Chronic Wasting Disease Herd Certification Program and Interstate Movement of Farmed or Captive Deer, Elk, and Moose, 41682-41707 [06-6367]
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Federal Register / Vol. 71, No. 140 / Friday, July 21, 2006 / Rules and Regulations
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 55 and 81
[Docket No. 00–108–3]
RIN 0579–AB35
Chronic Wasting Disease Herd
Certification Program and Interstate
Movement of Farmed or Captive Deer,
Elk, and Moose
Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
AGENCY:
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SUMMARY: We are establishing a herd
certification program to eliminate
chronic wasting disease (CWD) from
farmed or captive cervids in the United
States. Participating deer, elk, and
moose herds will have to follow
program requirements for animal
identification, testing, herd
management, and movement of animals
into and from herds. After 5 years of
enrollment with no evidence of chronic
wasting disease, a herd may be granted
‘‘Certified’’ status. Owners of herds may
enroll in a State program that we have
determined has requirements equivalent
to the Federal program, or may enroll
directly in the Federal program if no
State program exists. We are also
establishing interstate movement
requirements to prevent the interstate
movement of deer, elk, and moose that
pose a risk of spreading CWD. These
actions will help to eliminate CWD from
the farmed or captive deer, elk, and
moose herds in the United States.
DATES: Effective Date: October 19, 2006.
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 2005, 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
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natural routes of transmission include
Rocky Mountain elk, mule deer, whitetailed deer, black-tailed deer, and
moose. Noncervid ruminant species,
including wild ruminants and domestic
cattle, sheep, and goats, have been
housed in wildlife facilities in direct or
indirect contact with CWD-affected deer
and elk, and as of June 2005 there has
been no evidence of transmission of
CWD to these other species. Additional
studies to delineate the host range of
CWD are underway.
In the United States, CWD has been
confirmed in free-ranging deer and elk
in Colorado, Illinois, Nebraska, New
Mexico, New York, South Dakota, Utah,
West Virginia, Wisconsin, and
Wyoming, and, as of October 2005, in 31
farmed or captive elk herds in Colorado,
Kansas, Minnesota, Montana, Nebraska,
Oklahoma, South Dakota, and
Wisconsin, and in 8 farmed or captive
deer herds in New York 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.
The Animal and Plant Health
Inspection Service’s (APHIS’s)
regulations in 9 CFR subchapter B
govern cooperative programs to control
and eradicate communicable diseases of
livestock. In accordance with 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, and to pay claims growing out
of the destruction of animals.
On December 24, 2003, we published
in the Federal Register (68 FR 74513–
74529, Docket No. 00–108–2) a proposal
to amend 9 CFR subchapter B by
establishing regulations in part 55 for a
CWD Herd Certification Program to help
eliminate chronic wasting disease from
the farmed or captive deer and elk herds
in the United States. Under that
proposal, deer and elk herd owners who
choose to participate would have to
follow program requirements for animal
identification, testing, herd
management, and movement of animals
into and from herds. We also proposed
to amend 9 CFR subchapter B by
establishing a new part 81 containing
interstate movement requirements to
prevent the interstate movement of deer
and elk that pose a risk of spreading
CWD.
We solicited comments concerning
our proposal for 60 days ending
February 23, 2004. We received 105
comments by that date, from cervid
ranches, national and State cervid
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producer associations, national wildlife
associations, State wildlife and
agriculture agencies, and others. These
comments are discussed below by topic.
In response to these comments, APHIS
has decided to amend the proposed rule
by making the following changes:
• Adding moose to the animals
covered by the regulations, in addition
to deer and elk.
• Change the definition of
commingled, commingling by replacing
‘‘30 feet of physical separation’’ with
‘‘10 feet of physical separation’’ and by
eliminating the exception for animals in
brief contact for less than 48 hours.
• Change the definition of CWDpositive animal to require two positive
official CWD tests, rather than one.
• Change the definition of CWDsuspect animal to clarify that it would
include animals that have tested
positive to an unofficial CWD test.
• Change the definition of herd plan
to specify that it must be signed by the
herd owner, in addition to APHIS and
the State, to emphasize the involvement
of all three parties in a herd plan’s
development.
• Change the requirements for animal
identification to require that freeranging animals captured for interstate
movement and release, like other
farmed or captive cervids, must have
two forms of animal identification,
including one form with a nationally
unique animal identification number.
Add ‘‘or other identification approved
by APHIS’’ to the list of allowed
identification devices we proposed
(electronic implant, flank tattoo, ear
tattoo, or tamper-resistant ear tag).
• Change the interstate movement
restrictions for farmed or captive cervids
to exempt cervids moving directly to
slaughter from the requirements of
§ 81.3, ‘‘General restrictions,’’ when the
sending and receiving States have
agreed to the movement and certain
other conditions are met.
• Change the responsibilities for herd
owners participating in the program to
require that they report animal deaths
and make the carcasses available for
testing for all animals 12 months and
older, rather than 16 months as
proposed. Also require herd owners to
report any animals that escape or
disappear.
• Change the inventory requirements
for participating herds to specify that
the ‘‘physical herd inventory with
verification reconciling animals and
identifications with the records
maintained by the owner’’ must be
conducted annually, rather than ‘‘upon
request’’ as we proposed. Also change
the inventory requirements to make it
clear that the owner must present the
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entire herd for inspection under
conditions where the APHIS employee
or State representative can safely read
all identification on the animals. The
owner will be responsible for
assembling, handling and restraining
the animals and for all costs and
liabilities incurred to present the
animals for inspection.
• Add a requirement that cervids held
for research purposes may only be
moved interstate under a USDA permit.
In the proposal, such animals were
completely exempt from the
requirements of the rule.
• Make minor changes to improve
clarity in other sections of the rule.
Comments on Definitions in the
Proposed Rule
Approved State CWD Herd Certification
Program
One commenter noted that although
the term Approved State CWD Herd
Certification Program appears in the
regulations its meaning is not defined
and must be derived from context. In
response we have added a definition of
this term that reads ‘‘A program
operated by a State government for
certification of cervid herds with respect
to CWD that the Administrator has
determined to meet the requirements of
§ 55.23(a).’’
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Definition of Farmed or Captive
Several commenters stated that when
referring to cervids, the term ‘‘captive’’
should be changed to ‘‘privately
owned,’’ ‘‘domestic,’’ or ‘‘farmed.’’ They
stated that the term captive implies the
animal was captured from the wild, but
cervid ranches and farms primarily
contain animals born on a commercial
premises. Some commenters stated that
the words ‘‘captive’’ or ‘‘captured’’ have
a negative connotation about the cervid
industry.
We understand that producers that
maintain herds of cervids that were born
in captivity and do not deal in animals
captured from the wild believe that their
industry is properly associated with
other livestock industries, and that there
may be negative connotations in any
term that associates them with the
capture of wild cervids. However, some
herds of domesticated elk or deer do in
fact contain some animals captured
from the wild. While this is becoming
less common, if our certification
program only addressed herds in which
all animals were born into captivity, the
program would exclude too many herds,
reducing the program’s effectiveness in
controlling CWD. Many State CWD
regulations and programs recognize the
fact that a ‘‘captive’’ cervid may be
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either born into a herd or introduced
into it from the wild. Some States, in
their requirements for allowing cervids
to enter the State, require that the cervid
must come from a herd that has been
monitored for CWD for at least 5 years
under a State program, but do not
require that the cervid must have been
born into a captive herd; instead, they
require that all animals in the source
herd must be either natural additions or
have been in the herd for at least 1 year.
We believe that to effectively control
CWD our certification program must
address not only cervid herds
containing solely domesticated cervids
born into herds, but also must address
herds that contain one or more animals
introduced from the wild, cervids
captured from the wild and temporarily
maintained in captivity, and cervids
maintained by zoos and other
exhibitors. Also, the term captive
cervids is already in use in a number of
other Federal regulations (e.g., 9 CFR
Part 77—Tuberculosis, 9 CFR Part 50—
Animals Destroyed Because of
Tuberculosis, and 9 CFR Part 91—
Inspection and Handling of Livestock
For Exportation). It is also used in
several State laws, regulations, and
policy statements. Using an alternate
term such as ‘‘domestic cervid’’ or
‘‘farmed cervid’’ in our certification
regulations would be inconsistent and
could cause confusion.
However, we do agree that
incorporating the term ‘‘farmed’’ along
with the term ‘‘captive’’ would
emphasize the fact that many cervids
are domestic animals born in captivity.
Therefore, we are replacing the term
‘‘captive’’ with the term ‘‘farmed or
captive’’ throughout the regulations. We
are making no change to the definition
itself, so in this final rule, the term
farmed or captive will read as follows:
‘‘Privately or publicly maintained or
held for economic or other purposes
within a perimeter fence or confined
area, or captured from a free-ranging
population for interstate movement and
release.’’
Definition of Commingled, Commingling
Several commenters stated that there
is no scientific evidence supporting the
idea that animals are commingled to the
extent that disease transmission is
possible when the animals are separated
by less than 30 feet. These commenters
stated that CWD transmission at this
distance would be possible only through
aerosol routes, and no evidence has ever
been found that CWD passes via an
aerosol spray from animal to animal.
Commenters also stated that regulations
for control of other diseases, e.g.,
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tuberculosis, require separation of only
10 feet to prevent commingling.
Several commenters asked for
clarification of how the commingling
definition would apply to perimeter
fencing issues, and whether a certified
herd would lose its status (become an
exposed herd) if its premises does not
have a double fence with at least 30 feet
between the fences and a wild cervid in
the area is diagnosed with CWD. One
commenter suggested that perimeter
fences that maintain 30 feet of
separation from wild animals should be
clearly required for all farmed or captive
cervid premises, because, otherwise,
commingling with native animals could
not be avoided, increasing both the risk
that captive animals would contract
CWD from free-ranging animals and the
risk that farmed or captive animals
would spread CWD to free-ranging
native animals.
The term commingling is used in the
regulations in two distinct contexts—
that of temporary contact between
animals (e.g., during sale or transport or
at shows) and more long-term contact
between animals (e.g., when an owner
maintains two or more separate herds
on one premises, in accordance with
§ 55.23(b)(5)). The criteria used to
determine that commingling has
occurred are especially important
because if a herd was commingled with
a CWD-positive animal, it can be
declared to be a CWD-exposed herd.
We agree with the points made by
several commenters that it would be
both unnecessary and burdensome to
say that animals are commingled if there
is not a 30-foot buffer zone between
animals at all times. We are changing
this requirement in the definition of
commingling to 10 feet of separation,
and will make it clear that this
separation distance is adequate for
situations where animals are in
temporary association, such as at
auctions or during movement. We are
making this change because our level of
knowledge concerning transmission of
CWD from animal to animal has
increased since the proposed rule was
written. In the proposed rule we stated
‘‘A buffer zone of 30 feet was chosen
because in other APHIS disease control
programs this distance has been shown
to be effective in preventing aerosol
transmission of infective agents from
one animal to another. Because there is
not yet a detailed model of how TSE’s
are transmitted, APHIS believes it is
prudent to assume that they might
spread short distances as aerosols,
rather than only through more direct
contact.’’ Currrent evidence indicates
that transmission is most likely to occur
via an oral-fecal route, and that a 10-foot
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buffer zone should prevent this. A
buffer zone of 10 feet will prevent noseto-nose contact, make accidental fecal
contamination and transfer less likely,
and is the standard distance we use to
prevent ectoparasite transfer of other
diseases. Ten to 12 feet is also the
standard distance used for construction
of alleyways on farms and animal
holding facilities, so it will be relatively
easy to comply with this standard when
a producer needs to prevent
commingling of animals.
However, we also believe that it is
necessary for separate herds to have a
buffer zone of more than 10 feet
between them because risks of crossherd contamination are increased when
different herds are in close association
for long periods. Therefore, in addition
to changing ‘‘30 feet’’ to ‘‘10 feet’’ in the
definition of commingled, commingling,
we are also adding the following
italicized words to the paragraph
describing conditions for maintaining
separate herds, § 55.23(b)(5): ‘‘If an
owner wishes to maintain separate
herds, he or she must maintain separate
herd inventories, records, working
facilities, water sources, equipment, and
land use. There must be a buffer zone
of at least 30 feet between the perimeter
fencing around separate herds, and no
commingling of animals may occur.
Movement of animals between herds
must be recorded as if they were
separately owned herds.’’
Readers should note that this
requirement that herds must be
separated by 30 feet applies to cases
where a single owner maintains separate
herds, as well as to cases where
different owners have adjacent herds.
Several commenters stated that since
current scientific information indicates
CWD is transmitted laterally, animal to
animal, there is no basis for the ‘‘48hour exemption.’’ One commenter
stated that all animals grouped together
even briefly at a sale or auction should
assume the status of the lowest program
status animal in the group. Some
commenters stated that the definition’s
exemption for animals commingled for
less than 48 hours at sales or auctions
is arbitrary, but if used, it should also
apply to short-term commingling of
animals outside sales or auction
premises, when the owner can
document that the commingling was for
less than 48 hours.
A zoo association requested that
APHIS establish an exemption similar to
the 48-hour exemption for auctions and
sales for zoo animals that briefly share
holding or hospital pens for the purpose
of cleaning enclosures or shifting
animals.
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The ‘‘48 hour exemption’’ exists in
various forms in several other animal
disease control programs, and is based
on an assumption that transmission of
disease between animals is most likely
during periods of prolonged close
contact. APHIS has reexamined this
assumption with regard to CWD
transmission, and has found that there
are no completed studies of CWD
transmission rates that definitively
settle the question of what length of
time contact between animals is needed
before there is a significant risk of CWD
transmission. Therefore, we are
removing the ‘‘48 hour exemption’’ from
the definition of commingling. We may
address the risks associated with brief
contacts again in future rulemaking if
new studies of CWD transmission
provide relevant data.
Commenters also noted that the rule
did not clearly describe the actions
APHIS would take to reduce a herd’s
program status if its animals
commingled with animals from a lowerstatus herd. This reclassification of herd
status becomes even more important
now that we have eliminated the ‘‘48
hour exemption’’ for sales and auctions,
where commingling is likely to occur.
We agree that § 55.24, Herd status, does
not sufficiently describe APHIS or State
actions that may reduce herd status as
a result of commingling. Therefore, we
are adding a new paragraph § 55.24(b)(3)
that reads: ‘‘If an APHIS or State
representative determines that animals
from a herd enrolled in the program
have commingled with animals from a
herd with a lower program status, the
herd with the higher program status will
be reduced to the status of the herd with
which its animals commingled.’’
We expect the two changes discussed
above—removing the ‘‘48 hour
exemption’’ and adding an explicit
process to reduce the status of
commingled herds—will result in
operational changes at sales, auctions,
and other sites where animals are at risk
of commingling. Owners will probably
find it useful to plan animal grouping at
such sites so that only animals with
equal program status are grouped
together.
Based on some of the comments about
commingling, some readers appear not
to understand that the term is used in
the regulations for distinct and limited
purposes related to contact with other
farmed or captive cervids, and not
related to exposure to wild cervids in a
farm’s vicinity. The concept of
commingling is used when determining
whether groups of animals on a single
premises qualify as separate herds or
not, when determining whether animals
have been exposed to animals from a
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herd with a lower program status, and
when determining whether animals in a
suspect herd commingled with a CWDpositive animal, in which case the
suspect herd will lose its program status
and will be designated as a CWDexposed herd. However, as discussed
above regarding perimeter fence issues,
there is nothing in the regulations that
would reduce a herd’s program status
based on the lack of a 30-foot (10-foot,
under this final rule) physical
separation from animals in the wild.
Although APHIS encourages double
perimeter fencing, the requirement in
the regulations is for single-fencing. In
individual cases a herd plan developed
to eradicate CWD from a CWD-positive
herd, to control the risk of CWD in a
suspect herd, or to prevent introduction
of CWD into another herd, may specify
double perimeter fencing for a particular
herd, for example, when there is known
CWD infection in adjacent captive or
wildlife populations.
Definitions of CWD-Exposed Animal
and CWD-Exposed Herd
One commenter pointed out that the
defined terms for exposed animals and
herds omitted cases where the exposure
was not to a CWD-positive animal, but
to a CWD-exposed animal (which may
later prove to be CWD-positive). The
commenter suggested creating and
defining a term to cover such ‘‘exposed
to exposed’’ contacts for epidemiology
purposes.
We agree with the commenter that
awareness of ‘‘exposed-to-exposed’’
contacts can help epidemiologic
investigations and long-term tracking of
patterns of CWD transmission. However,
exposed animals and herds are already
subject to restrictions under the
regulations, and we do not believe that
the regulations should impose any
additional restrictions on ‘‘exposed-toexposed’’ animals. We do plan to
emphasize the importance of
investigating ‘‘exposed-to-exposed’’
contacts in our nonregulatory guidance
to APHIS and State veterinarians
conducting epidemiologic
investigations.
Definitions of CWD-Positive Animal and
CWD-Positive Herd
Several commenters questioned the
definition of a CWD-positive animal as
one that ‘‘has had a diagnosis of CWD
confirmed by means of an official CWD
test.’’ These commenters stated that at
least two positive results from certified
laboratories are needed to reliably
identify a positive animal. The
commenters said two tests should be
required because they believe that errors
in samples collected for CWD programs
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have been found (e.g., mislabeling or
collection of the wrong tissues) and that
current CWD tests require evaluation of
results in a manner that is subjective
and may be subject to error. Some
commenters stated that, after an animal
tests positive, 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. One commenter added that
a positive result on a CWD test is a
major crisis to any deer farmer, and the
expense of a second test and DNA
verification is a small price to pay to
ensure that the process has been free of
human or other error.
We agree with the comments
suggesting that a determination that an
animal is CWD-positive should not be
based on a single positive test result. We
are amending the definition of CWDpositive animal to read: ‘‘An animal that
has had a diagnosis of CWD confirmed
by means of two official CWD tests.’’ We
expect that, in most cases, the first test
would be conducted by a State, Federal,
or university laboratory approved to
conduct CWD official tests in
accordance with § 55.8, and the second,
confirmatory test would be conducted at
the National Veterinary Services
Laboratories (NVSL). In some cases,
both the initial and confirmatory test
may be conducted at NVSL.
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.
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Definition of CWD-Suspect Animal and
CWD-Suspect Herd
Several commenters suggested that it
was not clear whether the phrase
‘‘laboratory evidence or clinical signs
suggest a diagnosis of CWD’’ in the
definitions of CWD-suspect animal and
CWD-suspect herd meant that an animal
or herd could be found to be CWDsuspect based on the results of
unofficial CWD tests.
We planned to include unofficial
CWD test results as an indicator in this
definition. To clarify this, we are
changing the relevant phrase in both
definitions to read ‘‘unofficial CWD test
results, laboratory evidence, or clinical
signs suggest a diagnosis of CWD.’’
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One commenter pointed out that the
definition of CWD-suspect herd in § 55.1
said the determination could be made
by ‘‘an APHIS employee or State
representative,’’ but the definition of
CWD-suspect animal in § 81.1 mentions
only ‘‘an APHIS employee.’’ This was
an inadvertent omission, and we have
added ‘‘or State representative’’ to the
definition of CWD-suspect animal.
Definitions of Deer, Elk, and Moose
Some commenters noted that the
proposed definitions of deer and elk
were imprecise or incomplete, and there
was some confusion about when hybrid
animals would be considered deer and
when they would be considered elk.
Several commenters asked why certain
species were not included in either
definition when there is no conclusive
scientific evidence that the species are
not susceptible to CWD. Commenters
asked in particular about sika deer
(Cervus nippon), sambar (Cervus
unicolor), rusa deer (Cervus timorensis),
barasingha (Cervus duvauceli), and Pere
David’s deer (Elaphurus davidiensis).
Several commenters suggested that the
definitions be expanded to include more
deer and elk or other cervids.
We agree, and are replacing the term
‘‘deer and elk’’ with ‘‘deer, elk, and
moose’’ and are defining the term to
mean ‘‘all animals in the genera
Odocoileus, Cervus, and Alces and their
hybrids.’’ This change expands coverage
to all species of concern. This final
definition was developed by identifying
the species known to be susceptible to
natural spread of CWD and then
expanding coverage to the complete
genera that include these species, under
the assumption that related animals in
a genus may share similar susceptibility
to CWD even when all species in the
genus have not been shown to be
susceptible. We have expanded
coverage to include moose (genus Alces)
because CWD was recently diagnosed in
a moose for the first time. We have not
expanded coverage to genera in which
no species has demonstrated
susceptibility via natural routes of
transmission. To do so would extend
the requirements of this rule without a
sound basis, unnecessarily increasing
the burden on regulated parties,
especially zoos with large and varied
animal collections. We are prepared to
extend the definition in the future if
new research demonstrates additional
species in other genera are susceptible
to CWD by natural routes of
transmission. This change should make
it clear that the same program
requirements apply to deer, elk, moose,
and any hybrids of these animals.
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Definition of Herd Plan
Several commenters addressed the
part of the herd plan definition that said
a herd plan, among other things, will
specify ‘‘the time for which a premises
must not contain cervids after CWDpositive, -exposed, or -suspect animals
are removed from the premises.’’ These
commenters stated that there should be
a permanent ban on raising cervids on
any property that once contained CWDpositive animals, due to risks of
environmental transmission of CWD.
We do not agree with these
comments. The definition’s language
will allow a herd plan to prohibit
cervids from a premises for an
appropriate period based on the specific
risks and conditions of the individual
herd. Ongoing and future research may
help resolve many questions about
environmental transmission of CWD
and establish reasonable standards for
when it is safe to repopulate a
previously contaminated premises.
Establishing permanent restrictions on
repopulating premises with cervids
would be unnecessarily broad and harsh
when, in most cases, tailored herd plans
can be used to minimize both the risk
of CWD transmission and the financial
burden on owners of premises. The
length of a ban on restocking may be
stated as an actual time period in
months or years, or it may be conditiondependent, e.g., a herd plan might
prohibit restocking based on the
presence or levels of CWD in
surrounding herds or wildlife.
Some commenters suggested that the
definition of a herd plan in part 55
should state that it must be approved
and signed by all three involved
parties—APHIS, the State, and the herd
owner. As proposed, it seemed that the
document was executed between APHIS
and the State but affected the herd
owner.
As described in the proposal, the herd
plan will be developed with extensive
input from the herd owner, because it
will include procedures developed to
address the particular risks and
situation of a herd. We agree that,
although the APHIS Administrator has
the ultimate authority to determine that
a herd plan is adequate, all three
involved parties should approve and
sign the herd plan. Therefore we have
changed the language in the definition
to state that a herd plan will become
effective after ‘‘it has been reviewed and
signed by the Administrator, the State
representative, and the herd owner.’’
One commenter stated that the herd
plan definition’s requirement for
‘‘regular examination of animals in the
herd by a veterinarian for clinical signs
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of disease’’ was vague, and could mean
veterinarians must examine animals
once a year, every month, or any other
frequency.
We intend to establish the frequency
of veterinary examination for each herd
in the body of the herd plan developed
specifically for the herd. We did not
specify a frequency in the rule because
it will be set based on the particular
circumstances and risk conditions
associated with each herd.
A zoological association commented
that the herd plan definition could
impose a tremendous burden on zoos
with its requirement for ‘‘reporting to a
State or APHIS representative of any
clinical signs of a central nervous
system disease or chronic wasting
condition in the herd.’’ The association
interpreted this to mean that zoo
veterinarians would have to report every
cervid that exhibits chronic weight loss
or an unsteady gait, both of which are
common in older animals.
