[Federal Register: December 24, 2003 (Volume 68, Number 247)]
[Proposed Rules]
[Page 74513-74529]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24de03-26]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 55 and 81
[Docket No. 00-108-2]
RIN 0579-AB35
Chronic Wasting Disease Herd Certification Program and Interstate
Movement of Captive Deer and Elk
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to establish a herd certification program to
eliminate chronic wasting disease from captive cervids in the United
States. Participating deer and elk herds would 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 would be granted
``certified'' status. Owners of herds could enroll in a State program
that we have determined has requirements equivalent to the Federal
program, or could enroll directly in the Federal program if no State
program exists. We are also proposing to establish interstate movement
requirements to prevent the interstate movement of deer and elk that
pose a risk of spreading CWD. These actions are intended to eliminate
CWD from the captive deer and elk herds in the United States.
DATES: We will consider all comments that we receive on or before
February 23, 2004.
ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comment (an original and three copies) to: Docket
No. 00-108-2, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. 00-108-2. If you use e-mail,
address your comment to regulations@aphis.usda.gov. Your comment must
be contained in the body of your message; do not send attached files.
Please include your name and address in your message and ``Docket No.
00-108-2'' on the subject line.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Lynn Creekmore, Staff
Veterinarian, VS, APHIS, 2150 Centre Avenue, Fort Collins, CO 80526,
telephone (970) 494-7354.
[[Page 74514]]
SUPPLEMENTARY INFORMATION:
Background
Chronic wasting disease (CWD) is a transmissible spongiform
encephalopathy (TSE) of cervids (members of Cervidae, the deer family)
that as of November 2002 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 include Rocky Mountain
elk, mule deer, white-tailed deer, and black-tailed deer. Non-cervid
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 November
2002 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, South Dakota,
Utah, Wisconsin, and Wyoming, and in 27 captive (farmed) elk herds in
Colorado, Kansas, Minnesota, Montana, Nebraska, Oklahoma, South Dakota,
and Wisconsin, and in 2 captive deer herds in Wisconsin. The disease
was first detected in U.S. farmed elk in 1997.
Research is being conducted to develop live-animal diagnostic tests
for CWD. Currently, definitive diagnosis is based on postmortem
examination (necropsy) and testing of postmortem samples. On
microscopic examination, lesions of CWD in the central nervous system
resemble those of other TSE's. In addition, using a technique called
immunohistochemistry, scientists test brain tissues for the presence of
the protease-resistant prion protein.
The origin and mode of transmission of CWD is unknown. Animals born
in captivity and those born in the wild have been affected with the
disease. Based on epidemiology, transmission is thought to be lateral,
or from animal to animal. Although maternal transmission may also
occur, it appears to be a relatively uncommon form of transmission.
Surveillance for CWD in free-ranging deer and elk in Colorado and
Wyoming has been ongoing since 1983 and has defined the endemic areas
in those States. CWD was detected in 2000 and 2001 in free-ranging deer
in western Nebraska. The source of the disease is believed to be
natural spread from the Colorado and Wyoming endemic area. More
intensive surveillance to better define the prevalence and distribution
of the disease in free ranging deer in these States is underway.
However, in 2002, CWD was detected in wild cervids in northwestern
Colorado, southern New Mexico, southwestern South Dakota, and south
central Wisconsin. Detection of disease in these unexpected areas has
led to increased surveillance to better define the limits of the
endemic area and to determine the nationwide distribution and
prevalence of CWD in wild cervids. This surveillance effort is a two-
pronged approach consisting of hunter-harvest cervid surveys conducted
in many States, as well as surveillance targeting deer and elk
exhibiting clinical signs suggestive of CWD throughout the entire
country. Surveillance for CWD in captive elk began in 1997. Captive
cervid surveillance has increased each year since 1997 and will be an
integral part of the U.S. Department of Agriculture (USDA) program to
eliminate CWD from captive cervids. Surveillance in both wild and
captive animals has been a cooperative effort involving State
agriculture and wildlife agencies, USDA, elk and deer producers, and
hunters.
The presence of CWD in cervids causes significant economic and
market losses to U.S. producers. Canada recently prohibited the
importation of elk from Colorado and Wyoming and now requires that
other cervids be accompanied by a certificate stating that CWD has not
been diagnosed in the herd of origin. The Republic of Korea recently
suspended the importation of deer and elk and their products from the
United States and Canada. The domestic prices for elk and deer have
also been severely affected by fear of CWD.
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. Animal health regulations administered by the Department
under this authority include those specifically addressing control
programs and indemnity payments for tuberculosis (part 50), brucellosis
(part 51), pseudorabies (part 52), and scrapie (part 54), and
regulations in part 53 regarding payment of claims for other diseases.
We have already promulgated regulations to pay indemnity to the owners
of CWD-positive captive herds who voluntarily depopulate their herds.
These indemnity regulations, contained in 9 CFR part 55 and referred to
below as the indemnity interim rule, were published in the Federal
Register on February 8, 2002 (Docket No. 00-108-1, 67 FR 5925-5934).
While the indemnity program should contribute greatly to the
eventual eradication of CWD in the United States, it will not achieve
this goal unless it is supported by programs to actively identify herds
infected with CWD, and to manage these herds in a way that will prevent
further spread of CWD. To that purpose, we are proposing to create a
CWD Herd Certification Program to help eliminate chronic wasting
disease from the captive deer and elk herds in the United States. 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 are also
proposing to establish interstate movement requirements to prevent the
interstate movement of deer and elk that pose a risk of spreading CWD.
APHIS has established herd or flock certification programs in the
past to monitor animals for disease and eventually certify a herd or
flock as disease-free or low risk. Notably, we established the Scrapie
Flock Certification Program, which is described in 9 CFR part 54,
subpart B. The CWD Herd Certification Program that we are proposing in
this document has many features in common with the scrapie program.
Because both diseases are caused by TSE's and often have a long
incubation period, both programs require closely monitoring animals
over a period of years and restricting movements of animals into and
from herds.
Proposed CWD Herd Certification Program
We are proposing to create a cooperative Federal-State-private
sector program to contribute to the eradication of CWD from captive
deer and elk herds in the United States.
Jurisdiction over captive deer and elk varies from State to State.
The vast majority of captive deer and elk are domesticated or farmed;
that is, they are raised for profit on private ranches or farms. A
smaller number of captive deer and elk are maintained in zoos, other
exhibitions, or research facilities.
[[Page 74515]]
Farmed captive deer and elk are raised either for sale for meat, for
sale as breeding animals, for harvest of antler velvet, or for hunting
on private game facilities. In some States, the regulatory authority
over captive deer and elk resides with the State agricultural or animal
health agency or the State wildlife management agency, and in some
States the authority is shared between agricultural and wildlife
management agencies.
