[Federal Register Volume 61, Number 63 (Monday, April 1, 1996)]
[Rules and Regulations]
[Pages 14237-14239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7837]



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 Rules and Regulations
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  Federal Register / Vol. 61, No. 63 / Monday, April 1, 1996 / Rules 
and Regulations  

[[Page 14237]]


DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. 96-015-1]


Brucellosis; Approved Brucella Vaccines

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Interim rule and request for comments.

-----------------------------------------------------------------------

SUMMARY: We are amending the brucellosis regulations to remove the 
requirement that an approved brucella vaccine be, among other things, a 
Brucella abortus Strain 19 product. This change allows for the use of 
vaccines that have been developed using strains of Brucella other than 
Brucella abortus Strain 19. Specifically, this action allows the RB51 
brucella vaccine, which was licensed for use in cattle by the U.S. 
Department of Agriculture in February 1996, to be used in the 
cooperative State/Federal brucellosis eradication program.

DATES: Interim rule effective March 26, 1996. Consideration will be 
given only to comments received on or before May 31, 1996.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 96-015-1, 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. 96-015-1. 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. M.J. Gilsdorf, National 
Brucellosis Epidemiologist, Cattle Diseases and Surveillance Staff, VS, 
APHIS, 4700 River Road Unit 36, Riverdale, MD 20737-1228, (301) 734-
7708; E-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    Brucellosis is a contagious disease affecting animals and humans, 
caused by bacteria of the genus Brucella. In its principal animal 
hosts, brucellosis is characterized by abortion and impaired fertility.
    The brucellosis regulations contained in 9 CFR part 78 (referred to 
below as the regulations) provide a system for classifying States or 
portions of States according to the rate of Brucella abortus infection 
present and the general effectiveness of the brucellosis control and 
eradication program conducted in the State or area. The classifications 
are Class Free, Class A, Class B, and Class C; States or areas that do 
not meet the minimum standards for Class C may be placed under Federal 
quarantine.
    Through a cooperative State and Federal effort, the United States 
is now approaching total eradication of the field strain Brucella 
abortus in domestic cattle and bison herds. As of February 29, 1996, 
there were only 50 known affected cattle and bison herds, and the U.S. 
Department of Agriculture (USDA) had declared 34 States, Puerto Rico, 
and the U.S. Virgin Islands free of the disease.
    One element of the cooperative State/Federal brucellosis 
eradication effort is the use of approved Brucella vaccines on female 
cattle and female bison to protect those animals against the disease. 
The current definition of approved Brucella vaccine in Sec. 78.1 of the 
regulations specifies that such a vaccine must be a Brucella abortus 
Strain 19 product approved by, and produced under license of, the USDA 
for injection into cattle and bison to enhance their resistance to 
brucellosis. When that definition was written, Brucella abortus Strain 
19 was the only strain of Brucella being used to produce Brucella 
vaccine for cattle and bison. More recently, however, research 
conducted by the USDA and other public and private entities has yielded 
promising results with vaccines that are being developed using strains 
of Brucella other than Brucella abortus Strain 19. In February 1996, 
the USDA licensed one of those new vaccines, designated RB51, for use 
in cattle; its licensing for use in bison is expected in the near 
future, pending completion of ongoing tests.
    Although RB51 has been licensed and approved for use in cattle, the 
reference to Brucella abortus Strain 19 products prevents RB51, and any 
vaccines developed in the future from strains of Brucella other than 
Brucella abortus Strain 19, from meeting the definition of approved 
Brucella vaccine. Therefore, in order to eliminate that obstacle, we 
have removed the reference to Brucella abortus Strain 19 from the 
definition of approved Brucella vaccine; the regulations now require 
that the vaccine be a Brucella product without specifying a particular 
strain. Additionally, the definition states that an approved Brucella 
vaccine must be approved and licensed for injection into cattle and 
bison; as noted in the previous paragraph, RB51 has been licensed and 
approved for use in cattle before being licensed and approved for 
bison. To allow for the immediate use of RB51 in cattle, we are further 
amending the definition of approved Brucella vaccine to allow the 
licensing and approval to apply to a vaccine's injection into ``cattle 
or bison,'' rather than the more restrictive ``cattle and bison.'' 
Neither of these changes affects any currently licensed and approved 
Brucella vaccines, and the regulations still require that any approved 
Brucella vaccine must meet the USDA's approval and licensing 
requirements.
    Brucella abortus Strain 19 Brucella vaccines cause vaccinated 
animals to produce antibodies that are indistinguishable on standard 
diagnostic tests from the antibodies produced by animals infected with 
brucellosis. However, the RB51 vaccine, and other vaccines produced 
from strains of Brucella other than Brucella abortus Strain 19 that may 
attain approved Brucella vaccine status in the future, do not produce 
those interfering antibody titers. Because of this difference, we have 
amended the definition of official test in several places to 
distinguish between cattle and bison vaccinated with a Brucella abortus 
Strain 19 Brucella vaccine and

