Chronic Wasting Disease Herd Certification Program and Interstate Movement of Farmed or Captive Deer, Elk, and Moose, 14495-14506 [E9-7026]
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14495
Proposed Rules
Federal Register
Vol. 74, No. 60
Tuesday, March 31, 2009
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 55 and 81
[Docket No. 00–108–7]
RIN 0579–AB35
Chronic Wasting Disease Herd
Certification Program and Interstate
Movement of Farmed or Captive Deer,
Elk, and Moose
AGENCY: Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing further
amendments that would establish a herd
certification program to eliminate
chronic wasting disease from farmed or
captive cervids in the United States.
Under the 2006 Chronic Wasting
Disease (CWD) rule, participating deer,
elk, and moose herds would have to
follow CWD Herd Certification Program
requirements for animal identification,
testing, herd management, and
movement of animals into and from
herds. This document proposes
additional changes to the program
regarding recognition of State bans on
the entry of farmed or captive cervids
for reasons unrelated to CWD, the
number of years an animal must be
monitored for CWD before it may move
interstate, interstate movement of
cervids that originated from herds in
proximity to a CWD outbreak, herd
inventory procedures, and several other
matters. These actions are intended to
help eliminate CWD from the farmed or
captive cervid herds in the United
States.
DATES: We will consider all comments
that we receive on or before June 1,
2009.
You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/fdmspublic/
component/
ADDRESSES:
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main?main=DocketDetail&d=APHIS–
2006–0118 to submit or view comments
and to view supporting and related
materials available electronically.
• Postal Mail/Commercial Delivery:
Please send two copies of your comment
to Docket No. 00–108–7, 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. 00–108–7.
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.
Dean E. Goeldner, Senior Staff
Veterinarian, Ruminant Health
Programs, VS, APHIS, 4700 River Road
Unit 43, Riverdale, MD 20737–1231;
(301) 734–4916.
SUPPLEMENTARY INFORMATION:
Background
Chronic wasting disease (CWD) is a
transmissible spongiform
encephalopathy (TSE) of cervids
(members of Cervidae, the deer family)
that, as of October, 2008, has been found
only in wild and captive animals in
North America and in captive animals
in the Republic of Korea. First
recognized as a clinical ‘‘wasting’’
syndrome in 1967, the disease is
typified by chronic weight loss leading
to death. There is no known
relationship between CWD and any
other TSE of animals or people. Species
known to be susceptible to CWD via
natural routes of transmission include
Rocky Mountain elk, mule deer, whitetailed deer, black-tailed deer, and
moose.
In the United States, CWD has been
confirmed in free-ranging deer and elk
in Colorado, Illinois, Kansas, Nebraska,
New Mexico, New York, South Dakota,
Utah, West Virginia, Wisconsin, and
Wyoming, and, as of October 2008, in 32
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farmed elk herds and 11 farmed or
captive white-tailed deer herds in
Colorado, Kansas, Michigan, Minnesota,
Montana, Nebraska, New York,
Oklahoma, South Dakota, and
Wisconsin. The disease was first
detected in U.S. farmed elk in 1997. It
was also diagnosed in a wild moose in
Colorado in 2005.
Under the Animal Health Protection
Act (7 U.S.C. 8301 et seq.), the Secretary
of Agriculture has the authority to issue
orders and promulgate regulations to
prevent the introduction into the United
States and the dissemination within the
United States of any pest or disease of
livestock. The Animal and Plant Health
Inspection Service’s (APHIS’)
regulations in 9 CFR subchapter B
govern cooperative programs to control
and eradicate communicable diseases of
livestock.
On July 21, 2006, we published a final
rule in the Federal Register (71 FR
41682, Docket No. 00–108–3; ‘‘the CWD
final rule’’) amending 9 CFR subchapter
B by establishing regulations in part 55
for a Chronic Wasting Disease Herd
Certification Program to help eliminate
chronic wasting disease (CWD) from the
farmed or captive cervid herds in the
United States. Under that rule, owners
of deer, elk, and moose herds who
choose to participate would have to
follow the program requirements of a
cooperative State-Federal program for
animal identification, testing, herd
management, and movement of animals
into and from herds. The CWD final rule
also amended 9 CFR subchapter C by
establishing a new part 81 containing
interstate movement requirements to
prevent the spread of CWD.
After publication of the CWD final
rule, but before its effective date, APHIS
received three petitions requesting
reconsideration of several requirements
of the rule. On September 8, 2006, we
published a notice in the Federal
Register (71 FR 52983, Docket No. 00–
108–4) that delayed the effective date of
the CWD final rule while APHIS
considered those petitions. On
November 3, 2006, we published
another notice in the Federal Register
(71 FR 64650–64651, Docket No. 00–
108–5) that described the nature of the
petitions and made the petitions
available for public review and
comment, with a comment period
closing date of December 4, 2006. We
subsequently extended that comment
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period until January 3, 2007, in a
Federal Register notice published on
November 21, 2006 (71 FR 67313,
Docket No. 00–108–6).
We received 77 comments by that
date. They were from cervid producer
associations, individual cervid
producers, State animal health agencies,
State wildlife agencies, and others.
We have carefully considered the
merits of the petitions and of the public
comments received in response to them.
We believe that the petitioners and
commenters identified several areas
where the CWD final rule could be more
effective or less burdensome, and we
believe the CWD final rule could be
improved by making several changes to
its requirements. We are therefore
proposing certain changes to the CWD
final rule, described below. We plan to
withdraw the 2006 CWD final rule
published on July 21, 2006 and issue a
revised final rule based on this proposal
and on the CWD final rule, after
evaluating public comments on this
proposal.
Reconciling Federal and State
Requirements for the Interstate
Movement of Captive Cervids
One goal of the CWD final rule was
to provide a consistent, nationwide
standard for the interstate movement of
cervids, when such animals are allowed
to move in interstate commerce. For that
reason, the CWD final rule provided a
single set of CWD requirements to
follow when moving cervids interstate.
These requirements, developed with
input from States and producers, were
meant to standardize a variety of
differing CWD requirements and
restrictions imposed by States that
regulate the entry of cervids from other
States. For example, different States
have different requirements for how
long a cervid must have been in a herd
subject to CWD monitoring in order to
move, and different requirements for the
type of animal identification required
for cervids moving interstate.
APHIS continues to believe that the
Federal CWD regulations should
provide a consistent, nationwide set of
requirements designed to address CWD
risk for cervids that move interstate.
Where the Federal CWD final rule
establishes a standard for a particular
aspect of interstate movement of
cervids—identification requirements,
for example—the requirement in the
Federal CWD final rule will preempt
any inconsistent State requirement.
However, as the petitions and several
comments on the petitions stated, the
CWD final rule did not clearly resolve
the issue of whether a State has
authority to ban the movement of any
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farmed or captive cervids into the State
due to reasons other than CWD risks.
APHIS has sought and received
further information from States on the
nature of their State CWD regulations
and the reasons States have determined
such requirements to be necessary. In
States that allow farmed or captive
cervids from other States to enter under
restrictions, rather than prohibiting their
entry entirely, we found that the
purpose of the CWD restrictions and the
methods they employed were similar to
the purpose and methods of the CWD
final rule. In almost all cases, we believe
that the requirements in the FederalState cooperative CWD final rule will
achieve the State goal of allowing
interstate movement of farmed or
captive cervids under conditions
sufficient to prevent the spread of CWD.
In one case, discussed in the next
section of this document titled
‘‘Monitoring Period Required to Move
Cervids Interstate,’’ we believe the
‘‘monitoring period’’ requirement
currently employed by some States is
superior to the requirement in the CWD
final rule, and accordingly we propose
to revise the CWD final rule with
respect to the length of time a farmed or
captive cervid moved interstate must
have spent in an approved CWD herd
certification program, and thus the
length of time it has been subject to
monitoring for CWD and other herd
requirements.
However, in the course of considering
the petitions and comments on them,
APHIS has found that a number of
States prohibit the entry of farmed or
captive cervids for a variety of reasons,
and to control a variety of risks, which
are unrelated to CWD. State-imposed
bans on the movement of cervids that
are unrelated to CWD risks will not be
affected by the CWD final rule. While
Federal CWD requirements preempt
State CWD requirements when interstate
movement of cervids is allowed, we do
not believe it is necessary to preempt
State laws or regulations that prohibit
the entry of farmed or captive cervids
for other reasons when States have
articulated sound reasons for such bans.
This would include a State that bans
entry of cervids because the State does
not have or is phasing out a farmed or
captive cervid industry and States that
impose restrictions to address diseases
for which APHIS does not prohibit or
restrict interstate movement.
Some States that ban the entry of
farmed or captive cervids have cited
concerns about the potential spread of
CWD, brucellosis, and tuberculosis as
one reason for the bans. This is not, in
the agency’s view, a persuasive reason
to maintain a ban, because Federal
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regulations1 are specifically designed to
allow the interstate movement of
cervids without disseminating these
diseases. We believe that the proposed
Federal CWD requirements would be
effective and, if finalized, would
preempt conflicting State requirements.
However, States also cite other reasons
for their bans on the entry of farmed or
captive cervids, such as risks from a
number of diseases and parasites
associated with cervids. Excluding
examples for which there are already
mandatory Federal testing or interstate
movement requirements, the diseases
and parasites that support the need for
a ban in some States include epizootic
hemorrhagic disease/bluetongue,
Johne’s disease, malignant catarrhal
fever, and the meningeal worm
(Parelaphostrongylus tenuis). States also
base cervid bans on concerns that
farmed or captive cervids could contain
undesirable gene sequences that could
be introduced into wild cervid
populations if the cervids escape
captivity. These States noted that
maintaining the genetic purity of their
native elk and deer populations was
important to sportsmen and natural
resource interests. More generally,
States with bans cited concerns that
escaped farmed or captive cervids
would compete with wild populations
for food and habitat. Some States also
cited laws making it illegal to hold in
captivity certain species or breeds of
cervids covered by the CWD final rule.
Some States imposed a ban partly to
discourage high-fence trophy hunting
operations that depend on continual
restocking from out-of State sources.
Finally, some States cited
environmental concerns, including
ecosystem degradation resulting from
cervids maintained in captivity or
escaped cervids.
APHIS has concluded that many of
the above concerns are substantive and
that we should propose a way to
accommodate State interests in these
areas. APHIS believes that we can best
address the concerns of States that have
imposed a ban on the entry of farmed
or captive cervids for reasons unrelated
to CWD by changing the CWD final rule
to recognize such a ban for those States.
Therefore, we propose to add a new
§ 81.5 to the CWD final rule to clarify
that state laws and regulations
prohibiting the entry of farmed or
captive cervids for reasons unrelated to
CWD are not preempted by this part.
1 For interstate movement requirements for
cervids and other animals with respect to these
diseases, see 9 CFR part 77 for tuberculosis, 9 CFR
part 78 for brucellosis, and 9 CFR part 81 for CWD.
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Monitoring Period Required To Move
Cervids Interstate
Under the CWD final rule, during its
first year of implementation, cervids
would be allowed to move interstate if
they have been in an approved CWD
Herd Certification program, and thus
subject to monitoring for CWD and other
requirements, for at least 1 year. The
CWD final rule increased this length-oftime requirement in succeeding years of
implementation, so the time animals
would have had to be in a herd
certification program in order to move
interstate gradually increased to 2 years,
then 3, then 4, then 5 years. It was the
intent of the CWD final rule to provide
a consistent, nationwide standard for
the interstate movement of cervids.
Existing State laws and regulations
addressing movement of cervids vary in
the amount of time that the animals
must have been in a certification
program prior to entry, and some States
do not allow the entry of any cervids for
non-CWD-related reasons, as discussed
earlier. The gradual escalation of the
Federal standard in the CWD final rule
to 5 years was intended to achieve the
desired level of risk control represented
by 5 years of program participation and
disease-free surveillance and
monitoring, but to do so in a gradual
manner that would not cause
widespread economic harm to
producers by making it impossible for
some of them to move animals interstate
until 5 years after they join the CWD
Herd Certification Program.
The petitioners and many
commenters on the petitions questioned
whether the gradual approach reflected
in the rule’s Federal standard provided
adequate protection, especially during
the first 2 years of program
implementation. The petitioners and
most commenters suggested that the
available science and the known
epidemiology of CWD indicate that
animals should be monitored for CWD
for approximately 5 years before they
can be considered safe to move
interstate. Some commenters stated that
studies of the natural incubation period
in the wild are difficult to conduct and
no comprehensive studies have been
done; therefore, APHIS should not
assume that most cervids will develop
CWD within a year or two after
infection. They noted that while
animals developed signs of CWD within
1–2 years of infection in several cited
research studies, these were studies of
confined animals that were directly
infected with large quantities of the
CWD agent. This type of direct
experimental infection is known to
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result in minimum incubation periods
for diseases in general.
In view of these uncertainties about
the range of incubation periods for
CWD, the commenters suggested that it
would be prudent for the CWD program
to monitor animals for 5 years before
they can be considered safe to move
interstate. The 5-year period was
suggested because it is the period that
most researchers and State CWD
programs agree is a reasonable outer
boundary for the incubation period for
CWD.
In addition, comments on the
petitions revealed that most State
governments and industry
representatives agree that many cervid
producers who rely on moving animals
interstate for the success of their
businesses have already participated in
a State CWD herd certification and
monitoring program for 5 years or
longer, would not be adversely affected
by the adoption of a 5-year standard,
and believe a 5-year standard would
provide better protection against the
spread of CWD than a lesser monitoring
standard.
After considering comments, APHIS
has concluded that the CWD program
would be enhanced by requiring that
farmed or captive cervid herds must
have been monitored for at least 5 years
before animals from such herds may be
moved interstate. The CWD final rule
discussed why it is important to
consider possible exposure to CWD up
to 5 years in the past when evaluating
the CWD risk of a herd. The CWD final
rule would have required 5 years of
monitoring for a herd to reach the
Certified level in the CWD program,
although it would have established a
gradually increasing timetable that, in
early years of program implementation,
would have allowed interstate
movement of animals from herds with
as little as 1 year of monitoring. We now
believe that CWD incubation periods
have not been sufficiently studied to
justify using shorter monitoring periods
initially and ‘‘ramping up’’ the
monitoring requirement over time. Also,
upon reexamining several research
reports, we believe that they support the
conclusion that natural incubation
periods may last up to 5 years in enough
cases to warrant revising the CWD
program as designed in the CWD final
rule. For example, the CWD final rule
referred to a study 2 at the Colorado
Division of Wildlife, Foothills Wildlife
Research facility, which found that for
a studied group of elk that were
naturally exposed to CWD in a
contaminated environment, the average
incubation time was 26 months and the
incubation times ranged from 18 to 36
months. After the study ended, in the
same group of elk held in the same
pens, there was a case of CWD in an
individual animal that occurred 5 years
after the last CWD death in the herd.3
This could have been the result of a
later environmental exposure, or it
could represent a 5-year incubation
period.
