[Federal Register Volume 63, Number 68 (Thursday, April 9, 1998)]
[Rules and Regulations]
[Pages 17315-17316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9377]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 85

[Docket No. 96-013-2]


Official Pseudorabies Tests

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the pseudorabies regulations by adding the 
glycoprotein I Particle Concentration Fluorescence Immunoassay test to 
the list of official pseudorabies tests and allowing its use as an 
approved differential test. We are taking 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 rule 
allows 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 also allows 
its use for the testing of nonvaccinated swine.

EFFECTIVE DATE: April 9, 1998.

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: 
[email protected].

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.
    On December 15, 1997, we published in the Federal Register (62 FR 
65630-65631, Docket No. 96-013-1) a proposal to amend the pseudorabies 
regulations by adding the glycoprotein I (gpI) Particle Concentration 
Fluorescence Immunoassay (PCFIA) test to the list of official 
pseudorabies tests and allow its use as an approved differential test. 
We proposed this action based on a finding that the sensitivity and 
specificity of the gpI PCFIA test are equivalent to those of official 
tests for the diagnosis of pseudorabies.
    We solicited comments concerning our proposal for 60 days ending 
February 13, 1998. We did not receive any comments. Therefore, based on 
the rationale set forth in the proposed rule, we are adopting the 
provisions of the proposal as a final rule without change.

Effective Date

    This is a substantive rule that relieves restrictions and, pursuant 
to the provisions of 5 U.S.C. 553, may be made effective less than 30 
days after publication in the Federal Register.
    This rule will provide an alternative official pseudorabies test to 
be used as an approved differential test. It will allow the gpI PCFIA 
test to be used as an official pseudorabies test to qualify certain 
pseudorabies vaccinated swine for interstate movement to destinations

[[Page 17316]]

other than slaughter or a quarantined herd or quarantined feedlot. 
Making this rule effective immediately will allow producers of swine to 
use the gpI PCFIA test for the testing of nonvaccinated swine. 
Therefore, the Administrator of the Animal and Plant Health Inspection 
Service has determined that this rule should be effective upon 
publication in the Federal Register.

Executive Order 12866 and Regulatory Flexibility Act

    This 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 rule amends the pseudorabies regulations by adding the gpI 
PCFIA test to the list of official pseudorabies tests. This rule will 
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 will 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 was 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 will provide an extra choice of official pseudorabies test for 
those who raise swine, when a test is required for interstate movement. 
Testing costs will be incurred only when an owner chooses to move a 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 
are 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 will be beneficial in all 
stages of pseudorabies eradication.
    Allowing the use of the gpI PCFIA test to determine the 
pseudorabies status of nonvaccinated swine is not expected to have a 
significant economic impact on the owners of nonvaccinated swine, as it 
is only an additional pseudorabies testing tool to ensure the health of 
the U.S. swine population. It is likely, though, since the new gpI 
PCFIA test may be slightly higher in cost than other testing tools that 
are on the market, that most owners of nonvaccinated swine will 
continue using less expensive official pseudorabies tests until the 
cost of the gpI PCFIA test becomes 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 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 in conflict 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.).

List of Subjects in 9 CFR Part 85

    Animal diseases, Livestock, Quarantine, Reporting and recordkeeping 
requirements, Transportation.

    Accordingly, 9 CFR part 85 is amended as follows:

PART 85--PSEUDORABIES

    1. The authority citation for part 85 continues 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).

Sec. 85.1  [Amended]

    2. In Sec. 85.1, in the definition of official pseudorabies test, 
in the second sentence, item 6 is amended by adding the words ``, 
including the gpI PCFIA test'' immediately after the word ``Test''.


Sec. 85.6  [Amended]

    3. Section 85.6 is amended as follows:
    a. In paragraph (c)(2)(iii), the words ``or a gpI Particle 
Concentration Fluorescence Immunoassay (PCFIA)'' are added immediately 
after the word ``(ELISA)''.
    b. In paragraph (c)(2)(iv), the words ``or the gpI PCFIA'' are 
added immediately after the word ``ELISA''.
    c. In paragraph (c)(2)(v), the words ``or the gpI PCFIA'' are added 
immediately after the word ``ELISA''.

    Done in Washington, DC, on this 3rd day of April 1998.
Craig A. Reed,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 98-9377 Filed 4-8-98; 8:45 am]
BILLING CODE 3410-34-P