[[Page 14238]]
cattle and bison vaccinated with approved Brucella vaccines produced 
from strains of Brucella other than Brucella abortus Strain 19. 
Specifically, in the definition of official test we have amended the 
paragraphs regarding the standard tube test or standard plate test 
(paragraph (a)(2)), the manual complement-fixation test (paragraph 
(a)(3)), the technicon automated complement-fixation test (paragraph 
(a)(4)), and the rivanol test (paragraph (a)(5)) by listing the 
agglutination reactions for classifying official vaccinates that have 
been vaccinated with approved Brucella vaccines produced from strains 
of Brucella other than Brucella abortus Strain 19. The agglutination 
reactions we have added are, for each test, the same as those listed 
for cattle and bison that are not official vaccinates, since approved 
Brucella vaccines produced from strains of Brucella other than Brucella 
abortus Strain 19 will not cause vaccinated cattle or bison to produce 
antibody titers. The existing agglutination reactions listed for 
official vaccinates have not been changed, but the regulations now 
specify that those reactions are for official vaccinates that have been 
vaccinated with a Brucella abortus Strain 19 approved Brucella vaccine.
    To clear the way for the immediate use of RB51, we are also 
amending two other definitions, i.e., those for official adult 
vaccinate and official calfhood vaccinate. Each of those definitions 
contains a reference to a specific dosage of vaccine to be used in 
vaccinating female cattle and female bison; however, those dosages are 
appropriate for Brucella abortus Strain 19 vaccines only. Therefore, we 
are amending those definitions to specify that the dosage indicated is 
for Brucella abortus Strain 19 vaccines only, and that the dosage for 
other vaccines will be the dosage indicated on the vaccine's label 
instructions.
    In a final rule published in the Federal Register on September 12, 
1986 (51 FR 32574-32600, Docket No. 85-132), the specified dosages of 
Brucella vaccine for cattle and bison adults and calves were changed. 
To accommodate the owners of cattle and bison that had been vaccinated 
using the old dosage, the definitions for official adult vaccinate and 
official calfhood vaccinate provided that cattle or bison vaccinated 
prior to December 31, 1984, using the old dosage would still be 
considered to be official adult or calfhood vaccinates. It is unlikely 
that any cattle or bison herds in the United States contain cattle or 
bison vaccinated with the old dosage over 11 years ago, so we have 
removed that provision from the definitions for official adult 
vaccinate and official calfhood vaccinate.

