The Office of Personnel Management is making the following corrections in Title 5, Code of Federal Regulations:

• In § 451.104(g), we are correcting a citation to 5 U.S.C. 4505a(a)(2).

• In § 531.214(d)(2)(iii)(A), we are replacing the term “alternate” with “standard”.

• In § 531.214(d)(4)(iii), Step D, we are replacing the term “GS-11” with “GS-9”.

• In § 531.222(a)(2), we are moving the phrase “on a regular tour of duty” from paragraph (2)(i) to the introductory text of paragraph (2).

• In § 531.407(b)(2), we are inserting the phrase “(or would have resulted in)”.

• In § 531.602, we are replacing the word “rates” with the word “rate” in the second sentence of the definition of GS rate.

• In § 531.610(k), we are replacing the phrase “Lump-sum payments for accumulated and annual leave under 5 CFR part 550, subpart L” with “Lump-sum payments under 5 CFR part 550, subpart L, for accumulated and accrued annual leave”.

• In § 572.206(a)(4), we are replacing the word “recruitment” with “relocation.”

• In § 575.310(a), we are replacing the reference to paragraph “g” with “(f).”

Section 5304 of title 5, United States Code, authorizes locality pay for General Schedule (GS) employees with duty stations in the contiguous United States and the District of Columbia. By law, locality pay is set by comparing GS pay rates with non-Federal pay rates for the same levels of work in each locality pay area. Non-Federal pay levels are estimated by means of salary surveys conducted by the Bureau of Labor Statistics (BLS). In 2005, there are 32 locality pay areas: 31 separate metropolitan locality pay areas and a Rest of U.S. (RUS) locality pay area that consists of all locations in the contiguous United States that are not part of one of the 31 separate metropolitan locality pay areas.

Section 5304(f) of title 5, United States Code, authorizes the President's Pay Agent (the Secretary of Labor, the Director of the Office of Management and Budget (OMB), and the Director of the Office of Personnel Management (OPM)) to determine locality pay areas. The boundaries of locality pay areas must be based on appropriate factors, which may include local labor market patterns, commuting patterns, and the practices of other employers. The Pay Agent must give thorough consideration to the views and recommendations of the Federal Salary Council, a body composed of experts in the fields of labor relations and pay policy and representatives of Federal employee organizations. The President appoints the members of the Federal Salary Council, which submits annual recommendations to the President's Pay Agent about the locality pay program. Based on recommendations of the Federal Salary Council, we use Metropolitan Statistical Area (MSA) and Combined Statistical Area (CSA) definitions established by OMB as the basis for locality pay area definitions.

On June 20, 2005, OPM issued a proposed rule on behalf of the Pay Agent to—

• Create new locality pay areas for Buffalo, Phoenix, and Raleigh;

• Merge the Kansas City, St. Louis, and Orlando locality pay areas with the Rest of U.S. locality pay area;

• Include several new areas of application in the new Raleigh locality pay area; and

• Add Fannin County, TX, to the Dallas locality pay area, Culpepper County, VA, to the Washington, DC, locality pay area, and change the name of the Santa Barbara-Santa Maria-Goleta, CA, Metropolitan Statistical Area within the Los Angeles locality pay area.

We received 31 comments on the proposed regulations. Several of the commenters requested that separate locality pay areas be established in additional locations due to high living costs. The suggested areas included Eureka, CA; Fresno, CA; Las Vegas, NV; Norfolk, VA; Preston County, WV; Salt Lake City, UT; Tampa, FL; and Toledo, OH. Norfolk, Salt Lake City, and Tampa have been surveyed for the locality pay program in the past, but the surveys indicated that pay levels in each location were below pay levels in the RUS locality pay area.

Living costs are not directly considered in setting locality pay or defining locality pay areas. Locality pay is set by comparing GS and non-Federal pay for the same levels of work to allow the Government to recruit and retain an adequate workforce. Locality pay is not designed to equalize living standards for GS employees across the country. Since living costs are just one of many factors that affect the supply and demand for labor, they are not considered separately.

Several commenters were opposed to merging the Kansas City, St. Louis, and Orlando locality pay areas with the RUS area and expressed concerns about the impact on pay for employees in those areas. Salary survey results consistently show that the pay disparity in these three areas is below that in the RUS locality pay area. Since the purpose of locality pay is to enable the Government to offer higher pay in high-pay areas, there is no policy-based justification for continuing these three cities as separate locality pay areas.

Commenters expressed several other concerns about Kansas City, St. Louis, and Orlando. These included that pay levels are higher in the core city than the broader locality pay area, that including outlying areas reduces pay levels, that living costs are higher in the suburbs than in the inner cities, that reductions in locality rates will cause staffing problems, and that recent increases in oil prices have affected employees in these three areas. Some or all of these same factors may also apply in any of the other locality pay areas, but they do not justify treating Kansas City, St. Louis, and Orlando differently than the other areas. The Pay Agent does not anticipate any significant staffing difficulties in Kansas City, St. Louis, or Orlando due to this action because the differences between the RUS rate and the current locality rates in these areas are small and the regulations are expected to become effective at the same time as an across-the-board GS pay increase.

A number of commenters focused on the geographic coverage of existing locality pay areas. Some commenters recommended adding Colorado Springs to the Denver locality pay area, adding Toledo to the Detroit locality pay area, adding Fort Dix to the New York locality pay area, including San Diego in the Los Angeles locality pay area, including more locations in Pennsylvania near York County in the Washington-Baltimore locality pay area, extending locality pay to employees in foreign areas or in Alaska and Hawaii, and including nurses and other medical personnel in Fannin County, TX, who are paid under title 38, United States Code, in the Dallas locality pay area.

Colorado Springs, Toledo, Fort Dix, and the additional areas in Pennsylvania do not pass the criteria recommended by the Federal Salary Council for including a location in an existing locality pay area. San Diego is already surveyed separately, and recent survey results indicate that pay levels in San Diego are similar to those in the Los Angeles locality pay area. While the Federal Salary Council considered combining several existing locality pay areas in 2003 in order to free up survey resources (including merging the Los Angeles and San Diego locality pay areas), they took no action on the proposal because BLS indicated there would not be any significant reduction in survey work. Because the areas under consideration were all large areas, they would still have to be surveyed separately for BLS’ nationwide products, including the Employment Cost Index.

Section 5304 of title 5, United States Code, does not provide for locality payments in foreign areas or in Alaska or Hawaii, so the Pay Agent cannot extend locality payments to employees in those areas.

The Department of Veterans Affairs is responsible for setting pay for employees covered by title 38, United States Code, and is not required to use the locality pay area boundaries established by the President's Pay Agent under the GS locality pay program for those employees.

Finally, both the American Federation of Government Employees and the prison wardens at the Federal Correctional Facility, Butner, NC, expressed support for adding the entire facility to the new Raleigh locality pay area.

The final regulations include the Federal Correctional Complex, Butner, NC, in the new Raleigh locality pay area. Based on information provided by the wardens of the prison complex, about 1,050 General Schedule employees are stationed at the prison, with an additional 375 to be added in the spring of 2006. The Durham/Granville County line runs through the prison complex. In fact, the county line runs through several of the buildings at the facility, and many employees work in more than one building on a daily basis. Most of the prison land area and buildings are located in Durham County, inside the Raleigh CSA, but the Low Security Institute, with approximately 124 permanently assigned GS employees, is in Granville County, outside the Raleigh CSA but less than a mile from the county line. Granville County, with a total of about 134 GS employees, does not pass the GS employment criterion previously recommended by the Federal Salary Council for including an adjacent county in a higher-paying locality pay area. Likewise, the portion of the prison in Granville County, with 124 GS employees, does not pass the 750 GS employment criterion for including all of a Federal facility in a locality pay area. However, the Pay Agent concluded that it would not be administratively feasible or desirable to include only part of the prison facility in the new Raleigh locality pay area and proposed to include the entire correctional facility in that area.

The Pay Agent requested that the Federal Salary Council consider this matter when it met in 2005. At its meeting on October 3, 2005, the Council voted to amend its recommended criteria for evaluating Federal facilities that cross locality pay area boundaries. The Pay Agent concurs with the Council's recommended revision, as set forth here:

For Federal facilities that cross locality pay area boundaries: To be included in an adjacent locality pay area, the whole facility must have at least 500 GS employees, with the majority of those employees in the higher-paying locality pay area, or that portion of a Federal facility outside of a higher-paying locality pay area must have at least 750 GS employees, the duty stations of the majority of those employees must be within 10 miles of the separate locality pay area, and a significant number of those employees must commute to work from the higher-paying locality pay area.

The changes in locality pay area boundaries move about 34,000 GS employees to the RUS locality pay area and move about 25,000 GS employees from the RUS locality pay area to a separate metropolitan locality pay area.

In order to give practical effect to these regulations at the earliest possible moment, I find that good cause exists for making this rule effective in less than 30 days. The delay in effective date is waived so that affected agencies and employees may benefit from the new locality pay area definitions on the effective date of the January 2006 GS pay adjustment.

The Office of Management and Budget has reviewed this rule in accordance with E.O. 12866.

I certify that these regulations will not have a significant economic impact on a substantial number of small entities because they will apply only to Federal agencies and employees.

Regulation CC establishes the maximum period a depositary bank may wait between receiving a deposit and making the deposited funds available for withdrawal. 1 A depositary bank generally must provide faster availability for funds deposited by a “local check” than by a “nonlocal check.” A check drawn on a bank is considered local if it is payable by or at a bank located in the same Federal Reserve check processing region as the depositary bank. A check drawn on a nonbank is considered local if it is payable through a bank located in the same Federal Reserve check processing region as the depositary bank. Checks that do not meet the requirements for “local” checks are considered “nonlocal.”

Appendix A to Regulation CC contains a routing number guide that assists banks in identifying local and nonlocal banks and thereby determining the maximum permissible hold periods for most deposited checks. The appendix includes a list of each Federal Reserve check processing office and the first four digits of the routing number, known as the Federal Reserve routing symbol, of each bank that is served by that office for check processing purposes. Banks whose Federal Reserve routing symbols are grouped under the same office are in the same check processing region and thus are local to one another.

In the aftermath of Hurricane Katrina, the Federal Reserve Bank of Atlanta implemented its contingency operations plan, which included sending checks that normally would be processed by the New Orleans branch office instead to the Atlanta head office on a temporary basis. On December 5, 2005, the Federal Reserve Banks announced that banks with routing symbols currently assigned to the New Orleans branch office for check processing purposes would be reassigned to the Atlanta head office and that the New Orleans branch permanently would cease its check processing operations, effective March 31, 2006. 2 As a result, some checks that are drawn on and deposited at banks located in the affected check processing regions and that currently are nonlocal checks will become local checks subject to faster availability schedules. To assist banks in identifying local and nonlocal checks and making funds availability decisions, the Board is amending the lists of routing symbols associated with the Federal Reserve Bank of Atlanta to reflect the transfer of check-processing operations from the Reserve Bank's New Orleans branch office to its head office in Atlanta. To coincide with the effective date of the underlying check processing changes, these amendments are effective March 31, 2006. The Board is providing advance notice of these amendments to give affected banks ample time to make any needed processing changes. The advance notice also will enable affected banks to amend their availability schedules and related disclosures if necessary and provide their customers with notice of these changes. 3

The Reserve Banks had previously announced on August 2, 2004, that the check-processing operations of the Atlanta Reserve Bank's Nashville branch office would be transferred to the Atlanta Reserve Bank's head office by early 2006. 4 However, because of the permanent transfer of the New Orleans branch office's check-processing operations to the Atlanta head office, the transfer of the Nashville branch office's check-processing operations to the Atlanta head office will be delayed until 2007.

The Board also is making technical amendments to the list of routing symbols associated with the Helena branch office of the Federal Reserve Bank of Minnesota to correct typographical errors in the list. The lists of Federal Reserve routing symbols assigned to all other Federal Reserve branches and offices will remain the same at this time.

As the Federal Reserve Banks announced on May 25, 2005, 5 in response to the continued nationwide decline in check usage and to position themselves more effectively to meet the cost recovery requirements of the Monetary Control Act of 1980, the Reserve Banks have decided to stop processing checks at the East Rutherford office of the Federal Reserve Bank of New York. Checks currently processed by that office instead will be processed at the head office of the Federal Reserve Bank of Philadelphia. Although an exact date for this restructuring has not been determined, it is expected to take place in the latter half of 2006.

The Board intends to publish amendments to appendix A in connection with this restructuring to delete the reference to the East Rutherford office of the Federal Reserve Bank of New York and transfer the affected Federal Reserve routing symbols to the head office of the Federal Reserve Bank of Philadelphia at least 60 days prior to the effective date of the restructuring. This should give affected banks ample time to make appropriate programming changes and, if necessary, to amend their availability schedules and related disclosures and provide their customers with notice of any changes to their availability schedules. However, some affected banks might prefer to make or to plan for their necessary programming and availability changes prior to the effective dates of the relevant amendments. For the information and planning needs of affected banks, the Board today is providing advance notice that, as of the effective date of this restructuring, banks with the following Federal Reserve routing symbols will be local to the Philadelphia head office:

The Federal Reserve routing symbols assigned to all other Federal Reserve branches and offices will be unaffected by this restructuring.

The Board has not followed the provisions of 5 U.S.C. 553(b) relating to notice and public participation in connection with the adoption of the final rule. All the revisions to the appendix are technical in nature, and the routing symbol revisions for the Sixth District are required by the statutory and regulatory definitions of “check-processing region.” Because there is no substantive change on which to seek public input and because delaying the amendments may impede affected banks' ability to comply with Regulation CC, the Board has determined that the § 553(b) notice and comment procedures are unnecessary.

Pursuant to section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Board certifies that the final rule will not have a significantly adverse economic impact on a substantial number of small entities. These amendments are technical, and the routing number changes are required by law. Moreover, these amendments apply to all banks regardless of their size. Many small banks generally provide next-day availability for all checks and will not be affected by this amendment. For the subset of small banks that does distinguish between checks subject to next-day availability and those subject to longer holds, the final rule should necessitate only minimal programming changes. Some of these affected banks might also have to modify their funds availability disclosures and notify both new and existing customers of the modified funds availability schedules.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506; 5 CFR part 1320 Appendix A.1), the Board has reviewed the final rule under authority delegated to the Board by the Office of Management and Budget. This technical amendment to appendix A of Regulation CC will delete the reference to the New Orleans branch office of the Federal Reserve Bank of Atlanta and reassign the routing symbols listed under that office to the head office of the Federal Reserve Bank of Atlanta. The depository institutions that are located in the affected check processing regions and that include the routing numbers in their disclosure statements would be required to notify customers of the resulting change in availability under § 229.18(e). However, all paperwork collection procedures associated with Regulation CC already are in place, and the Board accordingly anticipates that no additional burden will be imposed as a result of this rulemaking. The Board is also correcting typographical errors in the routing symbol list under the Helena branch office of the Federal Reserve Bank of Minnesota. The Board anticipates that these corrections will not impose any burden.

The FAA has determined that notice and opportunity for prior public comment hereon are impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA, therefore, finds that good cause exists for making these special conditions effective upon issuance.

Interested persons are invited to submit such written data, views, or arguments, as they may desire. Communications should identify the regulatory docket or notice number and be submitted in duplicate to the address specified above. All communications received on or before the closing date for comments will be considered by the Administrator. The special conditions may be changed in light of the comments received. All comments received will be available in the Rules Docket for examination by interested persons, both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerning this rulemaking will be filed in the docket. Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this notice must include a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. CE236.” The postcard will be date stamped and returned to the commenter.

Envoy Aerospace made application to the FAA for a new Supplemental Type Certificate for several Raytheon King Air Models. The Raytheon Model B200, B200C, 300, B300, and B300C are currently approved under TC No. A24CE. The proposed modification incorporates a novel or unusual design features, such as a digital Primary Flight Display, that may be vulnerable to HIRF external to the airplane.

Under the provisions of 14 CFR part 21, § 21.101, Envoy Aerospace must show that the modified aircraft meet the original certification basis for the airplane, as listed on Type Data Sheet A24CE, additional certification requirements added for the Universal Avionics EFI-890R system, exemptions, if any; and the special conditions adopted by this rulemaking action. The rules that were applied at Part 23 Amendment 54 for the EFI-890R installation include §§ 23.1301, 23.1311, 23.1309, 23.1321, 23.1322, 23.1325, and 23.1543.

If the Administrator finds that the applicable airworthiness standards do not contain adequate or appropriate safety standards because of novel or unusual design features of an airplane, special conditions are prescribed under the provisions of § 21.16.

Special conditions, as appropriate, as defined in § 11.19, are issued in accordance with § 11.38 after public notice and become part of the type certification basis in accordance with § 21.101.

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model already included on the same type certificate to incorporate the same novel or unusual design feature, the special conditions would also apply to the other model under the provisions of § 21.101.

Envoy Aerospace plans to incorporate certain novel and unusual design features into the Raytheon King Air Models for which the airworthiness standards do not contain adequate or appropriate safety standards for protection from the effects of HIRF. These features include EFIS, which are susceptible to the HIRF environment, that were not envisaged by the existing regulations for this type of airplane.

Recent advances in technology have given rise to the application in aircraft designs of advanced electrical and electronic systems that perform functions required for continued safe flight and landing. Due to the use of sensitive solid-state advanced components in analog and digital electronics circuits, these advanced systems are readily responsive to the transient effects of induced electrical current and voltage caused by the HIRF. The HIRF can degrade electronic systems performance by damaging components or upsetting system functions.

Furthermore, the HIRF environment has undergone a transformation that was not foreseen when the current requirements were developed. Higher energy levels are radiated from transmitters that are used for radar, radio, and television. Also, the number of transmitters has increased significantly. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling to cockpit-installed equipment through the cockpit window apertures is undefined.

The combined effect of the technological advances in airplane design and the changing environment has resulted in an increased level of vulnerability of electrical and electronic systems required for the continued safe flight and landing of the airplane. Effective measures against the effects of exposure to HIRF must be provided by the design and installation of these systems. The accepted maximum energy levels in which civilian airplane system installations must be capable of operating safely are based on surveys and analysis of existing radio frequency emitters. These special conditions require that the airplane be evaluated under these energy levels for the protection of the electronic system and its associated wiring harness. These external threat levels, which are lower than previous required values, are believed to represent the worst case to which an airplane would be exposed in the operating environment.

These special conditions require qualification of systems that perform critical functions, as installed in aircraft, to the defined HIRF environment in paragraph 1 or, as an option to a fixed value using laboratory tests, in paragraph 2, as follows:

(1) The applicant may demonstrate that the operation and operational capability of the installed electrical and electronic systems that perform critical functions are not adversely affected when the aircraft is exposed to the HIRF environment defined below:

(2) The applicant may demonstrate by a system test and analysis that the electrical and electronic systems that perform critical functions can withstand a minimum threat of 100 volts per meter, electrical field strength, from 10 kHz to 18 GHz. When using this test to show compliance with the HIRF requirements, no credit is given for signal attenuation due to installation.

A preliminary hazard analysis must be performed by the applicant for approval by the FAA to identify either electrical or electronic systems that perform critical functions. The term “critical” means those functions, whose failure would contribute to, or cause, a failure condition that would prevent the continued safe flight and landing of the airplane. The systems identified by the hazard analysis that perform critical functions are candidates for the application of HIRF requirements. A system may perform both critical and non-critical functions. Primary electronic flight display systems, and their associated components, perform critical functions such as attitude, altitude, and airspeed indication. The HIRF requirements apply only to critical functions.

Compliance with HIRF requirements may be demonstrated by tests, analysis, models, similarity with existing systems, or any combination of these. Service experience alone is not acceptable since normal flight operations may not include an exposure to the HIRF environment. Reliance on a system with similar design features for redundancy as a means of protection against the effects of external HIRF is generally insufficient since all elements of a redundant system are likely to be exposed to the fields concurrently.

As discussed above, these special conditions are applicable to the Raytheon Model B200, B200C, 300, B300, and B300C. Should Envoy Aerospace apply at a later date for a supplemental type certificate to modify any other model on the same type certificate to incorporate the same novel or unusual design feature, the special conditions would apply to that model as well under the provisions of § 21.101.

This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The substance of these special conditions has been subjected to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. For this reason, and because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Raytheon Model B200, B200C, 300, B300, and B300C airplanes modified by Envoy Aerospace to add the Universal Avionics EFI-890R system.

1. Protection of Electrical and Electronic Systems from High Intensity Radiated Fields (HIRF). Each system that performs critical functions must be designed and installed to ensure that the operations, and operational capabilities of these systems to perform critical functions, are not adversely affected when the airplane is exposed to high intensity radiated electromagnetic fields external to the airplane.

2. For the purpose of these special conditions, the following definition applies: Critical Functions: Functions whose failure would contribute to, or cause, a failure condition that would prevent the continued safe flight and landing of the airplane.

The FAA has determined that notice and opportunity for prior public comment is impracticable because these procedures would significantly delay certification of the airplane and thus delivery of the affected aircraft. In addition, the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received. The FAA therefore finds that good cause exists for making these special conditions effective upon issuance; however, we invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning these special conditions. You may inspect the docket before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this preamble between 7:30 a.m. and 4 p.m., Monday through Friday, except Federal holidays.

We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions based on the comments we receive.

If you want the FAA to acknowledge receipt of your comments on these special conditions, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it back to you.

On June 6, 2005, AeroMech Incorporated, 1616 Hewitt Avenue, Suite 312, Everett, Washington 98201, applied for a supplemental type certificate (STC) to modify a Raytheon Aircraft Company Model HS.125 Series 400A airplane. This model is currently approved under Type Certificate No. A3EU. The Raytheon Model HS.125 airplane is a small transport category airplane powered by two turbine engines. It operates with a 2-pilot crew and can seat up to 15 passengers. The modification incorporates the installation of Innovative Solutions and Support air data display units. The avionics/electronics and electrical systems installed in this airplane have the potential to be vulnerable to high-intensity radiated fields (HIRF) external to the airplane.

Under the provisions of 14 CFR 21.101, AeroMech Incorporated must show that Raytheon Aircraft Company Model HS.125 Series 400A airplane, as changed, continues to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A3EU, or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The certification basis for the Raytheon Aircraft Company Model HS.125 Series 400A airplane includes Civil Air Regulations (CAR) 10, British Civil Airworthiness Requirements, and Special Conditions. This certification is equivalent to CAR 4b dated December 1953, Amendment 4b-1 through Amendment 4b-11, exclusive of CAR 4b.350(e), and includes Special Regulations SR.422B. Type Certificate No. A3EU was amended to include HS.125 Series 400A on November 15, 1968. Compliance over and above certification basis requirements has been met with CAR Amendment 4B-12 and Amendment 4B-14. Compliance has been established with the special retroactive requirements of 14 CFR 25.2 as amended by Amendment 25-1 through Amendment 25-20, 14 CFR 21 at Amendment 21-27, and 14 CFR 36(1)(c)(2).

If the Administrator finds that the applicable airworthiness regulations (i.e., part 25, as amended) do not contain adequate or appropriate safety standards for the Raytheon Model HS.125 Series 400A airplane because of a novel or unusual design feature, special conditions are prescribed under § 21.16.

In addition to the applicable airworthiness regulations and special conditions, Raytheon Aircraft Company Model HS.125 Series 400A airplane must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

Special conditions, as defined in 14 CFR 11.19, are issued under § 11.38 and become part of the type certification basis under § 21.101.

Special conditions are initially applicable to the model for which they are issued. Should AeroMech Incorporated apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A3EU to incorporate the same or similar novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

As noted earlier, Raytheon Model HS.125 airplane modified by AeroMech Incorporated will incorporate Innovative Solutions and Support air data display units that will perform critical functions. These systems may be vulnerable to high-intensity radiated fields external to the airplane. The current airworthiness standards of part 25 do not contain adequate or appropriate safety standards for the protection of this equipment from the adverse effects of HIRF. Accordingly, this system is considered to be a novel or unusual design feature.

There is no specific regulation that addresses protection requirements for electrical and electronic systems from HIRF. Increased power levels from ground-based radio transmitters and the growing use of sensitive avionics/electronics and electrical systems to command and control airplanes have made it necessary to provide adequate protection.

To ensure that a level of safety is achieved equivalent to that intended by the regulations incorporated by reference, special conditions are needed for Raytheon Aircraft Company Model HS.125 Series 400A airplane modified by AeroMech Incorporated. These special conditions require that new avionics/electronics and electrical systems that perform critical functions be designed and installed to preclude component damage and interruption of function due to both the direct and indirect effects of HIRF.

With the trend toward increased power levels from ground-based transmitters, and the advent of space and satellite communications coupled with electronic command and control of the airplane, the immunity of critical avionics/electronics and electrical systems to HIRF must be established.

It is not possible to precisely define the HIRF to which the airplane will be exposed in service. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling of electromagnetic energy to cockpit-installed equipment through the cockpit window apertures is undefined. Based on surveys and analysis of existing HIRF emitters, an adequate level of protection exists when compliance with the HIRF protection special condition is shown with either paragraph 1 OR 2 below:

1. A minimum threat of 100 volts rms (root-mean-square) per meter electric field strength from 10 KHz to 18 GHz.

a. The threat must be applied to the system elements and their associated wiring harnesses without the benefit of airframe shielding.

b. Demonstration of this level of protection is established through system tests and analysis.

2. A threat external to the airframe of the field strengths identified in the table below for the frequency ranges indicated. Both peak and average field strength components from the table are to be demonstrated.

The threat levels identified above are the result of an FAA review of existing studies on the subject of HIRF, in light of the ongoing work of the Electromagnetic Effects Harmonization Working Group of the Aviation Rulemaking Advisory Committee.

As discussed above, these special conditions are applicable to a Raytheon Aircraft Company Model HS.125 Series 400A airplane modified by AeroMech Incorporated. Should AeroMech Incorporated apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A3EU to incorporate the same or similar novel or unusual design feature, these special conditions would apply to that model as well under § 21.101.

This action affects only certain novel or unusual design features on a Raytheon Aircraft Company Model HS.125 Series 400A airplane modified by AeroMech Incorporated. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The substance of these special conditions has been subjected to the notice and comment procedure in several prior instances and has been derived without substantive change from those previously issued. Because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the supplemental type certification basis for the Raytheon Aircraft Company Model HS.125 Series 400A airplane modified by AeroMech Incorporated.

1. Protection from Unwanted Effects of HIRF. Each electrical and electronic system that performs critical functions must be designed and installed to ensure that the operation and operational capability of these systems to perform critical functions are not adversely affected when the airplane is exposed to high-intensity radiated fields.

2. For the purpose of these special conditions, the following definition applies: Critical Functions: Functions whose failure would contribute to or cause a failure condition that would prevent the continued safe flight and landing of the airplane.

A final rule AD, FR Doc. 05-19941, that applies to Aviointeriors S.p.A. (formerly ALVEN), series 312 box mounted seats, was published in the Federal Register on October 12, 2005 (70 FR 59243). The following correction is needed:

1. On June 2, 2005, the Commission issued Order No. 661, the Final Rule on Interconnection for Wind Energy (Final Rule). 1 Several entities have filed timely requests for rehearing and clarification of the Final Rule. 2 In this order, the Commission grants in part and denies in part the requests for rehearing and clarification.

2. In Order No. 2003, 3 the Commission adopted standard procedures and a standard agreement for the interconnection of large generation facilities. The Commission required public utilities that own, control, or operate facilities for transmitting electric energy in interstate commerce to file revised Open Access Transmission Tariffs (OATTs) containing these standard provisions, and use them to provide interconnection service to generating facilities having a capacity of more than 20 megawatts.

3. In Order No. 2003-A, on rehearing, the Commission noted that the standard interconnection procedures and agreement were based on the needs of traditional generation facilities and that a different approach might be more appropriate for generators relying on other technologies, such as wind plants. 4 Accordingly, the Commission granted certain clarifications, and also added a blank Appendix G to the standard Large Generation Interconnection Agreement (LGIA) for future adoption of requirements specific to other technologies. 5

4. The Commission issued a Notice of Proposed Rulemaking (NOPR) that proposed technical standards applicable to the interconnection of large wind generating plants  6 to be included in Appendix G of the LGIA. 7 We proposed the standards in light of our findings in Order No. 2003-A noted above and in response to a petition submitted by the American Wind Energy Association (AWEA). 8 Specifically, the Commission proposed to establish uniform standards in Appendix G that would require large wind plants seeking to interconnect to the grid to: (1) Demonstrate low voltage ride-through capability; in other words, show that the plant can remain on line during voltage disturbances up to specified time periods and associated voltage levels; (2) have supervisory control and data acquisition (SCADA) capability to transmit data and receive instructions from the Transmission Provider; and (3) maintain a power factor within the range of 0.95 leading to 0.95 lagging, measured at the high voltage side of the substation transformers. The Commission proposed to permit the Transmission Provider to waive the low voltage ride-through requirement on a comparable and not unduly discriminatory basis. We proposed to permit the Transmission Provider to waive or defer compliance with the power factor requirement where it is not necessary. The Commission did not propose to adopt a proposal by AWEA to allow a wind generator to “enter the interconnection queue and conduct its own Feasibility Study, having obtained the information necessary to do so upon paying the initial deposit and submitting its interconnection application” (referred to as “self-study” provisions). 9 The Commission did, however, ask for comments on how to balance the need of wind generators to obtain certain data from the Transmission Provider before completing their Interconnection Requests with the need to protect critical energy infrastructure information and commercially sensitive data against unwarranted disclosure.

5. In the Final Rule, the Commission adopted final standard procedures and technical requirements for the interconnection of large wind plants in Appendix G, and required all public utilities that own, control, or operate facilities for transmitting electric energy in interstate commerce to append Appendix G to the Large Generator Interconnection Procedures (LGIPs) and LGIAs in their OATTs. As described in more detail below, the Commission adopted provisions establishing standards for low voltage ride-through and power factor design criteria, and requiring that wind plants meet those standards if the Transmission Provider shows, in the System Impact Study, that they are needed to ensure the safety or reliability of the transmission system. Additionally, the Appendix G adopted by the Commission included a SCADA requirement applicable to all wind plants. Finally, as described in more detail below, the Commission adopted in Appendix G to the LGIP limited special interconnection procedures applicable to wind plants.

6. In the Final Rule, the Commission adopted a low voltage ride-through standard, but provided that a wind plant is required to meet the standard only if the Transmission Provider shows, in the System Impact Study, that low voltage ride-through capability is needed to ensure safety or reliability. The standard (adopted in Figure 1 of Appendix G to the LGIA), if applicable, requires the wind plant to stay online for specified time periods and at associated voltage levels where there is a disturbance on the transmission system. The Final Rule requires that the required voltage levels be measured at the Point of Interconnection.

7. Several entities requested rehearing of various aspects of the low voltage ride-through requirement and standard included in the Final Rule, including: (1) Provisions that require low voltage ride-though only when the System Impact Study shows that such capability is necessary for safety or reliability; (2) the specific low voltage ride-through standard adopted in the Final Rule; (3) the point of measurement for the standard; and (4) arguments that Transmission Providers should be permitted to adopt other provisions of the German low voltage ride-through standard (which the Commission referenced in the Final Rule).

8. However, as described in more detail below, NERC and AWEA jointly requested that the Commission delay the effective date of the Final Rule to give them time to resolve concerns expressed by NERC regarding the low voltage ride-through provisions. The Commission granted this extension, and on September 19, 2005, NERC and AWEA submitted a joint report with recommended revisions.

9. Prior to the NERC/AWEA joint report, several entities objected on rehearing to the Final Rule's adoption of a low voltage ride-through requirement on a case-by-case basis, placing the burden of proof on the Transmission Provider to show that low voltage ride-through capability is needed. ATC, EEI, NERC, NRECA/APPA, and SCE, among others, urged the Commission to return to the approach in the NOPR, which would have required low voltage ride-through for all wind plants unless waived by the Transmission Provider on a not unduly discriminatory basis. ATC noted that interconnection studies only consider a snapshot of the transmission system, and do not take into account changes in the future that may cause a need for low voltage ride-through capability to ensure reliability. ATC, as well as EEI and SCE, argued that under the case-by-case approach adopted in the Final Rule, Transmission Providers will need to perform additional analyses to determine if a reliability need will exist over the life of the wind plant. SCE, for example, noted that while a particular System Impact Study may not conclusively demonstrate that low voltage ride-through is needed at that time, if other generation projects are built, the first wind plant may come to need low voltage ride-through. According to various entities, the additional analyses needed to take these scenarios into account will increase the time, cost and complexity of wind plant interconnections and could be a barrier to their development. 10

10. Furthermore, ATC asserted that the case-by-case approach imposes the responsibility for resolving reliability concerns that arise in the future on the Transmission Provider because wind generating plants cannot be retrofitted with low voltage ride-through capability. Similarly, NRECA/APPA argued that this approach unduly discriminates in favor of wind plants in that low voltage ride-through capability may not be “necessary” (and therefore required) for a specific plant because other generators or Transmission Providers can “make up the difference.”  11 ATC also contended that the case-by-case approach may require the Transmission Provider to incur capital costs that should have been incurred by the wind plant.