Further supporting the points made
by the commenters, in other
pathogenesis studies in mule deer and
elk at the University of Wyoming,4 high
dose oral inoculation in mule deer
produced an incubation period range of
15 months to over 25 months, with an
average of 23 months. The researchers
acknowledged that experimental
infection (single-dose oral exposure to
brain material) probably underestimates
natural incubation times, as it is likely
that greater exposure results in shorter
duration of incubation. This supports
the conclusion that incubation times for
experimental infections most likely
represent the range of minimum
incubation times, so regulatory risk
considerations should not be based
solely on incubation periods
demonstrated by experimental direct
inoculations.
Based on our reevaluation of
incubation studies, we believe that the
longest incubation periods for regulated
cervids will likely fall between 3 and 5
years. While a CWD program with a 3year monitoring period might catch a
large majority of infected animals, it
appears that there would be enough
animals that would become infected
after a 4- or 5-year incubation period
that a 3-year monitoring period would
allow continued spread of CWD and
reduce the effectiveness of the program.
Therefore, we are proposing to
remove the gradual-escalation approach
from the CWD final rule and replace it
with a requirement that farmed or
captive cervids moved interstate must
be from herds that have had at least 5
years’ monitoring for CWD (i.e., herds
that have achieved ‘‘Certified’’ status in
the certification program). This
requirement is based on our
interpretation of currently available
research, and we may propose to modify
it in the future if additional research
provides a basis for doing so. This
change would affect the requirements
3 Miller,
personal communication.
et al. 2002. Chronic Wasting Disease
of Deer and Elk: A Review With Recommendations
for Management. Journal of Wildlife Management
66(3): 551–563.
4 Williams
2 Miller et al., 1998. Epidemiology of Chronic
Wasting Disease in Captive Rocky Mountain Elk,
Journal of Wildlife Diseases, 34:532–538.
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for cervids moved interstate for nonslaughter purposes on the basis of their
participation in the certification
program; it would not affect the
movement of cervids to slaughter.5
To make this change, we propose to
amend paragraph (a) of § 81.3 as
published at 71 FR 41706, which deals
with interstate movement of animals
from cervid herds that are enrolled in
the CWD Herd Certification Program
and are eligible for a certification status
level based on the length of time they
have successfully met program
standards. We propose to amend this
paragraph to state that the farmed or
captive cervid must be enrolled in the
CWD Herd Certification Program in a
herd that has achieved Certified status,
and must be accompanied by a
certificate that states this and that also
identifies the herd of origin and states
that the animal does not show clinical
signs associated with CWD.6
The change to the certificate
requirement to indicate that the animal
does not show clinical signs associated
with CWD replaces a required statement
that the animal is not a CWD-positive,
CWD-exposed, or CWD-suspect animal.
Requiring that the certificate state that
the animal does not show clinical signs
associated with CWD would be
consistent with the information that can
be obtained from an examination and
with other interstate animal movement
regulations. To complement this change,
we would also remove the definitions of
the terms CWD-positive animal, CWDexposed animal, and CWD-suspect
animal from § 81.1, because these terms
would no longer be used in part 81.
Proximity of Herd of Origin to CWD
Occurrences and CWD History of an
Animal’s Herd
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Some commenters also raised the
concern that the CWD final rule would
disrupt State program efforts to provide
an additional level of protection against
the spread of CWD by prohibiting entry
of farmed or captive cervids from those
areas where CWD has been detected.
Several States currently implement such
policies in various forms. The form of
the State requirement is usually to list
either counties, regions within a State,
or entire States where CWD has been
5 The final rule allows farmed or captive deer, elk,
or moose to be moved to slaughter regardless of
whether or not their herds are enrolled in the
certification program, or, if enrolled in the program,
regardless of their status relative to movement
requirements, if they have two forms of animal
identification and are accompanied by a certificate
issued in accordance with § 81.4.
6 Later in this document, we also propose a
change that would redesignate this paragraph (a) as
paragraph (b).
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detected and ban entry of cervids from
the listed areas.
We believe this is a useful risk
reduction approach for States that wish
to add another level of protection to the
requirements in the CWD final rule.
However, not all States believe they
need the additional risk reduction. Also,
although all the States that use this
method agree that its purpose is to
prohibit entry of cervids from areas in
proximity to occurrences of CWD, there
is substantial variation in the details of
such requirements for different States.
Therefore, we propose to change the
CWD final rule to allow States to elect
not to receive farmed or captive cervids
from areas in proximity to occurrences
of CWD in wild cervids. We also
propose to establish a single Federal
standard for such proximity in order to
make the standard consistent among all
States with such restrictions. We
propose to do this by (1) establishing a
list of States that do not accept entry of
farmed or captive cervids from herds of
origin in proximity to CWD occurrences
in wild cervids and (2) changing the
certificate requirement for interstate
movement of farmed or captive cervids
to document when animals are from
herds that are in proximity to CWD
occurrences in wild cervids.
Section 81.3(a)(2) of the CWD final
rule requires that farmed or captive
cervids that are moved interstate based
on their participation in the CWD Herd
Certification Program must be
accompanied by a certificate issued by
a State or Federal official or an
accredited veterinarian. The certificate
must contain information to help
identify the animals and document their
status in the certification program. The
contents required for a certificate are set
out in § 81.4 as published at 71 FR
41706.
To be consistent with the change
discussed above that animals moved
interstate must be from herds with
Certified status, we propose to change
the references in § 81.4 to herds
‘‘participating in the CWD Herd
Certification Program’’ to instead refer
to herds ‘‘that have achieved Certified
status in the CWD Herd Certification
Program.’’ We also propose to add the
following requirements to this
paragraph:
• The certificate would have to
include a statement by the issuing
accredited veterinarian, State
veterinarian, or Federal veterinarian that
the animals are not from farmed or
captive herds where CWD has been
diagnosed within the past 5 years or
epidemiologically linked to herds where
CWD has been diagnosed within the
past 5 years.
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The proposal to have a time limit of
5 years when considering CWD
infection or epidemiological linkage is
based on the same evidence cited in the
CWD final rule and in this proposal to
support the requirement for 5 years of
monitoring before a cervid may be
moved interstate. That decision was
based on several factors, including the
probable maximum incubation time for
CWD and timespans realistically needed
for reporting and evaluation of CWD
occurrences.
• The certificate would have to also
include a statement by the issuing
accredited veterinarian, State
veterinarian, or Federal veterinarian as
to whether or not the animals’ premises
are within 25 miles (40 km) of a
federally or State-identified case of
CWD in wild deer, elk, or moose, or
within 25 miles (40 km) of an area
where CWD has become established in
wild deer, elk, or moose, as defined by
APHIS and the State.
We believe that this proposed
requirement provides a reasonable
standard that can be consistently
applied and that provides the level of
additional risk reduction that meets or
exceeds that of similar current State
requirements. The proposal to set the
limits of proximity to CWD cases in the
wild at 25 miles (40 km) is consistent
with proximity guidelines used in some
State CWD programs applicable to both
captive and wild cervids, and is also
consistent with the current international
practice of several countries for
importing and exporting elk. For
example, the Quebec Department of
Agriculture, Fisheries and Food requires
a statement on certificates
accompanying elk imported into Quebec
that they are from a farm that ‘‘is located
more than 40 km from an enterprise
with an epidemiological link to a case
of CWD.’’ The United States regulations
for importing elk from Canada call for
a similar statement.7
In addition to adding this proximity
certification for moving farmed or
captive cervids interstate, we propose to
establish a list of States that do not
accept entry of farmed or captive
cervids from areas in proximity to CWD
occurrences. This list, called ‘‘States
That Limit Cervid Entry Based on
Proximity to CWD Occurrences,’’ would
be maintained and revised by APHIS,
and would be made available by APHIS
on its Web site and by mail upon
7 In ‘‘Protocol Respecting The Importation Of
Cervids From Other Provinces Or Countries Into
Quebec Under The Animal Health Protection Act
(R.S.Q., c. P–42)’’ and ‘‘Protocol For the Importation
of Farmed Cervids From Canada,’’ USDA, APHIS,
Veterinary Services, National Center for Import and
Export.
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request. The initial list would include
all States that currently have State laws
or regulations that ban entry of farmed
or captive cervids from areas in
proximity to CWD occurrences in the
wild. At any time, a State could request
to be removed from the list if it changes
to allow entry of farmed or captive
cervids from areas in proximity to CWD
occurrences in the wild. Any State not
on the list could request to be added to
the list by sending the Administrator a
written request to be added and a copy
of the State law or regulation that bans
entry of farmed or captive cervids from
areas in proximity to CWD occurrences
in the wild.
This list of States, in conjunction with
the new requirement of a certification
regarding proximity, will allow State
and Federal representatives to
determine when a shipment of cervids
may not be moved to a destination State
due to proximity restrictions. To make
it clear that these new requirements
apply in two ways—animals that do not
meet them may not be moved interstate
to listed States, and animals that do
meet them must have that fact
documented in the certificate—we
propose to redesignate the current
introductory text of § 81.3 as paragraph
(a) and add the new requirements in
subparagraphs (a)(1) and (a)(2) as set out
in the proposed regulatory text of this
document.
We are proposing one more change
related to the risks associated with
maintaining a CWD herd in proximity to
known occurrences of CWD in wild
cervids. While the level of such risk is
uncertain, it appears prudent to mitigate
the risk. A number of herds have been
long established in proximity to known
occurrences of CWD in the wild; in most
cases, the herd was established before
CWD was found in wild animals in the
area. Most of these herds have
participated in State CWD programs and
are eligible for the Federal-State
cooperative CWD program. It would be
very difficult to bar such herds from
participation in the program. It would
also be unnecessary if the herds have
already effectively complied with
program requirements for some years.
However, we have determined that it
would add to the effectiveness of CWD
control if, in the future, no new herds
were established in proximity to CWD
occurrences in the wild.
Therefore, we propose to amend
§ 55.22(a), Participation and enrollment,
by adding a provision that an
application for participation may also be
denied if APHIS or the State determines
that the applicant’s herd was
established after the effective date of a
final rule following this proposal on a
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premises within 25 miles (40 km) of a
Federally or State-identified case of
CWD in wild deer, elk, or moose, or
within 25 miles (40 km) of an area, as
defined by APHIS and the State, where
CWD has become established in wild
deer, elk or moose.
Monitoring and Surveillance of CWD in
Wild Cervids
The proposed changes discussed
above concerning proximity of herds to
known occurrences of CWD in wild
cervids would only be practical if
reliable data is available to identify
areas where CWD occurs in the wild.
States with significant wild cervid
populations currently conduct
monitoring and surveillance activities
for CWD in the wild. These activities are
often conducted by State wildlife
agencies, though some involve
agriculture agencies, and often Federal
agencies provide assistance or technical
support when resources are available to
do so. The types and extent of
surveillance for CWD in the wild vary.
The most extensive surveys rely on
testing samples submitted by hunters.
Some States also employ surveillance
methods such as harvesting and testing
a geographically targeted random
sampling of wild deer and elk, or testing
vehicle-killed cervids, to estimate CWD
distribution.
We expect States would continue
such surveillance activities. Because
several changes in this proposed rule
rely on identifying areas where CWD
occurs in the wild, we also propose to
make such continued surveillance a
requirement for a State program to
become an Approved State CWD Herd
Certification Program. Specifically, we
propose to add this requirement to the
list in § 55.23, Responsibilities of States
and enrolled herd owners, as paragraph
(a)(12).
Herd owners and Federal and State
representatives would use reports from
these monitoring and surveillance
activities to determine, for purposes of
the changes discussed above, when a
premises is ‘‘within 25 miles (40 km) of
a Federally or State-identified case of
CWD in wild deer, elk, or moose, or
within 25 miles (40 km) of an area, as
defined by APHIS and the State, where
CWD has become established in wild
deer, elk, or moose.’’
Additional Changes to Responsibilities
of States and Enrolled Herd Owners
(§ 55.23)
We propose to make several changes
to § 55.23 to clarify the responsibilities
of States and owners participating in the
cooperative Federal-State CWD
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program, and to reduce the compliance
burden where it is practical to do so.
State Enforcement of Quarantines
Paragraph (a)(4) of § 55.23 requires
States to place all known CWD-positive,
CWD-exposed, and CWD-suspect
animals and herds under movement
restrictions, with movement of animals
from those herds only for destruction or
under permit. We now propose to
expand this requirement to prohibit
CWD-positive, CWD-exposed, and
CWD-suspect herds from adding
animals to the herd from outside
sources. The CWD final rule did not
include such a requirement because it
seemed unlikely that many owners
would choose to expand herds that were
under restrictions and possibly destined
for destruction. However, there have
been some cases where the owners of
CWD-positive, CWD-exposed, and
CWD-suspect herds have added new
animals. This affects the CWD
indemnity program, which makes
indemnity available for eligible animals
based on the inventory at the time the
movement restrictions are imposed. An
increase in the size of a herd under
restriction due to CWD also causes a
corresponding increase in the program
resources devoted to the herd, and in
the amount of work for Federal and
State representatives working with the
herd. For instance, if animals from
several additional herds are added to a
CWD-exposed or CWD-suspect herd that
is later found positive for CWD, those
additional herds must also be evaluated
during traceback as possible sources of
CWD. Also, increasing the herd size
potentially increases the total number of
infected animals, and the risk of CWD
spread (e.g., more animals means more
opportunities for an animal to escape
confinement).
To address this problem, we propose
to change § 55.23(a)(4) to specifically
state that no movement of animals into
CWD-positive, CWD-exposed, and
CWD-suspect herds is allowed.
Herd Inventory Procedures
We are also proposing to make
changes to § 55.23 to address issues
concerning the practicality and the
burden on owners associated with
paragraph (b)(4), which describes herd
recordkeeping and annual inventory
requirements.
Section 55.23(b)(4) of the CWD final
rule requires owners to maintain herd
records that include a complete
inventory of animals, the age and sex of
each animal, the date of acquisition and
source of each animal that was not born
into the herd, the date of disposal and
destination of each animal, and all
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individual identification numbers (from
tags, tattoos, electronic implants, etc.)
associated with each animal. We do not
propose to change this requirement.
However, we do propose to change
other requirements in this paragraph,
which currently state that the owner
must allow an APHIS employee or State
representative access to the premises
and herd to conduct an annual physical
herd inventory to reconcile animals and
identifications with the records
maintained by the owner. The CWD
final rule currently requires that the
owner, when this physical inventory
occurs, must assemble, restrain, and
present the entire herd for inspection
under conditions where the APHIS or
State official can safely read all
identification on the animals. The
owner would be responsible for all costs
incurred to present the animals for
inspection.
