[Federal Register Volume 67, Number 27 (Friday, February 8, 2002)]
[Rules and Regulations]
[Pages 5925-5934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3081]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 55

[Docket No. 00-108-1]
RIN 0579-AB35


Chronic Wasting Disease in Cervids; Payment of Indemnity

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Interim rule and request for comments.

-----------------------------------------------------------------------

SUMMARY: We are establishing animal health regulations to provide for 
the payment of indemnity by the United States Department of Agriculture 
for the voluntary depopulation of captive cervid herds known to be 
infected with chronic wasting disease. The payment of indemnity will 
encourage depopulation of infected herds, and therefore will reduce the 
risk of other cervids becoming infected with the disease. We have 
determined that this action, which will accelerate existing chronic 
wasting disease eradication efforts, is necessary to protect cervids 
not infected with chronic wasting disease from the disease.

DATES: This interim rule was effective February 5, 2002. We invite you 
to comment on this docket. We will consider all comments we receive 
that are postmarked, delivered, or e-mailed by April 9, 2002.

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 (an original and three copies) to: Docket No. 00-108-1, 
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. 00-108-1. If you use e-mail, address your 
comment to [email protected]. 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. 00-108-1'' 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, 4101 LaPorte Avenue, Fort Collins, CO 80521, 
(970) 266-6128.

SUPPLEMENTARY INFORMATION:

Background

    Chronic wasting disease (CWD) is a transmissible spongiform 
encephalopathy (TSE) of cervids (elk, deer, and other members of the 
deer family) that to date has only been found in North America. First 
recognized as a clinical ``wasting'' syndrome in 1967, it is typified 
by chronic weight loss leading to death. Species that have been 
affected with CWD include Rocky Mountain elk, mule deer, white-tailed 
deer, and black-tailed deer. Other 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 to date there has been no evidence of transmission of 
CWD to these other species.
    In the United States, CWD has been confirmed in free-ranging deer 
and elk in a limited number of counties in northeastern Colorado, 
southeastern Wyoming, and western Nebraska. CWD has also been diagnosed 
in fewer than 20 captive (farmed) elk herds in South Dakota, Nebraska, 
Oklahoma, Montana, and Colorado.
    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

[[Page 5926]]

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 relatively unimportant in maintaining 
epidemics. These facts about CWD transmission, in conjunction with the 
small number of captive herds currently affected by CWD, suggest that 
prompt action now may control the CWD problem in captive herds, but 
lack of such action would allow more movement of CWD-infected animals 
to new herds, escalating the CWD problem.
    Surveillance for CWD in free-ranging deer and elk in Colorado and 
Wyoming has been ongoing since 1983, and, to date, has confirmed the 
limits of the endemic areas in those States. CWD in free-ranging deer 
in Nebraska was detected in 2000/2001; more intensive surveillance to 
better define the prevalence and distribution of the disease in free-
ranging deer in Nebraska is underway. An extensive nationwide 
surveillance effort was started in 1997-98 to better define the 
geographic distribution of CWD in free-ranging cervids in the United 
States. This surveillance effort is a two-pronged approach consisting 
of hunter-harvest cervid surveys conducted in many States, as well as 
surveillance throughout the entire country targeting deer and elk 
exhibiting clinical signs suggestive of CWD. Surveillance for CWD in 
captive elk began in 1997 and has been a cooperative effort involving 
State agriculture and wildlife agencies and the Animal and Plant Health 
Inspection Service (APHIS) of the U.S. Department of Agriculture (the 
Department). Farmed cervid surveillance has been increasing each year 
since 1997 and will be an integral part of the Department's program to 
eliminate CWD from captive cervids.
    The presence of CWD in cervids causes significant economic and 
market losses to U.S. producers. Recently, Canada has begun to require, 
as a condition for importing U.S. elk into Canada, that the animals be 
accompanied by a certificate stating that the herd of origin is not 
located in Colorado or Wyoming, and CWD has never been diagnosed in the 
herd of origin. South Korea and Japan recently suspended the 
importation of deer and elk and their products from the United States 
and Canada. The domestic prices for elk are severely affected by fear 
of CWD; it is extremely difficult to sell elk that have any history of 
exposure to CWD.
    APHIS's regulations in 9 CFR subchapter B govern cooperative 
programs to control and eradicate communicable diseases of livestock. 
In accordance with 21 U.S.C. 111-113, 114a, 115, 117, 120, 123, and 
134a, the Secretary of Agriculture has the authority to promulgate 
regulations and take measures to prevent the introduction into the 
United States and the interstate dissemination within the United States 
of communicable diseases of livestock and poultry, and to pay claims 
growing out of the destruction of animals. Animal health regulations 
promulgated 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.
    This interim rule establishes a new part 55, ``Control of Chronic 
Wasting Disease.''
Key Definitions
    We are establishing the following new definitions for part 55. We 
also define a number of other terms in part 55 that are not discussed 
below, because they are already defined in other parts of 9 CFR 
subchapter B with respect to other APHIS animal disease control 
programs.
    Captive is defined to distinguish captive cervids, the class 
eligible for indemnity, from other cervids. This term includes animals 
that are privately or publicly maintained or held for economic or other 
purposes within a perimeter fence or confined space. Animals that are 
held for research purposes are not included, because research animals 
will not be eligible for indemnity, and because we expect that future 
rulemaking affecting captive cervids will include interstate movement 
restrictions or other requirements that will not be necessary or 
suitable for research animals.
    Cervid is defined as all members of the family Cervidae and 
hybrids, including deer, elk, moose, caribou, reindeer, and related 
species.
    Chronic wasting disease is defined as a TSE of cervids.
    A CWD exposed animal is defined as an animal that is part of a CWD 
positive herd, or that was part of a herd within 5 years prior to that 
herd's designation as CWD positive, or an animal that has been housed 
with or been in direct contact with a positive animal, or an animal 
that has been on a contaminated premises.
    A CWD positive animal is defined as an animal that has had a 
diagnosis of CWD confirmed by means of an official CWD test.
    A CWD positive herd is defined as any herd in which a CWD positive 
animal resided at the time it was diagnosed and which has not been 
released from quarantine.
    A CWD suspect animal is defined as an animal for which an APHIS 
employee has determined that laboratory evidence or clinical signs 
suggest a diagnosis of CWD.
    A herd plan is defined as a written herd management agreement 
developed by APHIS with input from the herd owner, State 
representatives, and other affected parties. A herd plan sets out the 
steps to be taken to eradicate CWD from a CWD positive 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 signs 
of disease; reporting to a State or APHIS representative of any signs 
of central nervous system disease in herd animals; 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, 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 
condition of the herd and its premises, including but not limited to: 
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; depopulation or selective culling of 
animals; restrictions on sharing and movement of possibly contaminated 
livestock equipment; cleaning and disinfection requirements, or other 
requirements. APHIS may review and revise a herd plan at any time 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.
    Materials is defined to identify types of articles on a premises 
that may spread CWD if exposed to a CWD positive animal. The definition 
of materials includes parts of barns or other structures, straw, hay, 
and other feed for animals, farm products or equipment, clothing, and 
any other articles on the premises that have been in contact with 
captive cervids.

