[Federal Register Volume 61, Number 156 (Monday, August 12, 1996)]
[Rules and Regulations]
[Pages 41730-41733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20450]


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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

9 CFR Part 78

[Docket No. 96-015-2]


Brucellosis; Approved Brucella Vaccines

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Affirmation of interim rule as a final rule.

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SUMMARY: We are adopting as a final rule, without change, an interim 
rule that amended the brucellosis regulations to remove the requirement 
that an approved brucella vaccine be, among other things, a Brucella 
abortus Strain 19 product. The interim rule allowed for the use of 
vaccines that have been developed using strains of Brucella other than 
Brucella abortus Strain 19. Specifically, the interim rule allowed 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.

EFFECTIVE DATE: The interim rule was effective on March 26, 1996.

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

    In an interim rule effective March 26, 1996, and published in the 
Federal Register on April 1, 1996 (61 FR 14237-14239, Docket No. 96-
015-1), we amended the brucellosis regulations in 9 CFR part 78 by 
revising the definition of approved brucella vaccine and amending the 
definitions of official adult vaccinate, official calfhood vaccinate, 
and official test to provide for the use of approved brucella vaccines 
that have been developed using strains

[[Page 41731]]

of brucellosis other than Brucella abortus Strain 19. That action was 
necessary to allow 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.
    Comments on the interim rule were required to be received on or 
before May 31, 1996. We did not receive any comments by that date. The 
facts presented in the interim rule still provide a basis for the rule.
    This action also affirms the information contained in the interim 
rule concerning Executive Orders 12372 and 12778 and the Paperwork 
Reduction Act.

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 document makes final an interim rule effective March 26, 1996, 
and published in the Federal Register on April 1, 1996. In that interim 
rule, we stated that timely compliance with sections 603 and 604 of the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.) was impracticable due 
to the need to make the rule effective in time for U.S. cattle raisers 
to use RB51 to vaccinate the spring crop of calves before the calves 
were turned out for summer pasture. We further stated, however, that 
the final rule would include an analysis of the economic impact of the 
rule on small entities and would address any comments we received on 
the economic impact of the rule on small entities. We did not receive 
any comments regarding the impact of the rule on small entities, but we 
have prepared an analysis of the economic impact of the rule on small 
entities.
    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. Therefore, when a 
vaccinated animal is tested, the results of the test indicate that the 
animal may be a brucellosis reactor, even though the animal is not 
infected with the disease; this misleading result is known as a ``false 
positive.'' State or Federal animal health personnel must trace those 
animals to their herds of origin to determine whether or not the herd 
is actually affected with brucellosis. Because the RB51 vaccine does 
not cause vaccinated cattle to produce those interfering antibody 
titers, replacing the Strain 19 vaccines with the RB51 vaccine will 
almost entirely eliminate the costs associated with the retesting and 
traceback of false-positive reactors.
    In fiscal year (FY) 1995, about 6.7 million cattle (primarily 
calves between 4 and 12 months of age) were vaccinated against 
brucellosis using Strain 19 vaccine. Although brucellosis is expected 
to be eradicated in domestic cattle within 3 years, it is likely that 
some States will continue to encourage herd owners to vaccinate higher-
risk cattle herds.
    In FY 1995, blood samples taken from approximately 5,900 head of 
cattle at market or slaughter under the Market Cattle Identification 
(MCI) program tested positive for the brucella bacteria, requiring 
retesting and traceback to the herds of origin. By far, most of the 
positive tests proved to be false; only about 100 cattle were found to 
be infected. If the RB51 vaccine had been used, about 99 percent of the 
false-positive tests would not have occurred, so about 5,742 
unnecessary tracebacks and herd tests would have been prevented.
    An additional 6,000 of the MCI-sampled cattle had titer levels less 
than that indicative of a positive reaction, but sufficiently high to 
cause suspicion of the disease. An estimated 50 percent of these cattle 
also were traced back to their herds of origin, and the herd owners 
were contacted in about one-third of the cases. Again, the use of RB51 
would have prevented about 99 percent (5,940) of the suspect titers, 
thus precluding the need for about 2,970 tracebacks, about 1,980 herd 
owner contacts, and about 990 herd tests.
    The brucellosis ring test (BRT) for dairy herds in FY 1995 
indicated 732 suspected cases of the disease. After retesting, 235 
herds were subsequently blood-tested, but only 2 herds were found to be 
affected. Hence, 730 of the cattle tested were false-positive. Tracing 
and blood testing of their herds of origin would not have been 
necessary if the RB51 vaccine had been used.
    For all three categories--MCI reactors, MCI suspects, and BRT 
reactors--the use of RB51 vaccine instead of Strain 19 will eliminate 
nearly all false-positive reactors. The potential savings can be 
estimated by considering resources currently devoted to tracebacks, lab 
tests, and related activities.
    Estimated time required by major types of field work for which 
there will be resource savings when RB51 replaces Strain 19 are shown 
in Table 1.

Table 1.--Estimated Average APHIS/State Field Hours Spent on MCI and BRT
                          Tests and Tracebacks                          
------------------------------------------------------------------------
                                                                  Staff 
                            Activity                              hours 
------------------------------------------------------------------------
Epidemiology...................................................    10.15
Contacting herd owners.........................................     2.23
Contacting veterinarians.......................................     1.00
MCI herds of origin locating...................................     5.10
MCI herds of origin testing....................................    12.21
BRT suspicious herds blood testing.............................    13.00
------------------------------------------------------------------------

    In Table 2, the time requirements are multiplied by the estimated 
number of Strain 19 false-positives per year, yielding a potential 
field staff hour savings from using RB51 totaling 255,956 hours per 
year. Assuming an average staff hour cost of $27.85 (salary and 
benefits, plus support), annual field work savings for APHIS and 
cooperating States from replacing Strain 19 by RB51 would be about 
$7,128,000 (255,956 hours  x  $27.85 per hour). With reduced numbers of 
cattle vaccinated following brucellosis eradication, the number of 
false-positive reactors if Strain 19 were used would also be fewer; 
therefore, annual potential savings in subsequent years could be 
estimated at about one-half of current savings, or about $3,564,000, 
for field work that would no longer be necessary when RB51 is used in 
place of Strain 19.

