[Federal Register Volume 67, Number 229 (Wednesday, November 27, 2002)]
[Proposed Rules]
[Pages 70864-70875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30093]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 71

[Docket No. 99-017-1]
RIN 0579-AB13


Blood and Tissue Collection at Slaughtering Establishments

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to establish requirements for the collection 
of blood and tissue samples from livestock (horses, cattle, bison, 
captive cervids, sheep and goats, swine, and other farm animals) and 
poultry at slaughtering establishments when it is necessary for disease 
surveillance. We also propose that any person who moves or causes the 
movement of livestock or poultry interstate for slaughter may only move 
the animals to a slaughtering establishment that has been listed by the 
Administrator. The Administrator would list a slaughtering 
establishment after determining that the establishment provides the 
type of space and facilities specified by the regulations to safely 
collect blood and tissue samples for disease testing. The actual 
testing of samples could occur either at the establishment or at 
another location, as determined by the Administrator. Alternatively, 
the Administrator could list a slaughtering establishment that does not 
supply such space and facilities if the Administrator determines that 
it is not necessary to conduct testing of animals slaughtered at the 
establishment because the data collected through such testing would not 
significantly assist APHIS disease surveillance programs.
    This collection of blood and tissue samples would enable us to 
identify animals at slaughter that are affected by various communicable 
diseases of concern. This change would affect persons moving livestock 
or poultry interstate for slaughter, slaughtering plants that receive 
animals in interstate commerce, and, in cases where test-positive 
animals are successfully traced back to their herd or flock of origin, 
the owners of such herds or flocks. The long-term effects of this 
change would be to improve surveillance programs for animal diseases 
and to contribute to the eventual control or eradication of such 
diseases.

DATES: We will consider all comments that we receive on or before 
January 27, 2003.

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. 99-017-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1231. Please state 
that your comment refers to Docket No. 99-017-1. 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. 
99-017-1'' 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. Adam Grow, National Animal Health 
Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1231; 
(301) 734-4363.

SUPPLEMENTARY INFORMATION:

Background

    The Animal and Plant Health Inspection Service (APHIS), U.S. 
Department of Agriculture (USDA), has many programs to protect the 
health of livestock and poultry in the United States. These include 
programs to prevent endemic diseases and pests from spreading within 
the United States and programs to prevent the introduction of foreign 
animal diseases, as well as programs to control or eradicate certain 
animal diseases from the United States.
    Regulations governing the interstate movement of animals for the 
purpose of preventing the dissemination of animal diseases within the 
United States are contained in 9 CFR, subchapter C--``Interstate 
Transportation of Animals (Including Poultry) and Animal Products.''
    The legal authority for USDA to conduct testing was recently 
restated in the Animal Health Protection Act of 2002 (Subtitle E of the 
Farm Security and Rural Investment Act of 2002, Public Law 107-171). 
Section 10409 states that the Secretary of Agriculture ``may carry out 
operations and measures to detect, control, or eradicate any pest or 
disease of livestock (including the drawing of blood and diagnostic 
testing of animals), including animals at a slaughterhouse, stockyard, 
or other point of concentration.''

Proposed Changes to the Regulations

    We are proposing to amend the regulations in subchapter C, part 71, 
``General Provisions,'' to provide for the collection of blood and 
tissue samples from livestock (horses, cattle, bison, captive cervids, 
sheep and goats, swine, and other farmed animals) and poultry at 
slaughter. We propose to require that persons moving livestock and 
poultry interstate for slaughter may only move the animals to 
slaughtering establishments that have been listed by the Administrator 
of APHIS. We do not

[[Page 70865]]

propose to collect samples from all livestock or poultry at slaughter, 
but to collect samples whenever we believe it is necessary for 
effective surveillance. Some establishments slaughter relatively few 
animals, or process animals that are not susceptible to testing (e.g., 
sheep and goats that are too young to test for scrapie), or receive 
animals from sources for which we already have sufficient 
epidemiological data, and it would not substantially aid our 
surveillance to require testing at these establishments. Therefore, the 
Administrator would list some establishments to receive livestock or 
poultry without conducting testing at those establishments. For 
establishments where it is necessary to conduct testing, the 
Administrator would list the establishment only if it allows APHIS, 
FSIS, or APHIS contractors to collect blood and tissue samples from 
animals at the establishment. To be listed, a slaughtering 
establishment where testing is required would have to grant access to 
the personnel conducting the tests and provide certain space and 
equipment necessary to collect and process test samples. Slaughtering 
establishments that are not listed could not receive livestock moving 
in interstate commerce.
    In conjunction with this rulemaking, APHIS will develop a list of 
slaughtering establishments. Establishments will not have to actively 
contact APHIS in order to be placed on the list; APHIS will contact the 
plants where we intend to collect samples, and work with them to meet 
the requirements for listing. APHIS will list all plants that meet the 
qualifications, and will also list those plants at which APHIS has 
determined sample collection is not needed. There are 1,341 meat 
packing firms included in the North American Industry Classification 
System (NAICS) code of 311611, of which 1,260 are small businesses. 
Many of these small businesses are local operations that do not receive 
animals moving interstate, and thus do not need to be listed. We expect 
to conduct sampling at roughly 50 to 100 of the 1341 meat packing firms 
included in NAICS 311611. Since some of these firms have multiple 
plants, testing could occur at several hundred plants. In almost all 
cases, some testing already occurs at these plants; this rule would 
allow us to increase the level of testing as needed. While we will 
focus primarily on testing at the plants of large business firms, we 
will also test at some small plants, as necessary to ensure a valid 
representative sample for disease surveillance.
    We are particularly seeking comments on the standards APHIS should 
apply in identifying the plants where APHIS should conduct sampling. 
Our goal is to collect samples at a representative number of plants in 
each region, so that sample testing will provide a statistically valid 
nationwide profile of diseased animals sent to slaughter plants. 
Because sample collection imposes some financial and operational burden 
on plants, we wish to keep the number of plants sampled down to the 
minimum number required to provide the data we need. Therefore, we urge 
commenters to address how APHIS should select plants for sampling; 
e.g., their size, fraction of the regional market, proximity to other 
sampled plants, source of animals, and other characteristics.
    The provisions regarding the collection of blood and tissue samples 
would be set out in a new Sec.  71.21, ``Tissue and blood testing at 
slaughter.''
    In Sec.  71.1, we would amend the definition of livestock so that 
it includes horses, cattle, bison, captive cervids, sheep and goats, 
swine, and other farmed animals. (We would not include non-captive 
cervids in the definition because most such animals that go to 
slaughter plants are brought there by hunters, to a local slaughter 
plant, and do not thereafter move interstate in commerce. Also, the 
hunters generally gut and clean the animals in the field, reducing the 
opportunity to collect useful samples.)
    We would also define recognized slaughtering establishment to be 
``Any slaughtering establishment operating under the provisions of the 
Federal Meat Inspection Act (21 U.S.C. 601 et seq.) or a State meat 
inspection act. A list of recognized slaughtering establishments in any 
State may be obtained from an APHIS representative, the State animal 
health official, or a State representative.'' This definition is 
consistent with other APHIS and FSIS regulations addressing 
slaughtering plants. We need this defined term as part of the 
explanation in Sec.  71.21 of what types of establishments must be 
listed by the Administrator for interstate movement. Listing applies to 
both recognized slaughtering establishments, which are under mandatory 
inspection under the Federal Meat Inspection Act, and other specialty 
plants (e.g., for cervids and bison) that undergo voluntary inspection 
under the provisions of the Agricultural Marketing Act (12 U.S.C. 1141 
et seq.)).
    We would also add a definition of move (moved) to Sec.  71.1, to 
make it clear that the requirements of the rule would apply to both 
persons transporting livestock and poultry and persons who cause the 
livestock or poultry to be moved. This definition, which is identical 
to one used in part 78 of our regulations, would read ``Shipped, 
transported, delivered, or otherwise aided, induced, or caused to be 
moved.''
    We propose that the Administrator may list slaughtering 
establishments either when sample collection and testing is not needed 
at them to meet APHIS epidemiological surveillance needs, or when 
testing is needed and the establishment meets the following standards 
with regard to sample collection activities. The slaughtering plant 
would have to allow APHIS, FSIS, or APHIS contractors to collect and 
record any individual animal identification on animals, retain any 
identification devices on or in the animals (backtags, electronic 
implants, etc.), and take tissue and blood samples from animals at the 
facility. Slaughtering plants must allow samples to be collected at no 
cost to the United States; that is, they would not be able to charge 
the government for access to collect samples, or for the value of the 
samples collected. These are the basic tasks that need to be performed 
to test the animals for disease and collect the information that may be 
needed to trace back the animals.
    In terms of the specific space for sample collection activities, 
the slaughtering plant would have to space where samples could be 
safely and efficiently collected. The plant would have to provide 
office and sample collection space, including necessary furnishings, 
light, heat, and janitor service, rent free, for use by APHIS, FSIS, or 
APHIS contractors collecting samples for blood and tissue testing. At 
the discretion of the Administrator, small plants would not have to 
furnish facilities if adequate facilities exist in a nearby convenient 
location. The space provided by the slaughtering establishment would be 
subject to the approval of the Administrator. In many cases the 
facilities that establishments already provide for use by FSIS will 
also suffice for additional sample collection conducted under this 
proposed rule.
    When approving the space provided by a slaughtering plant in which 
testing is required, the Administrator would consider whether the 
space:
    1. Is conveniently located, properly ventilated, and provided with 
lockers suitable for the protection and storage of supplies;
    2. Has sufficient light to be adequate for proper conduct of sample 
collection and processing;

