Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules 42705

§ 71.6 [Amended]

6. In § 71.6, paragraph (a) would be

amended by removing the words ‘‘, or

carrying the infection of,’’.

7. In § 71.13, the undesignated

regulatory text would be revised to read

as follows:

§ 71.13 Inspection of shipments in transit

by APHIS inspector.

All persons having control of the

interstate transportation of animals

shall, when directed by an APHIS

inspector, stop the same in transit for

inspection, and if any of such animals

are found upon such inspection to be

affected with any contagious, infectious,

or communicable disease of livestock or

poultry, the person having control of the

transportation of such animals shall,

upon receipt of an order from an APHIS

inspector, cease the transportation of

such animals unless such transportation

can be accomplished in accordance with

the regulations in this subchapter

governing the interstate movement of

animals affected with such disease, and

in all cases after the discovery of such

infection or exposure thereto such

animals shall be handled in accordance

with such regulations.

8. In § 71.14, the section heading and

the undesignated regulatory text would

be revised to read as follows:

§ 71.14 Slaughter of animals to prevent

spread of disease; ascertainment of value

and compensation.

When, in order to prevent the spread

of any contagious, infectious, or

communicable disease of livestock or

poultry, it becomes necessary to

slaughter any animals affected with the

disease and the purchase of such

animals by the United States is

authorized by law and an appropriation

is available therefor, the value of the

animals shall be ascertained and

compensation made therefor in

accordance with the orders or

regulations of the Secretary of

Agriculture.

Done in Washington, DC, this 4th day of

August, 1997.

Terry L. Medley,

Administrator, Animal and Plant Health

Inspection Service.

[FR Doc. 97–20995 Filed 8–7–97; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

9 CFR Part 92

[Docket No. 96–052–2]

Horses From Mexico; Quarantine

Requirements

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We are proposing to amend

the regulations regarding the

importation of horses from Mexico to

remove the requirement that such

horses be quarantined for not less than

7 days in vector-proof quarantine

facilities before being imported into the

United States. We believe that this

action is warranted because Mexico has

reported no cases of Venezuelan equine

encephalomyelitis (VEE) in the past

year, and it appears that horses

imported into the United States from

Mexico without a 7-day quarantine

would not pose a risk of transmitting

VEE to horses in the United States.

DATES: Consideration will be given only

to comments received on or before

October 7, 1997.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 96–052–2, 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. 96–052–2. 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.

Gary Colgrove, Chief Staff Veterinarian,

National Center for Import and Export,

VS, APHIS, 4700 River Road Unit 38,

Riverdale, MD 20737–1231, (301) 734–

3276.

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 and animal

products, including horses from Mexico,

to prevent the introduction into the

United States of various animal

diseases.

On July 31, 1996, we published an

interim rule in the Federal Register (61

FR 39852–39853, Docket No. 96–052–1)

in which we required that horses

imported into the United States from

Mexico be quarantined for not less than

7 days in a vector-free facility. Prior to

our interim rule, horses from Mexico

were not required to be held in

quarantine for any specified number of

days, but were required, instead, to be

quarantined only long enough to

complete the testing required by the

regulations.

A 7-day quarantine became necessary

when the government of Mexico

reported that Venezuelan equine

encephalomyelitis (VEE) had been

detected in horses in that country. VEE

is an equine viral disease, transmitted

primarily by mosquitoes and other

hematophagous (blood-feeding) insects,

particularly flying insects, and results in

a high mortality rate in animals infected

with the disease. Although tests exist for

the presence of VEE in horses, the tests

currently available may yield positive

results for horses that have been

vaccinated for VEE but are not

otherwise infected with the disease. The

most efficient method for initial

identification of horses that may be

infected with VEE is observation of the

horses for clinical signs of the disease.

The clinical signs most commonly

exhibited by horses infected by VEE are

marked fever, depression, and

incoordination, followed by death. A

horse will usually exhibit signs of VEE

within 2–5 days after contracting the

disease. Seven days is considered the

length of time necessary to ensure that

any clinical signs of VEE manifest

themselves.

In this document, we are proposing to

remove the requirement that horses

from Mexico be quarantined for not less

than 7 days. We believe that the removal

of this requirement is warranted because

Mexico appears to be free of VEE.

