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

65630

Vol. 62, No. 240

Monday, December 15, 1997

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

9 CFR Part 85

[Docket No. 96–013–1]

Official Pseudorabies Tests

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We are proposing to amend

the pseudorabies regulations by adding

the glycoprotein I Particle Concentration

Fluorescence Immunoassay test to the

list of official pseudorabies tests and

allow its use as an approved differential

test. We are proposing to take this action

based on a finding that the sensitivity

and specificity of the glycoprotein I

Particle Concentration Fluorescence

Immunoassay test are equivalent to

those of official tests for the diagnosis of

pseudorabies. This proposed change

would allow the glycoprotein I Particle

Concentration Fluorescence

Immunoassay test to be used as an

official pseudorabies test to qualify

certain pseudorabies vaccinated swine

for interstate movement to destinations

other than slaughter or a quarantined

herd or quarantined feedlot. Adding the

glycoprotein I Particle Concentration

Fluorescence Immunoassay test to the

list of official pseudorabies tests would

also allow its use for the testing of

nonvaccinated swine.

DATES: Consideration will be given only

to comments received on or before

February 13, 1998.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 96–013–1, 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. 96–013–1. 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.

Arnold C. Taft, Senior Staff

Veterinarian, Swine Health Staff, VS,

APHIS, 4700 River Road Unit 43,

Riverdale, MD 20737–1231, (301) 734–

4916; or e-mail: ataft@aphis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

Pseudorabies is a contagious,

infectious, and communicable disease of

livestock, primarily swine, and other

animals. The disease, also known as

Aujeszky’s disease, mad itch, and

infectious bulbar paralysis, is caused by

a herpes virus. The Animal and Plant

Health Inspection Service’s (APHIS’)

regulations in 9 CFR part 85 (referred to

below as the regulations) govern the

interstate movement of swine and other

livestock (cattle, sheep, and goats) in

order to help prevent the spread of

pseudorabies.

For the purposes of interstate

movement, the regulations separate

swine into four basic categories: (1)

Swine infected with or exposed to

pseudorabies; (2) pseudorabies

vaccinated swine (except swine from

qualified negative gene-altered

vaccinated herds) not known to be

infected with or exposed to

pseudorabies; (3) swine not vaccinated

for pseudorabies and not known to be

infected with or exposed to

pseudorabies; and (4) swine from

qualified negative gene-altered

vaccinated herds. Provisions governing

the interstate movement of swine from

each category are found in §§ 85.5, 85.6,

85.7, and 85.8, respectively.

Paragraphs (a) and (b) of § 85.6

provide that pseudorabies vaccinate

swine, except swine from qualified

negative gene-altered vaccinated herds,

that are not known to be infected with

or exposed to pseudorabies may be

moved interstate directly to slaughter or

to a quarantined herd or quarantined

feedlot under certain specified

conditions. Paragraph (c) of § 85.6

further provides that such pseudorabies

vaccinate swine may be moved

interstate to destinations other than

slaughter or a quarantined herd or

quarantined feedlot if the swine have

been vaccinated for pseudorabies with a

glycoprotein I (gpI) deleted gene-altered

pseudorabies vaccine and they are

accompanied by a certificate that is

delivered to the consignee. The

regulations in § 85.6(c) also require that

the certificate contain certain additional

information, specifically: (1) The

identification of each swine; (2) a

statement that each swine was

vaccinated with a gpI deleted genealtered pseudorabies vaccine; (3) a

statement that each swine has been

subjected to an approved differential

pseudorabies test no more than 30 days

prior to the interstate movement and has

been found negative; (4) the date of the

approved differential pseudorabies tests;

and (5) the name of the laboratory that

conducted the approved differential

pseudorabies test. Currently, the

regulations provide only for the use of

the gpI enzyme-linked immunosorbent

assay (ELISA) as an approved

differential pseudorabies test to qualify

swine for interstate movement under

§ 85.6(c).

The Committee on Diagnostics and

Interpretive Serology of the American

Association of Veterinary Laboratory

Diagnosticians (AAVLD) has recognized

that the sensitivity and specificity of the

gpI Particle Concentration Fluorescence

Immunoassay (PCFIA) test are

equivalent to those of official tests for

the diagnosis of pseudorabies. Based on

that finding, we are proposing to add

the gpI PCFIA test to the list of official

pseudorabies tests in § 85.1 and allow

its use as an approved differential

pseudorabies test to qualify swine for

interstate movement under § 85.6(c).

Adding the gpI PCFIA test as an

official pseudorabies test would also

mean that the gpI PCFIA test would be

available for testing nonvaccinated

swine to determine their pseudorabies

status. As noted above, the AAVLD has

recognized that the sensitivity and

specificity of the gpI PCFIA test are

equivalent to those of official tests for

the diagnosis for pseudorabies. The gpI

PCFIA test is specific for antibodies to

the glycoprotein I present in the

pseudorabies virus; nonvaccinated

swine, as well as swine vaccinated with

a gpI-deleted vaccine, would not

produce positive results to the gpI

PCFIA test unless the swine were

infected with pseudorabies. Designating

the gpI PCFIA test as an official

pseudorabies test would enable swine
Federal Register / Vol. 62, No. 240 / Monday, December 15, 1997 / Proposed Rules 65631

producers to use a single test on both

gpI vaccinates and nonvaccinated

swine.

