Importation of Horses from CEM Countries

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 92

[Docket No. 95-054-2]

Importation of Horses from CEM Countries

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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

SUMMARY: We are amending the regulations regarding the importation of

horses from countries affected with contagious equine metritis by

incorporating new testing and treatment protocols for mares and

stallions, providing for the use of accredited veterinarians to monitor

horses temporarily imported into the United States for competition

purposes, incorporating a new testing protocol for thoroughbred horses

in training in their country of origin, and removing the requirements

for endometrial cultures and clitoral sinusectomies in mares. These

changes will update, clarify, and streamline the existing regulations

and will simplify the requirements for importing horses from countries

affected with contagious equine metritis without increasing the risk of

the disease being introduced into or disseminated within the United

States.

EFFECTIVE DATE: November 6, 1996.

FOR FURTHER INFORMATION CONTACT: Dr. Joyce Bowling, Staff Veterinarian,

Import/Export Animals, National Center for Import and Export, VS,

APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231, (301) 734-

6479; or E-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 92 (referred to below as the

regulations) prohibit or restrict the importation of certain animals

into the United States to prevent the introduction of communicable

diseases of livestock and poultry. Subpart C--Horses, Secs. 92.300

through 92.326 of the regulations, pertains to the importation of

horses into the United States. Sections 92.301 and 92.304 of the

regulations contain specific provisions for the importation and post-

entry handling of horses from countries affected with contagious equine

metritis (CEM), a highly contagious bacterial venereal disease.

On June 4, 1996, we published in the Federal Register (61 FR 28073-

28085, Docket No. 95-054-1) a proposal to amend the regulations by:

Reorganizing the CEM regulations to eliminate duplication

and to make their provisions easier to find and use;

Removing the requirements for clitoral sinusectomies and

endometrial cultures in female horses and establishing new protocols

for the collection of specimens for culturing;

Incorporating new testing and treatment protocols for

stallions and test mares;

Incorporating a new testing protocol for thoroughbred

horses in training in their country of origin; and

Providing for the use of accredited veterinarians to

monitor horses from CEM-affected countries that are temporarily in the

United States for competition purposes.

We solicited comments concerning our proposal for 60 days ending

August 5, 1996. We received eight comments by that date. They were from

a horse transporter/customs house broker, a State veterinarian, two

private practice veterinarians, two thoroughbred owners/breeders

associations, a horse industry council, and the director of a CEM

quarantine facility. All of the commenters supported the proposed rule,

although six of them offered suggestions or sought clarification

regarding the changes proposed in the proposed rule. Those comments are

discussed below.

Collection of Specimens

In the proposed rule, we proposed that for all mares over 731 days

of age offered for importation or in quarantine in an approved State,

specimens would be collected from the mucosal surfaces of the urethra,

clitoral sinuses, and cervix. Six of the commenters disagreed with

those proposed collection sites for two main reasons: (1) The

commenters

[[Page 52237]]

pointed out that experience in Europe and the United States has shown

the clitoral fossa, including the clitoral sinuses, to be the site from

which the CEM organism is most likely to be located, and (2) the

commenters all expressed reservations about the collection of specimens

from the cervix of pregnant mares, given the risk of infection or even

abortion that could result from swabbing that site. Based on those

considerations, the commenters suggested that the urethra and cervix be

eliminated as collection sites and that the clitoral fossa be added as

a collection site. We agree with the reasoning and suggestions of the

commenters and have, therefore, changed the collection sites for

samples from female horses in this final rule. Specifically, we have

changed the testing requirements for female thoroughbred horses in

Sec. 92.301(d)(1)(ii)(D), mares over 731 days of age in

Sec. 92.301(e)(1)(iii), and test mares in Secs. 92.301(e)(3)(i)(B),

92.301(e)(4)(ii), and 92.301(e)(5)(i) to require that specimens for

culturing be collected from the clitoral fossa and clitoral sinuses.

Treatment in Country of Origin

We had proposed to remove certain specific treatment instructions

for stallions diagnosed with CEM in their country of origin and replace

them with the requirement that the stallion be treated for CEM in a

manner approved by the national veterinary service of the country of

origin. One commenter was concerned that the treatment protocols used

in a stallion's country of origin may not be as demanding as those that

would be required by the Animal and Plant Health Inspection Service

(APHIS) and thus may not eliminate the CEM organism; rather, the

commenter suggested, the stallions should be treated in a manner

approved in the country of destination, i.e., the United States.

As noted in the proposed rule, the treatments performed in the

country of origin and the dates of the treatments will have to be

recorded on the horse's health certificate, so APHIS will have the

opportunity to consider the treatments used when the stallion is

offered for importation into the United States. Further, we will

continue to require that the stallion be retested no less than 21 days

following the completion of treatment and found free of CEM before it

will be eligible to enter the United States. Because that retesting

requirement will be in place, we believe that allowing the national

veterinary service of the country of origin to use its discretion in

deciding the appropriate treatment for stallions that have been found

to be positive for CEM will not result in an increased risk of CEM-

infected stallions entering the United States. We have not, therefore,

made any changes in response to that comment.

Treatment and Cleaning Protocol

The proposed rule also included a proposed protocol for the

treatment and cleaning of the clitoral sinuses of mares over 731 days

of age imported into an approved State. The protocol involved the

flushing of the clitoral sinuses with a cerumalytic agent, followed by

5 days of cleaning the external genitalia and vaginal vestibule,

including the clitoral fossa, with a solution of not less than 2

percent chlorhexidine in a detergent base and then filling the clitoral

fossa and sinuses, and coating the external genitalia and vaginal

vestibule, with an antibiotic ointment effective against the CEM

organism. Three of the commenters were concerned that the 5 consecutive

days of cleaning and coating would be irritating and even painful to a

mare and would likely result in the mare violently resisting the

treatment, which would pose a risk of injury to both the mare and the

person doing the cleaning and possibly result in the procedure not

being completed properly. Two commenters suggested that if the cleaning

procedure were conducted properly and thoroughly, the period of

treatment could be reduced to 3 or even 2 days.

The researchers who developed the cleaning and treatment procedure

described above concluded that the cleaning and flushing of the

clitoral sinuses should be followed by 5 consecutive days of washing

and application of ointment to ensure that the treatment is effective.

We will, therefore, retain the requirement for 5 days of post-flush

treatment. We acknowledge that a mare undergoing the treatment may well

become anxious or irritated as a result of the repeated handling of the

genitalia and thus require restraint or anesthesia; if that is the

case, the quarantine center personnel would be able to note the change

in the mare's disposition and take whatever precautions they deem

necessary to prevent any harm coming to them and to the mare. If

subsequent research indicates that the procedure should be modified to

reduce the length of treatment or increase its effectiveness, we will

publish a new proposed rule in the Federal Register to modify the

procedure. We have not, however, made any changes to the procedure in

this final rule.

Clitoral Sinusectomy

We had proposed to eliminate the requirement that certain mares

undergo a clitoral sinusectomy because the availability of procedures

for the cleaning and treatment of the clitoral sinuses to eliminate the

CEM organism had rendered clitoral sinusectomies unnecessary. One

commenter did not agree and recommended that the clitoral sinusectomy

be retained for use on mares that had tested positive for CEM, rather

than depending on the cleaning and treatment procedure to eliminate the

CEM organism. The cleaning and treatment procedure, the commenter

suggested, could be retained for use on mares that had tested negative

for CEM.