We have designed a Federal program to monitor the health of deer
and elk herds and eventually certify them as low risk for CWD. The CWD
Herd Certification Program relies primarily on animal identification,
regular surveillance of herds for evidence of CWD, testing for CWD of
animals that die in the monitored herds or are sent for slaughter, and
limiting new herd acquisitions to animals from herds that are also
enrolled in the program. These activities, along with State-Federal
cooperation in tracing the movements of CWD-positive animals and
identifying animals and herds that are exposed to them, are the
foundation of the CWD Herd Certification Program.
Several States already enroll deer and elk herd owners in programs
based on these principles. We believe that it is better to build a
Federal program that recognizes State activities than to replace them
with a strictly Federal program. Therefore, our proposal would
establish certain basic definitions and requirements that we believe
are consistent among different State programs to effectively address
CWD on a national level. We believe the States that have or are
developing CWD programs can readily incorporate our proposed minimum
criteria with few or no changes to State programs. Our proposal also
includes a process for APHIS to approve State programs that meet these
criteria as Approved State CWD Herd Certification Programs, and to
``grandfather'' all herds enrolled in those State programs into the CWD
Herd Certification Program. (Note that we do not propose separate
Federal and State programs; rather, the CWD Herd Certification Program
includes, as a subset, the Approved State CWD Herd Certification
Programs--those herds that did not apply directly to enroll in the CWD
Herd Certification Program, but that instead were admitted to it based
on their prior enrollment in a State program.)
By this means, State CWD programs would become consistent with
Federal minimum criteria and with each other. At the herd level,
activities and compliance would be based on State guidelines rather
than Federal ones. For herd owners who are involved with Approved State
CWD Herd Certification Programs, this means that the owners would
continue to work with the State contacts and procedures that are
familiar to them.
This proposal represents an attempt to apply current scientific and
diagnostic information to the disease control and management practices
of deer and elk production units. The science of CWD, like that of
other TSE's, is rapidly evolving. As new information becomes available,
the CWD Herd Certification Program will be updated. The current
proposal is designed to have the necessary flexibility to respond to
new developments.
The goal of the program is the eradication of CWD from captive deer
and elk herds in the United States. Captive herds are those animals
that are privately or publicly owned and held for economic or other
purposes within a perimeter fence or confined area. This includes
cervids that are ``farmed,'' ``ranched,'' ``game farmed,'' or owned by
zoos and other public or private entities. The proposed CWD Herd
Certification Program would not apply to animals being held for CWD
research purposes by State or Federal agencies or universities.
The CWD Herd Certification Program is designed for captive black-
tailed and mule deer (Odocoileus hemionus), white-tailed deer
(Odocoileus virginianus), red deer (Cervus elaphus), and captive elk
(Cervus elaphus) or elk-red deer hybrids. Except for red deer, all
these species are known to be susceptible to CWD; red deer are included
because of their extreme genetic similarity to elk. These deer and elk
belong to the Family Cervidae, along with other types of deer,
reindeer, sitka deer, and moose. Aside from research animals and
animals in zoological collections, elk and white-tailed deer are the
only captive cervid species in which CWD has been reported. However,
CWD has been reported in wild mule deer, white-tailed deer, and elk.
Should CWD be reported in other cervid species, this program may be
used as a model for those industries to follow.
The CWD Herd Certification Program does not apply to free-ranging
cervids under the management of Federal, State or Native American
Tribal management authorities. Although it is not directly addressed by
this proposal, the spread of CWD in free-ranging animals in its endemic
area (Colorado, Wyoming and Nebraska) and its appearance elsewhere,
such as in Wisconsin and New Mexico, is a major concern. USDA is
working as closely as possible with appropriate State and Federal
agencies to encourage management actions to address the presence of CWD
in all cervids. USDA will continue to support surveillance for CWD in
free-ranging cervids across the country.
Under this proposal, States would design and implement Approved
State CWD Herd Certification Programs for their own captive deer and
elk owners. If a State does not develop a program, cervid owners in
that State could directly enroll in the CWD Herd Certification Program.
If a State program meets minimum APHIS requirements to ensure that
programs are effective and consistent, the Administrator of APHIS would
designate the State program to be an Approved State CWD Herd
Certification Program. States could make program standards at the herd
level more stringent than the minimum criteria established by APHIS,
and could make participation in the CWD Herd Certification Program
mandatory if they chose.
Several States have already developed or are developing CWD
certification programs. Existing State CWD programs and the deer and
elk owners participating in them would be grandfathered into the
Federal program if they meet the minimal requirements. The date these
herds enrolled in a State program that APHIS subsequently determines
qualifies as an Approved State CWD Herd Certification Program would be
considered their enrollment date in the CWD Herd Certification Program.
Deer and elk owners in those States that do not have an Approved
State CWD Herd Certification Program would be able to join the CWD Herd
Certification Program by applying directly to APHIS through their
veterinarian in charge \1\ and complying with the minimum program
requirements for enrolled herd owners in proposed Sec. 55.23(b).
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\1\ A veterinarian in charge, as defined by current part 55, is
``the veterinary official of Veterinary Services, APHIS, who is
assigned by the Administrator to supervise and perform official
animal health work for APHIS in the State concerned.'' A list of
veterinarians in charge may be obtained from the Animal and Plant
Health Inspection Service, National Animal Health Programs Staff,
4700 River Road Unit 43, Riverdale, MD 20737-1235.
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This proposal contains mandatory Federal requirements affecting
interstate movement of deer and elk. APHIS would allow interstate
movement of captive deer or elk only from herds participating in the
program, and participation would have to be documented on the animal
health certificate required to move animals interstate. Therefore,
owners would
[[Page 74516]]
have to participate in the CWD Herd Certification Program if they
wished to move their animals to another State.
Section by Section Explanation of Proposal
We are proposing to add a new subpart to 9 CFR part 55 that
describes the CWD Herd Certification Program. We also propose to add a
new 9 CFR part 81, ``Chronic Wasting Disease in Captive Deer and Elk,''
which would contain the mandatory requirements for moving deer and elk
interstate. The next sections describe our proposed changes for parts
55 and 81.
Definitions (Sec. 55.1)
The interim indemnity rule established a ``Definitions'' section in
part 55 and established several definitions that are used in both the
indemnity program and in this proposed herd certification program. The
following definitions from the interim indemnity rule are also
important for the proposed certification rule.
CWD-positive animal. An animal that has had a diagnosis of CWD
confirmed by means of an official CWD test.
CWD-positive herd. A herd in which a CWD positive animal resided at
the time it was diagnosed and which has not been released from
quarantine.
CWD-suspect animal. An animal for which an APHIS employee has
determined that laboratory evidence or clinical signs suggest a
diagnosis of CWD.
We propose to retain these definitions as they are; we are setting
them out here only for information.
In addition, we are proposing to modify the definitions in part 55
of CWD-exposed animal, herd, and herd plan, as follows:
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.