11. EEI and NU argued that the case-by-case approach adopted by the Commission in the Final Rule “lowers the bar for reliability.”  12 NERC similarly asserted that requiring Transmission Providers to justify common elements of good utility practice on a case-by-case basis is unwise and may deter Transmission Providers from implementing and following good utility practice. 13 Southern Company states that the Transmission Provider, as the entity responsible for maintaining reliability, should not bear the burden of proof to establish what is required to maintain system reliability. Southern Company states that it supports the Commission's statement that Transmission Providers should not be permitted to require wind plants to install costly equipment that is not needed for reliability, but argues that the burden of proof should be shifted, and the System Impact Study should establish that such equipment is not required. Also, NRECA/APPA argued that the case-by-case approach imposes unreasonable reliability risks, and effectively voids the requirement that wind plants have low voltage ride-through capability “in a broad range of circumstances.”  14

12. Those requesting rehearing raised several other arguments regarding the case-by-case approach and burden of proof for applying the low voltage ride-through standard. NERC believed that the case-by-case approach could unintentionally create a “patchwork” of varying requirements. EEI and NU also suggested that requiring a showing of need may introduce prolonged uncertainties into the interconnection process if parties disagree as to the study assumptions. SCE asserted that rather than limiting opportunities for undue discrimination, the requirement of a showing of need could result in discriminatory treatment in areas with large amounts of wind generation because projects lower in the queue may be responsible for additional costs since the need for low voltage ride-through could not be demonstrated for earlier projects. EEI contended that Order No. 2003 already contains provisions allowing the parties to an interconnection to exercise their discretion in complying with system reliability obligations, and that there is no evidence of problems with these procedures that justifies such a significant departure from them in the Final Rule. Further, EEI argued that the Final Rule was a significant departure from the NOPR and that the Commission should not adopt it without providing an opportunity for comments on it. Finally, NRECA/APPA argued that the Commission has not explained how this approach is consistent with NERC and WECC standards.

13. Certain requests for rehearing and clarification also addressed the specific low voltage ride-through standard adopted by the Commission in the Final Rule. In its request for rehearing, NERC asserted that the standard in Figure 1 of the Final Rule is not appropriate. More specifically, NERC contended that Figure 1, by allowing a wind plant to disconnect from the transmission system when the voltage drops below 15 percent of the nominal voltage, could result in violation of NERC Reliability Standard TPL-002-0. This standard requires transmission planners to ensure that the system will remain stable and within applicable thermal and voltage ratings, with no loss of demand or curtailment of firm transfers, where there is a normally cleared fault on a single element, which is typically four to eight cycles or 0.067 to 0.133 seconds (67 to 133 milliseconds). According to NERC, a fault occurring on a transmission line near a wind plant could cause the voltage at that point to drop to zero for this clearing time. NERC stated that because Figure 1 would allow the wind plant to disconnect when the voltage drops below 15 percent of the nominal voltage, the loss of the single grid element (the transmission line) would be compounded by the loss of the real power (and any reactive power) produced by the wind plant. This “double contingency event” (loss of both the transmission line and wind plant) violates Reliability Standard TPL-002-0, NERC asserted.

14. To remedy this problem, NERC requested that the Commission simply require wind plants to meet NERC and regional reliability council requirements. 15 Alternatively, NERC argued that the rule should be modified to require wind plants to remain connected through a normally cleared single line to ground or three phase fault. Specifically, NERC asserted that Figure 1 should be altered to require a wind plant to remain online for 0.167 seconds (167 milliseconds), or ten cycles, if voltage at the high side of the wind plant step-up transformer is reduced to zero. After 0.167 seconds (167 milliseconds), but before 0.625 seconds (625 milliseconds), NERC argued that Figure 1 should require the wind plant to stay connected as long at the voltage is at or above 15 percent of the nominal voltage. NERC contended that these modifications would reduce the risk to the reliability of the electric system to an acceptable level. 16

15. Similarly, NU asserted that wind plants should be required to “remain on-line for all faults cleared by normal operation of all protective equipment unless clearing the fault * * * isolates the plant from the rest of the grid.”  17 According to NU, this change would require generators to have low voltage ride-through capability down to zero percent of the nominal voltage at the Point of Interconnection. CenterPoint also contend that wind plants should be required to maintain low voltage ride-through capability down to zero percent of the rated line voltage 150 milliseconds (.150 seconds) (the time generally needed for the transmission system protective equipment to clear the fault). NU and CenterPoint argued that this change would reduce the likelihood that a low voltage event would escalate to a cascading outage or voltage collapse. NU also asserted that this requirement is similar to those applicable to other generators, and could be achieved by wind turbines that are currently available. NU stated that the standard adopted in the Final Rule would threaten reliability by allowing a wind plant to reduce output, or trip offline, simply due to a typical system fault.

16. NRECA/APPA also objected to the low voltage ride-through standard adopted in the Final Rule. Specifically, they contended that the Final Rule should not have established the low voltage ride-through curve as an absolute standard, and instead should have permitted Transmission Providers to adopt an alternative curve (subject to review by the Commission if there is a dispute) when the System Impact Study shows that it is necessary. ISO-NE, going further, requested that if the Commission adopted a low voltage ride-through standard, it should be only a guideline for wind turbine manufacturers. NRECA/APPA asserted that the Final Rule did not conclude that the low voltage ride-through standard will protect reliability or address the technical concerns raised by comments, and, by stating that the Commission might consider an alternative low voltage ride-through standard, recognizes that it may not be adequate to preserve reliability in all circumstances. Alternatively, NRECA/APPA asked that the Commission clarify that Transmission Providers may support variations from the low voltage ride-through curve in the Final Rule, based on local and subregional reliability conditions, under the three variation standards adopted in the Final Rule.

17. EEI asserted that the technical challenges presented by wind generation are being considered by the industry worldwide, and that many international standards differ from the Commission's Final Rule. Both EEI and SCE objected to the specific low voltage ride-through standard through comparison to the German interconnection guidelines. Particularly, EEI noted that the German grid code requires wind plants to remain connected to the grid following a fault that results in the voltage at the Point of Interconnection dropping to 15 percent of the nominal voltage for as long as 0.15 seconds. According to EEI, revisions to the German grid code are nearing completion that will require wind plants to remain connected to the transmission system following a fault that drops the voltage at the Point of Interconnection to zero percent of the nominal voltage for as long at 0.15 seconds. Further, EEI reported that the Hydro-Québec requirements for wind farm interconnection are stricter than the Commission's Final Rule; they require wind plants to ride through a fault resulting in a voltage drop to zero percent of nominal voltage for as long as 0.15 seconds. Finally, EEI noted that Ireland requires wind plants to stay online after a fault that drops the voltage to 15 percent of nominal voltage for as long as 0.15 seconds. SCE additionally asserted that the requirement that low voltage ride-through be shown to be necessary in the System Impact Study conflicts with the German wind interconnection guidelines because those guidelines assume that all generation will meet the low voltage ride-through standard. SCE stated that the Final Rule should adopt low voltage ride-through capability as a governing standard, with exceptions approved by the governing technical body (NERC or the Western Electricity Coordinating Council (WECC), a regional reliability council), as in the German standard.

18. In the Final Rule, the Commission stated that “the low voltage ride-through requirement, and the time periods and associated voltage levels set forth in Appendix G, Figure 1, apply to three-phase faults.” ATC sought clarification as to whether the low voltage ride-through requirement applied only to three-phase faults. Assuming that is the case, ATC asked whether there was a requirement for single-phase and double-phase faults.

19. NERC argued on rehearing that because the Point of Interconnection may be some distance from a wind plant, the plant might actually disconnect at voltages higher than 15 percent of the nominal voltage at the high side of the wind plant step-up transformer. According to NERC, this could create a further risk of a double contingency event. 18 To avoid this risk, NERC contended that low voltage ride-through capability should be measured at the high voltage terminal of the wind plant step-up transformer. Southern Company stated that a revision to section A.i.2 of the LGIA Appendix G was necessary to reflect the Commission's decision in the Final Rule to adopt the Point of Interconnection as the measurement point.

20. SCE noted that while the Final Rule adopted a low voltage ride-through standard based on the German wind interconnection guidelines, the Commission did not adopt the related requirements in the German guidelines. It noted several provisions of the German guidelines that it stated go hand-in-hand with the low voltage ride-through standard. 19 SCE asked the Commission to clarify that Transmission Providers may implement these other guidelines in the German standard.

21. As noted above, NERC filed a request for rehearing of the Final Rule contending, in part, that the specific low voltage ride-through standard adopted by the Commission would permit violations of a NERC system performance standard. 20 On August 4, 2005, NERC and AWEA filed a request to extend the effective date of the Final Rule to allow for discussions to resolve the reliability concerns expressed by NERC. They committed to submitting to the Commission a joint final report on their discussions. On August 5, 2005, the Commission issued an order granting this request. 21

22. On September 19, 2005, NERC and AWEA submitted their joint final report, which recommended revisions to the low voltage ride-through provisions of the Final Rule. They state that the recommended revisions are supported by the NERC Planning Committee and AWEA members. NERC states that the concerns expressed in its request for rehearing will be resolved if the Commission adopts the recommended revisions.

23. Specifically, NERC and AWEA recommend a different low voltage ride-through section to be inserted in Appendix G. The recommended provisions include a transition period standard, which would apply to wind plants that either: (a) Have interconnection agreements signed and filed with the Commission, filed with the Commission in unexecuted form, or filed with the Commission as non-conforming agreements between January 1, 2006 and December 31, 2006, with a scheduled in-service date no later than December 31, 2007; or (b) involve wind turbines subject to a procurement contract executed before December 31, 2005 for delivery through 2007. During this transition period, wind plants would be required to ride through low voltage events down to 0.15 per unit for normal clearing times up to a maximum of nine cycles.

24. Following this transition period, the NERC/AWEA proposal would require wind plants to ride through low voltage events down to a zero voltage level for “location-specific” clearing times up to a maximum of nine cycles. If the fault on the transmission system remained after this clearing time, the joint recommendation would permit the wind plant to disconnect from the system.

25. Under the joint recommendation of NERC and AWEA, during both the transition period and after, low voltage ride-through capability would be required for all new wind plant interconnections, instead of only when the System Impact Study shows that such capability is needed for safety or reliability, as in the Final Rule. Additionally, in both cases the point of measurement for the requirement would be at the high side of the wind plant step-up transformer, instead of at the Point of Interconnection, as in the Final Rule. NERC and AWEA also recommend eliminating Figure 1 during both the transition period and after the transition period because the low voltage ride-through standard described in their Joint Report replaces the voltage trace represented by Figure 1.

26. Finally, NERC and AWEA recommend limiting the variations to the low voltage ride-through provisions that were permitted by the Final Rule. The Final Rule permits Transmission Providers to justify variations between their pro forma tariff and the Final Rule Appendix G based on the regional reliability, the “consistent with or superior to,” or the independent entity variation standards in Order No. 2003. 22 NERC and AWEA recommend that variations to their proposed low voltage ride-through provisions be permitted on an interconnection-wide basis only, reasoning that such a limitation is appropriate because the provisions are intended to satisfy a NERC reliability standard, and because wind generators could incur significant additional costs if they had to meet many different standards. NERC and AWEA note that limiting variations would not restrict the ability to request a deviation in a specific non-conforming agreement filed with the Commission (as opposed to a variation built into a pro forma tariff).

27. The Commission issued notice of the NERC/AWEA joint report on September 21, 2005, and provided interested parties with the opportunity to submit comments on or before October 3, 2005. FPL Energy, National Grid, New York ISO and PJM all filed comments supporting the technical recommendations in the joint report.

28. National Grid also asks that the Commission make two clarifications. First, it asks the Commission to clarify that while the point of measurement for compliance with the low voltage ride-through standard would be at the high side of the step-up transformer, the point of measurement for reactive power would remain at the Point of Interconnection. Second, National Grid requests that the nine cycle maximum clearing time in the low voltage ride-through provision applies only to three-phase faults. It says that single line-to-ground faults are typically much longer than nine cycles, so a general, non-specified standard is more appropriate for such faults.

29. New York ISO, while strongly supporting the technical aspects of the NERC/AWEA joint recommendations, urges the Commission to reject the proposal that variations to the low voltage ride-through provision be permitted only on an interconnection-wide basis or through individually-filed interconnection agreements. It argues that this could hamper efforts to preserve reliability in individual regions, and asserts that satisfying NERC planning standards is not sufficient to preserve reliability because New York State, as well as other regions, sometimes need more stringent reliability requirements than those of NERC. New York ISO says that the Commission has viewed NERC's criteria as being minimum reliability requirements, which individual regions may exceed if necessary. Therefore, New York ISO argues that at a minimum, the Commission should permit independent entities to seek variations from the low voltage ride-through standards recommended by NERC and AWEA.

30. Finally, New York ISO asks the Commission to clarify that, assuming the NERC/AWEA recommendations are adopted, the “filing date” for purposes of the proposed transition period includes the date that conforming interconnection agreements are fully and finally executed. New York ISO notes that executed conforming agreements need not be filed with the Commission. Therefore, it contends that the transition period should apply to agreements executed within its timeframe but not filed with the Commission.

31. The Commission grants rehearing with regard to the low voltage ride-through provisions, and adopts the joint recommendation of NERC and AWEA without modification. This provides a standard that will ensure that wind plants are interconnected to the grid in a manner that will not degrade system reliability. Furthermore, this standard satisfies the reliability concerns expressed by NERC, and either satisfies or renders moot many of the rehearing requests described above, including those related to the case-by-case application of the low voltage ride-through standard and point of measurement for the low voltage ride-through standard. Additionally, the joint recommendation also responds to the arguments on rehearing of EEI and SCE regarding comparison to the German interconnection guidelines.

32. We are eliminating Figure 1 from Appendix G because the standard we are adopting in Appendix G replaces that figure. Accordingly, all references to Figure 1 in the preamble to the Final Rule should be read to apply to the standard now described in Appendix G.

33. We also adopt the NERC/AWEA proposal to permit variations to the low voltage ride-through provisions of Appendix G only on an interconnection-wide basis. The low voltage ride-through provisions we adopt in this order on rehearing were crafted specifically, after negotiation among the wind industry and NERC, to ensure that NERC Reliability Standard TPL-002-0 is met in all regions. While other interconnection standards may be more susceptible to variation among Transmission Providers or independent entities, the close connection of this standard to an industry-wide reliability standard persuades us that limiting variations to those made on an interconnection-wide basis will best ensure that reliability is protected. Accordingly, we reject SCE's request that we clarify that Transmission Providers may implement other guidelines from the German interconnection standard. Adoption of other guidelines from the German standard on a Transmission Provider-specific basis could result in varying requirements that may not meet established reliability standards. For the same reasons, we also reject New York ISO's assertion that the Commission should continue to permit variations to the low voltage ride-through provisions under the three variation standards in the Final Rule, and particularly the independent entity variation. We note, however, that under section 1211 of the Energy Policy Act of 2005, the State of New York “may establish rules that result in greater reliability within that State, as long as such action does not result in lesser reliability outside the State than that provided by the reliability standards.”  23 Therefore, the Commission will consider proposed variations from the State of New York under this statutory provision.

34. In response to the arguments of NRECA/APPA that the Final Rule should have permitted Transmission Providers to adopt alternative low voltage ride-through standards, and ISO-NE's contention that the standard in the Final Rule should be only a guideline, we find that the definitive standard we adopt here will provide certainty to wind developers and manufacturers and ensure that reliability is maintained and NERC planning standards are met. If another standard is necessary for a specific wind plant interconnection to maintain reliability, a non-conforming agreement may be filed with the Commission.

35. In response to ATC and National Grid, we clarify that the low voltage ride-through provisions we are adopting apply to all types of faults, not just to three-phase faults. The standard refers to three-phase faults with normal clearing as well as single line to ground faults with delayed clearing. In response to National Grid's specific concern, we clarify that the nine cycle maximum clearing time expressed in the low voltage ride-through provisions applies only to three-phase faults. Single line to ground faults have typically much longer clearing times, as National Grid notes, and the low voltage ride-through provisions adopted here recognize this difference by specifically referring to “single line to ground faults with delayed clearing.” This non-specified standard is appropriate for those types of faults.

36. In the Final Rule, the Commission adopted in Appendix G to the LGIA a power factor standard applicable to wind plants. The Final Rule provides that wind plants are required to meet this standard only if the Transmission Provider shows, in the System Impact Study, that reactive power capability is necessary to ensure the safety or reliability of the transmission system. The specific power factor standard in Appendix G to the LGIA, if applicable, requires a wind plant to maintain a power factor within the range of 0.95 leading to 0.95 lagging (hereinafter +/−0.95), to be measured at the Point of Interconnection.

37. Requests for rehearing and/or clarification of these provisions concern whether wind plants should have to maintain a required power factor only where the System Impact Study shows that it is required for reliability or safety, and whether the power factor standard and point of measurement adopted by the Commission in the Final Rule are appropriate.

38. Several entities object to the provisions in the Final Rule that require wind plants to maintain the required power factor only when the Transmission Provider, in the System Impact Study, shows that it is necessary to ensure safety or reliability. NERC objects to this approach because it may deter Transmission Providers from implementing and following good utility practice and could create a “patchwork” of varying requirements. NU argues that this approach “lowers the bar for reliability,” and will add complexity, cost and delay to the generator interconnection process because Transmission Providers will be required to perform more studies to determine whether reactive power capability is necessary for reliability or safety. Southern Company states that the Transmission Provider, as the entity responsible for maintaining reliability, should not bear the burden of proof to establish what is required to maintain system reliability. It supports the Commission's statement that Transmission Providers should not be permitted to require wind plants to install costly equipment that is not needed for reliability, but argues that the burden of proof should be shifted to the generator.

39. NRECA/APPA notes that traditional generators are required to meet the power factor standard not because reactive power is needed in every case to preserve reliability, but instead because the transmission system is dynamic and requires flexibility over time to maintain reliability. They state that the need for reactive power in the future under a variety of operating conditions cannot be determined with perfect certainty in the System Impact Study. The case-by-case approach, they contend, grants an undue preference to wind plants, imposes risks to system reliability, and shifts costs to consumers and other generating plants. The risk to system reliability is that the Final Rule may only require a wind plant to provide reactive power after other wind plants have been installed without such capability, and that at that point the resources from that single plant may not be enough to protect the transmission system. NRECA/APPA also asserts that the case-by-case approach increases uncertainty, contrary to the Commission's conclusion in the Final Rule, because each wind plant will face different requirements based on the outcome of the System Impact Study. Additionally, it contends that this approach creates more opportunities for discrimination because it would permit wind plants to be treated differently.

40. ATC contends that the Commission has offered no guidance as to what power factor range would be acceptable if a reliability need is not identified (and thus reactive power is not required), and whether wind plants in this instance must operate within any particular reactive power operating band. Similarly, NU expresses concern that wind plants could operate at any power factor in the absence of a showing of need in the System Impact Study, and thus avoid a physical requirement for delivering power onto the transmission system. According to ATC, the rule could be interpreted to permit wind plants to operate at any power factor they choose. It claims that reactive power is needed for each generator, and that each generator should be obligated to operate within a range of power factors, regardless of whether the transmission system as a whole needs additional reactive power capability. ATC recommends that at a minimum, the Commission require all wind plants to meet a power factor range of 0.95 leading to 1.0 (unity), and allow the Transmission Provider to require a range of 1.0 (unity) to 0.95 lagging if the System Impact Study shows that there is a reliability need.

41. The Commission will not modify the Final Rule to require wind plants to meet the power factor standard without a showing by the Transmission Provider, through the System Impact Study, that it is needed for safety or reliability. The case-by-case approach to a reliability needs assessment adopted in the Final Rule will not threaten reliability, as several of those seeking rehearing argue. As we noted in the Final Rule, if reactive power is necessary to maintain the safety or reliability of the transmission system, the System Impact Study performed by the Transmission Provider will establish that need. 24 We stated in the Final Rule, and reiterate here, that the System Impact Study is the appropriate study for determining whether reactive power capability is needed. 25 Furthermore, we reasoned in the Final Rule that requiring wind plants to maintain the power factor standard only if the System Impact Study shows it to be necessary will not only ensure that increased reliance on wind power will not degrade system safety or reliability, but also will limit opportunities for undue discrimination by ensuring that Transmission Providers do not require costly equipment that is not necessary for reliability. 26

42. NERC states that the decision in Order No. 661 to use a case-by-case approach may deter Transmission Providers from following Good Utility Practice, and may have the unintended consequence of spawning a patchwork of varying requirements. We agree with NERC that Transmission Providers must follow Good Utility Practice when interconnecting all generating plants, including wind plants, and that not following Good Utility Practice when performing System Impact Studies could lead to problems. However, the Commission points out that every Transmission Provider is required under Order No. 2003 to follow Good Utility Practice. Transmission Providers are required to complete a detailed System Impact Study, and are required to ensure that NERC reliability standards are met in all instances. This includes performing studies to determine what is necessary to ensure that the interconnection of a wind generating facility does not degrade grid reliability. The Commission recognizes that the industry (and particularly NERC) is continuing to address technical issues involved in the interconnection of wind plants. If NERC through its stakeholders and Board approval process develops a new standard, the Commission will entertain such a standard. Finally, we disagree with NRECA/APPA's suggestion that the Final Rule threatens the reliability of the transmission system because it may require only wind plants later in the queue to provide reactive power, which may not be sufficient to protect the grid. The System Impact Study will take into account the system's need for reactive power, both as it exists today and under reasonable anticipated assumptions. NRECA/APPA has not explained how assessing the need for reactive power through the System Impact Study process will result in too little reactive power being available in the future. Whenever a new generator is added to its system, the Transmission Provider must complete a new System Impact Study to ensure that reliability requirements are met; this may require a new wind generator later in the queue to meet the reactive power requirement.

43. We also reject arguments that the case-by-case approach is inappropriate because of the dynamic nature of the transmission system. The fact that the transmission system is constantly changing is not new or unique to the study of wind plant interconnections. The studies that are part of the interconnection process should take into account likely circumstances that could occur on the Transmission Provider's system, whether the studies are conducted in connection with a proposed wind plant or another type of generating facility.

44. Furthermore, we are not persuaded that the approach adopted in the Final Rule will result in additional studies, increased costs and delays, and cost shifts. First, as noted previously, the System Impact Study, as well as the other interconnection studies, should take into account a variety of assumptions concerning anticipated transmission system conditions. If additional or expanded studies are needed to determine whether the power factor standard is necessary, the Commission does not believe that the additional burden will outweigh the cost considerations underlying the case-by-case approach. Finally, although the case-by-case approach may result in some delay, we remind the parties to a wind plant interconnection, like other interconnections, that they are still required to meet the milestones set forth in the LGIP. Any increased costs from completing expanded or additional studies within the timeframe required by this rule will be borne by the wind plant Interconnection Customer, as provided in Order No. 2003, which will leave other generators and the Transmission Provider unharmed.

45. The Commission also rejects arguments that the case-by-case approach provides more opportunities for discrimination. As we noted in the Final Rule Appendix G was adopted to take into account the technical differences between wind plants and traditional generating plants. One of these differences is that for wind plants, reactive power capability is a significant added cost, while it is not a significant additional cost for traditional generators. Given these technical differences, treating wind plants differently with regard to reactive power requirements is not unduly discriminatory or preferential. Additionally, we note that the outcome of the System Impact Study, which determines whether reactive power will be required, can be challenged, which will serve to minimize the opportunities for discrimination by the Transmission Provider. Also, the wind plant Interconnection Customer will have recourse to the Commission if it believes the Transmission Provider has acted in a discriminatory manner.

46. The Commission declines to adopt ATC's request that all wind plants, at a minimum, operate within a power factor range of 0.95 leading to 1.0 (unity). This requirement would essentially require reactive power in every case, which we have already rejected. If reactive power capability is needed, including a power factor range of 0.95 leading to 1.0 (unity), the System Impact Study will demonstrate this need.

47. NRECA/APPA argues that the Commission should clarify that wind generators must meet the same reactive power requirements as other generators, provided the requirements are imposed in a nondiscriminatory manner. It notes that some Transmission Providers impose a power factor range wider that +/−0.95 on all new generation, and argues that in such cases, the same range should be applied to wind plants. It argues that not imposing the same range threatens reliability and shifts the costs of preserving reliability to customers or competing generators.

48. EEI and NU assert that wind plants should regulate voltage to a set point established by the Transmission Provider, as do synchronous generators. EEI contends that the language it offered in its initial comments would provide this necessary clarity, while also maintaining the flexibility provided in Order No. 2003 so that individual, site-specific conditions may be addressed. 27 NU states that wind turbines have this capability, either inherently (doubly fed induction generators) or through external equipment.

49. NRECA/APPA also expresses concern that the phrase “taking into account any limitations due to voltage level, real power output, etc.” in the power factor requirements section of Appendix G could create operational problems for Transmission Providers with wind plants on their systems. Specifically, it is concerned that this language could exempt wind plants from their reactive power requirements during startup and low output periods, which could degrade reliability during a system contingency.

50. With regard to NRECA/APPA's request for clarification that wind generators must meet a wider power factor range because some Transmission Providers impose a power factor range wider that +/−0.95 on all new generation, we note that if we were to allow the Transmission Provider to impose a wider power factor range as a matter of routine, that would defeat the purpose of adopting a reactive power standard for wind generators. However, we note that if the System Impact Study shows the need for a power factor range wider than +/−0.95 for safety or reliability, the Transmission Provider must file a non-conforming agreement, as Order No. 2003 permits. The Commission will consider these non-conforming agreements on a case by case basis. If a Transmission Provider has a different power factor range in its LGIA and wishes to apply that same range in Appendix G, it may seek a variation from the Commission under the variation standards approved in the Final Rule. 28 We remind Transmission Providers, however, that the Commission has adopted a specific power factor standard for wind plants because of their technical differences. Any proposed variations will be viewed in light of these technical differences.

51. In response to the assertion of EEI and NU that wind plants should regulate voltage to a set point established by the Transmission Provider, we note that in the Final Rule we concluded that article 9.6.2 of the LGIA (which applies to all plants, including wind plants) already requires that the “Interconnection Customer * * * operate the Large Generating Facility to maintain the specified output voltage or power factor at the Point of Interconnection.”  29

52. Finally, the Commission addressed in the Final Rule the concerns raised by NRECA/APPA regarding the phrase “taking into account any limitations due to voltage level, real power output, etc.” We stated that this language was necessary due to the technical limitations of wind generating technology. 30 We noted that all wind generating equipment vendors cannot meet the required power factor range at all levels of output. We reiterate that these technical differences make the disputed language necessary. Furthermore, without this language, a Transmission Provider could discriminate against a wind plant by requiring that it operate at the stated power factor at voltages where it is technically infeasible to do so.

53. National Grid asks that if the Commission adopts the recommended revisions to the low voltage ride-through provisions filed jointly by AWEA and NERC, it clarify that while the point of measurement for compliance with the low voltage ride-through standard would be at the high-side of the step-up transformer, the point of measurement for reactive power is at the Point of Interconnection.

54. We clarify that the point of measurement for the reactive power standard is at the Point of Interconnection.

55. In the Final Rule, the Commission adopted special interconnection procedures that allow the wind plant Interconnection Customer, when completing the Interconnection Request form required by section 3.3 of the LGIP, to provide the Transmission Provider with a simplified set of preliminary data depicting the wind plant as a single equivalent generator. 31 Once the wind generator has provided this data and satisfied all other applicable Interconnection Request conditions, the special procedures permit the wind plant to enter the queue and receive the base case data as provided for in the LGIP. Finally, the special procedures adopted in the Final Rule require the wind plant Interconnection Customer to submit, within six months of submitting the Interconnection Request, completed detailed electrical design specifications and other data (including collector system layout data) needed by the Transmission Provider to complete the System Impact Study.

56. Southern Company argues on rehearing that these provisions give wind developers a special preference that unfairly disfavors other generating technologies.

57. EEI, NU and Southern Company contend that the “self-study” provisions of the Final Rule will add further complexity and uncertainty to the queue process and make queue management and assignment of cost responsibilities more difficult for Transmission Providers with large wind-powered generation projects in their queue. Southern Company adds that the self-study provisions could increase costs to market participants because the Transmission Provider will have to run multiple studies. EEI argues that until the industry can fully address the issues raised by these provisions in a technical forum, the Commission should remove the provisions from Appendix G. EEI and NU assert that the provisions do not protect against a wind plant Interconnection Customer making significant revisions to its project proposal. If the Commission does not remove the provisions entirely, EEI and NU suggest that the Commission allow the Transmission Provider to determine whether the detailed electrical design specifications later submitted by the wind plant Interconnection Customer are a material modification to the initial proposal, which would result in the initial Interconnection Application being withdrawn.

58. Midwest ISO agrees with the Commission that a wind plant should be able to enter the queue and receive base case data based on preliminary design specifications. However, it seeks rehearing of the provision that permits a wind plant to wait up to six months before submitting final design specifications. It argues that this procedure promotes inefficiency because the Transmission Provider may be able to evaluate the proposed interconnection, but cannot do so because it lacks necessary data. Midwest ISO requests that the Commission revise the Appendix G self-study provisions to permit the Transmission Provider to notify the wind plant Interconnection Customer of its intent to start the System Impact Study. Once this notice is given, the wind plant developer would have five business days to “submit either actual design specifications or generic specifications based on typical equipment used in the industry.”  32 Further, Midwest ISO proposes that if the wind plant Interconnection Customer submits generic specifications, it should have to accept cost uncertainty, because additional facilities may be required when the actual design specifications are taken into account. Midwest ISO asserts that this would limit delays in the study process and would allow the Transmission Provider to identify potential problems or eliminate tenuous or technically deficient projects earlier and to better use its resources to study proposed interconnections.

59. The Commission will deny these requests for rehearing. We will make one minor revision to label these special interconnection procedures for wind plants as “Appendix 7” to the LGIP, as discussed in more detail below.

60. In response to arguments that the self-study procedures for wind plants give these plants a preference, we reiterate that these procedures were developed to recognize the technical differences of wind plants. Unlike conventional generators, wind plant design specifications and configurations can change significantly based on their placement on the transmission system. 33 For example, the placement of wind turbines, voltage support devices, transformers, and other equipment (including the layout of the medium voltage collector system) depend on the location of the wind plant, the location of other generators on the transmission system, and other information included in the base case data. 34 To accommodate these differences, the Final Rule permits wind plants to enter the interconnection queue with a set of preliminary electrical design specifications depicting the wind plant as a single generator, instead of providing detailed design specifications as required by Order No. 2003. Treating wind plants differently in this regard is not unduly discriminatory or preferential, but as noted elsewhere, simply recognizes that wind plants have different technical characteristics than the more traditional forms of generation that the LGIP and LGIA were designed to accommodate. We continue to believe that without this reasonable accommodation, Transmission Providers could frustrate the interconnection of wind plants by requiring them to submit detailed design data, which they cannot do until later in the interconnection process.

61. We are not persuaded that the reasonable self-study provision we adopted will make the interconnection queue process significantly more difficult or complex. Wind plant Interconnection Customers who provide the preliminary single generator equivalent data are required to provide final detailed electrical design specifications no later than six months after submitting the initial Interconnection Request. This six-month time period takes into account the procedures needed before the start of the System Impact Study, including the Feasibility Study and negotiation of study agreements. Therefore, the Transmission Provider will receive from the wind plant the detailed design information needed to conduct the System Impact Study. For this reason, we also deny Midwest ISO's request to modify the six-month deadline. If we adopted Midwest ISO's proposed modifications, the Transmission Provider could request that the wind plant provide detailed design specifications at any time it believes it is ready to begin the System Impact Study, even a day after the initial Interconnection Request is submitted. As a result, this modification would defeat the purpose of permitting wind plants to submit preliminary design specifications, and could allow Transmission Providers to frustrate the interconnection of wind plants.

62. With respect to the alternative suggestion by EEI and NU that the Transmission Provider be permitted to determine that a detailed design specification later submitted by the wind plant Interconnection Customer is a material modification of the Interconnection Request, we note that section 4.4 of the LGIP already addresses modifications and will apply to wind plants as well as other generating technologies. When applying this section to wind plant Interconnection Requests that first submit preliminary design specifications, Transmission Providers are not to consider the detailed design data provided later by the wind plant Interconnection Customer to be a material modification unless it significantly departs from the preliminary specifications provided. In other words, the detailed design provided later should be substantially the same as the initial single-generator equivalent design in terms of its costs and effect on the transmission system.

63. Finally, to avoid confusion, the Commission will rename the Appendix G to the LGIP it adopted in the Final Rule as “Appendix 7, Interconnection Procedures for a Wind Generating Plant.” Accordingly, when complying with the Final Rule and this order on rehearing, public utilities must adopt the special interconnection procedures applicable to wind plants as Appendix 7 to their LGIPs. The low voltage ride-through, power factor design criteria and SCADA provisions should continue to be labeled “Appendix G” to the LGIA.

64. EEI and NU each generally argue that the Commission should apply Appendix G only on an interim basis, and should defer to NERC and Institute of Electrical and Electronics Engineers (IEEE) processes to develop formal technical standards. Southern Company argues that the Commission should defer to NERC, regional reliability councils, and other technical organizations to develop technical requirements for wind plants, and should suspend application of the Final Rule and formally request that these entities develop technical standards. Southern Company argues that this would avoid the problems that result from having the Commission review each variation to Appendix G as the technical standards are developed and revised. It also asserts that the Commission should not be the arbiter of technical disputes, such as the outcome of the System Impact Study or specific SCADA requirements, as the Final Rule provides.

65. As noted above, NERC similarly argues that the Commission should only require wind plants to meet NERC and regional reliability council requirements, noting that Figure 1 is likely to remain static over time, which could hamper the development of wind generator technology. EEI notes that NERC has established a Wind Generator Task Force that is examining existing standards and will make proposals later this year. It states that the industry worldwide is addressing technical challenges presented by wind generation. Significant modifications are being developed for the German grid code, and Hydro-Que bec is considering several reliability issues regarding wind generator interconnection. NERC further notes that Hydro-Que bec requires the same dynamic performance of wind plants that it requires of other generating facilities, and that major wind turbine manufacturers have shown that they can meet this requirement. EEI proposes that the industry conduct a technical forum to resolve issues related to wind plant interconnection, concluding with formal recommendations to the Commission that could be used in a new NOPR, or to develop formal proposals for NERC or IEEE standards.

66. The Commission denies these requests for rehearing, and others noted earlier, that ask us to adopt Appendix G only on an interim basis. Standards are needed today because no nationwide standard is currently in place and it is uncertain when such a standard will be finalized. Without a firm standard in place, the current ad hoc practices for wind interconnection requirements may frustrate the interconnection of wind plants. As we noted in the Final Rule, Appendix G is necessary to recognize the technical differences between wind plants and traditional plants to ensure that the entry of wind generation into markets is not unnecessarily inhibited.

