Federal Register / Vol. 63, No. 16 / Monday, January 26, 1998 / Proposed Rules 3671

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

9 CFR Parts 54 and 79

[Docket No. 97–093–1]

RIN 0579–AA90

Interstate Movement of Sheep and

Goats From States That Do Not

Quarantine Scrapie Infected and

Source Flocks

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: We are soliciting public

comment to help us develop options for

potential changes to our regulations for

the interstate movement of sheep and

goats. We believe changes may be

necessary to improve control and limit

the spread of scrapie, a serious disease

of sheep and goats. After evaluating

public comment on the issues presented

in this notice, we will determine

whether proposing changes to our

regulations is necessary.

DATES: Consideration will be given only

to comments received on or before

March 27, 1998.

ADDRESSES: Comments may be

submitted as paper copies or through

the World Wide Web. If you submit

paper copies, please send an original

and three copies of your comments to

Docket No. 97–093–1, 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. 97–093–1. We encourage the

submission of copies through the World

Wide Web, since this both facilitates our

analysis of the comments and allows us

to make the text of comments available

to the public via the Internet. The Web

page address for comments on this

proposed rule is http://

www.aphis.usda.gov/ppd/scrapie. This

Web page also contains copies of the

proposed rule in several formats and

links to related information. Please be

sure to include your full name and

organization in any comments you

submit via the Web. If your Web

comment is a duplicate of a paper copy

you have submitted, please state this in

the first line of your Web message. Both

paper and Web 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.

Joseph VanTiem, Senior Staff

Veterinarian, National Animal Health

Programs, VS, APHIS, 4700 River Road

Unit 46, Riverdale, MD 20737–1231,

(301) 734–7716.

SUPPLEMENTARY INFORMATION:

Background

Scrapie is a degenerative and

eventually fatal disease affecting the

central nervous systems of sheep and

goats. Its control is complicated because

the disease often has an extremely long

incubation period without clinical signs

of disease, and because there is no

validated live-animal test for the

disease.

Scrapie is the prototype of the group

of diseases known as the transmissible

spongiform encephalopathies (TSEs).

These diseases are caused by a

transmissible agent which is yet to be

fully characterized. TSEs share the

following common characteristics:

• A prolonged incubation period of

months or years;

• A progressive debilitating

neurological illness that is always fatal;

• When examined by electron

microscopy, detergent treated extracts of

brain tissue from animals or humans

affected by these diseases reveal the

presence of scrapie associated fibrils;

• Pathological changes are confined

to the central nervous system and

include vacuolation, astrocytosis, and

glyosis. Amyloid plaques may be seen,

especially in mice and hamsters; and

• The transmissible agent elicits no

detectable specific immune response in

the host.

Several recent scientific findings are

relevant to the understanding and

control of scrapie. While there is still no

validated live animal test for scrapie, a

recent study conducted in The

Netherlands (Schreuder et al., 1996)

indicates that immunohistochemical

analysis of tonsil samples may be useful

in detecting scrapie in sheep prior to the

onset of clinical signs. The Animal and

Plant Health Inspection Service (APHIS)

is currently completing a pilot study to

harvest various tissues (tonsil, head

lymph nodes, and brain) from mature

sheep at slaughter and then test them

using immunohistochemistry to

ascertain if the partially proteaseresistant form of the prion protein

(PrPsc—the protein associated with

scrapie) may be routinely detected in

the preclinical animal. If this proves to

be an effective method of surveillance,

it may prove useful as a screening tool

and facilitate tracebacks to infected

flocks.

In addition to the possibility that a

validated live-animal test for scrapie

may be developed, genetic studies have

yielded a greater understanding of the

role of specific genes in determining the

incubation period of scrapie in sheep.

However, there is still much to be

determined about the role of genetics in

scrapie susceptibility. A key question is

whether certain genotypes fully prevent

scrapie infection, or merely protect

against clinical manifestation in an

animal while possibly allowing the

animal to serve as a carrier of scrapie.

While these advances may come to

significantly affect the control of

scrapie, current control programs rely

largely on postmortem diagnosis of

scrapie, traceback of animal movements,

and certification of flocks’ scrapie status

based on monitoring the flock for

scrapie over a period of years.

Current APHIS initiatives concerning

scrapie include interstate movement

regulations in 9 CFR part 79, which

restrict the interstate movement of

certain sheep and goats in order to help

control the spread of scrapie, and the

Voluntary Scrapie Flock Certification

Program (the Voluntary Program),

described in regulations in 9 CFR part

54 and in a program standards

document entitled ‘‘Uniform Methods

and Rules—Voluntary Scrapie Flock

Certification’’ (UM&R), which is

available at http://www.aphis.usda.gov/

vs/scrapie/umr. A hard-copy of the

UM&R may be obtained by contacting

the individual listed under FOR FURTHER

INFORMATION CONTACT.

