96-8471. Animal and Plant Health Inspection Service  

  • [Federal Register Volume 61, Number 67 (Friday, April 5, 1996)]
    [Rules and Regulations]
    [Pages 15180-15184]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-8471]
    
    
    
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    DEPARTMENT OF AGRICULTURE
    
    
    Animal and Plant Health Inspection Service
    
    9 CFR Part 98
    
    [Docket No. 94-006-2]
    
    Importation of Embryos From Ruminants and Swine From Countries 
    Where Rinderpest or Foot-and-Mouth Disease Exists
    
    AGENCY: Animal and Plant Health Inspection Service, USDA.
    
    ACTION: Final rule.
    
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    SUMMARY: We are amending the regulations to allow, under specified 
    conditions, the importation of embryos from all ruminants, including 
    cervids, camelids, and all species of cattle, and from swine from 
    countries where rinderpest or foot-and-mouth disease exists. The 
    regulations currently provide for importing only embryos from certain 
    species of cattle in countries where rinderpest or foot-and-mouth 
    disease exists. Research now indicates that embryos from all species of 
    cattle, from ruminants other than cattle, and from swine, which are 
    produced, collected, and handled under certain conditions in countries 
    where rinderpest or foot-and-mouth disease exists, can be imported with 
    virtually no risk of introducing communicable diseases of livestock 
    into the United States. This action will make additional sources of 
    genetic material available to domestic animal breeders.
    
    EFFECTIVE DATE: April 5, 1996.
    
    FOR FURTHER INFORMATION CONTACT: Dr. Roger Perkins, Staff Veterinarian, 
    Import Animals Program, National Center for Import and Export, VS, 
    APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231, (301) 734-
    8170.
    
    SUPPLEMENTARY INFORMATION:
    
    Background
    
        The regulations in 9 CFR part 98 (referred to below as the 
    regulations) govern the importation of animal germ plasm so as to 
    prevent the introduction of contagious diseases of livestock or poultry 
    into the United States. Subpart A of part 98 applies to ruminant and 
    swine embryos from countries free of rinderpest and foot-and-mouth 
    disease (FMD), and to embryos of horses and asses. Subpart B applies to 
    certain cattle embryos from countries where rinderpest or FMD exists. 
    Subpart C applies to certain animal semen.
        Subpart B currently allows for the importation of embryos from 
    cattle (Bos indicus and Bos taurus) from countries where rinderpest or 
    FMD exists only if embryos are produced, collected, and handled under 
    certain conditions. However, research 1 has demonstrated that the 
    same conditions effectively ensure that embryos from all species of 
    cattle, and from swine, and from ruminants other than cattle, including 
    camelids and cervids, can also be imported into the United States from 
    countries where rinderpest or FMD exists without significant risk of 
    introducing these diseases.
    
        \1\ Information about pertinent research may be obtained from 
    the Animal and Plant Health Inspection Service, Veterinary Services, 
    National Center for Import-Export, 4700 River Road Unit 38, 
    Riverdale, Maryland 20737-1231.
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        At this time, only Bos indicus and Bos taurus cattle embryos may be 
    imported into the United States from countries where rinderpest or FMD 
    exists. The available gene pool for swine and ruminants other than 
    cattle cannot be enlarged by using embryos from animals in countries 
    where rinderpest or FMD exists. Because of this, U.S. livestock 
    interests, except cattle-related interests, cannot fully participate in 
    the growing international market in germ plasm.
        On June 6, 1995, we published in the Federal Register (60 FR 29781-
    29784, Docket No. 94-006-1) a proposal to amend the regulations in 
    subpart B to allow embryos from all ruminants, including cervids and 
    camelids, from countries where rinderpest or FMD exists, to be imported 
    into the United States under the same conditions under which Bos 
    indicus and Bos taurus cattle embryos may be imported from those 
    countries into the United States. Also, we proposed to amend the 
    regulations in subpart B to allow embryos from swine from countries 
    where rinderpest or FMD exists to be imported into the United States 
    under conditions that are the same as those for Bos indicus and Bos 
    taurus cattle embryos, except with respect to the specific diseases for 
    which we would screen.
        We solicited comments concerning our proposal for 60 days ending 
    August 7, 1995. We received 30 comments by that date. They were from 
    individuals and groups involved with veterinary medicine, from a State 
    Department of Agriculture, and from individuals, businesses, and 
    associations interested in artificial insemination (AI).
        Of the 30 comments received, 2 were supportive. Of the others, 23 
    were identical form letters. The issues raised in these comments are 
    discussed below by topic.
    
