AGENCY:
Animal and Plant Health Inspection Service, USDA.
ACTION:
Final rule.
SUMMARY:
We are amending the regulations to increase the user fees for veterinary diagnostic services to reflect changes in our operating costs and changes in calculating our costs. We are also setting rates for multiple fiscal years. These actions are necessary to ensure that we recover the actual costs of providing these services. We are also providing for a reasonable balance, or reserve, in the veterinary diagnostics user fee account. The Food, Agriculture, Conservation, and Trade Act of 1990, as amended, authorizes us to set and collect these user fees.
DATES:
Effective Date: June 7, 2004.
FOR FURTHER INFORMATION CONTACT:
For information concerning program operations, contact Dr. Randall Levings, Director, National Veterinary Services Laboratories, 1800 Dayton Road, PO Box 844, Ames, IA 50010; (515) 663-7357.
For information concerning user fee rate development, contact Mrs. Kris Caraher, User Fees Section Head, Financial Systems and Services Branch, APHIS, 4700 River Road Unit 54, Riverdale, MD 20737-1232; (301) 734-5901.
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 (referred to below as the regulations). These user fees are authorized by § 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 or poultry within the United States.
On July 24, 2003, we published in the Federal Register (68 FR 43661-43673, Docket No. 00-024-1) a proposed rule to increase the user fees for veterinary diagnostic services to reflect changes in our operating costs and changes in calculating our costs, and to establish rates for multiple fiscal years. Operating costs have increased since these user fees were established in a final rule published in the Federal Register on October 7, 1998 (63 FR 53783-53798, Docket No. 94-115-2). Therefore, the user fees need to be updated to reflect those increases. However, the main reason for the increase in the fees is cost data gathered through new cost-finding techniques employed by APHIS. The Statement of Federal Financial Accounting Standards (SFFAS) No. 4, “Managerial Cost Accounting Standards and Concepts,” issued by the Office of Management and Budget, mandated that APHIS capture cost accounting data in its program costs. We were required to accumulate and report the costs of veterinary diagnostic activities on a regular basis through the use of cost accounting systems and cost finding techniques. In order to comply with SFFAS No. 4, APHIS conducted an Activity Based Costing (ABC) project at the National Veterinary Services Laboratories in Ames, IA, which identified the sources of all costs for veterinary diagnostic services. As a result of that project, we determined that costs for user fee-related services were not adequately being recovered through user fee collections. Based on this determination, we proposed new fees to recover these newly identified costs. Each of the updated user fees contains a proportionate share of the costs identified in the ABC study.
We solicited comments concerning our proposal for 60 days ending September 22, 2003. We received two comments by that date, from a livestock exporting company and a State laboratory.
One commenter, the livestock exporter, stated that the proposed fee increases could force his company to move its operations to Canada, where he says costs are lower, or to cease operations. He described his company as the Pacific Northwest's only permanent livestock export inspection facility.
APHIS has received no directly appropriated funds to provide import- and export-related services for animals, animal products, birds, germ plasm, organisms, and vectors since fiscal year 1992. Rather, the Food, Agriculture, Conservation, and Trade Act of 1990, as amended, and the Animal Health Protection Act authorize the U.S. Department of Agriculture to prescribe and collect user fees for those services. Therefore, to continue to provide those services, we must recover our costs from the customers who benefit from those services.
For reasons described in the economic analysis we provided in the proposed rule, we do not anticipate that the fee increases in this rule will cause exports to decline or result in decreased testing. While APHIS hopes that this fee increase does not cause the commenter's inspection facility to close, such facilities operate throughout the United States; if the commenter's facility closed, inspections would be performed at the next closest or next convenient location. We are not making any changes to the proposed rule in response to this comment.
One commenter stated that the user fee increases in our proposed rule would result in a loss of revenue for the National Veterinary Services Laboratories, creating a need for further increases in the user fees.
In response, we would like to reiterate that our user fees are calculated for full cost recovery only. They are not designed to meet any other financial goals, including revenue generation.
One commenter suggested that the proposed fee increases would result in APHIS’ veterinary diagnostic services being used less frequently, which would in turn negatively affect the agency's proficiency levels and information base.
As mentioned previously, we do not expect that APHIS’ veterinary diagnostic services will be used less frequently under the new user fees. In any case, we believe that our veterinary diagnostic professionals have proficiency levels and an information base that are adequate to ensure continued competent performance.
One commenter stated that the fees in our proposed rule did not consider economies of scale.