APHIS worked with industry to

develop the Voluntary Program, under

which participating flocks follow strict

identification, recordkeeping and other

requirements and may eventually be

certified free from scrapie. If a flock that

is participating in the Voluntary

Program is identified as an infected

flock or source flock, it is removed from

the program until the flock completes a

flock plan. The flock plan calls for an

epidemiologic investigation to remove

high-risk animals from the flock and

includes other conditions, such as

cleaning and disinfection of flock

premises, educating flock personnel in

techniques to recognize clinical signs of

scrapie and control its spread, and

maintaining records of animals in the

flock.

The regulations in part 79 also restrict

the interstate movement of scrapiepositive sheep and goats, and sheep and

goats from scrapie infected and source

flocks. The regulations impose minimal

restrictions on the interstate movement
3672 Federal Register / Vol. 63, No. 16 / Monday, January 26, 1998 / Proposed Rules

1Throughout this document, when the term

‘‘animals’’ is used, it refers only to sheep and goats.

of animals 1 under 1 year of age destined

for slaughter and animals marked on the

jaw with a 1-inch letter ‘‘S.’’ Other

animals from scrapie infected and

source flocks may be moved interstate

under requirements that limit the

further spread of scrapie and make it

feasible to trace back the movements of

animals that are later diagnosed with

scrapie. These requirements include:

• The owner of the flock or his or her agent

has signed an agreement with the

Administrator in which the owner of the

flock or his or her agent agrees to comply

with the requirements of 9 CFR 79.2 until the

time the flock is no longer an infected flock

or source flock.

• The owner of the flock or his or her agent

shall immediately report to a State

representative, APHIS representative, or an

accredited veterinarian any animals in the

flock exhibiting the following: weight loss

despite retention of appetite; behavioral

abnormalities; pruritus (itching); wool

pulling; biting at legs or side; lip smacking;

motor abnormalities such as incoordination,

high stepping gait of forelimbs, bunny hop

movement of rear legs, swaying of back end;

increased sensitivity to noise and sudden

movement; tremor, ‘‘star gazing,’’ head

pressing, recumbency, or other signs of

neurological disease or chronic wasting

illness. Such animals must not be removed

from the flock without written permission of

an APHIS representative or State

representative.

• The owner of the flock or his or her agent

shall identify all animals 1 year of age or over

within the flock. All animals less than 1 year

of age will be identified when a change of

ownership occurs, with the exception of

those moving within slaughter channels. The

form of identification shall be an electronic

implant, flank tattoo, or ear tattoo, providing

a unique identification number that may be

applied by the owner of the flock or his or

her agent in accordance with instructions by

an APHIS representative, State

representative, or an accredited veterinarian.

• The owner of the flock or his or her agent

shall maintain, and keep for a minimum of

5 years after an animal dies or is otherwise

removed from a flock, the following records

for each animal in the flock: The animal’s

individual identification number from its

electronic implant, flank tattoo, or ear tattoo,

and any secondary form of identification the

owner of the flock may choose to maintain;

sex; breed; date of acquisition and source

(previous flock), if the animal was not born

in the flock; and disposition, including the

date and cause of death, if known, or date of

removal from the flock.

• The owner of the flock or his or her agent

shall allow breed associations and registries,

livestock markets, and packers to disclose

records to APHIS representatives or State

representatives, to be used to trace source

flocks and expose animals.

• The owner of the flock or his or her agent

shall make animals in the flock and records

required to be kept under paragraph (a)(2)(iv)

of 9 CFR 79.2 available for inspection by

APHIS representatives and State

representatives, given reasonable prior

notice.

• Upon request of an APHIS

representative, the owner of the flock or his

or her agent will have an accredited

veterinarian collect and submit tissues from

animals reported in accordance with

paragraph (a)(2)(ii) of 9 CFR 79.2 to a

laboratory designated by an APHIS

representative.

However, part 79 applies only when

flock owners wish to move sheep

interstate. Part 79 does not restrict the

intrastate movement of animals from

infected and source flocks, and such

movement may spread scrapie to other

animals in a State. If these other

animals, which are not subject to the

restrictions in part 79, then move

interstate, scrapie could be spread

interstate.

Therefore, there is a risk that scrapie

infection that originated in an infected

or source flock could spread interstate

despite part 79. This risk is very low

where State authorities have imposed

quarantines on infected and source

flocks that keep animals in these flocks

from contact with other animals. The

risk is higher in States that do not

quarantine scrapie infected and source

flocks.

