[Federal Register Volume 62, Number 220 (Friday, November 14, 1997)]
[Rules and Regulations]
[Pages 61005-61007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-29990]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 130

[Docket No. 96-089-1]


Import/Export User Fees; Exemptions

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Interim rule and request for comments.

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SUMMARY: We are amending the user fee regulations to provide that user 
fees are not charged for veterinary diagnostic services in the 
following cases: When veterinary diagnostic services are provided in 
connection with Federal programs to control or eradicate diseases or 
pests of livestock or poultry in the United States (program diseases) 
or in support of zoonotic disease surveillance when there is a 
significant risk to human health; and when veterinary diagnostic 
reagents are distributed within the United States for testing for 
foreign animal diseases. In addition, we are eliminating the user fee 
for export health certificates that are requested and reviewed, but not 
endorsed. We are making these changes to eliminate confusion, clarify 
when certain user fees apply, and eliminate an unnecessary user fee.

DATES: Interim rule effective November 7, 1997. Consideration will be 
given only to comments received on or before January 13, 1998.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 96-089-1, Regulatory Analysis and Development, PPD, APHIS, 
suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please 
state that your comments refer to Docket No. 96-089-1. Comments 
received may be inspected at USDA, room 1141, South Building, 14th 
Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 
4:30 p.m., Monday through Friday, except holidays. Persons wishing to 
inspect comments are requested to call ahead on (202) 690-2817 to 
facilitate entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Ms. Donna Ford, Section Head, 
Financial Systems and Services Branch, Budget and Accounting Division, 
M&B, 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-related and export-related services for live 
animals and birds and animal products are contained in 9 CFR part 130. 
Sections 130.14 through 130.18 list the various veterinary diagnostic 
services for which user fees are charged and the associated user fees.
    We are proposing to amend 9 CFR part 130 (the regulations) to 
provide that user fees will not be charged for veterinary diagnostic 
services listed in Secs. 130.14 through 130.18 in the following cases: 
(1) When veterinary diagnostic services are provided in connection with 
Federal programs to control or eradicate diseases or pests of animals 
in the United States (program diseases) or in support of zoonotic 
disease surveillance when there is a significant risk to human health; 
and (2) when veterinary diagnostic reagents are distributed within the 
United States for testing for foreign animal diseases. In addition, we 
are eliminating the user fee listed in Sec. 130.20(d) for export health 
certificates that are requested and reviewed, but not endorsed.

Veterinary Diagnostic Services

    Veterinary diagnostics is the work performed in a laboratory to 
determine if a disease-causing organism or

[[Page 61006]]

chemical agent is present in body tissues or cells and to identify 
those organisms or agents. Services in this category include performing 
laboratory tests at the National Veterinary Services Laboratories 
(NVSL) and providing diagnostic reagents and other veterinary 
diagnostic materials and services. Diagnostic reagents are biological 
materials used in diagnostic tests to detect disease agents or 
antibodies by causing an identifiable reaction. NVSL also collects data 
and compiles statistics on the incidence of various livestock diseases 
based on the results of the veterinary diagnostic tests.
    We do not charge user fees for veterinary diagnostic services 
provided in connection with Federal programs to control or eradicate 
diseases or pests (program diseases). Examples of program diseases are 
tuberculosis, brucellosis, and pseudorabies. These activities are 
covered by appropriated funding. Our policy not to charge for these 
services was specified in the background portion in previously 
published proposed and final rules concerning user fees for veterinary 
diagnostic services (58 FR 15292-15301, Docket No. 91-021-4, March 22, 
1993, and 58 FR 38954-38961, Docket No. 91-021-5, July 21, 1993). In 
this document, we are amending the regulations to specify that user 
fees are not charged for these services.
    While not specified in earlier user fee rules, there are other 
activities which we cover by appropriated funding instead of user fees. 
We routinely distribute veterinary diagnostic reagents free of charge 
to laboratories throughout the United States for testing for foreign 
animal diseases. This allows these laboratories to immediately test 
animals suspected of being infected with a foreign animal disease. The 
distribution of these diagnostic reagents is covered by appropriated 
funding to ensure that we are able to identify foreign animal diseases 
as quickly as possible. In this document, we are clarifying the 
regulations by specifying that this service is exempt from user fees.
    In addition, we provide veterinary diagnostic services in support 
of zoonotic disease surveillance. Zoonotic diseases are those that 
affect both animals and humans and are communicable from animals to 
humans. Examples of zoonotic diseases are anthrax, brucellosis, 
leptospirosis, rabies, salmonellosis, tuberculosis, and vesicular 
stomatitis. Some of these are program diseases and, therefore, user 
fees are not charged, as stated above. Occasionally, there are zoonotic 
diseases that pose a significant threat to human health, and a thorough 
knowledge of the prevalence of the disease in animals will directly 
benefit control of the disease in humans. In these cases, we believe 
that the cost of the testing related to the zoonotic disease 
surveillance should be covered by appropriated funds. At this time, 
salmonellosis is the only zoonotic disease that falls into this second 
category, and user fees are not charged for the salmonella testing that 
will provide direct benefit to control of disease in humans. User fees 
are charged for other salmonellosis testing. Therefore, we are amending 
our regulations to state that user fees are not charged for veterinary 
diagnostic services provided in relation to zoonotic diseases when the 
Administrator has determined that there is a significant threat to 
human health.
    We are adding a new Sec. 130.49 to the regulations that lists the 
circumstances under which we do not charge user fees for veterinary 
diagnostic services. The exemptions will be specified as follows: User 
fees for veterinary diagnostic services, including, but not limited to, 
tests and diagnostic reagents specified in Secs. 130.14 through 130.18, 
are not charged under the following conditions:
    (1) When veterinary diagnostic services are provided in connection 
with Federal programs to control or eradicate diseases or pests of 
animals in the United States (program diseases);
    (2) When veterinary diagnostic services are provided in support of 
zoonotic disease surveillance when the Administrator has determined 
that there is a significant risk to human health; and
    (3) When veterinary diagnostic reagents are distributed within the 
United States for testing for foreign animal diseases.