[[Page 5927]]

    An official appraiser is a person authorized by APHIS (an APHIS 
official appraiser) or a State (a State official appraiser) to appraise 
animals for the purposes of this part. The official appraiser may be an 
APHIS employee, a State employee, or a professional livestock appraiser 
working under contract to APHIS or a State.
    An official CWD test is defined as any test for the diagnosis of 
CWD approved by the Administrator and conducted in a laboratory 
approved by the Administrator in accordance with Sec. 55.8, ``Official 
CWD tests and approval of laboratories to conduct official CWD tests.''
    The requirements of Sec. 55.8 regarding how APHIS will authorize 
official tests and approve laboratories to conduct them is essentially 
the same as requirements APHIS has established for this purpose in 
other animal disease programs, e.g., scrapie (9 CFR part 54) and 
pseudorabies (9 CFR part 52). They include requirements such as using 
test protocols provided by the National Veterinary Services 
Laboratories, and demonstrating that laboratories have the necessary 
equipment and personnel skills to properly conduct the tests listed in 
Sec. 55.8(a) and properly record and preserve test results data.

Payment of Indemnity

    We have determined that all of the factors discussed above--the 
danger of further spread of CWD, the relatively small number of herds 
currently infected with CWD, and the opportunity to limit the CWD 
problem before it escalates--make this an appropriate time to 
accelerate the CWD eradication effort by swift and thorough elimination 
of infected herds. Coordinated action at the Federal level will 
accelerate the efforts toward removal of infected cervids already 
underway at the State level. Therefore, in this interim rule, we are 
establishing regulations that will allow the Department to pay 
indemnity to owners of herds who destroy positive, exposed, or suspect 
animals. We are also authorizing payments to reimburse State animal 
health agencies that have paid indemnity to owners prior to the 
effective date of this rule, in accordance with cooperative agreements 
between the States and APHIS and the maximum indemnity amounts in this 
rule, to purchase and destroy positive, exposed, or suspect animals. 
APHIS has used such cooperative agreements with States to enhance the 
ability of State programs to contribute to the control of CWD. States 
will be reimbursed for their costs for indemnity payments to owners, 
and for associated carcass disposal and cleaning and disinfecting 
costs, as authorized in a cooperative agreement. These cooperative 
agreements will be quite restrictive, as our intent is not to reimburse 
States for all of the CWD indemnity payments they may choose to make in 
the future. This provision will only provide reimbursement for certain 
payments States made in support of Federal efforts to control CWD 
before Federal indemnity funds were available.
    Although the regulations being established will allow for the 
payment of indemnity by the Department, participation in the indemnity 
program will be entirely voluntarily for producers. Producers who 
choose not to have an eligible herd depopulated will not be required by 
APHIS to do so. However, State quarantines on CWD positive herds will 
probably serve as a strong incentive for participation.
    We intend to pay indemnity primarily for whole-herd depopulation of 
herds of captive cervids that are determined to be CWD positive. Given 
CWD's long incubation period, the absence of a live animal, pre-
clinical test, and our incomplete knowledge of CWD transmission, whole 
herd depopulation with no restocking on depopulated premises without 
APHIS approval appears to be the best option to prevent further spread 
of the disease once a positive diagnosis has been made. However, in the 
future we may develop alternative approaches to address situations 
where whole-herd depopulation is impractical or unnecessary. For 
example, better understanding of modes of transmission of CWD might 
make it possible to remove selected high risk animals rather than 
depopulating entire herds.
    We will also pay indemnity when APHIS removes individual animals 
from herds to euthanize them and test for CWD. We do this when animals 
have been identified as CWD suspect or exposed; e.g., we might remove 
and test animals from a herd that received animals from another herd 
that was later determined to be CWD positive.

Indemnity Program Guidelines for Producers

    Cervid producers who choose to take part in the indemnity program 
may apply for participation as of the effective date of this interim 
rule. The indemnity program will extend from the effective date of this 
interim rule until funds allocated for the program are depleted.
    The owner of any herd that is determined to be a CWD positive herd 
will be eligible to apply for payment of indemnity for depopulation.