Several commenters noted that it was
unclear whether an actual physical
inventory of assembled animals was
required each year, or only ‘‘upon
request.’’ They also suggested that a
physical inventory would impose a
considerable burden if conducted on an
annual basis. The CWD final rule
estimated that for a herd of 50 elk, the
annual physical inventory cost would
be approximately $1,000, including
veterinary fees of approximately $500
and hired labor costs of approximately
$500. This cost could be significantly
higher in some cases; for example, labor
costs for skilled cervid handlers are
higher in some areas, and the physical
assembly and restraint could cause
injury to some cervids, with further
costs to the owner for subsequent
veterinary care or loss of the animal.
We agree that the CWD final rule
language is unclear on the requirement
for physical inventories. Our intention
is to conduct an actual physical
inventory of assembled animals when
an APHIS employee or State
representative finds it to be needed for
program purposes. We propose that a
physical assembly would be required at
the time a herd is enrolled in the
Federal-State cooperative CWD
program, in order to provide a reliable
baseline record for the herd’s
participation. After this initial physical
assembly for inventory purposes, further
physical inventories would be
scheduled when the APHIS employee or
State representative finds it necessary to
verify herd compliance with program
standards — for example, if there has
been significant movement of animals
into or from the herd, or if other
conditions warrant a physical inventory
to confirm the herd records. Physical
inventories would usually be several
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years apart, and would never be ordered
more than once per year, unless we
determine that more frequent
inventories are needed based on
indications that the herd may not be in
compliance with CWD Herd
Certification Program requirements.
However, some type of herd inventory
would be performed annually. When the
inventory does not include physical
assembly of the entire herd, it would
include, at a minimum, review of all
owner records documenting animal
identification and records of animals
added to or removed from the herd. It
would also include observation of the
herd’s unrestrained animals in a
viewable, enclosed area or space where
the inspector could reconcile all visible
identification devices with prior records
and check for any obvious
inconsistencies between the number,
age, and gender of animals observed and
the animals documented in the owner
records. During such inventories, the
owner and the person performing the
inventory would work together to
resolve any discrepancies to the
satisfaction of the person performing the
inventory.
This proposed change should also
make it possible in many cases to plan
the timing of a physical assembly of a
herd for inventory so that it is
coordinated with cervid testing for
brucellosis and tuberculosis. Such
testing occurs for cervid herds
participating in the cooperative State–
Federal Cervid Brucellosis Program or
Cervid Tuberculosis Program. The
Uniform Methods and Rules for these
programs describe when such herds
must be assembled and tested for these
diseases. For example, to maintain a
herd’s Certified status with regard to
brucellosis, or its Accredited status with
regard to tuberculosis, the herd must be
retested for the relevant disease every 21
to 27 months under current brucellosis
and tuberculosis regulations. This
timetable may change in the future. We
expect that, in many cases, when a
cervid herd participates in the CWD
program and one or both of the
tuberculosis and brucellosis programs,
any required physical assembly of the
herd can be planned so that during a
single assembly, requirements for all of
the programs can be met. For example,
the initial physical assembly would
serve to establish and confirm the
required inventory, records, and
individual animal identification
requirements for CWD, but it could also
be used to conduct testing and any other
requirements for the tuberculosis or
brucellosis programs. If the APHIS
employee or State representative later
finds it necessary to schedule another
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physical assembly for inventory, it is
likely that it could be scheduled to
allow any required tuberculosis or
brucellosis testing to occur during the
assembly.
APHIS plans to develop additional
guidance in the future, after we gain
additional experience working with
herd inventories, to clarify when an
actual physical inventory of assembled
animals will be required, and to provide
more information on the different
activities involved in the different levels
of a physical inventory of assembled
animals. When developed, such
guidance will be made available in the
CWD program Uniform Methods and
Rules or in other program guides.
Readers should also note that in
addition to Federal regulations
concerning inventory requirements,
individual States may have
requirements in this area in State law or
regulations.
In § 55.23(b)(4) on page 41704 of the
final rule, we also inadvertently omitted
accredited veterinarians as one of the
types of officials authorized to conduct
the herd inventory. Since accredited
veterinarians play an important role in
implementing the CWD program, we
propose to change this reference to also
allow access to the premises by an
accredited veterinarian who has been
designated to conduct an inventory. To
implement these changes to inventory
requirements, we propose to revise all
but the first sentence of § 55.23(b)(4).
Enrollment Dates
Section 55.22(a)(1)(ii)(B) concerns
setting an enrollment date for herds that
enroll directly in the Federal CWD Herd
Certification Program, and ensuring that
the enrollment date gives some credit
for the time period during which herds
substantially met Certification Program
standards before they could enroll in the
Program. This paragraph reads, in part,
‘‘If APHIS determines that the herd
owner has maintained the herd in a
manner that substantially meets the
conditions specified in § 55.23(b) for
herd owners, the first day that the herd
participated in such a program.
However, in such cases the enrollment
date may not be set at a date more than
2 years prior to the date that APHIS
approved enrollment of the herd.’’
We propose to change that
requirement to allow APHIS to set an
enrollment date for such herds that is
up to 3 years prior to the date APHIS
actually processed and approved
enrollment. We propose this revision
because implementation of the
Certification Program has proceeded
more slowly than planned, in part due
to the need to resolve the issues
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discussed in this proposed rule. To
minimize possible losses to herd owners
who have managed their herds in
compliance with program requirements
but could not be formally enrolled
because no State CWD program was
available and the CWD final rule was
not in effect, we propose to allow up to
3 years’ credit instead of 2. Since this
rule also proposes to limit interstate
movement to cervids that have been
enrolled for 5 years and have achieved
Certified status, we expect this change
would affect a small number of herds
that become enrolled directly in the
Federal CWD program after the effective
date of a final rule. If such herds qualify
for 3 years’ credit upon enrollment,
animals from the herd could be moved
interstate approximately 2 years later if
and when the herd achieves Certified
status.
Confirmatory DNA Testing of Official
Test Samples
On page 41685 of the CWD final rule,
we responded to comments that
suggested that, after an animal tests
positive for CWD, the owner should
have the opportunity to have the
sample’s DNA matched to DNA from the
owner’s animal to prove that the correct
sample was tested. In response, we
stated, ‘‘With regard to DNA matching
to confirm that positive samples are
indisputably associated with the correct
animal, we plan to allow such
confirmation, at the owner’s expense,
when the owner of the CWD-positive
animal requests it. DNA verification will
be possible because our instructions on
how to collect and submit tissue
samples will require submission of all
manmade identification devices on the
animal, with part of the ear or skin to
which they are attached, in a manner
that preserves the chain of custody.’’
Since the CWD final rule was
published, APHIS has discussed this
issue with owners and laboratories and
has developed procedures to work with
owners who wish to order such
confirmatory DNA testing. In this NPRM
we propose to change paragraph (c)(1) of
§ 55.24 (71 FR 41705) of the final rule
so that such testing would be available
through the following arrangements.
At the time an owner allows tissues
samples to be collected from an animal
for official CWD testing, the owner
would be able to reserve the option for
DNA comparison testing by informing
the Federal or State representative or
accredited veterinarian who collects the
tissues. To allow for later DNA
comparison testing, the person
collecting the tissues would have to also
collect from the animal some somatic
tissue (usually an ear) that contains an
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official identification device, along with
the tissue samples routinely collected
for CWD testing (brain stem, lymph
nodes, etc.). Submitting tissues attached
to an official ID device establishes a
reliable chain of custody that allows
later DNA tests to be compared to a
tissue sample that verifiably comes from
the owner’s animal in question.
If the CWD official tests show that
owner’s animal is CWD-positive, the
owner could employ the appeal
provisions of § 55.24(c) to request that
the tissue samples that were tested for
CWD be compared to the ear or other
tissues submitted with the animal ID
attached. If the DNA in the tissues
tested for CWD and the DNA in the
tissues attached to the ID device match,
there is confidence that the positive
CWD tests do in fact pertain to the
correct animal. If the DNA in the
respective test results does not match,
that may justify the Administrator
granting the appeal. In such cases the
animal would be redesignated CWDsuspect pending further investigation to
establish the final proper status of the
animal and its herd.
We propose that if an owner requests
confirmatory DNA testing, the owner
would pay for the cost of the test. If this
proposed rule is adopted as final,
APHIS will publish additional guidance
on how to request confirmatory DNA
testing and how to arrange payment for
such tests.
To recognize this procedure in the
regulations, we propose making changes
to the CWD final rule to document the
owner’s right to order and pay for
confirmatory DNA testing when one or
more of the owner’s animals tests
positive for CWD. We would change
paragraph (c)(1) of § 55.24, which deals
with an owner’s right to appeal the
designation of their herd’s status, by
adding a provision for appeals based on
the results of a DNA test requested and
paid for by the owner to determine
whether previous official CWD test
results were correctly associated with an
animal that belonged to the owner.
Miscellaneous Changes
We also propose to change the
definition of premises identification
number (PIN) in parts 55 and 81 and to
add a definition for National Uniform
Eartagging System to both parts. These
proposed changes are intended to
achieve greater standardization and
uniformity of official numbering
systems and eartags used in the National
Animal Identification System and in
animal disease programs and to enhance
animal traceability. We also propose to
add the following sentence to the
definition of official animal
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14501
identification: ‘‘The CWD program
allows the use of either the eightcharacter or nine-character format for
cervids.’’ This proposed change would
allow use of either larger eartags with
nine-character unique numbers, or
smaller eartags with eight-character
numbers. We propose to allow use of
both size tags because the use of the
smaller eartags is sometimes advisable
to reduce stress on younger elk and
deer.
Executive Order 12866 and Regulatory
Flexibility Act (RFA)
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.
In accordance with 5 U.S.C. 603, we
have performed an initial regulatory
flexibility analysis, which is set out
below, regarding the potential effects of
the proposed action on small entities.
This initial analysis indicates that the
benefits of the proposed action would
exceed its costs. We do not currently
have all the data necessary for a
comprehensive analysis of the effects of
this rule on small entities. Therefore, we
are inviting comments concerning
potential effects.
The changes proposed in this
document would, if adopted, modify the
requirements set forth in the CWD final
rule.8 For that reason, the economic
analysis that follows considers the
impact of the proposed changes using
the CWD final rule as a baseline. An
economic analysis was prepared for the
CWD final rule, and that analysis is
incorporated in this document by
reference.
The proposed changes would have the
most impact on cervid farms, most of
which are believed to be small in size
under the U.S. Small Business
Administration’s standards.
The proposal to remove the gradualescalation monitoring period
requirement for interstate movement
and replace it with a 5-year minimum
requirement would adversely impact
current farmers with less than 5 years in
the program who wish to ship at least
some of their animals interstate for
purposes other than slaughter. The
number of such farmers is unknown,
although it is estimated that many, if not
most, herd owners who rely on
interstate movement for the success of
8 The effective date of the CWD final rule, which
was published in the Federal Register on July 21,
2006 (71 FR 41682–41707, Docket No. 00–108–3),
has been delayed pending consideration of the
changes proposed in this document.
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their businesses already meet the 5-year
standard by way of their participation in
an existing State CWD certification
program. Under the proposal, time spent
in an APHIS-approved State program
would count towards the time needed to
satisfy the 5-year requirement, and
many farmers have participated in a
State program for at least 5 years. It is
estimated that at least 20 States have
formal CWD certification programs for
cervids in place.
Any adverse impact of the proposed
5-year standard on current farmers
would be further muted to the extent
that a number of States have already
adopted that standard themselves.
Currently, States have the authority to
regulate farmed cervids, including the
authority to establish requirements for
entry of cervids. In response to APHIS’
CWD proposed rule published in
December 2003, and its CWD final rule
published in July 2006, several States
have decided to adopt a 5-year
monitoring period requirement for
cervids entering those States. Both the
December 2003 proposed rule and the
July 2006 final rule included an
eventual 5-year monitoring period
requirement for interstate movement.
For those farmers who would be
adversely affected by a shift to a 5-year
monitoring period requirement, the
economic impact would vary depending
on the circumstances of each—such as
the time, if any, already spent in a State
program, the number and value of
animals that would otherwise be
shipped interstate, and the alternative
opportunities available for sales within
the State. Although data for individual
herd owners are not available, those
who are located in States that do not
now have a State program and who
cannot qualify for a herd status upgrade
would likely suffer the most severe
economic consequences, since they
would have to participate in the Federal
program (or a newly established State
program) for 5 years before they could
move their cervids interstate.9 Under
the CWD final rule, these same herd
owners would have been able to move
their animals interstate after only 1 year
in the program. (For these and other
herd owners who do not meet the 5-year
monitoring requirement, the only
alternative under the proposal that
would allow for earlier interstate
movement would be to sell or otherwise
dispose of their existing cervids and
replace them with animals from a herd
with higher status. However, this
9 Herd owners who are not in a State program but
who can demonstrate that they have maintained
their herds in a manner that would substantially
meet the program conditions established by APHIS
may qualify for up to 3 years’ enrollment credit.
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alternative would not come without a
price; all else being equal, the cost of
each replacement cervid is likely to
exceed the proceeds from the sale or
disposition of each existing animal,
given the former’s higher status.) It is
conceivable that the shift to a 5-year
monitoring requirement could
effectively force some farmers out of the
cervid business, especially those with
little or no time in State programs. On
the other hand, the change that would
allow APHIS to set an enrollment date
for herds that is up to 3 years prior to
the date APHIS actually processed and
approved enrollment should preclude
this outcome for most herds.
The adoption of the proposed 5-year
monitoring period requirement could
also impact prospective new entrants
into the cervid farming business, to the
extent that it requires them to acquire
higher status, and presumably more
costly, animals when initially stocking
their herds. Under the proposal, for
example, new entrants would be eligible
to ship their animals interstate
immediately only if they stocked their
herds with cervids from certified herds.
By contrast, the CWD final rule would
have allowed new entrants to ship
interstate immediately with animals
acquired from herds having as low as
Second Year status.
Relative to the CWD final rule, the
impact on farmers of the proposal to
give States the option to ban the entry
of certain farmed and captive cervids is
uncertain. We propose to allow States
that completely prohibit the entry of
farmed or captive cervids for reasons
which are unrelated to CWD (e.g., for
genetic purity or environmental reasons)
to continue to do so. We also propose
that States may decline to accept cervids
from areas in proximity to CWD
outbreaks. In both cases, impacts on
States that have either type of ban
would be nonexistent or minimal. The
difference in impacts regarding State
bans between this proposal and the final
rule may be considered as follows. On
the one hand, the CWD final rule would
have given farmers with potentially
risky animals access to markets in other
States that are currently closed to them.
