[Federal Register: January 12, 2006 (Volume 71, Number 8)]
[Proposed Rules]
[Page 1985-1988]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja06-22]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 77
[Docket No. 04-094-1]
Tuberculosis in Captive Cervids; Extend Interval for Conducting
Reaccreditation Test
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the regulations regarding
tuberculosis in captive cervids by extending, from 2 years to 3, the
term for which accredited herd status is valid and increasing by 12
months the interval for conducting the reaccreditation test required to
maintain the accredited tuberculosis-free status of cervid herds. We
are also proposing to reduce, from three tests to two, the number of
consecutive negative official tuberculosis tests required of all
eligible captive cervids in a herd before a herd can be eligible for
recognition as an accredited herd. These actions would reduce testing
costs for herd owners, lessen the potential for animal injury or death
during testing, and lower administrative costs for State and Federal
regulatory agencies. In addition, we are proposing to amend the
regulations by removing references to the blood tuberculosis test for
captive cervids, as that test is no longer used in the tuberculosis
eradication program for captive cervids. This proposed change would
update the regulations so that they refer only to those official tests
currently in use.
DATES: We will consider all comments that we receive on or before March
13, 2006.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov
and, in the ``Search for Open Regulations'' box,
select ``Animal and Plant Health Inspection Service'' from the agency
drop-down menu, then click on ``Submit.'' In the Docket ID column,
select APHIS-2005-0119 to submit or view public comments and to view
supporting and related materials available electronically. After the
close of the comment period, the docket can be viewed using the
``Advanced Search'' function in Regulations.gov.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 04-094-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 04-094-1.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room 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) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Michael Dutcher, Senior Staff
Veterinarian, National Tuberculosis Eradication Program, Eradication
and Surveillance Team, National Center for Animal Health Programs, VS,
APHIS, 4700 River Road Unit 43, Riverdale, MD, 20737-1231, (301) 734-
5467.
SUPPLEMENTARY INFORMATION:
Background
Bovine tuberculosis (tuberculosis) is a contagious and infectious
granulomatous disease caused by Mycobacterium bovis. It affects cattle,
bison, deer, elk, goats, and other warm-blooded species, including
humans. Tuberculosis in infected animals and humans manifests itself in
lesions of the lung, bone, and other body parts, causes weight loss and
general debilitation, and can be fatal. At the beginning of the past
century, tuberculosis caused more losses of livestock than all other
livestock diseases combined. This prompted the establishment of the
National Cooperative State/Federal Bovine Tuberculosis Eradication
Program for bovine tuberculosis in livestock. Through this program, the
Animal and Plant Health Inspection Service (APHIS) works cooperatively
with the national livestock industry and state animal health agencies
to eradicate 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'' (UMR), which is incorporated by reference into the
regulations. The regulations restrict the interstate movement of
cattle, bison, and captive cervids to prevent the spread of
tuberculosis. Subpart C of the regulations (Sec. Sec. 77.20 to 77.41)
addresses captive cervids.
Accredited Herd Status
In Sec. 77.20, accredited herd is defined as ``A herd of captive
cervids that has tested negative to at least three consecutive official
tuberculosis tests of all eligible captive cervids in accordance with
Sec. 77.33(f) and that meets the standards set forth in Sec. 77.35.
The tests [i.e., the three tests necessary to qualify for accredited
herd status] must be conducted at 9-15 month intervals.'' The
regulations in Sec. 77.35(d) set out the conditions that must be met
in order for a herd of captive cervids to maintain its accredited herd
status. Specifically, to maintain status as an accredited herd, the
herd must test negative to an official tuberculosis test within 21-27
months from the anniversary date of the third consecutive test with no
evidence of tuberculosis disclosed (that is, the final test necessary
for the herd to be recognized as an accredited herd). Each time the
herd is tested for reaccreditation, it must be tested 21-27 months from
the anniversary date of the accrediting test, not from the last date of
reaccreditation (for example, if a herd is accredited on January 1 of a
given year, the anniversary date will be January 1 of every second year
thereafter). Accredited herd status is valid for 24 months (730 days)
from the anniversary date of the accrediting test. If the herd is
tested between 24 and 27 months after the anniversary date, its
accredited herd status will be suspended for the interim between the
anniversary date and the reaccreditation test. During the suspension
period, the herd will be considered ``unclassified'' and captive
cervids may be moved interstate from the herd only in accordance with
the movement requirements for the state or zone in which the herd is
located.