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.

This proposed rule would amend the

pseudorabies regulations by adding the

gpI PCFIA test to the list of official

pseudorabies tests. This proposed

change would allow the gpI PCFIA test

to be used as an official pseudorabies

test to qualify certain pseudorabies

vaccinated swine for interstate

movement to destinations other than

slaughter or a quarantined herd or

quarantined feedlot. Adding the gpI

PCFIA test to the list of official

pseudorabies tests would also allow its

use for the testing on nonvaccinated

swine.

The total U.S. inventory of hogs and

pigs was approximately 56 million,

valued at $5.283 billion, in 1996. The

gross income of the inventory is

approximately $11 billion. More than 99

percent of swine producers are

considered to be small entities.

According to the standard set by the

Small Business Administration for

agricultural producers, a producer with

less than $0.5 million annually in sales

qualifies as a small entity.

Nearly 95 percent of the swine

inventory within the United States has

not yet achieved pseudorabies-free

status. The addition of this new test

would provide an extra choice of official

pseudorabies test for those who raise

swine, when a test is required for

interstate movement. Testing costs

would be incurred only when an owner

chose to move gpI vaccinates interstate

to destinations other than slaughter or a

quarantined herd or quarantined

feedlot, since pseudorabies vaccinated

swine do not require a test prior to

interstate movement for slaughter or to

a quarantined herd or quarantined

feedlot. The cost of the gpI PCFIA test

is within the range of the currently

available tests. The test is highly

automated and those laboratories that

have the test kit would be expected to

accomplish the testing on large numbers

of samples with greater speed. The test

results have been found to produce

fewer false negatives, reducing the need

for tracebacks. The positive effect of

having accurate results in a short time

would be beneficial in all stages of

pseudorabies eradication.

The provisions of this proposed rule

that would allow the use of the gpI

PCFIA test to determine the

pseudorabies status of nonvaccinated

swine are not expected to have a

significant economic impact on the

owners of nonvaccinated swine, as it

only introduces an additional

pseudorabies testing tool to ensure the

health of the U.S. swine population. It

is likely, though, that since the new gpI

PCFIA test may be slightly higher in

cost than other testing tools that are on

the market, most owners of

nonvaccinated swine would continue

using less expensive official

pseudorabies test until the cost of the

gpI PCFIA test became comparable to

that of other official tests.

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 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 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 in conflict 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

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 85

Animal diseases, Livestock,

Quarantine, Reporting and

recordkeeping requirements,

Transportation.

Accordingly, 9 CFR part 85 would be

amended as follows:

PART 85—PSEUDORABIES

1. The authority citation for part 85

would continue to read as follows:

Authority: 21 U.S.C. 111, 112, 113, 115,

117, 120, 121, 123–126, 134b, and 134f; 7

CFR 2.22, 2.80, and 371.2(d).

§ 85.1 [Amended]

2. In § 85.1, in the definition of

official pseudorabies test, in the second

sentence, item 6 would be amended by

adding the words ‘‘, including the gpI

PCFIA test’’ immediately after the word

‘‘Test’’.

§ 85.6 [Amended]

3. Section 85.6 would be amended as

follows:

a. In paragraph (c)(2)(iii), the words

‘‘or a gpI Particle Concentration

Fluorescence Immunoassay (PCFIA)’’

would be added immediately after the

word ‘‘(ELISA)’’.

b. In paragraph (c)(2)(iv), the words

‘‘or the gpI PCFIA’’ would be added

immediately after the word ‘‘ELISA’’.

c. In paragraph (c)(2)(v), the words ‘‘or

the gpI PCFIA’’ would be added

immediately after the word ‘‘ELISA’’.

Done in Washington, DC, this 9th day of

December 1997.

Craig A. Reed,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 97–32658 Filed 12–12–97; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 96–ANM–15]

RIN 2120–AA66

Proposed Modification of VOR Federal

Airway V–465

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: This action proposes to

modify Federal Airway 465 (V–465) by

lowering the floor of a portion of the

airway from 12,400 feet mean sea level

(MSL) to 1,200 feet above the surface.

This action also proposes to establish a

new segment of V–465 between Billings,

Montana, and Miles City, Montana. The

FAA is proposing this action to support

an instrument approach procedure that

is being developed for the Jackson Hole

Airport, Wyoming, and to enhance

aircraft operations management in the

Jackson Hole, Wyoming, area.

DATES: Comments must be received on

or before January 28, 1998.

ADDRESSES: Send comments on the

proposal in triplicate to: Manager, Air

Traffic Division, ANM–500, Docket No.

96–ANM–15, Federal Aviation

Administration, 1601 Lind Avenue,

SW., Renton, WA 98055–4056. The