We believe this commenter did not
take into account that this requirement
applies only to herds that are under a
herd plan, and that most zoos will not
be subject to herd plans. A zoo, like any
herd, would become subject to a herd
plan only after it is found to be CWDpositive, CWD-exposed, or CWDsuspect. This should happen to zoos
only rarely, but when it does, it is
important that all clinical signs that may
indicate CWD be reported and
investigated.
Consistency Between CWD Regulations
and Other TSE Regulations
Several commenters stated that the
regulations for CWD, BSE, and scrapie
should have similar structures, accepted
risk levels, and effects. They stated that
TSE causal agents for each disease and
their effects on ruminants are
sufficiently similar to demand virtually
complete compatibility between
regulations. They said that the
continuing risk of cross contamination
between species also requires regulatory
consistency. Another reason they
provided for consistency between CWD,
BSE, and scrapie regulations is that,
without it, cervid producers may be
subject to discriminatory, anti-farming
regulatory pressures. Some commenters
suggested that farmed or captive deer,
and elk generally should be treated the
same as other domestic livestock. Some
commenters questioned why owners of
farmed or captive cervids are expected
to test 100 percent of on-farm
mortalities, while owners of cattle
(potentially affected by BSE) test very
few on-farm mortalities and a fraction of
downer animals sent to slaughter, and
owners of sheep (potentially affected by
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scrapie) usually test only animals
exhibiting clinical signs of scrapie.
In responding to these comments, we
emphasize that the TSE diseases that
affect different species of domestic
livestock are not all the same disease.
They have different modes of
transmission and different
pathogenicity, and taking these facts
into account means that we cannot have
the same approaches for all of our TSE
programs and still attain our goals. At
this point in time, the BSE program is
a surveillance and prevention program,
not a disease control program like the
CWD certification program, and, as
such, requires completely different
standards and testing levels. The scrapie
program, like the CWD program, is a
certification program for an endemic
disease. Where possible, we have tried
to make the CWD program consistent
with the scrapie certification program.
However, several factors make it
necessary that participants in the CWD
program, unlike the scrapie program,
must make all herd mortalities (over 12
months of age) and all animals sent to
slaughter available for sample collection
and testing. The most obvious reason for
this difference is that two powerful
surveillance tools are available to the
scrapie program that are not available to
the CWD program, a live animal test for
scrapie and scrapie susceptibility
genotyping.
The 5-Year Standard
Many commenters addressed the
provisions of the rule that use a 5-year
standard regarding risks of CWD. Some
commenters questioned the part of these
definitions that would classify an
animal or herd as exposed based on
contact with a CWD-positive animal
anytime within the preceding 5 years.
These commenters stated that including
exposure that occurred 5 years before is
not based on known risk or scientific
fact, and suggested that a 3-year limit
would be sufficient.
The 5-year standard is used in the
definitions of commingled, CWDexposed animal, and CWD-exposed
herd, and the progress of a herd to
‘‘Certified’’ status also requires 5 years
of monitoring without evidence of CWD.
All of these uses assume that a cervid
that contracts CWD will develop signs
of the disease—in fact will almost
certainly die from the disease—in less
than 5 years. Based on that assumption,
the rule requires investigation of an
animal or herd’s exposure to incidents
within the past 5 years and, if a herd is
continually monitored for CWD for 5
years without positive test results, the
CWD risk in the herds is considered
low.
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All commenters agreed that the
incubation period for CWD is less than
5 years. The key question for many
commenters is, how much less? The
expense of participating in the CWD
program increases incrementally with
the length of time required to reach
‘‘Certified’’ status. Also, with regard to
exposure to CWD, many more animals
and herds must be considered exposed
if we consider exposure that happened
5 years ago than if we consider only
exposures that happened in the past 2
or 3 years.
Many commenters suggested that a 3year standard for exposure and for
reaching ‘‘Certified’’ status is adequate
and is justified by scientific research on
the CWD incubation period. A few
commenters also suggested either
shorter or longer periods than 3 years
for this standard. In addition to citing
scientific research that supported an
incubation period of from 24 to 34
months, some commenters also referred
to State animal health agency records as
supporting a 3-year standard. They
stated that records of trace-back and
trace-forward investigations of animals
associated with CWD-positive herds did
not show any cases where a CWDpositive animal acquired the disease
more than 30 months prior to diagnosis.
Some commenters stated that using a 5year standard is arbitrary and simply
incorporates a 2-year safety margin.
Some commenters stated that certain
existing State CWD programs allow
animals to move into their States after
only 3 years of monitoring for CWD.
We are not changing the 5-year
standard in response to these comments.
The choice of 5 years was made based
on several factors, including the
probable maximum incubation time for
CWD and program design decisions
about time spans realistically needed for
all the participants in a herd
certification program (Federal and State
animal health personnel, cervid
producers, laboratories, and others) to
perform all the duties required of them.
The goal of the CWD certification
program is to rapidly eliminate a disease
that is not currently widespread in the
farmed cervid industries. It will take
much longer to achieve this goal if the
program standards are set too low at the
outset and must be made more stringent
later; if, for example, we applied a 3year standard at the outset only to find
that it allowed CWD-positive animals to
further spread CWD without being
detected. Until there is definitive data to
allow for less stringent measures, we
must use a conservative approach based
on current knowledge.
We agree that many studies suggest an
average incubation period for CWD of
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no more than 36 months. For example,
a study 1 in captive elk at the Colorado
Division of Wildlife, Foothills Wildlife
Research facility, found that the average
incubation period for elk in its herd that
were naturally exposed to CWD in a
contaminated environment was 26
months (range 18–36 months). However,
in this same group of elk and 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. This could have been the result of
a later environmental exposure or it
could represent a 5-year incubation
period.2 Preliminary reports from an
ongoing APHIS and Agricultural
Research Service research project in
Ames, IA have also identified animals
that did not show signs of disease until
at least 4 years after infection, and
animals that do not show signs of
disease 4 years after infection but that
test positive for CWD through unofficial
tests such as rectal biopsy and the third
eyelid test.
In pathogenesis studies 3 in mule deer
and elk at the University of Wyoming,
high dose oral inoculation produced an
average incubation (from exposure to
onset of clinical disease) of 23 months
(range 15 months to >25 months) in
mule deer. Similar work in elk showed
the range of incubation was 12–34
months. The researchers acknowledged
that experimental infections (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. In other words,
experimental infections most likely
represent the range of minimum
incubation times. Maximum incubation
times are not known but most likely
exceed 25 months for mule deer and 34
months for elk.
For these reasons, we believe that
incubation periods for low dose natural
exposures may be longer than
incubation periods for high dose oral
inoculations used in most research.
Based on the information we have now,
the longest incubations likely fall
between 3 and 5 years. This supports
establishing the program with a 5-year
timeframe for tracing animals and
certifying herds to ensure the program
locates CWD-positive animals.
We anticipate that research,
monitoring, and surveillance will reveal
1 Miller et al., 1998 Epidemiology of Chronic
Wasting Disease in Captive Rocky Mountain Elk,
Journal of Wildlife Diseases, 34:532–538.
2 Miller, personal communication.
3Williams et al. 2002. Chronic Wasting Disease of
Deer and Elk. A Review With Recommendations for
Management. Journal of Wildlife Management
66(3): 551–563.
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more precise data about CWD
transmission over the next few years. If
new data support changing the 5-year
standard, APHIS will initiate
rulemaking to modify it.
Animal Identification
Many commenters addressed the
proposed animal identification
requirements. Some requested more
flexibility in the type of approved
identification so that producers could
make better economic decisions about
what type of identification worked best
for their herds. We agree, and have
added the phrase ‘‘or other device
approved by APHIS’’ to the lists of
approved identification devices
(electronic implant, flank tattoo, ear
tattoo, or tamper-resistant ear tag) in
§ 55.25, Animal identification and
§ 81.2, Identification of deer, elk, and
moose in interstate commerce. We will
approve alternative identification on a
case-by-case basis as the program is
implemented. The criteria for approving
identification devices will be whether
they provide permanent, secure
identification, are cost effective, and are
practical for those who must apply and
read the devices.
Many cervid producers commented
that the proposal to require two forms
of official identification would be very
burdensome, due to the expense and
difficulty of assembling and restraining
an entire herd to apply the devices. This
involves high labor costs, risks of
harming the animals, and, if tranquilizer
darts are used, dart drug costs of $30 to
$35 per animal. Some commenters
suggested that APHIS could mitigate
this burden by phasing in the two
identification requirements over the first
2 or 3 years of program participation.
Some commenters also suggested that a
second form of official identification
should only be required when animals
are moved from an owner’s premises,
not for every animal in the herd.
We are making several changes to the
animal identification requirements,
discussed below, in response to these
comments. We also intend to work with
producers when they enroll in the
program to allow them to apply the
required animal identification at a time
and in a manner that minimizes the
burden on the producer, who is
responsible for ensuring that animals
are identified when required and for the
costs associated with identifying the
animals.
When applying identification devices,
producers may be able to schedule
identification activities at a time when
they already need to restrain animals,
such as the annual physical inventory,
or may be able to apply identification to
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a few animals at a time over extended
periods, or may find other ways to
economize on the process. More
information is being developed on
flexible alternatives for accomplishing
program requirements, including
application of animal identification
devices required by the program, and
this information will be made available
to the public when it is ready.
We are not eliminating the
requirement for a second form of animal
identification because accurate
identification is a critical element of the
program, and loss or obliteration of
identification devices is quite common
with cervids. A producer who can’t
logistically meet the identification and
inventory standards will be unable to
participate in the CWD Herd
Certification Program. Participation
must be contingent on ability to meet
the requirements, or the program will
lose effectiveness and industry
confidence. Producers who want their
herds to achieve ‘‘Certified’’ status may
need to alter their management practices
in order to meet program requirements.
However, we are changing the
identification requirement so that only
one of the two required identification
devices attached to the animal must
have a nationally unique animal
identification number that is linked to
that animal in the CWD National
Database, where information on the
animal’s current herd may be crossreferenced. The other animal
identification device need only be
unique within the animal’s herd; that is,
it does not need a nationally unique
number, but may instead merely
identify the herd and distinguish
different animals in the herd. Since the
second means of animal identification is
only required to be unique for the
individual animal within its herd, this
should allow continued use of most
existing forms of animal identification
as the required second means of
identification.
To accomplish this change, we are
separating the proposed defined term
official identification into two new
defined terms, animal identification and
official animal identification. We are
also retitling § 55.25, Official
identification, as Animal identification,
and are changing it as described below.
We define animal identification as a
device or means of animal identification
approved by APHIS for use under 7 CFR
part 55. The definition also notes that
examples of animal identification
devices that APHIS has approved are
listed in § 55.25.
We define official animal
identification to mean devices or means
of animal identification approved by
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APHIS to uniquely identify individual
animals, with examples provided in
§ 55.25. The definition states that
official animal identification must
include a nationally unique animal
identification number that adheres to
either the National Uniform Eartagging
System, the AIN (Animal identification
number) system, a premises-based
numbering system that uses an official
premises identification number (PIN), or
another numbering system approved by
the Administrator for the identification
of animals in commerce.
Revised § 55.25, Animal
identification, now says that each
animal required to be identified must
have at least two forms of animal
identification attached to the animal,
that the means of animal identification
must be an electronic implant, flank
tattoo, ear tattoo, tamper-resistant ear
tag, or other device approved by APHIS.
The revised section states that one of the
animal identifications must be official
animal identification as defined, with a
nationally unique animal identification
number that is linked to that animal in
the CWD National Database. The second
animal identification must be unique for
the individual animal within the herd
and also must be linked to that animal
and herd in the CWD National Database.
The nationally unique identification
number and all the animal’s
identification data from the second form
of identification will be entered into the
CWD National Database. This will allow
an authorized user of the CWD National
Database to use either identification
number to retrieve all information on
the animal and its herd and premises.
The nationally unique identification
number approach is consistent with the
national animal identification system
(NAIS) that APHIS is in the process of
developing and implementing in
cooperation with States and animal
industries. The NAIS is intended to be
an effective, uniform, consistent, and
efficient national animal identification
system. An overview of the NAIS is
available at https://
animalid.aphis.usda.gov/nais/
index.shtml.
To make our CWD regulations
consistent with the NAIS approach that
is under development, we are also
adding a definition recently added to
other APHIS domestic livestock
regulations. On November 8, 2004, we
published in the Federal Register an
interim rule concerning livestock
identification and the use of numbering
systems for identification devices (69 FR
64644–64651; Docket No. 04–052–1).
The interim rule amended the APHIS
regulations that address interstate
movement of livestock (9 CFR parts 71,
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77, 78, 79, 80, and 85). One purpose of
the interim rule was to authorize use of
an alternative numbering system for
individual animal identification that
assigns a unique number to each animal
identified under the system, to
encourage consistency with the NAIS.
The interim rule included definitions of
animal identification number (AIN) and
premises identification number (PIN),
which we are adding to the CWD
regulations in 9 CFR parts 55 and 81.
The definition of animal identification
number (AIN) reads: ‘‘A numbering
system for the official identification of
individual animals in the United States.
The AIN contains 15 digits, with the
first 3 being the country code (840 for
the United States), the alpha characters
USA, or the numeric code assigned to
the manufacturer of the identification
device by the International Committee
on Animal Recording.’’ The definition
of premises identification number reads:
‘‘Premises identification number (PIN).
A unique number assigned by a State or
Federal animal health authority to a
premises that is, in the judgment of the
State or Federal animal health authority,
a geographically distinct location from
other livestock production units. The
premises identification number is
associated with an address or legal land
description and may be used in
conjunction with a producer’s own
livestock production numbering system
to provide a unique identification
number for an animal. The premises
identification number may consist of:
(1) The State’s two-letter postal
abbreviation followed by the premises’
assigned number; or (2) A sevencharacter 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.’’
This definition of AIN is added to
clarify the sentence in the new
definition of official animal
identification that reads: ‘‘The official
animal identification for an animal must
include a nationally unique animal
identification number, such as an AIN
number.’’ While the rule does not
require use of an AIN—other nationally
unique identification numbers can meet
the requirement—we wanted to make it
clear, in preparation for implementation
of the NAIS, that NAIS-compliant
individual animal identification will
also meet the requirements of this CWD
rule.
Some commenters suggested that the
regulations should specifically
‘‘grandfather in’’ as animal
identification any form of identification
that is currently accepted by a State
CWD program.
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We are not giving blanket approval to
all forms of identification currently used
by a State CWD program because we
may not be aware of the characteristics
of all such devices in use, and a few
may not be adequate for program
purposes. We do expect to approve
most, if not all, identification devices in
use by State CWD programs, under the
provision we are adding (discussed
above) to allow identification by ‘‘any
other device approved by APHIS.’’
Some commenters suggested that
cervids captured from a free-ranging
population for interstate movement and
release should also be required to have
two forms of animal identification
because such animals are not regularly
observed and hence are more likely to
lose one form of identification between
extended observation periods.
We agree, and we are changing the
requirements for animal identification
to require that free-ranging animals
captured for interstate movement and
release, like other farmed or captive
cervids, must have two forms of animal
identification, one of which must be
official animal identification. We are
making this change by removing the
phrase ‘‘except for free-ranging animals
captured for interstate movement and
release in accordance with § 81.3(b),
which must have at least one form of
identification’’ from § 81.2,
Identification of deer, elk, and moose in
interstate commerce, and revising the
phrase ‘‘has at least one form of official
identification’’ in § 81.3(b) to read, ‘‘has
two forms of animal identification, one
of which is official animal
identification.’’
Several commenters asked whether
there was a specific age before which
animals in participating herds must be
officially identified.
The proposed rule did not establish a
specific age by which animals must be
identified. We did not do so because
local herd conditions will affect both
when identification is needed, and
when it is practical to apply it.
However, the commenters are correct
that the rule should be more specific
about when identification must be
applied, both to help herd owners
comply with the requirement and to
ensure that the animals are officially
identified before certain events that
present risks of spreading CWD can take
place, such as interstate or intrastate
movement of the animal from the
premises, which may result in exposure
to other animals.
Therefore, we are adding the
following sentences to paragraph (b)(1)
of § 55.23, Responsibilities of herd
owners: ‘‘All animals in an enrolled
herd must be identified before reaching
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12 months of age. In addition, all
animals of any age in an enrolled herd
must be identified before being moved
from the herd premises. In addition, all
animals in an enrolled herd must be
identified before the inventory required
under paragraph (b)(4) of this section,
and animals found to be in violation of
this requirement during the inventory
must be identified during or after the
inventory on a schedule specified by the
APHIS employee or State representative
conducting the inventory.’’ We are using
12 months as the age by which animals
must be identified because that age has
been suggested before by industry
members as a reasonable standard, and
because the seasonal nature of livestock
management means that herd
management events where applying
identification is feasible are likely to
repeat on a 12-month cycle.
We expect that many herd owners
will use the annual inventory process as
an opportunity to apply animal
identification to animals born into the
herd in the prevous year. The Uniform
Methods and Rules for the Chronic
Wasting Disease Herd Certification
Program (UM&R) describes other
situations where owners may wish to
apply identification at other times.
APHIS Authority To Regulate Wild
Cervid Capture and Release
Several commenters stated that
APHIS is overstepping its authority by
regulating interstate movement of
cervids captured and released from a
free-ranging population. The
commenters believe that any regulation
of such movement should be under the
authority of the respective State wildlife
agencies. The commenters did not
oppose requiring animal identification
and documentation that such animals
are free from CWD for such movements,
but they did oppose including such
requirements in APHIS regulations.
APHIS works cooperatively on CWD
issues with many State wildlife agencies
and will continue to do so. We rely on
these agencies to apply and administer
their State authorities over wildlife in
support of mutual State-Federal goals
for CWD control. We will work
cooperatively with these agencies to
achieve safe, low-risk movement of
cervids captured and released from a
free-ranging population. APHIS shares
with State wildlife agencies the goal of
avoiding the establishment of CWD in
wildlife in new areas.
APHIS does not agree that we are
exceeding our authority in applying
regulatory requirements in an APHIS
rule to the capture and release of cervids
from a free-ranging population. The
Animal Health Protection Act of 2002
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(‘‘the Act’’) grants the Secretary of
Agriculture (and by delegation of
authority, the Administrator of APHIS)
ample authority to do so. Under the Act,
the Secretary may prohibit or restrict the
movement in interstate commerce of
any animal if the Secretary determines
that it is necessary to prevent the
introduction or dissemination of any
pest or disease of livestock.
Under the Act’s definitions, it is clear
that this authority extends to regulating
the interstate movement of cervids
captured from one free-ranging
population for release in another such
population. The Act broadly defines
animal as ‘‘any member of the animal
kingdom (except a human),’’ which
includes wild cervids. The Act broadly
defines interstate commerce to include
‘‘trade, traffic, or other commerce’’
between or through U.S. States,
territories, and possessions. The act of
capturing animals, moving them
interstate, and releasing them falls
within this scope. The Act’s definition
of move specifically covers, among other
things, the act of transporting, and the
act of releasing into the environment;
both apply to the translocation of
captured cervids. It is not uncommon
for multiple governmental agencies to
have authority over the same things or
transactions for similar or different
purposes. One agency having authority
to regulate a thing or transaction for one
purpose does not preclude another
agency from having authority over the
same thing for a similar or different
purpose. This is especially true when
dealing at different levels of
government, but is also true when
dealing within the Federal government
or within a State’s or other jurisdiction’s
regulatory scheme. Nothing precludes
such multiple authorities over the same
thing or transaction, if each agency
exercising authority with regard to the
thing or transaction in question has the
requisite jurisdiction to do so. The
Secretary (and by delegation of
authority, the Administrator of APHIS)
has clearly been granted that authority
under the Animal Health Protection Act.
Applicability To Hunting Operations
Several commenters suggested that
hunting ranches should be regulated in
an alternate manner that recognizes the
constraints that exist for these farms.
According to the commenters, most
hunting operations are very large
premises that do not normally restrain
their animals’ movements within the
premises, making identification and
inventory very difficult. Commenters
said that detection of incidental
mortalities throughout the year in order
to make tissues available for testing
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would be difficult and that dead
animals in such facilities might not be
located quickly enough to obtain
samples suitable for testing.
Commenters said that hunting
operations are also seasonal, meaning
that the requirement that all animals
that die on the premises must be made
available for testing would mean a flood
of sampling for 4 to 5 months each year
when hunters kill animals on the
premises. They said that the volume of
work during this period could adversely
affect the quality of tissue collection,
recordkeeping, and laboratory analysis.
These commenters suggested that
instead of the CWD Certification
program as proposed, hunting
operations could participate in a
surveillance and monitoring program
that was harvest-based, without strict
animal identification and inventory
requirements but including testing a
statistical sample of each year’s harvest
for 3 to 5 years.
APHIS is willing to work with
hunting premises owners and States to
consider and evaluate suggested
alternative approaches for hunting
premises to meet program requirements.
However, none of the approaches
suggested in comments would be
adequate to detect the presence of CWD
with sufficient confidence to allow
certification of the herd or to control the
spread of CWD in hunting premises
effectively. We believe that
identification of all animals, an annual
herd inventory, and extensive testing
are the keystones of an effective CWD
program, and these are the requirements
that hunting premises owners asked us
to reduce or eliminate. Alternative
surveillance programs that sample a
percentage of animals in hunting herds
and that do not include identifying and
inventorying all animals might
ameliorate some concern about the
presence of CWD, but we do not believe
such an approach could provide the
same degree of confidence that the CWD
certification program requirements
provide. If hunting premises owners
want their herds to be certified, they
must meet the requirements for the
certification program.
Eligibility of Cervid Owners To
Participate in the Program and
Enrollment Dates
Some commenters suggested that
CWD Certification Program
participation should be limited to herd
owners with no prior violations of State
laws and regulations for livestock and
animal care.
We agree with the spirit of this
comment but believe that banning
producers with ‘‘any violation’’ would
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be too severe and could unnecessarily
reduce participation in the program and
program effectiveness. While sometimes
APHIS officials may have information
about relevant violations by applicants,
we believe the enforcement and
recordkeeping activities of State
governments usually make them the
best level to address questions about
when particular producers have
committed violations that indicate they
are unlikely to comply with CWD
Certification Program requirements fully
and honestly. State veterinarians and
other officials can address this question
when deciding whether to admit a herd
to their Approved State CWD Herd
Certification Program or, in cases where
there is no approved State program, the
State veterinarians can still advise
APHIS officials about violations by
applicants applying to enter the Federal
program directly. If an applicant has
committed relevant violations, this may
be cause to refuse consideration of the
application if the violations are known
at the time of application, or to deny the
application if the violations are
discovered later during evaluation of the
application. To make this clear, we are
adding the following sentence to
§ 55.22, Participation and enrollment:
‘‘An application for participation may
be denied if APHIS or the State
determines that the applicant has
previously violated State or Federal
laws or regulations for livestock, and
that the nature of the violation indicates
that the applicant may not faithfully
comply with the requirements of the
CWD Herd Certification Program.’’
Several commenters addressed
procedures for ‘‘grandfathering’’ herds
already in State CWD programs into the
APHIS CWD Certification Program.
Some believe that herds that have
complied with a State program should
be grandfathered in with the status they
have achieved, even if their State
program has not been designated as an
Approved State CWD Herd Certification
Program under APHIS regulations.
Commenters stated that producers
should not be penalized simply because
their State, for whatever reason, did not,
does not, or will not cooperate to get
Federal recognition for the State
program. Commenters also addressed
the problem of ‘‘grandfathered’’ credit
for herd owners who wish to enroll
directly in the Federal CWD program
because there is no State program
available to them. Such owners may
have maintained their herds for some
time, in some type of voluntary
individual or other non-State program,
under conditions equivalent to the
Federal program standards (animal
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identification, monitoring, testing of
suspect animals, restrictions on animals
added to the herd, etc.), and should
receive some sort of credit for this.