In this document, we are proposing to amend the regulations to
increase, by 1 year, the term for which accredited herd status is valid
and to allow reaccreditation tests to be performed within 33-39 months
of the anniversary date. We are also proposing to amend the regulations
by reducing, from three tests to two, the number of consecutive
negative official tuberculosis tests required of all eligible captive
cervids in a herd before a herd can be eligible for recognition as an
accredited herd.
[[Page 1986]]
Experience has shown that careful management in accredited herds of
captive cervids in accordance with the regulations and the UMR
virtually eliminates the already low probability of introducing
tuberculosis into the herd from outside sources. Amending our
regulations to extend the period between reaccreditation tests of
captive cervid herds, as well as reducing the number of consecutive
negative official tuberculosis tests required of all eligible captive
cervids in a herd before a herd can be eligible for recognition as an
accredited herd, would reduce testing costs for herd owners, lessen the
potential for animal injury or death during testing, and lower
administrative costs for state and Federal regulatory agencies.
Tuberculin testing, including veterinary fees and handling
expenses, costs about $10 to $15 per test. Thus, increasing the term
for which accredited herd status is valid would result in a savings of
$10 to $15 per head over a 6-year period, as there would be only two
tests required instead of three. Similarly, reducing the number of
tests required to qualify for accredited herd status would save another
$10 to $15 per head, again due to a reduction in the number of tests
from three to two. Additionally, injury and death losses of about 3 to
5 percent can occur in captive cervid herds as animals attempt to jump
fences and other hurdles during roundup for testing. Extending the
testing period and reducing the number of qualifying tests would
eliminate some of these costs as well.
We do not believe that these proposed changes would reduce the
effectiveness of our tuberculosis surveillance and eradication program.
On the contrary, we expect that lengthening the reaccreditation
interval would encourage owners to continue to test their herds rather
than abandoning the program. Continued participation by owners in this
program will yield monitoring and surveillance data on cervids that is
extremely important to our efforts to detect and eliminate
tuberculosis-affected herds in the United States.
With respect to the number of qualifying tests, recent surveillance
in captive cervids shows that the prevalence of tuberculosis is far
lower than originally thought, and we no longer believe that the risk
of tuberculosis in captive cervids is high enough to justify requiring
three negative official tuberculosis tests before a herd can be
eligible for recognition as an accredited herd. In addition, by
reducing the number of consecutive negative tests required, we would
bring the requirements for the accreditation of cervid herds more in
line with the existing bovine tuberculosis regulations and UMR testing
requirements for cattle and bison.
Thus, the proposed changes would reduce testing costs for the herd
owner, lessen the potential of animal injury or death during testing,
and lower administrative costs for State and Federal regulatory
agencies. In addition, these proposed rule changes would help further
tuberculosis eradication efforts and protect livestock not infected
with bovine tuberculosis from the disease.
Blood Tuberculosis Test
The definition of official tuberculosis test in Sec. 77.20
identifies the single cervical tuberculin (SCT) test, the comparative
cervical tuberculin (CCT) test, and the blood tuberculosis (BTB) test
as official tests for tuberculosis in captive cervids. However, the BTB
test is no longer used in the program because its sensitivity and
specificity were determined to be inadequate for the tuberculosis
eradication program's needs; in effect, the test can miss some infected
animals and misdiagnose non-infected animals at rates that are
unacceptable. Because the BTB test is no longer being used to test
captive cervids, we are proposing to amend the definition of official
tuberculosis test in Sec. 77.20 so that it refers only to the SCT and
CCT tests. We would also remove the other references to the BTB test
that appear in the regulations.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be not significant for the purposes of
Executive Order 12866 and, therefore, has not been reviewed by the
Office of Management and Budget.
