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.

Proposed Rules Federal Register

21389

Vol. 61, No. 92

Friday, May 10, 1996

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

9 CFR Part 92

[Docket No. 95–053–1]

Horses Imported Into the United States

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We are proposing to amend

the horse importation regulations to

clarify the information required on the

application for a permit to import horses

into the United States and to clarify

health certificate requirements for

imported horses that transit another

country en route to the United States.

We believe that these proposed actions

are necessary to ensure that importers of

horses provide adequate and accurate

information on import permit

applications and to ensure that horses

are properly handled from the time the

horses leave their farm of origin until

the horses arrive in the United States.

These proposed amendments appear

necessary to ensure the continued

protection of the health of horses in the

United States.

DATES: Consideration will be given only

to comments received on or before July

9, 1996.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 95–053–1, Regulatory

Analysis and Development, PPD,

APHIS, suite 3C03, 4700 River Road

Unit 118, Riverdale, MD 20737–1238.

Please state that your comments refer to

Docket No. 95–053–1. Comments

received may be inspected at USDA,

room 1141, South Building, 14th Street

and Independence Avenue SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing to

inspect comments are requested to call

ahead on (202) 690–2817 to facilitate

entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Dr.

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) 734–8170.

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 92

(referred to below as ‘‘the regulations’’)

govern the importation into the United

States of specified animals, including

horses, to prevent the introduction of

various animal diseases into the United

States.

Under § 92.304, importers must apply

for a permit to import horses into the

United States. The regulations state that

importers must provide certain

information, including the route of

travel, for horses being imported into

the United States, and the required

information must appear on the

application for an import permit.

Under § 92.314, horses imported into

the United States must be accompanied

by a health certificate completed by a

salaried veterinary officer of the

national government of the country of

origin indicating the horses’ freedom

from communicable diseases such as

contagious equine metritis and African

horse-sickness. Additionally, § 92.314

requires that ‘‘a horse presented for

importation from a country where it has

been for less than 60 days shall be

accompanied by a like certificate

similarly 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 shipment from the last

country from which it is shipped to the

United States.’’

We are proposing to amend the

regulations by adding definitions of the

terms ‘‘country of origin’’ and ‘‘country

of transit’’ and by adding an explanation

of the words ‘‘route of travel.’’

We propose to define ‘‘country of

origin’’ as the ‘‘country in which the

horse was born, was raised, and

remained until shipment to the United

States, or the country into which the

horse was legally imported and has

remained for a period of not less than

60 days prior to shipment to the United

States.’’ In cases of horses legally

imported into their country of origin, we

have determined that a 60-day residency

requirement would maintain

consistency with other requirements in

the regulations. We would define

‘‘country of origin’’ in the regulations

because, in the past, there has been

some confusion on the part of importers

concerning the meaning of the term

‘‘country of origin,’’ especially when a

horse is moved to another country for

shipment to the United States. In

limited cases, the country from which

the horse was directly shipped to the

United States was mistakenly identified

as the country of origin on the horse’s

import permit. We also propose to

define ‘‘country of transit’’ as a ‘‘country

through which a horse travels en route

from the country of origin to the United

States.’’ A complete list of the countries

of transit should appear in the ‘‘route of

travel’’ section of the import permit

application, but, on occasion, importers

have mistakenly omitted countries

through which a shipment of horses

traveled en route to the United States.

In addition, we propose to specify

that ‘‘route of travel’’ must include a list

of all of the countries that the horse will

transit en route to the United States, all

of the modes of transportation that will

be used to move the horse from the

country of origin to the port of entry in

the United States, and all of the

locations where the horse will be

offloaded prior to arrival at the U.S. port

of entry. In the past, in addition to

neglecting to list all of the countries of

transit, some importers have mistakenly

omitted information on the modes of

transportation used to transport a

shipment of horses and locations where

the shipment of horses will be

offloaded. Because different countries

have different disease statuses, and the

risk of the horses’ exposure to disease

increases when shipped by ground

transportation and when offloaded at

some locations within countries of

transit, a complete assessment of the

import risk associated with a particular

shipment of horses is only possible

when all of the essential information is

available on the import permit

application.