We have full confidence in the efficacy of the procedures described

in the proposed rule for flushing and cleaning the clitoral sinuses,

cleaning and washing the external genitalia and vaginal vestibule, and

filling the clitoral fossa and sinuses and coating the external

genitalia and vaginal vestibule with an antibiotic ointment effective

against the CEM organism. This procedure has been shown to effectively

eliminate debris that could harbor the CEM organism, which we believe

renders clitoral sinusectomies in all mares, whether they have been

diagnosed with CEM or not, unnecessary. We have, therefore, made no

changes in response to that comment.

High-Risk Mares

Two commenters suggested that mares that had been diagnosed with

and treated for CEM in their country of origin prior to importation

into the United States should be classified as ``high-risk mares.'' The

commenters did not recommend that any additional restrictions be placed

on such mares, but only that APHIS notify the animal health authorities

in the approved State to which a high-risk mare has been consigned when

the mare is released from CEM quarantine.

Under the provisions of the regulations, a mare cannot be imported

into the United States from a CEM country until a set of specimens has

been collected from the mare and cultured negative for CEM. Once the

mare has been imported into the United States and released from Federal

port-of-entry quarantine, specimens must be collected from that mare

three more times over a 7-day period and cultured, all with negative

results. The mare must then undergo the cleaning and treatment

procedure described in the previous paragraphs. Only after the mare has

satisfied all those requirements may it

[[Page 52238]]

be released from quarantine. With these requirements in place, we are

confident that any mare released from quarantine will be free from CEM;

in that case, one mare would not present a higher risk than another. We

do not believe, therefore, that it is necessary to differentiate

between mares that have not been diagnosed with CEM and mares that were

diagnosed with and effectively treated for CEM prior to their

importation into the United States, so we have made no changes to this

rule in response to that comment.

Use of Accredited Veterinarians

Two commenters supported the idea of allowing accredited

veterinarians to conduct the monitoring required for horses imported

for no more than 90 days to compete in specified events, but the

commenters suggested that the accredited veterinarians be required to

undergo some type of additional training to ensure that they are fully

versed in the regulations regarding such temporary importations.

The monitoring required by Sec. 92.301(f)(2)(ii) is to ensure that

the horse is kept on a premises approved by an APHIS representative; is

kept, except when actually competing or being exercised, in a stall

that prevents any contact with other horses; and has no sexual contact

with other horses and does not undergo any genital examinations. As

noted in the proposed rule, an accredited veterinarian must be familiar

with APHIS' animal health programs and regulations in order to be

approved by the Administrator to perform the functions associated with

those programs, and any accredited veterinarian monitoring temporarily

imported horses would be subject to spot checks by an APHIS

representative. Although we do not believe that accredited

veterinarians will need to receive any additional training, as

suggested by the commenter, we believe it would be useful for the APHIS

Veterinarian in Charge in the State where the monitoring would take

place to check with the accredited veterinarian to make sure that he or

she is conversant in the duties and responsibilities associated with

the monitoring of temporarily imported horses. We have, therefore,

modified Sec. 92.301(f)(2)(ii) in this final rule to state that the

Veterinarian in Charge will ensure that the accredited veterinarian is

familiar with the requirements of the regulations with regard to

monitoring temporarily imported horses.

Release from Quarantine

One commenter sought clarification in three areas regarding the

timing or sequence of certain testing and treatment requirements for

stallions and mares in quarantine. First, the commenter asked whether

the release of a stallion from quarantine would be a set number of days

after it entered quarantine or if the release would be contingent upon

the receipt of the results of the complement fixation test conducted 15

days after breeding on the two test mares. The regulations in

Sec. 92.301(e)(3)(iii) state that a stallion may be released from

quarantine only if all cultures and tests of specimens from the mares

used for test breeding are negative for CEM and all cultures performed

on specimens taken from the stallion are negative for CEM. Because the

results of all tests and cultures must be negative before the stallion

can be released from quarantine, the release of a stallion from

quarantine would indeed be contingent upon the receipt of the results

of the complement fixation tests.

The commenter also noted that because many imported stallions have

no previous breeding experience, it often takes several days to train

them to safely breed a mare. Under the provisions described in the

proposed rule, the stallion is test bred to two mares after it has been

cultured negative for CEM, which the commenter speculated could be as

soon as the stallion's first day in quarantine. The commenter

recommended, therefore, that some flexibility should be built into the

regulations to allow the quarantine facility staff sufficient time to

train imported stallions to safely breed the test mares. Because there

is no set time limit in the regulations for the completion of the test

breeding, the flexibility sought by the commenter is, in fact, already

present. The regulations in Sec. 92.301(e)(3)(i) require only that the

test breeding take place after negative results have been obtained from

the stallion's CEM cultures, which is usually at least 2 or 3 days

after the collection of specimens. If an imported stallion requires

training to safely breed a mare, there is nothing in the regulations to

prevent a quarantine facility's staff from taking the time necessary to

conduct that training.

Finally, the commenter asked that we clarify the sequence of the

actions described in the proposed rule under Sec. 92.301(e)(5),

``Testing and treatment requirements for mares.'' The commenter was

uncertain as to whether the washing and packing of the mare's external

genitalia and vaginal vestibule was to be conducted prior to, or

concurrent with, the collection of specimens from the mare on days one,

four, and seven of quarantine. Actually, the washing and packing is to

be after the three sets of specimens have been collected. The required

actions are listed sequentially in Sec. 92.301(e)(5): Collect three

sets of specimens over 7 days, then clean and flush the sinuses, then

wash and pack for 5 consecutive days. The commenter's confusion could

be due to a lack of clarity at the start of Sec. 92.301(e)(5)(ii),

which begins ``Following the collections of specimens * * *'' without

specifying that all three sets of specimens must be collected before

the cleaning and flushing of the clitoral sinuses begins. In order to

eliminate that potential source of confusion, we have modified the

language in Sec. 92.301(e)(5) in this final rule to make it clear that

the collection of specimens is to be completed prior to the cleaning

and flushing.

Another instance where a lack of clarity could lead to confusion is

in Sec. 92.301(d)(3). That paragraph states that thoroughbred horses

found free from CEM and imported under Sec. 92.301(d)(1) may be

released after completing the Federal quarantine required under

Sec. 92.308; the paragraph does not, however, specify the post-entry

requirements for thoroughbred horses over 731 days of age that were

found positive for CEM and subsequently treated and retested for CEM as

provided by Sec. 92.301(d)(2). It was our intent when drafting the

proposed rule that such thoroughbred horses, as is required for all

other horses over 731 days of age that have been found positive for CEM

and subsequently treated and retested for CEM, should be consigned to

an approved State for post-entry testing and treatment. We have,

therefore, modified the language in Sec. 92.301(d)(3) to make it clear

that thoroughbred horses over 731 days of age that have been treated

and retested for CEM in accordance with Sec. 92.301(d)(2) must undergo

post-entry quarantine in an approved State.