We generally agree that herd owners
should be given appropriate credit for
time their herds were maintained under
restrictions equivalent to those in the
Federal CWD program, whether that
time was spent enrolled in a State
program that later becomes an
Approved State CWD Herd Certification
Program, in a State program that does
not choose to apply to be approved, or
in some other program that nevertheless
applied the same sort of herd
maintenance conditions. Whenever we
evaluate an existing State CWD program
that has applied for approval and
participation in the National CWD
Program, we will carefully compare the
requirements of the program as followed
by that State to determine that the State,
and thus herds in good standing in the
State’s program, have met the minimum
standards of our program. For herds in
States that have not applied to become
Approved State CWD Herd Certification
Programs, appropriate credit will be
granted for periods when the herd was
complying with standards equivalent to
the APHIS CWD Certification Program
requirements, regardless of whether or
not there is a State CWD program or
whether the relevant State has formally
requested status as an Approved State
CWD Herd Certification Program.
However, we are imposing one limit
on credit for herds that enroll directly
in the Federal CWD program and have
not participated in a State CWD
program. If APHIS determines that the
owner of such a herd has maintained
the herd in a manner that substantially
meets the conditions specified in
§ 55.23(b), the owner will be granted up
to a maximum of 2 years’ credit. That
is, in cases where a herd directly enrolls
in the Federal CWD program and the
herd is given credit for participation in
an individual or other non-State CWD
program, the herd’s enrollment date
may not be set at a date more than 2
years prior to the date that APHIS
approves enrollment of the herd.
We are prepared to grant unlimited
credit for time spent in certain
Approved State CWD programs but only
a maximum of 2 years for time spent in
an individual or other non-State CWD
programs because State programs have
the extensive infrastructure,
enforcement mechanisms, and record
systems that verify participation and
support reasonable confidence that
herds in these programs can fully meet
the program requirements over long
periods of time. While individual herd
owners may also devise or join non-
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State programs that meet the necessary
animal identification, monitoring, and
other requirements, and their
compliance may be documented
through herd records and animal
records in various State and market
records collections, it is simply harder
to establish with confidence that such
herds comply with requirements over
lengthy periods. We have chosen to
limit the credit granted to such herds to
2 years because such a policy also has
been used in the Canadian program for
granting credit to herds.
One commenter stressed the
importance of requiring that enrolling
herds with pre-existing State status
levels into the Federal program should
be done only after inventory
reconciliation with death records and
review of mortalities and test results by
APHIS to ensure that these
‘‘grandfathered’’ herds do, in fact, meet
the same regulatory standards as the
Federal program. We agree and intend
to carefully evaluate existing State CWD
programs and carefully compare the
requirements of the program to the
requirements of this rule before
establishing herd enrollment dates and
determining if herds may be enrolled at
an advanced status.
Some commenters suggested that the
granting of ‘‘grandfathered’’ credit
should be something that occurs only
during the early stages of program
implementation. They suggested that it
would be unwise to allow herds to enter
the Federal program several years from
now and to grant them credit for time
the herds spent in some other type of
CWD program, while at the same time
the Federal CWD program existed and
was available.
We agree. We have always intended
that ‘‘grandfathered’’ credit be a
transitional tool used in early stages of
program implementation. Once the
Federal CWD program and Approved
State CWD Herd Certification Programs
are fully implemented, they should be
the only way to accrue program status
because they will have the most
extensive and reliable enforcement and
records systems. To make this intent
clear, we are stating in paragraph
(a)(1)(i) of § 55.22, Participation and
enrollment, that constructed enrollment
dates (grandfathering) will be
unavailable for herds that apply to
enroll more than 1 year after the
effective date of this rule, and the
enrollment date for herds that apply
after that date will be the date APHIS
approves the herd participation.
In an issue similar to the
grandfathering policy, the proposed rule
did not clearly state how the enrollment
date or the herd status would be set
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when a newly-formed herd enrolls and
the herd contains only animals from
herds that were already enrolled in the
Program. Throughout this rule a guiding
principle is that the status of herds is
determined by the lowest status animal
contained in the herd. To make it clear
that this also applies in situations where
herds are formed using animals from
herds that have already achieved some
status in the program, we are adding the
following language to the sections
addressing enrollment dates and herd
status.
In § 55.22(a)(1), Participation and
enrollment, we are adding a new
paragraph (ii) to read ‘‘For new herds
that were formed from and contain only
animals from herds enrolled in the CWD
Herd Certification Program, the
enrollment date will be the latest
enrollment date for any source herd for
the animals.’’
In § 55.24(a), Initial and subsequent
status, we are adding the phrase ‘‘except
that; if the herd is comprised solely of
animals obtained from herds already
enrolled in the Program, the newly
enrolled herd will have the same status
as the lowest status of any herd that
provided animals for the new herd.’’
One comment noted that the proposal
said a CWD-positive or -exposed herd
may not apply to enroll, and suggested
that it would be better to allow these
herds to apply and develop a herd plan
than to have them remain unmonitored
and outside the system.
We agree that it would benefit
program goals to include such herds. To
do so, we are revising paragraph (a) of
§ 55.22, Participation and enrollment.
The proposed first sentence of this
paragraph read ‘‘Any owner of a captive
deer or elk herd (except for CWDpositive herds, CWD-exposed herds, and
CWD-suspect herds) may apply to enroll
in the CWD Herd Certification Program
by sending a written request to the State
animal health agency, or to the
veterinarian in charge if no Approved
State CWD Herd Certification Program
exists in the herd’s State.’’ We are
removing the phrase ‘‘(except for CWDpositive herds, CWD-exposed herds, and
CWD-suspect herds).’’ We are also
adding the following sentence later in
the paragraph: ‘‘If the enrolling herd is
a CWD-positive herd or CWD-exposed
herd, immediately after enrollment it
must begin complying with a herd plan
developed in accordance with § 55.24.’’
A zoological association
recommended that those zoological
institutions that possess reliable
traceback capabilities on cervid
necropsy samples should be
grandfathered into the certification
program with an enrollment date set at
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the date in which the first samples (if
properly saved, stored, and
representative of all cervid deaths in the
collection) were obtained and archived.
We believe that the regulations as
proposed will allow us to take such
necropsy sampling evidence and other
zoo disease control program activities
into account when setting the
enrollment date for zoos and similar
institutions. There are several problems
associated with enrolling zoos into the
certification program, and the special
circumstances associated with zoos may
be the subject of future rulemaking
addressing the certification program.
For example, many zoos have not been
considered eligible to enroll in State
CWD programs and, consequently, there
may be few State records documenting
CWD monitoring at zoos. On the other
hand, the records maintained by
individual zoos for their disease control
programs may sometimes provide
documentation equivalent to State CWD
program records. APHIS recognizes that
most zoos have very active programs to
prevent the spread of diseases such as
CWD within their animal collections
and to prevent the spread of disease to
other sites when animals are removed
from the zoo. If other program
requirements have been met and
documented by a zoo through
appropriate recordkeeping, up to 2nd
year status in the CWD Herd
Certification Program can be granted.
Economic Effects
Several commenters questioned some
of the figures and assumptions in the
proposed rule’s economic analysis. Most
of these commenters expressed concern
that the analysis underestimated the
degree of adverse impact; some were
concerned that the additional costs of
program participation would drive
many cervid producers out of business.
Some commenters suggested the
analysis overestimated the price owners
can currently get when they sell
animals, and underestimated the annual
costs of compliance in estimating
‘‘increased direct costs totaling about
$1,600 annually for the ‘‘average’’ elk
herd owner (i.e., one with a herd of 50
elk).’’ One commenter stated that, based
on his experience, it was possible to
participate in his State herd surveillance
program for CWD at an annual cost of
a fraction of $1,600. Several commenters
stated that herds participating in the
program would be essentially unable to
sell animals or do business for 5 years,
until the herd achieved ‘‘Certified’’
status, and that herds could not survive
without income for this long.
We used the best economic data
available at the time the proposed rule
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was written. The cervid market is
volatile, and some cost, price, and
inventory data has changed since that
time. We have updated the economic
analysis for this final rule with data
from several sources, including the 2002
Census of Agriculture. While some of
the dollar estimates in the analysis have
changed, its overall conclusion remains
the same. The rule should have a
positive economic effect on deer and elk
farmers, both large and small, over the
long term, with collateral benefits due to
a decreased risk of spreading CWD from
farmed or captive to wild cervids. There
is currently no significant moose
farming industry in the United States,
and if one develops in the future, the
economic effects of this rule on moose
farming should be similar to its effects
on deer and elk farming. The effects on
herd owners will vary depending on
their circumstances. In many cases the
annual costs for an owner will not
increase significantly because the herd
is already participating in a State CWD
program with similar requirements and
costs. It is not true that participating
herds will be unable to generate any
income until 5 years pass, or until they
are certified. First, many herds that
participate will enter at a higher herd
status than First Year because they
retain their status from a State program
when such programs are
‘‘grandfathered’’ into the Federal
program. Second, participating herds
that enroll at the beginning of the
program and attain Second Year or
above herd status can sell animals
interstate to herds of an equal or lower
status. Finally, this final rule establishes
an exemption (discussed below) from
the requirements of § 81.3 for animals
moved interstate for slaughter.
Herd Owner Responsibilities
Numerous commenters addressed the
description of the responsibilities of
enrolled herd owners in § 55.23(b). One
commenter stated that the requirement
setting the minimum age over which
animals that die are subject to testing at
16 months is arbitrary and unscientific.
This commenter stated that, since
infection seems to predominately
emanate from calfhood, a more realistic
age estimate is perhaps 9 months, and
suggested that younger animals are
carrying the disease but are just not
being tested for it.
The proposed minimum age of 16
months (which is changed to 12 months
in this final rule) was based both on
testing practices in most existing State
CWD programs and on average
minimum incubation times observed in
experimental inoculation of elk and
deduced from surveillance records.
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While we might be able to detect CWD
in younger animals if all ages were
tested, and while we would like to
detect CWD as early as possible, the
goals of the program are to control the
spread of the disease through consistent
and economically practical herd testing
and certification over longer periods of
time. Testing very young animals
imposes additional costs on producers,
States, and APHIS in exchange for
additional epidemiological information
of minimal value to the program goals.
However, we agree that the best
available scientific knowledge
concerning the age when animals may
be infected and the age that tests can
reveal infection suggest that testing
animals somewhat younger than 16
months could provide additional
epidemiological data useful to
controlling CWD. Therefore, we are
changing the rule to require testing of
animals 12 months or older. The 12month standard is based on our best
approximation of the point where the
value of additional epidemiological
information exceeds the costs to
producers and to program
administration of testing younger
animals. We believe this standard will
not significantly increase costs for
producers. We also note that this change
only affects activities after the effective
date of this rule—that is, existing State
programs that tested animals 16 months
and older prior to this date will still be
eligible to be ‘‘grandfathered in’’ as
Approved State CWD Herd Certification
Programs, provided they meet the other
eligibility requirements.
One commenter suggested that, in
addition to being required to report all
deaths of herd animals, the owner
should also be required to report all
animals that escape or disappear. This
would ensure program officials were
aware when unusually large losses
might indicate either the presence of
disease or inaccurate recordkeeping.
This would also allow the program to
address the risks associated with
reintroduction of an accidentally
released deer or elk back into the farm.
We agree, and have added this
requirement to § 55.23(b)(3).
One commenter questioned the
requirement that owners must make
available for tissue sampling and testing
the carcasses of all herd animals that die
aged 16 months or older. The
commenter stated that there needs to be
an allowance for a percentage of
mortalities not discovered in time to
preserve the carcass. The commenter
believes this should be allowed because
CWD is highly contagious and missing
a percentage of the herd should not
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result in the overall testing program
missing the disease in the herd.
We do not agree with the reasoning of
the commenter and do not think it is
necessary to make any change to the
rule in response to this comment. While
a herd owner will be in violation of a
requirement if he or she does not
provide a carcass for testing, we realize
that there may be certain situations
where a herd owner will not be able to
provide a fresh carcass or a high quality
sample. Program officials have ample
flexibility to deal with such situations
without adversely affecting the enrolled
herd’s status.
Several commenters questioned the
requirement in proposed § 55.23(b)(3)
that the owner must ‘‘immediately
report to an APHIS employee or State
representative all animals that escape or
disappear, and all deaths of deer, elk,
and moose in the herd aged 16 months
or older.’’ The commenters suggested
that the meaning of ‘‘immediately’’ be
clarified, perhaps to mean ‘‘within 24
hours,’’ and also asked for further
details on what information should be
included in such a report. A zoological
association and a State agency also
noted that hundreds of individual
notifications could overwhelm APHIS
and State personnel and suggested that,
since there are many causes of mortality
within farmed or captive cervid
populations that involve nervous system
complications and chronic weight loss
unrelated to CWD, submission of
periodic cervid mortality reports might
be allowed for herds where CWD is not
known to occur.
APHIS deliberately used the word
‘‘immediately’’ for the notification
requirement because we want owners to
notify the APHIS employee or State
representative as soon as possible in
every case. Immediate notification is
required because the quality of tissue
samples and related test results are
directly related to the length of time that
elapses between death and sample
collection, and it takes time to arrange
for sample collection after notification.
We did not use a standard such as
‘‘within 24 hours’’ because in some
cases owners may then wait nearly 24
hours to notify us, even if it was
possible to notify us within an hour
after the animal’s death or
disappearance was discovered. In
enforcing the ‘‘immediately’’ standard,
APHIS will allow for reasonable delays
due to such things as the time it takes
an owner to consult inventory records to
determine the identity of the animal, or
the possibility that the APHIS employee
or State representative is not available to
receive notice when the animal is
discovered. For example, if a dead
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animal is discovered early in the
morning, APHIS would expect to be
notified that day, not the next; but if the
animal were discovered late in the
evening, and the APHIS employee or
State representative had not supplied
the owner a means of giving notice at
any time (e.g., a 24-hour telephone
number for notifications), then the next
morning would be considered soon
enough for ‘‘immediate notice.’’
Regarding the comment requesting
what information should be contained
in the notice, we have added in
§ 55.23(b)(3) a requirement that the
notice must include the identification
numbers of the animal involved and the
estimated time and date of the death,
escape, or disappearance.
In response to the zoological
association and State agency’s requests
that periodic cervid mortality reports
might be allowed instead of immediate
notification in some cases, we believe
that, in a very few situations, such
arrangements might work depending on
the particular situations of herds
(including zoo collections) and their
respective APHIS employees or State
representatives. In this final rule,
§ 55.23(b)(3) provides that APHIS
employees or State representatives may
approve reporting schedules other than
immediate notification when herd
conditions warrant it in the opinion of
both APHIS and the State. We are also
willing to receive and evaluate
suggestions for how the regulations
could be changed in future rulemaking
to provide additional flexibilities for
cervid herds or collections in special
circumstances that justify alternative
approaches to issues such as animal
mortality reporting.
To accomplish these changes, we are
revising proposed § 55.23(b)(3) to read
as follows: ‘‘The owner must
immediately report to an APHIS
employee or State representative all
animals that escape or disappear, and
all deaths (including animals killed on
premises maintained for hunting and
animals sent to slaughter) of deer, elk,
and moose in the herd aged 12 months
or older. A herd owner may make
arrangements as to what constitutes
immediate notification with the APHIS
employee or State representative
responsible for the herd, who may, at
his or her discretion, allow delays in
notification caused by extenuating
circumstances such as weather or other
conditions beyond the control of the
herd owner. The report must include
the identification numbers of the
animals involved and the estimated
time and date of the death, escape, or
disappearance. For animals that die
(including animals killed on premises
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maintained for hunting and animals
sent to slaughter), the owner must make
the carcasses of the animals available for
tissue sampling and testing. In cases
where animals escape or disappear and
thus are not available for tissue
sampling and testing, an APHIS
representative will investigate whether
the unavailability of animals for testing
constitutes a failure to comply with
program requirements and will affect
the herd’s status in the CWD Herd
Certification Program.’’
Herd Status, Suspension, and Appeals
Some commenters stated that the
proposed procedure to appeal herd
status decisions is unfair because the
hearing would be held by the
Administrator rather than an
independent third party. One stated that
‘‘the herd plan suspension procedures
are an invitation to litigation as the
determination and hearing the appeal is
made by the undefined Administrator
who always has the last word.’’
Commenters stated that this would not
be considered fair by any farmer or
producer, and suggested that APHIS
should use more sophisticated
arbitration procedures with
independent third parties as judges.
The appeal and hearing provisions in
§ 55.24(c)(1) are virtually identical to
provisions in other APHIS regulations,
and meet the legal requirements for
appealing decisions at the agency level.
We believe that hundreds of previous
administrative hearings conducted by
APHIS provide ample evidence that the
rules of practice employed by the
Administrator for hearings provide a fair
and impartial hearing opportunity. Herd
owners who do not agree with the
decision of the Administrator after a
hearing can exercise their due process
legal rights to pursue redress in Federal
court.
One commenter stated that the
requirement that herd owners must
make their appeal in writing to the
Administrator within 10 days does not
allow owners sufficient time to gather
the information that is required in the
formal appeal. The commenter
suggested that, after requesting a
hearing, the owner should be granted
additional time to organize a defense.
We believe that 10 days is sufficient
time for herd owners to prepare a
simple letter of appeal that states all of
the facts and reasons upon which the
herd owner relies to show that the
reasons for the proposed action are
incorrect or do not support the action.
The form and content of the appeal
letter do not need to follow any
requirements for rules of evidence or
legal briefs; the letter simply needs to
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state the basis for the appeal. If the
appeal letter also identifies a conflict as
to any material fact, then a hearing will
be scheduled and the owner will have
additional time to prepare for the
hearing.
One commenter addressed the
proposed requirement in § 55.24(b)(2)(ii)
that a suspended herd that is reinstated
into the program after a herd plan is
developed for it ‘‘will be reinstated into
the CWD Herd Certification Program at
the First Year status level, with a new
enrollment date set at the date the herd
entered into Suspended status.’’ The
commenter stated that setting a new
enrollment date for these herds and
making them lose their accrued program
status would often be unfair, because
herds may be placed in Suspended
status even if they faithfully comply
with program requirements for several
years. The commenter believed that
time spent complying with program
requirements without signs of CWD in
the herd decreases the herd risk and
should be reflected in the herd status.
For example, consider a herd that has
spent 3 years in the program and has
complied with all identification, testing,
and other requirements. Suppose that 6
months before joining the program, the
herd acquired an animal from another
herd, and the animal died shortly after
arriving in the herds and was not tested.
Today, APHIS discovers that the source
herd for that animal is positive for CWD.
Therefore, the herd that received an
animal from it, and is now in Fourth
Year status in the CWD Herd
Certification Program, is suspended. If
that herd is reinstated with a new
enrollment date and First Year status,
that amounts to saying that it has the
same risk as a herd that is enrolling for
the first time and which has absolutely
no previous history of monitoring and
testing for CWD. This is inconsistent
with the principle in the rest of the rule
that regulatory requirements should
decrease proportional to the amount of
time a herd has spent monitoring and
testing for CWD.
We agree and have made
corresponding changes to
§ 55.24(b)(2)(ii). The changes allow
reinstatement of a Suspended herd with
its original enrollment date if the herd
is in good standing in the program and
has complied with its requirements. All
Suspended herds that are reinstated still
must comply with a herd plan
developed to address the possible risks
that caused their suspension. The
relevant new language reads: ‘‘the herd
will be reinstated to its former program
status, and the time spent in Suspended
status will count toward its promotion
to the next herd status level; Except
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that, if the epidemiological investigation
finds that the herd has not fully
complied with program requirements
for animal identification, animal testing,
and recordkeeping, the herd will be
reinstated into the CWD Herd
Certification Program at the First Year
status level, with a new enrollment date
set at the date the herd entered into
Suspended status.’’
Interstate Movement Restrictions
Several commenters stated that it is
critical that the regulations establish a
consistent nationwide standard for
interstate movement that preempts State
rules where needed. For example, some
States only allow entry of animals that
have been monitored for 5 years,
regardless of the status of the herd to
which the animals are moved. They said
that current State-established interstate
movement requirements are
inconsistent and often not based on
science, and that it is difficult to make
business plans when movement
requirements vary from State to State.
This rule will preempt State
requirements for movement of cervids
into States to the extent that the State
requirements are in conflict with this
rule. In addition, we expect that all
States with significant cervid industry
will develop Approved State CWD Herd
Certification Programs, meaning that
their requirements will be consistent
with those of the Federal program, i.e.,
that State programs will have similar
definitions and applicability and will
impose requirements that are consistent
with the Federal program. With regard
to requirements for moving cervids into
a State, we believe the requirements of
this rule provide appropriate protection
against the risk of spreading CWD
through such movements. The gradual
increase in program status required by
§ 81.3 to move cervids interstate will
mean that eventually all cervids moved
interstate must be from herds that have
reached ‘‘Certified’’ status, entailing at
least 5 years of monitoring.
One commenter stated that allowing
facilities to move animals before
reaching ‘‘Certified’’ status will have
two negative effects. First, it is a
disincentive for herds to reach
‘‘Certified’’ status if they can move
animals without doing so. Second, it
encourages States to maintain their own,
stricter, movement requirements if they
believe movements from lower-status
herds present risks.
We do not agree and believe the
commenter has misstated the effects of
the rule. There are significant limits on
moving animals before a herd reaches
‘‘Certified’’ status. Animals may not be
moved interstate while the herd is in
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First Year status, and after that animals
may only be moved to herds with equal
or lesser status (the receiving herd
reverts to the lower status). There is also
the gradual escalation of the status
required to move animals interstate, so
that 63 months after this rule takes
effect, only animals from certified herds
may move interstate. We also believe
that States will find it to their economic
benefit to allow movement of cervids
into their States as long as they are
moving to herds of equal program status
and, therefore, similar risk levels.
One commenter suggested that an
interstate movement requirement in
proposed § 81.3(a)(1)(ii), requiring that
‘‘the herd is accompanied by a
certificate * * *’’ should read ‘‘the
animals are accompanied by a certificate
* * * ’’ because whole herds are not
usually moved interstate. We agree, and
have corrected this misstatement in the
final rule. The language is corrected to
read ‘‘the farmed or captive deer or elk
is accompanied by a certificate * * *’’
and is now located in § 81.3(a)(2).
Interstate Movement Restrictions—
Exemption for Slaughter Animals
Many commenters stated that there
should be an exemption to interstate
movement restrictions to allow any
cervid, whether or not enrolled in the
program, to move interstate directly to
slaughter. Some of these comments
compared the risks of CWD to BSE,
where younger animals may be moved
to slaughter in the traditional feed lot
and food chain situation because the age
of the animals precludes significant risk.
Several commenters also suggested
that cervids moved interstate for
placement on a shooting preserve
should be exempted from interstate
movement restrictions if there were a
guarantee that the animal would not
come off the preserve alive.
In response to these comments, we
have decided to create a partial
exemption for animals moved directly
to slaughter. We believe that doing so
will not significantly increase the risk of
spreading CWD since slaughter animals
will be removed from contact with other
animals, and we understand that
increasing the opportunity to move
animals to slaughter will provide
economic relief for some owners.