The revision would substitute the standard of being ``exposed to a
CWD-positive animal'' for language in the earlier definition that based
the exposed classification on whether the animal was part of a herd
within 5 years prior to that herd's designation as CWD-positive, or had
been housed with or been in direct contact with a positive animal, or
had been on a contaminated premises.
Herd. One or more animals that are (a) under common ownership or
supervision and are grouped on one or more parts of any single premises
(lot, farm, or ranch) or (b) all animals under common ownership or
supervision on two or more premises which are geographically separated
but on which animals have been interchanged or had direct or indirect
contact with one another.
The definition of herd would be revised by changing its current
statement that it applies to ``a group of animals'' to read ``one or
more animals,'' since in some rare circumstances the owner of a single
animal may wish to enroll in the CWD Herd Certification Program.
Herd plan. A written herd management agreement developed by a State
representative with input from the herd owner, his or her veterinarian,
and other affected parties. The State representative will then submit
the herd plan to the Administrator, and the herd plan will not be valid
until it has been reviewed and signed by the Administrator. 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 suspect herd, or to prevent
introduction of CWD into another 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; cleaning and disinfection requirements; or other
requirements. A herd plan may be reviewed and revised 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 must also be submitted to the Administrator for review and
signature.
This revision would emphasize that a herd plan is developed
primarily not by APHIS, but by a State representative and the herd
owner, working in concert with the herd's veterinarian and any other
affected parties. Under this definition, APHIS would retain the right
to approve or disapprove herd plans. The revision also clarifies that
when veterinarians examine animals in accordance with a herd plan they
are looking for clinical signs of disease, including signs of chronic
wasting conditions, and states that sometimes herd plan requirements
may include depopulating the herd.
In addition to the definitions above that are already established,
we propose to add the following new definitions to part 55 in support
of the CWD Herd Certification program.
Commingled, commingling. Animals are commingled if they have direct
contact with each other, have less than 30 feet of physical separation,
or share equipment, pasture, or water sources/watershed, except for
periods of less than 48 hours at sales or auctions when an APHIS
employee or State representative has determined such contact presents
minimal risk of CWD transmission. Animals are considered to have
commingled if they have had such contact with a positive animal or
contaminated premises within the last 5 years.
This definition is needed to address situations where a healthy
animal, because it was commingled with a CWD-positive animal, was put
at risk of contracting CWD. 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.
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.
This definition is needed because herds exposed to CWD should be
restricted and monitored until sufficient evidence is available to
confirm whether or not the exposure caused new cases of CWD in the
herd. Because current evidence strongly suggests that a cervid would
die from CWD no more than 5 years after acquiring the disease, we are
not concerned about exposures that took
[[Page 74517]]
place more than 5 years before an animal is diagnosed with CWD.
CWD Herd Certification Program. The Chronic Wasting Disease Herd
Certification Program established by this part.
CWD-suspect herd. A herd for which laboratory evidence or clinical
signs suggest a diagnosis of CWD for an animal or animals within the
herd, as determined by an APHIS employee or State representative, but
for which laboratory results have been inconclusive or not yet
conducted.
This definition is needed to designate herds that are a high risk
because they may be determined CWD-positive in the near future, so that
appropriate restrictions may be placed on the herd pending final
confirmation of the herd's CWD status.
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.
Deer. Mule deer (Odocoileus hemionus), black-tailed deer
(Odocoileus hemionus), white-tailed deer (Odocoileus virginianus), red
deer (Cervus elaphus), and hybrids of these species.
Elk. North American wapiti (Cervus elaphus) and wapiti x red deer
hybrids.
Herd status. The status of a herd assigned under the CWD Herd
Certification Program in accordance with proposed 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 identification. Identification mark or device approved by
APHIS for use in the CWD Herd Certification Program. Examples are
listed in proposed Sec. 55.25.
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.
Administration (Sec. 55.21)
This proposed section states that the CWD Herd Certification
Program is a cooperative effort between APHIS, State animal health
agencies, and deer or elk owners. It explains that, under the program,
APHIS coordinates with State animal health agencies to encourage deer
and elk owners to certify their herds as free of CWD by remaining in
continuous compliance with the CWD Herd Certification Program
standards.
Participation (Sec. 55.22)
This proposed section describes the eligibility of captive deer or
elk herd owners and State animal health agencies to participate in the
CWD Herd Certification Program. Herds of any size, even a single
animal, may participate in the program. This section states that any
owner of a captive deer or elk herd (except for a CWD-positive herd, a
CWD-exposed herd, and a CWD-suspect herd) may apply to enroll, and any
State may apply to have its CWD program approved, by contacting the
appropriate APHIS or State offices.\2\ Before determining that the herd
is eligible to join, APHIS or the State may contact the herd owner to
obtain more information about the herd and its operations, if needed.
APHIS or the State animal health agency will send each approved herd
owner a notice of enrollment that includes the herd's enrollment date
(in the case of 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 qualifies as an
Approved State CWD Herd Certification Program). This proposed section
also states that APHIS intends to maintain a list of herds
participating in the CWD Herd Certification Program, and the
certification status of each herd, available on an Internet Web site
and by written request.
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\2\ A list of these offices may be obtained from the Animal and
Plant Health Inspection Service, National Animal Health Programs
Staff, 4700 River Road Unit 43, Riverdale, MD 20737-1235.
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With regard to States applying to have a State program approved,
this section states that the Administrator will approve or disapprove a
State program in accordance with proposed Sec. 55.23(a), discussed
below. This section also says that in States with an Approved State CWD
Herd Certification Program, program activities would be conducted in
accordance with the guidelines of that program, as long as the State
program meets certain minimum requirements of the subpart.
Responsibilities of States and Enrolled Herd Owners (Sec. 55.23)
This proposed section describes the minimum requirements State
programs must meet in order to be approved by the Administrator. It
also describes the responsibilities of herd owners who enroll in the
CWD Herd Certification Program.
The Administrator would review a letter from the State describing
its CWD control and deer and elk herd certification activities, and
would also review relevant State statutes, regulations, and directives
pertaining to animal health activities, and reports and publications of
the State animal health agency. The Administrator would determine
whether the State had sufficient authority and active programs to
conduct traceback, surveillance, and testing activities needed to
identify herds exposed to CWD, and to restrict the movement of all CWD-
positive, CWD-suspect, and CWD-exposed animals. The Administrator would
also look for effective State programs to require individual animal
identification in participating deer or elk herds, and to require
prompt reporting of suspected cases of CWD and test results for CWD to
State or Federal authorities.
We also propose that the State program must have placed all known
CWD-positive and CWD-exposed herds under movement restrictions, with
movement of animals only for destruction or for research. States must
remove herd movement restrictions placed on CWD-positive or CWD-exposed
herds only after the herds complete a herd plan. States must also have
programs to educate those engaged in the interstate movement of deer
and elk regarding requirements of the State program. States would also
have to sign a memorandum of understanding with APHIS that delineates
the respective roles of each in the CWD Herd Certification Program
implementation.