In addition to the changes discussed above, we have also made

several nonsubstantive editorial changes for the sake of clarity or

consistency.

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.

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.

[[Page 52239]]

This rule amends the regulations regarding the importation of

horses from countries affected with CEM by incorporating new testing

and treatment protocols for mares and stallions, providing for the use

of accredited veterinarians to monitor horses temporarily imported into

the United States for competition purposes, incorporating a new testing

protocol for thoroughbred horses in training in their country of

origin, and removing the requirements for endometrial cultures and

clitoral sinusectomies in mares. These changes will update, clarify,

and streamline the existing regulations and simplify the requirements

for importing horses from countries affected with CEM without

increasing the risk of the disease being introduced into or

disseminated within the United States.

The United States is a net exporter of horses, exporting

approximately two horses for every one imported, and unit values for

imports and exports slightly favored the United States during fiscal

year (FY) 1994 and FY 1995. The unit value of exports was $3,762 per

head in FY 1994, while the unit import value was $3,336 per head; in FY

1995, these values shifted to $2,742 per head (export) and $2,674 per

head (import).

In FY 1994, U.S. exports of horses totaled 62,064 head valued at

$233.4 million; in FY 1995, the total was 81,487 head valued at $223.4

million. Most of those horses were exported to Canada, Mexico, and

Western Europe (especially the United Kingdom and Ireland). U.S.

imports of horses, on the other hand, are small relative to total

inventory and equal about half of U.S. horse exports. In FY 1994, U.S.

horse imports totaled 17,881 head valued at $59.6 million; in FY 1995,

the total was 43,545 head valued at $116.4 million. Canada and Mexico

were the source of over 90 percent of all U.S. horse imports in those

years. In each year, those imports equaled approximately 1 percent of

the domestic horse inventory (USDA, Economic Research Service,

``Foreign Agricultural Trade of the United States,'' Fiscal Year 1995

Supplement). Small entities maintain almost 95 percent of the domestic

horse inventory.

The new testing and treatment protocols presented in this document

are the only aspects of this rule that are expected to have an economic

impact. In each case, the changes will reduce the time required to

collect samples, conduct tests, and administer treatments, which will

shorten the period that an imported horse will have to spend in

quarantine. Because the importer or owner of an imported horse must

bear the cost of providing care, feeding, and handling of the horse

during the time it is quarantined for CEM testing and treatment in an

approved State, a shorter quarantine period will clearly reduce an

owner's or importer's boarding costs. The current course of testing and

treatment runs, on average, from 4 to 6 weeks; the testing and

treatment protocols in this rule are expected to cut that time frame to

2 to 3 weeks.

We do not expect, however, that these changes will result in an

increase of horse imports into the United States. Those countries that

can already profitably ship horses to the United States and meet the

current requirements of the regulations will not be significantly

affected, and those countries that do not currently meet those

requirements are not expected to meet the new requirements either.

Under these circumstances, the Administrator of the Animal and

Plant Health Inspection Service has determined that this action will

not have a significant economic impact on a substantial number of small

entities.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic

Assistance under No. 10.025 and is subject to Executive Order 12372,

which requires intergovernmental consultation with State and local

officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

This rule has been reviewed under Executive Order 12988, 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

This rule contains no new information collection or recordkeeping

requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501

et seq.).

Regulatory Reform

This action is part of the President's Regulatory Reform

Initiative, which, among other things, directs agencies to remove

obsolete and unnecessary regulations and to find less burdensome ways

to achieve regulatory goals.

List of Subjects in 9 CFR Part 92

Animal diseases, Imports, Livestock, Poultry and poultry products,

Quarantine, Reporting and recordkeeping requirements.

Accordingly, 9 CFR part 92 is amended as follows:

PART 92--IMPORTATION OF CERTAIN ANIMALS AND POULTRY AND CERTAIN

ANIMAL AND POULTRY PRODUCTS; INSPECTION AND OTHER REQUIREMENTS FOR

CERTAIN MEANS OF CONVEYANCE AND SHIPPING CONTAINERS THEREON

1. The authority citation for part 92 continues 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, 135, 136, and 136a; 31

U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.2(d).

2. In Sec. 92.300, the definition of Weanling or yearling is

revised to read as follows:

Sec. 92.300 Definitions.

* * * * *

Weanling or yearling. Any horse, weaned from its dam, that was

foaled not more than 731 days prior to its being offered for entry into

the United States. A horse will not be considered to be a weanling or

yearling if its first permanent incisors have erupted.

Secs. 92.303 and 92.304 [Amended]

3. Sections 92.303 and 92.304 are amended as follows:

a. In Sec. 92.304, footnote 12 and its reference in the section

heading are removed.

b. In Sec. 92.303(e), footnote 11 and its reference are

redesignated as footnote 12.

4. In Sec. 92.301, paragraph (c) is revised and new paragraphs (d)

through (i) are added to read as follows:

Sec. 92.301 General prohibitions; exceptions.

* * * * *

(c) Specific prohibitions regarding contagious equine metritis;

exceptions--(1) Importation prohibited. Except as provided in paragraph

(c)(2) of this section, notwithstanding the other provisions of this

part concerning the importation of horses into the United States, the

importation of all horses from any of the following listed countries

and the importation of all horses that have been in any listed country

within the 12 months immediately preceding their being offered for

entry into the United States is prohibited, either because contagious

equine metritis (CEM) exists in the listed country or because the

listed country trades horses freely with a country in which CEM exists

without testing for CEM: Austria, Belgium, Bosnia and Herzegovina,

Croatia, Czech Republic, Denmark, Finland, France, Germany, Guinea-

Bissau, Ireland, Italy,

[[Page 52240]]

Japan, the Member States of the European Union, The Netherlands,

Norway, Slovakia, Slovenia, Sweden, Switzerland, The Former Yugoslav

Republic of Macedonia, the United Kingdom (England, Northern Ireland,

Scotland, Wales, and the Isle of Man), and the nonrecognized areas of

the former Yugoslavia (Montenegro and Serbia).

Note: Montenegro and Serbia have asserted the formation of a

joint independent State entitled ``The Federal Republic of

Yugoslavia,'' but this entity has not been formally recognized by

the United States.

(2) Exceptions. The provisions of paragraph (c)(1) of this section

shall not apply to the following:

(i) Wild (non-domesticated) 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;

(ii) Geldings;

(iii) Weanlings or yearlings whose age is certified on the import

health certificate required under Sec. 92.314(a);

(iv) Horses imported in accordance with conditions prescribed by

the Administrator as provided in Sec. 92.301(a);

(v) 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;

(vi) Stallions or mares over 731 days of age imported for permanent

entry if the horses meet the requirements of paragraph (e) of this

section;

(vii) Horses over 731 days of age imported into the United States

for no more than 90 days to compete in specified events if the horses

meet the requirements of paragraph (f) of this section; and

(viii) Horses temporarily exported from the United States or from

another country not known to be affected with CEM to a country listed

in paragraph (c)(1) of this section within the 12 months immediately

preceding their being offered for entry into the United States if the

horses meet the requirements of paragraph (g) of this section.