    Treatment-Based Import Conditions
    
        Most of the comments stated that our regulations for importing 
    embryos should be completely revised. The commenters advocated a 
    treatment-based approach to preventing the importation of disease via 
    embryos, rather than the disease prevention/disease avoidance system we 
    now have, which is based on serologic testing.
        We have carefully considered these comments. We are constantly 
    reviewing our regulations to ensure that they reflect the latest proven 
    technology and are as effective as possible. The proposed regulations 
    published in June, 1995, included the regulatory changes we believe are 
    technically sound and most needed and desirable at this time. However, 
    we intend to review all the regulations in part 98. At that time, we 
    will consider whether we should adopt a treatment-based approach for 
    any diseases. If we determine that changes are warranted, we will 
    publish proposed regulations for public comment in the Federal 
    Register.
    
    Applying Same Requirements to Other Species
    
        Our regulations currently apply only to embryos from Bos taurus and 
    Bos indicus cattle from countries where foot-and-mouth disease or 
    rinderpest exists. Many of the commenters questioned the scientific 
    basis for our proposal to allow importation of other species and 
    expressed the belief that it would cause ``undue risk'' or that it was 
    ``not without risk.''
        Our regulations require embryos for importation to be washed. 
    Washing removes some disease agents. It is correct that the washing 
    procedures required under our regulations have not been tested for 
    efficacy against all disease agents specific to swine, or against all 
    disease agents of all species of ruminants. However, this is not 
    necessary as our regulations are based on serologic testing of the 
    donor animals. Under proposed Sec. 98.15, we would require donor dams 
    to be obtained from herds which have been free of all diseases of 
    concern for at least 1 year before embryo collection and require donor 
    dams to be tested and found free of all diseases of concern. In this 
    way we would ensure that embryos from donor animals are free of 
    diseases which would pose a disease threat to U.S. livestock.
    
    Washing Embryos With Trypsin
    
        Many of the commenters suggested we amend the regulations to 
    require that
    
    [[Page 15181]]
    bovine embryos be washed with trypsin. Trypsin is an enzyme. It weakens 
    the attachment between infectious bovine rhinotracheitis virus (IBRV) 
    and embryos. Washing embryos with water alone removes other disease 
    agents of concern to APHIS; adding trypsin allows IBRV to be removed.
        Our regulations require embryos for importation into the United 
    States to be washed at least 10 times (see Sec. 98.17(f)(3)). The 
    regulations do not require washing with trypsin--any importer may use 
    trypsin if he or she wishes to. We do not believe it is desirable at 
    this time to require all embryos to be washed with trypsin. Although 
    trypsin offers protection against IBRV, we do not believe the cost of 
    requiring it to be used for all bovine embryos is justified.
        Under our current regulations, however, we may require specific 
    embryos to be washed with trypsin. Section 98.17, paragraph (f)(6) 
    states: ``The Administrator may require additional measures to be taken 
    in processing embryos after collection (for example, adding trypsin to 
    the washes) if he or she determines that such measures are necessary to 
    ensure the embryos freedom from infectious agents that may cause 
    communicable diseases.'' As stated in Sec. 98.17(f)(6), circumstances 
    that may result in such additional measures being required include, but 
    are not limited to: (1) The existence of communicable diseases of 
    livestock, other than the diseases specifically listed, in the country 
    of origin, and (2) a high prevalence or an increase in the incidence of 
    a communicable disease in the country of origin.
    
