[Federal Register Volume 62, Number 240 (Monday, December 15, 1997)]
[Proposed Rules]
[Pages 65630-65631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32658]
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Proposed Rules
Federal Register
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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.
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Federal Register / Vol. 62, No. 240 / Monday, December 15, 1997 /
Proposed Rules
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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.
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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 Secs. 85.5, 85.6, 85.7, and 85.8,
respectively.
Paragraphs (a) and (b) of Sec. 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 Sec. 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 Sec. 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 gene-altered 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 Sec. 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 Sec. 85.1 and allow its use as an
approved differential pseudorabies test to qualify swine for interstate
movement under Sec. 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
[[Page 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).
Sec. 85.1 [Amended]
2. In Sec. 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''.
Sec. 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