67. We recognize, however, that the industry continues to study and address issues raised by the interconnection and operation of wind plants. For that reason, the Commission stated in the Final Rule that if another entity develops an alternate standard, a Transmission Provider may seek to justify adopting it as a variation from Appendix G. 35 We also stated that we would consider a future industry petition to revise Appendix G to conform to a NERC-developed standard. 36 We reiterate both of those statements here, and also note that under the Energy Policy Act of 2005, the Commission will be addressing mandatory reliability standards. 37

68. In the Final Rule, the Commission adopted a transition period that applies to the low voltage ride-through, power factor design criteria and SCADA requirements. These technical requirements in the Final Rule Appendix G, if applicable, apply only to LGIAs signed, filed with the Commission in unexecuted form, or filed as non-conforming agreements, on or after January 1, 2006, or the date six months after publication of the Final Rule in the Federal Register , whichever is later. 38 The Commission adopted this transition period to allow wind equipment currently in the process of being manufactured to be completed without delay or added expense, and to ensure that the Final Rule did not interrupt the supply of wind turbines.

69. NRECA/APPA argues that the transition period is arbitrary, capricious, and unduly discriminatory. NRECA/APPA asserts that the Commission adopted the transition period with no technical justification and no explanation of how the transition period will maintain the reliability of the transmission system. They contend that the transition period requires transmission customers and competing generators to bear the reliability effects of wind plants interconnected during the transition period. While NRECA/APPA state that there are “valid commercial considerations” that should be taken into account for the existing inventory of wind equipment, they contend that such determinations should be made on a case-by-case basis.

70. The Commission declines to remove the transition period as NRECA/APPA request. We adopted this reasonable transition mechanism to allow wind turbines in the process of being manufactured to be completed without delay or additional expense. 39 The transition period ensures that the supply of wind turbines is not unfairly or unreasonably interrupted. 40 Furthermore, contrary to NRECA/APPA's contention, the Commission considered the possible reliability effects of the transition period, and concluded that the remaining provisions of Order No. 2003 will adequately protect reliability. 41 The remaining provisions of Order No. 2003 will also ensure that other generators or the Transmission Provider will not bear the reliability effects of a wind plant because that rule, and the LGIA and LGIP contained in it, ensure that generating facilities are not interconnected in a manner that degrades reliability.

71. In addition to publishing the full text of this document in the Federal Register , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through FERC's Home Page ( http://www.ferc.gov ) and in FERC's Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426.

72. From the Commission's Home Page on the Internet, this information is available in the Commission's document management system, eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.

73. User assistance is available for eLibrary and the Commission's Web site during normal business hours. For assistance, please contact FERC Online Support at 1-866-208-3676 (toll free) or 202-502-6652 (e-mail at FERCOnlineSupport@FERC.gov ), or the Public Reference Room at 202-502-8371, TTY 202-502-8659 (e-mail at public.referenceroom@ferc.gov ).

74. As noted above, on August 5, 2005, the Commission issued an order extending the effective date of the Final Rule to October 14, 2005. 42 Those provisions of the Final Rule not revised in this order on rehearing and clarification are effective as of that date. Changes made to the Final Rule in this order on rehearing and compliance will become effective on January 18, 2006.

75. In the Commission's August 5, 2005 order extending the effective date of the Final Rule, the Commission also extended to November 14, 2005, the date by which all public utilities that own, control, or operate transmission facilities in interstate commerce are to adopt, in their OATTS, the Final Rule Appendix 7 (as described above)  43 as an amendment to the LGIP, and Final Rule Appendix G as an amendment to the LGIA. By further notice issued October 28, 2005, the Commission extended this date further, to December 30, 2005. Public utilities who have already filed a Final Rule Appendix G as amendments to the LGIPs and LGIAs in their OATTs must file, by December 30, 2005, the revisions to the Final Rule Appendix G to the LGIA made in this order on rehearing.

Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 141-087 for QUEST (moxidectin 2.0%) Gel and to NADA 141-216 for QUEST Plus (moxidectin 2.0%/praziquantel 12.5%) Gel. Both products are used for the treatment and control of various species of internal parasites in horses and ponies. The supplements provide for the addition of two new species of adult small strongyles to product labeling. The supplemental NADAs are approved as of November 23, 2005, and 21 CFR 520.1452 and 520.1453 are amended to reflect the approval. The basis of approval is discussed in the freedom of information summaries.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and effectiveness data and information submitted to support approval of these applications 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 (21 U.S.C. 360b(c)(2)(F)(iii)), these approvals qualify for 3 years of marketing exclusivity beginning November 23, 2005. Exclusivity applies only to the effectiveness claim for adult Cylicocyclus radiatus and Petrovinema poculatus for which new data were required.

The agency has determined under 21 CFR 25.33(d)(1) that these actions are of a type that do 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.

Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002, has informed FDA that it has transferred ownership of, and all rights and interest in, the following four approved NADAs, to Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408:

Accordingly, the agency is amending the regulations in 21 CFR 520.2455, 520.2456, and 558.600 to reflect the transfer of ownership and a current format.

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.

On December 13, 1985, FDA proposed to amend the biologics regulations and proposed to classify the bacterial vaccines and toxoids on the bases of findings and recommendations of the Panel. The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. After reviewing the Panel's report and comments on the proposal, FDA published a final rule and final order on January 5, 2004 (69 FR 255). On October 27, 2004, the U.S. District Court for the District of Columbia vacated the January 5, 2004, final rule and final order. On December 29, 2004, FDA published a withdrawal of the January 5, 2004, final rule and final order. Concurrently with the withdrawal of the final rule and final order, FDA published again a proposed rule and proposed order (69 FR 78281) to provide notice and to give interested persons an opportunity to comment.

The purpose of this document is to: (1) Categorize those bacterial vaccines and toxoids licensed before July 1972 according to the evidence of their safety and effectiveness, thereby determining whether they may remain licensed and on the market; 1 (2) issue a final response to recommendations made in the Panel's report. 2 These recommendations concern conditions relating to active components, labeling, tests required before release of product lots, product standards, or other conditions considered by the Panel to be necessary or appropriate for assuring the safety and effectiveness of the reviewed products; and (3) revise the standard for potency of Tetanus Immune Globulin in § 610.21 (21 CFR 610.21).

In the Federal Register of February 13, 1973 (38 FR 4319), FDA issued procedures for the review by independent advisory review panels of the safety, effectiveness, and labeling of biological products licensed before July 1, 1972. This process was eventually codified in § 601.25 (21 CFR 601.25) (38 FR 32048 at 32052, November 20, 1973). Under the panel assignments published in the Federal Register of June 19, 1974 (39 FR 21176), FDA assigned the biological product review to one of the following groups: (1) Bacterial vaccines and bacterial antigens with “no U.S. standard of potency,” (2) bacterial vaccines and toxoids with standards of potency, (3) viral vaccines and rickettsial vaccines, (4) allergenic extracts, (5) skin test antigens, and (6) blood and blood derivatives.

Under § 601.25, FDA assigned responsibility for the initial review of each of the biological product categories to a separate independent advisory panel consisting of qualified experts to ensure objectivity of the review and public confidence in the use of these products. Each panel was charged with preparing an advisory report to the Commissioner of Food and Drugs which was to: (1) Evaluate the safety and effectiveness of the biological products for which a license had been issued, (2) review their labeling, and (3) identify the biological products that are safe, effective, and not misbranded. Each advisory panel report was also to include recommendations classifying the products reviewed into one of three categories.

• Category I, designating those biological products determined by the panel to be safe, effective, and not misbranded.

• Category II, designating those biological products determined by the panel to be unsafe, ineffective, or misbranded.

• Category III, designating those biological products determined by the panel not to fall within either Category I or Category II on the basis of the panel's conclusion that the available data were insufficient to classify such biological products, and for which further testing was therefore required. Category III products were assigned to one of two subcategories. Category IIIA products were those that would be permitted to remain on the market pending the completion of further studies. Category IIIB products were those for which the panel recommended license revocation on the basis of the panel's assessment of potential risks and benefits.

In its report, the panel could also include recommendations concerning any condition relating to active components, labeling, tests appropriate before release of products, product standards, or other conditions necessary or appropriate for a biological product's safety and effectiveness.

In accordance with § 601.25, after reviewing the conclusions and recommendations of the review panels, FDA would publish in the Federal Register a proposed order containing: (1) A statement designating the biological products reviewed into Categories I, II, IIIA, or IIIB, (2) a description of the testing necessary for Category IIIA biological products, and (3) the complete panel report. Under the proposed order, FDA would propose to revoke the licenses of those products designated into Category II and Category IIIB. After reviewing public comments, FDA would publish a final order on the matters covered in the proposed order.

In the Federal Register of November 21, 1980 (45 FR 77134), FDA issued a notice of availability of the Panel's final report. In the Federal Register of December 13, 1985 (50 FR 51002), FDA issued a proposed rule that contained the full Panel report 3 and FDA's response to the recommendations of the Panel (the December 1985 proposal). In the December 1985 proposal, FDA proposed regulatory categories (Category I, Category II, or Category IIIB as defined previously in this document) for each bacterial vaccine and toxoid reviewed by the Panel, and responded to other recommendations made by the Panel. The public was offered 90 days to submit comments in response to the December 1985 proposal.

The definition of Category IIIA as described previously in this document was applied at the time of the Panel's review and served as the basis for the Panel's recommendations. In the Federal Register of October 5, 1982 (47 FR 44062), FDA revised § 601.25, and codified 21 CFR 601.26 which, established procedures to reclassify those products in Category IIIA into either Category I or Category II based on available evidence of effectiveness. The Panel recommended that a number of biological products be placed into Category IIIA. FDA assigned the review of those products previously classified into Category IIIA to the Vaccines and Related Biological Products Advisory Committee. FDA has addressed the review and reclassification of bacterial vaccines and toxoids classified into Category IIIA through a separate administrative procedure (see the Federal Register of May 15, 2000 (65 FR 31003), and May 29, 2001 (66 FR 29148)). Therefore, FDA does not further identify or discuss in this document any bacterial vaccines and toxoids classified into Category IIIA.

FDA received four letters of comments in response to the December 1985 proposal. One letter from a licensed manufacturer of bacterial vaccine and toxoid products concerned the confidentiality of information it had submitted for the Panel's review. As provided in § 601.25(b)(2), FDA considered the extent to which the information fell within the confidentiality provisions of 18 U.S.C. 1905, 5 U.S.C. 552(b), or 21 U.S.C. 331(j), before placing the information in the public docket for the December 1985 proposal. Another comment from a member of the Panel provided an update of important scientific information related to bacterial vaccines and toxoids that had accrued since the time of the Panel's review. The letter did not comment on the December 1985 proposal nor did it contend that the newly available information should result in modification of the Panel's recommendations or FDA's proposed actions. FDA's responses to the comments contained in the remaining two letters follow.

This document amends the Income Tax Regulations (26 CFR part 1) under section 141 of the Internal Revenue Code (Code) by providing rules on the application of the private activity bond tests to refunding issues. This document also amends the Income Tax Regulations under sections 145, 149 and 150 by providing rules on certain related matters.

On May 14, 2003, the IRS published in the Federal Register a notice of proposed rulemaking (REG-113007-99) (68 FR 25845) (the proposed regulations) relating to the matters addressed in this Treasury decision. A public hearing on the proposed regulations was scheduled for September 9, 2003. However, the public hearing was cancelled because no requests to speak were received. Written comments on the proposed regulations were received. After consideration of all the written comments, the proposed regulations are adopted as revised by this Treasury decision (the final regulations). The revisions are discussed below.

In general, under section 103, gross income does not include the interest on any State or local bond. However, this exclusion does not apply to private activity bonds (other than certain qualified bonds). Section 141(a) defines a private activity bond as any bond issued as part of an issue that meets either (1) the private business use test in section 141(b)(1) and the private security or payment test in section 141(b)(2) (the private business tests) or (2) the private loan financing test in section 141(c) (the private business tests and the private loan financing test are referred to collectively as the “private activity bond tests”).

The private business use test is met if more than 10 percent of the proceeds of an issue are to be used for any private business use. Section 141(b)(6) defines private business use as use directly or indirectly in a trade or business that is carried on by any person other than a governmental unit.

The private security or payment test is met if the payment of the principal of, or the interest on, more than 10 percent of the proceeds of an issue is directly or indirectly (1) secured by an interest in property used or to be used for a private business use, (2) secured by an interest in payments in respect of such property, or (3) to be derived from payments, whether or not to the issuer, in respect of property, or borrowed money, used or to be used for a private business use.

The private loan financing test is satisfied if more than the lesser of $5 million or 5 percent of the proceeds of an issue are to be used to make or finance loans to persons other than governmental units.

On January 16, 1997, final regulations (TD 8712) relating to the definition of private activity bonds and related rules under sections 103, 141, 142, 144, 145, 147, 148, and 150 were published in the Federal Register (62 FR 2275) (the 1997 regulations). Under the 1997 regulations, the amount of private business use of property financed by an issue is equal to the average percentage of private business use of that property during a defined measurement period. The measurement period begins on the later of the issue date of the issue or the date that the property is placed in service and ends on the earlier of the last date of the reasonably expected economic life of the property or the latest maturity date of any bond of the issue financing the property (determined without regard to any optional redemption dates). In general, under the 1997 regulations, the amount of private security or private payments is determined by comparing the present value of the private security or private payments to the present value of the debt service to be paid over the term of the issue, using the bond yield as the discount rate. The 1997 regulations reserve § 1.141-13 for rules regarding the application of the private business tests and the private loan financing test to refunding issues.

1. In general. The proposed regulations provide that, in general, a refunding issue and a prior issue are tested separately under section 141. Thus, the determination of whether a refunding issue consists of private activity bonds generally does not depend on whether the prior issue consists of private activity bonds.

Commentators supported this separate testing principle. The final regulations retain this approach.

2. Allocation of proceeds. The proposed regulations provide that, in applying the private business tests and the private loan financing test to a refunding issue, the proceeds of the refunding issue are allocated to the same purpose investments (including any private loan under section 141(c)) and expenditures as the proceeds of the prior issue.

Comments were not received on this allocation provision. The final regulations retain this rule.

3. Measurement of private business use. The proposed regulations generally provide that the amount of private business use of a refunding issue is determined based on the separate measurement period for the refunding issue under § 1.141-3(g) (for example, without regard to any private business use that occurred before the issue date of the refunding issue). Thus, for instance, if an issuer refunds a taxable bond or an exempt facility bond, any private business use of the refinanced facilities before the issue date of the refunding issue is disregarded in applying the private business use test to the refunding issue.

In the case of a refunding issue that refunds a prior issue of governmental bonds, however, the amount of private business use is generally determined based on a combined measurement period. For purposes of the proposed regulations, a governmental bond is any bond that, when issued, purported to be either a governmental bond, as defined in § 1.150-1(b), or a qualified 501(c)(3) bond, as defined in section 145(a). The combined measurement period is the period that begins on the first day of the measurement period (as defined in § 1.141-3(g)) for the prior issue (or the first issue of governmental bonds in the case of a series of refundings of governmental bonds) and ends on the last day of the measurement period for the refunding issue.

As an alternative to the combined measurement period approach, the proposed regulations permit issuers to measure private business use based on the separate measurement period of the refunding issue, but only if the prior issue of governmental bonds does not meet the private business use test during a shortened measurement period. The shortened measurement period begins on the first day of the measurement period of the prior issue (or the first issue of governmental bonds in the case of a series of refundings of governmental bonds) and ends on the issue date of the refunding issue. Whether a prior issue meets the private business use test during the shortened measurement period is determined based on the actual use of proceeds, without regard to the reasonable expectations test of § 1.141-2(d).

Commentators suggested that the proposed regulations be modified with respect to governmental bonds: (1) To delete the shortened measurement period concept; (2) to provide, absent any evidence to the contrary, and subject to general anti-abuse rules, a presumption that an issuer did not exceed the ten percent private business use limit; and (3) to specify that the amount of private business use of the refunding issue is the amount of private business use during either the separate measurement period for the refunding issue or the combined measurement period.

These commentators suggested that a separate measurement period approach would not allow an issuer to increase the amount of private business use without jeopardizing the tax exemption of the prior issue, and thus an issuer generally should be permitted to measure private business use of a refunding issue using a separate measurement period. Nevertheless, these commentators suggested that the regulations include a general anti-abuse rule. They noted, for example, that a separate measurement period approach could permit an issuer to have an additional ten percent of private business use in connection with a refunding issue after the period of limitations for the prior bonds has run. These commentators suggested that, in such a situation, it would be fair to consider the refunding issue to be an abuse if the issuer is deliberately trying to exploit the private business use limit.

The final regulations retain the basic approach of the proposed regulations to measuring private business use. The final regulations do not adopt the suggestions to delete the shortened measurement period concept and to provide that private business use may be measured during either a separate or combined measurement period. These suggestions are not adopted because they could result in more private business use than otherwise would be permitted after the expiration of the period of limitations for the prior issue.

The final regulations do not adopt the suggestion to create a presumption that the private business use limit was not exceeded with respect to prior bonds. It is not clear such a presumption is warranted in all cases.

The final regulations also do not adopt the suggestion to add an anti-abuse rule. The IRS and Treasury Department have concluded that the bright-line rule in the proposed regulations for determining when issuers must apply a combined measurement period and when issuers may apply either a combined measurement period or a separate measurement period is an appropriate methodology for measuring the private business use of a refunding issue and provides more administrative certainty than would be provided by an anti-abuse rule.

Commentators expressed concern regarding an issuer's ability to establish the amount of private business use during a combined measurement period if the period begins a significant amount of time before the refunding bonds are issued. They noted that, in some cases, the refunded bonds may have been issued as many as twenty years or more before the refunding bonds are issued. These commentators stated that document retention policies vary by issuer and retaining or locating the necessary information over such long periods of time may be difficult.

The final regulations apply prospectively and only to refunding bonds that are subject to the 1997 regulations. In general, under § 1.141-15, the 1997 regulations apply to refunding bonds only if, among other requirements, (1) the refunded bonds were originally issued on or after May 16, 1997, (2) the weighted average maturity of the refunding bonds is longer than the weighted average maturity of the refunded bonds, or (3) the issuer chooses to apply the 1997 regulations to the refunding bonds. Thus, the final regulations will not apply to any refunding of bonds originally issued before May 16, 1997, unless the issuer extends the weighted average maturity of the prior bonds or otherwise chooses to have the 1997 regulations apply to the refunding bonds (or an earlier issue of bonds).

In addition, to address commentators' concerns, the final regulations provide transitional relief for refundings of bonds originally issued before May 16, 1997 (the effective date of the 1997 regulations). Specifically, the final regulations provide that, if the prior issue (or, in the case of a series of refundings of governmental bonds, the first issue of governmental bonds in the series) was issued before May 16, 1997, then the issuer, at its option, may treat the combined measurement period as beginning on the date (the transition date) that is the earlier of (1) December 19, 2005 or (2) the first date on which the prior issue (or an earlier issue in the case of a series of refundings of governmental bonds) became subject to the 1997 regulations. This transitional relief, which was not contained in the proposed regulations, has been added to the final regulations in response to concerns expressed by commentators regarding an issuer's ability to establish the amount of private business use during a combined measurement period if the period begins a significant amount of time before the refunding bonds are issued.

Some commentators requested guidance on how the private business tests apply to the shortened and combined measurement periods for refundings of bonds originally issued before the effective date of the Tax Reform Act of 1986, 100 Stat. 2085 (the 1986 Act), if the refunding does not qualify for transitional relief under the 1986 Act or prior law. Specifically, commentators requested guidance on whether (1) the ten-percent private business use limitation under the 1986 Act or (2) the applicable private business use limitation under prior law (for example, the 25-percent limitation under the Internal Revenue Code of 1954) applies in the case of a non-transitioned refunding of a bond issued under law in effect prior to the 1986 Act. The final regulations clarify in an example that the 1986 Act limitations apply to the shortened and combined measurement periods. The issuer, however, may treat these periods as beginning on the transition date described above.

4. Measurement of private security and private payments . Under the proposed regulations, if the amount of private business use is determined based on the separate measurement period for the refunding issue, then the amount of private security and private payments allocable to the refunding issue is determined under § 1.141-4 by treating the refunding issue as a separate issue. On the other hand, if the amount of private business use is determined based on a combined measurement period, then the amount of private security and private payments allocable to the refunding issue is determined under § 1.141-4 by treating the refunding issue and all earlier issues taken into account in determining the combined measurement period as a combined issue. The proposed regulations contain specific rules for determining the present value of the debt service on, and the private security and private payments allocable to, a combined issue.

Commentators requested clarification regarding how the private security or payment test applies under the combined issue methodology in the case of a refunding of only a portion of the original principal amount of a prior issue. The final regulations clarify that, in these circumstances, (1) the refunded portion of the prior issue is treated as a separate issue and (2) any private security or private payments with respect to the prior issue are allocated ratably between the combined issue and the unrefunded portion of the prior issue in a consistent manner based on relative debt service.

The proposed regulations also permit an issuer to use the yield on a prior issue of governmental bonds to determine the present value of private security or private payments under arrangements that were not entered into in contemplation of the refunding issue. For this purpose, any arrangement that was entered into more than one year before the issue date of the refunding issue will be treated as not entered into in contemplation of the refunding issue.

Comments were not received on this special rule for arrangements not entered into in contemplation of the refunding issue. The final regulations retain this provision.

5. Multipurpose issue allocations. Section 1.148-9(h) permits an issuer to use a reasonable, consistently applied allocation method to treat the portion of a multipurpose issue allocable to a separate purpose as a separate issue for certain of the arbitrage provisions of section 148. Section 1.141-13(d) of the proposed regulations allows an issuer to apply § 1.148-9(h) to a multipurpose issue for certain purposes under section 141. An allocation will not be reasonable for this purpose if it achieves more favorable results under section 141 than could be achieved with actual separate issues. In addition, allocations under the proposed regulations and § 1.148-9(h) must be consistent for purposes of sections 141 and 148. The proposed regulations do not permit allocations for purposes of section 141(c)(1) (relating to the private loan financing test) or section 141(d)(1) (relating to certain restrictions on acquiring nongovernmental output property).

Commentators supported the multipurpose allocation provisions in the proposed regulations. The final regulations retain those provisions. Commentators also requested clarification that an allocation under § 1.141-13(d) may be made at any time. The final regulations provide that an allocation under § 1.141-13(d) may be made at any time, but once made may not be changed. The final regulations also provide that the issue to be allocated and each of the separate issues under the allocation must consist of one or more tax-exempt bonds. Thus, an allocation of a multipurpose issue into two or more separate issues is not permitted under § 1.141-13(d) if, at the time of the allocation, the issue to be allocated or any of the separate issues under the allocation consists of taxable private activity bonds.

6. Application of reasonable expectations test to certain refunding bonds . Section 1.141-2(d) provides that an issue consists of private activity bonds if the issuer (1) reasonably expects, as of the issue date, that the issue will meet either the private business tests or the private loan financing test, or (2) takes a deliberate action, subsequent to the issue date, that causes the conditions of either the private business tests or the private loan financing test to be satisfied. Section 1.141-2(d)(3) provides, in general, that a deliberate action is any action taken by the issuer that is within its control.

The proposed regulations provide that an action that would otherwise cause a refunding issue to satisfy the private business tests or the private loan financing test is not taken into account under the reasonable expectations test of § 1.141-2(d) if (1) the action is not a deliberate action within the meaning of § 1.141-2(d)(3), and (2) the weighted average maturity of the refunding bonds is not greater than the remaining weighted average maturity of the prior bonds.

Commentators suggested that the limitation on the weighted average maturity of the refunding bonds to the remaining weighted average maturity of the prior bonds could penalize issuers for issuing shorter-term obligations initially, or provide an incentive to issue longer-term obligations initially. These commentators requested that the weighted average maturity of the refunding bonds be limited only to 120 percent of the weighted average reasonably expected economic life of the property financed by the prior bonds. The final regulations amend this provision to provide that the weighted average maturity of the refunding bonds may not exceed the weighted average reasonably expected economic life of the property financed by the prior bonds.

Commentators also requested that an example illustrating this provision be added to the regulations. The final regulations add such an example.

7. Refundings of certain general obligation bonds. Section 1.141-2(d)(5) provides that the determination of whether bonds of an issue are private activity bonds may be based solely on the issuer's reasonable expectations as of the issue date (and not on whether there are any subsequent deliberate actions) if, among other requirements, the issue is an issue of general obligation bonds of a general purpose governmental unit that finances at least 25 separate purposes.

Commentators suggested that a refunding issue should not consist of private activity bonds if the prior issue meets the requirements of § 1.141-2(d)(5). The final regulations adopt this comment.

Under the 1997 regulations, the use of proceeds of an issue of qualified 501(c)(3) bonds to pay issuance costs of the issue is treated as a private business use. The proposed regulations provide that, solely for purposes of applying the private business use test to a refunding issue, the use of proceeds of the prior issue (or any earlier issue in a series of refundings) to pay issuance costs of the prior issue (or the earlier issue) is treated as a government use.

Comments were not received on this provision. The final regulations retain this rule.

Under section 149(d)(2), interest on a bond is not excluded from gross income if any portion of the issue of which the bond is a part is issued to advance refund a private activity bond (other than a qualified 501(c)(3) bond). The proposed regulations provide that, for purposes of section 149(d)(2), the term private activity bond includes a qualified bond described in section 141(e) (other than a qualified 501(c)(3) bond), regardless of whether the refunding issue consists of private activity bonds under the proposed regulations. The proposed regulations also provide that, for purposes of section 149(d)(2), the term private activity bond does not include a taxable bond. Section 1.150-1(b) defines taxable bond as any obligation the interest on which is not excludable from gross income under section 103.

Commentators recommended that the regulations be modified to permit a tax-exempt private activity bond to be advance refunded by a governmental bond if the nongovernmental entity's participation in the financing has been terminated and the only beneficiary of the financing is the governmental unit. Based on the plain language of section 149(d)(2) and the policies underlying that Code provision, the final regulations do not adopt this comment.

The final regulations apply to bonds that are (1) sold on or after February 17, 2006 and (2) subject to the 1997 regulations.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply.

The principal authors of these regulations are Johanna Som de Cerff and Laura W. Lederman, Office of Chief Counsel (Tax-exempt and Government Entities), Internal Revenue Service and Stephen J. Watson, Office of Tax Legislative Counsel, Department of the Treasury. However, other personnel from the IRS and Treasury Department participated in their development.

Regulatory Information

On May 20, 2004, we published a notice of proposed rulemaking (NPRM) entitled “Security Zones; Oahu, Maui, Hawaii, and Kauai, Hawaii,” in the Federal Register (69 FR 29114). We received five letters commenting on the proposed rule. No public meeting was requested, and none was held. On June 7, 2005, we published a supplemental NPRM (SNPRM) entitled “Security Zones; Oahu, Maui, HI, and Kauai, HI,” in the Federal Register (70 FR 33047). We received one letter and one phone call commenting on the SNPRM. No public meeting was requested, and none was held.

The terrorist attacks against the United States that occurred on September 11, 2001, have emphasized the need for the United States to establish heightened security measures in order to protect the public, ports and waterways, and the maritime transportation system from future acts of terrorism or other subversive acts. The terrorist organization Al Qaeda and other similar groups remain committed to conducting armed attacks against U.S. interests, including civilian targets within the United States. Accordingly, the President has continued the national emergencies he declared following the attacks: national emergency with respect to terrorist attacks, 70 FR 54229, September 13, 2005; and national emergency with respect to persons who commit, threaten to commit, or support acts of terrorism, 70 FR 55703, September 22, 2005. Pursuant to the Magnuson Act, 50 U.S.C. 191, et seq. , the President also has found that the security of the United States is and continues to be endangered by the September 11, 2001 attacks (E.O. 13273, 67 FR 56215, September 3, 2002). National security and intelligence officials warn that future terrorist attacks are likely.

In response to this threat, on April 25, 2003, the Coast Guard established permanent security zones in designated waters surrounding the Hawaiian Islands (68 FR 20344). These security zones have been in operation for more than 2 years. We have conducted periodic review of port and harbor security procedures and considered the oral feedback that local vessel operators gave to Coast Guard units enforcing the zones. In response, the Coast Guard is continuing most of the current security zones but is reducing the size and scope of some to afford acceptable protection to critical assets and maritime infrastructure and minimize the disruption to maritime commerce and inconvenience to small entities.

This rule establishes permanently-existing security zones in the waters surrounding the islands of Oahu, Maui, Kauai, and Hawaii. Specifically, 13 permanent security zones affect the following locations and facilities: (1) Honolulu Harbor, Oahu; (2) Honolulu Harbor General Anchorages B, C, and D, Oahu; (3) Kalihi Channel and Keehi Lagoon, Oahu; (4) Honolulu International Airport, North Section, Oahu; (5) Honolulu International Airport, South Section, Oahu; (6) Barbers Point Offshore Moorings, Oahu; (7) Barbers Point Harbor, Oahu; (8) Kahului Harbor, Maui; (9) Lahaina, Maui; (10) Hilo Harbor, Hawaii; (11) Kailua-Kona Harbor, Hawaii; (12) Nawiliwili Harbor, Lihue, Kauai; and (13) Port Allen, Kauai. When activated and enforced by the Captain of the Port or his or her representative, persons and vessels must not enter these security zones without the express permission of the Captain of the Port.

In response to our initial proposed rule published on May 20, 2004, the Coast Guard received five letters. Two letters from the State of Hawaii are in favor of the rulemaking and contained no objections. One letter from a maritime association is also in favor with no objections. These three letters recognize the need for the security zones and reiterate the Coast Guard's reasons for proposing them, raising no additional issues. The remaining two letters raised issues that are discussed below.

A letter from a Hawaii-based oil company is in favor of the changes to the security zones, but suggests that the Coast Guard include a provision allowing such companies to submit an advance transportation schedule to the Captain of the Port that would permit fuel barges to conduct transit and fuel-transfer operations in port within a large cruise ship (LCS) security zone under normal circumstances. The letter also states that there should be more explicit language assuring minimal interruption of businesses that conduct routine operations in the commercial harbors when the Maritime Security (MARSEC) Level is not elevated.

Coast Guard Response: For these security zones to be effective in safeguarding ports, facilities, and vessels from acts of terrorism and sabotage, the Captain of the Port must have access to accurate and timely information regarding current vessel traffic in any designated security zone. Paragraph 165.1407(c)(2) in the rule below specifically authorizes the public to employ either oral or written means to request permission to enter and operate within a designated security zone. This rule does not preclude the submission of an accurate operating schedule as a means of obtaining permission to enter the security zones established by this rule. Any party desiring to submit a schedule in writing to the Captain of the Port for approval may call the Sector Honolulu Command Center at (808) 842-2600. Approval of such requests is at the discretion of the Captain of the Port.

The final letter commenting on the security-zone changes is from a maritime association and raises three separate issues:

Issue 1: The letter comments that, because Maui, Hawaii, and Kauai, each contain port facilities within 100 yards of each other, the security zone around a large cruise ship moored at one of those facilities would preclude the simultaneous use of that harbor by any other vessel, especially the tugs and barges that frequently transit the area. The comment emphasizes that tug and barge operations are the main “life line” of the outlying islands, and that large crew ship (LCS) traffic is expected to increase, with no increase in facilities, so the security zones around these ships will soon have an even greater negative impact on such operations.

Coast Guard Response: These security zones do not preclude simultaneous use of a harbor when an LCS is moored at one of the facilities. We acknowledge that the security zones around large cruise ships occasionally may cause inconvenience to other vessels and operators within the immediate area because they will have to get permission before entering those zones. We do not agree, however, that this inconvenience is unreasonable considering the benefits provided by the security zones.

With their high profile and passenger-carrying capacity, large cruise ships are attractive targets for acts of sabotage and terrorism, particularly when they are stationary at a pier or mooring. Nevertheless, in response to this comment, we have considered reducing the size of the zones around stationary LCSs, but we determined that an effective security zone must be large enough to allow security personnel to identify and respond to potential threats. Moreover, any person affected by the security zone around a large cruise ship may request permission to enter and transit the zone by contacting the Sector Honolulu Command Center via VHF channel 16 (156.8 Mhz) or phone: (808) 842-2600. Operators who frequently operate in the vicinity of a security zone have the option of submitting a written schedule for advance approval to minimize any potential disruption.

Issue 2: The letter comments that the language in the NPRM about security zones around large cruise ships and designated enforcement zones is confusing, as is much of the other terminology, and certain paragraphs of the proposed rule should be reworded.

Coast Guard Response: We agree and have extensively revised both the wording and organization of our rule. We separated the zones by island and gave each of the four islands a separate section in the CFR. This change allows us to focus the regulation paragraphs on LCS zones for the islands of Maui, Kauai, and Hawaii, because the LCS zones are for those islands only; none are for Oahu. This change also allows us to focus the regulation and notice paragraphs in the Oahu CFR section on the three Oahu zones (Kalihi Channel and Keehi Lagoon; Honolulu International Airport, South Section; and Barbers Point Harbor) that are enforced only upon a rise in the MARSEC level or when the Captain of the Port has determined there is a heightened risk of a transportation security incident.

As for wording changes, we inserted the word “activated” several times to help discern when certain security zones are enforced. It is important to note, however, that these security zones are permanently established, and that the word “activated” is only meant to distinguish whether the permanently-established zone is subject to enforcement. We made numerous similarly non-substantive wording changes for the SNPRM that did not change the meaning or intent of our initial proposed rule but were intended to improved the clarity of the rule in response to this letter.

Issue 3: The letter suggests removing the Honolulu International Airport Security Zone from Category 1 (zones subject to enforcement at all times) and placing it in Category 2 (zones subject to enforcement only during heightened threat conditions, as provided in the rule). The commenter noted that this area is planned for future ocean recreation expansion and it should not be continuously and permanently removed from public use, and the alignment with the adjacent Keehi Lagoon Security Zone (Category 2) would preserve public use of the entire Keehi Lagoon area for future recreational and commercial improvements.