(d) Thoroughbred horses from France, Germany, Ireland, and the

United Kingdom. (1) Thoroughbred horses may be imported for permanent

entry from France, Germany, Ireland, or the United Kingdom if the

horses meet the following requirements:

(i) Each horse is accompanied at the time of importation by an

import permit in accordance with Sec. 92.304;

(ii) Each horse is accompanied at the time of importation by an

import health certificate issued in accordance with Sec. 92.314(a). In

addition to the information required by Sec. 92.314(a), the

veterinarian signing and issuing the certificate shall certify that:

(A) He or she has examined the daily records of the horse's

activities maintained by the trainer and certified to be current, true,

and factual by the veterinarian in charge of the training or racing

stable;

(B) He or she has examined the records of the horse's activities

maintained by a breed association specifically approved by the

Department 6 and certified by the breed association to be current,

true, and factual for the following information: Identification of the

horse by name, sex, age, breed, and all identifying marks;

identification of all premises where the horse has been since reaching

731 days of age and the dates that the horse was at such premises; and

that none of the premises are breeding premises;

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

\6\ The following breed associations and their record systems

have been approved by the Department: Weatherby's Ltd. for the

United Kingdom and Ireland; Haras du Pain for France; and

Direktorium fur Vollblutzucht und Rennen e.v. for Germany.

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

(C) He or she has compared the records maintained by the approved

breed association with the records kept by the trainer and has found

the information in those two sets of records to be consistent and

current;

(D) For thoroughbred horses over 731 days of age, cultures negative

for CEM were obtained from sets of specimens collected on 3 separate

occasions within a 7-day period from the mucosal surfaces of the

clitoral fossa and the clitoral sinuses of any female horses and from

the surfaces of the prepuce, the urethral sinus, and the fossa glandis,

including the diverticulum of the fossa glandis, of any male horses.

For both female and male horses, the sets of specimens must be

collected on days 1, 4, and 7 of the 7-day period, and the last of

these sets of specimens must be collected within 30 days of

exportation. All specimens required by this paragraph must be collected

by a licensed veterinarian who either is, or is acting in the presence

of, the veterinarian signing the certificate; and

(E) All specimens required by paragraph (d)(1)(ii)(D) of this

section were received within 48 hours of collection by a laboratory

approved to culture for CEM by the national veterinary service of the

country of export and were accompanied by a statement indicating the

date and time of their collection.

(2) If any specimen collected in accordance with paragraph

(d)(1)(ii)(D) of this section is found to be positive for CEM, the

horse must be treated for CEM in a manner approved by the national

veterinary service of the country of export. After the treatment is

completed, at least 21 days must pass before the horse will be eligible

to be tested again in accordance with paragraph (d)(1)(ii)(D) of this

section. All treatments performed, and the dates of the treatments,

must be recorded on the health certificate.

(3) Thoroughbred horses imported under paragraph (d)(1) of this

section may be released upon completion of the Federal quarantine

required under Sec. 92.308. Thoroughbred horses found positive for CEM

that have been treated and retested as provided in paragraph (d)(2) of

this section shall, upon completion of the Federal quarantine required

under Sec. 92.308, be consigned to an approved State listed in

paragraph (h)(6) or (h)(7) of this section, where they shall be

quarantined under State or Federal supervision until the stallions have

met the testing and treatment requirements of paragraph (e)(3) of this

section and the mares have met the testing and treatment requirements

of paragraph (e)(5) of this section.

(e) Stallions and mares over 731 days of age from CEM-affected

countries. (1) Stallions or mares over 731 days of age may be imported

for permanent entry from a country listed in paragraph (c)(1) of this

section if the horses meet the following requirements:

(i) Each horse is accompanied at the time of importation by an

import permit issued in accordance with Sec. 92.304. The import permit

must indicate that, after completion of the Federal quarantine required

in Sec. 92.308, the stallion or mare will be consigned to a State that

the Administrator has approved to receive such horses in accordance

with paragraph (h) of this section;

(ii) The horses are accompanied at the time of importation by an

import health certificate issued in accordance with Sec. 92.314(a);

(iii) A set of specimens must be collected from each horse within

30 days prior to the date of export by a licensed veterinarian who

either is, or is acting in the presence of, the veterinarian signing

the certificate. For stallions, the specimens must be collected from

the prepuce, urethral sinus, and fossa glandis, including the

diverticulum of the fossa glandis; for mares, the specimens must be

collected from the mucosal surfaces of the clitoral fossa and the

clitoral sinuses. All of the specimens collected must be cultured for

CEM with negative results in a laboratory approved to culture for CEM

[[Page 52241]]

by the national veterinary service of the country of origin;

(iv) The horses described on the certificate must not have been

used for natural breeding, for the collection of semen for artificial

insemination in the case of stallions, or for artificial insemination

in the case of mares, from the time the specimens were collected

through the date of export;

(v) All specimens required by paragraph (e)(1)(iii) of this section

must be received within 48 hours of collection by a laboratory approved

to culture for CEM by the national veterinary service of the country of

export and must be accompanied by a statement indicating the date and

time of their collection; and

(vi) If any specimen collected in accordance with paragraph

(e)(1)(iii) of this section is found to be positive for CEM, the

stallion or mare must be treated for CEM in a manner approved by the

national veterinary service of the country of export. After the

treatment is completed, at least 21 days must pass before the horse

will be eligible to be tested again in accordance with paragraph

(e)(1)(ii) of this section. All treatments performed, and the dates of

the treatments, must be recorded on the health certificate.

(2) Post-entry. (i) Stallions and mares imported under paragraph

(e)(1) of this section must complete the Federal quarantine required

under Sec. 92.308. Upon completion of the Federal quarantine, stallions

must be sent to an approved State listed in paragraph (h)(6) of this

section, and mares must be sent to an approved State listed in

paragraph (h)(7) of this section.

(ii) Once in the approved State, the stallions or mares shall be

quarantined under State or Federal supervision until the stallions have

met the testing and treatment requirements of paragraph (e)(3) of this

section and the mares have met the testing and treatment requirements

of paragraph (e)(5) of this section.

(iii) All tests and cultures required by paragraphs (e)(3) through

(e)(5) of this section shall be conducted at the National Veterinary

Services Laboratories, Ames, IA, or at a laboratory approved by the

Administrator in accordance with paragraph (i) of this section to

conduct CEM cultures and tests.

(iv) To be eligible for CEM culture or testing, all specimens

collected in accordance with paragraphs (e)(3) through (e)(5) of this

section must be received by the National Veterinary Services

Laboratories or the approved laboratory within 48 hours of collection

and must be accompanied by a statement indicating the date and time of

their collection.

(3) Testing and treatment requirements for stallions. (i) Once the

stallion is in the approved State, one specimen each shall be taken

from the prepuce, the urethral sinus, and the fossa glandis, including

the diverticulum of the fossa glandis, of the stallion and be cultured

for CEM. After negative results have been obtained, the stallion must

be test bred to two test mares that meet the requirements of paragraph

(e)(4) of this section. Upon completion of the test breeding:

(A) The stallion must be treated for 5 consecutive days by

thoroughly cleaning and washing (scrubbing) its prepuce, penis,

including the fossa glandis, and urethral sinus while the stallion is

in full erection with a solution of not less than 2 percent surgical

scrub chlorhexidine and then thoroughly coating (packing) the

stallion's prepuce, penis, including the fossa glandis, and urethral

sinus with an ointment effective against the CEM organism.7 The

treatment shall be performed by an accredited veterinarian and

monitored by a State or Federal veterinarian.