On the other hand, there is no
assurance, even if the CWD final rule
had been in effect, that farmers would
have been able to sell a significant
number of their high-risk animals in
those markets anyway. The market for
cervids that are near CWD occurrences
is limited, given the animals’ added
disease risk, and the absence of a ban
option in the CWD final rule would not
have removed that risk.
Relative to the current situation, the
proposal to give States the option to ban
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the entry of certain cervids would have
no impact, since all States have that
option now. Currently, several States
have elected not to accept cervids if
they came from areas in proximity to
CWD in the wild.
The proposal to prohibit the program
participation of herds established in the
future in areas in proximity to CWD
occurrences in wild cervids should have
little or no impact. There are two
reasons. First, the proposal affects
newly established herds only, so no
current farmers would be affected.
Second, it is likely that few, if any,
farmers would want to establish a new
herd in areas in proximity to CWD in
the wild, given the added disease risk
and the attendant adverse marketing
consequences noted above.
The proposal to define ‘‘proximity’’ as
within 25 miles (40 km) of a CWD
occurrence should benefit herd owners
and the States, to the extent that it
removes uncertainty that may now exist
surrounding the definition of that term.
The proposed definition is also
consistent with current international
practice for importing and exporting elk.
The proposal to require States to
conduct monitoring and surveillance for
CWD in wild cervids in order to become
an approved State CWD program should
have little or no impact. This is because
such monitoring and surveillance is
already being conducted by those States
with significant cervid populations,
including those without a CWD
program.10
The proposal to prohibit CWDpositive, -exposed, and -suspect herds
that are under State quarantine from
adding animals to the herd from outside
sources should have little impact, since
few herds would be affected. It is
estimated that, over the last several
years, no more than about two or three
cervid herds under quarantine have
added animals from outside sources,
usually for hunting purposes.
The proposal to modify the herd
inventory requirements has the
potential to favorably impact herd
owners. Under the CWD final rule, herd
owners would be required to conduct a
physical inventory of assembled and
restrained cervids annually. Under this
proposed revision to the final rule, a
physical inventory would be required at
10 These activities are often conducted by State
wildlife agencies, though some involve agriculture
agencies, and often receive assistance or technical
support from Federal agencies. If Federal assistance
or support is reduced or withdrawn altogether in
the future, the States would have to bear more or
all of the cost of surveillance activities if they
wanted to remain an approved State CWD program.
At this time, there is no reason to believe that
Federal assistance or support will be reduced or
withdrawn in the future.
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the time a herd is enrolled in a CWD
program, and then only on an as-needed
basis thereafter to verify compliance
with program standards.11 The
proposed rule would still require an
annual herd inventory—including a
review of owner records and an
observation of the herd’s unrestrained
animals in a viewable, enclosed area—
but it would not require that the animals
be physically assembled and restrained.
Since herd owners are responsible for
all costs incurred in conducting a herd
inventory, the proposal has the potential
to offer them significant ongoing annual
savings. This is because a herd
inventory that does not require that the
animals be physically assembled and
restrained is less costly than one that
does. The CWD final rule estimated that
for a herd of 50 elk, the annual physical
inventory (with the animals assembled
and restrained) would cost
approximately $1,000, including
veterinary fees of approximately $500
and hired labor costs of approximately
$500. This cost could be significantly
higher in some cases; for example, labor
costs for skilled cervid handlers are
higher in some areas, and the physical
assembly and restraint could cause
injury to some cervids, with further
costs to the owner for subsequent
veterinary care or loss of the animal. By
contrast, a ‘‘nonphysical’’ herd
inventory can be scheduled at a time
when it is likely to add only minimally
to herd owner operating costs, since
most of the activities required for such
an inventory are performed from time to
time as part of routine herd
management.
This proposed change to the herd
inventory requirements should also
make it possible in many cases to plan
the timing of a physical inventory so
that it is coordinated with cervid testing
for brucellosis and tuberculosis. Such
testing occurs for cervid herds
participating in the cooperative StateFederal Cervid Brucellosis Program or
Cervid Tuberculosis Program. The
Uniform Methods and Rules for these
programs describe when such herds
must be assembled and tested for these
diseases. For example, to maintain a
herd’s Certified status with regard to
brucellosis, or its Accredited status with
regard to tuberculosis, the herd must be
retested for the relevant disease every 21
to 27 months (under current brucellosis
11 APHIS has not yet developed guidelines for
determining when a post-initial enrollment
physical inventory would be required. The agency
plans to do so in the future, after it gains additional
experience working with herd inventories. When
developed, such guidance will be made available in
the CWD program Uniform Methods and Rules or
in other program guides.
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and tuberculosis regulations; this
timetable may change in the future). We
expect that, in many cases, when a
cervid herd participates in the CWD
program and one or both of the
tuberculosis and brucellosis programs,
any required physical inventory can be
planned so that the requirements for all
of the programs can be met during a
single animal assembly. The initial and
any subsequent physical inventories
required for CWD purposes could also
be used to conduct testing and any other
requirements for the tuberculosis or
brucellosis programs.
A very small number of herd owners
may benefit from the new confirmatory
DNA test provisions for animals that test
CWD positive, in cases where a low-cost
confirmatory test shows that positive
test results were not associated with the
correct animal. The number of herd
owners who would benefit from the
proposal to modify the herd inventory
requirements is unknown.
The changes proposed in this
document could be expected to have
both positive and negative economic
consequences for cervid farmers.
Potentially, more cervid farmers stand
to benefit than not, given that the
proposal to modify the herd inventory
requirements has the potential to offer
significant ongoing annual cost savings
to all program participants, but any
adverse impact stemming from the
proposed shift to a 5-year monitoring
period requirement would be temporary
and probably affect far fewer farmers.
The proposed rule has no new
mandatory reporting, recordkeeping, or
other compliance requirements for U.S.
entities. Requirements associated with
the earlier final rule were discussed in
that rule.
The RFA requires agencies to identify,
to the extent practicable, any Federal
rule that may duplicate, overlap, or
conflict with the proposed rule. APHIS
has not identified any duplication,
overlap, or conflict of the proposed rule
with other Federal rules.
Finally, the RFA requires agencies to
describe any significant alternatives to
the proposed rule that accomplish the
stated objectives of applicable statutes
and that minimize any significant
economic impact of the proposed rule
on small entities. We do not have details
about the size of the 2,371 elk farms and
4,901 deer farms in the United States.
However, it is reasonable to assume that
most are small in size, under the U.S.
Small Business Administration’s (SBA)
standards. This assumption is based on
composite data for providers of the same
and similar services. In 2002, there were
41,238 U.S. farms in NAICS 11299, a
classification comprised solely of
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14503
establishments primarily engaged in
raising certain animals (including deer
and elk but excluding cattle, hogs and
pigs, poultry, sheep and goats, animal
aquaculture, apiculture, horses and
other equines, and fur-bearing animals).
For all 41,238 farms, the per farm
average gross receipts in 2002 was
$39,868, well below the SBA’s small
entity threshold of $750,000 for farms in
that NAICS category.
Of the proposed changes, the shift to
a 5-year monitoring period requirement
for interstate movement has the
potential to have the most significant
adverse impact on both small and large
cervid farmers. However, leaving the
gradual-escalation monitoring period
requirement in place would be
unsatisfactory, because the available
research suggests that it may not
provide an adequate level of protection
against the spread of CWD. Most
researchers and State CWD programs
agree that 5 years is a reasonable upper
bound for the incubation period for
CWD.
APHIS invites public comment on the
rule’s expected economic impacts,
including any comment on the impact
for 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.).
Lists of Subjects
9 CFR Part 55
Animal diseases, Cervids, Chronic
wasting disease, Deer, Elk, Indemnity
payments, Moose.
9 CFR Part 81
Animal diseases, Cervids, Deer, Elk,
Moose, Quarantine, Reporting and
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recordkeeping requirements,
Transportation.
Accordingly, we propose to amend 9
CFR parts 55 and 81 as previously
amended at 71 FR 41682–41707 on July
21, 2006, as follows:
PART 55—CONTROL OF CHRONIC
WASTING DISEASE
1. The authority citation for part 55
continues to read as follows:
Authority: 7 U.S.C. 8301–8317; 7 CFR
2.22, 2.80, and 371.4.
2. Section 55.1 is amended as follows.
a. By adding a definition for National
Uniform Eartagging System, in
alphabetical order, to read as set forth
below.
b. In the definition of official animal
identification, by adding at the end of
paragraph (1) the sentence ‘‘The CWD
program allows the use of either the
eight-character or nine-character format
for cervids.’’
c. By revising the definition for
premises identification number (PIN) to
read as set forth below.
§ 55.1
Definitions.
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*
*
*
*
*
National Uniform Eartagging System.
A numbering system for the official
identification of individual animals in
the United States providing a nationally
unique identification number for each
animal. The National Uniform
Eartagging System employs an eight- or
nine-character alphanumeric format,
consisting of a two-number State or
territory code, followed by two or three
letters and four additional numbers.
Official APHIS disease control programs
may specify which format to employ.
*
*
*
*
*
Premises identification number (PIN).
A nationally unique number assigned by
a State, Tribal, and/or Federal animal
health authority to a premises that is, in
the judgment of the State, Tribal, and/
or Federal animal health authority, a
geographically distinct location from
other premises. The premises
identification number is associated with
an address, geospatial coordinates, and/
or location descriptors which provide a
verifiably unique location. The premises
identification number may be used in
conjunction with a producer’s own
livestock production numbering system
to provide a unique identification
number for an animal. It may also be
used as a component of a group/lot
identification number. Premises
identification numbers issued on or
after [Insert effective date of final rule]
shall consist of a seven-character
alphanumeric code, with the right-most
character being a check digit. The check
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14:34 Mar 30, 2009
Jkt 217001
digit number is based upon the ISO
7064 Mod 36/37 check digit algorithm.
*
*
*
*
*
3. Section 55.22 is amended as
follows:
a. In the introductory text of
paragraph (a), by adding a sentence
following the third sentence to read as
set forth below.
b. In paragraph (a)(1)(ii)(B), by
removing the words ‘‘2 years prior’’ and
adding the words ‘‘3 years prior’’ in
their place.
§ 55.22
Participation and enrollment.
(a) * * * An application for
participation may also be denied if
APHIS or the State determines that the
applicant’s herd was established after
[insert effective date of final rule] on a
premises within 25 miles (40 km) of a
Federally or State-identified case of
CWD in wild deer, elk, or moose, or
within 25 miles (40 km) of an area, as
defined by APHIS and the State, where
CWD has become established in wild
deer, elk, or moose. * * *
*
*
*
*
*
4. Section 55.23 is amended as
follows:
a. By revising paragraph (a)(4) to read
as set forth below.
b. By adding a new paragraph (a)(12)
to read as set forth below.
c. By revising paragraph (b)(4) to read
as set forth below.
§ 55.23 Responsibilities of States and
enrolled herd owners.
(a) * * *
(4) Has placed all known CWDpositive, CWD-exposed, and CWDsuspect animals and herds under
movement restrictions, with no
movement of animals allowed into such
herds and with movement of animals
from them only for destruction or under
permit.
*
*
*
*
*
(12) Conducts monitoring and
surveillance activities to estimate
geographic distribution of CWD in the
State.
(b) * * *
(4) The owner must maintain herd
records that include a complete
inventory of animals that states the age
and sex of each animal, the date of
acquisition and source of each animal
that was not born into the herd, the date
of disposal and destination of any
animal removed from the herd, and all
individual identification numbers (from
tags, tattoos, electronic implants, etc.)
associated with each animal. Upon
request by an APHIS employee or State
representative, the owner must allow
either of these officials or a designated
accredited veterinarian access to the
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Fmt 4702
Sfmt 4702
premises and herd to conduct an
inventory. The owner will be
responsible for assembling, handling,
and restraining the animals and for all
costs incurred to present the animals for
inspection. The APHIS employee or
State representative may order either an
inventory that consists of review of herd
records with visual examination of an
enclosed group of animals, or a
complete physical herd inventory with
verification to reconcile all animals and
identifications with the records
maintained by the owner. In the latter
case the owner must present the entire
herd for inspection under conditions
where the APHIS employee, State
representative, or accredited
veterinarian can safely read all
identification on the animals. During
inventories, the owner must cooperate
with the inspector to resolve any
discrepancies to the satisfaction of the
person performing the inventory.
Inventory of a herd will be conducted
no more frequently than once per year,
unless an APHIS employee, State
representative, or accredited
veterinarian determines that more
frequent inventories are needed based
on indications that the herd may not be
in compliance with CWD Herd
Certification Program requirements.
*
*
*
*
*
5. In § 55.24, paragraph (c)(1) is
revised to read as follows:
§ 55.24
Herd status.
*
*
*
*
*
(c) * * *
(1) Herd owners may appeal
designation of an animal as CWDpositive, cancellation of enrollment of a
herd, or loss or suspension of herd
status by writing to the Administrator
within 10 days after being informed of
the reasons for the action. The appeal
must include all of the facts and reasons
upon which the herd owner relies to
show that the reasons for the action are
incorrect or do not support the action.
Specifically, to appeal designation of an
animal as CWD-positive, the owner may
present as evidence the results of a DNA
test requested and paid for by the owner
to determine whether previous official
CWD test results were correctly
associated with an animal that belonged
to the owner. If the owner intends to
present such test results as evidence, he
or she shall request the tests and state
this in the written notice sent to the
Administrator. In such cases the
Administrator may postpone a decision
on the appeal for a reasonable period
pending receipt of such test results. To
this end, approved laboratories are
authorized to conduct DNA tests to
compare tissue samples tested for CWD
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to samples from tissues that were
collected at the same time by the
accredited veterinarian or Federal or
State veterinarian and are attached to an
official identification device. Such DNA
tests are available only if the animal
owner arranged to submit animal tissue
attached to an official identification
device along with the other tissues that
were collected for the official CWD test.
The Administrator will grant or deny
the appeal in writing as promptly as
circumstances permit, stating the reason
for his or her decision. If the
Administrator grants an appeal of the
status of a CWD-positive animal, the
animal shall be redesignated as CWDsuspect pending further investigation to
establish the final status of the animal
and its herd. If there is a conflict as to
any material fact, a hearing will be held
to resolve the conflict. Rules of practice
concerning the hearing will be adopted
by the Administrator.
*
*
*
*
*
PART 81—CHRONIC WASTING
DISEASE IN DEER, ELK, AND MOOSE
6. The authority citation for part 81
continues to read as follows:
Authority: 7 U.S.C. 8301–8317; 7 CFR
2.22, 2.80, and 371.4.
