[Federal Register Volume 60, Number 95 (Wednesday, May 17, 1995)]
[Rules and Regulations]
[Pages 26353-26355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12149]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 85
[Docket No. 94-064-2]
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 enzyme-linked immunosorbent assay approved differential
test to the list of official pseudorabies tests. This rule will 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 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 [[Page 26354]] pseudorabies tests will also allow its
use for the testing of nonvaccinated swine.
EFFECTIVE DATE: June 16, 1995.
FOR FURTHER INFORMATION CONTACT: Dr. Arnold C. Taft, Senior Staff
Veterinarian, National Animal Health Programs, VS, APHIS, Suite 3A01,
4700 River Road Unit 43, Riverdale, MD 20737-1231; (301) 734-7767.
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 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.
On January 31, 1995, we published in the Federal Register (60 FR
5876-5880, Docket No. 94-064-1) a proposal to amend the regulations
governing the interstate movement of certain pseudorabies vaccinated
swine by adding the glycoprotein I (gpI) enzyme-linked immunosorbent
assay (ELISA) approved differential test to the list of official
pseudorabies tests. We also proposed to amend the definition of
certificate and add provisions to allow, under certain conditions, the
gpI ELISA approved differential test to be used as an official test to
qualify certain pseudorabies vaccinated swine for interstate movement
to destinations other than slaughter, quarantined herds, or quarantined
feedlots.
We solicited comments concerning our proposal for 60 days ending
April 3, 1995. We received three comments by that date. They were from
a State agriculture agency, a national veterinary association, and a
pharmaceutical company. Two of the commenters supported the proposed
rule without reservation. The third commenter, however, expressed
concern regarding the use of a term in the proposed regulations.
Specifically, the commenter noted that the proposed rule referred to
gpI-deleted pseudorabies vaccines as ``gene-altered'' pseudorabies
vaccines, which he felt inferred that only genetically engineered gpI
deletions would be acceptable, to the exclusion of natural gpI gene-
deleted pseudorabies vaccines.
We believe that our use of the term ``gene-altered'' does not
exclude natural gpI gene-deleted pseudorabies vaccines. The gpI-deleted
pseudorabies vaccine is an official gene-altered pseudorabies vaccine.
The regulations in Sec. 85.1 define official gene-altered pseudorabies
vaccine as ``[a]ny official pseudorabies vaccine for which there is an
approved differential pseudorabies test,'' and official pseudorabies
vaccine is defined as ``[a]ny pseudorabies virus vaccine produced under
license from the Secretary of Agriculture under the Virus, Serum and
Toxin Act of March 4, 1913, and any legislation amendatory thereof (21
U.S.C. 151 et seq.).'' Neither definition contains a requirement that
an official gene-altered pseudorabies vaccine be the product of genetic
engineering, so we have made no changes in this final rule based on
that comment.
Therefore, based on the rationale set forth in the proposed rule
and in this document, we are adopting the provisions of the proposal as
a final rule.
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 final rule amends 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 final
rule also allows the use of the gpI ELISA test to determine the
pseudorabies status of nonvaccinated swine.
In December 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 domestic swine
operations 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 rule pertaining to individual swine vaccinated with
the gpI-deleted pseudorabies vaccine (referred to below as gpI
vaccinates) will have an economic impact only on the owners of gpI
vaccinates that are not part of a qualified negative gene-altered herd.
Because there have been 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, this rule will have the effect of opening up new
markets for the owners of such swine. Testing costs will be incurred
only when an owner chooses 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 will accept the costs
of testing with the gpI ELISA test if they feel the economic
opportunities afforded by the new markets balance or outweigh the costs
associated with the interstate movement.
The provisions of this rule that allow the use of the gpI ELISA
test to determine the pseudorabies status of nonvaccinated swine will
not 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 other official serologic tests used to determine the
pseudorabies status of nonvaccinated swine, its use to test
nonvaccinated swine will be optional. It is likely, therefore, that
most owners of nonvaccinated swine will continue using less expensive
official pseudorabies tests until the cost of the gpI ELISA 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. [[Page 26355]]
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 rule has been reviewed under Executive Order 12778, 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
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 rule have been approved by the Office of Management
and Budget (OMB), and there are no new requirements. The assigned OMB
control number is 0579-0070.
List of Subjects in 9 CFR Part 85
Animal diseases, Livestock, Quarantine, Reporting and recordkeeping
requirements, Transportation.
Accordingly, 9 CFR part 85 is amended to read 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 2.17, 2.51, and 371.2(d).
Sec. 85.1 [Amended]
2. In Sec. 85.1, in the definition of certificate, the first
sentence is 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 is 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) is added to read as follows:
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 the laboratory that conducted the gpI ELISA
approved differential pseudorabies test.
Done in Washington, DC, this 11th day of May 1995.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-12149 Filed 5-16-95; 8:45 am]
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