[Federal Register Volume 71, Number 140 (Friday, July 21, 2006)]
[Rules and Regulations]
[Pages 41682-41707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6367]



[[Page 41681]]

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Part V





Department of Agriculture





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Animal and Plant Health Inspection Service



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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

  Federal Register / Vol. 71, No. 140 / Friday, July 21, 2006 / Rules 
and Regulations  

[[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

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entire herd for inspection under conditions where the APHIS employee or 
State representative can safely read all identification on the animals. 
The owner will be responsible for assembling, handling and restraining 
the animals and for all costs and liabilities incurred to present the 
animals for inspection.
     Add a requirement that cervids held for research purposes 
may only be moved interstate under a USDA permit. In the proposal, such 
animals were completely exempt from the requirements of the rule.
     Make minor changes to improve clarity in other sections of 
the rule.

Comments on Definitions in the Proposed Rule

Approved State CWD Herd Certification Program

    One commenter noted that although the term Approved State CWD Herd 
Certification Program appears in the regulations its meaning is not 
defined and must be derived from context. In response we have added a 
definition of this term that reads ``A program operated by a State 
government for certification of cervid herds with respect to CWD that 
the Administrator has determined to meet the requirements of 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

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of disease'' was vague, and could mean veterinarians must examine 
animals once a year, every month, or any other frequency.
    We intend to establish the frequency of veterinary examination for 
each herd in the body of the herd plan developed specifically for the 
herd. We did not specify a frequency in the rule because it will be set 
based on the particular circumstances and risk conditions associated 
with each herd.
    A zoological association commented that the herd plan definition 
could impose a tremendous burden on zoos with its requirement for 
``reporting to a State or APHIS representative of any clinical signs of 
a central nervous system disease or chronic wasting condition in the 
herd.'' The association interpreted this to mean that zoo veterinarians 
would have to report every cervid that exhibits chronic weight loss or 
an unsteady gait, both of which are common in older animals.
    We believe this commenter did not take into account that this 
requirement applies only to herds that are under a herd plan, and that 
most zoos will not be subject to herd plans. A zoo, like any herd, 
would become subject to a herd plan only after it is found to be 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.
---------------------------------------------------------------------------

    \4\ Elk Production; Economic and Production Information for 
Saskatchewan Producers, Saskatchewan Agriculture and Food, November 
2000.
---------------------------------------------------------------------------

    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

[[Page 41706]]

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;

[[Page 41707]]

    (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