supreg].
The definition of designated accredited veterinarian in Sec. 77.20
had stated that, among other things, a designated accredited
veterinarian is an accredited veterinarian who is trained and approved
to draw the blood samples needed for the CervidTB Stat-Pak[supreg] and
DPP[supreg] test. (Both tests are serological.) We are amending the
definition of designated accredited veterinarian to remove reference to
the CervidTB Stat-Pak[supreg] test.
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. We
are removing references to the CervidTB Stat-Pak[supreg] test from this
section. We are also updating the Web addresses provided in paragraph
(d)(2) of the section in light of a recent redesign of APHIS' Web site,
and replacing a reference to ``local area VS offices'' in the same
paragraph with the
[[Page 43925]]
term ``District offices,'' which reflects current Agency terminology.
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 primary tests for
tuberculosis are contained in paragraph (a) of Sec. 77.34;
requirements for supplemental tests in paragraph (b). We are amending
paragraph (a) of Sec. 77.34 to reflect the fact that the CervidTB
Stat-Pak[supreg] test is discontinued, and the DPP[supreg] test may now
be used as a primary test.
As amended, paragraph (a) of Sec. 77.34 specifies that the
DPP[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 specifies that, with limited exceptions, each captive cervid
that has non-negative test results to this initial DPP[supreg] test
will be classified as a suspect and retested with the DPP[supreg] test
no sooner than 30 days; a captive cervid that has non-negative test
results to the DPP[supreg] test must not be retested using the SCT or
CCT test. (We are also amending the paragraph to specify that the each
captive cervid that responds to the SCT test must not be retested with
the DPP[supreg] test.) Finally, it allows the DPP[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 DPP[supreg]
test will be classified as a reactor, unless APHIS determines that the
captive cervid should be classified as a suspect because of possible
exposure to a tuberculous animal.
With minor changes, these requirements for the use of the
DPP[supreg] test as a primary test mirror the requirements that had
previously been in paragraph (a) of Sec. 77.34 regarding use of the
CervidTB Stat-Pak[supreg] test as a primary test. Most of the changes
are editorial; one, which removes a reference to designated
tuberculosis epidemiologists, reflects an organizational restructuring
in APHIS and is discussed in greater detail later in this document.
We are specifying that most captive cervids that have non-negative
test results to the initial DPP[supreg] test must be classified as
suspects and retested no sooner than 30 days later using the
DPP[supreg] test as a supplemental test. By reduplicating the initial
testing conditions to the extent practicable at such an interval, we
have firm confidence in the test results provided by this second
DPP[supreg] test.
As amended, paragraph (b) of Sec. 77.34 specifies that the
DPP[supreg] test may be used as a supplemental test to retest captive
cervids that have been classified as suspects based on an initial
DPP[supreg] test. It further specifies that this supplemental test must
evaluate a serum sample drawn from the cervid no sooner than 30 days
after the initial DPP[supreg] test, and that a captive cervid that has
non-negative test results to two successive DPP[supreg] tests must be
classified as a reactor, unless APHIS determines that another disease
classification is warranted.
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. We are removing references to and provisions regarding
the CervidTB Stat-Pak[supreg] test from this section.
Miscellaneous
Since the January 2013 interim rule to add the CervidTB Stat-
Pak[supreg] and DPP tests to the captive cervid regulations was issued,
the Office of Management and Budget (OMB) has approved the paperwork
associated with that interim rule under the control number 0579-0412.
We are adding a reference to this approval to Sec. 77.33, which
contains the paperwork requirements for which we sought OMB approval.
Additionally, since the interim rule was published, APHIS'
Veterinary Services program has undergone a reorganization. As a result
of this reorganization, APHIS has eliminated the role of designated
tuberculosis epidemiologist (DTE). The functions previously reserved
for DTEs are now performed by various APHIS personnel. As a result, we
are removing references to DTEs from the captive cervid regulations,
and are removing the definition of designated tuberculosis
epidemiologist from Sec. 77.2 of the regulations. We are replacing the
references to DTEs within the captive cervid regulations with
references to APHIS.
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 following
discontinuation of the CervidTB Stat-Pak[supreg] test. 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.
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 removes the CervidTB Stat-Pak[supreg] as an official
tuberculosis test for captive cervids, and establishes a testing
protocol where the DPP[supreg] test may be used in lieu of the CervidTB
Stat-Pak[supreg] test.
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 DPP[supreg] test to
cost approximately $13 to $15 per head. Owners of captive cervids will
not be required to use the DPP[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
DPP[supreg] test as official primary tuberculosis test for captive
cervids. This is because of the nature of the DPP[supreg] test. As a
serological test, it is relatively easy to administer, in comparison to
the SCT and CCT tests, and does 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
[[Page 43926]]
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
This rule contains no new information collection or recordkeeping
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
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.