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

\7\ A list of ointments effective against the CEM organism may

be obtained from the National Center for Import and Export, Import/

Export Animals, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD

20737-1231.

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

(B) Each mare to which the stallion has been test bred shall be

cultured for CEM from sets of specimens that are collected from the

mucosal surfaces of the clitoral fossa and clitoral sinuses on the

third, sixth, and ninth days after the breeding, with negative results.

A complement fixation test for CEM must be done with negative results

on the fifteenth day after the breeding.

(ii) If any culture or test required by this paragraph is positive

for CEM, the stallion shall be treated as described in paragraph

(e)(3)(i)(A) of this section and retested by being test bred to two

mares no less than 21 days after the last day of treatment.

(iii) A stallion may be released from State quarantine only if all

cultures and tests of specimens from the mares used for test breeding

are negative for CEM and all cultures performed on specimens taken from

the stallion are negative for CEM.

(4) Requirements for test mares. (i) Mares to be used to test

stallions for CEM shall be permanently identified before the mares are

used for such testing with the letter ``T.'' The marking shall be

permanently applied by an inspector, a State inspector, or an

accredited veterinarian who shall use a hot iron, freezemarking, or a

lip tattoo. If a hot iron or freezemarking is used, the marking shall

not be less than 2 inches (5.08 cm) high and shall be applied to the

left shoulder or left side of the neck of the mare. If a lip tattoo is

used, the marking shall not be less than 1 inch (2.54 cm) high and 0.75

inch (1.9 cm) wide and shall be applied to the inside surface of the

upper lip of the test mare.

(ii) The test mares must be qualified prior to breeding as

apparently free from CEM and may not be used for breeding from the time

specimens are taken to qualify the mares as free from CEM. To qualify,

each mare shall be tested with negative results by a complement

fixation test for CEM, and specimens taken from each mare shall be

cultured negative for CEM. For culture, sets of specimens shall be

collected on the first, fourth, and seventh days of a 7-day period from

the mucosal surfaces of the clitoral fossa and clitoral sinuses.

(iii) A test mare that has been used to test stallions for CEM may

be released from quarantine only if:

(A) The test mare is found negative for CEM on all cultures and

tests required under paragraph (e)(3)(ii) of this section; or

(B) The test mare is subjected to an ovariectomy by an accredited

veterinarian under the direct supervision of a State or Federal

veterinarian; or

(C) The test mare is treated and handled in accordance with

paragraph (e)(5) of this section; or

(D) The test mare is moved directly to slaughter without unloading

en route, is euthanized, or dies.

(5) Testing and treatment requirements for mares. (i) Once the mare

is in the approved State, sets of specimens shall be collected from the

mare on three separate occasions within a 7-day period. On days 1, 4,

and 7, an accredited veterinarian shall collect specimens from the

mucosal surfaces of the clitoral fossa and clitoral sinuses and shall

submit each set of specimens to the National Veterinary Services

Laboratories, Ames, IA, or to a laboratory approved by the

Administrator in accordance with paragraph (i) of this section to

conduct CEM cultures and tests.

(ii) After the three sets of specimens required by paragraph

(e)(5)(i) of this section have been collected, an accredited

veterinarian shall manually remove organic debris from the sinuses of

each mare and then flush the sinuses with a cerumalytic agent.8

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

\8\ Recommended protocols for the flushing of sinuses may be

obtained from the National Center for Import and Export, Import/

Export Animals, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD

20737-1231.

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

[[Page 52242]]

(iii) For 5 consecutive days after the sinuses have been cleaned,

an accredited veterinarian shall aseptically clean and wash (scrub) the

external genitalia and vaginal vestibule, including the clitoral fossa,

with a solution of not less than 2 percent chlorhexidine in a detergent

base and then fill the clitoral fossa and sinuses, and coat the

external genitalia and vaginal vestibule with an antibiotic ointment

effective against the CEM organism.9

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

\9\ A list of ointments effective against the CEM organism may

be obtained from the National Center for Import and Export, Import/

Export Animals, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD

20737-1231.

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

(iv) A mare may be released from State quarantine only if all

cultures performed on specimens taken from the mare are negative for

CEM.

(v) If any culture required by this paragraph is positive for CEM,

the mare shall be treated as described in paragraphs (e)(5)(ii) and

(e)(5)(iii) of this section. No less than 21 days after the last day of

treatment, the mare shall be tested again in accordance with paragraph

(e)(5)(i) of this section. If all specimens are negative for CEM, the

mare may be released from quarantine.

(f) Special provisions for temporary importation. Horses over 731

days of age may be imported into the United States for no more than 90

days to compete in specified events if the following conditions are

met:

(1) The horse may remain in the United States for not more than 90

days following the horse's arrival in the United States, except as

provided in paragraph (f)(6) of this section and, while in the United

States, the horse must be moved according to the itinerary and methods

of transport specified in the import permit provided for in Sec. 92.304

of this part;

(2) While the horse is in the United States, the following

conditions must be met:

(i) Except when in transit, the horse must be kept on a premises

that has been approved, orally or in writing, by an APHIS

representative. If the approval is oral, it will be confirmed in

writing by the Administrator as soon as circumstances permit. To

receive approval, the premises:

(A) Must not be a breeding premises; and

(B) Must be or contain a building in which the horse can be kept in

a stall that is separated from other stalls containing horses, either

by an empty stall, by an open area across which horses cannot touch

each other, or by a solid wall that is at least 8 feet (2.4 m) high.

(ii) While at the premises at which the horse competes, the horse

must be monitored by an accredited veterinarian or APHIS representative

to ensure that the provisions of paragraphs (f)(2)(i), (f)(2)(iv), and

(f)(2)(v) of this section are met. If the monitoring is performed by an

accredited veterinarian, the Veterinarian in Charge will ensure that

the accredited veterinarian is familiar with the requirements of this

section and spot checks will be conducted by an APHIS representative to

ensure that the requirements of this section are being met. If an APHIS

representative finds that requirements are not being met, the

Administrator may require that all remaining monitoring for the event

be conducted by APHIS representatives to ensure compliance.

(iii) While in transit, the horse must be moved in either an

aircraft or a sealed van or trailer. If the horse is moved in a sealed

van or trailer, the seal may be broken only by an APHIS representative

at the horse's destination, except in situations where the horse's life

is in danger.

(iv) Except when actually competing or being exercised, the horse

must be kept in a stall that is separated from other stalls containing

horses, either by an empty stall, by an open area across which horses

cannot touch each other, or by a solid wall that is at least 8 feet

(2.4 m) high.

(v) The horse may not be used for breeding purposes (including

artificial insemination), may not have any other sexual contact with

other horses, and may not undergo any genital examinations.

(vi) After the horse is transported anywhere in the United States,

any vehicle in which the horse was transported must be cleaned and

disinfected in the presence of an APHIS representative, according to

the procedures specified in Secs. 71.7 through 71.12 of this chapter,

before any other horse is transported in the vehicle.

