[Federal Register Volume 65, Number 64 (Monday, April 3, 2000)]
[Proposed Rules]
[Pages 17455-17458]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-8123]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 65, No. 64 / Monday, April 3, 2000 / Proposed 
Rules

[[Page 17455]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 93

[Docket No. 99-054-1]


Spanish Pure Breed Horses from Spain

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations that govern the 
importation of Spanish Pure Breed horses from Spain, a country in which 
contagious equine metritis, a venereal disease of horses, may exist. We 
would allow Spanish Pure Breed horses to be imported from Spain into 
the United States under the same conditions that apply to thoroughbred 
horses from certain other regions in which contagious equine metritis 
either exists or may exist. We are proposing this action because 
Spanish Pure Breed horses, like thoroughbred horses from those other 
regions, are less likely to be infected with contagious equine metritis 
than other horses, largely because the life history and medical records 
of each horse is known and can be certified by a veterinarian of the 
national government of the region of origin. This action would relieve 
some restrictions on the importation of Spanish Pure Breed horses into 
the United States.

DATES: We invite you to comment on this docket. We will consider all 
comments that we receive by June 2, 2000.

ADDRESSES: Please send your comment and three copies to:

    Docket No. 99-054-1, Regulatory Analysis and Development, PPD, 
APHIS, Suite 3C03, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Please state that your comment refers to Docket No. 99-054-1.
    You may read any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue, SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS rules, are available on the Internet at http://
www.aphis.usda.gov/ppd/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Morley Cook, Senior Staff 
Veterinarian, Animals Program, National Center for Import and Export, 
VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231; (301) 
734-6479.

SUPPLEMENTARY INFORMATION:

Background

    The animal importation regulations (contained in 9 CFR part 93 and 
referred to below as the regulations), among other things, prohibit or 
restrict the importation of certain animals, including horses, into the 
United States to protect U. S. livestock from communicable diseases, 
including contagious equine metritis (CEM). CEM is a contagious 
venereal disease of horses and other equidae that affects breeding and 
fertility.
    To prevent the introduction of CEM, Sec. 93.301(c)(1) lists regions 
in which CEM exists or in which CEM may exist because those regions 
have traded horses freely with regions in which CEM exists without 
testing for CEM. These regions are referred to below as listed regions. 
Paragraph (c)(1) prohibits the importation of horses into the United 
States from listed regions unless the horses are imported in accordance 
with certain requirements. The horses must be:

     Wild species of equidae if captured in the wild or 
imported from a zoo or other facility where it would be unlikely 
that the animal would come in contact with domesticated horses used 
for breeding;
     Geldings;
     Weanlings or yearlings;
     Horses imported in specific cases under conditions 
prescribed by the Administrator of APHIS as provided in 
Sec. 93.301(a);
     Thoroughbred horses imported for permanent entry from 
France, Germany, Ireland, or the United Kingdom as provided in 
Sec. 93.301(d);
     Stallions or mares over 731 days of age for permanent 
entry as provided in Sec. 93.301(e) (which requires pre-export 
testing, Federal quarantine upon arrival, and post-entry quarantine 
in a State approved to receive horses from listed regions);
     Horses over 731 days of age imported for no more than 
90 days to compete in specified events as provided in 
Sec. 93.301(f); or
     U.S. horses returning to the United States as provided 
in Sec. 93.301(g).

    The Equine Breeding Service of the Spanish Government has requested 
that we amend the regulations to allow Spanish Pure Breed horses to be 
imported into the United States from Spain under the same conditions 
that apply to thoroughbred horses from France, Germany, Ireland, and 
the United Kingdom. Currently, Spanish Pure Breed horses other than 
weanlings and yearlings may be imported for permanent entry into the 
United States only in accordance with Sec. 93.301(e). France, Germany, 
Ireland, and the United Kingdom are listed regions, as is Spain. 
However, the requirements in Sec. 93.301(d) for importing thoroughbred 
horses from France, Germany, Ireland, and the United Kingdom are less 
restrictive than the requirements in Sec. 93.301(e) because the life 
history and medical records of each thoroughbred horse imported from 
these countries is known and can be certified by a veterinarian of the 
national government of the region of origin.
    Under Sec. 93.301(d), each thoroughbred horse from France, Germany, 
Ireland, and the United Kingdom must be accompanied at the time of 
importation by an import permit and an import health certificate. The 
requirements related to import permits are contained in Sec. 93.304 of 
the regulations. The requirements related to import health certificates 
are contained in Sec. 93.314 of the regulations.
    According to Sec. 93.314, an import health certificate must be 
issued by a salaried veterinary officer of the national government of 
the region of origin, and it must certify that each horse has been in 
that region for the 60 days preceding exportation; that each horse has 
been inspected on the premises of origin and has been found free of 
evidence of communicable disease, and exposure to communicable disease, 
during the 60 days preceeding exportation; and that each horse has not

