99-31087. Scrapie in Sheep and Goats; Interstate Movement Restrictions and Indemnity Program  

  • [Federal Register Volume 64, Number 229 (Tuesday, November 30, 1999)]
    [Proposed Rules]
    [Pages 66791-66812]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-31087]
    
    
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    DEPARTMENT OF AGRICULTURE
    
    Animal and Plant Health Inspection Service
    
    9 CFR Parts 54 and 79
    
    [Docket No. 97-093-2]
    RIN 0579-AA90
    
    
    Scrapie in Sheep and Goats; Interstate Movement Restrictions and 
    Indemnity Program
    
    AGENCY: Animal and Plant Health Inspection Service, USDA.
    
    ACTION: Proposed rule.
    
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    SUMMARY: We are proposing to restrict the interstate movement of sheep 
    and goats from States that do not follow effective flock management 
    practices for scrapie. We also propose to require animal identification 
    for sheep and goats moving interstate and to reinstate a scrapie 
    indemnity program to compensate owners of certain animals destroyed due 
    to scrapie. These changes would help prevent the interstate spread of 
    scrapie, an infectious disease of sheep and goats.
    
    DATES: Consideration will be given only to comments received on or 
    before December 30, 1999.
    
    ADDRESSES: Please send an original and three copies of your comments to 
    Docket No. 97-093-2, Regulatory Analysis and Development, PPD, APHIS, 
    suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238.
    
    [[Page 66792]]
    
    Please state that your comments refer to Docket No. 97-093-2. Comments 
    received may be inspected at USDA, room 1141, South Building, 14th 
    Street and Independence Avenue, SW., Washington, DC, between 8 a.m. and 
    4:30 p.m., Monday through Friday, except holidays. Persons wishing to 
    inspect comments are requested to call ahead on (202) 690-2817 to 
    facilitate entry into the comment reading room.
    
    FOR FURTHER INFORMATION CONTACT: Dr. Diane Sutton, Senior Staff 
    Veterinarian, National Animal Health Programs Staff, 4700 River Road 
    Unit 43, Riverdale, MD 20737-1235, (301) 734-7709.
    
    SUPPLEMENTARY INFORMATION: Scrapie is a degenerative and eventually 
    fatal disease affecting the central nervous systems of sheep and goats, 
    a member of a class of diseases called transmissible spongiform 
    encephalopathies (TSEs). Its control is complicated because the disease 
    has an extremely long incubation period without clinical signs of 
    disease, and because there is no live-animal test for the disease that 
    has been validated (demonstrated to be accurate by impartial research).
        Scrapie is not a highly contagious disease; however, transmission 
    to uninfected and susceptible animals can sometimes occur following 
    exposure to small amounts of tissues from an infected animal. The exact 
    conditions favorable to animal-to-animal transmission are not fully 
    understood, though some factors that increase the risk are known (e.g., 
    contact of a young animal with the afterbirth of an infected female 
    animal). The scrapie agent moves from infected to susceptible animals 
    by direct animal-to-animal contact, or indirect contact through 
    contaminated premises and may enter through the gastrointestinal tract, 
    open wounds, or other routes. Consequently, its spread appears to be 
    both maternal (mother to offspring) and horizontal (direct contact 
    between unrelated sheep).
        There is no evidence that any human has ever contracted scrapie or 
    any similar disease by eating lamb or mutton. However, it has been 
    theorized that scrapie may have been spread to other animals when whole 
    scrapie-positive animals have been rendered and used as animal feed. 
    This is a prominent theory for the origin of bovine spongiform 
    encephalopathy (BSE) in cattle in the United Kingdom. As a 
    precautionary measure to prevent the possible spread of TSEs via 
    ruminant feed in the United States, the U.S. Food and Drug 
    Administration published a final rule on June 5, 1997 (62 FR 30935-
    30978) that prohibited the use of animal protein derived from most 
    mammalian tissues in ruminant feed.
        While diseases caused by TSEs do not frequently or easily cross 
    species lines, there is reason to be concerned that TSEs infecting one 
    species could at some point lead to diseases in other animal species or 
    humans, as has been demonstrated with BSE in cattle in the United 
    Kingdom. New variant Creutzfeldt Jakob Disease (vCJD) is a human 
    neurological disease recently identified in the United Kingdom that is 
    believed to have its origins in the BSE outbreak in cattle in the 
    United Kingdom. The agent that causes vCJD is indistinguishable from 
    the causative agent of BSE. As of September 21, 1999, 46 cases of vCJD 
    had been identified in the United Kingdom and one in France. The exact 
    means by which the victims were exposed to the agent is uncertain; it 
    may have been through eating beef products that contained high risk 
    materials (brain and spinal cord) from BSE-positive cattle or through 
    some other exposure.
        Based on the above facts, it is reasonable to conclude that control 
    of scrapie in the United States, in addition to addressing a disease 
    problem in sheep, would also reduce concerns about the apparently low 
    but undefined risks that the scrapie agent could lead to diseases in 
    other species.
        There are nearly 8 million sheep and lambs in the United States. It 
    is impossible to estimate with any accuracy how many of them are 
    infected with scrapie. This is because the disease may go undiagnosed. 
    Scrapie has a lengthy incubation period, which complicates 
    epidemiological studies, and there has been no live-animal test to 
    diagnose it. These factors have impeded surveillance programs for 
    scrapie, requiring it to be identified by symptoms and postmortem 
    examination. However, the following information can be used to develop 
    a rough estimate of the number of sheep in the United States that may 
    be infected with scrapie: (1) In a 1996 NAHMS report, 1.2 percent of 
    participating producers reported that they had seen scrapie in their 
    flock in the last 5 years; (2) The average flock size in the United 
    States is 105 animals; (3) The number of flocks in the United States is 
    68,800; (4) In a flock that has had one case, the percent of animals 
    that will come down with scrapie is highly variable. Based on this 
    data, it is likely that at least 826 flocks are affected and that at 
    least 86,730 sheep have been exposed to and may be infected with 
    scrapie. It is likely that the number of exposed and potentially 
    infected animals is significantly higher since owners are likely to 
    under report disease because it is confused with another disease.
        To control the spread of scrapie within the United States, the 
    Animal and Plant Health Inspection Service (APHIS), U.S. Department of 
    Agriculture (USDA), administers regulations at 9 CFR part 79, which 
    restrict the interstate movement of certain sheep and goats. APHIS also 
    administers the Voluntary Scrapie Flock Certification Program (the 
    VSFCP), described in regulations at 9 CFR part 54, and produces a 
    program standards document entitled ``Program Standards--Voluntary 
    Scrapie Flock Certification Program,'' which is available at http://
    www.aphis.usda.gov/vs/scrapie/umr. A hard-copy of the Program Standards 
    may be obtained by contacting the individual listed under FOR FURTHER 
    INFORMATION CONTACT. The regulations at 9 CFR parts 54 and 79 are 
    referred to below as the scrapie regulations.
        For over 40 years USDA has had programs to eradicate or reduce the 
    incidence of scrapie in the United States. While comprehensive data on 
    the incidence of scrapie has always been hard to assemble due to the 
    nature of the disease and its diagnosis, these programs apparently have 
    not resulted in a major reduction in the incidence of scrapie. A major 
    reason for this result is that State programs for scrapie have varied 
    tremendously in their resources and effectiveness, from State to State 
    and over time. States where sheep are not a major agricultural 
    commodity may not invest sufficient resources to identify infected 
    flocks or reduce the incidence of scrapie within that State, and sheep 
    with undiagnosed cases of scrapie could then easily move to other 
    States, infecting new flocks. Therefore, we believe that to build an 
    effective national scrapie program, the current regulations must be 
    adjusted to recognize that sheep from States with minimal or 
    nonexistent scrapie programs represent a higher risk than sheep from 
    other States.
        In an advance notice of proposed rulemaking (ANPR) published in the 
    Federal Register on January 26, 1998 (63 FR 3671-3673, Docket No. 97-
    093-1), we solicited public comments to help us develop options for 
    potential changes to the scrapie regulations. The primary issues on 
    which we sought comment were:
         Should APHIS further restrict interstate movement of 
    animals from States that do not consider scrapie a reportable disease 
    or do not quarantine infected flocks or source flocks? Should APHIS 
    define how a State must conduct a quarantine in order to avoid further
    
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    restrictions on interstate movement of animals from that State?
         Should APHIS restrict interstate movement of high-risk 
    animals from flocks that are not infected flocks or are not source 
    flocks, and if so, how?
         Should any of the definitions in the scrapie regulations 
    be revised (e.g., the definitions of source flock, trace flock, and 
    high-risk animal)?
         Should there be additional permit or official 
    identification requirements for the interstate movement of any classes 
    of sheep and goats to allow for a more effective national program for 
    surveillance for scrapie and traceback of scrapie-positive animals?
         Should APHIS continue to provide the following information 
    on the World Wide Web: The identity of scrapie infected flocks and 
    source flocks designated under part 79, and the identity and 
    certification status of flocks participating in the VSFCP?
        We solicited comments concerning our ANPR for 60 days ending March 
    27, 1998. We received 27 comments by that date. The commenters were 
    sheep producers, industry associations, State agencies, and 
    individuals. The comments and data submitted were carefully reviewed, 
    and helped us develop this proposed rule.
        Briefly, the three major changes we are proposing to the scrapie 
    regulations are:
         Further restrictions on the interstate movement of sheep 
    and goats from States that do not consider scrapie a reportable disease 
    or do not quarantine infected flocks or source flocks. We are also 
    proposing standards describing how a State must conduct a quarantine in 
    order to avoid further restrictions on interstate movement of animals.
         Additional official identification requirements for the 
    interstate movement of sheep and goats to allow for a more effective 
    national program for surveillance for scrapie and traceback of scrapie-
    positive animals. The proposed identification requirements are similar 
    to current requirements for cattle and swine.
         Reinstatement of a scrapie indemnification program for 
    sheep and goats that owners agree to destroy. The owners of destroyed 
    high-risk animals and animals diagnosed as scrapie positive by an 
    approved live-animal test would be eligible for indemnity payments.
    
    State Quarantine Activities and Interstate Movement Restrictions
    
        Many commenters supported the idea that States should have 
    intrastate quarantines and controls on the movement of sheep and goats 
    sufficient to prevent intrastate spread of scrapie from known sources, 
    and that States lacking such quarantines and controls should have the 
    interstate movement of their sheep and goats further restricted. These 
    commenters expressed the opinion that the current regulations do not do 
    enough to prevent the spread of scrapie from States with weak scrapie 
    programs into States with more effective scrapie programs. Most of 
    these commenters supported the idea that an adequate State program is 
    one that considers scrapie to be a reportable disease, that quarantines 
    scrapie infected and source flocks and maintains them under a flock 
    plan, and that imposes intrastate movement restrictions equivalent to 
    Federal interstate movement restrictions imposed under current part 79.
        Commenters generally stated that if a State has or develops such an 
    intrastate program, and APHIS determines the State program to be 
    comparable in effectiveness to its interstate regulations in part 79, 
    that State should not be subject to further interstate movement 
    restrictions. However, a few commenters suggested that if a State 
    implements a program of intrastate restrictions, that should be 
    sufficient to avoid further interstate movement restrictions on sheep 
    from that State, without an APHIS determination that the State program 
    is comparable in effectiveness to the Federal program under part 79.
        Commenters also generally stated that flocks participating in the 
    VSFCP should not be subject to further interstate movement 
    restrictions, even if they are in a State that does not have an 
    adequate intrastate program as described above.
        We believe that programs developed and implemented by States are 
    essential to the control and eradication of scrapie, and we encourage 
    varying approaches to these programs to meet individual State needs and 
    to try and evaluate different control methods. However, we also believe 
    APHIS should have a role in determining that each State program 
    achieves a minimum level of effectiveness to serve national needs. 
    Valid complaints in the past have noted that some State programs exist 
    as little more than a name, and are ineffective. This introduces 
    unacceptable hazards when sheep and goats from such States move in 
    interstate commerce. Additionally, the creation of a uniform minimal 
    standard on the national level would be consistent with the 
    recommendations of international animal health organizations and the 
    World Trade Organization, both of which recommend that a national 
    authority establish minimum standards for programs affecting trade.
        Therefore, we are proposing that if a State is to avoid the 
    requirements described below under ``Additional Interstate Movement 
    Restrictions for Sheep and Goats,'' the State program must be reviewed 
    by APHIS and determined to be comparable to the Federal program 
    contained in part 79. APHIS would conduct this review by evaluating the 
    State statutes, regulations, and directives pertaining to animal health 
    activities to determine whether the State has established authority to 
    conduct a scrapie control program comparable to the Federal one, and 
    would also examine reports and publications of the State animal health 
    agency to determine whether the existing authorities are being 
    exercised in the form of an effective program. The States would be 
    required to submit a written statement containing this information and 
    certifying that they are in compliance with this section.
    
    Additional Interstate Movement Restrictions for Sheep and Goats
    
        Most commenters supported the idea that APHIS should further 
    restrict interstate movement of sheep and goats from States that do not 
    consider scrapie a reportable disease, or that do not quarantine 
    infected and source flocks. Most commenters also stated APHIS should 
    set minimum criteria for how a State must conduct a quarantine. Four 
    commenters opposed APHIS setting minimum criteria in this area because 
    they were concerned that APHIS would dictate detailed command-and-
    control requirements to State programs, rather than minimum 
    effectiveness criteria. This is not the intention of APHIS.
        In this proposal, we describe two sets of interstate movement 
    restrictions: One set for ``Consistent States'' and another set for 
    ``Inconsistent States.'' Consistent States would be States that conduct 
    an active State scrapie program which effectively enforces certain 
    requirements to identify scrapie in flocks and control its spread. We 
    propose to establish in the new Sec. 79.6 the requirements a State 
    would have to meet to be a Consistent State. These requirements include 
    reporting and investigating any scrapie suspect animal, affected 
    animal, or scrapie-positive animal; identifying and quarantining 
    infected and source flocks; and individually identifying certain 
    exposed animals and individually identifying and monitoring certain 
    high-risk animals in all flocks, not just source or infected flocks. 
    All States that are not Consistent States would be Inconsistent States. 
    APHIS believes almost all States currently have the State legislative
    
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    authority and animal health infrastructure to qualify as Consistent 
    States. However, this must be confirmed on a State-by-State basis 
    through discussions between APHIS and State animal health authorities. 
    Before this proposal is finalized, APHIS will develop and publish for 
    comment a list of States that qualify as Consistent States. After 
    finalizing the rule, APHIS will insert the list of ``Consistent 
    States'' in Sec. 79.1. From time to time, APHIS will amend the list 
    when it is determined that States meet or do not meet the definition of 
    Consistent State in Sec. 79.1.
        While this proposal does not require it, it may also be desirable 
    to require all Consistent States to sign a compliance agreement with 
    APHIS describing the State scrapie program operations; we would 
    appreciate public comment on whether our regulations should require 
    such an APHIS-State compliance agreement.
        Such an agreement would provide evidence of the intent of a State 
    to impose the requirements and provide the services necessary for it to 
    be considered a Consistent State. The agreement could also describe 
    cooperative activities between the State and APHIS to support the State 
    scrapie regulatory activities. This agreement would be similar to, or 
    could be made a part of, the cooperative agreement or memorandum of 
    understanding that some States have signed with APHIS to cooperate in a 
    number of animal disease control programs, including the VSFCP (see 
    Sec. 54.13). Under part 54, some States may have already signed a 
    cooperative agreement with APHIS that describes the respective roles of 
    APHIS and State personnel in implementing the VSFCP. Such agreements 
    also specify the financial, material, and personnel resources to be 
    committed by the State and APHIS and assign specific activities to 
    APHIS or State personnel.
        APHIS considered adding one other requirement to the standard for a 
    State to qualify as a Consistent State. The proposed requirement states 
    that Consistent States must report and investigate any scrapie suspect 
    animal, affected animal, or scrapie-positive animal, but it does not 
    specify any particular level of effectiveness in these investigations, 
    nor does it require that States be able, in their investigation, to 
    trace back a scrapie-positive animal to its flock of birth, if it was 
    born in that State, and otherwise to its State of origin. When an 
    animal that has moved through several flocks is identified as scrapie-
    positive, e.g., at slaughter, it greatly aids the scrapie control 
    program when the animal can be traced back to its flock of birth. This 
    is not always possible to do with the records and identification 
    required by current State programs. However, it might significantly 
    increase the burden on States to upgrade their programs to the point 
    where any animal sold for slaughter, breeding, or other purposes can be 
    traced back to its flock of birth. Therefore, we would appreciate 
    receiving comments on whether the standard for declaring a State to be 
    a Consistent State should include a requirement that the State's 
    scrapie control program must be able to trace any animal from a flock 
    in that State back to its flock of birth, if it was born in that State, 
    and otherwise to its State of origin, and whether provisions for 
    monitoring and when available live-animal testing of such flocks should 
    be required.
        The interstate movement restrictions proposed for Consistent States 
    are similar to the regulations in current part 79, except that they 
    include additional identification requirements and would restrict the 
    interstate movement of high-risk animals and prohibit the interstate 
    movement of scrapie positive, affected, and suspect animals (except 
    when they are moved for destruction or research under conditions 
    approved by the Administrator). The restrictions proposed for 
    Inconsistent States are stricter, and are designed to minimize several 
    areas of risk associated with the indeterminate scrapie status of sheep 
    and goats from these States. Sheep and goats from Inconsistent States 
    would be subject to stricter movement conditions to minimize their 
    contact with other animals, and stricter identification requirements to 
    aid traceback from any scrapie outbreak that may be associated with the 
    animals. Also, sheep and goats from Inconsistent States could not move 
    interstate for breeding purposes unless they are enrolled in the VSFCP 
    or an equivalent APHIS-recognized State flock certification program. An 
    equivalent APHIS-recognized State flock certification program does not 
    equate to a Consistent State. It is possible, though unlikely, that a 
    State might not institute the Statewide controls that would qualify it 
    as a Consistent State--investigation and identification of all suspect 
    and high-risk animals, quarantine of all source and infected flocks, 
    etc.--but would have a program providing VSFCP-like standards for 
    particular individual flocks within the State whose owners request it.
        The following chart describes the proposed interstate movement 
    conditions.
    
