E8-19864. Fiscal Year 2009 Veterinary Diagnostics Services User Fees and Agricultural Quarantine and Inspection User Fees

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

This notice pertains to user fees charged for certain veterinary diagnostics services and to fees charged for agricultural quarantine and inspection services that are provided in connection with certain commercial vessels, commercial trucks, loaded commercial railroad cars, commercial aircraft, and international airline passengers arriving at ports in the Customs territory of the United States. The purpose of this notice is to remind the public of the user fees for fiscal year 2009 (October 1, 2008, through September 30, 2009).

FOR FURTHER INFORMATION CONTACT:

For information concerning veterinary diagnostic program operations, contact Dr. Elizabeth Lautner, Director, National Veterinary Services Laboratories, VS, APHIS, 1800 Dayton Avenue, Ames, IA 50010; [phone].

For information on Agricultural Quarantine program operations, contact Mr. William E. Thomas, Director for Quarantine Policy, Analysis, and Support, PPQ, APHIS, 4700 River Road Unit 60, Riverdale, MD 20737-1231; [phone].

For information concerning user fee rate development, contact Mrs. Kris Caraher, Section Head, User Fees Section, Financial Management Division, MRPBS, APHIS, 4700 River Road Unit 55, Riverdale, MD20737-1232; [phone].

SUPPLEMENTARY INFORMATION:

Veterinary Diagnostic Services User Fees

User fees to reimburse APHIS for the costs of providing veterinary diagnostic services are contained in 9 CFR part 130 (referred to below as the regulations). These user fees are authorized by section 2509(c) of the Food, Agriculture, Conservation, and Trade Act of 1990, as amended (21 U.S.C. 136a), which provides that the Secretary of Agriculture may, among other things, prescribe regulations and collect fees to recover the costs of veterinary diagnostics relating to the control and eradication of communicable diseases of livestock and poultry within the United States.

In a final rule published in the Federal Register on December 19, 2007 (72 FR 71744-71750, Docket No. APHIS-2006-0161), and effective January 18, 2008, we established, for fiscal years 2008 through 2012 and beyond, user fees for certain veterinary diagnostic services, including certain diagnostic tests, reagents, and other veterinary diagnostic materials and services. Veterinary diagnostics is the work performed in a laboratory to determine whether a disease-causing organism or chemical agent is present in body tissues or cells and, if so, to identify those organisms or agents. Services in this category include: (1) Performing identification, serology, and pathobiology tests and providing diagnostic reagents and other veterinary diagnostic materials and services for the National Veterinary Services Laboratory (NVSL) in Ames, IA; and (2) performing laboratory tests and providing reagents and other veterinary diagnostic materials and services at the NVSL Foreign Animal Disease Diagnostic Laboratory (NVSL FADDL) in Greenport, NY.

APHIS veterinary diagnostic user fees fall into six categories:

(1) Laboratory tests, reagents, and other veterinary diagnostic services performed at NVSL FADDL;

(2) Laboratory tests performed as part of isolation and identification testing at NVSL in Ames or other authorized sites;

(3) Laboratory tests performed as part of serology testing at NVSL in Ames or other authorized sites;

(4) Laboratory tests performed at the pathobiology laboratory at NVSL in Ames or other authorized sites;

(5) Diagnostic reagents produced at NVSL in Ames or other authorized sites; and

(6) Other veterinary diagnostic services or materials provided at NVSL in Ames.