Amount of Indemnity Payments and Conditions for Receiving Indemnity

    Subject to the availability of funding, the amount of indemnity 
payments for eligible animals will be determined by appraisal, with the 
indemnity payment set at 95 percent of the appraised value, with a cap 
on payments of $3,000 per animal. CWD positive herds will be appraised 
by an APHIS official appraiser and a State official appraiser jointly, 
or, if APHIS and State authorities agree that both appraisers are not 
needed for a given situation, by either a State official appraiser or 
an APHIS official appraiser alone. The appraised value of the cervids 
will be their fair market value as determined by the meat or breeding 
value of the animals. Animals may be appraised in groups, provided that 
where appraisal is by the head, each animal in the group is the same 
value per head, and where appraisal is by the pound, each animal in the 
group is the same value per pound.
    To make this indemnity program equitable for producers in all the 
States that might participate, we will reduce the Federal indemnity 
payment for an animal when indemnity payments for the same animal from 
non-Federal sources exceed 5 percent of its appraised value. The 
reduction in the Federal payment will equal the amount by which the 
non-Federal payments exceed 5 percent of the animal's appraised value. 
We are taking this action to prevent inequities that could reduce 
participation by owners who believe that the total Federal and non-
Federal payments offered to them is unfairly lower than payments 
offered in other States.
    Appraisals of cervids must be reported on forms furnished by APHIS 
and signed by the appraisers and the owner of the cervids. Reports of 
appraisals must show the number of cervids and the value per head or 
the weight and value by pound. We will not pay indemnity unless the 
owners have signed the appraisal form, indicating their agreement with 
the appraisals.
    As a condition of receiving indemnity, producers must sign a 
written agreement with APHIS in which they agree that if they maintain 
cervids in the future on their premises, they will maintain the animals 
in accordance with a herd plan developed by APHIS, and they will not 
introduce cervids to the premises until after the date specified in 
that herd plan. We are currently evaluating research to determine how 
to effectively clean and disinfect premises, and how long to wait 
before reintroducing cervids in order to

[[Page 5928]]

minimize risks of CWD transmission through the premises environment. We 
particularly seek public comments on these two points.
    After cervids are destroyed, their premises must be cleaned and 
disinfected. All structures on the premises, including barns, 
stockyards, and pens used to house the cervids, all cars and other 
conveyances used to transport the cervids, and the materials on those 
premises or conveyances must be cleaned and disinfected under the 
supervision of an APHIS employee or a State representative, using 
methods specified by the APHIS employee or a State representative, 
before being reused to house or convey cervids. Generally, the owners 
of the cervids for which indemnity is paid will be responsible for the 
costs of all cleaning and disinfection, except that APHIS or a State 
will pay for the cleaning and disinfection of conveyances used to 
transport the cervids to the disposal location. APHIS may also decide 
to pay the cost of cleaning and disinfecting premises when the 
procedures needed to conduct effective cleaning and disinfection are 
unusually extensive and require methods that are not normally available 
on a premises. For example, normal procedures would include washing 
surfaces with high-pressure hoses and disinfectants and burying or 
burning contaminated materials. Unusually extensive procedures would 
include, but are not limited to, disposing of contaminated materials by 
digestive disposal or high-temperature incineration.
    Owners who receive indemnity but then fail to comply with the 
cleaning and disinfection requirements, or the requirement not to 
reintroduce cervids to the premises for a period defined in the herd 
plan, will be in violation of the regulations and may be subject to 
civil or criminal penalties under 18 U.S.C. 1001, 21 U.S.C. 117 and 
122, or other statutory authorities. In addition, State governments are 
prepared to cooperate with APHIS to ensure compliance by using 
appropriate State quarantine authorities to prevent movement of cervids 
onto or from premises that have been exposed to CWD and have not been 
cleaned and disinfected. Such State cooperation will also help address 
situations where a premises exposed to CWD is sold to a new owner who 
has not signed a herd plan with APHIS; in such cases, many State animal 
health statutes allow States to exercise authority over the premises.
    Claims for indemnity for the value of animals destroyed must be 
documented on a form furnished by APHIS and presented to an APHIS 
employee or a State representative authorized to accept the claims. The 
owner of the animals must certify on the form that the animals covered 
either are or are not subject to any mortgage. If the owner states that 
there is a mortgage, the owner, and each person holding a mortgage on 
the animals, must sign forms furnished by APHIS consenting to the 
payment of indemnity to the owner or lienholder.
    APHIS will pay the reasonable costs of destruction and carcass 
disposal for animals that are indemnified. To obtain reimbursement for 
disposal costs, animal owners must obtain written approval of the 
disposal costs from APHIS, prior to disposal. Except in cases where 
APHIS or a State directly arranges for disposal, the owner of the 
animals must present an APHIS employee with a written contract or 
estimate of disposal costs. Prior to receiving reimbursement the owner 
must also present an APHIS employee with a copy of either a receipt for 
expenses paid by the owner or a bill for services rendered to the 
owner. Any bill for services rendered presented by the owner must not 
be greater than the normal fee for similar services provided by a 
commercial entity. APHIS does not intend to allow owners to personally 
dispose of carcasses on their premises, so this provision does not 
allow claims from owners for their own labor.
    This interim rule provides that no indemnity will be paid if the 
eligible animals have been moved or handled by the owner in violation 
of a law or regulation administered by the Secretary regarding animal 
disease, or in violation of a law or regulation for which the Secretary 
has entered into a cooperative agreement.
    At the option of APHIS, cervids for which we pay indemnity will be 
destroyed on their premises, moved to another location for destruction 
under conditions specified by APHIS, or moved to an approved research 
facility under conditions specified by APHIS.
    The carcasses of any cervids destroyed in accordance with this rule 
must be incinerated, destroyed in an alkaline hydrolysis tissue 
digestor, or disposed of by another method authorized by an APHIS 
employee and in accordance with local, State, and Federal laws. The 
carcasses may not be sold to be processed for human or animal food, 
including dietary supplements.