However, we need to monitor the
movement of these animals to ensure
that they do, in fact, move only to
slaughter. We also wish to be kept
informed when farmed or captive deer,
elk, and moose are moved to slaughter,
especially from herds not in the
certification program or from herds that
have not yet attained ‘‘Certified’’ status
in the program, so we can arrange to
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collect samples for testing, as
appropriate, from these higher-risk
animals. Therefore, we are adding a new
paragraph § 81.3(c) to the interstate
movement restrictions section to allow
farmed or captive deer, elk, or moose,
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, to move interstate directly
to a recognized slaughtering
establishment for slaughter if they have
two forms of animal identification and
are accompanied by a certificate issued
in accordance with § 81.4. The required
certificate is similar to the certificate
used to move animals in the
certification program interstate, in that
it states the animal identification
numbers of each animal moved, the
number of animals covered by the
certificate, the purpose of the
movement, the points of origin and
destination, the consignor, and the
consignee. A certificate used to move
animals to slaughter differs from the
certificate used to move certification
program animals interstate in that it
does not need to state that the animals
are from a herd participating in the
CWD Herd Certification Program.
Instead, a certificate for movement to
slaughter must state that an APHIS
employee or State representative has
been notified in advance of the date the
animals are being moved to slaughter.
This requirement will ensure that
APHIS or the State can collect samples
from these animals at slaughter when
needed.
We are not creating an interstate
movement exemption for cervids moved
interstate for placement on a shooting
preserve. Some commenters stated that
the risk level of such animals is similar
to that of slaughter animals, but the
situations and risks are not similar.
Animals moved to slaughter are kept
from contact with other (nonslaughter)
animals, and are slaughtered within a
short time following movement.
Animals moved to shooting preserves
may live for years after movement and
may come in contact with other
domestic or wild cervids frequently
during that time. The strong restrictions
on slaughter animals result in lower risk
levels than the minimal restrictions on
shooting preserve animals. If exempted
from the regulations’ controls,
movement of shooting preserve animals
would present a continuing risk because
there is no guarantee that the animal
would actually be hunted and killed on
the new premises—or if the animal has
CWD, that it would be killed before
spreading the disease. CWD positive
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animals inadvertently moved to a
hunting premises could thus spread the
disease to new populations of captive or
wild animals, and without the paper
trail created by interstate movement
restrictions, Federal or State animal
health officials would have no
opportunity to prevent it, and might be
unable to determine the source of the
new disease locus.
We did determine, however, that we
needed to provide, when the
Administrator’s evaluation of the
specific circumstances of a herd justifies
it, greater flexibility in the interstate
movement regulations to allow for
movement of animals from herds that
have not attained ‘‘Certified’’ status but
whose surveillance and mitigation
procedures are adequate to prevent the
spread of CWD. We are, therefore,
adding a new § 81.3(e), which states that
notwithstanding any other requirements
in the rule, interstate movement of
farmed or captive deer, elk, and moose
may also be allowed on a case-by-case
basis under permit as approved by the
Administrator, provided that adequate
survey and mitigation procedures are in
place to prevent dissemination of CWD.
Recordkeeping and Inventory
Several commenters stated that the
regulations should clarify how and by
whom registration and certification
records will be maintained. Some
commenters also stated that they
understood that an annual physical
inventory of herd animals would be
required, but they did not see this
requirement in the section describing
herd owner responsibilities. One
commenter stated that, when the
proposal discussed the need for a
physical inventory of animals, there was
no discussion of the owner’s
responsibility to ensure that State or
APHIS representatives could conduct
the inventory without substantial risk of
injury to animals or workers. The
commenter suggested that the final rule
clarify the owner’s responsibility to
gather the herd and sufficiently restrain
each animal to allow inventory and
verification of identification.
The UM&R includes descriptions of
the procedures we expect to employ for
recordkeeping and the annual physical
inventory. We have also slightly revised
§ 55.23(b)(4) to clarify the owner’s
responsibilities for recordkeeping and
for the annual physical inventory. As
revised, the paragraph reads: ‘‘The
owner must maintain herd records
including a complete inventory of
animals that records 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
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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, the owner must allow an APHIS
employee or State representative access
to the premises and herd to conduct an
annual physical herd inventory with
verification reconciling animals and
identifications with the records
maintained by the owner. The owner
must present the entire herd for
inspection under conditions where the
APHIS employee or State representative
can safely read all identification on the
animals. The owner will be responsible
for assembling, handling, and
restraining the animals and for all costs
incurred to present the animals for
inspection.’’
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Reduced Testing Requirements for
Certified Herds
Several commenters suggested that,
instead of the proposed herd
certification program, APHIS should
implement a surveillance program that
relies on statistical sampling of a
fraction of the cervids that die or are
sent to slaughter. Some suggested that
this approach, coupled with a
requirement that herds maintain good
records on animal acquisitions, could be
effective and much less burdensome,
especially for hunting operations.
We are not making any change based
on this comment. Partial surveillance of
mortalities in a herd, whether of a
portion of the natural mortalities, of
slaughtered animals, or of a
combination, is not an effective
approach for identifying and controlling
a very low prevalence disease like CWD.
Our epidemiological analyses show that
while these surveillance strategies,
especially combined with slaughter
testing, could identify some affected
herds, the disease would likely spread
faster than containment resulting from
the commenter’s proposed surveillance
strategy. Effective control requires
animal identification, monitoring,
recordkeeping, surveillance of all
mortalities of animals 12 months and
older, and interstate movement
restrictions for as many herds as
possible.
Surveillance as an Alternative to Herd
Certification
Two commenters noted that § 55.24(a)
of the proposal stated that, when a herd
reaches ‘‘Certified’’ status, testing is no
longer required for animals that are sent
to slaughter or are killed on the
premises of hunting or ‘‘shooter’’
operations. The commenters stated that
such testing is good continuing
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surveillance for CWD and recommended
continued testing at a certain
percentage.
We are not making any change based
on this comment. While such testing is
not required for animals in certified
herds, the herd owners must still submit
samples for all animals that die on the
premises (not including animals killed
by hunting as part of ‘‘shooter’’
operations or animals sent to slaughter).
Testing these animals provides a better
basis for continuing monitoring for
CWD than would testing a percentage of
random animals sent to slaughter or
killed by hunters. Studies have shown
that, when scrapie is present, it is found
in a higher percentage of dead animals
than in live animals, and we assume
this is also the case with CWD, so
testing all animals that die in a certified
flock is likelier to disclose an outbreak
than testing a percentage of all animals
sent to slaughter or killed by hunters.
Perimeter Fencing Requirements
Several commenters asked for
clarification regarding perimeter fencing
requirements. They were unsure
whether APHIS expected single fences,
double fences for all herds, double
fences in areas where CWD was
endemic in wild cervids nearby, or
something else.
The basic requirement of the
regulation is for a single perimeter
fence. As discussed above, two separate
fenced areas with at least a 30-foot gap
between them would be needed if an
owner wanted to maintain two separate
herds side-by-side. (See the discussion
of the definition of commingling above.)
Individual herd plans may also specify
double perimeter fences for some herds,
on a case-by-case basis, to address
conditions such as CWD in nearby wild
cervids or in farmed or captive cervids
on adjacent premises. We plan to
develop additional examples and
guidance to help herd owners better
understand this issue.
Program Administration
One commenter noted that proposed
§ 55.21, Administration, described the
CWD Herd Certification Program as ‘‘a
cooperative effort between APHIS, State
animal health agencies, and deer and
elk owners.’’ The commenter suggested
that State wildlife agencies also be
mentioned, since the program involves
cooperation with such agencies for the
capture and release of wild cervids and
other matters.
We agree and have changed § 55.21
accordingly. Cooperation with State
wildlife agencies is an important part of
the program, as described in the
preamble of the proposed rule. We
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recognize that these agencies have
regulatory authority for all or part of the
farmed or captive cervids in some
States.
Another commenter noted that
proposed § 55.21 was the only part of
the proposed rule that mentioned
certifying herds as ‘‘free of CWD’’ and
suggested that, consistent with the rest
of the proposal, this reference should be
to certifying herds as ‘‘low risk for
CWD.’’ We agree, and have made the
requested change.
Research Animal Exemption
At least 10 commenters stated that the
proposed requirements would be
incomplete and ineffective if the rule
exempted cervids at research facilities
from all requirements, which would be
the effect of the proposed definition of
captive. These commenters stated that
CWD is known to have spread from
research animals to wild cervids, and
probably to captive cervids, either
through release or escape of research
animals or contact between research and
wild cervids. Commenters variously
suggested that interstate movement of
research animals should be ‘‘monitored
and controlled’’ or ‘‘closely regulated’’
and that ‘‘their destination research
facilities should be known.’’ A
commenter also stated that ‘‘an approval
process should be identified’’ for
research animal movement.
Although it is still unproven that
CWD has spread from research animals
to wild cervids in the past, we agree that
research animals should not be totally
exempted from movement requirements
and have made changes to address this
problem. We believe it would be
unworkable to simply change the
definition of farmed or captive to
include research animals, and then
allow research herds to enroll in the
Certification program, due to the
different nature and purpose of research
herds. However, we can exercise close
control over interstate movement of
research animals by requiring a USDA
permit for their movement. We have
added this requirement to new § 81.3(d)
of this final rule. We are also removing
from the definition of farmed or captive
the following sentence: ‘‘Animals that
are held for research purposes by State
or Federal agencies or universities are
not included.’’
The new research animal permit
requirement in § 81.3(d) states that the
Administrator may issue a permit if he
or she determines that the movement
authorized will not result in the
interstate dissemination of CWD, and
requires applicants to submit the
following information when applying
for a permit: The name and address of
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the persons seeking the permit, the
persons holding the research cervids to
be moved interstate, and the person
receiving the cervids to be moved
interstate; the number and type of
cervids; the reason for the interstate
movement; any safeguards in place to
prevent transmission of CWD during
movement or at the receiving location;
and the date on which movement will
occur. The new requirement also states
that a copy of the research animal
permit must accompany the cervids
moved, and copies must be submitted so
that a copy is received by the State
animal health official and the
veterinarian in charge for the State of
destination at least 72 hours prior to the
arrival of the cervids at the destination
listed on the research animal permit.
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State Responsibilities
Several commenters asked whether
the scant availability of funds for
program activities in various States
could keep States from meeting their
responsibilities under the proposed
program. They stressed that if the
program is to succeed, States need
adequate funds to enforce quarantines,
participate in developing herd plans,
and conduct the necessary tracebacks.
We agree that active participation by
States is important to the success of the
certification program. That is why the
description of State responsibilities in
§ 55.23(a) requires that States must have
‘‘effectively implemented’’ policies and
programs to carry out the necessary
quarantine enforcement, tracebacks,
epidemiologic investigation, and other
activities that rely on State involvement.
If APHIS determines that a State has not
devoted sufficient funds or personnel to
perform these activities, APHIS will not
be able to certify the State’s CWD
program as an Approved State CWD
Herd Certification Program.
Executive Order 12866 and Regulatory
Flexibility Act
This final rule has been reviewed
under Executive Order 12866. The rule
has been determined to be significant
for the purposes of Executive Order
12866 and, therefore, has been reviewed
by the Office of Management and
Budget.
For this final rule, we have prepared
an economic analysis. The economic
analysis provides a cost-benefit analysis
as required by Executive Order 12866,
as well as an analysis of the potential
economic effects of this final rule on
small entities, as required under 5
U.S.C. 604. The economic analysis is
summarized below. Much of the data
regarding the cervid industry was
provided by the two major industry
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associations, the North American Elk
Breeders Association (NAEBA) and the
North American Deer Farmers
Association (NADeFA). See the full
analysis for the complete list of
references used in this document.
Copies of the full analysis are available
by contacting the person listed under
FOR FURTHER INFORMATION CONTACT, or
from this final rule’s docket at the
Federal Rulemaking Portal at https://
www.regulations.gov.
Under the Animal Health Protection
Act (7 U.S.C. 8301 et seq.), the Secretary
of Agriculture is authorized to regulate
the movement in interstate commerce of
any animal if the Secretary determines
it necessary to prevent the introduction
or dissemination of a livestock pest or
disease; to hold, seize, quarantine, treat,
destroy, dispose of, or take other
remedial action with respect to such
animals; to carry out operations and
measures to detect, control, or eradicate
diseases of livestock; and to cooperate
with States or political subdivisions of
States in programs to control livestock
diseases.
Alternatives Considered
In assessing the need for this final
rule, we identified three alternatives.
One was to maintain the status quo,
where State efforts are supported by
Federal technical assistance and
compensation programs. We rejected
this alternative because it does not fully
address disease risk, i.e., the possibility
of disease spread through interstate
movement. The current patchwork of
State regulations hinders movement of
animals believed to be at low risk for
CWD and hence hinders growth of the
industry. Also, this alternative does not
give herd owners in States that do not
have certification programs the
opportunity to participate in such
programs if they so desire. The status
quo alternative would have no cost
effects for APHIS but over time would
impose additional costs on herd owners,
who would face costs due to loss of
animals from increased spread of CWD,
loss of interstate and international
markets, and possibly increased
compliance costs for stricter State CWD
programs as States react to CWD spread.
Another alternative was to simply
prohibit the interstate movement of
deer, elk, and moose altogether, without
establishing a Federal herd certification
program. This alternative would not
significantly increase costs to APHIS,
and would help reduce costs due to loss
of animals caused by disease spread
through interstate movement. However,
this alternative does not afford
producers the opportunity to seek the
best-paying market for their animals in
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any State. Accordingly, this alternative
was rejected.
The third alternative, the one that we
chose, was the establishment of a
Federal herd certification program with
interstate movement of animals
contingent on participation in that
program (with certain exceptions such
as slaughter and research animals). This
alternative substantially reduces the risk
of exporting CWD from one state to
another—because only deer, elk, and
moose that have been subject to certain
minimum surveillance criteria can be
moved interstate—but at the same time
allows producers the opportunity to
seek the best-paying market for their
animals. The costs and benefits of this
alternative are discussed below.
Summary of Economic Analysis
This final rule will establish a CWD
Herd Certification Program for farmed or
captive deer, elk, and moose, and
prohibit the interstate movement of
deer, elk, and moose that are not
enrolled in the program, with certain
exceptions such as slaughter and
research animals. Herds that participate
will have to follow program
requirements for animal identification,
testing, herd management, and
movement of animals to and from herds.
Herd owners will be able to enroll in an
Approved State CWD Herd Certification
Program that meets minimum standards
established by APHIS, or enroll directly
in the Federal CWD Herd Certification
Program if there is no approved State
program in their location.
The following analysis is based
largely on data collected from industry
associations and sources of agricultural
statistics, including census data. Prior to
this rule, there were no Federal
requirements regarding CWD for the
interstate movement of deer, elk, and
moose. However, at least 23 States have
banned cervid introductions from other
States, and at least 20 States have formal
CWD certification programs for cervids
in place, with requirements similar to
the Federal requirements in this rule.
The Federal program is designed to
build on, rather than replace, existing
State programs or State programs that
are currently being developed. Herd
owners in States that do not have an
APHIS-approved program will be able to
enroll in the Federal program.
This rule is intended to help
eliminate CWD from farmed or captive
cervids in the United States. It will
support an existing APHIS program that
pays indemnities to owners of CWDpositive herds who voluntarily
depopulate their herds.
The final rule will primarily affect
deer and elk farms and other cervid
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facilities including zoos. In 2002 in the
United States, there were an estimated
97,901 elk on 2,371 farms, and 286,863
deer on 4,901 farms. There are no
known commercial moose farming
operations, though some may emerge in
the future. Without improved CWD
control efforts, the disease could
eventually infect almost all U.S. farmed
or captive elk, deer and moose herds.
The final rule should have a positive
economic effect on farmed and captive
cervid operations, both large and small,
over the long term. In the shorter term,
the economic effect on deer and elk
facilities will vary depending on the
circumstances of each. Some operations,
especially those who already participate
in State programs and who take
advantage of the increased access to outof-State markets, should benefit
immediately. Conversely, some
operations could experience a
significant adverse effect, especially
those who cannot afford to pay the
program’s annual costs. However, given
the available data, there is no basis to
conclude that the final rule will have a
significant negative economic impact on
a substantial number of small entities in
the short term.
The economic importance of the
farming industries notwithstanding, the
rule’s primary benefits appear to lie in
its ability to reduce the potential for the
introduction or spread of CWD.
However, it is difficult to translate that
reduced potential into a dollar benefit.
The Deer, Elk, and Moose Industries and
the Impact of CWD
The number of deer, elk, and moose
in the United States that have died as a
result of contracting CWD is unknown,
largely because there is no way to track
deaths among the free-ranging segment
of the population. However, sampling
has suggested infection rates ranging
from less than 1 percent among wild
white-tailed deer in Wisconsin to up to
15 percent among wild mule deer in
northeastern Colorado. For farmed
animals, the number of deaths directly
attributed to CWD to date has been
relatively low. However, for every
infected animal, far more have been
exposed to the disease.
Deer and elk are farmed for breeding
stock, velvet antler, meat, and sales to
game parks, hunting facilities, and
exhibits. Velvet antler, considered a
medical or dietary aid, is produced
primarily for Asian markets. Deer and
elk meat is a low-fat, low-cholesterol
product, and when it is derived from
farmed or captive herds (as opposed to
meat harvested directly by hunters from
wild populations) it is marketed
primarily to gourmet restaurants, for
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consumption by health-conscious
dieters. The breeding stock market
satisfies the need for replacement
animals.
The most recent census data shows
that there were 97,901 elk on 2,371 U.S.
farms in 2002. The number of elk per
farm varies, from a high of ‘‘500 plus’’
(for commercial farms) to a low of about
10 (for hobby farms). The value of each
elk held also varies, depending on the
type of animal (e.g., bull, cow, or calf),
market conditions, and other factors.
The average value of each elk is roughly
estimated at $2,000, with the typical
high end value at about $5,000. (The
more valuable trophy animals hunted
on game farms tend to be worth more
than this average.) Based on the
estimated average of $2,000 per animal,
the value of all 97,901 elk on U.S. farms
is estimated at about $196 million
(97,901 × $2,000). In 2001, gross receipts
for members of the North American Elk
Breeders Association (NAEBA), an
industry group, totaled an estimated
$44.3 million.
The most recent census data shows
that, in 2002, there were 286,863 deer
on 4,901 U.S. farms. The number of deer
per farm varies, from a high of about
3,000 (for commercial farms) to a low of
about 5 (for hobby farms). The value of
each deer also varies, depending on
such factors as the type of animal and
market conditions. An earlier estimate
by the North American Deer Farmers
Association put the average per animal
value of all deer on member farms at
$1,687, which would make the
estimated value of all 286,863 deer on
U.S. farms about $484 million (286,863
× $1,687). As of January, 2002, capital
investment (including land, fencing) in
white-tailed deer farms totaled an
estimated $2.5 billion.
Benefits of Rule
The final rule will benefit the national
cervid industry, cervid product
consumers, individual herd owners, and
individual States. The effects on each
are discussed below, and benefits for
small businesses are directly addressed
in the section ‘‘Analysis of the
Economic Effects on Small Entities.’’
The interstate movement restrictions
that allow only ‘‘program’’ deer, elk, and
moose to be moved interstate will help
to prevent the spread of CWD among
both the farmed and wild populations.
Participation in a certification program
substantially reduces the risk of
spreading CWD from one State to
another, because only deer, elk, and
moose that have been subject to certain
minimum surveillance and other criteria
can be moved interstate.
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Preventing the spread of CWD among
deer, elk, and moose benefits entities
and individuals that rely on those
animals for their income. These include
cervid farms, State agencies that sell
hunting licenses, and employees of
motels and restaurants in hunting areas.
It also benefits individuals that rely on
those animals for recreation and food. A
study by a sociologist in Wisconsin
found that when the disease seems
contained there is little hunter effect.
However, if the disease becomes
widespread, data in his study suggest
that hunters will abandon the sport.
Also, hunters from counties in which
CWD-positive animals were found were
more likely to skip the 2002 gun season
than were hunters from non-CWD
counties.
Preventing disease spread also offers
the potential for other, more farreaching benefits. Although there is no
known relationship between CWD and
other spongiform encephalopathies of
animals or humans, bovine spongiform
encepalopathy (BSE) has had an
immense negative impact upon
European livestock systems. Action by
USDA on CWD will demonstrate to our
trading partners the seriousness with
which we view the prevention and
control of these types of diseases.
The outbreak of CWD in wildlife and
farmed herds has motivated States to
restrict the movement of elk and deer
into States; and to start programs to
control the disease within States. Prior
to this rule, the various States did not
follow a standard interstate movement
policy, nor were there standards to
ensure equivalency between State CWD
programs. This resulted in a failure to
maintain a nationwide marketing
system under which healthy farmed elk
and deer can be bought and sold
throughout the United States. Producers
of elk and deer are, therefore, generally
limited to sales in their local marketing
areas. The lack of a Federal CWD
program has also limited U.S.
producers’ access to international
markets for products such as antler
velvet.
Based on the rate of increase in the
number of infected herds in recent
years, it is estimated that, without
improved CWD control efforts, the
disease could eventually infect almost
all U.S. farmed and captive elk herds.
Large movements of animals between
herds exacerbate risks of disease spread.
In Canada, after CWD was discovered in
1996, movements of animals from one
herd resulted in the infection of 38 other
herds, which caused the Canadian
Government to buy and destroy 7,400
animals. While it is risky to extrapolate
from limited data covering only a few
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years, the few herds studied in detail do
suggest that CWD is easily spread
through unrestricted commerce in deer
and elk, and could readily become
established in most U.S. herds. The rule,
therefore, could serve to protect
substantial cervid industry livestock
assets, valued at an estimated $196
million for elk and $484 million for
deer.
For farmers with infected cervids, the
losses can extend far beyond the direct
loss of livestock. They can also incur
costs for the disposal of the animal
carcasses, as well as costs for cleaning
and disinfecting their premises. In some
areas, positive animals have to be
disposed of through costly incineration
or digestion, since even landfills require
a negative test before accepting a carcass
for disposal. Perhaps most important of
all, owners of infected herds may also
face State-imposed quarantines and
State-imposed restrictions on the
subsequent agricultural use of their
land, actions which many view as
tantamount to closure.
Even farmers with animals that have
not been infected or exposed to CWD
are affected, as evidenced by recent
action taken by the Republic of Korea.
That country recently suspended all
imports of deer and elk, and their
products, from the United States, due to
concern that there may be a link
between CWD and other transmissible
spongiform encephalopathies of animals
or humans. The precise impact of
Korea’s suspension is unknown,
because data that are compiled on U.S.
exports do not provide the level of
detail necessary to identify deer and elk
and their products. However, New
Zealand is a major competitor to U.S.
producers in the area of deer antler
exports to Korea, and in 2001 the value
of New Zealand antler exports to Korea
increased from NZ$34 million to NZ$37
million. In 1998, Canada, another major
competitor, sold 100,000 kg. of elk
velvet, worth about CA$13 million, to
the Republic of Korea; Canada’s sales
dropped by 80 percent the next year,
after CWD was introduced into Korea
from Saskatchewan.4 To the extent that
the Federal certification program will
reassure foreign trading partners that all
State programs meet a standard for
effectiveness, increased international
sales are likely.
The rule’s primary benefits are to help
prevent the spread of and eradicate
CWD in farmed deer, elk, and moose;
assist efficient domestic elk and deer
4 Elk Production; Economic and Production
Information for Saskatchewan Producers,
Saskatchewan Agriculture and Food, November
2000.
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marketing; maintain and enhance export
markets of cervid products; protect
wildlife resources; and obviate the need
for greater public and private
expenditures related to CWD in the
future. The introduction of an aggressive
control program now, when the number
of known infected herds is small,
reduces the risk of higher future Federal
eradication program costs, such as
Canada faced in 1996 when it had no
certification program and CWD
infection in one herd quickly spread to
38 herds, causing 7,400 elk to be
destroyed.