We believe that by defining the terms

‘‘country of origin’’ and ‘‘country of

transit’’ and by clarifying the words

‘‘route of travel,’’ importers would know

exactly what information needs to be

provided on the application for an

import permit. This action would

improve compliance with the

regulations and continue to ensure that
21390 Federal Register / Vol. 61, No. 92 / Friday, May 10, 1996 / Proposed Rules

horses intended for importation into the

United States do not pose a disease risk

to the domestic horse population.

We are also proposing to clarify the

regulations concerning locations for

offloading. Currently, the regulations do

not specify appropriate locations where

horses may be offloaded in countries of

transit. We are proposing to require that

if, during shipment to the United States,

a horse is offloaded in a country of

transit, then that horse must be

offloaded in a facility that is capable of

being cleaned and disinfected and that

is approved by the country of transit’s

Ministry of Agriculture for the

offloading of in-transit horses. We are

also proposing to specify that while the

horse is offloaded in the facility, the

horse must be kept separate from all

other horses. This action would reduce

the risk that horses intended for

importation into the United States

would come into contact with other

horses of unknown disease status en

route to the United States.

Additionally, we are proposing to

clarify the requirements concerning

health certificates from countries of

transit. We propose to amend § 92.314

to ensure that the regulations clearly

state that if, during shipment to the

United States, a horse is offloaded in a

country of transit, then that horse must

undergo a veterinary inspection and

obtain a health certificate from a

salaried veterinary officer of the

national government of the country of

transit in which the horse is offloaded.

If a horse is offloaded in more than one

country of transit, then that horse would

be required to undergo a veterinary

inspection and obtain a health

certificate from a salaried veterinary

officer of the national government in

every country of transit in which the

horse is offloaded. This clarification of

the requirements would ensure that any

communicable diseases in horses

intended for importation into the United

States are diagnosed as early as possible

and that appropriate action is taken to

prevent those diseases from being

carried into the United States.

We propose that, after performing the

veterinary inspection, the veterinary

officer of a country of transit must

complete a form that describes the horse

being shipped, certifies that a health

inspection has been performed on that

horse, and assures that the horse is free

from evidence of communicable

diseases. We are proposing that the

certification read, ‘‘The animals

described on this form have been given

a careful veterinary inspection and

found to be free from evidence of

communicable disease and, in my

opinion, are fit to travel.’’ The

veterinarian would sign this certificate

to attest to the fact that the horse has

been inspected, determined to be free of

evidence of communicable diseases, and

judged to be in a condition that would

indicate that the animal would be in the

same health upon arrival at its

destination in the United States as when

inspected in the country of transit. This

inspection and certification would

ensure that horses imported into the

United States present a minimal disease

risk to the U.S. horse population.

In addition, we propose to specify

that the veterinary inspection must be

performed in the country of transit no

earlier than 24 hours before the horse is

reloaded on a transport vehicle for

shipment to the United States. We are

proposing a 24-hour time limit in order

to provide flexibility in the timing of the

veterinary inspection while ensuring

that the inspection takes place as close

to the time of the horse’s departure from

a country of transit as possible.

If a horse intended for importation

into the United States travels through

any countries other than its country of

origin and the United States but is not

offloaded in a country of transit, we

propose that the owner of the horse, or

the owner’s representative, must sign a

certification statement prior to the

horse’s shipment from the country of

origin that certifies that the horse will

be shipped directly to the United States.

We are proposing that the certification

read, ‘‘The horse will be sent directly

from the premises of origin to the

premises of destination without coming

into contact with other equine animals

not accompanied by an official health

certificate, in vehicles cleaned and

disinfected in advance with a

disinfectant officially recognized in the

country of origin.’’ This statement

would have to be presented upon the

horse’s arrival in the United States. If,

however, for reasons beyond the

importer’s or shipper’s control, the

horse experiences an unscheduled

offloading in a country of transit, then

the horse would have to undergo a

veterinary inspection and obtain a

health certificate from a salaried

veterinary officer of the national

government of the country of transit.