Emergency Action

    This rulemaking is necessary on an emergency basis to ensure that 
the CWD indemnity program is implemented as soon as possible to prevent 
the spread of CWD. Under these circumstances, the Administrator has 
determined that prior notice and opportunity for public comment are 
contrary to the public interest and that there is good cause under 5 
U.S.C. 553 for making this rule effective less than 30 days after 
publication in the Federal Register.
    We will consider comments we receive during the comment period for 
this interim rule (see DATES above). After the comment period closes, 
we will publish another document in the Federal Register. The document 
will include a discussion of any comments we receive and any amendments 
we are making to the rule as a result of the comments.

Executive Order 12866 and Regulatory Flexibility Act

    This 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.
    Below is a summary of the economic analysis for the chronic wasting 
disease indemnity program described in this document. The economic 
analysis provides a cost-benefit analysis as required by Executive 
Order 12866 and an analysis of the potential economic effects on small 
entities as required by the Regulatory Flexibility Act. A copy of the 
full economic analysis is available for review in our reading room 
(information on the location and hours of the reading room is listed 
under the heading ADDRESSES at the beginning of this document).
    We do not have enough data for a comprehensive analysis of the 
economic effects of this interim rule on small entities. Therefore, in 
accordance with 5 U.S.C. 603, we have performed an initial regulatory 
flexibility analysis for this interim rule. We are inviting comments 
about this interim rule as it relates to small entities. In particular, 
we are interested in determining the number and kind of small entities 
who may incur benefits or costs from implementation of this rule and 
the economic impact of those benefits or costs.
    In accordance with 21 U.S.C. 111-113, 114a, 115, 117, 120, 123, and 
134a, the Secretary of Agriculture has the authority to promulgate 
regulations and take measures to prevent the introduction into the 
United States and the interstate dissemination within the United States 
of communicable diseases of livestock and poultry, and to pay claims 
growing out of the destruction of animals. Animal health regulations 
promulgated by the Department under

[[Page 5929]]

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.

Program Description and Benefits

    CWD is recognized to cause considerable and growing economic 
losses. The Secretary of Agriculture has authorized the transfer of 
$2.65 million in funds from the Commodity Credit Corporation to begin 
conducting a CWD indemnity program. Most of this money will be used for 
indemnity costs, and the remainder will be used for euthanasia, 
transport, disposal, cleanup, and surveillance. Payment of indemnity 
will be based on fair market value, and the amount paid per cervid will 
likely fluctuate during the course of the CWD indemnity program. 
Participation may be limited if funds are exhausted due to increases in 
the fair market value above our current estimates. Since this is a 
voluntary indemnity program, some eligible producers may not choose to 
participate.
    This interim rule provides Federal indemnification of up to $3,000 
per animal for the depopulation of CWD positive, CWD exposed, or CWD 
suspect captive cervids. Previously, there was no such indemnification 
program.
    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 cervid 
population. However, sampling in a limited area where CWD is known to 
exist in wildlife--i.e., northern Colorado, southern Wyoming, and 
southwestern Nebraska--has suggested an infection rate of 15 percent 
among wild mule deer and 2 percent among wild elk. For captive cervids, 
the number of deaths to date has been relatively low. Based on 
nonmandatory stock sale and disease report records kept by industry 
associations, it is estimated that fewer than 50 farmed elk, and no 
farmed deer, have died as a result of contracting CWD.\1\ The number of 
captive elk that have died is equivalent to less than one-tenth of 1 
percent of the current U.S. captive elk population, estimated at 
110,000. However, for every infected animal, far more have been exposed 
to the disease.
---------------------------------------------------------------------------

    \1\ Source: NADeFA and NAEBA.
---------------------------------------------------------------------------

    Limited hard statistical data exist on the deer and elk farming 
industries, mostly compiled by the two major industry associations--the 
North American Elk Breeders Association (NAEBA) and the North American 
Deer Farmers Association (NADeFA). Deer and elk farms are not included 
as a separate line item in the most recent agricultural census data.
    NAEBA estimates that there are about 110,000 elk on 2,300 U.S. 
farms. The number of elk per farm varies, from a high of about 700 (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. NAEBA, which 
maintains detailed records of average sale prices to assist their 
members in business planning, estimates that the average value of each 
elk is $2,000, with the typical high-end value at about $5,000.\2\ 
Based on the average of $2,000 per animal, the value of all 110,000 elk 
on U.S. farms is estimated at $220 million (110,000  x  $2,000). In 
1999, gross receipts for the elk farming and velvet antler industry in 
North America totaled an estimated $150 million.\3\
---------------------------------------------------------------------------

    \2\ Gross receipts data for the United States, as a separate 
entity within North America, are not available.
    \3\ Source: NAEBA.
---------------------------------------------------------------------------

    NADeFA estimates that there are between 100,000 and 150,000 deer on 
approximately 2,000 U.S. farms. The number of deer per farm varies, 
from a high of about 3,000 (for commercial farms) to a low of about 5 
(for hobby farms). The value of each deer also varies, depending on 
such factors as the type of animal (e.g., wapiti, white-tailed, 
fallow). NADeFA estimates the value of all 66,172 deer on its member 
farms at $111.6 million, an average of $1,687 per animal. At the high 
end, wapiti deer are valued at $4,000 each; fallow deer are at the low 
end, with a value of $375 each. NADeFA-member revenues from deer or 
deer products are estimated at $5.4 million annually, with sales of 
livestock comprising 41 percent, or $2.2 million, of that amount. 
NADeFA members have 527 employees, and operate on 65,032 acres of 
fenced land valued at $38.8 million.\4\
---------------------------------------------------------------------------

    \4\ Source: NADeFA.
---------------------------------------------------------------------------