[[Page 70866]]

    3. Includes racks, receptacles, or other suitable devices for 
retaining such parts as the head, glands, and viscera, and all parts 
and blood to be collected, until after the post-mortem examination is 
completed;
    4. Includes tables, benches, and other equipment on which sample 
collection and processing are to be performed, of such design, 
material, and construction as to enable sample collection and 
processing in a ready, efficient, and clean manner;
    5. Has adequate arrangements, including liquid soap and cleansers, 
for cleansing and disinfecting hands, dissection tools, floors, and 
other articles and places that may be contaminated by diseased 
carcasses or otherwise; and
    6. Has adequate facilities, including denaturing materials, for the 
proper disposal of tissue, blood, and other waste generated during test 
sample collection.
    We believe the space provided by the slaughtering plant should have 
these characteristics in order to allow APHIS, FSIS, or APHIS 
contractor personnel to collect and process test samples in an 
accurate, efficient, and safe manner.
    We also propose that the Administrator or his or her designee would 
give the owner of a slaughtering establishment notice as to when we 
would be collecting test samples at the plant. The Administrator would 
give the operator of the slaughtering establishment as much advance 
notice as possible. However, the actual amount of notice would depend 
on the specific situation.
    We also propose to include language allowing the Administrator to 
deny or withdraw listing of a slaughtering establishment if the 
establishment does not comply with the requirements of the regulations. 
This language is essentially the same as existing language in Sec.  
71.20 concerning denial and withdrawal of approval of livestock 
facilities.

Effects on Slaughter Plants Where APHIS Conducts Sampling

    Under our proposal, sample collection would be done on the premises 
of the slaughtering plant. Full testing of samples might sometimes 
occur on the premises, although APHIS often will elect to send the 
samples offsite for testing. APHIS employees, FSIS employees, or a 
contractor hired by APHIS would collect the samples. There would be no 
personnel cost to slaughtering plants, although they would incur some 
expenses in providing the space and equipment used by APHIS, FSIS, or 
contractors. In some cases, the slaughtering plant itself may be the 
contractor employed by APHIS to collect samples.
    The difficulty and expense of collecting the samples would depend 
on the type of testing. The most difficult sampling involves the 
collection of tissue from sheep to test for scrapie. We may wish to 
test any slaughtered sheep or goat after we determine that it has 
sufficient animal identification to trace it back to its flock of 
origin. Collecting the sample involves removing the brainstem from an 
animal through the spinal opening and sending it to a laboratory for 
histopathological procedures, and may involve collecting other tissue 
or blood samples as well, depending on the tests in use at the time.
    Collecting samples to test for tuberculosis is also difficult, 
involving necropsy to collect multiple tissue samples. Collecting 
samples to test for brucellosis and pseudorabies is a relatively simple 
matter of collecting blood samples.
    We realize that collection of tissue and blood samples at slaughter 
may affect slaughtering plant operations by disrupting or slowing down 
the work. While many samples can be collected without slowing down 
production lines, there would be occasional slowdowns. We also realize 
that plants would have to set aside, or make available, adequate and 
suitable space for us to work. This could be inconvenient and involve 
additional expense. APHIS intends to be as flexible as possible in 
adapting the proposed requirements to the needs of individual 
slaughtering plants. When it is possible, we would share space and 
facilities at the plant that are already devoted to other Federal or 
State inspection activities, and when this is not possible, we would 
work with slaughtering plant management to minimize their expenses. The 
proposed rule would also allow sample processing to occur outside the 
slaughtering plant in some cases; e.g., at some small sheep plants, it 
may be possible for APHIS to simply collect the heads of animals to be 
tested and take them to a nearby laboratory or other facility for 
processing.
    Also, we are not proposing to test all slaughtered livestock all 
the time. We believe our more limited proposal--to test when we believe 
it is necessary and to test only those animals we believe are 
necessary, based on epidemiological information--is justified because 
it would substantially enhance the control of livestock diseases, 
particularly brucellosis, tuberculosis, scrapie, and pseudorabies, in 
the United States. We anticipate that the sampling of sheep would occur 
only at plants that kill sheep old enough to test for scrapie, so 
operations at plants that slaughter only lambs would not be 
significantly affected. Also, APHIS would be able to modify its 
sampling to some degree to accommodate special needs at individual 
plants, e.g., to avoid damaging the heads of sheep when there is a 
contract to sell the heads as meat, or to suspend sampling when plant 
renovations are underway.

Background on the Scope and Purpose of Sample Collection in APHIS 
Programs

    As described in the preceding section, the essential changes 
proposed by this rule are a requirement that persons moving livestock 
and poultry interstate for slaughter may only move the animals to 
slaughtering establishments that have been listed by the Administrator 
of APHIS, and a requirement that slaughtering establishments where we 
choose to collect samples must grant access to the personnel conducting 
the tests and provide certain space and equipment necessary to collect 
and process test samples. This rule would therefore chiefly affect 
slaughtering establishments that must allow us to collect samples.
    This section provides additional background to help interested 
persons understand the role of sampling and testing in various APHIS 
animal disease programs, and the difficulties and costs involved in 
different types of sample collection and testing.
    Testing animals' blood or tissue for diseases is an important 
component of APHIS regulations. Although the regulations in subchapter 
C do not require testing for most animals moving interstate, testing 
with negative results is often one of several options for qualifying an 
animal for interstate movement. In some programs (e.g., brucellosis), 
APHIS regulations also require that certain animals and herds be 
tested, including at slaughter, in order for a State or area to achieve 
or maintain a particular disease status. At other times, voluntary 
testing allows the owners of animals to achieve a market advantage by 
certifying their animals free of particular diseases.
    In support of both mandatory and voluntary testing programs, APHIS 
cooperates with State and local governments, as well as individuals and 
businesses. In some situations, APHIS personnel collect blood or tissue 
samples to be tested immediately or sent to laboratories for testing. 
In other situations, accredited veterinarians, State or local 
veterinary officials, or

