On October 31, 2003, the Office of Personnel Management (OPM) published a proposed rule (68 FR 62027) to change the timing of annual wage surveys conducted by the Bureau of Reclamation (BOR), Department of the Interior (DOI), to determine prevailing rates of pay for supervisors of negotiated rate wage employees in the Bureau's Mid-Pacific Region. The proposed rule had a 30-day comment period, during which we received no comments. Currently, BOR conducts wage surveys in the region in October each year. Wage surveys will be conducted in the future in February.

DOI asked OPM to change the survey month for local wage surveys in the Mid-Pacific Region because February represents the best timing in relation to wage adjustments in the surveyed local private enterprise establishments and would improve the quality of data BOR collects during local wage surveys in this special wage area. Local private industry establishments surveyed by BOR in the Mid-Pacific Region typically make their wage adjustments effective in January of each year. BOR will conduct wage surveys in February in the Mid-Pacific Region beginning in calendar year 2004. Since DOI implements the results of the wage surveys in the month following the survey month, wage adjustments for supervisors of negotiated rate wage employees in the Mid-Pacific Region will become effective in March. Thus, they will more closely coincide with local prevailing rates.

I certify that this regulation would not have a significant economic impact on a substantial number of small entities because it would affect only Federal agencies and employees.

This 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 (OMB).

This rule is excluded from the scope of Executive Order 12372, Intergovernmental Consultation, which may require consultation with State and local officials. See the final rule related notice entitled, “Department Programs and Activities Excluded from Executive Order 12372,” (50 FR 47034) advising that RUS loans and loan guarantees were not covered by Executive Order 12372.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. RUS has determined that this rule meets the applicable standards provided in section 3 of the Executive Order. In addition, all State and local laws and regulations that are in conflict with this rule will be preempted; no retroactive effect will be given to this rule; and in accordance with section 212(e) of the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. 6912(e)) administrative appeal procedures, if any, must be exhausted before an action against the Department or its agencies may be initiated.

It has been determined that the Regulatory Flexibility Act is not applicable to this rule since the Rural Utilities Service is not required by 5 U.S.C. 551 et seq. or any other provision of law to publish a notice of proposed rulemaking with respect to the subject matter of this rule.

The Administrator of RUS has determined that this rule will not significantly affect the quality of the human environment as defined by the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ). Therefore, this action does not require an environmental impact statement or assessment.

The program described by this rule is listed in the Catalog of Federal Domestic Assistance Programs under number 10.850, Rural Electrification Loans and Loan Guarantees. This catalog is available on a subscription basis from the Superintendent of Documents, the United States Government Printing Office, Washington, DC 20402-9325, telephone number (202) 512-1800.

The reporting and recordkeeping requirements contained in this rule have been approved by the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35) under OMB control number 0572-0107.

This rule contains no Federal mandates (under the regulatory provision of Title II of the Unfunded Mandates Reform Act of 1995) for State, local, and tribal governments or the private sector. Thus, this rule is not subject to the requirements of sections 202 and 205 of the Unfunded Mandates Reform Act of 1995.

The standard loan agreement between RUS and its electric borrowers provides that, in accordance with applicable RUS regulations, the borrower shall use standard forms of contracts promulgated by RUS for construction, procurement, engineering services, and architectural services financed by a loan made or guaranteed by RUS. RUS also provides forms of contracts which serve as guidance to borrowers and which borrowers may use at their discretion. RUS is updating, consolidating, and streamlining the standard forms of contracts used for construction and procurement. The forms affected are:

1. RUS Form 198, Rev. 2-95, Equipment Contract. This form is used for equipment purchases.

2. RUS Form 200, Rev. 2-95, Construction Contract—Generating. This form is used for generating plant construction or for the furnishing and installation of major items of equipment.

3. RUS Form 201, Rev. 2-95, Right-of-Way Clearing Contract. This form is used for distribution line right-of-way clearing work which is to be performed separate from line construction.

4. RUS Form 203, Rev. 2-95, Transmission System Right-of-Way Clearing Contract. This form is used for transmission right-of-way clearing work which is to be performed separate from line construction.

5. RUS Form 257, Rev. 2-95, Contract to Construct Buildings. This form is used to construct headquarters buildings and other structure construction.

6. RUS Form 764, Rev. 2-95, Substation and Switching Station Erection Contract. This form is used to construct substations and switching stations.

7. RUS Form 786, Rev. 2-95, Electric System Communications and Control Equipment Contract. This form is used for delivery and installation of equipment for system communications.

8. RUS Form 790, Rev. 2-95, Distribution Line Extension Construction Contract (Labor and Materials). This form is used for limited distribution construction accounted for under work order procedure.

9. RUS Form 792, Rev. 2-95, Distribution Line Extension Construction Contract (Labor Only). This form is used for limited distribution construction accounted for under work order procedure.

10. RUS Form 830, Rev. 2-95, Electric System Construction Contract (Labor and Materials). This form is used for distribution and transmission line project construction.

11. RUS Form 831, Rev. 2-95, Electric Transmission Construction Contract (Labor and Materials). This form is used for transmission line project construction.

1. RUS Form 168b, Rev. 2-95, Contractor's Bond. This form is used to obtain a surety bond and is included in RUS Forms 200, 201, 203, 257, 764, 786, 790, 792, 830, and 831.

2. RUS Form 168c, Rev. 2-95, Contractor's Bond (less than $1 million). This form is used in lieu of RUS Form 168b to obtain a surety bond when contractor's surety has accepted a Small Business Administration guarantee.

3. RUS Form 180, Rev. 2-95, Construction Contract Amendment. This form is used to amend distribution line construction contracts.

4. RUS Form 181, Rev. 2-95, Certificate of Completion, Contract Construction for Buildings. This form is used for the closeout of RUS Form 257.

5. RUS Form 187, Rev. 2-95, Certificate of Completion, Contract Construction. This form is used for the closeout of and is included in RUS Forms 200, 203, 764, 786, 830, and 831.

6. RUS Form 213, Rev. 11-99, Certificate (“Buy American”). This form is used to document compliance with the “Buy American” requirement.

7. RUS Form 224, Rev. 2-95, Waiver and Release of Lien. This form is used for the closeout of and is included in RUS Forms 200, 203, 764, 786, 830, and 831.

8. RUS Form 231, Rev. 2-95, Certificate of Contractor. This form is used for the closeout of and is included in RUS Forms 200, 203, 764, 786, 830, and 831.

9. RUS Form 238, Rev. 2-95, Construction or Equipment Contract Amendment. This form is used to amend contracts except distribution line construction contracts.

10. RUS Form 251, Rev. 2-95, Material Receipt. This form is used to document receipt of owner furnished materials and is included in RUS Forms 764, 830, and 831.

11. RUS Form 254, Rev. 2-95, Construction Inventory. This form is used for the closeout of RUS Forms 203, 764, 830, and 831.

12. RUS Form 307, Rev. 2-95, Bid Bond. This form is used to obtain a bid bond and is included in RUS Forms 200, 203, 257, 764, 830, and 831.

13. RUS Form 792b, Rev. 2-95, Certificate of Construction and Indemnity Agreement. This form is used for the closeout of and is included in RUS Forms 201, 790, 792.

14. RUS Form 792c, Rev. 2-95, Supplemental Contract for Additional Project. This form is used to amend and is included in RUS Forms 201, 790, 792.

1. RUS Form 172, Rev. 9-58, Certificate of Inspection, Contract Construction. This form is used to notify RUS that construction is ready for inspection.

2. RUS Form 173, Rev. 3-55, Materials Contract. This form is used for distribution, transmission, and general plant material purchases.

3. RUS Form 274, Rev. 6-81, Bidder's Qualifications. This form is used to document bidder's qualifications.

4. RUS Form 282, Rev. 11-53, Subcontract. This form is used for subcontracting.

5. RUS Form 458, Rev. 3-55, Materials Contract. This form is used to obtain generation plant material and equipment purchases not requiring acceptance tests at the project site.

The revisions to the listed contract forms include:

1. Eliminate unneeded forms. This includes merging the Form 181 into the Form 187, merging the Form 180 and 792c into the Form 238, merging the Form 201, 203, and 764 into the Form 830, and eliminating Forms 180, 181, 201, 203, 764 and 792c. We are also eliminating infrequently used guidance forms (Forms 172, 173, 274, 282, and 458.)

2. Make forms suitable for “subject to” or “not subject to” RUS approval. This includes merging the Form 831 into the Form 830 and eliminating Form 831.

3. Make construction contract forms suitable for “labor only” or “labor and material.” This includes merging the Form 792 into the Form 790 and eliminating Form 792.

4. Standardize tables and information pages and incorporate them as separate attachments. RUS is planning to publish the “Construction Assembly Units” pages as a separate bulletin. This would allow the borrower to include in its bid package only those construction assembly unit pages that are relevant to a particular project.

5. Maximize consistency among forms. This includes standardizing common provisions and terminology, and adding a “Notice and Instructions to Bidders” to forms not having one. This also includes restructuring the Form 198, Equipment Contract, to a “proposal” and “acceptance” format (like the other forms), and adding certain provisions, such as insurance and protection to persons and property, applicable to work performed at the project site, such as technical assistance during installation.

6. Add a provision regarding assignment of the contract to RUS for security purposes.

7. Update and clarify certain contract provisions in the forms. This includes:

a. Clarify that the contractor (not the owner or engineer) is solely responsible for the means and methods of construction and for the supervision of the contractor's employees.

b. Delete the reference to a “Supervisor” appointed by RUS.

c. Delete the reference to the loan contract and owner's access to funding.

d. Delete the option for eliminating retainage after the contract is 50 percent complete.

e. Update the “Buy American” and “Civil Rights” requirements.

f. Eliminating gender specific terms such as him, his, and materialmen.

RUS published an Advanced Notice of Proposed Rulemaking in the Federal Register on September 16, 1998, at 63 FR 49503. Comments were received from two distribution borrowers and two power supply borrowers. RUS also published a Notice of Proposed Rulemaking in the Federal Register on July 2, 2002, at 67 FR 44396. Comments were received from one distribution borrower, one power supply borrower, and two engineering consultants. RUS reviewed and considered all comments. Several of the comments are addressed herein. Commenters requested that RUS:

• Add a liquidated damages clause to the Forms 198 and 200. This comment has been incorporated.

• Allow electronic reproduction for all or part of the forms. This comment has been incorporated. RUS has removed many of the tables contained in the forms and made them optional attachments which may be modified (electronically or otherwise) as needed. RUS is also allowing exact electronic reproduction of the contract forms. This change is also being made to 7 CFR 1724, Electric Engineering, Architectural Services and Design Policies and Procedures.

• Modify the closeout and accounting requirements for certain types of contract forms. RUS has determined that it will not make this suggested change. RUS believes that the existing requirements are a reasonable balance between ease of use and accountability.

• Include certification forms concerning lobbying and debarment. RUS has included a certification form for debarment. RUS has determined that a lobbying form is not needed in the contract forms.

