[Federal Register: April 27, 2006 (Volume 71, Number 81)]
[Rules and Regulations]
[Page 24803-24806]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ap06-1]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
[[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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\ See Docket No. 00-108-2, published in the Federal Register
on December 24, 2003 (68 FR 74513-74529).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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