States would also have to designate at least one State animal
health official to coordinate CWD Herd Certification Program activities
in the State, and would have to agree to update the National CWD
Database administered by APHIS with information about the CWD status of
herds in the State and information about animals being traced across
State lines.
Regarding the responsibilities of deer or elk herd owners who
enroll in the CWD Herd Certification Program, proposed Sec. 55.23(b)
states that they must agree to maintain their herds in accordance with
certain program conditions. These proposed conditions are:
[sbull] Each cervid on the premises in the herd must be officially
identified using means of identification allowed by proposed Sec.
55.25;
[sbull] The herd premises must have perimeter fencing adequate to
prevent ingress or egress of cervids. This fencing must comply with any
applicable State regulations;
[sbull] The owner must immediately report to an APHIS employee or
State representative all deaths of deer or elk
[[Page 74518]]
aged 16 months or older, and must make the carcasses of such animals
available for tissue sampling and testing. This includes animals killed
on premises maintained for hunting. The owner also must allow test
samples to be collected from any animals sent to slaughter that APHIS
desires to test;
[sbull] 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 destination of any animal removed
from the herd, and all individual animal 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 a physical
herd inventory with verification reconciling animals and
identifications with the records maintained by the owner;
[sbull] 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. No commingling of animals may
occur. Movement of animals between herds must be recorded as if they
were separately owned herds; and
[sbull] New animals may be introduced into the herd only from other
herds enrolled in the CWD Herd Certification Program (including herds
in Approved State CWD Herd Certification Programs). 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.
Herd Status and Movement of Animals Between Enrolled Herds (Sec.
55.24)
In this proposed section, the progress of a herd through the
various stages of the program are described. When a herd is first
enrolled in the CWD Herd Certification Program, it would be placed in
First Year status. If the herd continues to meet the requirements of
the program, each year, on the anniversary of the enrollment date the
herd status would 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
would be changed to Certified, and the herd would remain in Certified
status as long as it remained enrolled in the program (and provided no
signs of CWD are detected). Once the herd has received Certified
status, the requirements the herd must meet to remain in the program
would be slightly reduced. Testing of all animals sent to slaughter and
all animals killed on hunting premises would no longer be required,
because 5 years of program participation would have documented a
minimal herd risk that does not justify such expensive comprehensive
testing, but other requirements of the program would remain in force.
This proposed section also describes how a herd could lose its herd
status or have it temporarily suspended. If a herd is designated a CWD-
positive herd or a CWD-exposed herd, it would immediately lose its
program status, and the owner could only re-enroll after completing a
herd plan. Owners of CWD-positive herds must make a business decision
on whether it is worthwhile to complete a herd plan, which usually
would require depopulation of the herd. If an owner completes a herd
plan, he or she can at least use the same premises and equipment to
raise elk in the future, even if the herd animals are depopulated. If
the owner elects not to complete a herd plan, animals from the herd may
not move interstate, and the owner may find it difficult to sell
animals even within the State, due to buyer reluctance and State
restrictions. If a herd is designated a CWD-suspect herd, a trace back
herd, or a trace forward herd, it would immediately be placed in
Suspended status pending an epidemiologic investigation by APHIS or a
State animal health agency. This epidemiologic investigation could have
three possible outcomes: It could determine that the investigated herd
was not commingled with a CWD-positive animal; it could determine that
the herd was commingled with a CWD-positive animal; or it could be
unable to make a definite determination of exposure.
If the epidemiologic investigation determined that the herd was not
commingled with a CWD-positive animal, the herd would be reinstated to
its former program status, and the time spent in Suspended status would
count toward its promotion to the next herd status level.
If the epidemiologic investigation determines that the herd was
commingled with a CWD-positive animal, the herd would lose its program
status and would be designated a CWD-exposed herd. The herd would not
be eligible to reenroll in the CWD Herd Certification Program until it
completed a herd plan.
If the epidemiological investigation was unable to make a
determination regarding the exposure of the herd, because the necessary
animal or animals were 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 would continue as Suspended unless and until a
herd plan was developed for the herd. If a herd plan was developed, the
herd would 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. Treatment of these indeterminate
status herds differs from treatment of Exposed herds in that
indeterminate status herds can re-enter the program as soon as a herd
plan is developed, while Exposed herds cannot re-enter until they have
completed a herd plan and are no longer classified Exposed. The
indeterminate herd would have to comply with the requirements of the
herd plan as well as the requirements of the CWD Herd Certification
Program, and the herd plan would require testing of all animals that
die in the herd for any reason, regardless of the age of the animal,
and could require movement restrictions for animals in the herd based
on epidemiologic evidence regarding the risk posed by the animals in
question.
Herds could also lose their program status if the Administrator
determined that the herd owner failed to comply with the requirements
of the program.
We propose to allow an appeals process for herd owners subject to
cancellation of enrollment or loss or suspension of herd status. Herd
owners could appeal any of these actions by writing to the
Administrator within 10 days after being informed of the reasons for
the proposed action. The appeal would have to 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 would 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 would be held to
resolve the conflict. Rules of practice concerning the hearing would be
adopted by the Administrator. However, cancellation of enrollment or
loss or suspension of herd status would become effective pending final
determination in the proceeding if the Administrator determines that
such action is necessary to prevent the possible spread of CWD. This
cancellation of enrollment or loss or suspension of herd status would
continue in effect pending the completion of the proceeding, and any
[[Page 74519]]
judicial review thereof, unless otherwise ordered by the Administrator.
This proposed section also describes restrictions of the source of
animals that could be added to an enrolled herd. A herd could add
animals from herds with the same or an earlier enrollment date in the
CWD Herd Certification Program with no negative impact on the
certification status of the receiving herd.\3\ If animals were acquired
from a herd with a later date of enrollment, the receiving herd would
revert to the program status of the sending herd. If a herd
participating in the program acquired animals from a nonparticipating
herd, the receiving herd would revert to First Year status with a new
enrollment date of the date of acquisition of the animal.
---------------------------------------------------------------------------
\3\ Note that in addition to this requirement, proposed Sec.
81.3 contains restriction on the interstate movement of captive deer
and elk.
---------------------------------------------------------------------------
Official Identification (Sec. 55.25)
This section proposes that each animal required to be identified
under the CWD Herd Certification Program must have at least two forms
of APHIS-approved identification, because a single form of
identification can sometimes become detached or obscured (e.g., eartags
are sometimes torn loose on brush, or lost due to frostbite damage;
tattoo inks sometimes fade, or are obliterated by scarring). Even
though not required by most regulations, the use of two forms of animal
ID has become common in animal industries, and we believe its program
benefits outweigh the additional expense. The official identification
would have to be an ear tattoo, tamper-resistant ear tag, electronic
implant, or flank tattoo approved for this use by APHIS. The official
identification would have to provide a unique identification number
that is applied by the owner of the herd or his or her agent and is
linked to that herd in the National CWD Database.