    This action will provide herd owners with a financial incentive to 
identify and destroy their CWD positive, exposed, and suspect animals, 
thus arresting the spread of the disease and accelerating eradication 
efforts. Those producers not engaging in surveillance of their herds 
would have incentive to do so. Several benefits flow from this action. 
First, it will reduce costs to the elk and deer industries from animal 
mortality, reductions in per animal breeding, meat, and recreation 
values from being associated with an infected herd, costs from possible 
State regulatory actions, and trade restrictions on U.S. elk, deer, and 
related product exports. Second, this action will also help reduce the 
possibility of cross-species transmission. Third, an accelerated 
program now, while the number of known infected herds is small, may 
obviate the need for higher future Federal costs to contain a more 
widespread outbreak.
    While the number of captive cervids that have died from or are 
infected with CWD is currently small, it is possible that the number 
could quickly expand. Based on the rate of increase in the number of 
infected herds in recent years, APHIS estimates that without improved 
CWD control efforts, the disease could infect almost the entire U.S. 
captive elk herd over the next 15-20 years. This estimate is based on 
an unpublished study by the APHIS Centers for Epidemiology and Animal 
Health that employed informal growth rate models based on the limited 
available data. Data is limited because the spread of CWD has been 
closely studied for only a few years, but the 15-20 year estimate takes 
into account CWD spread patterns in both the United Sates and Canada. 
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 resulted in the 
Canadian government buying and destroying 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 become established in 
most U.S. herds within 15 years. Hence, we feel that almost the entire 
U.S. elk herd, currently valued at an estimated $220 million, is at 
risk. The value of animals from herds known to be infected are sharply 
discounted compared to animals from CWD-free herds. Action now could 
protect substantial industry assets. CWD has not been diagnosed in 
captive deer except in association with positive captive elk, so 
comparable projections of savings are not available for the captive 
deer industry.
    Other benefits would be expected from this action. Eradication of 
CWD may save owners of infected herds

[[Page 5930]]

future costs from State-imposed quarantines and other restrictions on 
the subsequent agricultural use of their land, actions which many view 
as tantamount to closure.
    This action would also reduce the impact, felt by owners of 
infected and non-infected animals, of trade restrictions due to CWD. 
South Korea and Japan temporarily suspended all imports of deer and 
deer products (including antler velvet) from the United States and 
Canada. Cervid exports to Canada also must meet CWD-specific Canadian 
import requirements.
    This rule will also produce third-party trade benefits by 
demonstrating to trading partners the intent and ability of the United 
States to protect its animal industries, thus easing ability to 
negotiate access to foreign markets.
    A further benefit of the rule is to reduce the potential for any 
transmission of CWD across species. While current evidence does not 
indicate much risk of such transmission, much remains unknown about the 
CWD disease agent.
    If producers participate in this program, this action would also 
help reduce potential future eradication program costs. As cited 
earlier, Government costs to operate the scrapie eradication program 
may have been reduced with more aggressive action upon initial 
diagnoses. Similarly, the Canadian Government estimates that delayed 
action has increased its eradication program costs.

Costs

    Under this interim rule, subject to available funding, cervid herd 
owners would be eligible for Federal indemnity payments equal to 95 
percent of the appraised value of each animal, up to a cap of $3,000 
per animal, when they destroy their eligible CWD positive, CWD exposed, 
or CWD suspect animals. Currently, there are an estimated 1,500 CWD 
positive or CWD exposed captive elk in the United States, spread among 
7 herds (including 1 herd with approximately 700 affected elk). 
Assuming an average indemnity payment of $1,900 per animal (i.e., 95 
percent of the $2,000 average value of each captive elk), APHIS' 
indemnity liability, based on the number of elk now known to be 
infected or exposed, would be $2.85 million (1,500 x $1,900). We may 
also request additional funding, if needed, to complete the indemnity 
program in the future.
    Due to limited funding for surveillance and other initiatives, the 
full extent of infection in captive cervids is unknown. It is likely 
that there are some infected herds that have not been detected, and 
that additional funds would have to be expended to indemnify owners for 
the destruction of these animals. It is also possible that 
imperfections in our current state of knowledge about CWD e.g., how to 
effectively clean and disinfect premises, or exactly how long an 
infected premises should lie fallow before restocking with elk--may 
result in elk on restocked premises becoming infected with CWD, causing 
additional indemnity to be paid.

Options Considered

    In assessing the need for this interim rule, we identified three 
alternatives. The first was to maintain the status quo, where State 
efforts are supported by Federal technical assistance but not by 
Federal compensation programs or interstate movement restrictions. We 
rejected this option because it does not fully address the animal 
disease risks associated with CWD. While States generally have 
authority to quarantine a herd once it is known to be infected with 
CWD, they may lack the legal authorities, infrastructure, and resources 
for comprehensive testing and traceback programs to identify newly 
infected herds. States also lack authority to directly regulate 
interstate commerce in elk. Finally, while State quarantines are an 
important tool, quarantining a herd does not eliminate the risk posed 
by the herd, since people may deliberately or accidentally violate the 
quarantine. Making Federal indemnity funds available serves as a 
powerful incentive for owners of quarantined herds to depopulate, 
eliminating the risk of further spread of CWD from the herd.
    The second option would have been to provide financial and 
technical assistance to the cervid industry for continuation and 
expansion of a variety of herd management practices to reduce or 
eliminate CWD. Although this option may be less costly than the option 
we chose, option 3 below, we did not select it because it does not 
allow us to advance CWD eradication as quickly or effectively as the 
chosen option. However, APHIS will continue to work with industry to 
develop voluntary herd management practices to preserve and increase 
the reduction in CWD levels that the indemnity program is expected to 
achieve.
    The third option, to provide indemnity payments to depopulate CWD-
infected herds, was the one we chose. Given our current understanding 
of the disease, depopulation of infected herds is currently the most 
effective way to eliminate CWD. Under this alternative, producers will 
gain partial compensation for animals in CWD positive herds. These 
animals are often unable to be sold at prices anywhere near the price 
brought by similar animals from herds that are not CWD positive.

