Veterinary Diagnostic Services User Fees
Federal RegisterMay 4, 1998
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 130
[Docket No. 94-115-1]
RIN 0579-AA70
Veterinary Diagnostic Services User Fees
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to revise user fees for veterinary diagnostic
services to reflect changes in operating costs and changes in
calculations. In addition, we are proposing to add new user fees to
cover the costs of additional veterinary diagnostic services. In
addition, we propose to reorganize these user fees by type of service
and location where the service is provided, and to group reagents into
categories. We are also proposing to revise user fees for the use of
animal import centers operated by the Animal and Plant Health
Inspection Service, and to add new user fees for new spaces. These
actions are necessary to ensure that we recover our costs. The Food,
Agriculture, Conservation, and Trade Act of 1990, as amended,
authorizes us to set and collect these user fees.
DATES: Consideration will be given only to comments received on or
before July 6, 1998.
ADDRESSES: Please send an original and three copies of your comments to
Docket 94-115-1, 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. 94-115-1. 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: For information concerning services
provided for live animals and germ plasm, contact Dr. Gary S. Colgrove,
Chief Staff Veterinarian, National Center for Import and Export, VS,
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
3294.
For information concerning services provided for veterinary
diagnostics, contact Dr. James E. Pearson, Director,
[[Page 24474]]
National Veterinary Services Laboratories, VS, APHIS, P.O. Box 844,
Ames, IA 50010; (515) 239-8266.
For information concerning program operations for Veterinary
Services, contact Ms. Louise Lothery, Director, Veterinary Services
Resource Management Staff, APHIS, 4700 River Road Unit 44, Riverdale,
MD 20737-1231; (301) 734-7517.
For information concerning rate development of the proposed user
fees, contact Ms. Donna Ford, Section Head, Financial Systems and
Services Branch, Budget and Accounting Division, APHIS, 4700 River Road
Unit 54, Riverdale, MD 20737-1232; (301) 734-8351.
SUPPLEMENTARY INFORMATION:
Background
User Fees Authorized Under the Farm Bill
The Food, Agriculture, Conservation and Trade Act of 1990, as
amended (referred to below as the Farm Bill), authorizes the Secretary
to prescribe regulations and collect fees to reimburse the Secretary
for the cost of carrying out the provisions of the Federal Animal
Quarantine Laws that relate to the importation, entry, and exportation
of animals, articles, or means of conveyance (sec. 2509(c)(1) of the
Farm Bill). The Farm Bill also authorizes the Secretary of Agriculture,
among other things, to prescribe regulations and collect fees to
recover the costs of veterinary diagnostics relating to the control and
eradication of communicable diseases of livestock or poultry within the
United States (sec. 2509(c)(2) of the Farm Bill).
User fees to reimburse the Animal and Plant Health Inspection
Service (APHIS) for the costs of providing veterinary diagnostic
services and import-and export-related services for live animals and
birds and animal products are contained in 9 CFR part 130 (the
regulations).
Regulations Proposed in This Document
We propose to revise the user fees for certain veterinary
diagnostic services, including certain diagnostic tests, reagents, and
other veterinary diagnostic materials and services. Operating costs
have increased since these user fees were established in a final rule
published in the Federal Register on September 1, 1993 (58 FR 38954-
38961, Docket No. 91-021-5). Therefore, the user fees need to be
revised to reflect the increases. Additional reviews of these user fees
show that some of the original estimates did not include enough direct
labor hours and that the direct labor calculations need to be revised
to accurately reflect the costs of providing services. In reexamining
our user fees, we believe that a comprehensive overhaul of the
Veterinary Diagnostics user fees would more accurately recover our
costs and provide clarity and ease of use for customers needing to look
up user fees for our tests and other services. As discussed below, this
overhaul would include reorganizing the presentation of user fees in
the regulations, grouping reagents into simpler categories,
implementing new user fees, and revising all of the existing Veterinary
Diagnostic user fees.
The proposed user fees increase by varying amounts based on how
close the existing user fee is to our actual costs. Some user fees
required modest adjustments while others required large increases.
These proposed changes are based on recalculating user fees to include
adequate direct labor hours and use average laboratory employee
salaries to calculate direct labor costs. The amount of the change
proposed varies based on individual tests and services; therefore, the
amount of the changes varies. Overall, we do not expect these proposed
changes to significantly impact users. In most cases, the historical
volume, associated with the tests and services for which we propose
significant increases, is small.
In addition, we are proposing to add new user fees for other
veterinary diagnostic services we provide. We continue to provide new
services as required. We need to add user fees for services that we
have added since the veterinary diagnostic user fees were first
established. In addition, we believe that we need to add user fees for
specific services which may be required or requested and for which
there are currently no specific user fees. These new user fees are
discussed in detail later in this document.
We are proposing two changes in the organization of user fees for
veterinary diagnostics. First, we would reorganize the user fees by
type of service and location where the service is provided. Second, we
would group diagnostic reagents into categories. These changes are
discussed in detail later in this document.
Additionally, we propose to revise user fees for the use of APHIS-
operated animal import centers, to cover the costs for birds or poultry
requiring nonstandard housing, care, or handling and to more accurately
reflect the space utilization. For example, expenses for offices and
hallways would be included in the overhead portion of the user fee
calculation, instead of the user fee portion available to the animals,
which is higher than the overhead portion of the user fees. We propose
to add new user fees for the use of new spaces at the APHIS animal
import center in Newburgh, NY. We propose to revise the user fees
specified in Sec. 130.8 for import compliance assistance and release
from agricultural hold to more accurately reflect the cost of the
services we provide. We also propose miscellaneous changes to the user
fee regulations to eliminate duplication, add clarity, and incorporate
provisions of the Debt Collection Improvement Act of 1996.
Veterinary Diagnostics
Veterinary diagnostics is the work performed in a laboratory to
determine if a disease-causing organism or chemical agent is present in
body tissues or cells and, if so, to identify those organisms or
agents. Services in this category include: (1) Performing laboratory
tests and providing diagnostic reagents and other veterinary diagnostic
materials and services at the National Veterinary Services
Laboratories' (NVSL) Foreign Animal Disease Diagnostic Laboratory
(FADDL) at Greenport, NY, and (2) performing identification, serology,
and pathobiology tests and providing veterinary diagnostic reagents and
other materials and services at NVSL at Ames, IA. Diagnostic reagents
are biological materials used in diagnostic tests to detect disease
agents or antibodies by causing an identifiable reaction. We also
consider sterilization by gamma radiation to be a veterinary
diagnostics service. Other miscellaneous veterinary diagnostic services
include, but are not limited to, providing check tests, test kits,
manuals, standard operating procedures, and training.
We have reviewed the user fees that we charge for these services
and have determined that we need to revise the amount of these user
fees to reflect changes in costs and to recover the full cost of
providing veterinary diagnostic services. We are also proposing to add
new user fees to cover all veterinary diagnostic services. All of the
proposed veterinary diagnostic user fees are listed below by type of
service.
Currently, the Veterinary Diagnostic user fees are contained in
Secs. 130.14-130.18 of the regulations. The regulations separately list
user fees for tests at NVSL and FADDL; reference assistance tests at
NVSL; diagnostic reagents at NVSL; diagnostic reagents, slide sets, and
tissue sets at NVSL and FADDL; and sterilization by gamma radiation.
The proposed regrouping of tests into identification, serology, or
pathobiology tests and the regrouping of
[[Page 24475]]
reagents by bacteriology or virology type will be much easier for
customers and the laboratories to reference. Due to the differences
between requirements for tests being performed at NVSL and FADDL, we
believe that user fees for these tests and services should be listed by
location. In this proposal, all FADDL fees are listed in a single
section (9 CFR 130.14). In addition, reference assistance tests are
tests performed at NVSL, and the regulations currently unnecessarily
duplicate these user fees. Therefore, we believe that all NVSL tests
should be listed together.
In order to clarify, simplify, and eliminate redundancy, we are
proposing to reorganize the veterinary diagnostic user fees into the
following sections. Proposed Sec. 130.14 would include user fees for
laboratory tests, reagents, and other veterinary diagnostics services
we perform at FADDL. Proposed Sec. 130.15 would include user fees for
laboratory tests we perform to isolate and identify pathogenic agents
at the Diagnostic Bacteriology Laboratory (DBL) and at the Diagnostic
Virology Laboratory (DVL) at NVSL. Proposed Sec. 130.16 would include
user fees for laboratory tests we perform as part of serology testing
at DBL and DVL at NVSL. Proposed Sec. 130.17 would include user fees
for toxicological and other tests performed by the Pathobiology
Laboratory (PL) at NVSL. Proposed Sec. 130.18 would include user fees
for diagnostic reagents we provide from NVSL. Proposed Sec. 130.19
would include user fees for other veterinary diagnostics services we
provide at NVSL (e.g., check tests, test kits, manuals, standard
operating procedures, and training).
Currently, Sec. 130.49 specifies exemptions to user fees for
veterinary diagnostic services listed in Secs. 130.14 through 130.18.
These exemptions would still apply to all of our veterinary diagnostic
services. Therefore, we propose to revise Sec. 130.49 to specify that
the exemptions apply to veterinary diagnostic services listed in
Secs. 130.14 through 130.19.
Components of Proposed User Fees
The user fees proposed in this document are based on fiscal year
1998 salaries, more accurate estimates of the average number of direct
labor hours required to provide each service, and average salaries for
the laboratory where the work is performed. The proposed user fees have
been calculated to recover the full costs for tests, diagnostic
reagents, and other veterinary diagnostic services. These costs include
direct labor, administrative support, premium costs (if any), Agency
overhead costs, and Departmental charges. These components are
described below.
We propose to charge a specific dollar amount for each service we
provide; that is, each test we perform or each diagnostic reagent or
other veterinary diagnostic service we provide. We have attempted to
minimize the cost of our services, thereby keeping APHIS user fees at
the lowest possible level. If, in the future, a user requests a test,
diagnostic reagent, or other veterinary diagnostic material or service
that is not on the list, we would charge the proposed hourly user fee
for the amount of time required to perform the service, calculated to
the nearest quarter of an hour.
Each user fee varies based on the direct labor hours required to
perform the test or provide the diagnostic reagent or other veterinary
diagnostic material or service. For example, the time spent by
laboratory personnel to prepare a sample and conduct and read the test
would be part of the direct labor hours for testing a tissue sample for
disease-causing organisms. In cases where a test is performed for more
than one disease, it may take different amounts of time for each
disease. Those times have been averaged to calculate the user fee. We
have carefully calculated all of our proposed user fees to correctly
reflect the direct labor hours required for each test, reagent, or
service. We took into account variations in the time needed to provide
a service by determining the average time necessary.
Direct labor costs are the average salary and benefit costs of the
laboratory employees performing the service multiplied by the direct
labor hours required. Average costs were used to calculate direct labor
costs because we have determined that it is more accurate to use the
average salary for the laboratory employees to calculate the user fee.
Currently, some veterinary diagnostics user fees are based on salary
and benefit costs for a specific employee at the laboratory. We have
determined that this does not accurately reflect the cost of providing
services, because in many cases various employees at different salaries
may perform part or all of a test or service. The calculations for
these proposed user fees are consistent with the calculations used for
the other user fees throughout 9 CFR part 130.
Administrative support costs are incurred at the local level, that
is, at the laboratories. They include clerical and administrative
activities; direct materials; indirect labor hours; travel and
transportation for personnel, supplies, equipment, and other necessary
items; training; legal counsel; general supplies for offices,
washrooms, cleaning, etc.; contractual services; grounds maintenance;
and utilities. Direct materials include the cost of any materials
needed to conduct the test or provide the diagnostic reagent, slide
set, tissue set, or service. For example, direct materials for
conducting a laboratory test include, but are not limited to,
glassware, chemicals, and other supplies necessary to perform the test.
These direct materials are included in administrative support costs
because they are standard laboratory supplies and not purchased solely
for a specific test. Indirect labor hours include supervision of
personnel and time spent doing necessary work that is not directly
connected with a test, diagnostic reagents, or other veterinary
diagnostic material or service, such as equipment repair. Contractual
services may include, but are not limited to, guard service and
maintenance. Some administrative support items may or may not be
contractual, depending on local circumstances. For example, trash
pickup may be provided as a utility or a contractual service. However,
the costs are all administrative support. Utilities include water,
telephone, electricity, natural and propane gas, heating and diesel
oil. The costs of administrative support are applied as a percentage of
the base direct labor amount. At NVSL, administrative support is 113
percent of direct labor, and, at FADDL, administrative support is 625
percent of direct labor.
Premium costs are expenses that are incurred solely for a specific
test or service. For example, certain tests require expensive reagents
in addition to the direct labor time and laboratory materials included
in administrative support costs. Premium costs required for the
proposed flat rate user fees have already been included in the
calculations. Any premium costs required for hourly rate user fees
would be added to the calculated user fee. For example, the polymerase
chain reaction test would be performed for an hourly rate user fee, and
any applicable royalties for this test would be added to the calculated
hourly rate user fee.
Agency overhead is the pro-rata share, attributable to a particular
diagnostic reagent, material, or veterinary diagnostic service, of the
management and support costs for all Agency activities at the regional
level and above. Also included are the costs of providing budget and
accounting services, management support at the headquarters and
regional level, including the Administrator's office, and personnel
services, public
[[Page 24476]]
information services, and liaison with Congress.
Departmental charges are APHIS's share, expressed as a percentage
of the total cost, of services provided centrally by the U.S.
Department of Agriculture. Services the Department provides centrally
include the Federal telephone service; mail; National Finance Center
processing of payroll, billing, collections, and other money
management; unemployment compensation; Office of Workers Compensation
Programs; and central supply for storing and issuing commonly used
supplies and Departmental forms. The Department informs APHIS as to how
much the agency owes for these services. We have included a pro-rata
share of these Departmental charges, as attributed to a particular
test, diagnostic reagent, or other veterinary diagnostic material or
service, in our user fee calculations.
Rounding
When we first adopted user fees, we determined that it was
reasonable that our user fees for veterinary diagnostic services should
be rounded up to the nearest quarter. This is necessary to ensure that
we collect enough revenue to cover the costs of providing these
services. If we were to round down, many user fees would be lower than
the cost of the service. As we do not have a reserve fund, there would
be no immediate funds for us to draw on to make up the deficiency.
We have considered changing the rounding of user fees from rounding
up to the nearest quarter to rounding up to the nearest dollar to make
administration less burdensome and to simplify collections and
accounting. We realize that rounding to the next whole dollar would add
to the balance of overall user fees collected. The magnitude of this
additional amount varies by user fee category, and would vary similarly
in fees we intend to propose in the future, if the same technique were
used. We would monitor the effects of rounding to the next whole dollar
on the balances in the account and propose adjustments in the fees as
necessary. We invite comments specifically addressing the advantages
and disadvantages of this rounding technique. Such a change in our
approach to rounding would be reflected in future APHIS user fee
rulemaking.
Calculation of Proposed User Fees
The basic steps in the calculation, for each particular service,
are: (1) Calculate direct labor costs by determining the average amount
of direct labor required to perform the service and multiply the
average direct labor hours by the average salary and benefit costs for
laboratory employees; (2) calculate the pro-rata share of
administrative support; (3) determine the premium costs (if any); (4)
calculate the pro-rata share of Agency overhead and Departmental
charges, respectively; (5) add all costs; and (6) round total cost up
to the nearest quarter.
The result of these calculations is a user fee that covers the
total cost to perform a particular test or provide a particular
veterinary diagnostic material or service one time, rounded up to the
nearest quarter.
We have individually calculated costs for each veterinary
diagnostic test and service based on the formula shown in Table 1, FY
98 User Fee Calculations.
As is the case with all APHIS user fees, we intend to review, at
least annually, the user fees proposed in this document. We will
publish any necessary adjustments in the Federal Register.
FADDL Costs Compared to NVSL Costs
Readers may note that our proposed user fees for tests performed at
FADDL are higher than our proposed user fees for the same tests
performed at NVSL. Both FADDL and NVSL work with infectious and
contagious disease agents. However, FADDL, which is isolated from the
United States mainland, is designed to work specifically with highly
infectious diseases exotic to the United States. Because of this,
special biosecurity measures are required at FADDL that are not
required at NVSL. As a result, FADDL operating costs are higher than
NVSL operating costs. The higher FADDL operating costs are incorporated
into the Administrative support costs; in addition to the typical
administrative support costs, FADDL, as a high-tech facility requiring
special biosecurity measures, generates additional, higher expenses.
Primarily, the rent for the facility is significantly higher than for a
standard laboratory. In addition, since FADDL must be located on an
island, all employees and supplies must be transported by boat to the
facility, therefore, high transportation expenses are included. The
user fees we are proposing reflect this difference in costs.
Table 1.--FY 98 User Fee Calculations
[Example using one hour of direct labor]
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Laboratory
---------------------------------------------------
User fee component NVSL
--------------------------------------- FADDL
DVL DBL PL
----------------------------------------------------------------------------------------------------------------
Laboratory average grade and step for salary................ GS10-5 GS9-4 GS12-5 GS11-4
Hourly salary rate.......................................... $18.97 $16.33 $24.72 $20.30
+Benefits (calculated as a % of salary)..................... $4.15 $3.58 $5.41 $4.44
= Average laboratory salary and benefits.................... $23.12 $19.91 $30.13 $24.74
x Direct labor time (in hours).............................. 1 1 1 1
= Direct labor costs (salary and benefits).................. $23.12 $19.91 $30.13 $24.74
+ Administrative support costs\1\ (113% of direct labor at
NVSL, 625% of direct labor at FADDL)....................... $26.13 $22.50 $34.05 $154.63
---------------------------------------------------
+ Premium costs (if any).................................... $0.00 $0.00 $0.00 $0.00
---------------------------------------------------
Subtotal 1............................................ $49.25 $42.21 $64.18 $179.37
---------------------------------------------------
+ Agency overhead (16.15% of subtotal 1).................... $7.95 $6.85 $10.37 $28.97
===================================================
Subtotal 2............................................ $57.20 $49.26 $74.55 $208.34
---------------------------------------------------
+ Departmental charges (5.55% of subtotal 2)................ $3.17 $2.73 $4.14 $11.46
===================================================
[[Page 24477]]
Subtotal 3 \2\........................................ $60.37 $51.99 $78.69 $219.80
---------------------------------------------------
+ Rounding up to the nearest $0.25.......................... $0.13 $0.01 $0.06 $0.20
===================================================
User fee.............................................. $60.50 $52.00 $78.75 $220.00
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\1\ For every $1 incurred in direct labor at NVSL, another $1.13 is incurred in administrative support costs.
For every $1 incurred in direct labor at FADDL, another $6.25 is incurred in administrative support costs.
\2\ If the total direct labor time used produced more than one unit, then Subtotal 3 would be divided by the
total number of units produced at this point. For example, when diagnostic reagents are produced, more than
one unit of the reagent is produced in a batch, i.e., it takes approximately 54 hours to produce a batch of
200 individual 1 ml units of glanders CF antigen. Therefore, the subtotal would be divided by 200 to estimate
the cost for a 1 ml unit.
Discounts
Currently, in Secs. 130.14, 130.15, and 130.16 we discount user
fees for the second and subsequent tests with multiple antigens
performed on the same submission at FADDL and NVSL for the following
tests: Complement fixation, hemagglutination inhibition, and virus
neutralization. For example, in Secs. 130.14 and 130.16, the user fee
for a complement fixation test at NVSL is $9.00 for the first test
performed on a sample and $2.00, or $1.80 (20 percent of $9.00) rounded
up to the nearest quarter of a dollar, for the second and each
subsequent complement fixation test on the same sample. As explained
below, we are proposing to revise these discounts by (1) eliminating
the discounts for tests performed at FADDL, (2) eliminating the
discounts when the tests are performed for certain diseases, and (3)
revising the way the discounts are applied. In addition, we propose to
add discounts for several tests.
We have reviewed the costs for tests at FADDL that are currently
listed in Sec. 130.15 and have determined that, due to differences in
workload, each subsequent test performed on a sample at FADDL costs the
same as the first test. The discounted user fees have not recovered the
full costs for tests performed at FADDL, and we propose to eliminate
discounts at FADDL that are currently listed in Sec. 130.15.
We have reviewed the costs for tests at NVSL (other than FADDL)
that are currently listed in Secs. 130.14 and 130.16 and have
determined that the current discounts do not recover the full costs of
performing the tests. For example, testing related to equine
piroplasmosis, bovine plasmosis, dourine, and glanders require
monoclonal antibodies that are expensive to produce. Because it costs
as much to do each subsequent test, we do not recover our actual costs
when we discount tests for these diseases. In addition, a certain
amount of time and effort is required to prepare reagents and
appropriate controls to conduct the first 10 of any of the other tests
for which discounts are offered in Secs. 130.14 and 130.16. Once the
reagents and controls have been prepared for the first 10 tests, less
time and effort is necessary to test additional samples and the costs
are lower for each additional test. Because we discount the second and
additional tests, the discounted user fees do not cover our actual
costs to perform these tests. Therefore, we propose to eliminate the
discount for testing related to equine piroplasmosis, bovine plasmosis,
dourine, and glanders, and to revise the discounts for the other tests
to apply to the 11th and subsequent tests of the same type on the same
sample. The discounted user fee for the 11th and subsequent tests would
be 20 percent of the proposed user fee for each subsequent test on the
same submission by the same submitter for the same test and antigen.
For example, the user fee for the fluorescent antibody test is $9.75,
and the discounted user fee would be $2.00, or $1.95 (20 percent of
$9.75) rounded up to the nearest quarter of a dollar.
We have determined that several additional tests performed at NVSL
may be appropriate for discounts. Therefore, in proposed
Secs. 130.15(a) and 130.16 we propose to add discounts for fluorescent
antibody, indirect fluorescent antibody, and peroxidase linked antibody
tests. The discounted user fee for the 11th and subsequent tests would
be 20 percent of the proposed user fee for each subsequent test on the
same submission by the same submitter for the same test and antigen.
Hourly Rate Veterinary Diagnostic User Fees
We propose to add an hourly rate user fee for FADDL and NVSL to
Secs. 130.14(c) and 130.19, respectively. These hourly rate user fees
would be used for services that do not have an identified flat rate
user fee (for example, tests and reagents that are not available now
and those services whose costs would be more accurately represented by
an hourly rate user fee instead of a flat rate). For example, a per
slide flat rate user fee for a polymerase chain reaction test would not
take into account the differences in the time required based on the
number of slides. Using an hourly rate user fee for the polymerase
chain reaction test would more accurately reflect the time required to
perform the test. Therefore, the hourly rate user fee would be charged.
The hourly rate user fees would be based on the actual time
required to render the service calculated to the nearest quarter of an
hour. Any applicable premium costs for hourly rate user fees would be
added to the calculated user fee. For example, the polymerase chain
reaction test would be performed for an hourly rate user fee and any
applicable royalties.
In addition, we propose to remove the current flat rate user fee in
Secs. 130.14, 130.15, and 130.16 for histopathology and apply the
hourly rate user fee to histopathology tests. We believe that the
hourly rate user fee would provide a more accurate user fee based on
the amount of time it takes to perform the test versus the flat rate
user fee based on the number of slides that are tested. We believe that
this change to an hourly rate user fee would allow for economies of
scale and therefore, lower charges for tests requiring multiple slides.
[[Page 24478]]
Restructured CFR Sections
For clarity, simplicity, and ease of use, we are proposing to
reorganize the veterinary diagnostic user fees in the regulations.
Currently, the regulations list a separate user fee for each veterinary
diagnostic test, reagent, and service. These user fees are currently
grouped in the following manner: Tests related to the importation or
exportation of animals or birds at NVSL or FADDL (Secs. 130.14 and
130.15); reference assistance testing for a veterinarian, State animal
health official, or university to establish or confirm a diagnosis
(Sec. 130.16); reagents, slide sets, and tissue sets at NVSL or FADDL
(Sec. 130.17); and sterilization by gamma radiation (Sec. 130.18).
We are proposing to revise the veterinary diagnostic user fee
sections to group the user fees based on the type of service and the
location where the service is provided. Currently, some of the
veterinary diagnostic user fees are grouped by type of service and
location. We propose to group all of the veterinary diagnostic user
fees first by location and second by type of test or service.
We believe that we no longer need to separately distinguish
reference assistance testing as is currently done in Sec. 130.16
because these tests can be performed for reasons other than to
establish or confirm a diagnosis for a veterinarian, State animal
health official, or university. Regardless of the reason APHIS conducts
the test, the user fee would be the same. Therefore, we no longer need
to duplicate these user fees in a separate section for reference
assistance testing. User fees for bacterial identification tests and
toxicology tests, which are currently listed only as reference
assistance tests, would be incorporated into proposed Secs. 130.15 and
130.17, respectively. Because we would no longer separate reference
assistance testing, we also propose to remove the definition for
reference assistance testing.
As explained earlier, there are inherent differences between work
that may be performed at FADDL and work that may be performed at NVSL
or other authorized import sites (for example, handling foreign
diseases). Therefore, we propose to group all FADDL user fees together.
Currently, FADDL user fees are included in Secs. 130.15, 130.16,
130.17, and 130.18. We propose to incorporate all FADDL user fees into
a new Sec. 130.14. The FADDL user fees would be grouped by reagents,
tests, and other veterinary diagnostic services.
Currently, all NVSL user fees are listed in Secs. 130.14, 130.16,
and 130.17. We propose to group all NVSL veterinary diagnostic user
fees by type of test: Identification tests (proposed Sec. 130.15),
serology tests (proposed Sec. 130.16), and other tests (proposed
Sec. 130.17). The reagents would also be grouped by the type of
reagent: Bacteriology and virology (proposed Sec. 130.18). Within these
reagent groups, we would change the reagent user fees from the current
user fee for each individual reagent to a user fee for each category of
reagent. These reagent categories are determined by the composition of
the reagent and the application for the reagent. Finally, we propose to
group the remaining other veterinary diagnostic services together
(proposed Sec. 130.19).
Comparison of Proposed Veterinary Diagnostic User Fees With Current
User Fees
The following comparison tables show the proposed changes from the
current user fees, including the change in the dollar amount and the
percentage change. When we proposed a new name for a user fee, the
table lists the current name for comparison purposes. In addition, the
reagent comparison tables list the specific current reagents that are
combined into the proposed reagent categories.
FADDL Reagent User Fees
Table 2 shows the user fees proposed in Sec. 130.14(a) for FADDL
reagents. We propose to implement three new user fees for FADDL
reagents. In addition, we propose to move nine user fees for FADDL
reagents that are currently listed in Sec. 130.17(b) of the regulations
into Sec. 130.14(a). These nine reagents would be grouped into seven
reagent categories. All of these user fees would increase.
Table 2. User Fees for FADDL Reagents (Proposed Sec. 130.14(a))
----------------------------------------------------------------------------------------------------------------
Change in user fee
Proposed reagent Proposed Unit Current user -------------------------
user fee fee Amount Percent
----------------------------------------------------------------------------------------------------------------
Bovine antiserum, any agent........ $80.00 1 ml.................. ............ ........... ...........
(was Bovine antiserum, any ........... ...................... $2.50 $77.50 3100
agent).
(was Foot-and-mouth disease ........... ...................... 5.00 75.00 1500
anti-VIAA serum).
Caprine antiserum, any agent....... 97.50 1 ml.................. 0 ........... ...........
Cell culture antigen/microorganism. 63.75 1 ml.................. ............ ........... ...........
(was ASF-immunosmophoresis ........... ...................... 60.75 3.00 5
antigen).
(was FMD virus associated ........... ...................... 36.75 27.00 73
antigen).
Equine antiserum, any agent........ 100.50 1 ml.................. 0 ........... ...........
Fluorescent antibody conjugate..... 120.25 1 ml.................. 48.50 71.75 148
Monoclonal antibody (was Monoclonal 122.75 1 ml.................. 14.75 108.00 732
antibodies, mouse ascitic fluid).
Other spp. antiserum, any agent 104.50 1 ml.................. 12.75 91.75 720
(was Anti-FMD antigen, guinea pig
origin).
Ovine antiserum, any agent......... 94.25 1 ml.................. 2.00 92.25 4613
Porcine antiserum, any agent (was 81.25 1 ml.................. 2.00 79.25 3963
Swine antiserum, any agent).
Rabbit antiserum, any agent........ 98.50 1 ml.................. 0 ........... ...........
----------------------------------------------------------------------------------------------------------------
FADDL Veterinary Diagnostic Tests User Fees
Table 3 shows the user fees proposed in Sec. 130.14(b) for FADDL
veterinary diagnostic tests. We propose to implement five new user fees
for FADDL veterinary diagnostic tests. We propose to move 12 of the
user fees currently listed in Sec. 130.15(a) of the regulations into
Sec. 130.14(b). On average, most of these user fees would increase by
less than 20 percent.
[[Page 24479]]
Table 3.--User Fees for FADDL Veterinary Diagnostic Tests (Proposed Sec. 130.14(b))
----------------------------------------------------------------------------------------------------------------
Change in user fee
Proposed veterinary diagnostic test Proposed Unit Current user -------------------------
user fee fee Amount Percent
----------------------------------------------------------------------------------------------------------------
Agar gel immunodiffusion........... $14.75 Test.................. $13.50 $1.25 9
Card............................... 8.25 Test.................. 0
Complement fixation................ 33.00 Test.................. 30.50 2.50 8
Direct immunofluorescent antibody.. 11.00 Test.................. 9.50 1.50 16
Enzyme linked immunosorbent assay.. 12.75 Test.................. 11.00 1.75 16
Fluorescent antibody neutralization 96.00 Test.................. 22.00 74.00 336
(hog cholera).
Hemagglutination inhibition........ 27.75 Test.................. 0
Immunoperoxidase................... 18.25 Test.................. 0
Indirect fluorescent antibody...... 23.25 Test.................. 21.50 1.75 8
In-vitro safety.................... 299.50 Test.................. 0
In-vivo safety..................... 4,345.75 Test.................. 4,177.00 168.75 4
Latex agglutination................ 11.00 Test.................. 9.25 1.75 19
Tube agglutination................. 14.00 Test.................. 0
Virus isolation in embryonated eggs 176.00 Test.................. 163.75 12.25 7
Virus isolation (oesophageal/ 88.25 Test.................. 80.00 8.25 10
pharyngeal).
Virus isolation, other............. 84.50 Test.................. 77.75 6.75 9
Virus neutralization............... 25.75 Test.................. 22.00 3.75 17
----------------------------------------------------------------------------------------------------------------
FADDL Other Veterinary Diagnostics
Table 4 shows the user fees proposed in Sec. 130.14(c) for other
veterinary diagnostics provided at FADDL. We propose to implement new
user fees for three tests and a new hourly user fee for other FADDL
veterinary diagnostics for which there are no identified flat rate user
fees or for which an hourly user fee is more appropriate. In addition,
we propose to move four user fees currently listed in Secs. 130.17(a)
and (b) and 130.18 of the regulations into Sec. 130.14(c). On average,
these user fees would increase between 20 and 35 percent.
Table 4.--User Fees for FADDL Other Veterinary Diagnostics (Proposed Sec. 130.14(c))
----------------------------------------------------------------------------------------------------------------
Change in user fee
Other veterinary diagnostics Proposed Unit Current user -------------------------
user fee fee Amount Percent
----------------------------------------------------------------------------------------------------------------
Bacterial isolation................ $55.00 Test.................. 0 ........... ...........
Hourly user fee services........... 220.00 Hour.................. 0 ........... ...........
55.00 Quarter Hour.......... 0 ........... ...........
Infected cells on chamber slides or 31.00 Slide................. 23.00 8.00 35
plates (was ASF--slide set for
direct fluorescent antibody test).
Reference animal tissues for 94.25 set................... 76.75 17.50 23
immunohistochemistry (was ASF and
Hog Cholera tissue sets).
Sterilization by gamma radiation... 530.00 can................... 427.75 102.25 24
Training (school or technical 450.00 Per person per day.... 0
assistance).
Virus Titration.................... 55.00 Test.................. 0
----------------------------------------------------------------------------------------------------------------
Bacteriology Isolation and/or Identification Tests
Table 5 shows the user fees proposed in Sec. 130.15(a) for
bacteriology isolation and/or identification tests. We propose to
implement 19 new user fees for bacteriology isolation and/or
identification tests. In addition, we propose to move seven user fees
that are currently listed in Sec. 130.16(a) of the regulations into
Sec. 130.15(a). On average, these user fees would increase by less than
10 percent.
Table 5.--User Fees for Bacteriology Isolation and Identification Tests (Proposed Sec. 130.15(a))
----------------------------------------------------------------------------------------------------------------
Proposed bacteriology Change in user fee
isolation or identification Proposed Unit Current user -------------------------
test user fee fee Amount Percent
----------------------------------------------------------------------------------------------------------------
Bacterial identification, $16.00 Isolate..................... $15.00 $1.00 7
automated (was Bacterial
identification/isolation,
routine).
Bacterial identification, non- 61.25 Isolate..................... 0 ........... ...........
automated.
Bacterial isolation (was 16.00 Sample...................... 15.00 1.00 7
Bacterial identification/
isolation, routine).
Bacterial serotyping, all 30.75 Isolate..................... 0 ........... ...........
other.
Bacterial serotyping, 7.50 Isolate..................... 0 ........... ...........
Pasteurella multocida.
Bacterial serotyping, 21.25 Isolate..................... 20.00 1.25 6
Salmonella (was Salmonella
serotyping).
Bacterial toxin typing....... 91.50 Isolate..................... 0 ........... ...........
Bacteriology requiring 27.00 Test........................ 25.00 2.00 8
special characterization.
DNA fingerprinting........... 36.50 Test........................ 0 ........... ...........
[[Page 24480]]
DNA probe.................... 29.50 Test........................ 0 ........... ...........
Fluorescent antibody......... 9.75 Test........................ 0 ........... ...........
Leptospira culturing (was 27.00 Sample...................... 25.00 2.00 8
Leptospira cultures).
Leptospira serotyping........ 80.50 Isolate..................... 75.00 5.50 7
Mycobacterium avian 157.50 Isolate..................... 0 ........... ...........
serotyping.
Mycobacterium identification 63.25 Isolate..................... 0 ........... ...........
(biochemicals).
Mycobacterium identification 26.50 Procedure................... 0 ........... ...........
(gas chromatography).
Mycobacterium isolation, 520.50 Submission.................. 0 ........... ...........
animal inoculations.
Mycobacterium isolation, all 105.50 Submission.................. 0 ........... ...........
other.
Mycobacterium 26.50 Submission.................. 0 ........... ...........
paratuberculosis isolation.
Mycology culture 52.75 Isolate..................... 0 ........... ...........
identification.
Mycology/fungus culture or 26.50 Sample...................... 0 ........... ...........
isolation.
Mycoplasma identification.... 26.25 Isolate..................... 0 ........... ...........
Mycoplasma isolation......... 26.25 Sample...................... 0 ........... ...........
Phage typing, Salmonella 10.75 Isolate..................... 10.00 0.75 8
enteritidis (was Phage
typing).
Phage typing, all other...... 26.50 Isolate..................... 0 ........... ...........
Plasmid typing............... 26.50 Isolate..................... 25.00 1.50 6
Warburg...................... 316.50 Isolate..................... 0 ........... ...........
----------------------------------------------------------------------------------------------------------------
Virology Identification Tests
Table 6 shows the user fees proposed in Sec. 130.15(b) for virology
identification tests. We propose to implement a new user fee for
virology identification tests. In addition, we propose to move two user
fees that are currently listed in Sec. 130.16(a) of the regulations
into Sec. 130.15(b). On average, these user fees would increase by less
than 10 percent.
Table 6.--User Fees for Virology Identification Tests (Proposed Sec. 130.15(b))
----------------------------------------------------------------------------------------------------------------
Change in user fee
Proposed virology identification Proposed Unit Current user -------------------------
test user fee fee Amount Percent
----------------------------------------------------------------------------------------------------------------
Fluorescent antibody tissue section $18.25 Test.................. 0 ........... ...........
Virus isolation (except for 31.50 Test.................. 29.75 1.75 6
Newcastle disease virus).
Virus isolation for Newcastle 15.25 Test.................. 14.00 1.25 9
disease virus.
----------------------------------------------------------------------------------------------------------------
Bacteriology Serology Tests
Table 7 shows the user fees proposed in Sec. 130.16(a) for
bacteriology serology tests. We propose to implement seven new user
fees for bacteriology serology tests. In addition, we propose to move
11 user fees that are currently listed in Sec. 130.14(a) of the
regulations into Sec. 130.16(a). On average, most of these user fees
would increase by less than 15 percent.
Table 7.--User Fees for Bacteriology Serology Tests (Proposed Sec. 130.16(a))
----------------------------------------------------------------------------------------------------------------
Change in user fee
Proposed bacteriology serology Proposed Unit Current user ---------------------------
test user fee fee Amount Percent
----------------------------------------------------------------------------------------------------------------
Brucella milk ELISA............... $15.75 Test................. 0 ............ ............
Brucella ring (BRT)............... 10.50 Test................. 0 ............ ............
Brucella ring, heat inactivated 10.50 Test................. 0 ............ ............
(HIRT).
Brucella ring, serial (serial BRT) 15.75 Test................. 0 ............ ............
Buffered acidified plate antigen 4.00 Test................. 3.50 0.50 14.29
presumptive.
Card.............................. 2.00 Test................. 2.00 0.00 0
Complement fixation............... 9.00 Test................. 9.00 0.00 0
Enzyme linked immunosorbent assay, 4.75 Test................. 4.75 0.00 0
all other.
Enzyme linked immunosorbent assay 9.00 Test................. 4.75 4.25 89
for dourine, glanders, or
piroplasmosis.
Indirect fluorescent antibody..... 9.75 Test................. 9.00 0.75 8
Mercaptoethanol................... 4.00 Test................. 3.50 0.50 14
Microscopic agglutination-- 11.00 Sample............... 10.00 1.00 10
includes up to 5 serovars.
Mycology/fungus serology.......... 10.50 Test................. 0 ............ ............
Particle concentration fluorescent 18.25 Test................. 0 ............ ............
immuno assay (PCFIA).
Plate............................. 4.00 Test................. 3.50 0.50 14
Rapid automated presumptive....... 4.25 Test................. 0 ............ ............
Rivanol........................... 4.00 Test................. 3.75 0.25 7
Tube agglutination................ 4.00 Test................. 3.50 0.50 14
----------------------------------------------------------------------------------------------------------------
[[Page 24481]]
Virology Serology Tests
Table 8 shows the user fees proposed in Sec. 130.16(b) for virology
serology tests. We propose to implement two new user fees for virology
serology tests. In addition, we propose to move eight user fees that
are currently listed in Sec. 130.14(a) of the regulations into
Sec. 130.16(b). On average, these user fees would increase by less than
10 percent.
Table 8.--User Fees for Virology Serology Tests (Proposed Sec. 130.16(b))
----------------------------------------------------------------------------------------------------------------
Change in user fee
Proposed virology serology test Proposed Unit Current user -------------------------
user fee fee Amount Percent
----------------------------------------------------------------------------------------------------------------
Agar gel immunodiffusion........... $5.00 Test.................. $4.75 $0.25 5
Complement fixation................ 9.00 Test.................. 9.00 0.00 0
Enzyme linked immunosorbent assay.. 4.75 Test.................. 4.75 0.00 0
Hemagglutination inhibition........ 7.50 Test.................. 7.50 0.00 0
Indirect fluorescent antibody...... 9.75 Test.................. 9.00 0.75 8
Latex agglutination................ 5.00 Test.................. 4.75 0.25 5
Peroxidase linked antibody......... 9.75 Test.................. 0 ........... ...........
Plaque reduction neutralization 7.75 Test.................. 7.50 0.25 3
(was Plaque neutralization).
Rabies fluorescent antibody 26.50 Test.................. 0 ........... ...........
neutralization.
Virus neutralization............... 7.75 Test.................. 7.50 0.25 3
----------------------------------------------------------------------------------------------------------------
Pathobiology Tests
Table 9 shows the user fees proposed in Sec. 130.17 for
pathobiology tests. We propose to implement 23 new user fees for
pathobiology tests. In addition, we propose to move 11 user fees that
are currently listed in Secs. 130.14(a) and 130.16(a) of the
regulations into Sec. 130.17. On average, most of these user fees would
increase between 5 and 15 percent.
Table 9.--User Fees for Pathobiology Laboratory Tests (Proposed Sec. 130.17(a))
----------------------------------------------------------------------------------------------------------------
Change in user fee
Proposed pathobiology laboratory Proposed Unit Current user -------------------------
test user fee fee Amount Percent
----------------------------------------------------------------------------------------------------------------
Aflatoxin quantitation............. $20.50 Test.................. 0 ........... ...........
Aflatoxin screen................... 11.25 Test.................. ............ ........... ...........
Agar gel immunodiffusion spp. 6.25 Test.................. 0 ........... ...........
identification.
Antibiotic (bioautography) 25.00 Test.................. 0 ........... ...........
quantitation.
Antibiotic (bioautography) screen.. 50.00 Test.................. 0 ........... ...........
Antibiotic inhibition.............. 25.25 Test.................. 0 ........... ...........
Arsenic............................ 6.75 Test.................. 0 ........... ...........
Ergot alkaloid screen.............. 25.25 Test.................. 0 ........... ...........
Ergot alkaloid confirmation........ 33.00 Test.................. 0 ........... ...........
Feed microscopy.................... 25.25 Test.................. 0 ........... ...........
Fumonisin only..................... 20.50 Test.................. 0 ........... ...........
Gossypol........................... 37.75 Test.................. 0 ........... ...........
Mercury............................ 56.00 Test.................. 0 ........... ...........
Metals screen (was ICP metals-- 29.75 Test.................. 26.25 3.50 13
screen).
Metals single element confirmation 6.75 Test.................. 6.00 0.75 13
(was ICP metals--confirmation).
Mycotoxin: aflatoxin-liver......... 82.25 Test.................. 0 ........... ...........
Mycotoxin screen................... 34.00 Test.................. 30.75 3.25 11
Nitrate/nitrite.................... 25.00 Test.................. 0 ........... ...........
Organic compound confirmation (was 34.00 Test.................. 31.00 3.00 10
GC/MS organic compound--
confirmation).
Organic compound screen (was GC/MS 114.75 Test.................. 106.50 8.25 8
organic compound--screen).
Parasitology....................... 19.25 Test.................. 17.00 2.25 13
Pesticide quantitation............. 51.25 Test.................. 47.50 3.75 8
Pesticide screen................... 38.00 Test.................. 34.25 3.75 11
pH test............................ 10.00 Test.................. 0 ........... ...........
Plate cylinder..................... 37.75 Test.................. 0 ........... ...........
Selenium........................... 33.25 Test.................. 30.50 2.75 9
Silicate/carbonate disinfectant.... 25.00 Test.................. 0 ........... ...........
Temperature disks.................. 50.25 Test.................. 0 ........... ...........
Toxicant quantitation, other....... 42.25 Test.................. 39.75 2.50 6
Toxicant screen, other............. 25.00 Test.................. 39.75 -14.75 -37
Vomitoxin only..................... 20.75 Test.................. 0 ........... ...........
Water activity..................... 12.50 Test.................. 0 ........... ...........
Zearaleone quantitation............ 20.50 Test.................. 0 ........... ...........
Zearaleone screen.................. 11.25 Test.................. 0 ........... ...........
----------------------------------------------------------------------------------------------------------------
Diagnostic Bacteriology Reagents
Table 10 shows the user fees proposed in Sec. 130.18(a) for
diagnostic bacteriology reagents. We propose to implement 33 new user
fees for reagent categories. In addition, we propose to move 11 user
fees that are currently listed in
[[Page 24482]]
Sec. 130.17(a) of the regulations into Sec. 130.18(a). All of these
proposed reagent categories include changes in the amount of the user
fee.
Table 10.--User Fees for Diagnostic Bacteriology Reagents (Proposed Sec. 130.18(a))
----------------------------------------------------------------------------------------------------------------
Change in user fee
Proposed reagent Proposed Unit Current user -------------------------
user fee fee Amount Percent
----------------------------------------------------------------------------------------------------------------
Anaplasma card test antigen...... $34.00 2 ml................. 0 ........... ...........
Anaplasma card test kit without 105.50 Kit.................. 0 ........... ...........
antigen.
Anaplasma CF antigen............. 17.00 2 ml................. 0 ........... ...........
Anaplasma stabilate.............. 67.25 4.5 ml............... 0 ........... ...........
Avian origin bacterial 11.50 1 ml................. 0 ........... ...........
antiserums, mycoplasma.
Avian origin bacterial 17.75 1 ml................. 10.00 7.75 78
antiserums, all other (was
Pasteurella antiserum).
Bacterial agglutinating antigens 30.50 5 ml................. 0 ........... ...........
other than brucella and
salmonella pullorum.
Bacterial conjugates (was Lepto 36.00 1 ml................. 19.25 16.75 87
FA conjugate).
Bacterial disease CF antigens, 8.50 1 ml................. 2.25/1 ml 6.25 278
all other (was Brucella ovis (5.50/2 ml)
antigen).
Bacterial ELISA antigens......... 9.50 1 ml................. 0 ........... ...........
Bacterial or protozoal 7.25 1 ml................. 0 ........... ...........
antiserums, all other.
Bacterial reagent cultures (was 21.25 Culture.............. 20.00 1.25 -125
Leptospira and Pasteurella
antigens).
Bacterial reference culture...... 63.25 Culture.............. 0 ........... ...........
Bacteriophage reference culture.. 63.25 Culture.............. 0 ........... ...........
Bovine serum factor.............. 1.25 2 ml................. 0 ........... ...........
Brucella abortus CF antigen...... 34.00 60 ml................ 0 ........... ...........
Brucella agglutination antigens, 34.00 60 ml................ 0 ........... ...........
all other.
Brucella buffered plate antigen.. 50.00 60 ml................ 0 ........... ...........
Brucella canis tube antigen (was 30.50 25 ml................ 103.13/25 ml -72.63 -70
Brucella canis antigen). (8.25/2 ml)
Brucella card test antigen 19.50 Package.............. 0 ........... ...........
(packaged).
Brucella card test kit without 70.25 Kit.................. 0 ........... ...........
antigen.
Brucella cells................... 5.25 Gram................. 0 ........... ...........
Brucella cells, dried............ 2.00 Pellet............... 0 ........... ...........
Brucella ring test antigen....... 72.75 60 ml................ 0 ........... ...........
Brucella rivanol solution........ 8.75 60 ml................ 0 ........... ...........
Dourine CF antigen............... 17.50 1 ml................. 0 ........... ...........
Dourine stabilate................ 34.75 4.5 ml............... 0 ........... ...........
Equine and bovine origin 21.25 1 ml................. 0 ........... ...........
hemoparasitic antiserums.
Equine negative control CF 171.25 1 ml................. 0 ........... ...........
antigen.
Equine origin glanders antiserum. 18.25 1 ml................. 0 ........... ...........
Flazo-orange (was Lepto FA Flazo- 6.25 3 ml................. 6.00 0.25 4
orange).
Glanders CF antigen.............. 17.50 1 ml................. 0 ........... ...........
Hemoparasitic disease CF 158.25 1 ml................. 0 ........... ...........
antigens, all other.
Leptospira transport medium...... 3.25 10 ml................ 3.00 0.25 8
Monoclonal antibody.............. 37.50 1 ml................. 0 ........... ...........
Mycobacterium spp. Old tuberculin 3.75 1 ml................. 6.125/1 ml -2.38 -39
(was Johnin OT). (12.25 /2 ml)
Mycobacterium spp. PPD (was 3.25 1 ml................. 5.38/1 ml -2.13 -40
Johnin PPD). (10.75/2 ml)
Mycoplasma hemagglutination 105.50 5 ml................. 0 ........... ...........
antigens.
Negative control serums.......... 4.00 1 ml................. 0 ........... ...........
Other spp. antiserum, any........ 32.75 1 ml................. 0 ........... ...........
Rabbit origin bacterial 14.25 1 ml................. 2.25/1 ml 12.00 533
antiserums (was Leptospira (4.50/2 ml)
antiserum).
Salmonella pullorum 6.25 5 ml................. 0 ........... ...........
microagglutination antigen.
Stabilates, all other............ 258.25 4.5 ml............... 0 ........... ...........
----------------------------------------------------------------------------------------------------------------
Diagnostic Virology Reagents
Table 11 shows the user fees proposed in Sec. 130.18(b) for
diagnostic virology reagents. We propose to implement seven new user
fees for reagent categories. In addition, we propose to move 125 user
fees that are currently listed in Sec. 130.17(a) of the regulations
into Sec. 130.18(b). The individual user fees for these 126 reagents
would be reorganized into 12 reagent categories. All of these current
user fees for reagents would change.
Table 11.--User Fees for Diagnostic Virology Reagents (Proposed Sec. 130.18(b))
--------------------------------------------------------------------------------------------------------------------------------------------------------
Change in user fee
Proposed reagent Proposed Unit Current user -------------------------
user fee fee Amount Percent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Antigen, except avian influenza and chlamydia $41.50 2 ml........................................... ............... ........... ...........
psittaci antigens, any.
[[Page 24483]]
(was Avian adenovirus 127, paramyxovirus-2, ........... ............................................... $39.50 $2.00 5
paramyxovirus-3; and Newcastle disease
antigens).
(was Contagious ecthyma CF antigen)........ ........... ............................................... 14.00 /2 ml 27.50 196
(7.00/1 ml)
(was Infectious bursal disease antigen).... ........... ............................................... 16.00 /2 ml 25.50 159
(8.00/1 ml)
Avian antiserum except avian influenza 23.00 2 ml........................................... ............... ........... ...........
antiserum, any.
(was Avian adenovirus 127, ........... ............................................... 21.75 1.25 6
encephalomyelitis, paramyxovirus-2, and
paramyxovirus-3; Duck viral enteritis;
Infectious bronchitis virus, bursal
disease, and laryngotracheitis; Newcastle
disease; and Psittacine herpes virus
(standard) antiserums).
(was Chlamydia psittaci antiserum)......... ........... ............................................... 43.50/2 ml -20.50 -47
(21.75/1 ml)
Avian influenza antigen, any................... 9.25 2 ml........................................... 8.75 0.50 6
Avian influenza antiserum, any................. 53.75 6 ml........................................... 51.00/6 ml 2.75 5
Bovine or ovine serum, any..................... 88.00 2 ml........................................... ............... ........... ...........
(was Bluetongue; Bovine coronavirus, herpes ........... ............................................... 83.50 4.50 5
virus type 1, herpes virus type 2, herpes
virus type 4, papular stomatitis,
parvovirus, respiratory syncytial virus,
rotavirus, and viral diarrhea; Epizootic
hemorrhagic disease; and Parainfluenza-3
antiserums).
(was Contagious ecthyma antiserum)......... ........... ............................................... 5.25/2 ml 82.75 1576
Cell culture................................... 20.00 Flask.......................................... 0 ........... ...........
Chlamydia psittaci spp. of origin monoclonal 47.25 Panel.......................................... 0 ........... ...........
antibody panel.
Conjugate, any................................. 20.25 1 ml........................................... ............... ........... ...........
(was Bluetongue; Bovine coronavirus, herpes ........... ............................................... 19.25 1.00 5
virus type 1, herpes virus type 2, herpes
virus type 4, papular stomatitis,
parvovirus, respiratory syncytial virus,
rotavirus, viral diarrhea; Chlamydia
psittaci; Contagious ecthyma; Encephalomyo-
carditis; Epizootic hemorrhagic disease;
Hemagglutinating encephalomyelitis;
Parainfluenza-3; Porcine adenovirus (AV),
parvovirus (PPV), reovirus, and rotavirus;
Swine influenza, and Transmissible
gastroenteritis conjugates).
(was Duck viral enteritis conjugate)....... ........... ............................................... 31.25 -11.00 -35
(was Equine adenovirus, Equine herpes type ........... ............................................... 24.00 -3.75 -16
1, and Psittacine herpes virus conjugates).
Diluted positive control serum, any............ 6.75 2 ml........................................... ............... ........... ...........
(was Encephalomyo-carditis; ........... ............................................... 6.25 0.50 8
Hemagglutinating encephalomyelitis;
Parainfluenza-3; Porcine parvovirus (PPV),
and rotavirus; Swine influenza; and
Transmissible gastroenteritis positive
control serums).
(was Bovine herpes virus type 1, and type ........... ............................................... 4.50 2.25 50
2, parvovirus, respiratory syncytial
virus, and viral diarrhea positive control
serums).
Equine antiserum, any.......................... 12.25 2 ml........................................... ............... ........... ...........
(was Equine adenovirus, herpes type 1, ........... ............................................... 11.50 0.75 7
herpes type 2, and herpes type 3
antiserums).
(was Equine influenza antiserum)........... ........... ............................................... 21.75 -9.50 -44
(was Equine viral arteritis antiserum)..... ........... ............................................... 19.30/2 ml -7.05 -37
(48.25/5 ml)
Hog Cholera tissue sets........................ 81.50 Tissue set..................................... 76.75 4.75 6.19
Monoclonal antibody............................ 37.50 1 ml........................................... 0 ........... ...........
Other spp. antiserum, any...................... 32.75 1 ml........................................... 0 ........... ...........
Porcine antiserum, any (was Encephalomyo- 60.50 2 ml........................................... 57.50 3.00 5
carditis; Hemagglutinating encephalomyelitis;
Porcine adenovirus (AV), parvovirus (PPV),
reovirus, and rotavirus; Swine influenza; and
Transmissible gastroenteritis antiserums).
Positive control tissues, all.................. 4.25 2 cm\2\ section................................ 0 ........... ...........
Rabbit origin antiserums....................... 14.25 1 ml........................................... 0 ........... ...........
Reference virus, any........................... 63.50 0.6 ml......................................... 0 ........... ...........
[[Page 24484]]
Viruses (except reference viruses), chlamydia 5.50 0.6 ml......................................... ............... ........... ...........
psittaci agent, or chlamydia psittaci antigen,
any.
(was Avian encephalomyelitis, paramyxovirus- ........... ............................................... 5.25 0.25 5
2, paramyxovirus-3, and reovirus;
Bluetongue; Bovine coronavirus, herpes
type 1, type 2, and type 4, papular
stomatitis, parvovirus, respiratory
syncytial, rotavirus, and viral diarrhea;
Chlamydia psittaci agent; Contagious
ecthyma; Duck viral enteritis;
Encephalomyo-carditis; Epizootic
hemorrhagic disease; Equine adenovirus,
herpes type 1, type 2, and type 3,
influenza, and viral arteritis;
Hemagglutinating encephalomyelitis;
Infectious bursal disease; Infectious
laryngotracheitis; Newcastle disease;
Parainfluenza-3; Porcine adenovirus (AV),
parvovirus (PPV), reovirus, and rotavirus;
Psittacine herpes; Quail bronchitis; Swine
influenza; and Transmissible
gastroenteritis viruses).
(was Chlamydia psittaci antigen)........... ........... ............................................... 3.15/0.6 ml 2.35 75
(5.25/1 ml)
(was Infectious bronchitis virus).......... ........... ............................................... 4.50 1.00 22
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Veterinary Diagnostics
Table 12 shows the user fees proposed in Sec. 130.19 for other
veterinary diagnostics. We propose to implement 13 new user fees and a
new hourly user fee for other NVSL veterinary diagnostics for which
there are no identified flat rate user fees or for which an hourly user
fee is more appropriate. In addition, we propose to move a user fee
that is currently listed in Sec. 130.8(a) of the regulations into
Sec. 130.19.
Table 12.--User Fees for Other Veterinary Diagnostics (Proposed Sec. 130.19)
----------------------------------------------------------------------------------------------------------------
Change in user fee
Proposed other veterinary Proposed Unit Current user -------------------------
diagnostics services user fee fee Amount Percent
----------------------------------------------------------------------------------------------------------------
Antimicrobial susceptibility $30.50 Isolate..................... 0 ........... ...........
test.
Avian safety test............ 2701.75 Test........................ 0 ........... ...........
Check tests, anaplasma 132.00 Kit......................... 0 ........... ...........
complement fixation.
Check tests, culture......... 88.00 Kit......................... 0 ........... ...........
Check tests, serology, all 125.75 Kit......................... 0 ........... ...........
other.
Fetal bovine serum safety 673.50 Verification................ 666.00 7.50 1
test (was fetal bovine serum
sample verification).
Hourly user fee services..... 56.00 Hour........................ 56.00 0.00 0
Quarter hour................. 14.00 Quarter hour................ 14.00 0.00 0
Minimum...................... 16.50 Minimum..................... 16.50 0.00 0
Manual, Brucellosis 13.00 Manual...................... 0 ........... ...........
complement fixation.
Manual, Brucellosis culture.. 52.75 Manual...................... 0 ........... ...........
Manual, Tuberculosis culture 79.25 Manual...................... 0 ........... ...........
(English or Spanish).
Manual, Veterinary mycology.. 105.50 Manual...................... 0 ........... ...........
Manual, Anaplasmosis, Johne's 21.25 Manual...................... 0 ........... ...........
disease, mycoplasma
hyopnuemonia, piroplasmosis,
dourine, or glanders.
Manuals or standard operating 13.25 Manual or SOP copy.......... 0 ........... ...........
procedure (SOP), All other.
Manuals or SOP, per page..... 2.00 Page........................ 0 ........... ...........
Training (school or technical 120.00 Per person per day.......... 0 ........... ...........
assistance).
----------------------------------------------------------------------------------------------------------------
Definitions (Sec. 130.1)
We propose to add a definition for APHIS representative to the
regulations. This term is defined and used throughout subchapter D,
which covers the exportation and importation of animals (including
poultry) and animal products. Currently, the terms APHIS animal health
technician and APHIS veterinarian are defined in Sec. 130.1. The term
animal health technician is used in Sec. 130.3 in reference to services
provided at APHIS animal import centers. The term APHIS veterinarian is
used in Sec. 130.20 in reference to inspection services provided in
conjunction with endorsements of export health certificates. For
consistency, we propose to replace the terms APHIS animal health
technician and APHIS veterinarian with APHIS representative. The
proposed definition would read as follows: ``An individual, including,
but not limited to animal health technicians and veterinarians,
authorized by the Administrator to perform the services for which the
user fees in this part are charged.'' Because an APHIS representative
would cover APHIS animal health technicians and APHIS veterinarians, we
propose to remove those definitions.
[[Page 24485]]
We propose to revise the definition for export health certificate.
Currently, the definition specifies that an APHIS veterinarian endorses
the export health certificate. In some cases an APHIS representative
who is not a veterinarian may be able to endorse an export health
certificate. For example, export health certificates for animal
products may not require the endorsement of an APHIS veterinarian.
Therefore, we propose to change APHIS veterinarian to APHIS
representative in the definition for export health certificate.
Currently, the definition for export health certificate covers only
animals or birds. Based on an importing country's requirements, an
export health certificate may be required for animal products,
organisms, and vectors as well as animals and birds. Therefore, we
propose to expand the definition to read as follows: ``An official
document that, as required by the importing country, is endorsed by an
APHIS representative and states that animals, animal products,
organisms, vectors, or birds to be exported from the United States were
found to be healthy and free from evidence of communicable diseases and
pests.''
We propose to add new definitions for nonstandard care and handling
and nonstandard housing. Currently, Sec. 130.2 includes user fees for
birds in nonstandard housing or receiving nonstandard care and handling
at APHIS animal import centers. Nonstandard housing, care, and handling
are defined in Sec. 130.2(b) and (c). For consistency, we propose to
move these definitions to Sec. 130.1.
We propose to revise the definition of pet birds. Currently, the
definition only covers birds that are imported. User fees may apply to
pet birds that are exported, as for example, when another country
requires an export health certificate for a pet bird. Therefore, we
propose to extend the definition to include both importation and
exportation. In addition, currently the definition of pet birds
excludes only ratites. We believe that hatching eggs should also be
excluded from consideration as pet birds. Therefore, we propose to add
hatching eggs to the exceptions in the definition. The proposed
definition would read as follows: Birds, except hatching eggs and
ratites, that are imported or exported for the personal pleasure of
their individual owners and are not intended for resale.
As discussed above, we believe we no longer need to separately
identify reference assistance tests from other veterinary diagnostics
tests. Therefore, we propose to remove the definition for reference
assistance testing.
User Fees for Animal Import Centers (Sec. 130.2)
Currently, Sec. 130.2 specifies the user fees for animals and birds
quarantined in APHIS animal import centers. Currently, Sec. 130.2(a)
specifies the applicable user fees. Currently, Secs. 130.2(b) through
130.2(e) address nonstandard housing, nonstandard care and handling,
nonstandard feed, and reservation fees, respectively. As discussed
above under definitions, we propose to move the definitions for
nonstandard care, handling, and housing from Sec. 130.2(b) and (c) to
Sec. 130.1. We have reviewed these user fees and are proposing several
user fee changes and several nonsubstantive changes as described below.
Our review showed that we are not recovering our full costs for
quarantining zoo animals in APHIS animal import centers. We have
determined that our costs for quarantining zoo animals is equivalent to
our costs for quarantining domestic animals. Therefore, we propose to
combine the user fees for domestic and zoo animals. The user fees for
domestic animals would remain the same; however, the user fee for zoo
animals would increase from $32.25 to $56.50 per day. In addition, we
would revise the list of domestic animals to correct an error by
eliminating the word ``buffalo'' and adding the word ``bulls''. The
list currently includes the word ``bison'' which covers buffalo. Bulls
were inadvertently omitted. We propose to remove the separate listing
for zoo animals.
Our review showed that we are not recovering our full costs for
quarantining large birds or poultry receiving nonstandard care,
handling, or housing in APHIS animal import centers. We believe that we
need to increase this user fee to recover our costs; however, smaller
birds and poultry receiving nonstandard care, handling, or housing in
APHIS animal import centers do not cost as much to quarantine.
Therefore, we propose separate user fees for birds or poultry requiring
nonstandard care, handling, or housing based on the size of the bird or
the type of poultry. Birds that are less than or equal to 250 grams,
doves, pigeons, and quail would be charged $3.25 per day. This user fee
would be less than the current user fee for birds and poultry. Birds
that are between 251 and 1,000 grams, chickens, ducks, grouse, guinea
fowl, partridges, pea fowl, and pheasants would be charged $7.50 per
day. This user fee would remain the same for birds and would be less
than the current user fee for poultry. Birds that are more than 1,000
grams, large poultry, and large waterfowl, including, but not limited
to, game cocks, geese, swans, and turkeys, would be charged $14.00 per
day. This user fee would be more than the current user fee for birds
and poultry. In addition, we propose to move these user fees for
nonstandard care, handling, and housing into a separate section
(proposed Sec. 130.2(b)) to replace the current sections defining
nonstandard housing (Sec. 130.2(b)) and nonstandard care and handling
(Sec. 130.2(c)).
As a result of these proposed changes, we would redesignate current
Sec. 130.2(d) on nonstandard feed as proposed Sec. 130.2(c). We also
propose to make nonsubstantive edits to the text.
Currently, Sec. 130.2(e) specifies that a reservation fee paid by
the importer under part 93 of this chapter will be applied to the APHIS
user fee due for animals or birds quarantined in an animal import
center operated by APHIS. Sections 130.2 and 130.3 both list user fees
for animals or birds quarantined in animal import centers operated by
APHIS. Therefore, Sec. 130.2(e) should apply to the user fees in
Secs. 130.2 and 130.3. We believe that the reservation fees reference
would be more appropriate in proposed Sec. 130.50(b), which addresses
associated charges. Therefore, we propose to move Sec. 130.2(e) into
proposed Sec. 130.50(b)(1).
User Fees for Exclusive Use of Animal Import Centers (Sec. 130.3)
We reviewed our user fees for the exclusive use of APHIS animal
import centers and have determined that we should change the way we
calculate the user fees listed for the buildings in Newburgh, NY, and
add a user fee for a new building, also in Newburgh, NY. Currently, the
published dimensions represent the outside building dimensions. These
measurements include office space, bathrooms, utility, and storage
areas. We believe that the costs for those items should be included in
the administrative support cost factor. Therefore, we recalculated the
dimensions for spaces A and B and have recalculated the user fees based
on the proposed dimensions. Space A would be $43,102.00 per month for
5,396 sq. ft. (503.1 sq. m.), rather than $47,609.00 per month for
5,904 sq. ft. (248.5 sq. m.). Space B would be $71,118.50 per month for
8,903 sq. ft. (827.1 sq. m.), rather than $78,555.00 per month for
9,742 sq. ft. (905 sq. m.). In addition, we propose to add a new,
smaller space C at $7,229.00 per month for 905 sq. ft. (84.1 sq. m.).
[[Page 24486]]
User Fees for Services at Privately Operated Import Quarantine
Facilities (Sec. 130.5)
Currently, Sec. 130.5(a) addresses who must pay user fees for
services at privately operated import quarantine facilities. Currently,
Sec. 130.5(b) lists the hourly rate user fees for these services. For
consistency with Sec. 130.9, which consolidates in Sec. 130.9(a) the
hourly rate user fees and the services to which they apply, we propose
to consolidate in Sec. 130.5(a) the hourly rate user fees and the
services to which these user fees apply.
User Fees for Other Services (Sec. 130.8)
Currently, Sec. 130.8 includes a user fee for fetal bovine serum
sample verification. Fetal bovine serum sample verification is a
veterinary diagnostics service which we provide at NVSL. We propose to
add the user fee into proposed Sec. 130.19, as explained above.
Therefore, we propose to remove the user fee from Sec. 130.8 to avoid
duplication.
Currently, Sec. 130.8 includes user fees for import compliance
assistance and release from export agricultural hold. We have reviewed
these user fees and determined that the estimates used for the current
user fees do not include enough direct labor time for these services.
In addition, the services we provide for both of these activities fall
into two categories. First, all the information provided by the
importer or exporter is complete and correct. In these cases, the
processing is straightforward and generally takes less than half an
hour to process. Second, the information provided by the importer or
exporter is not complete or some other factor requires additional
effort. In these cases, more time, on average 3.5 hours, is required,
for example, to review the forms, to request more information from the
importer/exporter, to research various aspects of the product, organism
or vector being imported or exported, or to correspond with NVSL about
tests. While our experience shows that most importers and exporters fit
the first category, they should not have to subsidize those who fit
into the second category. Therefore, we propose to set two user fees
for each of these services. The user fee for a simple import compliance
assistance or a simple release from agricultural hold would be $51.25.
A simple case would be one that required 2 or less hours of assistance.
The user fee for a complicated import compliance assistance or a
complicated release from agricultural hold would be $131.75. A
complicated case would be one that required more than 2 hours of
assistance.
Hourly Rate User Fees (Sec. 130.21)
Currently, Sec. 130.21(a) lists services for which hourly user fees
are charged for inspection and supervision services provided within the
United States for export animals, birds, and animal products.
Currently, Sec. 130.21(b) lists the hourly rate user fees for the
services listed in Sec. 130.21(a). For consistency with Sec. 130.9,
which consolidates in Sec. 130.9(a) the hourly rate user fees and the
services to which they apply, we propose to consolidate in
Sec. 130.21(a) the hourly rate user fees and the services to which
these user fees apply.
In addition, we are proposing to remove the word ``byproducts''
from the section heading. The term ``byproducts'' is generally used to
refer to inedible animal products. APHIS inspects and issues export
health certificates for both inedible and edible animal products. The
term ``products'' covers both. Therefore, we would change the section
heading to ``User fees for inspection services provided within the
United States for export animals, birds, and animal products.''
Payment of User Fees (Sec. 130.50)
To eliminate duplication throughout part 130 and to add clarity to
the requirements in Sec. 130.50, we are proposing miscellaneous
nonsubstantive changes throughout Sec. 130.50, including adding
paragraph headers. As a result of these changes, Sec. 130.50(a) and (b)
would be redesignated as Sec. 130.50(c) and (d), respectively. All of
the changes to Sec. 130.50 are described below and summarized in a
chart at the end of this section.
We propose to add language in proposed Sec. 130.50(a) to clarify
who must pay APHIS user fees. In addition, we would specify throughout
part 130 that all of the user fees listed must be paid in accordance
with Secs. 130.50 and 130.51.
Currently, Secs. 130.14(c), 130.15(c), 130.16(c), 130.17(c), and
130.18(b) provide for payment of costs that are incurred due to special
mail handling, such as express, overnight, or foreign mailing. If
special mail handling is required, all costs incurred must be paid in
addition to the user fee for the test or service requiring special mail
handling. We believe that this same requirement should apply to the
user fees listed throughout part 130. Therefore, we propose to
eliminate duplication within Secs. 130.14 through 130.18 and expand the
special mail handling requirement to all of the user fees in part 130
by moving it from Secs. 130.14(c), 130.15(c), 130.16(c), 130.17(c), and
130.18(b) into proposed Sec. 130.50(b)(2), where it will apply to all
user fees in part 130.
Currently, Secs. 130.6(b), 130.7(b), 130.8(b), 130.14(b),
130.15(b), 130.16(b), and 130.20(e) provide for reimbursable overtime
to be paid in addition to the listed flat rate user fee when we provide
services during overtime (i.e., on a Sunday or holiday or at any other
time outside the normal tour of duty of the employee). In addition,
currently, Secs. 130.5, 130.9, and 130.21 provide for the premium rate
user fee to be applied in lieu of the hourly rate user fee when we
provide services during overtime. All of our user fees were calculated
based on direct labor costs for services provided during the normal
tour of duty for our employees. When services are provided on overtime,
reimbursable overtime or the premium user fee should be charged to
recover the full costs of providing flat rate or hourly rate user fee
services, respectively. Therefore, to eliminate duplication and expand
these requirements for overtime services to cover all user fees in part
130, we would move the reimbursable overtime requirement from
Secs. 130.6(b), 130.7(b), 130.8(b), 130.14(b), 130.15(b), 130.16(b),
and 130.20(e) into proposed Sec. 130.50(b)(3)(i), where it would apply
to all flat rate user fees in part 130. We would also move the premium
rate user fee requirement from Secs. 130.5, 130.9, and 130.21 into
proposed Sec. 130.50(b)(3)(ii), where it would apply to all hourly rate
user fees in part 130.
Currently, Sec. 130.50(a) specifies when user fee payments are due.
We would redesignate current Sec. 130.50(a) as proposed Sec. 130.50(c)
and revise the text to add references to the sections of the
regulations that list the user fees for which payment is due, and to
clarify and eliminate duplication, as described below.
Currently, Secs. 130.50(a)(1) and (a)(2) specify when user fees for
animals and birds in an animal import center or privately operated
permanent import quarantine facility and animals and birds in a
privately operated temporary import quarantine facility, respectively
must be paid. All of these user fees must be paid when the animals or
birds are released from quarantine. Therefore, we propose to combine
Secs. 130.50(a)(1) and (a)(2) into proposed Sec. 130.50(c)(1) to
eliminate duplication.
Currently, Sec. 130.50(a)(3) contains provisions for the payment of
user fees for inspection services, including when these services are
covered by a compliance agreement signed in accordance with 9 CFR part
156. We
[[Page 24487]]
propose to expand this provision to include inspection services covered
by any compliance agreement signed in accordance with title 9, chapter
I, of the Code of Federal Regulations, and to put the expanded
provision in proposed Sec. 130.50(c)(2).
Currently, Sec. 130.50(a)(4) provides for user fees for export
health certificates to be paid when billed or prior to receipt of the
endorsed certificate. We would clarify these provisions in proposed
Sec. 130.50(c)(3).
Currently, Sec. 130.50(a)(5) specifies provisions for the payment
of user fees for veterinary diagnostics. In proposed Sec. 130.50(c)(4)
we would clarify when the user fees could be paid when billed versus
the requirement to be paid when the veterinary diagnostic service is
requested. In addition, we would simplify the text by referring to
these services as veterinary diagnostic services rather than listing
tests, diagnostic reagents, slide sets, tissue sets, and sterilization
by gamma radiation.
Currently, Sec. 130.50(a)(6) contains provisions for payment of
user fees for reference assistance tests. As stated earlier, we believe
we no longer need to separately distinguish reference assistance
testing from other veterinary diagnostic tests. We propose to include
the user fees for these tests with other veterinary diagnostic tests.
Therefore, the payment of these user fees would be covered by proposed
Sec. 130.50(c)(4), which would allow an additional option for paying
user fees for these tests when billed.
Currently, Sec. 130.50(a)(7) through (a)(9) specify provisions for
the payment of user fees for live animals presented for importation at
a port of entry, inspections and permit services, and hourly rate user
fees, respectively. We would combine these provisions into proposed
Sec. 130.50(c)(5) and revise the payment options for the user fees
specified in Sec. 130.8 to include the option for payment when billed.
In addition, we would edit the text to clarify that the user fees could
be paid when billed versus the requirement to be paid when the service
is provided.
In addition, we propose to combine Secs. 130.50(b) and (c) into
proposed Sec. 130.50(d). Currently, Sec. 130.50(b) identifies
acceptable payment methods. Currently, Sec. 130.50(c) specifies that
payment must be for the exact amount due. We propose to combine these
provisions to specify that payment for the exact amount due must be
made by one of the acceptable methods. In addition, we propose to
revise the cash payment provision currently in Sec. 130.50(b)(4) to
incorporate the provision currently specified in Sec. 130.51(a)(4) that
cash payments would be accepted only during normal business hours.
The following table summarizes all of these changes, listed in
order for the proposed sections in Sec. 130.50.
----------------------------------------------------------------------------------------------------------------
Proposed location Requirement Action
----------------------------------------------------------------------------------------------------------------
Sec. 130.50(a)................................... Any person for whom a service Clarify by adding language
is performed and the person from the Farm Bill.
requesting the service would
be jointly and severally
liable for the payment of
APHIS user fees.
Sec. 130.50(b)(1)................................ Reservation fees would be Move from Sec. 130.2(a) to
applied to the APHIS user expand the applicability to
fees specified in Secs. all relevant user fees.
130.2 and 130.3.
Sec. 130.50(b)(2)................................ All costs incurred for Move from Secs. 130.14(c),
special mail handling would 130.15(c), 130.16(c),
be paid by the user, in 130.17(c), 130.17(c), and
addition to the user fee for 130.18(b) to eliminate
the service. duplication in these
sections and to expand the
applicability to all user
fees in 9 CFR part 130.
Sec. 130.50(b)(3)(i)............................. Reimbursable overtime would Move from Secs. 130.6(b),
be paid in addition to the 130.7(b), 130.8(b),
listed flat rate user fee 130.14(b), 130.15(b),
when we provide services 130.16(b), and 130.20(e) to
during overtime. eliminate duplication and
expand the applicability to
all flat rate user fees in 9
CFR part 130.
Sec. 130.50(b)(3)(ii)............................ Premium rate user fees would Move from Secs. 130.5(c),
be applied in lieu of the 130.9(b), and 130.21(c) to
hourly rate user fee when we eliminate duplication and
provide services during expand the applicability to
overtime. all hourly rate user fees in
9 CFR part 130.
Sec. 130.50(c)(1)................................ User fees for animal and bird Combine Sec. 130.50(a)(1)
quarantines and related and (a)(2) to eliminate
tests must be paid prior to duplication and move into
their release from proposed Sec. 130.50(c). In
quarantine. addition, add section
references for user fees.
Sec. 130.50(c)(2)................................ User fees for supervision and Move from Sec. 130.50(a)(3).
inspection services for
export animals and animal
products must be paid when
billed, or as specified in a
compliance agreement.
Sec. 130.50(c)(3)................................ User fees for export health Move from Sec. 130.50(a)(4),
certificates would be paid add section references for
prior to receipt of endorsed user fees, and clarify when
certificates or when billed. the billing option would
apply.
Sec. 130.50(c)(4)................................ User fees for veterinary Move from Sec. 130.50(a)(5),
diagnostics would be paid add section references for
when the service is user fees, and clarify when
requested or when billed. the billing option would
apply. (NOTE: This would
also cover user fees
formerly addressed by Sec.
130.50(a)(6).)
Sec. 130.5(c)(5)................................. User fees for other services Combine Sec. 130.50(a)(7),
would be paid when the (8), and (9) to eliminate
service is provided or when duplication; add section
billed. references for user fees;
clarify when the billing
option would apply; and
expand the billing option to
apply to user fees for
inspection and permit
services.
Sec. 130.50(d)(1) through (d)(4)................. Acceptable forms of payment.. Redesignate from Sec.
130.50(b)(1) through (b)(4)
and combine Sec. 130.50(c).
----------------------------------------------------------------------------------------------------------------
[[Page 24488]]
Penalties for Nonpayment or Late Payment of User Fees (Sec. 130.51)
We are proposing several changes to Sec. 130.51, including the
incorporation of relevant provisions of the Debt Collection Improvement
Act of 1996. These changes are described below. In addition we propose
to make miscellaneous nonsubstantive changes, such as adding paragraph
headers and renumbering paragraphs as necessitated by other proposed
changes.
We propose to incorporate the provision currently specified in
Sec. 130.51(a)(4) that cash payments would be accepted only during
normal business hours into proposed Sec. 130.50(d)(1). Therefore, we
propose to remove Sec. 130.51(a)(4). As a result of this change, we
would redesignate Sec. 130.51(a)(5) as proposed Sec. 130.51(a)(4).
Currently, Secs. 130.51(b)(3) and (b)(4) refer to veterinary
diagnostic tests and other veterinary diagnostic services,
respectively. As we have proposed throughout part 130, we would combine
these to group the veterinary diagnostics together. Therefore, proposed
Sec. 130.51(b)(3) would be simplified by referring to these services as
veterinary diagnostic services.
We are proposing to add a new Sec. 130.51(d) to specify that user
fees paid with dishonored payments, such as a check returned for
insufficient funds, will be subject to interest and penalty charges in
accordance with the Debt Collection Improvement Act (as specified in 30
U.S.C. 3717). Administrative charges will be assessed at $20.00 per
dishonored payment to be paid in addition to the original amount owed.
These payments must be made in guaranteed form, such as money order,
certified check, or cash.
We propose to add a new Sec. 130.51(e) to incorporate the relevant
provisions of the Debt Collection Improvement Act of 1996 (31 U.S.C.
3701, 3716, 3717, 3719, and 3720A). These provisions address taxpayer
identification numbers, administrative offset, cross servicing, and
delinquent debt reporting. Taxpayer identification numbers must be
obtained from all persons, other than Federal agencies, who must pay
user fees. All debts that have not been paid within 180 days would be
eligible for administrative offset and cross servicing. Administrative
offset means withholding funds payable by the United States (including
funds payable by the United States on behalf of a State government) to,
or held by the United States for, a person to satisfy a claim. Under
administrative offset, APHIS would notify the Department of Treasury of
the debts that are over 180 days delinquent and the Department of
Treasury could offset the debt from certain Federal payments that may
be made to the debtor. Cross servicing means that one program services
many agencies. In this case, it means that the Department of Treasury
could collect debts on behalf of APHIS. For cross servicing, APHIS
would transfer debts that are over 180 days delinquent to the
Department of Treasury. In addition, APHIS would report all unpaid
debts to credit reporting bureaus.
In addition, we would add the relevant sections of the Debt
Collection Improvement Act of 1996 to the authority citation for part
130.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
This rule has been determined to be significant for the purposes of
Executive Order 12866 and, therefore, has been reviewed by the Office
of Management and Budget.
Below is a summary of the economic analysis for the changes in
APHIS user fees proposed in this document. The economic analysis
provides a cost-benefit analysis as required by E.O. 12866 and the
analysis of impacts of small entities as required by the Regulatory
Flexibility Act. A copy of the full economic analysis, which includes
comparisons of each user fee change and the change in collections for
each user fee, is available for review at the location listed in the
ADDRESSES section at the beginning of this document.
We do not have enough data for a comprehensive analysis of the
economic impacts of this proposed rule on small entities. Therefore, in
accordance with 5 U.S.C. 603, we have performed an Initial Regulatory
Flexibility Analysis for this proposed rule. We are inviting comments
about this proposed rule as it relates to small entities. In
particular, we are interested in determining the number and kind of
small entities that may incur benefits or costs from implementation of
this proposed rule and the economic impact of those benefits or costs.
User Fees Authorized Under the Farm Bill
The provisions in 21 U.S.C. 114a authorize the Secretary of
Agriculture to control and eradicate communicable diseases of livestock
and poultry. The Food, Agriculture, Conservation and Trade Act of 1990,
as amended (referred to below as the 1990 Farm Bill), authorizes the
Secretary of Agriculture, among other things, to prescribe regulations
and collect fees to recover the costs of carrying out the provisions of
21 U.S.C. 114a that relate to veterinary diagnostics (sec. 2509(c)(2)
of the 1990 Farm Bill).
The 1990 Farm Bill further authorizes the Secretary to prescribe
and collect fees to reimburse the Secretary for the cost of carrying
out the provisions of the Federal Animal Quarantine laws that relate to
the importation, entry, and exportation of animals, articles, or means
of conveyance (section 2509(c)(1) of the 1990 Farm Bill).
In addition, section 2509(d) of the 1990 Farm Bill provides that
the Secretary may prescribe such regulations as the Secretary
determines necessary to carry out these provisions of the 1990 Farm
Bill.
Regulations Proposed in This Document
We are proposing to revise the user fees for certain veterinary
diagnostic services, including certain diagnostic tests, reagents, and
other veterinary diagnostic materials and services. In addition, we are
proposing to add new user fees for other veterinary diagnostic services
we provide. We are proposing to reorganize the regulations in 9 CFR
part 130 to list user fees by type of service and location where
service is provided, and to group diagnostic reagents into categories.
Veterinary diagnostics is the work performed in a laboratory to
determine if a disease-causing organism or chemical agent is present in
body tissues or cells and to identify those organisms or agents.
Services in this category include: (1) Performing laboratory tests and
providing diagnostic reagents and other veterinary diagnostic materials
and services at the Foreign Animal Disease Diagnostic Laboratory
(FADDL) at Greenport, NY, and (2) performing identification, serology,
and pathobiology tests and providing veterinary diagnostic reagents and
other materials and services at the National Veterinary Services
Laboratories (NVSL) at Ames, IA. Diagnostic reagents are biological
materials used in diagnostic tests to detect disease agents or
antibodies by causing an identifiable reaction. We also consider
sterilization by gamma radiation to be a veterinary diagnostics
service. Other miscellaneous veterinary diagnostic services include,
but are not limited to, providing check tests, test kits, manuals,
standard operating procedures, and training.
Small Entities Impacted by Proposed Changes
Users of these veterinary diagnostic services are importers,
exporters, veterinarians, commercial laboratories,
[[Page 24489]]
State laboratories, universities, and foreign governments.
The Small Business Administration's criteria for a small entity
engaged in importing and exporting live animals, poultry, and birds is
one whose total sales are less than $5 million annually. This is also
the criteria for small testing laboratories, veterinary service
providers, and research organizations.
Except for those entities who deal exclusively in purebred or
registered animals, 1995 data from the Bureau of the Census shows that
the majority of agricultural entities who deal in grade animals can be
considered small. However, the number of entities who specifically
trade in live animals and who would qualify as a small entity under
this definition cannot be determined.
According to the Bureau of the Census, 94 percent of testing
laboratories can be considered small. While veterinary testing
laboratories comprise part of this classification, it cannot be
determined how many entities performing veterinary services would be
considered small under the Small Business Administration's guidelines.
To the extent that changes in user fees alter operational costs,
any entity who utilizes APHIS' services that are subject to user fees
may be affected by the proposed changes in user fees. The degree to
which an entity is affected depends on its market power, or the ability
to which costs can be either absorbed or passed on to its buyers.
Without information on either profit margins and operational expenses
of the affected entities,1 or the supply responsiveness of
the affected industry,2 the scale of impacts cannot be
precisely predicted.
---------------------------------------------------------------------------
\1\ Profits for sales of small entities are proprietary in
nature and are not a part of the public record.
\2\ The measurement of supply responsiveness would provide
information on the likely impact on an entity's production due to
changes in operating costs.
---------------------------------------------------------------------------
Changes in Collections
The estimated increased collections generated by the proposed user
fees in this document could be $1.28 million annually (collections
could increase from $2.13 million collected in FY 97 to $3.41 million).
This represents an increase in user fee collections for veterinary
diagnostics and other import-and export-related services of
approximately 40 percent. (See Table 13.)
Table 13.--Summary of Current and Projected Collections for APHIS User
Fees
------------------------------------------------------------------------
Current user Projected Change in
User fee categories fee user fee user fee
collections collections collections
-------------------------------------\1\--------------------------------
Revised Veterinary
Diagnostics User Fees:
FADDL: \2\
Reagents, Tests,
Other (Sec. 130.14) $508,297 $1,074,542 $566,245
NVSL:
Identification Tests
(Sec. 130.15)...... 398,023 428,581 30,558
Serology Tests (Sec.
130.16)............. 727,979 928,506 200,527
Pathobiology Tests
(Sec. 130.17)...... 81,260 90,608 9,348
Reagents (Sec.
130.18)............. 76,534 84,321 7,787
Other (Sec. 130.19). 149,184 174,832 25,648
------------------------------------------
Total Revised
Veterinary
Diagnostics User
Fees............ 1,941,277 2,781,390 840,113
==========================================
New Veterinary Diagnostics
User Fees:
FADDL:
Reagents, Tests,
Other (Sec. 130.14) .............. 98,126 98,126
NVSL:
Identification Tests
(Sec. 130.15)...... .............. 47,476 47,476
Serology Tests (Sec.
130.16)............. .............. 1,000 1,000
Pathobiology Tests
(Sec. 130.17)...... .............. 1,397 1,397
Reagents (Sec.
130.18)............. .............. 154,929 154,929
Other (Sec. 130.19). .............. 104,589 104,589
--------------------------
Total New
Veterinary
Diagnostics User
Fees............ .............. 407,517 407,517
Total Veterinary
Diagnostics User
Fees Collections 1,941,277 3,188,907 1,247,630
==========================================
Other User Fee Changes:
Zoo Animals Quarantined
in APHIS Animal Import
Centers (Sec. 130.2
(a)).................... 1,935 3,192 1,257
Non-Standard Care and
Handling for Birds or
Poultry (Sec. 130.2
(b)).................... 33,780 37,965 4,185
Exclusive Use of Space at
APHIS Animal Import
Center in Newburgh, NY
(Sec. 130.3)........... 126,164 121,450 (4,714)
User Fees for Other
Services (Sec. 130.8).. 27,528 62,970 35,442
------------------------------------------
Total Other User Fee
Changes............. 189,407 225,577 36,170
------------------------------------------
Total Changes in User
Fee Collections..... 2,130,684 3,414,484 1,283,800
------------------------------------------------------------------------
\1\ Source: USDA--APHIS--FSO, NVSL, FADDL.
\2\ Includes collections from cooperative agreements where user fees are
the basis for determining amount to be charged.
The benefit of user fees is the shift in the payment of services
from taxpayers as a whole to those persons who are receiving the
government services. While taxes may not change by the same amount as
the change in user fee collections, there is a related shift in the
appropriations of taxes to government programs, which allows those tax
dollars to be applied to other programs which benefit the public in
general. Therefore, there could be a relative
[[Page 24490]]
savings to taxpayers of $1.28 million annually as a result of the
proposed changes in user fees.
The administrative cost involved in obtaining these savings would
be minimal. APHIS already has a user fee program and a mechanism for
collecting user fees in place. This proposal would update existing user
fees in the system and require collection of additional user fees.
Therefore, increases in administrative costs would be small. Because
the savings are sufficiently large, and the administrative costs would
be small, it is likely that the net gain in reducing the burden on
taxpayers as a whole would outweigh the cost of administering the
revisions of the user fees.
Estimated Impact
The proposed user fees fall into two categories: New and revised
user fees. The vast majority of the proposed user fees are expected to
make only small contributions to the total new collections. Most
(nearly 70 percent) of the proposed new user fees would be less than
$50 each and 40 percent would be less than $25. Most (approximately 70
percent) of the proposed revised user fees increase by less than 20
percent, with many (more than 50 percent) of them increasing by less
than 10 percent.
We anticipate a low demand for the majority of the proposed new
user fees that are greater than $50 and the proposed revised user fees
that would increase by more than 20 percent. Most of the proposed new
user fees that exceed $50 either include more direct labor time than
those services with lower user fees or require premium costs to pay for
special materials.
The proposed revised user fees that would increase by more than 20
percent include those user fees that were underestimated when initially
established. Experience and more accurate accounting data have shown
that most of these services require more direct labor hours, require
premium costs to pay for special materials, or should be calculated
using average lab salaries, which is consistent with the calculations
for other user fees throughout 9 CFR part 130.
Alternatives
One alternative to this proposed rule would be to make no changes
to the current user fees. We do not consider making no changes to the
current user fees a reasonable alternative because we would not recover
the full cost of providing veterinary diagnostic and import- and
export-related services. Therefore, the only way to pay for these
services is through charges to the customer through user fees or other
forms of reimbursable agreements.
Another alternative to this proposed rule would be to either exempt
small businesses from these user fees or establish a different user fee
structure for small businesses. APHIS cannot exempt certain classes of
users, such as small businesses, from the user fees, and cannot charge
user fees that recover less than the full cost of providing the
service. In addition, every business, including small businesses, using
a government service needs to pay the cost of that service, rather than
having other businesses pay a disproportionate share or passing those
costs on to the general public, who are not the primary beneficiary of
the service. Therefore, we do not consider exempting small businesses
from these user fees or establishing a different user fee structure for
small businesses as viable options.
Another alternative to this proposed rule would be to spread the
proposed increased costs over all of the user fees, so no single user
fee would increase significantly. Our user fees are calculated to
recover the costs of the service for which each user fee is charged. To
spread the proposed increases among user fees would mean that some
entities would subsidize others. The intent of user fees is to shift
the burden of the cost of these services from the general taxpayer to
the entity receiving the service. Therefore, APHIS cannot spread the
increases evenly over all of the user fees.
This proposed rule contains no new information collection or
recordkeeping requirements.
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent 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 1995 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this proposed rule have been approved by the Office of
Management and Budget (OMB), and there are no new requirements. The
assigned OMB control numbers are 0579-0015, 0579-0040, 0579-0055, and
0579-0094.
List of Subjects in 9 CFR Part 130
Animals, Birds, Diagnostic reagents, Exports, Imports, Poultry,
Quarantine, Reporting and recordkeeping requirements, Tests.
Accordingly, 9 CFR part 130 would be amended as follows:
PART 130--USER FEES
1. The authority citation for part 130 would be revised to read as
follows:
Authority: 5 U.S.C. 5542; 7 U.S.C. 1622; 19 U.S.C. 1306; 21
U.S.C. 102-105, 111, 114, 114a, 134a, 134b, 134c, 134d, 134f, 135,
136, and 136a; 31 U.S.C. 3701, 3716, 3717, 3719, and 3720A; 7 CFR
2.22, 2.80, and 371.2(d).
2. Section 130.1 would be amended as follows:
a. The definitions for APHIS animal health technician, APHIS
veterinarian, and reference assistance testing would be removed.
b. Definitions for APHIS representative, nonstandard care and
handling, and nonstandard housing would be added, in alphabetical
order, to read as set forth below.
c. The definitions for export health certificate and pet birds
would be revised to read as set forth below.
d. Footnotes 3 and 4 and their references would be removed, and
footnote 2 and its reference would be redesignated as footnote 3.
e. At the end of the definitions for zoo bird and zoo equine a
reference to footnote 3 would be added.
Sec. 130.1 Definitions.
* * * * *
APHIS representative. An individual, including, but not limited to,
animal health technicians and veterinarians, authorized by the
Administrator to perform the services for which the user fees in this
part are charged.
* * * * *
Export health certificate. An official document that, as required
by the importing country, is endorsed by an APHIS representative and
states that animals, animal products, organisms, vectors, or birds to
be exported from the United States were found to be healthy and free
from evidence of communicable diseases and pests.
* * * * *
Nonstandard care and handling. Nonstandard care and handling
includes hand-feeding, more than one feeding per day, frequent
observation, and any handling or observation which requires personnel
to attend to the birds or poultry outside of normal business
hours.2
---------------------------------------------------------------------------
\2\ Normal business hours at the APHIS Animal Import Centers
are: 7:30 a.m. to 11:30 a.m., Honolulu, HI; 7 a.m. to 3:30 p.m.,
Miami, FL; and 8 a.m. to 4:30 p.m., Newburgh, NY.
---------------------------------------------------------------------------
[[Page 24491]]
Nonstandard housing. Nonstandard housing is individual housing not
normally available at an APHIS Animal Import Center, any housing
constructed or purchased at the request of the importer, any housing
with blinds, dense foliage, or plants, and any housing where the
temperature can be adjusted.
* * * * *
Pet birds. Birds, except hatching eggs and ratites, which are
imported or exported for the personal pleasure of their individual
owners and are not intended for resale.
* * * * *
4. Section 130.2 would be revised to read as follows:
Sec. 130.2 User fees for individual animals and certain birds
quarantined in APHIS Animal Import Centers.
(a) Standard requirements. User fees for each animal or bird
receiving standard housing, care, feed, and handling while quarantined
in an APHIS owned or operated Animal Import Center or quarantine
facility are listed in the following table. Each user fee listed in the
table is assessed per animal or bird quarantined by APHIS. The person
for whom the service is provided and the person requesting the service
are jointly and severally liable for payment of these user fees in
accordance with Secs. 130.50 and 130.51.
------------------------------------------------------------------------
Daily user
Animal or bird fee
------------------------------------------------------------------------
Birds (excluding ratites and pet birds imported in
accordance with part 93 of this subchapter):
0-250 grams............................................ $1.00
251-1,000 grams........................................ 3.25
Over 1,000 grams....................................... 7.50
Domestic or zoo animals (except equines, birds, and
poultry):
Bison, bulls, camels, cattle, or zoo animals........... 56.50
All other--including but not limited to alpacas,
llamas, goats, sheep, and swine....................... 15.00
Equines (including zoo equines, but excluding miniature
horses):
1st through 3rd day.................................... 149.50
4th through 7th day.................................... 108.25
8th and subsequent days................................ 91.75
Miniature horses........................................... 40.25
Poultry:
Doves, pigeons, quail.................................. 2.00
Chickens, ducks, grouse, guinea fowl, partridges, pea
fowl, pheasants....................................... 3.50
Large poultry and large waterfowl including but not
limited to game cocks, geese, swans, and turkeys...... 8.25
Ratites:
Chicks (less than 3 months old)........................ 5.75
Juveniles (between 3 and 10 months old)................ 8.00
Adults (11 months old and older)....................... 16.25
------------------------------------------------------------------------
(b) Special requirements. User fees for birds or poultry, including
zoo birds or poultry, receiving nonstandard housing, care, or handling
to meet special requirements while quarantined in an APHIS owned or
operated Animal Import Center or quarantine facility are listed in the
following table. The user fees listed in the table are assessed for
each bird or poultry quarantined by APHIS. Special requirements may be
requested by the importer or required by an APHIS representative.
Certain conditions or traits, such as pregnancy or aggression, may
necessitate special requirements for certain birds or poultry. The
person for whom the service is provided and the person requesting the
service are jointly and severally liable for payment of these user fees
in accordance with Secs. 130.50 and 130.51.
------------------------------------------------------------------------
Daily user
Bird or poultry (nonstandard housing, care, or handling) fee
------------------------------------------------------------------------
Birds 0-250 grams and doves, pigeons, and quail............ $3.25
Birds 251-1,000 grams and poultry such as chickens, ducks,
grouse, guinea fowl, partridges, pea fowl, and pheasants.. 7.50
Birds over 1,000 grams and large poultry and large
waterfowl including but not limited to game cocks, geese,
swans, and turkeys........................................ 14.00
------------------------------------------------------------------------
(c) Feed. The importer must either provide feed or pay for it on an
actual cost basis, including the cost of delivery to the APHIS owned or
operated Animal Import Center or quarantine facility, for any animal or
bird that requires a diet other than standard feed, including but not
limited to diets of fruit, insects, nectar, or fish.
(Approved by the Office of Management and Budget under control number
0579-0094)
5. Section 130.3 would be amended by revising paragraph (a)(1),
including the table, to read as follows:
Sec. 130.3 User fees for exclusive use of space at APHIS Animal Import
Centers.
(a)(1) An importer may request to exclusively occupy a space at an
APHIS Animal Import Center. The user fees for spaces at APHIS Animal
Import Centers are listed in the following table. The person for whom
the service is provided and the person requesting the service are
jointly and severally liable for payment of these user fees in
accordance with Secs. 130.50 and 130.51.
------------------------------------------------------------------------
Monthly (30
APHIS animal import center Space day) user fee
------------------------------------------------------------------------
* * * *
* * *
Newburgh, NY:
Space A.................... 5,396 sq. ft. (503.1 $43,102.00
sq. m.).
Space B.................... 8,903 sq. ft. (827.1 71,118.50
sq. m.).
[[Page 24492]]
Space C.................... 905 sq. ft. (84.1 sq. 7,229.00
m.).
------------------------------------------------------------------------
* * * * *
6. Sections 130.5 through 130.8 would be revised to read as
follows:
Sec. 130.5 User fees for services at privately operated permanent and
temporary import quarantine facilities.
(a) User fees for each animal quarantined in a privately operated
permanent or temporary import quarantine facility will be calculated at
$56.00 per hour, or $14.00 per quarter-hour, with a minimum fee of
$16.50, for each employee required to perform the service. The person
for whom the service is provided and the person requesting the service
are jointly and severally liable for payment of these user fees in
accordance with Secs. 130.50 and 130.51.
(b) [Reserved]
(Approved by the Office of Management and Budget under control number
0579-0094)
Sec. 130.6 User fees for import or entry services for live animals at
land border ports along the United States-Mexico border.
(a) User fees, with a minimum fee of $16.50, for live animals
presented for importation into or entry into the United States through
a land border port along the United States-Mexico border are listed in
the following table. The person for whom the service is provided and
the person requesting the service are jointly and severally liable for
payment of these user fees in accordance with the provisions in
Secs. 130.50 and 130.51.
------------------------------------------------------------------------
User fee
Type of live animal (per head)
------------------------------------------------------------------------
Feeder..................................................... $1.75
Slaughter.................................................. 2.50
Horses, other than slaughter............................... 29.25
In-bond or in transit...................................... 3.75
Any ruminants not covered above............................ 6.00
------------------------------------------------------------------------
(b) [Reserved]
(Approved by the Office of Management and Budget under control numbers
0579-0055 and 0579-0094)
Sec. 130.7 User fees for import or entry services for live animals at
all other ports of entry.
(a) User fees, with a minimum fee of $16.50, for live animals
presented for importation into or entry into the United States through
any port of entry, other than a land border port along the border
between the United States and Mexico, are listed in the following
table. The person for whom the service is provided and the person
requesting the service are jointly and severally liable for payment of
these user fees in accordance with the provisions in Secs. 130.50 and
130.51.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Type of live animal User fee
--------------------------------------------------------------------------------------------------------------------------------------------------------
Animals being imported into the United States:
Horses, other than slaughter and in transit............................ $19.00 per head.
Breeding animals (Grade animals, except horses):
Swine.............................................................. 0.50 per head.
Sheep and goats.................................................... 0.50 per head.
All others......................................................... 2.25 per head.
Registered animals, all types.......................................... 4.00 per head.
Feeder animals:
Cattle (not including calves)...................................... 1.00 per head.
Swine.............................................................. 0.25 per head.
Sheep and calves................................................... 0.25 per head.
Slaughter animals, all types........................................... 16.50 per load.
Poultry (including eggs), imported for any purpose..................... 33.00 per load.
Animals transiting \1\ the United States
Cattle................................................................. 1.00 per head.
Swine.................................................................. 0.25 per head.
Sheep and goats........................................................ 0.25 per head.
Horses and all other animals........................................... 4.50 per head.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The user fee in this section will be charged for intransit authorizations at the port where the authorization services are performed. For additional
services provided by APHIS, at any port, the applicable hourly user fee will apply.
(b) [Reserved]
(Approved by the Office of Management and Budget under control numbers
0579-0055 and 0579-0094)
Sec. 130.8 User fees for other services.
(a) User fees for other services that are not specifically
addressed elsewhere in part 130 are listed in the following table. The
person for whom the service is provided and the person requesting the
service are jointly and severally liable for payment of these user fees
in accordance with the provisions in Secs. 130.50 and 130.51.
[[Page 24493]]
----------------------------------------------------------------------------------------------------------------
Service User fee
----------------------------------------------------------------------------------------------------------------
Germ Plasm Being exported: \2\
Embryo:
(up to 5 donor pairs).............................. $54.75 per certificate.
(each additional group of donor pairs, up to 5 24.75 per group of donor pairs.
pairs per group, on the same certificate).
Semen.................................................. 33.50 per certificate.
Germ Plasm Being imported: \1\
Embryo................................................. 39.50 per load.
Semen.................................................. 39.50 per load.
Import compliance assistance:
Simple (2 hours or less)............................... 51.25 per release.
Complicated (more than 2 hours)........................ 131.75 per release.
Inspection for approval of slaughter establishment:
Initial approval....................................... 246.50 for all inspections required during the
year.
Renewal................................................ 213.50 for all inspections required during the
year.
Inspection of approved establishments, warehouses, and
facilities under 9 CFR parts 94 through 96:
Approval (Compliance Agreement)........................ 262.75 for first year of 3-year approval (for all
inspections required during the year).
Renewed approval....................................... 152.00 per year for second and third years of 3-
year approval (for all inspections required during
the year).
Pet birds, except pet birds of U.S. origin entering the
United States from Canada:
Which have been out of United States 60 days or less... 71.25 per lot.
Which have been out of United States more than 60 days. 169.75 per lot.
Processing VS form 16-3, ``Application for Permit to Import
Controlled Material/Import or Transport Organisms or
Vectors'':
For permit to import fetal bovine serum when facility 208.50 per application.
inspection is required.
For all other permits.................................. 27.50 per application.
Amended application.................................... 11.50 per amended application
Application renewal.................................... 15.00 per application.
Release from export agricultural hold:
Simple (2 hours or less)............................... 51.25 per release.
Complicated (more than 2 hours)........................ 131.75 per release.
----------------------------------------------------------------------------------------------------------------
\1\ For inspection of empty containers being imported into the United States, the applicable hourly user fee
would apply, unless a user fee has been assessed under 7 CFR 354.3.
\2\ This user fee includes a single inspection and resealing of the container at the APHIS employee's regular
tour of duty station or at a limited port. For each subsequent inspection and resealing required, the
applicable hourly user fee would apply.
(b) [Reserved]
(Approved by the Office of Management and Budget under control numbers
0579-0015, 0579-0040, 0579-0055, and 0579-0094)
7. Section 130.9 would be amended by revising the introductory text
of paragraph (a) to read as follows and by removing and reserving
paragraph (b).
Sec. 130.9 User fees for miscellaneous import or entry services.
(a) User fees for import or entry services listed in (a)(1) through
(a)(4) of this paragraph will be calculated at $56.00 per hour, or
$14.00 per quarter hour, with a minimum fee of $16.50, for each
employee required to perform the service. The person for whom the
service is provided and the person requesting the service are jointly
and severally liable for payment of these user fees in accordance with
Secs. 130.50 and 130.51.
* * * * *
(b) [Reserved]
(Approved by the Office of Management and Budget under control numbers
0579-0055 and 0579-0094)
8. In Sec. 130.10, the introductory text of paragraph (a) would be
revised to read as follows:
Sec. 130.10 User fees for pet birds quarantined at APHIS-owned or
supervised quarantine facilities.
(a) User fees for each pet bird quarantined in an animal import
center 4 or other APHIS-owned or supervised quarantine
facility are listed in the following table. These user fees include
standard care, feed, and handling. The person for whom the service is
provided and the person requesting the service are jointly and
severally liable for payment of these user fees in accordance with
Secs. 130.50 and 130.51.
---------------------------------------------------------------------------
\4\ APHIS animal import centers are located in Honolulu, HI,
Miami, FL, and Newburgh, NY. The addresses of these facilities are
published in part 93 of this chapter.
---------------------------------------------------------------------------
* * * * *
9. Sections 130.14 through 130.18 would be revised to read as
follows:
Sec. 130.14 User fees for FADDL veterinary diagnostics.
(a) Diagnostic reagents. User fees for diagnostic reagents
5 provided by
[[Page 24494]]
FADDL are listed in the following table. The person for whom the
service is provided and the person requesting the service are jointly
and severally liable for payment of these user fees in accordance with
Secs. 130.50 and 130.51.
---------------------------------------------------------------------------
\5\ Reagents provided by FADDL are for the diagnosis of animal
diseases foreign to the United States. These reagents may be
available to customers on the mainland after safety testing with
permission from the Administrator. The customer may have to pay the
cost for the safety test in addition to the reagent user fee. For
more information on the specific reagents contact: Laboratory Chief,
USDA, APHIS, VS, FADDL, Greenport, NY 11344; phone (516) 323-2500,
FAX (516) 323-2798.
------------------------------------------------------------------------
Reagent User fee Unit
------------------------------------------------------------------------
Bovine antiserum, any agent.................. $80.00 1 ml.
Caprine antiserum, any agent................. 97.50 1 ml.
Cell culture antigen/microorganism........... 63.75 1 ml.
Equine antiserum, any agent.................. 100.50 1 ml.
Fluorescent antibody conjugate............... 120.25 1 ml.
Guinea pig antiserum, any agent.............. 104.50 1 ml.
Monoclonal antibody.......................... 122.75 1 ml.
Ovine antiserum, any agent................... 94.25 1 ml.
Porcine antiserum, any agent................. 81.25 1 ml.
Rabbit antiserum, any agent.................. 98.50 1 ml .
------------------------------------------------------------------------
(b) Veterinary diagnostics tests. User fees for veterinary
diagnostic tests performed at FADDL are listed in the following table.
The person for whom the service is provided and the person requesting
the service are jointly and severally liable for payment of these user
fees in accordance with Secs. 130.50 and 130.51.
------------------------------------------------------------------------
Test User fee Unit
------------------------------------------------------------------------
Agar gel immunodiffusion..................... $14.75 Test.
Card......................................... 8.25 Test.
Complement fixation.......................... 33.00 Test.
Direct immunofluorescent antibody............ 11.00 Test.
Enzyme linked immunosorbent assay............ 12.75 Test.
Fluorescent antibody neutralization (hog 96.00 Test.
cholera).
Hemagglutination inhibition.................. 27.75 Test.
Immunoperoxidase............................. 18.25 Test.
Indirect fluorescent antibody................ 23.25 Test.
In-vitro safety.............................. 299.50 Test.
In-vivo safety............................... 4345.75 Test.
Latex agglutination.......................... 11.00 Test.
Tube agglutination........................... 14.00 Test.
Virus isolation (oesophageal/pharyngeal)..... 88.25 Test.
Virus isolation in embryonated eggs.......... 176.00 Test.
Virus isolation, other....................... 84.50 Test.
Virus neutralization......................... 25.75 Test.
------------------------------------------------------------------------
(c) Other veterinary diagnostic services. User fees for other
veterinary diagnostic services performed at FADDL are listed in the
following table. The person for whom the service is provided and the
person requesting the service are jointly and severally liable for
payment of these user fees in accordance with Secs. 130.50 and 130.51.
----------------------------------------------------------------------------------------------------------------
Veterinary diagnostic service User fee Unit
----------------------------------------------------------------------------------------------------------------
Bacterial isolation........................................ $55.00 Test.
Hourly user fee services \1\............................... 220.00 Hour.
Hourly user fee services--Quarter hour..................... 55.00 Quarter hour.
Infected cells on chamber slides or plates................. 31.00 Slide.
Reference animal tissues for immunohistochemistry.......... 94.25 Set.
Sterilization by gamma radiation........................... 530.00 Can.
Training (school or technical assistance).................. 450.00 Per person per day.
Virus titration............................................ 55.00 Test.
----------------------------------------------------------------------------------------------------------------
\1\ For all veterinary diagnostic services for which there is no flat rate user fee, the hourly rate user fee
will be calculated for the actual time required to provide the service.
(Approved by the Office of Management and Budget under control numbers
0579-0055 and 0579-0094)
Sec. 130.15 User fees for veterinary diagnostic isolation and
identification tests performed at NVSL (excluding FADDL) or other
authorized site.
(a) Bacteriology isolation and identification tests. User fees for
bacteriology isolation and identification tests performed at NVSL
(excluding FADDL) or other authorized sites are listed in the following
table. The person for whom the service is provided and the person
requesting the service are jointly and severally liable for payment of
these user fees in accordance with Secs. 130.50 and 130.51.
------------------------------------------------------------------------
Test User fee Unit
------------------------------------------------------------------------
Bacterial identification, automated...... $16.00 Isolate.
Bacterial identification, non-automated.. 61.25 Isolate.
Bacterial isolation...................... 16.00 Sample.
Bacterial serotyping, all other.......... 30.75 Isolate.
Bacterial serotyping, Pasteurella 7.50 Isolate.
multocida.
[[Page 24495]]
Bacterial serotyping, Salmonella......... 21.25 Isolate.
Bacterial toxin typing................... 91.50 Isolate.
Bacteriology requiring special 27.00 Test.
characterization.
DNA fingerprinting....................... 36.50 Test.
DNA probe................................ 29.50 Test.
Fluorescent antibody \1\................. 9.75 Test.
Leptospira culturing..................... 27.00 Sample.
Leptospira serotyping.................... 80.50 Isolate.
Mycobacterium avian serotyping........... 157.50 Isolate.
Mycobacterium identification 63.25 Isolate.
(biochemical).
Mycobacterium identification (gas 26.50 Procedure.
chromatography).
Mycobacterium isolation, animal 520.50 Submission.
inoculations.
Mycobacterium isolation, all other....... 105.50 Submission.
Mycobacterium paratuberculosis isolation. 26.50 Submission.
Mycology culture identification.......... 52.75 Isolate.
Mycology/fungus culture or isolation..... 26.50 Isolate.
Mycoplasma isolation..................... 26.25 Sample.
Mycoplasma identification................ 26.25 Isolate.
Phage typing, all other.................. 26.50 Isolate.
Phage typing, Salmonella enteritidis..... 10.75 Isolate.
Plasmid typing........................... 26.50 Isolate.
Warburg.................................. 316.50 Isolate.
------------------------------------------------------------------------
\1\ A discount will apply to all diagnostic, non-import related
complement fixation, hemagglutination inhibition, fluorescent
antibody, indirect fluorescent antibody, virus neutralization, and
peroxidase linked antibody tests. This discount only applies to the
11th and subsequent tests on the same submission by the same submitter
for the same test and antigen. The user fee for each discounted test
will be 20 percent of the original user fee rounded up to the nearest
quarter. This discount will apply for tests for all diseases except
equine piroplasmosis, bovine piroplasmosis, dourine, and glanders.
(b) Virology identification tests. User fees for virology
identification tests performed at NVSL (excluding FADDL) or other
authorized sites are listed in the following table. The person for whom
the service is provided and the person requesting the service are
jointly and severally liable for payment of these user fees in
accordance with Secs. 130.50 and 130.51.
------------------------------------------------------------------------
Test User fee Unit
------------------------------------------------------------------------
Fluorescent antibody tissue section.......... $18.25 Test.
Virus isolation for Newcastle disease virus.. 15.25 Test.
Virus isolation (except for Newcastle disease 31.50 Test.
virus).
------------------------------------------------------------------------
(Approved by the Office of Management and Budget under control numbers
0579-0055 and 0579-0094)
Sec. 130.16 User fees for veterinary diagnostic serology tests
performed at NVSL (excluding FADDL) or at authorized sites.
(a) Bacteriology serology tests. User fees for bacteriology
serology tests performed at NVSL (excluding FADDL) or other authorized
sites are listed in the following table. The person for whom the
service is provided and the person requesting the service are jointly
and severally liable for payment of these user fees in accordance with
Secs. 130.50 and 130.51.
------------------------------------------------------------------------
Test User fee Unit
------------------------------------------------------------------------
Brucella milk ELISA......................... $15.75 Test.
Brucella ring (BRT)......................... 10.50 Test.
Brucella ring, Heat inactivated (HIRT)...... 10.50 Test.
Brucella ring, Serial (Serial BRT).......... 15.75 Test.
Buffered acidified plate antigen presumptive 4.00 Test.
Card........................................ 2.00 Test.
Complement fixation \1\..................... 9.00 Test.
Enzyme linked immunosorbent assay for 9.00 Test.
dourine, glanders, or piroplasmosis.
Enzyme linked immunosorbent assay, all other 4.75 Test.
Indirect fluorescent antibody \1\........... 9.75 Test.
Mercaptoethanol............................. 4.00 Test.
Microscopic agglutination--includes up to 5 11.00 Sample.
serovars \2\.
Mycology/fungus serology.................... 10.50 Test.
Particle concentration fluorescent 18.25 Test.
immunoassay (PCFIA).
Plate....................................... 4.00 Test.
Rapid automated presumptive................. 4.25 Test.
Rivanol..................................... 4.00 Test.
Tube agglutination.......................... 4.00 Test.
------------------------------------------------------------------------
\1\ A discount will apply to all diagnostic, non-import related
complement fixation, hemagglutination inhibition, fluorescent
antibody, indirect fluorescent antibody, virus neutralization, and
peroxidase linked antibody tests. This discount only applies to the
11th and subsequent tests on the same submission by the same submitter
for the same test and antigen. The user fee for each discounted test
will be 20 percent of the original user fee rounded up to the nearest
quarter. This discount will apply for tests for all diseases except
equine piroplasmosis, bovine piroplasmosis, dourine, and glanders.
\2\ The user fee for the sixth and subsequent serovar will be $2.00
each.
[[Page 24496]]
(b) Virology serology tests. User fees for virology serology tests
performed at NVSL (excluding FADDL) or at authorized sites are listed
in
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