Coast Guard Response: The security zone nearest Honolulu International Airport in particular must remain a Category 1 zone because all major airports are possible terrorist targets. The Category 1 designation of this area is specifically meant to protect the Honolulu International Airport, as well as all the aircraft and people working or transiting that facility. Designating this area a Category 2 zone would compromise security by removing the continuous waterside buffer around the airport afforded by the Category 1 designation. Those wishing to enter the zone, however, need only to seek and obtain prior approval. The Captain of the Port will not manage security zones solely based on possible future scenarios but rather adjust as appropriate to the current threat situation so security can be maintained while minimizing disruption to commercial and recreational traffic.

The comments received affected this rule to the extent described above, but we also made additional substantive changes from the proposed rule published on May 20, 2004 (69 FR 29114) that necessitated the SNPRM. We proposed an additional security zone, described in this rule, § 165.1407(a)(4)(ii), as Honolulu International Airport, South Section. This zone, encompassing Honolulu Harbor anchorages B, C, and D, is a Category 2 zone, subject to enforcement only in times of raised MARSEC levels or other threats. We determined there is a need to add this zone to establish an extra protective buffer around the airport when necessary.

The separately-designated Honolulu Harbor Anchorages B, C, and D security zone remains the same as in our initial proposed rule: limited to the waters extending 100 yards in all directions from vessels over 300 gross tons anchored there. The 100-yard security zone around those vessels is still activated and enforced at all times regardless of whether an emerging threat has necessitated the additional activation and enforcement of the encompassing Honolulu International Airport, South Section security zone for increased airport protection.

The name of the Honolulu International Airport security zone in our initial proposed rule is changed to Honolulu International Airport, North Section , § 165.1407(a)(4)(i), to distinguish it from the Honolulu International Airport, South Section security zone. The Honolulu International Airport, North Section security zone remains a Category 1 zone, enforced and activated at all times, extending only about 800 yards offshore from the airport, the minimal distance required for low-level security conditions.

We also eliminated an unnecessary notification requirement that was in our initial proposed rule. We have determined that the best public notification of the presence of an LCS security zone is the presence of the LCS itself, which is obvious to operators well before they reach the 100-yard zone. Therefore, while we may use other notification methods, like a broadcast notice to mariners, the requirement to make such other notification is not in this rule.

Additionally, in the paragraphs of our rule that address permission to transit a security zone, we have included language that eliminates the need for seaplane operators to get Coast Guard permission while they are in compliance with established Federal Aviation Administration regulations regarding flight-plan approval. We have determined that this change is necessary to limit the communications that pilots would otherwise have to make when transiting the zones. For the convenience of the reader, we included a cross reference to the relevant FAA regulations in the regulation text.

We have also revised our penalty paragraphs so that they are limited to referencing the statutes (33 U.S.C. 1232 and 50 U.S.C. 192) that provide violation penalties. This change eliminates the need to amend those paragraphs every time the penalty statutes are amended.

Other corrections of our initial proposed rule include the addition of the words “or hundredths”in § 165.1407(a) to more accurately describe how security-zone coordinates are expressed, and an update of Sector Honolulu's contact information to reflect recent changes.

In response to our SNPRM published on June 7, 2005, the Coast Guard received one phone call and one letter. The phone call from the National Oceanic and Atmospheric Administration highlighted an inconsistency within our description of the Honolulu International Airport, South Section security zone, § 165.1407(a)(4)(ii). The description erroneously suggested that Kalihi Channel buoy “5” is located at 21°18.0′ N/157°53.92′ W. To avoid any potential misunderstanding, we deleted those coordinates from the description in the final rule, leaving the buoy itself as the pertinent reference point.

The letter commenting on our SNPRM is from a maritime association and raises several issues, including calls for more specific language in various parts of our Discussion of Proposed Rule section. We drafted that section, however, solely for our SNPRM to help the public understand the proposal and formulate comments. As the regulatory text makes clear, all LCS security zones are activated at least 3 nautical miles seaward of the six harbors that have LCS security zones: Kahului Harbor, Maui; Lahaina, Maui; Hilo Harbor, Hawaii; Kailua-Kona, Hawaii; Nawiliwili Harbor, Lihue, Kauai; and Port Allen, Kauai The letter raised four other issues, addressed as follows:

Issue 1: The letter comments that the SNPRM did not include Sector Honolulu's toll-free telephone number for requesting permission to enter a zone. It recommends that we include the number in our final rule for the use of mariners transiting the other Hawaiian islands' zones.

Coast Guard Response: We understand that a toll-free line for requesting permission to enter a zone would ease the burden on mariners calling from the affected islands. The Sector's toll-free number, however, is a direct line to the Search and Rescue Controller, who must not be distracted by routine transit requests. We have determined that the use of the contact information provided in the SNPRM is not excessively burdensome, especially considering the abundance of options, including phone, fax, radio, and mail.

Issue 2: The ports at Hilo, Kahului, and Nawiliwili are large enough to completely accommodate LCSs, so there is no need for the LCSs to anchor seaward of those harbors. Therefore, the enforcement areas 3 nautical miles seaward of those harbors should be deleted.

Coast Guard Response: We have considered deleting the seaward enforcement areas for those harbors, but we determined that they must remain because they enable the Coast Guard to bolster an LCS's security before it reaches the harbor. This provision allows security personnel to identify and respond to potential threats before the harbor itself is threatened by the arrival of an unsecured LCS. Additionally, depending on the status of harbor traffic at the time or the intentions of LCS masters, it is conceivable that vulnerable LCSs will anchor within the enforcement areas seaward of those harbors.

Issue 3: In paragraph (c)(1) of §§ 165.1408, 165.1409, and 165.1410 of this rule, the last sentence (“No person is allowed within 100 yards * * *”) should specify that that restriction applies to LCSs within designated geographic locations.

Coast Guard Response: We agree and have inserted the phrase “in any of the areas described by paragraph (a) of this section” into that last sentence of paragraph (c)(1) in each of those three sections to clarify the restriction.

Issue 4: The SNPRM's proposed § 165.1407(a) fails to specify paragraph (d) as a provision affecting enforcement of the zones.

Coast Guard Response: We agree and have revised paragraph (a) of that section to include a reference to paragraph (d).

We changed from our proposed regulatory text to the extent described above. Our final rule otherwise remains the same as that published in our SNPRM.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

The Coast Guard expects the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This expectation is based on the short activation duration of most of the zones and the limited geographic area affected by them. We considered our changes to the regulatory text resulting from our NPRM and SNPRM and determined that they do not alter our expectation.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule will have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. While we are aware that many affected areas have small commercial entities, including canoe and boating clubs and small commercial businesses that provide recreational services, we expect that there will be little or no impact to these small entities due to the narrowly tailored scope of these security zones. We considered our changes to the regulatory text resulting from our NPRM and SNPRM and determined that they do not change the information upon which we based our original assessment of impact on small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding this rule so that they could better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and either preempts State law or imposes a substantial direct cost of compliance on them. We have analyzed this rule under that Order, including our changes to the regulatory text resulting from our NPRM and SNPRM, and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

This rule meets 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 an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because 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. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards is inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, under figure 2-1, paragraph (34)(g) of the Commandant Instruction M16475.1D, this rule is categorically excluded from further environmental documentation.

Regulated Entities. Categories and entities potentially regulated by this action include:

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 examples of the types of entities EPA is now aware could potentially be regulated by this action. Other types of entities not listed could also be affected. To determine whether your facility, company, business, organization, etc., is regulated by this action, you should examine the applicability criteria in 40 CFR 63.1200. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Worldwide Web (WWW). In addition to being available in the docket, an electronic copy of today's direct final rule will also be available on the WWW at http://www.epa.gov/hwcmact.

Comments. We are publishing the direct final rule amendments without prior proposal because we view the amendments as noncontroversial and do not anticipate adverse comments. However, in the Proposed Rules section of this issue of the Federal Register , we are publishing a separate document that will serve as the proposal to amend the NESHAP for hazardous waste combustors if adverse comments are filed. If we receive any adverse comments on one or more distinct amendments, we will publish a timely withdrawal in the Federal Register informing the public which provisions will become effective, and which provisions are being withdrawn due to adverse comment. We will address all public comments in a subsequent final rule, should the Agency determine to issue one. Any of the distinct amendments in today's direct final rule for which we do not receive adverse comment will become effective on the previously mentioned date. We will not institute a second comment period on the direct final rule amendments. Any parties interested in commenting must do so at this time.

Judicial Review. Under section 307(b)(1) of the Clean Air Act (CAA), judicial review of a final action is available only by filing a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit. Under section 307(d)(7)(B) of the CAA, only an objection to the direct final rule amendments that was raised with reasonable specificity during the period for public comment can be raised during judicial review. Moreover, under section 307(b)(2) of the CAA, the requirements established by the direct final rule amendments may not be challenged separately in any civil or criminal proceeding brought by EPA to enforce these requirements.

Today's notice makes specific changes to the National Emission Standards for Hazardous Air Pollutants (NESHAP): Final Standards for Hazardous Air Pollutants for Hazardous Waste Combustors (Phase I Final Replacement Standards and Phase II), published October 12, 2005 (70 FR 59402). In that rule, we inadvertently included three new or revised bag leak detection system requirements for Phase I sources—incinerators, cement kilns, and lightweight aggregate kilns—among implementation requirements taking effect on December 12, 2005, rather than, as intended, after three years when the sources begin complying with the revised emission standards under §§ 63.1219, 63.1220, and 63.1221. We intended to establish the compliance date for these provisions three years after promulgation—October 14, 2008—because the provisions establish more stringent requirements for Phase I sources and these sources will need three years to comply with these more stringent requirements.

The final standards for hazardous air pollutants for hazardous waste combustors (HWC) are NESHAP that establish controls on toxic emissions from the burning of hazardous waste in incinerators, cement kilns, lightweight aggregate kilns, liquid fuel boilers, solid fuel boilers, and hydrochloric acid production furnaces. The standards replace existing NESHAP for Phase I sources—incinerators, cement kilns, and lightweight aggregate kilns—and establish new NESHAP for Phase II sources—liquid fuel boilers, solid fuel boilers, and hydrochloric acid production furnaces.

These NESHAP create a technology-based national cap for hazardous air pollutant emissions from the combustion of hazardous waste in these devices. Additional risk-based conditions necessary to protect human health and the environment may be imposed (assuming a proper, site-specific justification) under section 3005(c)(3) of the Resource Conservation and Recovery Act (RCRA).

Section 112(d) of the Clean Air Act (CAA) requires NESHAP to be based on the performance of the Maximum Achievable Control Technology (MACT). These NESHAP are expected to achieve significant reductions in the amount of hazardous air pollutants being emitted each year by these sources.

Additionally, these NESHAP satisfy our obligation under RCRA (the main statute regulating hazardous waste management) to ensure that hazardous waste combustion is conducted in a manner protective of human health and the environment. By using both CAA and RCRA authorities in a harmonized fashion, we consolidate regulatory control of hazardous waste combustion into a single set of regulations, thereby minimizing the potential for conflicting or duplicative federal requirements.

More information on these NESHAP is available electronically from the World Wide Web at http://www.epa.gov/hwcmact.

This amendment establishes an October 14, 2008 compliance date for cement kilns equipped with fabric filters to comply with the bag leak detection system (BLDS) requirements under § 63.1206(c)(8). See amended § 63.1206(a)(1)(i).

The HWC NESHAP revised the bag leak detection system (BLDS) requirements for Phase I sources—incinerators, cement kilns, and lightweight aggregate kilns—to require cement kilns equipped with a fabric filter to use a BLDS to ensure compliance with the particulate matter and nonmercury metal emission standards. Prior to this revision, only incinerators and lightweight aggregate kilns equipped with a fabric filter were required to use a BLDS. 64 FR 52827 (September 30, 1999); 67 FR 6967 (February 14, 2002). Cement kilns were subject to an opacity standard in lieu of the BLDS. In the October 12, 2005 HWC NESHAP, however, we concluded that a BLDS provided better compliance assurance than an opacity standard and required cement kilns to use a BLDS in lieu of compliance with the opacity standard. 69 FR at 21346-47. That rule also subjected Phase II sources—liquid fuel boilers, solid fuel boilers, and hydrochloric acid production furnaces—equipped with a fabric filter to the same BLDS requirements.

We intended for cement kilns to begin complying with this new requirement when they begin complying with the revised emission standards under § 63.1220—not later than October 14, 2008. Cement kilns need time to design, install, and address start-up problems with the BLDS. Although a three-year compliance date is appropriate, we were inadvertently silent on this issue in the October 2005 rule, and failed to specify that these provisions would not be effective until the effective date of the new emission standards. Consequently, absent this amendment, the BLDS requirement for cement kilns would be applicable immediately—on December 12, 2005.

We note that § 63.1209(a)(1)(ii)(A and B) indicate that we had intended for cement kilns to comply with the BLDS requirement when they begin complying with § 63.1220. Paragraph (a)(1)(ii)(A) states that cement kilns subject to the emission standards under § 63.1204 continue to be subject to the opacity standard, while paragraph (a)(1)(ii)(B) states that, when complying with the revised emission standards under § 63.1220, only those cement kilns that are not equipped with a BLDS or particulate matter detection system continue to be subject to the opacity standard. Thus, we had intended to subject cement kilns to the BLDS requirements when they begin complying with the revised standards under § 63.1220. Cement kilns must comply with those revised standards by October 14, 2008 unless a time extension is granted under § 63.6(i) or § 63.1213. See § 63.1206(a)(1)(ii).

This amendment establishes an October 14, 2008 compliance date for the excessive exceedances notification requirement for bag leak detection systems (BLDS) under § 63.1206(c)(8)(iv). See amended § 63.1206(a)(1)(i).

The October 2005 rule establishes an excessive exceedances notification requirement for bag leak detection systems (BLDS). See § 63.1206(c)(8)(iv). If the alarm level is exceeded for more than five percent of the time in a 6-month block, the source must notify the permitting authority.

We intended for Phase I sources to begin complying with this new requirement when they begin complying with the revised emission standards under §§ 63.1219, 63.1220, and 63.1221—not later than October 14, 2008. Phase I sources need time to install the data logging and recording equipment to aggregate the time that the source is operating when the alarm level is exceeded. Although a three-year compliance date is appropriate, we were inadvertently silent on this issue in the October 2005 rule, and failed to specify that these provisions would not be effective until the effective date of the new emission standards. Consequently, absent this amendment, the excessive exceedances notification requirement would be applicable immediately—on December 12, 2005.

This amendment establishes an October 14, 2008 compliance date for the revised detection limit requirement for bag leak detection systems (BLDS) under § 63.1206(c)(8)(ii)(A). See amended § 63.1206(a)(1)(i).

The October 2005 rule revised the detection limit for BLDS for Phase I sources to require a 1.0 mg/acm detection limit for the BLDS unless you demonstrate in an alternative monitoring petition under § 63.1209(g)(1) that a higher detection limit would routinely detect particulate matter loadings during normal operations. See § 63.1206(c)(8)(ii)(A). The previous detection limit requirement applicable to Phase I sources allowed a higher detection limit under § 63.1209(g)(1) if you demonstrate “that a higher sensitivity would adequately detect bag leaks.” The revised detection limit requirement is applicable to both Phase I and Phase II sources.

We revised the detection limit requirement as an outgrowth of our reconsideration of the BLDS detection limit for Phase I sources. When investigating whether it was appropriate to continue allowing sources to petition under § 63.1209(g)(1) to use a detector with a detection limit higher than 1.0 mg/acm, we concluded that the basis for approving a higher detection limit should be more prescriptive. 69 FR at 21340. Thus, the October 2005 rule requires the detector to be able to detect increases in normal emissions rather than simply being able to detect bag leaks.

We intended for the revised detection limit requirement to become applicable to Phase I sources when they begin complying with the revised emission standards under §§ 63.1219, 63.1220, and 63.1221—not later than October 14, 2008. Phase I sources that were granted approval under § 63.1209(g)(1) to use a bag leak detector with a detection limit greater than 1.0 mg/acm may be required to resubmit the alternative monitoring petition to document that the detector can detect particulate matter loadings under normal operations. In addition, some sources may be required to upgrade their BLDS to ensure that it can detect particulate matter loadings during normal operations. Although a three-year compliance date is appropriate, we were inadvertently silent on this issue in the October 2005 rule, and failed to specify that these provisions would not be effective until the effective date of the new emission standards. Consequently, absent this amendment, the revised detection limit would be applicable immediately—on December 12, 2005.

Under Executive Order 12866 (58 FR 51735 (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.

Pursuant to the terms of Executive Order 12866, it has been determined that the direct final amendments do not constitute a “significant regulatory action” because this action creates no new regulatory requirements that meet any of the above criteria. Consequently, this action was not submitted to OMB for review under Executive Order 12866.

The information collection requirements in the final rule (70 FR 59402, October 12, 2005) were submitted to and approved by OMB under the Paperwork Reduction Act, 44 U.S.C. 3501, et seq. , and assigned OMB control number 2050-0171. An Information Collection Request (ICR) document was prepared by EPA (ICR No. 1773.08) and a copy may be obtained from Susan Auby by mail at Office of Environmental Information Collection Strategies Division (ME-2822T), 1200 Pennsylvania Avenue, NW., Washington DC 20460, by e-mail at auby.susan@epa.gov , or by calling (202) 566-1672. A copy may also be downloaded from the internet at http://www.epa.gov/icr .

Today's action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Because there is no additional burden on the industry as a result of the direct final rule amendments, the ICR has not been revised.

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.

EPA has determined that it is not necessary to prepare a regulatory flexibility analysis in connection with today's action.

For purposes of assessing the impacts of today's direct final rule amendments on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administrations' regulations at 13 CFR 121.201; (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 the field.

After considering the economic impacts of today's direct final rule amendments on small entities, EPA has concluded that this action will not have a significant economic impact on a substantial number of small entities. This action does not create any new regulatory requirements. Rather, they continue to apply existing requirements by delaying the compliance date for new or more stringent requirements. After considering the economic impacts of today's direct final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 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 under 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.

EPA has determined that the direct final rule amendments do not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, or tribal governments, in the aggregate, or to the private sector in any one year. Thus, today's action is not subject to sections 202 and 205 of the UMRA. EPA has also determined that the direct final rule amendments contain no regulatory requirements that might significantly or uniquely affect small governments. Thus, today's direct final rule amendments are not subject to the requirements of section 203 of the UMRA no new enforceable duty on any State, local or tribal governments or the private sector.

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 action delays the compliance date of new or more stringent requirements. 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.” This final rule does not have tribal implications, as specified in Executive Order 13175. This action delays the compliance date of new or more stringent requirements. Thus, Executive Order 13175 does not apply to this rule.

“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.

Today's final rule is not subject to E.O. 13045 because it does not meet either of these criteria. The rule simply delays the compliance date of new or more stringent requirements.

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.

As noted in the proposed rule, Section 12(d) of the National Technology Transfer and 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 action does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.

EPA is committed to addressing environmental justice concerns and is assuming a leadership role in environmental justice initiatives to enhance environmental quality for all residents of the United States. The Agency's goals are to ensure that no segment of the population, regardless of race, color, national origin, or income bears disproportionately high and adverse human health and environmental impacts as a result of EPA's policies, programs, and activities, and that all people live in clean and sustainable communities. In response to Executive Order 12898 and to concerns voiced by many groups outside the Agency, EPA's Office of Solid Waste and Emergency Response formed an Environmental Justice Task Force to analyze the array of environmental justice issues specific to waste programs and to develop an overall strategy to identify and address these issues (OSWER Directive No. 9200.3-17).

Today's rule delays the compliance date of new or more stringent requirements and will not result in any disproportionately negative impacts on minority or low-income communities relative to affluent or non-minority communities.

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. Section 804 exempts from section 801 the following types of rules (1) rules of particular applicability; (2) rules relating to agency management or personnel; and (3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding today's action under section 801 because this is a rule of particular applicability, applying only to a specific waste type at two facilities under particular (and, as noted, exceptional) circumstances.

A major rule cannot take effect until 60 days after it is published in the Federal Register . The direct final rule is not a “major rule” as defined by 5 U.S.C. 804 (2). This rule is effective on February 17, 2006.

Regulated Entities. Entities potentially affected by this action are those industrial facilities that manufacture or use MEK. This action amends the HAP list contained in section 112(b)(1) of the CAA by removing the compound MEK. The decision to issue a final rule to delist MEK removes MEK from regulatory consideration under section 112(d) of the CAA.

Judicial Review. Under section 307(b)(1) of the CAA, judicial review is available only by filing a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit by 60 days from publication in the Federal Register . Under section 307(d)(7)(B) of the CAA, only an objection to a rule or procedure raised with reasonable specificity during the period for public comment can be raised during judicial review. Moreover, under section 307(b)(2) of the CAA, the requirements established by the final rule may not be challenged separately in any civil or criminal proceeding brought to enforce these requirements.

Outline. The information presented in this preamble is organized as follows:

Section 112 of the CAA contains a mandate for EPA to evaluate and control emissions of HAP. Section 112(b)(1) includes an initial HAP list that is composed of specific chemical compounds and compound classes to be used by EPA to identify source categories for which EPA will subsequently promulgate emissions standards.

CAA section 112(b)(2) requires EPA to make periodic revisions to the initial HAP list set forth in CAA section 112(b)(1) and outlines criteria to be applied in deciding whether to add or delete particular substances. Section 112(b)(2) identifies pollutants that should be listed as:

To assist EPA in making judgments about whether a pollutant causes an adverse environmental effect, CAA section 112(a)(7) defines an “adverse environmental effect” as:

Section 112(b)(3) establishes general requirements for petitioning EPA to modify the HAP list by adding or deleting a substance. Although the Administrator may add or delete a substance on his own initiative, in the case where a party petitions the Agency to add or delete a substance, the burden has historically been on the petitioner to include sufficient information to support the requested addition or deletion under the substantive criteria set forth in CAA section 112(b)(3)(B) and (C). The Administrator must either grant or deny a petition within 18 months of receipt of a complete petition. If the Administrator decides to grant a petition, EPA publishes a written explanation of the Administrator's decision, along with a proposed rule to add or delete the substance. If the Administrator decides to deny the petition, EPA publishes a written explanation of the basis for denial. A decision to deny a petition is final Agency action subject to review in the DC Circuit Court of Appeals under CAA section 307(b).

To promulgate a final rule deleting a substance from the HAP list, CAA section 112(b)(3)(C) provides that the Administrator must determine that:

EPA will grant a petition to delete a substance and publish a proposed rule to delete that substance if it makes an initial determination that this criterion has been met. After affording an opportunity for comment and for a hearing, EPA will make a final determination whether the criterion has been met.

EPA does not interpret CAA section 112(b)(3)(C) to require absolute certainty that a pollutant will not cause adverse effects on human health or the environment before it may be deleted from the list. The use of the terms “adequate” and “reasonably” indicate that EPA must weigh the potential uncertainties and their likely significance. Uncertainties concerning the risk of adverse health or environmental effects may be mitigated if EPA can determine that projected exposures are sufficiently low to provide reasonable assurance that such adverse effects will not occur. Similarly, uncertainties concerning the magnitude of projected exposure may be mitigated if EPA can determine that the levels that might cause adverse health or environmental effects are sufficiently high to provide reasonable assurance that exposures will not reach harmful levels. However, the burden remains on a petitioner to resolve any critical uncertainties associated with missing information. EPA will not grant a petition to delete a substance if there are major uncertainties that need to be addressed before EPA would have sufficient information to make the requisite determination.

On November 27, 1996, the American Chemistry Council's Ketones Panel submitted a petition to delete MEK (CAS No. 78-93-3) from the HAP list in CAA section 112(b)(1). Following the receipt of the petition, EPA conducted a preliminary evaluation to determine whether the petition was complete according to EPA criteria (58 FR 45081). To be deemed complete, a petition must consider all available health and environmental effects data. A petition must also provide comprehensive emissions data, including peak and annual average emissions for each source or for a representative selection of sources, and must estimate the resulting exposures of people living in the vicinity of the sources. In addition, a petition must address the environmental impacts associated with emissions to the ambient air and impacts associated with the subsequent cross-media transport of those emissions.

EPA published a notice of receipt of a complete petition to delist MEK in the Federal Register on June 23, 1999 (64 FR 33453), and requested information to assist us in technically reviewing the petition in addition to other comments. In response to the request for comment, EPA received ten submissions that included information to aid in the technical review of the petition.

Based on a comprehensive review of the data provided in the petition and from other sources, EPA made an initial determination that the statutory criterion for deletion of MEK from the HAP list had been met. EPA, therefore, granted the petition by the American Chemistry Council's Ketones Panel and issued a proposed rule to delist MEK on May 30, 2003 (68 FR 32608). EPA responded to substantive comments on the notice of receipt of a complete petition in the preamble to the proposed rule. The delay between receiving a complete petition and publishing the proposal to delist was due, in part, to the time it took to reevaluate and update the human health toxicity value for MEK.

EPA received a total of 57 comments on the proposed rule and responds to the substantive comments below. There was no request for a public hearing.

In the preamble to the proposed rule, EPA stated that it would not make the final decision whether to delist MEK until it considered the inhalation reference concentration (RfC) resulting from an updated Integrated Risk Information System (IRIS) review. This review was completed in 2003. The MEK RfC is a peer-reviewed value defined as an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily inhalation exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime.

The 2003 RfC was not yet finalized when EPA received the petition. However, to support statutory requirements and assist in the determination of the technical merits of the petition to delist MEK, EPA's Office of Research and Development derived an interim health effects threshold for MEK inhalation exposure that considered current data and current EPA science policy. That process resulted in the derivation of a prospective RfC of 9 milligrams per cubic meter (mg/m 3 ). The analysis underlying the development of the prospective RfC can be found in “A Prospective Reference Concentration for MEK (78-93-3),” which is in the docket. In the preamble to the proposed rule, EPA stated that while it would base its initial determination to delist MEK on the prospective RfC, it would rely on the RfC and other information resulting from the completed IRIS assessment in making its determination whether to delist MEK.

The 2003 RfC was published in IRIS on September 26, 2003. Where the prospective RfC was 9 mg/m 3 , the 2003 RfC is slightly lower at 5 mg/m 3 because of a difference in dose-response methodology and interpretation of remaining uncertainties. To evaluate the potential impact of the 2003 RfC on the decision to delist, EPA recalculated the inhalation hazard quotient (HQ) using the 2003 RfC and the estimate of maximum exposure cited in the proposed rule. Whereas the HQ calculated in the proposed rule was 0.1, the new HQ is 0.2, or 20 percent of the RfC. EPA still finds the recalculated HQ to be below a level of concern. Thus, the 2003 RfC did not change the scientific basis of EPA's determination that emissions, ambient concentrations, bioaccumulation, or deposition of MEK may not reasonably be anticipated to cause adverse human health or environmental effects.

In the preamble to the proposed rule, EPA addressed acute exposure from MEK using the Dick et al. (1992) study (Dick study), which assessed neurotoxic effects. EPA concluded that the Dick study indicated that exposures to MEK of up to 200 parts per million (ppm) (590 mg/m 3 ) for up to 4 hours would be an appropriate no-adverse-effect concentration for the general population for both subjective effects (such as objectionable odor or irritancy) and for neurobehavioral effects.

EPA used the Dick study to examine the potential effects of short-term exposure to MEK because no short-term human health values have been finalized for MEK. The Dick study is the best study in the MEK database with which to assess short-term effects of MEK exposure.

During public comment, EPA did not receive any negative comment on our interpretation of the Dick study. EPA did, however, receive a request to address the potential for developmental effects as a result of short-term exposure because the RfC that EPA used to assess long-term exposure to MEK was based on a developmental endpoint.

EPA agrees that this is appropriate to do since the Agency, thus far, has not finalized an acute reference exposure methodology. EPA is in the process of developing this methodology and sought the Science Advisory Board's (SAB) review of the draft methodology in 1998 (The SAB report is available at: http://www.epa.gov/sab/pdf/ehc9905.pdf ). Thus, EPA considered several types of analysis. One type of analysis EPA considered was a general approach consistent with that used for the chronic RfC and based on the developmental study that was the basis for the RfC.

The quantitative aspect of EPA's RfC methodology is a two-step approach that distinguishes analysis of the dose-response data from inferences made about lower doses. The first step is an analysis of dose and response in the range of observation of the experimental and/or epidemiologic studies. The modeling or statistical significance testing yields a point of departure (POD) from the range of observation. The second step is extrapolation to lower doses. Thus, the RfC is derived from the POD (in terms of human equivalent exposure) for the critical effect by consistent application of uncertainty factors (UFs). The UFs are applied to account for recognized uncertainties in the extrapolations from the experimental data conditions to an estimate appropriate to the assumed human scenario (U.S. EPA, 1994).

The POD from the developmental study is a 24-hour human equivalent exposure concentration of 1,517 mg/m 3 . In the derivation of the chronic RfC, this POD was divided by a cumulative UF of 300. The cumulative factor comprised three UFs, accounting for uncertainties in interspecies (3) and intraspecies (10) extrapolation, as well as uncertainty in the database with regard to chronic exposures (10). In calculating an acute reference value, the latter would not be relevant, resulting in a cumulative UF of 30. Thus, one analysis of the short-term exposure potential might result in a short-term (24 hour) reference value of 50 mg/m 3 by dividing 1,517 mg/m 3 by a cumulative UF of 30. The petitioner's maximum modeled 24-hour average MEK concentration in air of 10 mg/m3 is lower than this potential short-term reference value by a factor of 5.

An alternate approach is that routinely employed by EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS), which involves consideration of the margin of exposure (MOE) between the POD and the estimated exposure concentration of interest (67 FR 60886). For decision-making purposes, the OPPTS MOE level of concern is the value derived from multiplicative factors representing key outstanding areas of uncertainty with regard to the chemical's toxicity. Given the available data for MEK, which includes an animal study on developmental toxicity, the predominant outstanding areas of uncertainty with regard to short-term toxicity are the potential for interspecies and intraspecies differences in susceptibility. Assigning them each the traditional default value of 10 yields a MOE of 100. 1 Therefore, in evaluating the potential for adverse human health effects to occur from acute exposures to MEK from inhalation, EPA considers adverse effects to be unlikely if the MOE is at least 100.

Using the petition's maximum modeled 24-hour average MEK concentration in air of 10 mg/m 3 , and the 24-hour human equivalent exposure concentration at the POD from the study used to develop the RfC of 1,517 mg/m 3 , EPA calculates a margin of exposure of 152. Therefore, based on either of the two approaches outlined above, the predicted 24-hour exposures to MEK may not reasonably be anticipated to pose appreciable risk of adverse developmental health effects. This conclusion, when added to the previous conclusions described in the preamble to the proposed rule, further supports our determination that emissions of MEK may not reasonably be anticipated to cause adverse health or environmental effects.

Since proposal, EPA's OPPTS has proposed several Acute Exposure Guideline Levels (AEGLs) for MEK. The AEGLs represent threshold exposure limits for the general public for various degrees of severity of toxic effects, and are applicable to emergency exposure periods ranging from 10 minutes to 8 hours. It is believed that the recommended exposure levels are applicable to the general population including infants and children, and other individuals who may be susceptible.

The AEGL value for the lowest severity level, the AEGL-1, is the airborne concentration of a substance above which it is predicted that the general population, including susceptible individuals, could experience notable discomfort, irritation, or certain asymptomatic nonsensory effects. However, the effects are not disabling and are transient and reversible upon cessation of exposure. With increasing airborne concentrations above each AEGL, there is a progressive increase in the likelihood of occurrence and the severity of effects described for each corresponding AEGL. Although the AEGL values represent threshold levels for the general public, including susceptible subpopulations, such as infants, children, the elderly, persons with asthma, and those with other illnesses, it is recognized that individuals, subject to unique or idiosyncratic responses, could experience the effects described at concentrations below the corresponding AEGL.

The interim AEGL-1 value for MEK is 200 ppm (for all exposure periods up to 8 hours). This is the same concentration as the no-adverse-effect concentration for the general population derived from the Dick Study, which provides further support for the use of the Dick study for assessing short-term exposures.

In the preamble to the proposed rule, EPA stated that it would not make the final decision whether to delist MEK until it considered the results of the peer consultation of the industry's tier 1 submission for MEK under the Voluntary Children's Chemical Evaluation Program (VCCEP). The VCCEP is intended to provide information to enable the public to understand the potential health risks to children associated with exposures to certain chemicals. Under the VCCEP, EPA has asked industries that manufacture or import certain chemicals to sponsor these chemicals to develop assessments regarding the potential health effects, exposures, and risks of those chemicals to children (see http://www.epa.gov/chemrtk/vccep/index.htm ).

EPA received the industry's submission under the VCCEP on December 1, 2003. The peer consultation meeting for MEK was held on February 19, 2004. On April 19, 2004, EPA received the report of the peer consultation. Peer consultation panel members concluded that the MEK database and submission were adequate, and the key areas of hazard, exposure, and risk were sufficient to characterize risks to children for the purposes of the VCCEP. None of the panelists thought that further data or analyses were needed to characterize MEK's risks to children for the purposes of the VCCEP. Subsequent to completion of the final meeting report, EPA requested additional MEK exposure information from the industry sponsors. This information was provided to EPA on January 12, 2005 (see http://www.tera.org/peer/vccep/MEK/MEKwelcome.html ).

The only substantive issue raised by the peer consultation that is relevant to the final rule pertains to acute exposures to MEK. To characterize potential impacts from short-term exposures to MEK, the VCCEP submission took much the same approach that EPA took in the proposed rule. That is, they estimated maximum short-term exposures and compared them to a short-term health value that was based on irritation. Like the public commenter, the VCCEP peer consultation panel requested that the sponsor compare the short-term exposures to a developmental endpoint because the RfC was based on a developmental endpoint.

