Veterinary Services User Fees; Biosecurity Level Three Laboratory Inspection Fee

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 130

[Docket No. 98-052-2]

Veterinary Services User Fees; Biosecurity Level Three Laboratory

Inspection Fee

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending existing user fees for the inspection for

approval of biosecurity level three laboratories. Existing user fees

require biosecurity level three laboratories to pay user fees for

inspection based on hourly rates. We are replacing the hourly rates for

this specific service with a flat rate user fee that would cover all

the costs of inspection related to approving a laboratory for handling

one defined set of organisms or vectors. We are taking this action in

order to ensure that the user fees cover our costs.

EFFECTIVE DATE: January 3, 2000.

FOR FURTHER INFORMATION CONTACT: For information concerning program

operations for Veterinary Services, contact Ms. Louise Lothery,

Administrative Officer, Management Support Staff, VS, APHIS, 4700 River

Road Unit 44, Riverdale, MD 20737-1231; (301) 734-7517.

For information concerning rate development of the proposed user

fee, contact Ms. Donna Ford, Section Head, Financial Systems and

Services Branch, Budget and Accounting Service Enhancement Unit, MRPBS,

APHIS, 4700 River Road Unit 54, Riverdale, MD 20737-1232; (301) 734-

8351.

SUPPLEMENTARY INFORMATION:

Background

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. Section

130.8 lists miscellaneous flat rate user fees. Section 130.9 lists the

hourly rate user fees charged for APHIS' import or entry services,

including inspection of laboratories within the United States.

On July 14, 1999, we published in the Federal Register (64 FR

37903-37905, Docket No. 98-052-1) a proposal to amend the existing user

fees for the inspection for approval of biosecurity level three

laboratories. Existing user fees require biosecurity level three

laboratories to pay user fees for inspection based on hourly rates. We

proposed to replace the hourly rates for this specific service with a

flat rate user fee that would cover all the costs of inspection related

to approving a laboratory for handling one defined set of organisms or

vectors.

We solicited comments concerning our proposal for 60 days ending

September 13, 1999. We did not receive any comments. Therefore, for the

reasons given in the proposed rule, we are adopting the proposed rule

as a final rule, without change.

Executive Order 12866 and Regulatory Flexibility Act

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

In accordance with 5 U.S.C. 604, we have performed a final

regulatory flexibility analysis, which is set out below, regarding the

economic effects of this rule on small entities.

User fees to reimburse 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.

Prior to the effective date of this rule, APHIS charged user fees for

the inspection of biosecurity level three laboratories under the hourly

rate user fees contained in Sec. 130.9.

APHIS inspects several laboratories in the United States that

conduct biosecurity level three research on high-risk organisms and

vectors. Under the hourly rate user fees, laboratories pay an average

of $462 for inspections required to be approved to handle a defined set

of organisms or vectors. The average actual cost of providing this

service, including the cost of air travel and lodging necessary to

inspect certain laboratories, is $977 per laboratory. APHIS has not

been able to recover all costs of inspection associated with approving

these laboratories under the hourly rate user fee structure because the

regulations only provide for 6 hours of ground travel.

Therefore, we are amending the regulations in Sec. 130.8 by

establishing a flat rate user fee of $977 for this service, which would

cover the average cost of inspection related to approving a laboratory

to handle one defined set of organisms or vectors. The flat rate user

fee will enable all laboratories to know in advance what costs they

will incur.

We arrived at the flat rate user fee by using the average of the

number of hours required for an APHIS inspector

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to complete an inspection, travel costs (including airfare and lodging,

when appropriate), per diem, and miscellaneous travel expenses.

Effects on Small Entities

Under Small Business Administration (SBA) guidelines, a biosecurity

level three laboratory with less than $5 million in annual sales is

considered a small entity. All of the laboratories we inspect are small

entities.