7. Section 81.1 is amended as follows:
a. By removing the definitions for
CWD-positive animal, CWD-exposed
animal, and CWD-suspect animal.
b. By adding a definitions for National
Uniform Eartagging System, in
alphabetical order, to read as set forth
below.
c. In the definition of official animal
identification, by adding at the end of
paragraph (1) the sentence ‘‘The CWD
program allows the use of either the
eight-character or nine-character format
for cervids.’’
d. By revising the definition of
premises identification number (PIN) to
read as set forth below.
§ 81.1
Definitions.
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*
*
*
*
*
National Uniform Eartagging System.
A numbering system for the official
identification of individual animals in
the United States providing a nationally
unique identification number for each
animal. The National Uniform
Eartagging System employs an eight- or
nine-character alphanumeric format,
consisting of a two-number State or
territory code, followed by two or three
letters and four additional numbers.
Official APHIS disease control programs
may specify which format to employ.
*
*
*
*
*
Premises identification number (PIN).
A nationally unique number assigned by
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14:34 Mar 30, 2009
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a State, Tribal, and/or Federal animal
health authority to a premises that is, in
the judgment of the State, Tribal, and/
or Federal animal health authority, a
geographically distinct location from
other premises. The premises
identification number is associated with
an address, geospatial coordinates, and/
or location descriptors which provide a
verifiably unique location. The premises
identification number may be used in
conjunction with a producer’s own
livestock production numbering system
to provide a unique identification
number for an animal. It may also be
used as a component of a group/lot
identification number. Premises
identification numbers issued on or
after [Insert effective date of final rule]
shall consist of a seven-character
alphanumeric code, with the right-most
character being a check digit. The check
digit number is based upon the ISO
7064 Mod 36/37 check digit algorithm.
8. Section 81.3 is amended as follows:
a. By redesignating paragraphs (a), (b),
(c), (d), and (e) as paragraphs (b), (c), (d),
(e), and (f), respectively.
b. By redesignating the introductory
text as paragraph (a) introductory text
and adding new paragraphs (a)(1) and
(a)(2) to read as set forth below.
c. By revising newly designated
paragraph (b) to read as set forth below.
§ 81.3
General restrictions.
(a) No farmed or captive deer, elk, or
moose may be moved interstate unless
it meets the requirements of this section.
(1) No farmed or captive deer, elk, or
moose may be moved interstate from
farmed or captive herds where CWD has
been diagnosed within the past 5 years
or epidemiologically linked to herds
where CWD has been diagnosed within
the past 5 years.
(2) No farmed or captive deer, elk, or
moose may be moved interstate to any
State listed on the list of States That
Limit Cervid Entry Based on Proximity
to CWD Occurrences 1 unless the
certificate accompanying the animal
states that its premises are at least 25
miles (40 km) from any location where
a Federal or State agency identified a
case of CWD in wild deer, elk, or moose,
and from any area, as defined by APHIS
and the State, where CWD has become
established in wild deer, elk, or moose.
This list is maintained by the
Administrator, and a State will be added
to or removed from the list after the
Administrator receives a written request
to do so from the State government,
documenting that State law or
regulation bans the movement into the
1 This list will be maintained on the APHIS Web
site at https://www.aphis.usda.gov.
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Fmt 4702
Sfmt 4702
14505
State of farmed or captive cervids from
herds in proximity to CWD occurrences,
or documenting that such a ban in State
law or regulation has been repealed.
(b) Animals in the CWD Herd
Certification Program. The farmed or
captive deer, elk, or moose is:
(1) Enrolled in the CWD Herd
Certification Program and the herd has
achieved Certified status in accordance
with § 55.24 of this chapter; and
(2) Is accompanied by a certificate
issued in accordance with § 81.4 that
identifies its herd of origin and that
states that the animal’s herd has
achieved Certified status and that the
animal does not show clinical signs
associated with CWD.
*
*
*
*
*
9. In § 81.4, paragraph (a) is revised to
read as follows:
§ 81.4
Issuance of certificates.
(a) Information required on
certificates. A certificate must show any
official animal identification numbers of
each animal to be moved. A certificate
must also show the number of animals
covered by the certificate; the purpose
for which the animals are to be moved;
the points of origin and destination; the
consignor; and the consignee. The
certificate must include a statement by
the issuing accredited veterinarian,
State veterinarian, or Federal
veterinarian that the animals were not
exhibiting clinical signs associated with
CWD at the time of examination and
that the animals are from a herd that has
achieved Certified status in the CWD
Herd Certification Program, and must
provide the herd’s program status;
Except that, certificates issued for
animals moved directly to slaughter do
not need to state that the animals are
from a herd that has achieved Certified
status in the CWD Herd Certification
Program and must state that an APHIS
employee or State representative has
been notified in advance of the date the
animals are being moved to slaughter.
The certificate must also include a
statement by the issuing accredited
veterinarian, State veterinarian, or
Federal veterinarian that the animals are
not from farmed or captive herds where
CWD has been diagnosed within the
past 5 years or epidemiologically linked
to herds where CWD has been
diagnosed within the past 5 years. The
certificate must also include a statement
by the issuing accredited veterinarian,
State veterinarian, or Federal
veterinarian as to whether or not the
animals’ premises are within 25 miles
(40 km) of a Federally or State-identified
case of CWD in wild deer, elk, or moose,
or within 25 miles (40 km) of an area,
as defined by APHIS and the State,
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where CWD has become established in
wild deer, elk or moose.
*
*
*
*
*
10. A new § 81.5 is added to read as
follows:
§ 81.5 State prohibitions on cervid
movement not related to CWD.
State laws and regulations prohibiting
the entry of farmed or captive cervids
for reasons unrelated to CWD are not
preempted by this part.
Done in Washington, DC, this 25th day of
March 2009.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E9–7026 Filed 3–30–09; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade
Bureau
Trade Bureau, P.O. Box 14412,
Washington, DC 20044–4412; or
• Hand Delivery/Courier in Lieu of
Mail: Alcohol and Tobacco Tax and
Trade Bureau, 1310 G Street, NW., Suite
200–E, Washington, DC 20005.
See the Public Participation section of
this notice for specific instructions and
requirements for submitting comments,
and for information on how to request
a public hearing.
You may view copies of this notice,
any comments received, and the related
temporary rule at https://
www.regulations.gov. A direct link to
the appropriate Regulations.gov docket
is also available under Notice No. 93 on
the TTB Web site at https://www.ttb.gov/
regulations_laws/all_rulemaking.shtml.
You also may view copies of these
documents by appointment at the TTB
Information Resource Center, 1310 G
Street, NW., Washington, DC 20220. To
make an appointment, call 202–927–
2400.
domestic production facilities and
brought to the United States from Puerto
Rico. In addition, TTB is responsible for
collecting the floor stocks tax imposed
by CHIPRA on tobacco products (except
large cigars) and cigarette papers and
tubes held for sale on April 1, 2009.
The temporary regulations published
elsewhere in this issue of the Federal
Register involve amendments to parts
40, 41, 44, 46, and 71 of the TTB
regulations (27 CFR parts 40, 41, 44, 46,
and 71). The text of the temporary
regulations serves as the text of these
proposed regulations. The preamble to
the temporary regulations explains the
proposed regulations.
For
questions concerning floor stocks tax,
contact the National Revenue Center,
Alcohol and Tobacco Tax and Trade
Bureau (FloorStocksTax@ttb.gov, 513–
684–3334 or 1–877–TTB–FAQS (1–877–
882–3277)); for other questions
concerning this document, contact Amy
Greenberg, Regulations and Rulings
Division, Alcohol and Tobacco Tax and
Trade Bureau (202–927–8210).
SUPPLEMENTARY INFORMATION:
You may submit comments on this
notice by one of the following three
methods:
• Federal e-Rulemaking Portal: You
may electronically submit comments on
this notice through ‘‘Regulations.gov,’’
the Federal e-rulemaking portal. A
direct link to the Regulations.gov docket
containing this notice and its related
comment submission form is available
on the TTB Web site at https://
www.ttb.gov/regulations_laws/
all_rulemaking.shtml under Notice No.
93. You may also reach this notice and
its related comment form via the
Regulatons.gov search page at https://
www.regulations.gov. Supplemental
files may be attached to comments
submitted via Regulations.gov. For
complete instructions on how to use
Regulations.gov, visit the site and click
on ‘‘User Guide’’ under ‘‘How to Use
this Site.’’
• Mail: You may send written
comments to the Director, Regulations
and Rulings Division, Alcohol and
Tobacco Tax and Trade Bureau, P.O.
Box 14412, Washington, DC 20044–
4412.
• Hand Delivery/Courier: You may
hand-carry your comments or have them
hand-carried to the Alcohol and
Tobacco Tax and Trade Bureau, 1310 G
Street, NW., Suite 200–E, Washington,
DC 20005.
Please submit your comments by the
closing date shown above in this notice.
Your comments must reference Notice
No. 93 and include your name and
mailing address. Your comments also
must be made in English, be legible, and
be written in language acceptable for
public disclosure. We do not
FOR FURTHER INFORMATION CONTACT:
27 CFR Parts 40, 41, 44, 46, and 71
[Docket No. TTB–2009–0001; Notice No. 93;
Re: T.D. TTB–75]
RIN 1513–AB70
Increase in Tax Rates on Tobacco
Products and Cigarette Papers and
Tubes; Floor Stocks Tax on Certain
Tobacco Products, Cigarette Papers,
and Cigarette Tubes; and Changes to
Basis for Denial, Suspension, or
Revocation of Permits (2009R–118P)
Alcohol and Tobacco Tax and
Trade Bureau, Treasury.
ACTION: Notice of proposed rulemaking;
cross-reference to temporary rule.
tjames on PRODPC61 with PROPOSALS
AGENCY:
SUMMARY: Elsewhere in this issue of the
Federal Register, the Alcohol and
Tobacco Tax and Trade Bureau is
issuing a temporary rule implementing
certain provisions of the Children’s
Health Insurance Program
Reauthorization Act of 2009 (CHIPRA).
The text of the regulations in the
temporary rule published in the Rules
and Regulations section of this issue of
the Federal Register serves as the text
of the proposed regulations.
DATES: Comments must be received on
or before June 1, 2009.
ADDRESSES: You may send comments on
this notice to one of the following
addresses:
• https://www.regulations.gov (via the
online comment form for this notice as
posted within Docket No. TTB–2009–
0001 at ‘‘Regulations.gov,’’ the Federal
e-rulemaking portal);
• Director, Regulations and Rulings
Division, Alcohol and Tobacco Tax and
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14:34 Mar 30, 2009
Jkt 217001
Background
In the Rules and Regulations section
of this issue of the Federal Register, we
are publishing a temporary rule setting
forth regulatory amendments to
implement certain provisions of the
Children’s Health Insurance Program
Reauthorization Act of 2009 (CHIPRA).
The temporary rule amends the existing
regulations to reflect increases in the tax
rates on tobacco products and cigarette
papers and tubes, revising existing floor
stocks tax regulations to reflect the
scope of the CHIPRA floor stocks tax
provisions, and revising existing
regulations to include the new statutory
criteria for denial, suspension, or
revocation of tobacco permits.
The Alcohol and Tobacco Tax and
Trade Bureau (TTB) is responsible for
the administration of the Internal
Revenue Code of 1986 provisions
relating to qualification of
manufacturers of tobacco products and
cigarette papers and tubes, importers of
those products, and export warehouses
for those products. TTB is also
responsible for collecting the excise
taxes on tobacco products and cigarette
papers and tubes removed from
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
Public Participation
Comments Invited
We invite comments from interested
members of the public on this proposed
rulemaking.
Submitting Comments
E:\FR\FM\31MRP1.SGM
31MRP1
Agencies
[Federal Register Volume 74, Number 60 (Tuesday, March 31, 2009)]
[Proposed Rules]
[Pages 14495-14506]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7026]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 74, No. 60 / Tuesday, March 31, 2009 /
Proposed Rules
[[Page 14495]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 55 and 81
[Docket No. 00-108-7]
RIN 0579-AB35
Chronic Wasting Disease Herd Certification Program and Interstate
Movement of Farmed or Captive Deer, Elk, and Moose
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: We are proposing further amendments that would establish a
herd certification program to eliminate chronic wasting disease from
farmed or captive cervids in the United States. Under the 2006 Chronic
Wasting Disease (CWD) rule, participating deer, elk, and moose herds
would have to follow CWD Herd Certification Program requirements for
animal identification, testing, herd management, and movement of
animals into and from herds. This document proposes additional changes
to the program regarding recognition of State bans on the entry of
farmed or captive cervids for reasons unrelated to CWD, the number of
years an animal must be monitored for CWD before it may move
interstate, interstate movement of cervids that originated from herds
in proximity to a CWD outbreak, herd inventory procedures, and several
other matters. These actions are intended to help eliminate CWD from
the farmed or captive cervid herds in the United States.
DATES: We will consider all comments that we receive on or before June
1, 2009.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0118 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send two copies of
your comment to Docket No. 00-108-7, 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. 00-108-7.
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. Dean E. Goeldner, Senior Staff
Veterinarian, Ruminant Health Programs, VS, APHIS, 4700 River Road Unit
43, Riverdale, MD 20737-1231; (301) 734-4916.
SUPPLEMENTARY INFORMATION:
Background
Chronic wasting disease (CWD) is a transmissible spongiform
encephalopathy (TSE) of cervids (members of Cervidae, the deer family)
that, as of October, 2008, has been found only in wild and captive
animals in North America and in captive animals in the Republic of
Korea. First recognized as a clinical ``wasting'' syndrome in 1967, the
disease is typified by chronic weight loss leading to death. There is
no known relationship between CWD and any other TSE of animals or
people. Species known to be susceptible to CWD via natural routes of
transmission include Rocky Mountain elk, mule deer, white-tailed deer,
black-tailed deer, and moose.
In the United States, CWD has been confirmed in free-ranging deer
and elk in Colorado, Illinois, Kansas, Nebraska, New Mexico, New York,
South Dakota, Utah, West Virginia, Wisconsin, and Wyoming, and, as of
October 2008, in 32 farmed elk herds and 11 farmed or captive white-
tailed deer herds in Colorado, Kansas, Michigan, Minnesota, Montana,
Nebraska, New York, Oklahoma, South Dakota, and Wisconsin. The disease
was first detected in U.S. farmed elk in 1997. It was also diagnosed in
a wild moose in Colorado in 2005.
Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the
Secretary of Agriculture has the authority to issue orders and
promulgate regulations to prevent the introduction into the United
States and the dissemination within the United States of any pest or
disease of livestock. The Animal and Plant Health Inspection Service's
(APHIS') regulations in 9 CFR subchapter B govern cooperative programs
to control and eradicate communicable diseases of livestock.