[[Page 70867]]

other individuals may collect the samples.
    APHIS uses epidemiological data from many mandatory and voluntary 
tests to assess the prevalence of disease and to identify sources of 
diseases. When testing is coupled with animal identification, we can 
trace a positive animal's movements and identify other animals it may 
have been in contact with that were exposed to the disease. We call 
this process ``traceback.'' We can then test source herds or flocks and 
exposed animals and take other measures to ensure that the disease does 
not spread.
    Testing at slaughter is extremely important. Not only is it the 
last point in normal channels for animal movement when we can test an 
animal, but for some diseases for which there is no validated live-
animal test, like bovine spongiform encephalopathy or chronic wasting 
disease, it is the only time we can conduct routine diagnostic testing. 
For other diseases, such as tuberculosis in cattle and bison, 
brucellosis in cattle, bison, and swine, and exotic Newcastle disease 
in poultry, testing at slaughter provides a cost-effective means of 
monitoring the extent of the diseases and detecting areas where the 
diseases are highly prevalent. APHIS has not been able to use voluntary 
cooperation by slaughter plants to obtain all the samples it needs for 
optimal disease surveillance. For instance, APHIS has been allowed to 
collect some samples in 45 of the 50 major swine processing plants, but 
we need samples from all 50 plants to construct a valid model of swine 
disease incidence. Also, when APHIS collectors have gone into plants to 
replace voluntary collection by the slaughtering plants, the number of 
samples collected has increased two fold, indicating that voluntary 
collection has not been effective.
    APHIS has held substantial discussions with animal industry groups 
to explore options for collecting all the samples we need for optimal 
disease surveillance. Most recently, we participated in a National 
Dialogue on Animal Disease Surveillance on March 12, 2002, that was 
sponsored by the National Institute for Animal Agriculture in 
Arlington, VA. We also participated in a follow-up conference call for 
interested industry members on April 9, 2002. The approach of this 
proposed rule has taken those discussions and the concerns of industry 
members into account.
    The reasons why slaughter testing is important in the control of 
various diseases are discussed below. This discussion does not attempt 
to identify every disease for which APHIS may want to test animals at 
slaughter, but is intended to identify the benefits of such testing 
with regard to certain diseases of major concern, and to identify where 
testing might help us determine whether other diseases have a greater 
effect than is currently understood.
    There is no simple answer to the question ``How much slaughter 
testing is needed for proper surveillance of a disease?'' If the 
animals continually passing through slaughter plants constituted a true 
random sample of animal populations in the United States, it would be 
possible to identify a statistically valid number of animals to test, 
in order to detect animal diseases in U.S. animal populations at 
whatever prevalence we choose, with whatever confidence we choose. 
However, the animals passing through a slaughter plant at any given 
time do not constitute a random sample of the national population. The 
desirable level of testing at slaughter is also affected by the amount 
of data already available from non-slaughter testing (e.g., federal and 
State herd and flock testing, and voluntary testing by animal owners). 
Finally, the amount of slaughter testing required for proper 
surveillance will vary with increasing or decreasing national animal 
inventories each year.
    For informational purposes, this document projects certain levels 
of sample collection at slaughter that we currently believe are 
required for optimal surveillance of various animal diseases. These 
estimates of the number of samples required take into account the 
factors mentioned above--biases in the composition of animals at 
slaughter plants that make them non-random samples; availability of 
test data from non-slaughter testing for various diseases; and varying 
animal populations.
    To illustrate the requirements of APHIS sample collection programs, 
the following discussion examines programs for several major animal 
diseases: tuberculosis, brucellosis, pseudorabies, and scrapie.

Tuberculosis

    Bovine tuberculosis is a contagious, infectious, and communicable 
disease caused by Mycobacterium bovis. It affects cattle, bison, deer, 
elk, goats, and other species, including humans. Bovine tuberculosis in 
infected animals and humans manifests itself in lesions of the lung, 
bone, and other body parts, causes weight loss and general 
debilitation, and can be fatal. At the beginning of this century, 
bovine tuberculosis caused more losses of livestock than all other 
livestock diseases combined.
    While cooperation with USDA's Food Safety and Inspection Service 
(FSIS) and slaughtering plants already allows us to perform a large 
amount of tuberculosis testing, this proposal would allow us to perform 
additional testing of animals at slaughtering plants if and when we 
determine such testing is necessary to improve our knowledge of the 
distribution of tuberculosis. The data gained through additional 
testing would improve our ability to administer national tuberculosis 
programs and to design effective program improvements. Because the 
activities of FSIS inspectors address primarily human food safety risks 
rather than animal disease risks, APHIS has never been able to rely 
completely on sample collection by FSIS inspectors to provide all the 
samples needed for a statistically valid evaluation of the animal 
disease profile of animals passing through a slaughter plant. Testing 
by APHIS rather than FSIS will become increasingly important as FSIS 
continues to implement its Hazard Analysis Critical Control Point 
(HACCP) approach to food safety at slaughter plants. The critical 
control points implemented by slaughter plants to ensure food safety 
and verified by FSIS do not necessarily provide the sample collection 
and testing APHIS needs for animal disease surveillance purposes. 
Therefore, APHIS needs the proposed authority to design and perform its 
own testing at slaughter plants.

Brucellosis

    Brucellosis is a contagious disease affecting animals and humans, 
caused by bacteria of the genus Brucella. In its principal animal 
hosts, brucellosis is characterized by abortion and impaired fertility. 
The brucellosis regulations, contained in 9 CFR part 78, prescribe 
conditions for the interstate movement of cattle, bison, and swine, and 
provide a system for classifying States or portions of States (areas) 
according to the rate of Brucella abortus infection present and the 
general effectiveness of the brucellosis control and eradication 
program conducted in the State or area.
    This proposal would allow us to perform additional testing of 
animals for brucellosis at slaughtering plants if and when we determine 
such testing is necessary to improve our knowledge of the distribution 
of brucellosis. The data gained through additional testing would 
improve our ability to properly classify herds and States, to 
administer national brucellosis programs, and to design effective 
program improvements.

[[Page 70868]]

    Under existing programs to detect brucellosis, two primary 
surveillance procedures are used to locate infection without having to 
test each animal in every herd. Milk from dairy herds is checked two to 
four times a year by testing a small sample obtained from creameries or 
farm milk tanks for evidence of brucellosis, and some animals from 
bison herds and cattle herds that do not produce milk for sale are 
tested for brucellosis at livestock markets or at slaughter. While 
these surveillance programs are valuable in monitoring brucellosis, the 
availability of slaughter testing under this proposal is critical to 
provide complete coverage in the data provided by current surveillance 
efforts.

Pseudorabies

    Pseudorabies is a contagious, infectious, and communicable disease 
of livestock, primarily swine, and other animals. The disease is caused 
by a herpes virus. Our regulations in 9 CFR part 85 govern the 
interstate movement of swine and other livestock in order to help 
prevent the spread of pseudorabies.
    A great many feeder pigs and butcher hogs move to slaughter each 
year, and such swine are not currently required to be tested for 
pseudorabies. This proposal would allow APHIS to test such swine at 
slaughter if we find it necessary to do so to improve our knowledge of 
the prevalence and distribution of pseudorabies. Such testing could 
also help us assess the success of the recent indemnification program 
to reduce the incidence of pseudorabies by destroying affected animals.

Scrapie

    Scrapie is a degenerative and eventually fatal disease affecting 
the central nervous systems of sheep and goats. Currently, to 
definitively test for scrapie, the brainstem of an animal must be 
removed through the spinal opening and sent to a laboratory for 
histopathological procedures. In the near future, testing may involve 
collecting other tissue or blood samples as well, depending on the 
tests in use at the time.
    APHIS is attempting to improve the effectiveness of its scrapie 
control program. On August 21, 2001, we published a final rule (Docket 
No. 97-093-5, 66 FR 43963) in the Federal Register that encourages 
improvement of State quarantine programs for scrapie, reinstituted a 
Federal indemnity program for scrapie, and made other changes to 
strengthen scrapie control. Slaughter testing for scrapie would 
dramatically improve surveillance for scrapie and is an important and 
necessary part of the broader efforts to improve scrapie control.
    Currently, slaughter testing is not required for sheep and goats. 
There is a small amount of voluntary testing of sheep and goats at 
slaughter, where we have made special arrangements with slaughtering 
establishments. However, this is not sufficient because so few sheep 
are tested at slaughter. Although we do not believe it is necessary to 
test all sheep and goats at slaughter, we believe that additional 
animals must be tested at slaughter if we are to have an effective 
surveillance program and, in turn, control and eventually eradicate the 
disease.