• Eliminate the requirement to include owner furnished materials under the contractor's bond for certain contracts. RUS has determined that it will not make this suggested change. RUS believes that the existing bonding requirements are necessary for protection of the borrower's and the government's financial interests.

• Add or modify a number of contract provisions to define or clarify the contractor's obligations. RUS has modified the contract provisions as appropriate to clarify the contractor's obligations.

• Clarify the nature of Form 830. Form 830 is called a “Lump Sum” contract, but the document refers to a “Proposal on Unit Basis” (Article I, Section 5). This comment has been incorporated by revising the subtitle of the Form 830 to read “Project Construction.”

• Expand the “Discrepancy in Unit Prices” section (Notice & Instructions to Bidders, Item 15) to include multiplication as well as addition. This comment has been incorporated.

• Add a statement regarding new equipment and materials to Article I, Section 4. This comment has been incorporated and we have combined Sections 2 and 4.

• Add a provision that observation or testing by the Owner does not relieve the Bidder of its obligations under the contract. This comment has been incorporated.

• Add a provision to the warranty concerning warranty of work repaired or replaced under the warranty. This comment has been incorporated.

• Change payment terms to allow the Owner to determine the number of elapsed days before payment is due to the Bidder. In the interest of fairness to both parties to the contract, RUS has determined that it will not make this suggested change.

• Revise payment terms on “1 Lot” contracts. Since projects of this type are not common under this standard form of contract, RUS has determined that it will not make this suggested change.

• Add “grazing land” to the protection provision concerning “cultivated lands.” This comment has been incorporated.

• Add a provision for contract termination for Owner's convenience. In the interest of fairness to both parties to the contract, RUS has determined that it will not make this suggested change.

• Add a provision concerning Owner's right to duplicate and use drawings and other technical data furnished under the contract. Since the contract form does not specifically request drawings and other technical data, RUS has determined that it will not make this suggested change. If the Owner or Engineer requests such information, details concerning the Owner's right to duplicate and use such information should be included in such a request.

• In Form 257, Buildings, remove references to “unit prices” and “de-energize.” This comment has been incorporated.

• In Form 198, Equipment Contract, revise the “Due Diligence” provision concerning knowledge of the site. This comment has been incorporated.

• RUS should specify when contracts require RUS approval. RUS has determined that it will not make this suggested change. The Owner is to insert this information into the standard form.

• Eliminate the requirement for bid bonds for small projects. RUS has determined that it will not make this suggested change. A bid bond (or check) is equally important for a small project as for a large project.

• Remove the cost of “Owner Furnished Materials” from “labor only” contracts. RUS has determined that it will not make this suggested change. However, if a borrower can demonstrate a reasonable benefit and adequate material control, we will consider allowing a borrower to remove the cost of owner furnished material from the cost of the contract on a case-by-case basis.

• Eliminate the requirement to include “Owner Furnished Materials” under the Contractor's Bond. RUS has determined that it will not make this suggested change. Since the contractor has control of the Owner Furnished Materials, it is important to have the protection of the Contractor's Bond for the full amount of the contract.

• Include a provision to prevent the Contractor for changing the Owner for salvaged materials reused in the line construction. RUS has determined that it will not make this suggested change. With proper material control, this should not be an issue.

• Clarify whether the Form 830, Project Construction Contract, will include a provision concerning salvage and reuse of the Owner's material. RUS has determined that it will not make this suggested change. With proper material control, this should not be an issue.

• Clarify whether a Form 254, Construction Inventory, is needed with a Form 830, Project Construction Contract. Form 254 is required for a Form 830 contract by § 1726.403.

• Include a provision for assessing damages for late performance by the contractor in the Form 790, Non-Site Specific Construction Contract. RUS has determined that it will not make this suggested change. The borrower has adequate remedies under the law.

• Clarify the remedy for Contractor's failure to pay material suppliers and subcontractors. RUS has determined that it will not make this suggested change. The borrower has adequate remedies under the law.

• Change the engineer's certification in Form 187, Certificate of Completion, from “in all respects in strict compliance” to “in compliance” with the contract. This comment has been incorporated.

• Allow an “Hourly Labor and Equipment Rate Schedule” in the contract forms. RUS has determined that it will not make this suggested change.

• Add a “Third Year” option to the Form 790, Non-Site Specific Construction Contract. This comment has been incorporated by changing the form to allow the borrower to insert an option of up to four years.

• Correct various editorial and reference inconsistencies. This comment has been incorporated by making these corrections as applicable.

One commenter suggested that by eliminating Form 274, Bidder's Qualifications, RUS is not encouraging prequalification of bidders. On the contrary, RUS requires prequalification of bidders ( see 7 CFR 1726.23) for all contracts. RUS is eliminating the Form 274 because RUS believes that the substance of the bidder's qualification is more important than the form used. Borrowers and engineers may use whatever form or format they feel is appropriate for obtaining bidder's qualifications.

In addition to the modifications of the contract forms and the associated changes in 7 CFR 1726, RUS is making several other minor changes and corrections to 7 CFR 1726. For example, § 1726.125(b), which covers approval by RUS of plans and specifications for generating facilities, is being removed because this topic is now covered in 7 CFR 1724, Electric Engineering, Architectural Services and Design Policies and Procedures. Since some of the electric program contract forms are also used in the RUS telecommunications program, RUS is changing the list of forms in 7 CFR 1755. RUS is also removing the reference to year 2000 compliance since this is no longer relevant.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 99-21-09, amendment 39-11352 (64 FR 54199, October 6, 1999), which is applicable to certain Bombardier Model DHC-8-102, -103, -106, -201, -202, -301, -311, and -315 airplanes, was published in the Federal Register on October 20, 2003 (68 FR 59892). The action proposed to continue to require a one-time inspection to detect chafing of electrical wires in the cable trough below the cabin floor; repair, if necessary; installation of additional tie-mounts and tie-wraps; and application of sealant to rivet heads. The action also proposed to add an additional modification of the electrical wires in certain sections.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the single comment received.

The commenter notes that the proposed AD specifies accomplishment of the modification (including a general visual inspection and any applicable repair) per Part III, paragraphs 1 through 9 and 12 through 20, of the Accomplishment Instructions of Bombardier Service Bulletin 8-53-80, Revision A, dated July 25, 2000. The commenter states that operators may have already accomplished the actions per the original issue of the service bulletin (Bombardier Service Bulletin 8-53-80, dated December 22, 1999). The commenter adds that the only difference between the original issue and Revision A is that the number of work hours was not specified in the original issue. The commenter asks that the proposed AD be changed to give credit for using the original issue of the service bulletin. We agree with the commenter and have changed this final rule accordingly.

After careful review of the available data, including the comment noted above, we have determined that air safety and the public interest require the adoption of the rule with the change previously described. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 173 airplanes of U.S. registry that will be affected by this AD.

The actions that are currently required by AD 99-21-09 take between 80 and 100 work hours per airplane (depending on the airplane model) to accomplish, at an average labor rate of $65 per work hour. Required parts are provided by the manufacturer at no cost to the operator. Based on these figures, the cost impact of the currently required actions is estimated to be between $5,200 and $6,500 per airplane.

The additional modification that is required in this AD action will take about 10 work hours per airplane to accomplish, at an average labor rate of $65 per work hour. Required parts will be provided by the manufacturer at no cost to the operator. Based on these figures, the cost impact of the required modification on U.S. operators is estimated to be $112,450, or $650 per airplane.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that is applicable to Eurocopter Model AS332C, L, and L1 helicopters was published in the Federal Register on December 31, 2002 (67 FR 79893). That action proposed to require inspecting the bevel gear for cracks using a borescope within 50 hours TIS, and thereafter at intervals not to exceed 150 hours TIS, for bevel gears with more than 6,600 hours TIS. If a crack was found in the bevel gear, it was proposed that replacing the bevel gear would be required. However, before the final rule was published, we discovered that certain part-numbered bevel gears were omitted from the applicability and one was incorrectly stated in that previous proposal. Also, the manufacturer revised the service information to introduce the new inspection interval of 1,000 cycles for helicopter operations involving a torque application frequency of more than 4 cycles per hour for helicopters that conduct external load operations involving more frequent torque applications. Additionally, we inadvertently included Model AS332C1 helicopters in the “Applicability” section of the proposal—those model helicopters are not on the U.S. Registry. Finally, the DGAC issued a revised AD for helicopters operated in France. Therefore, we reopened the comment period by publishing a supplemental notice of proposed rulemaking on September 18, 2003 (68 FR 54686). That action:

• Corrected the basic bevel gear part number (P/N) stated in the “Applicability” of the proposal to state “332A32-2181-00”;

• Added bevel gear P/Ns 332A32-2181-01 and -08 to the “Applicability”;

• Deleted the Model AS332C1 helicopters from the “Applicability”;

• Incorporated the latest Eurocopter Alert Telex and referenced the latest DGAC AD;

• Proposed requiring the repetitive inspection at intervals not to exceed 150 hours TIS or 1,000 torque cycles, whichever occurs first; and

• Excluded from the “Applicability” any main gearbox (regardless of the P/N of the main reduction gear module or bevel gear) overhauled after December 31, 2002, and any P/N inspected in accordance with AS332 letter to Repair Stations No. 183 or repaired in accordance with Repair Sheet (F.R.) 332A32-2181-ZA or 331A32-3110-ZA.

The Direction Generale De L'Aviation Civile (DGAC), the airworthiness authority for France, notified the FAA that an unsafe condition may exist on Eurocopter Model AS332C, C1, L, and L1 helicopters. The DGAC advises that borescope inspections of the bevel gear are necessary to detect cracks.

Eurocopter has issued Alert Telex No. 05.00.58 R2, dated February 3, 2003, which indicates that as a result of metal particles found on the chip detector of the main gearbox sump on a helicopter, further investigation has revealed a longitudinal crack that grows lengthwise in the shaft, up to the combiner gear, in the bevel gear where the ring retains the pinion toe bearing. The alert telex specifies inspecting the bevel gear for cracks using a borescope, pending the result of the investigation into the cause of the fatigue crack initiation currently being conducted in France. The DGAC classified this alert telex as mandatory and issued AD 2002-424-081(A) R2, dated March 19, 2003, to ensure the continued airworthiness of these helicopters in France.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on the proposal or the FAA's determination of the cost to the public. The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

The FAA estimates that this AD will affect 4 helicopters of U.S. registry, and the required actions will take approximately 4 work hours for the inspections and 16 work hours to replace the bevel gear, if necessary, at an average labor rate of $65 per work hour. Required parts will cost approximately $31,372. Based on these figures, we estimate the total cost impact of the AD on U.S. operators to be $130,688, assuming that upon the first inspection a crack is detected and the bevel gear will need to be replaced.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES .

In FR Doc. 03-32255, appearing on page 255, in the Federal Register of January 5, 2004, the following corrections are made:

1. On page 265, in the third column, the second reference is corrected to read “Lois M. Joellenbeck, Lee L. Zwanziger, Jane S. Durch, and Brian L. Strom, Editors, Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, Medical Follow-Up Agency, The National Academies Press, Washington, DC, April 2002, http://www.nap.edu/catalog/10310.html (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site after this document publishes in the Federal Register ).”