The rule also demonstrates to our
trading partners that the United States is
able and willing to take early and
aggressive action to protect the health of
its animal and animal industries,
making it easier for U.S. exporters to
negotiate access to foreign markets.
Costs of Rule
The final rule has cost implications
for herd owners, individual States, and
APHIS. The impact on each is discussed
below, and cost effects for small
businesses are directly addressed in the
section ‘‘Analysis of the Economic
Effects on Small Entities.’’
Cost for Herd Owners
Participation in a State, or Federal,
certification program will require that
herd owners employ certain minimum
disease preventative measures
established by APHIS. The cost to
comply with these minimum
requirements will vary among
individual herd owners, depending on
the circumstances of each. Many herd
owners, especially the larger ones, are
likely to already be in at least partial
compliance with one or more of the
requirements on a voluntary basis, since
they constitute sound management
practice. Perimeter fencing is a case in
point. Most herd owners already have
perimeter fencing in place, if for no
other reason than to keep animals from
escaping.
The certification program requires
that herd owners must make available
for sample collection and testing the
carcasses of all dead deer, elk, and
moose 12 months of age or older
(including animals killed on hunting
premises). Many herd owners will hire
an accredited veterinarian to remove
and submit the required tissue samples.
Collecting a sample and packing it for
submission usually takes under an hour.
Veterinarians charge herd owners about
$100 to collect each sample.
Participating herd owners will have to
identify each animal uniquely, using
two approved forms of identification,
such as tattoos, ear tags, or electronic
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implants. Although many herd owners
already identify their animals, only a
few are likely to use two forms of
identification. The cost of identifying an
animal will vary, depending on the type
of identification used and other factors,
including any costs associated with
‘‘rounding up’’ the animals for
installation of the identification. The
rules allow for the multiple use of the
same form of identification, so,
conceivably, each animal could have
two ear tags, potentially the least costly
form of identification. Ear tags cost
about $2 each. By comparison,
veterinarians could be expected to
charge herd owners at least about $25 to
implant each microchip.
It has been estimated that the
program’s minimum disease
preventative measures will result in
increased direct costs totaling about
$1,600 annually for the ‘‘average’’ elk
herd owner (i.e., one with a herd of 50
elk), exclusive of any costs stemming
from a CWD discovery within the herd.
It is assumed that deer herd owners
would face similar costs. The annual
cost of $1,600 includes $1,000 for the
annual inventory, $100 for the
maintenance of program records, $250
for tagging, and $200 for sample
collection by a veterinarian, and $50 for
ancillary costs. The annual inventory
cost of $1,000 assumes veterinary fees to
‘‘read’’ tags ($500) and hired labor
($500). The sample collection cost of
$200 assumes that 2 animals over 12
months of age die per year. It is
expected that the cost of sample
collection will be less of a burden for
hunting premises than for production or
breeding herds, because of the relatively
high per-animal profit margin for
hunting premises, and because these
businesses are already organized to pass
on fees (e.g., for State-required tagging)
to their customers. The price these
premises charge to hunt an elk varies
with the quality of the animal, and
ranges from about $3,000 for a lesserquality bull elk to about $10,000 for bull
elk that score over 375 by the Boone and
Crockett scoring system (i.e., an animal
with an exceptional antler rack).
Because these businesses generally
schedule their hunts well in advance, it
should be possible for them to schedule
a veterinarian to collect samples at
appropriate times without disrupting
business or customer schedules.
Participating herds that are found to
have CWD-positive or CWD-exposed
animals will immediately lose their
program status, and could reenroll only
after entering into a herd plan. (A herd
plan is a written herd management
agreement, developed by APHIS with
input from the herd owner, State
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representatives, and other affected
parties, which sets forth the steps to be
taken to eradicate CWD from a positive
herd.) It is estimated that, in about 90
percent of herd plans, herd owners will
agree to depopulate their herds, for
which APHIS will pay eligible owners
indemnities of up to $3,000 per animal.
Two likely consequences for a positive
herd are State-imposed quarantines that
can last several years, and Stateimposed restrictions on the
repopulation of cervids on the same
premises. Fortunately, herd infection is
rare. As of October 2005, only 31 farmed
elk herds and 8 farmed deer herds have
been found positive, representing less
than 2 percent of all elk farms and much
less than 1 percent of all deer farms. We
estimate that 20 currently infected elk
herds will be detected over the next 2
years after this rule is adopted.
Finally, the certification program will
establish herd status, based on the
number of years of enrollment in the
program with no evidence of disease.
Herd status will affect the movement of
animals, since additions from a herd
with a later enrollment date will cause
the acquiring herd to revert to the status
of the herd from which the deer, elk,
and moose were acquired. Herd status,
therefore, will tend to make animals
from lower status herds less valuable
than those from higher status herds, due
to the reduced marketability of the
former. This will be an issue for new (or
short-term) participants in a
certification program. Because they
would have little or no previous
surveillance history, their herds would
be accorded lower status, an action that
would likely cause a decline in the
market value of their animals. This
effect will decline over time as herds
accumulate years in the program. Also,
the ‘‘grandfather’’ provision for
Approved State CWD programs means
that in many cases the time herds spent
in a State program, prior to adoption of
this rule, will count toward their
program status. Herd owners who
choose not to participate in a
certification program could also face a
loss in animal value, since participating
herds will be less likely to acquire
animals from nonparticipating herds,
due to penalties.
Cost for States
After this rule is adopted, we expect
that all States which permit cervid
farming will participate by developing
approved State CWD programs under
the regulations. Many of these States
will likely make participation
mandatory for all in-State herd owners.
States that do establish a certification
program will incur the costs of setting
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up and administering that program,
including costs for the development of
legislative/regulatory authority,
surveillance and monitoring,
recordkeeping and data sharing, disease
research, and education and outreach to
farmers. As a point of reference in this
regard, it has been conservatively
estimated that such costs for
establishing and maintaining a CWD
program for farmed elk will amount to
$47,000 per State per year.
In addition, States may also incur
costs stemming from a possible disease
discovery, such as costs for: the
maintenance of quarantines, diagnostic
testing, disposition of positive/exposed
herds, and carcass disposal. The costs
associated with a discovery of the
disease can vary significantly,
depending on the number of animals in
an affected herd, the herd plan
developed to deal with the disease, the
type of carcass disposal, and other
factors. Based on the experience of 5 of
the States with farmed elk that have
tested positive for CWD, the cost of
responding to a disease finding is
estimated at $20,285 per herd, on
average.
APHIS assists the States in their CWD
eradication efforts by conducting testing
and supporting surveillance and other
activities that the States would
otherwise have to fund themselves.
Through fiscal year 2002, $17.3 million
of Commodity Credit Corporation
funding was transferred to APHIS for
CWD eradication activities. In addition,
$0.8 million of APHIS contingency
funds were used for CWD eradication
efforts. In FY 2003, APHIS received its
first appropriated funding for CWD of
$14.9 million. That figure was $17.8
million in FY 2004, $17.9 million in FY
2005, and $18.5 million in FY 2006.
Cost for APHIS
The direct costs APHIS will incur
from this rule are the costs of approving
and monitoring CWD programs
established by States and the costs
associated with establishing and
administering a Federal program for
herd owners who wish to participate but
who are not located in States with
programs. Both costs should be
relatively insignificant increases, since
APHIS already works closely with
States on their CWD programs, and
direct enrollment of herds into a Federal
program is expected to be needed in no
more than a few States with only a few
cervid herds in each. APHIS may also
incur some costs to the extent that it
assists in the design and
implementation of State programs that
are established (or modified) in
response to the rule.
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41699
APHIS’ liability for indemnities could
also be affected, if the newly established
State programs result in the detection of
more positive animals than would
otherwise be the case. To date, APHIS
has paid out more than $12.5 million for
CWD indemnities.
Cost for Others
It is likely that many hunting
operations may elect not to participate
in the program, especially those with
large premises that do not normally
restrain their animals, a situation that
makes animal identification and
inventory difficult. For hunting
operations, any negative impact of not
participating in the program should be
minimal. First of all, most hunting
operations are animal importers, not
exporters; hunting operations—as
distinct from separate breeding
operations located nearby that support
the hunting operations—generally do
not ship their animals interstate.
Second, those who pay thousands of
dollars to hunt at hunting premises
generally are in search of trophy antlers,
not food; accordingly, hunters who
patronize hunting premises may not be
as concerned about CWD as hunters
elsewhere. The fact that hunting
operations do not participate in the
program, therefore, should not be a
significant issue for most prospective
hunters at those facilities, especially if
the facilities conduct alternative
surveillance and monitoring activities or
if the States where the hunting
operations are located require CWD
testing.
The final rule also adds a new
requirement that animals moved for
research purposes must be moved under
a USDA permit. Owners of research
animals should be only minimally
affected by the rule, since few, if any,
research animals are moved interstate.
Furthermore, the permit that owners of
research facilities would need in order
to move their animals interstate should
be easily obtainable, since the permit
application requires only rudimentary
information regarding the movement,
i.e., information that should be readily
available to animal owners at no cost to
them to generate.
Analysis of the Economic Effects on
Small Entities
The Regulatory Flexibility Act
requires that agencies consider the
economic effects of rules on small
entities. This final rule primarily affects
deer and elk farms, because they are
most likely to be affected by the
program’s requirements and the
interstate movement restrictions.
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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
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.
To the extent that the rule prevents
the spread of—and perhaps eliminates
altogether—CWD in farmed cervids in
the United States, small herd owners
should benefit over the long term. The
rule will also provide herd owners with
increased access to potentially betterpaying out-of-State markets. By
establishing equivalency between State
programs, and replacing the current
patchwork of State regulations, the rule
will reduce the cost of complying with
multiple sets of requirements and
facilitate the safe movement of animals
between States. Even herd owners who
sell their animals in-State only stand to
benefit, since the program reduces their
disease risk when importing animals
from other States.
The benefits, however, do not come
without a price. As indicated above, it
is estimated that the direct cost to
satisfy the program’s prescribed
minimum disease preventative
measures will total about $1,600
annually for the average elk herd owner
(i.e., one with a herd of 50 elk),
exclusive of any costs stemming from a
CWD discovery within the herd.
However, the annual cost does not
appear to be particularly burdensome,
since it is equivalent to 4 percent of the
2002 per farm average gross receipts for
all U.S. farms in NAICS 11299 ($1,600/
$39,868). Those herd owners who have
the option and elect not to participate
will avoid the program’s annual costs
but they will see the value of their
animals discounted in the marketplace,
since ‘‘non-program’’ animals will likely
carry a stigma of inferiority. As
discussed below, the discount is likely
to exceed the program’s annual cost for
most herd owners, making participation
mandatory from a practical economic
standpoint for those who are not
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required by their respective State to
participate.
According to NAEBA, all herd owners
sell breeding quality animals, and it is
not unusual for the average elk herd
owner to sell 10 or more breeding
quality animals per year, commonly in
the range of between $2,500 and $5,000
per animal. NAEBA estimates that, with
a Federal certification program in place,
non-program breeding quality animals
could be sold in-State for breeding
purposes, but only at a discount of
about 50 percent from their value as
program animals. By electing to
participate, therefore, the average elk
herd owner would more than offset the
$1,600 in added program costs with the
sale of just 1 high value, or 2 low value,
breeding animals per year. From an
economic standpoint, therefore, most
‘‘elective’’ herd owners would be better
off participating in the program than not
participating.
The previous discussion assumes, of
course, that the herd owners wished to
continue in the cervid business. It is
possible that the investment returns
experienced by some herd owners are
already so low that paying the added
costs to join the program would not
make economic sense. These herd
owners, therefore, would effectively be
forced out of the cervid business by the
rule. The number of such herd owners
is unknown but it is likely to be small,
given that the added costs are
equivalent to 4 percent of 2002 average
annual gross receipts for farms in
NAICS 11299, a category that includes
deer and elk farms.
The presence of CWD in a herd is
more likely to be detected if the herd is
a participating herd, given the increased
surveillance. For herd owners who are
found to have positive animals, the
negative impact of State-imposed
quarantines and State-imposed
restrictions on the repopulation of
cervids on the same premises would
likely more than offset the benefits of
any indemnity payments. Indeed, it is
very likely that most would elect to
cease cervid production altogether.
Fortunately for herd owners, the
likelihood of a herd becoming infected
has been rare, as only 31 farmed elk
herds and 8 farmed deer herds have
been found positive as of October 2005,
representing less than 2 percent of all
elk farms and much less than 1 percent
of all deer farms in the United States in
2002. It is estimated that additional
CWD-positive deer and elk herds will be
detected over the next 2 years, after
which a drop off in detection will occur.
This drop off will be the result of
reduced movement of infected animals
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between herds due to the program’s
operations.
All in all, the rule can be expected to
have a positive economic effect on deer
and elk farmers, both large and small,
over the long term. In the shorter term,
the economic effect on farmers will vary
depending on the circumstances of
each. Some farmers, especially those
who already participate in State
programs and who take advantage of the
increased access to out-of-State markets,
could benefit immediately. Conversely,
a small number of farmers could
experience a significant adverse impact,
especially any farmers whose revenue is
so small they cannot afford to pay the
program’s annual costs. There is no
basis to conclude that the rule will have
a significant economic impact on a
substantial number of small entities.
Under these circumstances, the
Administrator of the Animal and Plant
Health Inspection Service has
determined that this action will not
have a significant economic impact on
a substantial number of small entities.
Executive Order 12372
This program/activity is listed in the
Catalog of Federal Domestic Assistance
under No. 10.025 and is subject to
Executive Order 12372, which requires
intergovernmental consultation with
State and local officials. (See 7 CFR part
3015, subpart V.)
Executive Order 12988
This final rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts
all State and local laws and regulations
that are in conflict with this rule; (2) has
no retroactive effect; and (3) does not
require administrative proceedings
before parties may file suit in court
challenging this rule.
Paperwork Reduction Act
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.), the information collection or
recordkeeping requirements included in
this rule have been approved by the
Office of Management and Budget
(OMB) under OMB control number
0579–0237.
This final rule includes certain
regulatory provisions that differ from
those included in the December 2003
proposed rule. Some of those provisions
involve minor changes from or
additions to the information collection
requirements set out in the December
2003 proposed rule. These changes
include the following:
Two changes were made regarding
animal identification requirements. One
change required that free-ranging
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animals captured, moved, then released
must have two forms, rather than one
form, of official animal identification.
The other change set a definite age (12
months) by which animals in the
certification program must first be
officially identified. While the proposed
rule required animal identification,
these particular changes are new
requirements in the final rule.
The final rule also requires a research
animal permit for the interstate
movement of cervids for research
purposes. The permit contains
information about the animals, their
movement, and their destination and
also specifies any special conditions of
the movement determined by the
Administrator to be necessary to prevent
the dissemination of CWD.
Estimate of burden: The public
reporting burden for the new or changed
collections of information is estimated
to average 0.4 hours per response.
Respondents: Federal and State
wildlife management agencies,
researchers, universities, and any other
parties who move and release wild
cervids or move cervids for research
purposes.
Estimated annual number of
respondents: 12.
Estimated annual number of
responses per respondent: 15.
Estimated annual number of
responses: 180.
Estimated total annual burden on
respondents: 72 hours.
Government Paperwork Elimination
Act Compliance
The Animal and Plant Health
Inspection Service is committed to
compliance with the Government
Paperwork Elimination Act (GPEA),
which requires Government agencies in
general to provide the public the option
of submitting information or transacting
business electronically to the maximum
extent possible. For information
pertinent to GPEA compliance related to
this rule, please contact Mrs. Celeste
Sickles, APHIS’ Information Collection
Coordinator, at (301) 734–7477.
List of Subjects
9 CFR Part 55
Animal diseases, Cervids, Chronic
wasting disease, Deer, Elk, Indemnity
payments, Moose.
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9 CFR Part 81
Animal diseases, Cervids, Deer, Elk,
Moose, Quarantine, Reporting and
recordkeeping requirements,
Transportation.
Accordingly, we are amending 9 CFR
chapter I as follows:
I
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PART 55—CONTROL OF CHRONIC
WASTING DISEASE
1. The authority citation for part 55 is
revised to read as follows:
I
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 removing the definition of
captive.
I b. In the definition of herd, by
removing the words ‘‘A group of
animals’’ and adding in their place the
words ‘‘One or more animals’’.
I c. By revising the definitions of
animal, CWD-exposed animal, CWDpositive animal, CWD-suspect animal,
and herd plan to read as set forth below.
I d. By adding definitions for animal
identification, animal identification
number (AIN), Approved State CWD
Herd Certification Program,
commingled, commingling, CWDexposed herd, CWD Herd Certification
Program, CWD-source herd, CWDsuspect herd, deer, elk, and moose,
farmed or captive, herd status, official
animal identification, premises
identification number (PIN), trace back
herd, and trace forward herd, in
alphabetical order, to read as set forth
below.
I
I
§ 55.1
Definitions.
*
*
*
*
*
Animal. Any farmed or captive
cervid.
*
*
*
*
*
Animal identification. A device or
means of animal identification approved
for use under this part by APHIS.
Examples of animal identification
devices that APHIS has approved are
listed in § 55.25.
Animal identification number (AIN).
A numbering system for the official
identification of individual animals in
the United States. The AIN contains 15
digits, with the first 3 being the country
code (840 for the United States), the
alpha characters USA, or the numeric
code assigned to the manufacturer of the
identification device by the
International Committee on Animal
Recording.
*
*
*
*
*
Approved State CWD Herd
Certification Program. A program
operated by a State government for
certification of cervid herds with respect
to CWD that the Administrator has
determined to meet the requirements of
§ 55.23(a).
*
*
*
*
*
Commingled, commingling. Animals
are commingled if they have direct
contact with each other, have less than
10 feet of physical separation, or share
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41701
equipment, pasture, or water sources/
watershed. Animals are considered to
have commingled if they have had such
contact with a positive animal or
contaminated premises within the last 5
years.
CWD-exposed animal. An animal that
is part of a CWD-positive herd, or that
has been exposed to a CWD-positive
animal or contaminated premises within
the previous 5 years.
CWD-exposed herd. A herd in which
a CWD-positive animal has resided
within 5 years prior to that animal’s
diagnosis as CWD-positive, as
determined by an APHIS employee or
State representative.
CWD Herd Certification Program. The
Chronic Wasting Disease Herd
Certification Program established by this
part. This program includes both herds
that are directly enrolled in the CWD
Herd Certification Program and herds
that are included based on their
participation in Approved State CWD
Herd Certification Programs.
CWD-positive animal. An animal that
has had a diagnosis of CWD confirmed
by means of two official CWD tests.
*
*
*
*
*
CWD-source herd. A herd that is
identified through testing, tracebacks,
and/or epidemiological evaluations to
be the source of CWD-positive animals
identified in other herds.
CWD-suspect animal. An animal for
which an APHIS employee or State
representative has determined that
unofficial CWD test results, laboratory
evidence or clinical signs suggest a
diagnosis of CWD, but for which official
laboratory results have been
inconclusive or not yet conducted.
CWD-suspect herd. A herd for which
unofficial CWD test results, laboratory
evidence, or clinical signs suggest a
diagnosis of CWD, as determined by an
APHIS employee or State representative,
but for which official laboratory results
have been inconclusive or not yet
conducted.
Deer, elk, and moose. All animals in
the genera Odocoileus, Cervus, and
Alces and their hybrids.
*
*
*
*
*
Farmed or captive. Privately or
publicly maintained or held for
economic or other purposes within a
perimeter fence or confined area, or
captured from a free-ranging population
for interstate movement and release.
*
*
*
*
*
Herd plan. A written herd and/or
premises management agreement
developed by APHIS in collaboration
with the herd owner, State
representatives, and other affected
parties. The herd plan will not be valid
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until it has been reviewed and signed by
the Administrator, the State
representative, and the herd owner. A
herd plan sets out the steps to be taken
to eradicate CWD from a CWD-positive
herd, to control the risk of CWD in a
CWD-exposed or CWD-suspect herd, or
to prevent introduction of CWD into
that herd or any other herd. A herd plan
will require specified means of
identification for each animal in the
herd; regular examination of animals in
the herd by a veterinarian for clinical
signs of disease; reporting to a State or
APHIS representative of any clinical
signs of a central nervous system
disease or chronic wasting condition in
the herd; maintaining records of the
acquisition and disposition of all
animals entering or leaving the herd,
including the date of acquisition or
removal, name and address of the
person from whom the animal was
acquired or to whom it was disposed;
and the cause of death, if the animal
died while in the herd. A herd plan may
also contain additional requirements to
prevent or control the possible spread of
CWD, depending on the particular
circumstances of the herd and its
premises, including but not limited to
depopulation of the herd, specifying the
time for which a premises must not
contain cervids after CWD-positive,
-exposed, or -suspect animals are
removed from the premises; fencing
requirements; selective culling of
animals; restrictions on sharing and
movement of possibly contaminated
livestock equipment; premises cleaning
and disinfection requirements; or other
requirements. A herd plan may be
reviewed and changes to it suggested at
any time by any party signatory to it, in
response to changes in the situation of
the herd or premises or improvements
in understanding of the nature of CWD
epidemiology or techniques to prevent
its spread. The revised herd plan will
become effective after it is reviewed by
the Administrator and signed by the
Administrator, the State representative,
and the herd owner.
Herd status. The status of a herd
assigned under the CWD Herd
Certification Program in accordance
with § 55.24, indicating a herd’s relative
risk for CWD. Herd status is based on
the number of years of monitoring
without evidence of the disease and any
specific determinations that the herd
has contained or has been exposed to a
CWD-positive, -exposed or -suspect
animal.
*
*
*
*
*
Official animal identification. A
device or means of animal identification
approved for use under this part by
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APHIS to uniquely identify individual
animals. Examples of approved official
animal identification devices are listed
in § 55.25. The official animal
identification must include a nationally
unique animal identification number
that adheres to one of the following
numbering systems:
(1) National Uniform Eartagging
System.
(2) Animal identification number
(AIN).
(3) Premises-based number system.
The premises-based number system
combines an official premises
identification number (PIN), as defined
in this section, with a producer’s
livestock production numbering system
to provide a unique identification
number. The PIN and the production
number must both appear on the official
tag.
(4) Any other numbering system
approved by the Administrator for the
identification of animals in commerce.
*
*
*
*
*
Premises identification number (PIN).
A unique number assigned by a State or
Federal animal health authority to a
premises that is, in the judgment of the
State or Federal animal health authority,
a geographically distinct location from
other livestock production units. The
premises identification number is
associated with an address or legal land
description and may be used in
conjunction with a producer’s own
livestock production numbering system
to provide a unique identification
number for an animal. The premises
identification number may consist of:
(1) The State’s two-letter postal
abbreviation followed by the premises’
assigned number; or
(2) 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.
*
*
*
*
*
Trace back herd. A herd in which a
CWD-positive animal formerly resided.
Trace forward herd. A herd that has
received exposed animals from a CWDpositive herd within 5 years prior to the
diagnosis of CWD in the positive herd
or from the identified date of entry of
CWD into the positive herd.
*
*
*
*
*
I 3. In part 55, a new subpart B is added
to read as follows:
Subpart B—Chronic Wasting Disease Herd
Certification Program
Sec.
55.21 Administration.
55.22 Participation and enrollment.
55.23 Responsibilities of States and
enrolled herd owners.
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55.24
55.25
Herd status.
Animal identification.
