[Federal Register Volume 60, Number 20 (Tuesday, January 31, 1995)]
[Proposed Rules]
[Pages 5876-5880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2315]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 85
[Docket No. 94-064-1]
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 enzyme-linked immunosorbent assay approved
differential test to the list of official pseudorabies tests, which
would allow certain pseudorabies vaccinated swine to be moved
interstate to destinations other than those currently allowed. Under
the current pseudorabies regulations, pseudorabies vaccinated swine
that are not from a qualified negative gene-altered vaccinated herd may
be moved interstate only for slaughter or to a quarantined herd or
quarantined feedlot. This proposed change would allow, under certain
conditions, the glycoprotein I enzyme-linked immunosorbent assay
approved differential test to be used as an official pseudorabies test
to qualify certain [[Page 5877]] pseudorabies vaccinated swine for
interstate movement to destinations other than slaughter or a
quarantined herd or quarantined feedlot. Adding the glycoprotein I
enzyme-linked immunosorbent assay approved differential 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 April 3, 1995.
ADDRESSES: Please send an original and three copies of your comments to
Chief, Regulatory Analysis and Development, PPD, APHIS, USDA, P.O.
Drawer 810, Riverdale, MD 20738. Please state that your comments refer
to Docket No. 94-064-1. 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, Veterinary Services, APHIS, USDA,
P.O. Drawer 810, Riverdale, MD 20738. The telephone number for the
agency contact will change when agency offices in Hyattsville, MD, move
to Riverdale, MD, during January 1995. Telephone: (301) 436-7767
(Hyattsville); (301) 734-7767 (Riverdale).
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.
Swine that have been vaccinated for pseudorabies are further
characterized as either official pseudorabies vaccinates or official
gene-altered pseudorabies vaccinates. The essential difference between
these two categories is the availability of tests that can
differentiate between vaccinated and infected swine. Swine vaccinated
with an official pseudorabies vaccine produce antibodies to the vaccine
that cannot be distinguished by traditional pseudorabies tests from
antibodies produced in response to the field strain of the virus that
causes pseudorabies infection. However, swine vaccinated with an
official gene-altered pseudorabies vaccine may be tested with an
approved differential pseudorabies test that can distinguish between
antibodies produced in response to the vaccine and antibodies produced
in response to the field strain of the virus that causes pseudorabies
infection. The two official gene-altered pseudorabies vaccines that are
used most often in the United States are vaccines from which a
nonessential glycoprotein--either glycoprotein X (gpX) or glycoprotein
I (gpI)--has been deleted. Swine vaccinated with one of those
glycoprotein-deleted vaccines would not produce antibodies to the
deleted glycoprotein unless the swine were infected with the
pseudorabies field virus or had been vaccinated with a vaccine
containing the glycoprotein antigen.
The regulations contain provisions that allow swine herds to attain
qualified negative gene-altered vaccinated herd status. Simply put,
such status may be attained by first subjecting a herd of swine not
known to be infected with or exposed to pseudorabies to an official
pseudorabies test, or, if there are already gene-altered vaccinates in
the herd, to an approved differential test. A herd already designated
as a qualified pseudorabies negative herd does not require another test
as a first step. If all swine in the herd are negative to a test for
pseudorabies, or if the herd is a qualified pseudorabies negative herd,
all swine in the herd over 6 months of age are then vaccinated with an
official gene-altered pseudorabies vaccine. Qualified negative gene-
altered vaccinated herd status is maintained by controlling the entry
of new swine to the herd, vaccinating young swine in the herd as they
reach 6 months of age, and subjecting all swine in the herd over 6
months of age to an approved differential test once per year with
negative results. The specific requirements for achieving and
maintaining qualified negative gene-altered vaccinated herd status are
contained in Sec. 85.1 in the definition of ``qualified negative gene-
altered vaccinated herd.''