2. On page 266, in the first column, the third reference is corrected to read “Fellows, P. F., M. K. Linscott, B. E. Ivins, M. L. M. Pitt, C. A. Rossi, P. H. Gibbs and A. M. Friedlander, `Efficacy of a Human Anthrax Vaccine in Guinea Pigs, Rabbits, and Rhesus Macaques Against Challenge by Bacillus Anthracis Isolates of Diverse Geographical Origin,' Vaccine , 19(23/24):3241-3247, 2001.”

3. On page 266, in the first column, the fourth reference is corrected to read “Ivins, B. E., P. F. Fellows, M. L. M. Pitt, J. E. Estep, S. L. Welkos, P. L. Worsham and A. M. Friedlander, `Efficacy of a Standard Human Anthrax Vaccine Against Bacillus Anthracis Aerosol Spore Challenge in Rhesus Monkeys,' Salisbury Medical Bulletin 87(Suppl.):125-126, 1996.”

4. On page 266, in the first column, the fifth reference is corrected to read “Ivins, B. E.; M. L. M. Pitt; P. F. Fellows; J. W. Farchaus; G. E. Benner; D. M. Waag; S. F. Little; G. W. Anderson, Jr.; P. H. Gibbs; and A. M. Friedlander, `Comparative Efficacy of Experimental Anthrax Vaccine Candidates Against Inhalation Anthrax in Rhesus Macaques,' Vaccine , 16(11/12):1141-1148, 1998.”

5. On page 266, in the first column, the seventh reference is corrected to read “Wright, G. G.; Green, T. W.; and Kanode, Jr., R. G., `Studies on Immunity in Anthrax: V. Immunizing Activity of Alum-Precipitated Protective Antigen,' Journal of Immunology , 73:387-391, 1954.”

6. On page 266, in the first column, the tenth reference is corrected to read “`Guidance for Industry: How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1)', September 1998, http://www.fda.gov/cber/gdlns/vaers-1.pdf . (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site after this document publishes in the Federal Register ).”

7. On page 266, in the first column, the eleventh reference is corrected to read “`Estimated Vaccination Coverage With 3+DTP Among Children 19-35 Months of Age by Race/Ethnicity,' and by State and Immunization Action Plan Area—U.S., National Immunization Survey, Q3/2000 - Q2/2001, http://www.cdc.gov/nip/coverage/NIS/00-01/tab19-3dpt_race_iap.htm . (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site after this document publishes in the Federal Register ).”

8. On page 266, in the second column, the twelfth reference is corrected to read “Protecting Our Kids: What Is Causing the Current Shortage in Childhood Vaccines?—Testimony Before the Committee on Governmental Affairs, United States Senate, June 12, 2002, http://www.cdc.gov/nip/news/testimonies/vac-shortages-walt-6-12-2002.htm. (FDA has verified the Web site address, but we are not responsible for subsequent changes to the Web site after this document publishes in the Federal Register ).”

Ivy Laboratories, Division of Ivy Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a supplement to ANADA 200-346 for COMPONENT TE-200 (trenbolone acetate and estradiol) with TYLAN, a subcutaneous implant used for increased rate of weight gain and improved feed efficiency in steers fed in confinement for slaughter. The supplemental ANADA provides for the addition of a pellet containing 29 milligrams tylosin tartrate to the approved implant. The supplemental application is approved as of January 9, 2004, and the regulations are amended in 21 CFR 522.2477 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

An electronic copy of this document may be downloaded by using a computer, modem, and suitable communications software from the Government Printing Office's Electronic Bulletin Board Service at (202) 512-1661. Internet users may reach the Office of the Federal Register's Home page at: http://www.archives.gov and the Government Printing Office's Web site at: http://www.gpo.gov.

Over time various legislative or policy changes have made sections of title 23 of the Code of Federal Regulations (CFR) obsolete. This rulemaking will remove several regulations that have become obsolete or redundant as a result of various surface transportation statutes and other pertinent laws. Specifically, we believe that the following regulations must be removed or amended as described in the following section-by-section analysis.

Section 1305 of the Transportation Equity Act for the 21st Century (TEA-21) (Pub. L. 105-178, 112 Stat. 107, June 9, 1998, as amended) repealed former 23 U.S.C. 106(c), which contained the 15 percent limitation previously established for Federal-aid reimbursement of construction engineering costs. The limitation for Federal-aid reimbursement of construction engineering costs was established by section 1018(a) of the Intermodal Surface Transportation Efficiency Act of 1991 (ISTEA) (Pub. L. 102-240, 105 Stat. 1914, December 18, 1991).

On July 22, 1993, the FHWA amended 23 CFR part 140 to conform with section 1018 of the ISTEA. However, section 1305 of the TEA-21 amended 23 U.S.C. 106 by deleting 23 U.S.C. 106(c), “Limitation on Estimates for Construction Engineering,” and substituting a new 23 U.S.C. 106(c), “Assumption by States of Responsibilities of the Secretary.” Therefore, 23 CFR 140, Subpart B, is revised to remove the limitation on construction engineering costs.

However, this subpart is not necessary in order for a State to recover these costs. We have determined that 23 CFR 1.11 allows for the reimbursement of “directly attributable and properly allocable” engineering costs incurred by a State or local transportation department for specific highway construction projects. For State or local transportation departments that have chosen to include construction engineering costs with other overhead costs, section 1212(a) of the TEA-21 amended 23 U.S.C. 302(b) to allow reimbursement of indirect costs through a cost allocation plan approved by the FHWA. Therefore we believe that 23 CFR part 140, Subpart B, is no longer necessary, and may be removed without adversely impacting the ability of the FHWA or the State or local transportation departments to carry out the Federal-aid Highway Program (FAHP).

This subpart is revised to conform with the removal of Part 640, Certification Acceptance. Section 200.13 is removed.

This subpart is revised to conform with the removal of Part 640, Certification Acceptance. Section 630.203 is revised.

This subpart is revised to conform with the removal of Part 640, Certification Acceptance. Section 633.102(c) is removed and reserved.

Prior to 1984, Federal procurement was done using one of two procedures. The military followed the Defense Acquisition Regulations (DAR) while civilian agencies followed the Federal Procurement Regulations (FPR).

In the Office of Federal Procurement Policy Act of 1974 (Pub. L. 93-400, 88 Stat. 796, August 30, 1974), the Congress ordered that a unified procurement system be developed for the Federal government. The Federal Acquisition Regulations System (FARS) was implemented in 1984. The FHWA is required to comply with FARS when the agency directly procures highway-related design or construction services.

The FHWA issued 23 CFR 633, Subpart C, on June 24, 1974, at 39 FR 22418. This subpart deals primarily with supplementary language for the Standard Form 19A (Labor Standards Provisions) which is an obsolete FPR form. Labor Standards provisions are now covered by FARS clauses in 48 CFR 52.222. Additionally, the remaining requirements contained in Subpart C are covered by current FARS clauses. Therefore, 23 CFR part 633, subpart C, and Appendix A to subpart C are removed to avoid any conflict with the FARS.

This subpart is revised to conform with the removal of part 640, Certification Acceptance. Sections 635.103 and 635.124 are amended.

This subpart is revised to conform with the removal of part 640, Certification Acceptance. Section 635.202 is amended.

This subpart is revised to conform with the removal of part 640, Certification Acceptance. Section 635.303 is amended.

This subpart is revised to conform with the removal of part 640, Certification Acceptance. Section 635.405 is amended.

Section 1306(a) of the TEA-21 removed 23 U.S.C. 109(m) which contained the requirement for Interstate maintenance guidelines. Additionally, TEA-21, section 1107 revised 23 U.S.C. 119 to create the Interstate Maintenance Program. Section 116 of the Surface Transportation Assistance Act of 1978 (Pub. L. 95-599, 92 Stat. 2689), codified as 23 U.S.C. 109(m) and 119(b), required the FHWA to issue guidelines that would ensure the Interstate System was being maintained appropriately. The legislation also required that we receive an annual certification from each State transportation department that the Interstate highways within the State were being maintained. However, sections 1306(a) and 1107 of the TEA-21 eliminated the requirements for both Interstate Maintenance guidelines and the annual certification; therefore, 23 CFR part 635, subpart E, is now obsolete and is removed from the regulations. The removal of the Interstate maintenance guidelines and annual certification does not change the States' responsibility for maintenance under 23 CFR 1.27, nor does it affect the FHWA's role in ensuring that adequate maintenance is being performed.

Section 1601 of the TEA-21 eliminated the certification acceptance program implemented by this part; therefore, part 640 is removed from the regulation without adverse impact to the FAHP. For conformity within 23 CFR, references to the certification acceptance program are removed from 23 CFR 200.13, 23 CFR 630.203, 23 CFR 633.102(c), 23 CFR 635.103, 635.124(b), 635.202, 635.303, and 635.405.

Under the Administrative Procedure Act (APA) (5 U.S.C. 553(b)), an agency may waive the prior notice and opportunity for public comment requirements if it finds, for good cause, that the requirements are impracticable, unnecessary, or contrary to the public interest. The issuance of this rule without prior notice and opportunity for public comment is based on the good cause exception in 5 U.S.C. 553(b)(3)(B). Seeking public comment is unnecessary and contrary to the public interest. This action is merely a ministerial action to remove obsolete regulations from the CFR and the removal of these regulations will have no substantive impact. Therefore, the FHWA does not anticipate receiving meaningful comments on a proposal to remove these provisions from the CFR. Prior notice is therefore unnecessary, and it would be contrary to the public interest to delay unnecessarily this effort to eliminate outdated rules. Furthermore, the FHWA believes that because the underlying statutory authority for these regulations no longer exist, we are eliminating any confusion that may be caused by their existence in the CFR.

The APA also allows agencies, upon finding of good cause, to make a rule effective immediately upon publication (5 U.S.C. 533(d)(3)). For the same reasons discussed above, the agency believes good cause exists for making this action effective immediately upon publication.

We have determined that this action is not a significant regulatory action within the meaning of Executive Order 12866 nor is it significant within the meaning of Department of Transportation regulatory policies and procedures. We anticipate that the economic impact of this rulemaking will be minimal. The removal of 23 CFR part 140, subpart B, and 23 CFR part 633, subpart C, eliminates redundancy and the removal of part 635, subpart E, and 23 CFR part 640 conforms with TEA-21. For conformity within the regulations, obsolete references to 23 CFR part 640 are removed from 23 CFR parts 200, 630, 633, and 635.

This final rule will not adversely affect, in a material way, any sector of the economy. In addition, these changes will not interfere with any action taken or planned by another agency and will not materially alter the budgetary impact of any entitlements, grants, user fees, or loan programs.

In compliance with the Regulatory Flexibility Act (RFA) of 1980 (5 U.S.C. 601-612), we have evaluated the effects of this action on small entities and have determined that the action will not have a significant economic impact on a substantial number of small entities. Deletion of these regulations will eliminate redundancy and possible conflicts within the regulations. Administration of Federal-aid highway construction projects by small entities will not be affected by the deletions. For these reasons, we certify that this action would not have a significant economic impact on a substantial number of small entities.