As discussed in the proposed rule, we considered continuing a discount that applied to all diagnostic, non-import-related complement fixation, hemagglutination inhibition, fluorescent antibody, indirect fluorescent antibody virus neutralization, and peroxidase linked antibody tests. This discount applied to the 11th and subsequent tests on the same submission by the same submitter for the same test and antigen. However, we reevaluated the time it takes to conduct these additional tests and determined that it was no longer cost effective to perform the tests at a discount. If we determine that our veterinary diagnostic services can be provided at a discount at certain volumes, we will adjust our user fees accordingly in a subsequent rulemaking.
One commenter expressed concern about the effect the proposed user fees would have on U.S. exporters in general.
We realize that any increase in user fees will increase the up-front cost of doing business for exporters, and we have attempted to keep the costs of our services as low as possible. However, as we explained in the proposed rule, operating costs have increased since the user fees for veterinary diagnostic services were established in 1998, and the ABC project at the National Veterinary Services Laboratories demonstrated that APHIS has not been recovering the full costs of providing user-fee related services through its established user fees. Implementing the user fees in this final rule will ensure that APHIS is able to provide veterinary diagnostic services and recover the cost of these services by the user fees charged. We are making no changes to the proposed rule in response to this comment.
One commenter suggested that APHIS should not collect user fees for tests for animal diseases that can severely impact public health or have serious economic consequences for other reasons. The commenter gave as an example arboviral encephalitides, stating that the costs for diagnosing and controlling this disease were funded through tax dollars in New Jersey.
Our regulations exempt from user fees veterinary diagnostic services provided in connection with (1) Federal programs to control or eradicate diseases or pests of livestock or poultry in the United States (program diseases), (2) zoonotic disease surveillance when the Administrator has determined that there is a significant threat to human health, and (3) detection of foreign animal diseases. We believe that these exemptions address the problem of funding diagnostic services for animal diseases that could have major public health or economic impacts.
One commenter suggested that, with the fee increases proposed, APHIS would become more like a business than a service organization, and the agency's partnership with the States would be strained.
APHIS is committed to cooperating with the States in order to safeguard U.S. animal health, and, as described above, APHIS provides many services to help control dangerous animal diseases at no cost. However, we must charge user fees that accurately reflect the cost of providing veterinary diagnostic services in order to provide those services. We are making no changes in response to these comments.
However, we are making a change to one of the proposed user fees in this final rule. The proposed user fee schedule for virus titration, which was listed in a table in § 130.14(c), listed the fee for that service for fiscal year 2006 as $110.00. The correct fee is $119.00. We are correcting the error in this final rule.
Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the change discussed above.
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 this final rule, we are increasing the user fees for veterinary diagnostic services to reflect changes in operating costs and changes in calculating our costs. These actions are necessary to ensure that we recover the actual costs of providing these services. We are also providing for a reasonable balance, or reserve, in the veterinary diagnostics user fee account. The reserve will ensure that we have sufficient operating funds in cases of fluctuations in activity volumes, bad debt, program shutdown, or customer insolvency. The Food, Agriculture, Conservation, and Trade Act of 1990, as amended, authorizes us to set and collect these user fees.
In our July 2003 proposed rule, under the heading “Executive Order 12866 and Regulatory Flexibility Act,” we provided a detailed analysis of the possible economic effects of the proposed fee increases on users of veterinary diagnostic services. The conclusions of that analysis are summarized below.
The impacts of the increases in veterinary diagnostic user fees in this final rule are expected to be muted. The majority of the changes to the user fees are either small, associated with few users, or both. Over the period covered by this final rule, more than 60 percent of the individual increases are less than $50, nearly 16 percent increase by less than $10, and about 65 percent are associated with 100 or fewer users. The majority of the fees in this final rule should also make only a small contribution to the total additional fee collections and, therefore, will have a minor impact on the users of those services. This is either because the change is small or the projected volume associated with the user fee is small, or both. Even in those instances in which the change in a user fee will generate a larger total increase in collections, the impact should not be significant because the fees are: Small fees applied to a large annual volume of users, large fees applied to a very small volume of users, fees that represent a small percentage of the overall costs associated with a user's output, single fees for reagents with numerous final users, or fees that enhance the marketability of the user's final outputs. Therefore, the increases are not generally expected to substantially reduce profits or impede exports or imports. Indeed, the full burden of the user fee changes is not likely to be borne entirely by the purchasers of products and services.
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 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 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 3701, 3716, 3717, 3719, and 3720A; 7 CFR 2.22, 2.80, and 371.4.