The sponsors proposed one of the approaches EPA considered above, the approach based on the RfC. The sponsors proposed to begin with the 2003 RfC of 5 mg/m 3 , then remove the 10-fold database uncertainty factor. This results in a 24-hour value of 50 mg/m 3 . The reason given for the removal of the uncertainty factor is that it was applied to the RfC to account for the lack of chronic studies. Since considering chronic studies is not relevant to the development of a short-term health value, there is no need for the 10-fold database uncertainty factor. EPA agrees with the approach submitted to the VCCEP and, as described above, EPA considered this approach as well as other methods.

Of the 57 written comments EPA received pertaining to the proposed delisting of MEK, 42 supported the proposal to delist, 13 opposed the proposal to delist and 2 comments neither supported nor opposed the proposal. EPA received comments on the development of the RfC used in the decision and on the exposure assessment.

EPA has considered carefully all the comments, focusing in particular on comments which suggested potential deficiencies in the substantive rationale upon which EPA based its initial determination that the criterion in CAA section 112(b)(3)(C) had been met. A summary of the comments and EPA responses has been included in the docket. In this preamble, EPA will discuss adverse comments received and our responses to them.

The proposed rule invited comment from interested parties on the proposal to delist MEK. In addition, EPA specifically requested comments on our prospective RfC for MEK (the interim health value EPA developed for the proposal). EPA also solicited comment on the portion of our human health risk characterization based on this prospective RfC. In addition, EPA requested comment on whether it would be appropriate to delist MEK if the RfC resulting from an updated IRIS review differed from the prospective RfC; for example, EPA requested comment on the appropriateness of delisting if the RfC were 3 mg/m 3 , the level suggested by industry in its petition, or if it remained unchanged from the 1992 RfC of 1 mg/m 3 .

Comment: One commenter asserted that the 1992 RfC of 1 mg/m 3 was set to protect against birth defects and it should not be changed. Another commenter stated that the 2003 RfC (external review draft), which was based on the same study from 1991, does not adequately provide an estimate “likely to be without an appreciable risk of deleterious effects during a lifetime.”

Response: The RfC is designed to consider all adverse noncancer effects associated with lifetime exposure to a chemical. The 2003 RfC is also based on developmental effects, and is based on the methodologies that were in place at the time of derivation, including (1) the methods for the use of inhalation dosimetry to extrapolate from animal to human exposures (U.S. EPA, 1994) and (2) benchmark dose methods (U.S. EPA, 2000, external review draft). Those methods have been subject to peer review.

Comment: One commenter asserted that the toxicological database is not complete regarding developmental effects, and stated that there is inadequate evidence to assess the carcinogenic potential of MEK (i.e., there are no 2-year animal cancer bioassays).

Response: There are adequate data on developmental effects and on cancer effects to support a decision to delist MEK. The principal study (Schwetz et al. , 1991), a developmental toxicity study in the mouse, is well-designed and tests several exposure concentrations over a reasonable range that include maximum tolerated doses for dams and fetuses. Also, animal studies in a second species (rats) corroborate the effect level for developmental toxicity (Deacon et al. , 1981; Schwetz et al. , 1974).

Regarding carcinogenicity, the current IRIS file (completed in September of 2003) states that the data for MEK are characterized as “inadequate for an assessment of human carcinogenic potential.” The “Toxicological Review of Methyl Ethyl Ketone” (U.S. EPA, 2003) (Toxicological Review of MEK), upon which the IRIS file is based states, “Under EPA's draft revised cancer guidelines (U.S. EPA, 1999), data are inadequate for an assessment of human carcinogenic potential for MEK because studies of humans chronically exposed to MEK are inconclusive, and MEK has not been tested for carcinogenicity in animals by the oral or inhalation routes.” Recent revision of these guidelines does not materially affect this conclusion.

The traditional 2-year animal cancer study has not been conducted for MEK, nor is EPA aware of any organization planning to conduct one. EPA believes one reason no cancer assay has been done is that the results from the majority of the genotoxicity tests (which are often used as an indicator of the need to pursue a 2-year cancer study) are negative, indicating that MEK is a low priority for further study. In 1997, the Organization for Economic Cooperation and Development (OECD) reached this conclusion. OECD's report states that “MEK is not genotoxic and is not likely to be carcinogenic.” (OECD, 1997). The report also states that MEK is “* * * currently of low priority for further work.” (OECD, 1997).

The general descriptors recommended by EPA's “Guidelines for Carcinogen Risk Assessment” (U.S. EPA, 1999) for characterizing the weight of evidence with regard to a chemical's potential for human carcinogenicity did not explicitly recognize this situation. The descriptor applied to MEK in the 2003 IRIS assessment (i.e., “data are inadequate for an assessment of human carcinogenic potential”) pertains to cases where “* * * there is a lack of pertinent or useful data.” (U.S. EPA, 1999). While lacking data or studies that would clearly support their placement in other categories (e.g., the traditional 2-year rodent study), chemicals included within this broad category may, however, have pertinent or useful data which do not indicate any potential for carcinogenicity, consequently providing no support for the performance of the traditional, resource-intensive studies.

Accordingly, EPA's Toxicological Review of MEK also states, “the majority of short-term genotoxicity testing of MEK has demonstrated no activity, and the Structure Activity Relationship (SAR) analysis suggests that MEK is unlikely to be carcinogenic.” (U.S. EPA, 2003). One study (Woo et al. , 2002) has given MEK and other unsubstituted mono-ketones (a compound class to which MEK belongs) a low concern rating (unlikely to be of cancer concern) because these chemicals lack electrophilic activity ( i.e., a structural alert of carcinogenicity) and are generally not associated with carcinogenicity.

There is an absence of positive results in the majority of mutagenicity and genotoxicity tests which are designed to indicate the potential for carcinogenicity. Methyl ethyl ketone has been tested for activity in an extensive spectrum of in vitro and in vivo genotoxicity assays and has shown no evidence of genotoxicity in most conventional assays (National Toxicology Program, no date; World Health Organization 1992; Zeiger et al. , 1992). Methyl ethyl ketone tested negative in bacterial assays (both the S. typhimurium (Ames) assay, with and without metabolic activation, and E. coli ), the unscheduled deoxyribonucleic acid (DNA) synthesis assay, the assay for sister chromatid exchange (SCE) in Chinese hamster ovary (CHO) cells, the mouse lymphoma assay, the assay for chromosome aberrations in CHO cells, and the micronucleus assay in the mouse and hamster. The only evidence of mutagenicity was mitotic chromosome loss at high concentrations in a study of aneuploidy in yeast S. cerevisiae (Zimmerman et al. , 1985), but the relevance of this finding to humans is questionable. Overall, studies of MEK yield little or no evidence of genotoxicity.

However, the finding of low potential for genotoxicity alone is not the sole criterion for an assessment of carcinogenic potential, as non-genotoxic mechanisms can also result in carcinogenesis. While developing the final rule, EPA learned that preliminary results of a recent cancer bioassay by the National Toxicology Program suggested that methyl isobutyl ketone (MIBK) appears to be a weak or marginally active carcinogen in rats and mice, possibly by a nongenotoxic mode of action. Both MEK and MIBK are small molecular weight alkyl ketones, and this similarity raised some questions regarding the possible relevance of the preliminary MIBK results to MEK. To investigate this further, EPA undertook SAR analysis of MIBK and MEK. These two ketones have a key difference in their chemical structure: MIBK is branched, while MEK is linear. EPA's SAR analysis indicates that MIBK's toxicity and possible carcinogenicity are likely due to its branched alkyl structure. Methyl ethyl ketone, like acetone, is linear and lacks this structure. Thus, the analysis concluded that in analogy to acetone and its metabolite isopropanol (which has shown no evidence of carcinogenicity), MEK and its metabolite (2-butanol) are linear and, therefore, have low concern for carcinogenicity potential. A short document describing the analysis, “Acetone, MEK, and MIBK—SAR Analysis on Carcinogenicity/Toxicity,” is included in the docket. Subsequently, EPA conducted an external peer review of this document. All three reviewers found the reasoning to be sound and supported the conclusions of the analysis. These reviews are also included in the docket. Thus, EPA concludes that the available scientific evidence shows a low potential for carcinogenicity in MEK.

Comment: One commenter suggested that the UFs for the prospective RfC were not adequate. The commenter disagreed with the reduction of the interspecies UF and stated that it should have remained at 10 because there are no developmental and reproductive studies available for humans and animals. Another commenter suggested that the human equivalent concentration (HEC) resulted in low confidence because it was based on the same mouse study (1991) as the 1992 RfC, and the prospective RfC was not robust enough to warrant decreasing the interspecies UF from 10 to 3. This commenter also asserted that the chronic and reproductive studies are still missing and, therefore, EPA's proposal of reducing the database UF is not valid. The commenter contended that the lack of current information results in continued low confidence in the database because the data used are from the original studies used to develop the 1992 RfC. The commenter believes that the Dick study did not provide adequate statistical power. Consequently, the commenter believes that the lack of toxicity was not demonstrated, and that the modifying factor should be maintained at 3. The commenter concluded that the “absence of data should not conclude an absence of toxicity.”

Response: An interspecies UF of 3 was applied in deriving both the prospective RfC and the 2003 RfC, consistent with EPA guidance for deriving RfCs in effect at the time (U.S. EPA, 1994). The UF for interspecies extrapolation is not intended to address database deficiencies. A database UF of 10 was used in developing the 2003 RfC to account for the lack of a chronic inhalation toxicity study and multigeneration reproductive toxicity study.

Modifying factors have been used in the past in RfC derivations, where the magnitude of the factor reflected the scientific uncertainties of the study and database that were not explicitly treated with standard uncertainty factors. For the 2003 RfC, the default modifying factor of one was used because EPA concluded that the modifying factor was sufficiently subsumed in the general database UF.

Comment: The petitioner stated that EPA did not present adequate scientific justification for applying a duration adjustment to the inhalation developmental toxicity study and, at the very least, the additional conservatism added by the application of this factor should be explicitly recognized. The commenter pointed to the draft Toxicological Review that indicated that MEK was rapidly absorbed, distributed, and metabolized, suggesting that the duration adjustment may be inappropriate.

Response: Duration adjustment of the exposure concentrations in the developmental study of MEK (Schwetz et al. , 1991) was performed consistent with the EPA Risk Assessment Forum RfD/RfC Technical Panel report, “A Review of the Reference Dose and Reference Concentration Processes” (U.S. EPA, 2002). The report recommends that procedures for adjusting to continuous exposure based on the product of concentration and time be used as a default for inhalation developmental toxicity studies as it is for other health effects from inhalation exposure. While the recommendation is based on evidence that shows that some agents cause developmental toxicity more as a function of peak concentration, the effects of other agents are related to area-under-the-curve (AUC). The latter is true even of some developmental toxicants with a short half-life. In the absence of data that support peak concentration or AUC as more closely correlated with developmental toxicity, EPA's 2002 review document recommends duration adjustment as the more health-protective default procedure. As noted in the Toxicological Review of MEK, because the data are insufficient to argue convincingly for either peak exposure level or AUC as the most appropriate metric, the more health-protective procedure (duration adjustment) was applied as a policy matter.

Comment: The petitioner commented on our interpretation of the Cavender et al. (1983) study. They stated that EPA regarded 5,000 ppm in a 90-day inhalation study as the Lowest Observed Adverse Effect Level (LOAEL) based on reduced weight gain, increased liver weight, and decreased brain weight. The commenter stated that this was inconsistent with the 1992 IRIS database where EPA indicated that a change in liver weight may not be conclusively caused by MEK inhalation. The petitioner recommended that 5,000 ppm be the No Observed Adverse Effect Level (NOAEL).

Response: In the 2003 IRIS assessment, EPA gave further consideration to the biological significance of the findings in the 5,000 ppm animals in the Cavender et al. (1983) study, specifically the organ weight findings. Although the decrease in brain weight in female high-dose animals is of some concern, EPA agrees that this effect, in the absence of corresponding histopathology and functional abnormalities, cannot be clearly characterized as being of toxicological relevance. In light of these uncertainties, characterization of the effects associated with the 5,000 ppm exposure level as adverse, use of that level as a LOAEL, and the use of mid-dose group (2,518 ppm) as a NOAEL were dropped.

Comment: Three commenters suggested that the actual emissions of MEK may result in environmental concentrations below the RfC, but allowable emissions would not. This means that should the emissions reach allowable limits, then the concentrations of MEK will be above the RfC. One commenter provided an example of a facility that emits 500 tons per year (tpy) of MEK but is permitted to emit up to 2,200 tpy. The commenter states that a simple screening model run (most likely similar to the tier 1 or tier 2 analysis submitted by the petitioner) of this facility at the allowable emission rate predicts 24-hour peak concentrations to be about 75 mg/m 3 , which is above the maximum predicted 24-hour average concentration of 10 mg/m3 that EPA cited in the preamble.

Response: The maximum offsite 24-hr MEK concentration for the worst-case facility in the petition as predicted by the Industrial Source Complex Short Term 3 (ISCST3) model was 10 mg/m 3 . The maximum annual concentration was 1.2 mg/m 3 . This facility emits about 500 tpy MEK. The maximum offsite concentration occurs within a few hundred meters of the facility.

The commenters provided limited information on the facility that has the potential to emit 2,200 tpy. EPA contacted the commenter in order to understand how they estimated the value of 75 mg/m 3 . EPA was told that the SCREEN3 model was used to estimate this concentration. However, EPA was unable to obtain the modeling runs which would contain important model input data (e.g., stack heights and distances from stacks to fence lines). From the comment, EPA does know that the maximum offsite concentration for this facility as predicted by the SCREEN3 model was 75 mg/m 3 for a 24-hr average and 1.1 mg/m 3 for an annual average. If this facility were modeled with a more refined dispersion model, such as the ISCST3 model, EPA would expect impacts that are considerably lower than those predicted with the more conservative SCREEN3 model. Most likely, the maximum offsite concentration for the facility would be much closer to 10 mg/m 3 for a 24-hr average near the facility, and well below 1 mg/m 3 for the annual average. EPA would suspect that the facility to which the commenter refers has much better dispersion characteristics than the petitioner's worst-case facility, which had a very low stack and nearby fenceline.

Comment: Three commenters stated that EPA failed to meet the CAA deadline (18 months) for adding or deleting a substance from the HAP list, instead taking 78 months total. Therefore, the commenters believed the 1994 Toxic Release Inventory (TRI) data used in the assessment were not appropriate and that current TRI data should have been used. These commenters also contended that the calculations in the petition did not consider potential increases in MEK use once MEK is delisted, and that EPA should base its decision to delist MEK on emission levels and locations expected after delisting.

Response: EPA interprets the CAA to require consideration of current emissions. It is not appropriate to make a decision on what can only be speculative emissions. EPA states in the final rule to delist caprolactam (61 FR 30816, June 18, 1996) that “EPA does not interpret section 112(b)(3)(C) to require consideration of hypothetical emissions from facilities that might be constructed in the future. The logical consequence of such an expansive construction would be that no substance could ever be delisted, due to the hypothetical possibility of some future facility that has uncontrolled emissions large enough to cause adverse effects. In the event some future facility has uncontrolled caprolactam emissions great enough to change the conclusion of the current EPA risk assessment, EPA can revisit its decision to delist caprolactam at that time.” It is not the case, however, that EPA can never take potential increases in emissions into account. For example, such consideration is appropriate where EPA has information regarding specific facilities, such as the information it considered in denying the methanol delisting petition (66 FR 21929, May 2, 2001).

Using similar logic in this case, EPA does not interpret CAA section 112 (b)(3)(C) to require consideration of hypothetical emissions from facilities that might be constructed in the future, nor projections of increases in emissions from existing facilities.

There are several reasons why EPA does not expect that increases in emissions of MEK will cause health or environmental concerns. With regard to increased emissions themselves, EPA believes that such increases will be limited by good housekeeping practices which are designed to save product. Methyl ethyl ketone is an effective solvent, but one that evaporates readily. Employing techniques to prevent wasting the product also results in decreased emissions.

Due to the health-protective nature of the analysis upon which the decision to delist is based, EPA concludes that the potential risks from outdoor exposures to MEK are overestimated. It is unlikely that future emissions increases will result in unacceptable risk. For example, the petitioner based the risk assessment on 1994 TRI total air emissions of MEK, which were 628 tpy for the worst-case facility. This facility's modeled annual average concentration is only 20 percent of the RfC. This facility could increase emissions significantly before the concentration would be above a level of concern. The highest-emitting facility in the 2003 TRI emits 638 tpy of MEK, only slightly higher than the 1994 TRI emissions for the worst-case facility.

In addition, the national trend in MEK emissions is distinctly downward. Comparing the 1994 and 2003 TRI MEK air emissions data for the 100 highest-emitting facilities indicates that emissions have decreased by approximately 20 percent during that nine year period.

The risk assessment was based on a maximum off-site concentration. The assessment did not consider the amount of time people would be at that location, or other factors that address the amount of exposure faced by actual individuals. Further, this maximum concentration was located at the entrance to a facility in an industrial park. The probability that an individual would live at this location in the future is extremely low.

Given the low hazard presented by the worst-case facility, the health-protective nature of the analysis, and the overall downward trend of MEK emissions over the last several years, EPA believes that emissions of MEK may not reasonably be anticipated to cause adverse human health effects.

The preamble to the proposed rule discussed the March 30, 1998, Federal Register notice (63 FR 15195) in which EPA issued a Denial of Petition entitled “Methyl Ethyl Ketone; Toxic Chemical Release Reporting; Community Right-to-Know.” The denial was in response to a petition from the Ketones Panel of the Chemical Manufacturers Association (CMA) that requested the deletion of MEK from the list of chemicals reportable under section 313 of the Emergency Planning and Community Right-To-Know Act of 1986 (EPCRA) and section 6607 of the Pollution Prevention Act.

The American Chemistry Council (formerly the Chemical Manufacturers Association) filed suit challenging EPA's decision in the United States District Court for the District of Columbia. Subsequently, the court granted summary judgment in favor of EPA ( American Chemistry Council v. Whitman, 309 F.Supp. 2d 111 (D.D.C. 2004)). On appeal, the Court of Appeals for the District of Columbia Circuit reversed the lower court's decision, vacating the lower court's decision, and directed the district court to issue an order to “direct EPA to delete MEK from the TRI” (406 F.3d 738, 742 (DC Cir. 2005)). The circuit court issued its mandate on June 13, 2005 and, accordingly, on June 30, 2005, EPA issued a final rule (70 FR 37698) revising the EPCRA section 313 list of reportable chemicals in 40 CFR 372.65 to delete MEK.

The deletion of MEK from the EPCRA section 313 list eliminates the main source of data EPA uses to track MEK emissions. However, there are other data sources available to estimate MEK emissions, including market research data on MEK production, import, export, and consumption. Consumption of MEK should provide an adequate surrogate for emissions to determine whether significant increases in emissions are occurring. If data indicate that MEK emissions are increasing significantly, EPA has the option to add MEK back on the HAP list.

Comment: One commenter suggested that the risk was not adequately identified because the industry was not studied comprehensively enough to determine chronic exposure.

Response: In order to determine the risks from emissions of MEK, the petitioner used the 1994 TRI as the basis of an emissions inventory intended to quantify annual emissions of MEK, to identify and locate emissions sources, and to acquire some facility-specific emissions information. The 1994 TRI shows that there are over 2,000 sources with reported emissions of MEK. The petition states that over 85 percent of these facilities (approximately 1,700) emit 25 tpy or less. The petition also states that approximately 800 facilities emit between 10 and 200 tpy, and 27 facilities emit 200 tpy or more. In addition to using the 1994 TRI, the petitioner queried a subset of individual sources to obtain site-specific source, release, and facility information for the purpose of conducting more detailed risk assessments. EPA has determined that this approach to establishing reasonable worst-case exposures to MEK emissions is an adequate basis upon which to base a decision to delist MEK. EPA states in the preamble to the proposed rule that it does not interpret CAA section 112(b)(3)(C) to require absolute certainty that a pollutant will not cause adverse effects on human health or the environment before it may be deleted from the list. The use of the terms “adequate and “reasonably” indicate that EPA must weigh the potential uncertainties and likely significance. In this case, the uncertainty in the predicted exposure levels is biased toward protecting public health. Therefore, EPA concludes that delisting MEK is appropriate.

Comment: Several commenters contended that chronic effects of MEK had not been adequately studied or evaluated, and that the delisting was not supported by new or compelling scientific evidence. One commenter requested that EPA conduct long-term health effects studies. Additionally, the commenters stated that there were no lifetime-chronic studies included, no studies evaluating developmental effects, nor studies concerning reproductive toxicity. Moreover, these commenters asserted, there were no multigenerational studies included, and the evaluation of the carcinogenic potential was not adequate.

Response: EPA's RfC methodology (U.S. EPA, 1994) does not always require a complete database in order to develop an RfC; however, the database must at least meet minimum data requirements. For MEK, “* * * confidence in the database is medium * * *.” (U.S. EPA, 2003). “The subchronic study by Cavender et al. (1983) satisfies the minimum inhalation database requirements for derivation of an RfC.” (U.S. EPA, 2003).

In the case where there are enough quality data with which to set an RfC, but where the database is less than complete, EPA adds a database uncertainty factor to account for the lack of data. For MEK, that factor is 10. EPA acknowledges the lack of a chronic toxicity bioassay and an inhalation multigeneration reproductive toxicity study (an oral multigeneration is available), but notes that contrary to the commenters' statements, the developmental toxicity of MEK has been well studied.

As stated above, the RfC is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily inhalation exposure to the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects during a lifetime. Because maximum expected ambient air concentrations are well below the RfC, EPA does not expect adverse noncancer effects to result.

In addition, the health-protective nature of the assessment described above adds to our confidence that no adverse health effects will occur from ambient exposures to MEK.

Comment: One commenter asserted that the appropriate averaging time for assessing the potential for adverse developmental effects to occur is the 24-hour average, not an annual average. The commenter held that evaluating developmental toxicity on a 24-hour basis is supported by EPA guidelines for evaluating developmental risk. This issue was also raised by the VCCEP review panel as they considered the information industry submitted on MEK and children's health.

Response: EPA agrees with the commenter that potential concern for developmental effects from short-term exposures should be addressed, and EPA did so elsewhere in this preamble. With regard to the use of endpoint-specific reference values, EPA's review of the RfD/RfC processes recommended against the use of endpoint-specific reference values, and instead recommended that duration-specific reference values be derived in consideration of the full range of adverse effects.

Comment: A commenter remarked that EPA did not take into account all routes of exposure to MEK and, therefore, did not adequately identify the risk.

Response: MEK is neither bioaccumulative nor persistent. It has a half-life of approximately 9 days. The releases of MEK to air are unlikely to result in elevated concentrations in surface water, ground water, or the food supply. Therefore, the route of exposure EPA is concerned with is direct inhalation of MEK released to the ambient air. For this reason, inhalation was the focus of the analysis. The petitioner also assessed the potential for risks due to ingestion of water contaminated with MEK. In both cases, the risks were below a level of concern.

Comment: One commenter asserted that the risk assessment did not fully address: (1) Other solvents released from stationary and area sources of MEK, (2) actual ambient concentrations near stationary and area sources (only modeled concentrations were used), and (3) the human health effects within the facilities as opposed to fenceline ambient concentrations.

Response: The maximum annual average air concentration resulting from emissions of MEK is not expected to exceed an HQ of 0.2. This value, which is 20 percent of the RfC, is quite low. EPA believes that there is a large enough margin of exposure to preclude a need to address any other emitted HAP that may affect the same target organ as MEK.

The petitioner did not monitor ambient air around actual MEK-emitting facilities. Such an effort would not add to the analysis, or change EPA's conclusion with regard to delisting. This is because the maximum monitored concentration EPA found in the U.S. was over two orders of magnitude below the maximum modeled concentration, and because the modeling conducted was designed to over-estimate ambient concentrations. For example, the model assumed that individuals are continuously exposed to the maximum modeled concentrations of MEK in air for 70 years, and EPA used the maximum annual average concentration as a surrogate for long-term exposure. Also, the model used 1994 emission rates which are significantly higher than current emissions for the facility with the highest estimated HQ of 0.2. EPA believes that the health-protective air dispersion modeling performed as part of the petition and described in detail in the proposed rule resulted in higher concentrations than would monitoring around facilities.

EPA cannot consider the health effects of emissions within facility boundaries. That is the purview of the Occupational Safety and Health Administration.

Comment: One commenter recommended that a comparative analysis with the 1998 Office of Pollution Prevention and Toxics (OPPT) assessment (located in the docket) be done to fully assess the risks of MEK.

Response: EPA agrees with the comment, and EPA conducted a comparison of the 1998 OPPT assessment and the assessment in the proposal to delist MEK.

The assessment presented in the petition to delist MEK estimated a maximum annual average MEK concentration of 1.2 mg/m 3 . It used the ISCST3 model, which is a refined air dispersion model that predicts an annual average by averaging 8,760 hours of real time meteorological data. The ISCST3 model predicted a maximum 24-hour average MEK concentration of 10 mg/m 3 .

The 1998 OPPT study estimated maximum 24-hour average concentrations of 100-200 mg/m 3 . It used a screening model similar to the SCREEN3 model and predicted 1-hour average concentrations under defined meteorological conditions with the assumption that the receptor is always directly downwind from the source. Such screening model runs typically result in high air concentrations as compared to the ISCST3 model. EPA would expect the difference in concentrations to be as high as a factor of 10. In addition, the OPPT study applied a multiplicative factor to predict typical (5), stagnant (10), and maximum (60) acute impacts. Thus, the difference between the two model results can be attributed to the multiplicative factors and differences between a refined and screening model.

Comment: One commenter recommended that EPA not wait for the formal IRIS review of MEK or the VCCEP results to make a final decision regarding delisting of MEK, as there was enough evidence to delist MEK without the additional information. Another commenter asserted that if the RfC resulting from the completed IRIS assessment is different from the prospective RfC, then the petition should be reconsidered and an additional public comment period should be allowed giving the public an opportunity to comment on EPA's decision. This commenter also stated that the results of the VCCEP should be concluded before the comments on the delisting are due.

Response: Regarding the first comment, EPA waited to make a final decision to delist MEK until the 2003 IRIS RfC was determined and until the information submitted by industry under the VCCEP was reviewed in case the results of each of these processes altered our decision to remove MEK from the HAP list.

Regarding the second comment, EPA considers an additional comment period unnecessary for a number of reasons. First, EPA explicitly solicited comment on the effect of a difference between the prospective RfC and the RfC resulting from the completed IRIS assessment. EPA specifically requested comments on the decision in light of potential values for the RfC of 9 mg/m 3 , 3 mg/m 3 and 1 mg/m 3 . The 2003 RfC of 5 mg/m 3 is in the middle of the range upon which EPA solicited comment. Second, while the 2003 RfC is lower than the prospective RfC, the result of this change was only to increase the HQ for the maximum annual average ambient exposure from 0.1 to 0.2 (20 percent of the RfC). This HQ is well below a level of concern.

In addition, EPA judges that the exposures to MEK of actual persons living in the immediate vicinity of an MEK emission source would more typically be at least a factor of 2 to 10 less than the predicted maximum ambient concentration presented in the petition of 1 mg/m 3 . This is because the concentration of MEK declines very rapidly as the plume disperses, and the analysis showed that people do not live at the point of maximum concentration. Therefore, actual exposed individuals would be subject to MEK concentrations less than 1 mg/m 3 . If EPA were to replace the maximum ambient concentration with a more realistic exposure scenario, it would yield an HQ less than 0.2. Based on the current information, and given the conservative nature of the parameters used to estimate the maximum exposure, and because the petition and subsequent analyses characterize the vast majority of MEK exposures from stationary sources, EPA concludes that by applying the RfC of 5 mg/m 3 , potential ambient exposures to MEK may not reasonably be anticipated to cause adverse human health effects.

With respect to the results of the VCCEP, EPA found it unnecessary to extend the public comment period until after the review of the industry-submitted information was complete. This is because the industry provided no new information to EPA that was not already available. Therefore, there was no new information upon which to solicit comments.

Comment: Many commenters noted that the interactions with n-hexane and other ketones have not been sufficiently investigated should the MEK emissions increase. These commenters stated that MEK interactions with n-hexane have been shown to increase neurotoxicity of n-hexane.

Response: EPA stated in the preamble to the proposed rule that MEK has been shown to potentiate the neurotoxicity of other solvents in experiments with laboratory animals when both MEK and the other solvent are present in high concentrations. EPA also stated that studies of occupationally-exposed populations (as reviewed by Noraberg and Alien-Soborg, 2000) provide some evidence of possible interactions in humans. EPA reviewed the occupational epidemiology literature in more depth during the development of the 2003 RfC for MEK. These findings are summarized in the Toxicological Review for MEK ( http://www.epa.gov/iris/toxreviews/0071-tr.pdf, section 4.4.4). Available occupational studies involving multiple chemical exposures do not provide information adequate to clearly establish an interaction between MEK and other neurotoxic solvents in humans. In studies suggesting a potential interaction, neurotoxicity has been observed only in workplace populations exposed to solvent mixtures where reported MEK air concentrations reached levels at or above the Threshold Limit Value (TLV) (200 ppm or 590 mg/m 3 ). EPA concluded that the concerns for chemical interactions are especially diminished at the low levels seen in this assessment: Less than 1 mg/m 3 for chronic exposures, 10 mg/m 3 for 24-hour exposures and 25 mg/m 3 for a 1-hour exposure. These exposures are all well below the reversible effects level of 590 mg/m 3 . Therefore, EPA does not expect possible potentiation of n-hexane by MEK at the low environmental concentrations that would be associated with industrial releases.

Comment: One commenter was concerned that MEK was detected by the National Health and Nutrition Examination Survey in biomonitoring programs.

Response: EPA acknowledged in the preamble to the proposed rule that MEK has been reported to be found in blood. EPA also stated that the data indicated the source of the MEK is likely a by-product of normal human metabolism, and it is reasonable to expect it did not result from an air exposure to MEK at the concentrations seen in the ambient air.

Comment: One commenter requested that EPA consider the role of MEK as an ozone precursor in deciding the petition.

Response: EPA stated in the preamble to the proposed rule that it was inappropriate to consider the role of MEK as an ozone precursor because the “dual structure (differentiating between HAP and criteria pollutants/precursors) would lose its significance if EPA were to include substances on the HAP list solely as a result of their contribution to concentrations of criteria air pollutants.” Specifically, the structure of the CAA is best protected by including compounds on the HAP list only where such inclusion is warranted based upon the HAP noncriteria pollutant related effects. This interpretation is supported by the following prohibition related to listing of new HAP contained in CAA section 112(b)(2): “No air pollutant which is listed under section 7408(a) of this title [the criteria pollutant list] may be added to the list under this section, except that the prohibition of this sentence shall not apply to any pollutant which independently meets the listing criteria of this paragraph and is a precursor to a pollutant which is listed under section 7408(a) * * *.”

Comment: One commenter stated that decisions to list or delist are governed by the precautionary principle. The commenter stated that, “in considering whether a petitioner has met the heavy burden of demonstrating that a substance should be removed from the hazardous air pollutant list, the precautionary principle requires that EPA resolve uncertainty in favor of more protection, not less. The recognition of uncertainty in the listing and delisting process does not give EPA discretion to delist a chemical based on incomplete and outdated information as it has proposed to do with MEK.”

Response: EPA does not believe it is appropriate to require that all uncertainty be resolved in favor of not delisting. Such a requirement of absolute certainty is inconsistent with our interpretation of the requirement that to delist a HAP, EPA must determine that there are “adequate data on the health and environmental effects of the substance to determine that emissions, ambient concentrations, bioaccumulation or deposition of the substance may not reasonably be anticipated to cause any adverse effect to human health or adverse environmental effects.” As explained in denying the petition to delist methanol, EPA does “not interpret CAA section 112(b)(3)(C) to require absolute certainty that the pollutant will not cause adverse effects on human health * * * before it may be deleted from the list. The use of the terms ‘adequate’ and ‘reasonably’ indicate that EPA must weigh the potential uncertainties and their likely significance.” (See 66 FR 21929-21930, May 2, 2001.) For the reasons explained above, EPA determined that this burden has been met here. Responses with respect to the contention that the database was outdated and/or incomplete are also addressed elsewhere is this preamble.

Comment: One commenter asserted that EPA has not adequately considered the odor problems associated with MEK. The commenter stated that odors can cause neurological problems such as fatigue, dizziness, headache, and nausea resulting in a diminished quality of life. The commenter also stated that odor thresholds for MEK have been reported in the range of 6-250 mg/m 3 , and the estimates presented in the proposed rule for a 1-hour maximum concentration near MEK sources is 25 mg/m 3 , which is within the range of the reported odor thresholds. The commenter also suggested that EPA recognize that the risk to sensitive individuals could increase after delisting.

Response: While EPA does not expressly consider odor as a health endpoint, EPA considers the physiological effects of chemical exposures, including the neurological effects that the commenter described. In the proposed rule, EPA stated the following, “The IRIS assessment of MEK states that at present, there is no convincing experimental evidence that MEK is neurotoxic * * * other than possibly inducing CNS (central nervous system) depression at high exposure levels.” The IRIS documentation shows that no peripheral neurohistopathological changes were reported in rats exposed continuously to 3,320 mg/m 3 of MEK for up to 5 months (Saida et al. , 1976). No treatment-related central or peripheral neurohistopathology was observed in rats exposed for 90 days (6 hours/day, 5 days/week) at concentrations of MEK as high as 14,865 mg/m 3 , even among animals in animal tissues specifically prepared and examined for neurohistopathology (Cavender et al. , 1983). Also, ten of ten rats exposed to MEK at 17,700 mg/m 3 and higher for 8 hours/day, 7 days/week, died in the seventh week of exposure without neurological symptoms or histopathology (Altenkirch et al. , 1978).

Regarding sensitive individuals, EPA could not identify any specific data that address the potential differences in susceptibility to adverse effects from MEK exposure. In the MEK Toxicological Review in support of the IRIS assessment, EPA did note that “The potential exists for increased susceptibility to neurotoxicity, hepatotoxicity, and renal toxicity following exposure to MEK in combination with certain other solvents * * *.” The potentiating effects of MEK on the toxicity of other solvents have only been demonstrated at relatively high exposure concentrations (200-1,000 ppm or 590-2950 mg/m 3 ).