This rule does not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 109 Stat. 48, March 22, 1995) as it will not result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector (2 U.S.C. 1532). This rule simply deletes obsolete and redundant regulatory provisions.

The FHWA has analyzed this rule in accordance with the principles and criteria of Executive Order 13132, dated August 4, 1999. We have determined that this action will not have a substantial direct effect on the States. Since this rule is intended only to remove obsolete or redundant regulations from title 23 of the Code of Federal Regulations, we have determined that this rule does not have federalism implications.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et. seq. ), the FHWA must obtain approval from the Office of Management and Budget (OMB) for each collection of information we conduct, sponsor, or require through regulations. Since we do not seek to collect any information through this rule, the requirements of the PRA do not apply.

We have analyzed this action for the purposes of the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321 et seq. ), and have determined that it would not have any effect on the quality of the environment.

We have analyzed this rule under Executive Order 13175, dated November 6, 2000, and we believe that our action will not have substantial direct effects on one or more Indian tribes; will not impose substantial direct compliance costs on Indian tribal governments; and will not preempt tribal laws. Therefore, a tribal summary impact statement is not required.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use dated May 18, 2001. We have determined that this rule is not a significant energy action under that order since it is not a significant regulatory action under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution or use of energy. Therefore, a Statement of Energy Effects is not required.

This rule meets the applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not economically significant and does not concern an environmental risk to health or safety that might disproportionately affect children.

This rule will not result in a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

Catalog of Federal Domestic Assistance Program Number 20.205, Highway planning and construction. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.

A regulation identification number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You can use the RIN contained in the heading of this document to cross reference this action with the Unified Agenda.

The PBGC's regulations prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits of terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions are intended to reflect current conditions in the financial and annuity markets.

Three sets of interest assumptions are prescribed: (1) A set for the valuation of benefits for allocation purposes under section 4044 (found in Appendix B to Part 4044), (2) a set for the PBGC to use to determine whether a benefit is payable as a lump sum and to determine lump-sum amounts to be paid by the PBGC (found in Appendix B to Part 4022), and (3) a set for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology (found in Appendix C to Part 4022).

Accordingly, this amendment (1) adds to Appendix B to Part 4044 the interest assumptions for valuing benefits for allocation purposes in plans with valuation dates during March 2004, (2) adds to Appendix B to Part 4022 the interest assumptions for the PBGC to use for its own lump-sum payments in plans with valuation dates during March 2004, and (3) adds to Appendix C to Part 4022 the interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using the PBGC's historical methodology for valuation dates during March 2004.

For valuation of benefits for allocation purposes, the interest assumptions that the PBGC will use (set forth in Appendix B to part 4044) will be 4.10 percent for the first 20 years following the valuation date and 5.00 percent thereafter. These interest assumptions are unchanged from those in effect for February 2004.

The interest assumptions that the PBGC will use for its own lump-sum payments (set forth in Appendix B to part 4022) will be 3.00 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. These interest assumptions represent a decrease (from those in effect for February 2004) of 0.25 percent for the period during which a benefit is in pay status and are otherwise unchanged.

For private-sector payments, the interest assumptions (set forth in Appendix C to part 4022) will be the same as those used by the PBGC for determining and paying lump sums (set forth in Appendix B to part 4022).

The PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect, as accurately as possible, current market conditions.

Because of the need to provide immediate guidance for the valuation and payment of benefits in plans with valuation dates during March 2004, the PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

The PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

On August 7, 1992 (57 FR 35006), the Office of Government Ethics published a final rule on Standards of Ethical Conduct for Employees of the Executive Branch. The OGE standards (5 CFR part 2635), which took effect on February 3, 1993, establish uniform ethical conduct standards applicable to all executive branch personnel.

When OGE published the standards, it stated that although most existing individual agency standards of conduct would be superseded when the standards took effect, an agency's standards dealing with outside employment would be preserved for one year or until the agency issued a supplemental regulation, whichever occurred first. (The time period was subsequently extended, but has now expired for the PBGC.)

On January 14, 1993 (58 FR 4318), the PBGC issued a final rule that amended its regulations on the Ethical Conduct of Employees (subpart A of 29 CFR part 2602) by removing all provisions other than those dealing with outside employment. These outside employment provisions, which are now codified at 29 CFR part 4904, have been superseded by OGE's government-wide regulations. Accordingly, the PBGC is removing part 4904 from its regulations.

Because this rule involves agency management and personnel (5 U.S.C. 553(a)(2)), general notice of proposed rulemaking and a delayed effective date are not required (5 U.S.C. 553(b), (d)).

Because no general notice of proposed rulemaking is required, the Regulatory Flexibility Act does not apply (5 U.S.C. 601(2)).

Pursuant to section 4 of the Federal Civil Penalties Inflation Adjustment Act of 1990, 28 U.S.C. 2461 note, as amended by the Debt Collection Improvement Act of 1996, 31 U.S.C. 3701 note, (“DCIA”), each federal agency is required to issue regulations adjusting for inflation the maximum civil monetary penalties that can be imposed pursuant to such agency's statutes. The purpose of these adjustments is to maintain the deterrent effect of CMPs and to further the policy goals of the laws. The DCIA requires adjustments to be made at least once every four years following the initial adjustment. The EPA's initial adjustment to each CMP was published in the Federal Register on December 31, 1996, at (61 FR 69360) and became effective on January 30, 1997.

This rule adjusts the amount for each type of CMP that EPA has jurisdiction to impose in accordance with these statutory requirements. It does so by revising the table contained in 40 CFR 19.4. The table identifies the statutes that provide EPA with CMP authority and sets out the inflation-adjusted maximum penalty that EPA may impose pursuant to each statutory provision. This rule also revises the effective date provisions of 40 CFR 19.2 to make the penalty amounts set forth in 40 CFR 19.4 apply to all applicable violations that occur after the effective date of this rule.

The DCIA requires that the adjustment reflect the percentage increase in the Consumer Price Index between June of the calendar year preceding the adjustment and June of the calendar year in which the amount was last set or adjusted. The DCIA defines the Consumer Price Index as the Consumer Price Index for all urban consumers published by the Department of Labor (“CPI-U”). As the initial adjustment was made and published on December 31, 1996, the inflation adjustment for the CMPs set forth in this rule was calculated by comparing the CPI-U for June 1996 (156.7) with the CPI-U for June 2003 (183.7), resulting in an inflation adjustment of 17.23 percent. In addition, the DCIA's rounding rules require that an increase be rounded to the nearest multiple of: $10 in the case of penalties less than or equal to $100; $100 in the case of penalties greater than $100 but less than or equal to $1,000; $1,000 in the case of penalties greater than $1,000 but less than or equal to $10,000; $5,000 in the case of penalties greater than $10,000 but less than or equal to $100,000; $10,000 in the case of penalties greater than $100,000 but less than or equal to $200,000; and $25,000 in the case of penalties greater than $200,000.

The amount of each CMP was multiplied by 17.23 percent (the inflation adjustment) and the resulting increase amount was rounded up or down according to the rounding requirements of the statute. Certain CMPs were adjusted for the first time and were increased by only 10 percent without being subject to the rounding procedures as required by the DCIA. The table below shows the inflation-adjusted CMPs and includes only the CMPs as of the effective date of this rule. EPA intends to readjust these amounts in the year 2008 and every four years thereafter, assuming there are no further changes to the mandate imposed by the DCIA.

On June 18, 2002, the EPA published a direct final rule and a parallel proposed rule in the Federal Register (67 FR 41343). The direct final rule would have amended the Civil Monetary Penalty Inflation Adjustment Rule, as mandated by the DCIA, to adjust EPA's civil monetary penalties for inflation. EPA stated in the direct final rule that if we received adverse comment by July 18, 2002, EPA would publish a timely notice of withdrawal on or before the August 19, 2002 effective date, and then address that comment in a subsequent final action based on the parallel proposal published at (67 FR 41363). EPA subsequently received one adverse comment on the direct final rule from the General Accounting Office (“GAO”), which asserted that EPA had misinterpreted the rounding formula provided in the DCIA. Accordingly, EPA withdrew the direct final rule on August 19, 2002 (67 FR 53743).

The formula for the amount of the penalty adjustment is prescribed by Congress in the DCIA and these changes are not subject to the exercise of discretion by EPA. However the rounding requirement of the statute is subject to different interpretations. Some agencies rounded the increase based on the amount of the current penalty before adjustment, while other agencies have rounded the increase based on the amount of the increase resulting from the CPI percentage calculation. Still other agencies first added the CPI increase to the amount of the current penalty and then rounded the total based on the amount of the increased penalty. The penalties in EPA's direct final rule were rounded based on the amount of the increase resulting from the CPI percentage increase because this approach appears to achieve the intent of the DCIA by steadily tracking the CPI over time. However, the GAO's adverse comment asserts that a strict reading of the DCIA requires rounding the CPI increase based on the amount of the current penalty before adjustment.

On July 3, 2003, EPA published a proposed rule that appeared in the Federal Register at (68 FR 39882), entitled “Civil Monetary Penalty Inflation Adjustment Rule,” as mandated by the Debt Collection Improvement Act of 1996, to adjust EPA's civil monetary penalties for inflation on a periodic basis. EPA subsequently published a technical correction in the Federal Register on August 4, 2003 at (68 FR 45788) to correct errors in the language of the proposal that mistakenly referred to the proposed effective date as July 3, 2003. EPA proposed to adopt GAO's interpretation of the DCIA rounding rules and, thus, proposed to round the CPI increases in the proposed rule based on the amount of the current penalty before adjustment.

In accordance with the DCIA, EPA's proposed rule used the CPI-U from June 2002 to calculate the penalty adjustments. EPA also stated in the proposal that it intends to use this formula for calculating future adjustments to the CMPs and will not provide additional comment periods at the time future adjustments are made. EPA received comments on the proposed rule from two commenters.

One commenter supported the “greatest legal increase possible” to discourage polluters from treating the fines as just a “cost of doing business.” This final rule enables EPA to impose the maximum fines provided under the law, but is not intended to address when a maximum fine is appropriate. Instead, EPA makes that decision on a case-by-case basis, and considers numerous factors in determining the appropriate penalty in each case, including the gravity of the violation and the extent to which the violator gained an economic benefit as a result of violating the law.

