[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]



=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    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

[[Page 15182]]
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.
---------------------------------------------------------------------------

    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.

[[Page 15183]]

    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