Subpart B—Chronic Wasting Disease
Herd Certification Program
§ 55.21
Administration.
The CWD Herd Certification Program
is a cooperative effort between APHIS,
State animal health and wildlife
agencies, and deer, elk, and moose
owners. APHIS coordinates with these
State agencies to encourage deer, elk,
and moose owners to certify their herds
as low risk for CWD by being in
continuous compliance with the CWD
Herd Certification Program standards.
§ 55.22
Participation and enrollment.
(a) Participation by owners. Any
owner of a farmed or captive deer, elk,
or moose herd may apply to enroll in
the CWD Herd Certification Program by
sending a written request to the
appropriate State agency, or to the
veterinarian in charge if no Approved
State CWD Herd Certification Program
exists in the herd’s State. APHIS or the
State will determine the herd’s
eligibility, and if needed will require the
owner to submit more details about the
herd animals and operations. An
application for participation may be
denied if APHIS or the State determines
that the applicant has previously
violated State or Federal laws or
regulations for livestock, and that the
nature of the violation indicates that the
applicant may not faithfully comply
with the requirements of the CWD Herd
Certification Program. If the enrolling
herd is a CWD-positive herd or CWDexposed herd, immediately after
enrollment it must begin complying
with a herd plan developed in
accordance with § 55.24. After
determining that the herd is eligible to
participate in accordance with this
paragraph, APHIS or the appropriate
State agency will send the herd owner
a notice of enrollment that includes the
herd’s enrollment date. Inquiries
regarding which herds are participating
in the CWD Herd Certification Program
and their certification should be
directed to the State representative of
the relevant State.
(1) Enrollment date. With the
exceptions listed in this paragraph, the
enrollment date for any herd that joins
the CWD Herd Certification Program
after the effective date of this rule will
be the date the herd is approved for
participation.
(i) For herds already participating in
State CWD programs, the enrollment
date will be the first day that the herd
participated in a State program that
APHIS subsequently determines
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qualifies as an Approved State CWD
Herd Certification Program in
accordance with § 55.23(a) of this part.
This type of constructed enrollment
date will be unavailable for herds that
apply to enroll after October 19, 2007,
and herds that apply to enroll after that
date will have an enrollment date of the
date APHIS approves the herd
participation.
(ii) For herds that enroll directly in
the Federal CWD Herd Certification
Program, which is allowed only when
there is no Approved State CWD Herd
Certification Program in their State, the
enrollment date will be the earlier of:
(A) The date APHIS approves
enrollment; or
(B) 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. This
type of constructed enrollment date will
be unavailable for herds that apply to
enroll after October 19, 2007, and herds
that apply to enroll after that date will
have an enrollment date of the date
APHIS approves the herd participation.
(iii) For new herds that were formed
from and contain only animals from
herds enrolled in the CWD Herd
Certification Program, the enrollment
date will be the latest enrollment date
for any source herd for the animals.
(2) [Reserved]
(b) Participation by States. Any State
that operates a State program to certify
the CWD status of deer, elk, or moose
may request the Administrator to
designate the State program as an
Approved State CWD Herd Certification
Program. The Administrator will
approve or disapprove a State program
in accordance with § 55.23(a) of this
subpart. In States with an Approved
State CWD Herd Certification Program,
program activities will be conducted in
accordance with the guidelines of that
program as long as the State program
meets the minimum requirements of
this part. A list of Approved State CWD
Herd Certification Programs may be
obtained by writing to the National
Center for Animal Health Program, VS,
APHIS, 4700 River Road Unit 43,
Riverdale, MD 20737–1235.
(Approved by the Office of Management and
Budget under control number 0579–0237)
§ 55.23 Responsibilities of States and
enrolled herd owners.
(a) Approval of State programs and
responsibilities of States. In reviewing a
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State program’s eligibility to be
designated an Approved State CWD
Herd Certification Program, the
Administrator will evaluate a written
statement from the State that describes
State CWD control and deer, elk, and
moose herd certification activities and
that cites relevant State statutes,
regulations, and directives pertaining to
animal health activities and reports and
publications of the State. In determining
whether the State program qualifies, the
Administrator will determine whether
the State:
(1) Has the authority, based on State
law or regulation, to restrict the
intrastate movement of all CWDpositive, CWD-suspect, and CWDexposed animals.
(2) Has the authority, based on State
law or regulation, to require the prompt
reporting of any animal suspected of
having CWD and test results for any
animals tested for CWD to State or
Federal animal health authorities.
(3) Has, in cooperation with APHIS
personnel, drafted and signed a
memorandum of understanding with
APHIS that delineates the respective
roles of the State and APHIS in CWD
Herd Certification Program
implementation.
(4) Has placed all known CWDpositive, CWD-exposed, and CWDsuspect animals and herds under
movement restrictions, with movement
of animals from them only for
destruction or under permit.
(5) Has effectively implemented
policies to:
(i) Promptly investigate all animals
reported as CWD-suspect animals;
(ii) Designate herds as CWD-positive,
CWD-exposed, or CWD-suspect and
promptly restrict movement of animals
from the herd after an APHIS employee
or State representative determines that
the herd contains or has contained a
CWD-positive animal;
(iii) Remove herd movement
restrictions only after completion of a
herd plan agreed upon by the State
representative, APHIS, and the owner;
(iv) Conduct an epidemiologic
investigation of CWD-positive, CWDexposed, and CWD-suspect herds that
includes the designation of suspect and
exposed animals and that identifies
animals to be traced;
(v) Conduct tracebacks of CWDpositive animals and traceouts of CWDexposed animals and report any out-ofState traces to the appropriate State
promptly after receipt of notification of
a CWD-positive animal; and
(vi) Conduct tracebacks based on
slaughter or other sampling promptly
after receipt of notification of a CWDpositive animal at slaughter.
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41703
(6) Effectively monitors and enforces
State quarantines and State reporting
laws and regulations for CWD.
(7) Has designated at least one State
animal health official, or has worked
with APHIS to designate an APHIS
official, to coordinate CWD Herd
Certification Program activities in the
State.
(8) Has programs to educate those
engaged in the interstate movement of
deer, elk, and moose regarding the
identification and recordkeeping
requirements of this part.
(9) Requires, based on State law or
regulation, and effectively enforces
identification of all animals in herds
participating in the CWD Herd
Certification Program;
(10) Maintains in the CWD National
Database administered by APHIS, or in
a State database approved by the
Administrator as compatible with the
CWD National Database, the State’s:
(i) Premises information and assigned
premises numbers;
(ii) Individual animal information on
all deer, elk, and moose in herds
participating in the CWD Herd
Certification Program in the State;
(iii) Individual animal information on
all out-of-State deer, elk, and moose to
be traced; and
(iv) Accurate herd status data.
(11) Requires that tissues from all
CWD-exposed or CWD-suspect animals
that die or are depopulated or otherwise
killed be submitted to a laboratory
authorized by the Administrator to
conduct official CWD tests and requires
appropriate disposal of the carcasses of
CWD-positive, CWD-exposed, and
CWD-suspect animals.
(b) Responsibilities of enrolled herd
owners. Herd owners who enroll in the
CWD Herd Certification Program agree
to maintain their herds in accordance
with the following conditions:
(1) Each animal in the herd must be
identified using means of animal
identification specified in § 55.25 of this
subpart. All animals in an enrolled herd
must be identified before reaching 12
months of age. In addition, all animals
of any age in an enrolled herd must be
identified before being moved from the
herd premises. In addition, all animals
in an enrolled herd must be identified
before the inventory required under
paragraph (b)(4) of this section, and
animals found to be in violation of this
requirement during the inventory must
be identified during or after the
inventory on a schedule specified by the
APHIS employee or State representative
conducting the inventory;
(2) The herd premises must have
perimeter fencing adequate to prevent
ingress or egress of cervids. This fencing
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must also comply with any applicable
State regulations;
(3) The owner must immediately
report to an APHIS employee or State
representative all animals that escape or
disappear, and all deaths (including
animals killed on premises maintained
for hunting and animals sent to
slaughter) of deer, elk, and moose in the
herd aged 12 months or older; Except
that, APHIS employees or State
representatives may approve reporting
schedules other than immediate
notification when herd conditions
warrant it in the opinion of both APHIS
and the State. The report must include
the identification numbers of the
animals involved and the estimated
time and date of the death, escape, or
disappearance. For animals that die
(including animals killed on premises
maintained for hunting and animals
sent to slaughter), the owner must
inform an APHIS or State representative
and must make the carcasses of the
animals available for tissue sampling
and testing in accordance with
instructions from the APHIS or State
representative. In cases where animals
escape or disappear and thus are not
available for tissue sampling and
testing, an APHIS representative will
investigate whether the unavailability of
animals for testing constitutes a failure
to comply with program requirements
and will affect the herd’s status in the
CWD Herd Certification Program;
(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, the owner must allow an APHIS
employee or State representative access
to the premises and herd to conduct an
annual physical herd inventory with
verification reconciling animals and
identifications with the records
maintained by the owner. The owner
must present the entire herd for
inspection under conditions where the
APHIS employee or State representative
can safely read all identification on the
animals. The owner will be responsible
for assembling, handling and restraining
the animals and for all costs incurred to
present the animals for inspection;
(5) If an owner wishes to maintain
separate herds, he or she must maintain
separate herd inventories, records,
working facilities, water sources,
equipment, and land use. There must be
a buffer zone of at least 30 feet between
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the perimeter fencing around separate
herds, and no commingling of animals
may occur. Movement of animals
between herds must be recorded as if
they were separately owned herds;
(6) New animals may be introduced
into the herd only from other herds
enrolled in the CWD Herd Certification
Program. If animals are received from an
enrolled herd with a lower program
status, the receiving herd will revert to
that lower program status. If animals are
obtained from a herd not participating
in the program, then the receiving herd
will be required to start over in the
program.
(Approved by the Office of Management and
Budget under control number 0579–0237)
§ 55.24
Herd status.
(a) Initial and subsequent status.
When a herd is first enrolled in the
CWD Herd Certification Program, it will
be placed in First Year status, except
that; if the herd is comprised solely of
animals obtained from herds already
enrolled in the Program, the newly
enrolled herd will have the same status
as the lowest status of any herd that
provided animals for the new herd. If
the herd continues to meet the
requirements of the CWD Herd
Certification Program, each year, on the
anniversary of the enrollment date the
herd status will be upgraded by 1 year;
i.e., Second Year status, Third Year
status, Fourth Year status, and Fifth
Year status. One year from the date a
herd is placed in Fifth Year status, the
herd status will be changed to
‘‘Certified’’, and the herd will remain in
‘‘Certified’’ status as long as it is
enrolled in the program, provided its
status is not lost or suspended in
accordance with this section. Once the
herd has received ‘‘Certified’’ status,
slaughter surveillance and surveillance
of animals killed in shooter operations
will no longer be required, but other
requirements of the program will remain
in force.
(b) Loss or suspension of herd status.
(1) If a herd is designated a CWDpositive herd or a CWD-exposed herd, it
will immediately lose its program status
and may only reenroll after entering into
a herd plan.
(2) If a herd is designated a CWDsuspect herd, a trace back herd, or a
trace forward herd, it will immediately
be placed in Suspended status pending
an epidemiologic investigation by
APHIS or a State animal health agency.
If the epidemiologic investigation
determines that the herd was not
commingled with a CWD-positive
animal, the herd will be reinstated to its
former program status, and the time
spent in Suspended status will count
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toward its promotion to the next herd
status level.
(i) If the epidemiologic investigation
determines that the herd was
commingled with a CWD-positive
animal, the herd will lose its program
status and will be designated a CWDexposed herd.
(ii) If the epidemiological
investigation is unable to make a
determination regarding the exposure of
the herd, because the necessary animal
or animals are no longer available for
testing (i.e. a trace animal from a known
positive herd died and was not tested)
or for other reasons, the herd status will
continue as Suspended unless and until
a herd plan is developed for the herd.
If a herd plan is developed and
implemented, the herd will be
reinstated to its former program status,
and the time spent in Suspended status
will count toward its promotion to the
next herd status level; Except that, if the
epidemiological investigation finds that
the owner of the herd has not fully
complied with program requirements
for animal identification, animal testing,
and recordkeeping, the herd will be
reinstated into the CWD Herd
Certification Program at the First Year
status level, with a new enrollment date
set at the date the herd entered into
Suspended status. Any herd reinstated
after being placed in Suspended status
must then comply with the
requirements of the herd plan as well as
the requirements of the CWD Herd
Certification Program. The herd plan
will require testing of all animals that
die in the herd for any reason,
regardless of the age of the animal, may
require movement restrictions for
animals in the herd based on
epidemiologic evidence regarding the
risk posed by the animals in question,
and may include other requirements
found necessary to control the risk of
spreading CWD.
(3) If an APHIS or State representative
determines that animals from a herd
enrolled in the program have
commingled with animals from a herd
with a lower program status, the herd
with the higher program status will be
reduced to the status of the herd with
which its animals commingled.
(c) Cancellation of enrollment by
Administrator. The Administrator may
cancel the enrollment of an enrolled
herd by giving written notice to the herd
owner. In the event of such cancellation,
the herd owner may not reapply to
enroll in the CWD Herd Certification
Program for 5 years from the effective
date of the cancellation. The
Administrator may cancel enrollment
after determining that the herd owner
failed to comply with any requirements
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of this section. Before enrollment is
canceled, an APHIS representative will
inform the herd owner of the reasons for
the proposed cancellation.
(1) Herd owners may appeal
cancellation of enrollment or loss or
suspension of herd status by writing to
the Administrator within 10 days after
being informed of the reasons for the
proposed action. The appeal must
include all of the facts and reasons upon
which the herd owner relies to show
that the reasons for the proposed action
are incorrect or do not support the
action. The Administrator will grant or
deny the appeal in writing as promptly
as circumstances permit, stating the
reason for his or her decision. 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. However, cancellation of
enrollment or loss or suspension of herd
status shall become effective pending
final determination in the proceeding if
the Administrator determines that such
action is necessary to prevent the
possible spread of CWD. Such action
shall become effective upon oral or
written notification, whichever is
earlier, to the herd owner. In the event
of oral notification, written confirmation
shall be given as promptly as
circumstances allow. This cancellation
of enrollment or loss or suspension of
herd status shall continue in effect
pending the completion of the
proceeding, and any judicial review
thereof, unless otherwise ordered by the
Administrator.
(2) [Reserved]
(d) Herd status of animals added to
herds. A herd may add animals from
herds with the same or a higher herd
status in the CWD Herd Certification
Program with no negative impact on the
certification status of the receiving
herd.2 If animals are acquired from a
herd with a lower herd status, the
receiving herd reverts to the program
status of the sending herd. If a herd
participating in the CWD Herd
Certification Program acquires animals
from a nonparticipating herd, the
receiving herd reverts to First Year
status with a new enrollment date of the
date of acquisition of the animal.
(Approved by the Office of Management and
Budget under control number 0579–0237.)
sroberts on PROD1PC70 with RULES
§ 55.25
Animal identification.
Each animal required to be identified
by this subpart must have at least two
2 Note that in addition to this requirement, § 81.3
of this chapter restricts the interstate movement of
farmed and captive deer, elk, and moose based on
their status in the CWD Herd Certification Program.
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forms of animal identification attached
to the animal. The means of animal
identification must be approved for this
use by APHIS, and must be an
electronic implant, flank tattoo, ear
tattoo, tamper-resistant ear tag, or other
device approved by APHIS. One of the
animal identifications must be official
animal identification as defined in this
part, with a nationally unique animal
identification number that is linked to
that animal in the CWD National
Database. The second animal
identification must be unique for the
individual animal within the herd and
also must be linked to that animal and
herd in the CWD National Database.
(Approved by the Office of Management and
Budget under control number 0579–0237)
4. A new part 81 is added to read as
follows:
I
PART 81—CHRONIC WASTING
DISEASE IN DEER, ELK, AND MOOSE
Sec.
81.1
81.2
Definitions.
Identification of deer, elk, and moose
in interstate commerce.
81.3 General restrictions.
81.4 Issuance of certificates.
Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22,
2.80, and 371.4.
§ 81.1
Definitions.
Animal. Any farmed or captive deer,
elk, or moose.
Animal and Plant Health Inspection
Service (APHIS). The Animal and Plant
Health Inspection Service of the United
States Department of Agriculture.
Animal identification. A device or
means of animal identification approved
for use under this part by APHIS.
Examples of animal identification
devices that APHIS has approved are
listed in § 55.25 of this chapter.
Animal identification number (AIN).
A numbering system for the official
identification of individual animals in
the United States. The AIN contains 15
digits, with the first 3 being the country
code (840 for the United States), the
alpha characters USA, or the numeric
code assigned to the manufacturer of the
identification device by the
International Committee on Animal
Recording.
APHIS employee. Any individual
employed by the Animal and Plant
Health Inspection Service who is
authorized by the Administrator to do
any work or perform any duty in
connection with the control and
eradication of disease.
Cervid. All members of the family
Cervidae and hybrids, including deer,
elk, moose, caribou, reindeer, and
related species.
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Chronic wasting disease (CWD). A
transmissible spongiform
encephalopathy of cervids. Clinical
signs in affected animals include, but
are not limited to, loss of body
condition, behavioral changes, excessive
salivation, increased drinking and
urination, depression, and eventual
death.
CWD-exposed animal. An animal that
is part of a CWD-positive herd, or that
has been exposed to a CWD-positive
animal or contaminated premises within
the previous 5 years.
CWD Herd Certification Program. The
Chronic Wasting Disease Herd
Certification Program established in part
55 of this chapter.
CWD-positive animal. An animal that
has had a diagnosis of CWD confirmed
by means of two official CWD tests as
defined in § 55.1 of this chapter.
CWD-suspect animal. An animal for
which an APHIS employee or State
representative has determined that
unofficial CWD test results, laboratory
evidence, or clinical signs suggest a
diagnosis of CWD.
Deer, elk, and moose. All animals in
the genera Odocoileus, Cervus, and
Alces and their hybrids.
Farmed or captive. Privately or
publicly maintained or held for
economic or other purposes within a
perimeter fence or confined area, or
captured from a free-ranging population
for interstate movement and release.
Official animal identification. A
device or means of animal identification
approved for use under this part by
APHIS to uniquely identify individual
animals. Examples of approved official
animal identification devices are listed
in § 55.25 of this chapter. The official
animal identification must include a
nationally unique animal identification
number that adheres to one of the
following numbering systems:
(1) National Uniform Eartagging
System.
(2) Animal identification number
(AIN).
(3) Premises-based number system.
The premises-based number system
combines an official premises
identification number (PIN), as defined
in this section, with a producer’s
livestock production numbering system
to provide a unique identification
number. The PIN and the production
number must both appear on the official
tag.
(4) Any other numbering system
approved by the Administrator for the
identification of animals in commerce.
Premises identification number (PIN).
A unique number assigned by a State or
Federal animal health authority to a
premises that is, in the judgment of the
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State or Federal animal health authority,
a geographically distinct location from
other livestock production units. The
premises identification number is
associated with an address or legal land
description and may be used in
conjunction with a producer’s own
livestock production numbering system
to provide a unique identification
number for an animal. The premises
identification number may consist of:
(1) The State’s two-letter postal
abbreviation followed by the premises’
assigned number; or
(2) 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.
§ 81.2 Identification of deer, elk, and
moose in interstate commerce.
Each animal required to be identified
by this subpart must have at least two
forms of animal identification attached
to the animal. The means of animal
identification must be approved for this
use by APHIS, and must be an
electronic implant, flank tattoo, ear
tattoo, tamper-resistant ear tag, or other
device approved by APHIS. One of the
animal identifications must be an
official animal identification as defined
in this part, with a nationally unique
animal identification number that is
linked to that animal in the CWD
National Database. The second animal
identification must be unique for the
individual animal within the herd and
also must be linked to that animal and
herd in the CWD National Database.
(Approved by the Office of Management and
Budget under control number 0579–0237)
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§ 81.3
General restrictions.
No farmed or captive deer, elk, or
moose may be moved interstate unless
it meets the requirements of this section.
(a) Animals in the CWD Herd
Certification Program. The captive deer,
elk, or moose is:
(1) Enrolled in the CWD Herd
Certification Program and:
(i) If the movement occurs between
October 19, 2006 and January 19, 2009,
the herd has achieved at least Second
Year status in accordance with § 55.24
of this chapter;
(ii) If the movement occurs between
January 19, 2009 and January 19, 2010,
the herd has achieved at least Third
Year status in accordance with § 55.24
of this chapter;
(iii) If the movement occurs between
January 19, 2010 and January 19, 2011,
the herd has achieved at least Fourth
Year status in accordance with § 55.24
of this chapter;
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18:49 Jul 20, 2006
Jkt 208001
(iv) If the movement occurs between
January 19, 2011 and January 19, 2012,
the herd has achieved at least Fifth Year
status in accordance with § 55.24 of this
chapter;
(v) If the movement occurs after
January 19, 2012, the herd has achieved
Certified status in accordance with
§ 55.24 of this chapter; and
(2) The farmed or captive deer, elk, or
moose is accompanied by a certificate
issued in accordance with § 81.4 of this
part that identifies its herd of origin and
its herd’s CWD Herd Certification
Program status, and states that it is not
a CWD-positive, CWD-exposed, or
CWD-suspect animal.
(b) Animals captured for interstate
movement and release. If the captive
deer, elk, or moose was captured for
interstate movement and release from a
free-ranging population, each animal
must have two forms of animal
identification, one of which is official
animal identification, and a certificate
accompanying the animal must
document the source population to be
low risk for CWD, based on a CWD
surveillance program that is approved
by the State Government of the
receiving State and by APHIS.
(c) Animals moved to slaughter. The
farmed or captive deer, elk, or moose
must be moved directly to a recognized
slaughtering establishment for slaughter,
must have two forms of animal
identification, one of which is official
animal identification, and must be
accompanied by a certificate issued in
accordance with § 81.4.
(d) Research animal movements and
permits. A research animal permit is
required for the interstate movement of
cervids for research purposes. The
permit will specify any special
conditions of the movement determined
by the Administrator to be necessary to
prevent the dissemination of CWD. The
Administrator may, at his or her
discretion, issue the permit if he or she
determines that the destination facility
has adequate biosecurity and that the
movement authorized will not result in
the interstate dissemination of CWD.
(1) To apply for a research animal
permit, contact an APHIS employee or
State representative and provide the
following information:
(i) The name and address of the
person to whom the special permit is
issued, the address at which the
research cervids to be moved interstate
are being held, and the name and
address of the person receiving the
cervids to be moved interstate;
(ii) The number and type of cervids to
be moved interstate;
(iii) The reason for the interstate
movement;
PO 00000
Frm 00026
Fmt 4701
Sfmt 4700
(iv) Any safeguards in place to
prevent transmission of CWD during
movement or at the receiving location;
and
(v) The date on which movement will
occur.
(2) A copy of the research animal
permit must accompany the cervids
moved, and copies must be submitted so
that a copy is received by the State
animal health official and the
veterinarian in charge for the State of
destination at least 72 hours prior to the
arrival of the cervids at the destination
listed on the research animal permit.
(e) Interstate movements approved by
the Administrator. Notwithstanding any
other provision of this part, interstate
movement of farmed or captive deer,
elk, and moose may be allowed on a
case-by-case basis when the
Administrator determines that adequate
survey and mitigation procedures are in
place to prevent dissemination of CWD
and issues a permit for the movement.
§ 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
participating 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
participating 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.