Another commenter argued that any ambiguity in the rounding requirement of the statute was due to a “scrivener's error.” This commenter supported an interpretation that penalties be rounded based on the amount of the increase resulting from the CPI adjustment, rather than the amount of the penalty. However, we determined after carefully considering GAO's comment and examining the practices of other agencies, that following the plain meaning of the statutory language is appropriate. As GAO's adverse comment states “[n]othing in the plain language of the statute, nor the legislative history, permits an agency to use the size of the increase to determine the appropriate category of rounding.” This commenter also noted that EPA had not published this second round of adjustments within four years of the initial adjustments as set forth in the statute. EPA's earlier direct final rulemaking was delayed due to EPA's need to analyze and reconcile the potential ambiguities arising from the statutory language including review of other agencies rulemakings under DCIA and discussions with other agencies regarding their approaches to interpreting the DCIA. Prior to GAO's involvement in the process, no federal agency had assumed a leadership in providing guidance on how the DCIA rounding rule should be implemented. Since the time that GAO became involved in the process, including the submission of its adverse comment on EPA's direct final rule, EPA has worked with GAO and other agencies to resolve the appropriate interpretation of the statutory language. Finally, the commenter also suggested that all of the penalties should be adjusted from their original base and not their adjusted base. The statute does not provide for a return to the original base penalty in calculating the adjustment but provides that the adjustment “shall be determined by increasing the maximum civil penalty * * * by the cost-of-living adjustment.”

As discussed above, EPA's proposed rule used the CPI-U from June 2002 because EPA proposed the rule in 2003. However, since EPA is issuing the final rule in 2004 and DCIA requires EPA to use the CPI-U for June of the calendar year preceding the adjustment, the penalty adjustments in this final rule use the CPI-U for June 2003 which result in an inflation adjustment of 17.23 percent rather than the 14.8 percent adjustment in the proposed rule. Thus, to derive the CMPs for this final rule, the amount of each CMP was multiplied by 17.23 percent and the resulting increase was rounded according to the rounding rules of DCIA as EPA proposed and is adopting in this final rule. As a result of using the June 2003 CPI-U, some of the adjusted CMPs in this final rule are different than those in the July 2003 proposed rule. However, this difference results solely from the requirement in DCIA to use the June 2003 CPI-U and application of the same rounding rules that EPA proposed in July 2003.

Under 5 U.S.C. 553(b)(B), EPA finds that there is good cause to promulgate this rule without providing for further public comment even though the rule uses a CPI-U value different than the CPI-U value used in the proposal. EPA already provided an opportunity for public comment on the rounding rules that EPA has used in this final rule and the DCIA requires that an agency use the CPI-U from June of the year prior to the adjustment. Therefore, further public comment is unnecessary because EPA has no discretion to do other than to use the June 2003 CPI-U.

Under Executive Order 12866, [58 FR 51,735 (October 4, 1993)] the Agency must determine whether the regulatory action is “significant” and therefore subject to OMB review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1) have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities;

(2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

It has been determined that this rule is not a “significant regulatory action” under the terms of Executive Order 12866, and is therefore not subject to review by the Office of Management and Budget.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ). Burden means the total time, effort, financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

The Regulatory Flexibility Act, as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq. , generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as (1) a small business as defined in the Small Business Administration regulations at 13 CFR Part 121; (2) a small governmental jurisdiction that is a government of a city, county, town school district, or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. EPA is required by the DCIA to adjust civil monetary penalties for inflation. The formula for the amount of the penalty adjustment is prescribed by Congress and is not subject to the exercise of discretion by EPA. EPA's action implements this statutory mandate and does not substantively alter the existing regulatory framework. This rule does not affect mechanisms already in place, including statutory provisions and EPA policies, that address the special circumstances of small entities when assessing penalties in enforcement actions.

Although this rule will not have a significant economic impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this rule on small entities. Small entities may be affected by this rule only if the federal government finds them in violation and seeks monetary penalties. EPA's media penalty policies generally take into account an entity's “ability to pay” in determining the amount of a penalty. Additionally, the final amount of any civil penalty assessed against a violator remains committed to the discretion of the federal judge or administrative law judge hearing a particular case.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “federal mandates” that may result in expenditures to state, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed a small government agency plan under section 203 of the UMRA. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

This rule contains no federal mandates (under the regulatory provisions of Title II of the UMRA) for state, local, or tribal governments or the private sector because the rule implements mandate(s) specifically and explicitly set forth by the Congress without the exercise of any policy discretion by EPA. Thus, this rule is not subject to the requirements of sections 202 and 205 of the UMRA. EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments.

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in executive Order 13132. Thus, Executive Order 13132 does not apply to this rule.

Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” As this rule will not have substantial direct effects on tribal governments, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, Executive Order 13175 does not apply to this rule.

Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be “economically significant” as defined under E.O. 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. EPA interprets E.O. 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Order has the potential to influence the regulation. This rule is not subject to E.O. 13045 because it does not establish an environmental standard intended to mitigate health or safety risks. Because this action does not involve technical standards, EPA did not consider the use of any voluntary consensus standards under the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note).

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

Section 12(d) of the National Technology Transfer Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This rulemaking does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards. Because this action does not involve technical standards, EPA did not consider the use of any voluntary consensus standards under the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note).

This action does not require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

The Congressional Review Act, 5 U.S.C. § 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

1. The Regional Office has established an official public rulemaking file available for inspection at the Regional Office. EPA has established an official public rulemaking file for this action under FL-91. The official public file consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public rulemaking file does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public rulemaking file is the collection of materials that is available for public viewing at the Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the contact listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 9 to 3:30, excluding Federal holidays.

2. Copies of the State submittal and EPA's technical support document are also available for public inspection during normal business hours, by appointment, at the State Air Agency. Florida Department of Environmental Protection, Twin Towers Office Building, 2600 Blair Stone Road, Tallahassee, Florida 32399-2400.

3. Electronic Access. You may access this Federal Register document electronically through the Regulation.gov Web site located at http://www.regulations.gov where you can find, review, and submit comments on Federal rules that have been published in the Federal Register , the Government's legal newspaper, and are open for comment.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing at the EPA Regional Office, as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in the official public rulemaking file. The entire printed comment, including the copyrighted material, will be available at the Regional Office for public inspection.

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate rulemaking identification number by including the text “Public comment on proposed rulemaking FL-91” in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

1. Electronically. If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD-ROM you submit, and in any cover letter accompanying the disk or CD-ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

i. E-mail. Comments may be sent by electronic mail (e-mail) to lesane.heidi@epa.gov . Please include the text “Public comment on proposed rulemaking FL-91“ in the subject line. EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly without going through Regulations.gov, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

ii. Regulation.gov. Your use of Regulation.gov is an alternative method of submitting electronic comments to EPA. Go directly to Regulations.gov at http://www.regulations.gov , then select Environmental Protection Agency at the top of the page and use the go button. The list of current EPA actions available for comment will be listed. Please follow the online instructions for submitting comments. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

iii. Disk or CD-ROM. You may submit comments on a disk or CD-ROM that you mail to the mailing address identified in Section 2, directly below. These electronic submissions will be accepted in WordPerfect, Word or ASCII file format. Avoid the use of special characters and any form of encryption.

2. By Mail. Send your comments to: Heidi LeSane, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. Please include the text “Public comment on proposed rulemaking FL-91” in the subject line on the first page of your comment.

3. By Hand Delivery or Courier. Deliver your comments to: Heidi LeSane, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, 12th floor, U.S. Environmental Protection Agency Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are only accepted during the Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday through Friday, 9 to 3:30 excluding Federal holidays.

Do not submit information that you consider to be CBI electronically to EPA. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD-ROM, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the official public regional rulemaking file. If you submit the copy that does not contain CBI on disk or CD-ROM, mark the outside of the disk or CD-ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public file and available for public inspection without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the FOR FURTHER INFORMATION CONTACT section.

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at your estimate.

5. Provide specific examples to illustrate your concerns.

6. Offer alternatives.

7. Make sure to submit your comments by the comment period deadline identified.

8. To ensure proper receipt by EPA, identify the appropriate regional file/rulemaking identification number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.

The air quality maintenance plan is a requirement of the 1990 CAA for nonattainment areas that come into compliance with the national ambient air quality standard (NAAQS). The Southeast Florida area (Dade, Broward, and Palm Beach Counties) were not in compliance with the 1-hour ozone air quality standard until 1990, when air quality measurements showed compliance with the standard. The State subsequently requested that EPA redesignate these counties as attainment/maintenance for the 1-hour ozone standard. Included with this request was a 10-year air quality maintenance plan covering the years 1995 to 2005. This plan was developed in accordance with the appropriate guidelines. The EPA published approval of this plan on February 24, 1995, and it became effective on April 25, 1995 (60 FR 10325).

Subsequent revisions to this maintenance plan were made. The Florida Department of Environmental Protection (FDEP) revised the original plan to update emissions inventories reflecting more accurate emission estimates, to define specific MVEBs, to remove emissions reduction credits attributable to the motor vehicle inspection program (MVIP) (66 FR 40137), and to provide sub-area MVEBs for the three maintenance counties in Southeast Florida (63 FR 56568). The current plan was approved by EPA on August 2, 2001, and became effective on September 4, 2001 (66 FR 40137).

On December 20, 2002, the FDEP submitted revisions to Florida SIP to provide a 10-year extension to the maintenance plan as required by section 175A(b) of the CAA as amended in 1990. The underlying strategy of the maintenance plan is to maintain compliance with the 1-hour ozone standard by assuring that current and future emissions of volatile organic compounds (VOC) and nitrogen oxides (NO X ) remain at or below attainment year emission levels. The estimated emissions of ozone precursors ( i.e. ,VOC and NO X ) for the three counties for the Southeast Florida area during the 1990 ozone season are provided in the following table. Projected VOC and NO X emissions for 2005 and 2015 are also provided.

This SIP revision satisfies the requirement of the CAA for the second 10-year update for the Southeast Florida area 1-hour ozone maintenance plan. Changes to the current maintenance plan include revisions to the emissions inventory for both on-road and non-road mobile sources, reflecting improved methodologies contained in the MOBILE6 and NONROAD emission models. New emissions data for both the base year (attainment year) and the projected years (2005 and 2015) are calculated.

The second 10-year update for the Southeast Florida area 1-hour ozone maintenance plan also contains updated MVEBs in support of the transportation conformity process. These updated MVEBs are defined for volatile organic compounds (VOC) and nitrogen oxides (NO X ) for each county in the Southeast Florida maintenance area. The updated budgets for 2005 replace the previous MVEBs contained in the first maintenance plan, which were based on an older emissions estimate using MOBILE5 emission factors for on-road motor vehicles. Additionally, this maintenance plan update provides new MVEBs for the year 2015.

The availability of the SIP with MVEBs for 2015 was placed on EPA's adequacy Web page on January 7, 2003. No request for this SIP submittal or adverse comments were received by the end of the public comment period on February 7, 2003. In this action, EPA finds the 2015 MVEBs adequate for transportation conformity, and is approving the MVEBs for 2005 and 2015. Note, since the 2005 MVEBs are replacing existing 2005 MVEBs, these budgets are not subject to EPA's adequacy process. This is because EPA generally will not review the adequacy of a budget from a submitted SIP that revises an existing approved SIP with budgets for the same year and CAA requirement (68 FR 38974).

Under the CAA, States are required to submit, at various times, control strategy SIPs and maintenance plans in ozone areas. These control strategy SIPs ( e.g. reasonable further progress SIPs and attainment demonstration SIPs) and maintenance plans create MVEBs for criteria pollutants and/or their precursors to address pollution from cars and trucks. The MVEBs are the portion of the total allowable emissions that is allocated to highway and transit vehicle use and emissions. The MVEBs serve as a ceiling on emissions from an area's planned transportation system. The MVEB concept is further explained in the preamble to the November 24, 1993, transportation conformity rule (58 FR 62188). The preamble also describes how to establish the MVEBs in the SIP and revise the MVEBs.