Other Diseases

    There are many other animal diseases that APHIS may test for at 
slaughter to gain better data about their extent and their effects on 
productivity. For example, The National Poultry Improvement Plan 
(NPIP), described in 9 CFR parts 145 and 147, is a cooperative Federal-
State-industry mechanism that includes slaughter testing to control 
certain poultry diseases, particularly those caused by various species 
of Salmonella, Mycoplasma gallisepticum, M. synoviae, M. meleagridis, 
and avian influenza viruses.
    Equine infectious anemia (EIA), also known as swamp fever, is a 
viral disease of equines that is characterized by sudden fever, 
swelling of the legs and lower parts of the body, severe weight loss, 
and anemia. Approximately 1 million live horses are tested for EIA each 
year, and approximately 0.2 percent of these test positive. However, no 
comprehensive testing for EIA is currently done at slaughter.
    Johne's disease, also known as paratuberculosis, is a disease 
caused by Mycobacterium paratuberculosis. This disease primarily 
affects cattle, sheep, goats, elk, and other domestic, exotic, and wild 
ruminants. Improved testing at slaughter for Johne's disease would 
improve our baseline knowledge of the distribution and extent of 
Johne's disease and would allow us to better calculate the true cost of 
this disease to animal industries.
    Slaughter testing can also yield valuable information about 
reservoirs of bluetongue, can help distinguish the prevalence of 
different strains of this virus, and can also distinguish bluetongue 
from epizootic hemorrhagic disease. Slaughter testing could also help 
us better understand the significance of diseases such as porcine 
reproductive and respiratory syndrome, chronic wasting disease, and 
other diseases of emerging importance. In addition, if bovine 
spongiform encephalopathy (BSE) or other transmissible spongiform 
encephalopathies (TSE's) ever become established in the United States, 
slaughter testing would be essential for their control. It should be 
noted that extensive testing for TSE's, should it ever be needed, would 
raise the overall cost of our testing program considerably, since these 
tests require necropsy and tissue collection rather than a simple blood 
sample.

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. The economic analysis prepared for this 
proposed rule is set out below. It includes both a cost-benefit 
analysis as required by Executive Order 12866 and an analysis of the 
economic effects on small entities as required by the Regulatory 
Flexibility Act.
    APHIS is proposing to require persons moving horses, cattle, bison, 
sheep, swine, cervids, or poultry interstate to slaughter to move them 
only to slaughtering establishments that have been listed by the 
Administrator. The Administrator would list an establishment after 
determining that it is not necessary to conduct testing there, or 
determining that testing is necessary and that the establishment 
provides access and facilities for the collection of tissue and blood 
samples from the animals slaughtered. We are proposing this action to 
increase the effectiveness of our surveillance for livestock diseases. 
Collection of samples currently occurs on a small, voluntary scale, but 
it needs to be expanded and to include both large and small 
slaughtering plants. Samples are currently collected by personnel 
employed by APHIS, FSIS, or the slaughtering plants themselves.
    According to NASS and FSIS statistics for slaughtering 
establishments that may receive animals in interstate movement, there 
are approximately 795 plants slaughtering cattle, 757 plants 
slaughtering swine, and 350 plants slaughtering poultry. Fourteen of 
the cattle plants and 11 of the swine plants are very large operations 
that account for 50 percent of the cattle and swine slaughtered each 
year. Several dozen of the plants are of moderate size; the rest are 
small businesses. Some of these plants slaughter both cattle and swine, 
and some slaughter other animals as

[[Page 70869]]

well (sheep, horses, cervids, etc.). Some degree of sample collection 
already occurs at virtually all of the cattle plants, e.g., to collect 
the 12 million blood samples required each year under Part 78 for 
States to maintain their brucellosis classifications. Sample collection 
also occurs at virtually all of the poultry plants in accordance with 
the National Poultry Improvement Plan. Some sample collection already 
occurs at about 20-25 of the largest swine plants to collect blood 
samples for pseudorabies testing.
    This proposed rule would allow us to collect samples at plants 
where sampling does not now occur, but where sampling is needed to fill 
information gaps in our animal disease programs. We expect to initiate 
testing at several large plants, primarily swine plants, where testing 
has not occurred before, and at approximately 20 small businesses.
    As noted above, many slaughtering plants already voluntarily 
cooperate with APHIS to allow us to collect samples for testing. 
Because of the relatively small number of additional animals that would 
be tested and the relatively small number of cases of disease expected 
to be identified, we do not expect that this rule would have a 
significant economic effect on any affected entities. Based on 
discussions with livestock industry groups and slaughter industry 
groups, and the fact that most slaughtering plants accepting animals in 
interstate commerce already cooperate with voluntary testing programs, 
we expect there will be minimal effects on most slaughtering plants in 
complying with the proposed standards. While this proposal may increase 
costs slightly for some slaughtering plants, prices for agricultural 
products vary for many reasons, and it is unlikely that additional 
testing for this disease would have any measurable effect on costs for 
producers or consumers.
    The primary economic effects of this proposal would be direct costs 
to those slaughter plants that would have to provide us with access, 
workspace, and equipment to collect samples. We do not have reliable 
data to document these costs, but we estimate that they would average 
no more than a few thousand dollars a year per plant, for 20 to 30 
plants that have not already been providing access under voluntary 
sampling programs. We particularly invite small businesses that may be 
affected by this proposed rule to comment on its economic impacts. We 
are seeking additional data on whether small businesses that must 
provide space and access for sample collection will incur additional 
expenses for rents, facility costs, or salaries. We are also seeking 
data on costs that slaughter plants might incur if it is necessary to 
slow the production line to collect some types of samples (e.g., tissue 
samples).
    In the following sections we discuss potential economic effects on 
the various categories of slaughtering plants, based on the types of 
animals each processes. First, we present two tables summarizing the 
per-unit costs and the total industry costs estimated to result from 
the blood and tissue sampling requirements in this proposed rule for 
cattle, swine, and sheep. Bear in mind that the major costs of sample 
collection are borne by the Federal government, and that the costs to 
slaughter plants are limited to costs associated with providing access 
for sample collection.

                                           Table 1.--Per-unit Cost of Blood and Tissue Sampling--Annual Basis
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        Number                                                                                Cost of         Cost of
              Animal                  slaughtered          Disease          Samples currently        Samples needed         collection     testing (per
                                      (millions)                                collected                                   (per unit)         unit)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cattle............................            35.5  Brucellosis..........  12 million.........  12 million..............     \1\ $0.50-1      $0.10-0.50
Cattle............................            35.5  Tuberculosis.........  1,200..............  4,000...................       \2\ 11-14              20
Swine.............................           101.1  Pseudorabies.........  750,000............  1.2 million.............       0.45-0.90          1-1.50
Swine.............................           101.1  Brucellosis..........  750,000............  1.2 million.............           (\3\)          1-1.50
Sheep.............................             4.0  Scrapie..............  12,000.............  75,000..................        \4\ 5-10             30
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Contracts for collecting brucellosis samples are negotiated individually, prices vary widely.
\2\ To collect a sample for tuberculosis testing takes a veterinarian about a half-hour. An approximate hourly wage rate for a veterinarian employed in
  a slaughtering facility would range from $22 to $28 per hour. (Veterinarians in this type of job would typically be at a GS-12 level). Additionally,
  the plant incurs a cost because the speed at which the processing line moves is slowed or stopped for a sample to be taken. Also, the carcass must be
  held by the plant while the testing is done, which typically takes 3 days. If the test is negative, the carcass is released. If the test is positive,
  the carcass cannot be sold and steps are taken to trace the disease back to its source.
\3\ No cost because the same blood sample is used to test for pseudorabies and brucellosis.
\4\ Animal health technicians normally collect scrapie test samples. An animal health technician can collect approximately 10 samples for scrapie
  testing per hour. Adjusting for time spent bagging samples for shipment, collecting identification devices, other administrative duties, and varying
  levels of efficiency at different facilities based on their layout and slaughter volume, the actual average collection rate would probably be 2 to 3
  samples per hour. An approximate hourly wage rate for a technician employed in a slaughtering facility would range from $16 per hour to $21 per hour,
  based on the GS-7 pay scale plus benefits. Additionally, the plant would incur a cost because the processing line may be slowed or stopped for a
  sample to be taken.