Under the regulations in Sec. 85.8, swine from a qualified negative
gene-altered vaccinated herd are subject to relatively few restrictions
on interstate movement. As set forth in Sec. 85.8, swine from a
qualified negative gene-altered vaccinated herd may be moved interstate
without restriction if they are moved: (1) Directly to a recognized
slaughtering establishment; (2) through one or more slaughter markets
to a recognized slaughtering establishment; (3) directly to a feedlot,
quarantined feedlot, or approved livestock market; or (4) from an
approved livestock market to a feedlot, quarantined feedlot, or other
approved livestock market. For any other interstate movement, the swine
must be accompanied by a certificate containing certain information
regarding the interstate movement and the swine being moved.
Individual official gene-altered vaccinates that are not from a
qualified negative gene-altered vaccinated herd do not, however, enjoy
the same relative freedom from restrictions on interstate movement.
Rather, such swine must meet the conditions of Sec. 85.6, ``Interstate
movement of pseudorabies vaccinate swine, except swine from qualified
negative gene-altered vaccinated herds, not known to be infected with
or exposed to pseudorabies.'' The provisions of Sec. 85.6 are more
restrictive than those of Sec. 85.8, allowing vaccinated swine to be
moved interstate only if: (1) The swine are accompanied by an owner-
shipper statement and are moved directly to slaughter, or (2) the swine
are accompanied by a permit and moved directly to a quarantined herd or
quarantined feedlot.
The differing restrictions on the interstate movement of official
gene-altered pseudorabies vaccinates that are from a qualified negative
gene-altered vaccinated herd and official gene-altered pseudorabies
vaccinates that are not from such a herd were based on the level of
confidence that APHIS had in the reliability of the approved
differential tests when provisions for the use of approved differential
tests and gene-altered vaccines were first added to the regulations in
a final rule published in the Federal Register on May 9, 1990 (55 FR
19245-19253, [[Page 5878]] Docket No. 89-211). During the public
comment period that preceded the publication of that final rule,
several commenters requested that APHIS allow the use of approved
differential tests to qualify individual gene-altered vaccinates for
interstate movement in the same way as nonvaccinated swine may be
qualified for interstate movement with an official pseudorabies
serologic test under the regulations in Sec. 85.7. APHIS declined,
noting that the HerdCheck anti-pseudorabies gpX enzyme-linked
immunosorbent assay (ELISA) test, which was the only approved
differential pseudorabies test being conducted in APHIS-approved
laboratories at that time, had been recommended as a diagnostic test
for herds, and not for individual swine, by the American Association of
Veterinary Laboratory Diagnosticians (AAVLD), the United States Animal
Health Association (USAHA), and the test's manufacturer because the
test was less sensitive than standard serological procedures in
detecting pseudorabies virus antibodies.
Following the publication of the May 1990 final rule, APHIS
approved several laboratories to conduct the gpI ELISA test, thus
making two gene-altered vaccine/test combinations available to swine
producers in the United States. The gpI ELISA test is more sensitive
than the gpX ELISA test and has become the approved differential test
used by the majority of those swine producers who have chosen to
vaccinate their swine for pseudorabies.
The AAVLD's Committee on Diagnostic and Interpretative Serology has
recognized that the sensitivity and specificity of the gpI ELISA test
is equivalent to that of official tests for the diagnosis of
pseudorabies. Based on that finding, the committee recommended that
APHIS designate the gpI ELISA approved differential test as an official
pseudorabies test and allow its use to qualify individual swine
vaccinated with the gpI-deleted pseudorabies vaccine (referred to below
as gpI vaccinates) for interstate movement.
Therefore, we are proposing to allow, under certain conditions, the
use of the gpI ELISA test as an official pseudorabies test to qualify
gpI vaccinates that are not from a qualified negative gene-altered
vaccinated herd for interstate movement to destinations other than
slaughter or a quarantined herd or quarantined feedlot. The AAVLD did
not change its recommendation regarding other differential pseudorabies
tests, so the gpI ELISA test is the only approved differential
pseudorabies test included in this proposal. Additionally, we are not
proposing to make any changes to the regulations pertaining to swine
from qualified negative gene-altered vaccinated herds. Rather, we are
proposing to designate the gpI ELISA approved differential test as an
official pseudorabies test to allow individual gpI vaccinates to
qualify for general interstate movements (i.e., interstate movements to
destinations other than slaughter, feedlots, quarantined herds, or
quarantined feedlots) under provisions similar to those of
Sec. 85.7(c), which allow nonvaccinated swine not known to be infected
with or exposed to pseudorabies to qualify for general interstate
movements.