          Interstate Movement General Restrictions for Sheep and Goats
    ------------------------------------------------------------------------
                                       Moved from            Moved from
     Type of interstate movement   INCONSISTENT State     CONSISTENT State
    ------------------------------------------------------------------------
    Sale or other movement of
     breeding animals, show
     animals or any other animal
     not specifically addressed
     below:
        High-risk animal,         Prohibited*.........  Prohibited*.
         scrapie positive,
         suspect, or affected
         animal.
        Non-high risk animal      Prohibited*.........  Prohibited*.
         from an infected or
         source flock.
        Other animal............  Flock must be         Individual animal ID
                                   enrolled in the       and certificate.
                                   Complete Monitored
                                   category of the
                                   Scrapie Flock
                                   Certification
                                   Program or
                                   equivalent APHIS-
                                   recognized program
                                   and have
                                   certificate.
    Sale or other movement
     directly to slaughter or
     through slaughter channels
     to slaughter of animals
     under 6 months of age:
        Scrapie positive,         Prohibited*.........  Prohibited*.
         suspect, or affected
         animal.
    
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        High-risk animals and     Individual animal ID  Individual animal ID
         animals from infected     and permit, or        and permit, or
         or source flock.          sealed conveyance     sealed conveyance
                                   and permit (no        and permit (no
                                   individual ID) when   individual ID) when
                                   moving directly to    moving directly to
                                   slaughter, or a       slaughter, or a
                                   permit (no            permit (no
                                   individual ID) and    individual ID) and
                                   an indelible ``S''    an indelible ``S''
                                   mark on the left      mark on the left
                                   jaw.                  jaw.
        Other animal............  Premises ID** and     None.
                                   certificate.
    Sale or other movement
     directly to slaughter or
     through slaughter channels
     to slaughter of animals
     over 6 months of age, or
     animals of any age to
     feedlots for later movement
     to slaughter:
        Scrapie positive,         Prohibited*.........  Prohibited*.
         suspect, or affected
         animal.
        High-risk animals and     Individual animal ID  Individual animal ID
         animals from infected     and permit.           and permit.
         or source flock.
        Other exposed animals...  Individual animal ID  Individual animal
                                   and permit.           ID.
        Other animals over 1      Individual animal ID  Individual animal
         year of age.              and certificate.      ID.
        Other animals between 6   Individual animal ID  Premises ID* *.
         months and 1 year of      and certificate.
         age, or animals under 6
         months of age moving to
         feedlots for later
         movement to slaughter.
    Movement of animals for
     grazing or other management
     purposes without change of
     ownership
        Scrapie positive,         Prohibited*.........  Prohibited*.
         suspect, or affected
         animal.
        High-risk animal or       Prohibited*.........  Prohibited*.
         animal from infected or
         source flock.
        Exposed animals.........  Individual animal ID  Premises ID.
                                   and certificate.
        Other animal............  Premises ID and       None.
                                   certificate.
    ------------------------------------------------------------------------
    * Animals prohibited movement may be moved interstate only if they are
      moving interstate for destruction or research approved by the
      Administrator.
    * * Premises ID is not required for slaughter animals if the animals are
      kept as a group on the same premises on which they were born and are
      not commingled with animals from another premises at any time,
      including throughout the slaughter process, or, if they are commingled
      during the slaughter process, they are officially identified on
      arrival at the slaughter facility such that any animal can be traced
      back to its flock of origin.
     
    Note: A CONSISTENT STATE is one whose intrastate identification,
      quarantine and movement restrictions for infected and source flocks
      and high-risk animals are consistent with the APHIS standards for
      State scrapie programs.
    
        As summarized in the above chart, there are different interstate 
    movement conditions depending on the State's scrapie program status, 
    age of the animal moved, and on whether the animal is moved for 
    slaughter or for other purposes. The movement conditions vary with the 
    risk of spreading scrapie by the movement, and range from no 
    requirements for animals of no known risk moved to slaughter from a 
    State with a strong scrapie program, through severe requirements for 
    animals of known risk moving from Inconsistent States, to outright 
    prohibition of movement for the highest risk categories. The 
    requirements employed to control risk in the middle range include 
    premises identification (ID), individual animal ID, certificates, 
    permits, and sealed conveyances. The meanings of these terms are 
    discussed below under ``Changes to Definitions in Parts 54 and 79.''
        The interstate movement of all scrapie-positive animals, suspect 
    animals, and affected animals is prohibited unless the Administrator 
    approves their movement for destruction or research. Uncontrolled 
    movement of these animals always poses a risk that they may come in 
    contact with other sheep and goats and spread scrapie to these other 
    animals. Therefore, when the Administrator approves movement for 
    destruction or research, the animals must be moved and maintained under 
    conditions to prevent the spread of scrapie.
        The interstate movement of high-risk animals and animals from 
    infected or source flocks is subject to various restrictions that 
    depend on the age and source of the animal and the purpose of the 
    movement. High-risk animals and animals from infected or source flocks 
    are prohibited movement unless they are moving to slaughter or moving 
    in slaughter channels. Such animals of any age may be moved to a 
    feedlot for later slaughter if they have individual animal ID and a 
    permit. High-risk animals and animals from infected or source flocks 
    may move directly to slaughter if they are over 6 months old and have 
    individual animal ID and a permit. The purpose of the permit is to 
    trace the movement of each lot of animals, and the purpose of the 
    individual ID is to make it easy to ensure that individual animals are 
    not diverted out of slaughter channels, e.g., by becoming mixed with 
    other animals at feedlots prior to slaughter.
        High-risk animals and animals from infected or source flocks 
    animals under 6 months of age may be moved directly to slaughter if 
    they meet one of three conditions: (1) Individual animal ID and a 
    permit; (2) A sealed conveyance (no animal ID) and a permit; or (3) A 
    permit and an indelible ``S'' mark on the jaw, in lieu of animal ID. 
    These additional options are provided for animals under 6 months of age 
    due to the large volume of lambs shipped to slaughter, and because it 
    is often impractical or uneconomical to individually identify younger 
    lambs.
        Animals that are not in the categories described above (i.e., they 
    are not scrapie-positive animals, suspect animals, affected animals, or 
    high-risk animals) may move interstate to slaughter under conditions 
    that vary depending on their age, and whether they are moving from a 
    Consistent or
    
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    Inconsistent State. Generally, the older the animal moving to 
    slaughter, the more requirements apply, because older animals may have 
    had more opportunities to move from one flock to another and thereby 
    increase their exposure to scrapie. The program is more likely to need 
    records that allow the older animals to be traced back to earlier 
    premises. While it would usually be possible to trace the movement of 
    an animal from flock to flock in a Consistent State based on flock 
    records, individual animal ID makes this task easier for animals over 1 
    year of age, which have a longer history than lambs and may have had 
    several owners. Also, it is currently impossible to diagnose scrapie in 
    animals under 6 months of age, by either a live-animal test or 
    necropsy, so there is no opportunity to identify a scrapie-positive 
    animal under 6 months of age and trace it back to its origin. 
    Therefore, individual animal ID is seldom required for animals under 6 
    months of age; it is only required when the point of the identification 
    is not traceback, but to ensure individual animals are not commingled 
    with animals from other lots (e.g., when they are sent to a feedlot en 
    route to slaughter).
        When animals that are not scrapie-positive animals, suspect 
    animals, affected animals, or high-risk animals move from a Consistent 
    State, the animals may move with no requirements if they are under 6 
    months of age and are moving to slaughter. However, if such animals 
    under 6 months of age are moving from an Inconsistent State to 
    slaughter, they require a premises ID and a certificate. When they are 
    over 6 months of age but less than 1 year of age, such animals may move 
    from a Consistent State to slaughter, or to a feedlot, with only a 
    premises ID; but if they are moving from an Inconsistent State, they 
    require individual animal ID and a certificate. In this case the 
    individual animal ID is required for animals from Inconsistent States 
    because it is sometimes possible to diagnose scrapie in an animal 
    between 6 months to 1 year of age, and tracing these animals back to 
    origin in an Inconsistent State is not possible with only a premises ID 
    because Inconsistent States would not require records that would allow 
    the animal to be traced back farther than the premises from which the 
    animal was shipped to slaughter. When they are over 1 year of age, such 
    animals may move from a Consistent State to slaughter, or to a feedlot, 
    only if they have individual animal ID; but if they are moving from an 
    Inconsistent State, they require both individual animal ID and a 
    certificate. The higher requirements for animals from Inconsistent 
    States are largely due to the fact that Consistent States impose 
    significant restrictions on movements between flocks within the State 
    but Inconsistent States do not, so our regulations must use 
    certificates and individual animal ID more extensively for Inconsistent 
    States to increase the probability of successful tracebacks.
        The proposed requirements also address interstate movement for 
    purposes other than slaughter. Animals that are not scrapie-positive 
    animals, suspect animals, affected animals, high-risk animals, or 
    animals from infected or source flocks may move interstate from a 
    Consistent State for grazing or other management purposes, without 
    change of ownership, with no requirements (unless the animal is an 
    exposed animal as defined in the regulations, in which case a premises 
    ID is required). Such animals moving interstate from an Inconsistent 
    State must have a premises ID and certificate, unless they are exposed 
    animals, in which case individual animal ID and a certificate is 
    required.
    
    Indemnification Program
    
        We are also proposing to reinstate an indemnification program to 
    compensate the owners for destruction of high-risk animals, animals 
    diagnosed scrapie-positive by an approved live-animal test, affected 
    animals, suspect animals (if the postmortem indicates them to be 
    scrapie-positive), and other groups of animals when the Administrator 
    determines that their destruction will contribute to the eradication of 
    scrapie. We believe indemnification is necessary to contribute to 
    scrapie control, mainly by providing the economic incentive to remove 
    scrapie-positive and high-risk animals from flocks and reduce the 
    number of flocks under quarantine. This economic incentive, combined 
    with advances in diagnostic techniques that allow faster and more 
    accurate identification of scrapie-positive animals, should contribute 
    substantially to reducing the incidence of scrapie in the United 
    States.
        The types of animals proposed as eligible for indemnity are animals 
    diagnosed with scrapie, or known to be closely associated with animals 
    diagnosed with scrapie under conditions where they could contract the 
    disease. These animals could potentially cause many new cases of 
    scrapie, and, therefore, we believe paying indemnity to destroy them is 
    in the interest of effective scrapie control.
        The indemnity payments would be $150 for registered animals and $50 
    for other animals. As of January 1, 1999, the national average sale 
    price of a sheep was $88; as of January 1, 1998, it was $102. These 
    average sale prices reflect the sale of millions of slaughter sheep and 
    a few thousand valuable registered breeding sheep. The average price 
    for registered breeding sheep is in the range of $300, with some 
    selling for thousands of dollars. Therefore, if sale prices persist in 
    the range experienced in the past 2 years, the average owners of both 
    slaughter and registered sheep who accept indemnity for their animals 
    rather than selling them would recover about half the market value of 
    the animals.
        The indemnity amounts of $150 and $50 represent an effort to 
    provide an indemnity that will be attractive, while also stretching 
    available indemnity funds to ultimately remove as large a number of 
    diseased animals as possible. The indemnity amounts are not so high, 
    compared to fair market value, as to provide a perverse incentive, 
    i.e., to encourage flock owners to expose animals to scrapie to obtain 
    a higher price. The indemnity amounts were decided based on our past 
    experience with industry participation in scrapie indemnity programs, 
    and the $150 and $50 amounts are the same indemnities used in our 
    previous scrapie indemnity program which expired in 1996, at which time 
    the national average sale price of a sheep was $87.
        We considered whether it would be appropriate to pay a lower 
    indemnity, either for all eligible animals or for those that test 
    positive for scrapie on a future live-animal test, in view of the 
    economic fact that sheep infected with scrapie really have little or no 
    economic value. However, we believe that reducing the indemnities below 
    the proposed values would encourage owners to hide the presence of 
    scrapie and thus hurt the effectiveness of the scrapie control program. 
    This view is supported by the experience of the British Government in 
    controlling BSE. When the British Government increased the indemnity 
    for BSE-infected cattle from 50 percent of market value to 100 percent, 
    the number of reported BSE cases increased by 73 percent.\1\
    ---------------------------------------------------------------------------
    
        \1\ Food Microbiology (1990) 7:253-279.
    ---------------------------------------------------------------------------
    
        It should be noted that if this proposal is adopted, the total 
    number of animals that can be indemnified each year and the total 
    amount of indemnity funds expended will be limited by the amount of 
    program funding appropriated for that purpose. We invite comments on 
    the total amount of indemnity that should be needed, and on whether the 
    payment amounts are appropriate.
    
    [[Page 66797]]
    
        In deciding to propose this indemnity program, we examined 
    alternatives to determine whether the same funds could be expended on 
    other activities to control scrapie and achieve a greater reduction in 
    the disease. Two activities that could produce substantial reductions 
    in scrapie are development of a live-animal test and education of sheep 
    producers and veterinarians to recognize and control scrapie. However 
    current and planned funds for both of these initiatives appear to be at 
    a level that will produce optimal results, and we do not believe 
    diverting indemnity funds to them would accelerate their progress. 
    Instead, an indemnity program would complement use of a live-animal 
    test and education programs. The three approaches together will be 
    needed to successfully control scrapie.
        Another alternative we considered, under the assumption that a 
    live-animal test for scrapie will soon be available, was to impose a 
    large-scale, mandatory live-animal testing requirement of all animals 
    moved interstate for other than slaughter purposes. For this approach 
    to be effective, we would need to condemn and destroy any animals that 
    tested positive, to ensure they do not come in contact with and infect 
    other animals in the future. This alternative was rejected because an 
    approved live-animal test is not currently available. Once a live-
    animal test has been approved and fully evaluated, this option will be 
    reconsidered.
        We also considered prohibiting the movement in interstate commerce 
    for any purpose of any animal that was considered to be at high risk of 
    being scrapie infected. This was rejected because: (1) There is no 
    evidence that scrapie is a threat to public health; (2) Scrapie-
    infected animals moving to slaughter pose little risk of spreading the 
    disease; and (3) Given the past history of scrapie indemnity funding, 
    it is likely that we would be unable to indemnify all of these animals 
    causing a significant economic hardship on owners of high-risk sheep. 
    To mitigate the remote risk that these animals pose when moving in 
    slaughter channels, we have proposed to indemnify and destroy them 
    whenever possible. Finally, we considered restricting these animals 
    without compensation. This option was rejected for the reasons 
    discussed under indemnification.
    