Potential Impact on Small Entities

    This interim rule establishes a voluntary program that allows 
cervid producers to be paid indemnity for CWD positive, CWD exposed, or 
CWD suspect animals. Many producers, as well as a number of slaughter 
plants that process cervids, may be small businesses.
    To the extent that the interim rule contributes to the elimination 
of CWD in captive cervid herds in the United States, all herd owners 
should benefit over the long term. In the short term, the economic 
impact on herd owners will vary. In most cases, the payment of 
indemnity will allow owners to recoup much of the value of destroyed 
animals. In cases where the animals destroyed are highly valuable 
breeding stock, the authorized indemnity payments will fall far short 
of the potential value of such animals if they were CWD free; however, 
in the real market, a breeding elk from highly regarded stock loses 
almost all of its value if it is suspected of being infected with CWD. 
Another variable arises in view of the fact that, while indemnity 
payments may cover the full market value of an animal, an owner may 
face additional costs associated with cleaning and disinfecting 
premises, delays in restocking, and complying with herd plan conditions 
for a restocked herd (identification and health monitoring 
requirements, etc.). The cost of cleaning and disinfection will vary 
with the size and characteristics of the premises. The costs caused by 
delayed restocking and herd plan conditions would also vary depending 
on the nature of the owner's business operations.
    The number and size of the affected herd owners is unknown. 
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 the United States. 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 
cervids 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 were $105,624, well below the SBA's small entity 
threshold

[[Page 5931]]

of $750,000 for farms in that NAICS category.\5\
---------------------------------------------------------------------------

    \5\ Source: 1997 Census of Agriculture and SBA.
---------------------------------------------------------------------------

    This interim rule contains various recordkeeping and reporting 
requirements. These requirements are described in this document under 
the heading ``Paperwork Reduction Act.''

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule: (1) Preempts all State and local laws and 
regulations that are in conflict with this rule; (2) has no retroactive 
effect; and (3) does not require administrative proceedings before 
parties may file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(j) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this interim rule have been 
submitted for emergency approval to the Office of Management and Budget 
(OMB). OMB has assigned control number 0579-0189 to the information 
collection and recordkeeping requirements.
    We plan to request continuation of that approval for 3 years. 
Please send written comments on the 3-year approval request to the 
following addresses: (1) Office of Information and Regulatory Affairs, 
OMB, Attention: Desk Officer for APHIS, Washington, DC 20503; and (2) 
Docket No. 00-108-1, Regulatory Analysis and Development, PPD, APHIS, 
suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please 
state that your comments refer to Docket No. 00-108-1 and send your 
comments within 60 days of publication of this rule.
    This interim rule establishes regulations to provide for the 
payment of indemnity by the Department for the voluntary depopulation 
of CWD positive, exposed, or suspect animals. In order to take part in 
the indemnity program, cervid producers must apply for participation, 
must sign a payment, appraisal, and agreement form, and must certify as 
to whether any other parties hold mortgages on the herd. Implementing 
this program will entail the use of two information collection 
activities: an Appraisal/ Indemnity Claim Form, and a Herd Plan 
Agreement. We are soliciting comments from the public (as well as 
affected agencies) concerning our information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the 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 
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 1 hour per response.
    Respondents. Cervid herd owners, State personnel who perform 
appraisal work.
    Estimated annual number of respondents. 10.
    Estimated annual number of responses per respondent. 1.
    Estimated annual number of responses. 10.
    Estimated total annual burden on respondents. 10. (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.

List of Subjects in Part 55

    Animal diseases, Cervids, Chronic wasting disease, Deer, Elk, 
Indemnity payments, Transportation.

    Accordingly, we are amending 9 CFR, chapter I, subchapter B, by 
adding a new part 55 to read as follows:

PART 55 CONTROL OF CHRONIC WASTING DISEASE

Sec.
55.1   Definitions.
Subpart A--Chronic Wasting Disease Indemnification Program
55.2   Payment of indemnity.
55.3   Appraisal and destruction of captive cervids.
55.4   Disinfection of premises, conveyances, and materials.
55.5   Presentation of claims for indemnity.
55.6   Mortgage against animals.
55.7   Claims not allowed.
55.8   Official CWD tests and approval of laboratories to conduct 
official CWD tests.

Subpart B--[RESERVED]

    Authority: 21 U.S.C. 111-113, 114, 114a, 114a-1, 120, 121, 125, 
and 134b; 7 CFR 2.22, 2.80, and 371.4.


Sec. 55.1  Definitions.

    Administrator. The Administrator, Animal and Plant Health 
Inspection Service, or any other employee of the Animal and Plant 
Health Inspection Service, United States Department of Agriculture, 
delegated to act in the Administrator's stead.
    Animal. Any captive cervid.
    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 
space. Animals that are held for research purposes are not included.
    Cervid. All members of the family Cervidae and hybrids, including 
deer, elk, moose, caribou, reindeer, and related species.
    Chronic wasting disease, CWD. A transmissible spongiform 
encephalopathy of cervids.
    CWD exposed animal. An animal that is part of a CWD positive herd, 
or that was part of a herd within 5 years prior to that herd's 
designation as CWD positive, or an animal that has been housed with or 
been in direct contact with a positive animal, or an animal that has 
been on a contaminated premises.
    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.
    Department. The United States Department of Agriculture.
    Herd. A group of animals that are:
    (1) Under common ownership or supervision and are grouped on one or 
more parts of any single premises (lot, farm, or ranch) or

[[Page 5932]]