We are proposing to amend the regulations regarding tuberculosis in
captive cervids by extending, from 2 years to 3, the term for which
accredited herd status is valid and increasing by 12 months the
interval for conducting the reaccreditation test required to maintain
the accredited tuberculosis-free status of cervid herds. We are also
proposing to reduce, from three tests to two, the number of consecutive
negative official tuberculosis tests required of all eligible captive
cervids in a herd before a herd can be eligible for recognition as an
accredited herd. These actions would reduce testing costs for herd
owners, lessen the potential for animal injury or death during testing,
and lower administrative costs for state and Federal regulatory
agencies. In addition, we are proposing to amend the regulations by
removing references to the blood tuberculosis test for captive cervids,
as that test is no longer used in the tuberculosis eradication program
for captive cervids. This proposed change would update the regulations
so that they refer only to those official tests currently in use.
Of primary importance among captive cervids are deer and elk, which
are farmed for breeding stock, velvet antler, meat, and sales to game
parks and exhibits. This is a relatively small industry, and as such
was not tracked as a separate line item in census data before the 2002
Census of Agriculture. The 2002 Census estimates there are 286,863 deer
being raised on 4,901 farms, and 97,901 elk on 2,371 farms in the
United States. Due to the devastating effects of chronic wasting
disease in captive cervids, these numbers are largely believed to be an
overstatement of current market conditions. Unfortunately, the census
data do not consider the per head value of deer or elk. However,
limited data are collected by the two major cervid industry
associations, the North American Elk Breeders Association (NAEBA) and
the North American Deer Farmers Association (NADeFA). Membership in the
above mentioned associations is estimated to constitute 60 percent of
the farmed cervid industry. Attempts to get current information on deer
and elk industries and corresponding values were unsuccessful. However,
we previously gathered information from the above mentioned major
industry associations in connection with another rulemaking related to
deer and elk,\1\ and have used that information as the source of the
estimates in this analysis. We welcome public comment regarding current
market conditions in the farmed cervid industry.
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\1\ See Docket No. 00-108-2, published in the Federal Register
on December 24, 2003 (68 FR 74513-74529).
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NAEBA estimates about 75 percent of its members have 100 or fewer
animals, 15 percent have more than 100 but fewer than 500, and the
remaining 10 percent have more than 500 elk. Numbers of elk per farm
vary depending on the farm classification, commercial or hobby. The
value per elk also varies, depending on type of animal (e.g., bull,
calf) and market conditions, ranging from a high of $5,000 for superior
animals to a low of $500 for non-pedigree animals. In 2002, NAEBA
estimated the average value per head of elk was $2,000; using this
figure, we can approximate the value of the 97,901 elk on U.S. farms to
be $195.8 million. In
[[Page 1987]]
2001, gross receipts for members in NAEBA (velvet antler, breeding
stock, and meat) totaled $44.3 million.
NADeFA estimates there are an average of 50 deer per farm. The
actual number of deer per farm varies, depending on usage, from a high
of 3,000 for commercial farms to a low of 5 for hobby farms. The value
of each deer also varies depending on the type of animal (e.g., wapiti,
white-tail, fallow) and market conditions. NADeFA estimates the average
value per animal to be $1,687, with wapiti deer at the high end at
$4,000 each, and fallow deer at the low end at $375 each. Using this
average per head value of $1,687, the value of the 286,863 deer on U.S.
farms can be approximated at $483.9 million.