(b) Animal identification documents
attached to certificates. As an
alternative to typing or writing
individual animal identification on a
certificate, another document may be
used to provide this information, but
only under the following conditions:
(1) The document must be a State
form or APHIS form that requires
individual identification of animals;
(2) A legible copy of the document
must be stapled to the original and each
copy of the certificate;
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sroberts on PROD1PC70 with RULES
(3) Each copy of the document must
identify each animal to be moved with
the certificate, but any information
pertaining to other animals, and any
unused space on the document for
recording animal identification, must be
crossed out in ink; and
(4) The following information must be
typed or written in ink in the
identification column on the original
VerDate Aug<31>2005
18:49 Jul 20, 2006
Jkt 208001
and each copy of the certificate and
must be circled or boxed, also in ink, so
that no additional information can be
added:
(i) The name of the document; and
(ii) Either the serial number on the
document or, if the document is not
imprinted with a serial number, both
the name of the person who issued the
document and the date the document
was issued.
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41707
(Approved by the Office of Management and
Budget under control number 0579–0237)
Done in Washington, DC, this 14th day of
July 2006.
Charles D. Lambert,
Acting Under Secretary for Marketing and
Regulatory Programs.
[FR Doc. 06–6367 Filed 7–20–06; 8:45 am]
BILLING CODE 3410–34–P
E:\FR\FM\21JYR2.SGM
21JYR2
Agencies
[Federal Register Volume 71, Number 140 (Friday, July 21, 2006)]
[Rules and Regulations]
[Pages 41682-41707]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-6367]
[[Page 41681]]
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Part V
Department of Agriculture
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Animal and Plant Health Inspection Service
-----------------------------------------------------------------------
9 CFR Parts 55 and 81
Chronic Wasting Disease Herd Certification Program and Interstate
Movement of Farmed or Captive Deer, Elk, and Moose; Final Rule
Federal Register / Vol. 71, No. 140 / Friday, July 21, 2006 / Rules
and Regulations
[[Page 41682]]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 55 and 81
[Docket No. 00-108-3]
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: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are establishing a herd certification program to eliminate
chronic wasting disease (CWD) from farmed or captive cervids in the
United States. Participating deer, elk, and moose herds will have to
follow program requirements for animal identification, testing, herd
management, and movement of animals into and from herds. After 5 years
of enrollment with no evidence of chronic wasting disease, a herd may
be granted ``Certified'' status. Owners of herds may enroll in a State
program that we have determined has requirements equivalent to the
Federal program, or may enroll directly in the Federal program if no
State program exists. We are also establishing interstate movement
requirements to prevent the interstate movement of deer, elk, and moose
that pose a risk of spreading CWD. These actions will help to eliminate
CWD from the farmed or captive deer, elk, and moose herds in the United
States.
DATES: Effective Date: October 19, 2006.
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 2005, 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. Noncervid ruminant species, including
wild ruminants and domestic cattle, sheep, and goats, have been housed
in wildlife facilities in direct or indirect contact with CWD-affected
deer and elk, and as of June 2005 there has been no evidence of
transmission of CWD to these other species. Additional studies to
delineate the host range of CWD are underway.
In the United States, CWD has been confirmed in free-ranging deer
and elk in Colorado, Illinois, Nebraska, New Mexico, New York, South
Dakota, Utah, West Virginia, Wisconsin, and Wyoming, and, as of October
2005, in 31 farmed or captive elk herds in Colorado, Kansas, Minnesota,
Montana, Nebraska, Oklahoma, South Dakota, and Wisconsin, and in 8
farmed or captive deer herds in New York 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.
The Animal and Plant Health Inspection Service's (APHIS's)
regulations in 9 CFR subchapter B govern cooperative programs to
control and eradicate communicable diseases of livestock. In accordance
with 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, and to pay claims growing out of the destruction
of animals.
On December 24, 2003, we published in the Federal Register (68 FR
74513-74529, Docket No. 00-108-2) a proposal to amend 9 CFR subchapter
B by establishing regulations in part 55 for a CWD Herd Certification
Program to help eliminate chronic wasting disease from the farmed or
captive deer and elk herds in the United States. Under that proposal,
deer and elk herd owners who choose to participate would have to follow
program requirements for animal identification, testing, herd
management, and movement of animals into and from herds. We also
proposed to amend 9 CFR subchapter B by establishing a new part 81
containing interstate movement requirements to prevent the interstate
movement of deer and elk that pose a risk of spreading CWD.
We solicited comments concerning our proposal for 60 days ending
February 23, 2004. We received 105 comments by that date, from cervid
ranches, national and State cervid producer associations, national
wildlife associations, State wildlife and agriculture agencies, and
others. These comments are discussed below by topic. In response to
these comments, APHIS has decided to amend the proposed rule by making
the following changes:
Adding moose to the animals covered by the regulations, in
addition to deer and elk.
Change the definition of commingled, commingling by
replacing ``30 feet of physical separation'' with ``10 feet of physical
separation'' and by eliminating the exception for animals in brief
contact for less than 48 hours.
Change the definition of CWD-positive animal to require
two positive official CWD tests, rather than one.
Change the definition of CWD-suspect animal to clarify
that it would include animals that have tested positive to an
unofficial CWD test.
Change the definition of herd plan to specify that it must
be signed by the herd owner, in addition to APHIS and the State, to
emphasize the involvement of all three parties in a herd plan's
development.
Change the requirements for animal identification to
require that free-ranging animals captured for interstate movement and
release, like other farmed or captive cervids, must have two forms of
animal identification, including one form with a nationally unique
animal identification number. Add ``or other identification approved by
APHIS'' to the list of allowed identification devices we proposed
(electronic implant, flank tattoo, ear tattoo, or tamper-resistant ear
tag).
Change the interstate movement restrictions for farmed or
captive cervids to exempt cervids moving directly to slaughter from the
requirements of Sec. 81.3, ``General restrictions,'' when the sending
and receiving States have agreed to the movement and certain other
conditions are met.
Change the responsibilities for herd owners participating
in the program to require that they report animal deaths and make the
carcasses available for testing for all animals 12 months and older,
rather than 16 months as proposed. Also require herd owners to report
any animals that escape or disappear.
Change the inventory requirements for participating herds
to specify that the ``physical herd inventory with verification
reconciling animals and identifications with the records maintained by
the owner'' must be conducted annually, rather than ``upon request'' as
we proposed. Also change the inventory requirements to make it clear
that the owner must present the
[[Page 41683]]
entire herd for inspection under conditions where the APHIS employee or
State representative can safely read all identification on the animals.
The owner will be responsible for assembling, handling and restraining
the animals and for all costs and liabilities incurred to present the
animals for inspection.
Add a requirement that cervids held for research purposes
may only be moved interstate under a USDA permit. In the proposal, such
animals were completely exempt from the requirements of the rule.
Make minor changes to improve clarity in other sections of
the rule.
Comments on Definitions in the Proposed Rule
Approved State CWD Herd Certification Program
One commenter noted that although the term Approved State CWD Herd
Certification Program appears in the regulations its meaning is not
defined and must be derived from context. In response we have added a
definition of this term that reads ``A program operated by a State
government for certification of cervid herds with respect to CWD that
the Administrator has determined to meet the requirements of Sec.
55.23(a).''
Definition of Farmed or Captive
Several commenters stated that when referring to cervids, the term
``captive'' should be changed to ``privately owned,'' ``domestic,'' or
``farmed.'' They stated that the term captive implies the animal was
captured from the wild, but cervid ranches and farms primarily contain
animals born on a commercial premises. Some commenters stated that the
words ``captive'' or ``captured'' have a negative connotation about the
cervid industry.
We understand that producers that maintain herds of cervids that
were born in captivity and do not deal in animals captured from the
wild believe that their industry is properly associated with other
livestock industries, and that there may be negative connotations in
any term that associates them with the capture of wild cervids.
However, some herds of domesticated elk or deer do in fact contain some
animals captured from the wild. While this is becoming less common, if
our certification program only addressed herds in which all animals
were born into captivity, the program would exclude too many herds,
reducing the program's effectiveness in controlling CWD. Many State CWD
regulations and programs recognize the fact that a ``captive'' cervid
may be either born into a herd or introduced into it from the wild.
Some States, in their requirements for allowing cervids to enter the
State, require that the cervid must come from a herd that has been
monitored for CWD for at least 5 years under a State program, but do
not require that the cervid must have been born into a captive herd;
instead, they require that all animals in the source herd must be
either natural additions or have been in the herd for at least 1 year.
We believe that to effectively control CWD our certification
program must address not only cervid herds containing solely
domesticated cervids born into herds, but also must address herds that
contain one or more animals introduced from the wild, cervids captured
from the wild and temporarily maintained in captivity, and cervids
maintained by zoos and other exhibitors. Also, the term captive cervids
is already in use in a number of other Federal regulations (e.g., 9 CFR
Part 77--Tuberculosis, 9 CFR Part 50--Animals Destroyed Because of
Tuberculosis, and 9 CFR Part 91--Inspection and Handling of Livestock
For Exportation). It is also used in several State laws, regulations,
and policy statements. Using an alternate term such as ``domestic
cervid'' or ``farmed cervid'' in our certification regulations would be
inconsistent and could cause confusion.
However, we do agree that incorporating the term ``farmed'' along
with the term ``captive'' would emphasize the fact that many cervids
are domestic animals born in captivity. Therefore, we are replacing the
term ``captive'' with the term ``farmed or captive'' throughout the
regulations. We are making no change to the definition itself, so in
this final rule, the term farmed or captive will read as follows:
``Privately or publicly maintained or held for economic or other
purposes within a perimeter fence or confined area, or captured from a
free-ranging population for interstate movement and release.''
Definition of Commingled, Commingling
Several commenters stated that there is no scientific evidence
supporting the idea that animals are commingled to the extent that
disease transmission is possible when the animals are separated by less
than 30 feet. These commenters stated that CWD transmission at this
distance would be possible only through aerosol routes, and no evidence
has ever been found that CWD passes via an aerosol spray from animal to
animal. Commenters also stated that regulations for control of other
diseases, e.g., tuberculosis, require separation of only 10 feet to
prevent commingling.
Several commenters asked for clarification of how the commingling
definition would apply to perimeter fencing issues, and whether a
certified herd would lose its status (become an exposed herd) if its
premises does not have a double fence with at least 30 feet between the
fences and a wild cervid in the area is diagnosed with CWD. One
commenter suggested that perimeter fences that maintain 30 feet of
separation from wild animals should be clearly required for all farmed
or captive cervid premises, because, otherwise, commingling with native
animals could not be avoided, increasing both the risk that captive
animals would contract CWD from free-ranging animals and the risk that
farmed or captive animals would spread CWD to free-ranging native
animals.
The term commingling is used in the regulations in two distinct
contexts--that of temporary contact between animals (e.g., during sale
or transport or at shows) and more long-term contact between animals
(e.g., when an owner maintains two or more separate herds on one
premises, in accordance with Sec. 55.23(b)(5)). The criteria used to
determine that commingling has occurred are especially important
because if a herd was commingled with a CWD-positive animal, it can be
declared to be a CWD-exposed herd.
We agree with the points made by several commenters that it would
be both unnecessary and burdensome to say that animals are commingled
if there is not a 30-foot buffer zone between animals at all times. We
are changing this requirement in the definition of commingling to 10
feet of separation, and will make it clear that this separation
distance is adequate for situations where animals are in temporary
association, such as at auctions or during movement. We are making this
change because our level of knowledge concerning transmission of CWD
from animal to animal has increased since the proposed rule was
written. In the proposed rule we stated ``A buffer zone of 30 feet was
chosen because in other APHIS disease control programs this distance
has been shown to be effective in preventing aerosol transmission of
infective agents from one animal to another. Because there is not yet a
detailed model of how TSE's are transmitted, APHIS believes it is
prudent to assume that they might spread short distances as aerosols,
rather than only through more direct contact.'' Currrent evidence
indicates that transmission is most likely to occur via an oral-fecal
route, and that a 10-foot
[[Page 41684]]
buffer zone should prevent this. A buffer zone of 10 feet will prevent
nose-to-nose contact, make accidental fecal contamination and transfer
less likely, and is the standard distance we use to prevent
ectoparasite transfer of other diseases. Ten to 12 feet is also the
standard distance used for construction of alleyways on farms and
animal holding facilities, so it will be relatively easy to comply with
this standard when a producer needs to prevent commingling of animals.
However, we also believe that it is necessary for separate herds to
have a buffer zone of more than 10 feet between them because risks of
cross-herd contamination are increased when different herds are in
close association for long periods. Therefore, in addition to changing
``30 feet'' to ``10 feet'' in the definition of commingled,
commingling, we are also adding the following italicized words to the
paragraph describing conditions for maintaining separate herds, Sec.
55.23(b)(5): ``If an owner wishes to maintain separate herds, he or she
must maintain separate herd inventories, records, working facilities,
water sources, equipment, and land use. There must be a buffer zone of
at least 30 feet between the perimeter fencing around separate herds,
and no commingling of animals may occur. Movement of animals between
herds must be recorded as if they were separately owned herds.''
Readers should note that this requirement that herds must be
separated by 30 feet applies to cases where a single owner maintains
separate herds, as well as to cases where different owners have
adjacent herds.
Several commenters stated that since current scientific information
indicates CWD is transmitted laterally, animal to animal, there is no
basis for the ``48-hour exemption.'' One commenter stated that all
animals grouped together even briefly at a sale or auction should
assume the status of the lowest program status animal in the group.
Some commenters stated that the definition's exemption for animals
commingled for less than 48 hours at sales or auctions is arbitrary,
but if used, it should also apply to short-term commingling of animals
outside sales or auction premises, when the owner can document that the
commingling was for less than 48 hours.
A zoo association requested that APHIS establish an exemption
similar to the 48-hour exemption for auctions and sales for zoo animals
that briefly share holding or hospital pens for the purpose of cleaning
enclosures or shifting animals.
The ``48 hour exemption'' exists in various forms in several other
animal disease control programs, and is based on an assumption that
transmission of disease between animals is most likely during periods
of prolonged close contact. APHIS has reexamined this assumption with
regard to CWD transmission, and has found that there are no completed
studies of CWD transmission rates that definitively settle the question
of what length of time contact between animals is needed before there
is a significant risk of CWD transmission. Therefore, we are removing
the ``48 hour exemption'' from the definition of commingling. We may
address the risks associated with brief contacts again in future
rulemaking if new studies of CWD transmission provide relevant data.
Commenters also noted that the rule did not clearly describe the
actions APHIS would take to reduce a herd's program status if its
animals commingled with animals from a lower-status herd. This
reclassification of herd status becomes even more important now that we
have eliminated the ``48 hour exemption'' for sales and auctions, where
commingling is likely to occur. We agree that Sec. 55.24, Herd status,
does not sufficiently describe APHIS or State actions that may reduce
herd status as a result of commingling. Therefore, we are adding a new
paragraph Sec. 55.24(b)(3) that reads: ``If an APHIS or State
representative determines that animals from a herd enrolled in the
program have commingled with animals from a herd with a lower program
status, the herd with the higher program status will be reduced to the
status of the herd with which its animals commingled.''
We expect the two changes discussed above--removing the ``48 hour
exemption'' and adding an explicit process to reduce the status of
commingled herds--will result in operational changes at sales,
auctions, and other sites where animals are at risk of commingling.
Owners will probably find it useful to plan animal grouping at such
sites so that only animals with equal program status are grouped
together.
Based on some of the comments about commingling, some readers
appear not to understand that the term is used in the regulations for
distinct and limited purposes related to contact with other farmed or
captive cervids, and not related to exposure to wild cervids in a
farm's vicinity. The concept of commingling is used when determining
whether groups of animals on a single premises qualify as separate
herds or not, when determining whether animals have been exposed to
animals from a herd with a lower program status, and when determining
whether animals in a suspect herd commingled with a CWD-positive
animal, in which case the suspect herd will lose its program status and
will be designated as a CWD-exposed herd. However, as discussed above
regarding perimeter fence issues, there is nothing in the regulations
that would reduce a herd's program status based on the lack of a 30-
foot (10-foot, under this final rule) physical separation from animals
in the wild. Although APHIS encourages double perimeter fencing, the
requirement in the regulations is for single-fencing. In individual
cases a herd plan developed to eradicate CWD from a CWD-positive herd,
to control the risk of CWD in a suspect herd, or to prevent
introduction of CWD into another herd, may specify double perimeter
fencing for a particular herd, for example, when there is known CWD
infection in adjacent captive or wildlife populations.
Definitions of CWD-Exposed Animal and CWD-Exposed Herd
One commenter pointed out that the defined terms for exposed
animals and herds omitted cases where the exposure was not to a CWD-
positive animal, but to a CWD-exposed animal (which may later prove to
be CWD-positive). The commenter suggested creating and defining a term
to cover such ``exposed to exposed'' contacts for epidemiology
purposes.
We agree with the commenter that awareness of ``exposed-to-
exposed'' contacts can help epidemiologic investigations and long-term
tracking of patterns of CWD transmission. However, exposed animals and
herds are already subject to restrictions under the regulations, and we
do not believe that the regulations should impose any additional
restrictions on ``exposed-to-exposed'' animals. We do plan to emphasize
the importance of investigating ``exposed-to-exposed'' contacts in our
nonregulatory guidance to APHIS and State veterinarians conducting
epidemiologic investigations.
Definitions of CWD-Positive Animal and CWD-Positive Herd
Several commenters questioned the definition of a CWD-positive
animal as one that ``has had a diagnosis of CWD confirmed by means of
an official CWD test.'' These commenters stated that at least two
positive results from certified laboratories are needed to reliably
identify a positive animal. The commenters said two tests should be
required because they believe that errors in samples collected for CWD
programs
[[Page 41685]]
have been found (e.g., mislabeling or collection of the wrong tissues)
and that current CWD tests require evaluation of results in a manner
that is subjective and may be subject to error. Some commenters stated
that, after an animal tests positive, 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. One commenter added
that a positive result on a CWD test is a major crisis to any deer
farmer, and the expense of a second test and DNA verification is a
small price to pay to ensure that the process has been free of human or
other error.
We agree with the comments suggesting that a determination that an
animal is CWD-positive should not be based on a single positive test
result. We are amending the definition of CWD-positive animal to read:
``An animal that has had a diagnosis of CWD confirmed by means of two
official CWD tests.'' We expect that, in most cases, the first test
would be conducted by a State, Federal, or university laboratory
approved to conduct CWD official tests in accordance with Sec. 55.8,
and the second, confirmatory test would be conducted at the National
Veterinary Services Laboratories (NVSL). In some cases, both the
initial and confirmatory test may be conducted at NVSL.
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.
Definition of CWD-Suspect Animal and CWD-Suspect Herd
Several commenters suggested that it was not clear whether the
phrase ``laboratory evidence or clinical signs suggest a diagnosis of
CWD'' in the definitions of CWD-suspect animal and CWD-suspect herd
meant that an animal or herd could be found to be CWD-suspect based on
the results of unofficial CWD tests.
We planned to include unofficial CWD test results as an indicator
in this definition. To clarify this, we are changing the relevant
phrase in both definitions to read ``unofficial CWD test results,
laboratory evidence, or clinical signs suggest a diagnosis of CWD.''
One commenter pointed out that the definition of CWD-suspect herd
in Sec. 55.1 said the determination could be made by ``an APHIS
employee or State representative,'' but the definition of CWD-suspect
animal in Sec. 81.1 mentions only ``an APHIS employee.'' This was an
inadvertent omission, and we have added ``or State representative'' to
the definition of CWD-suspect animal.
Definitions of Deer, Elk, and Moose
Some commenters noted that the proposed definitions of deer and elk
were imprecise or incomplete, and there was some confusion about when
hybrid animals would be considered deer and when they would be
considered elk. Several commenters asked why certain species were not
included in either definition when there is no conclusive scientific
evidence that the species are not susceptible to CWD. Commenters asked
in particular about sika deer (Cervus nippon), sambar (Cervus
unicolor), rusa deer (Cervus timorensis), barasingha (Cervus
duvauceli), and Pere David's deer (Elaphurus davidiensis). Several
commenters suggested that the definitions be expanded to include more
deer and elk or other cervids.
We agree, and are replacing the term ``deer and elk'' with ``deer,
elk, and moose'' and are defining the term to mean ``all animals in the
genera Odocoileus, Cervus, and Alces and their hybrids.'' This change
expands coverage to all species of concern. This final definition was
developed by identifying the species known to be susceptible to natural
spread of CWD and then expanding coverage to the complete genera that
include these species, under the assumption that related animals in a
genus may share similar susceptibility to CWD even when all species in
the genus have not been shown to be susceptible. We have expanded
coverage to include moose (genus Alces) because CWD was recently
diagnosed in a moose for the first time. We have not expanded coverage
to genera in which no species has demonstrated susceptibility via
natural routes of transmission. To do so would extend the requirements
of this rule without a sound basis, unnecessarily increasing the burden
on regulated parties, especially zoos with large and varied animal
collections. We are prepared to extend the definition in the future if
new research demonstrates additional species in other genera are
susceptible to CWD by natural routes of transmission. This change
should make it clear that the same program requirements apply to deer,
elk, moose, and any hybrids of these animals.
Definition of Herd Plan
Several commenters addressed the part of the herd plan definition
that said a herd plan, among other things, will specify ``the time for
which a premises must not contain cervids after CWD-positive, -exposed,
or -suspect animals are removed from the premises.'' These commenters
stated that there should be a permanent ban on raising cervids on any
property that once contained CWD-positive animals, due to risks of
environmental transmission of CWD.
We do not agree with these comments. The definition's language will
allow a herd plan to prohibit cervids from a premises for an
appropriate period based on the specific risks and conditions of the
individual herd. Ongoing and future research may help resolve many
questions about environmental transmission of CWD and establish
reasonable standards for when it is safe to repopulate a previously
contaminated premises. Establishing permanent restrictions on
repopulating premises with cervids would be unnecessarily broad and
harsh when, in most cases, tailored herd plans can be used to minimize
both the risk of CWD transmission and the financial burden on owners of
premises. The length of a ban on restocking may be stated as an actual
time period in months or years, or it may be condition-dependent, e.g.,
a herd plan might prohibit restocking based on the presence or levels
of CWD in surrounding herds or wildlife.
Some commenters suggested that the definition of a herd plan in
part 55 should state that it must be approved and signed by all three
involved parties--APHIS, the State, and the herd owner. As proposed, it
seemed that the document was executed between APHIS and the State but
affected the herd owner.
As described in the proposal, the herd plan will be developed with
extensive input from the herd owner, because it will include procedures
developed to address the particular risks and situation of a herd. We
agree that, although the APHIS Administrator has the ultimate authority
to determine that a herd plan is adequate, all three involved parties
should approve and sign the herd plan. Therefore we have changed the
language in the definition to state that a herd plan will become
effective after ``it has been reviewed and signed by the Administrator,
the State representative, and the herd owner.''
One commenter stated that the herd plan definition's requirement
for ``regular examination of animals in the herd by a veterinarian for
clinical signs
[[Page 41686]]
of disease'' was vague, and could mean veterinarians must examine
animals once a year, every month, or any other frequency.
We intend to establish the frequency of veterinary examination for
each herd in the body of the herd plan developed specifically for the
herd. We did not specify a frequency in the rule because it will be set
based on the particular circumstances and risk conditions associated
with each herd.
A zoological association commented that the herd plan definition
could impose a tremendous burden on zoos with its requirement for
``reporting to a State or APHIS representative of any clinical signs of
a central nervous system disease or chronic wasting condition in the
herd.'' The association interpreted this to mean that zoo veterinarians
would have to report every cervid that exhibits chronic weight loss or
an unsteady gait, both of which are common in older animals.