    (2) 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.
    Herd plan. A written herd management agreement developed by APHIS 
with input from the herd owner, State representatives, and other 
affected parties. A herd plan sets out the steps to be taken to 
eradicate CWD from a CWD positive 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 signs of disease; reporting 
to a State or APHIS representative of any signs of central nervous 
system disease in herd animals; 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, 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 condition of the herd and 
its premises, including but not limited to: 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; 
depopulation or selective culling of animals; restrictions on sharing 
and movement of possibly contaminated livestock equipment; cleaning and 
disinfection requirements, or other requirements. APHIS may review and 
revise a herd plan at any time 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.
    Materials. Parts of barns or other structures, straw, hay, and 
other feed for animals, farm products or equipment, clothing, and any 
other articles on the premises that have been in contact with captive 
cervids.
    Mortgage. Any mortgage, lien, or other security or beneficial 
interest held by any person other than the one claiming indemnity.
    Official appraiser (APHIS official appraiser, State official 
appraiser). A person authorized by APHIS (an APHIS official appraiser) 
or a State (a State official appraiser) to appraise animals for the 
purposes of this part. An official appraiser may be an APHIS employee, 
a State employee, or a professional livestock appraiser working under 
contract to APHIS or a State.
    Official CWD test. Any test for the diagnosis of CWD approved by 
the Administrator and conducted in a laboratory approved by the 
Administrator in accordance with Sec. 55.8 of this part.
    Person. Any individual, corporation, company, association, firm, 
partnership, society, joint stock company, or other legal entity.
    Secretary. The Secretary of Agriculture of the United States, or 
any officer or employee of the Department delegated to act in the 
Secretary's stead.
    State. Each of the States of the United States, the District of 
Columbia, Puerto Rico, the Northern Mariana Islands, Guam, the Virgin 
Islands of the United States, or any other territory or possession of 
the United States.
    State representative. A person regularly employed in the animal 
health work of a State and who is authorized by that State to perform 
the function involved under a cooperative agreement with the United 
States Department of Agriculture.
    Veterinarian in charge. 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.

Subpart A--Chronic Wasting Disease Indemnification Program


Sec. 55.2  Payment of indemnity.

    The Administrator is authorized to pay for the purchase and 
destruction of CWD positive animals, CWD exposed animals, and CWD 
suspect animals. Subject to available funding, the amount of the 
Federal payment for any such animals will be 95 percent of the 
appraised value established in accordance with Sec. 55.3 of this part, 
but the Federal payment shall not exceed $3,000 per animal. If a non-
Federal source makes a payment for an animal for which a Federal 
indemnity is paid, and the non-Federal payment exceeds 5 percent of the 
appraised value established in accordance with Sec. 55.3 of this part, 
the amount of the Federal payment for any such animals will be reduced 
by the amount by which the non-Federal payment exceeds 5 percent of the 
appraised value. The Administrator is also authorized to reimburse 
State governments or State animal health agencies for payments they 
make for the purchase and destruction, on or after October 1, 2001, of 
CWD positive animals, CWD exposed animals, and CWD suspect animals, and 
for State expenditures for associated carcass disposal and cleaning and 
disinfection costs resulting from such purchase and destruction, in 
accordance with cooperative agreements signed by the Administrator and 
the duly authorized agent of the State.


Sec. 55.3  Appraisal and destruction of captive cervids.

    (a) CWD positive herds, or individual CWD suspect animals or 
exposed animals removed by APHIS from a herd for testing, will be 
appraised by an APHIS official appraiser and a State official appraiser 
jointly, or, if APHIS and State authorities agree, by either a State 
official appraiser or an APHIS official appraiser alone.
    (b) The appraisal of cervids will be the fair market value as 
determined by the meat or breeding value of the animals. Animals may be 
appraised in groups, provided that where appraisal is by the head, each 
animal in the group is the same value per head, and where appraisal is 
by the pound, each animal in the group is the same value per pound.
    (c) Appraisals of cervids must be reported on forms furnished by 
APHIS and signed by the appraisers, and signed by the owner of the 
cervids to indicate agreement with the appraisal amount. Reports of 
appraisals must show the number of cervids and the value per head or 
the weight and value by pound.
    (d) In accordance with instructions from an APHIS employee, cervids 
for which indemnification is sought must be:
    (1) Destroyed on the premises where they are held, pastured, or 
penned at the time indemnity is approved;
    (2) Moved to another location for destruction under conditions 
specified by the APHIS employee; or
    (3) Moved to an approved research facility under conditions 
specified by the APHIS employee.
    (e) The carcasses of any cervids destroyed in accordance with this 
part are authorized by the Administrator to be incinerated, destroyed 
in an alkaline hydrolysis tissue digestor, or disposed of by any other 
method authorized by an APHIS employee and in accordance with local, 
State, and Federal laws. APHIS will pay the reasonable costs of 
destruction and carcass disposal for animals that are indemnified. To 
obtain reimbursement for disposal costs, animal owners must obtain 
written approval of the disposal costs from APHIS, prior to disposal. 
Except in cases where APHIS or a State directly arranges for disposal, 
the owner of the animals must present an APHIS employee with a written 
contract or estimate of disposal costs. Prior to

[[Page 5933]]

receiving reimbursement, the owner must also present an APHIS employee 
with a copy of either a receipt for expenses paid by the owner or a 
bill for services rendered to the owner. Any bill for services rendered 
presented by the owner must not be greater than the normal fee for 
similar services provided by commercial entities. The carcasses of 
cervids destroyed in accordance with this section may not be sold to be 
processed for human or animal food, including dietary supplements.


(Approved by the Office of Management and Budget under control number 
0579-0189).


Sec. 55.4  Disinfection of premises, conveyances, and materials.