This proposed rule would amend the regulations by extending the
term for which accredited herd status is valid, increasing the interval
for conducting reaccreditation tests, and reducing the number of
consecutive negative official tuberculosis tests required of all
eligible captive cervids in a herd before a herd can be eligible for
recognition as an accredited herd. We expect these proposed changes
would encourage producers already participating in this voluntary
program to maintain accredited herds, as they would reduce testing
costs. Continued participation in this program is important to bovine
tuberculosis eradication efforts, as accreditation testing yields
monitoring and surveillance data on cervids which greatly assist in our
efforts to detect and eliminate tuberculosis-affected herds in the
United States.
The potential benefits of this proposed rule are fairly clear, the
most obvious being decreased testing costs for those producers
maintaining accredited herds. Furthermore, reducing testing
requirements would lower administrative costs for state and Federal
regulatory agencies. In addition, by extending the interval between
reaccreditation tests and reducing the number of qualifying tests, the
need to round up deer and elk for testing, and the potential for animal
injury or death during that process, would be reduced.
Currently, APHIS records indicate there are 1,024 accredited herds
of captive cervids in the United States. APHIS is currently in the
process of researching the average cost to producers of identifying
animals and testing them for tuberculosis, and we welcome public
comment on these costs with respect to cervids. Our preliminary
research indicates the average cost of tuberculosis testing ranges from
$10 to $15 per head. Thus, in a 6-year period, the proposed changes in
the regulations would translate to a cost savings of $20 to $30 per
head, as there would be only two tests required for reaccreditation and
two tests required to qualify for initial accreditation instead of
three in each case. If we were to assume each of the 1,024 accredited
herds had an average of 50 animals, the longer interval between
reaccreditation tests and the reduction in the number of qualifying
tests would result in a total cost savings to the domestic industry of
approximately $1,024,000 to $1,536,000 over a 6-year period.\2\
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\2\ Calculation: 1,024 herd x 50 animals per herd x $10 (or $15
for high-end estimate) x 2 tests.
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According to the two major cervid associations, the majority of
their members would be classified as small entities by U.S. Small
Business Administration standards.\3\ For producers wishing to maintain
accredited status, considering that the estimated average value per
head is $2,000 and $1,687 for elk and deer, respectively, the cost
savings of reduced testing represent less than 2 percent of the per
head value. In general practice, we assume a regulation that has
compliance costs which equal a small business' profit margin, or 5 to
10 percent of annual sales, pose an impact which can be considered
``significant.'' \4\ For the purposes of illustration and analysis of
potential effects on small entities, if we assume a cervid producer
owns only a single average herd of 50 deer, with annual sales or value
of approximately $84,350, compliance costs totaling between $4,218 and
$8,435 would qualify as posing a ``significant'' economic impact on
this entity. In this case, the average compliance costs of tuberculosis
testing for an entire herd would be $750, using the high-end average
cost per head of $15, which would not qualify as monetarily
significant. Thus, for those producers participating in the voluntary
cervid accreditation program, the cost savings from the elimination of
two tests, while beneficial, would not represent a significant monetary
savings.
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\3\ NAEBA estimates 75 percent of its members have 100 or fewer
animals, which translates to an average value per elk farm of
$200,000 (100 animals x $2,000). NADeFA estimates there are an
average of 50 deer per farm, which translates into an average total
value per deer farm of $84,350 (50 animals x $1,687). A small cervid
operation is one having $750,000 or less in annual receipts. Table
of Size Standards based on NAICS 2002. Washington, DC: U.S. Small
Business Administration, 2004.
\4\ Verkuil, Paul R. ``A Critical Guide to the Regulatory
Flexibility Act.'' Duke Law Journal, Apr. 1982: 928.