For a gpI vaccinate that is not from a qualified negative gene-
altered vaccinated herd to be moved interstate to destinations other
than slaughter or a quarantined herd or quarantined feedlot, we are
proposing to require that the swine be subjected to a gpI ELISA
approved differential test, with negative results, within 30 days prior
to the interstate movement. Given the sensitivity of the gpI ELISA test
and the fact that the regulations require that the test be conducted in
a laboratory approved by APHIS, we believe that any gpI vaccinates
infected with pseudorabies would be detected as a result of the
testing, thus ensuring that pseudorabies-infected swine would not be
moved interstate without appropriate controls.
To document the required testing proposed above, and to provide a
record regarding the identity, health status, origin, and destination
of individual gpI vaccinates (i.e., not from a qualified negative gene-
altered vaccinated herd) moving interstate to destinations other than
slaughter or a quarantined herd or quarantined feedlot, we are further
proposing to require that such gpI vaccinates be accompanied by a
certificate during the interstate movement and that the certificate be
delivered to the person receiving the swine. The certificate would be
issued by an APHIS representative, State representative, or accredited
veterinarian prior to the interstate movement.
As set forth in the definition of certificate in Sec. 85.1, a
certificate must state:
The number and description of the swine to be moved;
That the swine to be moved are not known to be infected
with or exposed to pseudorabies;
The purpose for which the swine are to be moved;
The points of origin and destination; and
The consignor and consignee.
Our proposed amendment would require that, in addition to the
information described in Sec. 85.1, the certificate also state:
The identification required by the regulations in 9 CFR
71.19;
That each animal to be moved was vaccinated for
pseudorabies with the glycoprotein I (gpI) gene-altered pseudorabies
vaccine;
That each animal to be moved was subjected to an approved
differential pseudorabies test within 30 days prior to the interstate
movement and was found negative;
The date of the approved differential pseudorabies test;
and
The name of the laboratory that conducted the approved
differential pseudorabies test.
The proposed certificate requirement would ensure that there was an
official record of the testing and interstate movement of individual
gpI vaccinates and would enable an official pseudorabies epidemiologist
to trace the movements of the gpI vaccinates forward from their farm of
origin or back from their present location should an investigation
become necessary.
The definition of certificate currently states that a certificate
is issued for ``the interstate movement of swine that * * * are not
pseudorabies vaccinates, except for official gene-altered pseudorabies
vaccinates from a qualified negative gene-altered vaccinated herd.''
Because this proposal contains provisions for the issuance of
certificates for the interstate movement of gpI vaccinates that are not
from a qualified negative gene-altered vaccinated herd, we would amend
the definition of certificate to include gpI vaccinates in the scope of
the definition.
Adding the gpI ELISA test as an official pseudorabies test would
also mean that the gpI ELISA 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 ELISA test is equivalent to that of official tests for the
diagnosis of pseudorabies. The gpI ELISA 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 ELISA test
unless the swine were infected with pseudorabies. Designating the gpI
ELISA test as an official pseudorabies test would enable swine
producers to use a single test on both gpI vaccinates and nonvaccinated
swine. [[Page 5879]]
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 to
allow, under certain conditions, swine vaccinated with a gpI-deleted
gene-altered pseudorabies vaccine, but that are not from a qualified
negative gene-altered vaccinated herd, to be moved interstate to
destinations other than slaughter or a quarantined herd or quarantined
feedlot. This proposed rule would also allow the use of the gpI ELISA
test to determine the pseudorabies status of nonvaccinated swine.
In December of 1993, there were 235,840 swine operations in the
United States with a total inventory of about 56.8 million head. The
value of the total swine inventory was estimated to be about $4.3
billion (Agricultural Statistics Board, National Agricultural
Statistics Service, U.S. Department of Agriculture, ``Hogs and Pigs,''
December 29, 1993). We believe that about 99 percent of all swine
operations in the United States would be considered small entities.