Miscellaneous

We are proposing to make other

minor, nonsubstantive changes to

§ 92.304, such as correcting

punctuation. Additionally, we are

proposing to amend §§ 92.304 and

92.314 by adding a reference to the end

of each section for the Office of

Management and Budget control

number assigned to approved

information collection and

recordkeeping requirements.

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.

We are proposing to clarify the

information required on the application

for a permit to import horses into the

United States and to clarify health

certificate requirements for imported

horses that transit another country en

route to the United States.

As this proposal simply clarifies the

regulations and as most horses arrive in

the United States with proper

documentation, we do not expect a

significant number of importers to be

affected by this action. For importers

not currently in compliance with the

regulations, any cost incurred in

complying with the regulations should

be offset by the costs currently incurred

by importers when a shipment of horses

arrives in the United States without

proper documentation. Currently, when

a horse arrives in the United States

without proper documentation, that

horse remains in quarantine until the

proper documents are produced, or the

horse is refused entry if the proper

documents are not produced. Therefore,

the importer incurs additional user fee

costs while the horse is held in

quarantine, or the importer incurs the

cost of shipping the horse back to the

country of origin. Therefore, we have

determined that the effect on any U.S.

entities, large or small, would be

insignificant.

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 12778

This proposed rule has been reviewed

under Executive Order 12778, Civil

Justice Reform. If this proposed rule is

adopted: (1) All State and local laws and

regulations that are inconsistent with

this rule will be preempted; (2) no

retroactive effect will be given to this

rule; and (3) administrative proceedings

will not be required before parties may

file suit in court challenging this rule.

Paperwork Reduction Act

In accordance with section 3507(d) of

the Paperwork Reduction Act of 1995

(44 U.S.C. 3501 et seq.), the information
Federal Register / Vol. 61, No. 92 / Friday, May 10, 1996 / Proposed Rules 21391

12See footnote 7 to subpart C.

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. 95–053–1. Please

send a copy of your comments to: (1)

Docket No. 95–053–1, Regulatory

Analysis and Development, PPD,

APHIS, suite 3C03, 4700 River Road

Unit 118, Riverdale, MD 20737–1238,

and (2) Clearance Officer, OIRM, USDA,

room 404–W, 14th Street and

Independence Avenue SW.,

Washington, DC 20250. 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 would require

that, upon arrival in the United States,

horses travelling through countries of

transit en route to the United States be

accompanied by either a certification

signed by the horses’ owner verifying

that the horses were not offloaded in

any countries of transit or a certification

signed by a veterinary officer of the

country of transit in which the horses

were offloaded that attests to the horses’

freedom from evidence of

communicable disease when the horse

was offloaded and a veterinary

inspection was performed in the

country of transit. This proposed rule

would therefore introduce two new

information collection requirements that

would enable us to ensure that horses

destined for the United States are

healthy when they leave their country of

origin, remain healthy during their

journey, and pose a minimal health risk

to the U.S. horse population upon

arriving in the United States. We are

soliciting comments from the public (as

well as affected agencies) concerning

our proposed information collection.

We need this outside input to 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 5 minutes per

response.

Respondents: Veterinarians and horse

owners.

Estimated number of respondents:

250.

Estimated number of responses per

respondent: 1.

Estimated Total Annual Burden on

Respondents: 21 hours.

Copies of this information collection

can be obtained from the Department of

Agriculture, Clearance Officer, OIRM,

Ag. Box 7630, Washington, DC 20250.

List of Subjects in 9 CFR Part 92

Animal disease, Imports, Livestock,

Poultry and poultry products,

Quarantine, Reporting and

recordkeeping requirements.

