[Federal Register Volume 69, Number 43 (Thursday, March 4, 2004)]
[Rules and Regulations]
[Pages 10137-10151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4810]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 71

[Docket No. 99-017-3]
RIN 0579-AB13


Blood and Tissue Collection at Slaughtering and Rendering 
Establishments

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations governing interstate

[[Page 10138]]

transportation of animals 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-raised animals) 
and poultry at slaughtering and rendering establishments when it is 
necessary for disease surveillance. Any person who moves livestock or 
poultry interstate for slaughter or rendering may only move the animals 
to a slaughtering or rendering establishment listed by the 
Administrator. The Administrator may list an establishment after 
determining either that the establishment provides the type of space 
and facilities specified by the regulations to safely collect blood and 
tissue samples for disease testing; or that it is not currently 
necessary to conduct testing at the establishment because the data 
collected through such testing would not significantly assist the 
Agency's disease surveillance programs and the facility has agreed to 
allow testing and provide access to facilities upon future APHIS 
notification that testing is required. This change will affect persons 
moving livestock or poultry interstate for slaughter or rendering, 
slaughtering and rendering 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 will be to improve 
surveillance programs for animal diseases, to contribute to the 
eventual control or eradication of such diseases, and to assist in 
certifying the status of the United States or its regions with regard 
to freedom from specific animal diseases.

EFFECTIVE DATE: March 4, 2004.

FOR FURTHER INFORMATION CONTACT: Dr. Adam Grow, National Center for 
Animal Health Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, 
MD 20737-1231; (301) 734-6954.

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 (7 U.S.C. 8301 through 
8317). Section 10409 of that Act (7 U.S.C. 8308) 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.''
    On November 27, 2002, we published in the Federal Register a 
proposed rule (67 FR 70864-70875, Docket No. 99-017-1) 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 farm-raised animals) and poultry at slaughter. We proposed to 
require that persons moving livestock and poultry interstate for 
slaughter only move the animals to slaughtering establishments, 
including rendering establishments, that have been listed by the 
Administrator of APHIS. We did not propose to collect samples from all 
livestock or poultry at slaughter, but to collect samples whenever we 
believe it is necessary for effective surveillance.
    We solicited comments concerning the proposed rule for 60 days 
ending January 27, 2003. On January 27, 2003, we published in the 
Federal Register a notice (68 FR 3826, Docket No. 99-017-2) in which we 
extended the comment period for a period of 60 days ending March 28, 
2003. We received a total of 19 comments by the close of the extended 
comment period. The comments were submitted by livestock industry and 
trade associations, individual producers, and other members of the 
public. Ten commenters were generally supportive of the proposed rule, 
although most suggested that APHIS make some changes or provide some 
more explanation in the final rule. The other commenters expressed 
concern about the effects of the proposed rule and about some of the 
specific provisions of the proposal, or suggested that the rule should 
not apply to particular levels of livestock industries. These comments 
are discussed by subject below.

Comments on Listing of Establishments and Selection of Establishments 
for Testing

    One commenter stated that it is unclear how the list of 
establishments in proposed Sec.  71.21(a) would be used. As proposed, 
the list would include both plants that have agreed to sampling and 
plants where APHIS has determined sampling is unneeded. What would 
happen when someday APHIS decides it needs to collect samples at one of 
the ``sampling is unneeded'' plants? The commenter suggested that the 
list should include only plants that have agreed to sampling, even if a 
subset of plants on the list have been told there are no immediate 
plans to sample there and they do not need to provide facilities at 
this time.
    We agree with the commenter's concern. In preparing the proposed 
rule, APHIS sought to minimize effects on plants where we did not plan 
to conduct testing in the near future. We thought the best way to do 
this was to simply add such plants to the list, allowing them to 
continue operations without the need for any correspondence with APHIS 
regarding testing. If it later became necessary to conduct testing at 
one of these plants, we could contact the plant and inform them that 
they needed to provide access and facilities for testing at some future 
date, or they would be delisted and unable to receive livestock moved 
interstate.
    Further study of this issue has convinced us that the list would be 
more useful, and better understood by industry, if all the plants 
listed have agreed to provide access and facilities for testing, when 
needed. APHIS is now prepared to contact all plants engaged in the 
receipt of livestock moved interstate. We will inform some plants that 
we wish to conduct testing in the near future, and will add these 
plants to the list if they agree to provide the access and facilities 
required for our testing schedule. We will inform the remainder of the 
plants that we have no immediate plans to conduct testing at them, but 
that it may become necessary to do so in the future, and we will add 
these plants to the list if they agree to provide the required access 
and facilities if and when they are needed.
    To accomplish this change, we would change one sentence in Sec.  
71.21(a). In the proposed rule, the sentence read ``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.'' In this final rule, 
we are changing that sentence to read ``The

[[Page 10139]]

Administrator may list a slaughtering establishment or a rendering 
establishment after determining that collecting samples for testing 
from the establishment is not currently necessary for the purposes of 
APHIS disease surveillance programs and the establishment has agreed to 
allow testing and to provide the access and facilities required by this 
section upon future APHIS notification that testing is required at the 
establishment.''
    Several commenters were concerned that APHIS would be unaware of 
some small establishments and fail to list them, possibly causing 
severe economic harm to plants that are thereby prohibited from 
accepting animals in interstate commerce. These commenters were 
concerned that the APHIS list may deal with large establishments, but 
may miss some plants because they are very small or because APHIS has 
no interest in sampling there. How will APHIS ensure completeness of 
the list?
    This is a valid concern, but we do not believe any change to the 
rule is needed to resolve it. Since the proposed rule was published, 
APHIS has been collecting and verifying the contact information for all 
plants that would be affected by the regulations, to ensure that we are 
able to contact them all. If we still fail to contact a plant eligible 
for listing and leave it off the first list, we are prepared to add the 
plant to the list after being informed of the omission. \1\ A plant in 
this situation will still be able to accept animals moved interstate 
while APHIS is in the process of adding it to the list, because APHIS 
is the agency that would be responsible for denying such movement, and 
we do not intend to do so when the plant's eligibility to receive such 
animals is in doubt because of a mistake APHIS made in not contacting 
the plant about its listing status.
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    \1\ Plants may request to be added to the list by writing to 
National Center for Animal Health Programs, VS, APHIS, 4700 River 
Road Unit 43, Riverdale, MD 20737-1231.
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    One commenter stated that when APHIS selects plants for sampling, 
the decision should be based on sound epidemiology, and should consider 
that surveillance at slaughter at any point in time is not a true 
random sample of the population. Producers generally only send healthy 
animals to slaughter. Plant selection would be different depending on 
whether APHIS was trying to prove freedom from a disease, or delimit a 
known or suspected disease.
    We agree, and intend to follow these principles in determining when 
and where to collect samples.