APHIS does not have statutory

authority to require intrastate movement

restrictions for sheep and goats (unless

the Secretary has declared an

extraordinary emergency). However,

APHIS does have statutory authority to

restrict the interstate movement of

animals from a State if intrastate

movement practices result in a threat of

spreading disease interstate. We are

seeking public input on whether and

how APHIS should restrict the interstate

movement of animals from States that

do not quarantine infected and source

flocks.

We are examining current interstate

movement restrictions both to ensure

effective domestic control of scrapie and

to ensure that our domestic interstate

restrictions are consistent with our

requirements for importing sheep and

goats. The World Trade Organization

principles of ‘‘national treatment’’ and

‘‘transparency’’ state that regulations

shall be applied without discrimination

between domestic and imported

consignments, and that countries shall

make available to trading partners the

rationale of their requirements. Our

current regulations for importing sheep

and goats use equivalency with the

Voluntary Program to qualify certain

animals for import (see 9 CFR 93.435),

and we wish to ensure consistency

between our import requirements and

our interstate movement requirements.

We believe the interstate movement

restrictions and the definition of ‘‘flock

plan’’ in part 79 provide a good model

for how an infected or source flock may

be effectively quarantined and managed

until release from quarantine is

justified. One possible approach to

controlling the intrastate contact risks

described above would be to amend part

79 to prohibit or restrict movement of

animals from a State unless the State

quarantines infected and source flocks

in a manner that is equivalent to the

methods employed by part 79. However,

commenters may well suggest other

approaches to revising part 79 to

address the risks of intrastate

movements from infected and source

flocks.

In particular, we ask commenters to

address the following areas that apply to

possible State quarantine standards, the

alignment of Federal interstate

movement restrictions with State

standards, and Voluntary Program

standards:

• Should APHIS further restrict interstate

movement of animals from States that do not

consider scrapie a reportable disease or do

not quarantine infected flocks or source

flocks? If so, should restrictions focus on

high-risk animals or on broader classes of

animals? (A high-risk animal is defined in 9

CFR 79.1. In short, a high-risk animal is: (1)

An animal that is the progeny of a scrapiepositive dam; (2) an animal born in the same

flock during the same lambing season as

progeny of a scrapie-positive dam, with

certain exceptions outlined in the definition;

or (3) an animal born during the same

lambing season as a scrapie-positive ewe or

ram in a source flock or trace flock.)

• Currently, part 79 does not restrict

interstate movement of high-risk animals

from flocks that are not infected flocks or are

not source flocks. Should APHIS restrict such

movements, and if so, how?

• Should APHIS define how a State must

conduct a quarantine in order to avoid

further restrictions on interstate movement of

animals from that State? If so, how should

APHIS describe the necessary quarantine

conditions (e.g., imposition of the quarantine;

movement of animals into and from

quarantined flocks; duration of the

quarantine; identification requirements for

quarantined animals, development and use of

a flock plan; procedures for release from

quarantine and follow-up monitoring)?

• Should any of the definitions in the

interstate movement regulations in part 79 or

the Voluntary Program in part 54 be revised

to better address this problem (e.g., the

definitions of source flock, trace flock, and

high-risk animal)?

• Should there be additional permit or

official identification requirements for the

interstate movement of any classes of sheep

and goats to allow for a more effective

national program for surveillance for scrapie

and traceback of scrapie-positive animals?

• Currently APHIS makes the following

information available on its World Wide Web
Federal Register / Vol. 63, No. 16 / Monday, January 26, 1998 / Proposed Rules 3673

site: The identity of scrapie infected flocks

and source flocks designated under part 79,

and the identity and certification status of

flocks participating in the Voluntary

Program. Should APHIS continue to provide

this information on the Web?

• To assess the impacts of options

regarding the interstate movement of sheep

and goats, baseline estimates of costs and

benefits are needed. What are the costs and

benefits of the current system of part 79,

State quarantine standards, and the

Voluntary Program? For example, what costs

are involved in complying with State

quarantine programs and how large are these

costs? Similarly, what are the costs to a flock

owner who participates in the Voluntary

Program?

We invite comments on these topics.

We also welcome ideas as to different

approaches we might take to improve

our scrapie programs. In responding to

the questions posed in this notice,

commenters are urged to include

economic reasons and data supporting

their positions.

Whenever possible, please refer to

specific terms, definitions, or

procedures contained in the current

regulations in 9 CFR parts 54 and 79,

and in the program standards UM&R

(available at http://

www.aphis.usda.gov/vs/scrapie/umr). A

hard-copy of the program standards

UM&R may be obtained by contacting

the individual listed under FOR FURTHER

INFORMATION CONTACT. These resources

should provide a common context for

discussing suggested changes. You may

also wish to refer to the Scrapie Flock

Status Report on the APHIS Web, which

lists the certification status of flocks in

the Voluntary Program and identifies

known infected and source flocks

nationwide. This report is at http://

www.aphis.usda.gov/vs/scrapie/

status.html.