2. In § 130.14, the tables in paragraphs (a) through (c) are revised to read as follows:
(a) * * *
| Reagent | Unit | User fee | |||
|---|---|---|---|---|---|
| June 7, 2004-Sept. 30, 2004 | Oct. 1, 2004-Sept. 30, 2005 | Oct. 1, 2005-Sept. 30, 2006 | Beginning Oct. 1, 2006 | ||
| Bovine antiserum, any agent | 1 mL | $150.00 | $155.00 | $160.00 | $165.00 |
| Caprine antiserum, any agent | 1 mL | 184.00 | 189.00 | 195.00 | 202.00 |
| Cell culture antigen/microorganism | 1 mL | 103.00 | 106.00 | 109.00 | 111.00 |
| Equine antiserum, any agent | 1 mL | 186.00 | 192.00 | 198.00 | 204.00 |
| Fluorescent antibody conjugate | 1 mL | 169.00 | 172.00 | 176.00 | 179.00 |
| Guinea pig antiserum, any agent | 1 mL | 184.00 | 189.00 | 194.00 | 200.00 |
| Monoclonal antibody | 1 mL | 222.00 | 229.00 | 235.00 | 243.00 |
| Ovine antiserum, any agent | 1 mL | 176.00 | 181.00 | 187.00 | 193.00 |
| Porcine antiserum, any agent | 1 mL | 152.00 | 157.00 | 162.00 | 167.00 |
| Rabbit antiserum, any agent | 1 mL | 179.00 | 185.00 | 190.00 | 196.00 |
(b) * * *
| Test | Unit | User fee | |||
|---|---|---|---|---|---|
| June 7, 2004-Sept. 30, 2004 | Oct. 1, 2004-Sept. 30, 2005 | Oct. 1, 2005-Sept. 30, 2006 | Beginning Oct. 1, 2006 | ||
| Agar gel immunodiffusion | Test | $30.00 | $31.00 | $32.00 | $33.00 |
| Card | Test | 17.00 | 17.00 | 18.00 | 18.00 |
| Complement fixation | Test | 36.00 | 37.00 | 38.00 | 40.00 |
| Direct immunofluorescent antibody | Test | 22.00 | 23.00 | 24.00 | 25.00 |
| Enzyme linked immunosorbent assay | Test | 26.00 | 27.00 | 28.00 | 29.00 |
| Fluorescent antibody neutralization (classical swine fever) | Test | 194.00 | 201.00 | 208.00 | 215.00 |
| Hemagglutination inhibition | Test | 57.00 | 59.00 | 61.00 | 63.00 |
| Immunoperoxidase | Test | 29.00 | 30.00 | 31.00 | 32.00 |
| Indirect fluorescent antibody | Test | 35.00 | 36.00 | 37.00 | 39.00 |
| In-vitro safety | Test | 570.00 | 589.00 | 609.00 | 630.00 |
| In-vivo safety | Test | 5,329.00 | 5,387.00 | 5,447.00 | 5,509.00 |
| Latex agglutination | Test | 23.00 | 24.00 | 25.00 | 26.00 |
| Tube agglutination | Test | 28.00 | 28.00 | 29.00 | 30.00 |
| Virus isolation (oesophageal/pharyngeal) | Test | 180.00 | 186.00 | 192.00 | 199.00 |
| Virus isolation in embryonated eggs | Test | 346.00 | 358.00 | 370.00 | 383.00 |
| Virus isolation, other | Test | 155.00 | 160.00 | 166.00 | 171.00 |
| Virus neutralization | Test | 52.00 | 54.00 | 56.00 | 58.00 |
(c) * * *
3. In § 130.15, the tables in paragraphs (a) and (b) are revised to read as follows:
(a) * * *
| Test | Unit | User fee | |||
|---|---|---|---|---|---|
| June 7, 2004-Sept. 30, 2004 | Oct. 1, 2004-Sept. 30, 2005 | Oct. 1, 2005-Sept. 30, 2006 | Beginning Oct. 1, 2006 | ||
| Bacterial identification, automated | Isolate | $48.00 | $50.00 | $51.00 | $53.00 |
| Bacterial identification, non-automated | Isolate | 81.00 | 84.00 | 87.00 | 90.00 |
| Bacterial isolation | Sample | 33.00 | 34.00 | 35.00 | 36.00 |
| Bacterial serotyping, all other | Isolate | 51.00 | 52.00 | 53.00 | 55.00 |
| Bacterial serotyping, Pasteurella multocida | Isolate | 16.00 | 17.00 | 18.00 | 18.00 |
| Bacterial serotyping, Salmonella | Isolate | 33.00 | 34.00 | 35.00 | 36.00 |
