[Federal Register Volume 71, Number 81 (Thursday, April 27, 2006)]
[Rules and Regulations]
[Pages 24803-24806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3984]



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  Federal Register / Vol. 71, No. 81 / Thursday, April 27, 2006 / Rules 
and Regulations  

[[Page 24803]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 77

[Docket No. 04-094-2]


Tuberculosis in Captive Cervids; Extend Interval for Conducting 
Reaccreditation Test

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending 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 
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. These actions will 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 amending 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 
change updates the regulations so that they refer only to those 
official tests currently in use.

DATES: Effective Date: April 21, 2006.

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

    Through the National Cooperative State/Federal Bovine Tuberculosis 
Eradication Program, the Animal and Plant Health Inspection Service 
(APHIS) 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'' (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.
    On January 12, 2006, we published in the Federal Register (71 FR 
1985-1988, Docket No. 04-094-1) a proposal \1\ 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 
also proposed 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. We proposed these actions to 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 proposed 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. We proposed this change to 
update the regulations so that they refer only to those official tests 
currently in use.
---------------------------------------------------------------------------

    \1\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov, click on the ``Advanced Search'' tab, 
and select ``Docket Search.'' In the Docket ID field, enter APHIS-
2004-0119, then click on ``Submit.'' Clicking on the Docket ID link 
in the search results page will produce a list of all documents in 
the docket.
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    We solicited comments on our proposal for 60 days ending on March 
13, 2006. We received 32 comments by that date, from producers, 
industry group representatives, private citizens, and one State agency. 
In all, 30 of the 32 commenters supported the rule, although three of 
these commenters had questions or suggestions regarding the proposed 
rule. The two remaining commenters were opposed to the proposed rule. 
The issues raised by the commenters are discussed below.
    Two commenters opposed the change to the current testing 
requirements. One of these commenters was concerned that the proposed 
rule would not protect the health of Americans or the health of 
America's livestock industry. The commenter stated that by allowing 
cervid producers to obtain accredited tuberculosis-free status with 
fewer consecutive negative tests, as well as allowing these same herds 
to retain that status for longer periods without required re-testing, 
the U.S. food supply will be endangered. This commenter also stated 
that the U.S. Animal Health Association's (USAHA) Committee on 
Tuberculosis noted that ``there is continuing concern that the level of 
surveillance for TB in captive cervids may be inadequate.''
    We do not believe the changes in this rule will reduce the 
effectiveness of our tuberculosis surveillance and eradication program, 
nor will they increase the risk of captive herds endangering the U.S. 
food supply. Further, the proposed rule was prepared in an effort to 
directly address the concerns of the USAHA Committee on Tuberculosis 
regarding surveillance for tuberculosis in captive cervids, and has 
been endorsed by that committee. By reducing testing costs for herd 
owners and lessening the potential for animal injury or death during 
testing, we are making the program more accessible to cervid producers. 
This will result in better surveillance for tuberculosis due to greater 
participation by cervid producers in the eradication program. 
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

[[Page 24804]]

introducing tuberculosis into a herd from outside sources. Because of 
this, it is also our belief that the greater producer participation and 
the resulting improved surveillance will address, in part, the concerns 
over the level of surveillance in cervids as reported in the 
aforementioned 2005 Report from the USAHA Committee on Tuberculosis. 
Additionally, 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 food safety issue 
raised by the commenter, the Centers for Disease Control and Prevention 
reports that, while rare, humans can become infected with Mycobacterium 
bovis, but that the most common cause of such infection is through the 
consumption of unpasteurized milk products from infected cows. The 
consumption of meat is not considered to present a risk of transmitting 
M. bovis to humans. We are not making any changes to the final rule as 
a result of this comment.
    Two of the commenters who supported the rule suggested we add 
additional blood tests--one specifically suggested Cervigam and/or the 
Rapid Test--to the list of official tests for tuberculosis in cervids.
    Because we recognize the need for more modern and practical tests 
for tuberculosis in captive cervids, we plan to conduct validation 
studies of both the Cervigam test and the Rapid Test. If the studies 
demonstrate that these two tests are acceptable, we will initiate the 
process of making the Cervigam and the Rapid Test official tests for 
tuberculosis in captive cervids. At this time, however, we are not 
making any changes to the regulations as a result of this comment.
    Another commenter who supported the rule questioned whether or not 
he would have to retest his cervids for tuberculosis if he sold deer 
and needed to move them across State lines. This commenter also 
suggested that certification should be ``federally sponsored.''
    Under the regulations as amended by this rule, animals moving 
interstate from an accredited tuberculosis-free herd would not require 
testing as long as the herd's most recent test was within the past 36 
months. The regulations in part 77 and the specific requirements 
regarding the interstate movement of cervids from accredited herds are 
administered by APHIS and thus do provide the Federal ``sponsorship'' 
suggested by the commenter.
    Another commenter who supported the rule stated that the 
tuberculosis testing costs and high and low ranges of animal values 
presented in the proposed rule's economic analysis were too low. The 
commenter stated that the average cost of tuberculosis testing is 
``significantly higher'' than $10 to $15 a head, and that the high/low 
ranges of animal values were likewise too low.
    We acknowledge that our estimates of testing costs, which we 
acknowledged were preliminary, and animal values, which were based on 
limited industry information, may be too low in some cases. Higher 
costs and values would, however, further emphasize the economic 
benefits of adopting this rule, insofar as the savings to producers 
would be even higher than estimated. We will continue to seek 
additional information that will allow us to more accurately estimate 
the costs of testing and the value of animals.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, without 
change.