Authority: 21 U.S.C. 111–114, 114a, 115,

117, 120, 121, 123–126, 134a–134h; 7 CFR

2.22, 2.80, and 371.2(d).

Done in Washington, DC, this 21st day of

January 1998.

Thomas E. Walton,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 98–1810 Filed 1–21–98; 4:40 pm]

BILLING CODE 3410–34–M

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 50

RIN 3150–AE26

Industry Codes and Standards:

Amended Requirements

AGENCY: Nuclear Regulatory

Commission.

ACTION: Extension of public comment

period on proposed rule.

SUMMARY: On December 3, 1997, (62 FR

63892) the NRC published for public

comment a proposed rule to amend its

regulations to incorporate by reference

later editions and addenda of the

American Society of Mechanical

Engineers Boiler and Pressure Vessel

Code. The comment period for this

proposed rule was to have expired on

March 3, 1998. The Nuclear Energy

Institute (NEI), on behalf of the nuclear

energy industry, requested an extension

of the comment period for the proposed

revision. NEI stated that the

comprehensive nature of this proposed

rule will require a significant effort to

collect and review comments from

members of the industry. The NRC

agrees that the proposed rule constitutes

a significant revision to 10 CFR 50.55a.

In order to ensure that the NRC receives

comments from the parties most likely

to be affected by the revision, the NRC

has decided to extend the public

comment period for an additional 30

days. The extended comment period

now expires on April 3, 1998.

DATES: The comment period has been

extended and now expires April 3,

1998. Comments received after this date

will be considered if it is practical to do

so, but the Commission is able to ensure

consideration only for comments

received on or before this date.

ADDRESSES: Comments may be sent to:

Secretary, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001. ATTN: Rulemaking and

Adjudications Staff. Hand deliver

comments to 11545 Rockville Pike,

Rockville, Maryland, 20852, between

7:30 am and 4:15 pm on Federal

workdays.

You may also provide comments via

the NRC’s interactive rulemaking

website through the NRC home page

(http://www.nrc.gov). This site provides

the availability to upload comments as

files (any format), if your web browser

supports that function. For information

about the interactive website, contact

Ms. Carol Gallagher, (301) 415–5905;

e-mail CAG@nrc.gov.

Single copies of this proposed

rulemaking may be obtained by written

request or telefax to 301–415–2260 or

from Frank C. Cherny, Division of

Engineering Technology, Office of

Nuclear Regulatory Research, U.S.

Nuclear Regulatory Commission,

Washington, DC 20555–0001,

Telephone: 301–415–6786, or Wallace

E. Norris, Division of Engineering

Technology, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001, Telephone: 301–415–6796.

Certain documents related to this

rulemaking, including comments

received, may be examined at the NRC

Public Document Room, 2120 L Street

NW. (Lower Level), Washington, DC.

These same documents may also be

viewed and downloaded via the

interactive rulemaking website as

established by NRC for this rulemaking.

FOR FURTHER INFORMATION CONTACT:

Frank C. Cherny, 301–415–6786.

Dated at Rockville, Maryland, this 14th day

of January, 1998.

For the Nuclear Regulatory Commission.

L. Joseph Callan,

Executive Director for Operations.

[FR Doc. 98–1750 Filed 1–23–98; 8:45 am]

BILLING CODE 7590–01–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 97–ASO–31]

Proposed Amendment to Class E

Airspace; Daytona Beach, FL

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: This notice proposes to

amend Class E airspace at Daytona

beach, FL. A Global Positioning System

(GPS) Runway (RWY) 6 (Special)

Standard Instrument Approach

Procedure (SIAP) has been developed

for Spruce Creek Airport. As a result,

additional controlled airspace extending

upward from 700 feet Above Ground

Level (AGL) is needed to accommodate

the SIAP and for Instrument Flight

Rules (IFR) operations at Spruce Creek

Airport. The operating status of the

airport will change from Visual Flight

Rules (VFR) to include IFR operations

concurrent with the publication of the

SIAP.

DATES: Comments must be received on

or before February 25, 1998.

ADDRESSES: Send comments on the

proposal in triplicate to: Federal

Aviation Administration, Docket No.

97–ASO–31, Manager, Airspace Branch,

ASO–520, P.O. Box 20636, Atlanta,

Georgia 30320.

The official docket may be examined

in the Office of the Assistant Chief

Counsel for Southern Region, Room 550,

1701 Columbia Avenue, College Park,

Georgia 30337; telephone (404) 305–

5586.

FOR FURTHER INFORMATION CONTACT:

Nancy B. Shelton, Airspace Branch, Air