(vii) The cleaning and disinfection specified in paragraph

(f)(2)(vi) of this section must be completed before the vehicle is

moved from the place where the horse is unloaded. In those cases where

the facilities or equipment for cleaning and disinfection are

inadequate at the place where the horse is unloaded, the Administrator

may allow the vehicle to be moved to another location for cleaning and

disinfection when the move will not pose a disease risk to other horses

in the United States.

(viii) The owner or importer of the horse must comply with any

other provisions of this part applicable to him or her.

(3) If the owner or importer wishes to change the horse's itinerary

or the methods by which the horse is transported from that which he or

she specified in the application for the import permit, the owner or

importer must make the request for change in writing to the

Administrator. Requests should be sent to the Administrator, c/o

Import-Export Animals Staff, VS, APHIS, 4700 River Road Unit 39,

Riverdale, MD 20737-1231. The change in itinerary or method of

transport may not be made without the written approval of the

Administrator, who may grant the request for change when he or she

determines that granting the request will not endanger other horses in

the United States and that sufficient APHIS personnel are available to

provide the services required by the owner or importer. If more than

one application for an import permit is received, APHIS personnel will

be assigned in the order that the applications that otherwise meet the

requirements of this section are received.

(4) The Administrator may cancel, orally or in writing, the import

permit provided for under Sec. 92.304 of this part whenever the

Administrator finds that the owner or importer of the horse has not

complied with the provisions of paragraphs (f)(1) through (f)(3) of

this section or any conditions imposed under those provisions. If the

cancellation is oral, the Administrator will confirm the cancellation

and the reasons for the cancellation in writing as soon as

circumstances permit. Any person whose import permit is canceled may

appeal the decision in writing to the Administrator within 10 days

after receiving oral or written notification of the cancellation,

whichever is earlier. If the appeal is sent by mail, it must be

postmarked within 10 days after the owner or importer receives oral or

written notification of the cancellation, whichever is earlier. The

appeal must include all of the facts and reasons upon which the person

relies to show that the import permit was wrongfully canceled. The

Administrator will grant or deny the appeal in writing as promptly as

circumstances permit, stating the reason for his or her decision. If

there is a conflict as to any material fact, a hearing will be held to

resolve the conflict. Rules of practice concerning the hearing will be

adopted by the Administrator.

(5) Except in those cases where an appeal is in process, any person

whose import permit is canceled must move the horse identified in the

import permit out of the United States within 10 days after receiving

oral or written

[[Page 52243]]

notification of cancellation, whichever is earlier. The horse is not

permitted to enter competition from the date the owner or importer

receives the notice of cancellation until the horse is moved out of the

United States or until resolution of an appeal in favor of the owner or

importer. Except when being exercised, the horse must be kept, at the

expense of the owner or importer, in a stall on the premises where the

horse is located when the notice of cancellation is received, or, if

the horse is in transit when the notice of cancellation is received, on

the premises where it is next scheduled to compete according to the

import permit. The stall in which the horse is kept must be separated

from other stalls containing horses, either by an empty stall, by an

open area across which horses cannot touch each other, or a by solid

wall that is at least 8 feet (2.4 m) high. In cases where the owners of

the above specified premises do not permit the horse to be kept on

those premises, or when the Administrator determines that keeping the

horse on the above specified premises will pose a disease risk to

horses in the United States, the horse must be kept, at the expense of

the owner or importer, on an alternative premises approved by the

Administrator.

(6) Stallions or mares over 731 days of age that are imported for

no more than 90 days in accordance with paragraphs (f)(1) through

(f)(3) of this section may be eligible to remain in the United States

if the following is completed:

(i) Following completion of the itinerary specified in the import

permit provided for in Sec. 92.304 of this part, the horse's owner or

importer applies for and receives a new import permit that specifies

that the stallion or mare will be moved to an approved State listed in

paragraph (h)(6) or (h)(7) of this section; and

(ii) The stallion or mare is transported in a sealed vehicle that

has been cleaned and disinfected to an approved facility in an approved

State where it is quarantined under State or Federal supervision until

the stallion or mare has met the testing and treatment requirements of

paragraph (e)(3) or (e)(5) of this section.

(7) All costs and charges associated with the supervision and

maintenance of a horse imported under paragraphs (f)(1) through (f)(3)

of this section will be borne by the horse's owner or importer. The

costs associated with the supervision and maintenance of the horse by

an APHIS representative at his or her usual places of duty will be

reimbursed by the horse's owner or importer through user fees payable

under part 130 of this chapter.

(8) In the event that an APHIS representative must be temporarily

detailed from his or her usual place of duty in connection with the

supervision and maintenance of a horse imported under paragraphs (f)(1)

through (f)(3) of this section, the owner or importer of the horse must

execute a trust fund agreement with APHIS to reimburse all expenses

(including travel costs, salary, per diem or subsistence,

administrative expenses, and incidental expenses) incurred by the

Department in connection with the temporary detail. Under the trust

fund agreement, the horse's owner or importer must deposit with APHIS

an amount equal to the estimated cost, as determined by APHIS, for the

APHIS representative to inspect the premises at which the horse will

compete, to conduct the monitoring required by paragraph (f)(2)(ii) of

this section, and to supervise the cleaning and disinfection required

by paragraph (f)(2)(vi) of this section. The estimated costs will be

based on the following factors:

(i) Number of hours needed for an APHIS representative to conduct

the required inspection and monitoring;

(ii) For services provided during regular business hours (8 a.m. to

4:30 p.m., Monday through Saturday, except holidays), the average

salary, per hour, for an APHIS representative;

(iii) For services provided outside regular business hours, the

applicable rate for overtime, night differential, or Sunday or holiday

pay, based on the average salary, per hour, for an APHIS

representative;

(iv) Number of miles from the premises at which the horse competes

to the APHIS office or facility that is monitoring the activities;

(v) Government rate per mile for automobile travel or, if

appropriate, cost of other means of transportation between the premises

at which the horse competes and the APHIS office or facility;

(vi) Number of trips between the premises at which the horse

competes and the APHIS office or facility that APHIS representatives

are required to make in order to conduct the required inspection and

monitoring;

(vii) Number of days the APHIS representative conducting the

inspection and monitoring must be in ``travel status;''

(viii) Applicable government per diem rate; and

(ix) Cost of related administrative support services.

(9) If a trust fund agreement with APHIS has been executed by the

owner or importer of a horse in accordance with paragraph (f)(8) of

this section and APHIS determines, during the horse's stay in the

United States, that the amount deposited will be insufficient to cover

the services APHIS is scheduled to provide during the remainder of the

horse's stay, APHIS will issue to the horse's owner or importer a bill

to restore the deposited amount to a level sufficient to cover the

estimated cost to APHIS for the remainder of the horse's stay in the

United States. The horse's owner or importer must pay the amount billed

within 14 days after receiving the bill. If the bill is not paid within

14 days after its receipt, APHIS will cease to perform the services

provided for in paragraph (f)(2) of this section until the bill is

paid. The Administrator will inform the owner or importer of the

cessation of services orally or in writing. If the notice of cessation

is oral, the Administrator will confirm, in writing, the notice of

cessation and the reason for the cessation of services as soon as

circumstances permit. In such a case, the horse must be kept, at the

expense of the owner or importer and until the bill is paid, in a stall

either on the premises at which the horse is located when the notice of

cessation of services is received, or, if the horse is in transit when

the notice of cessation of services is received, on the premises at

which it is next scheduled to compete according to the import permit.