    Diseases of Concern
    
        One commenter objected to our listing vesicular stomatitis as a 
    ``disease of concern'' in Sec. 98.15 of the proposed rule because 
    vesicular stomatitis is present in the United States. We agree that 
    vesicular stomatitis is present in the United States. Brucellosis and 
    tuberculosis, also listed in our proposed rule as ``diseases of 
    concern'' are also present in the United States. These are diseases for 
    which we have Federal or Federal-State cooperative control and 
    eradication programs. We want to prevent the importation of embryos 
    which could transmit vesicular stomatitis, brucellosis, or tuberculosis 
    to livestock in this country. Infected embryos imported into this 
    country would be additional sources of infection. This would make it 
    more difficult to control and eradicate these diseases in the United 
    States. For this reason, we are making no changes in the proposed 
    regulations based on this comment.
        One commenter asked us to test imported embryos for diseases in 
    addition to those listed in the proposed regulations as ``diseases of 
    concern.'' Another commenter stated that scrapie should be included as 
    a ``disease of concern.'' This same commenter also stated that the 
    regulations should include safeguards to ensure that swine embryos 
    cannot transmit pseudorabies or any other virus.
        The diseases listed in the regulations are those we consider the 
    most dangerous. We require serologic testing and other measures to 
    ensure that embryos that could transmit these diseases are not imported 
    (see Secs. 98.14 through 98.17 of the current regulations, and proposed 
    Secs. 98.15). With regard to pseudorabies, Sec. 98.15(a) of our 
    proposal lists pseudorabies as a disease of concern for swine. With 
    regard to scrapie, we have published proposed regulations designed to 
    ensure that embryos which could transmit scrapie are imported into the 
    United States under conditions where they do not pose a threat to the 
    health of livestock in the United States (see Docket No. 94-085-2, 
    published May 11, 1995, at 60 FR 25151-25162).
        In addition to the diseases listed in the regulations, we test 
    embryos for other diseases if other diseases exist in the country of 
    origin that could pose a threat to U.S. livestock. For these reasons, 
    we do not believe our proposed regulations need to be amended based on 
    these comments.
    
    On-Site Compliance
    
        One commenter suggested we add specific on-site compliance 
    validation procedures to ensure that imported embryos have been 
    prepared and shipped properly. Other commenters stated that we need to 
    amend our regulations to provide for enforcement of import protocols.
        We have carefully considered these comments and determined that 
    changes in the regulations are warranted. We are therefore amending 
    Secs. 98.16 and 98.17(b). Section 98.16 is amended to require that an 
    APHIS veterinarian inspect and approve embryo collection units as 
    meeting our requirements. Requirements for embryo collection units are 
    listed in Sec. 98.16. However, the regulations have not included any 
    mechanism for ensuring that the requirements are met. We believe this 
    deficiency in the regulations will be corrected by this amendment. We 
    are also amending Sec. 98.17(b) to require that an APHIS veterinarian 
    supervise all stages of embryo collection and processing. Section 
    98.17(b) provides that an ``official veterinarian'' must supervise 
    embryo collection. An ``official veterinarian'' is either an APHIS 
    veterinarian or a full-time salaried veterinarian of the national 
    government of the country of origin. We believe not only that an APHIS 
    veterinarian can best perform this function, but that when an APHIS 
    veterinarian supervises the work, we can better verify, on-site, that 
    requirements and procedures are met. We are further amending 
    Sec. 98.17, paragraphs (b) and (g), to specify that an APHIS 
    veterinarian must supervise, in person, certain procedures. Included 
    are collecting, pooling, freezing, and sending test samples to the 
    Foreign Animal Disease Diagnostic Laboratory, and collecting, 
    processing, and storing embryos. These are the crucial stages of embryo 
    collection and processing. We believe they require the closest possible 
    supervision to ensure that requirements and procedures are met.
    
    Publish Import Protocols
    
        Commenters stated that import protocols for individual countries 
    should be ``mentioned'' in the regulations and that APHIS should 
    consider all diseases present in the country of origin. Import 
    protocols for individual countries do take into account all diseases 
    that are present in that country. Import protocols are constantly 
    changed, sometimes daily, depending on the disease situation in that 
    country, the requirements of foreign governments, and many other 
    factors. Protocols exist for numerous countries. At the time an 
    importer applies for an import permit, he or she is given up-to-date 
    information on the particular import requirements that apply to the 
    embryos they wish to import. Our offices also provide current 
    information to anyone who calls or writes concerning the protocols for 
    a particular country. Under these circumstances, we do not believe the 
    regulations need to be changed based on these comments.
    
