[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