    Live-Animal Testing
    
        While no live-animal test for scrapie has yet been approved, 
    several varieties of live-animal tests show promise, and we anticipate 
    the availability of a live-animal test in the near future. Therefore, 
    this proposed rule includes reference to live-animal tests as a means 
    to identify scrapie-positive animals and affected animals, without 
    specifying the exact protocols of the live-animal tests. As discussed 
    below, the definitions for live-animal screening test (used to identify 
    affected animals) and scrapie-positive animal state that the tests must 
    use protocols approved by the Administrator and must be performed by 
    laboratories approved by the Administrator. Once developed, the 
    Administrator will initiate rulemaking in the Federal Register to 
    publish these protocols or incorporate them by reference.
        The availability of a validated live-animal test will significantly 
    affect the nature of the scrapie control program. Such a test would 
    make it possible to identify confirmed infected live animals for 
    destruction, reducing the need to destroy large groups or entire flocks 
    of suspect animals in order to control the spread of scrapie.
    
    Changes to Definitions in Parts 54 and 79
    
        Three definitions would be removed because they are no longer 
    needed for the proposed regulations (bloodline animal, because this 
    category has not been used since termination of an earlier indemnity 
    program; department, because we refer instead in this proposal to 
    APHIS; and trace flock, because its definition has been absorbed by the 
    new definition of source flock discussed below). Nine other definitions 
    would be amended (affected animal, destroyed, exposed animal, flock, 
    flock plan, high-risk animal, infected flock, scrapie-positive animal, 
    and source flock). Some of these changes would be made to adapt the 
    regulations to the probability that a validated live-animal test for 
    scrapie may be available in the near future. The definition of 
    destroyed would be changed to remove movement to slaughter as a means 
    of destruction. Animals to be destroyed would have to be euthanized, 
    and the carcasses disposed of by means authorized by the Administrator. 
    Animals for which an indemnity is paid under the regulations must be 
    destroyed, rather than sent to slaughter, for two reasons. First, any 
    movement of animals eligible for indemnity represents a potential risk 
    of spreading scrapie, and we do not want to encourage movement of these 
    animals to slaughter when we have the alternative of destroying them on 
    their home premises and disposing of the carcasses safely. Second, if 
    animals eligible for indemnity are slaughtered, this may result in the 
    scrapie agent entering the animal food chain, and we want to avoid 
    this. The Food and Drug Administration has published regulations (62 FR 
    30935-30978, June 5, 1997) requiring that ruminant feed must not 
    contain animal protein derived from mammalian tissues, in order to 
    prevent the possible spread of transmissible spongiform 
    encephalopathies, such as scrapie, to ruminants. However, sheep protein 
    is still used for other nonruminant animal feed, such as zoo animal 
    foods. Research has shown that a variety of species can conceivably 
    contract some form of spongiform encephalopathy by oral inoculation 
    with protein from a scrapie-positive animal. The wide distribution of 
    meat byproducts from slaughter plants makes it likely that if indemnity 
    animals were allowed to go to slaughter, some of their protein would be 
    used in nonruminant animal feed. The risk that nonruminants could 
    contract a transmissible spongiform encephalopathy from consuming 
    animal feed containing protein from a scrapie-positive animal is 
    extremely small. However, we propose to control this small risk by 
    taking the opportunity presented by the indemnity program to order 
    indemnity animals to be destroyed, rather than sent for slaughter. The 
    Administrator will authorize disposal methods (often incineration or 
    burial) that are consistent with local laws and conditions and that 
    minimize the dispersal of possibly infectious material. The proposed 
    definition of destroyed ties into the proposed Procedures for 
    destruction of animals in Sec. 54.7. These procedures include a 
    requirement that carcasses may not be processed for animal food unless 
    subjected to a treatment process approved by the Administrator and 
    known to eliminate the agents of transmissible spongiform 
    encephalopathies. This requirement would address the established risk 
    that some species of animals conceivably could contract scrapie by 
    consuming animal feed generated from scrapie-positive animals.
        Exposed animal would be redefined as any animal that has been in 
    the same flock at the same time within the previous 60 months as a 
    scrapie-positive animal, excluding limited contacts, and any animal 
    born in a flock after a scrapie-positive animal was born into that 
    flock, if born before that flock completes the requirements of a flock 
    plan. The earlier definition of this term also defined limited 
    contacts, which would now be defined in a separate definition. The 
    earlier definition also did not include animals that were born into a 
    flock after the removal of a scrapie-positive animal born into that 
    flock. We believe such animals should
    
    [[Page 66798]]
    
    be considered exposed because there is some risk that they may contract 
    scrapie from objects or animals the earlier scrapie-positive animal 
    came in contact with, unless this risk has been mitigated by the 
    completion of a flock plan.
        Because the definition of flock plan currently contains a large 
    volume of procedures not appropriate for a definition, this definition 
    would be shortened by expanding and moving some of its text to new 
    Sec. 54.14, ``Requirements for flock plans and post-exposure management 
    monitoring plans.'' The definition of Uniform methods and rules--
    voluntary scrapie flock certification would be updated and renamed 
    Scrapie Flock Certification Program standards, consistent with the 
    program name change discussed elsewhere in this document. For the same 
    reason, a definition would be added for the Scrapie Flock Certification 
    Program.
        The following new definitions for terms used in the proposed rule 
    would also be added to part 54, part 79, or both:
        Area veterinarian in charge would be defined as ``The veterinary 
    official of APHIS who is assigned by the Administrator to supervise and 
    perform the official animal health work of APHIS in the State 
    concerned.'' This definition is needed to identify those veterinarians 
    who perform certain duties under the regulations including processing 
    of indemnification applications.
        Certificate would be defined as ``An official document issued in 
    accordance with Sec. 79.5 of this part by an APHIS representative, 
    State representative, or accredited veterinarian at the point of origin 
    of an interstate movement of animals, which includes a statement that 
    the animals were not exhibiting clinical signs associated with scrapie 
    at the time of examination.'' A certificate is required by the 
    regulations for interstate movement of certain animals.
        Consistent State would be defined as ``A State which the 
    Administrator has determined conducts an active State scrapie control 
    program which either: (1) meets the requirements of Sec. 79.6 of this 
    part, or (2) effectively enforces a State designed plan that the 
    Administrator determines is at least as effective in controlling 
    scrapie as the requirements of Sec. 79.6 of this part.'' This 
    definition would be the basis for determining whether animals from a 
    particular State qualify for the less restrictive, or more restrictive, 
    interstate movement requirements proposed in Sec. 79.3. When the list 
    of Consistent States is developed, it will be added to this definition. 
    Any State not listed would be an Inconsistent State.
        Designated scrapie epidemiologist would be defined as ``An 
    epidemiologist selected by the State animal health official and the 
    area veterinarian in charge to reclassify animals already designated as 
    high-risk, exposed, or affected with scrapie, based on epidemiologic 
    investigation or the results of a live-animal test. The regional 
    epidemiologist and the APHIS National Scrapie Program Coordinator must 
    concur in the selection and appointment of the designated scrapie 
    epidemiologist.'' Designated scrapie epidemiologists would operate 
    under proposed Sec. 79.4 to reclassify animals as necessary.
        Electronic implant, one form of allowed animal identification, 
    would be defined as ``Any radio frequency identification device 
    approved for use in the scrapie program by the Administrator. The 
    Administrator will approve an electronic implant after determining that 
    it is tamper resistant, not harmful to the animal, and readable by 
    equipment available to APHIS and State representatives.''
        The definition of flock would be amended to clarify when more than 
    one flock may be maintained on a single premises without being 
    considered a single flock. This definition considers that flocks on a 
    premises are separate if they never commingle, never share facilities 
    and equipment, and have separate flock records and identification. To 
    address questions raised by flock owners, this revised definition also 
    states that changes in ownership of a flock do not change the identity 
    of the flock or the regulatory requirements applicable to the flock.
        Individual animal identification would be defined as ``An 
    electronic implant, flank tattoo, ear tattoo, or tamper-resistant ear 
    tag approved by APHIS. In the case of goats, the form of identification 
    may alternatively be a tail fold tattoo. The official identification 
    must provide a unique identification number that is applied by the 
    owner of the flock or his or her agent in accordance with instructions 
    by an APHIS representative or State representative.''
        Inconsistent State would be defined as ``Any State other than a 
    Consistent State.''
        Interstate commerce would be defined as ``Trade, traffic, 
    transportation, or other commerce between a place in a State and any 
    place outside of that State, or between points within a State but 
    through any place outside that State.''
        Limited contacts would be defined as ``Incidental contacts between 
    animals off the flock's premises such as at fairs, shows, exhibitions 
    and sales; between ewes being inseminated, flushed, or implanted; or 
    between rams at ram test or collection stations. Embryo transfer and 
    artificial insemination equipment and surgical tools must be sterilized 
    between animals for these contacts to be considered limited contacts. 
    Limited contacts do not include any contact with an animal during, or 
    up to 60 days after, lambing or kidding. Limited contacts do not 
    include any activity where uninhibited contact occurs, such as sharing 
    an enclosure, sharing a section of a transport vehicle, or 
    transportation to other flocks for breeding, except as allowed by the 
    Scrapie Flock Certification Program standards.'' This definition is 
    needed to help distinguish between contacts that do not present a 
    pronounced risk of spreading scrapie (e.g., casual contacts between 
    animals at fairs or shows) and contacts that present a pronounced risk 
    (e.g., contacts with animals during or within 60 days following 
    lambing, when infectivity is high and infectious materials such as 
    afterbirth are present).
        Post-exposure management and monitoring plan would describe an 
    agreement written jointly by the flock owner, an accredited 
    veterinarian, and an APHIS or State representative in which each 
    participant agrees to undertake certain actions to monitor for the 
    occurrence or recurrence of scrapie in the flock for at least 5 years 
    after the flock was exposed to a scrapie-positive animal, or contained 
    a high-risk animal. Experience in monitoring flocks has shown that if 
    scrapie recurs from a previous outbreak in a flock, its signs are 
    likely to become evident within 5 years. This definition, like the 
    definition of flock plan, would refer to new Sec. 54.14, ``Requirements 
    for flock plans and post-exposure management monitoring plans.'' 
    Federally required post-exposure monitoring is necessary to guard 
    against recurrence of scrapie, because flocks whose owners receive 
    indemnity payments may or may not be subject to State quarantines, and 
    even if they are subject to State quarantine there is great variation 
    in the effectiveness of State quarantine procedures in detecting signs 
    of scrapie in a timely manner. As discussed in proposed Sec. 54.5, in 
    order to receive indemnity an owner must agree to maintain their flock 
    under a post-exposure monitoring management plan for 5 years after 
    removal of the last high-risk or scrapie-positive animal. Based on the 
    typical clinical progress of scrapie, we believe any renewed outbreak 
    of
    
    [[Page 66799]]
    
    scrapie in the flock would show signs within 5 years.
        Premises identification, one requirement of proposed Sec. 79.3 for 
    moving certain animals interstate, would be defined as ``An APHIS 
    approved eartag, backtag, or tattoo bearing the premises identification 
    number assigned by a State or Federal animal health official to the 
    premises on which the sheep or goats originated, or a brand registered 
    with an official brand registry.''
        The definition of scrapie-positive animal would be updated by 
    referring to additional laboratory techniques (western blotting, 
    bioassay, fibril detection by electron microscopy) that have proven 
    useful in confirming scrapie from tissue samples, by allowing 
    confirmation of scrapie-positive status by ``any other test method 
    approved by the Administrator,'' and by adding a footnote describing 
    how the Administrator will approve laboratories to conduct tests for 
    scrapie-positive animals.
        The definition of infected flock would be changed to include any 
    flock in which a scrapie-positive animal had lambed within the past 18 
    months, counted from the time the tissues used to diagnose the scrapie-
    positive animal were collected from the scrapie-positive animal. This 
    change would be made as a result of evidence that placenta shed 15\1/2\ 
    months prior to death may contain infectious agent. Since the progress 
    of the disease and the level of infectivity can be expected to vary 
    somewhat among individual animals, we set the lambing limit at 18 
    months rather than 15\1/2\ months to allow a margin of error, and 
    because 18 months is an easier figure than 15\1/2\ months for planning 
    and compliance activities of both regulators and sheep producers. Also, 
    in the definitions for infected flock and source flock, we are dropping 
    a reference limiting their application to cases where the scrapie-
    positive diagnosis was made ``after March 31, 1989.'' This date was 
    added to the regulations in 1992 to cover a temporary situation where 
    diagnoses employed one standard before 1989 and another afterwards. Due 
    to the lifespan of sheep and goats, there are no more flock situations 
    where a diagnosis prior to that date would be relevant or used, and so 
    the date would be deleted as superfluous and confusing.
        The current definition of source flock includes flocks in which at 
    least two animals later diagnosed as scrapie-positive are born. Because 
    we agree with comments that stated that the birth of a single animal 
    later determined to be scrapie-positive indicates that a flock is a 
    significant risk as a source of scrapie, we would change this 
    definition to include flocks where a single animal later diagnosed as 
    scrapie-positive is born.
        The definition of affected animal would be changed to allow the use 
    of a live-animal test as a screening test without affecting flock 
    status. The designation ``affected animal'' could be used if a live-
    animal test is developed that proves to be less specific than the 
    current tests used to classify an animal as a scrapie-positive animal 
    as defined in Sec. 54.1. The type of test that may be approved to 
    identify affected animals is described in a new definition for live-
    animal screening test, which reads ``Any test for the diagnosis of 
    scrapie in a live animal that is approved by the Administrator as 
    usually reliable but not definitive for diagnosing scrapie, and that is 
    conducted in a laboratory approved by the Administrator.'' This 
    definition also includes a footnote describing how the Administrator 
    will approve laboratories to conduct this test.
    
    Genetics and DNA Testing Issues
    
        Much current research addresses methods for identifying gene 
    sequences in sheep that affect the animal's resistance or 
    susceptibility to scrapie, or the length of the incubation period. As 
    answers emerge from research, we will propose further changes to our 
    scrapie programs to take advantage of new knowledge about the role of 
    genetics in the disease-host interaction. In time, it may be possible 
    to exempt certain breeds of sheep, or sheep that have been tested for 
    particular codon sequences, from some program requirements because of 
    their ``natural immunity.'' We are prepared to amend our regulations 
    when specific, relevant genetic results are confirmed, but we do not 
    believe any such changes to the regulations would be appropriate at the 
    current time.
    
    Change of Name--Voluntary Scrapie Flock Certification Program to 
    Scrapie Flock Certification Program
    
        We are proposing to change the name of the Voluntary Scrapie Flock 
    Certification Program, described in 9 CFR part 54, to the Scrapie Flock 
    Certification Program (SFCP). The purpose of the change is to increase 
    acceptance of the program for export purposes. There has been some 
    confusion and administrative delay in the acceptance by other national 
    governments of health certificates and other documents issued for U.S. 
    sheep and goats and sheep and goat products when these documents base 
    their determination of health status on a ``voluntary'' program; the 
    term is not used consistently in international commerce. In some uses 
    it has implied that participants adhere to some standards part of the 
    time, rather than meaning that participants voluntarily commit to 
    following all standards the entire time they participate in a program. 
    Removing the term ``voluntary'' will result in expedited processing of 
    these documents, and a clearer understanding that this program is a 
    valid determination of flock status that is monitored by the U.S. 
    Government. There is no intent to change the voluntary nature of the 
    program, as should be clear from the unchanged description of the 
    nature of the program contained in Sec. 54.10, ``Administration,'' and 
    Sec. 54.11, ``Participation.''
    