Comment: One commenter recommended changing the hazardous waste regulations that apply to MEK as follows: Remove MEK as a listed toxicity characteristic in 40 CFR 261.64; remove MEK as a toxic constituent in part 261, appendix VIII; and remove MEK from the F005 listing, but it may be appropriate to add it to F2003 listing.

Response: EPA was petitioned under CAA section 112(b)(3) to remove MEK from the CAA section 112 HAP list. This is the only action under consideration as part of the final rule.

The detailed factual rationale for supporting EPA's initial determination that the criterion in CAA section 112(b)(3)(C) had been met is set forth in the proposed rule published in the Federal Register on May 30, 2003 (68 FR 32606). Although, as described above, EPA has done some additional analysis pursuant to public comments received on the subsequent action, none of those comments nor EPA analyses have caused EPA to revise the scientific basis upon which that initial determination was predicated. Except as modified or clarified above, EPA hereby incorporates into its rationale for the final rule the substantive assessment of potential hazards, projected exposures, human risk, and environmental effects set forth in the proposed rule to delist MEK. Based on that assessment, EPA's evaluation of the comments and additional information submitted during the rulemaking process (as summarized above), and on other materials, EPA has made a determination that there are adequate data on the health and environmental effects of MEK to determine that emissions, ambient concentrations, bioaccumulation, or deposition of the compound may not reasonably be anticipated to cause adverse human health or environmental effects.

The final rule will be effective on December 19, 2005. Although section 553(d) of the Administrative Procedure Act, 5 U.S.C. 553(d), provides that substantive rules must be published at least 30 days prior to their effective date, this requirement does not apply to this action. First, the final rule was promulgated pursuant to CAA section 307(d), and that provision expressly states that the provisions of section 553 of the Administrative Procedure Act do not apply to this action. Second, even under section 553, the requirement that a rule be published 30 days prior to its effective date does not apply to a rule, “which grants or recognizes an exemption or relieves a restriction.”

Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA must determine whether the regulatory action is “significant” and, therefore, subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Executive 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 adverse affect in a material way the economy, a sector to 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 obligation 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 OMB review.

Today's final action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The final action will remove MEK from the CAA section 112(b)(1) HAP list and, therefore, eliminate the need for information collection under the CAA. 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 are listed in 40 CFR part 9 and 48 CFR chapter 15.

EPA has determined that it is not necessary to prepare a regulatory flexibility analysis in connection with this final rule. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administrations' regulations at 13 CFR 121.201; (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 final rule on small entities, EPA has concluded that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the proposed rule on small entities.” 5 U.S.C. sections 603 and 604. Thus, an agency may conclude that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule.

The final rule will eliminate the burden of additional controls necessary to reduce MEK emissions and the associated operating, monitoring and reporting requirements. EPA has, therefore, concluded that today's final rule will relieve regulatory burden for all small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 1044, 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 final 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 1 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 under 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 final rule contains no Federal mandates for State, local, or tribal governments or the private sector. The final rule imposes no enforceable duty on any State, local or tribal governments or the private sector. In any event, EPA has determined that the final rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. Because the final rule removes a compound previously labeled in the CAA as a HAP, it actually reduces the burden established under the CAA. Thus, today's final rule is not subject to the requirements of sections 202 and 205 of the UMRA. Since the final rule contains no Federal mandates and imposes no enforceable duties on any entity, 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.”

The 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. Today's final rule removes the substance MEK from the list of HAP contained under section 112(b)(1) of the CAA. It does not impose any additional requirements on the States and does not affect the balance of power between the States and the Federal government. Thus, Executive Order 13132 does not apply to this rule.

Executive Order 13175 (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.” The final rule does not have tribal implications, as specified in Executive Order 13175.

A review of the available emission inventory does not indicate tribal MEK emissions sources subject to control under the CAA and, therefore, the final rule is not anticipated to have tribal implications. In addition, the final rule will eliminate control requirements for MEK and, therefore, reduce control costs and reporting requirements for any tribal entity operating a MEK source subject to control under the CAA which EPA might have missed. Thus, Executive Order 13175 does not apply to the final rule.

Executive Order 13045 (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, EPA 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 Executive Order 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 Executive Order has the potential to influence the regulation. The final rule is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because EPA does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This determination is based on the fact that the RfC is determined to be protective of sensitive sub-populations, including children. Also, the single study cited during public comment to indicate a potential effect on children has been reviewed during this petition process and found to be limited in design and execution. Consequently, EPA determined that the study was of insufficient quality to provide information regarding health risks (leukemia) of MEK to children. Also, EPA evaluated industry's submission to the first tier of the VCCEP program and has determined that there are no data which specifically indicate that the RfC will not be protective of children.

The final 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 112(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 915 U.S.C. 272 note), directs all Federal agencies to use voluntary consensus standards instead of government-unique standards in their regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., material specifications, test method, sampling and analytical procedures, business practices, etc.) that are developed or adopted by one or more voluntary consensus standards bodies. Examples of organizations generally regarded as voluntary consensus standards bodies include the American society for Testing and Materials (ASTM), the National Fire Protection Association (NFPA), and the Society of Automotive Engineers (SAE). The NTTAA requires Federal agencies like EPA to provide Congress, through OMB, with explanations when an agency decides not to use available and applicable voluntary consensus standards. The final rule does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards.

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 today's final 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 . This action is not a “major rule” as defined by 5 U.S.C. 804(2). The final rule will be effective on December 19, 2005.

You may be potentially affected by this action if you manufacture (defined by statute at 15 U.S.C. 2602(7) to include import) chemical substances, including inorganic chemical substances, subject to reporting under the TSCA Inventory Update Reporting (IUR) regulations at 40 CFR part 710. Any use of the term “manufacture” in this document will encompass “import,” unless otherwise stated. Potentially affected entities may include, but are not limited to:

Chemical manufacturers and importers, including chemical manufacturers and importers of inorganic chemical substances (North American Industrial Classification System (NAICS) codes 325, 32411).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The NAICS codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions at 40 CFR 710.48. If you have any questions regarding the applicability of this action to a particular entity, consult the technical contact person listed under FOR FURTHER INFORMATION CONTACT .

In addition to using EDOCKET ( http://www.epa.gov/edocket ), you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 710 is available on E-CFR Beta Site Two at http:// www.gpoaccess.gov/ecfr/.

Through this action, EPA is promulgating amendments to the IUR regulations that were proposed on January 26, 2005 (70 FR 3658) (FRL-7332-2), taking into consideration comments received on the proposed rule. The amendments to the IUR regulation that are contained in this final rule pertain to 40 CFR Part 710, Subpart C--Inventory Update Reporting for 2006 and Beyond. The following is a brief listing of the changes made to the IUR regulations via this rule. These changes are described in more detail in Unit II.D., along with a summary of the comments received and the Agency's response to those comments.

First, EPA is amending 40 CFR 710.43, 40 CFR 710.46, 40 CFR 710.48, and 40 CFR 710.52 to change the reporting cycle from 4 years to 5 years.

Second, EPA is amending 40 CFR 710.53 to adjust the dates of the submission period within which manufacturers and importers must report IUR data to EPA. For data required to be submitted in 2006, the submission period remains August 25 to December 23, 2006. Beginning in 2010 and for each subsequent submission period, the submission period will begin June 1 and end September 30. EPA is also clarifying the recordkeeping requirements by identifying that the 5-year record retention period begins on the last day of the submission period.

Third, EPA is clarifying the partial exemption for petroleum process streams and amending 40 CFR 710.46(b)(1) to add certain petroleum process streams to the listing.

Fourth, EPA is amending 40 CFR 710.46(b)(2) to add an explanation that, for the partial exemption for chemicals for which the IUR processing and use information is of low current interest, petitions must include a written rationale for suggested additions of a chemical to or deletions of a chemical from the list of partially exempt chemical substances.

Fifth, EPA is further amending 40 CFR 710.46 to remove the references to the 1985 edition of the TSCA Inventory from paragraphs (a)(1)(i) and (ii).

Sixth, EPA is amending 40 CFR 710.52(c)(4)(ii)(A) to change the list of commercial and consumer product use categories by adding a new category.

Seventh, EPA is amending 40 CFR 710.52(c)(3)(iv) to require separate reporting of manufacture and import volumes.

Eighth, EPA is amending 40 CFR 710.52(c)(4) to limit the reporting of processing and use information to domestic processing and use activities only.

Ninth, EPA is removing the provision regarding the confidentiality of production volume information within specified ranges (40 CFR 710.52(c)(3)(v)).

EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and keep current an inventory of chemical substances manufactured or processed in the United States. This inventory is known as the TSCA Chemical Substances Inventory (the TSCA Inventory). In 1977, EPA promulgated a rule (42 FR 64572, December 23, 1977) under TSCA section 8(a), 15 U.S.C. 2607(a), to compile an inventory of chemical substances in commerce at that time. In 1986, EPA promulgated the initial IUR regulation under TSCA section 8(a) at 40 CFR part 710 (51 FR 21438, June 12, 1986) to facilitate the periodic updating of the TSCA Inventory and to support activities associated with the implementation of TSCA. In 2003, EPA promulgated extensive amendments to the IUR regulation (68 FR 848, January 7, 2003) (FRL-6767-4) (2003 Amendments) to collect exposure-related information associated with the manufacturing, processing, and use of eligible chemical substances and to make certain other changes (Ref. 1).

TSCA section 8(a)(1) authorizes the EPA Administrator to promulgate rules under which manufacturers and processors of chemical substances and mixtures (referred to hereinafter as chemical substances) must maintain such records and submit such information as the Administrator may reasonably require. TSCA section 8(a) generally excludes small manufacturers and processors of chemical substances from the reporting requirements established in TSCA section 8(a). However, EPA is authorized by TSCA section 8(a)(3) to require TSCA section 8(a) reporting from small manufacturers and processors with respect to any chemical substance that is the subject of a rule proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or that is the subject of an order under TSCA section 5(e), or that is the subject of relief that has been granted pursuant to a civil action under TSCA section 5 or 7. The standard for determining whether an entity qualifies as a small manufacturer for purposes of 40 CFR part 710 generally is found at 40 CFR 704.3. Processors are not currently subject to the regulations at 40 CFR part 710.

The data reported pursuant to the IUR regulations are used to update the information maintained on the TSCA Inventory. EPA uses the TSCA Inventory and data reported under the IUR regulation to support many TSCA-related activities and to provide overall support for a number of EPA and other federal health, safety, and environmental protection activities. The IUR regulations, as amended by the 2003 Amendments (Ref. 1), require U.S. manufacturers (including importers) of chemicals listed on the TSCA Inventory to report to EPA every 4 years the identity of chemical substances manufactured (including imported) during the reporting year in quantities of 25,000 pounds or more at any single site they own or control (see 40 CFR part 710, subpart C). The IUR regulation generally excludes several groups of chemical substances from its reporting requirements, i.e., polymers, microorganisms, naturally occurring chemical substances, and certain natural gas substances (40 CFR 710.46). Persons manufacturing or importing chemical substances are required to report information such as company name, site location and other identifying information, production volume of the reportable chemical substance, and exposure-related information associated with the manufacture of each reportable chemical substance, including the physical form and maximum concentration of the chemical substance and the number of potentially exposed workers (40 CFR 710.52).

Manufacturers (including importers) of chemicals in larger volumes (i.e., 300,000 lbs. or more manufactured (including imported) during the reporting year at any single site) are additionally required to report certain processing and use information (40 CFR 710.52(c)(4)). This information includes process or use category, NAICS code, industrial function category, percent production volume associated with each process or use category, number of use sites, number of potentially exposed workers, and consumer/commercial information such as use category, use in or on products intended for use by children, and maximum concentration.

For the 2006 submission period, manufacturers (including importers) of inorganic chemical substances will be required to report for the first time. However, for the 2006 submission period only, manufacturers (including importers) of inorganic chemical substances will be partially exempt from reporting under IUR regulations, regardless of production volume. A partial exemption means that a submitter is exempt from the processing and use reporting requirements described in 40 CFR 710.52(c)(4). After the 2006 submission period, the partial exemption for inorganic chemicals will no longer be applicable and submitters will fully report information on inorganic chemical substances, including information on processing and use (40 CFR 710.46(b)(3)). In addition, specifically listed petroleum process streams and other specifically listed chemical substances are partially exempt, and manufacturers of such substances are not required to report processing and use information during the 2006 or in any subsequent submission periods, for as long as the chemical substances remain on these partial exemption lists (40 CFR 710.46(b)(1) and (b)(2)).

1. What changes are being made to the chemical substances covered by the IUR regulations? --a. Partially exempt petroleum process streams. Certain petroleum process streams listed in 40 CFR 710.46(b)(1) are exempted from additional reporting requirements under the IUR regulations for chemical substances manufactured in amounts of 300,000 lbs. or more. EPA is adding chemicals to this list and is clarifying EPA's intention concerning the scope of this partial exemption. Additionally, EPA proposed changing the name of this partial exemption from “petroleum process streams” to “petroleum refinery process streams” to clarify the types of covered substances. EPA received comments which indicated that the proposed change was misunderstood; EPA, therefore, at this time, is retaining the name “petroleum process streams.”

EPA is amending the list of partially exempt substances by adding the following 25 petroleum refinery process streams, listed by CAS registry number: 67254-74-4, 67891-81-0, 67891-86-5, 68476-27-7, 68477-98-5, 68477-99-6, 68478-31-9, 68513-03-1, 68514-39-6, 73138-65-5, 92045-43-7, 92045-58-4, 92062-09-4, 98859-55-3, 98859-56-4, 101316-73-8, 164907-78-2, 164907-79-3, 178603-63-9, 178603-64-0, 178603-65-1, 178603-66-2, 212210-93-0, 221120-39-4, and 445411-73-4. EPA also is adding the following two petroleum process streams listed by CAS registry number: 68919-16-4 and 61789-60-4. They were inadvertently left off the initial partial exemption list established by the 2003 Amendments

The petroleum process stream partial exemption was established by the 2003 Amendments (Ref. 1). As described in the preamble to the 2003 Amendments, EPA established the exemption based upon expected exposures and uses of the listed chemical substances. In the 2003 Amendment preamble, EPA explained that these chemicals are frequently processed at the site where they are produced in vessels which are designed to minimize losses and, coincidentally, the potential for releases and exposure. Also, in many cases, the flammable nature of these products requires that they also be transported, processed, and stored in well controlled vessels. For these reasons, EPA believed worker exposure to the chemicals termed “petroleum process streams” for purposes of IUR was diminished and thus IUR processing and use reporting was not considered to be warranted at the time the 2003 Amendments were promulgated. The initial listing of chemical substances in 40 CFR 710.46(b)(1), was derived from the 1983 publication of the American Petroleum Institute (API) document entitled Petroleum Process Stream Terms Included in the Chemical Substances Inventory Under the Toxic Substances Control Act (TSCA) (API publication) (Ref. 2).

In developing the proposed IUR Revisions rule, EPA considered adding potential petroleum process streams, identified by API as having been added to the TSCA Inventory since the 1983 publication was compiled, to the 40 CFR 710.46(b)(1) listing. As noted in the proposed rule, in order to determine which of these substances qualified as petroleum process streams, EPA applied the criteria embodied in the Agency's petroleum stream descriptions contained in EPA's January 1978 Addendum I to the TSCA Candidate List of Chemical Substances, entitled Generic Terms Covering Petroleum Refinery Process Streams (Addendum I) (Ref. 3). Based on Addendum I, EPA described in the proposal the reasons why several of the suggested chemical substances were not considered to be petroleum process streams for IUR reporting purposes: (i) The chemical substance consists of a complex mixture of one class of hydrocarbons, e.g., all alkanes or all alkenes (with defined carbon number ranges) and aromatic hydrocarbons (without defined carbon number range), which do not specify petroleum as a source material in the chemical name; (ii) the chemical substance is a well defined alkylbenzene, or is an alkylbenzene fractionation product or distillation residues. Alkylbenzenes are typical downstream petrochemical products that are made synthetically from benzene and paraffinic hydrocarbons in a chemical process that does not involve refinery processing; (iii) the chemical substance includes the chemical modification terms sulfated, bisulfited, sulfurized, sulfonated, esters, and reaction products etc., are not substances produced within the scope of petroleum refining operations, but rather they are considered to be products from other chemical manufacturing processes; or (iv) the chemical substance is derived using a chemical process (a Fischer-Tropsch process) from a non-petroleum source (Refs. 1 and 4).

There is one point regarding the petroleum process stream exemption that EPA wishes to clarify. In the proposed rule, EPA stated that the decision criteria used to develop both the initial list in 40 CFR 710.46(b)(1) and the then-proposed additions were applied in a consistent manner. The API document, used to compile the initial list, and EPA's Addendum I, used to compile today's additions, do vary in approach. The API document includes a number of substances that would not be included as petroleum process streams in Addendum I. For instance, the API publication contained individual light hydrocarbons and related gases (Class I substances) which were not identified in Addendum I. EPA intends to revisit the list in 40 CFR 710.46(b)(1) after the 2006 reporting cycle to ensure that all chemicals listed are consistent with Addendum I.

The Agency received many comments on the proposed changes to the petroleum process streams partial exemption. In general, the commenters supported adding chemicals to the partial exemption chemical list. One commenter felt that EPA's proposed change in the name of the partial exemption to “petroleum refinery process streams” was constricting. Another commenter stated that the scope of the proposed change excludes a variety of substances that are in fact petroleum process streams produced in a refinery.

EPA is not promulgating the name change and will retain “petroleum process streams” to describe the partial exemption. EPA's inclusion of the term “refinery” was intended to indicate that the streams were refining streams and to make the title consistent with terms used in EPA's Addendum I document. This name change was not intended to affect the scope of the partial exemption nor was it intended to restrict substances to only those produced at a refinery. Although EPA acknowledges that petroleum process streams can be manufactured outside of a refinery, the Agency also notes that some substances produced in a refinery are petrochemicals and do not qualify as petroleum process streams.

Two commenters highlighted EPA's statement that “Qualifying petroleum process streams are produced only in a petroleum refinery, are further refined at the same site, and are processed and used in closed equipment, or are used as fuel.” 70 FR 3662. According to these commenters, limiting the scope of the partial exemption to petroleum refineries was inappropriate because certain chemicals are produced in closed systems at production facilities other than refineries, in a manner similar to their production at refineries. One of the commenters stated that denying the partial exemption to all except petroleum refineries violates the Paperwork Reduction Act (PRA) and offers a competitive advantage to refineries. One commenter requested that, if EPA implements its proposed definition of petroleum process stream as a substance produced only in a petroleum refinery, further refined at the same site, and processed and used in closed equipment or used as fuel, the Agency should acknowledge that the definition is not intended for any purpose other than for identifying partially exempt chemicals for the IUR regulation.

The statement concerning qualifying petroleum process streams was included in the discussion describing the Agency's decision concerning whether or not to list certain substances suggested by the API. EPA did not intend the proposed change to alter the status of chemicals currently on the list nor did EPA intend to change the exemption to be based upon the location at which a substance is manufactured. A chemical substance listed by CAS Registry Number (CASRN) at 40 CFR 710.46(b)(1) is exempt from reporting requirements of 40 CFR 710.52(c)(4), unless the substance is ineligible because of exceptions noted in the introductory text of 40 CFR 710.46. For example, one of the commenters noted that calcined petroleum coke (CASRN 64743-05-1) can be manufactured either in a petroleum refinery or in another type of facility. This substance, since it is listed by CASRN at 40 CFR 710.46(b)(1), is exempted from reporting IUR processing and use information regardless of where it is manufactured. Therefore, refineries are not receiving any competitive advantage over other manufacturers of these chemicals. As recognized by the commenters, EPA stated that qualifying petroleum process streams are produced only in a petroleum refinery. In light of the confusion identified by the comments, and to recognize that qualifying petroleum process streams may occur outside of a petroleum refinery, EPA is now stating that qualifying petroleum process streams to be added in 40 CFR 710.46(b)(1) are produced within the scope of petroleum refining operations. Additionally, while EPA did not define the term “petroleum process stream” in its proposal, the Agency agrees that the discussion included in the proposed revisions preamble is intended solely for reporting under the IUR regulations.

b. “Low current interest” partial exemption. 40 CFR 710.46(b)(2) exempts manufacturers (including importers) of certain chemical substances from reporting processing and use information under 40 CFR 710.52(c)(4) if EPA has determined that it has a “low current interest” in the IUR processing and use information for that chemical substance. The public may request EPA to add a substance to, or remove a substance from, the list of chemicals partially exempt from reporting by submitting a petition that addresses the considerations set forth in 40 CFR 710.46(b)(2)(ii).

In the proposed rule, the Agency sought to clarify the process for petitioning EPA to add a chemical to, or remove it from, the list at 40 CFR 710.46(b)(2)(iv). The revisions were intended to more clearly state that the burden is on the petitioner to demonstrate that the collection of information on the production and use of the chemical substance is or is not of low current interest. The proposed rule also clarified that it is the petitioner's obligation to address the considerations set forth in § 710.46(b)(2)(ii) by providing sufficient information, including documentation and relevant citations to supporting information. In addition, the proposed rule altered the consideration of whether a chemical substance was adequately managed by broadening it to include entities other than Federal agencies. (See 70 FR 3658).

Many persons commented that the proposed change would clarify the requirements for a petition for partial exemption under the IUR regulations and supported the change. In addition, one person commented that the proposed changes support the continued consideration of the totality of information available on a chemical in deciding to grant or deny a partial exemption. EPA is finalizing the changes to this partial exemption as proposed.

Several comments addressed issues beyond the Agency's proposed actions, advocating substantive changes to the partial exemption. For example, two persons believed that EPA should provide additional certainty to the exemption process. Another commented that, while a formal risk assessment was not needed, review of requests for partial exemption must be objective. This commenter supported a delisting process that incorporated the criteria used for exempting petroleum streams, described by the commenter as exempting intermediates processed in closed equipment or burned as fuels. Another commenter suggested adding additional criteria which promoted pollution prevention and resource recovery and ongoing programs of other offices within EPA. Finally, one commenter advocated removing the partial exemption process entirely. EPA intends to further consider these suggestions concerning the “low current interest” partial exemption. If change is warranted, EPA will initiate a separate rulemaking.

2. How is this rule changing the data elements reported by all submitters? --a. Production volume reporting. EPA is requiring that domestic production volume data be reported separately from import volume data. Prior to the 2003 Amendments, submitters were required to report the domestically manufactured volume data separate from the imported volume data for each reportable substance. With the 2003 Amendments, persons manufacturing and/or importing a reportable chemical substance were required to aggregate the amounts of a chemical imported and manufactured domestically and to report the total. In the proposed rule, EPA suggested a return to the previous method of reporting data on manufactured volumes separately from imported volumes. EPA explained that it is frequently useful to distinguish between the volume of a chemical manufactured in the United States and imported into this country to understand the nature of chemical production in the United States, characterize the markets for chemicals, and assess potential exposures during importation and domestic manufacture of chemical substances (See 70 FR 3658).

Several persons who commented on the proposed rule agreed with the proposed change. One person noted that separate reporting of the manufactured and imported volumes for chemical substances will allow the Agency to separately evaluate manufacturing and import activities and assist the Agency in characterizing exposures to these chemical substances. EPA concurs with these observations and is promulgating the proposed change.

b. Production volume range confidentiality claims. EPA is removing the requirement that submitters who claim production volume as TSCA confidential business information (CBI) must indicate whether they are also claiming a specified range within which the production volume falls as confidential (40 CFR 710.52 (c)(3)(v)).

EPA received 11 comments on the proposed removal of the requirement that submitters indicate whether or not production volumes submitted in ranges should be treated as CBI. While one commenter supported this change, the others opposed it. Commenters that opposed the change expressed concern that such a change would decrease the protection of CBI, and several proposed that EPA simply adjust the ranges that it uses to publicly release aggregated production volume data to match those of the IUR regulation.

EPA believes that many of the objections to this proposed change result from a misunderstanding of EPA's intent in removing this requirement. As a general matter, EPA releases IUR production volume range information for a chemical only after aggregating the data across all reporting sites. In the 2003 Amendments, EPA included a provision requiring each IUR submitter to report whether its production volume, when considered in a range specified in § 710.52(c)(3)(v), should be treated as CBI. This amendment was included in the 2003 final rule as part of an effort to make available to the public site- and chemical-specific production volume range information from the IUR that was not claimed as CBI.

Upon consideration of various public comments and internal discussion, the Agency has decided that a submitter may no longer claim as CBI a specified production volume range that corresponded to the submitter's site-specific production volume data. Submitters will be able to continue to claim their actual production volume as CBI. EPA's decision not to allow confidentiality claims for the standardized production volume ranges in 40 CFR 710.52(c)(3)(v) is based on several concerns, most importantly issues inherent in releasing both aggregated data and site-specific production volume ranges. Because of this difficulty, the Agency has determined that this provision regarding the confidentiality of production volume information within specified ranges is not likely to result in greater availability of production volume information to the public, which was the goal of this data element as expressed in the 2003 Amendments (Ref. 1). Additionally, several commenters suggested that EPA should not release these standardized production volume ranges. It is important to note that, by this change, EPA is not presuming consent to release these production volume ranges for site-specific production volume ranges or otherwise lessening any CBI protections. Any production volume information released to the public will be in the form of production volume data that is aggregated and ranged.

3. How have the data elements reported only by larger production volume manufacturers changed? --a. Reporting processing and use information for domestic activities only. Persons manufacturing 300,000 lbs. or more of a reportable chemical substance were required to report processing and use information for that chemical substance to the extent that the information is readily obtainable. EPA is restricting the processing and use information reported under 40 CFR 710.52(c)(4) to domestic processing and use activities for two reasons. First, EPA is primarily focused on exposures to chemical substances resulting from domestic processing and use of the chemicals. Second, EPA anticipates that restricting the processing and use information that must be reported by larger production volume manufacturers to that associated with domestic activities will reduce the burden associated with reporting this information. The Agency estimates that the average burden for reporting the IUR processing and use information is reduced by about 15%, resulting in a total savings of approximately $8 million per reporting period (Ref. 5).

Many commenters supported limiting reported processing and use information to that associated with domestic activities. Those commenters supported this proposal as narrowly tailored to satisfy the Agency's data needs while reducing the burden on entities subject to reporting under the IUR regulations. They noted that chemicals sold in international commerce are frequently distributed through brokers and as a consequence the information on processing and use of exported chemicals is, in their view, not readily obtainable. In addition, the commenters stated that information from foreign sources may be less easily verified and therefore could reduce the accuracy of the data collected. One person commented that tracking the processing and use of domestically manufactured volumes separately from exported volumes would require separate tracking systems and would increase the burden associated with larger production volume manufacturers' reporting under the IUR regulations. EPA anticipates that, for most submitters, limiting the reporting of processing and use information to that associated with domestic activities will decrease the burden associated with reporting under the IUR regulation. For these reasons, EPA is finalizing the proposal to restrict information reported in response to 40 CFR 710.52(c)(4) to domestic processing and use of chemical substances.

b. Consumer and commercial product categories. Persons manufacturing 300,000 lbs. or more of a reportable chemical substance must report the commercial and consumer product category or categories that best describe the commercial and consumer products in which each reportable chemical substance is used (see 40 CFR 710.52(c)(4)(ii)(A)). EPA proposed the following changes to the list of categories:

EPA received comments supporting the consolidation of these two categories, however no specific reasons were provided for their support. EPA also received a comment stating that combining these categories will result in a loss of information. The latter commenter, Environmental Defense, et.al., (ED) provided specific information on the “Soaps and Detergents” and “Polishes and Sanitation Goods” categories, noting that these categories have distinct six-digit North American Industry Classification System (NAICS) codes and showing that these categories are readily distinguishable from each other. EPA found the same information provided by ED at the following U.S. Census Bureau's web site: http://www.census.gov/epcd/naics02/def/NDEF325.HTM#N3256. The website defines “soaps and detergents” and “polishes and sanitation goods” by further breaking those categories into more distinct subcategories, demonstrating that there are real differences between those two categories. For instance, “Soaps and Detergents” contains bar soaps manufacturing; dentifrices manufacturing; dishwasher detergents manufacturing; hand soaps (e.g., hard, liquid, soft) manufacturing; toothpastes, gels, and tooth powders manufacturing; and other categories. “Polishes and Sanitation Goods” contains air fresheners manufacturing; ammonia, household-type, manufacturing; brass polishes manufacturing; floor polishes and waxes manufacturing; shoe polishes and cleaners manufacturing; wallpaper cleaners manufacturing; and other categories. Please note that, as described in the preamble to the 2003 Amendments, submitters under the IUR will not be required to report on non-TSCA downstream uses of the TSCA chemicals that they manufacture (See 68 FR 871, Unit III.B.3.b.).

Additionally, ED stated that “the two different types of uses may have significant implications for exposure patterns. For example, the former category primarily includes products that many people would use several times a day, while the latter includes products that most consumers would use considerably less frequently” (Ref. 6). EPA more carefully considered the way in which it would utilize these categories in a screening-level exposure assessment. While there are products in the “Polishes and Sanitation Goods” category that could be used on a daily basis in similar quantities as products in the “Soaps and Detergents” category, there are also products with very different use scenarios. For instance, EPA has developed default scenarios in the Agency's screening level Consumer Exposure Module, which is embedded into the Agency's Exposure, Fate Assessment Screening Tool (E-FAST) (see http://www.epa.gov/opptintr/exposure/docs/efast.htm ), for laundry detergent (in the “Soap and Detergent” category) and for solid air fresheners (in the “Polishes and Sanitation Goods” category). These use scenarios are different from each other and therefore would generate different potential exposure results. Therefore, based upon a further analysis of the NAICS Index Entries and EPA's screening models, EPA has decided not to combine the two categories and will maintain separate reporting categories for “Soaps and Detergents” and “Polishes and Sanitation Goods.”

(ii) Add a category called “Agricultural Products (non-pesticidal).” Comments addressing this addition were all favorable, and EPA is finalizing the addition of this category. Without this category, agricultural uses of chemicals would have been reported under the miscellaneous “Other” category.

One commenter requested a definition for “non-pesticidal,” which is used in the “Agricultural Products” category as well as the existing “Lawn and Garden Products (non-pesticidal)” category. For guidance as to what substances are considered to be “pesticides” and information as to what uses are considered to be pesticidal uses, refer to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) definition of “pesticide” (7 U.S.C. 136(u) or FIFRA section 2(u)), which generally defines the term as “(1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant, and (3) any nitrogen stabilizer. . .” If the subject persons find that the agricultural or lawn and garden product on which they are reporting does not meet the definition under FIFRA section 2(u), their product will fall into the “Agricultural Products (non-pesticidal)” or the “Lawn and Garden Products (non-pesticidal) category.

(iii) The Agency had also proposed removing the category “Photographic Chemicals,” due to the expected decline in the traditional film photofinishing industry, which indicates that consumer/commercial exposure issues associated with photographic chemicals may be of diminished importance. Six commenters stated their general support of changes made to the commercial and consumer product categories, although no commenter specifically mentioned photographic chemicals or provided any specific reason for their support. One comment supported maintaining the “Photographic Chemicals” category, stating that any burden associated with the reporting of a category covering uses that are less prevalent over time ought to also decline, and that there are indications of a relatively stable remaining core of film users and therefore the associated chemicals will continue to be used. Upon further investigation, EPA has decided to maintain this category. According to several industry sources, despite the displacement of analog photography by digital imaging, U.S. consumption of film and paper chemicals is projected to remain relatively stable. Included in this category are many substances that have a role in digital as well as analog imaging. Also, toners and resins for copiers included in this category are continuing to increase in volume. Thus, while specific types of photographic chemicals may decrease in use, it seems unlikely that use of chemical substances in the “Photographic Chemicals” category as a whole will drastically decrease, as EPA originally thought (Ref. 7).

4. What other changes are being made? --a. Reporting frequency and recordkeeping. The IUR regulations require reporting every 4 years. The first submission period to occur after the 2003 Amendments will be in 2006, at which time submitters will report information based on the 2005 reporting year. EPA proposed to change the reporting frequency so that, after the 2006 submission period, the reporting frequency will be every 5 years instead of every 4 years. This means that the second submission period after the 2003 Amendments would be 2011 (i.e., 5 years after 2006) and would then occur every 5 years thereafter. The reporting year would continue to occur in the calendar year immediately preceding the submission period, i.e., 2010, 2015, etc.

EPA received a variety of comments on the proposed change to the IUR reporting cycle from every 4 years to every 5 years. Several companies and trade associations supported this extension to the reporting cycle. Those who supported the change generally recognized that the extended reporting cycle would result in burden reduction, particularly in the wake of the amended reporting requirements promulgated in 2003 (68 FR 848, January 7, 2003), while agreeing that the extended reporting cycle would still meet EPA's data needs. Certain commenters correctly understood that the extended cycle would allow inorganic chemical manufacturers to become familiar with IUR reporting (which will be required for inorganic chemical substances for the first time as of the 2006 submission period) before having to report processing and use information during submission periods after 2006. One company indicated that, although it was supportive of changing from a 4-year to a 5-year reporting cycle, such a change would not result in a reduced (or increased) burden to industry because the 4-year reporting cycle has been in effect for some time, and companies have this frequency integrated into their regulatory compliance calendars.

Other commenters did not support the proposed change in reporting frequency. A group of organizations and individuals indicated that reporting every 5 years will not meet the Agency's and others' critical data needs. They suggested that the large fluctuation in the universe of high production volume chemicals from 1990-2002 indicates a need for more frequent, rather than less frequent, reporting, and they also provided an analysis of publicly available IUR information to bolster the assertion that the chemical industry is dynamic and that production volumes change dramatically over the 4 years between reporting cycles. These commenters suggested that annual reporting of production volume data would be more appropriate, but if EPA chose not to require annual reporting of this data, it should require the reporting of yearly production volume data every 5 years. They also recognized that EPA bases many of its actions on information reported under the IUR regulation, and contended that more accurate reporting will lead to better risk management at a lower cost.