The stall in which the horse is kept must be separated from other

stalls containing horses either by an empty stall, an open area across

which horses cannot touch each other, or a solid wall that is at least

8 feet (2.4 m) high. In cases where the owners of the above specified

premises do not permit the horse to be kept on those premises, or when

the Administrator determines that keeping the horse on the above

specified premises will pose a disease risk to other horses in the

United States, the horse must be kept, at the expense of the owner or

importer, on an alternative premises approved by the Administrator.

Until the bill is paid, the horse is not permitted to enter

competition. Any amount deposited in excess of the costs to APHIS to

provide the required services will be refunded to the horse's owner or

importer.

(g) Special provisions for the importation of horses that have been

temporarily exported to a CEM-affected country. If a horse has been

temporarily exported for not more than 60 days from the United States

to a CEM-affected country listed in paragraph (c)(1) of this section,

or if a horse has been temporarily exported for not more than 60 days

from another country not

[[Page 52244]]

known to be affected with CEM to a CEM-affected country during the 12

months preceding its exportation to the United States, the horse may be

eligible for return or importation into the United States without

meeting the requirements of paragraphs (d) through (f) of this section

under the following conditions:

(1) The horse must be accompanied by a certificate that meets the

requirements of Sec. 92.314(a) of this part issued by each CEM-affected

country that the horse has visited during the term of its temporary

exportation, and each certificate must contain the following additional

declarations:

(i) That the horse was held separate and apart from all other

horses except for the time it was actually participating in an event or

was being exercised by its trainer;

(ii) That the premises on which the horse was held were not used

for any equine breeding purpose;

(iii) That the horse was not bred to or bred by any animal, nor did

it have any other sexual contact or genital examination while in such

country; and

(iv) That all transport while in such country was carried out in

cleaned and disinfected vehicles in which no other horses were

transported since such cleaning and disinfection;

(2) The horse is accompanied by an import permit issued in

accordance with Sec. 92.304 of this part at the time of exportation;

(3) If the horse was temporarily exported from the United States

and is being returned to the United States, the horse must be

accompanied by a copy of the United States health certificate issued

for its exportation from the United States and endorsed in accordance

with the export regulations in part 91 of this chapter;

(4) The horse must be examined by an inspector at the U.S. port of

entry and found by the inspector to be the identical horse covered by

the documents required by paragraphs (a) through (c) of this section

and found by the inspector to be free of communicable disease and

exposure thereto; and

(5) The horse must be quarantined and tested at the U.S. port of

entry as provided in Sec. 92.308 of this part prior to release.

(h) Approval of States. In order for a State to be approved to

receive stallions or mares over 731 days of age from a CEM-affected

country listed in paragraph (c)(1) of this section that are imported

under paragraph (e) of this section, the State must meet the following

conditions:

(1) The State must enter into a written agreement with the

Administrator, whereby the State agrees to enforce its laws and

regulations to control CEM and to abide by the conditions of approval

established by the regulations in this part.

(2) The State must agree to quarantine all stallions and mares over

731 days of age imported under the provisions of paragraph (e) of this

section until the stallions have been treated in accordance with

paragraph (e)(3) of this section and the mares have been treated in

accordance with paragraph (e)(5) of this section.

(3) The State must agree to quarantine all mares used to test

stallions for CEM until the mares have been released from quarantine in

accordance with paragraph (e)(4) of this section.

(4) The State must have laws or regulations requiring that

stallions over 731 days of age imported under paragraph (e) of this

section be treated in the manner specified in paragraph (e)(3) of this

section, and that mares over 731 days of age imported under paragraph

(e) of this section be treated in the manner specified in paragraph

(e)(5) of this section.

(5) Approval of any State to receive stallions or mares imported

from countries affected with CEM may be suspended by the Administrator

upon his or her determination that any requirements of this section are

not being met. After such action is taken, the animal health

authorities of the approved State will be informed of the reasons for

the action and afforded an opportunity to present their views thereon

before such suspension is finalized; however, such suspension of

approval shall continue in effect unless otherwise ordered by the

Administrator. In those instances where there is a conflict as to the

facts, a hearing shall be held to resolve such conflict.

(6) The following States have been approved to receive stallions

over 731 days of age imported under paragraph (e) of this section:

The State of Alabama

The State of California

The State of Colorado

The State of Florida

The State of Kentucky

The State of Louisiana

The State of Maryland

The State of Montana

The State of New Hampshire

The State of New Jersey

The State of New York

The State of North Carolina

The State of Ohio

The State of South Carolina

The State of Tennessee

The State of Texas

The State of Virginia

The State of Wisconsin

(7) The following States have been approved to receive mares over

731 days of age imported under paragraph (e) of this section:

The State of Alabama

The State of California

The State of Colorado

The State of Kentucky

The State of Louisiana

The State of Maryland

The State of Montana

The State of Hew Hampshire

The State of New Jersey

The State of New York

The State of North Carolina

The State of Ohio

The State of South Carolina

The State of Tennessee

The State of Texas

The State of Virginia

The State of Wisconsin

(i) Approval of laboratories. (1) The Administrator will approve a

laboratory to conduct CEM cultures and tests only after consulting with

the State animal health official in the State in which the laboratory

is located and after determining that the laboratory:

(i) Has technical personnel assigned to conduct the CEM culturing

and testing who possess the following minimum qualifications:

(A) A bachelor's degree in microbiology;

(B) A minimum of 2 years experience working in a bacteriology

laboratory; and

(C) Experience working with the CEM organism, including knowledge

of the specific media requirements, atmospheric requirements, and

procedures for the isolation and identification of the CEM

organism.10

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

\10\ When training regarding CEM culturing and testing is

necessary, it may be obtained at the National Veterinary Services

Laboratories, Ames, IA 50010.

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

(ii) Follows standard test protocols that will reliably and

consistently provide for the isolation and identification of the CEM

organism; 11 and

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

\11\ Standard test protocols recommended by the National

Veterinary Services Laboratories and a list of approved laboratories

can be obtained from the National Veterinary Services Laboratories,

Ames, IA 50010.

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

(iii) Reports all official test results to the State animal health

official and the Veterinarian in Charge.

(2) To retain approval, the laboratory must meet the requirements

prescribed in paragraph (i)(1) of this section, and shall test with the

CEM organism each lot of media it prepares to ensure that the media

will support growth of the laboratory's reference culture. Media that

will not support growth of the reference culture must be discarded.

[[Page 52245]]

(3) The Administrator may deny or withdraw approval of any

laboratory to conduct CEM culturing or testing upon a determination

that the laboratory does not meet the criteria for approval or

maintenance of approval under paragraphs (i)(1) and (i)(2) of this

section.