As specified in § 130.15(a), the user fees for bacteriology isolation and identification tests performed at NVSL (excluding FADDL) or other authorized sites for fiscal year 2009 are as follows:

Test	Unit	User fee
Bacterial identification, automated	Isolate	$54.00
Bacterial identification, non-automated	Isolate	92.00
Bacterial isolation	Sample	37.00
Bacterial serotyping, all other	Isolate	56.00
Bacterial serotyping, Pasteurella multocida	Isolate	19.00
Bacterial serotyping, Salmonella	Isolate	37.00
Bacterial toxin typing	Isolate	123.00
Bacteriology requiring special characterization	Test	94.00
DNA fingerprinting	Test	61.00
DNA probe	Test	85.00
Fluorescent antibody	Test	19.00
Mycobacterium identification (biochemical)	Isolate	117.00
Mycobacterium identification (gas chromatography)	Procedure	99.00
Mycobacterium isolation, animal inoculations	Submission	852.00
Mycobacterium isolation, all other	Submission	154.00
Mycobacterium paratuberculosis isolation	Submission	74.00
Phage typing, all other	Isolate	43.00
Phage typing, Salmonella enteritidis	Isolate	24.00

As specified in § 130.15(b), the user fees for virology identification tests performed at NVSL (excluding FADDL) or other authorized sites for fiscal year 2009 are as follows:

Test	Unit	User fee
Fluorescent antibody tissue section	Test	$30.00
Virus isolation	Test	49.00

As specified in § 130.16(a), the user fees for bacteriology serology tests performed at NVSL (excluding FADDL) or other authorized sites for fiscal year 2009 are as follows:

Test	Unit	User fee
Brucella ring (BRT)	Test	$37.00
Brucella ring, heat inactivated (HIRT)	Test	37.00
Brucella ring, serial (Serial BRT)	Test	56.00
Buffered acidified plate antigen presumptive	Test	7.25
Card	Test	4.00
Complement fixation	Test	17.00
Enzyme linked immunosorbent assay	Test	17.00
Indirect fluorescent antibody	Test	15.00
Microscopic agglutination—includes up to 5 serovars	Sample	24.00
Microscopic agglutination—each serovar in excess of 5 serovars	Sample	4.50
Particle concentration fluorescent immunoassay (PCFIA)	Test	37.00
Plate	Test	7.25
Rapid automated presumptive	Test	7.00
Rivanol	Test	7.25
Tube agglutination	Test	7.25

As specified in § 130.16(b), the user fees for virology serology tests performed at NVSL (excluding FADDL) or other authorized sites for fiscal year 2009 are as follows:

Test	Unit	User fee
Agar gel immunodiffusion	Test	$17.00
Complement fixation	Test	17.00
Enzyme linked immunosorbent assay	Test	17.00
Hemagglutination inhibition	Test	15.00
Indirect fluorescent antibody	Test	15.00
Latex agglutination	Test	17.00
Peroxidase linked antibody	Test	16.00
Plaque reduction neutralization	Test	18.00
Rabies fluorescent antibody neutralization	Test	46.00
Virus neutralization	Test	13.00

As specified in § 130.17(a), the user fees for veterinary diagnostic tests performed at the Pathobiology Laboratory at NVSL (excluding FADDL) or other authorized sites for fiscal year 2009 are as follows:

Test	Unit	User fee
Aflatoxin quantitation	Test	$31.00
Aflatoxin screen	Test	29.00
Agar gel immunodiffusion spp. identification	Test	13.00
Antibiotic (bioautography) quantitation	Test	67.00
Antibiotic (bioautography) screen	Test	122.00
Antibiotic inhibition	Test	67.00
Arsenic	Test	18.00
Ergot alkaloid screen	Test	67.00
Ergot alkaloid confirmation	Test	88.00
Feed microscopy	Test	67.00
Fumonisin only	Test	38.00
Gossypol	Test	100.00
Mercury	Test	148.00
Metals screen	Test	45.00
Metals single element confirmation	Test	13.00
Mycotoxin: aflatoxin-liver	Test	122.00
Mycotoxin screen	Test	49.00
Nitrate/nitrite	Test	67.00
Organic compound confirmation	Test	90.00
Organic compound screen	Test	155.00
Parasitology	Test	29.00
Pesticide quantitation	Test	135.00
Pesticide screen	Test	62.00
pH	Test	27.00
Plate cylinder	Test	100.00
Selenium	Test	45.00
Silicate/carbonate disinfectant	Test	67.00
Temperature disks	Test	133.00
Toxicant quantitation, other	Test	112.00
Toxicant screen, other	Test	33.00
Vomitoxin only	Test	54.00
Water activity	Test	33.00
Zearaleone quantitation	Test	54.00
Zearaleone screen	Test	29.00

