[Federal Register Volume 64, Number 134 (Wednesday, July 14, 1999)]
[Proposed Rules]
[Pages 37903-37905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17938]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 130
[Docket No. 98-052-1]
Veterinary Services User Fees; Biosecurity Level Three Laboratory
Inspection Fee
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend 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 proposing 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 are taking this action in order to ensure that the user
fees cover our costs.
DATES: We invite you to comment on this docket. We will consider all
comments that we receive by September 13, 1999.
ADDRESSES: Please send your comment and three copies to: Docket No. 98-
052-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03,
4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state that
your comment refers to Docket No. 98-052-1.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue, SW., Washington
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS rules, are available on the Internet at http://
www.aphis.usda.gov/ppd/rad/webrepor.html.
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 Sec. 130.9 lists
the hourly rate user fees charged for APHIS' import or entry services,
including inspection of laboratories within the United States.
In accordance with 9 CFR part 122, we require inspection of
biosecurity level three laboratories prior to their receiving and
handling high risk organisms or vectors. Biosecurity level three
laboratories are used to conduct research on foreign animal disease
agents, especially viruses, with high disease risks. These laboratories
utilize containment facilities that use special precautions, such as
negative pressure ventilation, to keep the disease agents within the
facility and to protect the researchers who work with them.
We are proposing to revise the user fees for inspection of these
laboratories based on our review of user fees and the costs of service.
Under the current hourly rate user fees in Sec. 130.9, APHIS has been
unable to recover all of the costs associated with inspecting
biosecurity level three laboratories. Under the hourly rate user fee
structure, the traveltime allowance provides for a maximum of 6 hours
of round-trip ground travel. This traveltime allowance is insufficient
in that air travel and overnight lodging are required in order to
access more than half of the laboratories APHIS currently inspects.
Under the current hourly rates, the average user fee collected for
inspection for approval of biosecurity level three laboratories is
approximately $462 per laboratory. The actual average cost of
inspecting these laboratories is approximately $977 per laboratory. The
portion of the actual cost that we are not currently able to recover is
the portion of transportation (i.e., airfare and related expenses) and
lodging costs we incur above the 6-hour traveltime allowance for
laboratories that are not located near an authorized APHIS inspector's
place of duty. We do not believe it is fair to charge those
laboratories a higher fee than others based solely on their physical
location in relation to authorized inspectors' official duty stations.
Therefore, in order to ensure that we recover all costs, we are
proposing to amend 9 CFR part 130 to establish a flat rate user fee of
$977 to cover the cost of APHIS' inspection of biosecurity level three
laboratories. The flat rate user fee would cover all costs of
inspection, including airfare and/or ground travel, lodging,
inspection, per diem, and miscellaneous travel expenses. We are also
proposing to amend Sec. 130.1 to add a definition for ``biosecurity
level three laboratory'' to read: ``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.''
We are also proposing to clarify that the hourly rate user fees
contained in Sec. 130.9 are not applicable to services that are billed
under flat rate fees contained in other sections of part 130.
Executive Order 12866 and Regulatory Flexibility Act
This proposed 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. 603, we have performed an initial
regulatory flexibility analysis, which is set out below, regarding the
economic effects of this proposed rule on small entities. Based on the
information we have, there is no basis to conclude that this rule will
result in any significant economic effect on a substantial number of
small entities. However, we do not currently have all of the data
necessary for a comprehensive analysis of the effects of this proposed
rule on small entities. Therefore, we are inviting comments on
potential effects.
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
[[Page 37904]]
animal products are contained in 9 CFR part 130. Currently, APHIS
charges user fees for the inspection of biosecurity level three
laboratories under the hourly rate user fees contained in Sec. 130.9.
APHIS currently inspects several laboratories in the United States
that conduct biosecurity level three research on high-risk organisms
and vectors. These facilities currently 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 current hourly rate user fee structure,
because current regulations only provide for 6 hours of ground travel.
Therefore, we are proposing to amend 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.
We arrived at the flat rate user fee that we are proposing by using
the average of the number of hours required for an APHIS inspector 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 proposed 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 proposed 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.
The proposed flat rate user fees will enable all laboratories to
know in advance what costs they will incur.
Alternatives Considered
In developing this proposed rule, we considered: (1) Making no
changes to our existing method of recovering costs for inspecting
biosecurity level three laboratories; (2) proposing to charge
laboratories the exact costs incurred during each individual
inspection, including costs of travel and lodging; or (3) proposing to
charge 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.
The proposed changes to the regulations would result in 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 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
This proposed 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 propose to amend 9 CFR part 130 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, 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'' would be 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 would be 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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[[Page 37905]]
* * * *
* * *
Inspection for approval of $977.00 for all costs of inspection
biosecurity level three related to approving the laboratory for
laboratories. handling one defined set of organisms or
vectors.
* * * *
* * *
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4. In Sec. 130.9, the introductory text of paragraph (a) would be
revised to read as follows:
Sec. 130.9 User fees for miscellaneous import or entry services.
(a) User fees for import or entry services listed in paragraphs
(a)(1) through (a)(4) 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 8th day of July 1999.
A. Cielo,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-17938 Filed 7-13-99; 8:45 am]
BILLING CODE 3410-34-P