[Federal Register Volume 60, Number 108 (Tuesday, June 6, 1995)]
[Proposed Rules]
[Pages 29781-29784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13667]



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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 98

[Docket No. 94-006-1]


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: Proposed rule.

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SUMMARY: We are proposing to amend 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, could be imported 
with virtually no risk of introducing communicable diseases of 
livestock into the United States. This action would make additional 
sources of genetic material available to domestic animal breeders.

DATES: Consideration will be given only to comments received on or 
before August 7, 1995.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 94-006-1, Regulatory Analysis and Development, PPD, APHIS, 
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. 
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. Roger Perkins, Staff Veterinarian, 
Import/Export Animals, National Center for Import and Export, VS, 
APHIS, Suite 3B05, 4700 River Road Unit 39, Riverdale, MD 20737-1231. 
Telephone: (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 would 
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, [[Page 29782]] cannot fully 
participate in the growing international market in germ plasm.
    Therefore, we are proposing 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 are proposing 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.
    Under our proposed regulations, the ``General prohibitions'' in 
Sec. 98.12, which now apply only to Bos indicus and Bos taurus cattle 
embryos, would be amended to cover embryos from all ruminants, 
including camelids and cervids, and swine. In addition, import permits 
and health certificates would be required for all ruminant and swine 
embryos, just as they are now required for Bos indicus and Bos taurus 
cattle embryos (see Secs. 98.13 and 98.14). Collection, processing, and 
handling requirements for all ruminant and swine embryos would also be 
the same as those now in place for Bos indicus and Bos taurus cattle 
embryos (see Secs. 98.16, 98.17 and 98.18). In addition, requirements 
concerning arrival and inspection at the port of entry and embryos 
refused entry would be the same for all ruminant and swine embryos as 
those now in place for Bos indicus and Bos taurus cattle embryos (see 
Secs. 98.19 and 98.20).
    Health requirements would also be the same for all ruminant embryos 
as are those now in place for Bos indicus and Bos taurus cattle embryos 
(see Sec. 98.15). The health requirements for swine embryos would 
differ only in regard to the listed diseases for which would screen. 
The current regulations are designed to ensure that embryos from Bos 
indicus and Bos taurus cattle are free of certain listed diseases. 
These regulations, in part, address the health of the donor dam and the 
herds in which it was present, the health of the animals in the embryo 
collection unit with the donor dam, and the presence of specific 
diseases in the locales of the embryo collection unit and of any herd 
in which the donor dam was present, over the previous 12 months.
    The listed diseases of concern for embryos from Bos indicus and Bos 
taurus cattle are bovine spongiform encephalopathy, brucellosis, 
contagious bovine pleuropneumonia, FMD, Rift Valley fever, rinderpest, 
tuberculosis, and vesicular stomatitis. All of these diseases may 
affect other ruminants, including cervids, all other species of cattle, 
and camelids. Under our proposed regulations, all ruminant embryos 
would have to meet the same health regulations as Bos indicus and Bos 
taurus cattle embryos must now meet, to ensure that they are not 
infected with any of these diseases. Except for brucellosis and 
tuberculosis, none of these diseases are present in the United States 
and we want to prevent their introduction. Brucellosis and tuberculosis 
are present in the United States. However, we have programs to control 
their spread and to eradicate them. Therefore, we do not want infected 
embryos imported into the United States, where they could spread 
infection and increase the cost and difficulty of controlling and 
eradicating these diseases.
    The proposed diseases of concern for swine embryos, which would be 
listed in the regulations, are African swine fever, brucellosis, FMD, 
hog cholera, pseudorabies, rinderpest, swine vesicular disease, 
tuberculosis, and vesicular stomatitis. Except for brucellosis, 
pseudorabies, and tuberculosis, these are diseases which are not 
present in the United States and which may infect swine. Brucellosis, 
pseudorabies, and tuberculosis are present in the United States. 
However, we have programs to control their spread and to eradicate 
them. We therefore do not want infected embryos imported into the 
United States. Rinderpest is not normally considered a swine disease, 
but we are proposing to require that swine embryos be free of 
rinderpest because rare infections do occur in domestic Asiatic swine.
    We are also proposing to amend part 98 to remove the definition of 
cattle and add a definition of ruminant. Cervids, camelids, and all 
species of cattle would be included under the proposed definition of 
ruminant. Camelids are often considered to be ruminants. However, they 
are not true ruminants as they do not have four stomach compartments. 
There is no disease risk basis to treat them differently than true 
ruminants under these regulations. Therefore, we propose to include 
them under the definition of ruminant.
Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. 
The rule has been determined to be not significant for purposes of 
Executive Order 12866, and, therefore, has not been reviewed by the 
Office of Management and Budget.
    In accordance with 5 U.S.C. 603, we have performed an Initial 
Regulatory Flexibility Analysis, which is set out below, regarding the 
impact of this proposed rule on small entities. However, we do not 
currently have all the data necessary for a comprehensive analysis of 
the effects of this rule on small entities. Therefore, we are inviting 
comment concerning potential effects. In particular, we are interested 
in determining the number and kind of small entities that may incur 
benefits or costs from implementation of this proposed rule.
    In accordance with 21 U.S.C. 111, the Secretary of Agriculture is 
authorized to promulgate regulations to prevent the introduction or 
dissemination of any communicable disease of animals from a foreign 
country into the United States. This proposed rule would allow 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.
    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 that this proposed rule change would 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 can 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 would 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 putting [[Page 29783]] down either a 
letter of credit or a $50,000 deposit), 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, would also 
be realized.
    This proposed rule contains paperwork and recordkeeping 
requirements. Under this proposed rule, import permits and health 
certificates would be required for all ruminant and swine embryos, as 
they are now required for Bos indicus and Bos taurus cattle embryos.
    The alternatives to this proposed rule would be to take no action, 
or to allow the importation of embryos under different conditions than 
those proposed. 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 proposed a 
viable option. The only available research concerns embryos handled and 
treated as proposed in this document. 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 proposed rule has been reviewed under Executive Order 12778, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent 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 the Paperwork Reduction Act of 1980 (44 U.S.C. 
3501 et seq.), the information collection or recordkeeping requirements 
included in this proposed rule will be submitted for approval to the 
Office of Management and Budget. Please send written comments to the 
Office of Information and Regulatory Affairs, OMB, Attention: Desk 
Officer for APHIS, Washington, DC 20503. Please send a copy of your 
comments to: (1) Docket No. 94-006-1, Regulatory Analysis and 
Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238 and (2) Clearance Officer, OIRM, USDA, room 
404-W, 14th Street and Independence Avenue SW., Washington, DC 20250.
List of Subjects in 9 CFR Part 98