As specified in § 130.18(a), the user fees for bacteriology reagents produced by the Diagnostic Bacteriology Laboratory at NVSL (excluding FADDL) or other authorized sites for fiscal year 2009 are as follows:

Reagent	Unit	User fee
Anaplasma card test antigen	2 mL	$97.00
Anaplasma card test kit without antigen	Kit	130.00
Anaplasma CF antigen	2 mL	46.00
Anaplasma stabilate	4.5 mL	178.00
Avian origin bacterial antiserums	1 mL	49.00
Bacterial agglutinating antigens other than brucella and salmonella pullorum	5 mL	55.00
Bacterial conjugates	1 mL	99.00
Bacterial disease CF antigens, all other	1 mL	30.00
Bacterial ELISA antigens	1 mL	30.00
Bacterial or protozoal antiserums, all other	1 mL	61.00
Bacterial reagent culture 1	Culture	74.00
Bacterial reference culture 2	Culture	233.00
Bacteriophage reference culture	Culture	176.00
Bovine serum factor	1 mL	18.00
Brucella abortus CF antigen	60 mL	154.00
Brucella agglutination antigens, all other	60 mL	154.00
Brucella buffered plate antigen	60 mL	176.00
Brucella canis tube antigen	25 mL	116.00
Brucella card test antigen (packaged)	Package	92.00
Brucella card test kit without antigen	Kit	114.00
Brucella cells	Gram	19.00
Brucella cells, dried	Pellet	6.00
Brucella ring test antigen	60 mL	246.00
Brucella rivanol solution	60 mL	30.00
Dourine CF antigen	1 mL	91.00
Dourine stabilate	4.5 mL	111.00
Equine and bovine origin babesia species antiserums	1 mL	130.00
Equine negative control CF antigen	1 mL	283.00
Flazo-orange	3 mL	13.00
Glanders CF antigen	1 mL	79.00
Hemoparasitic disease CF antigens, all other	1 mL	553.00
Leptospira transport medium	10 mL	4.50
Monoclonal antibody	1 mL	97.00
Mycobacterium spp. old tuberculin	1 mL	24.00
Mycobacterium spp. PPD	1 mL	19.00
Mycoplasma hemagglutination antigens	5 mL	184.00
Negative control serums	1 mL	19.00
Rabbit origin bacterial antiserum	1 mL	53.00
Salmonella pullorum microagglutination antigen	5 mL	16.00
Stabilates, all other	4.5 mL	690.00
1 A reagent culture is a bacterial culture that has been subcultured one or more times after being tested for purity and identity. It is intended for use as a reagent with a diagnostic test such as the leptospiral agglutination test.
2 A reference culture is a bacterial culture that has been thoroughly tested for purity and identity. It should be suitable as a master seed for future cultures.

As specified in § 130.18(b), the user fees for virology reagents produced by the Diagnostic Virology Laboratory at NVSL (excluding FADDL) or other authorized sites for fiscal year 2009 are as follows:

Reagent	Unit	User fee
Antigen, except avian influenza and chlamydia psittaci antigens, any	2 mL	$62.00
Avian antiserum except avian influenza antiserum, any	2 mL	49.00
Avian influenza antigen, any	2 mL	34.00
Avian influenza antiserum, any	6 mL	105.00
Bovine or ovine serum, any	2 mL	130.00
Cell culture	Flask	154.00
Chlamydia psittaci spp. of origin monoclonal antibody panel	Panel	96.00
Conjugate, any	1 mL	75.00
Diluted positive control serum, any	2 mL	25.00
Equine antiserum, any	2 mL	46.00
Monoclonal antibody	1 mL	104.00
Other spp. antiserum, any	1 mL	52.00
Porcine antiserum, any	2 mL	108.00
Porcine tissue sets	Tissue set	157.00
Positive control tissues, all	2 cm 2 section	62.00
Rabbit origin antiserum	1 mL	53.00
Reference virus, any	0.6 mL	184.00
Viruses (except reference viruses), chlamydia psittaci agent or chlamydia psittaci antigen, any	0.6 mL	31.00

As specified in § 130.19(a), the user fees for other veterinary diagnostic services or materials available from NVSL (excluding FADDL) for fiscal year 2009 are as follows:

Service	Unit	User fee
Antimicrobial susceptibility test	Isolate	$107.00
Avian safety test	Test	4,090.00
Check tests, culture	Kit 1	179.00
Check tests, serology	Kit 1	369.00
Fetal bovine serum safety test	Verification	1,122.00
Hourly user fees 2	Hour	104.00
Quarter hour	Quarter hour	26.00
Minimum		31.00
Manual, brucellosis culture	1 copy	117.00
Manual, tuberculosis culture (English or Spanish)	1 copy	176.00
Manual, Veterinary mycology	1 copy	176.00
Manuals or standard operating procedure (SOP), all other	1 copy	35.00
Manuals or SOP, per page	1 page	2.50
Training (school or technical assistance)	Per person per day	339.00
1 Any reagents required for the check test will be charged separately.
2 For veterinary diagnostic services for which there is no flat user fee the hourly rate user fee will be calculated for the actual time required to provide the service.

Agricultural Quarantine and Inspection Services User Fees

User fees to reimburse APHIS for the costs of providing inspection of certain commercial conveyances are found in 7 CFR part 354 (referred to below as the regulations). These user fees are authorized by Section 2509(a) of the Food, Agriculture, Conservation, and Trade Act of 1990 (21 U.S.C. 136a), which authorizes APHIS to collect user fees for agricultural quarantine and inspection (AQI) services.

In a final rule published in the Federal Register on December 9, 2004 (69 FR 71660-71683, Docket No. 04-042-1), and effective January 1, 2005, we established, for fiscal years 2005 through 2010, user fees for each of the types of conveyances or persons to whom AQI services are provided, i.e., commercial vessels (watercraft), commercial trucks, loaded commercial railroad cars, commercial aircraft, and international airline passengers. The regulations provide specific information regarding the applicability of, and exceptions to, AQI user fees. As specified in 7 CFR 354.3, the user fees for these AQI services for fiscal year 2009 are as follows:

Service	Unit	Amount
Inspection of commercial vessels of 100 net tons or more (see 7 CFR 354.3(b))	Per entry 1	$494.00
Inspection of commercial trucks (see 7 CFR 354.3(c))	Per entry 2	5.25
Inspection of commercial railroad cars (see 7 CFR 354.3(d))	Per entry 3	7.75
Inspection of commercial aircraft (see 7 CFR 354.3(e))	Per entry	70.75
Inspection of international aircraft passengers (see 7 CFR 354.3(f))	Per entry	5.00
1 Not to exceed 15 payments in a calendar year (i.e., no additional fee will be charged for a 16th or subsequent arrival in a calendar year).
2 A prepaid AQI permit valid for 1 calendar year may be obtained for an amount 20 times the AQI use fee for each arrival ($105 from October 1, 2008, through September 30, 2009).
3 The AQI user fee may be prepaid for all arrival of a commercial railroad car during a calendar year for an amount 20 times the AQI use fee for each arrival ($155 from October 1, 2008, through September 30, 2009).

Done in Washington, DC, this 21st day of August, 2008.

Kevin Shea,

Acting Administrator, Animal and Plant Health Inspection Service.