[[Page 17456]]

been vaccinated with a live, attenuated, or inactivated vaccine for the 
14 days preceding exportation, unless authorized by the Administrator 
of APHIS.
    Paragraph (d) of Sec. 93.301 requires that the veterinarian signing 
and issuing the import health certificate also certify that he or she 
has examined the daily records of the horse's activities maintained by 
the trainer and the records of the horse's activities maintained by a 
breed association that is specifically approved by the U.S. Department 
of Agriculture. The veterinarian must certify that the information in 
these records is consistent and current.
    For thoroughbred horses over 731 days of age, the import health 
certificate must also certify that cultures negative for CEM have been 
obtained from sets of specimens collected from each horse on 3 separate 
occasions within a 7-day period. The last set of specimens must have 
been collected within 30 days of exportation. All specimens must have 
been received within 48 hours of collection by a laboratory approved to 
culture for CEM by the national veterinary service of the region of 
export. All specimens must have been accompanied by a statement 
indicating the time and date of their collection.
    Under Sec. 93.301(d), if any specimen is found positive for CEM, 
the horse it was collected from must be treated for CEM in a manner 
approved by the national veterinary service of the region of export. 
After the treatment is completed, at least 21 days must pass before the 
horse is eligible to be tested again.
    Additionally, Sec. 93.301(d) requires that thoroughbred horses 
imported from France, Germany, Ireland, and the United Kingdom complete 
the Federal quarantine required under Sec. 93.308 before they can be 
released in the United States. Thoroughbred horses that were found 
positive for, and were treated for, CEM in the region of export must be 
further quarantined under State or Federal supervision until they have 
met the additional testing and treatment requirements in 
Sec. 93.301(e)(3) for stallions or Sec. 93.301(e)(5) for mares.
    Under Sec. 93.301(e)(3), specimens must be collected from each 
stallion's prepuce, urethral sinus, and fossa glandis, including the 
diverticulum of the fossa glandis, and must be cultured for CEM. If the 
results are negative, the stallion must be test bred to two mares, 
after which the stallion must undergo the following treatment for 5 
consecutive days: the prepuce, the penis, including the fossa glandis, 
and the unrethral sinus of the stallion must be thoroughly cleaned and 
scrubbed with a solution of not less than 2 percent surgical scrub 
chlorhexidine, while the stallion is in full erection, and then 
thoroughly coated with an ointment effective against the CEM organism.
    Cultures must be made from sets of specimens collected from the 
mucosal surfaces of the clitoral fossa and clitoral sinuses of each 
test mare on the third, sixth, and ninth days after test breeding. A 
complement fixation test for CEM must be performed on each test mare on 
the fifteenth day after the test breeding. If the result of any culture 
taken from either of the test mares or from the stallion is positive 
for CEM, the stallion must undergo the treatment described above and 
then be test bred again to two mares no sooner than 21 days after the 
last day of the treatment. Treatment and test breeding must be repeated 
until all tests are negative for CEM.
    Under Sec. 93.301(e)(5), sets of specimens must be taken from mares 
on days 1, 4, and 7 of a 7-day period. The specimens must be taken from 
the mucosal surfaces of the clitoral fossa and the clitoral sinuses and 
cultures must be made. After the three sets of specimens have been 
taken, organic debris must be manually removed from the clitoral 
sinuses of each mare and the sinuses must be flushed with a cerumalytic 
agent. For 5 consecutive days after the sinuses of the mare have been 
cleaned, the external genitalia and vaginal vestibule, including the 
clitoral fossa, must be aseptically cleaned and washed with a solution 
of not less than 2 percent chlorhexidine in a detergent base, and then 
the clitoral fossa and the clitoral sinuses must be filled and the 
external genitalia and vaginal vestibule must be coated with an 
antibiotic ointment effective against the CEM organism. All test 
results must be negative for CEM before the mare may be released from 
quarantine. If any test is positive, the mare must be treated again and 
then tested no less than 21 days after the last day of the treatment 
described above. Treatment and testing must be repeated until all tests 
are negative for CEM.
    All specimen collections, test breeding, and treatments required 
under Sec. 93.301(e)(3) and Sec. 93.301(e)(5) must be performed by an 
accredited veterinarian. All specimens must be submitted to the 
National Veterinary Services Laboratories, Ames, IA, or to a laboratory 
approved by the Administrator to conduct CEM cultures and tests. All 
test results must be negative for CEM before the horses may be released 
from quarantine.
    These conditions ensure that thoroughbred horses imported into the 
United States from France, Germany, Ireland, and the United Kingdom are 
free of CEM.
    At the request of the Equine Breeding Service of the Spanish 
Government, we are proposing to allow Spanish Pure Breed horses to be 
imported from Spain into the United States under the same conditions 
that apply to thoroughbred horses from France, Germany, Ireland, and 
the United Kingdom. We would add the Servicio de Cria Caballar y 
Remonta as the breed association that is specifically approved by the 
U.S. Department of Agriculture for the purposes of Sec. 93.301(d).
    The Spanish Pure Breed horse is only one of seven or eight breeds 
of purebred horses originating in Spain, but current and accurate 
historical and medical information is not readily available for the 
other breeds, so they are not included in this proposed rule. This 
action would relieve some restrictions on the importation of Spanish 
Pure Breed horses from Spain (i.e., the horses would not have to 
undergo the testing and treatment requirements in Sec. 93.301(e)(3) and 
Sec. 93.301(e)(5) unless they were found positive for, and were treated 
for, CEM prior to exportation).
    We have conducted a risk assessment for this proposed rule to 
ensure that this action would pose a negligible risk of introducing CEM 
into the United States. The risk assessment contains a qualitative 
analysis of 11 risk factors, which are listed in 9 CFR part 92, 
``Importation of Animals and Animal Products: Procedures for Requesting 
Recognition of Regions,'' and a quantitative analysis that evaluates 
the frequency with which a Spanish Pure Breed horse infected with CEM 
might be imported from Spain into the United States if this proposed 
rule were adopted.
    According to the qualitative analysis of the risk assessment, Spain 
is likely to be free of CEM. Additionally, Spanish veterinary 
authorities have the capabilities needed to culture and diagnose CEM. 
Routine breeding soundness examinations and investigations of 
reproductive diseases and reproductive failures conducted by the 
Spanish Government and military veterinarians would detect CEM if it 
were to occur in Spanish Pure Breed horses. There has never been a 
reported case of CEM in Spain. However, even if CEM were introduced 
into Spain, there is very little chance that it would affect the 
Spanish Pure Breed population since Spain does not import Spanish Pure 
Breed horses and Spanish Pure Breed horses are not bred with other 
breeds.