On July 21, 2006, we published a final rule in the Federal Register
(71 FR 41682, Docket No. 00-108-3; ``the CWD final rule'') amending 9
CFR subchapter B by establishing regulations in part 55 for a Chronic
Wasting Disease Herd Certification Program to help eliminate chronic
wasting disease (CWD) from the farmed or captive cervid herds in the
United States. Under that rule, owners of deer, elk, and moose herds
who choose to participate would have to follow the program requirements
of a cooperative State-Federal program for animal identification,
testing, herd management, and movement of animals into and from herds.
The CWD final rule also amended 9 CFR subchapter C by establishing a
new part 81 containing interstate movement requirements to prevent the
spread of CWD.
After publication of the CWD final rule, but before its effective
date, APHIS received three petitions requesting reconsideration of
several requirements of the rule. On September 8, 2006, we published a
notice in the Federal Register (71 FR 52983, Docket No. 00-108-4) that
delayed the effective date of the CWD final rule while APHIS considered
those petitions. On November 3, 2006, we published another notice in
the Federal Register (71 FR 64650-64651, Docket No. 00-108-5) that
described the nature of the petitions and made the petitions available
for public review and comment, with a comment period closing date of
December 4, 2006. We subsequently extended that comment
[[Page 14496]]
period until January 3, 2007, in a Federal Register notice published on
November 21, 2006 (71 FR 67313, Docket No. 00-108-6).
We received 77 comments by that date. They were from cervid
producer associations, individual cervid producers, State animal health
agencies, State wildlife agencies, and others.
We have carefully considered the merits of the petitions and of the
public comments received in response to them. We believe that the
petitioners and commenters identified several areas where the CWD final
rule could be more effective or less burdensome, and we believe the CWD
final rule could be improved by making several changes to its
requirements. We are therefore proposing certain changes to the CWD
final rule, described below. We plan to withdraw the 2006 CWD final
rule published on July 21, 2006 and issue a revised final rule based on
this proposal and on the CWD final rule, after evaluating public
comments on this proposal.
Reconciling Federal and State Requirements for the Interstate Movement
of Captive Cervids
One goal of the CWD final rule was to provide a consistent,
nationwide standard for the interstate movement of cervids, when such
animals are allowed to move in interstate commerce. For that reason,
the CWD final rule provided a single set of CWD requirements to follow
when moving cervids interstate. These requirements, developed with
input from States and producers, were meant to standardize a variety of
differing CWD requirements and restrictions imposed by States that
regulate the entry of cervids from other States. For example, different
States have different requirements for how long a cervid must have been
in a herd subject to CWD monitoring in order to move, and different
requirements for the type of animal identification required for cervids
moving interstate.
APHIS continues to believe that the Federal CWD regulations should
provide a consistent, nationwide set of requirements designed to
address CWD risk for cervids that move interstate. Where the Federal
CWD final rule establishes a standard for a particular aspect of
interstate movement of cervids--identification requirements, for
example--the requirement in the Federal CWD final rule will preempt any
inconsistent State requirement. However, as the petitions and several
comments on the petitions stated, the CWD final rule did not clearly
resolve the issue of whether a State has authority to ban the movement
of any farmed or captive cervids into the State due to reasons other
than CWD risks.
APHIS has sought and received further information from States on
the nature of their State CWD regulations and the reasons States have
determined such requirements to be necessary. In States that allow
farmed or captive cervids from other States to enter under
restrictions, rather than prohibiting their entry entirely, we found
that the purpose of the CWD restrictions and the methods they employed
were similar to the purpose and methods of the CWD final rule. In
almost all cases, we believe that the requirements in the Federal-State
cooperative CWD final rule will achieve the State goal of allowing
interstate movement of farmed or captive cervids under conditions
sufficient to prevent the spread of CWD. In one case, discussed in the
next section of this document titled ``Monitoring Period Required to
Move Cervids Interstate,'' we believe the ``monitoring period''
requirement currently employed by some States is superior to the
requirement in the CWD final rule, and accordingly we propose to revise
the CWD final rule with respect to the length of time a farmed or
captive cervid moved interstate must have spent in an approved CWD herd
certification program, and thus the length of time it has been subject
to monitoring for CWD and other herd requirements.
However, in the course of considering the petitions and comments on
them, APHIS has found that a number of States prohibit the entry of
farmed or captive cervids for a variety of reasons, and to control a
variety of risks, which are unrelated to CWD. State-imposed bans on the
movement of cervids that are unrelated to CWD risks will not be
affected by the CWD final rule. While Federal CWD requirements preempt
State CWD requirements when interstate movement of cervids is allowed,
we do not believe it is necessary to preempt State laws or regulations
that prohibit the entry of farmed or captive cervids for other reasons
when States have articulated sound reasons for such bans. This would
include a State that bans entry of cervids because the State does not
have or is phasing out a farmed or captive cervid industry and States
that impose restrictions to address diseases for which APHIS does not
prohibit or restrict interstate movement.
Some States that ban the entry of farmed or captive cervids have
cited concerns about the potential spread of CWD, brucellosis, and
tuberculosis as one reason for the bans. This is not, in the agency's
view, a persuasive reason to maintain a ban, because Federal
regulations\1\ are specifically designed to allow the interstate
movement of cervids without disseminating these diseases. We believe
that the proposed Federal CWD requirements would be effective and, if
finalized, would preempt conflicting State requirements. However,
States also cite other reasons for their bans on the entry of farmed or
captive cervids, such as risks from a number of diseases and parasites
associated with cervids. Excluding examples for which there are already
mandatory Federal testing or interstate movement requirements, the
diseases and parasites that support the need for a ban in some States
include epizootic hemorrhagic disease/bluetongue, Johne's disease,
malignant catarrhal fever, and the meningeal worm (Parelaphostrongylus
tenuis). States also base cervid bans on concerns that farmed or
captive cervids could contain undesirable gene sequences that could be
introduced into wild cervid populations if the cervids escape
captivity. These States noted that maintaining the genetic purity of
their native elk and deer populations was important to sportsmen and
natural resource interests. More generally, States with bans cited
concerns that escaped farmed or captive cervids would compete with wild
populations for food and habitat. Some States also cited laws making it
illegal to hold in captivity certain species or breeds of cervids
covered by the CWD final rule. Some States imposed a ban partly to
discourage high-fence trophy hunting operations that depend on
continual restocking from out-of State sources. Finally, some States
cited environmental concerns, including ecosystem degradation resulting
from cervids maintained in captivity or escaped cervids.
---------------------------------------------------------------------------
\1\ For interstate movement requirements for cervids and other
animals with respect to these diseases, see 9 CFR part 77 for
tuberculosis, 9 CFR part 78 for brucellosis, and 9 CFR part 81 for
CWD.
---------------------------------------------------------------------------
APHIS has concluded that many of the above concerns are substantive
and that we should propose a way to accommodate State interests in
these areas. APHIS believes that we can best address the concerns of
States that have imposed a ban on the entry of farmed or captive
cervids for reasons unrelated to CWD by changing the CWD final rule to
recognize such a ban for those States. Therefore, we propose to add a
new Sec. 81.5 to the CWD final rule to clarify that state laws and
regulations prohibiting the entry of farmed or captive cervids for
reasons unrelated to CWD are not preempted by this part.
[[Page 14497]]
Monitoring Period Required To Move Cervids Interstate
Under the CWD final rule, during its first year of implementation,
cervids would be allowed to move interstate if they have been in an
approved CWD Herd Certification program, and thus subject to monitoring
for CWD and other requirements, for at least 1 year. The CWD final rule
increased this length-of-time requirement in succeeding years of
implementation, so the time animals would have had to be in a herd
certification program in order to move interstate gradually increased
to 2 years, then 3, then 4, then 5 years. It was the intent of the CWD
final rule to provide a consistent, nationwide standard for the
interstate movement of cervids. Existing State laws and regulations
addressing movement of cervids vary in the amount of time that the
animals must have been in a certification program prior to entry, and
some States do not allow the entry of any cervids for non-CWD-related
reasons, as discussed earlier. The gradual escalation of the Federal
standard in the CWD final rule to 5 years was intended to achieve the
desired level of risk control represented by 5 years of program
participation and disease-free surveillance and monitoring, but to do
so in a gradual manner that would not cause widespread economic harm to
producers by making it impossible for some of them to move animals
interstate until 5 years after they join the CWD Herd Certification
Program.
The petitioners and many commenters on the petitions questioned
whether the gradual approach reflected in the rule's Federal standard
provided adequate protection, especially during the first 2 years of
program implementation. The petitioners and most commenters suggested
that the available science and the known epidemiology of CWD indicate
that animals should be monitored for CWD for approximately 5 years
before they can be considered safe to move interstate. Some commenters
stated that studies of the natural incubation period in the wild are
difficult to conduct and no comprehensive studies have been done;
therefore, APHIS should not assume that most cervids will develop CWD
within a year or two after infection. They noted that while animals
developed signs of CWD within 1-2 years of infection in several cited
research studies, these were studies of confined animals that were
directly infected with large quantities of the CWD agent. This type of
direct experimental infection is known to result in minimum incubation
periods for diseases in general.
In view of these uncertainties about the range of incubation
periods for CWD, the commenters suggested that it would be prudent for
the CWD program to monitor animals for 5 years before they can be
considered safe to move interstate. The 5-year period was suggested
because it is the period that most researchers and State CWD programs
agree is a reasonable outer boundary for the incubation period for CWD.
In addition, comments on the petitions revealed that most State
governments and industry representatives agree that many cervid
producers who rely on moving animals interstate for the success of
their businesses have already participated in a State CWD herd
certification and monitoring program for 5 years or longer, would not
be adversely affected by the adoption of a 5-year standard, and believe
a 5-year standard would provide better protection against the spread of
CWD than a lesser monitoring standard.
After considering comments, APHIS has concluded that the CWD
program would be enhanced by requiring that farmed or captive cervid
herds must have been monitored for at least 5 years before animals from
such herds may be moved interstate. The CWD final rule discussed why it
is important to consider possible exposure to CWD up to 5 years in the
past when evaluating the CWD risk of a herd. The CWD final rule would
have required 5 years of monitoring for a herd to reach the Certified
level in the CWD program, although it would have established a
gradually increasing timetable that, in early years of program
implementation, would have allowed interstate movement of animals from
herds with as little as 1 year of monitoring. We now believe that CWD
incubation periods have not been sufficiently studied to justify using
shorter monitoring periods initially and ``ramping up'' the monitoring
requirement over time. Also, upon reexamining several research reports,
we believe that they support the conclusion that natural incubation
periods may last up to 5 years in enough cases to warrant revising the
CWD program as designed in the CWD final rule. For example, the CWD
final rule referred to a study \2\ at the Colorado Division of
Wildlife, Foothills Wildlife Research facility, which found that for a
studied group of elk that were naturally exposed to CWD in a
contaminated environment, the average incubation time was 26 months and
the incubation times ranged from 18 to 36 months. After the study
ended, in the same group of elk held in the same pens, there was a case
of CWD in an individual animal that occurred 5 years after the last CWD
death in the herd.\3\ This could have been the result of a later
environmental exposure, or it could represent a 5-year incubation
period.
---------------------------------------------------------------------------
\2\ Miller et al., 1998. Epidemiology of Chronic Wasting Disease
in Captive Rocky Mountain Elk, Journal of Wildlife Diseases, 34:532-
538.
\3\ Miller, personal communication.
---------------------------------------------------------------------------
Further supporting the points made by the commenters, in other
pathogenesis studies in mule deer and elk at the University of
Wyoming,\4\ high dose oral inoculation in mule deer produced an
incubation period range of 15 months to over 25 months, with an average
of 23 months. The researchers acknowledged that experimental infection
(single-dose oral exposure to brain material) probably underestimates
natural incubation times, as it is likely that greater exposure results
in shorter duration of incubation. This supports the conclusion that
incubation times for experimental infections most likely represent the
range of minimum incubation times, so regulatory risk considerations
should not be based solely on incubation periods demonstrated by
experimental direct inoculations.
---------------------------------------------------------------------------
\4\ Williams et al. 2002. Chronic Wasting Disease of Deer and
Elk: A Review With Recommendations for Management. Journal of
Wildlife Management 66(3): 551-563.
---------------------------------------------------------------------------
Based on our reevaluation of incubation studies, we believe that
the longest incubation periods for regulated cervids will likely fall
between 3 and 5 years. While a CWD program with a 3-year monitoring
period might catch a large majority of infected animals, it appears
that there would be enough animals that would become infected after a
4- or 5-year incubation period that a 3-year monitoring period would
allow continued spread of CWD and reduce the effectiveness of the
program.
Therefore, we are proposing to remove the gradual-escalation
approach from the CWD final rule and replace it with a requirement that
farmed or captive cervids moved interstate must be from herds that have
had at least 5 years' monitoring for CWD (i.e., herds that have
achieved ``Certified'' status in the certification program). This
requirement is based on our interpretation of currently available
research, and we may propose to modify it in the future if additional
research provides a basis for doing so. This change would affect the
requirements
[[Page 14498]]
for cervids moved interstate for non-slaughter purposes on the basis of
their participation in the certification program; it would not affect
the movement of cervids to slaughter.\5\
---------------------------------------------------------------------------
\5\ The final rule allows farmed or captive deer, elk, or moose
to be moved to slaughter regardless of whether or not their herds
are enrolled in the certification program, or, if enrolled in the
program, regardless of their status relative to movement
requirements, if they have two forms of animal identification and
are accompanied by a certificate issued in accordance with Sec.
81.4.
---------------------------------------------------------------------------
To make this change, we propose to amend paragraph (a) of Sec.
81.3 as published at 71 FR 41706, which deals with interstate movement
of animals from cervid herds that are enrolled in the CWD Herd
Certification Program and are eligible for a certification status level
based on the length of time they have successfully met program
standards. We propose to amend this paragraph to state that the farmed
or captive cervid must be enrolled in the CWD Herd Certification
Program in a herd that has achieved Certified status, and must be
accompanied by a certificate that states this and that also identifies
the herd of origin and states that the animal does not show clinical
signs associated with CWD.\6\
---------------------------------------------------------------------------
\6\ Later in this document, we also propose a change that would
redesignate this paragraph (a) as paragraph (b).
---------------------------------------------------------------------------
The change to the certificate requirement to indicate that the
animal does not show clinical signs associated with CWD replaces a
required statement that the animal is not a CWD-positive, CWD-exposed,
or CWD-suspect animal. Requiring that the certificate state that the
animal does not show clinical signs associated with CWD would be
consistent with the information that can be obtained from an
examination and with other interstate animal movement regulations. To
complement this change, we would also remove the definitions of the
terms CWD-positive animal, CWD-exposed animal, and CWD-suspect animal
from Sec. 81.1, because these terms would no longer be used in part
81.
