Brucellosis; Approved Brucella Vaccines

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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