| Bacterial toxin typing | Isolate | 109.00 | 112.00 | 116.00 | 120.00 |
| Bacteriology requiring special characterization | Test | 83.00 | 86.00 | 89.00 | 92.00 |
| DNA fingerprinting | Test | 54.00 | 56.00 | 58.00 | 59.00 |
| DNA/RNA probe | Test | 77.00 | 79.00 | 81.00 | 83.00 |
| Fluorescent antibody | Test | 17.00 | 17.00 | 18.00 | 19.00 |
| Mycobacterium identification (biochemical) | Isolate | 104.00 | 107.00 | 111.00 | 114.00 |
| Mycobacterium identification (gas chromatography) | Procedure | 87.00 | 90.00 | 93.00 | 96.00 |
| Mycobacterium isolation, animal inoculations | Submission | 770.00 | 791.00 | 814.00 | 837.00 |
| Mycobacterium isolation, all other | Submission | 136.00 | 141.00 | 146.00 | 151.00 |
| Mycobacterium paratuberculosis isolation | Submission | 65.00 | 67.00 | 70.00 | 72.00 |
| Phage typing, all other | Isolate | 38.00 | 39.00 | 41.00 | 42.00 |
| Phage typing, Salmonella enteritidis | Isolate | 21.00 | 22.00 | 23.00 | 24.00 |
(b) * * *
| Test | Unit | User fee | |||
|---|---|---|---|---|---|
| June 7, 2004-Sept. 30, 2004 | Oct. 1, 2004-Sept. 30, 2005 | Oct. 1, 2005-Sept. 30, 2006 | Beginning Oct. 1, 2006 | ||
| Fluorescent antibody tissue section | Test | $27.00 | $27.00 | $28.00 | $29.00 |
| Virus isolation | Test | 43.00 | 45.00 | 46.00 | 48.00 |
4. In § 130.16, the tables in paragraphs (a) and (b) are revised to read as follows:
(a) * * *
| Test | Unit | User fee | |||
|---|---|---|---|---|---|
| June 7, 2004-Sept. 30, 2004 | Oct. 1, 2004-Sept. 30, 2005 | Oct. 1, 2005-Sept. 30, 2006 | Beginning Oct. 1, 2006 | ||
| Brucella ring (BRT) | Test | $33.00 | $34.00 | $35.00 | $36.00 |
| Brucella ring, heat inactivated (HIRT) | Test | 33.00 | 34.00 | 35.00 | 36.00 |
| Brucella ring, serial (Serial BRT) | Test | 49.00 | 51.00 | 53.00 | 54.00 |
| Buffered acidified plate antigen presumptive | Test | 6.00 | 7.00 | 7.00 | 7.00 |
| Card | Test | 4.00 | 4.00 | 4.00 | 4.00 |
| Complement fixation | Test | 15.00 | 15.00 | 16.00 | 16.00 |
| Enzyme linked immunosorbent assay | Test | 15.00 | 15.00 | 16.00 | 16.00 |
| Indirect fluorescent antibody | Test | 13.00 | 13.00 | 14.00 | 14.00 |
| Microscopic agglutination-includes up to 5 serovars | Sample | 21.00 | 22.00 | 23.00 | 24.00 |
| Microscopic agglutination-each serovar in excess of 5 serovars | Sample | 4.00 | 4.00 | 4.00 | 4.00 |
| Particle concentration fluorescent immunoassay (PCFIA) | Test | 33.00 | 34.00 | 35.00 | 36.00 |
| Plate | Test | 6.00 | 7.00 | 7.00 | 7.00 |
| Rapid automated presumptive | Test | 6.00 | 6.00 | 6.00 | 7.00 |
| Rivanol | Test | 6.00 | 7.00 | 7.00 | 7.00 |
| Tube agglutination | Test | 6.00 | 7.00 | 7.00 | 7.00 |
(b) * * *
| Test | Unit | User fee | |||
|---|---|---|---|---|---|
| June 7, 2004-Sept. 30, 2004 | Oct. 1, 2004-Sept. 30, 2005 | Oct. 1, 2005-Sept. 30, 2006 | Beginning Oct. 1, 2006 | ||
| Agar gel immunodiffusion | Test | $15.00 | $15.00 | $16.00 | $16.00 |
| Complement fixation | Test | 15.00 | 15.00 | 16.00 | 16.00 |
| Enzyme linked immunosorbent assay | Test | 15.00 | 15.00 | 16.00 | 16.00 |
| Hemagglutination inhibition | Test | 13.00 | 13.00 | 14.00 | 14.00 |
| Indirect fluorescent antibody | Test | 13.00 | 13.00 | 14.00 | 14.00 |