[[Page 17457]]

    The quantitative analysis evaluates the number of Spanish Pure 
Breed horses that are likely to be imported from Spain, the probability 
that a randomly selected horse would be infected with CEM, and the 
probability that the infection would be detected by the testing 
required under this proposed rule.
    According to the quantitative analysis, the predicted average 
frequency, with a 95 percent confidence level, with which a Spanish 
Pure Breed horse infected with CEM would be released into the United 
States is once every 700 years or less often. With a 50 percent 
confidence level, the predicted average frequency is one release every 
2,300 years or less often.
    Thus, based on the risk assessment, we have determined that this 
action would pose a negligible risk of introducing CEM into the United 
States.
    The complete risk assessment for this proposed rule may be obtained 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

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 the purposes of 
Executive Order 12866 and, therefore, has not been reviewed by the 
Office of Management and Budget.
    This proposed rule would allow Spanish Pure Breed horses to be 
imported from Spain into the United States under the same conditions 
that apply to thoroughbred horses from France, Germany, Ireland, and 
the United Kingdom. We are considering this action in response to a 
request we have received from Spain's Equine Breeding Service to 
relieve some of the restrictions on the importation of Spanish Pure 
Breed horses from Spain since the life histories and medical records of 
these horses can be certified by Spanish Government veterinarians.
    The following analysis addresses the economic effect the proposed 
rule would have on small entities, as required by the Regulatory 
Flexibility Act.
    In 1997, there were 375,218 farms in the United States keeping 
2,427,277 horses of all kinds. Approximately 79,516 farms sold 325,306 
horses, receiving $1.03 billion in sale revenues. Approximately 98 
percent of the farms that sold horses have less than $500,000 in annual 
revenue and, therefore, are considered small entities by the U.S. Small 
Business Administration.
    U.S. importers and breeders of Spanish Pure Breed horses would be 
affected by this rule. This rule would make it less expensive for 
importers to import Spanish Pure Breed horses from Spain.
    There are approximately 270 domestic breeders of Spanish Pure Breed 
horses in the United States, most of which are likely to be small 
entities. In 1998, there were approximately 2,500 Spanish Pure Breed 
horses in the United States and only 225 foals were registered that 
year.
    In 1995 and 1996, 4 horses (not all of which were Spanish Pure 
Breed horses) were imported into the United States from Spain; there 
were 21 horses in 1997, 39 in 1998, and 46 in 1999. If the proposed 
rule is adopted, we estimate that the number of Spanish Pure Breed 
horses imported into the United States from Spain will most likely 
increase to an average of about 60 per year, for the next 3 to 5 years, 
with a maximum of 100 in any given year.
    Currently, the demand for Spanish Pure Breed horses in the United 
States is greater than can be supplied by domestic breeders and the 
small number of these horses imported from Costa Rica, Mexico, and 
Spain. In 1997, 225 Spanish Pure Breed foals were registered in the 
United States, while a total of 50 were imported into the United States 
from all over the world, despite the high costs of shipping 
(approximately $5000 per horse for air freight plus insurance against 
mortality, figured at 1 percent of the horse's declared value), 
quarantine, and testing. Because domestic Spanish Pure Breed horses are 
less expensive than imports, the demand for domestic Spanish Pure Breed 
horses would not decrease as a result of this rule. This rule would 
help satisfy the growing demand for the horses in the United States, 