Effective Date

    This is a substantive rule that relieves restrictions and, pursuant 
to the provisions of 5 U.S.C. 553, may be made effective less than 30 
days after publication in the Federal Register.
    This final rule extends the term for which accredited herd status 
is valid, increases the interval for conducting reaccreditation tests, 
and reduces 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. Making this rule 
effective immediately will 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. 
Therefore, the Administrator of the Animal and Plant Health Inspection 
Service has determined that this rule should be effective upon 
signature.

Executive Order 12866 and Regulatory Flexibility Act

    This 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 amending 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 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. 
These actions will 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 amending 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 
change will 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 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 major industry 
associations in connection with another rulemaking related to deer and 
elk,\2\ and have used that information as the source of the estimates 
in this analysis.
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    \2\ 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

[[Page 24805]]

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 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 final rule amends 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 changes will 
encourage producers already participating in this voluntary program to 
maintain accredited herds, as they will 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 final 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, will 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. Our preliminary research 
indicates the average cost of tuberculosis testing ranges from $10 to 
$15 per head. Thus, in a 6-year period, the changes in the regulations 
will translate to a cost savings of $20 to $30 per head, as there will 
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 will result in a total cost 
savings to the domestic industry of approximately $1,024,000 to 
$1,536,000 over a 6-year period.\3\
---------------------------------------------------------------------------

    \3\ Calculation: 1,024 herds 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.\4\ 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.'' \5\ 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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    \4\ 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.
    \5\ 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 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 final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are in conflict with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    This final 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.

0
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 for accredited herd, by removing the word 
``three'' and adding the word ``two'' in its place.
0
b. By removing the definition for blood tuberculosis (BTB) test.
0
c. In the definition for negative, by removing the words ``classified 
by the testing laboratory as ``avian'' or ``negative'' on the BTB 
test,''.
0
d. By revising the definition for official tuberculosis test to read as 
set forth below.
0
e. In the definition for reactor, by removing the words ``, or is 
classified by

[[Page 24806]]

the testing laboratory as ``M. bovis positive'' on the BTB test,''.
0
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 revisions read 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.
* * * * *


Sec.  77.33  [Amended]

0
3. Section 77.33 is amended as follows:
0
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.
0
b. By removing and reserving paragraphs (a)(2), (b)(2), (d)(2), and 
(e)(3).


Sec.  77.34  [Amended]

0
4. Section 77.34 is amended as follows:
0
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.
0
b. By removing paragraph (c).

0
5. Section 77.35 is amended as follows:
0
a. In paragraph (a)(1), by removing the word ``three'' in the first 
sentence and adding the word ``two'' in its place.
0
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]

0
6. In Sec.  77.37, paragraph (a)(2), footnote 3 is redesignated as 
footnote 2.

0
7. In Sec.  77.39, paragraph (a) is amended as follows:
0
a. In paragraph (a)(1)(i) introductory text, by removing the words ``or 
the BTB test''.
0
b. By removing and reserving paragraph (a)(1)(i)(B).
0
c. In paragraph (a)(1)(ii) introductory text, by removing the words 
``or the first BTB test''.
0
d. In paragraph (a)(1)(ii)(A), by removing the word ``; or'' and adding 
a period in its place.
0
e. By removing and reserving paragraph (a)(1)(ii)(B).
0
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 movements.

* * * * *
    (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 21st day of April 2006.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 06-3984 Filed 4-26-06; 8:45 am]
BILLING CODE 3410-34-P