    Executive Order 12866 and Regulatory Flexibility Act
    
        This proposed rule has been reviewed under Executive Order 12866. 
    The rule has been determined to be significant for the purposes of 
    Executive Order 12866 and, therefore, has been reviewed by the Office 
    of Management and Budget.
        We do not currently have all the data necessary for a comprehensive 
    analysis of the effects of this rule on small entities. Therefore, in 
    accordance with 5 U.S.C. 603, we have performed an Initial Regulatory 
    Flexibility Analysis, which is summarized below. We are inviting 
    comments concerning potential effects. In particular, we are interested 
    in determining whether sheep and goat producers would be affected 
    positively or negatively by this rule, and whether any additional costs 
    may result from this rule that are not discussed in this analysis.
        Below is a summary of the economic analysis for the changes to the 
    scrapie regulations proposed in this document. The economic analysis 
    provides a cost-benefit analysis as required by Executive Order 12866 
    and the initial analysis of impacts on small entities as required by 
    the Regulatory Flexibility Act. A copy of the full economic analysis is 
    available for review at the location listed in the ADDRESSES section at 
    the beginning of this document.
        We are considering taking the actions described in this proposed 
    rule in order to strengthen scrapie control programs on the national 
    level, to reduce the losses that scrapie causes to the sheep and goat 
    industries. This action is considered necessary because not all State 
    scrapie control programs are effective in identifying animals that may 
    be infected with scrapie and controlling
    
    [[Page 66800]]
    
    their movement in intrastate and interstate commerce in a manner that 
    will prevent the further spread of scrapie. Statutory authorities 
    including 21 U.S.C. 111, 114, 114a, and 134a-134h authorize the 
    Department of Agriculture to conduct programs for the control of 
    communicable animal diseases and to restrict the interstate movement of 
    animals that may spread disease.
        As alternatives to this action, APHIS considered a complete ban on 
    interstate movement of sheep and goats from States that do not have 
    effective scrapie control programs. We also considered adding stricter 
    certification, recordkeeping, and animal identification requirements 
    for all sheep and goats moving interstate, without regard to the 
    effectiveness of individual State scrapie programs. We also considered 
    setting up a system to employ a prospective live-animal test in 
    mandatory testing of sheep and goats before they could be sold for any 
    commercial purpose, with mandatory destruction and disposal of animals 
    that fail the test. All of these alternatives would impose more costs 
    and recordkeeping requirements than the proposed alternative, and we do 
    not believe any of these alternatives would control scrapie more 
    effectively than the selected alternative. A complete ban on movements 
    from Inconsistent States would hurt the economies of those States, and 
    while it would provide other States with some protection against 
    infection from Inconsistent States, it would not eradicate the 
    reservoirs of scrapie in those States. The alternative of stricter 
    recordkeeping and identification for all interstate movements would not 
    be effective as long as some of the information to be recorded is 
    unknown or dubious, as can frequently happen when the animal originates 
    in a State with a weak scrapie program. The alternative of mandatory 
    testing and destruction of animals that fail was discussed earlier in 
    this proposal, it is not a practical option because a live-animal test 
    has not been validated and approved and also impractical at this time 
    on economic grounds.
        This rule would result in the expenditure of indemnity funds by 
    APHIS to compensate the owners of certain animals destroyed to prevent 
    the spread of scrapie. This would also encourage certain States to 
    improve the effectiveness of their State scrapie programs, to avoid 
    additional restrictions on the movement of sheep and goats from their 
    States. Finally, because this rule allows certain interstate movements 
    only if the flock is enrolled in the Scrapie Flock Certification 
    Program or an equivalent State program, this rule would encourage 
    producers to enroll in such programs and bear the resulting flock 
    management and identification costs.
        The budgetary effects on APHIS of this proposal would fall into 
    three categories: A small increase in outlays for staff to work with 
    States and producers as they adapt to the new scrapie program 
    requirements, a new program for indemnity payments, and the cost of 
    providing official eartags and backtags, all within available funds. 
    The initial amount of indemnity payments (the first year) is estimated 
    to be approximately $384,250, based on an estimated 3,074 animals 
    eligible for indemnity in known scrapie-infected and source flocks, but 
    may be more than that if producer response to the availability of 
    indemnity results in new admissions of infection that reveal additional 
    cases of scrapie. The amount of indemnity paid should decline in 
    subsequent years, although if slaughter surveillance is initiated or if 
    live-animal tests are approved and widely used, this decline may not 
    occur for several years, depending on the number of scrapie-positive 
    animals that are revealed by initial use of these tests. This indemnity 
    program would be less costly than some previous indemnity programs 
    since it focuses on eliminating individual infected and high-risk 
    animals rather than entire flocks, a focus that should be aided in the 
    near future by the availability of a validated live-animal test. If a 
    live-animal test is accepted for official use, an increase in indemnity 
    costs would be expected initially as new infected flocks are 
    identified.
        Some States would bear additional costs to improve their State 
    scrapie programs so that the producers in their States could avoid 
    additional interstate movement restrictions proposed for States without 
    effective intrastate programs. However, we believe that most States 
    already have effective intrastate programs that would qualify them as 
    Consistent States and that all but two or three States have the 
    necessary authority and infrastructure to run an effective intrastate 
    program.
    
    Overview of U.S. Sheep and Goat Industry Operations, Inventory and 
    Trade
    
        There were 7.822 million sheep and lambs in the United States based 
    on 1997 Census of Agriculture reports. In the national inventory, 5.85 
    million were breeding sheep and lambs and the rest were market sheep, 
    based on National Agricultural Statistics Service reports. Ewes, 1 year 
    old or older, totaled 4.57 million during the same period.
        Small farms, as shown in Table 1, accounted for over 99 percent of 
    all the farms raising sheep and lambs, while farms considered to be 
    large accounted for less than 0.3 percent. About 85 percent of the 
    farms had an inventory of less than 100 animals and accounted for about 
    17 percent of the total inventory of sheep and lambs. On the other 
    hand, sheep operations with an inventory of 5,000 sheep or more 
    represented less than 0.3 percent of the farms but accounted for nearly 
    26 percent of the total inventory.
    
           Table 1 Sheep and Lambs: Farms and Inventory by Size, 1997
    ------------------------------------------------------------------------
                                        Number of                 Inventory
              Farm inventory              farms      Farm share     share
    ------------------------------------------------------------------------
    1 to 24..........................       35,584         0.54        0.045
    25 to 99.........................       20,461         0.31        0.123
    100 to 299.......................        6,010         0.09        0.123
    300 to 999.......................        2,429         0.04        0.158
    1,000 to 2,499...................          820         0.01        0.160
    2,500 to 4,999...................          297        0.005        0.128
    5,000 or more....................          189        0.003        0.263
                                      -------------
        Total........................      65,790
    ------------------------------------------------------------------------
    Source: USDA, Census of Agriculture 1997.
    
    
    [[Page 66801]]
    
        Of the total number of operations, about 60 percent were full 
    owners, about 32 percent were part owners, and about 8 percent were 
    tenants.
        Sheep are produced in all parts of the United States, although 
    stock levels vary from State to State. Ten States accounted for nearly 
    73 percent of the total inventory, mostly in western and central areas. 
    Northern and southeastern States have the smallest sheep populations, 
    accounting only for 5.2 percent of the total. About 3.805 million sheep 
    were commercially slaughtered in 1997. Additionally, about 57,000 sheep 
    were slaughtered on the farms, yielding a total of about 3.861 million 
    sheep slaughtered in 1997. About 3.62 million slaughtered sheep were 
    Federally inspected, of which 3.46 million were lambs and yearlings and 
    about 211,000 were mature sheep.
        There were about 1.99 million goats in the United States in 1997, 
    of which 52 percent were goats other than Angora or milk goats, 41 
    percent were Angora goats and about 7 percent were milk goats. The 
    State of Texas accounted for about 64.3 percent of the goat inventory. 
    Other States where goats are raised include Arizona, California, 
    Georgia, New Mexico, North Carolina, Oklahoma, and Tennessee. These 
    States together represented another 14.2 percent of the U.S. goats 
    holdings. An average holding was about 35 goats. All goat holdings were 
    considered to be small.
        During 1997 the United States produced about 267 million pounds of 
    mutton, lamb and goat meat. It exported 6.4 million pounds and imported 
    about 84 million pounds valued at $145 million. The United States 
    exported 1,474,060 sheep and goats valued at $63 million in 1997, of 
    which 1,457,144 went to Mexico. The United States imported 47,405 sheep 
    and goats valued at $6.684 million in 1997, of which 46,991 were from 
    Canada, 364 from New Zealand, 40 from Mexico, and 10 from Australia. 
    The United States imported 83,472,084 pounds of sheep and goat meat 
    valued at $145.174 million and exported 6,528,605 pounds of sheep and 
    goat meat valued at $7.362 million in 1997. Most lamb and mutton 
    imports came from Australia and New Zealand, countries recognized as 
    being free from scrapie. The United States is a net importer of lamb 
    and mutton.
    
    Sheep and Goats Affected by Scrapie Interstate Movement 
    Restrictions
    
        At present, of the approximately 8 million sheep and 2 million 
    goats in the United States,\2\ over 90 percent belong to commercial 
    flocks (operations rearing sheep for sale, mostly to be slaughtered). 
    There are 14 States altogether with 72 flocks that were on the infected 
    or source flock list as of June 6, 1999 (66 are scrapie infected 
    flocks, 6 are scrapie source flocks). Also, 31 other flocks contained a 
    scrapie-positive animal during FY 1998, but the implicated animals were 
    destroyed and the flocks are therefore not infected or source flocks. 
    Infected and source flocks are potential candidates for destruction and 
    indemnity payments. Additionally, over the last 8 years (1990-1997), an 
    annual average of 132 individual suspect scrapie cases have been 
    reported, of which approximately 48.6 percent were determined to be 
    scrapie-positive animals. However, it is likely that the number of 
    reported cases will increase as the indemnity payments become 
    available. There are about 1.932 million breeding sheep and lambs in 
    the 14 States in which positive cases have occurred in FY 1998 or in 
    which a source or infected flock exists. These animals represent 
    approximately 33 percent of all breeding sheep and lambs in the United 
    States and have a market value of about $185 million.
    ---------------------------------------------------------------------------
    
        \2\ USDA, Sheep and Goats. Washington, DC: Agricultural 
    Statistics Board, Februrary 1991.
    ---------------------------------------------------------------------------
    
        The average size of a flock in an operation in the 14 States was 
    86, with between 21 and 479 per operation. Approximately 82.5 percent 
    of these sheep are marketed, in most cases across State lines. However, 
    nearly 33 percent of the marketed sheep are lambs less than 6 months of 
    age, and would be exempt from individual animal identification under 
    the proposed rule.
    
    Indemnity Costs for Animals Destroyed Due to Scrapie
    
        The exact number of scrapie-positive and high-risk animals that 
    would qualify for indemnity payments is not known. However, an estimate 
    of the number of animals potentially eligible for indemnity would be 
    48.6 percent of the animals in an average scrapie infected or source 
    flock (based on past field experience). There are currently 66 scrapie 
    infected flocks and 6 scrapie source flocks. Additionally there were 64 
    other infected animals diagnosed in the past year that are no longer in 
    flocks on the infected flock list, because the flock owners voluntarily 
    destroyed the implicated animals. Thus, based on average flock size and 
    the average percentage of scrapie-positive animals in infected and 
    source flocks, the number that could be estimated to qualify for 
    indemnity payments during the first year would be 3,074 animals 
    (=(72 x 86 x .0486+64)). This estimate implies that about 0.15 percent 
    of the total number of breeding sheep and goats in the 14 States that 
    could potentially move interstate would be designated as high-risk 
    animals and be eligible for indemnity. The proportion of more expensive 
    registered animals was 74.38 percent (8,199/11,023).\3\ Assuming a 75 
    percent registered to 25 percent nonregistered animal composition, with 
    a $150 and $50 per animal indemnity payments, the estimated indemnity 
    expenditure would be about $384,250 
    (3.074 x 0.75 x 150+3,074 x 0.25 x 50). If the producer response to 
    indemnity payment availability is positive, resulting in an increased 
    number of indemnity requests, the expenditure would increase 
    accordingly. However, even if a much larger number of animals were to 
    be indemnified, the destruction of all known infected animals would 
    greatly advance the goal of scrapie eradication, and could only be 
    positive in terms of long-term reduced expenditure.
    ---------------------------------------------------------------------------
    
        \3\ Based on the composition of 8,199 registered and 2,824 
    commercial animals as reported by APHIS personnel.
    ---------------------------------------------------------------------------
    
    Costs to Producers and APHIS for Official Identification of Animals 
    Moving Interstate
    
        The animal identification that would be required by this proposed 
    rule would result in additional costs. Of the approximately 8 million 
    sheep and lambs and 2 million goats in the United States, about 82.5 
    percent are potentially interstate movers and of these about 33 percent 
    are lambs less than 6 months of age, which would not require 
    identification tags under the new rule. Currently, the cost of metal 
    identification tags for cattle is about $0.15 per animal. Assuming the 
    total number of sheep and goats that would need identification tags is 
    4.633 million, the tag cost would be approximately $695,000 
    (4,633,000 x 0.15) for identifying interstate movers. If the time it 
    takes the owner to apply the tag (about 2 minutes per animal) is valued 
    at $7.36 per hour (the average wage for livestock workers in April, 
    1999), this labor cost represents another $1.137 million. In some 
    States, tags are provided by APHIS free to accredited veterinarians, 
    while in others, they are purchased by accredited veterinarians through 
    the State. Generally, wherever APHIS directly distributes tags they are 
    free; where States distribute them, there may be no charge, a small 
    processing fee, or a fee covering the full cost of the
    
    [[Page 66802]]
    
    tags, depending on State regulations. If owners elect to use backtags, 
    the costs would be less. Owners will incur the costs of applying 
    identification. The impact on goat owners would be less, since about 72 
    percent of goats are the angora type, which are raised for their mohair 
    and are less frequently moved interstate. Thus the total potential 
    identification cost for goat owners would be in the range of $37,000.
    