Immediate Action

    The Administrator of the Animal and Plant Health Inspection Service 
has determined that there is good cause for publishing this interim 
rule without prior opportunity for public comment. This rule allows the 
U.S. cattle industry to use the RB51 brucella vaccine, which was 
licensed by the USDA for use in February 1996, to vaccinate the spring 
crop of calves before the calves are turned out on summer pastures, 
which is especially important in high-risk areas where the calves may 
be exposed to infected animals. The U.S. cattle industry and Federal 
and State animal health agencies will benefit economically from using 
the new vaccine because the RB51 vaccine does not cause vaccinated 
animals to produce interfering antibody titers on diagnostic tests, so 
the need for traceback investigations will be significantly reduced.
    Because prior notice and other public procedures with respect to 
this action are impracticable and contrary to the public interest under 
these conditions, we find good cause under 5 U.S.C. 553 to make it 
effective upon signature. We will consider comments that are received 
within 60 days of publication of this rule in the Federal Register. 
After the comment period closes, we will publish another document in 
the Federal Register. It will include a discussion of any comments we 
receive and any amendments we are making to the rule as a result of the 
comments.

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.
    Currently available Brucella abortus Strain 19 brucella vaccines 
cause vaccinated animals to produce antibodies that are 
indistinguishable on standard diagnostic tests from the antibodies 
produced by animals infected with brucellosis. Because of this, State 
or Federal animal health personnel must trace those animals to their 
herds of origin to investigate whether or not the herd is actually 
affected with brucellosis. This rule allows for the use of a new 
brucella vaccine that will not cause vaccinated cattle to produce those 
interfering antibody titers. This will save the cattle industry and 
Federal and State animal health authorities the expense of tracing 
animals with vaccination titers. This rule, therefore, is expected to 
have a favorable economic impact. The need to make this rule effective 
in time for U.S. cattle raisers to use RB51 to vaccinate the spring 
crop of calves before the calves are turned out for summer pasture 
makes timely compliance with sections 603 and 604 of the Regulatory 
Flexibility Act (5 U.S.C. 601 et seq.) impracticable. The final rule 
for this action will include an analysis of the economic impact of this 
rule on small entities and will address any comments we receive on the 
economic impact of the rule on 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 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

    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 78

    Animal diseases, Bison, Cattle, Hogs, Quarantine, Reporting and 
recordkeeping requirements, Transportation.

    Accordingly, 9 CFR part 78 is amended to read as follows:

PART 78--BRUCELLOSIS

    1. The authority citation for part 78 continues to read as follows:

    Authority: 21 U.S.C. 111-114a-1, 114g, 115, 117, 120, 121, 123-
126, 134b, and 134f; 7 CFR 2.22, 2.80, and 371.2(d).

    2. Section 78.1 is amended as follows:
    a. By revising the definition of Approved brucella vaccine to read 
as set forth below.
    b. In the definition of official adult vaccinate, by revising 
paragraph (a) to read as set forth below.

[[Page 14239]]

    c. In the definition of official calfhood vaccinate, by revising 
paragraph (a) to read as set forth below.
    d. By amending the definition of official test as follows:
    i. In paragraph (a)(2), by revising the heading for the first table 
to read ``SPT OR STT CLASSIFICATION--OFFICIAL VACCINATES VACCINATED 
WITH A Brucella abortus STRAIN 19 APPROVED BRUCELLA VACCINE'' and by 
adding a new table immediately following the first table to read as set 
forth below.
    ii. In paragraph (a)(3), the introductory text of paragraph 
(a)(3)(ii) is amended by adding the words ``vaccinated with a Brucella 
abortus Strain 19 approved brucella vaccine'' after the word 
``vaccinates'', and a new paragraph (a)(3)(iii) is added to read as set 
forth below.
    iii. In paragraph (a)(4), the introductory text of paragraph 
(a)(4)(ii) is amended by adding the words ``vaccinated with a Brucella 
abortus Strain 19 approved brucella vaccine'' after the word 
``vaccinates'', and a new paragraph (a)(4)(iii) is added to read as set 
forth below.
    iv. The introductory text of paragraph (a)(5)(ii) is amended by 
removing the words ``and official calfhood vaccinates'' and adding the 
words ``with a Brucella abortus Strain 19 approved brucella vaccine and 
official calfhood vaccinates vaccinated with a Brucella abortus Strain 
19 approved brucella vaccine'' in their place.
    v. The introductory text of paragraph (a)(5)(iii) is amended by 
adding the words ``with a Brucella abortus Strain 19 approved brucella 
vaccine'' immediately after the word ``vaccination''.
    vi. A new paragraph (a)(5)(iv) is added to read as set forth below.