Comments on Applicability of Rule to Rendering Plants

    Two commenters suggested that to achieve its purpose, the rule 
should apply not only to slaughtering establishments producing meat for 
human food, but also to businesses such as rendering plants that accept 
livestock to produce other products.
    The proposed rule applied to all establishments that slaughter 
livestock, regardless of the intended use of the products produced at 
the establishment. The proposal covered meat and poultry slaughter 
establishments operating under federal inspection, state inspection, 
and slaughter establishments operating under voluntary inspection 
pursuant to the Agricultural Marketing Act of 1946, 7 U.S.C. 1621 et 
seq. The provisions of the Federal Meat Inspection Act (FMIA, 21 U.S.C. 
601 et seq.) and Poultry Products Inspection Act (PPIA, 21 U.S.C. 451 
et seq.) cover both establishments that slaughter specified animals for 
human consumption as well as establishments which slaughter specified 
animals for other than human consumption. The FMIA and PPIA merely 
exempt certain establishments, such as those which slaughter specified 
animals which are not intended for human consumption, from the 
inspection requirements of the Acts. Therefore, we believe that the 
proposed rule clearly applied to establishments slaughtering livestock 
or poultry for human consumption, rendering establishments that 
slaughter livestock or poultry for processing into products intended 
for human food, and rendering establishments that slaughter livestock 
or poultry for processing into products other than human food. However, 
to make this clear, we have added the phrases ``slaughtering 
establishments, including rendering establishments'' and ``slaughtering 
or rendering establishments'' in the regulation.
    There are about 130 packer/renderer operations in the United 
States, where a rendering establishment operates on the same premises 
as a slaughtering establishment and processes primarily waste from that 
slaughtering establishment. The proposed rule as written would allow 
APHIS to conduct necessary sampling at such establishments by granting 
access to the slaughtering establishment. However, there are about 150 
``independent renderer'' establishments in the United States that do 
not operate on the premises of a slaughtering establishment or process 
mainly waste from a single establishment. Some of these independent 
renderers directly accept livestock for rendering, and these are the 
types of establishments where APHIS may need to conduct sampling.
    In fact, in some circumstances animals received by rendering plants 
may have a high incidence of disease and provide particularly useful 
opportunities for sampling, due to the debilitated nature of many 
animals sent to such plants. Such plants also provide an opportunity to 
collect a large volume of brain and tissue samples needed for 
surveillance of bovine spongiform encephalopathy (BSE) and other 
transmissible spongiform encephalopathy (TSE) diseases, with less 
disruption to plant operations than would occur in slaughtering 
establishments.
    Recent events have made APHIS testing of cattle at rendering plants 
even more important. Following the December, 2003, diagnosis of BSE in 
a single cow in Washington State, the Food Safety Inspection Service 
(FSIS) implemented a new policy regarding Federally approved 
slaughtering plants. In an interim rule published in the Federal 
Register on January 12, 2004 (69 FR 1861-1874, Docket No. 03-025IF), 
FSIS added language to their regulations excluding all non-ambulatory 
disabled cattle from the human food supply, and requiring that any such 
cattle that arrive at a slaughter establishment must be condemned and 
disposed of through approved means. One approved means for disposing of 
non-ambulatory disabled cattle is through rendering the cattle for use 
in products that are inedible for human food. Therefore, APHIS expects 
a substantial increase in the number of non-ambulatory disabled cattle 
that are sent to rendering plants.
    APHIS has also taken action in response to the diagnosis of BSE in 
a cow in Washington State. Among other actions, APHIS plans to increase 
its level of BSE testing in domestic cattle. In each of the past 
several years, APHIS has tested about 20,000 cattle for BSE. Because 
non-ambulatory cattle have been identified as a high risk group for 
BSE, three-fourths, or 15,000, of the cattle tested each year have been 
non-ambulatory cattle. APHIS selected most of these cattle from the 
non-ambulatory cattle processed at slaughter plants.
    In 2004, APHIS plans to increase substantially the number of cattle 
it tests for BSE. We expect to select many of these cattle from those 
sent to rendering plants.
    Therefore, to emphasize the rule's coverage of rendering plants 
that accept livestock moved interstate, we are slightly amending the 
text of Sec.  71.21(a). We are also removing the definition of

[[Page 10140]]

recognized slaughtering establishment from Sec.  71.1 because the term 
no longer appears in the revised text.
    In the proposed rule, the introductory text of proposed Sec.  
71.21(a) read ``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 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 slaughtering establishment that 
undergoes voluntary inspection under the provisions of the Agricultural 
Marketing Act (12 U.S.C. 1141 et seq.), and that it: * * *.'' The 
section then went on to describe facility space, equipment, and access 
requirements.
    In this final rule, we have amended that text to read as follows: 
``Any person moving livestock or poultry interstate for slaughter or 
rendering may only move the animals to a slaughtering establishment or 
a rendering establishment that has been listed by the Administrator for 
the purposes of this part.

    Note: A list of these slaughtering establishments, including 
rendering establishments, may be obtained by writing to National 
Center for Animal Health Programs, VS, APHIS, 4700 River Road Unit 
43, Riverdale, MD 20737-1231.

    Livestock or poultry may not be removed from the premises of a 
slaughtering establishment or a rendering establishment listed by the 
Administrator except under a permit issued by APHIS, and in accordance 
with applicable FSIS regulations in this title. A slaughtering 
establishment or rendering establishment may receive livestock or 
poultry in interstate commerce only if the establishment has been 
listed by the Administrator. The Administrator may list a slaughtering 
establishment or a rendering establishment after determining that 
collecting samples for testing from the establishment is not currently 
necessary for the purposes of APHIS disease surveillance programs and 
the establishment has agreed to allow testing and to provide the access 
and facilities required by this section upon future APHIS notification 
that testing is required at the establishment. The Administrator will 
list a slaughtering or rendering establishment after determining that 
it meets the following facility and access requirements: * * *.''

