Tuberculosis in Captive Cervids; Extend Interval for Conducting Reaccreditation Test, 1985-1988 [E6-198]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 71, Number 8 (Thursday, January 12, 2006)]
[Proposed Rules]
[Pages 1985-1988]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-198]


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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 https://
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 https://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]
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