[Federal Register: July 21, 2006 (Volume 71, Number 140)]
[Rules and Regulations]
[Page 41681-41707]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy06-7]
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Part V
Department of Agriculture
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Animal and Plant Health Inspection Service
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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
[[Page 41682]]
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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.
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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 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
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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
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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 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 http://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 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 Sec. 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-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 Sec. 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
[[Page 41691]]
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 Sec. 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 Sec. 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 Sec. 55.22, Participation
and enrollment. The proposed first sentence of this paragraph read
``Any owner of a captive deer or elk herd (except for CWD-positive
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 CWD-positive 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
Sec. 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 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 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 Sec. 81.3 for animals moved interstate for slaughter.
Herd Owner Responsibilities
Numerous commenters addressed the description of the
responsibilities of enrolled herd owners in Sec. 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.
[[Page 41692]]
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 12-month 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 Sec. 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 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 Sec.
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 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 Sec. 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, Sec. 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 Sec.
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
[[Page 41693]]
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 Sec. 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 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 Sec.
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 Sec.
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 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 Sec. 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
[[Page 41694]]
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 Sec. 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 Sec.
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 collect samples for testing, as
appropriate, from these higher-risk animals. Therefore, we are adding a
new paragraph Sec. 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 Sec. 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 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 Sec. 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 Sec. 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
[[Page 41695]]
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.''
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 Sec. 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 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 Sec. 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 Sec. 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 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 Sec. 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 Sec. 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 Sec. 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
[[Page 41696]]
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.
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 Sec. 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
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 http://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 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 CWD-positive herds who voluntarily
depopulate their herds.
The final rule will primarily affect deer and elk farms and other
cervid
[[Page 41697]]
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 out-of-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 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 x $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 x $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.
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
far-reaching 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
[[Page 41698]]
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.
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\4\ Elk Production; Economic and Production Information for
Saskatchewan Producers, Saskatchewan Agriculture and Food, November
2000.
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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 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 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 lesser-quality 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
[[Page 41699]]
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 State-imposed 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 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.
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.
[[Page 41700]]
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 better-paying
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 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 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
[[Page 41701]]
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.
9 CFR Part 81
Animal diseases, Cervids, Deer, Elk, Moose, Quarantine, Reporting
and recordkeeping requirements, Transportation.
0
Accordingly, we are amending 9 CFR chapter I as follows:
PART 55--CONTROL OF CHRONIC WASTING DISEASE
0
1. The authority citation for part 55 is revised to read as follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
0
2. Section 55.1 is amended as follows:
0
a. By removing the definition of captive.
0
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''.
0
c. By revising the definitions of animal, CWD-exposed animal, CWD-
positive animal, CWD-suspect animal, and herd plan to read as set forth
below.
0
d. By adding definitions for animal identification, animal
identification number (AIN), Approved State CWD Herd Certification
Program, commingled, commingling, CWD-exposed herd, CWD Herd
Certification Program, CWD-source herd, CWD-suspect 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.
Sec. 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 Sec.
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
Sec. 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 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
[[Page 41702]]
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 Sec. 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 APHIS to uniquely
identify individual animals. Examples of approved official animal
identification devices are listed in Sec. 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
CWD-positive 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.
* * * * *
0
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.
55.24 Herd status.
55.25 Animal identification.
Subpart B--Chronic Wasting Disease Herd Certification Program
Sec. 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.
Sec. 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 CWD-exposed herd, immediately after
enrollment it must begin complying with a herd plan developed in
accordance with Sec. 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
[[Page 41703]]
qualifies as an Approved State CWD Herd Certification Program in
accordance with Sec. 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 Sec.
55.23(b) for herd owners, the first day that the herd participated in
such a program. However, in such cases the enrollment date may not be
set at a date more than 2 years prior to the date that APHIS approved
enrollment of the herd. 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 Sec. 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)
Sec. 55.23 Responsibilities of States and enrolled herd owners.
(a) Approval of State programs and responsibilities of States. In
reviewing a 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 CWD-positive, CWD-suspect, and
CWD-exposed 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 CWD-positive, CWD-exposed, and CWD-suspect
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, CWD-
exposed, and CWD-suspect herds that includes the designation of suspect
and exposed animals and that identifies animals to be traced;
(v) Conduct tracebacks of CWD-positive animals and traceouts of
CWD-exposed animals and report any out-of-State 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 CWD-positive animal at
slaughter.
(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 Sec. 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
[[Page 41704]]
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 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)
Sec. 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 CWD-positive 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 CWD-suspect 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 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 CWD-exposed 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
[[Page 41705]]
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.
---------------------------------------------------------------------------
\2\ Note that in addition to this requirement, Sec. 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.
(Approved by the Office of Management and Budget under control
number 0579-0237.)
Sec. 55.25 Animal identification.
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 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)
0
4. A new part 81 is added to read as follows:
PART 81--CHRONIC WASTING DISEASE IN DEER, ELK, AND MOOSE
Sec.
81.1 Definitions.
81.2 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.
Sec. 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 Sec.
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.
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 Sec. 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 Sec. 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.
Sec. 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)
Sec. 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 Sec. 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 Sec. 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 Sec. 55.24 of this chapter;
(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 Sec. 55.24 of this chapter;
(v) If the movement occurs after January 19, 2012, the herd has
achieved Certified status in accordance with Sec. 55.24 of this
chapter; and
(2) The farmed or captive deer, elk, or moose is accompanied by a
certificate issued in accordance with Sec. 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 Sec. 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;
(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.
Sec. 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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(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 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.
(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