Under section 176(c) of the CAA, new transportation projects, such as the construction of new highways, must “conform” to ( e.g. be consistent with) the part of the State's air quality plan that addresses pollution from cars and trucks. “Conformity” to the SIP means that transportation activities will not cause new air quality violations, worsen existing violations, or delay timely attainment of the national ambient air quality standards. If a transportation plan does not “conform,” most projects that would expand the capacity of roadways cannot go forward. Regulations at 40 CFR part 93 set forth EPA policy, criteria, and procedures for demonstrating and assuring conformity of such transportation activities to a SIP.

When reviewing submitted “control strategy” SIPs or maintenance plans containing MVEBs, EPA must affirmatively find the MVEBs contained therein are “adequate” for use in determining transportation conformity. Once EPA affirmatively finds the submitted MVEBs are adequate for transportation conformity purposes, that MVEB can be used by the State and Federal agencies in determining whether proposed transportation projects “conform” to the State implementation plan as required by section 176(c) of the Clean Air Act. EPA's substantive criteria for determining “adequacy” of MVEBs are set out in 40 CFR 93.118(e)(4).

EPA's process for determining “adequacy” consists of three basic steps: public notification of a SIP submission, a public comment period, and EPA's adequacy finding. This process for determining the adequacy of submitted SIP MVEBs is set out in EPA's May 14, 1999 guidance, “Conformity Guidance on Implementation of March 2, 1999, Conformity Court Decision”. This guidance is incorporated into EPA's June 30, 2003, EPA proposed rulemaking entitled “Transportation Conformity Rule Amendments: Response to Court Decision and Additional Rule Changes” (68 FR 38974). EPA follows this guidance in making its adequacy determination.

Specific emissions budget is defined for VOC and NO X for the Southeast Florida area in the Florida submittal. Pursuant to 40 CFR 93.124(d), Southeast Florida has elected to allocate subarea budgets for each of the counties for the purpose of transportation conformity. The specific MVEBs for Dade County in 2005 and 2015 are 74.6 tpd for VOC and 127.5 tpd for NO X . Broward County's MVEB for 2005 and 2015 are 66.1 tpd for VOC and 113 tpd for NO X . Palm Beach County's MVEB for 2005 and 2015 are 49.5 tpd for VOC and 84.6 tpd for NO X . With this allocation, each county must demonstrate conformity to the county-specific subarea budgets. The chart below provides a summary of the county-specific subarea budgets.

The MVEBs are defined for each Southeast Florida county, for 2005 and 2015, in the State's submittal. The values, for both years, are equal to the 2005 on-road mobile source projected level of emissions plus a buffer of 25 percent. This buffer, which is an allocation from the safety margin, accounts for uncertainty in the projections and is available because of significant reductions of VOC and NO X that have occurred, and are projected to occur, primarily from mobile sources. The MVEBs are constrained in each of the budget years to assure that the total emissions ( i.e. , all source categories) do not exceed the 1990 attainment year emissions. In no case are the projected total emissions from mobile sources for any year, greater than the attainment year emissions totals for either VOC or NO X .

Under 40 CFR 93.101, the term safety margin is the difference between the attainment level (from all sources) and the projected level of emissions (from all sources) in the maintenance plan. The attainment level of emissions is the level of emissions during one of the years in which the area met the air quality health standard. The safety margin credit can be allocated to the transportation sector, however the total emission level must stay below the attainment level.

EPA is approving the second 10-year update for the Southeast Florida area 1-hour ozone maintenance plan. In this action, EPA also finds the 2015 MVEBs adequate for transportation conformity purposes and is approving the MVEBs for 2005 and 2015. EPA's adequacy determination for the 2015 MVEBs is based on EPA's finding that the substantive criteria for determining adequacy of a MVEB, under 40 CFR 93.118(e)(4), have been met. The MVEBs will be available for use upon the effective date of this action. The MVEBs, based on the on-road mobile sources, are to be used by the local metropolitan planning organizations and transportation authorities to assure that transportation plans, programs, and projects are consistent with, and conform to, the long term maintenance of acceptable air quality in the Southeast Florida area.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective April 13, 2004 without further notice unless the Agency receives adverse comments by March 15, 2004.

If the EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on April 13, 2004 and no further action will be taken on the proposed rule. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under State law and does not impose any additional enforceable duty beyond that required by State law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 13, 2004. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

On December 30, 2003 (68 FR 75191), EPA published a notice of proposed rulemaking (NPR) for the State of Maryland. The NPR proposed approval of revisions to the Baltimore area's ROP plan for 2005. The revisions update the plan's mobile emissions inventories and 2005 MVEBs to reflect the use of MOBILE6, an updated model for calculating mobile emissions of ozone precursors. The NPR also proposed approval of revisions which amend the contingency measures associated with the Baltimore area's 2005 ROP plan. These SIP revisions were proposed under a procedure called parallel processing, whereby EPA proposes a rulemaking action concurrently with a state's procedures for amending its SIP. The State's proposed SIP revisions were submitted to EPA on November 3, 2003, by the Maryland Department of the Environment (MDE). On December 30, 2003 (68 FR 75191), EPA proposed approval of Maryland's November 3, 2003, submittal. No comments were received during the public comment period on EPA's December 30, 2003, proposal. The MDE formally submitted the final SIP revisions on December 23, 2003. That final submittal had no substantive changes from the proposed version submitted on November 3, 2003. A detailed description of Maryland's submittal and EPA's rationale for its proposed approval were presented in the December 30, 2003, NPR and will not be restated in their entirety here.

Maryland's December 23, 2003, SIP revisions consist of revised 1990 and 2005 motor vehicle emissions inventories and 2005 MVEBs calculated using the MOBILE6 motor vehicle emissions model. Consistent with EPA's “Policy Guidance on the Use of MOBILE6 for SIP Development and Transportation Conformity,” MDE has demonstrated that the new levels of motor vehicle emissions calculated using MOBILE6 continue to demonstrate the required ROP for the Baltimore area by 2005. In addition to the revised motor vehicle emissions, MDE reallocated some of the contingency measures established in prior SIP revisions to the control measures portion of the 2005 ROP plan. EPA guidance allows States an additional year to adopt new contingency measures to replace those reallocated to the control measures portion of the plan. The State of Maryland's December 23, 2003, SIP revision submittal includes an enforceable commitment to replace those contingency measures reallocated to the control measures portion of the plan and to submit an updated plan reflecting these additional contingency measures by October 31, 2004.

The revised mobile inventories and MVEBs being approved for the Baltimore area's 2005 ROP Plan are shown in tons per day (tpd) in Tables 1 and 2, respectively.

Under section 111 of the Clean Air Act (CAA), EPA is authorized to establish new source performance standards (NSPS), which impose Federal technology-based requirements on new and modified stationary sources of pollution. EPA has developed NSPS standards for numerous source categories, which are published at 40 CFR parts 60 and 62. Although EPA has responsibility for implementing and enforcing the NSPS regulations, section 111(c) authorizes EPA to delegate primary implementation and enforcement responsibility to State and local agencies that develop and submit to EPA procedures for implementing and enforcing the NSPS where EPA determines that such procedures are adequate. Even where EPA has delegated primary responsibility for the NSPS to a State or local agency, however, EPA retains concurrent authority to enforce the NSPS. See CAA sections 111(c)(2) and 113.

Ecology, BCAA, ORCAA, NWAPA, PSCAA, SCAPCA and SWCAA have had delegation of various NSPS for more than a decade. YRCAA had delegation of early NSPS standards in the 1970s, but has not requested delegation of new or revised standards since that time. In the last two years, all of these Washington agencies requested delegation based on implementation of State or local rules that adopt by reference more current Federal NSPS. EPA approved these requests because these agencies meet the requirements for delegation.

The delegations discussed today are for new and revised NSPS effective on or before the dates specified below and in the table at the end of this notice. These dates vary by State or local agency and NSPS subpart.

The delegation of the Federal NSPS to Ecology and the local air agencies is subject to the terms and conditions contained in the letters from EPA granting the delegation. The letter from EPA granting delegation of the identified NSPS standards to Ecology reads as follows. Note that the version of Attachment A reprinted below is a revised version that accompanied that letter from EPA granting delegation to YRCAA and shows the most current delegation status for Washington air authorities.

The terms and conditions of the letters delegating authority to BCAA, NWAPA, ORCAA, PSCAA, SCAPCA, SWCAA, and YRCAA including Attachments A and B to the letters, are the same in the Ecology delegation letter with the following exceptions:

a. The NSPS delegated and the dates of the NSPS that are delegated vary. Attachment A to the Ecology letter identifies the NSPS subparts delegated to each agency and the date of the NSPS.

b. Only PSCAA, along with Ecology, has delegation of authority over sources and activities on non-trust land within the 1873 Survey Area of the Puyallup Indian Reservation.

c. Based on an opinion letter from an attorney for PSCAA, EPA has determined that the restriction on the issuance of civil penalties in Chapter 43.05 of the Revised Code of Washington (RCW), often referred to as “House Bill 1010,” does not apply to local air authorities in Washington.

Copies of the delegation letters can be obtained by contacting EPA at the address above.

The letters granting delegation to these State and local air agencies specify that the updated delegations of the identified NSPS are effective November 20, 2001 for Ecology, BCAA, and SWCAA; February 5, 2002 for ORCAA; February 5, 2003, for NWAPA, PSCAA, and SCAPCA; and December 15, 2003, 2003, for YRCAA. The letters specified that the delegations were effective immediately as of the signature date of the letters and that if the recipient agency did not agree to the terms of the delegation, they could submit a written Notice of Objection within 10 days of the receipt of the letter and EPA would withdraw delegation. No agency submitted a Notice of Objection.

All reports required to be submitted to EPA pursuant to the Federal NSPS from sources located within Washington, except for sources in Indian Country  1 and sources regulated by the EFSEC, should be submitted to Ecology or the local agency that has delegation for the relevant NSPS standard at the address set forth in 40 CFR 60.4(b)(WW). All reports required to be submitted pursuant to the Federal NSPS from sources located in Indian Country in Washington and sources regulated by the EFSEC should be submitted to EPA Region 10, Director, Office of Air Quality, OAQ-107, 1200 Sixth Avenue, Seattle, WA 98101.

EPA is notifying the public of recent updates to NSPS delegations for Ecology, BCAA, NWAPA, ORCAA, PSCAA, SCAPCA, SWCAA, and YRCAA. These actions are already final and were granted by letters from the Director, Office of Air Quality, EPA, Region 10, to the air program directors at Ecology, BCAA, NWAPA, ORCAA, PSCAA, SCAPCA, SWCAA, and YRCAA. These delegations are subject to all EPA policy, guidance and determinations issued pursuant to 40 CFR Part 60 and to the conditions in the letters granting the delegation.