    Emergency Preparedness and Post-Entry Surveillance
    
        Several commenters stated that APHIS needs to be adequately 
    prepared to handle a foreign animal disease outbreak in the United 
    States.
        Our regulations are designed to offer multiple levels of security. 
    One level consists of requirements designed to prevent the introduction 
    of foreign animal diseases into the United States. The regulations in 
    this rulemaking are in this category. Another level consists of 
    requirements designed to control and eradicate livestock and poultry 
    diseases
    
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    within the United States, and to regulate the interstate transportation 
    of animals, including poultry, and animal products to prevent the 
    spread of diseases and pests. These regulations are contained in the 
    Code of Federal Regulations, Title 9, chapter I, subchapters B and C. 
    In addition, APHIS maintains a staff devoted to emergency planning and 
    preparedness, to contain and eradicate any outbreak of animal disease 
    in the United States that should occur.
        For these reasons, we believe APHIS is adequately prepared to 
    handle an outbreak of a foreign animal disease, should that occur.
        Several commenters also suggested that we include a post-entry 
    surveillance program as part of our regulations. As explained above, 
    our multi-level system of regulation is designed to ensure that foreign 
    animal diseases are not introduced into the United States. Our controls 
    on importation include requirements that we be notified of the 
    destination of embryos. Our domestic animal identification system, 
    coupled with requirements concerning interstate transportation of 
    animals, allow us to trace animals which may be infected with disease. 
    These programs have worked effectively for many years. In the case of 
    embryos from sheep and goats that may be affected with scrapie, we have 
    published proposed regulations requiring that these embryos be imported 
    only into flocks or herds participating in the Voluntary Scrapie Flock 
    Certification Program (see Docket 94-085-2, published May 11, 1995, at 
    60 FR 25151-25162). All animals in flocks and herds participating in 
    this program are under our surveillance.
        Additional post-entry surveillance requirements would not appear to 
    increase the effectiveness of most of our programs, but would add costs 
    for both APHIS and for the regulated industries. We are therefore not 
    making any changes in this document based on these comments.
    
    Economic Analysis
    
        One commenter questioned the value we placed on embryos imported 
    into the United States. In our proposed rule of June 6, 1995 (see 60 FR 
    29782), we stated that cattle embryos imported into the United States 
    ``during the past several years has averaged in the hundred of 
    thousands of dollars.'' This data is from the Foreign Agricultural 
    Trade of the United States, Fiscal Year 1994 Supplement (USDA, Economic 
    Service).2
    
        \2\ Page 298 of the Foreign Agricultural Trade of the United 
    States, Fiscal Years 1994 Supplement includes a table showing that 
    cattle embryos imported into the United States were valued at 
    $160,000 during FY 1992, $228,000 during FY 1993, and $219,000 
    during FY 1994.
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        Therefore, based on the rationale set forth in the proposed rule 
    and in this document, we are adopting the provisions of the proposal as 
    a final rule with the changes discussed in this document.
    
    Miscellaneous
    
        We are amending several sections of the regulations in part 98 to 
    add Office of Management and Budget (OMB) control numbers for 
    previously approved information collection and recordkeeping 
    requirements. We did not propose to amend these sections in the 
    proposed rule of June 6, 1995. However, adding OMB control numbers to 
    the regulations is a minor administrative change and does not affect 
    the regulations substantively.
    
    Effective Date
    
        This is a substantive rule that relieves restrictions and, pursuant 
    to the provisions of 5 U.S.C. 553, may be made effective less than 30 
    days after publication in the Federal Register. This rule will allow 
    the importation of embryos from all ruminants, including cervids, 
    camelids, and all species of cattle, and from swine from countries 
    where rinderpest or foot-and-mouth disease exists. This action will 
    make additional sources of genetic material available to domestic 
    animal breeders. Therefore, the Administrator of the Animal and Plant 
    Health Inspection Service has determined that this rule should be 
    effective less than 30 days after publication in the Federal Register.
    