                                             Table 2.--Total Cost of Blood and Tissue Sampling--Annual Basis
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                       Estimated total   Estimated total
                                                                                      Per-unit  cost   Per-unit cost  cost (millions)-  cost (millions)-
                 Animal disease                             Samples needed             of collection    of testing       lower bound       upper bound
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cattle brucellosis..............................  12 million........................         $0.50-1      $0.10-0.50             $7.2               $18
Cattle tuberculosis.............................  4,000.............................           11-14              20            0.124             0.136
Swine pseudorabies..............................  1.2 million.......................       0.45-0.90          1-1.50             1.74              2.88
Swine brucellosis...............................  1.2 million.......................  ..............          1-1.50              1.2               1.8
Sheep scrapie...................................  75,000............................            5-10              30            2.625                 3
                                                 -------------------------------------
    Totals......................................  ..................................  ..............  ..............           12.889           25.816
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Only approximately 25% of these costs come from increases in sampling resulting from the proposed rule; the remainder represent sampling already
  occurring under previous authorizations.


[[Page 70870]]

Profile of Cattle and Swine Slaughtering Plants

    APHIS is trying to increase surveillance for brucellosis, 
pseudorabies, and tuberculosis at these plants. Collection of samples 
needs to be expanded to include both large and small slaughtering 
plants. Under this proposed rule, samples would be collected by APHIS 
or FSIS personnel, contractors, or the slaughtering plants themselves.
    The meat packing industry is included in the North American 
Industry Classification System code of 311611. The Small Business 
Administration (SBA) definition of small business for NAICS 311611 is a 
firm with less than 500 employees.
    In 1996, 91 percent (1,260) of the total number of firms (1,341) in 
the meat packing business qualified as small businesses. Only firms 
with more than $100 million in sales average more than 500 employees. 
Eighty-one firms had sales of more than $100 million in 1996. (SBA 
Office of Advocacy, http://www.sba.gov/advo/stats/int_data.html.)
    There are 795 federally inspected plants that slaughtered at least 
one head of cattle in 1998. Fourteen plants account for over 50 percent 
of the total cattle killed. (Agricultural Statistics Board, National 
Agricultural Statistics Service (NASS), Livestock Slaughter 1998 
Summary, March 1999.) There are 757 plants that slaughter hogs. Eleven 
plants account for 48 percent of the total hogs killed.

Cost of Testing Additional Tissue Samples for Tuberculosis

    Currently, FSIS collects about 1,200 tissue samples from slaughter 
cattle each year to be tested for tuberculosis. There are approximately 
100 positive test results per year. It is estimated that .0002 percent 
of all U.S. cattle may be infected with tuberculosis. There were 98.5 
million head of cattle in the United States as of January 1, 1999. 
Therefore, it is estimated that fewer than 200 head of cattle are 
infected with tuberculosis at any one time.
    Under this proposed rule, the direct costs of collecting a tissue 
sample and testing it for tuberculosis would be borne by APHIS, in 
either salary or contractor costs. It takes a veterinarian about a 
half-hour to collect a sample for tuberculosis testing. An approximate 
hourly wage rate for a Federal or contractor veterinarian to do these 
duties would be $22 to $28 per hour. The cost of laboratory analysis to 
test for tuberculosis is about $20.00.
    A slaughtering plant may incur a cost if the speed at which the 
processing line moves is slowed or stopped for a sample to be taken. 
Usually, samples can be collected without slowing the line. Also, the 
carcass must be held by the plant while the testing is done, which 
typically takes 3 days. Currently about 0.003 percent (1,200) of cattle 
slaughtered are tested for tuberculosis, and this rule proposes to 
initially increase testing to 4,000 head annually. Because of the small 
number of additional tests for tuberculosis, this aspect of the 
proposed rule would not have a material effect on small business 
entities.
    If a tuberculosis test is negative, the carcass is released. If the 
test is positive, the carcass cannot be sold and steps are taken to 
trace the disease back to its source. If this traceback is successful, 
the herd has to be quarantined while it is tested and may be 
depopulated if found positive. However, economic effects related to 
herd quarantine and depopulation are not reasonably linked to this 
proposal, since herds are already quarantined and depopulated under 
other APHIS regulations.

Cost of Testing Additional Blood Samples for Cattle Brucellosis

    This proposed rule would not change the number of brucellosis test 
samples collected from cattle or the way in which they are processed. 
This proposed rule would have no significant economic effect with 
regard to cattle tested for brucellosis.
    Currently there are approximately 12 million blood samples 
collected each year to test for brucellosis. Under part 78, States must 
collect these samples in order to maintain their brucellosis status.
    There are 795 federally inspected plants that slaughtered at least 
one head of cattle in 1998. Fourteen plants account for over 50 percent 
of the total cattle killed. (Agricultural Statistics Board, NASS, 
Livestock Slaughter 1998 Summary, March 1999.) All slaughtering plants 
that ship product across State lines are subject to Federal inspection.
    In 1998, there were 35.5 million head of cattle slaughtered; 98.1 
percent were subject to Federal inspection. Only cattle that are 2 
years old or older are tested for brucellosis.
    Most of the blood sample collection is done by plant personnel or 
by FSIS. APHIS personnel collect only a small percentage of the total 
samples, approximately 50,000 samples per year, or 0.4 percent of the 
total.
    Testing of the samples for brucellosis costs between $0.10 and 
$0.50 per sample. The high range of costs would cover follow-up tests 
from a positive result.

Cost of Testing Additional Blood Samples for Swine Pseudorabies

    Currently there are about 750,000 samples collected per year. An 
estimated 1.2 million samples are needed for more complete testing. We 
estimate that less than 1 percent of swine herds are infected with 
pseudorabies.
    At a large plant, two people would be needed to do the collection 
of blood samples on a full-time basis, at a cost to the government of 
$25,000 to $30,000 per year.
    At smaller plants, where not enough swine are slaughtered to 
warrant having an employee collect blood samples full time, APHIS pays 
for each sample collected. Rates range from $.45 to $.90 cents per 
sample.
    The sample is sent to a lab for testing. It costs approximately 
$1.00 per sample for testing. APHIS has some contracts and cooperative 
agreements with universities to do some testing. The cost is negotiated 
with each lab separately. The rate can be up to $1.50 per sample.
    One reason for some firms' reluctance to participate in collecting 
blood samples is concern about liability. Collection is often done in 
potentially hazardous conditions; for example, the floors may be wet, 
the quarters may be cramped, and there are sharp knives and equipment 
present.
    It is difficult to estimate the average cost incurred because of 
liability issues. The relevant issue here is the marginal increase in 
liability costs due to this regulation. Slaughtering plants are already 
involved in a potentially hazardous activity. Adding the requirement to 
collect blood and tissue samples would not add significantly to the 
liability incurred by a plant; but a small increase in liability costs 
may be expected.
    There are 757 plants that slaughter swine. Eleven plants account 
for 48 percent of the total swine killed. In 1998, 101.1 million swine 
were slaughtered; 98.3 percent of all swine slaughtered are slaughtered 
under federal inspection. (Agricultural Statistics Board, NASS, 
Livestock Slaughter 1998 Summary, March 1999.) All slaughtering plants 
that ship products across State lines are subject to Federal 
inspection. Some 96 percent of the Federally inspected swine at 
slaughter was barrows and gilts (younger pigs, with less fat, that are 
used for higher quality cuts of pork). There were about 4 million sows 
and boars slaughtered in 1998. For testing for pseudorabies, these are 
the swine

[[Page 70871]]

that we are concerned about. There is about a 40 percent turnover in 
sows per year.
    If a herd tests positive, it is then quarantined. The swine can be 
sold for slaughter but cannot be sold for breeding stock. Swine sold 
for breeding stock are typically twice as expensive as swine sold for 
slaughter.