Comments on Poultry Industry Issues

    Four commenters stated that poultry slaughter plants should be 
exempted from the rule because poultry disease issues are significantly 
different from disease issues faced by red meat industries, testing for 
TSE diseases is an important goal of the rule and there are no TSE 
diseases known to affect poultry, and existing disease monitoring 
programs (e.g., the National Poultry Improvement Plan and existing Food 
Safety and Inspection Service [FSIS] sampling programs) are sufficient 
to monitor for poultry diseases.
    We believe that basic disease management issues are similar enough 
in poultry and red meat industries to support a role for slaughter 
testing in both. We do not maintain that slaughter testing will ever be 
the primary means of dealing with poultry disease issues. However, data 
collected from poultry slaughter testing can be very valuable in 
dealing with certain disease issues, particularly identifying and 
characterizing emerging poultry diseases. Slaughter testing at poultry 
plants has not been needed on as large a scale as it is needed in red 
meat plants, due to several reasons, including the large amount of 
poultry testing data already generated under the National Poultry 
Improvement Plan at the producer level. However, APHIS must have access 
to collect samples at poultry plants when disease outbreak situations 
occur that require more surveillance.
    One commenter stated that the major differences between poultry and 
red meat slaughter industries (animal size, layout and construction of 
plants, diseases and diagnostic methods) mean that a single set of 
regulatory requirements cannot realistically cover both.
    We agree that no single sampling protocol or diagnostic approach 
would apply to both red meat and poultry industries, due to the 
different types of diseases involved. However, the rule does not 
specify this type of detail. It only deals with gaining access to 
plants to collect samples; it does not include detailed requirements 
for how to collect samples, how many samples to collect, or how to 
process them. APHIS will determine the number and type of samples that 
must be collected from different plants at different times based on 
current needs for sound epidemiological surveillance of diseases of 
current concern. Details regarding how samples will be collected--e.g., 
on which days, at what time of day, at what point in the production 
line--will be worked out between APHIS and individual plants, taking 
into account the nature of the facility in each case. We believe the 
basic requirements for access and workspace to collect samples apply 
equally well to poultry and red meat facilities.
    Two commenters stated that slaughter testing of poultry will not 
prevent productivity losses, because flock monitoring by company 
veterinarians and diagnostic labs provide earlier, more useful 
awareness of manifestations of disease. One commenter stated that in 
commercial poultry, velogenic viscerotropic Newcastle disease (VVND) 
and similar diseases are detected by an extreme surge in mortality, not 
by slaughter surveillance.
    Existing flock monitoring programs produce excellent results in 
identifying problems with well-known diseases in poultry industries. 
However, these programs are not designed to focus on new, emerging, or 
unknown diseases, some of which may not cause immediate large-scale 
losses to the flock. Slaughter sampling can help APHIS to characterize 
such diseases and develop useful data about emerging diseases on a 
national level.
    One commenter suggested that alternate sample collection methods 
should be used for poultry plants that lack space and layout for 
dedicated inspector facilities. Birds could be bled in the unloading/
hanging area before they actually enter the plant. Existing FSIS 
inspectors on the line could bag and label viscera from birds and place 
them in a cooler for later, offsite examination.
    APHIS will consider using all of these methods if they work well at 
a particular plant. Procedures for sample collection will be devised in 
cooperation with the management of each plant to ensure that the needed 
samples are collected with minimum disruption to plant operations. 
Certainly, it will be possible to collect needed samples at some 
poultry plants without adding new inspectors to the production line.
    One commenter asked how the rule would enhance VVND detection, and 
whether there was a blood test suitable for slaughter testing that is 
specific for VVND.
    VVND is not a primary disease target for our plans for slaughter 
testing, since other effective means of surveillance for it are 
currently in place. There is no approved blood test for VVND. If it

[[Page 10141]]

becomes necessary to test for VVND at slaughter, tissue samples would 
be sent to a laboratory for diagnosis--as with other diseases for which 
there is no blood test.
    Three commenters stated that the rule should apply to all State and 
federally inspected poultry slaughtering establishments.
    Limits to APHIS authority require that our primary focus must be on 
establishments that receive livestock or poultry moved interstate. 
However, APHIS always has worked with States cooperatively when States 
exercise their authority to conduct sampling at plants conducting 
business intrastate. APHIS and States share testing data from tests 
conducted under their respective areas of authority.
    One commenter stated that the rule would eliminate the need for the 
National Avian Influenza Program (NAIP) developed with the United 
States Animal Health Association (USAHA), but would be more intrusive 
and costly, and not nearly as effective.
    This rule would only affect NAIP testing to the extent that we 
implement sample collection for avian influenza testing under the rule. 
We will discuss any perceived need for additional avian influenza 
testing with NAIP participants, and would only implement additional 
testing at slaughter if it would clearly contribute valuable additional 
data about the disease.
    Three commenters stated that with regard to poultry, the rule 
should be limited to control of ``program'' diseases only, i.e., 
diseases for which a Federal control or emergency program exists.
    Such an approach would not be practical or proactive. One purpose 
of the sampling conducted under the rule will be to identify and 
characterize new and emerging disease problems for which Federal or 
State programs do not exist. Another purpose is to document freedom 
from exotic diseases that do not exist in the United States, and 
therefore may not have Federal or State control programs, but which 
might be introduced at any time. It is important to recognize that our 
surveillance programs are intended to both characterize known disease 
problems and to identify emerging disease problems.
    Two commenters stated that the proposed rule erroneously stated 
that the National Poultry Improvement Plan ``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.''
    The commenter is correct, and we apologize for the error in the 
preamble to the proposed rule that described slaughter testing as part 
of the National Poultry Improvement Plan procedures.
    Three commenters suggested that the rule should include ways to use 
the data collected from testing to facilitate poultry exports by 
providing the basis for addressing the export requirements of trading 
partners.
    We agree that data from slaughter testing authorized by this rule 
may be used to support statements regarding national or regional 
freedom from specified diseases on export certificates. However, no 
change to the rule is needed to make this possible. The currently 
established procedures for export certification described by APHIS 
regulations in 9 CFR part 91, by the Office International des 
Epizooties, and by the World Trade Organization allow national 
governments to use such data in support of certificate statements. 
APHIS intends to do so when slaughter testing produces data relevant to 
export certification.