    Executive Order 12866 and Regulatory Flexibility Act
    
        This rule has been reviewed under Executive Order 12866. The rule 
    has been determined to be not significant for the purposes of Executive 
    Order 12866 and, therefore, has not been reviewed by the Office of 
    Management and Budget.
        This rule allows the importation of certain embryos from swine and 
    ruminants, including camelids, cervids, and all species of cattle, from 
    countries where rinderpest or foot-and-mouth disease exists, under 
    restrictions that appear adequate to prevent the introduction or 
    dissemination of rinderpest, foot-and-mouth disease, and other 
    communicable diseases of livestock.
        As part of the proposed rule document published June 6, 1995, we 
    invited comments concerning potential effects of the proposed rule. We 
    stated that we were particularly interested in determining the number 
    and kind of small entities that might incur benefits or costs from 
    implementation of the rule. Other than the comment discussed above 
    under the heading ``Economic Analysis,'' none of the comments we 
    received addressed our Initial Regulatory Flexibility Analysis, and 
    none provided any information of the type we requested. We have 
    therefore based this Final Regulatory Flexibility Analysis on the data 
    available to us.
        The annual value of cattle embryos imported during the past several 
    years has averaged in the hundreds of thousands of dollars. We do not 
    expect this rule change to result in a significant increase in cattle 
    embryo imports, since demand will continue to be predominantly for the 
    Bos indicus and Bos taurus species. However, APHIS does foresee the 
    importation of embryos of other species, such as water buffalo and 
    certain breeds of sheep and goats from Africa.
        At present, ruminants and swine from countries where rinderpest or 
    foot-and-mouth disease exists may only enter the United States 
    following quarantine at the Harry S Truman Animal Import Center 
    (HSTAIC). Allowing embryos of additional ruminant species and swine to 
    be imported will enable importers to forgo quarantine and other costs 
    of importing live animals. For example, we estimate that the cost to 
    importers of importing approximately 500 Boer goats from South Africa 
    would average more than $2,000 per animal for quarantine in HSTAIC. 
    This does not include testing, post-quarantine clean-up expenses, and 
    other costs associated with importing animals through HSTAIC. In 
    addition, importers must undergo the inconvenience and uncertainty of 
    lottery selection (including submitting a cashier's check of $32,000 
    for each application for the lottery), must bear the costs of 
    qualifying animals for importation through HSTAIC, and must assume the 
    risk that animals may not qualify for importation after quarantine. 
    Quarantine-related costs could easily exceed the cost of implanting an 
    imported embryo. Savings in transporting embryos rather than live 
    animals, both before and after entry into the United States, will also 
    be realized.
        This final rule contains paperwork and recordkeeping requirements. 
    Under this rule, import permits and health certificates will be 
    required for all ruminant and swine embryos, as they are now required 
    for Bos indicus and Bos taurus cattle embryos. These requirements have 
    been approved by the Office of Management and Budget.
    
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        The alternatives to this final rule are to take no action, or to 
    allow the importation of embryos under different conditions than those 
    adopted in this rule. We did not consider taking no action a reasonable 
    alternative, because it would, in our opinion, prohibit the importation 
    of embryos which pose no significant risk of disease. We also did not 
    consider importation under conditions other than those adopted a viable 
    option. The only available research concerns embryos handled and 
    treated using the methods required by this final rule. Embryos handled 
    and treated using other methods have not been tested. We therefore have 
    no data demonstrating that other methods would be adequate to prevent 
    the importation of rinderpest, foot-and-mouth disease, and other 
    communicable diseases of livestock.
    
    Executive Order 12778
    
        This rule has been reviewed under Executive Order 12778, Civil 
    Justice Reform. This rule: (1) Preempts all State and local laws and 
    regulations that are inconsistent with this rule; (2) has no 
    retroactive effect; and (3) does not require administrative proceedings 
    before parties may file suit in court challenging this rule.
    
    Paperwork Reduction Act
    
        In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
    3501 et seq.), the information collection or recordkeeping requirements 
    included in this rule have been approved by the Office of Management 
    and Budget under OMB control number 0579-0040 and 0579-0120.
    
    List of Subjects in 9 CFR Part 98
    
        Animal diseases, Imports, Reporting and recordkeeping requirements.
    
        Accordingly, 9 CFR part 98 is amended as follows:
    
    PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN
    
        1. The authority citation for part 98 is revised to read as 
    follows:
    
        Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 103-105, 
    111, 134a, 134b, 134c, 134d, 134f, 136 and 136a; 31 U.S.C. 9701; 7 
    CFR 2.22, 2.80, and 371.2(d).
    