    International Trade Effects
    
        The United States has limited foreign trade both in live sheep and 
    goats and their products. Australia, a potential major importer of U.S. 
    sheep for breeding purposes, is scrapie-free and prohibits imports of 
    sheep from the United States. Australia allows imports of live goats 
    from the United States only if they undergo a 3-year quarantine upon 
    arrival. Canada and Mexico both allow the importation of U.S. sheep 
    only if the sheep are from flocks enrolled in the Voluntary Scrapie 
    Flock Certification Program or if USDA can certify the flock's scrapie 
    status. In 1997 the total earnings from exports of live sheep, goats, 
    and sheep and goat meat and meat products was approximately $65 
    million. The United States is a net exporter of live animals, while it 
    is a net importer of mutton, lamb and goat meat. Both the sources of 
    imports and destinations of exports are concentrated in a few 
    countries. Scrapie-free animals, and to some extent their products, are 
    likely to be highly valued in the domestic and international markets. 
    U.S. breeding stock that can be certified scrapie-free is expected to 
    be in high demand internationally. While scrapie-free status would do 
    little to enhance domestic or export consumption of U.S. mutton and 
    lamb, the lack of scrapie-free status could seriously reduce demand for 
    these products if public fears about transmissible spongiform 
    encephalopathies ever become associated with U.S. sheep products.
        The U.S. competitiveness in the domestic and international markets 
    depends upon its reputation for producing high quality animals and 
    products. The actual product, as well as the purchasers' perception of 
    quality, both contribute to continued market acceptance. Thus, efforts 
    to eradicate scrapie and secure the health of U.S. sheep and goats will 
    continue to serve the economic interests of the industry and nation. 
    This proposed rule could give incentive for more rigorous efforts to 
    find infection and proceed rapidly to eradicate infected animals in 
    order to preserve a scrapie-free status.
        This proposed rule should benefit U.S. producers in a number of 
    ways, especially by avoiding a number of direct costs and market 
    losses. Associations representing breeding sheep owners, slaughter 
    sheep owners, and wool-production sheep owners have all submitted 
    comments supporting the approach of this proposed rule and also stated 
    their associations' opinion that the benefits of the program would 
    greatly exceed the costs. Scrapie may cost the sheep industry as much 
    as $20.1 million per year in direct losses ($10 million in lost 
    breeding stock and embryo export sales, $3.95 million in disposal costs 
    for offal, and $6.176 to divert offal from ruminant food chains and in 
    loss of offal export markets. Scrapie also costs an unknown amount in 
    lost potential international markets and lost flock productivity. 
    Additionally, the sheep industry currently loses sales to drug 
    companies because the U.S. Food and Drug Administration requires 
    scrapie-free sources of sheep or goat materials for pharmaceutical or 
    biological products implanted or injected in humans.
        Therefore, adopting this proposal could make the U.S. sheep 
    industry more competitive, particularly in live sheep and goat exports, 
    since current trade shows that the value of live animal exports is 
    almost four times that of the meat in the global market. This proposal 
    also addresses consumer concerns about the presence of a transmissible 
    spongiform encephalopathy in food. While there is no evidence that 
    scrapie is a human health risk, there is a perception of risk. This 
    perception might be playing a significant role in encouraging U.S. 
    imports of over $170 million worth of lamb and mutton, since imported 
    lamb sells at a higher price than domestic lamb and mutton.
        In summary, this proposed rule would regulate the interstate 
    movement of sheep and goats from States that do not follow effective 
    flock management practices for scrapie. Interstate movement of sheep 
    and goats is beneficial, as it reduces interstate price differences 
    faced by consumers of livestock products, and allows producers to seek 
    the best available prices for their products. The proposed rule would 
    encourage States to carry out the necessary surveillance and quarantine 
    activities quickly, thereby reducing the spread of the disease. The 
    process outlined in the proposed rule would encourage these States to 
    begin stringent surveillance procedures immediately to identify any 
    additional infected flocks and help to realize the goal of eradicating 
    scrapie from the United States. The proposed rule would also encourage 
    flock owners to participate in State scrapie programs or the Federal 
    Scrapie Flock Certification Program, contributing further to the 
    control of scrapie. Apart from the cost of program activities by APHIS 
    and State agencies, and expenditure of indemnity funds by APHIS, the 
    cost of identifying animals for interstate movement is the primary cost 
    imposed by this proposed rule. This cost will impose some burden upon 
    owners, which will be passed along to those who are interested in 
    buying these animals, possibly reducing interstate commerce in sheep 
    and goats slightly.
        The proposed changes to the regulations would result in new 
    information collection or recordkeeping requirements, as described 
    below under the heading ``Paperwork Reduction Act.'' Executive Order 
    12612 and Federalism
        It has been determined under section 6(a) of Executive Order 12612, 
    Federalism, that this rule does not have sufficient federalism 
    implications to warrant the preparation of a federalism assessment. The 
    provisions contained in this proposed rule would not have a substantial 
    direct effect on States or their political subdivisions or on the 
    distribution of power and responsibilities among the various levels of 
    government.
        The Administrator has examined the federalism implications of the 
    requirements in this proposal, i.e., different interstate movement 
    requirements for sheep and goats depending on whether they are moving 
    from a Consistent State or an Inconsistent State. The Administrator 
    believes that this action adheres to Constitutional principles for the 
    exercise of Federal power and is clearly authorized by statutory 
    authorities delegated to APHIS.
        This action would not absolutely impose any new compliance costs on 
    State or local governments, but it is true that, if adopted, this rule 
    would strongly encourage some States to expend additional funds to 
    upgrade their State programs for disease control in sheep and goats. 
    Owners of sheep and goats in States that do not fund their programs to 
    an extent that allows them to qualify as Consistent States would face 
    additional restrictions on the interstate movement of their sheep and 
    goats.
        As discussed above, this proposal was preceded by an advance notice 
    of proposed rulemaking which sought comments from the public, industry, 
    and State and local officials. That notice specifically requested 
    comments addressing ``the alignment of Federal interstate movement 
    restrictions with State standards.'' The comments that we received and 
    considered when drafting
    
    [[Page 66803]]
    
    this proposal, including comments on State issues, are addressed above. 
    Additionally, in drafting this proposal, APHIS had many discussions 
    with officials of animal health agencies in affected States.
        During these consultations, most States supported the proposal's 
    intention to establish a system to certify that State programs for 
    sheep and goats meet certain minimum standards, in order to provide a 
    baseline of protection against the spread of disease when moving sheep 
    and goats in interstate commerce. A very few officials commented that 
    APHIS should accept any State animal health program without enforcing 
    minimum standards. APHIS disagrees with this position because 
    experience in animal health programs on a national level has shown that 
    the absence of effective programs for scrapie in a few States can 
    quickly cause animal disease problems and financial losses affecting 
    many States as animals move in interstate commerce.
        State and local governments have the opportunity to comment on this 
    proposed rule, and we encourage them to submit comments on federalism 
    concerns or any other issues. As this rulemaking continues, APHIS 
    intends to continue active consultation with State animal health 
    agencies and the elected officials of affected State and local 
    governments.
    
    Executive Order 12988
    
        This proposed rule has been reviewed under Executive Order 12988, 
    Civil Justice Reform. If this proposed rule is adopted: (1) All State 
    and local laws and regulations that are in conflict with this rule will 
    be preempted; (2) No retroactive effect will be given to this rule; and 
    (3) Administrative proceedings will not be required before parties may 
    file suit in court challenging this rule.
    
    Paperwork Reduction Act
    
        In accordance with section 3507(d) of the Paperwork Reduction Act 
    of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
    recordkeeping requirements included in this proposed rule have been 
    submitted for approval to the Office of Management and Budget (OMB). 
    Please send written comments to the Office of Information and 
    Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
    DC 20503. Please state that your comments refer to Docket No. 97-093-2. 
    Please send a copy of your comments to: (1) Docket No. 97-093-2, 
    Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River 
    Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, 
    OCIO, USDA, room 404-W, 14th Street and Independence Avenue SW., 
    Washington, DC 20250. A comment to OMB is best assured of having its 
    full effect if OMB receives it within 30 days of publication of this 
    proposed rule.
        This proposed rule would revise various recordkeeping and 
    notification requirements of APHIS scrapie regulations and the 
    Voluntary Scrapie Flock Certification Program. The purpose of these 
    requirements is primarily to prevent the uncontrolled interstate 
    movement of animals that could spread scrapie, and to identify and 
    certify flocks that are free of scrapie in order to prevent the disease 
    from spreading.
        Collecting this information necessitates the use of a number of 
    information-gathering documents, including certificates and permits, 
    that are critical to our ability to locate flocks infected with scrapie 
    and to prevent the interstate spread of scrapie. The collection of this 
    information is therefore crucial to the success of scrapie control. 
    State animal health agencies would also have to submit descriptions of 
    their scrapie program activities to assist APHIS in determining whether 
    they qualify for Consistent State status.
        We are soliciting comments from the public (as well as affected 
    agencies) concerning our proposed information collection and 
    recordkeeping requirements. We need this outside input to help us:
        (1) Evaluate whether the proposed information collection is 
    necessary for the proper performance of our agency's functions, 
    including whether the information will have practical utility;
        (2) Evaluate the accuracy of our estimate of the burden of the 
    proposed information collection, including the validity of the 
    methodology and assumptions used;
        (3) Enhance the quality, utility, and clarity of the information to 
    be collected;
        (4) Minimize the burden of the information collection on those who 
    are to respond (such as through the use of appropriate automated, 
    electronic, mechanical, or other technological collection techniques or 
    other forms of information technology, e.g., permitting electronic 
    submission responses).
        Estimate of burden: The public reporting burden for this collection 
    of information is estimated to average 2.5049 hours per response.
        Respondents: Flock owners, State animal health officials, 
    accredited veterinarians, State and Federal veterinary medical 
    officers, and State and Federal diagnostic laboratory personnel.
        Estimated annual number of respondents: 1,180.
        Estimated annual number of responses per respondent: 5.3610.
        Estimated annual number of responses: 6,326.
        Estimated total annual burden on respondents: 15,846 hours. (Due to 
    rounding, the total annual burden hours may not equal the product of 
    the annual number of responses multiplied by the average reporting 
    burden per response.)
        Copies of this information collection can be obtained from: 
    Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence 
    Avenue, SW., Washington, DC 20250.
    
    Unfunded Mandates Reform Act of 1995
    
        Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
    Law 104-4, establishes requirements for Federal agencies to assess the 
    effects of their regulatory actions on State, local, tribal 
    governments, and the private sector. Under section 202 of the UMRA, 
    APHIS generally must prepare a written statement, including a cost-
    benefit analysis, for proposed and final rules with ``Federal 
    mandates'' that may result in expenditures by State, local, or tribal 
    governments, in the aggregate, or to the private sector, of $100 
    million or more in any one year. When such a statement is needed for a 
    rule, section 205 of the UMRA generally requires APHIS to identify and 
    consider a reasonable number of regulatory alternatives and adopt the 
    least costly, more cost-effective, or least burdensome alternative that 
    achieves the objectives of the rule.
        This rule contains no Federal mandates (under the regulatory 
    provisions of Title II of the UMRA) that may result in expenditures by 
    State, local, and tribal governments, in the aggregate, or to the 
    private sector, of $100 million or more in any one year. A few States 
    may not qualify as Consistent States under this rule unless and until 
    they choose to increase their expenditures on scrapie control programs, 
    but based on knowledge of current State budgets and our experience with 
    the costs involved in conducting sheep and goat disease programs, we 
    estimate that the possible increases in expenditures by these States 
    will fall far below $100 million. Thus, this rule is not subject to the 
    requirements of sections 202 and 205 of the UMRA.
    
    [[Page 66804]]
    
    List of Subjects
    
    9 CFR Part 54
    
        Animal diseases, Goats, Indemnity payments, Scrapie, Sheep.
    
    9 CFR Part 79
    
        Animal diseases, Goats, Quarantine, Reporting and recordkeeping 
    requirements, Scrapie, Sheep, Transportation.
    
        Accordingly, we are proposing to revise 9 CFR parts 54 and 79 as 
    follows:
    
    PART 54--CONTROL OF SCRAPIE
    
    Sec.
    54.1  Definitions.
    
    Subpart A--Scrapie Indemnification Program
    
    54.3  Animals eligible for indemnity payments.
    54.4  Application by owners for indemnity payments.
    54.5  Certification by owners.
    54.6  Amount of indemnity payments.
    54.7  Procedures for destruction of animals.
    
    Subpart B--Scrapie Flock Certification Program
    
    54.10  Administration.
    54.11  Participation.
    54.12  State scrapie certification boards.
    54.13  Cooperative agreements with States.
    54.14  Requirements for flock plans and post-exposure management 
    monitoring plans.
    
        Authority: 21 U.S.C. 111, 114, 114a, and 134a-134h; 7 CAR 2.22, 
    2.80, and 371.2(d).
    
    
    Sec. 54.1  Definitions.
    
        Accredited veterinarian. A veterinarian approved by the 
    Administrator in accordance with part 161 of this chapter to perform 
    functions specified in subchapters B, C, and D of this chapter.
        Administrator. The Administrator of the Animal and Plant Health 
    Inspection Service, or any employee of the United States Department of 
    Agriculture authorized to act for the Administrator.
        Affected animal. An animal for which a diagnosis of scrapie has 
    been made by an APHIS or State representative based on the results of a 
    live-animal screening test approved for this use by the Administrator. 
    A live-animal screening test may be approved for this use without also 
    being approved for the official diagnosis of a scrapie-positive animal.
        Animal. A sheep or goat.
        Animal and Plant Health Inspection Service (APHIS). The Animal and 
    Plant Health Inspection Service of the United States Department of 
    Agriculture.
        APHIS representative. An individual employed by APHIS in animal 
    health activities who is authorized by the Administrator to perform the 
    function involved.
        Area veterinarian in charge. The veterinary official of APHIS who 
    is assigned by the Administrator to supervise and perform the official 
    animal health work of APHIS in the State concerned.
        Breed association and registries. Organizations that maintain the 
    permanent records of ancestry or pedigrees of animals (including the 
    animal's sire and dam), individual identification of animals, and 
    ownership of animals.
        Commingled, commingling. Animals grouped together and having 
    physical contact with each other, including contact through a fence, 
    but not limited contacts. Commingling also includes sharing the same 
    section in a transportation unit where there is any physical contact.
        Destroyed. Euthanized by means other than slaughter, and the 
    carcass disposed of, by means authorized by the Administrator.
        Electronic implant. Any radio frequency identification implant 
    device approved for use in the scrapie program by the Administrator. 
    The Administrator will approve an electronic implant after determining 
    that it is tamper resistant, not harmful to the animal, and readable by 
    equipment available to APHIS and State representatives.
        Exposed animal. Any animal that has been in the same flock at the 
    same time within the previous 60 months as a scrapie-positive animal, 
    excluding limited contacts. Any animal born in a flock after a scrapie-
    positive animal was born into that flock, if born before that flock 
    completes the requirements of a flock plan.
        Flock. All animals that are maintained on a single premises and all 
    animals under common ownership or supervision on two or more premises 
    with animal interchange between the premises. Changes in ownership of a 
    flock do not change the identity of the flock or the regulatory 
    requirements applicable to the flock. More than one flock may be 
    maintained on a single premises if:
        (1) The flocks are enrolled as separate flocks in the SFCP, or an 
    APHIS representative determines based upon examination of flock records 
    that no animals have moved between the flocks;
        (2) The flocks never commingle and are kept at least 30 feet apart 
    at all times;
        (3) The flocks have separate flock records and identification;
        (4) The flocks have separate lambing facilities, including 
    buildings and pastures, and a pasture or building used for lambing by 
    one flock is not used by the other flock at any time;
        (5) The flocks do not share equipment without cleaning and 
    disinfection in accordance with the guidelines published in the Scrapie 
    Flock Certification Program standards; and
        (6) There is no interchange of animals between the flocks.
        Flock plan. A written flock management agreement designed by the 
    owner of a flock, an accredited veterinarian, and an APHIS 
    representative or State representative in which each participant agrees 
    to undertake actions specified in the flock plan to control the spread 
    of scrapie from, and eradicate scrapie in, an infected flock or source 
    flock or to reduce the risk of the occurrence of scrapie in a flock 
    that contains a high-risk or an exposed animal. As part of a flock 
    plan, the flock owner must provide the facilities and personnel needed 
    to carry out the requirements of the flock plan. The flock plan must 
    include the requirements in Sec. 54.14 of this part.
        High-risk animal. An animal that is:
        (1) The progeny of a scrapie-positive dam;
        (2) Born in the same flock during the same lambing season as 
    progeny of a scrapie-positive dam, unless the progeny of the scrapie-
    positive dam are from separate contemporary lambing groups; or
        (3) Born in the same flock during the same lambing season that a 
    scrapie-positive animal was born, or during any subsequent lambing 
    season.
        Infected flock. Any flock in which an APHIS representative or a 
    State representative has determined an animal to be a scrapie-positive 
    animal or in which an APHIS representative or a State representative 
    has determined that a scrapie-positive animal had lambed within 18 
    months of the time at which the tissues used for diagnosis were 
    collected from the scrapie-positive animal. A flock will no longer be 
    considered an infected flock after it has completed the requirements of 
    a flock plan.
        Limited contacts. Incidental contacts between animals off the 
    flock's premises such as at fairs, shows, exhibitions and sales; 
    between ewes being inseminated, flushed, or implanted; or between rams 
    at ram test or collection stations. Embryo transfer and artificial 
    insemination equipment and surgical tools must be sterilized between 
    animals for these contacts to be considered limited contacts. Limited 
    contacts do not include any contact, incidental or otherwise, with an 
    animal during, or up to 60 days after, lambing or kidding.
    