    After cervids are destroyed in accordance with this part, all 
premises, including barns, stockyards and pens, all cars and other 
conveyances, and all other materials on any premises or conveyances 
used to house or transport such cervids must be cleaned and disinfected 
under the supervision of an APHIS employee or a State representative, 
using methods specified by the APHIS employee or a State 
representative. Premises may not be restocked with cervids until after 
the date specified in the herd plan required by Sec. 55.7(b) of this 
part. The owner to whom the indemnity is paid will be responsible for 
expenses incurred in connection with the cleaning and disinfection, 
except that APHIS or a State will pay for cleaning and disinfection of 
the conveyances used to transport the cervids to the location of 
disposal. However, APHIS may also decide to pay the cost of cleaning 
and disinfecting premises when the procedures needed to conduct 
effective cleaning and disinfection are unusually extensive and require 
methods that are not normally available on a premises. For example, 
normal procedures would include washing surfaces with high-pressure 
hoses and disinfectants and burying or burning contaminated materials. 
Unusually extensive procedures would include disposing of contaminated 
materials by digestive disposal or high-temperature incineration.


Sec. 55.5  Presentation of claims for indemnity.

    Claims for indemnity for the value of animals destroyed must be 
documented on a form furnished by APHIS and presented to an APHIS 
employee or a State representative authorized to accept the claims.


(Approved by the Office of Management and Budget under control number 
0579-0189).


Sec. 55.6  Mortgage against animals.

    When cervids have been destroyed under this part, any claim for 
indemnity must be presented on forms furnished by APHIS. The owner of 
the cervids must certify on the forms that the cervids covered are, or 
are not, subject to any mortgage as defined in this part. If the owner 
states there is a mortgage, the owner and each person holding a 
mortgage on the cervids must sign, consenting to the payment of 
indemnity to the person specified on the form.


(Approved by the Office of Management and Budget under control number 
0579-0189).


Sec. 55.7  Claims not allowed.

    (a) The Department will not allow claims arising out of the 
destruction of cervids unless the cervids have been appraised as 
prescribed in this part and the owners have signed the appraisal form 
indicating agreement with the appraisal amount as required by 
Sec. 55.3(c) of this part.
    (b) The Department will not allow claims arising out of the 
destruction of cervids unless the owners have signed a written 
agreement with APHIS in which they agree that if they maintain cervids 
in the future on the premises used for cervids for which indemnity is 
paid, they will maintain the cervids in accordance with a herd plan and 
will not introduce cervids onto the premises until after the date 
specified in that herd plan. Persons who violate this written agreement 
may be subject to civil and criminal penalties.
    (c) The Department will not allow claims arising out of the 
destruction of cervids that have been moved or handled by the owner or 
a representative of the owner in violation of a law or regulation 
administered by the Secretary regarding animal disease, or in violation 
of a law or regulation for which the Secretary has entered into a 
cooperative agreement.


(Approved by the Office of Management and Budget under control number 
0579-0189).


Sec. 55.8  Official CWD tests and approval of laboratories to conduct 
official CWD tests.

    (a) An official CWD test is:
    (1) Histopathological examination of central nervous system (CNS) 
tissues from the animal for characteristic microscopic lesions of CWD, 
using test protocols provided by the National Veterinary Services 
Laboratories (NVSL);
    (2) The use of proteinase-resistant protein analysis methods 
including but not limited to immunohistochemistry and/or western 
blotting on CNS and/or peripheral tissue samples from a live or a dead 
animal, using test protocols provided by NVSL; or
    (3) Any other test method approved by the Administrator in 
accordance with this section.
    (b) The Administrator may approve new tests for the diagnosis of 
CWD conducted on live or dead animals, and will base the approval or 
disapproval of a test on the evaluation by APHIS and, when appropriate, 
outside scientists, of:
    (1) A standardized test protocol that must include a description of 
the test, a description of the reagents, materials, and equipment used 
for the test, the test methodology, and any control or quality 
assurance procedures;
    (2) Data to support reproducibility, that is, the ability to 
reproduce the same result repeatedly on a given sample;
    (3) Data to support suitability, that is, data to show that similar 
results can be produced when the test is run at other laboratories;
    (4) Data to support the sensitivity and specificity of the test; 
and
    (5) Any other data requested by the Administrator to determine the 
suitability of the test for program use.
    (c) Specific protocols for official CWD tests are available upon 
request to NVSL.
    (d) State, Federal, and university laboratories will be approved by 
the Administrator to conduct official CWD tests when he or she 
determines that the laboratory:
    (1) Employs personnel assigned to supervise the testing who are 
qualified to conduct the test based on education, training, and 
experience and who have been trained by NVSL or who have completed 
equivalent training approved by NVSL;
    (2) Has adequate facilities and equipment to conduct the test;
    (3) Follows standard test protocols;
    (4) Meets check test proficiency requirements;
    (5) Meets recordkeeping requirements;
    (6) Will retain records, slides, blocks, and other specimens from 
all cases for at least 1 year and from positive cases for 5 years;
    (7) Will allow APHIS to inspect \1\ the laboratory without notice 
during normal business hours; and
---------------------------------------------------------------------------

    \1\ An inspection may include, but is not limited to, review and 
copying of records, examination of slides, observation of the test 
being conducted, and interviewing of personnel.
---------------------------------------------------------------------------

    (8) Will report all test results to State and Federal animal health 
officials within agreed timeframes.

[[Page 5934]]

    (e) The Administrator may withdraw approval of any laboratory for 
failure to meet any of the conditions required by paragraph (d) of this 
section. The Administrator shall give written notice of the proposed 
withdrawal to the director of the laboratory and shall give the 
director an opportunity to respond. If there are conflicts as to any 
material fact concerning the reason for withdrawal, a hearing will be 
held to resolve the conflicts. The hearing will be conducted in 
accordance with rules of practice that will be adopted by the 
Administrator for the proceeding.

    Done in Washington, DC, this 5th day of February, 2002.
James G. Butler,
Acting Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 02-3081 Filed 2-7-02; 8:45 am]
BILLING CODE 3410-34-U