and make it less expensive for U.S. breeders and importers to obtain 
them from Spain.
    We do not expect domestic breeders of Spanish Pure Breed horses to 
be affected by this rule if it is adopted, since the demand in the 
United States for Spanish Pure Breed horses is greater than the 
domestic supply and since domestic Spanish Pure Breed horses will still 
be less expensive than imported ones.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

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 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 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. 99-054-1. 
Please send a copy of your comments to: (1) Docket No. 99-054-1, 
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 may increase the number of import permits and 
import health certificates that will be issued for the importation of 
thoroughbred horses into the United States.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will 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; and
    (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 of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average .78947 hours per response.

[[Page 17458]]

    Respondents: Salaried veterinary officers of the Spanish Government 
and U.S. importers of Spanish Pure Breed horses.
    Estimated annual number of respondents: 15.
    Estimated annual number of responses per respondent: 6.333.
    Estimated annual number of responses: 95.
    Estimated total annual burden on respondents: 75 hours.
    (Due to rounding, the total annual burden may not equal the product 
of the annual 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.

List of Subjects in 9 CFR Part 93

    Animal diseases, Imports, Livestock, Poultry and poultry products, 
Quarantine, Reporting and recordkeeping requirements.
    Accordingly, we propose to amend part 93 as follows:

PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, AND POULTRY, AND 
CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS 
OF CONVEYANCE AND SHIPPING CONTAINERS

    1. The authority citation for part 93 continues to read as follows:

    Authority: 7 U.S.C. 1622; 19 U.S.C. 1306; 21 U.S.C. 102-105, 11, 
114a, 134a, 134b, 134c, 134d, 134f, 136, and 136a; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.2(d).


Sec. 93.301  [Amended]

    2. In Sec. 93.301, footnote 6 would be amended by adding the words 
``Servicio de Cria Caballar y Remonta for Spain;'' immediately after 
the word ``Department:''.
    3. In Sec. 93.301, paragraph (c)(2)(v), the heading to paragraph 
(d), and the introductory text in paragraph (d)(1) would be revised to 
read as follows:


Sec. 93.301  General prohibitions; exceptions.

* * * * *
    (c) * * *
    (2) * *  *
    (v) Spanish Pure Breed horses imported for permanent entry from 
Spain or thoroughbred horses imported for permanent entry from France, 
Germany, Ireland, or the United Kingdom if the horses meet the 
requirements of paragraph (d) of this section;
* * * * *
    (d) Spanish Pure Breed horses from Spain and thoroughbred horses 
from France, Germany, Ireland, and the United Kingdom. (1) Spanish Pure 
Breed horses from Spain and thoroughbred horses from France, Germany, 
Ireland, and the United Kingdom may be imported for permanent entry if 
the horses meet the following requirements:
* * * * *
    4. In Sec. 93.301, in paragraph (d)(1)(ii)(D), the first sentence, 
the words ``For thoroughbred horses'' would be removed and the words 
``For Spanish Pure Breed horses and thoroughbred horses'' would be 
added in their place.
    5. In Sec. 93.301, in paragraph (d)(3), the words ``Thoroughbred 
horses'' would be removed and the words ``Spanish Pure Breed horses and 
thoroughbred horses'' would be added in their place each time they 
appear.

    Done in Washington, DC, this 28th day of March 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-8123 Filed 3-31-00; 8:45 am]
BILLING CODE 3410-34-U