Nonendorsed Export Health Certificates

    We established a user fee for nonendorsed export health 
certificates in a final rule published in the Federal Register on May 
7, 1996 (61 FR 20421-20437, Docket No. 92-174-2). These are 
certificates that are requested from the Animal and Plant Health 
Inspection Service (APHIS) and then are reviewed by APHIS, but either 
withdrawn or returned without being endorsed. The user fee was intended 
to cover the costs of the APHIS review. We have reviewed this user fee 
and have determined that we do not need to charge for these services 
because these services are comparable to those consultation services 
that we provide via the telephone to customers requesting information 
about animal or animal product exportation requirements. Most export 
health certificates that are returned by the APHIS veterinarian for 
corrective action are later resubmitted and endorsed. The user fee for 
the endorsement of these export health certificates recovers the costs 
for the full review including any consultations. Therefore, we are 
removing Sec. 130.20(d) from the regulations and will not charge a user 
fee for export health certificates that are reviewed but not endorsed.

Immediate Action

    The Administrator of the Animal and Plant Health Inspection Service 
has determined that there is good cause for publishing this interim 
rule without prior opportunity for public comment. Immediate action is 
warranted to encourage participation in programs to control and 
eradicate disease and pests of livestock or poultry, eliminate 
confusion about when user fees are charged, and to eliminate an 
unnecessary user fee. These changes will benefit users and help ensure 
that veterinary diagnostic services will continue to be requested for 
testing in connection with program diseases and zoonotic disease 
surveillance when there is a significant risk to human health.
    Because prior notice and other public procedures with respect to 
this action are impracticable and contrary to the public interest under 
these conditions, we find good cause under 5 U.S.C. 553 to make it 
effective upon signature. We will consider comments that are received 
within 60 days of publication of this rule in the Federal Register. 
After the comment period closes, we will publish another document in 
the Federal Register. It will include a discussion of any comments we 
receive and any amendments we are making to the rule as a result of the 
comments.

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.
    This rule provides that we do not charge user fees for (1) 
veterinary diagnostic services related to program diseases, (2) 
veterinary diagnostic services related to zoonotic disease surveillance 
when there is a significant risk to human health, (3) the distribution 
of diagnostic reagents within the United States used in testing for 
foreign animal diseases, or (4) services provided to review, but not 
endorse, export health certificates. Our policy, has been not to charge 
user fees for these services, and we are now

[[Page 61007]]

clarifying that policy in the regulations. Therefore, this rule should 
have no impact on entities whether they are large or small.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

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 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 rule contains no information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

Regulatory Reform

    This action is part of the President's Regulatory Reform 
Initiative, which, among other things, directs agencies to remove 
obsolete and unnecessary regulations and to find less burdensome ways 
to achieve regulatory goals.

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, 9 CFR part 130 is amended 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, 134b, 134c, 134d, 134f, 135, 
136, and 136a; 7 CFR 2.22, 2.80, and 371.2(d).


Sec. 130.20  [Amended]

    2. Section 130.20 is amended by removing paragraph (d) and 
redesignating paragraph (e) as paragraph (d).
    3. A new Sec. 130.49 is added to read as follows.


Sec. 130.49  Exemptions.

    (a) Veterinary diagnostics. User fees for veterinary diagnostic 
services, including, but not limited to, tests and diagnostic reagents 
specified in Secs. 130.14 through 130.18, are not charged under the 
following conditions:
    (1) When veterinary diagnostic services are provided in connection 
with Federal programs to control or eradicate diseases or pests of 
livestock or poultry in the United States (program diseases);
    (2) When veterinary diagnostic services are provided in support of 
zoonotic disease surveillance when the Administrator has determined 
that there is a significant threat to human health; and
    (3) When veterinary diagnostic reagents are distributed within the 
United States for testing for foreign animal diseases.
    (b) [Reserved].

    Done in Washington, DC, this 7th day of November 1997.
Charles Schwalbe,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-29990 Filed 11-13-97; 8:45 am]
BILLING CODE 3410-34-P