[Federal Register Volume 64, Number 232 (Friday, December 3, 1999)]
[Rules and Regulations]
[Pages 67697-67698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31371]


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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

[[Page 67698]]

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) * * *

------------------------------------------------------------------------
                  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]
BILLING CODE 3410-34-U