EPA intends to consider further the suggestion to adopt a provision requiring persons to report their annual production volumes for each of the 5 years preceding the submission period. If the reporting of annual volumes appears to be an appropriate change to the IUR regulations, EPA may initiate a separate rulemaking.

EPA recognizes that more frequent reporting could track more closely the actual amounts of IUR reportable chemical substances manufactured (including imported) in the U.S. In this rule, the Agency is incorporating its proposed change to IUR reporting frequency in an effort to reduce burden to industry while still meeting the Agency's basic information needs. The Agency believes that reporting every 5 years will meet EPA's most critical needs, particularly given that the information that will be reported under the newly amended IUR will be significantly more useful for exposure and risk screening purposes than the information that was reported under IUR in the past. EPA also agrees that the extended reporting cycle will allow increased time for industry (particularly inorganic chemical manufacturers) to learn how to comply with the amended IUR, and may result in submissions with fewer errors.

EPA disagrees with the comment that the change from a 4-year reporting cycle to a 5-year reporting cycle does not affect industry burden. Over a 20-year period, a 5-year frequency results in 4 submission periods while a 4-year frequency results in 5 submission periods. As a result of requiring one less submission period over the course of 20 years, EPA estimates that a 5-year frequency will save regulated entities from $59.3 to $75.7 million over 20 years at a 3% discount rate (about a 16% reduction), and from $41.2 to $52.6 million over 20 years at a 7% discount rate (Ref. 5), and would still meet EPA's most critical data needs.

Currently, submitters are required to retain records relevant to reporting during a submission period for a period of 5 years beginning with the effective date of that submission period. EPA is clarifying this requirement by changing “beginning with the effective date” to “beginning on the last day” of that submission period (i.e., for a submission period ending December 23, 2006, submitters would be required to retain records relevant to that submission until December 23, 2011). EPA is also adding a sentence to the recordkeeping provisions to encourage submitters to retain records longer than 5 years to ensure that past records are available as a reference when submitters are generating subsequent submissions.

One commenter noted that, under the current IUR regulations, persons submitting their information at the beginning of the submission period rather than at the end will have to review their records twice, once in preparation for making the submission and then again for records retention purposes at the end of the submission period. The commenter stated that this could result in submitters who report early in the submission period keeping all IUR records from two submission periods for a period of time, even if the submitter determines the older records are not necessary to help guide subsequent reporting. The commenter suggests that to reduce burden and encourage early reporting, the required period for record retention be changed from 5 years from the last day of the submission period to “5 years or until the date of their next IUR submission to EPA, whichever is less.” In addition to the submitter having its past records to refer to, EPA proposed the change from “beginning with the effective date” to “beginning on the last day” of the submission period to clarify the records retention requirement. EPA is concerned that following the commenter's suggestion would result in a lack of clarity concerning what date is considered the date of submission or when the 5-year period begins. Additionally, EPA suspects that most submitters review past submissions well before submitting their information to EPA. A submitter can identify records it no longer finds useful at the time of review for the current submission and will easily be able to later identify those records. EPA does not require that a submitter destroy records by a certain date, and believes the method and timing of such an action is entirely up to the submitter, as long as the IUR regulations record retention requirement is met.

b. Submission period. Under the current IUR rule, submitters are required to report on a recurring basis every 4 years, and that report is required to be submitted to EPA during the period of August 25 through December 23 in the year immediately following each reporting year. In today's action, for the submission period in 2006, EPA is retaining August 25 through December 23 as the submission period, but for future submission periods beginning in 2011 and thereafter, the submission period will be moved up to June 1 through September 30. This means that in the next submission period in 2011, submitters are required to submit reports between June 1 and September 30, 2011.

In the proposed rule, EPA solicited comment on its proposal to move the submission period to January 1 through April 30 of the year following the reporting year. The 2003 amendment to the IUR regulation also changed the reporting year from the company's fiscal year to the calendar year beginning in 2005. Therefore, all of the information required to be submitted to EPA should be available early in 2006 for all companies. Moving the submission period to earlier in the calendar year would allow the Agency to obtain and process the information in a more timely manner, and therefore make the information available for use closer in time to the period in which it was generated.

The Agency received many comments on its proposal to move the submission period to a point earlier in the year. The majority of commenters opposed the change to the submission period, stating:

(1) The proposed submission period of January 1 to April 30 coincides with the time when many other reports must be filed, and the current period (August 25 through December 23) works well allowing reporting companies time to generate accurate data. A trade group indicated that all of its members surveyed reported to the IUR in December.

(2) It is unreasonable for EPA to shorten the submission period in light of the increased reporting requirements enacted by the 2003 Amendments to the IUR. Inorganic chemical producers, who will be reporting for the first time under the IUR regulation in 2006, felt that adjusting to the reporting requirements would take considerable time. Most suggested that respondents will struggle to collect the required data in time. Firms reporting on a large number of chemicals were of the opinion that the complexity of their reporting would make meeting the April 30 deadline difficult due to obligations of other forms of regulatory compliance occurring early in the calendar year. Importers pointed out the complexity of their situation, especially because they will often have to rely on Customs Entry forms that can be delayed up to 30 days.

(3) Numerous other EPA reporting programs require reporting in the first half of the year, such as the Toxics Release Inventory (TRI), as do other state and federal environmental programs. This would strain staff responsible for reporting, and lead to inaccuracy. Some commenters identified approximately 30 additional federal, state and local reporting programs that require their attention. Other commenters stated that they believe the coordination of these IUR and TRI reporting deadlines may encourage submitters to coordinate their data collection processes.

(4) Several persons commenting on the proposal believed that delaying the reporting until later in calendar year 2006 would improve the accuracy of the information reported. These persons pointed out that import notifications are often delayed by up to 30 days after the chemical is imported thereby reducing the time available to incorporate this information into IUR reporting. In addition, those firms whose byproducts are either beneficially reused or disposed as wastes will need additional time to report because the determination of beneficial use may be made months after the byproducts are manufactured.

(5) Requiring accelerated submissions based on “timeliness” of the data is inconsistent with EPA's proposal to extend the reporting cycle from 4 to 5 years because a delay of several additional months is insignificant when compared to the extension of the reporting cycle by an additional year. Some commenters pointed out that by waiting an extra few months, EPA would collect more accurate data. One commenter questioned EPA's rationale for moving up the submission period to better coincide with the change of the reporting year from the fiscal year to the calendar year. This commenter suggested that EPA's reasoning was erroneous because many businesses, in their experience, had fiscal years ending significantly before July and therefore, for those companies, the period to prepare and submit IUR reports has been reduced from approximately 1 year (for companies with a fiscal year coinciding with the calendar year) to only 4 months.

(6) Almost all of the commenters objected to the change in the submission period for the 2006 reporting cycle. Based on the comments, EPA believes these objections are due to the commenter's unfamiliarity with the new requirements imposed by the amended IUR regulations. Many commenters mentioned that EPA guidance for the 2006 reporting period is not yet available (though several mentioned and appreciated that EPA was conducting IUR training), noted that EPA's electronic reporting program for 2002 was flawed, and questioned whether the 2006 materials would be ready in time to be adequately tested before reporting is required. Others stated that they were already planning IUR information-gathering activities around the August-December timeframe.

Most commenters, while preferring that EPA retain the current submission period, suggested alternatives. These included deadlines of October 31, August 31, July 1 (to coincide with TRI reporting), and May 1, and a submission period from July 1 through October 31.

In response to the many objections to the proposed change to the submission period, EPA has reconsidered its proposal to move the submission period to January 1 through April 30. The proposed change was not intended to place additional burdens on industry, but to remove an unnecessary delay in collecting the IUR data. In light of the commenters' concerns about their ability to collect accurate data in a timely fashion and submit them during the proposed submission period, EPA will maintain the current submission period of August 25 through December 23 for the 2006 reporting cycle, and switch to a June 1 through September 30 submission period for all future reporting cycles beginning in 2011. Recognizing that companies may have already begun planning data collection activities around the August to December submission period for the 2006 reporting cycle, and that the data collection will include new requirements resulting from the 2003 Amendments, EPA recognizes that altering the 2006 IUR submission period at this time could be overly burdensome to some reporters. Beginning in 2011, and for all future reporting cycles thereafter, EPA believes that the June 1 through September 30 submission period balances industry's needs in collecting the data with EPA's desire to begin analyzing the data in a timely manner.

c. Polymer exemption . Chemical substances meeting the definition for polymers included in 40 CFR 710.46(a)(1) are fully exempt from reporting under the IUR regulations. EPA is changing the references included in the polymer definition from the “1985 edition of the Inventory or the Master Inventory File” to the more general and current “Master Inventory File” by removing the reference to the 1985 edition of the Inventory. The Master Inventory File has been regularly updated since the 1985 edition of the Inventory was published, and is the more appropriate reference for use within the IUR polymer exemption. All who commented on this subject agreed with this change, and EPA is finalizing the definition as proposed.

An official docket was established under docket ID number EPA-HQ-OPPT-2004-0106. The official public docket includes information considered by EPA in developing this final rule, such as the documents specifically referenced in this action, any public comments received, and other information related to this action. In addition, interested parties should consult documents that are referenced in the documents that EPA has placed in the docket, regardless of whether these referenced documents are physically located in the docket. For assistance in locating documents that are referenced in documents that EPA has placed in the docket, but that are not physically located in the docket, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT . The official public docket is available for review as specified in ADDRESSES . The following is a listing of the documents referenced in this preamble that have been placed in the official docket for this final rule:

1. USEPA, “TSCA Inventory Update Rule Amendments” (68 FR 848, January 7, 2003) (FRL-6767-4).

2. American Petroleum Institute, “Petroleum Process Stream Terms Included in the Chemical Substances Inventory Under the Toxic Substances Control Act (TSCA),” Health and Safety Regulation Committee Task Force on Toxic Substances Control, February 1985.

3. USEPA, “Toxic Substances Control Act (TSCA) PL 94-469 Candidate List of Chemical Substances Addendum I Generic Terms Covering Petroleum Refinery Process Streams,” January 1978.

4. USEPA, “Technical Support Document Inventory Update Reporting Rule Petroleum Process Stream Partial Exemption Added Petroleum Process Chemicals” OPPT, April 17, 2004. Revised, July 6, 2005.

5. USEPA, “Economic Analysis of the IUR Revisions Final Rule,” Office of Pollution Prevention and Toxics, July 2005.

6. Comment from Denison, Richard A., Environmental Defense, on Comments on Proposed Rule, TSCA Inventory Update Reporting Revisions (70 FR 3658, 26 January 2005). Submitted via EDOCKET on 18 February, 2005.

7. USEPA, “Summary of Information on Photographic Chemicals,” Office of Pollution Prevention and Toxics, July 2005.

Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that this action is not a “significant regulatory action” subject to review by OMB because it does not meet the criteria in section 3(f) of the Executive Order.

EPA has prepared an economic analysis of the potential impacts of this action, which is contained in a document entitled Economic Analysis of the IUR Revisions Final Rule (Ref. 1). This document is available as a part of the public version of the official record for this action and is briefly summarized here.

These revisions will reduce IUR reporting costs. The quantified portions of the rule are estimated to save $6 million to $7 million per year when annualized over the next 20 years at a 3% or a 7% discount rate. Most of the savings of these revisions will accrue to the chemical industry in the form of decreased costs of complying with the IUR regulations. There will also be some savings to EPA in the form of decreased costs to administer the regulation and maintain the collected data.

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations, after initial display in the Federal Register and in addition to its display on any related collection instrument, are listed in 40 CFR part 9.

The information collection requirements related to the IUR regulations have already been approved by OMB pursuant to the PRA under OMB control number 2070-0162. This action would not impose any burden requiring additional OMB approval. Instead, this action would reduce reporting burden by 113,000 to 123,000 hours in the 2006 reporting cycle and 112,000 to 121,000 hours in subsequent reporting cycles. This reduction is out of a total burden of 1,300,000 to 1,658,000 hours in the 2006 reporting cycle, and 1,189,000 to 1,516,000 in future reporting cycles.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division (2822), Office of Environmental Information, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .), the Agency hereby certifies that this action will not have a significant adverse economic impact on a substantial number of small entities. The factual basis for the Agency's determination is summarized below.

The term “small entities” includes small businesses, small not-for profit organizations, and small governmental jurisdictions, but because not-for-profit organizations and governmental jurisdictions will not be affected by this rule, “small entity” in this analysis is synonymous with small business.

Small manufacturers that fully meet the 40 CFR 704.3 definition are generally exempt from reporting under the IUR regulations, and thus are not significantly impacted by IUR reporting. Nevertheless, this rulemaking is expected to reduce IUR reporting costs for businesses of all sizes. Thus, EPA concludes that these revisions will not result in significant adverse effects on a substantial number of small entities.

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) (UMRA), EPA has determined that this regulatory action does not contain a Federal mandate that may result in expenditures of $100 million or more for state, local, and tribal governments, in the aggregate, or for the private sector in any 1 year. As described in Unit IV.A., the rule is expected to decrease expenditures by $6 million to $7 million per year. EPA has also determined that the rule would not significantly or uniquely affect small governments and is not subject to the requirements of sections 202, 203, 204, and 205 of UMRA.

This rule will not have a substantial direct effect on 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, entitled Federalism (64 FR 43255, August 10, 1999).

This rule will not have tribal implications because it is not expected to 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, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000).

This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

This action is not subject to Executive Order 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.

Since this action does not involve any technical standards, 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), does not apply to this action.

This action does not involve special considerations of environmental justice related issues as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996).

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 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 . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

This is a summary of the Commission's Order , CG Docket Nos. 02-278 and 05-338, FCC-05-206, adopted and released December 9, 2005. The Order further delays the effective date of a rule initially adopted in Rules and Regulations Implementing the Telephone Consumer Protection Act of 1991 , Report and Order, ( 2003 TCPA Order ), CG Docket No. 02-278, FCC 03-153, released July 3, 2003; published at 68 FR 44144, July 25, 2003. In association with this Order , the Commission released a NPRM , FCC 05-206, adopted and released December 9, 2005, that proposes amendments to its unsolicited facsimile advertising rules and seeks comment on related aspects of those rules. The NPRM also opens a new docket—CG Docket No. 05-338—for all filings in response to this document and those addressing the facsimile advertising rules generally.

This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, it does not contain new or modified “information collection burdens for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Copies of any subsequently filed documents in this matter will be available for public inspection and copying during regular business hours at the FCC Reference Information Center, Portals II, Room CY-A257, 445 12th Street, SW., Washington, DC 20054. The complete text of this decision may be purchased from the Commission's duplicating contractor at Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554. Customers may contact the Commission's contractor at their Web site: www.bcpiweb.com or call 1-800-378-3160. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an e-mail to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice) or (202) 418-0432 (TTY). The Order can also be downloaded in Word and Portable Document Format (PDF) at http://www.fcc.gov/cgb/policy .

On June 27, 2005, the Commission released an order, CG Docket No. 02-278, published at 70 FR 37705, delaying until January 9, 2006, the effective date of the Commission's determination that an established business relationship (EBR) will no longer be sufficient to show that an individual or business has given its permission to receive unsolicited facsimile advertisements. Consistent with the Junk Fax Prevention Act of 2005, the Commission extends the stay of the Commission's existing facsimile advertising rules until the conclusion of this rulemaking. Specifically, the Commission delays until the conclusion of this rulemaking, the effective date of: (1) The Commission's prior determination that an EBR will no longer be sufficient to show that an individual or business has given prior express permission to receive an unsolicited facsimile advertisement; (2) § 64.1200(a)(3)(i) of the Commission's rules, which requires a person or entity sending a facsimile advertisement to obtain a prior signed, written statement as evidence of a facsimile recipient's permission to receive the advertisement; and (3) the rule establishing the duration of an EBR as applied to the sending of unsolicited facsimile advertisements.

The Commission notes that no Final Regulatory Flexibility Analysis is necessary for this Order . The Commission is not making any changes to the Commission's rules; rather, we are simply delaying the effective date of a rule.

The Commission will not send a copy of this Order pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the adopted rules are rules of particular applicability.

Pursuant to the authority contained in sections 1-4, 227, and 303(r), of the Communications Act of 1934, as amended; 47 U.S.C. 151-154, 227, and 303(r); the Junk Fax Prevention Act of 2005, and § 64.1200 of the Commission's rules, 47 CFR 64.1200 and 64.2401, this Order in CG Docket 02-278 and 05-338 is adopted .

The Commission's Consumer & Governmental Affairs Bureau, Reference Information Center, Shall send a copy of the Order to the Chief Counsel for Advocacy of the Small Business Administration.

Section 4(b)(3)(B) of the Endangered Species Act of 1973, as amended (Act) (16 U.S.C. 1531 et seq. ), requires that, for any petition to revise the List of Threatened and Endangered Species containing substantial scientific and commercial information indicating listing may be warranted, we make a finding within 12 months of the date of receipt of the petition. The finding must be that the petitioned action is one of the following: (a) Not warranted, (b) warranted, or (c) warranted but that the immediate proposal of a regulation implementing the petitioned action is precluded by other pending proposals to determine whether a species is threatened or endangered, and expeditious progress is being made to add or remove qualified species from the List of Endangered and Threatened Species. Section 4(b)(3)(C) of the Act requires that a petition for which the requested action is found to be warranted but precluded be treated as though resubmitted on the date of such finding, that is, requiring a subsequent finding to be made within 12 months. Such 12-month findings must be published in the Federal Register .

On July 8, 2003, we received a petition requesting that we list a karst meshweaver, Cicurina cueva (no common name), as an endangered species with critical habitat. On May 25, 2004, Save Our Springs Alliance (SOSA) filed a complaint against the Secretary of the Interior and the Service for failure to make a 90-day petition finding under section 4 of the Act for C. cueva. In our response to Plaintiff's motion for summary judgment on October 15, 2004, we informed the court that we believed that we could complete a 90-day finding by January 20, 2005, and if we determined that the 90-day finding provided substantial information that listing may be warranted, we could make a 12-month finding by December 8, 2005. On February 1, 2005 (70 FR 5123), we published a 90-day finding and initiation of status review on a petition to list C. cueva as an endangered species. On March 18, 2005, the District Court for the Western District of Texas, Austin Division, adopted our schedule and ordered the Service to issue a 12-month finding on or before December 8, 2005.

Gertsch (1992) described and named C. cueva , C. bandida , and C. reyesi from adult, female specimens collected from Cave X in 1962 by Bell and Woolsey, Bandit Cave in 1966 by Reddell and Fish, and Airman's Cave in 1989 by Reddell and Reyes, respectively. The three Cicurina species are all unpigmented and range in length from 5 millimeters (mm) (0.19 inches (in)) to 5.6 mm (0.2 in). Gertsch (1992) distinguished these three species by differences he perceived in the female reproductive system.

Cicurina cueva , C. bandida and C. reyesi were described by Gertsch (1992) on the basis of female genitalia of a small number of specimens. Because there were some locations that only had records of immature Cicurina that could not be identified to the species level, we contracted Drs. Marshal Hedin and Pierre Paquin on September 24, 2004, to determine whether species-level identification of immature specimens of blind Cicurina spiders from southern Travis and northern Hays counties could be made using a genetic assessment technique they had previously applied to other species of Cicurina (see Paquin and Hedin 2004 for methods). Their report on the contracted study concludes that C. cueva and two other formally described species, C. bandida and C. reyesi (Gertsch 1992), likely represent variants of a single species that shows genetic structuring across its range. They explain that “This finding makes biological sense, as we would expect geographically-adjacent cave populations to share more genetic similarity than caves that are distant in space. The genetic structuring observed is a natural consequence of the fragmented nature of cave habitats, and the unique habitat limitations of these spiders * * *” (Paquin and Hedin 2005). The report authors suggest that rather than three different species, the populations collected represent one species, which they informally refer to as the “C. cueva complex.” They say “We suggest that conservation activities concerning cave populations in this confined geographic region be based on this single species hypothesis.” Since a formal revision reflecting this change in taxonomy (the naming and classification of organisms) has not been published in a peer-reviewed scientific journal, the Service requested independent peer review of the report. We believe we should now make this 12-month finding based on the taxonomic treatment recommended in the contracted report (Paquin and Hedin 2005).

Drs. Paquin and Hedin submitted a report in May 2005, titled, “Genetic and morphological analysis of species limits in Cicurina spiders (Araneae, Dictynidae) from southern Travis and northern Hays counties, with emphasis on Cicurina cueva Gertsch and relatives.” When Cicurina specimens from Travis, Hays, and Williamson counties, Texas, were compared to sampled populations of C. cueva , Paquin and Hedin (2005) found that the C. cueva complex (including all three named species) forms a monophyletic group (defined as a group descended from a single common ancestral form) or clade (a group of organisms that share features derived from a common ancestor) within a mitochondrial phylogeny (the evolutionary development and history of a species or higher taxonomic group based on mitochondrial DNA). Additionally, both C. bandida and C. reyesi are deeply embedded within the mitochondrial DNA clade corresponding to the C. cueva complex, indicating that they are part of the same group. In addition, they examined female genital morphology and found that “a similar genital morphology, with slight variations, is shared across the entire distribution of this species [the C. cueva complex].” Based on the Paquin and Hedin 2005 genetic and morphological results, they concluded that these three named taxa represent variants of a single species. Ultimately, when C. cueva , C. bandida , and C. reyesi are formally combined as a single species, the authors propose all populations within this expanded species be referred to as C. bandida , as this name has page priority in Gertsch (1992). Paquin and Hedin (2005) acknowledge that formal taxonomic decisions must involve publication in a scientific journal; therefore, the authors suggest using “ C. cueva complex” to refer to the morphologically variable and genetically divergent populations within this single species until the formal change is published. In consideration of this information for use in our 12-month finding, we conducted a scientific peer review of Paquin and Hedin's 2005 report to determine if the proposed change in taxonomy was likely to be accepted.

On May 6, 2005, we sent the report to 20 scientists, 19 with Ph.Ds, with expertise in genetics, morphology, and/or conservation biology for peer review. We asked that they particularly review the completeness of the data in the report and identify any pertinent information that may be missing and the soundness of the methodology, data analysis, conclusions, and recommendations in the report. Each invited reviewer was assigned a number, which will be referred to here. We received eight responses (reviewers 2, 4, 5, 7, 8, 10, 13, 14). Dr. Mark Kirkpatrick (co-petitioner) also submitted two letters to the Service and personal email correspondence with Dr. Hedin (regarding the report). Because Dr. Kirkpatrick is a co-petitioner he was not considered a peer reviewer. However, the Service acknowledges his considerable expertise in genetics. To allow peer reviewers the opportunity to comment on the issues presented by Dr. Kirkpatrick, we sent a second request for peer review to the same twenty scientists on June 20, 2005, and received ten peer reviews (from reviewers 5, 7, 8, 9, 10, 12, 13, 14, 19, 20). We asked the peer reviewers for their opinion on what degree of certainty they would assign to each of the following hypotheses/conclusions: (1) C. cueva , C. bandida , and C. reyesi are all one species (Paquin and Hedin conclusion), (2) they are all separate species, or (3) another hypothesis/conclusion is possible. We asked them to explain their views on appropriate criteria for delimiting species using the types of morphological and genetic data available in this case, and how those criteria apply to their review.

Of the 14 peer reviewers that responded to one or more requests for reviews, 10 reviewers (2, 4, 5, 8, 10, 12, 13, 19, 20, and 22) expressed general agreement with Paquin and Hedin's conclusion that C. cueva , C. bandida , and C. reyesi represent a single species, one reviewer (9) expressed support for continuing to recognize them as three separate species, and three reviewers (7, 14, and 21) concluded that more study was needed to distinguish between the one-species and three species alternatives. In addition to these overall conclusions, most reviewers provided additional comments on various aspects of the Paquin and Hedin report, and on pertinent issues related to the taxonomic interpretation of genetic and morphological data. These comments on specific issues are summarized below.

Six of the twelve peer reviewers (2, 4, 5, 9, 10, 19) who responded to at least one of these two requests for review indicated the study overall was well done and the methods used in the genetic aspects of this study were scientifically sound. However, we did receive a variety of comments. Below we discuss the comments from both of these sets of reviews in regard to the methods, analysis, and conclusions in the study.

Concerns were raised by five peer reviewers (4, 5, 7, 9, 14) regarding the authors' use of a single region of the mitochondrial DNA. Some believed the report would be strengthened by a larger sample size from each sampling locality, inclusion of data from other mitochondrial DNA regions, and an analysis of genetic markers from nuclear DNA. Three peer reviewers (4, 5, 14) speculated that the conclusion to group the three taxa into a single species would probably still be the same even with further genetic analysis.

Two reviewers (13, 14) questioned the use of particular phylogenetic methods to analyze the genetic data and construct the tree diagrams of relationships. The authors' present two different trees, or phylogenies, based on a single data set; one generated by neighbor joining (NJ) analyses and the other by Bayesian phylogenetics. These methods differ in that NJ is a distance-based approach based on analysis of a matrix of genetic distances (Hedrick 2000), and Bayesian phylogenetics is a character-based approach (Avise 2004). Although they rely on different assumptions and may give somewhat different results, both are generally accepted methods for analyzing and presenting DNA sequence data (Avise 2004), and Avise (2004, page 142) recommends that studies include both a distance-based approach and a character-based approach for comparison. The authors stated that they also analyzed the data using maximum likelihood analysis, which is another character-based method (Avise 2004). They did not present a phylogenetic tree representing the results of the maximum likelihood analysis but stated that the results were similar to their Bayesian analysis (Dr. Paquin, San Diego State University, pers. comm., 2005; Hedin and Paquin 2005). Although we acknowledge that there are a number of additional methods of phylogenetic analysis (Hedrick 2000, Avise 2004), the authors presented trees representing the two major types of trees, as recommended by Avise (2004).

Three peer reviewers (8, 13, 14) suggested different conclusions could be drawn, even if the phylogenies are accepted. These alternative interpretations reflect differing views on the appropriate amount of genetic difference for delineating species boundaries, which is an active area of debate in taxonomy (Sites and Marshall 2004).

One peer reviewer (14) suggested that the study of additional morphological characters, rather than genitalia, such as somatic (non-sexual) characters, might find diagnosable differences within the “ C. cueva complex.” However this peer reviewer doubted that the outcome of such studies would likely affect the authors' conclusion that C. cueva is not a species. Additionally, one reviewer (14) stated the assessment of genitalic variation was subjective and would have been better if the different genitalic parameters could have been quantified somehow with the variation analyzed statistically. Reviewers 7 and 12 stated that morphology clearly plays a critical role in deciphering the systematics of this group, and reviewer 7 wondered if some statistical quantification of patterns in morphological characters is possible. Gertsch's (1992) original diagnoses for these three species included only collection locality and characters of the female reproductive system; no other characters were identified in the diagnosis. The diagnosis that accompanies the original description of a new species is important because it provides the characters or character states that allow that species to be distinguished from other species. Gertsch (1992) expressed doubts that other characters were useful; for example, “ Cicurella [the subgenus to which the species in question belong] * * * offer few coloration or somatic features to allow easy identification.” Gertsch (1992) was also dismissive of the value of different reproductive features in males and notes that males are much less available for study, as they represent only a fifth the number of mature females.

One reviewer (22) noted variation in female genitalia observed among the specimens presented in the report was considered “well within” the range of intraspecific (within-species) variation typically observed in female genitalia of other species and adequately demonstrates that there is no morphological reason to consider C. cueva, C. bandida , and C. reyesi as three separate species. We recognize that study of additional morphological characters and more quantitative analysis of current characters could increase our understanding of morphological variation within this group of spiders, but we find little support for rejecting the authors' recommended taxonomy, considering their findings and the peer reviewers' comments on the morphological data.

Dr. Kirkpatrick thought the Paquin and Hedin (2005) report did not statistically disprove the “established taxonomy” previously described by Gertsch (1992). However, two peer reviewers (8 and 22) expressed concern that Gertsch (1992) did not sufficiently account for the possibility of intraspecific variation in genitalic characters and improperly recognized minor morphological variants as different species and that his species descriptions were based on small sample sizes. While such a lack of statistical analysis is common in the field of systematic biology, we believe that since two experts (19 and 22) in this field have expressed strong doubts about the basis of the species-level taxonomy presented by Gertsch, the alternative taxonomic delineation presented by Paquin and Hedin (2005) deserves serious consideration. We also note that Paquin and Hedin's (2005) morphological studies were based on more than double the number of specimens available to Gertsch (1992) when he originally described the species.

We received a variety of responses to the specific question in the second peer review regarding the degree of certainty that the reviewer would assign to the various hypotheses or possible conclusions about species limits. Two reviewers (8 and 19) clearly supported the Paquin and Hedin conclusion that C. cueva, C. bandida , and C. reyesi are all one species. However, reviewer 8 did disagree about the assignment of three or four of the populations to this group and did differ with Paquin and Hedin about the level of differences accepted to represent a species. One of the reviewers (13) was “unconvinced that the report's conclusions are correct”, and suggested an alternate hypothesis and classification. Reviewers 7 and 9 believe the Paquin and Hedin conclusions should be considered preliminary and premature, respectively. Reviewers 5, 10, 12, and 20 tended to accept the Paquin and Hedin hypothesis based on the information presented; however, they each expressed some uncertainty or suggested that additional data collection and analysis would be advisable. Reviewer 14 felt that both Hedin and Kirkpatrick provided “solid, convincing arguments for their points of view'; this reviewer doubted that further investigation would lead to improved resolution on the question of how many species there are and believes this is ultimately a matter of interpretation.

In response to divergent opinions regarding how to define species limits and how much data are needed to confidently make a species determination, and because some but not all peer reviewers were familiar with spider taxonomy in particular, we conducted a third peer review. We sent four arachnologists the Paquin and Hedin 2004 publication (that described the methods used in this study) and 2005 report, the first peer review request and responses, Dr. Kirkpatrick's letters and emails, and the second peer review request and responses. We received two responses (reviewers 21 and 22). One of these reviewers (22) stated that “Based on the evidence presented by Hedin & Paquin, the only well supported scientific conclusion at this time, is that only one species is present.” The other reviewer (21) stated Paquin and Hedin clearly explained their methods and that they are adequate for their questions. The reviewer also stated that “Paquin and Hedin have given a conservative conclusion based on their data, and have noted alternative explanations and the need for more specimens”.The reviewer stated that “without more of this work I do not see a way to resolve the concerns about data interpretation raised by Dr. Mark Kirkpatrick.”

There is ongoing debate among many scientists regarding methods for species differentiation (Sites and Marshall 2004). Some believe defining species boundaries requires a “total evidence” approach that includes data from multiple genes and morphology, as well as ecology and behavior. Although it is reasonable to believe this debate will continue, the Service's “Interagency Cooperative Policy on Information Standards under the Endangered Species Act” (59 FR 34271) requires we use the “best available comprehensive technical information” in making Federal listing determinations. The Paquin and Hedin (2005) report provides genetic data for the first time and morphological data based on an increased number of specimens; both approaches fail to distinguish C. cueva from C. bandida and C. reyesi. In addition, the claim by the petitioners that the genetic analysis employed is not informative about taxonomic standing within the C. cueva complex is not supported by the clear correspondence between geography and branching patterns of both phylogenetic trees. The correspondence between geography and phylogeny indicates that the phylogenetic patterns have a biological basis and do not simply present “noise” that is obscuring biologically important patterns. We believe, based on our review and the results of the peer reviews, the Paquin and Hedin (2005) report provides the best available information on the current taxonomic status of the Cicurina complex. Although it is always possible that future analyses on other morphological characters or genetic markers may convince spider taxonomists that another taxonomic interpretation is appropriate, we cannot base our findings on the speculative outcomes of studies not yet performed. We find, however, that the Paquin and Hedin (2005) report is based on procedures and methods of analysis that are generally accepted in the application of molecular methods to taxonomy. Although additional study could affect the taxonomic conclusions of the report, according to the requirements of the Act the best available genetic and morphological data at this time support the recommendation of Paquin and Hedin (2005) to treat these three species as one species.

Previous Federal actions can be found in our 90-day finding that published on February 1, 2005 (70 FR 5123), and in our notice reopening the comment period on August 16, 2005 (70 FR 48093). That information is incorporated by reference into this 12-month finding.

In addition to information incorporated by reference we note that the first comment period for providing information for our status review closed May 15, 2005. Pursuant to 50 CFR 424.16(c)(2), we may extend or reopen a comment period upon finding that there is good cause to do so. We reopened the comment period from May 23 to June 22, 2005 (70 FR 29471; May 23, 2005), since additional information from the genetic analysis of Cicurina species in southern Travis County was completed. Several parties requested another extension of the comment period. We reopened the public comment period from August 16 to 30, 2005 (70 FR 48093; August 16, 2005). During this final comment period, we made available the results of our peer review on the Paquin and Hedin (2005) report.

We have carefully assessed the best scientific and commercial information available regarding the taxonomic status of Cicurina cueva. We reviewed the petition, available published and unpublished scientific and commercial information, and information submitted to us during the public comment periods on our status review following our 90-day finding. This finding reflects and incorporates information we received during the public comment periods. We also consulted with recognized spider and karst invertebrate experts. On the basis of this review, we find that listing C. cueva is not warranted because C. cueva does not meet the definition of a “species” under the Act.

A complete list of all references cited herein is available upon request from the Field Supervisor at the Austin Ecological Services Office (see ADDRESSES section).

The primary author of this document is the Austin Ecological Services Office (see ADDRESSES section).

Regulations governing the summer flounder fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is apportioned on a percentage basis among the coastal states from North Carolina through Maine. The process to set the annual commercial quota and the percent allocated to each state is described in § 648.100.