The table in paragraph 40 CFR 60.4(b)(WW)(ix) is being revised to show the specific NSPS subparts delegated to each Washington air agency. The names and addresses of the delegated Washington State and local air agencies are also being revised to reflect current information.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). The Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). This rule does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 13, 2004. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Under section 111 of the Clean Air Act (CAA), EPA is authorized to establish new source performance standards (NSPS), which impose Federal technology-based requirements on new and modified stationary sources of pollution. EPA has developed NSPS standards for numerous source categories, which are published at 40 CFR parts 60 and 62. Although EPA has responsibility for implementing and enforcing the NSPS regulations, section 111(c) authorizes EPA to delegate primary implementation and enforcement responsibility to State and local agencies that develop and submit to EPA procedures for implementing and enforcing the NSPS where EPA determines that such procedures are adequate. Even where EPA has delegated primary responsibility for the NSPS to a State or local agency, however, EPA retains concurrent authority to enforce the NSPS. See CAA sections 111(c)(2) and 113.

ODEQ has had delegation of various NSPS since 1976. In letters dated March 10, 2003 and August 26, 2003, ODEQ requested an updated delegation based on implementation of State rules that adopt by reference more current Federal NSPS. EPA approved these requests because ODEQ meets the requirements for delegation. The delegation discussed today is for new and revised NSPS effective on or before July 1, 2002.

The delegation of the Federal NSPS to ODEQ is subject to the terms and conditions contained in the following letter dated December 15, 2003 from EPA granting the delegation:

The letter granting delegation to ODEQ specifies that the updated delegation of the identified NSPS is effective December 15, 2003. The letter specifies that the delegation was effective immediately as of the signature date of the letter and that if ODEQ did not agree to the terms of the delegation, ODEQ could submit a written Notice of Objection within 10 days of the receipt of the letter and EPA would withdraw delegation. ODEQ did not submit a Notice of Objection.

All reports required to be submitted to EPA pursuant to the Federal NSPS from sources located within Oregon, except for sources in Indian Country and in Lane County, should be submitted to ODEQ. All reports required to be submitted pursuant to the Federal NSPS from sources located in Indian Country in Oregon should be submitted to EPA Region 10, Director, Office of Air Quality, OAQ-107, 1200 Sixth Avenue, Seattle, WA 98118. All reports required to be submitted pursuant to the Federal NSPS for sources located in Lane County should be submitted to Lane Region Air Pollution Control Authority (LRAPA) if the federal NSPS standard has been delegated to LRAPA and to EPA Region 10 in all other cases. The current delegation to LRAPA is discussed in 48 FR 8570 (March 1, 1983), as corrected by 48 FR 16740 (April 19, 1983).

EPA is notifying the public of a recent update to the NSPS delegation for ODEQ. This action is already final and was granted by a letter from the Director, Office of Air Quality, EPA, Region 10, to Air Quality Division Administrator for ODEQ. This delegation is subject to all EPA policy, guidance and determinations issued pursuant to 40 CFR part 60 and to the conditions in the letter granting the delegation.

The addresses of the delegated agencies in Oregon are being revised to reflect current information.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). The Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). This rule does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 13, 2004. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307(b)(2).)

Use of the Colitag TM method approved in this action is voluntary. If, however, it is used to support compliance monitoring, then compliance with the procedures specified in the method is required.

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your facility is regulated by this action, you should carefully examine the applicability criteria in § 141.21 of title 40 the Code of Federal Regulations (CFR). If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

1. EPA has established an official public docket for this action under Docket ID No. OW-2002-0031. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Water Docket in the EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Water Docket is (202) 566-2426. If you would like to schedule an appointment for access to docket materials, please call (202) 566-2426.

2. You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publically available docket materials through the docket facility identified in section I.B.1. Once in the system, select “search,” then key in the appropriate docket identification number.

The Safe Drinking Water Act (SDWA), as amended in 1996, requires EPA to promulgate national primary drinking water regulations (NPDWRs) which specify maximum contaminant levels (MCLs) or treatment techniques for drinking water contaminants (SDWA section 1412 (42 U.S.C. 300g-1)). NPDWRs apply to public water systems pursuant to SDWA section 1401 (42 U.S.C. 300f(1)(A)). According to SDWA section 1401(1)(D), NPDWRs include “criteria and procedures to assure a supply of drinking water which dependably complies with such maximum contaminant levels; including accepted methods for quality control and testing procedures.” In addition, SDWA section 1445(a) authorizes the Administrator to establish regulations for monitoring to assist in determining whether persons are acting in compliance with the requirements of the SDWA. EPA's promulgation of analytical methods is authorized under these sections of the SDWA, as well as the general rulemaking authority in SDWA section 1450(a), (42 U.S.C. 300j-9(a)).

In this final rule, EPA is approving the Colitag  TM method for compliance monitoring of total coliforms and E. coli in drinking water. The action taken in this final rule was first proposed in the Federal Register published on March 7, 2002 (67 FR 10532). In October 2002, EPA decided to evaluate additional clarifying information from the developer of the Colitag  TM method, CPI International, and indicated such in the Federal Register notice on October 29, 2002 (67 FR 65888, 65891). EPA did not take final action on this method at that time and stated that all comments relating to the Colitag  TM method would be responded to in a future action.

EPA published a Federal Register Notice of Data Availability (NODA) on December 2, 2002 (67 FR 71520) to provide additional information concerning the results of studies that evaluated the comparability between Colitag  TM and the approved reference methods. The additional information in the NODA described the performance of the method, including additional analysis by EPA of the data in the original record associated with the March 2002 proposal, and included data from two additional studies.

Based on the evaluation of the comparability data generated for the Colitag  TM method, and taking into consideration the public comments received, EPA has concluded that the Colitag  TM method is acceptable as an alternative to the approved reference methods because the information available to EPA indicates that the performance of the Colitag method compares favorably to the approved reference methods. The Colitag  TM method was compared to Standard Method 9222B for total coliforms and to Standard Method 9222D for E. Coli (reference 1 in the table at § 141.21). EPA assessed the quality and quantity of the data provided by CPI International ( i.e. , data provided to support EPA's original evaluation of the Colitag  TM method and the additional clarifying information cited in the December 2, 2002, NODA) and conducted a thorough statistical analysis of relevant data, all of which was included in the public record.

As part of this assessment, EPA performed an extensive review of the information from each of the ten sets of method comparability studies, including the data sheets available from the independent laboratory that performed the total coliforms and E. coli analyses for the studies. EPA also addressed the following key issues as part of this process: adherence to the protocol used in the Agency's Alternate Test Procedure (ATP) program; adequacy of the stress applied to the target microorganisms prior to testing using the Colitag  TM method; and the time that elapsed between chlorine stressing and comparability test completion. As discussed later in “Summary of Comments,” each was addressed to EPA's satisfaction.

The full title of the Colitag  TM method approved in this action and how to obtain a copy of the method are being added to the table at § 141.21(f)(3), at footnote 15. The full title was included in the discussion of the method detailed in the proposal to this regulation, published in the Federal Register on March 7, 2002 (67 FR 10532).

EPA received five sets of comments related to the Colitag  TM method in response to the March 2002 proposal and received eight sets of comments in response to the December 2002 NODA. Four of the eight sets of NODA comments were from those who had also commented on the proposal; thus, in total, EPA received comments from nine commenters. Based on EPA's review of the comments, the Agency believes that today's action is warranted. Detailed responses to comments are contained in “Public Comment and Responses for the National Primary and Secondary Drinking Water Regulations: Approval of Colitag  TM for Compliance Monitoring of total coliforms and E. coli in Finished Drinking Water” which is available in Docket ID No. OW-2002-0031. See section I.B.1 (How Can I Get Copies Of Related Information?) for information on contacting the official public docket.

All comments are addressed in the aforementioned document. Three specific comment subjects are discussed as follows: (1) Adherence to the protocol used in the Agency's Alternate Test Procedures (ATP) program; (2) the adequacy of the stress applied to the target microorganisms prior to testing the Colitag  TM method; and (3) the time elapsed between chlorine stressing and the comparability study ( i.e. , “hold time”).

The ATP protocol that guided the Colitag  TM method comparability testing is titled “Protocol for Alternate Test Procedures for Coliform Bacteria in Compliance With Drinking Water Regulations,” published in 1995. The protocol is not a rule and is not mandatory in nature. Rather, EPA established the guidelines in the protocol to encourage the collection of adequate information for the Agency's evaluation of a new method ( i.e. , to allow the Agency to determine the comparability between the new method and the reference method). Keeping that objective in mind, EPA notes that it has exercised a degree of flexibility in the application of the guidance. While EPA believes that those who follow the protocol guidelines increase the likelihood that the Agency will have sufficient information on which to base an approval decision, EPA notes that following the guidelines precisely does not guarantee method approval. Similarly, deviation from the guidelines does not preclude EPA from considering a method for approval. EPA considers all information submitted and, when there is a question or concern ( e.g. , when there is a suggestion that some information was not collected precisely in accordance with the guidance), EPA generally considers the underlying issue that the protocol was designed to address. Where the Agency has concluded that adequate information is available to judge a particular issue, it has proceeded with the evaluation of the method; this approach has been reflected in EPA's past evaluation of numerous methods, including currently approved methods for the measurement of total coliforms and E. coli.

With respect to the comparability study tests to determine if Colitag  TM could adequately recover damaged total coliforms and E. coli, EPA experts evaluated the chlorine stress that was applied to the test bacteria and concluded that such bacteria had been adequately stressed. Consistent with the approach described above, EPA's microbiologists considered the underlying issue ( i.e. , “Can the Colitag  TM method adequately recover and detect chlorine-stressed bacteria?”). Acknowledging that the protocol, on which the tests were based recommended 3-4 logs of stress, EPA concluded that a lesser degree of chlorine stress applied in a number of the Colitag  TM samples still provided an adequate challenge to the method performance. Moreover, EPA's microbiologists, upon more closely examining the mechanisms by which bacteria become stressed and are subsequently recovered, concluded that a wider range (2-4 log reduction) for the chlorine-stress goal is reasonable for judging method comparability. As a result, the Colitag  TM test data support EPA's conclusion that the method is comparable to the reference methods in its ability to recover chlorine-stressed bacteria. Again, EPA notes that it has previously approved coliform methods that were tested with less than 3-4 logs of chlorine stressing; the Colitag  TM evaluation is not unique in this respect.

With respect to comments concerning “hold time,” EPA notes that it has not established guidelines for such in its ATP protocol. The Agency has not asked that hold time be documented, nor has it applied a standard for such in previous method evaluations. EPA's presumption with respect to this issue is that the certified drinking water laboratories performing the comparability studies will employ a reasonable hold time. To address this issue, however, EPA conducted a thorough review of the hold times for the ten samples collected in evaluating the Colitag  TM method. In doing so, EPA considered dates identified for sample collection; sample receipt at the laboratory; original density determination; and comparability study completion, as reflected in the worksheets, comparability study data sheets, and chain of custody documentation in the record. EPA further considered the chronology and duration of the steps associated with the various tests performed. Based on all of this information, EPA concluded that a reasonable hold time could be documented for the majority of the tests, but that clear hold times could not be conclusively determined for four of the tests (samples 990025A, 990052A, 990217A, and 990273A). EPA notes, however, that it was unable to determine that unreasonable hold times were employed for these four tests. Therefore, EPA has evaluated the results of all ten samples for the comparison analysis.