This concludes discussion of the changes proposed for part 55. The
contents of proposed new part 81 are discussed below.
Definitions (Sec. 81.1) and Identification of Deer and Elk in
Interstate Commerce (Sec. 81.2)
These proposed sections would be essentially the same as the
definitions and identification requirements discussed above with regard
to proposed Sec. Sec. 55.1 and 55.25. The definition of captive
proposed for part 81 differs slightly from the definition employed in
part 55, because under part 81 it is necessary to restrict the
interstate movement of animals that were captured from a free-ranging
population for interstate movement and release. Such animals are not
covered under the indemnity and certification programs of part 55. The
definition of chronic wasting disease (CWD) proposed for part 81 also
describes some clinical signs of CWD that are not needed in the similar
definition in part 55, because part 81 requires issuance of
certificates stating that animals do not exhibit clinical signs of CWD.
General Restrictions (Sec. 81.3)
This proposed section would institute the mandatory requirement
that no captive deer or elk may move interstate unless it originated in
a herd enrolled in the CWD Herd Certification Program and the herd
remained in the program long enough to reach a specified status. To
encourage early enrollment in the CWD Herd Certification Program and to
support its goal of eventually eradicating CWD from captive deer and
elk herds in the United States, we are proposing to establish a
timetable that gradually increases the time a herd must be in the
program in order to move animals interstate. Eventually, only animals
from herds that have been enrolled in the program for over 5 years
would be allowed to move interstate. If this proposed rule is adopted,
immediately after it takes effect, a herd would need to achieve Second
Year status before animals from the herd could be moved interstate.
(Some herds would have this or greater program status immediately upon
enrollment, due to the provisions to ``grandfather'' herds enrolled in
existing State programs that was discussed above.) As of 27 months
after the rule takes effect, a herd would need to achieve Third Year
status before animals from the herd could be moved interstate. Twelve
months later the herd would have to achieve Fourth Year status, then
after 12 more months, Fifth Year status, for animals to be moved
interstate. Finally, after 12 more months (approximately 5\1/4\ years
after the rule takes effect), the herd would have to achieve Certified
status. Under this schedule, the longer a herd owner waits before
enrolling in the CWD Herd Certification Program, the longer he or she
would have to wait before moving animals interstate. This gradually
increasing requirement also means that as time goes on, animals allowed
to move interstate will have spent more and more time in the CWD Herd
Certification Program, with a corresponding decrease in the risk that
such animals could spread CWD.
We also propose that captive deer or elk moved interstate must be
accompanied by a certificate that identifies its herd of origin, states
that the herd is participating in the CWD Herd Certification Program
and gives its program status, and states that it is not a CWD-positive,
CWD-exposed, or CWD-suspect animal. One exception to this requirement
is that deer or elk that are temporarily captured from free-ranging
populations may be moved interstate for release (translocated) without
enrollment in the CWD Herd Certification Program. Since the CWD Herd
Certification Program is not designed for free-ranging populations, we
propose that in such cases the free-ranging population must instead be
documented to be free from CWD based on a CWD surveillance program that
is approved by the State Government of the receiving State and by
APHIS.
Issuance of Certificates (Sec. 81.4)
This proposed section describes the function and contents of the
certificate that would be required by proposed Sec. 81.3. Animal
health certificates are used in this section in much the same way they
are used in many other APHIS regulations: to document the origin,
identity, and disease status of animals moving interstate. The
certificate would have to show the herd of origin and official
identification numbers of each animal to be moved. (Certificates issued
for the translocation of free-ranging animals caught in one State and
released in another would not need to record this information, since it
does not exist for such cases.) The certificate would also have to 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 would have to include a
statement by the issuing accredited, State, or Federal veterinarian
that the animals were not exhibiting clinical signs associated with CWD
at the time of examination. The certificate would also have to state
that the animals are from a herd participating in the CWD Herd
Certification Program, and give the herd's program status, or state
that the animals are free-ranging animals that are being translocated
from a herd that is documented to be free from CWD based on a CWD
surveillance program.
This proposed section also includes some administrative details
regarding how to attach secondary forms listing animal identification
information to an official certificate. We propose that animal
identification documents attached to certificates must be a legible
copy of State or APHIS forms that requires individual identification of
[[Page 74520]]
animals, and 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. We also propose that 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: the name
of the document; and 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. These proposed requirements would help us ensure the
authenticity and reliability of animal identification documents, and
help us trace the movement of animals when necessary.
Executive Order 12866 and Regulatory Flexibility Act
This proposed 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 proposed 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 proposed rule on small entities, as required under 5
U.S.C. 603. 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 (NADFA). 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.
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 proposed 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 free of CWD and hence 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 and elk altogether, without establishing a voluntary 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 voluntary Federal herd certification program with interstate
movement on animals contingent on participation in that program. This
alternative substantially reduces the risk of exporting CWD from one
state to another--because only deer and elk 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 proposed rule would establish a CWD Herd Certification Program
for captive elk and deer, and prohibit the interstate movement of deer
and elk that are not enrolled in the program. Herds that participate
would have to follow program requirements for animal identification,
testing, herd management, and movement of animals to and from herds.
Herd owners would be able to enroll in an Approved State CWD Herd
Certification Program that met minimum standards established by APHIS,
or enroll directly in the Federal CWD Herd Certification Program if
there is no State program in their location.
Currently, there are no Federal requirements for the interstate
movement of deer and elk. However, 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 proposed in this rule. The proposed 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 would be
able to enroll in the Federal program.
This proposal is intended to help eliminate CWD from captive
cervids in the United States. It would support an existing APHIS
program that pays indemnities to owners of CWD-positive herds who
voluntarily depopulate their herds.
The proposed rule would primarily affect deer and elk farms. In the
United States there are an estimated 150,000 elk on 2,300 farms, and
550,000 deer on 11,000 farms. It is estimated that, without improved
CWD control efforts, the disease could eventually infect almost all
U.S. captive elk herds.
The proposed rule should 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 would take advantage of the
increased access to out-of-State markets, would benefit immediately.
Conversely, some farmers could experience a significant adverse effect,
especially any farmers who cannot afford to pay the program's annual
costs. However, given the available data, there is no basis to conclude
that the proposed rule will have a significant negative economic impact
on a substantial number of small entities.
The economic importance of the deer and elk farming industries
notwithstanding, the rule's primary benefits would appear to lie in its
ability to reduce the potential for the introduction or spread of CWD.
[[Page 74521]]
However, it is difficult to translate that reduced potential into a
dollar benefit.