    [[Page 66805]]
    
    Limited contacts do not include any activity where uninhibited contact 
    occurs, such as sharing an enclosure, sharing a section of a transport 
    vehicle, or transportation to other flocks for breeding, except as 
    allowed by the Scrapie Flock Certification Program standards.
        Live-animal screening test. Any test for the diagnosis of scrapie 
    in a live animal that is approved by the Administrator as usually 
    reliable but not definitive for diagnosing scrapie, and that is 
    conducted in a laboratory approved by the Administrator.\1\
    ---------------------------------------------------------------------------
    
        \1\ The names and addresses of laboratories approved by the 
    Administrator to conduct live-animal screening tests will be 
    published in the Notices Section of the Federal Register. A list of 
    approved laboratories is also available upon request from the Animal 
    and Plant Health Inspection Service, Veterinary Services, National 
    Animal Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD 
    20737-1235. State, Federal, and university laboratories will be 
    approved by the Administrator when he or she determines that the 
    laboratory: (a) Employs personnel trained by the National Veterinary 
    Services Laboratories assigned to supervise the testing; (b) Follows 
    standard test protocols; (c) Meets check test proficiency 
    requirements; and (d) Will report all test results to State and 
    Federal animal health officials. Before the Administrator may 
    withdraw approval of any laboratory for failure to meet any of these 
    conditions, the Administrator must give written notice of the 
    proposed withdrawal to the director of the laboratory, and must give 
    the director an opportunity to respond. If there are conflicts as to 
    any material fact, a hearing will be held to resolve the conflict.
    ---------------------------------------------------------------------------
    
        Mortgage. Any mortgage, lien, or other security or beneficial 
    interest held by any person other than the one claiming indemnity.
        Owner. A person, partnership, company, corporation, or any other 
    legal entity who has legal or rightful title to animals, whether or not 
    they are subject to a mortgage.
        Post-exposure management and monitoring plan. A written agreement 
    designed by the owner of a flock, an accredited veterinarian, and an 
    APHIS representative or State representative in which each participant 
    agrees to undertake actions specified in the agreement to monitor for 
    the recurrence of scrapie in the flock for at least 5 years after the 
    last high-risk or scrapie-positive animal is removed from the flock or 
    to monitor for occurrence of scrapie for 5 years after the last 
    exposure of the flock to a scrapie-positive animal, unless otherwise 
    specified by an APHIS or state animal health official. As part of a 
    post-exposure management and monitoring plan, the flock owner must 
    provide the facilities and personnel needed to carry out the 
    requirements of the plan. The plan must include the requirements in 
    Sec. 54.14 of this part.
        Scrapie Flock Certification Program (SFCP). The cooperative 
    Federal-State-industry voluntary program for the control of scrapie 
    conducted in accordance with this subpart.
        Scrapie Flock Certification Program standards. Cooperative 
    procedures and standards adopted by APHIS and State scrapie 
    certification boards for reducing the incidence and controlling the 
    spread of scrapie through flock certification.\2\
    ---------------------------------------------------------------------------
    
        \2\ Individual copies of the Scrapie Flock Certification Program 
    standards may be obtained on the World Wide Web at URL http://
    www.aphis.usda.gov/vs/scrapie, or from the Animal and Plant Health 
    Inspection Service, National Animal Health Programs Staff, 4700 
    River Road Unit 43, Riverdale, MD 20737-1235.
    ---------------------------------------------------------------------------
    
        Scrapie-positive animal. An animal for which a diagnosis of scrapie 
    has been made by the National Veterinary Services Laboratories, United 
    States Department of Agriculture, or another laboratory authorized by 
    the Administrator to conduct scrapie tests in accordance with this 
    part, through:
        (1) Histopathological examination of central nervous system (CNS) 
    tissues from the animal for characteristic microscopic lesions of 
    scrapie;
        (2) The use of protease-resistant protein analysis methods 
    including but not limited to immunohistochemistry and/or western 
    blotting on CNS and/or peripheral tissue samples from a live or a dead 
    animal for which a given method has been approved by the Administrator 
    for use on that tissue;
        (3) Bioassay;
        (4) Scrapie associated fibrils (SAF) detected by electron 
    microscopy; or
        (5) Any other test method approved by the Administrator.\3\
    ---------------------------------------------------------------------------
    
        \3\ The names and addresses of laboratories approved by the 
    Administrator to conduct tests are published in the Notices Section 
    of the Federal Register. A list of approved laboratories is also 
    available upon request from the Animal and Plant Health Inspection 
    Service, Veterinary Services, National Animal Health Programs Staff, 
    4700 River Road Unit 43, Riverdale, MD 20737-1235. State, Federal, 
    and university laboratories will be approved by the Administrator 
    when he or she determines that the laboratory: (a) Employs personnel 
    trained by the National Veterinary Services Laboratories assigned to 
    supervise the testing; (b) Follows standard test protocols; (c) 
    Meets check test proficiency requirements; and (d) Will report all 
    test results to State and Federal animal health officials. Before 
    the Administrator may withdraw approval of any laboratory for 
    failure to meet any of these conditions, the Administrator must give 
    written notice of the proposed withdrawal to the director of the 
    laboratory, and must give the director an opportunity to respond. If 
    there are conflicts as to any material fact, a hearing will be held 
    to resolve the conflict.
    ---------------------------------------------------------------------------
    
        Separate contemporary lambing groups. To be a separate contemporary 
    lambing group, the group must be maintained separately such that the 
    animals cannot come into physical contact with other lambs, kids, ewes 
    or does or birth fluids or placenta from other ewes or does. This 
    separate maintenance must preclude contact through a fence, during 
    lambing and for 60 days following the date the last lamb or kid is born 
    in a lambing season, and must preclude using the same lambing facility 
    as other ewes or does, unless the lambing facility is cleaned and 
    disinfected between lambings in accordance with the guidelines 
    published in the Scrapie Flock Certification Program standards.
        Source flock. A flock in which an APHIS representative or a State 
    representative has determined that at least one animal was born that 
    was diagnosed as a scrapie-positive animal at an age of 54 months or 
    less. A flock will no longer be a source flock after it has completed 
    the requirements of a flock plan.
        State. Each of the 50 States, the District of Columbia, the 
    Northern Mariana Islands, Puerto Rico, and all territories or 
    possessions of the United States.
        State representative. An individual employed in animal health 
    activities by a State or a political subdivision of a State, and who is 
    authorized by the State or political subdivision to perform the 
    function involved.
        Suspect animal. A sheep or goat exhibiting any of the following 
    possible signs of scrapie and that has been determined to be suspicious 
    for scrapie by an accredited veterinarian, an APHIS representative, or 
    a State representative: Weight loss despite retention of appetite; 
    behavioral abnormalities; pruritus (itching); wool pulling; biting at 
    legs or side; lip smacking; motor abnormalities such as incoordination, 
    high stepping gait of forelimbs, bunny hop movement of rear legs, or 
    swaying of back end; increased sensitivity to noise and sudden 
    movement; tremor, ``star gazing,'' head pressing, recumbency, or other 
    signs of neurological disease or chronic wasting. A suspect animal will 
    no longer be a suspect animal upon determination by an APHIS 
    representative or a State representative that it no longer exhibits 
    such signs, or that the signs are not caused by scrapie.
    
    Subpart A--Scrapie Indemnification Program
    
    
    Sec. 54.3  Animals eligible for indemnity payments.
    
        (a) Indemnity may be paid for an animal only after the owner of the 
    animal has applied for indemnification and been approved in accordance 
    with 54.4 of this part. Indemnity may be paid only for the following:
        (1) Destruction of high-risk animals;
    
    [[Page 66806]]
    
        (2) Destruction of animals based on an epidemiologic investigation, 
    when the Administrator determines that the destruction of these animals 
    will contribute to the eradication of scrapie;
        (3) Destruction of live scrapie-positive animals;
        (4) Destruction of affected animals; and
        (5) Destruction of suspect animals that are subsequently determined 
    to be scrapie-positive animals.
        (b) No indemnity will be paid for an animal if the owner of the 
    animal fails to provide APHIS, within 30 days of request, with animal 
    registration certificates, sale and movement records, or other records 
    requested in accordance with Sec. 54.5 of this part. No indemnity will 
    be paid until the premises, including all structures, holding 
    facilities, conveyances, and materials contaminated because of 
    occupation or use by the depopulated animals, have been properly 
    cleaned and disinfected in accordance with the guidelines published in 
    the Scrapie Flock Certification Program standards. Premises or portions 
    of premises may be exempted from such cleaning and disinfecting 
    requirements if the APHIS or State representative determines that the 
    exempted buildings, holding facilities, conveyances, or other materials 
    on the premises do not require cleaning and disinfection to prevent the 
    spread of scrapie.
    
    
    Sec. 54.4  Application by owners for indemnity payments.
    
        (a) Normally, an application for indemnification will be initiated 
    by an APHIS or State representative who is working with the owner of a 
    flock that has already been determined to be an infected flock or 
    source flock, or that is already under a State quarantine. In such 
    cases, the flock owner will confirm information about the flock's 
    eligibility for indemnity that is contained in the application 
    submitted by the APHIS or State representative. However, an owner of a 
    flock that has or has not been determined to be an infected flock or 
    source flock, and is not under a State quarantine, may apply directly 
    to receive indemnification by submitting to the Administrator a written 
    request containing the following information:
        (1) Name, address, and social security number of the flock owner;
        (2) Number and breed(s) of animals in the flock, including a 
    current inventory;
        (3) Location of flock premises;
        (4) Reasons the owner believes animals in his or her flock may be 
    eligible for indemnification, including any diagnosis of scrapie made 
    for animals in the flock; any signs of scrapie observed in the flock by 
    the owner; and any movement of animals into the flock from flocks 
    infected with or exposed to scrapie;
        (5) A copy of the registration papers issued in the name of the 
    owner for any registered animals in the flock. If the registration 
    papers are unavailable or if the animals are less than 1 year old and 
    are not registered at the time the claim for indemnity is submitted, 
    the area veterinarian in charge may grant a 60-day extension or the 
    Administrator may grant an extension longer than 60 days for the 
    presentation of registration papers; and
        (6) Signed release letters addressed to any sheep or goat registry 
    associations that maintain records of the owner's sheep or goats, 
    requesting the associations to release to APHIS all records maintained 
    by the association on sheep or goats currently or formerly owned by the 
    applicant.
        (b) APHIS will evaluate each application to determine whether the 
    owner's flock contains animals eligible for indemnity in accordance 
    with 54.3 of this part.
    
    
    Sec. 54.5  Certification by owners.
    
        Before any indemnity is paid to an owner, the owner must sign a 
    written agreement with APHIS, certifying the following:
        (a) The owner will make available for review upon request by an 
    APHIS representative all bills of sale, pedigree registration 
    certificates, and other records regarding movement of animals into and 
    from the flock;
        (b) If the owner maintains any flock after the payment of indemnity 
    or acquires a new flock that is housed on the same premises within 5 
    years after the last high-risk or scrapie-positive animal is removed, 
    the owner will maintain the flock in accordance with a post-exposure 
    management and monitoring plan;
        (c) If the animal for which indemnity is paid is subject to any 
    mortgage, the owner consents to the payment of the indemnity, up to the 
    value of the mortgage, to the person(s) holding the mortgage.
    
    
    Sec. 54.6  Amount of indemnity payments.
    
        Indemnity paid in accordance with 54.3 of this part will be $150 
    for each registered animal destroyed and $50 for each unregistered 
    animal destroyed.
    
    
    Sec. 54.7  Procedures for destruction of animals.
    
        (a) Animals for which indemnification is sought must be destroyed 
    on the premises where held, pastured, or penned at the time indemnity 
    is approved, unless the APHIS representative involved approves in 
    advance of destruction moving the animals to another location for 
    destruction.
        (b) The carcasses of animals destroyed in accordance with this 
    section are authorized by the Administrator to be buried, incinerated, 
    or disposed of by other methods in accordance with local, State, or 
    Federal law. The carcasses must not be processed for animal food, 
    unless subjected to a treatment process approved by the Administrator 
    and known to eliminate the agents of transmissible spongiform 
    encephalopathies. The carcasses may not be processed for human food.
        (c) The destruction of animals and disposition of their carcasses 
    in accordance with this part must be monitored by an APHIS 
    representative who will prepare and transmit to the Administrator a 
    report identifying the animals and showing their disposition.
        (d) APHIS will not be responsible for any costs or charges for the 
    destruction and disposal of animals in accordance with this part.
    
    Subpart B--Scrapie Flock Certification Program
    
    
    Sec. 54.10  Administration.
    
        The Scrapie Flock Certification Program is a cooperative effort 
    between APHIS; members of the sheep and goat industry, including owners 
    of flocks, slaughtering and rendering establishments, and breed 
    associations and registries; accredited veterinarians; and State 
    governments. APHIS coordinates with State scrapie certification boards 
    and State animal health agencies to encourage flock owners to reduce 
    the incidence of scrapie by voluntarily complying with the Scrapie 
    Flock Certification Program standards.
    
    
    Sec. 54.11  Participation.
    
        Any owner of a sheep or goat flock may apply to enter the Scrapie 
    Flock Certification Program by sending a written request to a State 
    scrapie certification board or to the Administrator. A notice 
    containing a current list of flocks participating in the Scrapie Flock 
    Certification Program, and the certification status of each flock, may 
    be obtained from the APHIS website at URL http://www.aphis.usda.gov/vs/
    scrapie, and may also be obtained by writing to the Animal and Plant 
    Health Inspection Service, National Animal Health Programs Staff, VS, 
    APHIS, 4700 River Road Unit 43, Riverdale, MD 20737-1235.
    
    
    [[Page 66807]]
    
    
    (Approved by the Office of Management and Budget under control 
    number 0579-0101)
    
    
    Sec. 54.12  State scrapie certification boards.
    
        An area veterinarian in charge, after consulting with a State 
    representative and industry representatives, may appoint a State 
    scrapie certification board for the purpose of coordinating activities 
    for the Scrapie Flock Certification Program, including making decisions 
    to admit flocks to the Scrapie Flock Certification Program and to 
    change flock status in accordance with the Scrapie Flock Certification 
    Program standards. No more than one State scrapie certification board 
    may be formed in each State. Each State scrapie certification board 
    shall include as members the area veterinarian in charge, one or more 
    State representatives, one or more accredited veterinarians, and one or 
    more owners of flocks, and, at the discretion of the area veterinarian 
    in charge, may include other members.
    
    
    Sec. 54.13  Cooperative agreements with States.
    
        APHIS may execute a cooperative agreement with the animal health 
    agency of any State to cooperatively administer the Scrapie Flock 
    Certification Program within that State. These cooperative agreements 
    will describe the respective roles of APHIS and State personnel in 
    implementing the Scrapie Flock Certification Program standards and 
    other scrapie control measures. The agreement may specify the 
    financial, material, and personnel resources to be committed to the 
    Scrapie Flock Certification Program and other scrapie control measures 
    by APHIS and the State; assign specific Scrapie Flock Certification 
    Program activities and other activities related to the control of 
    scrapie within a State to APHIS or State personnel; establish schedules 
    for APHIS representatives or State representatives to visit 
    participating flocks; establish procedures for maintaining and sharing 
    Scrapie Flock Certification Program records specified in the Scrapie 
    Flock Certification Program standards, and specify other 
    responsibilities of State representatives and APHIS representatives in 
    support of the Scrapie Flock Certification Program and the State 
    scrapie control program.
    
    (Approved by the Office of Management and Budget under control 
    number 0579-0101)
    
    
    Sec. 54.14  Requirements for flock plans and post-exposure management 
    and monitoring plans.
    