Horses imported from Mexico would

still be required to be held in quarantine

until it has been determined that the

animals are free of exotic pests and

diseases.

The last case of VEE in Mexico was

reported in July 1996. Following the

initial outbreak of VEE in the Mexican

State of Oaxaca in June 1996, the

Government of Mexico instituted

emergency measures to locate, contain,

and eradicate the disease. These

emergency measures included the

following: activation of the country’s

animal health emergency group;

organization of groups such as regional

livestock associations and State

authorities; establishment of

quarantines in areas in which the
42706 Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules

disease was known to exist;

vaccinations of horses in affected areas;

traceback of horses that might have been

moved from affected areas before

quarantine measures were established;

and increased surveillance in States

surrounding the affected areas. Based on

these considerations, the Government of

Mexico has requested that the U.S.

Department of Agriculture consider

Mexico to be free of VEE.

Based on the documentation

submitted by the Government of

Mexico, it appears that no horses in that

country are infected with VEE. (This

documentation is available, upon

written request, from the person listed

under FOR FURTHER INFORMATION

CONTACT.) Therefore, we are proposing

to amend § 92.324 of the regulations to

remove the requirement that horses

intended for importation from Mexico

be quarantined for not less than 7 days

before being imported into the United

States.

We are also proposing to remove the

requirement in § 92.324 that horses from

Mexico intended for importation into

the United States through land border

ports be quarantined in Mexico at a

facility approved by the Administrator

of the Animal and Plant Health

Inspection Service (APHIS) and

constructed so as to prevent the entry of

mosquitoes and other hematophagous

insects. This requirement was necessary

when VEE was known to exist in horses

in Mexico, but we believe that it is

unnecessary now that Mexico appears to

be free of VEE.

Executive Order 12866 and Regulatory

Flexibility Act

This proposed rule has been reviewed

under Executive Order 12866. For this

action, the Office of Management and

Budget has waived its review process

required by Executive Order 12866.

We are proposing to amend the

regulations regarding the importation of

horses from Mexico to remove the

requirement that such horses be

quarantined for not less than 7 days in

vector-proof quarantine facilities before

being imported into the United States.

We believe that this action is warranted

because Mexico has reported no cases of

VEE in the past year, and it appears that

horses imported into the United States

from Mexico without a 7-day quarantine

would not pose a risk of transmitting

VEE to horses in the United States.

Horses imported from Mexico would

still be required to be held in quarantine

until it has been determined that the

animals are free of exotic pests and

diseases.

Horses enter the United States from

Mexico for a variety of reasons,

including for breeding, competition,

racing, research, and slaughter. During

fiscal year 1996, about 7,359 horses

were imported into the United States

from Mexico. In fiscal year 1995, there

were about 15,317 horses imported from

Mexico.

Under current restrictions placed on

imported Mexican horses due to an

outbreak of VEE in that country in 1996,

horses intended for importation into the

United States from Mexico must be held

in a vector-proof quarantine facility for

seven days prior to entering the United

States. Because Mexico has been

determined to be free of VEE, this rule

proposes to eliminate the requirement

for a 7-day quarantine at a facility

approved by the Administrator of

APHIS and constructed so as to prevent

the entry of mosquitoes and other

hematophagous insects. Horses

imported from Mexico would continue

to be required to be held in quarantine

until it has been determined that the

animal is free of exotic pests and

diseases. This quarantine period

generally lasts three or four days, based

on the turnaround time at the laboratory

where blood tests are performed.

Horses intended for importation into

the United States from Mexico are

quarantined in Mexican facilities

operated by the Mexican Cattleman’s

Association. Different fees are assessed

by the six State chapters which operate

facilities along the United States/Mexico

border. We estimate that the quarantine

charge at vector-proof facilities is

between $5.00 and $35.00 per head per

day for the current 7-day quarantine, or

$35 to $250 per animal imported.

Quarantine charges at the other

facilities, which are not vector-proof,

that would again be eligible to

quarantine horses intended for

importation into the United States if

Mexico is recognized as free of VEE

average $3.00 per head per day. A 4-day

quarantine would cost importers $12.00

per animal imported. Therefore,

importers could potentially save

between $23 and $238 per animal

imported in quarantine charges. Of

course, there are other amenities at

some of the vector-proof facilities that

could still draw some importers to those

facilities. At fiscal year 1996 import

levels, the elimination of the VEE

quarantine could decrease the

quarantine costs of domestic importers

by between $169,257 and $1.75 million

annually.