Proximity of Herd of Origin to CWD Occurrences and CWD History of an
Animal's Herd
Some commenters also raised the concern that the CWD final rule
would disrupt State program efforts to provide an additional level of
protection against the spread of CWD by prohibiting entry of farmed or
captive cervids from those areas where CWD has been detected. Several
States currently implement such policies in various forms. The form of
the State requirement is usually to list either counties, regions
within a State, or entire States where CWD has been detected and ban
entry of cervids from the listed areas.
We believe this is a useful risk reduction approach for States that
wish to add another level of protection to the requirements in the CWD
final rule. However, not all States believe they need the additional
risk reduction. Also, although all the States that use this method
agree that its purpose is to prohibit entry of cervids from areas in
proximity to occurrences of CWD, there is substantial variation in the
details of such requirements for different States.
Therefore, we propose to change the CWD final rule to allow States
to elect not to receive farmed or captive cervids from areas in
proximity to occurrences of CWD in wild cervids. We also propose to
establish a single Federal standard for such proximity in order to make
the standard consistent among all States with such restrictions. We
propose to do this by (1) establishing a list of States that do not
accept entry of farmed or captive cervids from herds of origin in
proximity to CWD occurrences in wild cervids and (2) changing the
certificate requirement for interstate movement of farmed or captive
cervids to document when animals are from herds that are in proximity
to CWD occurrences in wild cervids.
Section 81.3(a)(2) of the CWD final rule requires that farmed or
captive cervids that are moved interstate based on their participation
in the CWD Herd Certification Program must be accompanied by a
certificate issued by a State or Federal official or an accredited
veterinarian. The certificate must contain information to help identify
the animals and document their status in the certification program. The
contents required for a certificate are set out in Sec. 81.4 as
published at 71 FR 41706.
To be consistent with the change discussed above that animals moved
interstate must be from herds with Certified status, we propose to
change the references in Sec. 81.4 to herds ``participating in the CWD
Herd Certification Program'' to instead refer to herds ``that have
achieved Certified status in the CWD Herd Certification Program.'' We
also propose to add the following requirements to this paragraph:
The certificate would have to include a statement by the
issuing accredited veterinarian, State veterinarian, or Federal
veterinarian that the animals are not from farmed or captive herds
where CWD has been diagnosed within the past 5 years or
epidemiologically linked to herds where CWD has been diagnosed within
the past 5 years.
The proposal to have a time limit of 5 years when considering CWD
infection or epidemiological linkage is based on the same evidence
cited in the CWD final rule and in this proposal to support the
requirement for 5 years of monitoring before a cervid may be moved
interstate. That decision was based on several factors, including the
probable maximum incubation time for CWD and timespans realistically
needed for reporting and evaluation of CWD occurrences.
The certificate would have to also include a statement by
the issuing accredited veterinarian, State veterinarian, or Federal
veterinarian as to whether or not the animals' premises are within 25
miles (40 km) of a federally or State-identified case of CWD in wild
deer, elk, or moose, or within 25 miles (40 km) of an area where CWD
has become established in wild deer, elk, or moose, as defined by APHIS
and the State.
We believe that this proposed requirement provides a reasonable
standard that can be consistently applied and that provides the level
of additional risk reduction that meets or exceeds that of similar
current State requirements. The proposal to set the limits of proximity
to CWD cases in the wild at 25 miles (40 km) is consistent with
proximity guidelines used in some State CWD programs applicable to both
captive and wild cervids, and is also consistent with the current
international practice of several countries for importing and exporting
elk. For example, the Quebec Department of Agriculture, Fisheries and
Food requires a statement on certificates accompanying elk imported
into Quebec that they are from a farm that ``is located more than 40 km
from an enterprise with an epidemiological link to a case of CWD.'' The
United States regulations for importing elk from Canada call for a
similar statement.\7\
---------------------------------------------------------------------------
\7\ In ``Protocol Respecting The Importation Of Cervids From
Other Provinces Or Countries Into Quebec Under The Animal Health
Protection Act (R.S.Q., c. P-42)'' and ``Protocol For the
Importation of Farmed Cervids From Canada,'' USDA, APHIS, Veterinary
Services, National Center for Import and Export.
---------------------------------------------------------------------------
In addition to adding this proximity certification for moving
farmed or captive cervids interstate, we propose to establish a list of
States that do not accept entry of farmed or captive cervids from areas
in proximity to CWD occurrences. This list, called ``States That Limit
Cervid Entry Based on Proximity to CWD Occurrences,'' would be
maintained and revised by APHIS, and would be made available by APHIS
on its Web site and by mail upon
[[Page 14499]]
request. The initial list would include all States that currently have
State laws or regulations that ban entry of farmed or captive cervids
from areas in proximity to CWD occurrences in the wild. At any time, a
State could request to be removed from the list if it changes to allow
entry of farmed or captive cervids from areas in proximity to CWD
occurrences in the wild. Any State not on the list could request to be
added to the list by sending the Administrator a written request to be
added and a copy of the State law or regulation that bans entry of
farmed or captive cervids from areas in proximity to CWD occurrences in
the wild.
This list of States, in conjunction with the new requirement of a
certification regarding proximity, will allow State and Federal
representatives to determine when a shipment of cervids may not be
moved to a destination State due to proximity restrictions. To make it
clear that these new requirements apply in two ways--animals that do
not meet them may not be moved interstate to listed States, and animals
that do meet them must have that fact documented in the certificate--we
propose to redesignate the current introductory text of Sec. 81.3 as
paragraph (a) and add the new requirements in subparagraphs (a)(1) and
(a)(2) as set out in the proposed regulatory text of this document.
We are proposing one more change related to the risks associated
with maintaining a CWD herd in proximity to known occurrences of CWD in
wild cervids. While the level of such risk is uncertain, it appears
prudent to mitigate the risk. A number of herds have been long
established in proximity to known occurrences of CWD in the wild; in
most cases, the herd was established before CWD was found in wild
animals in the area. Most of these herds have participated in State CWD
programs and are eligible for the Federal-State cooperative CWD
program. It would be very difficult to bar such herds from
participation in the program. It would also be unnecessary if the herds
have already effectively complied with program requirements for some
years. However, we have determined that it would add to the
effectiveness of CWD control if, in the future, no new herds were
established in proximity to CWD occurrences in the wild.
Therefore, we propose to amend Sec. 55.22(a), Participation and
enrollment, by adding a provision that an application for participation
may also be denied if APHIS or the State determines that the
applicant's herd was established after the effective date of a final
rule following this proposal on a premises within 25 miles (40 km) of a
Federally or State-identified case of CWD in wild deer, elk, or moose,
or within 25 miles (40 km) of an area, as defined by APHIS and the
State, where CWD has become established in wild deer, elk or moose.
Monitoring and Surveillance of CWD in Wild Cervids
The proposed changes discussed above concerning proximity of herds
to known occurrences of CWD in wild cervids would only be practical if
reliable data is available to identify areas where CWD occurs in the
wild. States with significant wild cervid populations currently conduct
monitoring and surveillance activities for CWD in the wild. These
activities are often conducted by State wildlife agencies, though some
involve agriculture agencies, and often Federal agencies provide
assistance or technical support when resources are available to do so.
The types and extent of surveillance for CWD in the wild vary. The most
extensive surveys rely on testing samples submitted by hunters. Some
States also employ surveillance methods such as harvesting and testing
a geographically targeted random sampling of wild deer and elk, or
testing vehicle-killed cervids, to estimate CWD distribution.
We expect States would continue such surveillance activities.
Because several changes in this proposed rule rely on identifying areas
where CWD occurs in the wild, we also propose to make such continued
surveillance a requirement for a State program to become an Approved
State CWD Herd Certification Program. Specifically, we propose to add
this requirement to the list in Sec. 55.23, Responsibilities of States
and enrolled herd owners, as paragraph (a)(12).
Herd owners and Federal and State representatives would use reports
from these monitoring and surveillance activities to determine, for
purposes of the changes discussed above, when a premises is ``within 25
miles (40 km) of a Federally or State-identified case of CWD in wild
deer, elk, or moose, or within 25 miles (40 km) of an area, as defined
by APHIS and the State, where CWD has become established in wild deer,
elk, or moose.''
Additional Changes to Responsibilities of States and Enrolled Herd
Owners (Sec. 55.23)
We propose to make several changes to Sec. 55.23 to clarify the
responsibilities of States and owners participating in the cooperative
Federal-State CWD program, and to reduce the compliance burden where it
is practical to do so.
State Enforcement of Quarantines
Paragraph (a)(4) of Sec. 55.23 requires States to place all known
CWD-positive, CWD-exposed, and CWD-suspect animals and herds under
movement restrictions, with movement of animals from those herds only
for destruction or under permit. We now propose to expand this
requirement to prohibit CWD-positive, CWD-exposed, and CWD-suspect
herds from adding animals to the herd from outside sources. The CWD
final rule did not include such a requirement because it seemed
unlikely that many owners would choose to expand herds that were under
restrictions and possibly destined for destruction. However, there have
been some cases where the owners of CWD-positive, CWD-exposed, and CWD-
suspect herds have added new animals. This affects the CWD indemnity
program, which makes indemnity available for eligible animals based on
the inventory at the time the movement restrictions are imposed. An
increase in the size of a herd under restriction due to CWD also causes
a corresponding increase in the program resources devoted to the herd,
and in the amount of work for Federal and State representatives working
with the herd. For instance, if animals from several additional herds
are added to a CWD-exposed or CWD-suspect herd that is later found
positive for CWD, those additional herds must also be evaluated during
traceback as possible sources of CWD. Also, increasing the herd size
potentially increases the total number of infected animals, and the
risk of CWD spread (e.g., more animals means more opportunities for an
animal to escape confinement).
To address this problem, we propose to change Sec. 55.23(a)(4) to
specifically state that no movement of animals into CWD-positive, CWD-
exposed, and CWD-suspect herds is allowed.
Herd Inventory Procedures
We are also proposing to make changes to Sec. 55.23 to address
issues concerning the practicality and the burden on owners associated
with paragraph (b)(4), which describes herd recordkeeping and annual
inventory requirements.
Section 55.23(b)(4) of the CWD final rule requires owners to
maintain herd records that include a complete inventory of animals, the
age and sex of each animal, the date of acquisition and source of each
animal that was not born into the herd, the date of disposal and
destination of each animal, and all
[[Page 14500]]
individual identification numbers (from tags, tattoos, electronic
implants, etc.) associated with each animal. We do not propose to
change this requirement. However, we do propose to change other
requirements in this paragraph, which currently state that the owner
must allow an APHIS employee or State representative access to the
premises and herd to conduct an annual physical herd inventory to
reconcile animals and identifications with the records maintained by
the owner. The CWD final rule currently requires that the owner, when
this physical inventory occurs, must assemble, restrain, and present
the entire herd for inspection under conditions where the APHIS or
State official can safely read all identification on the animals. The
owner would be responsible for all costs incurred to present the
animals for inspection.
Several commenters noted that it was unclear whether an actual
physical inventory of assembled animals was required each year, or only
``upon request.'' They also suggested that a physical inventory would
impose a considerable burden if conducted on an annual basis. The CWD
final rule estimated that for a herd of 50 elk, the annual physical
inventory cost would be approximately $1,000, including veterinary fees
of approximately $500 and hired labor costs of approximately $500. This
cost could be significantly higher in some cases; for example, labor
costs for skilled cervid handlers are higher in some areas, and the
physical assembly and restraint could cause injury to some cervids,
with further costs to the owner for subsequent veterinary care or loss
of the animal.
We agree that the CWD final rule language is unclear on the
requirement for physical inventories. Our intention is to conduct an
actual physical inventory of assembled animals when an APHIS employee
or State representative finds it to be needed for program purposes. We
propose that a physical assembly would be required at the time a herd
is enrolled in the Federal-State cooperative CWD program, in order to
provide a reliable baseline record for the herd's participation. After
this initial physical assembly for inventory purposes, further physical
inventories would be scheduled when the APHIS employee or State
representative finds it necessary to verify herd compliance with
program standards -- for example, if there has been significant
movement of animals into or from the herd, or if other conditions
warrant a physical inventory to confirm the herd records. Physical
inventories would usually be several years apart, and would never be
ordered more than once per year, unless we determine that more frequent
inventories are needed based on indications that the herd may not be in
compliance with CWD Herd Certification Program requirements.
However, some type of herd inventory would be performed annually.
When the inventory does not include physical assembly of the entire
herd, it would include, at a minimum, review of all owner records
documenting animal identification and records of animals added to or
removed from the herd. It would also include observation of the herd's
unrestrained animals in a viewable, enclosed area or space where the
inspector could reconcile all visible identification devices with prior
records and check for any obvious inconsistencies between the number,
age, and gender of animals observed and the animals documented in the
owner records. During such inventories, the owner and the person
performing the inventory would work together to resolve any
discrepancies to the satisfaction of the person performing the
inventory.
This proposed change should also make it possible in many cases to
plan the timing of a physical assembly of a herd for inventory so that
it is coordinated with cervid testing for brucellosis and tuberculosis.
Such testing occurs for cervid herds participating in the cooperative
State-Federal Cervid Brucellosis Program or Cervid Tuberculosis
Program. The Uniform Methods and Rules for these programs describe when
such herds must be assembled and tested for these diseases. For
example, to maintain a herd's Certified status with regard to
brucellosis, or its Accredited status with regard to tuberculosis, the
herd must be retested for the relevant disease every 21 to 27 months
under current brucellosis and tuberculosis regulations. This timetable
may change in the future. We expect that, in many cases, when a cervid
herd participates in the CWD program and one or both of the
tuberculosis and brucellosis programs, any required physical assembly
of the herd can be planned so that during a single assembly,
requirements for all of the programs can be met. For example, the
initial physical assembly would serve to establish and confirm the
required inventory, records, and individual animal identification
requirements for CWD, but it could also be used to conduct testing and
any other requirements for the tuberculosis or brucellosis programs. If
the APHIS employee or State representative later finds it necessary to
schedule another physical assembly for inventory, it is likely that it
could be scheduled to allow any required tuberculosis or brucellosis
testing to occur during the assembly.
APHIS plans to develop additional guidance in the future, after we
gain additional experience working with herd inventories, to clarify
when an actual physical inventory of assembled animals will be
required, and to provide more information on the different activities
involved in the different levels of a physical inventory of assembled
animals. When developed, such guidance will be made available in the
CWD program Uniform Methods and Rules or in other program guides.
Readers should also note that in addition to Federal regulations
concerning inventory requirements, individual States may have
requirements in this area in State law or regulations.
In Sec. 55.23(b)(4) on page 41704 of the final rule, we also
inadvertently omitted accredited veterinarians as one of the types of
officials authorized to conduct the herd inventory. Since accredited
veterinarians play an important role in implementing the CWD program,
we propose to change this reference to also allow access to the
premises by an accredited veterinarian who has been designated to
conduct an inventory. To implement these changes to inventory
requirements, we propose to revise all but the first sentence of Sec.