Comments on Economic Impacts

    Five commenters stated that the rule should provide for 
remuneration by APHIS to plants when inspections disrupt operations, 
slow movement of the processing line, or cause other financial losses. 
One additional commenter stated that the rule should provide for 
remuneration by APHIS when sampling destroys a whole carcass or renders 
it unusable.
    We do not intend to establish a program to compensate plant owners 
for costs incidental to the process of collecting and testing samples. 
Many Federal agencies, including APHIS, FSIS, and the U.S. Food and 
Drug Administration, and others, are authorized to collect product 
samples for testing purposes and are not required by law to provide 
compensation for such samples. Such testing is in the public interest 
and addresses public health concerns. In cases where a plant owner 
believes the testing program has caused destruction of animals or other 
articles, the affected party could file a claim under 7 U.S.C. 
8308(b)(1), which states that the Secretary ``may pay a claim arising 
out of the destruction of any animal, article, or means of conveyance 
consistent with the purposes of this subtitle.''
    One commenter suggested that the rule should be amended to include 
only those species and classes of livestock that are currently 
routinely sampled at slaughter.
    As discussed above, our surveillance programs are intended to both 
characterize known disease problems and to identify emerging disease 
problems. Strictly limiting testing to species that have been tested in 
the past would not accomplish that. Certainly, the vast majority of 
samples will be collected from classes of livestock that are currently 
routinely sampled at slaughter, but when APHIS sees a reason to test 
other species of livestock (defined by the Animal Health Protection Act 
as ``all farm raised animals'') we will do so.
    Three commenters stated that the rule would impose substantial 
burdens on establishments that do not have the necessary size or 
facilities to accommodate the sampling.
    As discussed below in the section ``Executive Order 12866 and 
Regulatory Flexibility Act,'' we do not believe this will be the case. 
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 standards.
    One commenter stated that excessive facility adaption costs 
required by the rule may be passed on to producers, particularly 
harming those (typically small) producers without long-term marketing 
contracts.
    As discussed above, and in the section ``Executive Order 12866 and 
Regulatory Flexibility Act,'' we do not believe many facilities will 
face large adaption costs. The costs they do face may be passed on to 
producers, or to buyers of the establishment's products, or to both, 
depending on the business situation of the particular establishment.
    The same commenters suggested that some slaughter plants may use 
the rule's requirements to break existing contracts to buy animals at a 
certain price and renegotiate the contracts on terms advantageous to 
the slaughter plants. The example cited was that some pork slaughter 
plants are buying pigs under long-term contracts at prices that may be 
higher than current market prices. These plants may choose to become 
temporarily ``unlisted,'' effectively breaking the contract, then 
become listed and resume buying at lower prices, harming producers.
    This scenario seems unlikely, because the plant would be 
undertaking great risks in exchange for questionable gains. First, the 
plant might be hurt by adverse publicity and possibly lose desired 
business on a permanent basis during the time it is unlisted. Second, 
the plant could not make certain business plans based on an expectation 
that it would be

[[Page 10142]]

``delisted'' on a particular date and ``relisted'' on another 
particular date, because APHIS, not the plant, controls the dates of 
these actions.
    One commenter stated that the proposed rule's estimate that 
affected plants would spend ``a few thousand dollars'' to comply is 
highly questionable. Even minor modifications to plants often cost tens 
of thousands of dollars, and the APHIS estimate would not even cover 
preliminary engineering and design fees.
    Based on experience to date collecting samples at plants, the 
estimate did not assume that plants would have to build actual 
additions to plant buildings or engage in significant construction. 
APHIS is already collecting samples at most of the larger plants in the 
country where sampling is desired, so access and facilities for 
sampling are already in place at many large plants. APHIS will work 
with individual plants to minimize the need for expensive 
modifications. In view of this, we continue to believe that our 
estimated average cost to comply is accurate.
    One commenter asked whether products from carcasses APHIS samples 
would be withheld from commerce pending test results. If so, plants 
face significant costs with respect to sanitary segregation, product 
and offal storage, and possible adverse publicity.
    Typically, APHIS does not order carcasses held pending test results 
for animal diseases. If plants choose to hold carcasses voluntarily 
pending test results, that is their business decision, not a result of 
the rule. In accordance with longstanding practice, APHIS, in 
cooperation with FSIS, may order a carcass held if it is believed to be 
infected with an agent that poses a human health risk, e.g., 
tuberculosis, or possibly some emerging diseases. Also, in a recent 
policy notice published in the Federal Register on January 12, 2004 (69 
FR 1892, Docket No. 03-048N), FSIS announced that its inspectors will 
not mark ambulatory cattle that have been targeted for any BSE 
surveillance testing as ``inspected and passed,'' until negative test 
results are obtained. While the APHIS BSE testing program primarily 
tests non-ambulatory cattle that would not be at slaughter plants, we 
do intend to test some cattle from slaughter lines, so this policy may 
result in FSIS holds on several hundred to a few thousand cattle at 
slaughter plants each year.