    Animal diseases, Imports, Reporting and recordkeeping requirements.

    Accordingly, 9 CFR part 98 would be amended as follows:

PART 98--IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN

    1. The authority citation for part 98 would be revised to read as 
follows:

    Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 102-105, 
111, 114a, 134a, 134b, 134c, 134d, 134f, 136 and 136a; 31 U.S.C. 
9701; 7 CFR 2.17, 2.51, and 371.2(d).

Subpart B--Ruminant and Swine Embryos From Countries Where 
Rinderpest or Foot-and-Mouth Disease Exists

    2. The heading for subpart B would be revised to read as set forth 
above.
    3. Section 98.11 would be 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]

    4. In the following sections, the word ``Cattle'' would be removed 
and the words ``Ruminant, camelid, and swine'' would be 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.
    5. Section 98.15 would be amended as follows:
    a. In the introductory paragraph, the word ``Cattle'' would be 
removed and the words ``Ruminant and swine'' would be added in its 
place.
    b. Paragraphs (a)(1) and (a)(2) would be revised to read as set 
forth below:
    c. In paragraph (a)(4), the word ``cattle'' would be removed and 
the words ``ruminants or swine'' would be added in its place.
    d. In paragraph (a)(5), the first sentence would be designated as 
paragraph (a)(5)(i), the second sentence would be designated as 
paragraph (a)(5)(ii) and revised to read as set forth below, and the 
third and fourth sentences would be designated as paragraphs 
(a)(5)(iii) and (a)(5)(iv), respectively.
    e. In paragraph (a)(7), the first sentence would be designated as 
paragraph (a)(7)(i) and revised to read as set forth below, and the 
second sentence would be designated as paragraph (a)(7)(ii).
    f. In paragraph (a)(8), the first sentence would be designated as 
paragraph (a)(8)(i) and revised to read as set forth below, and the 
second sentence would be designated as paragraph (a)(8)(ii).
    The revisions read as follows:


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

[[Page 29784]]

    (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
    (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.
* * * * *


Sec. 98.16  [Amended]

    6. Sec. 98.16 would be amended as follows:
    a. In the introductory paragraph, the first sentence, the word 
``Cattle'' would be removed and the words ``Ruminant and swine'' would 
be added in its place.

    b. In paragraph (b), in the first sentence, the word ``cattle'' 
would be removed and the words ``embryo donors'' would be added in its 
place.

    Done in Washington, DC, this 30th day of May 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-13667 Filed 6-5-95; 8:45 am]
BILLING CODE 3410-34-P