In addition, the removal of the VEE

restriction would eliminate the need for

daily visits during the quarantine period

to the quarantine facility by APHIS’

veterinary medical officers (VMOs) and

animal health technicians (AHTs) to

conduct temperature checks of the

animals to be imported. APHIS charges

hourly user fees for inspection services

conducted outside the United States.

The published hourly fee for VMOs and

AHTs is $56.00. The agency estimates

that it takes 3 hours for APHIS

personnel to travel to Mexican

quarantine facilities and complete the

temperature checks. The elimination of

these checks would save the importer

about $1,176 per shipment. Since

slaughter horse imports from Mexico

average about 40 head per shipment,

this is a savings of about $29.40 per

head. Other types of imported horses

from Mexico average about two head per

shipment, for a savings of $588 per

head. At fiscal year 1996 import levels,

the elimination of the user fees for horse

inspection for VEE in Mexico would

decrease the cost of importation by

about $2.5 million annually.

The Regulatory Flexibility Act

requires that the Agency specifically

consider the economic impact

associated with rule changes on small

entities. The Small Business

Administration (SBA) has set forth size

criteria by Standard Industrial

Classification (SIC) which can be used

as a guide in determining which

economic entities meet the definition of

a small business. The SBA’s definition

of a small business engaged in the

wholesale trading of livestock is one

that employs no more than 100 persons.

Currently, there are 1,992 domestic

entities that trade livestock wholesale.

About 1,965 of these entities are

classified as small by the SBA. The

exact number of domestic wholesale

livestock traders currently importing

Mexican horses cannot be determined.

However, entities, whether large or

small, engaged in importing Mexican

horses would be positively impacted by

this rule change.

Under these circumstances, the

Administrator of the Animal and Plant

Health Inspection Service has

determined that this action would not

have a significant economic impact on

a substantial number of small entities.

Executive Order 12988

This proposed rule has been reviewed

under Executive Order 12988, Civil

Justice Reform. If this proposed rule is

adopted: (1) All State and local laws and

regulations that are inconsistent with

this rule will be preempted; (2) no

retroactive effect will be given to this

rule; and (3) administrative proceedings

will not be required before parties may

file suit in court challenging this rule.
Federal Register / Vol. 62, No. 153 / Friday, August 8, 1997 / Proposed Rules 42707

Paperwork Reduction Act

This proposed rule contains no new

information collection or recordkeeping

requirements under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.).

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, BIRDS, AND POULTRY,

AND CERTAIN ANIMAL, BIRD, AND

POULTRY PRODUCTS;

REQUIREMENTS FOR MEANS OF

CONVEYANCE AND SHIPPING

CONTAINERS

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).

§ 92.308 [Amended]

2. In § 92.308, paragraph (a)(1) would

be amended by removing the reference

to ‘‘§ 92.317’’ and adding in its place the

reference to ‘‘§§ 92.317 and 92.324’’.

§ 92.324 [Amended]

3. Section 92.324 would be amended

by removing the words ‘‘, for not less

than 7 days and’’ and by removing the

words ‘‘approved by the Administrator

and constructed so as to prevent the

entry of mosquitoes and other

hematophagous insects’’.

§ 92.326 [Amended]

4. In § 92.326, the first sentence

would be amended by removing the

words ‘‘92.323, and 92.324’’ and adding

in their place the words ‘‘and 92.323’’.

Done in Washington, DC, this 4th day of

August 1997.

Terry L. Medley,

Administrator, Animal and Plant Health

Inspection Service.

[FR Doc. 97–20994 Filed 8–7–97; 8:45 am]

BILLING CODE 3410–34–P

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 35

Medical Use of Byproduct Material;

Working Group for Revision

AGENCY: U.S. Nuclear Regulatory

Commission.

ACTION: Establishment of working group

and notice of meeting.