Accordingly, 9 CFR part 92 would be

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

would continue 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. Section 92.300 would be amended

by adding definitions for Country of

origin and Country of transit, in

alphabetical order, to read as follows:

§ 92.300 Definitions.

* * * * *

Country of origin. The country in

which a horse was born, was raised, and

remained until importation to the

United States, or the country into which

the horse was legally imported and

remained for a period of not less than

60 days prior to shipment to the United

States.

Country of transit. A country through

which a horse travels en route from the

country of origin to the United States.

* * * * *

3. Section 92.304 would be amended

as follows:

a. In paragraph (a)(1)(i), by revising

the second sentence to read as set forth

below.

b. At the end of the section, by adding

the following: ‘‘(Approved by the Office

of Management and Budget under

control number 0579–0040)’’.

§ 92.304 Import permits for horses from

countries affected with CEM, and for horse

specimens for diagnostic purposes; 12 and

reservation fees for space at quarantine

facilities maintained by APHIS.

(a) * * *

(1)(i) * * * The application must

specify the name and address of the

importer; the species, breed, number or

quantity of horses or horse test

specimens to be imported; the purpose

of the importation; individual horse

identification which includes a

description of the horse, name, age,

markings, if any, registration number, if

any, and tattoo or eartag; the country of

origin; the name and address of the

exporter; the port of embarkation in the

foreign country; the route of travel from

the country of origin to the United

States, including the country of origin,

all countries of transit, all modes of

transportation, all locations, if any,

where the horses will be offloaded, and

the port of entry in the United States;

the proposed date of arrival of the

horses or horse test specimens to be

imported; and the name of the person to

whom the horses or horse test

specimens will be delivered and the

location of the place in the United

States to which delivery will be made

from the port of entry. * * *

* * * * *

4. Section 92.314 would be amended

as follows:

a. By designating the existing text as

paragraph (a) and by adding a paragraph

heading to read ‘‘General requirements.’’

b. In newly designated paragraph (a),

the proviso beginning with ‘‘And

provided, further’’ and the text

following it is removed and new text is

added in its place to read as set forth

below.

c. By adding a new paragraph (b) to

read as set forth below.

d. At the end of the section, by adding

an OMB control number to read as set

forth below.

§ 92.314 Horses, certification, and

accompanying equipment.

(a) * * * And provided, further, That

upon inspecting horses at the port of

entry and before permitting them to

leave the port of entry, the inspector

may require their disinfection and the

disinfection of their accompanying

equipment as a precautionary measure

against the introduction of foot-andmouth disease or any other disease

dangerous to the livestock of the United

States.
21392 Federal Register / Vol. 61, No. 92 / Friday, May 10, 1996 / Proposed Rules

(b) Special requirements for horses

traveling through countries of transit. In

addition to meeting all of the applicable

requirements of this subpart, horses

shipped to the United States through a

country or countries of transit must

meet the following conditions:

(1) If a horse intended for importation

into the United States will travel

through a country or countries of transit

but will not be offloaded in the country

or countries of transit, then, prior to the

horse’s shipment from the country of

origin, the owner of the horse, or the

owner’s representative, must certify that

the horse will be shipped directly to the

United States. The certification must

read as follows: ‘‘The horse will be sent

directly from the premises of origin to

the premises of destination without

coming into contact with other equine

animals not accompanied by an official

health certificate, in vehicles cleaned

and disinfected in advance with a

disinfectant officially recognized in the

country of origin.’’ This certification

must be signed by the owner of the

horse or the owner’s representative, and

the signed certification must be

presented to an inspector at the port of

entry in the United States. If, after the

certification is signed, an unscheduled

offloading of a shipment of horses

occurs in a country of transit, then the

horses must meet all of the requirements

of paragraphs (b)(2) and (b)(3) of this

section.