Sec. 78.1  Definitions.

* * * * *
    Approved brucella vaccine. A Brucella product approved by and 
produced under license of the United States Department of Agriculture 
for injection into cattle or bison to enhance their resistance to 
brucellosis.
* * * * *
    Official adult vaccinate. (a) Female cattle or female bison older 
than the specified ages defined for official calfhood vaccinate and 
vaccinated by an APHIS representative, State representative, or 
accredited veterinarian with a reduced dose approved brucella vaccine, 
diluted so as to contain at least 300 million and not more than 1 
billion live cells per 2 mL dose of Brucella abortus Strain 19 vaccine 
or at the dosage indicated on the label instructions for other approved 
brucella vaccines, as part of a whole herd vaccination plan authorized 
jointly by the State animal health official and the Veterinarian in 
Charge; and
* * * * *
    Official calfhood vaccinate. (a) Female cattle or female bison 
vaccinated while from 4 through 12 months of age by an APHIS 
representative, State representative, or accredited veterinarian with a 
reduced dose approved brucella vaccine containing at least 2.7 billion 
and not more than 10 billion live cells per 2 mL dose of Brucella 
abortus Strain 19 vaccine or at the dosage indicated on the label 
instructions for other approved brucella vaccines; and
* * * * *
    Official test.
    (a) * * *
    (2) * * *

 Official Vaccinates Vaccinated With an Approved Brucella Vaccine Other 
       Than a Brucella Abortus Strain 19 Approved Brucella Vaccine      
------------------------------------------------------------------------
          Titer                                                         
--------------------------                 Classification               
  1:50    1:100    1:200                                                
------------------------------------------------------------------------
--.....      --       --   Negative.                                    
I......      --       --   Suspect.                                     
+......      --       --       Do.                                      
+......       I       --       Do.                                      
+......       +       --   Reactor.                                     
+......       +        I       Do.                                      
+......       +        +       Do.                                      
------------------------------------------------------------------------
-- No agglutination.                                                    
I Incomplete agglutination.                                             
+ Complete agglutination.                                               

* * * * *
    (3) * * *
    (iii) Official vaccinates vaccinated with an approved brucella 
vaccine other than a Brucella abortus Strain 19 approved brucella 
vaccine:
    (A) Fifty percent fixation (2 plus) in a dilution of 1:20 or 
higher--brucellosis reactor;
    (B) Fifty percent fixation (2 plus) in a dilution of 1:10 but less 
than 50 percent fixation (2 plus) in a dilution of 1:20--brucellosis 
suspect;
    (C) Less than 50 percent fixation (2 plus) in a dilution of 1:10--
brucellosis negative.
    (4) * * *
    (iv) Official vaccinates vaccinated with an approved brucella 
vaccine other than a Brucella abortus Strain 19 approved brucella 
vaccine:
    (A) Fixation in a dilution of 1:10 or higher--brucellosis reactor;
    (B) Fixation in a dilution of 1:5 but no fixation in a dilution of 
1:10-- brucellosis suspect;
    (C) No fixation in a dilution of 1:5 or lower--brucellosis 
negative.
    (5) * * *
    (v) Official vaccinates vaccinated with an approved brucella 
vaccine other than a Brucella abortus Strain 19 approved brucella 
vaccine:
    (A) Complete agglutination at a titer of 1:25 or higher--
brucellosis reactor;
    (B) Less than complete agglutination at a titer of 1:25--
brucellosis negative.
* * * * *
    Done in Washington, DC, this 26th day of March 1996.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-7837 Filed 3-29-96; 8:45 am]
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