We believe this commenter did not take into account that this
requirement applies only to herds that are under a herd plan, and that
most zoos will not be subject to herd plans. A zoo, like any herd,
would become subject to a herd plan only after it is found to be CWD-
positive, CWD-exposed, or CWD-suspect. This should happen to zoos only
rarely, but when it does, it is important that all clinical signs that
may indicate CWD be reported and investigated.
Consistency Between CWD Regulations and Other TSE Regulations
Several commenters stated that the regulations for CWD, BSE, and
scrapie should have similar structures, accepted risk levels, and
effects. They stated that TSE causal agents for each disease and their
effects on ruminants are sufficiently similar to demand virtually
complete compatibility between regulations. They said that the
continuing risk of cross contamination between species also requires
regulatory consistency. Another reason they provided for consistency
between CWD, BSE, and scrapie regulations is that, without it, cervid
producers may be subject to discriminatory, anti-farming regulatory
pressures. Some commenters suggested that farmed or captive deer, and
elk generally should be treated the same as other domestic livestock.
Some commenters questioned why owners of farmed or captive cervids are
expected to test 100 percent of on-farm mortalities, while owners of
cattle (potentially affected by BSE) test very few on-farm mortalities
and a fraction of downer animals sent to slaughter, and owners of sheep
(potentially affected by scrapie) usually test only animals exhibiting
clinical signs of scrapie.
In responding to these comments, we emphasize that the TSE diseases
that affect different species of domestic livestock are not all the
same disease. They have different modes of transmission and different
pathogenicity, and taking these facts into account means that we cannot
have the same approaches for all of our TSE programs and still attain
our goals. At this point in time, the BSE program is a surveillance and
prevention program, not a disease control program like the CWD
certification program, and, as such, requires completely different
standards and testing levels. The scrapie program, like the CWD
program, is a certification program for an endemic disease. Where
possible, we have tried to make the CWD program consistent with the
scrapie certification program. However, several factors make it
necessary that participants in the CWD program, unlike the scrapie
program, must make all herd mortalities (over 12 months of age) and all
animals sent to slaughter available for sample collection and testing.
The most obvious reason for this difference is that two powerful
surveillance tools are available to the scrapie program that are not
available to the CWD program, a live animal test for scrapie and
scrapie susceptibility genotyping.
The 5-Year Standard
Many commenters addressed the provisions of the rule that use a 5-
year standard regarding risks of CWD. Some commenters questioned the
part of these definitions that would classify an animal or herd as
exposed based on contact with a CWD-positive animal anytime within the
preceding 5 years. These commenters stated that including exposure that
occurred 5 years before is not based on known risk or scientific fact,
and suggested that a 3-year limit would be sufficient.
The 5-year standard is used in the definitions of commingled, CWD-
exposed animal, and CWD-exposed herd, and the progress of a herd to
``Certified'' status also requires 5 years of monitoring without
evidence of CWD. All of these uses assume that a cervid that contracts
CWD will develop signs of the disease--in fact will almost certainly
die from the disease--in less than 5 years. Based on that assumption,
the rule requires investigation of an animal or herd's exposure to
incidents within the past 5 years and, if a herd is continually
monitored for CWD for 5 years without positive test results, the CWD
risk in the herds is considered low.
All commenters agreed that the incubation period for CWD is less
than 5 years. The key question for many commenters is, how much less?
The expense of participating in the CWD program increases incrementally
with the length of time required to reach ``Certified'' status. Also,
with regard to exposure to CWD, many more animals and herds must be
considered exposed if we consider exposure that happened 5 years ago
than if we consider only exposures that happened in the past 2 or 3
years.
Many commenters suggested that a 3-year standard for exposure and
for reaching ``Certified'' status is adequate and is justified by
scientific research on the CWD incubation period. A few commenters also
suggested either shorter or longer periods than 3 years for this
standard. In addition to citing scientific research that supported an
incubation period of from 24 to 34 months, some commenters also
referred to State animal health agency records as supporting a 3-year
standard. They stated that records of trace-back and trace-forward
investigations of animals associated with CWD-positive herds did not
show any cases where a CWD-positive animal acquired the disease more
than 30 months prior to diagnosis. Some commenters stated that using a
5-year standard is arbitrary and simply incorporates a 2-year safety
margin. Some commenters stated that certain existing State CWD programs
allow animals to move into their States after only 3 years of
monitoring for CWD.
We are not changing the 5-year standard in response to these
comments. The choice of 5 years was made based on several factors,
including the probable maximum incubation time for CWD and program
design decisions about time spans realistically needed for all the
participants in a herd certification program (Federal and State animal
health personnel, cervid producers, laboratories, and others) to
perform all the duties required of them.
The goal of the CWD certification program is to rapidly eliminate a
disease that is not currently widespread in the farmed cervid
industries. It will take much longer to achieve this goal if the
program standards are set too low at the outset and must be made more
stringent later; if, for example, we applied a 3-year standard at the
outset only to find that it allowed CWD-positive animals to further
spread CWD without being detected. Until there is definitive data to
allow for less stringent measures, we must use a conservative approach
based on current knowledge.
We agree that many studies suggest an average incubation period for
CWD of
[[Page 41687]]
no more than 36 months. For example, a study \1\ in captive elk at the
Colorado Division of Wildlife, Foothills Wildlife Research facility,
found that the average incubation period for elk in its herd that were
naturally exposed to CWD in a contaminated environment was 26 months
(range 18-36 months). However, in this same group of elk and 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. This could have
been the result of a later environmental exposure or it could represent
a 5-year incubation period.\2\ Preliminary reports from an ongoing
APHIS and Agricultural Research Service research project in Ames, IA
have also identified animals that did not show signs of disease until
at least 4 years after infection, and animals that do not show signs of
disease 4 years after infection but that test positive for CWD through
unofficial tests such as rectal biopsy and the third eyelid test.
---------------------------------------------------------------------------
\1\ Miller et al., 1998 Epidemiology of Chronic Wasting Disease
in Captive Rocky Mountain Elk, Journal of Wildlife Diseases, 34:532-
538.
\2\ Miller, personal communication.
---------------------------------------------------------------------------
In pathogenesis studies \3\ in mule deer and elk at the University
of Wyoming, high dose oral inoculation produced an average incubation
(from exposure to onset of clinical disease) of 23 months (range 15
months to >25 months) in mule deer. Similar work in elk showed the
range of incubation was 12-34 months. The researchers acknowledged that
experimental infections (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. In other
words, experimental infections most likely represent the range of
minimum incubation times. Maximum incubation times are not known but
most likely exceed 25 months for mule deer and 34 months for elk.
---------------------------------------------------------------------------
\3\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.
---------------------------------------------------------------------------
For these reasons, we believe that incubation periods for low dose
natural exposures may be longer than incubation periods for high dose
oral inoculations used in most research. Based on the information we
have now, the longest incubations likely fall between 3 and 5 years.
This supports establishing the program with a 5-year timeframe for
tracing animals and certifying herds to ensure the program locates CWD-
positive animals.
We anticipate that research, monitoring, and surveillance will
reveal more precise data about CWD transmission over the next few
years. If new data support changing the 5-year standard, APHIS will
initiate rulemaking to modify it.
Animal Identification
Many commenters addressed the proposed animal identification
requirements. Some requested more flexibility in the type of approved
identification so that producers could make better economic decisions
about what type of identification worked best for their herds. We
agree, and have added the phrase ``or other device approved by APHIS''
to the lists of approved identification devices (electronic implant,
flank tattoo, ear tattoo, or tamper-resistant ear tag) in Sec. 55.25,
Animal identification and Sec. 81.2, Identification of deer, elk, and
moose in interstate commerce. We will approve alternative
identification on a case-by-case basis as the program is implemented.
The criteria for approving identification devices will be whether they
provide permanent, secure identification, are cost effective, and are
practical for those who must apply and read the devices.
Many cervid producers commented that the proposal to require two
forms of official identification would be very burdensome, due to the
expense and difficulty of assembling and restraining an entire herd to
apply the devices. This involves high labor costs, risks of harming the
animals, and, if tranquilizer darts are used, dart drug costs of $30 to
$35 per animal. Some commenters suggested that APHIS could mitigate
this burden by phasing in the two identification requirements over the
first 2 or 3 years of program participation. Some commenters also
suggested that a second form of official identification should only be
required when animals are moved from an owner's premises, not for every
animal in the herd.
We are making several changes to the animal identification
requirements, discussed below, in response to these comments. We also
intend to work with producers when they enroll in the program to allow
them to apply the required animal identification at a time and in a
manner that minimizes the burden on the producer, who is responsible
for ensuring that animals are identified when required and for the
costs associated with identifying the animals.
When applying identification devices, producers may be able to
schedule identification activities at a time when they already need to
restrain animals, such as the annual physical inventory, or may be able
to apply identification to a few animals at a time over extended
periods, or may find other ways to economize on the process. More
information is being developed on flexible alternatives for
accomplishing program requirements, including application of animal
identification devices required by the program, and this information
will be made available to the public when it is ready.
We are not eliminating the requirement for a second form of animal
identification because accurate identification is a critical element of
the program, and loss or obliteration of identification devices is
quite common with cervids. A producer who can't logistically meet the
identification and inventory standards will be unable to participate in
the CWD Herd Certification Program. Participation must be contingent on
ability to meet the requirements, or the program will lose
effectiveness and industry confidence. Producers who want their herds
to achieve ``Certified'' status may need to alter their management
practices in order to meet program requirements.
However, we are changing the identification requirement so that
only one of the two required identification devices attached to the
animal must have a nationally unique animal identification number that
is linked to that animal in the CWD National Database, where
information on the animal's current herd may be cross-referenced. The
other animal identification device need only be unique within the
animal's herd; that is, it does not need a nationally unique number,
but may instead merely identify the herd and distinguish different
animals in the herd. Since the second means of animal identification is
only required to be unique for the individual animal within its herd,
this should allow continued use of most existing forms of animal
identification as the required second means of identification.
To accomplish this change, we are separating the proposed defined
term official identification into two new defined terms, animal
identification and official animal identification. We are also
retitling Sec. 55.25, Official identification, as Animal
identification, and are changing it as described below.
We define animal identification as a device or means of animal
identification approved by APHIS for use under 7 CFR part 55. The
definition also notes that examples of animal identification devices
that APHIS has approved are listed in Sec. 55.25.
We define official animal identification to mean devices or means
of animal identification approved by
[[Page 41688]]
APHIS to uniquely identify individual animals, with examples provided
in Sec. 55.25. The definition states that official animal
identification must include a nationally unique animal identification
number that adheres to either the National Uniform Eartagging System,
the AIN (Animal identification number) system, a premises-based
numbering system that uses an official premises identification number
(PIN), or another numbering system approved by the Administrator for
the identification of animals in commerce.
Revised Sec. 55.25, Animal identification, now says that each
animal required to be identified must have at least two forms of animal
identification attached to the animal, that the means of animal
identification must be an electronic implant, flank tattoo, ear tattoo,
tamper-resistant ear tag, or other device approved by APHIS. The
revised section states that one of the animal identifications must be
official animal identification as defined, with a nationally unique
animal identification number that is linked to that animal in the CWD
National Database. The second animal identification must be unique for
the individual animal within the herd and also must be linked to that
animal and herd in the CWD National Database.
The nationally unique identification number and all the animal's
identification data from the second form of identification will be
entered into the CWD National Database. This will allow an authorized
user of the CWD National Database to use either identification number
to retrieve all information on the animal and its herd and premises.
The nationally unique identification number approach is consistent
with the national animal identification system (NAIS) that APHIS is in
the process of developing and implementing in cooperation with States
and animal industries. The NAIS is intended to be an effective,
uniform, consistent, and efficient national animal identification
system. An overview of the NAIS is available at https://
animalid.aphis.usda.gov/nais/index.shtml.
To make our CWD regulations consistent with the NAIS approach that
is under development, we are also adding a definition recently added to
other APHIS domestic livestock regulations. On November 8, 2004, we
published in the Federal Register an interim rule concerning livestock
identification and the use of numbering systems for identification
devices (69 FR 64644-64651; Docket No. 04-052-1). The interim rule
amended the APHIS regulations that address interstate movement of
livestock (9 CFR parts 71, 77, 78, 79, 80, and 85). One purpose of the
interim rule was to authorize use of an alternative numbering system
for individual animal identification that assigns a unique number to
each animal identified under the system, to encourage consistency with
the NAIS. The interim rule included definitions of animal
identification number (AIN) and premises identification number (PIN),
which we are adding to the CWD regulations in 9 CFR parts 55 and 81.
The definition of animal identification number (AIN) reads: ``A
numbering system for the official identification of individual animals
in the United States. The AIN contains 15 digits, with the first 3
being the country code (840 for the United States), the alpha
characters USA, or the numeric code assigned to the manufacturer of the
identification device by the International Committee on Animal
Recording.'' The definition of premises identification number reads:
``Premises identification number (PIN). A unique number assigned by a
State or Federal animal health authority to a premises that is, in the
judgment of the State or Federal animal health authority, a
geographically distinct location from other livestock production units.
The premises identification number is associated with an address or
legal land description and may be used in conjunction with a producer's
own livestock production numbering system to provide a unique
identification number for an animal. The premises identification number
may consist of: (1) The State's two-letter postal abbreviation followed
by the premises' assigned number; or (2) 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.''
This definition of AIN is added to clarify the sentence in the new
definition of official animal identification that reads: ``The official
animal identification for an animal must include a nationally unique
animal identification number, such as an AIN number.'' While the rule
does not require use of an AIN--other nationally unique identification
numbers can meet the requirement--we wanted to make it clear, in
preparation for implementation of the NAIS, that NAIS-compliant
individual animal identification will also meet the requirements of
this CWD rule.
Some commenters suggested that the regulations should specifically
``grandfather in'' as animal identification any form of identification
that is currently accepted by a State CWD program.
We are not giving blanket approval to all forms of identification
currently used by a State CWD program because we may not be aware of
the characteristics of all such devices in use, and a few may not be
adequate for program purposes. We do expect to approve most, if not
all, identification devices in use by State CWD programs, under the
provision we are adding (discussed above) to allow identification by
``any other device approved by APHIS.''
Some commenters suggested that cervids captured from a free-ranging
population for interstate movement and release should also be required
to have two forms of animal identification because such animals are not
regularly observed and hence are more likely to lose one form of
identification between extended observation periods.
We agree, and we are changing the requirements for animal
identification to require that free-ranging animals captured for
interstate movement and release, like other farmed or captive cervids,
must have two forms of animal identification, one of which must be
official animal identification. We are making this change by removing
the phrase ``except for free-ranging animals captured for interstate
movement and release in accordance with Sec. 81.3(b), which must have
at least one form of identification'' from Sec. 81.2, Identification
of deer, elk, and moose in interstate commerce, and revising the phrase
``has at least one form of official identification'' in Sec. 81.3(b)
to read, ``has two forms of animal identification, one of which is
official animal identification.''
Several commenters asked whether there was a specific age before
which animals in participating herds must be officially identified.
The proposed rule did not establish a specific age by which animals
must be identified. We did not do so because local herd conditions will
affect both when identification is needed, and when it is practical to
apply it. However, the commenters are correct that the rule should be
more specific about when identification must be applied, both to help
herd owners comply with the requirement and to ensure that the animals
are officially identified before certain events that present risks of
spreading CWD can take place, such as interstate or intrastate movement
of the animal from the premises, which may result in exposure to other
animals.
Therefore, we are adding the following sentences to paragraph
(b)(1) of Sec. 55.23, Responsibilities of herd owners: ``All animals
in an enrolled herd must be identified before reaching
[[Page 41689]]
12 months of age. In addition, all animals of any age in an enrolled
herd must be identified before being moved from the herd premises. In
addition, all animals in an enrolled herd must be identified before the
inventory required under paragraph (b)(4) of this section, and animals
found to be in violation of this requirement during the inventory must
be identified during or after the inventory on a schedule specified by
the APHIS employee or State representative conducting the inventory.''
We are using 12 months as the age by which animals must be identified
because that age has been suggested before by industry members as a
reasonable standard, and because the seasonal nature of livestock
management means that herd management events where applying
identification is feasible are likely to repeat on a 12-month cycle.
We expect that many herd owners will use the annual inventory
process as an opportunity to apply animal identification to animals
born into the herd in the prevous year. The Uniform Methods and Rules
for the Chronic Wasting Disease Herd Certification Program (UM&R)
describes other situations where owners may wish to apply
identification at other times.
APHIS Authority To Regulate Wild Cervid Capture and Release
Several commenters stated that APHIS is overstepping its authority
by regulating interstate movement of cervids captured and released from
a free-ranging population. The commenters believe that any regulation
of such movement should be under the authority of the respective State
wildlife agencies. The commenters did not oppose requiring animal
identification and documentation that such animals are free from CWD
for such movements, but they did oppose including such requirements in
APHIS regulations.
APHIS works cooperatively on CWD issues with many State wildlife
agencies and will continue to do so. We rely on these agencies to apply
and administer their State authorities over wildlife in support of
mutual State-Federal goals for CWD control. We will work cooperatively
with these agencies to achieve safe, low-risk movement of cervids
captured and released from a free-ranging population. APHIS shares with
State wildlife agencies the goal of avoiding the establishment of CWD
in wildlife in new areas.
APHIS does not agree that we are exceeding our authority in
applying regulatory requirements in an APHIS rule to the capture and
release of cervids from a free-ranging population. The Animal Health
Protection Act of 2002 (``the Act'') grants the Secretary of
Agriculture (and by delegation of authority, the Administrator of
APHIS) ample authority to do so. Under the Act, the Secretary may
prohibit or restrict the movement in interstate commerce of any animal
if the Secretary determines that it is necessary to prevent the
introduction or dissemination of any pest or disease of livestock.
Under the Act's definitions, it is clear that this authority
extends to regulating the interstate movement of cervids captured from
one free-ranging population for release in another such population. The
Act broadly defines animal as ``any member of the animal kingdom
(except a human),'' which includes wild cervids. The Act broadly
defines interstate commerce to include ``trade, traffic, or other
commerce'' between or through U.S. States, territories, and
possessions. The act of capturing animals, moving them interstate, and
releasing them falls within this scope. The Act's definition of move
specifically covers, among other things, the act of transporting, and
the act of releasing into the environment; both apply to the
translocation of captured cervids. It is not uncommon for multiple
governmental agencies to have authority over the same things or
transactions for similar or different purposes. One agency having
authority to regulate a thing or transaction for one purpose does not
preclude another agency from having authority over the same thing for a
similar or different purpose. This is especially true when dealing at
different levels of government, but is also true when dealing within
the Federal government or within a State's or other jurisdiction's
regulatory scheme. Nothing precludes such multiple authorities over the
same thing or transaction, if each agency exercising authority with
regard to the thing or transaction in question has the requisite
jurisdiction to do so. The Secretary (and by delegation of authority,
the Administrator of APHIS) has clearly been granted that authority
under the Animal Health Protection Act.
Applicability To Hunting Operations
Several commenters suggested that hunting ranches should be
regulated in an alternate manner that recognizes the constraints that
exist for these farms. According to the commenters, most hunting
operations are very large premises that do not normally restrain their
animals' movements within the premises, making identification and
inventory very difficult. Commenters said that detection of incidental
mortalities throughout the year in order to make tissues available for
testing would be difficult and that dead animals in such facilities
might not be located quickly enough to obtain samples suitable for
testing. Commenters said that hunting operations are also seasonal,
meaning that the requirement that all animals that die on the premises
must be made available for testing would mean a flood of sampling for 4
to 5 months each year when hunters kill animals on the premises. They
said that the volume of work during this period could adversely affect
the quality of tissue collection, recordkeeping, and laboratory
analysis. These commenters suggested that instead of the CWD
Certification program as proposed, hunting operations could participate
in a surveillance and monitoring program that was harvest-based,
without strict animal identification and inventory requirements but
including testing a statistical sample of each year's harvest for 3 to
5 years.
APHIS is willing to work with hunting premises owners and States to
consider and evaluate suggested alternative approaches for hunting
premises to meet program requirements. However, none of the approaches
suggested in comments would be adequate to detect the presence of CWD
with sufficient confidence to allow certification of the herd or to
control the spread of CWD in hunting premises effectively. We believe
that identification of all animals, an annual herd inventory, and
extensive testing are the keystones of an effective CWD program, and
these are the requirements that hunting premises owners asked us to
reduce or eliminate. Alternative surveillance programs that sample a
percentage of animals in hunting herds and that do not include
identifying and inventorying all animals might ameliorate some concern
about the presence of CWD, but we do not believe such an approach could
provide the same degree of confidence that the CWD certification
program requirements provide. If hunting premises owners want their
herds to be certified, they must meet the requirements for the
certification program.
Eligibility of Cervid Owners To Participate in the Program and
Enrollment Dates
Some commenters suggested that CWD Certification Program
participation should be limited to herd owners with no prior violations
of State laws and regulations for livestock and animal care.
We agree with the spirit of this comment but believe that banning
producers with ``any violation'' would
[[Page 41690]]
be too severe and could unnecessarily reduce participation in the
program and program effectiveness. While sometimes APHIS officials may
have information about relevant violations by applicants, we believe
the enforcement and recordkeeping activities of State governments
usually make them the best level to address questions about when
particular producers have committed violations that indicate they are
unlikely to comply with CWD Certification Program requirements fully
and honestly. State veterinarians and other officials can address this
question when deciding whether to admit a herd to their Approved State
CWD Herd Certification Program or, in cases where there is no approved
State program, the State veterinarians can still advise APHIS officials
about violations by applicants applying to enter the Federal program
directly. If an applicant has committed relevant violations, this may
be cause to refuse consideration of the application if the violations
are known at the time of application, or to deny the application if the
violations are discovered later during evaluation of the application.
To make this clear, we are adding the following sentence to Sec.
55.22, Participation and enrollment: ``An application for participation
may be denied if APHIS or the State determines that the applicant has
previously violated State or Federal laws or regulations for livestock,
and that the nature of the violation indicates that the applicant may
not faithfully comply with the requirements of the CWD Herd
Certification Program.''
Several commenters addressed procedures for ``grandfathering''
herds already in State CWD programs into the APHIS CWD Certification
Program. Some believe that herds that have complied with a State
program should be grandfathered in with the status they have achieved,
even if their State program has not been designated as an Approved
State CWD Herd Certification Program under APHIS regulations.
Commenters stated that producers should not be penalized simply because
their State, for whatever reason, did not, does not, or will not
cooperate to get Federal recognition for the State program. Commenters
also addressed the problem of ``grandfathered'' credit for herd owners
who wish to enroll directly in the Federal CWD program because there is
no State program available to them. Such owners may have maintained
their herds for some time, in some type of voluntary individual or
other non-State program, under conditions equivalent to the Federal
program standards (animal identification, monitoring, testing of
suspect animals, restrictions on animals added to the herd, etc.), and
should receive some sort of credit for this.
We generally agree that herd owners should be given appropriate
credit for time their herds were maintained under restrictions
equivalent to those in the Federal CWD program, whether that time was
spent enrolled in a State program that later becomes an Approved State
CWD Herd Certification Program, in a State program that does not choose
to apply to be approved, or in some other program that nevertheless
applied the same sort of herd maintenance conditions. Whenever we
evaluate an existing State CWD program that has applied for approval
and participation in the National CWD Program, we will carefully
compare the requirements of the program as followed by that State to
determine that the State, and thus herds in good standing in the
State's program, have met the minimum standards of our program. For
herds in States that have not applied to become Approved State CWD Herd
Certification Prog