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Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
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 proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are in conflict with this rule will
be preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
This proposed 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 propose to amend 9 CFR part 77 as follows:
PART 77--TUBERCULOSIS
1. The authority citation for part 77 would continue to read as
follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
2. Section 77.20 would be amended as follows:
a. In the definition for accredited herd, by removing the word
``three'' and adding the word ``two'' in its place.
b. By removing the definition for blood tuberculosis (BTB) test.
c. In the definition for negative, by removing the words
``classified by the testing laboratory as ``avian'' or ``negative'' on
the BTB test,''.
d. By revising the definition for official tuberculosis test to
read as set forth below.
e. In the definition for reactor, by removing the words ``, or is
classified by the testing laboratory as ``M. bovis positive'' on the
BTB test,''.
f. In the definition for suspect, by removing the words ``, or that
is classified by the testing laboratory as equivocal on the BTB
test,''.
The revision reads as follows:
[[Page 1988]]
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.
* * * * *
Sec. 77.33 [Amended]
3. Section 77.33 would be amended as follows:
a. In paragraph (a) introductory text, by removing the words ``in
paragraphs (a)(1) and (a)(2)'' and adding the words ``in paragraph
(a)(1)'' in their place.
b. By removing and reserving paragraphs (a)(2), (b)(2), (d)(2), and
(e)(3).
Sec. 77.34 [Amended]
4. Section 77.34 would be amended as follows:
a. In paragraph (a)(1), by removing the words ``either the CCT test
or the BTB test'' and adding the words ``the CCT test'' in their place.
b. By removing paragraph (c).
5. Section 77.35 would be amended as follows:
a. In paragraph (a)(1), by removing the word ``three'' in the first
sentence and adding the word ``two'' in its place.
b. By revising paragraph (d) to read as set forth below.
Sec. 77.35 Interstate movement from accredited herds.
* * * * *
(d) Maintenance of accredited herd status. To maintain status as an
accredited herd, the herd must test negative to an official
tuberculosis test within 33-39 months from the anniversary date of the
second consecutive test with no evidence of tuberculosis disclosed
(that is, the test on which the herd was recognized as accredited or
the accrediting test). Each time the herd is tested for
reaccreditation, it must be tested 33-39 months from the anniversary
date of the accrediting test, not from the last date of reaccreditation
(for example, if a herd is accredited on January 1 of a given year, the
anniversary date will be January 1 of every third year). Accredited
herd status is valid for 36 months (1,095 days) from the anniversary
date of the accrediting test. If the herd is tested between 36 and 39
months after the anniversary date, its accredited herd status will be
suspended for the interim between the anniversary date and the
reaccreditation test. During the suspension period, the herd will be
considered ``unclassified'' and captive cervids may be moved interstate
from the herd only in accordance with the movement requirements for the
State or zone in which the herd is located.
Sec. 77.37 [Amended]
6. In Sec. 77.37, paragraph (a)(2), footnote 3 would be
redesignated as footnote 2.
7. In Sec. 77.39, paragraph (a) would be amended as follows:
a. In paragraph (a)(1)(i) introductory text, by removing the words
``or the BTB test''.
b. By removing and reserving paragraph (a)(1)(i)(B).
c. In paragraph (a)(1)(ii) introductory text, by removing the words
``or the first BTB test''.
d. In paragraph (a)(1)(ii)(A), by removing the word ``; or'' and
adding a period in its place.
e. By removing and reserving paragraph (a)(1)(ii)(B).
f. In paragraph (e) introductory text, by removing the fourth
sentence after the paragraph heading and revising the last two
sentences of the paragraph to read as set forth below.
Sec. 77.39 Other interstate movemements.
* * * * *
(e) Herds that have received captive cervids from an affected herd.
* * * Any exposed captive cervid that responds to the SCT test must be
classified as a reactor and must be slaughter inspected or necropsied.
Any exposed captive cervid that tests negative to the SCT 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.
* * * * *
Done in Washington, DC, this 6th day of January 2006.
W. Ron DeHaven,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-198 Filed 1-11-06; 8:45 am]
BILLING CODE 3410-34-P