We anticipate that the economic effects of this rule on these

laboratories will be minimal. An informal survey of several of the

affected laboratories revealed that in some cases inspection costs at

laboratories are charged directly to a client if the client requested

analysis of the particular organism or vector for which the inspection

was undertaken. However, in most cases, laboratories pay for

inspections with overhead funds from their operating budget. There are

two types of biosecurity level three laboratories that we inspect. Some

laboratories are privately owned, for-profit enterprises that charge

clients fees to use the laboratory to research biosecurity level three

organisms or vectors. These laboratories typically bill their clients

for the cost of APHIS' inspection service and, therefore, are not

directly affected by the cost of inspections.

Other laboratories are publicly owned and are attached to

universities or government agencies. These laboratories typically

include anticipated APHIS inspection costs in their yearly budgets. We

do not have the data to assess the effect of the rate change on these

laboratories. On average, laboratories are inspected twice a year.

However, a laboratory working with many different types of organisms

could be subject to additional inspections.

In our proposal, we solicited comments on the potential effects of

the proposed action on small entities. In particular, we sought data

and other information to help us better determine what effects, if any,

this rule would on the small entities mentioned above. We received no

comments on the proposed rule.

Alternatives Considered

In developing this rule, we considered: (1) Making no changes to

our existing method of recovering costs for inspecting biosecurity

level three laboratories; (2) charging laboratories the exact costs

incurred during each individual inspection, including costs of travel

and lodging; or (3) charging a flat rate user fee for the inspection of

biosecurity level three laboratories.

We rejected the first alternative because, if we made no changes to

the regulations, we would continue to be unable to recover all of the

costs associated with the inspection of biosecurity level three

laboratories. All costs to APHIS for providing this service must be

recovered solely through user fees; there is no other form of funding

available to us that would cover this service.

We also rejected the second alternative, in which each laboratory

would be charged the exact cost of inspection, including travel and

lodging for APHIS personnel. We believe it is unfair to charge certain

customers higher fees than others simply because a qualified APHIS

inspector may not be stationed nearby. We believe that the fairest

method of charging customers for this service is through a flat rate

user fee.

This rule contains no new information collection or recordkeeping

requirements.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic

Assistance under No. 10.025 and is subject to Executive Order 12372,

which requires intergovernmental consultation with State and local

officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

This final 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

This final rule contains no new information collection or

recordkeeping requirements under the Paperwork Reduction Act of 1995

(44 U.S.C. 3501 et seq.).

List of Subjects in 9 CFR Part 130

Animals, Birds, Diagnostic reagents, Exports, Imports, Poultry and

poultry products, 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 continues 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, 134c, 134d, 134f, 136, and

136a; 31 U.S.C. 3701, 3716, 3717, 3719, and 3720A; 7 CFR 2.22, 2.80,

and 371.2(d).

2. In Sec. 130.1, a definition for ``biosecurity level three

laboratory'' is added in alphabetical order to read as follows:

Sec. 130.1 Definitions.

* * * * *

Biosecurity level three laboratory. A laboratory or production

facility that works with foreign or domestic animal disease agents,

organisms, or vectors that spread by aerosol route and that have

serious or lethal effects, therefore requiring special biocontainment

measures.

* * * * *

3. In Sec. 130.8, paragraph (a), the table is amended by adding a

new entry in alphabetical order to read as follows:

Sec. 130.8 User fees for other services.

(a) * * *

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Service User fee

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* * * * *

Inspection for approval of biosecurity $977.00 for all costs of

level three laboratories. inspection related to

approving the laboratory

for handling one defined

set of organisms or

vectors.

* * * * *

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* * * * *

4. In Sec. 130.9, the introductory text of paragraph (a) is revised

to read as follows:

Sec. 130.9 Hourly user fees for import or entry services.

(a) User fees for import or entry services listed in paragraphs

(a)(1) through (a)(5) of this section, except those services covered by

flat rate user fees elsewhere in this part, 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.

* * * * *

Done in Washington, DC, this 29th day of November 1999.

Bobby R. Acord,

Acting Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 99-31371 Filed 12-2-99; 8:45 am]

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