Comments on Records, Reports, and Animal Traceback

    Two commenters stated that the rule should require plants to 
collect information on the premises of origin of animals slaughtered 
there, and provide this information to APHIS upon request for traceback 
purposes. Establishment of a national premises identification program 
would allow more efficient slaughter surveillance.
    The issues of animal identification and traceback procedures are 
outside the scope of this rulemaking. APHIS is continually examining 
options to improve animal identification and traceback, and will 
consider these comments in relation to those issues, but will not make 
any change to this rule based on the comments.
    Five commenters stated that records generated under the rule should 
keep the identity of individual slaughter plants confidential and not 
subject to Freedom of Information Act (FOIA) requests.
    In general, testing results for surveillance purposes are combined 
and summarized in reports that do not contain information identifying 
the particular establishments where tests were conducted. APHIS will 
handle confidential business information from establishments in 
accordance with statutory and regulatory requirements established to 
protect it. With regard to FOIA, APHIS cannot make an advance 
determination to withhold all identifying information; each FOIA 
request must be evaluated according to current judicial decisions 
interpreting applicability of the FOIA statute. Exemption 4 of FOIA 
does protect ``trade secrets and commercial or financial information 
obtained from a person [that is] privileged or confidential,'' but 
court cases frequently affect how this exemption is applied. The 
Department of Justice maintains a ``FOIA Updates'' Web site that 
discusses how court cases and new interpretations have affected FOIA 
over time, at http://www.usdoj.gov/oip/foi-upd.htm.
    Two commenters stated that APHIS should generate an annual report 
of testing activities and results.
    APHIS intends to generate regular reports on the findings of 
surveillance testing done under this rule, as it does for its other 
surveillance programs. Among other reports, APHIS submits an annual 
report to the USAHA documenting the findings of APHIS disease 
surveillance activities.
    One commenter stated that while the proposed rule said APHIS and 
State representatives would provide a copy of the list of approved 
establishments upon request, APHIS should also consider easier means 
(e.g., a Web site) for producers to obtain the information.
    We agree with the commenter, and intend to establish a Web site 
that will contain the list of approved establishments, provide a 
procedure for establishments to request their addition to the list, and 
include links to other information and reports about slaughter 
surveillance testing.
    One commenter stated that plants should be promptly informed by 
APHIS as to what products are being tested and when results are 
expected, so plants can determine the manner in which they may wish to 
voluntarily hold and store products pending results.
    Section 71.21(c) provides that APHIS will notify establishments, 
with ``as much advance notice as possible,'' as to when APHIS will 
begin and end sampling at the establishment. This notice would also 
include the type and approximate number of samples APHIS will collect. 
Test results will be provided to establishments as soon as they are 
available to APHIS.

Comments on APHIS-FSIS Coordination

    Three commenters stated that the rule should provide that APHIS 
will fully use existing FSIS sampling activities and the plant 
facilities established for them before requesting additional 
facilities. A commenter also stated that the proposed rule is too vague 
regarding when APHIS would make plants provide space or facilities and 
when APHIS would make do with existing FSIS facilities. Terms like 
``when convenient,'' ``adequate,'' and ``at the Administrator's 
discretion'' do not help readers understand who will be affected or the 
degree of impact.
    APHIS intends to fully utilize existing FSIS sampling activities 
whenever possible, to avoid adding additional inspectors and increasing 
the burden on establishments. When APHIS can do so and when we must ask 
for additional access or facilities is a question that really must be 
worked out in discussions between APHIS and individual establishments 
after APHIS decides it must sample at an establishment. It is true that 
the rule does not let readers deduce which establishments will be 
sampled and which will not, because the establishments sampled will 
depend upon ongoing and continually evolving APHIS assessments of 
disease risk and epidemiology at a national level.
    Three commenters stated that APHIS and FSIS should establish a 
single set of harmonized sampling requirements to facilitate activities 
and minimize burdens.
    While APHIS and FSIS cooperate on sampling, the agencies' different 
areas of concern and the possibility of sudden external changes 
affecting disease risk make it unlikely that a single, enduring

[[Page 10143]]

set of sampling requirements is possible. FSIS continually adjusts its 
sampling levels to adapt to risk indicators or outbreak reports related 
to human food borne disease, and APHIS does the same with regard to 
animal diseases. The two agencies will coordinate their activities as 
much as possible to minimize burden on establishments.

Other Comments

    One commenter asked whether APHIS inspectors have the expertise to 
make a certain diagnosis in the field, or will they rely exclusively on 
preliminary tests such as PCR reactions?
    While the nature of individual tests and diagnostic procedures is 
outside the scope of this rule, it is safe to say that some samples 
will be subjected to rapid field tests, with positive results confirmed 
later by laboratory analysis. Other tests may only be performed at a 
laboratory.
    One commenter stated that sample collection by truly independent 
inspectors is needed to stop the plants from selling dirty, disease-
causing meat to American consumers.
    Since this comment seems to address human disease risks, rather 
than animal disease risks, it is outside the scope of the rule.
    One commenter suggested that massive levels of BSE and TSE testing 
(at least 1 million rapid tests a year for 5 years) are needed.
    APHIS intends to continue its surveillance for BSE and other TSE 
diseases, and will seek to increase the number of tests to an optimal 
level. As noted above, we initially expect to double the number of 
domestic cattle tested from BSE each year, from 20,000 to 40,000. Since 
the commenter did not provide a basis for suggesting 1 million tests a 
year for 5 years, we cannot evaluate this specific suggestion.
    One commenter stated that the goal of the proposal, which he 
summarized as providing a valid national profile of diseased animals 
going to slaughter, should be restated. In surveillance, negative 
results (healthy animals) can be as important as positive results 
(diseased animals) with regard to demonstrating freedom from disease to 
trading partners.
    We agree that both obtaining an accurate profile of animal disease 
on a national level and demonstrating freedom from particular diseases 
are important goals of the rule.
    One commenter noted that the proposal refers to cull sows and boars 
as the preferred population for pseudorabies testing. The commenter 
stated that in reality, two- and three-tier pork production systems 
with pigs moving between epidemiologically distinct sites mean that the 
health status of culls will not necessarily reflect the health status 
of market pigs. The Meat Juice Pilot Project was cited as an example of 
a better approach to test market swine at slaughter.
    APHIS has worked closely with the swine industry to ensure that 
even though swine move between several sites in large-scale production 
systems, we are still able to do meaningful tracebacks of diseased 
animals and develop good epidemiological information about production 
system premises. See, for example, our regulations about interstate 
movement of swine in production systems in 9 CFR part 71. The Meat 
Juice Pseudorabies Virus Pilot is an important proof-of-concept project 
that has tested hundreds of thousands of samples from swine packing 
plants in Iowa over the past several years. One of the things the pilot 
demonstrated is that it is possible to collect slaughter samples 
without unduly disrupting plant operations. APHIS intends to continue 
working with the pilot project, and to apply its principles as we 
develop additional testing under this rule.
    One commenter asked what the repercussions would be if an animal is 
unknowingly moved interstate to an unlisted plant. Is the person moving 
the animal (owner, trucker, manager) liable for not being properly 
informed?
    We are not able to give a blanket answer to this question about 
enforcement of the rule, because so much depends on the facts of each 
particular case. In general, persons moving livestock interstate are 
responsible for knowing the requirements of applicable rules and 
regulations governing such movement. However, plants will know whether 
or not they are listed as approved to receive livestock moved 
interstate, and will also typically know if the livestock they are 
buying were moved interstate, and an unlisted plant would clearly be in 
violation if it knowingly received animals moved interstate. During the 
early implementation of this rule, APHIS enforcement will take into 
account the need for a learning period while plants, producers, and 
transporters become familiar with its requirements.
    One commenter stated concerns about the risks posed by animals that 
are delivered to a slaughter plant but are then removed from the 
premises rather than slaughtered. Such animals might be infected with 
diseases that would not be discovered because the animals are not 
available for testing.
    APHIS is aware of this problem. Occasionally animals are removed 
from a slaughter plant premises and moved to either a producer's 
premises or another slaughter plant. Such uncontrolled movements do 
present a risk of exposing other animals if the animal being moved is 
infected, and the movements are inconsistent with the definition of 
``moved to slaughter'' in various APHIS regulations, which presumes 
that animals moved to slaughter will be slaughtered at the destination.
    Therefore, we are adding language in this final rule to prohibit 
the removal of animals moved interstate to a slaughter or rendering 
establishment from the premises of that slaughter or rendering 
establishment unless the animals are moved in accordance with a permit 
issued by APHIS. While removal of animals would generally not be 
allowed, APHIS may issue a permit for such movement in exceptional 
cases, e.g., if a plant accidentally receives a shipment of animals 
that it is unable to slaughter because the size of the animals does not 
match the slaughter plant's line capabilities, or the slaughter plant 
is experiencing mechanical difficulties that bring processing to a 
halt.
    To accomplish this change, we are adding the following sentence to 
Sec.  71.21(a): ``Livestock or poultry may not be removed from the 
premises of a slaughtering establishment or a rendering establishment 
except under a permit issued by APHIS, and in accordance with 
applicable FSIS regulations in this title.''
    One commenter stated that with regard to bovine tuberculosis 
testing, the proposed rule did not present statistically valid data or 
identify specific benefits for increasing testing from 1,200 head per 
year to 4,000 or more, since the current number of cattle infected does 
not seem significant enough to warrant increased testing.
    Eradication of bovine tuberculosis is a priority for USDA and the 
cattle industry. It should be remembered that bovine tuberculosis 
caused more losses among U.S. farm animals in the early part of the 
20th century than all other infectious diseases combined. Substantial 
decreases in tuberculosis levels in recent years are partly a result of 
increased testing for the disease. As levels of tuberculosis decline in 
a large national cattle population, its low incidence requires more 
testing to locate remaining pockets of the disease.
    One commenter stated that one purpose of the rule is stated as 
allowing APHIS to collect slaughter samples ``whenever we believe it is 
necessary.'' This commenter said APHIS should