Costs of Testing for Scrapie at Sheep Slaughtering Plants

    The slaughtering plant industry is included in NAICS code 311611. 
The SBA's definition of small business for NAICS 311611 is a firm with 
less than 500 employees. Only firms with more than $100 million in 
sales average more than 500 employees. Two slaughtering plants that 
process sheep had sales of more than $100 million in 1998. (SBA Office 
of Advocacy, http://www.sba.gov/advo/stats/int_data.html.)
    There are 556 federally inspected plants that slaughtered at least 
one sheep in 1998. Two plants account for over 40 percent of the total 
sheep slaughtered (Agricultural Statistics Board, NASS, Livestock 
Slaughter 1998 Summary, March 1999). In 1998, 4.429 million sheep were 
slaughtered, of which 94.8 percent were subject to Federal inspection. 
Only about 212,000 of these were mature sheep suitable for scrapie 
testing.
    It is estimated that roughly 1.2 percent of all U.S. sheep flocks 
are infected with scrapie. In 1998, there were only 63 cases of scrapie 
reported. Given this incidence, approximately 15,000 animals should be 
sampled at slaughter each year for optimal monitoring for scrapie. Five 
distinct tissue samples are collected from each animal's head, 
resulting in about 75,000 samples to be collected. This level of 
sampling will detect the incidence and distribution of scrapie with a 
confidence of over 95 percent.
    This proposed rule would not have a significant adverse economic 
effect on small businesses. Blood and tissue samples would be collected 
either by APHIS, FSIS, or a contractor paid for by USDA. Firms could 
incur secondary costs for collecting tissue samples for testing as a 
result of production lines that may have to be slowed down or stopped 
temporarily. Firms would also incur costs for providing the space, 
furnishings, and equipment required for the personnel collecting 
samples, although we believe many firms will be able to minimize these 
costs by utilizing some of the space and equipment already provided for 
Federal and State inspectors and firms' quality assurance personnel.
    The primary direct costs would be the cost of collecting samples 
and the cost of testing samples, both of which would be borne by USDA. 
Over the long term, samples will cost about $5 to $10 each to collect 
and $30 each to test. Additionally, the plant could incur a cost 
because the speed at which the processing line moves may be slowed or 
stopped for a sample to be taken, similar to the effects already caused 
by FSIS inspections. The sheep or goat carcass would not have to be 
held by the plant while the testing is done, so it would continue along 
on the processing line, and the processor would not incur the cost of 
having to hold the carcass.
    Additional testing for scrapie would provide a better record of 
diseases and enhance our ability to limit the infection of additional 
flocks with scrapie. While the costs of additional testing are visible, 
the benefits often are not. The true economic benefit of additional 
testing is that it will contribute to control and eventual eradication 
of scrapie, resulting in better overall flock productivity, a reduction 
in flocks depopulated due to scrapie, and expanded market opportunities 
for animals that can be marketed as scrapie-free. Production of 
agricultural commodities varies for many reasons, and it would be 
difficult to determine the change in production due to additional 
testing. Because the percentage of animals currently infected with 
scrapie is small, we expect that slaughter testing will result in the 
identification and quarantine of very few additional infected flocks. 
Quarantining the animals in these flocks is not likely to have a 
statistically significant effect on current or future production.

              Table 3.--Per-unit Cost of Collecting and Testing Sheep and Goat Samples for Scrapie
----------------------------------------------------------------------------------------------------------------
                                               Samples to  be                       Cost of          Cost of
         Animals slaughtered (1998)              collected      Samples needed   collection\1\     testing (per
                                                   (2000)                          (per unit)        sample)
----------------------------------------------------------------------------------------------------------------
4.03 million................................          12,000           75,000            $5-10             $30
----------------------------------------------------------------------------------------------------------------
\1\ See footnote 4 to table 1.


            Table 4.--Total Annual Cost of Collecting and Testing Sheep and Goat Samples for Scrapie
----------------------------------------------------------------------------------------------------------------
                                                                   Cost of          Cost of
                        Samples needed                         collection (per    testing (per     Total  cost
                                                                   sample)          sample)         (millions)
----------------------------------------------------------------------------------------------------------------
75,000.......................................................           $5-10              $30         $2.625-3
----------------------------------------------------------------------------------------------------------------

Costs of Testing Captive Cervids at Slaughter

    Captive cervids might be tested at slaughter for tuberculosis and 
for chronic wasting disease (CWD). The cost per animal of testing 
cervids for tuberculosis is similar to the cost per animal of testing 
cattle for this disease. The cost per animal of testing cervids for CWD 
is similar to the cost per animal of testing sheep for scrapie.
    The number of cervids farmed is small compared to cattle, swine, or 
sheep. Because it is a small industry, NASS does not collect data about 
cervid production or slaughter. According to the North American Elk 
Breeders Association, there are 150,000 to 160,000 elk being raised on 
farms in North America. This number includes elk raised in Canada and 
Mexico. The number of deer raised on farms is uncertain, but it is also 
a very small industry compared to cattle, swine, or sheep.
    As stated earlier, the meat packing industry is included in NAICS 
code 311611. The SBA's definition of small business for NAICS 311611 is 
a firm with less than 500 employees.
    In 1996, 91 percent (1,260) of the total number of firms (1,341) in 
the meat packing business qualified as small businesses. Only firms 
with more than $100 million in sales average more than

[[Page 70872]]

500 employees. Eighty-one firms had sales of more than $100 million in 
1996. (SBA Office of Advocacy, http://www.sba.gov/advo/stats/int_data.html.)
    Plants that slaughter captive cervids would qualify as small 
businesses. It seems that, currently, there are not enough cervids 
slaughtered per year to motivate large meat packing businesses to 
devote production lines to the slaughter of cervids.
    This proposed rule would not have an adverse effect on small 
businesses that slaughter cervids. Blood samples would be collected 
either by APHIS, by FSIS, by contractors, or by the firms themselves. 
Firms would be compensated on a per unit basis for collecting the 
samples. The costs of testing captive cervids would be similar to the 
costs of testing cattle. Because of the small number of tests that are 
expected to be done, this proposed rule would not have a material 
effect on small business entities.

Costs of Testing Poultry at Slaughter

    In 1997, there were 315 poultry processing firms (NAICS 311615) 
according to SBA statistics. To qualify as a small business, firms 
engaged in meat processing must have less than $500,000 in annual 
receipts. Even the smallest classification of poultry processing firms, 
those with less than 20 employees, averaged over $1 million in annual 
receipts in 1999. While this does not exclude the possibility that 
there may be poultry processing firms that qualify as small businesses, 
we have been unable to locate any such firms. This proposed rule would 
not have a significant adverse effect on small businesses.
    It is estimated that this proposed rule, if adopted, could result 
in the collection of a maximum of 300 samples per quarter, collected 
from about 100 different poultry plants, to conduct adequate testing 
for exotic Newcastle disease, avian influenza, or other diseases that 
APHIS may wish to monitor. Blood samples would be collected either by 
APHIS, by FSIS, by contractors, or by the firms themselves. Firms would 
be compensated on a per unit basis for collecting the samples.
    Additional testing that would be conducted under this proposed rule 
would be an insignificant amount compared to the testing and inspection 
already performed at poultry plants. The NASS Agricultural Statistics 
Board report entitled ``Poultry Slaughter,'' dated February 4, 2000, 
gives representative figures for the amount of poultry that is 
inspected or tested at processing plants, and the fraction that is 
condemned for failing inspection. In December 1999, the preliminary 
total live weight of poultry inspected was 3.95 billion pounds, up 
fractionally from the previous year. Ante-mortem condemnations during 
December 1999 totaled 15.3 million pounds. Condemnations were 0.39 
percent of the live weight inspected. Post-mortem condemnations, at 62 
million pounds (N.Y. dressed weight), were 1.75 percent of quantities 
inspected.
    In contrast, even if APHIS tested poultry plants at the maximum 
level envisioned under this proposed rule, and if such testing always 
resulted in destruction of the poultry tested rather than just 
collection of a test sample, the total effects would be collection of 
under 120,000 samples per year, and the loss of under 600,000 pounds of 
poultry per year.

