[Federal Register: November 27, 2002 (Volume 67, Number 229)]
[Proposed Rules]
[Page 70864-70875]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27no02-14]
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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 regulations@aphis.usda.gov. Your comment must
be contained in the body of your message; do not send attached files.
Please include your name and address in your message and ``Docket No.
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:
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\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