[[Page 10144]]

develop standards for when it is ``necessary,'' to avoid being 
arbitrary and capricious.
    Collecting slaughter samples is necessary at different times and 
under different circumstances to meet a wide variety of surveillance 
goals. It is not feasible to develop a rule of general applicability 
that will describe in advance when sampling will be necessary. Sampling 
may be used when it is suspected that a disease is in an area, to 
determine its presence or absence, and to estimate the incidence or 
prevalence if the disease is present. Sampling may be needed to provide 
data for new or updated risk analyses produced in support of disease 
control programs, or required to open international markets for 
products. Sampling may be increased in an area when a disease outbreak 
is suspected, then reduced in that area when sufficient tests have been 
done to prove the suspicion was unfounded. Constantly changing disease 
outbreak, trade, and livestock industry conditions make it necessary 
for APHIS surveillance experts to continually revise the mix and degree 
of sampling activities, based on application of their expert knowledge 
to current conditions.
    Other commenters raised several issues that were outside the scope 
of this rulemaking that will not be discussed in this final rule.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule with the 
changes discussed in this document.

Effective Date

    This rule is needed to allow APHIS to conduct effective 
surveillance programs for dangerous animal diseases, including improved 
surveillance for BSE in response to the finding of that disease in a 
cow in Canada, and the December 2003 diagnosis of BSE in a cow in 
Washington State. Therefore, the Administrator of the Animal and Plant 
Health Inspection Service has determined, in accordance with the 
provisions of 5 U.S.C. 553(d)(3), that there is good cause to make this 
rule effective less than 30 days after publication in the Federal 
Register.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been reviewed under Executive Order 12866. The 
rule has been determined to be significant for the purposes of 
Executive Order 12866 and, therefore, has been reviewed by the Office 
of Management and Budget.
    The economic analysis prepared for this final 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 will require persons moving livestock (horses, cattle, bison, 
captive cervids, sheep and goats, swine, and other farm-raised animals) 
and poultry interstate to slaughter or rendering to move them only to 
slaughtering or rendering establishments that have been listed by the 
Administrator. The Administrator may list an establishment after 
determining that it is not currently necessary to conduct testing there 
and that the facility has agreed to grant access and provide facilities 
if and when needed, or 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 taking 
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 National Agricultural Statistics Service (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, 350 plants 
slaughtering poultry, and 2 plants slaughtering horses. (The horse 
plants will not be addressed further in this analysis because APHIS 
currently has no plans to collect samples at them.) 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 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 APHIS's regulations in 9 CFR part 78 for States to 
maintain their brucellosis classifications. Some sample collection 
already occurs at about 20 to 25 of the largest swine plants to collect 
blood samples for pseudorabies testing.
    This final rule will 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 will 
be tested and the relatively small number of cases of disease expected 
to be identified, we do not expect that this rule will 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 standards.
    The primary economic effects of this rule will be direct costs to 
those slaughter and rendering plants that will have to provide us with 
access, workspace, and equipment to collect samples. We believe that 
some of the 20 to 30 plants that have not already been providing access 
under voluntary sampling programs may incur some facility adaption 
costs the first time that we collect samples at them, if they have to 
create or furnish new office space for inspectors to comply with Sec.  
71.21(b), and afterwards may incur some lesser costs if the speed at 
which the processing line moves is slowed or stopped for samples to be 
taken.
    In the following sections we discuss potential economic effects on 
the various categories of slaughtering plants, based on the types of 
animals each processes. We do not specifically address rendering plants 
in these sections because, excluding the effects of increased BSE 
testing, the rule is expected to affect only three or four rendering 
plants, those plants are not small businesses, and we cannot accurately 
estimate economic effects on rendering plants because we have little 
economic information concerning these plants. APHIS is currently 
developing plans to increase BSE testing of cattle at rendering plants, 
but we are not sure yet how many separate plants must be sampled to 
provide a representative sample. Preliminary information from the 
rendering industry suggests that plants that currently render non-
ambulatory animals would also process most of any increase in the 
number of such animals that is rendered. If this is the case, the 
number of rendering plants