    Subpart B--Ruminant and Swine Embryos From Countries Where 
    Rinderpest or Foot-and-Mouth Disease Exists
    
    
    Sec. 98.5  [Amended]
    
        2. Section 98.5 is amended by adding at the end of the section the 
    following:
    
    (Approved by the Office of Management and Budget under control 
    number 0579-0040.)
    
        3. The heading for subpart B is revised to read as set forth above.
        4. Section 98.11 is amended by removing the definition of Cattle, 
    and by adding, in alphabetical order, the following definitions, to 
    read as follows:
    
    
    Sec. 98.11  Definitions.
    
    * * * * *
        Ruminant. All animals which chew the cud, including cattle, 
    buffaloes, camelids, cervids (deer, elk, moose, and antelope), sheep, 
    goats, and giraffes.
        Swine. The domestic hog and all varieties of wild hogs.
    * * * * *
    
    
    Secs. 98.12, 98.13, 98.14  [Amended]
    
        5. In the following sections, the word ``Cattle'' is removed and 
    the words ``Ruminant and swine'' are added in its place:
        a. Sec. 98.12(a);
        b. Sec. 98.12(b);
        c. Sec. 98.13(a); and
        d. Sec. 98.14(a), the introductory text.
    
    
    Sec. 98.13  [Amended]
    
        6. Section 98.13 is amended by adding at the end of the section the 
    following:
    
    (Approved by the Office of Management and Budget under control 
    number 0579-0040).
    
    
    Sec. 98.14  [Amended]
    
        7. Section 98.14 is amended by adding at the end of the section the 
    following:
    
    (Approved by the Office of Management and Budget under control 
    number 0579-0040).
    
        8. Section 98.15 is amended as follows:
        a. In the introductory paragraph, by removing the word ``Cattle'' 
    and adding the words ``Ruminant and swine'' in its place.
        b. By revising paragraphs (a)(1) and (a)(2) to read as set forth 
    below.
        c. In paragraph (a)(4), by removing the word ``cattle'' and adding 
    the words ``ruminants or swine'' in its place.
        d. In paragraph (a)(5), by designating the first sentence as 
    paragraph (a)(5)(i), by designating the second sentence as paragraph 
    (a)(5)(ii) and revising it to read as set forth below; and by 
    designating the third and fourth sentences as paragraphs (a)(5)(iii) 
    and (a)(5)(iv), respectively.
        e. In paragraph (a)(7), by designating the first sentence as 
    paragraph (a)(7)(i) and revising it to read as set forth below; and by 
    designating the second sentence as paragraph (a)(7)(ii).
        f. In paragraph (a)(8), by designating the first sentence as 
    paragraph (a)(8)(i) and revising it to read as set forth below; and by 
    designating the second sentence as paragraph (a)(8)(ii).
    
    
    Sec. 98.15  Health requirements.
    
    * * * * *
        (a) * * *
        (1) During the year before embryo collection, no case of the 
    following diseases occurred in the embryo collection unit or in any 
    herd in which the donor dam was present:
        (i) Ruminant: Bovine spongiform encephalopathy, contagious bovine 
    pleuropneumonia, foot-and-mouth disease, Rift Valley fever, rinderpest, 
    or vesicular stomatitis; or
        (ii) Swine: African swine fever, foot-and-mouth disease, hog 
    cholera, pseudorabies, rinderpest, swine vesicular disease, or 
    vesicular stomatitis.
        (2) During the year before embryo collection, no case of the 
    following diseases occurred within 5 kilometers of the embryo 
    collection unit or in any herd in which the donor dam was present:
        (i) Ruminant: Bovine spongiform encephalopathy, contagious bovine 
    pleuropneumonia, foot-and-mouth disease, Rift Valley fever, rinderpest, 
    or vesicular stomatitis; or
        (ii) Swine: African swine fever, foot-and-mouth disease, hog 
    cholera, pseudorabies, rinderpest, swine vesicular disease, or 
    vesicular stomatitis.
    * * * * *
        (5) (i) * * *
        (ii) The donor dam was determined to be free of foot-and-mouth 
    disease based upon tests of the pair of serum samples. In addition, if 
    any of the following diseases exist in the country of origin, the donor 
    dam was determined to be free of these diseases based upon additional 
    tests of the serum samples:
        (A) Ruminant: Contagious bovine pleuropneumonia, Rift Valley fever, 
    rinderpest, or vesicular stomatitis; or
        (B) Swine: African swine fever, hog cholera, pseudorabies, 
    rinderpest, swine vesicular disease, or vesicular stomatitis.
    * * * * *
        (7) (i) Not less than 30 days nor more than 120 days after embryo 
    collection, the donor dam was examined by an official veterinarian and 
    found free of clinical evidence of the following diseases:
        (A) Ruminant: Bovine spongiform encephalopathy, brucellosis, 
    contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley 
    fever, rinderpest, tuberculosis, and vesicular stomatitis; or
    