55.23(b)(4).
Enrollment Dates
Section 55.22(a)(1)(ii)(B) concerns setting an enrollment date for
herds that enroll directly in the Federal CWD Herd Certification
Program, and ensuring that the enrollment date gives some credit for
the time period during which herds substantially met Certification
Program standards before they could enroll in the Program. This
paragraph reads, in part, ``If APHIS determines that the herd owner has
maintained the herd in a manner that substantially meets the conditions
specified in Sec. 55.23(b) for herd owners, the first day that the
herd participated in such a program. However, in such cases the
enrollment date may not be set at a date more than 2 years prior to the
date that APHIS approved enrollment of the herd.''
We propose to change that requirement to allow APHIS to set an
enrollment date for such herds that is up to 3 years prior to the date
APHIS actually processed and approved enrollment. We propose this
revision because implementation of the Certification Program has
proceeded more slowly than planned, in part due to the need to resolve
the issues
[[Page 14501]]
discussed in this proposed rule. To minimize possible losses to herd
owners who have managed their herds in compliance with program
requirements but could not be formally enrolled because no State CWD
program was available and the CWD final rule was not in effect, we
propose to allow up to 3 years' credit instead of 2. Since this rule
also proposes to limit interstate movement to cervids that have been
enrolled for 5 years and have achieved Certified status, we expect this
change would affect a small number of herds that become enrolled
directly in the Federal CWD program after the effective date of a final
rule. If such herds qualify for 3 years' credit upon enrollment,
animals from the herd could be moved interstate approximately 2 years
later if and when the herd achieves Certified status.
Confirmatory DNA Testing of Official Test Samples
On page 41685 of the CWD final rule, we responded to comments that
suggested that, after an animal tests positive for CWD, the owner
should have the opportunity to have the sample's DNA matched to DNA
from the owner's animal to prove that the correct sample was tested. In
response, we stated, ``With regard to DNA matching to confirm that
positive samples are indisputably associated with the correct animal,
we plan to allow such confirmation, at the owner's expense, when the
owner of the CWD-positive animal requests it. DNA verification will be
possible because our instructions on how to collect and submit tissue
samples will require submission of all manmade identification devices
on the animal, with part of the ear or skin to which they are attached,
in a manner that preserves the chain of custody.''
Since the CWD final rule was published, APHIS has discussed this
issue with owners and laboratories and has developed procedures to work
with owners who wish to order such confirmatory DNA testing. In this
NPRM we propose to change paragraph (c)(1) of Sec. 55.24 (71 FR 41705)
of the final rule so that such testing would be available through the
following arrangements.
At the time an owner allows tissues samples to be collected from an
animal for official CWD testing, the owner would be able to reserve the
option for DNA comparison testing by informing the Federal or State
representative or accredited veterinarian who collects the tissues. To
allow for later DNA comparison testing, the person collecting the
tissues would have to also collect from the animal some somatic tissue
(usually an ear) that contains an official identification device, along
with the tissue samples routinely collected for CWD testing (brain
stem, lymph nodes, etc.). Submitting tissues attached to an official ID
device establishes a reliable chain of custody that allows later DNA
tests to be compared to a tissue sample that verifiably comes from the
owner's animal in question.
If the CWD official tests show that owner's animal is CWD-positive,
the owner could employ the appeal provisions of Sec. 55.24(c) to
request that the tissue samples that were tested for CWD be compared to
the ear or other tissues submitted with the animal ID attached. If the
DNA in the tissues tested for CWD and the DNA in the tissues attached
to the ID device match, there is confidence that the positive CWD tests
do in fact pertain to the correct animal. If the DNA in the respective
test results does not match, that may justify the Administrator
granting the appeal. In such cases the animal would be redesignated
CWD-suspect pending further investigation to establish the final proper
status of the animal and its herd.
We propose that if an owner requests confirmatory DNA testing, the
owner would pay for the cost of the test. If this proposed rule is
adopted as final, APHIS will publish additional guidance on how to
request confirmatory DNA testing and how to arrange payment for such
tests.
To recognize this procedure in the regulations, we propose making
changes to the CWD final rule to document the owner's right to order
and pay for confirmatory DNA testing when one or more of the owner's
animals tests positive for CWD. We would change paragraph (c)(1) of
Sec. 55.24, which deals with an owner's right to appeal the
designation of their herd's status, by adding a provision for appeals
based on the results of a DNA test requested and paid for by the owner
to determine whether previous official CWD test results were correctly
associated with an animal that belonged to the owner.
Miscellaneous Changes
We also propose to change the definition of premises identification
number (PIN) in parts 55 and 81 and to add a definition for National
Uniform Eartagging System to both parts. These proposed changes are
intended to achieve greater standardization and uniformity of official
numbering systems and eartags used in the National Animal
Identification System and in animal disease programs and to enhance
animal traceability. We also propose to add the following sentence to
the definition of official animal identification: ``The CWD program
allows the use of either the eight-character or nine-character format
for cervids.'' This proposed change would allow use of either larger
eartags with nine-character unique numbers, or smaller eartags with
eight-character numbers. We propose to allow use of both size tags
because the use of the smaller eartags is sometimes advisable to reduce
stress on younger elk and deer.
Executive Order 12866 and Regulatory Flexibility Act (RFA)
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.
In accordance with 5 U.S.C. 603, we have performed an initial
regulatory flexibility analysis, which is set out below, regarding the
potential effects of the proposed action on small entities. This
initial analysis indicates that the benefits of the proposed action
would exceed its costs. We do not currently have all the data necessary
for a comprehensive analysis of the effects of this rule on small
entities. Therefore, we are inviting comments concerning potential
effects.
The changes proposed in this document would, if adopted, modify the
requirements set forth in the CWD final rule.\8\ For that reason, the
economic analysis that follows considers the impact of the proposed
changes using the CWD final rule as a baseline. An economic analysis
was prepared for the CWD final rule, and that analysis is incorporated
in this document by reference.
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\8\ The effective date of the CWD final rule, which was
published in the Federal Register on July 21, 2006 (71 FR 41682-
41707, Docket No. 00-108-3), has been delayed pending consideration
of the changes proposed in this document.
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The proposed changes would have the most impact on cervid farms,
most of which are believed to be small in size under the U.S. Small
Business Administration's standards.
The proposal to remove the gradual-escalation monitoring period
requirement for interstate movement and replace it with a 5-year
minimum requirement would adversely impact current farmers with less
than 5 years in the program who wish to ship at least some of their
animals interstate for purposes other than slaughter. The number of
such farmers is unknown, although it is estimated that many, if not
most, herd owners who rely on interstate movement for the success of
[[Page 14502]]
their businesses already meet the 5-year standard by way of their
participation in an existing State CWD certification program. Under the
proposal, time spent in an APHIS-approved State program would count
towards the time needed to satisfy the 5-year requirement, and many
farmers have participated in a State program for at least 5 years. It
is estimated that at least 20 States have formal CWD certification
programs for cervids in place.
Any adverse impact of the proposed 5-year standard on current
farmers would be further muted to the extent that a number of States
have already adopted that standard themselves. Currently, States have
the authority to regulate farmed cervids, including the authority to
establish requirements for entry of cervids. In response to APHIS' CWD
proposed rule published in December 2003, and its CWD final rule
published in July 2006, several States have decided to adopt a 5-year
monitoring period requirement for cervids entering those States. Both
the December 2003 proposed rule and the July 2006 final rule included
an eventual 5-year monitoring period requirement for interstate
movement.
For those farmers who would be adversely affected by a shift to a
5-year monitoring period requirement, the economic impact would vary
depending on the circumstances of each--such as the time, if any,
already spent in a State program, the number and value of animals that
would otherwise be shipped interstate, and the alternative
opportunities available for sales within the State. Although data for
individual herd owners are not available, those who are located in
States that do not now have a State program and who cannot qualify for
a herd status upgrade would likely suffer the most severe economic
consequences, since they would have to participate in the Federal
program (or a newly established State program) for 5 years before they
could move their cervids interstate.\9\ Under the CWD final rule, these
same herd owners would have been able to move their animals interstate
after only 1 year in the program. (For these and other herd owners who
do not meet the 5-year monitoring requirement, the only alternative
under the proposal that would allow for earlier interstate movement
would be to sell or otherwise dispose of their existing cervids and
replace them with animals from a herd with higher status. However, this
alternative would not come without a price; all else being equal, the
cost of each replacement cervid is likely to exceed the proceeds from
the sale or disposition of each existing animal, given the former's
higher status.) It is conceivable that the shift to a 5-year monitoring
requirement could effectively force some farmers out of the cervid
business, especially those with little or no time in State programs. On
the other hand, the change that would allow APHIS to set an enrollment
date for herds that is up to 3 years prior to the date APHIS actually
processed and approved enrollment should preclude this outcome for most
herds.
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\9\ Herd owners who are not in a State program but who can
demonstrate that they have maintained their herds in a manner that
would substantially meet the program conditions established by APHIS
may qualify for up to 3 years' enrollment credit.
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The adoption of the proposed 5-year monitoring period requirement
could also impact prospective new entrants into the cervid farming
business, to the extent that it requires them to acquire higher status,
and presumably more costly, animals when initially stocking their
herds. Under the proposal, for example, new entrants would be eligible
to ship their animals interstate immediately only if they stocked their
herds with cervids from certified herds. By contrast, the CWD final
rule would have allowed new entrants to ship interstate immediately
with animals acquired from herds having as low as Second Year status.
Relative to the CWD final rule, the impact on farmers of the
proposal to give States the option to ban the entry of certain farmed
and captive cervids is uncertain. We propose to allow States that
completely prohibit the entry of farmed or captive cervids for reasons
which are unrelated to CWD (e.g., for genetic purity or environmental
reasons) to continue to do so. We also propose that States may decline
to accept cervids from areas in proximity to CWD outbreaks. In both
cases, impacts on States that have either type of ban would be
nonexistent or minimal. The difference in impacts regarding State bans
between this proposal and the final rule may be considered as follows.
On the one hand, the CWD final rule would have given farmers with
potentially risky animals access to markets in other States that are
currently closed to them. On the other hand, there is no assurance,
even if the CWD final rule had been in effect, that farmers would have
been able to sell a significant number of their high-risk animals in
those markets anyway. The market for cervids that are near CWD
occurrences is limited, given the animals' added disease risk, and the
absence of a ban option in the CWD final rule would not have removed
that risk.
Relative to the current situation, the proposal to give States the
option to ban the entry of certain cervids would have no impact, since
all States have that option now. Currently, several States have elected
not to accept cervids if they came from areas in proximity to CWD in
the wild.
The proposal to prohibit the program participation of herds
established in the future in areas in proximity to CWD occurrences in
wild cervids should have little or no impact. There are two reasons.
First, the proposal affects newly established herds only, so no current
farmers would be affected. Second, it is likely that few, if any,
farmers would want to establish a new herd in areas in proximity to CWD
in the wild, given the added disease risk and the attendant adverse
marketing consequences noted above.
The proposal to define ``proximity'' as within 25 miles (40 km) of
a CWD occurrence should benefit herd owners and the States, to the
extent that it removes uncertainty that may now exist surrounding the
definition of that term. The proposed definition is also consistent
with current international practice for importing and exporting elk.
The proposal to require States to conduct monitoring and
surveillance for CWD in wild cervids in order to become an approved
State CWD program should have little or no impact. This is because such
monitoring and surveillance is already being conducted by those States
with significant cervid populations, including those without a CWD
program.\10\
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\10\ These activities are often conducted by State wildlife
agencies, though some involve agriculture agencies, and often
receive assistance or technical support from Federal agencies. If
Federal assistance or support is reduced or withdrawn altogether in
the future, the States would have to bear more or all of the cost of
surveillance activities if they wanted to remain an approved State
CWD program. At this time, there is no reason to believe that
Federal assistance or support will be reduced or withdrawn in the
future.
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The proposal to prohibit CWD-positive, -exposed, and -suspect herds
that are under State quarantine from adding animals to the herd from
outside sources should have little impact, since few herds would be
affected. It is estimated that, over the last several years, no more
than about two or three cervid herds under quarantine have added
animals from outside sources, usually for hunting purposes.
The proposal to modify the herd inventory requirements has the
potential to favorably impact herd owners. Under the CWD final rule,
herd owners would be required to conduct a physical inventory of
assembled and restrained cervids annually. Under this proposed revision
to the final rule, a physical inventory would be required at
[[Page 14503]]
the time a herd is enrolled in a CWD program, and then only on an as-
needed basis thereafter to verify compliance with program
standards.\11\ The proposed rule would still require an annual herd
inventory--including a review of owner records and an observation of
the herd's unrestrained animals in a viewable, enclosed area--but it
would not require that the animals be physically assembled and
restrained.
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\11\ APHIS has not yet developed guidelines for determining when
a post-initial enrollment physical inventory would be required. The
agency plans to do so in the future, after it gains additional
experience working with herd inventories. When developed, such
guidance will be made available in the CWD program Uniform Methods
and Rules or in other program guides.
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Since herd owners are responsible for all costs incurred in
conducting a herd inventory, the proposal has the potential to offer
them significant ongoing annual savings. This is because a herd
inventory that does not require that the animals be physically
assembled and restrained is less costly than one that does. The CWD
final rule estimated that for a herd of 50 elk, the annual physical
inventory (with the animals assembled and restrained) would cost
approximately $1,000, including veterinary fees of approximately $500
and hired labor costs of approximately $500. This cost could be
significantly higher in some cases; for example, labor costs for
skilled cervid handlers are higher in some areas, and the physical
assembly and restraint could cause injury to some cervids, with further
costs to the owner for subsequent veterinary care or loss of the
animal. By contrast, a ``nonphysical'' herd inventory can be scheduled
at a time when it is likely to add only minimally to herd owner
operating costs, since most of the activities required for such an
inventory are performed from time to time as part of routine herd
management.
This proposed change to the herd inventory requirements should also
make it possible in many cases to plan the timing of a physical
inventory so that it is coordinated with cervid testing for brucellosis
and tuberculosis. Such testing occurs for cervid herds participating in
the cooperative State-Federal Cervid Brucellosis Program or Cervid
Tuberculosis Program. The Uniform Methods and Rules for these programs
describe when such herds must be assembled and tested for these
diseases. For example, to maintain a herd's Certified status with
regard to brucellosis, or its Accredited status with regard to
tuberculosis, the herd must be retested for the relevant disease every
21 to 27 months (under current brucellosis and tuberculosis
regulations; this timetable may change in the future). We expect that,
in many cases, when a cervid herd participates in the CWD program and
one or both of the tuberculosis and brucellosis programs, any required
physical inventory can be planned so that the requirements for all of
the programs can be met during a single animal assembly. The initial
and any subsequent physical inventories required