[[Page 10145]]

affected by this rule would remain at three or four, or increase only 
slightly. In recent discussions, renderers have also suggested that 
allowing APHIS to collect sample would not impose significant costs. 
The renderers were concerned that later policy developments addressing 
food safety could significantly affect the costs involved in processing 
non-ambulatory animals. For example, renderers stated that if later 
decisions allow carcasses of non-ambulatory cattle to be rendered for 
edible products after the cattle have tested negative for BSE, the 
renderers would have to store the carcasses in refrigerated facilities 
while awaiting test results.
    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 final 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...........     $0.50-1 \1\      $0.10-0.50
Cattle.............................            35.5  Tuberculosis.........  1,200................  4,000................          22 \2\              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...............        5-10 \4\             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 30 minutes. A 2003 final rule by FSIS revised the hourly user fee FSIS
  charges for services under its inspection program to $43.64 per hour; this fee includes $25 to $32 per hour of salary (typically a GS-12 level) plus
  benefits, overhead, and certain travel, operating, and laboratory costs. 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, FSIS requires that the suspect carcass 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
  unless it is done in accordance with FSIS regulations at 9 CFR 311.2, and steps are taken to trace the diseased animal 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 will probably be 2 to 3
  samples per hour. An approximate hourly wage rate for a technician employed in a slaughtering facility ranges from $16 per hour to $21 per hour, based
  on the GS-7 pay scale plus benefits. Additionally, the plant will 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       Estimated
                                                   Per-unit cost   Per-unit cost    total cost      total cost
        Animal disease           Samples needed    of collection    of testing      (millions)      (millions)
                                                                                    lower bound     upper bound
----------------------------------------------------------------------------------------------------------------
Cattle brucellosis............  12 million......         $0.50-1      $0.10-0.50            $7.2             $18
Cattle tuberculosis...........  4,000...........              22              20           0.168           0.168
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....................  ................  ..............  ..............          12.933          25.848
----------------------------------------------------------------------------------------------------------------


    Note: Only approximately 25 percent of these costs come from 
increases in sampling resulting from the final rule; the remainder 
represents sampling already occurring under previous authorizations.

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 final rule, samples will 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 (NAICS) code of 311611. The Small 
Business Administration (SBA) definition of small business for NAICS 
311611 is a firm with less than 500 employees.
    In 2002, the vast majority of meat packing plants were small 
entities under SBA guidelines. There were 292 large meat packing plants 
under Federal inspection in 2002. The 50 largest meat companies in the 
industry had combined sales of $119.7 billion. Of this total amount, 
just the 10 largest companies produced $86.6 billion of the sales. The 
remaining 40 companies produced $33.1 billion in sales.
    There are 706 federally inspected plants that slaughtered at least 
one head of cattle in 2002. Fifteen plants account for over 56 percent 
of the total cattle killed. (Agricultural Statistics Board, NASS, 
Livestock Slaughter 2002 Summary, March 2003.) There are 683 plants 
that slaughter hogs. Nine plants account for 43 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 0.0002 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.

[[Page 10146]]

    Under this final rule, the direct costs of collecting a tissue 
sample and testing it for tuberculosis will be borne by APHIS, in 
either salary or contractor costs. It takes a veterinarian about 30 
minutes to collect a sample for tuberculosis testing. An approximate 
hourly wage rate for a Federal or contractor veterinarian to do these 
duties is $22 to $28 per hour. The cost of laboratory analysis to test 
for tuberculosis is about $20.
    A slaughtering plant may incur a cost if its processing line must 
be slowed or stopped for a sample to be taken. Usually, samples can be 
collected without slowing the line. Currently about 0.003 percent 
(1,200) of cattle slaughtered are tested for tuberculosis, and we 
anticipate that after this rule we will initially increase testing to 
4,000 head annually. Over time, the annual number of cattle tested for 
tuberculosis at slaughter may increase to about 5,300, to provide fully 
adequate surveillance. Because of the small number of additional tests 
for tuberculosis, this aspect of the final rule will not have a 
material effect on small business entities.
    If a tuberculosis test is negative, the carcass is processed and 
sold. If the test is positive, the carcass cannot be sold unless it is 
done in accordance with FSIS regulations at 9 CFR 311.2, and steps are 
taken to trace the diseased animal 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 rule, since herds are already quarantined and 
depopulated under other APHIS regulations.

Cost of Testing Additional Blood Samples for Cattle Brucellosis

    This final rule will not change the number of brucellosis test 
samples collected from cattle or the way in which they are processed. 
This final rule will 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 products 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 will cover followup 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 will 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 $0.45 to $0.90 cents per 
sample.
    The sample is sent to a lab for testing. It costs approximately $1 
per sample for testing. APHIS has some contracts and cooperative 
agreements with universities to do some testing. The cost is negotiated 
with each laboratory separately. The rate can be up to $1.50 per 
sample.
    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 were 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 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

    As noted previously, 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 final rule is not expected to have a significant adverse 
economic effect on small businesses. Blood and tissue samples will be 
collected by APHIS or FSIS personnel or by a contractor paid for by 
USDA. Firms may 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 will 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.

[[Page 10147]]

    The primary direct costs will be the cost of collecting samples and 
the cost of testing samples, both of which will 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 may 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 may continue along on the 
processing line, and the processor will not incur the cost of having to 
hold the carcass.
    Additional testing for scrapie will 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 is 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     testing  (per         Total cost  (millions)
                                              (per sample)       sample)
----------------------------------------------------------------------------------------------------------------
75,000.....................................           $5-10             $30  $2.625 to 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 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 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 final rule will not have an adverse effect on small businesses 
that slaughter cervids. Blood samples will be collected either by 
APHIS, by FSIS, by contractors, or by the firms themselves. Firms will 
be compensated on a per unit basis for collecting the samples. The 
costs of testing captive cervids will be similar to the costs of 
testing cattle. Because of the small number of tests that are expected 
to be done, this final rule will not have a material effect on small 
business entities.