(i) In the case of a denial of approval, the operator of the

laboratory will be informed of the reasons for denial and, upon

request, will be afforded an opportunity for a hearing with respect to

the merits or validity of the denial in accordance with rules of

practice that will be adopted for the hearing.

(ii) In the case of a withdrawal of approval, before such action is

taken, the operator of the laboratory will be informed of the reasons

for the proposed withdrawal and, upon request, will be afforded an

opportunity for a hearing with respect to the merits or validity of the

proposed withdrawal in accordance with rules of practice that will be

adopted for the hearing. However, the withdrawal will become effective

pending a final determination in the hearing when the Administrator

determines that such action is necessary to protect the public health,

interest, or safety. The withdrawal will be effective upon oral or

written notification, whichever is earlier, to the operator of the

laboratory. In the event of oral notification, written confirmation

will be given as promptly as circumstances allow. The withdrawal will

continue in effect pending completion of the hearing and any judicial

review of the hearing, unless otherwise ordered by the Administrator.

(iii) Approval for a laboratory to conduct CEM culturing or testing

will be automatically withdrawn by the Administrator when the operator

of the approved laboratory notifies the National Veterinary Services

Laboratories, Ames, IA 50010, in writing, that the laboratory no longer

conducts CEM culturing and testing.

(Approved by the Office of Management and Budget under control

number 0579-0040)

5. Section 92.304 is amended as follows:

a. The section heading is revised to read as set forth below.

b. In the introductory text of paragraph (a)(1)(ii), the reference

``Sec. 92.301(c)(2)(viii)'' is removed both times it appears and the

reference ``Sec. 92.301(f)'' added in its place.

c. In paragraph (a)(1)(iii), in the first sentence, the reference

``Sec. 92.301(c)(2)(viii)'' is removed and the reference

``Sec. 92.301(f)'' added in its place.

d. Paragraphs (a)(4) through (a)(12) are removed.

e. Paragraph (b) is revised to read as set forth below.

Sec. 92.304 Import permits for horses from countries affected with CEM

and for horse specimens for diagnostic purposes; reservation fees for

space at quarantine facilities maintained by APHIS.

* * * * *

(b) Permit. (1) When a permit is issued, the original and two

copies will be sent to the importer. It shall be the responsibility of

the importer to forward the original permit and one copy to the shipper

in the country of origin, and it shall also be the responsibility of

the importer to ensure that the shipper presents the copy of the permit

to the carrier and makes the necessary arrangements for the original

permit to accompany the shipment to the specified U.S. port of entry

for presentation to the collector of customs.

(2) Horses and horse test specimens for which a permit is required

under paragraph (a) of this section will be received at the port of

entry specified on the permit within the time prescribed in the permit,

which shall not exceed 14 days from the first day that the permit is

effective.

(3) Horses and horse test specimens for which a permit is required

under paragraph (a) of this section will not be eligible for entry if:

(i) A permit has not been issued for the importation of the horse

or horse test specimen;

(ii) If the horse or horse test specimen is unaccompanied by the

permit issued for its importation;

(iii) If the horse or horse test specimen is shipped from any port

other than the one designated in the permit;

(iv) If the horse or horse test specimen arrives in the United

States at any port other than the one designated in the permit;

(v) If the horse or horse test specimen offered for entry differs

from that described in the permit; or

(vi) If the horse or horse test specimen is not handled as outlined

in the application for the permit and as specified in the permit

issued.

Sec. 92.308 [Amended]

6. In Sec. 92.308(a)(3), footnote 16 and its reference in the text

are redesignated as footnote 14.

7. In Sec. 92.308(c)(1), footnote 17 and its reference in the text

are redesignated as footnote 15.

8. Section 92.314 is revised to read as follows:

Sec. 92.314 Horses, certification, and accompanying equipment.

(a) Horses offered for importation from any part of the world shall

be accompanied by a certificate of a salaried veterinary officer of the

national government of the country of origin, or if exported from

Mexico, shall be accompanied either by such a certificate or by a

certificate issued by a veterinarian accredited by the National

Government of Mexico and endorsed by a full-time salaried veterinary

officer of the National Government of Mexico, thereby representing that

the veterinarian issuing the certificate was authorized to do so,

showing that:

(1) The horses described in the certificate have been in said

country during the 60 days preceding exportation;

(2) That each horse has been inspected on the premises of origin

and found free of evidence of communicable disease and, insofar as can

be determined, exposure thereto during the 60 days preceding

exportation;

(3) That each horse has not been vaccinated with a live or

attenuated or inactivated vaccine during the 14 days preceding

exportation: Provided, however, that in specific cases the

Administrator may authorize horses that have been vaccinated with an

inactivated vaccine to enter the United States when he or she

determines that in such cases and under such conditions as he or she

may prescribe such importation will not endanger the livestock in the

United States, and such horses comply with all other applicable

requirements of this part;

(4) That, insofar as can be determined, no case of African horse

sickness, dourine, glanders, surra, epizootic lymphangitis, ulcerative

lymphangitis, equine piroplasmosis, Venezuelan equine

encephalomyelitis, or equine infectious anemia has occurred on the

premises of origin or on adjoining premises during the 60 days

preceding exportation; and

(5) That, except as provided in Sec. 92.301(g):

(i) The horses have not been in any country listed in

Sec. 92.301(c)(1) as affected with CEM during the 12 months immediately

prior to their importation into the United States;

(ii) The horses have not been on any premises at any time during

which time such premises were found by an official of the veterinary

services of the national government of the country where such premises

are located, to be affected with CEM;

[[Page 52246]]

(iii) The horses have not been bred by or bred to any horses from

an affected premises; and

(iv) The horses have had no other contact with horses that have

been found to be affected with CEM or with horses that were imported

from countries affected with CEM.

(b) If a horse is presented for importation from a country where it

has been for less than 60 days, the horse must be accompanied by a

certificate that meets the requirements of paragraph (a) of this

section that has been issued by a salaried veterinary officer of the

national government of each country in which the horse has been during

the 60 days immediately preceding its shipment to the United States.

The dates during which the horse was in each country during the 60 days

immediately preceding its exportation to the United States shall be

included as a part of the certification.

(c) Following the port-of-entry inspection required by Sec. 92.306

of this part, and before a horse offered for importation from any part

of the world is released from the port of entry, an inspector may

require the horse and its accompanying equipment to be disinfected as a

precautionary measure against the introduction of foot-and-mouth

disease or any other disease dangerous to the livestock of the United

States.

9. Preceding Sec. 92.315, in the undesignated center heading

``CANADA18'', footnote 18 and its reference are redesignated as

footnote 16.

10. Preceding Sec. 92.319, in the undesignated center heading

``COUNTRIES OF CENTRAL AMERICA AND WEST INDIES19'', footnote 19

and its reference are redesignated as footnote 17.

11. Preceding Sec. 92.321, in the undesignated center heading

``MEXICO20'', footnote 20 and its reference are redesignated as

footnote 18.

Sec. 92.324 [Amended]

12. In Sec. 92.324, in the third sentence, footnote 21 and its

reference in the text are redesignated as footnote 19.

Done in Washington, DC, this 2nd day of October 1996.

A. Strating,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 96-25639 Filed 10-04-96; 8:45 am]

BILLING CODE 3410-34-P