99-17938. Veterinary Services User Fees; Biosecurity Level Three Laboratory Inspection Fee  

  • [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
    
    
    

Document Information

Published:
07/14/1999
Department:
Animal and Plant Health Inspection Service
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
99-17938
Dates:
We invite you to comment on this docket. We will consider all comments that we receive by September 13, 1999.
Pages:
37903-37905 (3 pages)
Docket Numbers:
Docket No. 98-052-1
PDF File:
99-17938.pdf
CFR: (3)
9 CFR 130.1
9 CFR 130.8
9 CFR 130.9