Costs of Testing Poultry at Slaughter

    In 1997, there were 315 poultry processing firms (NAICS code 
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 fewer 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 final rule will not 
have a significant adverse effect on small businesses.
    It is estimated that this final rule may 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 will be collected either by APHIS, by 
FSIS, by contractors, or by the firms themselves. Firms will be 
compensated on a per unit basis for collecting the samples.
    We expect that additional testing conducted after this final rule 
takes effect will 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

[[Page 10148]]

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 that might be necessary under disease surveillance scenarios, 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.

Liability Costs for All Slaughter Industries

    Some firms expressed concern that sample collection in plants could 
result in accidents or injury that increase their liability costs. 
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, which is very small. 
Slaughtering plants are already involved in a potentially hazardous 
activity. Adding the requirement to collect blood and tissue samples 
will not add significantly to the liability incurred by a plant, but a 
small increase in liability costs may be expected.

Benefits of Additional Testing

    Additional testing will 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 will 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. Production of 
agricultural commodities varies for many reasons, and it is 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 will be that it will 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 will 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 final rule will not affect the number of samples from cattle 
collected to test for brucellosis or the way in which the testing is 
conducted. There will be no economic effect due to this final 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 will represent 
only a small part of the benefit of additional testing. One benefit of 
this final rule will 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 will 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 
insignificant level, several months earlier than would otherwise be 
possible. The additional slaughter testing that will be allowed will 
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 will aid eradication of scrapie, which will 
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 final rule will have a positive economic 
effect on producer incomes. The additional slaughter testing that will 
be conducted will 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 will be conducted under 
this final rule will 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, will benefit in 
the form of increased productivity and possible expansion of overseas 
markets. More effective disease surveillance is

[[Page 10149]]

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. More effective surveillance can also help reopen poultry 
export markets more quickly following an avian disease outbreak, by 
documenting containment of a problem.

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 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 final rule envisions for 
cattle, swine, and sheep is between $12.933 million and $25.848 
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 $3.4 million 
and $4.6 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 requested comments providing data on costs that 
slaughter plants might incur, including costs due to slowing the 
production line as well as office space, equipment, and other costs, 
but we did not receive any specific data on these subjects.
    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 under this final rule. 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 will 
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 will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

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

Paperwork Reduction Act

    The information collection burden in this final rule includes 120 
hours that were not included in the proposed rule. Specifically, the 
additional hours are for compliance by rendering plants, which were 
added to the coverage of the final rule. 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 rule have been approved by the Office of Management 
and Budget (OMB) under OMB control number 0579-0212.

Government Paperwork Elimination Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the Government Paperwork Elimination Act (GPEA), which 
requires Government agencies in general to provide the public the 
option of submitting information or transacting business electronically 
to the maximum extent possible. For information pertinent to GPEA 
compliance related to this rule, please contact Mrs. Celeste

[[Page 10150]]

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.

0
Accordingly, we are amending 9 CFR part 71 as follows:

PART 71--GENERAL PROVISIONS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


0
2. In Sec.  71.1, the definitions of livestock and moved (movement) in 
interstate commerce are revised and a definitions of Food Safety and 
Inspection Service (FSIS) is 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 farm-raised animals.
* * * * *
    Moved (movement) in interstate commerce. Shipped, transported, 
delivered, or otherwise aided, induced, or caused to be moved from the 
point of origin of the interstate movement to the animals' final 
destination, such as a slaughtering establishment or a farm for 
breeding or raising, and including any temporary stops along the way, 
such as at a stockyard or dealer premises for feed, water, rest, or 
sale.
* * * * *

0
3. A new Sec.  71.21 is added to read as follows:


Sec.  71.21  Tissue and blood testing at slaughter.

    (a) Any person moving livestock or poultry interstate for slaughter 
or rendering may only move the animals to a slaughtering establishment 
or a rendering establishment that has been listed by the Administrator 
\8\ for the purposes of this part. Livestock or poultry may not be 
removed from the premises of a slaughtering establishment or a 
rendering establishment listed by the Administrator except under a 
permit issued by APHIS, and in accordance with applicable FSIS 
regulations in this title. A slaughtering establishment or rendering 
establishment may receive livestock or poultry in interstate commerce 
only if the establishment has been listed by the Administrator. The 
Administrator may list a slaughtering establishment or a rendering 
establishment after determining that collecting samples for testing 
from the establishment is not currently necessary for the purposes of 
APHIS disease surveillance programs and the establishment has agreed to 
allow testing and to provide the access and facilities required by this 
section upon future APHIS notification that testing is required at the 
establishment. The Administrator will list a slaughtering or rendering 
establishment after determining that it meets the following facility 
and access requirements:
---------------------------------------------------------------------------

    \8\ A list of these slaughtering or rendering establishments may 
be obtained by writing to National Center for Animal Health 
Programs, VS, APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-
1231.
---------------------------------------------------------------------------

    (1) The establishment provides space and equipment in accordance 
with paragraph (b) of this section \9\ within their facility for blood 
and tissue sample collection;
---------------------------------------------------------------------------

    \9\ FSIS also has equipment and space requirements for official 
establishments at Sec.  307.2(c) of this title.
---------------------------------------------------------------------------

    (2) The establishment 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) The establishment allows APHIS, FSIS, or APHIS contractors to 
record the identification of individual animals and retain any external 
or internal identification devices.
    (b) The 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 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 an 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 in accordance with this chapter of tissue, blood, 
and other waste generated during test sample collection.
    (c) The Administrator will give the operator of the 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 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 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 an 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 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 establishment 
was wrongfully denied listing. The Administrator will grant or deny the 
appeal in writing as promptly as

[[Page 10151]]

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 establishment will be informed of the reasons for the 
proposed withdrawal. The operator of the 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 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.

(Approved by the Office of Management and Budget under control 
number 0579-0212.)

    Done in Washington, DC, this 1st day of March 2004.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 04-4810 Filed 3-3-04; 8:45 am]
BILLING CODE 3410-34-P