Benefits of Additional Testing

    Additional testing would provide a better record of diseases and 
enhance our ability to prevent potential outbreaks of diseases. While 
the costs of additional testing are visible, the benefits often are 
not. The true economic benefit of additional testing would be the 
amount by which production is increased or the amount by which 
production is not lost due to herds being depopulated because of 
disease. The benefits of this program include better animal disease 
control, greater productivity in flocks and herds, fewer animals lost 
to disease, and greater opportunity to develop export markets for 
animals and products that can have their disease status backed up by an 
effective slaughter testing program. Increased testing of slaughter 
samples will allow us to more quickly identify and isolate herds or 
flocks affected by disease, reducing the number of animals lost to 
disease control. Production of agricultural commodities varies for many 
reasons, and it would be difficult to determine the change in 
production due to additional testing. Because the percentages of 
animals currently infected with diseases such as pseudorabies and 
tuberculosis are very small, additional testing for these diseases 
resulting in the quarantine of some additional herds may not have a 
statistically significant effect on current or future swine and cattle 
production, but effective surveillance for these diseases can 
dramatically increase export markets, increasing the value of herds. 
Another benefit of additional testing would be that it would contribute 
to lowering the overall costs of animal disease control programs by 
generating epidemiological data to make these programs more effective. 
APHIS alone has spent hundreds of millions of dollars in the past 
decade on these programs, and more hundreds of millions of dollars on 
indemnity programs to buy and destroy diseased animals. Over time, a 
more effective slaughter testing program could reduce these costs. 
However, in the short-term, a more effective slaughter testing program 
may detect a higher incidence of diseases, and so may generate greater 
costs. Gains would accrue in the long-term from improved herd and flock 
health, reduced disease costs, reduced prophylactic costs, and expanded 
export opportunities.

Cattle Industry Benefits

    This proposed rule would not affect the amount of samples from 
cattle collected to test for brucellosis or the way in which the 
testing is conducted. There would be no economic effect due to this 
proposed rule with respect to collecting blood samples for cattle 
brucellosis. With regard to cattle tuberculosis, on average one herd 
per year has to be eradicated because of a positive tuberculosis test. 
The value of the average size herd in 1996 and 1997 ranged from $46,200 
to $52,976. The value of a herd that has to be eradicated can vary 
widely depending on the size of the herd and market prices. If one cow 
is found to be tuberculosis positive, the entire herd is quarantined 
and may be depopulated. Eliminating the cost of depopulating a herd 
would represent only a small part of the benefit of additional testing. 
One benefit of this proposed rule would be the value of the herds that 
do not have to be depopulated. As discussed above, another benefit to 
both the cattle industry and the general public would result from 
improved disease control and resultant increased productivity.

Swine Industry Benefits

    Elimination of pseudorabies directly impacts producer income. 
Producers who are able to eliminate this disease from their herds are 
able to earn up to $4 more per hog. In addition, pseudorabies kills 
numerous young piglets and causes reproductive problems in sows. 
Historically, each year pseudorabies has cost several billion dollars 
in lost producer revenues and the cost of control measures. To the 
extent that collecting blood samples and testing contributes to faster 
elimination of pseudorabies, this rule will have a positive economic 
impact on producer incomes. APHIS hopes to eliminate pseudorabies 
within the next year. Additional slaughter testing should allow 
pseudorabies to be eliminated from U.S. swine herds, or reduced to an

[[Page 70873]]

insignificant level, several months earlier than would otherwise be 
possible. The additional slaughter testing that would be allowed if 
this proposal is adopted would also help establish baseline data that 
could be used to develop disease control programs to reduce the impact 
on industry of other swine diseases such as porcine reproductive and 
respiratory syndrome.

Sheep Industry Benefits

    Improved surveillance would aid eradication of scrapie, which would 
directly affect producer income. Producers who are able to eliminate 
this disease from their flocks lose fewer animals to disease and can, 
therefore, maintain more animals at a lower production cost per animal. 
They can also sell their animals at a higher price and with fewer 
regulatory costs and may be able to sell to additional foreign markets. 
To the extent that collecting samples and testing contributes to 
elimination of scrapie, this proposed rule would have a positive 
economic effect on producer incomes. The additional slaughter testing 
that would be conducted if this proposal is adopted would also help 
establish baseline data that could be used to develop disease control 
programs to reduce the economic effect on industry of other sheep 
diseases.

Poultry Industry Benefits

    As noted above, the additional testing that would be conducted 
under this proposed rule would serve as a minor but valuable supplement 
to the poultry testing already conducted in accordance with the 
National Poultry Improvement Plan.
    The poultry industry, like other animal industries, would benefit 
in the form of increased productivity and possible expansion of 
overseas markets. More effective disease surveillance is particularly 
important in the poultry industry because outbreaks of severe avian 
disease frequently must be controlled by destroying a number of poultry 
houses in a flock or the entire flock. This often means the loss of 
tens of thousands of poultry to control a single outbreak.

Cervid Industry Benefits

    In addition to the benefits cited above for other industries, the 
cervid industry at present faces the possibility that its major export 
markets will be cut off unless there is an effective slaughter testing 
surveillance program for chronic wasting disease (CWD). The Republic of 
Korea recently banned importation of elk antlers from the United States 
due to concerns about this disease, and other countries may follow. The 
elk industry depends on foreign markets for a large part of its 
revenue, and these markets have indicated that they may not import U.S. 
elk products unless there is a reasonably effective testing program to 
ensure the products are not from CWD-positive elk.

Overall Summary

    The total direct cost of the testing this proposed rule envisions 
for cattle, swine, and sheep is between $12.889 million and $25.816 
million, borne by APHIS. However, as noted above, APHIS already 
conducts some of this testing on a voluntary basis, although we collect 
only a fraction of the samples we believe are needed for an effective 
testing program. If we subtract the cost of testing APHIS is already 
conducting, the new total direct costs are between about $4 million and 
$12 million. In addition to these direct costs for cattle, swine, and 
sheep, there will be direct testing costs for slaughter testing of 
horses, cervids and poultry. The extent of testing to be done in this 
area is still uncertain, but it will be much smaller than the program 
for cattle, sheep, and swine, and should not amount to more than a few 
million dollars in annual direct costs. In addition to direct testing 
costs borne by APHIS, slaughtering plants will bear certain direct 
costs related to providing space and access for sample collection, and 
possible losses if production lines must be slowed for sample 
collection. We are requesting comments providing data on costs that 
slaughter plants might incur if it is necessary to slow the production 
line to collect some types of sample.
    The benefits of this program include better animal disease control, 
greater productivity in flocks and herds, fewer animals lost to 
disease, and greater opportunity to develop export markets for animals 
and products that can have their disease status backed up by an 
effective slaughter testing program.
    The overall costs of this program that are borne by industry are 
expected to be relatively minor, though further information is needed 
to assess costs for those plants that need to make adjustments to their 
operations to comply. In most cases, small businesses will have to do 
little more than to allow sample collectors to have access to their 
production lines.
    In the following table, costs are compared for the level of 
slaughter sampling and testing APHIS currently conducts and the 
increase in such activities we expect would result if this proposed 
rule is adopted. This table does not include the benefits achieved by 
current and proposed sampling activity levels, because data are not 
available to quantify the benefits. As discussed above, the benefits 
result from avoiding animal disease outbreaks, and there are too many 
possible outbreak scenarios to allow a meaningful calculation of a 
benefits range. The expected benefits result from the expectation that 
sampling and testing helps APHIS avoid some additional animal disease 
outbreaks, thereby avoiding: (1) The direct cost of dealing with an 
outbreak (cleaning and disinfection, compensation to producers, 
quarantine enforcement, etc.); (2) production losses; (3) induced price 
changes, and (4) the effect of the outbreak on other sectors of the 
economy. In view of the fact that the economic output of U.S. livestock 
industries exceeds $100 billion, an avoided impact of even a fraction 
of 1 percent on this sector would substantially exceed the total 
sampling costs estimated in Table 5.

   Table 5--Costs of Sampling for Cattle Brucellosis and Tuberculosis,
          Swine Pseudorabies and Brucellosis, and Sheep Scrapie
------------------------------------------------------------------------
                                    Low Range            High Range
------------------------------------------------------------------------
Current sampling costs......  $9,494,700..........  $21,224,800
Additional sampling costs...  3,394,300...........  4,591,200
------------------------------------------------------------------------

    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.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance

[[Page 70874]]

under No. 10.025 and is subject to Executive Order 12372, which 
requires intergovernmental consultation with State and local officials. 
(See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are in conflict with this rule will 
be preempted; (2) no retroactive effect will be given to this rule; and 
(3) administrative proceedings will not be required before parties may 
file suit in court challenging this rule.