        (a) The owner of the flock or his or her agent must identify all 
    animals 1 year of age or over within the flock. All animals less than 1 
    year of age must be identified when a change of ownership occurs, with 
    the exception of those animals under 6 months of age moving within 
    slaughter channels that must be identified in accordance with Sec. 79.2 
    of this chapter. The form of identification must be an electronic 
    implant, flank tattoo, ear tattoo, or tamper-resistant ear tag approved 
    by APHIS. In the case of goats, the form of identification may 
    alternatively be a tail fold tattoo. The official identification must 
    provide a unique identification number that is applied by the owner of 
    the flock or his or her agent.
        (b) Upon request of an APHIS or State representative, the owner of 
    the flock or his or her agent must have an accredited veterinarian 
    collect and submit tissues from animals for scrapie diagnostic purposes 
    to a laboratory designated by an APHIS or State representative.
        (c) The owner of the flock or his or her agent, upon request, must 
    make animals in the flock and the records required to be kept as a part 
    of these plans available for inspection by APHIS representatives and 
    State representatives.
        (d) The owner of the flock or his or her agent must meet 
    requirements found necessary by the APHIS representative or State 
    representative to monitor for scrapie and to prevent the recurrence of 
    scrapie in the flock. These other requirements may include, but are not 
    limited to: Utilization of an approved live-animal test, segregated 
    lambing, cleaning and disinfection of lambing facilities, and/or 
    education of the owner of the flock and personnel working with the 
    flock in techniques to recognize clinical signs of scrapie and to 
    control the spread of scrapie.
        (e) The owner of the flock or his or her agent must immediately 
    report to a State representative, APHIS representative, or an 
    accredited veterinarian any animals in the flock exhibiting the 
    following: Weight loss despite retention of appetite; behavioral 
    abnormalities; pruritus (itching); wool pulling; biting at legs or 
    side; lip smacking; motor abnormalities such as incoordination, high 
    stepping gait of forelimbs, bunny hop movement of rear legs, swaying of 
    back end; increased sensitivity to noise and sudden movement; tremor, 
    ``star gazing'', head pressing, recumbency, or other signs of 
    neurological disease or chronic wasting illness. Such animals must not 
    be removed from the flock without written permission of an APHIS 
    representative or State representative.
        (f) Requirements for flock plans only:
        (1) An epidemiologic investigation must be conducted to identify 
    high-risk and exposed animals that currently reside in the flock or 
    that previously resided in the flock, and all high-risk animals, 
    scrapie-positive animals, affected animals, and suspect animals must be 
    removed from the flock. The animals must be removed by euthanization 
    and disposal of the carcasses by burial, incineration, or other methods 
    in accordance with State or Federal law, or, in the case of high-risk 
    animals, by movement to slaughter (slaughtered animals are not eligible 
    for indemnity) in accordance with the provisions of part 79 of this 
    chapter, or upon request in individual cases by another means 
    determined by the Administrator to be sufficient to prevent the spread 
    of scrapie;
        (2) The premises of a flock under a flock plan must be cleaned and 
    disinfected in accordance with the guidelines published in the Scrapie 
    Flock Certification Program standards;
        (3) The owner of the flock, or his or her agent, must request breed 
    associations and registries, livestock markets, and packers to disclose 
    records to APHIS representatives or State representatives, to be used 
    to identify source flocks and trace exposed animals, including high-
    risk animals; and
        (4) The flock owner must agree to conduct post-exposure management 
    and monitoring.
        (g) Requirements for post-exposure management and monitoring plans 
    only: The plan will require that an APHIS representative or State 
    representative inspect the flock and flock records at least once every 
    12 months. The owner of the flock or his or her agent must maintain, 
    and keep for a minimum of 5 years after an animal dies or is otherwise 
    removed from a flock, the following records for each animal in the 
    flock:
        (1) Any identifying marks or tags present on the animal including 
    the animal's individual official identification number from its 
    electronic implant, flank tattoo, ear tattoo tamper resistant ear tag, 
    or, in the case of goats, it may be a tail fold tattoo, and any 
    secondary form of identification the owner of the flock may choose to 
    maintain;
        (2) Sex, breed, sire, dam, and offspring of the animal;
        (3) Date of acquisition and previous flock, if the animal was not 
    born in the flock; and
        (4) Disposition of the animal, including the date and cause of 
    death, if known, or date of removal from the flock and name and address 
    of the person to whom the animal was transferred.
    
    [[Page 66808]]
    
    PART 79--SCRAPIE IN SHEEP AND GOATS
    
    Sec.
    79.1  Definitions.
    79.2  Identification of sheep and goats in interstate commerce.
    79.3  General restrictions.
    79.4  Designation of scrapie-positive animals, affected animals, 
    high-risk animals, exposed animals, suspect animals, source flocks, 
    and infected flocks; notice to owners.
    79.5  Issuance of certificates.
    79.6  Standards for State programs to qualify as Consistent States.
    
        Authority: 21 U.S.C. 111-113, 115, 117, 120, 121, 123-126, 134b, 
    and 134f; 7 CFR 2.22, 2.80, and 371.2(d).
    
    
    Sec. 79.1  Definitions.
    
        Accredited veterinarian. A veterinarian approved by the 
    Administrator in accordance with part 161 of this chapter to perform 
    functions specified in subchapters B, C, and D of this chapter.
        Administrator. The Administrator of the Animal and Plant Health 
    Inspection Service, or any employee of the United States Department of 
    Agriculture authorized to act for the Administrator.
        Affected animal. An animal for which a diagnosis of scrapie has 
    been made by an APHIS or State representative based on the results of a 
    live-animal screening test approved for this use by the Administrator. 
    A live-animal screening test may be approved for this use without also 
    being approved for the diagnosis of a scrapie-positive animal.
        Animal. A sheep or goat.
        Animal and Plant Health Inspection Service (APHIS). The Animal and 
    Plant Health Inspection Service of the United States Department of 
    Agriculture.
        APHIS representative. An individual employed by APHIS in animal 
    health activities who is authorized by the Administrator to perform the 
    function involved.
        Area veterinarian in charge. The veterinary official of APHIS who 
    is assigned by the Administrator to supervise and perform the official 
    animal health work of APHIS in the State concerned.
        Breed association and registries. Organizations that maintain the 
    permanent records of ancestry or pedigrees of animals (including the 
    animal's sire and dam), individual identification of animals, and 
    ownership of animals.
        Certificate. An official document issued in accordance with 
    Sec. 79.5 of this part by an APHIS representative, State 
    representative, or accredited veterinarian at the point of origin of an 
    interstate movement of animals, which includes a statement that the 
    animals were not exhibiting clinical signs associated with scrapie at 
    the time of examination.
        Commingled, commingling. Animals grouped together and having 
    physical contact with each other, including contact through a fence, 
    but not limited contacts. Commingling also includes sharing the same 
    section in a transportation unit where there is physical contact.
        Consistent State. A State that the Administrator has determined 
    conducts an active State scrapie control program that either:
        (1) Meets the requirements of Sec. 79.6 of this part; or
        (2) Effectively enforces a State designed plan that the 
    Administrator determines is at least as effective in controlling 
    scrapie as the requirements of Sec. 79.6 of this part.
        Designated scrapie epidemiologist. An epidemiologist selected by 
    the State animal health official and the area veterinarian in charge to 
    reclassify animals already designated as high-risk, exposed, or 
    affected with scrapie, based on epidemiologic investigation or the 
    results of a live-animal test. The regional epidemiologist and the 
    APHIS National Scrapie Program Coordinator must concur in the selection 
    and appointment of the designated scrapie epidemiologist.
        Electronic implant. Any radio frequency identification implant 
    device approved for use in the scrapie program by the Administrator. 
    The Administrator will approve an electronic implant after determining 
    that it is tamper resistant, not harmful to the animal, and readable by 
    equipment available to APHIS and State representatives.
        Exposed animal. Any animal that has been in the same flock at the 
    same time within the previous 60 months as a scrapie-positive animal, 
    excluding limited contacts. Any animal born in a flock after a scrapie-
    positive animal was born into that flock, if born before that flock 
    completes the requirements of a flock plan.
        Flock. All animals that are maintained on a single premises and all 
    animals under common ownership or supervision on two or more premises 
    with animal interchange between the premises. Changes in ownership of a 
    flock do not change the identity of the flock or the regulatory 
    requirements applicable to the flock. More than one flock may be 
    maintained on a single premises if:
        (1) The flocks are enrolled as separate flocks in the SFCP, or an 
    APHIS representative determines based upon examination of flock records 
    that no animals have moved between the flocks;
        (2) The flocks never commingle and are kept at least 30 feet apart 
    at all times;
        (3) The flocks have separate flock records and identification;
        (4) The flocks have separate lambing facilities, including 
    buildings and pastures, and a pasture or building used for lambing by 
    one flock is not used by the other flock at any time;
        (5) The flocks do not share equipment without cleaning and 
    disinfection in accordance with the guidelines published in the Scrapie 
    Flock Certification Program standards; and
        (6) There is no interchange of animals between the flocks.
        Flock plan. A written flock management agreement designed by the 
    owner of a flock, an accredited veterinarian, and an APHIS 
    representative or State representative in which each participant agrees 
    to undertake actions specified in the flock plan to control the spread 
    of scrapie from, and eradicate scrapie in, an infected flock or source 
    flock or to reduce the risk of the occurrence of scrapie in a flock 
    that contains a high-risk or an exposed animal. As part of a flock 
    plan, the flock owner must provide the facilities and personnel needed 
    to carry out the requirements of the flock plan. The flock plan must 
    include the requirements in Sec. 54.14 of this chapter.
        High-risk animal. An animal that is:
        (1) The progeny of a scrapie-positive dam;
        (2) Born in the same flock during the same lambing season as 
    progeny of a scrapie-positive dam, unless the progeny of the scrapie-
    positive dam are from separate contemporary lambing groups; or
        (3) Born in the same flock during the same lambing season that a 
    scrapie-positive animal was born, or during any subsequent lambing 
    season.
        Inconsistent State. Any State other than a Consistent State.
        Infected flock. Any flock in which an APHIS representative or a 
    State representative has determined an animal to be a scrapie-positive 
    animal or in which an APHIS representative or a State representative 
    has determined that a scrapie-positive animal had lambed within 18 
    months of the time at which the tissues used for diagnosis were 
    collected from the scrapie-positive animal. A flock will no longer be 
    considered an infected flock after it has completed the requirements of 
    a flock plan.
        Interstate commerce. Trade, traffic, transportation, or other 
    commerce between a place in a State and any place
    
    [[Page 66809]]
    
    outside of that State, or between points within a State but through any 
    place outside that State.
        Limited contacts. Incidental contacts between animals off the 
    flock's premises such as at fairs, shows, exhibitions and sales; 
    between ewes being inseminated, flushed, or implanted; or between rams 
    at ram test or collection stations. Embryo transfer and artificial 
    insemination equipment and surgical tools must be sterilized between 
    animals for these contacts to be considered limited contacts. Limited 
    contacts do not include any contact, incidental or otherwise, with an 
    animal during, or up to 60 days after, lambing or kidding. Limited 
    contacts do not include any activity where uninhibited contact occurs, 
    such as sharing an enclosure, sharing a section of a transport vehicle, 
    or transportation to other flocks for breeding, except as allowed by 
    the Scrapie Flock Certification Program standards.
        Live-animal screening test. Any test for the diagnosis of scrapie 
    in a live animal that is approved by the Administrator as usually 
    reliable but not definitive for diagnosing scrapie, and that is 
    conducted in a laboratory approved by the Administrator.\1\
    ---------------------------------------------------------------------------
    
        \1\ The names and addresses of laboratories approved by the 
    Administrator to conduct live-animal screening tests will be 
    published in the Notices Section of the Federal Register. A list of 
    approved laboratories is also available upon request from the Animal 
    and Plant Health Inspection Service, Veterinary Services, National 
    Animal Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD 
    20737-1235. State, Federal, and university laboratories will be 
    approved by the Administrator when he or she determines that the 
    laboratory: (a) Employs personnel trained by the National Veterinary 
    Services Laboratories assigned to supervise the testing; (b) follows 
    standard test protocols; (c) meets check test proficiency 
    requirements; and (d) will report all test results to State and 
    Federal animal health officials. Before the Administrator may 
    withdraw approval of any laboratory for failure to meet any of these 
    conditions, the Administrator must give written notice of the 
    proposed withdrawal to the director of the laboratory, and must give 
    the director an opportunity to respond. If there are conflicts as to 
    any material fact, a hearing will be held to resolve the conflict.
    ---------------------------------------------------------------------------
    
        Owner. A person, partnership, company, corporation, or any other 
    legal entity who has legal or rightful title to animals, whether or not 
    they are subject to a mortgage.
        Permit. An official document issued in connection with the 
    interstate movement of animals (VS Form 1-27 or a State form that 
    contains the same information) that is issued by an APHIS 
    representative, State representative, or an accredited veterinarian 
    authorized to sign such permits. A new permit is required for each 
    change in destination for an animal. A permit lists the owner's name 
    and address, points of origin and destination, number of animals 
    covered, purpose of the movement, whether the animals are from an 
    infected flock or a source flock, transportation vehicle license number 
    or other identification number, and seal number (if a seal is 
    required). A permit also lists all official identification on the 
    animals covered, including the official eartag number, individual 
    animal registered breed association registration tattoo, individual 
    animal registered breed association registration brand, United States 
    Department of Agriculture backtag (when applied serially, only the 
    beginning and the ending numbers need be recorded), individual animal 
    registered breed association registration number, or any other form of 
    official identification present on the animal.
        Premises identification. An APHIS approved eartag, backtag, or 
    tattoo bearing the premises identification number assigned by a State 
    or Federal animal health official to the premises on which the sheep or 
    goats originated, or a brand registered with an official brand 
    registry.
        Scrapie Flock Certification Program (SFCP). The cooperative 
    Federal-State-industry voluntary program for the control of scrapie 
    conducted in accordance with 9 CAR part 54, subpart B.
        Scrapie Flock Certification Program standards. Cooperative 
    procedures and standards adopted by APHIS and State Scrapie 
    Certification Boards for reducing the incidence and controlling the 
    spread of scrapie through flock certification.\2\
    ---------------------------------------------------------------------------
    
        \2\ Individual copies of the Program Standards may be obtained 
    on the World Wide Web at URL http://www.aphis.usda.gov/vs, or from 
    the Animal and Plant Health Inspection service, National Animal 
    Health Programs Staff, 4700 River Road Unit 43, Riverdale, MD 20737-
    1235.
    ---------------------------------------------------------------------------
    
        Scrapie-positive animal. An animal for which a diagnosis of scrapie 
    has been made by the National Veterinary Services Laboratories, United 
    States Department of Agriculture, or another laboratory authorized by 
    the Administrator to conduct scrapie tests in accordance with this 
    part, through:
        (1) Histopathological examination of central nervous system (CNS) 
    tissues from the animal for characteristic microscopic lesions of 
    scrapie;
        (2) By the use of protease-resistant protein analysis methods 
    including but not limited to immunohistochemistry and/or western 
    blotting on CNS and/or peripheral tissue samples from a live or a dead 
    animal for which a given method has been approved by the Administrator 
    for use on that tissue;
        (3) Bioassay;
        (4) Scrapie associated fibrils (SAF) detected by electron 
    microscopy; or
        (5) Another test method approved by the Administrator.
        Separate contemporary lambing groups. To be a separate contemporary 
    lambing group, the group must be maintained separately such that the 
    animals cannot come into physical contact with other lambs, kids, ewes 
    or does or birth fluids or placenta from other ewes or does. This 
    separate maintenance must preclude contact through a fence, during 
    lambing and for 60 days following the date the last lamb or kid is born 
    in a lambing season, and must preclude using the same lambing facility 
    as other ewes or does, unless the lambing facility is cleaned and 
    disinfected between lambings in accordance with the guidelines 
    published in Scrapie Flock Certification Program standards.
        Source flock. A flock in which an APHIS representative or a State 
    representative has determined that at least one animal was born that 
    was diagnosed as a scrapie-positive animal at an age of 54 months or 
    less. A flock will no longer be a source flock after it has completed 
    the requirements of a flock plan.
        State. Each of the 50 States, the District of Columbia, the 
    Northern Mariana Islands, Puerto Rico, and all territories or 
    possessions of the United States.
        State representative. An individual employed in animal health 
    activities by a State or a political subdivision of a State, and who is 
    authorized by the State or political subdivision to perform the 
    function involved.
        Suspect animal. A sheep or goat exhibiting any of the following 
    possible signs of scrapie and that has been determined to be suspicious 
    for scrapie by an accredited veterinarian, an APHIS representative, or 
    a State representative: Weight loss despite retention of appetite; 
    behavioral abnormalities; pruritus (itching); wool pulling; biting at 
    legs or side; lip smacking; motor abnormalities such as incoordination, 
    high stepping gait of forelimbs, bunny hop movement of rear legs, or 
    swaying of back end; increased sensitivity to noise and sudden 
    movement; tremor, ``star gazing,'' head pressing, recumbency, or other 
    signs of neurological disease or chronic wasting. A suspect animal will 
    no longer be a suspect animal upon determination by an APHIS 
    representative or a State representative that it no longer exhibits 
    such signs, or that the signs are not caused by scrapie.
    