The initial total commercial quota for summer flounder for the 2005 calendar year was set equal to 18,180,002 lb (8,246,395 kg) (70 FR 303, January 4, 2005). The percent allocated to vessels landing summer flounder in New York is 7.64699 percent, resulting in a commercial quota of 1,390,223 lb (630,601 kg). However, the 2005 allocation to New York was reduced to 1,374,164 lb (623,317 kg) due to research set-aside. The states of North Carolina, New Jersey, and Rhode Island and the Commonwealth of Virginia have transferred a total of 50,530 lb (22,920 kg) to New York in accordance with the Atlantic States Marine Fisheries Commission Addendum XV to the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan, bringing the total quota to 1,424,694 lb (646,241 kg).

Section 648.101(b) requires the Administrator, Northeast Region, NMFS (Regional Administrator) to monitor state commercial quotas and to determine when a state's commercial quota has been harvested. NMFS then publishes a notification in the Federal Register to advise the state and to notify Federal vessel and dealer permit holders that, effective upon a specific date, the state's commercial quota has been harvested and no commercial quota is available for landing summer flounder in that state. The Regional Administrator has determined, based upon dealer reports and other available information, that New York has harvested its quota for 2005.

The regulations at § 648.4(b) provide that Federal permit holders agree, as a condition of the permit, not to land summer flounder in any state that the Regional Administrator has determined no longer has commercial quota available. Therefore, effective 0001 hours, December 14, 2005, further landings of summer flounder in New York by vessels holding summer flounder commercial Federal fisheries permits are prohibited for the remainder of the 2005 calendar year, unless additional quota becomes available through a transfer and is announced in the Federal Register . Effective 0001 hours, December 14, 2005, federally permitted dealers may not purchase summer flounder from federally permitted vessels that land in New York for the remainder of the calendar year, or until additional quota becomes available through a transfer.

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.

This Federal Register document is also accessible via the Internet at: http://www.archives.gov/federal-register/publications .

On July 13, 2005, NMFS published in the Federal Register a proposed rule (70 FR 40302) that, depending on the fishing method and area where the vessels operate, would require owners and operators of Hawaii-based longline fishing vessels to either side-set (deploy longline gear from the side of the vessel rather than from the stern) or use a combination of other seabird mitigation measures to prevent seabirds from being accidentally hooked, entangled, and killed during fishing operations.

NMFS, the Western Pacific Fishery Management Council (WPFMC), and the fishing industry have collaborated on research to test side-setting and other measures as additional seabird deterrent methods for Hawaii longline vessels. The research results were analyzed and considered by the WPFMC as potential new seabird mitigation requirements to cost-effectively further reduce the effects of the Hawaii longline fleet on seabirds. In October 2004, the WPFMC recommended that NMFS amend the Fishery Management Plan for Pelagic Fisheries of the Western Pacific Region (Pelagics FMP) regulations to include the following seabird conservation measures: (a) when fishing north of 23° N. lat., all deep-setting Hawaii longline vessels must either side-set, or use a tori line (bird-scaring) system plus the currently-required measures (blue-dyed thawed bait, strategic offal discards, and line shooter with weighted branch lines), with the requirement to use strategic offal discards modified to require that vessel operators use them only when seabirds are present; and (b) all shallow-setting Hawaii longline vessels, wherever they fish, must either side-set, or use a tori line plus the currently required measures (night setting, blue dyed thawed bait, and strategic offal discards), with the requirement to use strategic offal discards modified to require that vessel operators use them only when seabirds are present.

In the ROD for the FEIS, NMFS selects the Preferred Alternative of the FEIS, modified slightly, to cost-effectively further reduce the potentially harmful effects of the Hawaii-based longline fishery on seabirds. The original Preferred Alternative included a requirement to add weights of 60 g (2.1 oz) to each branch line while side-setting. The modified Preferred Alternative reduces the weight requirement used on branch lines while side-setting to 45 g (1.6 oz). Additionally, the modified Preferred Alternative eliminates the requirement to use tori line systems.

Additional background on this final rule may be found in the preamble to the proposed rule (70 FR 40302, July 13, 2005) and is not repeated here.

NMFS received comments on the proposed rule (70 FR 40302, published July 13, 2005) from fishing industry organizations, government agencies, environmental groups, and private citizens. The responses are found later in this section. Based on comments received and on subsequent action by the WPFMC, the final rule contains changes to the proposed rule that change the weight required to sink branch lines and remove the proposed requirement to use tori lines when not side-setting, and clarify technical specifications related to gear deployment.

Prompted by several of the comments, the WPFMC held a meeting by teleconference on November 1, 2005, to address and discuss recent analyses involving two elements of the proposed rule, and to make adjustments to their recommendations in the proposed rule. As a result of the recommendations from that meeting, the final rule contains changes to the proposed rule that modify one technical requirement and remove another requirement.

The first issue addressed by the WPFMC, the requirement to use 60 g (2.1 oz) weights on branch lines used to sink baited hooks on branch lines when side-setting, was revisited on two grounds: safety and relative effectiveness. The final rule contains changes from the proposed rule that modify the specifications for the weights used on branch lines. These weights, deployed in the form of weighted swivels, are intended to quickly sink the baited hooks so that foraging seabirds are not attracted to the baits and subsequently hooked or entangled.

There is a concern for human safety because when a weighted branch line breaks under strain, it tends to lash backwards toward the crew members who are handling the gear. Fishermen report that heavier weights are more dangerous than lighter ones, and that severe injuries from backlashed weights have occurred in the longline fishery. Thus, from a safety perspective, fishermen prefer to use a lighter-weight swivel.

A recent study compared the effective sinking rates of baited hooks on branch lines weighted with a range of weights. The sink rates were almost identical for baited hooks with 40 g (1.4 oz) and 60 g (2.1 oz) weights. Thus, the advantage in sinking a baited hook out of the foraging range of seabirds using the 60 g (2.1 oz) weight had little advantage over using a 40 g (1.4 oz) weight. Because the industry preference is to use 45 g (1.6 oz) swivels, and because the weight requirement for branch lines when deep-setting from the stern is 45 g (1.6 oz), and because the differences in sink rates between the lighter and heavier weights were negligible, the WPFMC opted to modify its recommendation and require 45 g (1.6 oz) weights on the branch lines, rather than 60 g (2.1 oz) weights in the proposed rule. This final rule reflects that change.

The second issue addressed during the WPFMC meeting was the requirement to use tori line systems. The WPFMC acknowledged that its previous recommendation to use tori lines was an incentive for vessels to convert to side-setting, that other measures have been effective in reducing interactions with seabirds, and that the construction and operating performance standards of these systems had not been fully analyzed in the Hawaii longline fishery. The incentive to side-set has worked unexpectedly well, with more than 40 vessels already converted and more awaiting funding to convert. NMFS has provided financial assistance to help convert the Hawaii longline fleet to side-setting operations.

After the proposed rule was published, NMFS and the WPFMC received information that showed that interactions with seabirds have been reduced markedly from historical levels. When compared with the data from 1995-99, the rates for seabird takes (expressed as birds/1,000 hooks) in the first and second quarters of 2005 decreased on the order of 90-99% from the historical averages. This decrease in seabird takes can be attributed to the requirement to set at night when shallow-setting (starting one hour after local sunset and finishing one hour before local sunrise), combined with the effective use of other measures to reduce seabird interactions. These other measures include the use of thawed blue-dyed bait, strategic offal discards, and line shooters to sink lines quickly. Additionally, under a rule published on November 15, 2005 (70 FR 69282), shallow-set vessels are now required to use large, offset circle hooks, and this may also reduce the mortality of seabirds.

Because the existing seabird measures for this fishery are relatively effective in minimizing the take of seabirds, and because the construction and operating performance standards of using tori line systems in the Hawaii pelagic longline fleet have not been thoroughly studied, the WPFMC removed its previous recommendation to require tori lines in this fishery. This final rule reflects that recommendation.

Even though the WPFMC changed its previous recommendation to implement tori lines in the Hawaii longline fishery, NMFS understands that tori lines have proven to be effective in reducing interactions with seabirds in similar fisheries in other locations. NMFS is concerned that adding the tori line requirement at this time may potentially obscure the factors that have led to recent dramatic decreases in seabird catches. Based on the existing data and analyses, it is not clear whether tori line systems would lead to even further decreases in seabird interactions. Thus, NMFS views side-setting as a valuable addition to the techniques already in place, but will wait before considering other avoidance measures (e.g., tori lines). NMFS aims to collect information and analyze the effectiveness of the new measure before considering additional seabird mitigation measures.

The requirements in 600.35(a)(1)(i) and (iii) were changed to clarify that the mainline must be deployed, and the mainline shooter must be mounted, as far forward on the vessel as practicable, to comply with the terms and conditions of a US Fish and Wildlife Service (USFWS) Biological Opinion, as supplemented, on the effects of the Hawaii longline fleet on the endangered short-tailed albatross.

NMFS, the WPFMC, and fishery participants are continually collecting information about the effectiveness of fishing techniques that reduce the take of non-target species, including seabirds. This information comes from directed research, observer reports and other sources. Whenever new information is available and analyzed, NMFS and the Council can re-evaluate the management regime. In the future, if the information supports such actions, the WPFMC and NMFS may propose measures such as mandatory side-setting or tori lines, or the revision of existing measures such as blue-dyed bait, offal discards, etc.

NMFS responds to the received written comments on the proposed rule, as follows:

Comment 1: The take of albatrosses in the Hawaii longline fleet violates the Migratory Bird Treaty Act (MBTA) because there is no take authorization under this act.

Response: The MBTA applies only in nearshore waters, i.e., from the shoreline seaward to three nautical miles offshore. The Hawaii pelagic longline fleet does not operate in waters covered by the MBTA, so no take authorization is required.

Comment 2: Longline vessels should be required to use tori lines during gear hauling, in addition to during gear setting.

Response: For the reasons identified above, the use of tori lines is not required by this rule. As new information on the construction and operating performance standards of tori lines in the pelagic longline fishery becomes available and is analyzed, the WPFMC and NMFS may revisit this issue for future management consideration.

NMFS is taking a step-wise approach to building the suite of measures to reduce interactions between the Hawaii longline fleet and seabirds. Rather than adding two new measures at this time, only side-setting will be added as an optional measure. NMFS and the WPFMC intend to evaluate the effectiveness of side-setting and current suite of optional measures, and consider if future modifications to the regulations need to be made. This final rule allows NMFS and the WPFMC to assess how well side-setting works in a commercial setting.

Comment 3: The requirement for strategic offal discards will result in increased, rather than decreased, seabird captures.

Response: This measure complies with the non-discretionary terms and conditions of a USFWS Biological Opinion, as supplemented, on the effects of the Hawaii longline fleet on the endangered short-tailed albatross. The results of research on the effectiveness of strategic offal discards in the Hawaii pelagic longline swordfish fishery have demonstrated that offal, when discarded strategically, does reduce seabird interactions with longline gear.

The requirement for strategic offal discards applies only when birds are present. Although discarding offal during setting is designed to distract birds away from baited hooks and reduce interactions, there is some anecdotal information that indicates a possible unwanted effect of attracting some birds to the vessel, increasing potential captures. NMFS is continuing to assess the impacts and effectiveness of strategic offal discards, and as new information becomes available and is analyzed, the WPFMC and NMFS may revisit this issue.

Comment 4: The requirement to use weights on branch lines creates a safety hazard for the crew of Hawaii longline swordfish vessels.

Response: The requirement to attach weights to branch lines is necessary for the rapid sinking of branch lines and baited hooks to minimize interactions with seabirds. The use of weighted lines has, however, been identified as a potential safety hazard. NMFS and the WPFMC are continuing to assess the effectiveness of and safety aspects of weighted lines (see discussion above on safety aspects of weighted lines). As new information becomes available and is analyzed, however, the WPFMC and NMFS may adjust the management measures. In the meantime, crew members may minimize the risk of injury by using wire leaders in lieu of monofilament leaders, and may wear safety equipment such as eye protection and hard hats. Also see the response to Comment 5.

Comment 5: The use of 45 g (1.6 oz), not 60 g (2.1 oz), weighted swivels should be required to be used with side-setting.

Response: NMFS and the WPFMC agree. For the reasons identified above, the requirement for branch line weights is changed to a minimum of 45 g (1.6 oz) in the final rule, from a minimum of 60 g (2.1 oz) in the proposed rule. NMFS and the WPFMC are continuing to assess the effectiveness and safety aspects of weighted lines, and as new information becomes available and is analyzed, the WPFMC and NMFS may adjust the management measures.

Comment 6: The side-setting specifications should require deployment so that the baited hooks remain submerged all the time, not just when birds are present, because seabirds can arrive at any time.

Response: Based on current research results and understanding of the fishery and its interaction with seabirds, the specification to ensure that baited hooks remain submerged when birds are present is adequate to reduce interactions. NMFS is continuing to assess the effectiveness of this specification, and as new information becomes available and is analyzed, the WPFMC and NMFS may revisit this issue for future management consideration.

Comment 7: The term “submerged portion” in the definition of a tori line is problematic because the line may be dragging at the sea surface and not underwater.

Response: For the reasons identified above, the use of tori lines is not required by this rule.

Comment 8: To achieve the required lengths of the aerial portions of the tori line, items such as weighted funnels and buoys will need to be placed at the end of the line.

Response: See the response to Comment 7.

Comment 9: It is unclear why the regulations specify a minimum length of the portion of the tori line that must be in the water.

Response: See the response to Comment 7.

Comment 10: The design specified for the tori line for deep-setting longline vessels is unlikely to result in the aerial portion of the line maintaining a minimum length of 40 m (131 ft), as the regulations require.

Response: See the response to Comment 7.

Comment 11: More than three streamer pairs should be required to be used with each tori line.

Response: See the response to Comment 7.

Comment 12: The regulations do not specify whether flexible hollow rubber tubing may be used as streamer material.

Response: See the response to Comment 7.

Comment 13: The requirement to carry a minimum of two cans of blue dye is insufficient, as this amount of dye will not last for an entire trip.

Response: Research has indicated that two cans of dye are sufficient to dye the bait used during a normal longline fishing trip. Nothing in the regulations prevents operators from carrying more dye if they think it is necessary to ensure that they comply with the requirement to dye blue all deployed bait to the degree required in the regulations.

Comment 14: All vessels should be required to side-set unless they can demonstrate that doing so is impracticable.

Response: The purpose of the final rule is to cost-effectively further reduce the potentially harmful effects of the longline fishery on seabirds. Research in the Hawaii longline fishery and elsewhere has identified and demonstrated several cost-effective methods to minimize seabird captures, including the alternatives in the regulations. In addition to the primary goal of reducing seabird captures, the required seabird avoidance measures also consider economic impacts and practicality. Allowing vessels to choose between alternative effective methods ensures that vessels can select the options that are most viable for that vessel and fishing operation. NMFS and the WPFMC are continuing to assess the effectiveness of all measures that potentially reduce seabird captures. As new information becomes available and is analyzed, the WPFMC and NMFS may consider revisions to the measures contained in this final rule.

Comment 15: All longliners, not just shallow-set vessels, should be required to set at night when fishing north of 23° N. lat., in addition to the other measures that are currently required.

Response: See the response to Comment 14. The 23° N. lat. boundary for the deep-set component of the fishery conforms with a USFWS Biological Opinion, as supplemented, on the effects of the Hawaii longline fleet on the federally listed short-tailed albatross. These birds have not been observed to range south of this latitude.

Comment 16: The most effective combination of bird avoidance methods should be required to be used by all longline vessels to minimize bird captures, or the vessels should be required to use all known seabird avoidance methods in combination.

Response: See the response to Comment 14.

Comment 17: Vessels that choose not to side-set should be required to use paired tori lines, which were found to be effective in reducing bird captures in Alaska demersal longline fisheries.

Response: See the response to Comment 7. Also, Hawaii's pelagic longline fishery differs significantly from Alaska's demersal longline fishery in terms of target species, oceanographic and environmental conditions, and fishing operations, and there is currently no information available that assesses the effectiveness, economic viability, or practicality of paired tori lines in the Hawaii pelagic longline fishery. NMFS and the WPFMC are continuing to assess the effectiveness of tori lines, and as new information becomes available and is analyzed, the WPFMC and NMFS may consider revisions to the measures contained in this final rule.

Comment 18: Vessels should be required to use seabird avoidance methods everywhere that they fish. The requirement for the use of bird avoidance methods only when fishing N. of 23° N. lat. is insufficient because vessels catch seabirds south of this latitude.

Response: Shallow-set longline fishing operations must use seabird avoidance techniques wherever they fish. The 23° N. lat. boundary for the deep-set component of the fishery conforms with a USFWS Biological Opinion, as supplemented, on the effects of the Hawaii longline fleet on the federally listed short-tailed albatross. These birds have not been observed to range south of this latitude. The current catch levels of other seabirds in the Hawaii longline fishery, and the anticipated lower catch levels under the new regulations, are not anticipated to result in population-level effects on affected seabird populations. As new information on interactions with other seabirds becomes available and is analyzed, the WPFMC and NMFS may revisit this issue.

Comment 19: When compared with historical bird capture rates, the current seabird regulations are extremely effective at reducing bird captures and, therefore, the proposal to add a requirement for use of a tori line is not justified.

Response: NMFS and the WPFMC agree. For the reasons identified above, the use of tori lines is not required by this rule. As new information on the benefits and costs of tori lines in the pelagic longline fishery becomes available and is analyzed, the WPFMC and NMFS may revisit this issue for future management consideration.

Comment 20: NMFS should establish an annual cap on the number of seabirds that may be captured by the Hawaii longline fleet.

Response: The measures contained in the final rule comply with the requirements of a USFWS Biological Opinion on the effects of the Hawaii longline fishery on the endangered short-tailed albatross. Although no other seabird species with which the longline fishery interacts is listed as threatened or endangered, the measures are also effective at reducing interactions with other seabird species. The current seabird catch levels in the Hawaii longline fleet, and the anticipated lower levels under this final rule, are not believed to result in population-level effects on seabird populations. Establishing thresholds for the capture of these birds is, therefore, not necessary.

Comment 21: Longline fishing should be prohibited because it results in the mortality of endangered species.

Response: The western Pacific pelagic longline fishery is governed under the Magnuson-Stevens Act and other applicable laws, including the Endangered Species Act (ESA) which is designed to protect species under threat of extinction. NMFS and the USFWS have determined that the fishery is not likely to jeopardize threatened or endangered species under their purview. Provided that specified terms and conditions of biological opinions are met, the ESA does authorize specific levels of the incidental take of endangered species. NMFS does comply with these biological opinions, so an incidental take is authorized.

Federal and other fishery regulations benefit the Nation by minimizing and mitigating interactions with threatened and endangered species, while maintaining a viable and productive fishery. NMFS and the WPFMC continue to assess the effectiveness of all measures that potentially reduce the interactions between fishing gear and protected resources. As new information becomes available and is analyzed, the Council and NMFS may adjust the management regime, as appropriate.

Comment 22: Side-setting vessels should be monitored to measure the continuing effectiveness of this technique in reducing seabird captures. Half of the fleet should be required to side-set, so that observers on these vessels can evaluate the effectiveness of the seabird avoidance method. Observers need to determine if seabirds habituate to these techniques.

Response: By allowing vessels to choose between alternative effective mitigation methods, the final rule will allow for the collection of additional data regarding effectiveness of the various measures. More than 40 vessels in the fleet are currently side-setting. A NMFS and industry program is underway to provide technical assistance to vessels to convert to side-setting, so we anticipate a larger number of vessels to soon be converted to side-setting. NMFS is also in the process of conducting a survey of operators that are side-set longlining; the survey will identify strengths, weaknesses and issues related to this technique.

Observer data will enable an assessment of the relative effectiveness of vessels opting to side-set versus the alternative seabird avoidance measures. Analyses of observer data will enable an assessment of the long-term efficacy of side-setting in reducing seabird captures. As new information becomes available and is analyzed, the WPFMC and NMFS may revisit this issue for future management consideration.

Comment 23: More specific measures for the implementation of side-setting are needed in the regulations.

Response: The final rule specifies required elements of the side-setting technique, including line deployment and line shooter (if used) locations on the vessel, branch line weights, submergence of baited hooks, and bird curtain design. NMFS considers these specifications sufficient guidance for the technique.

In § 660.35, paragraphs (a)(1)(i) and (iii), are changed to clarify that, while side-setting, the mainline must be deployed as far forward on the vessel as practicable, but at least one meter from the stern. The mainline shooter, if used, must be mounted as far forward on the vessel as practicable, but at least one meter from the stern.

In § 660.35, paragraph (a)(1)(iv), the requirement to use branch line weights of at least 60 g (2.1 oz) is changed to require the use of branch line weights of at least 45 g (1.6 oz).

In § 660.35, paragraph (a)(2)(ix), the requirement to use tori lines when not side-setting is removed.

The Regional Administrator, Pacific Islands Region, NMFS, determined that this rule is necessary for the conservation and management of the pelagic fisheries in the western Pacific region, and that it is consistent with the Magnuson-Stevens Act and other applicable laws.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

The potential economic impacts of this final rule on small entities were identified in an Initial Regulatory Flexibility Analysis (IRFA) and summarized in the Federal Register published on July 13, 2005 (70 FR 40302). A FRFA was subsequently prepared. A description of the need for and objectives of the action may be found at the beginning of this section. There are no recordkeeping or reporting requirements in this rule. No public comment was made on the IRFA.

All vessels are considered to be small entities. Therefore, there are no economic impacts resulting from disproportionality between large and small vessels. A summary of the FRFA analysis follows.

This final rule applies to all holders of Hawaii longline limited access permits. The number of Hawaii longline limited access permits is 164. Not all such permits are renewed each year (approximately 110 were renewed in 2003, 122 in 2004, and 120 in 2005) and, of those renewed, not all are used to participate in the Hawaii-based longline fishery. In a few cases, multiple permits are held by a single business, so the number of businesses to whom the rule would apply is slightly smaller than the number of affected permit holders. All holders of Hawaii longline limited access permits are small entities (i.e., they are businesses that are independently owned and operated, and have no more than $3.5 million in annual receipts). Therefore, the number of entities to which the rule would potentially apply is approximately 164.

NMFS considered a range of 25 alternatives to this final rule. Each alternative would have applied one or more seabird deterrent strategies to the fishery sectors (deep- or shallow-setting) and by area (north of 23° N. lat., south of 23° N. lat., or all areas). Alternatives that would have applied deterrent measures to both fishery sectors in all areas were rejected as not being cost-effective, given that deep-setting vessels south of 23° N. lat. average just over one (1) seabird interaction per year. Alternatives that would have required the use of an underwater setting chute were rejected as untenable based on the fact that the hardware broke when used experimentally, and likely would not withstand the rigors of routine use aboard commercial fishing vessels.

Alternatives that would have required all shallow-setting vessels to side-set in one or more areas were rejected because (1) some smaller vessels may be unable to be reconfigured for side-setting, and (2) side-setting has been subject to limited experimental testing and, although it has been very promising for reducing seabird interactions, there has been limited commercial testing of this seabird deterrent method. NMFS and the WPFMC determined that voluntary implementation of side-setting would allow the collection and analysis of additional scientific information about, and further consideration of, the value of this mitigation measure.

This rule is expected to have mixed impacts on small entities. Current seabird deterrent requirements for all vessels fishing north of 23° N. lat. are modified to require that strategic offal discards be used only when seabirds are present. Vessel operators may opt to side-set with no additional deterrents. Operators of vessels that can be easily reconfigured for side-setting may find that their operations are more efficient because (1) less bait will be taken by seabirds, thus potentially increasing fish catch rates, and (2) side-setting can improve the efficiency of fishing operations because fishing crews do not have to move the fishing gear from one location on the vessel to another between sets. Whether or not these savings will be enough to offset the initial purchase and installation cost (up to approximately $4,000) and ongoing maintenance cost (estimated at $50/year) is unknown. Operators of vessels that cannot be easily reconfigured for side-setting will have to use the currently required measures at no additional cost.

To the extent that these measures increase fish catch rates by reducing bait loss, they will have a positive economic impact, but whether or not these savings will be enough to offset the costs of the measures is unknown. Under the rule, vessels that shallow-set south of 23° N. lat. will also be subject to seabird deterrent measures. Operators of these vessels will have to use the same measures as those required when shallow setting north of 23° N. lat. Impacts on these operations are likely to be similar to those described above, but if side-setting is not feasible, vessel operators will have to invest in blue dye (estimated to cost $1,400/year), and containers for offal discards (initial cost of about $150). Again, it is not known if potential increases in catch rates due to reduced bait loss will be enough to offset the costs of these deterrent measures. However, given the already low number of seabird interactions, this seems unlikely. In addition, estimates of net revenue per vessel from a 2000 survey of the longline fishery indicate that net revenues ranged from a low of $18,208 for the average large tuna longline vessel to $385,776 for the average large swordfish longline vessel, with an average net return of $27,483 and $55,058 for all swordfish and tuna vessels, respectively. This would indicate that relative reductions in profitability from this action based on size and target species may be disproportionately distributed among vessels in the Hawaii-based longline fleet. However, there is no indication that this rule would lead to the cessation of operations of any vessel participating in this fishery.

NMFS considered several alternatives (2A through 7C in the regulatory amendment document) that would have allowed vessel owners to minimize their costs for complying with this action by giving them the opportunity to use the current seabird avoidance methods at no additional cost. In addition, a USFWS Biological Opinion (which concluded that the shallow-set longline fishery was not likely to jeopardize the continued existence of the endangered short-tailed albatross), recommended that NMFS “implement and monitor side-setting or another appropriate seabird deterrent or combination of deterrents that the USFWS [Service] agrees is at least as effective as side-setting in reducing the risks to the short-tailed albatross in the shallow-set Hawaii-based longline fishery.” Recent information suggests that the measures currently required in the shallow-set fishery (night-setting and other measures) may be as effective as side-setting, so the WPFMC reversed its initial recommendation to require the use of tori lines. The WPFMC and NMFS will continue to analyze whether the additional use of tori lines would be justified in the future.

Copies of the FRFA are available from William L. Robinson (see ADDRESSES ).

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides”. The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rule making process, a small entity compliance guide (compliance guide) will be prepared. Copies of this final rule will be sent to all holders of permits issued for the western Pacific pelagic fisheries. Likewise, the compliance guide will be distributed to permit holders and will be available at the following web site http://swr.nmfs.noaa.gov/pir . Copies can also be obtained from the PIR (see ADDRESSES ).

NMFS determined that fishing activities conducted pursuant to this rule will not affect endangered and threatened species or critical habitat in any manner not considered in prior consultations on this fishery. In a February 11, 2005, letter from W. Robinson, NMFS, to G. Shultz, USFWS, NMFS provided a description of the proposed rule and notified the USFWS that reinitiating consultation under section 7 of the ESA was not warranted for the proposed Federal action because the proposed actions are consistent with the November 2002 and October 2004 biological opinions on short-tailed albatross. The USFWS concurred with this determination in a letter dated October 20, 2005.

NMFS prepared an FEIS for this regulatory amendment. A Notice of Availability of the FEIS was published on May 6, 2005. The Record of Decision is available from William L. Robinson (see ADDRESSES ).

NMFS manages the groundfish fisheries in the EEZ off the coast of Alaska according to the Fishery Management Plan for Groundfish of the Gulf of Alaska and the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands. These fishery management plans (FMPs) were prepared by the North Pacific Fishery Management Council (Council) and approved by the Secretary of Commerce (Secretary) under authority of the Magnuson-Stevens Act, 16 U.S.C. 1801 et seq. The FMPs are implemented by regulations at 50 CFR part 679. General provisions governing fishing by U.S. vessels in accordance with the FMPs appear at subpart H of 50 CFR part 600.

The management background and explanation of the need for this action were described in the preamble to the proposed rule published in the Federal Register on September 1, 2005 (70 FR 52060). Table 2 to Part 679 provides a list of FMP species and non-FMP species on which ADF&G and NMFS Alaska Region have agreed for use on ADF&G fish tickets as well as NMFS logbooks and forms. The FMP species are those which are managed under the FMPs and which must be recorded and reported in logbooks and forms. The non-FMP species are species that are frequently caught in association with FMP species, but that are not actively managed under the FMPs. These non-FMP species may be recorded and reported in logbooks and forms.

This action may require a few participants to learn to identify individual species of rockfish. An identification guide for rockfish of the Northeastern Pacific Ocean is available from NMFS, Alaska Region (see ADDRESSES ) or at: http://www.afsc.noaa.gov/race/media/publications/archives/pubs2000/techmemo117.pdf .

The proposed rule to implement these changes was published in the Federal Register on September 1, 2005, for a 30-day comment period that ended October 3, 2005 (70 FR 52060). No written comments were received.

1. The table is reformatted from one table into four separate tables (Tables 2a, 2b, 2c, and 2d).

2. The following rockfish group codes are removed from Table 2 to part 679: 144, slope rockfish; 168, demersal shelf rockfish; 169, pelagic shelf rockfish; and 171, shortraker/rougheye rockfish. Removal of these group codes does not alter the use of the terms, ''slope rockfish,'' ''demersal shelf rockfish,'' ''pelagic shelf rockfish,'' or ''shortraker/rougheye rockfish'' in Tables 10 and 11 to 50 CFR part 679. These terms are still valid for calculation of maximum retainable percentages for basis species.

3. In § 679.2, the definition for ''Groundfish product or fish product'' is revised by removing “Tables 1 and 2 to this part, excluding the prohibited species listed in Table 2 to this part” and adding in its place ''Tables 1, 2a, 2c, and 2d to this part.''

4. In § 679.5, paragraph (m)(3)(v) is revised by removing reference to group codes 144, 168, 169, and 171.

1. The table is entitled ''Species Codes: FMP Groundfish Species.'' This table contains the names and species codes of groundfish that are managed under the FMPs and that must be recorded and reported in NMFS logbooks and forms.

2. A species code, 702, is added to Table 2a to describe the species “big skates.” NMFS has implemented separate management and harvest specifications for the species “big skates” that require a new species code (69 FR 26313, May 12, 2004). An identification guide of big skates and longnose skates is available from NMFS, Alaska Region (see ADDRESSES ) or at http://www.fakr.noaa.gov/infobulletins/2003/Rajalposter.jpg .

3. The description ''skates general,'' code 700 in Table 2a, is revised to read ''Other (if longnose or big skates - use specific species code).''

4. The description ''sharks general,'' code 689 in Table 2a, is revised to read ''Other (if salmon, spiny dogfish or Pacific sleeper shark - use specific species code).''

5. The description ''miscellaneous flatfish,'' code 120, is removed from the group codes and added to the FMP species in Table 2a as ''Flatfish, miscellaneous (flatfish species without separate codes).''

6. The Latin name for all individual rockfish species is added to Table 2a.

7. In § 679.2, paragraph (1) of the definition for ''Groundfish'' is revised by removing ''Table 2'' and adding in its place ''Table 2a.''

1. The table is entitled ''Species Codes: FMP Prohibited Species.'' This table contains the names and species codes of species that are identified as prohibited species in the FMPs and that must be recorded and reported in NMFS logbooks and forms.

2. The species name for prohibited species code 932 in Table 2b, is changed from ''Opilio tanner crab'' to read ''Tanner, snow ( C. opilio ).''

3. The species name for prohibited species code 923 in Table 2b, is changed from ''Gold/brown king crab'' to read ''King, golden (brown).''

4. In § 679.2, the definition for ''Prohibited species'' is revised by adding a reference to ''Table 2b.''

5. In § 679.5, paragraph (n)(2)(iv)(D) is revised by removing ''Table 2'' and adding in its place ''Table 2b.''

6. In § 679.21, paragraph (b)(1) is revised by removing ''see § 679.2'' and adding in its place ''see § 679.2 and Table 2b to this part.''

1. The table is entitled ''Species Codes: FMP Forage Fish Species.'' This table contains the names and species codes of species that are identified as forage fish in the FMPs and that must be recorded and reported in NMFS logbooks and forms.

2. In § 679.2, the definition for ''Forage fish'' is revised by removing ''see Table 2 to this part'' and adding in its place ''see Table 2c to this part and § 679.20(i).''

3. In § 679.20, paragraph (i)(1) is revised by removing ''see § 679.2'' and adding in its place ''See Table 2c to this part.''

1. The table is entitled ''Species Codes: Non-FMP Species.'' This table contains the names and species codes of species that may be recorded in NMFS logbooks and forms but which recording is not required by regulations at 50 CFR part 679.

2. A species code, 112, is added to Table 2d for the species, Pacific hake. Fishermen increasingly are reporting catch of Pacific hake in the EEZ off Alaska. This creates the need for a new species code to record the catch.

3. The species name for non-FMP species code 961 in Table 2d, is changed from ''Pink shrimp'' to read ''Northern (pink).''

4. The species name for non-FMP species code 951 in Table 2d, is amended by adding the Latin name “Paralomis multispina.''

5. The species name for non-FMP species code 953 in Table 2d, is amended by adding the Latin name “Paralomis verilli.”

In § 679.5, the headings for paragraphs (a)(1)(ii)(A), (B), and (C) are revised by removing “groundfish and prohibited species” and by adding in its place ''groundfish, prohibited species, and forage fish.''

In § 679.5, paragraphs (a)(1)(ii)(A), (B), and (C) are revised by removing “all groundfish and prohibited species” and adding in its place “all groundfish (see Table 2a to this part), prohibited species (see Table 2b to this part), and forage fish (see Table 2c to this part).”

This rule has been determined to be not significant for purposes of Executive Order 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. No comments were received regarding this certification or the economic impacts of the rule. As a result, a regulatory flexibility analysis was not required and none was prepared.

This rule contains collection-of-information requirements that are subject to review and approval by OMB under the Paperwork Reduction Act (PRA) and which have been approved by OMB. The collections are listed below by OMB Control Number.

Total public reporting burden for this collection is 41,219 hours. Species codes are recorded and reported in this collection.

Total public reporting burden for this collection is 1,024 hours. Species codes are recorded and reported in this collection.

Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSEES ) and by e-mail to David_Rostker@omb.eop.gov , or fax to (202) 395 7285.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

This rule does not duplicate, overlap, or conflict with other Federal regulations.