| Latex agglutination | Test | 15.00 | 15.00 | 16.00 | 16.00 |
| Peroxidase linked antibody | Test | 14.00 | 14.00 | 15.00 | 15.00 |
| Plaque reduction neutralization | Test | 16.00 | 17.00 | 17.00 | 18.00 |
| Rabies fluorescent antibody neutralization | Test | 41.00 | 42.00 | 44.00 | 45.00 |
| Virus neutralization | Test | 12.00 | 12.00 | 13.00 | 13.00 |
5. In § 130.17, the table in paragraph (a) is revised to read as follows:
(a) * * *
| Test | Unit | User fee | |||
|---|---|---|---|---|---|
| June 7, 2004-Sept. 30, 2004 | Oct. 1, 2004-Sept. 30, 2005 | Oct. 1, 2005-Sept. 30, 2006 | Beginning Oct. 1, 2006 | ||
| Aflatoxin quantitation | Test | $27.00 | $28.00 | $29.00 | $30.00 |
| Aflatoxin screen | Test | 26.00 | 27.00 | 28.00 | 29.00 |
| Agar gel immunodiffusion spp. identification | Test | 11.00 | 12.00 | 12.00 | 13.00 |
| Antibiotic (bioautography) quantitation | Test | 59.00 | 61.00 | 63.00 | 65.00 |
| Antibiotic (bioautography) screen | Test | 108.00 | 112.00 | 115.00 | 119.00 |
| Antibiotic inhibition | Test | 59.00 | 61.00 | 63.00 | 65.00 |
| Arsenic | Test | 16.00 | 16.00 | 17.00 | 17.00 |
| Ergot alkaloid screen | Test | 59.00 | 61.00 | 63.00 | 65.00 |
| Ergot alkaloid confirmation | Test | 77.00 | 80.00 | 83.00 | 86.00 |
| Feed microscopy | Test | 59.00 | 61.00 | 63.00 | 65.00 |
| Fumonisin only | Test | 33.00 | 35.00 | 36.00 | 37.00 |
| Gossypol | Test | 89.00 | 92.00 | 95.00 | 98.00 |
| Mercury | Test | 131.00 | 135.00 | 140.00 | 145.00 |
| Metals screen | Test | 40.00 | 41.00 | 43.00 | 44.00 |
| Metals single element confirmation | Test | 11.00 | 12.00 | 12.00 | 13.00 |
| Mycotoxin: aflatoxin-liver | Test | 108.00 | 112.00 | 115.00 | 119.00 |
| Mycotoxin screen | Test | 43.00 | 44.00 | 46.00 | 48.00 |
| Nitrate/nitrite | Test | 59.00 | 61.00 | 63.00 | 65.00 |
| Organic compound confirmation | Test | 79.00 | 82.00 | 85.00 | 88.00 |
| Organic compound screen | Test | 137.00 | 141.00 | 146.00 | 151.00 |
| Parasitology | Test | 26.00 | 27.00 | 28.00 | 29.00 |
| Pesticide quantitation | Test | 119.00 | 123.00 | 128.00 | 132.00 |
| Pesticide screen | Test | 54.00 | 56.00 | 58.00 | 60.00 |
| pH | Test | 24.00 | 25.00 | 26.00 | 26.00 |
| Plate cylinder | Test | 89.00 | 92.00 | 95.00 | 98.00 |
| Selenium | Test | 40.00 | 41.00 | 43.00 | 44.00 |
| Silicate/carbonate disinfectant | Test | 59.00 | 61.00 | 63.00 | 65.00 |
| Temperature disks | Test | 118.00 | 122.00 | 126.00 | 130.00 |
| Toxicant quantitation, other | Test | 99.00 | 103.00 | 106.00 | 110.00 |
| Toxicant screen, other | Test | 30.00 | 31.00 | 32.00 | 33.00 |
| Vomitoxin only | Test | 48.00 | 49.00 | 51.00 | 53.00 |
| Water activity | Test | 30.00 | 31.00 | 32.00 | 33.00 |
| Zearaleone quantitation | Test | 48.00 | 49.00 | 51.00 | 53.00 |
| Zearaleone screen | Test | 26.00 | 27.00 | 28.00 | 29.00 |
6. In § 130.18, the tables in paragraphs (a) and (b) are revised to read as follows:
(a) * * *
(b) * * *
7. In § 130.19, the table in paragraph (a) is revised to read as follows:
(a) * * *
Done in Washington, DC, this 29th day of April 2004.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-10309 Filed 5-5-04; 8:45 am]
BILLING CODE 3410-34-P