    (Approved by the Office of Management and Budget under control 
    number 0579-0101)
    
    [[Page 66810]]
    
    Sec. 79.2  Identification of sheep and goats in interstate commerce.
    
        (a) No sheep or goat that is required to be individually identified 
    by Sec. 79.3 of this part may be sold, transported, received for 
    transportation, or offered for sale or transportation, in interstate 
    commerce, unless each sheep or goat is identified in accordance with 
    this section.
        (1) The sheep or goat must be identified at whichever of the 
    following comes first:
        (i) The point of first commingling of the sheep or goats in 
    interstate commerce with sheep or goats from any other source;
        (ii) Upon unloading of the sheep or goats in interstate commerce at 
    any livestock market;
        (iii) Upon transfer of ownership of the sheep or goats in 
    interstate commerce; or
        (iv) Upon arrival of the sheep or goats in interstate commerce at 
    their final destination.
        (2) The sheep or goats must be identified by one of the following 
    means of identification, and must remain so identified while they are 
    in interstate commerce:
        (i) Electronic implants for animals required to be identified by 
    the SFCP, when used in a flock participating in the SFCP;
        (ii) Official eartags, including tags approved for use in the SFCP, 
    when used on any sheep or goat;
        (iii) United States Department of Agriculture backtags, when used 
    on sheep or goats moving to slaughter;
        (iv) Official sheep or goat tattoos, when used on sheep or goats 
    participating in the SFCP; or
        (v) Official registry tattoos that have been recorded in the book 
    of record of a sheep or goat registry association.
        (3) Each person who buys or sells, for his or her own account or as 
    the agent of the buyer or seller, transports, receives for 
    transportation, offers for sale or transportation, or otherwise handles 
    sheep or goats in interstate commerce is responsible for the 
    identification of the sheep or goats as provided by this section.
        (b) Serial numbers of United States Department of Agriculture 
    backtags and official sheep and goat tattoos will be assigned to each 
    person who applies to the State animal health official or the area 
    veterinarian in charge for the State in which that person maintains his 
    or her place of business. Serial numbers of official eartags will be 
    assigned to each accredited veterinarian or State or Federal 
    representative who requests official eartags from the State animal 
    health official or the area veterinarian in charge, whoever is 
    responsible for issuing official eartags in that State. Premises 
    identification numbers will be assigned to participants in the SFCP by 
    the State animal health official or the area veterinarian in charge, 
    whoever is responsible for assigning premises codes in that State. 
    Persons assigned serial numbers of United States Department of 
    Agriculture backtags, official sheep and goat tattoos, and official 
    eartags must:
        (1) Record the following information on a document:
        (i) All serial numbers applied to the sheep or goat;
        (ii) Any other serial numbers and approved identification appearing 
    on the sheep or goat;
        (iii) The street address, including the city and State, or the 
    township, county, and State, of the premises where the approved means 
    of identification was applied; and
        (iv) The telephone number, if available, of the person who owns or 
    possesses the sheep or goat;
        (2) Maintain these records for 5 years; and
        (3) Make these records available for inspection and copying during 
    ordinary business hours (8 a.m. to 5:30 p.m., Monday through Friday) 
    upon request by any authorized employee of the United States Department 
    of Agriculture, and presentation of his or her official credentials.
        (c) Each person who buys or sells, for his or her own account or as 
    the agent of the buyer or seller, transports, receives for 
    transportation, offers for sale or transportation, or otherwise handles 
    sheep or goats in interstate commerce must keep records relating to the 
    transfer of ownership, shipment, or handling of the sheep or goats, 
    such as yarding receipts, sale tickets, invoices, and waybills.
        (1) The records must include:
        (i) If individual animal identification is required, all serial 
    numbers and other approved means of identification appearing on the 
    sheep or goat; and
        (ii) The street address, including city and State, or the township, 
    county, and State, and the telephone number, if available, of the 
    person from whom the sheep or goats were purchased or otherwise 
    obtained.
        (2) Each person required to keep records under this paragraph must 
    maintain the records for at least 5 years after the person has sold or 
    otherwise disposed of the sheep or goat to another person, and for such 
    further period as the Administrator may require by written notice to 
    the person, for purposes of any investigation or action involving the 
    sheep or goat identified in the records. The person must make the 
    records available for inspection and copying during ordinary business 
    hours (8 a.m. to 5:30 p.m., Monday through Friday) by any authorized 
    employee of the United States Department of Agriculture, upon that 
    employee's request and presentation of his or her official credentials.
        (d) No person may remove or tamper with any approved means of 
    identification required to be on sheep or goats pursuant to this 
    section while the animals are in interstate commerce, and at the time 
    of slaughter animal identification must be maintained throughout 
    postmortem inspection in accordance with regulations of the Food Safety 
    Inspection Service in chapter III of this title.
        (e) Written requests for approval of sheep or goat identification 
    devices and markings not listed in paragraph (b) of this section should 
    be sent to the Animal and Plant Health Inspection Service, Veterinary 
    Services, National Animal Health Programs Staff, 4700 River Road Unit 
    43, Riverdale, MD 20737-1235. If the Administrator determines that the 
    devices and markings will provide a means of tracing sheep and goats in 
    interstate commerce, a proposal will be published in the Federal 
    Register to add the devices and markings to the list of approved means 
    of sheep and goat identification.
    
    
    Sec. 79.3  General restrictions.
    
        The following prohibitions and movement conditions apply to the 
    interstate movement of sheep and goats, and no sheep or goat may move 
    interstate except in compliance with them.
    
    [[Page 66811]]
    
    
    
          Interstate Movement General Restrictions for Sheep and Goats
    ------------------------------------------------------------------------
                                       Moved from            Moved from
     Type of interstate movement   INCONSISTENT State     CONSISTENT State
    ------------------------------------------------------------------------
    (a) Sale or other movement
     of breeding animals, show
     animals or any other animal
     not specifically addressed
     below:
        (1) High-risk animal,     Prohibited*.........  Prohibited.*
         scrapie positive,
         suspect, or affected
         animal.
        (2) Non-high risk animal  Prohibited*.........  Prohibited.*
         from an infected or
         source flock.
        (3) Other animal........  Flock must be         Individual animal ID
                                   enrolled in the       and certificate.
                                   Complete Monitored
                                   category of the
                                   Scrapie Flock
                                   Certification
                                   Program or
                                   equivalent APHIS-
                                   recognized program
                                   and have
                                   certificate.
    (b) Sale or other movement
     directly to slaughter, or
     through slaughter channels
     to slaughter, of animals
     under 6 months of age:
        (1) Scrapie positive,     Prohibited*.........  Prohibited.*
         suspect, or affected
         animal.
        (2) High-risk animals     Individual animal ID  Individual animal ID
         and animals from          and permit or         and permit or
         infected or source        sealed conveyance     sealed conveyance
         flock.                    and permit when       and permit when
                                   moving directly to    moving directly to
                                   slaughter, or a       slaughter, or a
                                   permit and an         permit and an
                                   indelible''S'' mark   indelible ``S''
                                   on the left jaw.      mark on the left
                                                         jaw.
        (3) Other animal........  Premises ID** and     None.
                                   certificate.
    (c) Sale or other movement
     directly to slaughter, or
     through slaughter channels
     to slaughter, of animals
     over 6 months of age, or
     animals of any age to
     feedlots for later movement
     to slaughter:
        (1) Scrapie positive,     Prohibited*.........  Prohibited.*
         suspect, or affected
         animal.
        (2) High-risk animals     Individual animal ID  Individual animal ID
         and animals from          and permit.           and permit.
         infected or source
         flock.
        (3) Other exposed         Individual animal ID  Individual animal
         animals.                  and permit.           ID.
        (4) Other animals over 1  Individual animal ID  Individual animal
         year of age.              and certificate.      ID.
        (5) Other animals         Individual animal ID  Premises ID.**
         between 6 months and 1    and certificate.
         year of age, or animals
         under 6 months of age
         moving to feedlots for
         later movement to
         slaughter.
    (d) Movement of animals for
     grazing or other management
     purposes without change of
     ownership:
        (1) Scrapie positive,     Prohibited*.........  Prohibited.*
         suspect, or affected
         animal.
        (2) High-risk animal or   Prohibited*.........  Prohibited.*
         animal from infected or
         source flock.
        (3) Exposed animals.....  Individual animal ID  Premises ID.
                                   and certificate.
        (4) Other animal........  Premises ID and       None.
                                   certificate.
    ------------------------------------------------------------------------
    *Animals prohibited movement may be moved interstate only if they are
      moving interstate for destruction or research as approved by the
      Administrator.
    **Premises ID is not required for slaughter animals if the animals are
      kept as a group on the same premises on which they were born and are
      not commingled with animals from another premises at any time,
      including throughout the slaughter process, or, if they are commingled
      during the slaughter process, they are officially identified on
      arrival at the slaughter facility such that any animal can be traced
      back to its flock of origin.
    Note: A CONSISTENT STATE is one whose intrastate identification,
      quarantine and movement restrictions for infected and source flocks
      and high-risk animals are consistent with the APHIS standards for
      State scrapie programs.
    
    Sec. 79.4  Designation of scrapie-positive animals, affected animals, 
    high-risk animals, exposed animals, suspect animals, source flocks, and 
    infected flocks; notice to owners.
    
        (a) Designation. An APHIS representative or State representative 
    will designate an animal to be a scrapie-positive animal, affected 
    animal, high-risk animal, exposed animal, or suspect animal after 
    determining that the animal meets the criteria of the relevant 
    definition in Sec. 79.1 of this part. An APHIS representative or State 
    representative will designate a flock to be a source flock after 
    reviewing sale, movement, and breeding records that indicate the flock 
    meets the definition of a source flock in Sec. 79.1 of this part. An 
    APHIS representative or State representative will designate a flock to 
    be an infected flock after determining that the flock meets the 
    definition of an infected flock in Sec. 79.1 of this part.
        (b) Reclassification. A designated scrapie epidemiologist may 
    reclassify an exposed animal by removing that designation after 
    completing an epidemiologic investigation and determining that the 
    exposure was limited to a scrapie-positive male animal that was not 
    born in the flock (the scrapie-positive animal must have individual 
    animal identification traceable to the flock of origin), and was not 
    housed in lambing facilities or commingled with lambs while in the 
    flock. A designated scrapie epidemiologist may reclassify an animal 
    designated a high-risk animal as an exposed animal after receiving 
    negative results from an approved live-animal test.
        (c) Notice to owner. As soon as possible after making such a 
    determination, an APHIS representative or State representative will 
    attempt to notify the owner(s) of the flock(s) in
    
    [[Page 66812]]
    
    writing that their flock contained or contains a scrapie-positive 
    animal, an affected animal, a suspect animal, a high-risk animal or an 
    exposed animal, or that the flock is an infected flock, or source 
    flock. The notice will include a description of the interstate movement 
    restrictions and identification requirements contained in this part.
    
    
    Sec. 79.5  Issuance of certificates.
    
        (a) Certificates are required as specified by Sec. 79.3 of this 
    part for certain interstate movements of animals. A certificate must 
    show the official ear tag number, individual animal registered breed 
    association registration tattoo, individual animal registered breed 
    association registration brand, individual animal registered breed 
    association registration number, and any other official individual 
    identification of each animal to be moved; the number of animals 
    covered by the certificate; the purpose for which the animals are to be 
    moved; the points of origin and destination; the consignor; and the 
    consignee. Ownership brands or other premises identification may be 
    used in place of individual animal identification on certificates for 
    sheep and goats moved interstate when premises identification is 
    required under this part, provided the ownership brands are registered 
    with the official brand recording agency. Except as provided in 
    paragraphs (b) and (c) of this section, all of the information required 
    by this paragraph must be typed or written on the certificate.
        (b) As an alternative to typing or writing individual animal 
    identification on a certificate, another document may be used to 
    provide this information, but only under the following conditions:
        (1) The document must be a State form or APHIS form that requires 
    individual identification of animals;
        (2) A legible copy of the document must be stapled to the original 
    and each copy of the certificate;
        (3) Each copy of the document must identify each animal to be moved 
    with the certificate, but any information pertaining to other animals, 
    and any unused space on the document for recording animal 
    identification, must be crossed out in ink; and
        (4) The following information must be typed or written in ink in 
    the identification column on the original and each copy of the 
    certificate and must be circled or boxed, also in ink, so that no 
    additional information can be added:
        (i) The name of the document; and
        (ii) Either the serial number on the document or, if the document 
    is not imprinted with a serial number, both the name of the person who 
    prepared the document and the date the document was signed.
        (c) As an alternative to typing or writing ownership brands on a 
    certificate, an official brand inspection certificate may be used to 
    provide this information, but only under the following conditions:
        (1) A legible copy of the official brand inspection certificate 
    must be stapled to the original and each copy of the certificate;
        (2) Each copy of the official brand inspection certificate must 
    show the ownership brand of each animal to be moved with the 
    certificate, but any other ownership brands, and any unused space for 
    recording ownership brands, must be crossed out in ink; and
        (3) The following information must be typed or written in ink in 
    the official identification column on the original and each copy of the 
    certificate and must be circled or boxed, also in ink, so that no 
    additional information can be added:
        (i) The name of the attached document; and
        (ii) Either the serial number on the official brand inspection 
    certificate or, if the official brand inspection certificate is not 
    imprinted with a serial number, both the name of the person who 
    prepared the official brand inspection certificate and the date it was 
    signed.
    
    
    Sec. 79.6  Standards for State programs to qualify as Consistent 
    States.
    
        (a) In reviewing a State for Consistent State status, the 
    Administrator will evaluate the State statutes, regulations and 
    directives pertaining to animal health activities, reports and 
    publications of the State animal health agency, and a written statement 
    from the State animal health agency describing State scrapie control 
    activities and certifying that these activities meet the requirements 
    of this section. In determining whether a State is a Consistent State, 
    the Administrator will consider whether the State's scrapie control 
    program:
        (1) Requires the reporting of and investigation of any suspect 
    animal, affected animal, or scrapie-positive animal;
        (2) Requires the official permanent individual identification of 
    any live scrapie-positive, affected, or suspect animal of any age, and 
    of any exposed animal, including high-risk animals, 1 year of age or 
    over and any exposed animals less than 1 year of age when a change of 
    ownership occurs, except those animals under 6 months of age moving 
    within slaughter channels in accordance with this part (whether or not 
    the exposed animal resides in a source or infected flock);
        (3) Effectively enforces quarantines of all source and infected 
    flocks;
        (4) Effectively enforces quarantines of all high-risk, affected, 
    suspect, and scrapie-positive animals throughout their lives unless 
    moved in accordance with this part;
        (5) If an affected, suspect or scrapie-positive animal dies or is 
    destroyed, requires that tissues be submitted for diagnostic testing to 
    a laboratory authorized by the Administrator to conduct scrapie tests 
    in accordance with this part and that the carcass be completely 
    destroyed; and
        (6) Releases quarantines of these flocks only upon completion of a 
    flock plan and agreement by the owner to participate in a post-exposure 
    monitoring and management plan as defined in part 54 of this chapter.
        (b) [Reserved]
    
        Done in Washington, DC, this 23rd day of November 1999.
    Craig A. Reed,
    Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 99-31087 Filed 11-29-99; 8:45 am]
    BILLING CODE 3410-34-U
    
    
    

Document Information

Published:
11/30/1999
Department:
Animal and Plant Health Inspection Service
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
99-31087
Dates:
Consideration will be given only to comments received on or before December 30, 1999.
Pages:
66791-66812 (22 pages)
Docket Numbers:
Docket No. 97-093-2
RINs:
0579-AA90: Interstate Movement of Sheep and Goats From States That Do Not Quarantine Scrapie-Infected and Source Flocks
RIN Links:
https://www.federalregister.gov/regulations/0579-AA90/interstate-movement-of-sheep-and-goats-from-states-that-do-not-quarantine-scrapie-infected-and-sourc
PDF File:
99-31087.pdf
CFR: (18)
9 CFR 2.80
9 CFR 54.1
9 CFR 54.3
9 CFR 54.4
9 CFR 54.5
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