The Deer and Elk Industries and the Impact of CWD
The number of deer and elk 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 to-date has been relatively low. It is estimated that
fewer than 100 farmed elk and no farmed deer have died as a result of
contracting CWD. The number of farmed elk that have died is equivalent
to less than one-tenth of 1 percent of the current U.S. farmed elk
population, estimated at 150,000. 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 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 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.
NAEBA estimates that there are about 150,000 elk on 2,300 U.S.
farms. 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, heifer, calf), market conditions, and other factors. The
average value of each elk is roughly estimated at $2,500, with the
typical high end value at about $8,000. (The more valuable trophy
animals hunted on game farms tend to be worth more than this average.)
Based on the estimated average of $2,500 per animal, the value of all
150,000 elk on U.S. farms is estimated at $375 million (150,000 x
$2,500). In 1999, gross receipts for the elk farming and velvet antler
industry in North America totaled an estimated $150 million.
NADFA estimates that there are about 550,000 deer on U.S. farms.
Based on NADFA's estimate of 50 deer per farm, on average, the number
of deer farms in the United States would total 11,000. Assuming each
farm has 2.1 employees, the average for deer farms in Indiana,
employment on all of the estimated 11,000 deer farms would total
23,100. 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 (e.g., wapiti, white-tailed, fallow) and market conditions. An
earlier NADFA estimate put the average per animal value of all deer on
member farms at $1,687, which would make the estimated value of all
550,000 deer on U.S. farms $927.9 million (550,000 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 Proposed Rule
The proposed rule would 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 proposed interstate movement restrictions that would allow only
``program'' deer and elk to be moved interstate would 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 and elk
that have been subject to certain minimum surveillance and other
criteria could be moved interstate.
Preventing spread of CWD among deer and elk benefits entities and
individuals that rely on those animals for their income, e.g., deer and
elk farms, State agencies that sell hunting licenses, employees of
motels and restaurants in hunting areas. It 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. At this time, the
various States do not follow a standard interstate movement policy, nor
are there standards that would ensure equivalency between State CWD
programs. This has 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 elk
herds. The elk industry is in its early stages, which requires owners
to purchase and sell large numbers of animals for breeding stock as
they develop superior lines. Such large movements of animals between
herds exacerbates risks of disease spread. One herd in Colorado sold
approximately 400 animals to many other herds in one year. 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 years, the few herds
studied in detail do suggest that CWD is easily spread through
unrestricted commerce in elk, and could readily become established in
most U.S. herds. Adoption of the proposed rule, therefore, could serve
to protect substantial elk industry livestock assets, valued at an
estimated $375 million.
For farmers with infected deer and elk, 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.
[[Page 74522]]
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 spongiform encephalopathies of
animals or humans. The precise impact of Korea's suspension is unknown,
because data that is compiled on U.S. exports does 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
proposed Federal certification program would provide the basis for
equivalency between State programs, 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; assist efficient domestic elk and deer marketing;
maintain and enhance export markets of cervid products; 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 they had no certification program and CWD infection in one herd
quickly spread to 38 herds, causing 7,400 elk to be destroyed.
The proposed 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 Proposed Rule
The proposed 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 would
require that herd owners employ certain minimum disease preventative
measures established by APHIS. The cost to comply with these minimum
requirements would 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 already in place, if for no
other reason than to keep animals from escaping.
The certification program would require that herd owners submit the
carcasses of all dead deer and elk 16 months of age or older (including
animals killed on hunting premises) to a lab for tissue sampling and
testing. The rules would allow herd owners to collect and submit the
animal's entire head themselves, or to 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 would charge herd owners about $100 to collect each
sample.
Participating herd owners would 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 would 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 would 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 themselves cost about $2 each. By comparison, veterinarians could
be expected to charge herd owners at least about $25 to implant each
microchip.
It is estimated that adoption of the program's minimum disease
preventative measures would 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. 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 16 months of
age die per year. It is expected that the cost of sample collection
would 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
points (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.
However, APHIS particularly solicits comments on this point, since we
do not have detailed knowledge of hunting premises business operations.
Participating herds that are found to have CWD-positive or CWD-
exposed animals would immediately lose their program status, and could
re-enroll only after completing a herd plan. (A herd plan is a written
herd management agreement, developed by APHIS with input from the herd
owner, State representatives, and other affected parties, that 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 would
agree to depopulate their herds, for which APHIS would 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. Most herd owners would consider these actions as
tantamount to closure. Fortunately for herd owners,
[[Page 74523]]
herd infection is rare. Only 27 farmed elk herds and 2 farmed deer
herds have been found positive, representing only 1 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 two
years if this rule is adopted (if this rule is not adopted, there will
be less herd monitoring and fewer detections).
Finally, the proposed certification program would establish herd
status, based on the number of years of enrollment in the program with
no evidence of disease. Herd status would affect the movement of
animals, since additions from a herd with a later enrollment date would
cause the acquiring herd to revert to the status of the herd from which
the deer and elk were acquired. Herd status, therefore, would 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 would 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 would be less likely to acquire animals from
nonparticipating herds, due to penalties.
Cost for States
If this rule is adopted, we expect that all States which permit
cervid farming would participate by developing approved State CWD
programs under the regulations. Many of these States would likely make
participation mandatory for all in-State herd owners.
States that do establish a certification program would incur the
costs of setting up and administering that program, including costs
for: the development of legislative/regulatory authority, surveillance
and monitoring, 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 would 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 7
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, surveillance, and other activities that the States
would otherwise have to fund themselves. Through fiscal year 2002,
$17.3 million of CCC funding was transferred to APHIS for CWD
eradication activities. In addition, $0.8 million of APHIS contingency
funds were used for CWD eradication efforts over the last 4 fiscal
years.
Cost for APHIS
The direct costs APHIS would incur from this proposed 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 proposed rule.
APHIS' liability for indemnities could also be affected, if the
newly-established State programs result in more positive finds than
would otherwise be the case. To date, APHIS has paid out $12.5 million
for CWD indemnities.
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 proposed rule would
primarily affect deer and elk farms, because they are most likely to be
affected by the program's requirements and the interstate movement
restrictions.
We do not have details about the size of the 2,300 elk farms and
11,000 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 1997, there
were 10,045 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 10,045 farms, the per farm
average gross receipts in 1997 was $105,624, well below the SBA's small
entity threshold of $750,000 for farms in that NAICS category.