SUMMARY: A working group consisting of

representatives from the U.S. Nuclear

Regulatory Commission, the

Organization of Agreement States

(OAS), and the Conference of Radiation

Control Program Directors (CRCPD) has

been established in response to

Commission approval of the staff’s

proposed plan for revising 10 CFR part

35, associated guidance documents, and

the Commission’s 1979 ‘‘Medical Policy

Statement,’’ if necessary. With this

approval, the NRC staff has begun

developing draft rule language and

alternatives, using an entirely modalitybased approach, to help focus the public

input and the discussions during

facilitated public meetings. During this

process, the staff is examining the

applicability of risk-informed,

performance-based regulations and less

prescriptive approaches to regulation of

nuclear material used for medical

purposes. The working group will meet

at NRC Headquarters in Rockville,

Maryland, on August 19 and August 20,

1997, to review the early draft staff

documents and to discuss the major

regulatory issues associated with the

medical use of byproduct material.

DATES: The Working Group will meet on

August 19 and 20, 1997, from 9:00 a.m.

to 5:00 p.m.

ADDRESSES: U.S. Nuclear Regulatory

Commission, One White Flint North,

Auditorium, 11555 Rockville Pike,

Rockville, MD, 20852–2738.

FOR FURTHER INFORMATION CONTACT:

Cathy Haney, U.S. Nuclear Regulatory

Commission, Office of Nuclear Material

Safety and Safeguards, MS T8F5,

Washington, DC 20555, telephone (301)

415–6825, e-mail cxh@nrc.gov.

SUPPLEMENTARY INFORMATION: NRC has

examined the issues surrounding its

medical use program in great detail

during the last four years. This process

started with NRC’s 1993 internal senior

management review report; continued

with the 1996 independent external

review report by the National Academy

of Sciences, Institute of Medicine; and

culminated in NRC’s Strategic

Assessment and Rebaselining Project

(SA). In particular, medical oversight

was addressed in the SA DirectionSetting Issue Paper Number 7 (DSI 7)

(released September 16, 1996). In its

‘‘Staff Requirements Memorandum

(SRM)—COMSECY–96–057, Materials/

Medical Oversight (DSI 7),’’ dated

March 20, 1997, the Commission

directed staff to revise Part 35,

associated guidance documents, and, if

necessary, the Commission’s 1979

‘‘Medical Policy Statement.’’ The

Commission SRM specifically directed

the restructuring of Part 35 into a riskinformed, more performance-based

regulation.

A June 30, 1997, SRM informed the

staff of the Commission’s approval, with

comments, of the staff’s proposed

program in SECY–97–131,

Supplemental Information on SECY–

97–115, ‘‘Program for Revision of 10

CFR Part 35, ‘Medical Uses of

Byproduct Material,’ and Associated

Federal Register Notice,’’ dated June 20,

1997. After this approval, the NRC staff

initiated development of draft rule

language, using an entirely modalitybased approach. The modality approach

places all requirements for a given type

of treatment into a single section of the

regulation, including: (a) Who or what

organization is licensed; (b) what type of

license is issued; (c) the necessary

technical requirements, such as surveys

and calibration; (d) the training and

experience requirements; (e) the event

recording and reporting requirements;

and (f) the quality improvement and

management objectives.

Per NRC Management Directive 6.3,

‘‘The Rulemaking Process,’’ the

rulemaking will be conducted using a

group approach. A governmental

working group consisting of

representatives of NRC, OAS, and

CRCPD has been established to develop

rule text alternatives, including draft

guidance documents. State participation

in the process will enhance

development of corresponding rules in

State regulations, and provide an

opportunity for early State input and

will allow the State staff to assess

potential impacts of NRC draft language

on the regulation of non-Atomic Energy

Act materials used in medical diagnosis,

treatment, or research, in the States.

At the initial meeting of the working

group, on August 19–20, 1997, the

group will review the initial draft input

developed by the NRC staff, focusing its

discussion on the major regulatory

issues associated with the medical use

of byproduct material.

Committee Organization and

Operations

Cathy Haney, NRC, Office of Nuclear

Material Safety and Safeguards, will

serve as chairman. Other members are

from the NRC’s Office of Nuclear

Material Safety and Safeguards; Office

of Nuclear Regulatory Research; Office

of the General Counsel, and Office of

State Programs; and from OAS and

CRCPD.