We estimate that there are approximately 25,000 domestic swine
herds that contain vaccinated animals. Of those herds, there are only
about 250 qualified negative gene-altered vaccinated herds. The
provisions of this proposed rule pertaining to gpI vaccinates would
have an economic impact only on the owners of gpI vaccinates that are
not part of a qualified negative gene-altered herd. There are currently
no provisions for the interstate movement of gpI vaccinates that are
not part of a qualified negative gene-altered herd to destinations
other than slaughter, quarantined herds, or quarantined feedlots, so
this proposed rule would have the effect of opening up new markets for
the owners of such swine. 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.
We expect that swine owners would accept the costs of testing with the
gpI ELISA test if they felt the economic opportunities afforded by the
new markets balanced or outweighed the costs associated with the
interstate movement.
The provisions of this proposed rule that would allow the use of
the gpI ELISA test to determine the pseudorabies status of
nonvaccinated swine are not expected to have a significant economic
impact on the owners of nonvaccinated swine. Although the gpI ELISA
test costs from $0.50 to $1.00 more per test than the official
serologic tests currently used to determine the pseudorabies status of
nonvaccinated swine, its use to test nonvaccinated swine would be
optional. It is likely, therefore, that most owners of nonvaccinated
swine would continue using less expensive official pseudorabies tests
until the cost of the gpI ELISA 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 12778
This proposed rule has been reviewed under Executive Order 12778,
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
In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this proposed rule will be submitted for approval to the
Office of Management and Budget. Please send written comments to the
Office of Information and Regulatory Affairs, OMB, Attention: Desk
Officer for APHIS, Washington, DC 20503. Please send a copy of your
comments to: (1) Chief, Regulatory Analysis and Development, PPD,
APHIS, USDA, P.O. Drawer 810, Riverdale, MD 20738, and (2) Clearance
Officer, OIRM, USDA, room 404-W, 14th Street and Independence Avenue
SW., Washington, DC 20250.
List of Subjects in 9 CFR Part 85
Animal diseases, Livestock, Quarantine, Reporting and recordkeeping
requirements, Transportation.
Accordingly, 9 CFR part 85 would be revised to read 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, 134f; 7 CFR 2.17, 2.51, and 371.2(d).
Sec. 85.1 [Amended]
2. In Sec. 85.1, in the definition of certificate, the first
sentence would be amended by adding the words ``vaccinated with a
glycoprotein I (gpI) deleted gene-altered pseudorabies vaccine or''
immediately after the words ``gene-altered pseudorabies vaccinates''.
3. In Sec. 85.1, in the definition of official pseudorabies test,
in the second sentence, item 4 would be amended by adding the words
``other than the glycoprotein I (gpI) ELISA test'' immediately after
the word ``tests''.
4. In Sec. 85.6, a new paragraph (c) would be added to read as set
forth below:
Sec. 85.6 Interstate movement of pseudorabies vaccinate swine, except
swine from qualified negative gene-altered herds, not known to be
infected with or exposed to pseudorabies.
* * * * *
(c) General movements. Swine vaccinated for pseudorabies with a
glycoprotein I (gpI) deleted gene-altered pseudorabies vaccine and not
known to be infected with or exposed to pseudorabies, but that are not
from a qualified negative gene-altered vaccinated herd, may be moved
interstate to destinations other than those set forth in paragraphs (a)
and (b) of this section only if:
(1) The swine are accompanied by a certificate and such certificate
is delivered to the consignee; and
(2) The certificate, in addition to the information described in
Sec. 85.1, states: (i) The identification required by Sec. 71.19 of
this chapter; (ii) that each animal to be moved was vaccinated for
pseudorabies with a gpI-deleted gene-altered pseudorabies vaccine;
(iii) that each animal to be moved was subjected to a gpI enzyme-linked
immunosorbent assay (ELISA) approved differential pseudorabies test no
more than 30 days prior to the interstate movement and was found
negative; (iv) the date of the gpI ELISA approved differential
pseudorabies test; and (v) the name of [[Page 5880]] the laboratory
that conducted the gpI ELISA approved differential pseudorabies test.
Done in Washington, DC, this 25th day of January 1995.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-2315 Filed 1-30-95; 8:45 am]
BILLING CODE 3410-34-P