    [[Page 15184]]
    
        (B) Swine: African swine fever, brucellosis, foot-and-mouth 
    disease, hog cholera, pseudorabies, rinderpest, swine vesicular 
    disease, tuberculosis, and vesicular stomatitis.
    * * * * *
        (8) (i) Between the time the embryos were collected and all 
    examinations and tests required by this subpart were completed, no 
    animals in the embryo collection unit with the donor dam, or in the 
    donor dam's herd of origin, exhibited any clinical evidence of:
        (A) Ruminant: Bovine spongiform encephalopathy, brucellosis, 
    contagious bovine pleuropneumonia, foot-and-mouth disease, Rift Valley 
    fever, rinderpest, tuberculosis, and vesicular stomatitis; or
        (B) Swine: African swine fever, brucellosis, foot-and-mouth 
    disease, hog cholera, pseudorabies, rinderpest, swine vesicular 
    disease, tuberculosis, and vesicular stomatitis.
    * * * * *
        9. Section 98.16 is amended as follows:
        a. In the introductory paragraph, the first sentence, by removing 
    the word ``Cattle'' and adding the words ``Ruminant and swine'' in its 
    place.
        b. In the introductory paragraph, by revising the second sentence 
    to read as set forth below.
        c. In paragraph (b), the first sentence, by removing the word 
    ``cattle'' and adding the words ``embryo donors'' in its place.
    
    
    Sec. 98.16  The embryo collection unit.
    
        * * * The embryo collection unit may be located on the premises 
    where the donor dam's herd of origin is kept, or at any other location, 
    provided that the embryo collection unit has been inspected and 
    approved by an APHIS veterinarian and that the following requirements 
    are met:
    * * * * *
        10. Section 98.17 is amended as follows:
        a. By revising paragraph (b)(1) to read as set forth below.
        b. In paragraph (g), by adding, at the end of the first and second 
    sentences: ``under the personal supervision of an APHIS veterinarian''.
        c. By adding at the end of the section the following: ``(Approved 
    by the Office of Management and Budget under control number 0579-
    0040)''.
    
    
    Sec. 98.17  Procedures.
    
        (a) * * *
        (b) Oversight and supervision. (1) All procedures associated with 
    the production of embryos for importation into the United States, 
    including artificial insemination, natural breeding, and cleaning and 
    disinfection, must be performed under the oversight of an APHIS 
    veterinarian. Collecting test samples, and collecting, processing, and 
    storing embryos, must be supervised in person by an APHIS veterinarian.
    * * * * *
    
    
    Sec. 98.35  [Amended]
    
        11. Section 98.35 is amended by adding at the end of the section 
    the following:
    
    (Approved by the Office of Management and Budget under control 
    number 0579-0040)
    
        Done in Washington, DC, this 2nd day of April 1996.
    Lonnie J. King,
    Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 96-8471 Filed 4-4-96; 8:45 am]
    BILLING CODE 3410-34-P
    
    

Document Information

Effective Date:
4/5/1996
Published:
04/05/1996
Department:
Agriculture Department
Entry Type:
Rule
Action:
Final rule.
Document Number:
96-8471
Dates:
April 5, 1996.
Pages:
15180-15184 (5 pages)
PDF File:
96-8471.pdf
CFR: (8)
9 CFR 98.5
9 CFR 98.11
9 CFR 98.13
9 CFR 98.14
9 CFR 98.15
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