 Table 2.--Estimated Annual Field Staff Hour Savings to APHIS and States
From Using RB51 in Place of Strain 19, Based on FY 1995 and FY 1996 Data
------------------------------------------------------------------------
                                    Estimated                           
                                    number of                           
             Activity               Strain 19    Hours per   Total hours
                                      false       activity              
                                    positives                           
------------------------------------------------------------------------
Epidemiology:                                                           
    MCI reactors.................        5,742        10.15       58,281

[[Page 41732]]

                                                                        
    MCI suspects \1\.............        2,970        10.15       30,146
    BRT reactors.................          730        10.15        7,410
Contacts with herd owners:                                              
    MCI reactors.................       15,742         2.23       12,805
    MCI suspects \2\.............        1,980         2.23        4,415
    BRT reactors.................          730         2.23        1,628
Contact with veterinarians: \3\                                         
    MCI reactors.................        4,307         1.00        4,307
    MCI suspects.................          297         1.00          297
    BRT reactors.................          548         1.00          548
Locating herds of origin:                                               
    MCI reactors.................        5,742         5.10       29,284
    MCI suspects \4\.............        2,970         5.10       15,147
Testing herds of origin:                                                
    MCI reactors.................        5,742        12.21       70,110
    MCI suspects \5\.............          990        12.21       12,088
Testing suspect herds:                                                  
    BRT reactors.................          730        13.00       9,490 
------------------------------------------------------------------------
\1\ Epidemiology is conducted for an estimated 50 percent of MCI        
  suspects.                                                             
\2\ An estimated one-third of herd owners are contacted for MCI         
  suspects.                                                             
\3\ Veterinarians are contacted for an estimated 75 percent of MCI      
  reactors, 5 percent of MCI suspects, and 75 percent of BRT reactors.  
\4\ Herds of origin are located for an estimated 50 percent of MCI      
  suspects.                                                             
\5\ Herds of origin for MCI suspects are tested for an estimated one-   
  third of those located.                                               


    In addition to field staff savings, MCI laboratory costs associated 
with Strain 19 false-positive tests will also be eliminated by the use 
of RB51 vaccine. The concentration immunoassay technology (CITE') test 
costs $10.00, which is paid either by the State or the herd owner, 
depending on a particular State's regulations. The costs of other 
official tests--e.g., the Rivanol, particle concentration fluorescence 
immunoassay (PCFIA), and manual complement-fixation (CF) tests--are 
estimated to total about $15 to $20 per tested animal, including 
overhead. As shown in Table 3, a savings of more than $320,000 will 
result from the use of RB51, assuming an overall cost for all 
laboratory work of $27.50. As with the field staff savings, we can 
assume that laboratory savings of at least one-half this amount, or 
$160,000 per year, will be realized after eradication of brucellosis, 
given the expected reduction in the number of cattle vaccinated.

 Table 3.--Estimated Savings in Laboratory Costs Resulting From the Use 
             of RB51 Vaccines in Place of Strain 19 Vaccines            
------------------------------------------------------------------------
                                    Estimated                           
                                    number of     Average               
                                    Strain 19     cost per              
             Category                 false        set of     Total cost
                                    positives     analyses              
                                     per year                           
------------------------------------------------------------------------
MCI reactors.....................        5,742       $27.50     $157,905
MCI suspects.....................        5,940        27.50      163,350
------------------------------------------------------------------------

    Estimated combined field and laboratory gross savings from using 
RB51 vaccine total nearly $7.45 million per year at current levels of 
vaccination. After brucellosis has been eradicated, gross savings of at 
least $3.7 million per year can be expected. Except in those States 
where owners are directly charged for the CITE test, APHIS 
and cooperating States bear the costs associated with tracebacks and 
other activities required by false-positive tests. The general public, 
therefore, will benefit from the expected savings in government 
expenditures. Affected producers, most of whom can be considered small 
entities (gross annual incomes of less than $500,000), will also 
benefit by not having to spend time and resources in gathering their 
herds for testing to follow up on false-positive reactors and suspects.
    The RB51 vaccine costs more than the Strain 19 vaccine, $0.42 per 
dose compared to $0.30 per dose. Based on the number of vaccinations 
given in FY 1995, this cost difference amounts to $804,000 per year. 
Assuming an average of about 4 million vaccinations per year following 
brucellosis eradication, the additional cost of the RB51 vaccine will 
be about $480,000 after eradication. The net benefit of replacing 
Strain 19 by RB51 is therefore estimated at about $6.6 million per year 
before brucellosis eradication, and about $3.2 million per year 
afterwards.
    Lastly, because the RB51 vaccine will not cause false-positive 
titers as does Strain 19, it can be used to vaccinate older animals 
that might not otherwise be vaccinated. Although this advantage is not 
quantified, it will be a definite benefit for producers and States.

[[Page 41733]]

    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.

List of Subjects in 9 CFR Part 78

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

PART 78--BRUCELLOSIS

    Accordingly, we are adopting as a final rule, without change, the 
interim rule that amended 9 CFR part 78 and that was published at 61 FR 
14237-14239 on April 1, 1996.

    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).

    Done in Washington, DC, this 6th day of August 1996.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-20450 Filed 8-9-96; 8:45 am]
BILLING CODE 3410-34-P