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. 99-017-1. 
Please send a copy of your comments to: (1) Docket No. 99-017-1, 
Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 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.
    APHIS is responsible for preventing the dissemination of any 
contagious or communicable disease of animals or live poultry from one 
State to another. Disease surveillance plays an important role in the 
APHIS mission of protecting the health of the U.S. livestock and 
poultry populations, and testing animals for disease is an important 
surveillance tool. We can use epidemiological data from tests to assess 
the prevalence of disease and to identify sources of disease. When 
testing is coupled with animal identification, we can trace a positive 
animal's movements and identify other animals with which it may have 
come into contact.
    To enhance our surveillance capabilities, we are publishing this 
proposed rule to provide for the collection of blood and tissue samples 
from livestock (horses, cattle, bison, captive cervids, sheep and 
goats, swine, and other farmed animals) and poultry at slaughter. We 
would not collect samples from all livestock and poultry at slaughter; 
we would collect samples whenever we believe it is necessary for 
effective surveillance.
    Implementing a test-at-slaughter program will necessitate the use 
of a specimen submission form. We are asking OMB to approve, for 3 
years, our use of this information collection activity in connection 
with our efforts to perform testing at slaughter and thus prevent the 
spread of animal diseases within the United States.
    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 0.3333 hours per response.
    Respondents: Slaughtering plant personnel assigned to collect blood 
and tissue samples.
    Estimated number of respondents: 100.
    Estimated number of responses per respondent: 120.
    Estimated annual number of responses: 12,000.
    Estimated total annual burden on respondents: 4,000 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.

List of Subjects in 9 CFR Part 71

    Animal diseases, Livestock, Poultry and poultry products, 
Quarantine, Reporting and recordkeeping requirements, Transportation.

    Accordingly, we propose to amend 9 CFR part 71 as follows:

PART 71--GENERAL PROVISIONS

    1. The authority citation for part 71 would be revised to read as 
follows:

    Authority: 7 U.S.C. 8304-8306, 8308, 8310, 8313, and 8315; 7 CFR 
2.22, 2.80, and 371.4.

    2. In Sec.  71.1, the definition of livestock would be revised and 
three new definitions would be added in alphabetical order to read as 
follows:


Sec.  71.1  Definitions.

* * * * *
    Food Safety and Inspection Service (FSIS). The Food Safety and 
Inspection Service, United States Department of Agriculture.
* * * * *
    Livestock. Horses, cattle, bison, captive cervids, sheep and goats, 
swine, and other farmed animals.
* * * * *
    Move (moved). Shipped, transported, delivered, or otherwise aided, 
induced, or caused to be moved.
* * * * *
    Recognized slaughtering establishment. Any slaughtering 
establishment operating under the provisions of the Federal Meat 
Inspection Act (21 U.S.C. 601 et seq.) or a State meat inspection act. 
A list of recognized slaughtering establishments in any State may be 
obtained from an APHIS representative, the State animal health 
official, or a State representative.
* * * * *
    3. A new Sec.  71.21 would be added to read as follows:


Sec.  71.21  Tissue and blood testing at slaughter.

    (a) Any person moving livestock or poultry interstate for slaughter 
may only move the animals to a slaughtering establishment that has been 
listed by the Administrator \1\ for the purposes of this part. A 
slaughtering establishment may receive livestock or poultry in 
interstate commerce only if the slaughtering establishment has been 
listed by the Administrator. The Administrator may list a slaughtering 
establishment after determining that collecting samples for testing 
from the establishment is not necessary for the purposes of APHIS 
disease surveillance programs. Otherwise, the Administrator will list a 
slaughtering establishment after determining that it is a recognized 
slaughtering establishment or a

[[Page 70875]]

slaughtering establishment that undergoes voluntary inspection under 
the provisions of the Agricultural Marketing Act (12 U.S.C. 1141 et 
seq.), and that it:
---------------------------------------------------------------------------

    \1\ A list of these slaughtering establishments may be obtained 
by writing to National Animal Health Programs, VS, APHIS, 4700 River 
Road Unit 43, Riverdale, MD 20737-1231.
---------------------------------------------------------------------------

    (1) Provides space and equipment in accordance with paragraph (b) 
of this section within their facility for blood and tissue sample 
collection;
    (2) Allows APHIS, FSIS, or APHIS contractors to take blood and 
tissue samples from all livestock or poultry at the facility without 
cost to the United States, and specifically allows these personnel 
access to the processing line to collect samples; and
    (3) Allows APHIS, FSIS, or APHIS contractors to record the 
identification of individual animals and retain any external or 
internal identification devices.
    (b) The slaughtering establishment must provide office and sample 
collection space, including necessary furnishings, light, heat, and 
janitor service, rent free, for the use by APHIS, FSIS, or APHIS 
contractors collecting samples for blood and tissue testing under this 
section. The Administrator will inform each slaughtering establishment 
of the exact amount and type of space required, taking into account 
whether APHIS will be conducting complete tests at the facility, or 
only collecting samples and sending them elsewhere for testing. At the 
discretion of the Administrator, small plants need not furnish 
facilities as prescribed in this section if adequate facilities exist 
in a nearby convenient location. In granting or denying listing of a 
slaughtering establishment, the Administrator will consider whether the 
space at the facility:
    (1) Is conveniently located, properly ventilated, and provided with 
lockers suitable for the protection and storage of supplies;
    (2) Has sufficient light to be adequate for proper conduct of 
sample collection and processing;
    (3) Includes racks, receptacles, or other suitable devices for 
retaining such parts as the head, glands, and viscera, and all parts 
and blood to be collected, until after the post-mortem examination is 
completed;
    (4) Includes tables, benches, and other equipment on which sample 
collection and processing are to be performed, of such design, 
material, and construction as to enable sample collection and 
processing in a safe, ready, efficient, and clean manner;
    (5) Has adequate arrangements, including liquid soap and cleansers, 
for cleansing and disinfecting hands, dissection tools, floors, and 
other articles and places that may be contaminated by diseased 
carcasses or otherwise; and
    (6) Has adequate facilities, including denaturing materials, for 
the proper disposal of tissue, blood, and other waste generated during 
test sample collection.
    (c) The Administrator will give the operator of the slaughtering 
establishment actual notice that APHIS, FSIS, or an APHIS contractor 
will be taking blood and/or tissue samples at the establishment. The 
Administrator may give the operator of the slaughtering establishment 
notice in any form or by any means that the Administrator reasonably 
believes will reach the operator of the establishment prior to the 
start of sample collection.
    (1) The notice will include the anticipated date and time sample 
collection will begin. The notice will also include the anticipated 
ending date and time.
    (2) The Administrator will give the operator of the slaughtering 
establishment as much advance notice as possible. However, the actual 
amount of notice will depend on the specific situation.
    (d) Denial and withdrawal of listing. The Administrator may deny or 
withdraw the listing of a slaughtering establishment upon a 
determination that the establishment is not in compliance with the 
requirements of this section.
    (1) In the case of a denial, the operator of the slaughtering 
establishment will be informed of the reasons for the denial and may 
appeal the decision in writing to the Administrator within 10 days 
after receiving notification of the denial. The appeal must include all 
of the facts and reasons upon which the person relies to show that the 
slaughtering establishment was wrongfully denied listing. 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.
    (2) In the case of withdrawal, before such action is taken, the 
operator of the slaughtering establishment will be informed of the 
reasons for the proposed withdrawal. The operator of the slaughtering 
establishment may appeal the proposed withdrawal in writing to the 
Administrator within 10 days after being informed of the reasons for 
the proposed withdrawal. The appeal must include all of the facts and 
reasons upon which the person relies to show that the reasons for the 
proposed withdrawal are incorrect or do not support the withdrawal of 
the listing. 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, withdrawal shall 
become effective pending final determination in the proceeding when the 
Administrator determines that such action is necessary to protect the 
public health, interest, or safety. Such withdrawal shall be effective 
upon oral or written notification, whichever is earlier, to the 
operator of the slaughtering establishment. In the event of oral 
notification, written confirmation shall be given as promptly as 
circumstances allow. This withdrawal shall continue in effect pending 
the completion of the proceeding, and any judicial review thereof, 
unless otherwise ordered by the Administrator.

    Done in Washington, DC, this 21st day of November, 2002.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 02-30093 Filed 11-26-02; 8:45 am]
BILLING CODE 3410-34-P