To the extent that the proposed rule prevents the spread of--and
perhaps eliminates altogether--CWD in farmed deer and elk herds in the
United States, small herd owners should benefit over the long term. The
proposed rule would 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 would 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 would 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 less than 2 percent of the 1997
per farm average gross receipts for all U.S. farms in NAICS 11299
($1,600/$105,624). Those herd owners who have the option and elect not
to participate would avoid the program's annual costs but they would
see the value of their animals discounted in the marketplace, since
``non-program'' animals would likely carry a stigma of inferiority. As
discussed below, the discount is likely to exceed the program's annual
cost for
[[Page 74524]]
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, generally in the range of between
$2,500 and $8,000 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 proposed rule. The number of such herd
owners is unknown but it is likely to be small, given that the added
costs are equivalent to less than 2 percent of 1997 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 27 farmed elk herds and 2 farmed deer herds have
been found positive to-date, representing only 1 percent of all elk
farms and much less than 1 percent of all deer farms in the United
States at the present time. It is estimated that additional elk herds
will be detected over the next 2 years (with the proposed rule in
effect), 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 proposed 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 would 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.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,
DC 20503. Please state that your comments refer to Docket No. 00-108-2.
Please send a copy of your comments to: (1) Docket No. 00-108-2,
Regulatory Analysis and Development, PPD, APHIS, station 3C71, 4700
River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance
Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue
SW., Washington, DC 20250. A comment to OMB is best assured of having
its full effect if OMB receives it within 30 days of publication of
this proposed rule.
This proposed rule would require several information collection
activities, including written requests by State Governments and herd
owners to participate in the program, herd owner responses to requests
from APHIS or States for information about animals in their herds, the
development of written herd plans and the maintenance of herd records,
identification of cervids with ear-tags or other devices, issuance and
use of certificates to move cervids interstate, and the creation of a
memorandum of understanding between APHIS and each participating State.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology; e.g., permitting electronic
submission of responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average 2.664 hours per response.
Respondents: Herd owners, personnel employed by herd owners, State
animal health authorities, accredited veterinarians.
Estimated annual number of respondents: 5,000.
Estimated annual number of responses per respondent: 30.
Estimated annual number of responses: 150,000.
Estimated total annual burden on respondents: 399,602 hours. (Due
to averaging, the total annual burden hours may not equal the product
of the annual number of responses multiplied by the reporting burden
per response.)
Copies of this information collection can be obtained from Mrs.
Celeste Sickles, APHIS' Information Collection Coordinator, at (301)
734-7477.
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 proposed rule, please contact Mrs. Celeste
Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.
[[Page 74525]]
List of Subjects
9 CFR Part 55
Animal diseases, Cervids, Chronic wasting disease, Deer, Elk,
Indemnity payments.
9 CFR Part 81
Animal diseases, Cervids, Deer, Elk, Quarantine, Reporting and
recordkeeping requirements, Transportation.
Accordingly, we propose to amend 9 CFR chapter I as follows:
PART 55--CONTROL OF CHRONIC WASTING DISEASE
1. The authority citation for part 55 would be revised to read as
follows:
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
2. Section 55.1 would be amended as follows:
a. In the definition of herd, by removing the words ``A group of
animals'' and adding in their place the words ``One or more animals''.
b. By revising the definitions of CWD-exposed animal and herd plan
to read as set forth below.
c. By adding definitions for commingled, commingling, CWD-exposed
herd, CWD herd certification program, CWD-suspect herd, CWD-source
herd, deer, elk, herd status, official identification, trace back herd,
and trace forward herd. in alphabetical order, to read as set forth
below.
Sec. 55.1 Definitions.
* * * * *
CWD Herd Certification Program. The Chronic Wasting Disease Herd
Certification Program established by this part. This program includes
both herds that directly enroll in the CWD Herd Certification Program
and herds that are included based on their participation in Approved
State CWD Herd Certification Programs.
* * * * *
Commingled, commingling. Animals are commingled if they have direct
contact with each other, have less than 30 feet of physical separation,
or share equipment, pasture, or water sources/watershed, except for
periods of less than 48 hours at sales or auctions when an APHIS
employee or State representative has determined such contact presents
minimal risk of CWD transmission. 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-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 herd. A herd for which laboratory evidence or clinical
signs suggest a diagnosis of CWD, as determined by an APHIS employee or
State representative, but for which laboratory results have been
inconclusive or not yet conducted.
Deer. Mule deer (Odocoileus hemionus), black-tailed deer
(Odocoileus hemionus), white-tailed deer (Odocoileus virginianus), red
deer (Cervus elaphus), and hybrids of these species.
* * * * *
Elk. North American wapiti (Cervus elaphus) and wapiti x red deer
hybrids.
* * * * *
Herd plan. A written herd management agreement developed by a State
representative with input from the herd owner, his or her veterinarian,
and other affected parties. The State representative will then submit
the herd plan to the Administrator, and the herd plan will not be valid
until it has been reviewed and signed by the Administrator. 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 suspect herd, or to prevent
introduction of CWD into another 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; cleaning and disinfection requirements; or other
requirements. A herd plan may be reviewed and revised 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 must also be submitted to the Administrator for review and
signature.
Herd status. The status of a herd assigned under the CWD Herd
Certification Program in accordance with Sec. 55.24 of this part,
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 identification. Identification mark or device approved by
APHIS for use in the CWD Herd Certification Program. Examples are
listed in Sec. 55.25.
* * * * *
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.
* * * * *
3. In part 55, a new subpart B would be 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 Official identification.
Sec. 55.21 Administration.
(a) The CWD Herd Certification Program is a cooperative effort
between APHIS, State animal health agencies, and deer and elk owners.
APHIS coordinates with State animal health agencies to encourage deer
and elk
[[Page 74526]]
owners to certify their herds as free of 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 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. 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. After determining
that the herd is eligible to participate in accordance with this
paragraph, APHIS or the State animal health agency will send the herd
owner a notice of enrollment that includes the herd's enrollment date.
A notice containing a current list of herds participating in the CWD
Herd Certification Program and the certification status of each herd
may be obtained from the APHIS Internet Web site at http://www.aphis.usda.gov/vs/nahps/cwd/
, or by writing to the Animal and Plant
Health Inspection Service, National Animal Health Programs Staff, VS,
APHIS, 4700 River Road, Unit 43, Riverdale, MD 20737-1235.
(1) Enrollment date. 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. 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 qualifies as an Approved State CWD Herd
Certification Program in accordance with Sec. 55.23(a) of this part.
(2) [Reserved]
(b) Participation by States. Any State that operates a State
program to certify the CWD status of deer or elk 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
minium requirements of this part. A notice containing a current list of
Approved State CWD Herd Certification Programs may be obtained from the
APHIS Internet Web site at http://www.aphis.usda.gov/vs/nahps/cwd/, or
by writing to the Animal and Plant Health Inspection Service, National
Animal Health Programs Staff, VS, APHIS, 4700 River Road, Unit 43,
Riverdale, MD 20737-1235.
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 animal health agency that describes
State CWD control and deer and elk herd certification activities and
that cites relevant State statutes, regulations, and directives
pertaining to animal health activities and reports and publications of
the State animal health agency. 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 and CWD-exposed herds under
movement restrictions, with movement of animals only for destruction or
for research. CWD-positive and CWD-suspect animals may be moved only
for transport to an approved research facility or for purposes of
destruction.