(2) If a horse intended for importation

into the United States will travel

through a country or countries of transit

and will be offloaded in the country or

countries of transit, then the horse must

be offloaded in a facility that is capable

of being cleaned and disinfected and

that is approved by the country of

transit’s Ministry of Agriculture for the

offloading of in-transit horses. Within

the facility, the horse must be kept

separate from all other horses. All

horses offloaded in a country or

countries of transit must undergo a

veterinary inspection and receive a

health certificate from a salaried

veterinary officer of the national

government of each country of transit in

which the horse is offloaded. The

veterinary inspection must be

performed no earlier than 24 hours

before the horse is reloaded on a

transport vehicle for shipment. If, after

performing the inspection, the salaried

veterinary officer of the national

government of the country of transit

finds the horse intended for importation

into the United States to be free of

evidence of communicable diseases and

fit to travel, the veterinary officer must

complete the form shown in paragraph

(b)(3) of this section.

(3) A completed certificate of

inspection, as shown below, must

accompany any horse offloaded in a

country of transit to the U.S. port of

arrival and be produced for the

inspector at the port of arrival upon the

horse’s arrival in the United States.

Certification of Inspection of Import Animals

1. Permit No. llllllllllllll

2. Consignor’s Name (Last name, first name,

middle initial or business name) lllll

3. Consignor’s Street Address (Mailing address) llllllllllllllllll

4. Consignor’s City/Town lllllllll

5. Consignor’s Country llllllllll

6. Consignee’s Name (Last name, first name,

middle initial or business name) lllll

7. Consignee’s City/Town llllllll

8. Consignor’s State lllllllllll

9. Species of Animals Certified for Import l

10. Country of Origin llllllllll

11. Breed of Animals Certified for Import l

12. Number of Animals Inspected lllll

13. Country of Transit/City in Which Inspection Occurred llllllllllllll

14. Date of Arrival in and Date of Departure

from Country of Transit lllllllll

15. Name of Veterinarian Performing Inspection in Country of Transit llllllll

The animals described on this form have

been given a careful veterinary inspection

and found to be free from evidence of

communicable disease and, in my opinion,

fit to travel.

16. Signature of Veterinarian Performing Inspection in Country of Transit llllll

17. Date Issued lllllllllllll

18. Seal lllllllllllllllll

19. Remarks lllllllllllllll

(Approved by the Office of Management and

Budget under control number 0579–0040)

Done in Washington, DC, this 3rd day of

May 1996.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 96–11635 Filed 5–9–96; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter 1

[Docket No. 96N–0094]

Uniform Compliance Date for Food

Labeling Regulations; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

proposed rule that appeared in the

Federal Register of April 15, 1996 (61

FR 16422). The document proposed to

establish January 1, 1998, as its new

uniform compliance date for all food

labeling regulations that are issued after

the publication of a final rule based on

the proposal and before January 1, 1997.

The document was published with an

editorial error. This document corrects

that error.

FOR FURTHER INFORMATION CONTACT:

Gerad L. McCowin, Center for Food

Safety and Applied Nutrition (HFS–

150), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–205–4561.

In FR Doc. 96–9319, appearing on

page 16422 in the Federal Register of

Monday, April 15, 1996, the following

correction is made:

1. On page 16422, in the first column,

after the ‘‘DATES’’ caption, a new

caption is added to read as follows:

‘‘ADDRESSES: Submit written

comments to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.’’

Dated: May 6, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–11788 Filed 5–9–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 328

[Docket No. 95N–0341]

Over-the-Counter Drug Products

Intended for Oral Ingestion that

Contain Alcohol; Proposed

Amendment of Final Rule

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a notice

of proposed rulemaking that would

amend the regulations for over-thecounter (OTC) drug products intended

for oral ingestion that contain alcohol as

an inactive ingredient by exempting

ipecac syrup from the maximum

concentration limits of 0.5 percent

alcohol or less when used by children

under 6 years of age. This proposal is

part of the ongoing review of OTC drug

products conducted by FDA.

DATES: Submit written comments by

June 10, 1996; written comments on the

agency’s economic impact

determination by June 10, 1996. The

agency is proposing that any final rule

based on this proposal become effective

on the date of its publication in the

Federal Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch