Veterinary Diagnostic Services User Fees

Federal RegisterOct 7, 1998

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 130

[Docket No. 94-115-2]

RIN 0579-AA70

Veterinary Diagnostic Services User Fees

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are revising user fees for veterinary diagnostic services

to reflect changes in operating costs and changes in calculations. We

are also adding user fees to cover the costs of additional veterinary

diagnostic services. In addition, we are reorganizing these user fees

to list user fees by type of service and location where the service is

provided, and to group reagents into categories. We are also revising

user fees for the use of animal import centers operated by the Animal

and Plant Health Inspection Service and adding 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.

EFFECTIVE DATE: November 6, 1998.

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, 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.

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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; 21 U.S.C. 136a(c)(1)). 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; see 21 U.S.C. 114a).

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).

On May 4, 1998, we published in the Federal Register (63 FR 24473-

24500, Docket No. 94-115-1) a proposal to amend the regulations by

revising 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). Additionally, reviews of these user fees showed that some of

the original estimates did not include enough direct labor hours and

that the direct labor calculations needed to be revised to accurately

reflect the costs of providing services. We proposed a comprehensive

overhaul of the veterinary diagnostic user fees to more accurately

recover our costs and to provide clarity and ease of use for customers

needing to look up user fees for our tests and other services. Our

proposal included reorganizing the presentation of user fees in the

regulations, implementing new user fees, and revising all of the

existing veterinary diagnostic user fees.

We solicited comments concerning our proposal for 60 days ending

July 6, 1998. We received four comments by that date. They were from a

State department of agriculture, poultry associations, and a university

veterinary laboratory. They are discussed below.

Comment: Increases in user fees will significantly impact

diagnostic laboratories; user fee collections would rise by 60.3

percent.

Response: Veterinary diagnostic services user fees have not changed

since 1993. We are no longer appropriated funds for these services.

Therefore, to continue providing veterinary diagnostic services, we

must increase the user fees we charge diagnostic laboratories and other

customers who benefit from our veterinary diagnostic services. The

total overall anticipated increase in user fee collections is

$1,283,800 ($3,414,484 increased from $2,130,684), or 60.3 percent. As

specified in the proposed rule, most of the individual increases will

make only small contributions to the total new collections. Typically,

the large percentage increases in user fees are related to veterinary

diagnostic services which are ordered in small amounts. Therefore, the

increases should not have a significant affect on diagnostic

laboratories or other customers.

Comment: If fees continue to rise, many disease problems may go

undetected because small laboratories will simply not order reagents or

tests unless absolutely necessary. This will drive fees up even more as

the National Veterinary Services Laboratories (NVSL) at Ames, IA, tries

to meet its financial goals. APHIS mandates many programs, but seems

unwilling to help conduct those mandates. The proposed fee increases

will undermine any national efforts to collect data and protect animal

and public health.

Response: We do not believe that these user fee increases will

result in decreased testing or endanger animal or public health.

Section 130.49 of the regulations specifies exemptions to our user fees

for veterinary diagnostic services provided (1) in connection with

Federal programs to control or eradicate diseases or pests of livestock

or poultry in the United States (program diseases), (2) for zoonotic

disease surveillance, or (3) for the detection of foreign animal

diseases. Further, our user fees are calculated for full cost recovery

only. They are not designed to meet any other financial goals and are

not calculated based on the volume of tests conducted or reagents

supplied. The costs of reagents are a small part of the actual costs of

conducting a test. In addition, most of the individual user fee

increases are small. Therefore, we do not expect that these increases

will result in reduced testing by laboratories, large or small.

Comment: Public health concerns such as salmonella and its

diagnosis through salmonella serotyping should be part of the

appropriation. Unless this test is free of charge, no serotyping will

be conducted and the nation will suffer.

Response: Salmonella serotyping is part of zoonotic disease

surveillance and, therefore, is exempt from these user fees. It will

continue to be covered by appropriated funds.

Comment: As an alternative to increasing the user fees, the

administrative overhead costs should be trimmed to no more than 20

percent instead of 113 percent of direct labor.

Response: We continually strive to improve efficiency in operations

and review our costs to make sure they are as low as possible. Our

agency overhead and departmental charges are approximately 20 percent

of our user fees. Our administrative support costs, which are 113

percent of direct labor, include costs that are required to operate the

laboratories and perform veterinary diagnostic services. For every $1

incurred in direct labor at NVSL, another $1.13 is incurred in

administrative support costs. Some of these costs would typically be

broken out into costs for direct materials and other direct costs;

however, for simplicity, we group them all as administrative support

costs. As stated in the proposal, our administrative support costs

include costs for 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 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. Costs for these direct materials are included in

administrative support costs because direct materials are standard

laboratory supplies and not purchased solely for a specific test.

Indirect labor hours include time required for 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

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local circumstances. For example, trash pickup may be provided as a

utility or a contractual service. However, the costs are all for

administrative support. Utilities include water, telephone,

electricity, natural and propane gas, heating and diesel oil. We make

every effort to keep all of these costs as low as possible.

Comment: The proposed user fees for test reagents and sample

confirmation testing at NVSL and the Foreign Animal Disease Diagnostic

Laboratory (FADDL) at Greenport, NY, for diseases of national

importance, such as brucellosis and pseudorabies, will have a negative

impact on State laboratories because the fee increases for test

reagents would shift the cost from APHIS to the State laboratories. The

projected cost would increase by $2000 per year for a State laboratory.

Response: The user fee changes in this rule will not negatively

affect State laboratories or their testing for diseases of national

importance, such as brucellosis and pseudorabies. We specify in

Sec. 130.49 of the regulations that user fees are not charged for

veterinary diagnostic services provided in connection with Federal

programs to control or eradicate diseases or pests of livestock or

poultry in the United States.

Comment: The effect of the user fee increases for check samples,

reference sera, confirmation analysis, and standard operating

procedures and manuals is difficult to calculate. The estimated cost is

$1,000 per year for a State laboratory. This would have a negative

impact on State laboratories.

Response: We understand that adding user fees for check tests,

standard operating procedures, manuals, training, and technical

assistance will increase our customer's costs. We are no longer

appropriated funds to pay for these services. Therefore, to continue

providing these services, we must establish user fees to recover our

costs.

Comment: APHIS is proposing to increase user fees for veterinary

diagnostic services again. The poultry industry of Georgia opposes this

increase.

Response: This is the first increase in the veterinary diagnostic

user fees since they were established in 1993. We need to increase

these user fees because, as stated in the proposal, operating costs

have increased since these user fees were established in a final rule

published in the Federal Register on September 1, 1993.

Comment: These proposed fee increases would severely impact the

monitoring and diagnostic abilities of the extensive poultry laboratory

network in Georgia. We believe this increase would impact the health

and safety of the food supply of poultry and poultry products in

Georgia. Total fees would increase from current costs of $2,700 to

$42,881.25 ($1,305 from increased fees for DNA fingerprinting and

pasteurella antiserums; $40,181.25 from new fees for salmonella

bacterial serotyping, mycoplasma hemagglutination antigens, avian

influenza antigen, and avian influenza).

Response: We disagree. The user fee changes in this rule should not

affect monitoring and diagnostic abilities of the poultry laboratory

network in Georgia, and therefore, will not affect the health and

safety of the food supply of poultry and poultry products. While we are

implementing some new user fees, because we are no longer allocated

funds to pay for these services, we are not changing the exemptions

from existing user fees as specified in Sec. 130.49. Therefore, if you

were exempt from a specific user fee in the past, then you are still

exempt from that user fee. As stated above, we specify in the

regulations that user fees are not charged for veterinary diagnostic

services provided in connection with zoonotic disease surveillance,

such as salmonella serotyping, or for the detection of foreign animal

diseases, such as highly pathogenic avian influenza. Specifically, user

fees will not be charged for salmonella bacterial serotyping, avian

influenza antigen, and avian influenza antiserum. Because of these

exemptions, we estimate that the actual increase in user fees for the

services and reagents listed in the comment would be only $2,897.50,

due to revised and new user fees for DNA fingerprinting, pasteurella

antiserums, and mycoplasma hemagglutination antigens.

Comment: Delay the proposal until there can be a full discussion

and review.

Response: By publishing the proposed rule and requesting comments

for 60 days we believe that we have provided the public with ample

opportunity to review and comment on the changes in the veterinary

diagnostic services user fees.

Comment: If and when fee increases are justified, do them well in

advance of the budgeting period.

Response: We understand the need to plan budgets and the concern

about having budgets affected by increases in user fees. Different

customers start their budgeting periods at different times of the year.

Therefore, it would be impossible to schedule our fee changes in

advance of all customers' budgeting periods. Our proposal signaled our

intention to revise the user fees. The proposal was published in the

Federal Register on May 4, 1998, and was open for public comment for 60

days. This rule will not take effect until 30 days after the date it is

published in the Federal Register. This delay should give the commenter

and others adequate time to prepare.

Miscellaneous

We are making minor, nonsubstantive, editorial changes in the rule

for clarity.

Plain Language Change

On June 1, 1998, President Clinton issued a memorandum requiring

agencies to write all documents in plain language. Specifically, for

regulations, agencies must use plain language in all proposed rules

published in the Federal Register after January 1, 1999. Agencies must

also use plain language in all final rules published in the Federal

published before January 1, 1999. For existing regulations, the

memorandum encourages agencies to rewrite in plain language whenever

possible.

We try to make our regulations as clear as possible. With the plain

language initiative, we will increase our efforts to use active verbs

and personal pronouns to clarify who is responsible for what action. We

will also use a question and answer format where it makes sense, as

well as other techniques, to make our regulations easier to understand.

In this final rule, we have rewritten the overtime requirements in

Sec. 130.50(b)(3). We have used a question and answer format, changed

verbs from passive to active voice, used personal pronouns, and added a

chart. The chart shows information that readers previously would have

had to turn to 9 CFR part 97 to find.

Therefore, for the reasons given in the proposed rule and in this

document, we are adopting the proposed rule as a final rule, with the

changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been reviewed under Executive Order 12866. This rule

has been determined to be not significant for the purposes of Executive

Order 12866 and, therefore, has not been reviewed by the Office of

Management and Budget.

Below is a summary of the economic analysis for this final rule.

The economic analysis provides a cost-benefit analysis as required by

E.O. 12866 and a Final Regulatory Flexibility Analysis, analyzing the

effects of this

[[Page 53786]]

action on 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.

Need and Objective of This Rule

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; see 21 U.S.C. 114a).

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; 21 U.S.C.

136a(c)(1)).

In addition, section 2509(d) of the 1990 Farm Bill (21 U.S.C.

136a(d)) provides that the Secretary may prescribe such regulations as

the Secretary determines necessary to carry out these provisions of the

1990 Farm Bill.

New and Revised User Fees

We are revising the user fees for certain veterinary diagnostic

services, including certain diagnostic tests, reagents, and other

veterinary diagnostic materials and services. In addition, we are

adding new user fees for other veterinary diagnostic services we

provide. We are reorganizing 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 diagnostic service.

Other miscellaneous veterinary diagnostic services include, but are not

limited to, providing check tests, test kits, manuals, standard

operating procedures, and training.

Impact on Small Entities

Users of these veterinary diagnostic services are importers,

exporters, veterinarians, commercial laboratories, 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 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.

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\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.

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Changes in Collections

The estimated increased collections generated by the revised user

fees 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 60.3 percent. (See

Table 13.)

Table 13.--Summary of Current and Projected Collections for APHIS User Fees

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Current user Revised user Change in user

User fee categories fee fee 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

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[[Page 53787]]

Total Revised Veterinary Diagnostics User Fees...... 1,941,277 2,781,390 840,113

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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

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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

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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

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\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 savings to taxpayers of

$1.28 million annually as a result of the changes in user fees.

The administrative cost involved in obtaining these savings will be

minimal. APHIS already has a user fee program and a mechanism for

collecting user fees in place. The changes in this rule will update

existing user fees in the system and require collection of additional

user fees. Therefore, increases in administrative costs will be small.

Because the savings are sufficiently large, and the administrative

costs will be small, it is likely that the net gain in reducing the

burden on taxpayers as a whole will outweigh the cost of administering

the revisions of the user fees.

Estimated Impact

The user fee changes fall into two categories: New and revised user

fees. The vast majority of the user fees changes are expected to make

only small contributions to the total new collections. Most (nearly 70

percent) of the new user fees will be less than $50 each and 40 percent

will be less than $25. Most (approximately 70 percent) of the revised

user fees increase by less than 20 percent, with many (more than 50

percent) of them increasing by less than 10 percent.

Approximately 30 percent of the new and revised user fees are more

than $50 or increase by more than 20 percent, respectively. We were

concerned about the impact of these user fees, so we reviewed past

requests for the services to which these fees apply. Requests for these

services have been low and we do not expect them to change as a result

of these user fees. Most of the 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 revised user

fees that will 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 rule would be to make no changes to the

current user fees. We do not consider making any 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 rule would be to either exempt small

businesses from these user fees or establish a different user fee

structure for small businesses. We do not consider exempting small

businesses from these user fees or establishing a different user fee

structure for small businesses as viable options. Every business,

including small businesses, using a government service should 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.

Another alternative to this rule would be to spread the 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 increases

among user fees would mean that some entities

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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, it would not be equitable for APHIS

to spread the increases evenly over all of the user fees.

This rule contains no new information collection or recordkeeping

requirements.

Executive Order 12988

This rule has been reviewed under Executive Order 12988, Civil

Justice Reform. This rule: (1) Preempts all State and local laws and

regulations that are inconsistent with this rule; (2) has no

retroactive effect; and (3) does not require administrative proceedings

before parties may file suit in court challenging this rule.

Paperwork Reduction Act

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.

3501 et seq.), the information collection or recordkeeping requirements

included in this rule have been approved by the Office of Management

and Budget (OMB), and there are no new requirements. The assigned OMB

control 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, we are amending 9 CFR part 130 as follows:

PART 130--USER FEES

1. The authority citation for part 130 is 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 is amended as follows:

a. The definitions for APHIS animal health technician, APHIS

veterinarian, and reference assistance testing are removed.

b. Definitions for APHIS representative, nonstandard care and

handling, and nonstandard housing are added, in alphabetical order, to

read as set forth below.

c. The definitions for export health certificate and pet birds are

revised to read as set forth below.

d. Footnotes 3 and 4 and their references are removed, and footnote

2 and its reference are redesignated as footnote 3.

e. At the end of the definitions for zoo bird and zoo equine, a

reference to footnote 3 is added.

Sec. 130.1 Definitions.

* * * * *

APHIS representative. An individual, including, but not limited to,

an animal health technician or veterinarian, 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 that requires personnel to

attend to the birds or poultry outside of normal business hours.\2\

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\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.

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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, that are

imported or exported for the personal pleasure of their individual

owners and are not intended for resale.

* * * * *

4. Section 130.2 is 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.

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Daily user

Animal or bird fee

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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

[[Page 53789]]

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

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

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 is 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 day)

APHIS animal import center Space user fee

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

Miami, FL:

South Wing............... 6,952 sq. ft. (645.9 $30,285.00

sq. m.).

North Wing............... 6,545 sq. ft. (608.1 $29,377.00

sq. m.).

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.).

Space C.................. 905 sq. ft. (84.1 sq. 7,229.00

m.).

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

* * * * * * *

6. Sections 130.5 through 130.8 are 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)

[[Page 53790]]

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 $19.00 per head.

transit.

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 33.00 per load.

purpose.

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.

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

Service User fee

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

Germ plasm being exported: \1\

Embryo:

(up to 5 donor pairs).............. $54.75 per certificate.

(each additional group of donor 24.75 per group of donor

pairs, up to 5 pairs per group, on pairs.

the same certificate).

Semen.................................. 33.50 per certificate.

Germ plasm being imported:\2\

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 71.25 per lot.

days or less.

Which have been out of United States 169.75 per lot.

more than 60 days.

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 208.50 per application.

when facility inspection is required.

For all other permits.................. 27.50 per application.

Amended application.................... 11.50 per amended

application.

[[Page 53791]]

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\ 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.

\2\ 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.

(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 is 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.

* * * * *

8. In Sec. 130.10, the introductory text of paragraph (a) is

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 are 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 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 cholera)..... 96.00 Test.

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.

[[Page 53792]]

Virus neutralization.................................. 25.75 Test.

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

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 multocida........... 7.50 Isolate.

Bacterial serotyping, Salmonella...................... 21.25 Isolate.

Bacterial toxin typing................................ 91.50 Isolate.

Bacteriology requiring special characterization....... 27.00 Test.

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 (biochemical)............ 63.25 Isolate.

Mycobacterium identification (gas chromatography)..... 26.50 Procedure.

Mycobacterium isolation, animal inoculations.......... 520.50 Submission.

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 virus).. 31.50 Test.

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

[[Page 53793]]

(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 dourine, 9.00 Test.

glanders, or piroplasmosis.

Enzyme linked immunosorbent assay, all other.......... 4.75 Test.

Indirect fluorescent antibody1........................ 9.75 Test.

Mercaptoethanol....................................... 4.00 Test.

Microscopic agglutination--includes up to 5 serovars 2 11.00 Sample.

Mycology/fungus serology.............................. 10.50 Test.

Particle concentration fluorescent immuno assay 18.25 Test.

(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.

(b) Virology serology tests. User fees for virology serology tests

performed at NVSL (excluding FADDL) or at 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

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

Agar gel immunodiffusion.............................. $5.00 Test.

Complement fixation 1................................. 9.00 Test.

Enzyme linked immunosorbent assay..................... 4.75 Test.

Hemagglutination inhibition 1......................... 7.50 Test.

Indirect fluorescent antibody 1....................... 9.75 Test.

Latex agglutination................................... 5.00 Test.

Peroxidase linked antibody 1.......................... 9.75 Test.

Plaque reduction neutralization....................... 7.75 Test.

Rabies fluorescent antibody neutralization............ 26.50 Test.

Virus neutralization \1\.............................. 7.75 Test.