(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 both the State representative and APHIS;
(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 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 APHIS or State animal health
official to coordinate CWD Herd Certification Program activities in the
State.
(8) Has programs to educate those engaged in the interstate
movement of deer and elk regarding the identification and recordkeeping
requirements of this part.
(9) Requires, based on State law or regulation, and effectively
enforces official identification of all animals in herds participating
in the CWD Herd Certification Program;
(10) Maintains in the National CWD Database administered by APHIS,
or in a State database approved by the Administrator as compatible with
the National CWD Database, the State's:
(i) Premises information and assigned premises numbers;
(ii) Individual animal information on all deer and elk in herds
participating in the CWD Herd Certification Program in the State;
(iii) Individual animal information on all out-of-State deer and
elk to be traced; and
(iv) Accurate herd status data.
(11) Requires that tissues from all CWD-positive or CWD-suspect
animals be submitted to a laboratory authorized by the Administrator to
conduct official CWD tests and requires complete destruction of the
carcasses of CWD-positive 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 officially identified using
means of identification allowed by Sec. 55.25 of this subpart;
(2) The herd premises must have perimeter fencing adequate to
prevent ingress or egress of cervids. This fencing
[[Page 74527]]
must comply with any applicable State regulations;
(3) The owner must immediately report to an APHIS employee or State
representative all deaths of deer and elk in the herd aged 16 months or
older, and must make the carcasses of such animals available for tissue
sampling and testing. This includes animals killed on premises
maintained for hunting. The owner also must allow test samples to be
collected from all animals sent to slaughter;
(4) 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 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 a physical herd inventory
with verification reconciling animals and identifications with the
records maintained by the owner;
(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. 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.
Sec. 55.24 Herd status.
(a) When a herd is first enrolled in the CWD Herd Certification
Program, it will be placed in First Year status. 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 completing a herd plan. When
reenrolled, the herd will enter at a First Year status level, with a
new enrollment date reflecting the date the herd completed the 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, 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. The herd must comply with the
requirements of the herd plan as well as the requirements of the CWD
Herd Certification Program, and the herd plan will require testing of
all animals that die in the herd for any reason, regardless of the age
of the animal, and may require movement restrictions for animals in the
herd based on epidemiologic evidence regarding the risk posed by the
animals in question.
(c) 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 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) A herd may add animals from herds with the same or an earlier
enrollment date in the CWD Herd Certification Program with no negative
impact on the certification status of the receiving herd.\1\ If animals
are acquired from a herd with a later date of enrollment, 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 reverts to First Year
status with a new enrollment date of the date of acquisition of the
animal.
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\1\ Note that in addition to this requirement, Sec. 81.3 of
this chapter restricts the interstate movement of captive deer and
elk based on their status in the CWD Herd Certification Program.
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[[Page 74528]]
Sec. 55.25 Official identification.
(a) Each animal required to be identified by this subpart must have
at least two forms of identification. The official identification must
be approved for this use by APHIS, and must be an electronic implant,
flank tattoo, ear tattoo, or tamper-resistant ear tag. The official
identification must provide a unique identification number that is
applied by the owner of the herd or his or her agent and must be linked
to that herd in the National CWD Database.
4. A new part 81 would be added to read as follows:
PART 81--CHRONIC WASTING DISEASE IN DEER AND ELK
Sec.
81.1 Definitions.
81.2 Identification of deer and elk 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 captive deer or elk.
Animal and Plant Health Inspection Service (APHIS). The Animal and
Plant Health Inspection Service of the United States Department of
Agriculture.
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.
Captive. Animals that are privately or publicly maintained or held
for economic or other purposes within a perimeter fence or confined
area, or that were captured from a free-ranging population for
interstate movement and release. Animals that are held for research
purposes by State or Federal agencies or universities are not included.
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 an official CWD test.
CWD-suspect animal. An animal for which an APHIS employee has
determined that laboratory evidence or clinical signs suggest a
diagnosis of CWD.
Deer. Mule deer (Odocoileus hemionus), black-tailed deer
(Odocoileus hemionus), white-tailed deer (Odocoileus virginianus), red
deer (Cervus elaphus), and hybrids of these species.
Elk. North American wapiti (Cervus elaphus) and wapiti x red deer
hybrids.
Sec. 81.2 Identification of deer and elk in interstate commerce.
(a) Each animal required to be identified by this part must have at
least two forms of identification, except for free-ranging animals
captured for interstate movement and release in accordance with Sec.
81.3(a)(2), which must have at least one form of identification. The
form of identification must be an electronic implant, flank tattoo, ear
tattoo, or tamper-resistant ear tag approved for this use by APHIS. The
identification must provide a unique identification number that is
applied by the owner of the herd or his or her agent and is linked to
that herd in the National CWD Database.
Sec. 81.3 General restrictions.
(a) No captive deer or captive elk may be moved interstate unless
it:
(1) Is moved from a herd that is:
(i) Enrolled in the CWD Herd Certification Program and:
(A) If the movement occurs between [effective date of final rule]
and [date 27 months after effective date of final rule], the herd has
achieved at least Second Year status in accordance with Sec. 55.24 of
this chapter;
(B) If the movement occurs between [date 27 months after effective
date of final rule] and [date 39 months after effective date of final
rule], the herd has achieved at least Third Year status in accordance
with Sec. 55.24 of this chapter;
(C) If the movement occurs between [date 39 months after effective
date of final rule] and [date 51 months after effective date of final
rule], the herd has achieved at least Fourth Year status in accordance
with Sec. 55.24 of this chapter;
(D) If the movement occurs between [date 51 months after effective
date of final rule] and [date 63 months after effective date of final
rule], the herd has achieved at least Fifth Year status in accordance
with Sec. 55.24 of this chapter;
(E) If the movement occurs after [date 63 months after effective
date of final rule], the herd has achieved Certified status in
accordance with Sec. 55.24 of this chapter; and,
(ii) The herd is accompanied by a certificate issued in accordance
with Sec. 81.4 of this part that identifies its herd of origin and its
CWD Herd Certification Program status, and states that it is not a CWD-
positive, CWD-exposed, or CWD-suspect animal; or
(2) The captive deer or captive elk has at least one form of
official identification and was captured for interstate movement and
release from a free-ranging population that a certificate accompanying
the animals documents to be free from CWD based on a CWD surveillance
program that is approved by the State Government of the receiving State
and by APHIS.
Sec. 81.4 Issuance of certificates.
(a) A certificate must show the official 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, that the animals are
from a herd participating in the CWD Herd Certification Program, and
giving the herd's program status.
(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;
(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
[[Page 74529]]
the name of the person who issued the document and the date the
document was issued.
Done in Washington, DC, this 17th day of December, 2003.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 03-31543 Filed 12-23-03; 8:45 am]
BILLING CODE 3410-34-P