As a conservative measure, however, EPA repeated its statistical analysis of the Colitag  TM data set, excluding the results of the four aforementioned tests. The conclusion ( i.e. , that the comparability study did not identify a statistically significant difference in performance between the reference method and Colitag  TM ”) did not change, nor was the strength of the conclusion substantially different using the more limited (6-test) data set. Hence, even if the four tests were excluded, EPA's decision to approve Colitag  TM would not change.

Under Executive Order 12866, [58 FR 51735 (October 4, 1993)] the Agency must determine whether a regulatory action is “significant” and therefore subject to OMB review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities;

(2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

It has been determined that this rule is not a “significant regulatory action” under the terms of Executive Order 12866 and is therefore not subject to Executive Order 12866.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. This rule merely provides drinking water utilities an additional analytical method to use to meet existing monitoring requirements. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

The RFA provides default definitions for each type of small entity. It also authorizes an agency to use alternative definitions for each category of small entity, “which are appropriate to the activities of the agency” after proposing the alternative definition(s) in the Federal Register and taking comment. 5 U.S.C. 601(3)-(5). In addition to the above, to establish an alternative small business definition, agencies must consult with the Small Business Administration's (SBA) Chief Counsel for Advocacy.

For purposes of assessing the impacts of today's rule on small entities, EPA considered small entities to be public water systems serving 10,000 persons or fewer. This is the cut-off level specified by Congress in the 1996 Amendments to the SDWA for small system flexibility provisions. In accordance with the RFA requirements, EPA proposed using this alternative definition in the Federal Register , (63 FR 7620, February 13, 1998) requested comment, consulted with SBA, and expressed its intention to use the alternative definition for all future drinking water regulations in the Consumer Confidence Reports regulation (63 FR 44511, August 19, 1998). As stated in that final rule, the alternative definition would be applied to this regulation as well.

After considering the economic impacts of today's final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. The use of the Colitag TM method is optional. Additionally, the cost of using the Colitag TM is similar to the cost of using other previously approved methods for the measurement of total coliforms and E. coli. Thus, we have determined that this rule will not impact small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and Tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative, if the Administrator publishes with the final rule an explanation of why that alternative was not adopted.

Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under UMRA section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

Today's rule contains no Federal mandates (under the regulatory provision of Title II of the UMRA) for State, local, or Tribal governments or the private sector. The rule imposes no enforceable duty on any State, local, or Tribal governments or the private sector. It merely provides drinking water utilities an additional analytical method to use to meet existing monitoring requirements. Thus, today's rule is not subject to the requirement of sections 202 and 205 of the UMRA.

EPA has determined that this final rule contains no regulatory requirements that might significantly or uniquely affect small governments. The adoption and use of the Colitag TM method is voluntary because drinking water systems can continue to use the existing approved methods. Thus, today's rule is not subject to the requirements of section 203 of UMRA.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

This final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This final rule approves Colitag TM as an additional analytical method option, thereby allowing public water systems an additional choice to conduct analyses previously required. There is no added cost to State and local governments, and the rule does not preempt State law. Thus, Executive Order 13132 does not apply to this rule. In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicited comment on the proposed rule from State and local officials. No comments were received that concerned issues covered by Executive Order 13132.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.”

This final rule does not have Tribal implications. It will not have substantial direct effects on Tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. This final rule is to specify Colitag TM as an approved analytical method option, thereby allowing public water systems the choice to use it to conduct analyses previously required. Thus, Executive Order 13175 does not apply to this rule. Moreover, in the spirit of Executive Order 13175, and consistent with EPA policy to promote communications between EPA and Tribal governments, EPA specifically solicited comment on the proposed rule from Tribal officials. No comments concerning Tribal issues were received.

Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This final rule is not subject to Executive Order 13045 because it is not economically significant as defined under Executive Order 12866. Further, it does not concern an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. This rule merely provides an additional analytical method to use for monitoring. It does not require any public water systems to use this method.

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Effect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

As noted in the proposed rule, Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, Section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide to Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This rulemaking involves a technical standard. Therefore, the NTTAA requires that the Agency identify and consider potentially applicable voluntary consensus standards. In response to those requirements, EPA notes that it has recently approved updated versions of previously approved voluntary consensus methods for total coliforms and E. coli and published them in the Federal Register on October 23, 2002 (67 FR 65220). EPA has decided to approve the Colitag TM method in this regulation as an additional analytical method, submitted to EPA by industry, for use in drinking water compliance monitoring. This industry-developed method will supplement existing approved methods.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective on March 15, 2004.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS 111)

H5N1 avian influenza is a subtype of the type A influenza virus. Wild birds are the natural hosts of the virus, which circulates among birds worldwide. It is very contagious among birds and can be deadly to birds, particularly domesticated birds like chickens. Infected birds shed virus in saliva, nasal secretions, and feces. Avian influenza viruses spread among susceptible birds when they have contact with contaminated excretions.

Since mid-December, outbreaks of influenza A (H5N1), infection have been detected in the poultry populations of Cambodia, China, Hong Kong (in a single peregrine falcon), Indonesia, Japan, Korea, Laos, Thailand, and Vietnam. The virus does not typically infect humans, but in recent months, Vietnam has reported hospitalized cases of serious respiratory illness, primarily among children, most of whom have died. Thirteen of these patients were confirmed as having avian influenza A (H5N1), and nine of the confirmed cases have been fatal. The Ministry of Health of Thailand announced four confirmed cases of avian influenza A (H5N1) in humans; all four of the patients have died. It is believed that most cases of H5N1 infection in humans have resulted from contact with infected poultry or contaminated surfaces.

The incubation period for influenza is one to four days, with an average of two days. Uncomplicated influenza illness is characterized by the abrupt onset of constitutional and respiratory signs and symptoms ( e.g. , fever, myalgia, headache, severe malaise, nonproductive cough, sore throat, and rhinitis). Among children, otitis media, nausea, and vomiting are also commonly reported characteristics of influenza illness.

Influenza illness typically resolves after a limited number of days for the majority of persons, although cough and malaise can persist for more than two weeks. Among certain persons influenza can exacerbate underlying medical conditions ( e.g. , pulmonary or cardiac disease), lead to secondary bacterial pneumonia or primary influenza viral pneumonia, or occur as part of a co-infection with other viral or bacterial pathogens. Young children with influenza infection can have initial symptoms mimicking bacterial sepsis with high fevers, and less than or equal to 20% of children hospitalized with influenza can have febrile seizures. Influenza infection has also been associated with encephalopathy, transverse myelitis, Reye syndrome, myositis, myocarditis, and pericarditis. Influenza-related deaths can result from pneumonia as well as from exacerbations of cardiopulmonary conditions and other chronic diseases.

So far, H5N1 viruses have not been capable of efficient human-to-human transmission. The co-circulation of human and highly pathogenic animal influenza viruses is of serious concern to the World Health Organization (WHO), CDC, and other health authorities worldwide, since an exchange of genes between the two viruses might occur if individuals were co-infected with both human and avian influenza viruses. This gene exchange could give rise to a new influenza virus to which humans would have little or no immunity and which could be transmitted efficiently from person to person. If an avian influenza virus were able to infect people and gain the ability to spread easily from person to person, an “influenza pandemic” could begin. A pandemic is an outbreak of an infectious disease that rapidly spreads worldwide resulting in large amounts of morbidity and mortality. Three such pandemics occurred during the 20th century and resulted in many more deaths and hospitalizations than occur during a typical influenza season because the human population did not have underlying immunity to the newly circulating virus.

There is no current vaccine specifically formulated to provide immunity against H5N1 subtype of influenza. In addition, of the four antiviral agents currently licensed in the United States for treatment of influenza, genetic sequencing of influenza A (H5N1) virus samples from human cases in Vietnam shows antiviral resistance to two of them (amantadine and rimantadine). The remaining two antivirals (oseltamavir and zanamavir) should still be effective against this strain of H5N1.

The principal measures to control an outbreak of H5N1 in birds are the culling (killing) of sick and exposed birds and the restriction of movement of potentially exposed birds to unaffected areas. So far over 45 million birds have been culled. According to the U.S. Fish and Wildlife Service, the United States imports over 20,000 live birds from countries affected by the outbreak of avian influenza.

Introduction of influenza A (H5N1) infected birds into the United States could lead to outbreaks of disease in the human population, a significant public health threat. Banning the importation of all avian species from affected countries is an effective means of limiting this threat. CDC is therefore taking this action to reduce the chance of introduction or spread of influenza A (H5N1) into the United States. This order complements a similar action taken by the U.S. Department of Agriculture.

Because there is no current evidence suggesting that birds infected with influenza A (H5N1) have been imported and are causing disease in the United States, this order does not include restrictions upon the domestic movement of birds already in the United States.

Therefore, pursuant to 42 CFR 71.32(b) and in accordance with this order, no person may import or attempt to import any birds (Class: Aves), whether dead or alive, or any products derived from birds (including hatching eggs), from the following Southeast Asian countries:

Cambodia;

Indonesia;

Japan;

Laos;

People's Republic of China, including Hong Kong SAR;

South Korea;

Thailand; and

Vietnam.

This prohibition is effective immediately and until further notice. This prohibition does not include pet birds which originated in the United States (as defined in 9 CFR 93.100), provided that the importation of such birds complies with USDA requirements, which includes a 30-day quarantine in a USDA facility. This prohibition also does not apply to any person who imports or attempts to import products derived from birds if, as determined by federal officials, such products have been properly processed to render them noninfectious so that they pose no risk of transmitting or carrying the influenza A (H5N1) virus and which comply with USDA requirements. This order may be amended as necessary as the situation develops, for example, to add or remove countries.

The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Since the communities on the attached list have recently entered the NFIP, subsidized flood insurance is now available for property in the community.

In addition, the Federal Emergency Management Agency has identified the special flood hazard areas in some of these communities by publishing a Flood Hazard Boundary Map (FHBM) or Flood Insurance Rate Map (FIRM). The date of the flood map, if one has been published, is indicated in the fourth column of the table. In the communities listed where a flood map has been published, Section 202 of the Flood Disaster Protection Act of 1973, as amended, 42 U.S.C. 4016(a), requires the purchase of flood insurance as a condition of Federal or federally related financial assistance for acquisition or construction of buildings in the special flood hazard areas shown on the map.

The Administrator finds that delayed effective dates would be contrary to the public interest and that notice and public procedure under 5 U.S.C. 553(b) are impracticable and unnecessary.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601 et seq. , because the rule creates no additional burden, but lists those communities eligible for the sale of flood insurance.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, October 26, 1987, 3 CFR, 1987 Comp., p. 252.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of section 2(b)(2) of Executive Order 12778, October 25, 1991, 56 FR 55195, 3 CFR, 1991 Comp., p. 309.