Sec. 77.2 [Amended]
0
2. Section 77.2 is amended by removing the definition of designated
tuberculosis epidemiologist (DTE).
0
3. Section 77.20 is amended as follows:
0
a. In the definition of designated accredited veterinarian, by removing
the words ``CervidTB Stat-Pak[supreg] test and'';
0
b. By revising the definition of official tuberculosis test; and
0
c. By removing the definition of CervidTB Stat-Pak[supreg] test.
The revision reads as follows:
Sec. 77.20 Definitions.
* * * * *
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 Dual Path Platform (DPP[supreg]) test.
* * * * *
0
4. Section 77.33 is amended as follows:
0
a. In paragraph (a)(2), by removing the words ``CervidTB Stat-
Pak[supreg] or'';
0
b. By revising paragraphs (d)(2) and (e)(3);
0
c. By removing paragraph (e)(4); and
0
d. By adding an OMB citation at the end of the section.
The addition and revisions read as follows:
Sec. 77.33 Testing procedures for tuberculosis in captive cervids.
* * * * *
(d) * * *
(2) 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 DPP[supreg] test on the blood sample. The form
is available at the following Web site: http://www.aphis.usda.gov/wps/portal/footer/resources/forms; click on the ``VS forms'' link on that
Web page. The veterinarian must also fill out the relevant portions of
a test record. This form may be obtained by contacting the local
district VS office, information regarding which is available at: http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalhealth?1dmy&urile=wcm%3apath%3a%2Faphis_content_library%2Fsa_our_focus%2Fsa_animal_health%2Fsa_contact_us%2Fsa_map%2Fct_state_contacts_map. This record must be sent to the offices of the
State and Federal animal health officials in the State.
(e) * * *
(3) Interpretation of DPP[supreg] test results will be in
accordance with the classification requirements described in Sec.
77.34.
* * * * *
(Approved by the Office of Management and Budget under control number
0579-0412)
0
5. Section 77.34 is amended as follows:
0
a. In paragraphs (a)(1) and (b)(1), by removing the words ``the DTE''
each time that they occur, and adding the word ``APHIS'' in their
place;
0
b. In paragraph (a)(1), by removing the words ``CervidTB Stat-
Pak[supreg] or DPP[supreg] tests'' and adding the words ``DPP[supreg]
test'' in their place; and
0
c. By revising paragraphs (a)(2) and (b)(2).
The revisions read as follows:
Sec. 77.34 Official tuberculosis tests.
(a) * * *
(2) DPP[supreg] test. (i) The DPP[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 this initial DPP[supreg] test will be classified as a
suspect and retested with the DPP[supreg] test. A captive cervid that
has non-negative test results to the DPP[supreg] test must not be
retested using the SCT or CCT test.
(ii) The DPP[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 DPP[supreg] test will
be classified as a reactor, unless APHIS determines that the captive
cervid should be classified as a suspect because of possible exposure
to a tuberculous animal.
(b) * * *
(2) DPP[supreg] test. The DPP[supreg] test may be used as a
supplemental test in order to retest captive cervids that have been
classified as suspects based on an initial DPP[supreg] test. In such
instances, the supplemental DPP[supreg] test must evaluate a new serum
sample drawn from the cervid no sooner than 30 days after the initial
DPP[supreg] test. A captive cervid that has non-negative test results
on two successive DPP[supreg] tests will be classified as a reactor,
unless APHIS determines that another disease classification is
warranted.
Sec. 77.39 [Amended]
0
6. Section 77.39 is amended as follows:
0
a. By removing paragraph (a)(1)(iii);
0
b. By redesignating paragraph (a)(1)(iv) as paragraph (a)(1)(iii);
0
c. In paragraphs (b)(2)(iv) and (c), by removing the words ``the DTE''
and adding the word ``APHIS'' in their place;
0
d. In paragraph (e), introductory text, by removing the words
``CervidTB Stat-Pak[supreg]'' each time they appear and adding the word
``DPP[supreg]'' in their place;
0
e. In paragraph (e)(2), by removing the words ``the DTE'' and adding
the word ``APHIS'' in their place;
0
f. In paragraph (e)(3), by removing the words ``CervidTB Stat-
Pak[supreg]'' each time they appear and adding the word ``DPP[supreg]''
in their place;
0
g. In paragraph (f)(1), by removing the words ``CervidTB Stat-
Pak[supreg]'' each time they appear and adding the word ``DPP[supreg]''
in their place and by removing the words ``the DTE'' and adding the
word ``APHIS'' in their place; and
[[Page 43927]]
0
h. In paragraph (f)(2), by removing the words ``CervidTB Stat-
Pak[supreg]'' and adding the word ``DPP[supreg]'' in their place.
Done in Washington, DC, this 23rd day of July 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-17877 Filed 7-28-14; 8:45 am]
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